Devices, methods, and systems for analyzing a sample

Abstract

Devices, systems, and methods include a system for analyzing samples. The system may include a base, a top movably attached to the base, a sensor, and a processor. The base may be configured to hold a sample collector. The sensor may be positioned in the top and configured to sense one or more parameters related to a reactant array in fluid communication with a sample in the sample collector. The processor may be configured to receive data related to the reactant array from the sensor and analyze the data to identify one or more parameter values of the sample based on the reactant array interacting with one or more analytes of the sample.

Description

Atty. Docket No. 1519.1013111DEVICES, METHODS, AND SYSTEMS FOR ANALYZING A SAMPLECross-Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 713,805, filed October 30, 2024, the entirety of which is incorporated herein by reference.Technical Field

[0002] The present disclosure pertains to sensing and analysis tools, and the like. More particularly, the present disclosure pertains to devices and systems for sensing and analyzing samples, and methods for manufacturing and using such devices.Background

[0003] A wide variety of devices have been developed for collection, storing, sensing, and analyzing samples. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages.Brief Summary

[0004] This disclosure provides design, material, manufacturing method, and use alternatives for sensing and analysis devices. Although it is noted that collecting, storing, sensing, and analyzing approaches and systems are known, there exists a need for improvement on those approaches and systems.

[0005] An example system for analyzing samples may include a base configured to hold a sample container, a top movably attached to the base, a sensor positioned in the top, a reactant array configured to be positioned between the sensor and the sample, and a processor configured to receive data of the related to the reactant array from the sensor, and analyze the data to identify one or more parameter values of the sample based the reactant array interacting with one or more analytes of the sample.

[0006] Alternatively or additionally to any of the examples in this section, the system may include a display configured to show a status of the system, results of an analysis of the data, or both the status of the system and results of the analysis of the data.Atty. Docket No. 1519.1013111

[0007] Alternatively or additionally to any of the examples in this section, the system may include a sample container, and wherein the top is configured to move between an open position allowing placement of the sample container and a closed position for analysis of a sample in the sample container.

[0008] Alternatively or additionally to any of the examples in this section, the system may include an activator positioned in the base to accelerate expression of analytes from the sample.

[0009] Alternatively or additionally to any of the examples in this section, the activator may comprise one or more of a heater, a magnet, negative pressure, a gas supply and a mechanism to create bubbles or turbulence in the sample to aid in analyte expression from the sample.

[0010] Alternatively or additionally to any of the examples in this section, the system may include a cap configured to seal the sample container, wherein the reactant array is integrated into the cap.

[0011] Alternatively or additionally to any of the examples in this section, the cap may comprise a transparent top layer adjacent to the sensor, a transparent bottom layer adjacent to the sample, and the reactant array positioned between the top layer and the bottom layer.

[0012] Alternatively or additionally to any of the examples in this section, the bottom layer may comprise a breakable seal configured to expose the reactant array to the analyte from the sample when the breakable seal has been broken.

[0013] Alternatively or additionally to any of the examples in this section, the system may include a light source configured to illuminate the sample, wherein the processor is further configured to analyze color, turbidity, or color and turbidity of the sample based on light transmitted through the sample.

[0014] Alternatively or additionally to any of the examples in this section, the processor may be configured to identify multiple types of analytes from the sample and quantify concentrations of the identified types of the analytes.

[0015] An example method for analyzing a sample may include positioning a sample container in a base of an analysis system, closing a lid of the analysis system to position a reactant array adjacent to the sample container, capturing data from the reactant using a sensor at the lid, analyzing the data to detect changes in the reactant array caused by analytes from the sample, and identifying one or more types of analytesAtty. Docket No. 1519.1013111 from the sample based on the changes in the reactant array caused by the analytes interacting with the reactant array.

[0016] Alternatively or additionally to any of the examples in this section, the method may include activating the sample to accelerate analyte expression from the sample.

[0017] Alternatively or additionally to any of the examples in this section, activating the sample may comprise one or more of heating the sample, creating turbulence in the sample, stirring the sample, and applying gas to the sample.

[0018] Alternatively or additionally to any of the examples in this section, the method may include illuminating the sample with a light source and analyzing color, turbidity, or color and turbidity of the sample based on light transmitted through the sample.

[0019] Alternatively or additionally to any of the examples in this section, the method may include identifying multiple types of analytes from the sample and quantifying concentrations of the types of analytes identified.

[0020] An example cap for a sample container may include a transparent top layer, a transparent bottom layer with a breakable seal, and a reactant array positioned between the transparent top layer and the transparent bottom layer, wherein the cap may be configured to seal a sample container, expose the reactant array to analytes from a sample when the breakable seal is broken, and allow sensing of analyte-induced changes in the reactant array through the transparent top layer.

[0021] Alternatively or additionally to any of the examples in this section, the cap may include a tube integrated into the cap configured to introduce gas at the sample.

[0022] Alternatively or additionally to any of the embodiments in this section, the cap may include a wicking feature configured to draw the sample closer to the reactant array.

[0023] Alternatively or additionally to any of the examples in this section, the cap may include additional chemistries integrated into the cap for detecting analytes from the sample.

[0024] Alternatively or additionally to any of the examples in this section, an indicator configured to indicate exposure of the reactant array to air.

[0025] An example system for analyzing samples may include a base configured to receive a sample collector, a top movably coupled with the base, a sensor positioned inAtty. Docket No. 1519.1013111 the top and configured to sense one or more parameters related to a reactant array in fluid communication with a sample in the sample collector, and a processor configured to receive data related to the reactant array from the sensor and analyze the data to identify one or more parameter values of the sample based on the reactant array interacting with one or more analytes of the sample.

[0026] Alternatively or additionally to any of the examples in this section, the system may include a display configured to show a status of the system, results of an analysis of the data, or both the status of the system and the results of the analysis of the data.

[0027] Alternatively or additionally to any of the examples in this section, the system may include the sample collector configured to contain the sample and the reactant array may be configured to be positioned between the sample and the sensor, wherein the top may be configured to move between an open position allowing placement of the sample collector at the base and a closed position configured to allow the sensor to sense the one or more parameters related to the reactant array.

[0028] Alternatively or additionally to any of the examples in this section, the system may include a cap configured to seal the sample collector, the reactant array may be integrated into the cap.

[0029] Alternatively or additionally to any of the examples in this section, the cap may include a transparent top layer configured to face the sensor, a seal configured to face the sample, and the reactant array may be positioned between the transparent top layer and the seal.

[0030] Alternatively or additionally to any of the examples in this section, seal may be configured to expose the reactant array to the one or more analytes from the sample when the seal has been broken.

[0031] Alternatively or additionally to any of the examples in this section, the system may include an agitator configured to accelerate expression of the one or more analytes from the sample.

[0032] Alternatively or additionally to any of the examples in this section, the agitator may include one or more of a heater, a magnet, a negative pressure system, and a gas supply system.

[0033] Alternatively or additionally to any of the examples in this section, the system may include a light source configured to illuminate the sample, wherein theAtty. Docket No. 1519.1013111 processor may be configured to analyze color, turbidity, or color and turbidity of the sample based on light transmitted through the sample.

[0034] Alternatively or additionally to any of the examples in this section, the processor may be configured to identify multiple types of analytes from the sample and quantify concentrations of the types of the one or more analytes.

[0035] Alternatively or additionally to any of the examples in this section, an example sample sensing system may include a cap configured to couple with a sample container, the cap comprising a transparent top layer, a seal, and a reactant array positioned between the transparent top layer and the seal, the cap may be configured to seal the sample container, expose the reactant array to analytes from a sample when the seal is broken, and allow sensing of analyte-induced changes in the reactant array through the transparent top layer.

[0036] Alternatively or additionally to any of the examples in this section, the cap may include a first component comprising a first end, a second end, a through-hole, and a first connector, wherein the seal extends across the through-hole and a second component having an extension portion with a protrusion, the second component configured to couple with and adjust relative to the first component, the second component may have a first configuration relative to the first component in which the second component is coupled with the first component, the protrusion is proximal of the seal, and the reactant array is configured to be fluidly isolated from the analytes in the sample container, and the second component may have a second configuration relative to the first component in which the second component is coupled with the first component, the extension portion extends through the seal, and the seal is broken to allow fluid to reach the reactant array.

[0037] Alternatively or additionally to any of the examples in this section, the first component may be configured to engage the sample container.

[0038] Alternatively or additionally to any of the examples in this section, the second component may be configured to be uncoupled from the sample container in the first configuration and coupled with the sample container in the second configuration.

[0039] Alternatively or additionally to any of the examples in this section, the sample container may be configured to receive the first component within the sample container and engage the second component when the second component is in the second configuration.Atty. Docket No. 1519.1013111

[0040] Alternatively or additionally to any of the examples in this section, the reactant array may be angled at 150 degrees relative to a plane parallel to the transparent top layer.

[0041] Alternatively or additionally to any of the examples in this section, the seal is a perforated closed cell foam.

[0042] An example method of analyzing a sample may include positioning a sample collector in a base of an analysis system, engaging a top component of the analysis system with a cap of the sample collector to place a reactant array in the cap in fluid communication with fluid in a sample container of the sample collector, capturing data from the reactant array using a sensor of the analysis system, analyzing the data to detect changes in the reactant array caused by analytes from the sample, and identifying one or more types of analytes from the sample based on the changes in the reactant array caused by the analytes interacting with the reactant array.

[0043] An example method of analyzing a sample may include engaging a top component of an analysis system with a cap of a sample collector to place a reactant array in the cap in fluid communication with fluid in a sample container of the sample collector, capturing data from the reactant array using a sensor of the analysis system, analyzing the data to detect changes in the reactant array caused by analytes from the sample, and identifying one or more types of analytes from the sample based on the changes in the reactant array caused by the analytes interacting with the reactant array.

[0044] Alternatively or additionally to any of the examples in this section, identifying one or more types of analytes from the sample may include identifying multiple types of analytes from the sample, and the method include quantifying concentrations of the multiple types of analytes identified.

[0045] Alternatively or additionally to any of the examples in this section, engaging the top component of the analysis system with the cap on the sample container may be configured to break a seal fluidly isolating the reactant array from the fluid in the sample container to place the reactant array in fluid communication with the fluid in the sample container.

[0046] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.Atty. Docket No. 1519.1013111Brief Description of the Drawings

[0047] The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:

[0048] FIG. l is a schematic diagram of an illustrative sensing system;

[0049] FIG. 2 is a schematic diagram of an illustrative computing system;

[0050] FIG. 3 is a schematic perspective view of an illustrative sensing system in a first configuration;

[0051] FIG. 4 is a schematic perspective view of the sensing system of FIG. 3 in a second configuration;

[0052] FIG. 5 is a schematic perspective view of an illustrative sensing system in a second configuration;

[0053] FIG. 6 is a schematic perspective view of an illustrative sensing system in a first configuration;

[0054] FIG. 7 is a schematic front view of the sensing system depicted in FIG. 6;

[0055] FIG. 8 is a schematic side view of the sensing system depicted in FIG. 6;

[0056] FIG. 9 is a schematic perspective view of the illustrative sensing system depicted in FIG. 6 in a second configuration;

[0057] FIG. 10 is a schematic perspective view of an illustrative sensing system in a first configuration;

[0058] FIG. 11 is a schematic perspective view of the sensing system depicted in FIG. 10 with the door in a second configuration;

[0059] FIGS. 12-16 depict schematic views of steps in an illustrative method of analyzing a sample;

[0060] FIG. 17 is a schematic diagram of an illustrative sample collector;

[0061] FIG. 18 is a schematic perspective view of an illustrative sample collector in a second configuration;

[0062] FIG. 19 is a schematic cross-section of the illustrative sample collector depicted in FIG. 18 in a first configuration; and

[0063] FIGS. 20 and 21 depict schematic cross-section views of the illustrative sample collector depicted in FIG. 18 in an illustrative method of using a sample collector.

[0064] While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and willAtty. Docket No. 1519.1013111 be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.Atty. Docket No. 1519.1013111Detailed Description

[0065] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

[0066] The term “fluid” is inclusive of both liquids and gases.

[0067] All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure.

[0068] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0069] As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and / or” unless the content clearly dictates otherwise.

[0070] It is noted that references in the specification to “a configuration”, “some configurations”, “other configurations”, etc., indicate that the configuration described may include one or more particular features, structures, and / or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and / or characteristics. Additionally, when particular features, structures, and / or characteristics are described in connection with one configuration, it should be understood that such features, structures, and / or characteristics may also be used in connection with other configurations whether or not explicitly described unless clearly stated to the contrary.

[0071] The following detailed description should be read with reference to the drawings in which similar structures in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure. Additionally, it should be noted that in any given figure, some features may not be shown, or may be shown schematically, for clarity and / or simplicity. Additional details regarding some components and / or method steps may be illustrated in other figures in greater detail. The devices and / or methods disclosed herein may provide a number of desirable features and benefits as described in more detail below.Atty. Docket No. 1519.1013111

[0072] Fluids with concentrations of volatile compounds (e.g., volatile organic compounds (VOCs)), non-volatile compounds, and / or gasses, which may or may not be hazardous, may be sensed, analyzed, and / or monitored. Sensing, analyzing, and / or monitoring of fluids with analytes (e.g., non-volatile or volatile compounds, gases, liquids and / or other fluids) may utilize absorption and / or reflectance measurements of reactants exposed to such fluids for any purpose including, but not limited to, diagnostic purposes, hazard warning purposes, manufacturing processes or quality control purposes, record keeping purposes, archival purposes, product development purposes, product-consumer matching purposes, etc.

[0073] VOCs and / or gasses may be present in ambient fluid (e.g., ambient air, etc.) and sensed, analyzed, and / or monitored using reactants for real-time alarms, to treat subjects, or to collect and / or archive data for health records, regulatory compliance records, etc. Further, VOCs and / or gasses exhaled or emitted, metabolized, excreted, emanated, released, and / or secreted from a subject (e.g., humans, animals other than humans, food, produce, meat, alcohol, pathogens, bacteria (e.g., good and / or bad bacteria), plants, wounds, ulcers, surgical sites, skin of a subject, mouth of a subject, nasal passages of a subject, sinuses of a subject, rectum area of a subject, urinary tract of a subject, vaginal area of a subject, genitals area of a subject, ear canals of a subject, pores of a subject, etc.) may be sensed, analyzed, and / or monitored to assess hazardous, dangerous, illegal substances, or conditions in or at the subject or target site, a condition of lungs of a subject, a condition of a blood disease, a condition of a urinary tract, a condition of infections, conditions related to diseases or biological conditions, conditions related to general health, conditions related to food flavors, conditions related to perfumes or smells, and / or other suitable conditions.

[0074] The systems discussed herein for sensing, analyzing, and / or monitoring fluids (e.g., for analytes of interest) may be configured to accurately detect and record a reactant array (e.g., a reactant array of a colorimetric sensor array (CSA) or other suitable reactant array) response (e.g., spectral response) to exposure to the fluids. The systems may utilize techniques for non-invasively detecting one or more analytes of interest (e.g., one or more pathogens responsible for specific human skin infections including, but not limited to, skin infections, urinary tract infections (UTIs), sinusitis, endometriosis, vaginitis, wound infections, ulcers, etc., and / or other suitable analytes) from a fluid using a reactant array to allow for early detection of and early implementation of protocols to address one or more conditions associated with anyAtty. Docket No. 1519.1013111 sensed analytes of interest. In one example, enhanced classification of one or more analytes using the systems described herein may enable detection and identification of responsible pathogens at the very beginning stages of a bodily infection, which may result in a high level of protection and probability of a favorable outcome for subjects. In one example, enhanced classification of one or more analytes using the systems described herein may enable detection and identification of responsible pathogens at the very beginning stages of a urinary tract infection, which may result in providing a precise treatment for treating the identified pathogens and a high level of protection and probability of a favorable outcome. In another example, enhanced classification of one or more analytes using the systems described herein, may enable the detection and identification of pathogens, diseases, therapeutics, that they themselves do not produce analytes (e.g., viruses, antibiotics, blood cells, Parkinsons, MS etc.), but are inferred, correlated, and / or connected to the affect they have on the metabolism of the subject (e.g., the organism, pathogen, human body, organs, etc.)

[0075] The systems, devices, and methods for analyzing samples discussed herein may be configured to detect and / or identify analytes associated with the samples. Traditional approaches to sample analysis often require time-consuming laboratory cultures, sophisticated and expensive laboratory equipment, or rely on less accurate rapid tests. These approaches can lead to delayed diagnosis and treatment and / or potential misdiagnosis or incorrect treatments.

[0076] The disclosed systems and methods for analyzing samples address challenges of traditional sample analysis approaches by providing a system that is simple to use, while providing complex analysis of analytes from a sample. In some examples, the system and methods utilize one or more reactant arrays (e.g., one or more colorimetric sensor arrays (CSAs)) that interact with analytes (e.g., volatile or nonvolatile organic compounds, etc.) from a sample.

[0077] A system for analyzing samples (e.g., a reactant array or CSA analysis system) may include a reactant array (e.g., a CSA having a reactant array) and / or a reader device for reading or otherwise analyzing the reactant array before, during, and / or after the reactant array is exposed to a fluid. The reader device may be or may include one or more light or image sensors, and / or other suitable image or light collectors / sensors. In some instances, the reader device may be configured to be a handheld device, a benchtop device, and / or a module for integration into other equipment and / or devices or systems. Further, the reader device may be configured toAtty. Docket No. 1519.1013111 be simple to use, minimize human error, reduce cross contamination of samples, and reduce human risk of exposure to analytes received at the device.

[0078] The disclosed systems may include, among other suitable systems and / or components, a system having a base configured to hold a sample container and a movable lid or top, which may or may not be mechanically coupled with the base. In some examples, the top may be configured to move, relative to the base, between a first configuration (e.g., an open position) for sample placement and a second configuration (e.g., a closed position) for sensing and / or analysis, simplifying the sample testing process. In some examples, the base may be omitted.

[0079] The disclosed systems may include, among other suitable components, a drawer, a door, and / or an opening in or through which a sample container may be positioned. In some examples, the system may be fully enclosed within the movable drawer, base, and / or opening. In some examples and when the system includes the drawer or door, the drawer or door may be opened for sample placement through an opening and closed for analysis. In some examples and when the system includes the opening, the opening may provide an access location for the sample to be placed into the system for analysis.

[0080] A sensor (e.g., an optical sensor or other suitable light or imaging sensor) may be positioned in the top or at the top component of the system, which may facilitate precise imaging of or light capturing from a reactant array exposed to the sample (e.g., exposed to analytes from the sample). Although the sensor may be described as being in a top component, the sensor may be at other suitable locations of the reader device 14.

[0081] The reactant array may be designed to be positioned between the sensor and the sample container. In one example, the reactant array may be integrated into a cap for the sample container. The cap and the sample container may be part of a sample sensing system or sample collection system. In some examples, the cap and the sample container may be or may be part of a sample collector of the sample sensing system or sample collection system.

[0082] The cap for the sample container may have any suitable configuration. In some examples, the cap may include the reactant array, a top layer configured to be between the reactant array and the optical sensor, and a bottom layer configured to be between the sample and the reactant array (e.g., the reactant array may be positioned between the top layer and the bottom layer). In one example, the top layer of the capAtty. Docket No. 1519.1013111 may be transparent or opaque. In one example, the bottom layer of the cap may be transparent or opaque and may include one or more openings (e.g., holes, slots, perforations, etc.) that allow analytes from the sample to cross the bottom layer and permeate or otherwise interact with the reactant array.

[0083] The bottom layer may be or may incorporate a breakable seal, which, when broken, allows the reactant array to be exposed to the analytes from the sample. Alternatively or additionally, a seal of the cap may be separate from the bottom layer. In some examples, the seal may be a breakable seal configured to be located between the bottom layer and the sample. In some examples, the seal may be an adjustable seal between the bottom layer and the sample. Including a seal in the cap may ensure the reactant array remains unexposed to analytes and an ambient condition until the moment of analysis, preserving its sensitivity and accuracy. Utilizing an adjustable seal may allow for automatic resealing of the cap if or when the cap is removed from the sample container after exposure of the reactant array to analytes of or from the sample. Other suitable configurations of the cap are contemplated.

[0084] To improve the system's versatility and effectiveness, additional features may be incorporated into the cap design. For example, the cap may include a wicking feature to draw a sample or fluids from a sample closer to the reactant array, chemistries in addition to the reactant array for detecting non-volatile components and / or other suitable analytes in the sample, indicators to show if the reactant array has been previously exposed to air or other gases, chemistries or reagents (e.g., NaCl, reactive dye, etc.) contained within the cap that may be released into / onto the sample to aid in detection of analytes, and / or other suitable features and / or components.

[0085] To enhance the detection of analytes by the reactant array, the system may include one or more features or components (e.g., one or more agitators) configured to accelerate expression of the analytes from the sample. Example suitable features or components configured to accelerate expression of the analytes from the sample include, but are not limited to, a heater (e.g., a contact or non-contact heater) positioned (e.g., in the base, sides, and / or at one or more other suitable location) to warm the sample, components configured to create negative pressure in a sample container, mechanisms to create bubbles, turbulence, and / or cavitation in the sample, a magnetic system to stir the sample, a stir stick to stir the sample, a fluid source to create bubbles and / or turbulence in the sample, wavelengths of light to accelerate bacterial growth rate, and / or other suitable sample agitation mechanisms. Some configurations of theAtty. Docket No. 1519.1013111 system may include a magnetic stirring mechanism or other suitable stirring mechanism and / or a tube integrated into the cap to introduce fluid into the sample container and / or create bubbles.

[0086] The system may include a processor (e.g., one or more processors) configured to receive data (e.g., image data, light data, and / or other suitable data) related to the reactant array from the sensor and analyze this data to identify pathogens in the sample based on the VOCs detected by the reactant array. Advanced algorithms may be saved in memory of the system and executed by the processor to allow the system to identify multiple types of pathogens and quantify their concentrations, providing a comprehensive analysis of the sample.

[0087] In addition to analyte detection, the system may incorporate one or more features and / or components for broader sample analysis and identification. In some examples, an illumination sensor that may include an illumination source that may be utilized to illuminate the sample, allowing the processor to analyze the volume, color, and / or turbidity of the sample based on light transmitted through the sample and sensed by the illumination sensor. Other suitable features and / or components for analyzing and identification of a received sample are contemplated.

[0088] The system may include a display. For example, the display may be configured to show a status of the system, test results, and / or other suitable information. In some examples, the display may be located on the top component and / or proximate an outer surface of the system, but other suitable configurations are contemplated.

[0089] The systems and methods may include a technique for analyzing urine samples using the system. The technique may include positioning the sample container containing a urine sample in the base, closing a top on the sample container to position, expose, and / or align a reactant array relative to the sample and / or relative to one or more sensors, capturing image data and / or light data of or from the reactant array, analyzing the data captured to detect analyte-induced changes in the reactant array, and identifying types of analytes based on the changes detected. Although systems described herein may be described with response to sensing analytes from a sample of urine, analytes from other suitable samples may be analyzed and / or identified.

[0090] The systems and methods discussed herein provide advantages over traditional methods for sample analysis. The disclosed concepts for analyzing samples may provide results in a short time period (e.g., within 10 minutes or less of exposure to a sample and / or other suitable time period) and may facilitate quick diagnoses andAtty. Docket No. 1519.1013111 treatment decisions. The system may be configured to detect and identify multiple types of analytes simultaneously, quantify concentrations of detected types of analytes, and make assessments of the sample based on the types and concentrations of analytes identified, which results in a comprehensive sample analysis.

[0091] Turning to the Figures, FIG. 1 depicts a schematic diagram of an illustrative system 10 for analyzing a sample. Among other components the system 10 may include a reader device 14 and a sample collector 12 having a reactant array 16, where the reader device 14 may be configured to monitor and / or analyze the reactant array 16 (e.g., a device for analyzing a CSA or reactant array 16). In some examples, although the reactant array 16 is depicted in FIG. 1 as being part of the sample collector 12, the reactant array 16 may be incorporated into one or both of the sample collector 12 and the reader device 14. Although illustrative sizes, shapes, and configurations of the sample collector 12, the reader device 14, and components thereof are discussed herein and depicted herewith, the sample collector 12, the reader device 14, and the components thereof may have any suitable shape, orientation, size, and / or configuration.

[0092] The sample collector 12 may have any suitable configuration and may include any suitable components configured to facilitate receiving a sample, sensing analyte(s) of or from the sample, and interfacing with the reader device 14. Example components of the sample collector 12 include, but are not limited to, one or more reactant arrays 16, one or more containers configured to receive the sample, one or more caps or covers configured to cover the container, one or more agitator components, and / or one or more other suitable components and / or configurations. Components that the sample collector 12 may include but may not be depicted in FIG. 1 include, but are not limited to, a housing, one or more agitators, a window for viewing the reactant array 16, one or more compartments, one or more gaskets or other features for hermetically sealing the one or more compartments or the container, one or more access openings extending between the compartments and exterior of the housing, one or more seals, valves, caps (e.g., snap caps, screw caps, plug caps, etc.), foil, pierceable membranes, etc. configured to seal the container, one or more doors or lids, one or more motors for pumping fluid to the reactant array 16, tubing, one or more filters, one or more diaphragms or membranes, one or more single-use indicators, and / or other suitable components.Atty. Docket No. 1519.1013111

[0093] Although not depicted in FIG. 1, the sample collector 12 may include a first component such as the sample container and a second component such as the cap configured to cover the sample container. In some examples, the first component and / or the second component may be configured to entirely or at least partially enclose or house the reactant array(s) 18. The sample collector 12 may be a single component with one or more closable openings between the sample container and the cap and / or a plurality of components configured to couple together and seal the sample within the sample container and the cap.

[0094] The sample collector 12 may be formed in any suitable manner. In some examples, the sample collector 12 may be formed with one or more molding techniques, injection molding techniques, welding techniques, ultrasonic welding techniques, three-dimensional (3D) printing techniques, and / or other suitable techniques.

[0095] The sample collector 12 may be formed from any suitable material. Example suitable materials include, but are not limited to, polymers, metals, glass, fabrics, and / or other suitable types of materials.

[0096] The sample collector 12 may have any suitable shape and / or size configured to receive a sample, seal a sample therein, and facilitate analyzing the reactant array 16 exposed to analytes from the sample in the sample collector 12 using the reader device 14. For example, the sample collector 12 may have a cube shape, an elongate shape, a rectangular shape, an oval shape, a rounded shape, a circular shape, a ball shape, a cylinder shape, a globe shape, a cup shape, and / or other suitable shape.

[0097] The reactant array 16 may be any suitable array of one or more reactants (e.g., analyte sensitive material) and the reactants of the reactant array 16 may be formed from any suitable material. In some examples, the reactant array 16 may be part of or may form a colorimetric sensor array (CSA). The sample collector 12 may be configured to entirely or at least partially house or enclose the reactant array 16 (e.g., house the CSA including the reactant array 16).

[0098] The material of the reactants of the reactant array 16 may be reversible (e.g., reusable), semi-reversible, or non-reversible (e.g., single use). In some examples, the material of the reactants may be an optically responsive chemical material (e.g., a chemoresponsive material) that changes color in response to detecting one or more analytes (e.g., volatile compounds, gases, liquids, and / or other fluids) in a fluid to which the reactants are exposed, but other suitable material is contemplated. Example suitable materials for reactants include dyes from, but not limited to, the following classes:Atty. Docket No. 1519.1013111Lewis acid / base dyes (e.g., metal containing dyes), Brensted acidic or basic dyes (e.g., pH indicators), dyes with large permanent dipoles (e.g., solvatochromic dyes), redox responsive dyes (e.g., metal nanoparticle precursors), and / or other suitable classes of dyes. One example material for the reactants may be a silver nanoparticle material. Other suitable materials for the reactants are contemplated, including reactant material other than a printed dye or an optically responsive chemical material.

[0099] The reactants of the reactant array 16 may be applied to a substrate. When the reactant array 16 forms or is otherwise part of a CSA, the substrate may or may not be part of the CSA. Additionally or alternatively, the substrate may be or may include the sample collector 12 (e.g., the sample container, the cap, a middle layer of the cap, a bottom layer of the cap, etc.) or a component configured to be received in the sample collector 12.

[0100] The reactants of the reactant array 16 may be applied to a substrate in any suitable manner. In one example, the reactants may be applied to the substrate by printing the reactants (e.g., the material of the reactants) on the substrate. When printed, any suitable printing techniques may be utilized including, but not limited to, pin transfer, inkjet, silkscreen, and / or other suitable application techniques.

[0101] The reactants of the reactant array 16 may be applied to the substrate randomly and / or to form one or more patterns. Example configurations of the reactants of the reactant array applied to the substrate include, but are not limited to, grid patterns of rows and columns, concentric rings, color matching of a color of printed dye material with a color of a substrate material prior to interactions with analyte, patterns that result in identifiable shapes when the analyte sensitive material reacts to a particular analyte, other suitable configurations, and / or combinations thereof.

[0102] The reactant array 16 may include a single-use component configured to prevent contamination due to reuse of the reactant array 16 and / or prior exposure of the reactant array 16 to the ambient. In some examples, the single-use component may be a mechanical, electrical, electromechanical, optical, chemical, magnetic, and / or other suitable type of single-use feature that changes in response to being used with a singleuse or reusable reader device 14 for analyzing the reactant array 16 or in response to exposure to one or more conditions. In one example of a single-use component for the reactant array 16, an electronic single-use component may be imbedded within the reactant array 16 and either recognized by the reader device 14 as being intact or broken to indicate whether the reactant array 16 is new or has been used (e.g., been exposed toAtty. Docket No. 1519.1013111 the ambient), respectively. Example electronic single-use components include, but are not limited to memory devices, radio-frequency identification (RFID) devices, fuses, and / or other suitable electronic single-use components. When a memory device is used as a single-use component of the reactant array 16, the memory device may be accessed by the reader device 14 and modified by the reader device 14 after the reactant array 16 has been exposed to ambient fluid, used with the sample collector 12, and / or used with the reader device 14. When a fuse is used as a single-use component, the fuse may be broken (e.g., via excessive current or in other suitable manners) after the after the reactant array 16 has been exposed to ambient fluid, used with the sample collector 12, and / or used with the reader device 14, where the reader device 14 may be configured to identify the broken fuse and the reactant array 16 with the broken fuse may be prevented from being used in a subsequent analysis. Further, the single-use component may be or may include at least one visual indicator that may change state after the reactant array 16 has been exposed to ambient fluid, used with the sample collector 12, and / or used with the reader device 14 and that may be captured by an image capture sequence of the reader device 14, where the reader device 14 may prevent use of the reactant array 16 (e.g., stop analysis of a sample or test) if it determines from the indicator that the reactant array 16 has been used.

[0103] The sample collector 12 may include one or more compartments configured to receive the sample. The one or more compartments of the sample collector 12 may be entirely or at least partially defined by a housing of the sample collector 12. In some examples, the sample collector 12 may include a housing defining a single compartment or a plurality of compartments. In one example, the housing of the sample collector 12 may define the first component with a cup configuration having a single compartment. Other suitable configurations of the sample collector 12 are contemplated.

[0104] The one or more compartments of the sample collector 12 may include any suitable configuration of compartments. For example, the compartments may define a fluid path from a location of the a sample to the reactant array 16, may be a single compartment configured to include the reactant array 16 and receive the sample, may be or include a plurality of compartments fluidly coupled to allow fluid to pass between a location of the sample within the sample collector 12 and a location of the reactant array 16, and / or the compartment(s) may have one or more other suitable configurations. Although not depicted, the one or more compartments may be or may include one or more tubes defining at least part of a fluid path from a location of theAtty. Docket No. 1519.1013111 sample to the reactant array 16. When the sample collector 12 includes a plurality of compartments, one or more of the compartments may contain a reagent or other suitable element to interact with the sample in the sample collector 12, which may facilitate analyzing the sample and / or analytes from the sample. Example suitable reagents include, but are not limited to, NaCl, gram stain agents, fluorescent binder, lysostaphin, modified lysostaphin, and / or other suitable reagents.

[0105] One or more seals and / or valves may be located at or in the sample collector 12. The seals and / or valves may be configured to fluidly seal (e.g., hermetically seal) the sample within the sample collector 12 and / or fluidly isolate the reactant array 16 from the sample. In some examples, the sample collector 12 may include a housing defining the cup and the cap configured to couple with the cup, where the sample collector 12 includes a seal between the first component and the cap, a seal on the cup configured to seal with the sap, a seal on the cap that is configured to seal with the cup, and / or other suitable seals.

[0106] The one or more seals and / or valves may be or include a single valve (e.g., a check valve and / or other suitable type of valve) or multiple valves, which may be located across a fluid path between the sample in the sample collector 12 and the reactant array 16. The one or more valves may include a slit or other access location biased closed and that may be opened in response to engagement with the cap of the sample collector 12. When the second component or a component in communication with the second component extends through the valve, the valve may be configured to allow fluid to pass therethrough between the sample and the reactant array 16, but other suitable configurations are contemplated.

[0107] Alternatively or additionally to utilizing valves, one or more seals (e.g., a gasket, a rubberized layer, a single-use seal, such as a foil seal, a burstable membrane, a peel-away seal, and / or other suitable seals) may be utilized at or proximate an interface between the cup and the cap of the sample collector 12 to seal fluid in the sample collector 12 and isolate fluid on a first side of the seal from fluid on a second side of the seal. In some examples, a single-use seal may extend across an opening or pathway between the cup and the cap of the sample collector 12 to isolate the reactant array 16 from the fluid from the sample and may be pierced or broken in response to coupling the cap with the cup of the sample collector 12.

[0108] The sample collector 12 may include one or more filters in the fluid pathway the sample and the reactant array 16. When the sample collector 12 includes the cupAtty. Docket No. 1519.1013111 and the cap, the one or more filters may be located in the cup and / or in the cap. In some examples, the one or more filters may be configured to remove undesirable molecules from the fluid passing through the fluid pathway and allow desirable molecules to pass through the filter(s). In some examples, the one or more filters may be configured to interact with particular molecules to enhance reactivity of the reactant array 16 with the fluid passing through the pathway and / or to alter incoming fluid and / or analytes thereof into different constituents for greater sensitivity at the reactant array 16.

[0109] The filter(s) may be sized, shaped, doped, and / or impregnated with different constituents, and / or otherwise configured differently to address filtering out different molecules. Some variables that may be adjusted to configure the filter include, but are not limited to, material of the filter, pore sizes in the filter, pore concentrations in the filter, pore locations in the filter, etc.

[0110] The sample collector 12 may include a single-use component configured to prevent contamination due to reuse of the sample collector 12 and / or prior exposure of the reactant array 16 to the ambient. In some cases, the single-use component may be a mechanical, electrical, electromechanical, optical, chemical, magnetic, and / or other suitable type of single-use feature that changes in response to being used with a singleuse or reusable reader device 14 for analyzing the reactant array 16 or in response to exposure to one or more conditions. In one example of a single-use component for the sample collector 12, an electronic single-use component may be imbedded within the sample collector 12 and either recognized by the reader device 14 as being intact or broken to indicate whether the sample collector 12 is new or has been used, respectively. Example electronic single-use components include, but are not limited to memory devices, radio-frequency identification (RFID) devices, fuses, and / or other suitable electronic single-use components. When a memory device is used as a singleuse component of the sample collector 12, the memory device may be accessed by the reader device 14 and modified by the reader device 14 after the sample collector 12 has been used with the reader device 14. When a fuse is used as a single-use component, the fuse may be broken (e.g., via excessive current or in other suitable manners) after the reader device 14 analyzes the reactant array 16, where the reader device 14 may be configured to identify the broken fuse and the sample collector 12 with the broken fuse may be prevented from being used in a subsequent analysis. Further, the single-use component may be or may include at least one visual indicator that may change state after use in the reader device 14 and that may be captured by an image capture sequenceAtty. Docket No. 1519.1013111 of the reader device 14, where the reader device 14 may prevent use of the sample collector 12 if it determines from the indicator that the sample collector 12 has been used.[oni] In some cases, the sample collector 12 or ports of the sample collector 12 may be reusable. For example, in instances when the reactant array 16 and / or other components of the sample collector 12 that may be spent or contaminated with a sample or fluid from the sample (e.g., a liner, a filter, the cup, the cap, etc.), the reactant array 16 and / or other spent or contaminated components of the collector 12 may be removed from the sample collector 12 and the remaining components of the sample collector 12 may be reused after cleaning, as needed. In some cases, the reactant array 16 may include reversible reactant material and the reactant array 16 may be reused with other components of the sample collector 12.

[0112] Although the sample collector 12 may include a single fluid pathway extending between sample therein and to, through, and / or over the reactant array 16, the sample collector 12 may include a plurality of fluid pathways that are each configured to bring fluid to a same or different reactant array 16. In one example, the sample collector 12 may include a first fluid pathway extending between the sample a first reactant array 16, along with up to an nth (e.g., an integer number greater than one and all integers between one and the nth number) fluid pathway extending between the sample and an nth reactant array 16 in the nth fluid pathway.

[0113] The sample collector 12 may be configured to directly receive the sample or the sample may be obtained with a specimen component and then placed in the sample collector 12. The specimen component may be configured to collect and / or provide a sample from a target area or fluid from the sample or target area to the sample collector 12, where the sample or target area may be or may be configured to exude analytes. In some examples, the specimen component may be a carrier (e.g., a container, a compartment, etc.) configured to receive the sample, a specimen (e.g., swabs, swabs on a stick, sponges, sample plates, pipette, capsule containing the specimen, biopsy, test strips, etc.) configured to collect a sample from a target area, a collector configured to collect fluid (e.g., fluids containing analytes) from a target area, a concentrator, and / or other suitable components configured to provide sample or fluid from a sample to the cartridge. In some examples, the specimen component may include or may be coupled with tubing configured to transport fluid from the specimen component or target area to the sample collector 12, but other suitable configurations are contemplated.Atty. Docket No. 1519.1013111

[0114] The reader device 14 may include one more suitable components for reading and / or analyzing the reactant array 16. Example suitable components of the reader device 14 include, but are not limited to, one or more housings 18, one or more sample receptacles 20, one or more agitators 22, one or more illumination sensors 24, one or more imaging systems 26, one or more light or image sensors 28, one or more optical components or lenses 30, one or more illumination sources 32, one or more controllers 34, one or more user interfaces 36, one or more sample collector detectors configured to detect a presence of the sample collector 12 and / or a sample at the reader device 14, one or more motors, one or more pumps, one or more buttons, one or more displays, one or more light blockers, and / or other suitable components. In some examples, the reader device 14 may be a bench top device or a handheld device, each configured to be used with the sample collectors 12 discussed herein or otherwise and / or to analyze the reactant arrays 16 thereof or in fluid communication therewith. In some examples, the reader device 14 may be isolated from the sample and / or fluid from the sample in the sample collector 12 and may be configured for reuse. Although various components are depicted as being included in the reader device 14, one more of the depicted components may be omitted and / or one or more additional or alternative components may be utilized.

[0115] The reader device 14 may be powered with any suitable power source. Example suitable power sources for powering the reader device 14 include, but are not limited to, battery power in the reader device 14, solar power at the reader device 14, wall or line power, and / or other suitable power sources.

[0116] The housing 18 may be configured to house all or one or more of the components of the reader device 14. In some examples, the housing 18 may be omitted.

[0117] The sample receptacle 20 may have any suitable configuration configured to receive the sample collector 12. In some examples, the sample receptacle 20 may be or may include a base and / or a top configured to receive or hold the sample collector 12 (e.g., a sample container of the sample collector 12). In some examples, the sample collector 12 may be configured to receive the sample collector 12 and align the sample collector 12 with the imaging system 26. For example, the base and the top may be movable relative to one another so as to receive the sample collector 12 and then engage the sample collector 12 to align the sample collector with the imaging system 26 to facilitate imaging or obtaining light from the reactant array 16.Atty. Docket No. 1519.1013111

[0118] The agitator 22 may be any suitable component configured to agitate the sample or fluid from the sample within the sample collector 12 to accelerate expression of one or more analytes from the sample. For example, the agitator 22 may include one or more of a heater, a magnet, a pressurized system (e.g., a negative and / or positive pressure system), a gas supply system, a stirring component, a vibration component, an illumination component (e.g., which may be the illumination components discussed herein and / or a separate component) configured to provide wavelengths of light to the sample, and / or other suitable component configured to agitate the sample and / or fluid from the sample within the sample collector 12. In some examples, when the agitator 22 comprises a heater, the heater may be located in the base at the sample receptacle, but other suitable locations of the heater within or at the reader device 14 are contemplated. In some examples, when the agitator 22 comprises a magnet, a magnetic component may be placed in the sample collector 12, the sample collector 12 may be placed on base of the sample receptacle 20, and the magnet in the base of the sample receptacle 20 may be moved to move the magnetic component in the sample collector 12 and mix or stir the sample.

[0119] The agitator 22 may include a pump or at least one or more pumping components. In some cases, the pump or at least one or more pumping components may be fluidly isolated from the sample and fluid within the sample collector 12. Alternatively or additionally, the pump or at least one or more pumping components may be in fluid communication with the fluid and / or the sample within the sample collector 12.

[0120] The pumping components may be any suitable components configured to facilitate agitating the sample within the sample collector 12 to accelerate expression of analytes from the sample. Example suitable pump components include, but are not limited to, a flexible diaphragm or portion of tubing defining the sample collector 12, a flexible diaphragm, an impeller, a bellows, a propeller, an Archimedes screw, a piezoelectric mechanism, a plunger, a piston, an axel or extension, a coupler for coupling with other pump components, and / or other suitable pump components. In some configurations, the pump component may be a driven component configured to be driven by a drive component of the reader device 14. For example, a driven component (e.g., an impeller, propeller, Archimedes screw, piezoelectric mechanism, plunger, and / or other suitable driven component) may be integrated into the sample collector 12 and configured to engage with a drive component of the reader device 14Atty. Docket No. 1519.1013111(e.g., a motor, an actuator, a drive shaft, etc.) In some examples, an axle defining or in communication with the driven component of the sample collector 12 may protrude from the sample collector, while keeping a hermetic seal around the sample and fluid in the sample collector 12, and engage a motor or drive shaft of the motor (e.g., a drive component) in the reader device 14 that may be configured to drive (e.g., rotate) the axle and move the driven component of the sample collector 12. Additionally or alternatively, the sample collector 12 may include a mechanical (e.g., flexible diaphragms manually or automatically actuated, etc.), electrical (e.g., metallic or other suitable electrically conductive components), and / or magnetic contacts that engages (e.g., directly or indirectly) an associated mechanical, electrical, and / or magnetic contact on the reader device 14 such that the driven component of the sample collector 12 may be actuated in response to engagement of the respective contacts and / or signals passing between the contacts. Such mechanical, electrical, and / or magnetic contacts may allow for avoiding a leak point at an opening of the cartridge through which an axle, for example, may extend.

[0121] The illumination sensor 24 may be any suitable component configured to assess the presence or positioning of the sample collector 12 and / or one or more parameters related to the sample within the sample collector 12. In some examples, the illumination sensor 24 may be located in or proximate the base of the sample receptacle 20 at an interface for engaging the sample collector 12. The illumination sensor 24 may include a light source configured to transmit light through the sample in the sample collector 12 and a sensor of the illumination sensor 24 may sense light from the transmitted light passed through the sample and assess features of the sample (e.g., color, turbidity, particles, contents of the sample or identify the sample (e.g., via an artificial intelligence (Al) analysis, learning models, neural networks, and / or traditional algorithms), etc.) In some examples, the sensor of the illumination sensor 24 may be in a top component of the reader device 14 and / or at one or more other suitable locations. In some examples, the controller 34 or other suitable computing device may be configured to analyze data sensed by the illumination sensor 24 to analyze color, turbidity, or color and turbidity of the sample in the sample collector 12 based on light transmitted through the sample.

[0122] The reader device 14 may include one or more light blockers configured to prevent or mitigate ambient or unintended light from entering the sample collector 12, which may facilitate analyzing light applied to a sample with the illumination sensorAtty. Docket No. 1519.101311124. In some examples, the light blocker may be a vertically or circumferentially adjustable shade or curtain configured to extend around the sample collector 12 located at the sample receptacle 20. Other suitable configurations light blockers are contemplated.

[0123] The imaging system 26 may include any suitable components configured to image or sense light from the reactant array 16. Example suitable components of the imaging system 26 include, but are not limited to, the light or image sensor(s) 28, the lens(es) 30, the illumination source(s) 32, and / or other suitable components configured to image and or sense light from the reactant array 16.

[0124] The light or image sensor 28 may be and / or may include one or more light collectors of any suitable type. Example suitable types of light collectors may include, but are not limited to, a light sensor, an image sensor, an n-dimensional sensory array (e.g., where “n” equals 1, 2, etc.), a linear 2D light detector array image sensor, light detector array image sensor may, a spectrometer, a refractometer, a charge-coupled device (CCD) image sensor, complementary metal-oxide semiconductor (CMOS) image sensor, contact image sensor (CIS), color contact image sensor (CCIS), a camera, other suitable light collectors, and / or combinations of light collectors. In one example, the light collector may include or may be a spectrometer configured to measure photons collected from (e.g., reflected, transmitted, and / or otherwise received from) the target area. Utilizing a spectrometer may facilitate sensing wavelengths of light with high resolution in the nanometer range and may provide a continuous set of data over the wavelength range, which allows for a sensitive analysis of the data to identify components of a fluid to which the reactant array 16 was exposed relative to when other light collectors are used. In another example, the light collector may include a 2D pixel array image sensor configured to record multiple spatial interferograms in a pixel array direction of an interferogram representing a Fourier transform of the reactant array 16, which may provide sufficient sensitivity, while being compact and cost-effective.

[0125] The lens(es) 30 of the imaging system 26 may have any suitable configuration designed to focus light from the reactant array 16 onto the light or image sensor 28 and / or light from the illumination source 32 on the reactant array 16. In some examples, the lens(es) 30 may be fixed so as to focus light from a known location of the reactant array 16 of the sample collector 12 positioned on the sample receptacle 20 on the light or image sensor 28. In some examples, the lens(es) 30 may be adjustable so as to focus light from different locations or angles onto the light or image sensorAtty. Docket No. 1519.1013111 and / or to focus light from the illumination source(s) 32 onto different portions of the reactant array 16 and / or different locations at which the reactant array 16 may be located.

[0126] The controller 34 of the reader device 14 may be configured to control operations of the reader device 14 in response to receiving one or more control signals and / or use inputs. The controller 34 may store captured data at the reader device 14 and / or send data to a remote storage component for storage and the controller 34 may use stored captured data to analyze the reactant array 16. The controller 34 may be implemented entirely on the reader device 14, partially on the reader device 14 and partially remotely, and / or entirely remotely (e.g., on a server or other suitable computing device, on the sample collector 12, on a user’s mobile device, etc.)

[0127] The controller 34 of the reader device 14 may be coupled to one or more other electronic components of the system 10. For example, the controller 34 may be communicatively coupled with one or more of the illumination components, when included, the light or image sensor 28, and / or one or more other suitable components of the system 10 and / or remote components (e.g., servers, mobile devices, etc.) that may or may not be part of the system 10. In some examples, the controller 34 may be configured to receive an indication to initiate a fluid test (e.g., from a user via the user interface 36 of or in communication with the controller 34, etc.) and send coordinated control signals to one or more electronic components of the system 10.

[0128] The controller 34 may be configured to identify or may facilitate identifying a component of fluid in contact with the reactant array 16 and / or a condition of a sample or subject (e.g., person, animal, plant, food, etc.) from which the sample was taken based on measured (e.g., sensed and / or calculated) levels of light (e.g., interferograms, images, reflectance, etc.) or changes in light sensed or collected from the reactant array 16 with the light or image sensor 28. In some examples, the controller 34 may be configured to identify a component of fluid in contact with the reactant array 16 and / or a condition of the sample or subject from which the sample was taken based on one or more of a timing of levels of light from the reactant array 16 and an absolute change between a level of light from the reactant array 16 at a time of or prior to exposing the reactant array 16 to fluid within the sample collector 12 and at a predetermined or an indeterminate time (e.g., based on reactant array responses, analyte concentrations, fluid flow rate, fluid temperature, etc.) after exposing the reactant array 16 to fluid within the sample collector 12, and levels of light from the reactant array 16 relative toAtty. Docket No. 1519.1013111 predetermined or expected levels of light from the reactant array 16. The controller 34 may be configured to identify the component of the fluid in contact with the reactant array 16 and thus, a component of the sample in the sample collector 12 and / or a condition of the subject from which the sample was taken (e.g., a person, an animal, a wound, a flower, an infection, an exhalation from a subject, a sweat gland, etc.) based on light from the reactant array 16 that is received at the light or image sensor 28 in one or more additional or alternative manners.

[0129] The controller 34 and / or other components of the system 10 may be or may include one or more computing devices including or coupled with one or more user interfaces. FIG. 2 depicts a schematic diagram of an illustrative computing device 38 and the user interface 36, where the computing device 38 and / or the user interface 36 may be entirely or partially housed in one or more housings 42, which may be part of the housing 18 of the reader device 14 or separate from the housing 18. The housing 42 may be an optional component, as represented by the broken lines defining the housing 42 depicted in FIG. 2. Although various components are depicted as being included in the computing device 38 and the user interface 36, one more of the depicted components may be omitted and / or one or more additional or alternative components may be utilized.

[0130] The computing device 38 may be any suitable computing device configured to process data of or for the system 10 and may be configured to facilitate operation of the system 10. The computing device 38, in some cases, may be configured to control operation of the system 10 by establishing and / or outputting control signals to the light or image sensor 28 and / or other electronic components of the system 10 to run a test on fluid from the sample at the sample collector 12 that interacts with the reactant array 16 and / or monitor results of a test. In some examples, the computing device 38 may be part of the controller 34 and may communicate with other components over a wired or wireless connection, but other suitable configurations are contemplated. When the computing device 38, or at least a part of the computing device 38, is a component separate from a structure of the controller 34, the computing device 38 may communicate with electronic components of the system 10 over one or more wired or wireless connections or networks (e.g., LANs and / or WANs). In some cases, the computing device 38 may communicate with a remote server or other suitable computing device.Atty. Docket No. 1519.1013111

[0131] The illustrative computing device 38 may include, among other suitable components, one or more processors 44, memory 46, and / or one or more input / output (I / O) units 48. Example other suitable components of the computing device 38 that are not specifically depicted in FIG. 2 may include, but are not limited to, communication components, a touch screen, selectable buttons, and / or other suitable components of a computing device. As discussed, one or more components of the computing device 38 may be separate from the controller 34 and / or incorporated into the components of the controller 34.

[0132] The processor 44 of the computing device 38 may include a single processor or more than one processor working individually or with one another. The processor 44 may be configured to receive and execute instructions, including instructions that may be loaded into the memory 46 and / or other suitable memory. Example components of the processor 44 may include, but are not limited to, central processing units, microprocessors, microcontrollers, multi-core processors, graphical processing units, digital signal processors, application specific integrated circuits (ASICs), artificial intelligence accelerators, field programmable gate arrays (FPGAs), discrete circuitry, and / or other suitable types of data processing devices.

[0133] The memory 46 of the computing device 38 may include a single memory component or more than one memory component each working individually or with one another. Example types of memory 46 may include random access memory (RAM), EEPROM, flash, suitable volatile storage devices, suitable non-volatile storage devices, persistent memory (e.g., read only memory (ROM), hard drive, flash memory, optical disc memory, and / or other suitable persistent memory) and / or other suitable types of memory. The memory 46 may be or may include a transitory and / or non- transitory computer readable medium. The memory 46 may include instructions stored in a transitory state and / or a non-transitory state on a computer readable medium that may be executable by the processor 44 to cause the processor 44 to perform one or more of the methods and / or techniques described herein. Further, in some cases, the memory 46 and / or other suitable memory may store data received from the illumination sensor 24, the light or image sensor 28, and / or other components of or in communication with the system 10.

[0134] The VO units 48 of the computing device 38 may include a single VO component or more than one VO component each working individually or with one another. Example VO units 48 may be or may include any suitable types ofAtty. Docket No. 1519.1013111 communication hardware and / or software including, but not limited to, communication components or ports configured to communicate with electronic components of the system 10 and / or with other suitable computing devices or systems. Example types of VO units 48 may include, but are not limited to, wired communication components (e.g., HDMI components, Ethernet components, VGA components, serial communication components, parallel communication components, component video ports, S-video components, composite audio / video components, DVI components, USB components, optical communication components, and / or other suitable wired communication components), wireless communication components (e.g., radio frequency (RF) components, Low-Energy BLUETOOTH protocol components, BLUETOOTH protocol components, Near-Field Communication (NFC) protocol components, WI-FI protocol components, optical communication components, ZIGBEE protocol components, and / or other suitable wireless communication components), and / or other suitable I / O units 48.

[0135] The user interface 36 may be configured to communicate with the computing device 38 via one or more wired or wireless connections. The user interface 36 may include, among other components, one or more display devices 50, one or more input devices 52, one or more output devices 54, and / or one or more other suitable features. Although not depicted, the user interface 36 may include one or more indicators (e.g., light emitting diodes (LEDs), LED linear arrays, numbers, etc.) In some examples, the user interface 36 may be part of or may include the computing device 38. Alternatively or additionally, the user interface 36 may be part of a mobile device or remote computing system.

[0136] The display 50 may be any suitable display. Example suitable displays include, but are not limited to, touch screen displays, non-touch screen displays, liquid crystal display (LCD) screens, LED displays, head mounted displays, virtual reality displays, augmented reality displays, a mobile device display, and / or other suitable display types.

[0137] The input device(s) 52 may be and / or may include any suitable components and / or features for receiving user input via the user interface 36. Example input device(s) 52 may include, but are not limited to, touch screens, keypads, mice, touch pads, microphones, selectable buttons, selectable knobs, optical inputs, cameras, gesture sensors, eye trackers, voice recognition controls (e.g., microphones coupled to appropriate natural language processing components) and / or other suitable inputAtty. Docket No. 1519.1013111 devices. In one example, the input devices 52 may include a touch screen that allows for setting set points, initiating a fluid or target area analysis test, adjusting between screens (e.g., a testing screen, a data analysis screen, a results screen, etc.), and / or allows for taking one or more other suitable actions.

[0138] The output device(s) 54 may be and / or may include any suitable components and / or features for providing information and / or data to users and / or other computing components. Example output device(s) 54 include, but are not limited to, displays, speakers, vibration systems, tactile feedback systems, optical outputs, and / or other suitable output devices.

[0139] FIG. 3 depicts a schematic perspective view of an illustrative configuration of the system 10. As depicted in FIG. 3, the system 10 may include the sample collector 12 and the reader device 14. Although not depicted in FIG. 3, the reader device 14 may include or be in communication with one or more controllers 34 and / or computing devices 38 including one or more processors 44 configured to receive data related to the reactant array 16 exposed to a sample 64 in the sample collector 12 and analyze the data to identify one or more parameter values of the sample based on the reactant array 16 interacting with one or more analytes of or from the sample 64.

[0140] The sample collector 12 may have any suitable configuration. In some examples and as depicted in FIG. 3, the sample collector 12 may include a sample container 56 configured to hold a sample 64 and a cap 58 configured to couple with the sample container 56 and enclose the sample 64 within the sample collector 12. In some examples, the sample container 56 and / or the cap 58 may be configured to mate with one or more components of the reader device 14 to facilitate aligning the sample collector 12 at a desired location relative to the reader device 14.

[0141] The system 10 may be utilized to analyze any suitable biological or non- biological sample 64. Example suitable samples 64 that may be analyzed using the system 10 include, but are not limited to, urine, blood, cerebrospinal fluid (CSF), sputum, feces, breath, skin cells, puss, sebum, biopsy, bone, and / or other suitable types of samples. The analysis may be configured to detect types of analytes associated with cancer (e.g., prostate cancer and / or other suitable types of cancer), biomarkers, liver diseases, kidney issues, hypertension, diabetes, drugs, sexually transmitted diseases, etc. The analyses of samples 64 may be utilized to assess longevity of a subject, metabolic health or state, a nutrition level of a subject, a level of ingested drugs, etc. In one example, the system 10 may be configured to analyze a sample 64 of urine forAtty. Docket No. 1519.1013111 particular types of analytes (e.g., particular types of bacteria) associated with a urinary tract infection (UTI).

[0142] The reader device 14 may include one or more components (e.g., a sample collector detector) configured to detect a presence and / or positioning of the sample collector 12 at the reader device 14 and / or to detect the presence, depth, volume, turbidity, etc. and or identify the sample (e.g., urine, blood, feces, etc.) of the sample 64 in the sample collector 12. Any suitable components configured to detect the sample collector 12 and / or the sample 64 within the sample container 56 may be utilized including, but not limited to, the illumination sensor 24, a physical switch, a sonar system, sensors, image sensor, a reflective sensor, and / or other suitable components. When the reader device 14 includes the illumination sensor 24, a base 60 may include an illumination component at an interface for receiving the sample container 56. The illumination component may transmit light through the sample collector 12 and to the sample 64, and a sensor at the top component 62 or other suitable location of the reader device 14 may assess a presence of the sample collector 12, a presence of the sample 64 within the sample container 56, and / or features (e.g., color, turbidity, particles, contents, volume etc.) of the sample 64 based on light received or a lack of light received at the sensor.

[0143] The reader device 14 may have any suitable configuration. In some examples, the reader device 14 may include the base component 60 (e.g., a sample collector holder) and the top component 62 (e.g., a lid, etc.), among other suitable components and features. In some examples, an outer surface of the base 60 and / or an outer surface of the top 62 may be at least partially defined by the housing 18, as depicted in FIG. 3.

[0144] The base 60 and the top 62 (e.g., a cover, a lid, etc.) may have any suitable configuration relative to one another. In some examples, the top 62 may be movably attached to or coupled with the base 60 and configured to adjust relative the base 60 to facilitate receiving the sample collector 12 and aligning the sample collector 12 with a light or image sensor of the reader device 14. In one example, the top 62 may be rotationally coupled with respect to the base 60 such that the top 62 may be adjusted relative to the base 60 to receive the sample collector 12 and / or to provide user access to the sample collector 12. As depicted in FIG. 3, the top 62 may be in a first position (e.g., a closed position) relative to the base 60 and is configured to move between the first position and a second position (e.g., an opened position). With the top 62 in theAtty. Docket No. 1519.1013111 first position, the light or image sensor 28 may be positioned to sense one or more parameters related to the reactant array 16. With the top 62 in the second position, the sample collector 12 may be placed at the base 60.

[0145] The reader device 14 may be configured to lock the top 62 in one or more positions relative to the base 60. In some examples, the reader device 14 may include a lock configured to lock the top 62 in the first position relative to base 60 during an analysis of the sample 64 and lock the top 62 in one or more second positions relative to the base 60 such that the top 62 does not inadvertently return to the first position while the sample collector 12 is being moved relative to the reader device 14.

[0146] The base 60 and / or other suitable portions of the reader device 14 may include one or more agitators 22 (not depicted in FIG. 3) configured to aid in the activation, expression, release, and / or analysis of analytes from the sample 64 within the sample collector 12. For example, the base 60 may include the agitator 22 or a portion of the agitator 22 configured as or including one or more of a heater, vibration causing components (e.g., an ultrasound vibrator, etc.), illumination components, etc., a magnet, a stirring device, a mixing device, a pump, and / or other suitable component configured to improve or facilitate detection of analytes from the sample 64. When the agitator 22 includes or is configured as a magnet, a magnetic component may be placed in the sample collector 12, the sample collector 12 may be placed on the base 60, and the magnet in the base 60 may be moved to move the magnetic component in the sample container 56 to mix or stir the sample 64. Other suitable mixing, stirring, and / or agitating systems are contemplated.

[0147] Although not depicted in FIG. 3, the system 10 may include one or more light blockers configured to adjustably prevent ambient or unintended light from entering the sample collector 12. In some examples, the mitigation of light within the sample collector 12 may facilitate analyzing light applied to the sample 64 with an illumination component. In some examples, the light blocker may be a vertically or circumferentially adjustable wall, shade, or curtain configured to extend around the sample collector 12, the base 60, and / or the top 62. Other suitable configurations of the light blocker(s) are contemplated.

[0148] The top 62 may have any suitable configuration. In some examples and as discussed, the top 62 may be movable relative to the base 60 to allow the sample collector 12 to be placed at a desired location on the base 60. Once the sample collector 12 is placed at a desired location on the base 60, the top 62 may be moved to a locationAtty. Docket No. 1519.1013111 that may lock and / or hold the sample collector 12 at the desired location while analysis is performed on the sample 64 within the sample collector 12. In some examples, the top 62 may be configured to register and / or align the sample collector 12 by engaging the cap 58 such that the reactant array 16 exposed to the sample 64 in the sample collector 12 may be aligned with a sensor at the top 62. In some examples, engaging the top 62 with the cap 58 may result in breaking a seal between the reactant array 16 and the sample 64 such that the reactant array 16 may be exposed to fluid from the sample 64.

[0149] The reader device 14 may include a sensor interface 66 configured to interface with the sample collector 12 (e.g., the cap 58 of the sample collector 12). In some examples, the sensor interface 66 may be or may include an optical or imaging sensor (e.g., the light or image sensor 28, etc.) The sensor of the sensor interface 66 may be configured to facilitate assessing changes in the reactant array 16 (not depicted in FIG. 3) exposed to analytes from the sample 64 in the sample collector 12, detecting the presence of the sample collector 12 at the reader device 14 (e.g., at the base 60 and / or the top 62), providing a seal to or with the cap 58 of or for the sample collector 12, and / or aligning or registering the sample collector 12, the cap 58, and / or the reactant array 16 of the sample collector 12 with the sensor in or at the sensor interface 66. The sensor interface 66 may have other suitable configurations.

[0150] The user interface 36 of the reader device 14 may include one or more buttons 68. The buttons 68 may be located at any suitable location on the reader device 14. In one example, the one or more buttons 68 may be located on the top 62 of the reader device 14 (e.g., as depicted in FIG. 3), on the base 60, and / or at other suitable locations.

[0151] The button(s) 68 may be any suitable type of buttons. For example, the button 68 may be a button on a touch screen (e.g., a virtual button), a physical button (e.g., as depicted in FIG. 1), and / or other suitable type of button.

[0152] The button(s) 68 may be configured to effect one or more actions or inactions of the reader device 14 in response to user interaction with the button(s) 68. For example, in response to being selected, the buttons 68 may be configured to power electronics of the reader device 14 on and / or off, initiate the agitator(s) 22, release the top 62 from a locked position relative to the base 60, raise, lower, and / or rotate the top 62 relative to the base 60, adjust the light blocker, initiate a sample analysis, initiate the light or image sensor 28 to take an image or capture light, proceed to a previous or nextAtty. Docket No. 1519.1013111 step in a process, adjust what is depicted on a display, mark the sample collector 12 as used, initiate the display, and / or effect one or more other suitable actions or inactions by the reader device 14.

[0153] The user interface 36 of the reader device 14 may include one or more displays 50. The display(s) 50 may be or may include any suitable type(s) of displays 50 including, but not limited to, a liquid crystal display (LCD), light emitting diode (LED) display, a touch screen display, a fixed segment display, and / or other suitable type of display. In some examples, the display 50 may be configured to provide information related to a sample analysis, provide a sample analysis status, provide results of a sample analysis, provide a menu for operating the reader device 14, provide a help screen, provide a status of the system 10, and / or provide other suitable information. In one example, the reader device 14 may include a feature that provides instructions via images with or without text to advance a user through a sample analysis process and the display 50 may provide these instructions. When the reader device 14 includes the feature(s) that provides such instructions, the reader device 14 may be able to determine when a step of the sample analysis process has been completed or not completed and alert a user when a step has been completed or not completed and / or automatically advance to a next step of the process, but other suitable configurations are contemplated.

[0154] The user interface 36 of the reader device 14 may include one or more indicators 70. In some examples, one or more of the indicators 70 may be visual indicators, but audible, mechanical, and / or other suitable indicators 70 are contemplated.

[0155] The indicators 70 may be configured to provide any suitable information to a user. For example, the indicators 70 may be configured to indicate the reader device 14 is powered, actively analyzing a sample, is experiencing an error, has completed a sample analysis, and / or are configured to indicate one or more other suitable modes of the reader device 14. In some examples, the indicators 70 may be configured to provide indications relative to a mode or status of the reader device 14 in a manner that may be viewable by a user when the user is not proximate the reader device 14 (e.g., is not able to read the display 50, etc.). In one example, the indicators 70 may include a red light, a green light, and a yellow light, but other suitable configurations of the indicators 70 are contemplated.Atty. Docket No. 1519.1013111

[0156] FIG. 4 depicts a schematic perspective view of the illustrative configuration of the system 10 depicted in FIG. 3, with the top 62 in the second position relative to the base 60. As depicted in FIG. 4, the sample collector 12 may be placed at the base 60 without interference from the top 62. In some examples, examples the base 60 may include one or more alignment members 72 configured to receive (e.g., engage) the sample collector 12 (e.g., the sample container 56 of the sample collector 12) and align the sample collector 12 received at the alignment member(s) 72 with a sensor in the base 60, the top 62, and / or at another portion of the reader device 14.

[0157] The alignment members 72 may have any suitable configuration for aligning the sample collector 12 relative to one or more components of the reader device 14. For example, the alignment members 72 may be or include, but are not limited to, one or more physical, audible, and / or visual alignment indicators, one or more raised or protruding surfaces (e.g., a circular raised surface of the base 60 configured to engage a bottom of the sample collector 12, as depicted in FIG. 4, or other suitable raised surface), one or more recessed surfaces, a disc-shaped component, one or more visual alignment indicia, registration interface, and / or other suitable alignment members 72. In some examples, the sample container 56 may include one or more features or dimensions configured to mate with the alignment member(s) 72.

[0158] The sensor interface 66 may include one or more alignment members 74 (e.g., a registration interface and / or other suitable alignment member(s)) configured to receive (e.g., engage) the sample collector 12 (e.g., the cap 58 of the sample collector 12) and align the sample collector 12 with a sensor of in the base 60, the top 62, and / or at another portion of the reader device 14 when the alignment member(s) 74 interact with the sample collector 12. In some examples, the alignment member(s) 74 may be configured to engage the cap 58 and register or align the cap 58 with the light or image sensor 28 or other suitable sensor in or at the sensor interface 66 and / or the top 62. In some examples, the sensor interface 66 may aid in centering and / or holding the sample collector 12 and / or the top 62 in a desired position when the top 62 in the second position.

[0159] The alignment members 72 may have any suitable configuration for aligning and / or engaging the sample collector 12 relative to one or more components of the reader device 14. For example, alignment members 72 may be or include, but are not limited to, one or more physical, audible, and / or visual alignment indicators, one or more raised or protruding surfaces (e.g., a circular raised surface of the base 60Atty. Docket No. 1519.1013111 configured to engage a bottom of the sample collector 12, as depicted in FIG. 4, or other suitable raised surface), one or more recessed surfaces, a disc-shaped component, one or more visual alignment indicia, registration interface, and / or other suitable alignment members 72. In some examples and as depicted in FIG. 4, the alignment member(s) 74 may be a circular ridge configured to engage or mate with the cap 58, but other suitable configurations of the registration interface 8a are contemplated. In some examples, the cap 58 may include one or more features or dimensions configured to mate with the alignment member(s) 74.

[0160] As discussed, the top 62 of the reader device 14 may be adjustable relative to the base 60 in any suitable manner. In some examples, the reader device 14 may include one or more pivot components 76 (e.g., a hinge, slide, etc.) between the top 62 and the base 60 to facilitate pivotally adjusting the top 62 relative to the base 60. Other suitable configurations of the reader device 14 that facilitate adjustment of the top 62 relative to the base 60 are contemplated. In some examples, the top 62 may be adjustable relative to an extension 78 of the base 60, where the pivot components 76 may be arced and configured to move relative to the extension 78 to facilitate the rotation or pivoting of the top 62 relative to the base 60, as depicted in FIG. 4. Although the top 62 is depicted in the figures as being configured to pivot or rotate relative to the base 60, the top 62 and / or the base 62 may be configured to adjust relative to one another in other suitable manner including, but not limited to, by adjusting vertically, horizontally, diagonally, and / or in one or more other suitable manners relative to one another. Other suitable configurations for adjusting the top 62 relative to the base 60 are contemplated.

[0161] In some examples, the top 62 may be separate from the base 60 and / or the extension 78. For example, the top 62 may be removed from base 60 and or extension 78 to facilitate imaging of the reactant array 16 with or without a sample or container 56 that is remote from the base 60 and / or the extension 78 and / or to analyze the reactant array exposed to analytes from a sample that is not conducive to fitting within the reader device 14.

[0162] FIG. 5 depicts a schematic perspective view of an illustrative configuration of the system 10. Similar to as depicted in FIG. 4 with the top 62 in the second position relative to the base 60.

[0163] The cap 58 may include one or more transparent layers configured to be positioned or located between the sample 64 in the sample collector 12 and the light orAtty. Docket No. 1519.1013111 image sensor 28 at the top 62 of the reader device. In the example depicted in FIG. 5, the cap 58 may include a transparent first layer 80 (e.g., a top layer or other suitable layer of the cap 58) and a transparent second layer 82 (e.g., an intermediate layer or other suitable layer of the cap 58). In some examples, the transparent second layer 82 may be a substrate for the reactant array 16, but other suitable configurations are contemplated. Through the transparent second layer 82, the reactant array 16 may be exposed to the sample 64 in the sample container 56 and through the transparent first layer 80 and / or the second layer 82 or other layers, the reactant array 16 may be viewed visually by a user and / or by the light or image sensor 28 at the top 62 of the reader device 14 when the top 62 is in the position relative to the base 60, such that the light or image sensor 28 may sense one or more parameters related to the reactant array 16 in fluid communication with the sample 64 in the sample collector 12.

[0164] The layers of the cap 58 between the sample 64 and the top 62 of the reader device 14 may all be entirely transparent or at least include portions that are transparent and arranged in a manner that allows optical inspection of light from the sample 64 by one or more sensors. In some examples and as depicted in FIG. 5, the first layer 80 and the second layer 82 may be transparent and arranged on the cap 58 relative to the top 62 and the sample 64 such that one or more sensors at the top 62 may be able to sense light or an image from the sample 64 through the first layer 80 and / or the second layer 82 when the top 62 is in the first position relative to the base 60.

[0165] FIGS. 6-9 depict schematic views of an illustrative configuration of the system 10. FIG. 6 depicts a schematic perspective view of the illustrative configuration of the system 10, in the first configuration. FIG. 7 depicts a schematic front view of the illustrative configuration of the system 10 depicted in FIG. 6. FIG. 8 depicts a schematic side view of the illustrative configuration of the system 10 depicted in FIG. 6. FIG. 9 depicts a schematic perspective view of the illustrative configuration of the system 10 depicted in FIG. 6, with the system 10 in the second configuration.

[0166] As depicted in FIG. 6, the system 10 may include the reader device 14 with the housing 18 defining an outer surface of the reader device 14. Although not depicted in FIG. 6, the reader device 14 may include the base 60 and the top 62, along with other components of the reader device 14, within the housing 18. Although not depicted in FIG. 6, the reader device 14 may include or be in communication with one or more controllers 34 and / or the computing device 38 including one or more processors 44 configured to receive data related to the reactant array 16 exposed to the sample 64 inAtty. Docket No. 1519.1013111 the sample collector 12 and analyze the data to identify one or more parameter values of the sample based on the reactant array 16 interacting with one or more analytes of or from the sample 64.

[0167] The reader device 14 depicted in FIG. 6 may include the user interface 36 with the display 50. In some examples, the display 50 may be a touch screen display and include one or more buttons 68 (not depicted in FIG. 6) for user selection. In some examples, the display may be configured to show a status of the system, show the results an analysis of data from one or more sensors monitoring the reactant array 16, shown instructions for performing a sample analysis test, and / or show other information and / or indicia.

[0168] The configuration of the system 10 depicted in FIG. 6 may include one or more handles 86. In some examples, the handles 86 may extend outward, through the housing 18 and may be coupled with one of the base 60 and the top 62 within the housing 18. In some examples the handles 86 may be raised or lowered to adjust a relative position of the base 60 and the top 62 with respect to one another. In one example, the reader device 14 may include two handles 86 on opposing sides of the housing 18, as depicted for example in FIG. 6, and / or at other suitable locations, and the handles 86 may be positioned in a first position (e.g., a lower position or other suitable position) to configure the top 62 in the first position relative to the base 60 and the handles 86 may be adjusted to a second position (e.g., an upper position or other suitable position) to configure the top 62 in the second position relative to the base 60.

[0169] The reader device 14 may include a drawer 88 configured to adjust relative to the housing 18. As depicted in FIG. 6, the drawer 88 may have a first position (e.g., a closed position). The drawer 88 may be configured to adjust to a second position (e.g., an opened position, see e.g., FIG. 9) in an automated or manual manner. In some examples, the drawer 88 may be part of or may be coupled to the base 60 such that when the drawer 88 is in the second position, the sample collector 12 may be placed on the base and the drawer 88 may be adjusted to the second position to position the sample collector 12 at a desired location within the reader device 14.

[0170] The schematic front view of FIG. 7 depicts two handles 86 on opposing sides of the housing 18. In some examples, the housing 18 may include one or more indentations 90 configured to facilitate a user grasping the handles 86 and / or movement of the handles 86 between the first position and the second position.Atty. Docket No. 1519.1013111

[0171] The display 50 of the user interface 36 may be located at the top of the housing 18. The display 50 may be part of the housing 18 and / or may extend through the housing 18 to form an outer surface of the reader device 14.

[0172] The display 50 have any suitable configuration. In some examples, the display 50 may be angled toward the front of the reader device 14 to facilitate a user of the reader device 14 viewing a screen of the display 50 and / or for other purposes. In some examples, the display 50 may be a display separate from and / or remote from reader device 14. When the display 50 is remote from the reader device 14, the display 50 may be in wired or wireless communication with the reader device 14 and / or a computing device in communication with the reader device 14.

[0173] The drawer 88 of the reader device 14 may have any suitable configuration. In some examples, a front of the drawer 88 may be sized to close an opening 92 in the housing 18 when the drawer 88 is in a closed position, as depicted for example in FIG. 7. The opening 92 in the housing 18 may be sized and configured to receive the sample collector 12 and / or may be configured for other suitable uses.

[0174] The drawer 88 may be configured to adjust between opened and closed positions in any suitable manner. For example, the drawer 88 may be configured to adjust between the opened and closed positions automatically at a time during a sample analysis process, in response to a user interaction with the user interface 36, in response to adjustment of the handles 86, upon selection of one or more buttons 68 of the user interface 36, in response to a manual pull, in response to a manual push, and / or adjust between the opened and closed positions in one or more other suitable manners.

[0175] The side view of the system 10 depicted in FIG. 8 depicts the handle 86 extending inward into an opening 94 through the housing 18. In some examples, the opening(s) 94 through which the handle(s) 86 extend may be elongated, circular, rectangular, arced, and / or may have any suitable configuration. In one example, the opening(s) 94 may be arced and elongated to facilitate rotating or pivoting the top 62 (not shown in FIG. 8) between the first position and the second position. Additionally or alternatively, rotation of the handle 86 or the selection of a button 68 of the user interface 36 may facilitate adjusting the top 62 between the first position and the second position. As depicted in FIG. 8 and with the handle in the first position, the top 62 may be in the first position and the drawer 88 (not depicted in FIG. 8) may be in the closed position.Atty. Docket No. 1519.1013111

[0176] FIG. 9 depicts a schematic perspective view of the system 10, with the drawer 88 in the opened position and the base 60 extending out of the housing 18 through the opening 92. As depicted in FIG. 9, the handles 86 have been adjusted to a second position (e.g., along the opening 94) so as to adjust the top 62 (not depicted in FIG. 9) to the second position. The system 10 may be configured to automatically open the drawer 88 when the handles 86 are moved to the second position or beyond a threshold location, the system 10 may be configured to automatically open the drawer 88 at a predetermined time before, during, or after a sample analysis, the drawer 88 may be opened manually by a user, the drawer 88 may be opened in response to a user interaction with the button(s) of the user interface 36, and / or the drawer 88 may be opened in one or more additional or alternative manners.

[0177] The base 60 of or used with the drawer 88 may include one or more alignment members 72. In some examples, the alignment member 72 may be configured to align the sample container 56 relative to the base 60 and such that the sample collector 12 may be positioned at a desired location relative to a sensor at the top portion 62 and / or at one or more other suitable locations within the reader device 14. In some examples, the alignment member(s) 72 may be or may include a circular or ring configuration, as depicted in FIG. 9, but other suitable configurations are contemplated.

[0178] FIGS. 10 and 11 depict schematic views of an illustrative configuration of the system 10. In some examples, the configuration of the system 10 depicted in FIG. 10 may be similar to the configuration of the system 10 depicted in FIGS. 6-9. As such, the description of FIGS. 10 and 11 may focus on features and components that differ than those depicted in and discussed with respect to FIGS. 6-9. The features depicted in and described with respect to the configuration of the system 10 depicted in FIGS. 10 and 11 may be utilized with or as alternatives to features and components in the configuration of the system 10 depicted in FIGS. 6-9.

[0179] FIG. 10 is a schematic perspective view of the system 10 in a first configuration. As depicted in FIG. 10, the reader device 14 may include a door 96 configured to file or close the opening 92 through the housing 18 when in a closed position. The door 96 may be configured to adjust relative to the housing 18 in an automated or manual manner. As depicted in FIG. 10, the door 96 may have a first position (e.g., a closed position). The door 96 may be configured to adjust to a second position (e.g., an opened position, see e.g., FIG. 11). In some examples, the door 96Atty. Docket No. 1519.1013111 may be part of or may be coupled to the base 60 as depicted in FIG. 11 such that when the door 96 is in the second position, the sample collector 12 may be placed on the base and the door 96 may be adjusted to the second position to position the sample collector 12 at a desired location within the reader device 14.

[0180] The reader device 14 may include a connector 98 coupled with the door 96. In some examples, the connector 98 may be configured to connect the door 96 to the housing 18 or releasably fix the door 96 relative to at least a portion of the housing 18. The connector 98 may be any suitable type of connector. For example, the connector 98 may be and / or may include a latch, a snap, a protrusion, a recess, a magnet, a magnetic component, and / or other suitable connector 98 configured to facilitate at least temporarily fixing the door 96 with respect to a portion of the housing 18. In one example, the connector 98 may be a magnetic latch configured to engage an actuatable magnet of the reader device 14 that may be actuated between a magnetic configuration and a non-magnetic configuration.

[0181] As depicted in FIG. 10, the user interface 36 of the reader device 14 may include the display 50 and one or more buttons 68. In some examples, the user interface 36 of the reader device may include a first button 68a and a second button 68b configured to cause the reader device 14 and / or other portion of the system 10 to take one or more actions in response to actuation thereof. In some examples, the buttons 68 may be located in front of the display 50 to facilitate easy access for a user to select.

[0182] FIG. 11 depicts a schematic perspective view of the system 10 depicted in FIG. 10, with the door 96 in the opened position and the base 60 extending out of the housing 18 through the opening 92. As depicted in FIG. 11, the handles 86 have been adjusted to the second position (e.g., along the opening 94) so as to adjust the top 62 (not depicted in FIG. 11) to the second position. In some examples, the handles 86 may be manually adjusted between the first position and the second position. Additionally or alternatively, the handles 86 may be adjusted between the first position and the second position by the system 10 in an automated manner as part of a predetermined process (e.g., a process for testing a sample, etc.) The system 10 may be configured to automatically open the door 96 when the handles 86 are moved to the second position or beyond a threshold location, the system 10 may be configured to automatically open the door 96 at a predetermined time before, during, or after a sample analysis, the door 96 may be opened manually by a user, the door 96 may be opened in response to a userAtty. Docket No. 1519.1013111 interaction with the button(s) of the user interface 36, and / or the door 96 may be opened in one or more additional or alternative manners.

[0183] The door 96 may have any suitable configurations relative to other portions of the housing 18. In some examples, the door 96 may be configured to pivot or rotate about a pivot axis to move between an opened position and a closed position. In some examples and as depicted in FIG. 11, the base 60 may be coupled with or include the door 96 such that the base 60 moves out of the opening 94 when the door 96 is pivoted or rotated to an opened position (e.g., the base 60 may pivot or rotate with the door 96).

[0184] The reader device 14 may include a first connector 98 coupled with the door 96 or other portion of the housing 18. In some examples, the first connector 98 when coupled with the door 96 may be configured to connect the door 96 to the housing 18 or releasably fix the door 96 relative to at least a portion of the housing 18.

[0185] The reader device 14 may include a second connector 100 coupled with the housing 18, as depicted for example in FIG. 11, and configured to engage and / or couple with the first connector 98. In some examples, the second connector 100 may be configured to releasably engage and / or connect with the first connector 98 at the door 96 to releasably fix the door 96 relative to at least a portion of the housing 18.

[0186] The first connector 98 and the second connector 100 may be any suitable types of connectors. For example, the first connector 98 and / or the second connector 100 may be and / or may include mating component(s), one or more latches, one or more snaps, one or more protrusion, one or more recesses or indents, one or more magnets, one or more magnetic components, and / or other suitable types of connectors configured to facilitate at least temporarily fixing the door 96 with respect to a portion of the housing 18. In one example, the first connector 98 may be a magnetic latch configured to engage the second connector 100 configured as an actuatable magnet of the reader device 14 that may be actuated between a magnetic configuration and a non-magnetic configuration to facilitate locking and unlocking the door 96 in a closed configuration. Returning to the configuration of the system 10 depicted in FIGS. 6-9, although not expressly depicted in FIGS. 6-9 the configuration of the system 10 including the drawer 88 may include a first connector and a second connector that may be configured in a similar manner as or a different manner than the first connector 98 and the second connector 100 associated with the configuration of the system 10 including the door 96.

[0187] Returning to the configuration of the system 10 depicted in FIGS. 10 and 11, the base 60 of or used with the door 96 may include one or more alignment membersAtty. Docket No. 1519.101311172. In some examples, the alignment member 72 may be configured to align the sample container 56 relative to the base 60 and such that the sample collector 12 may be positioned at a desired location relative to a sensor at the top portion 62 and / or at one or more other suitable locations within the reader device 14. In some examples, the alignment member(s) 72 may be or may include a circular or ring configuration, as depicted in FIG. 9, but other suitable configurations are contemplated.

[0188] The sample collector 12 depicted in FIG. 11 may be similarly configured to the sample collectors 12 previously discussed herein and / or may have other suitable components and / or features. For example, the sample collector 12 depicted in FIG. 11 may include the sample container 56, the cap 58, a transparent first layer 80 (e.g., a top layer), the reactant array 16 on or as the second layer 82 and / or other suitable features or components. In some examples, the sample collector 12 may include a third layer 84 (e.g., a bottom layer) of material configured to be position between the between the sample 64 and the reactant array 16. The third layer 84, in some examples, may be a bottom layer and / or may include openings or vents to facilitate fluid from the sample basing to and interacting with the reactant array 16.

[0189] FIGS. 12-16 depict schematic perspective views of steps in an illustrative method of analyzing a sample. Although the steps of the method of analyzing a sample are depicted in FIGS. 12-16 using the configuration of the system 10 depicted in FIGS. 6-9 with the drawer 88, the method and described steps may be utilized with other suitable systems discussed herein or otherwise. As depicted in FIGS. 12-16, portions of the system 10 have been removed for clarity, including a portion of the housing 18.

[0190] FIG. 12 schematically depicts the system 10 after a user has initiated a sample analysis (e.g., after initiating a sample analysis test on a sample). In some examples, the user may interact with the user interface 36 to initiate the sample analysis using the system. In one example, a user may select a button on the display 50 or other portion of the user interface 36 to initiate an analysis of a sample using the reader device 14, but the analysis of the sample may be initiated in one or more other suitable manners.

[0191] In response to receiving a selection to initiate the sample analysis, the reader device 14 may be configured to adjustably position the base 60 and the drawer 88 at a location relative to the housing 18 (e.g., relative to other portions of the housing 18 when the drawer 88 and / or the base 60 for a portion of the housing 18) such that a sample collector 12 may be positioned on the base 60. In some examples and asAtty. Docket No. 1519.1013111 depicted in FIG. 12, the reader device 14 may adjust the base 60 outward relative to the housing 18 to a location that allows the sample collector 12 to be placed on the base 60 (e.g., within the alignment member 72).

[0192] With the drawer open 88, the sample collector 12 may be positioned on the base 60. Once the sample collector 12 has been positioned on the base 60, the drawer 88 may be closed. In some examples, the reader device 14 may be configured to sense that the sample collector 12 has been placed on the base 60 and in response to sensing the sample on the base 60, automatically close the drawer 88, automatically display an option on the display 50 for a user to select to close the drawer 88, automatically display instructions on the display 50 for the user to close the drawer 88, and / or take any other suitable action or take no action.

[0193] FIG. 13 schematically depicts the drawer 88 in the closed position with the sample collector 12 on the base 60 and within the reader device 14. In some examples, after the drawer 88 has closed and the sample collector 12 is positioned within the reader device 14, the screen may display instructions for the user to lower the top 62 toward and / or to the sample collector 12. In one example, the reader device 14 may display instruction that read “Lower Handles” or other suitable instructions to instruct the user to lower the handles 86 to lower the top 62 toward or to the sample collector. Alternatively or additionally, the top 62 may be automatically moved toward the sample collector 12, along with the handles 86 moving toward the first position (e.g., a lowered position), in response to the reader device 14 sensing that the sample collector 12 and / or the base 60 are positioned at a desired location within the reader device 14. In such examples, the display 50 may display a message indicating the top 62 is being moved toward the sample collector 12.

[0194] Positioning the top 62 at the sample collector 12 may include moving the top 62 into a sensing position relative to the sample collector 12, such that the light or image sensor 28 (not depicted in FIG. 13) may sense light or an image from the sample 64 and / or the reactant array 16. In some examples, moving the top 62 toward or to the sample collector 12 may include engaging the top 62 (e.g., the sensor interface 66 and / or the alignment members 74) with the cap 58 of the sample collector 12 to adjust the cap 58 relative to the sample container 56 to break a seal between the reactant array 16 and the sample 64 to place the reactor array 16 in fluid communication with the sample. Prior to being broken, the seal may fluidly isolate the reactant array 16 from fluid within the sample container 56.Atty. Docket No. 1519.1013111

[0195] FIG. 14 schematically depicts the top 62 moved toward the sample collector 12 and in a position to sense light and / or an image from the reactant array 16 and / or the sample 64. In some examples, the reader device 14 may include one or more stops 102 configured to engage and / or support the top 62 when the top 62 is in a position to sense light and / or an image from the reactant array 16 or the sample 64.

[0196] The stops 102, when included, may have any suitable configuration. For example, the stop(s) 102 may be post(s), brackets, ledges, shelves, and / or other suitable features configured to support the top 62 when the top 62 is in a position to sense light or images from the reactant array 16 and / or the sample 64. In one example, the stops 102 may be a portion of a bracket coupled with the housing 18, but other suitable configurations of the stops 102 are contemplated.

[0197] With top 62 in position to sense light and / or image from the reactant array 16 and / or the sample 64, the light or image sensor 28 and / or other components of the reader device 14 may capture data from the reactant array 16 and / or the sample 64. The data captured by the reader device 14 may be stored and / or analyzed at the reader device 14 and / or at a remote location, which may or may not be in direct wired or wireless communication with the reader device 14.

[0198] Then the reader device 14 and / or one or more computing devices 38 receiving the data collected may analyze the data. In some examples, the data may be analyzed to detect changes in the reactant array caused by analytes from the sample 64. In some examples, the data may be analyzed to determine a condition of the sample 64.

[0199] Any suitable analyses on the data collected may be performed. Examples suitable analyses include, but are not limited to, comparing images captured, comparing or assessing color of image and light collected, measuring levels of wavelength of light collected, and / or other suitable analyses may be performed on the data collected. Example techniques for measuring levels of wavelength of light collected from reactant arrays and for comparing measurements to known measurements associated with analytes of fluids include, but are not limited to, those discussed in PCT Publication No. WO2024124078, titled DEVICES, METHODS, AND SYSTEM FOR MEASURING AND RECORDING SPECTRUM OF A REACTANT ARRAY, and filed on December 8, 2023, which is hereby incorporated by reference in its entirety for any and all purposes. Other suitable techniques for analyzing collected light or image data are contemplated.Atty. Docket No. 1519.1013111

[0200] Once the reader device 14 has determined it has received a desired amount of data sufficient to perform the analysis of the sample 64, the reader device 14 may display indicia on the display 50 indicating the data collection and / or the sample analysis is complete. In some examples, in response to determining a sufficient amount of data has been collected and stored, the reader device 14 may display instructions on the display 50 to lift the handles 86 (e.g., the reader device 14 may cause “Finished! Lift Handles” to be displayed on the display 50 and / or other suitable message or indication) to space the top 62 from the sample collector 12. In some examples, in response to determining the reader device 14 has a sufficient amount of data, the reader device 14 may automatically move the top 62 away from the sample collector 12 or otherwise adjust the top 62 to facilitate removal of the sample collector 12 from the reader device 14.

[0201] FIG. 15 schematically depicts the handles 86 and the top 62 in a raised position to facilitate removal of the sample collector 12 from the reader device 14. With the top 62 spaced from the sample collector 12 and / or at one or more other suitable times, the reader device 14 may display an indication on the display 50 that the analysis is complete. In some examples, the reader device 14 may cause the display 50 to display results of the sample analysis. Alternatively, the results may not be displayed on the display 50 for privacy reasons or other reasons and instead, the results may be transferred to another computing device and / or stored in memory.

[0202] The results of the analysis of the data collected may provide any suitable information concerning the sample 64. In some examples, the analysis of the data collected may identify or facilitate identifying one or more types of analytes in or of the sample. In some examples, the identification of the type(s) of the analyte(s) may be based on changes in the reactant array 16 caused by the analytes from the sample 64 interacting with the reactant array 16. The identification of the type(s) of the analyte(s) may be based on additional or alternative data collected or known. In some examples, identifying the analytes (e.g., the types of analytes) may include quantifying concentrations of an analyte or multiple types of analytes detected in the fluid from the sample.

[0203] With the top 62 spaced from the sample collector 12, as depicted in FIG. 15, the drawer 88 may be opened and the base 60 may be adjusted outward from the housing 18. The reader device 14 may automatically open the drawer 88 in response to adjusting the top 62 relative to the sample collector 12. Alternatively or additionally, the openingAtty. Docket No. 1519.1013111 of the drawer 88 may be manually initiated by user and / or the drawer 88 may be manually opened by a user.

[0204] FIG. 16 schematically depicts the reader device 14 with the drawer 88 in an opened position. With the reader device 14 in the opened position, the sample collector 12 may be removed from the base 60. In some examples, the reader device 14 may display instructions on the display 50 to remove the sample from the reader device 14 (e.g., the display 50 may display “Remove Sample” and / or other suitable instructions) before, during, or after the drawer 88 is adjusted to the opened position. In one example, the reader device 14 may display the instructions in response to the top 62 being adjusted away from the sample collector 12 and / or in response to the drawer 88 being opened. Alternatively or additionally, the user interface 36 may display other suitable audible, visual, or mechanical indications that the system 10 has completed an analysis of the sample 64.

[0205] The steps of methods depicted in FIGS. 12-16 and described herein may be entirely or substantially automated by the system 10 after a user has selected to initiate a sample analysis and positioned the sample collector 12 on the reader device 14 until the user is instructed to remove the sample. Other configurations are contemplated where additional or alternative user interaction may be required to complete the methods of analyzing a sample.

[0206] FIG. 17 depicts a schematic diagram of an illustrative sample collector 12. In some examples, the sample collector 12 may be configured to receive a sample, contain the sample, and fluidly isolate the sample from the ambient.

[0207] The sample collector 12 may have any suitable configuration and components. In some examples, the sample collector 12 may include a housing 103. The housing 103 may include, among other suitable components, the sample container 56 and the cap 58. Although the sample container 56 may be discussed herein with respect to the cap 58, the sample container 56 may be configured to engage and / or couple with other suitable caps.

[0208] The sample container 56 may have any suitable configuration designed to receive and hold a sample and couple with the cap 58. In one example, the sample container 56 may be or have a cup shape, a cylinder shape, a bowl shape, a petri dish, a slide, and / or other suitable shape or configuration for containing or carrying a sample. In one example, the sample container 56 may be a cup shape, such as a standard urine sample cup. Other suitable configurations are contemplated.Atty. Docket No. 1519.1013111

[0209] The sample container 56 may be configured to couple with the cap 58 in any suitable manner. In some examples, the sample container 56 may include threads configured to engage the cap 58, one or more recesses configured to engage the cap 58, one or more protrusions configured to engage the cap 58, and / or one or more other suitable features configured to engage the cap 58.

[0210] The cap 58 may have any suitable configuration designed to engage the sample container 56 and hermetically seal the sample container 56. Although the cap 58 may be discussed herein with respect to the sample container 56, the cap 58 may be configured to engage and / or couple with other suitable sample containers.

[0211] The cap 58 may have any suitable configuration configured to be received by, engage, and / or seal the sample container 56. In some examples, the cap 58 may include the reactant array 16 integrated therein and may be configured to fluidly isolate the reactant array 16 from the sample when the cap 58 is in a first configuration and when the cap 58 is in a second configuration, facilitate fluid from a sample within the sample container 56 interacting with the reactants of the reactant array 16. In some examples, the cap 58 may be configured to allow or facilitate sensing or imaging analyte-induced changes in the reactant array 16.

[0212] The cap 58 may have any suitable components. In some examples, the cap 58 may include a first component 104, a second component 106, one or more seals 108 (e.g., one or more layers of material that seal the cap 58), one or more reactant arrays 16, one or more transparent layers, one or more layers of material, and / or other suitable components. In one example configuration of the cap 58, the cap 58 may comprise a transparent top layer configured to face an image or light sensor of a reader device (e.g., the reader device 14 and / or other suitable reader device), a bottom layer, and the reactant array 16 positioned between the transparent top layer and the bottom layer. The transparent top layer may facilitate sensing and / or imaging the reactant array 16 while isolating the reactant array 16 from the ambient.

[0213] The first component 104 may be configured to engage the sample container 56 and may include the seal 108. The first component 104 may be configured to engage the sample container 56 in any suitable manner including, but not limited to, by engaging a top surface of the sample container 56, engaging protrusions from the sample container 56, engaging recesses of the sample container 56, engaging a ledge of the sample container 56, engaging threads of the sample container 56, engaging an inner surface of the sample container 56, and / or engaging the sample container 56 in one orAtty. Docket No. 1519.1013111 more other suitable manners. In one example, the first component 104 may include a first end, a second end, a through-hole, and a first connector configured to engage the second component 106. Other suitable configurations of the first component 104 are contemplated.

[0214] The second component 106 may include the reactant array 16, may be configured to engage the first component 104, and / or may be configured to engage the sample container 56. The second component 106 may be configured to engage the sample container 56 in any suitable manner including, but not limited to, by engaging a top surface of the sample container 56, engaging protrusions from the sample container 56, engaging recesses of the sample container 56, engaging a ledge of the sample container 56, engaging threads of the sample container 56, engaging an exterior surface of the sample container 56, and / or engaging the sample container 56 in one or more other suitable manners. The second component 106 may be configured to engage the first component 104 in any suitable manner including, but not limited to, by engaging a top surface of the first component 104, engaging protrusions from the first component 104, engaging recesses of the first component 104, engaging a ledge of the of the first component 104, engaging threads of the first component 104, engaging an exterior surface of the first component 104, and / or engaging the first component 104 in one or more other suitable manners. In one example, the second component 106 may include an extension portion configured to engage the first component 104 and one or more arms configured to engage the sample container 56. In some examples, the second component 106 may be configured to couple with and adjust relative to the first component 104 and / or the sample container 56. Other suitable configurations of the second component 106 are contemplated.

[0215] The first component 104 and the second component 106 may be positioned in any suitable configuration relative to one another. In some examples, the first component 104 and the second component 106 may be configured to adjust between a first configuration and a second configuration. In the first configuration, the second component 106 may be coupled with the first component 104 at a first location and in the second configuration, the second component 106 may be coupled with the first component 104 at a second location. In some examples, in the first configuration, the reactant array 16 may be hermetically sealed from an environment around the cap 58. In some examples, in the second configuration, the second component 106 may extend through the first component 104 and the reactant array 16 may be exposed to theAtty. Docket No. 1519.1013111 ambient (e.g., an ambient within the sample container 56 when the cap 58 is coupled to the sample container 56).

[0216] FIG. 18 depicts a schematic perspective view of the sample collector 12, with the cap 58 in the second configuration. As discussed, the sample collector 12 may include the sample container 56 and the cap 58 coupled to or configured to couple with the sample container 56.

[0217] In the illustrative configuration of the cap 58 depicted in FIG. 18, the cap 58 may include the transparent first layer 80, a base or third layer 84, and the reactant array 16 positioned between the transparent first layer 80 and the base or third layer 84. In some examples, the reactants of the reactant array 16 may be on the second layer 82, but other suitable configurations are contemplated. In some examples, the first layer 80, the second layer 82, the third layer 84, and the reactant array 16 all may be part of the second component 106, but other suitable configurations are contemplated.

[0218] The third layer 84 may include one or more openings or vents 110. The openings or vents 110 may extend through the third layer 84 and may be configured to allow fluid and / or analytes from sample in the sample container 56 to interact with the reactants of the reactant array 16. In some examples, the openings or vents 110 may be hydrophobic or include a hydrophobic membrane such that liquid is prevented or mitigated from interacting with the reactants of the reactant array 16.

[0219] The second component 106 of the cap 58 may couple with the sample container 56 in any suitable manner. In some examples, the second component 106 of the cap 58 may include one or more tabs 119 configured to engage an exterior of sample container 56. The tab(s) 118, when included, may be flexible or resilient and configured to adjust radially outward to facilitate coupling and uncoupling the cap 58 with the sample container 56. In some examples, the tabs 119 may be irreversibly coupled with the sample container 56, but other suitable configurations are contemplated.

[0220] FIG. 19 is a schematic cross-section view of the sample collector 12 depicted in FIG. 18, with the cap 58 in a first configuration and sealing the sample collector (e.g., sealing the sample container 56). In the first configuration, only the first component 104 of the cap 58 may engage the sample container 56, but other suitable configurations are contemplated. In one example, an outer ledge 120 of the first component 104 may engage a top rim 122 of the sample container 56. In one example, at a portion of the first component 104 may be friction fit within the sample containerAtty. Docket No. 1519.101311156. The cap 58 may be coupled with the sample container 56 in one or more additional or alternative manners when the cap 58 is in the first configuration.

[0221] The first component 104 may include a first end 104a, a second end 104b, and a through-hole 124 extending from the first end 104a to the second end 104b. A seal 108 may extend across the seal 108 to fluidly isolate the reactant array 16 at the cap 58. The seal 108, however, may be located at one or more other suitable locations for fluidly isolating the reactant array 16 from the ambient.

[0222] The seal 108 may be any suitable type of seal configured to block fluid from reaching the reactant array 16 in the cap 58. For example, the seal 108 may be an adjustable seal, a breakable seal, a foam material, a perforated layer of material, a valve, a flap, an iris valve, and / or other suitable type of seal. In some examples, the seal 108 may be a closed-cell polyethylene foam. In some examples, the seal 108 may be a breakable seal configured to be permanently open once adjusted from a closed configuration to the open configuration. In some examples, the seal 108 may be an adjustable seal or valve that is configured to be biased to a closed position or otherwise re-closable and adjustable to an opened position in response to the cap 58 engaging the sample container 56 and / or in response to adjustment or actuation of a component of the cap 58 or other suitable actuator. When the cap 58 is disengaged from the sample container 56 and / or when the actuator is released or further actuated, the adjustable seal may automatically return to the closed position. Other suitable materials and configurations of the seal 108 are contemplated.

[0223] The seal 108 have any suitable dimensions. In some examples, the seal 108 may be a circular disc that is in a range from 0.25 millimeters (mm) to 0.50 mm thick. Other suitable thicknesses are contemplated.

[0224] The seal 108 may have one or more perforations to facilitate breaking the seal 108 with the second component 106. In some examples, the seal 108 may include eight perforated lines starting from a central location of the seal 108 and extending radially outward. The perforations, however, may be omitted and / or may have other suitable configurations.

[0225] The first component 104 may include a first connector 126. The first connector 126 may be configured to engage a connector of the second component 106. Although other suitable connectors are contemplated, the first connector 126 may be a protrusion or a recess and the connectors of the second component 106 configured to engage the first connector 126 may be the other of the protrusion and the recess. In oneAtty. Docket No. 1519.1013111 example, and as depicted in FIG. 19, the first connector 126 may be a protrusion that extends circumferentially around an inner surface of the first component 104 at or proximate the first end 104a of the first component 104. Other suitable configurations of the first connector 126 are contemplated.

[0226] As discussed, the second component 106 may include the top or first layer 80, the second layer 82, and the bottom or third layer 84, with the reactant array 16 between the first layer 80 and the third layer 84. The second component 106 may include an extension portion 112 configured to extend through the first end 104a of the first component 104 and into and / or through the through-hole 124.

[0227] The reactant array 16 may be positioned at any suitable angle relative to a plane perpendicular to a central axis of the sample collector 12 (e.g., a sensing axis of the reader device 14), such as a plane parallel to the first layer 80. For example, the reactants of the reactant array 16 may be at an angle that is perpendicular to the central axis (e.g., a plane parallel to the first layer 80 of the cap 58), an angle in a range of 120 degrees to perpendicular to the central axis, and / or at one or more other suitable angles with respect to the plane perpendicular to the central axis of the sample collector 12. In one example, the reactants of the reactant array 16 may be at an angle of 150 degrees relative to the plane perpendicular to the central axis of the sample collector 12 and the light or image sensor 28 of the reader device 14 may be configured to receive light from the reactant array 16 at that angle. Other suitable angles and orientations are contemplated.

[0228] The extension portion 112 of the second component 106 may include a second connector 128 and a third connector 130. In some examples, the second connector 128 may be configured to engage the first connector 126 in the first configuration of the cap 58 and the third connector 130 may be configured to engage the first connector 126 in the second configuration of the cap 58. The connectors and / or connections between the first component 104 and the second component 106 may have other suitable configurations configured to facilitate the first component 104 and the second component 106 adjusting between the first configuration and the second configuration.

[0229] The second connector 128 and the third connector 130 may be configured to engage the first connector 126 of the first component 104. In one example, and as depicted in FIG. 19, the second connector 128 and the third connector 130 may be protrusions that extend circumferentially around an outer surface of the secondAtty. Docket No. 1519.1013111 component 106, where the third connector 130 may be spaced in a proximal direction from the second connector 128. Other suitable configurations of the first connector 126, the second connector 128, and the third connector 130 are contemplated.

[0230] The extension portion 112 of the second component 106 may include one more seal -breaking protrusions 132. In some examples, the seal -breaking protrusions 132 may be configured to engage the seal 108 and break through the seal 108 when the first component 104 is on the sample container 56. In some examples, the seal -breaking protrusion 132 may be centrally located along the central axis of the sample collector 12, as depicted in FIG. 19, and / or may be radially spaced from the central axis.

[0231] In operation, when the cap 58 is in the first configuration and on the sample container 56 in a sealing manner, the first connector 126 of the first component 104 may be engaging the second connector 128 of the second component 106 and the protrusion 132 may be proximal of and / or may contact a proximal facing surface of the seal 108, such that the seal 108 may continue to seal the reactant array 16 from the ambient. With the first component 104 on the sample container 56 in a sealing manner, the second component 106 may be forced in a distal direction (e.g., opposite of the proximal direction) until the first connector 126 disengages the second connector 128 and engages the third connector 130. In the second configuration of the cap 58, engagement portions 116 of the tabs 119 may engage a lip 114 of the sample container 56 and the seal -breaking protrusion 132 may break and extend through the seal 108 (see FIG. 21).

[0232] FIGS. 20 and 21 depict schematic cross-section views of the sample collector 12, with a sample 64 sealed in the sample container 56 by the cap 58. In some examples, the sample 64 may be urine, but other suitable samples are contemplated.

[0233] FIG. 20 depicts the cap 58 of the sample collector 12 in the first configuration, with second component 106 uncoupled from the sample container 56 and the protrusion 132 proximal of the seal 108 (e.g., not extending through the seal 108). As depicted in FIG. 20, the reactant array 16 within the second component 106 of the cap 58 may be fluidly isolated from the ambient of the cap 58 (e.g., fluidly isolated from analytes in the sample container 56) when the cap 58 is in the first configuration. In some examples, the connection between the first connector 126 and the second connector 128, along with the seal 108 and the first layer 80, may hermetically seal the reactant array 16 within the cap 58. For example, the analytes andAtty. Docket No. 1519.1013111 fluid 118 from the sample 64 may be blocked from reaching the reactant array 16 when the cap 58 is in the first configuration, as depicted in FIG. 20.

[0234] FIG. 21 depicts the cap 58 of the sample collector 12 in the second configuration, with the first component 104 received within the sample container 56 and the second component 106 directly coupled with an exterior of the sample container 56. In some examples, the engagement portions 116 of the tabs 119 of the second component 106 may engage a lip 114 of the sample container 56 to secure the second component 106 with the sample container 56.

[0235] As depicted in FIG. 21, the reactant array 16 within the second component 106 of the cap 58 may be in fluid communication with the fluid 118 from the sample 64 in the sample container 56 to allow analytes and / or other fluid from the sample 64 to interact with reactants of the reactant array 16. In some examples, a force acting on the second component 106 in the distal direction (e.g., toward the sample container 56) may adjust the cap 58 from the first configuration in which the first connector(s) 126 are engaging the second connector(s) 128 to the second configuration in which the first connector(s) 126 are engaging the third connector(s) 130 and breaks the seal 108 in response to the protrusion 132 engaging the seal 108 as the second component 106 advances through the first component 104 of the cap 58. Breaking of the seal 108 may occur along perforations, when included, in the seal 108 and may result in allowing analytes and / or fluid 118 from the sample 64 to reach the reactant array 16.

[0236] Any suitable force causing relative axial movement of the second component 106 of the cap 58 relative to the first component 104 may be applied to the sample collector 12 to break the seal 108 and allow analytes and / or fluid 118 from the sample 64 to reach the reactant array 16. In some examples, the force in the distal direction acting on the cap 58 may be the result of a user pressing on the cap 58 and / or the sample container 56 or the top 62 of the reader device 14 engaging the cap 58 when the sample collector 12 has been inserted into the reader device 14.

[0237] Although the subject matter has been described in language specific to structural features and / or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.

[0238] Unless otherwise expressly stated, it is in no way intended that any method or technique set forth herein is to be construed as requiring that its steps be performedAtty. Docket No. 1519.1013111 in a specific order. This holds for any possible non-express basis for interpretation, including matters of logic with respect to arrangement of steps or operational flow, plain meaning derived from grammatical organization or punctuation, and the number or type of embodiments described in the specification

[0239] It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.

Claims

Atty. Docket No. 1519.1013111ClaimsWhat is claimed is:

1. A system for analyzing samples, comprising: a base configured to receive a sample collector; a top movably coupled with the base; a sensor positioned in the top and configured to sense one or more parameters related to a reactant array in fluid communication with a sample in the sample collector; a processor configured to: receive data related to the reactant array from the sensor, and analyze the data to identify one or more parameter values of the sample based on the reactant array interacting with one or more analytes of the sample.

2. The system of claim 1, further comprising: a display configured to show a status of the system, results of an analysis of the data, or both the status of the system and the results of the analysis of the data.

3. The system of claim 1 or claim 2, further comprising: the sample collector configured to contain the sample; and the reactant array configured to be positioned between the sample and the sensor, wherein the top is configured to move between an open position allowing placement of the sample collector at the base and a closed position configured to allow the sensor to sense the one or more parameters related to the reactant array.

4. The system of claim 3, further comprising: a cap configured to seal the sample collector, and wherein the reactant array is integrated into the cap.

5. The system of claim 4, wherein the cap comprises: a transparent top layer configured to face the sensor; a seal configured to face the sample; andAtty. Docket No. 1519.1013111 the reactant array is positioned between the transparent top layer and the seal.

6. The system of claim 5, wherein the seal is configured to expose the reactant array to the one or more analytes from the sample when the seal has been broken.

7. The system of any one of claims 1-6, further comprising: an agitator configured to accelerate expression of the one or more analytes from the sample.

8. The system of claim 7, wherein the agitator comprises one or more of a heater, a magnet, a negative pressure system, and a gas supply system.

9. The system of any one of claims 1-8, further comprising: a light source configured to illuminate the sample; and wherein the processor is further configured to analyze color, turbidity, or color and turbidity of the sample based on light transmitted through the sample.

10. The system of any one of claims 1-9, wherein the processor is further configured to: identify multiple types of analytes from the sample; and quantify concentrations of the types of the one or more analytes.

11. A sample sensing system, comprising: a cap configured to couple with a sample container, the cap comprising: a transparent top layer; a seal; and a reactant array positioned between the transparent top layer and the seal, wherein the cap is configured to: seal the sample container, expose the reactant array to analytes from a sample when the seal is broken, and allow sensing of analyte-induced changes in the reactant array through the transparent top layer.Atty. Docket No. 1519.101311112. The system of claim 11, wherein the cap comprises: a first component comprising a first end, a second end, a through-hole, and a first connector, wherein the seal extends across the through-hole; and a second component having an extension portion with a protrusion, the second component configured to couple with and adjust relative to the first component, wherein the second component has a first configuration relative to the first component in which the second component is coupled with the first component, the protrusion is proximal of the seal, and the reactant array is configured to be fluidly isolated from the analytes in the sample container, and wherein the second component has a second configuration relative to the first component in which the second component is coupled with the first component, the extension portion extends through the seal, and the seal is broken to allow fluid to reach the reactant array.

13. The system of claim 12, wherein the first component is configured to engage the sample container.

14. The system of claim 12 or claim 13, wherein the second component is configured to be uncoupled from the sample container in the first configuration and coupled with the sample container in the second configuration.

15. The system of any one of claims 12-14, further comprising: the sample container configured to receive the first component within the sample container and engage the second component when the second component is in the second configuration.

16. The system of any one of claims 11-15, wherein the reactant array is angled at 150 degrees relative to a plane parallel to the transparent top layer.

17. The system of any one of claims 11-16, wherein the seal is a perforated closed cell foam.

18. A method of analyzing a sample, comprising:Atty. Docket No. 1519.1013111 engaging a top component of an analysis system with a cap of a sample collector to place a reactant array in the cap in fluid communication with fluid in a sample container of the sample collector; capturing data from the reactant array using a sensor of the analysis system; analyzing the data to detect changes in the reactant array caused by analytes from the sample; and identifying one or more types of analytes from the sample based on the changes in the reactant array caused by the analytes interacting with the reactant array.

19. The method of claim 18, wherein identifying one or more types of analytes from the sample comprises identifying multiple types of analytes from the sample, and the method further comprises: quantifying concentrations of the multiple types of analytes identified.

20. The method of claim 18 or claim 19, wherein engaging the top component of the analysis system with the cap on the sample container is configured to break a seal fluidly isolating the reactant array from the fluid in the sample container to place the reactant array in fluid communication with the fluid in the sample container.

Images