Device, method and system for measuring and recording reactant arrays
The cartridge-based system with a colorimetric sensor array and pump mechanism addresses inefficiencies in existing devices by ensuring efficient analyte interaction and preventing contamination through closed-loop design and single-use features.
Patent Information
- Application Number
- JP2025533387
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-12-09
- Filing Date
- 2023-12-08
- Publication Date
- 2026-01-14
AI Technical Summary
Existing sensing and analysis devices for fluid analysis lack improvements in efficiency, contamination prevention, and reusability, particularly in the context of colorimetric sensor arrays.
A cartridge-based system with a colorimetric sensor array, input and output ports, and a fluid pathway, optionally forming a closed-loop system, combined with a pump mechanism and single-use features to enhance interaction with analytes and prevent contamination.
The system ensures efficient interaction of analytes with reactants, minimizes contamination risk, and prevents cross-contamination by using disposable cartridges, thereby improving analysis accuracy and safety.
Smart Images

Figure 2026501132000001_ABST
Abstract
Description
[Technical Field]
[0001] The present disclosure relates to sensing and analytical tools, etc. More particularly, the present disclosure relates to devices and systems for sensing and analyzing chemicals, and methods for making and using such devices. [Background technology]
[0002] A wide variety of devices have been developed for sample collection, storage, sensing, and analysis. These devices can be manufactured by any one of a variety of different manufacturing methods and used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. Summary of the Invention [Problem to be solved by the invention]
[0003] The present disclosure provides design, material, manufacturing methods, and use alternatives for sensing and analysis devices. It should be noted that collection, storage, sensing, and analysis techniques and systems are known, but there is a need for improvements to these techniques and systems. [Means for solving the problem]
[0004] An exemplary system may include a cartridge and a device for analyzing the colorimetric sensor array when the cartridge is received within the device, and the cartridge may include the colorimetric sensor array, an input port, an output port, and a pathway configured to be in fluid communication with the input port, the output port, and the colorimetric sensor array.
[0005] Alternatively or additionally to any of the embodiments in this section, the pathway may be configured to be in fluid communication with the target region. Alternatively or in addition to any of the embodiments in this section, the cartridge and device may define a pathway configured to be fluidly connected to the target area, forming a closed-loop system that returns fluid passing over the colorimetric sensor array to the target area.
[0006] Alternatively or additionally to any of the embodiments in this section, the cartridge may be a single-use component and the device may be a reusable component. Alternatively or additionally to any of the embodiments in this section, the device for analyzing the colorimetric sensor array may include a pump driving component, and the cartridge may include a pump driven component configured to be driven by the pump driving component when the cartridge is placed in the device to analyze the colorimetric sensor array.
[0007] In another example, a cartridge for use with a device for analyzing a colorimetric sensor array may include a colorimetric sensor array, a pathway extending across the colorimetric sensor array, the pathway configured to receive fluid from a target area, and a single-use feature configured to prevent the colorimetric sensor array from being reused.
[0008] Alternatively or in addition to any of the embodiments in this section, the single-use feature may be an electrical single-use feature. Alternatively or additionally to any of the embodiments in this section, the single use feature may be a mechanical single use feature. Alternatively or in addition to any of the embodiments in this section, the single-use feature may be one or more of the following types of single-use feature: mechanical single-use feature, electrical single-use feature, optical single-use feature, chemical single-use feature, magnetic single-use feature, and electromechanical single-use feature.
[0009] Alternatively or additionally to any of the embodiments in this section, the colorimetric sensor array may include a substrate. Alternatively or additionally to any of the embodiments in this section, the substrate may be configured to filter undesirable molecules from the fluid.
[0010] Alternatively or additionally to any of the embodiments in this section, the system may further include a filter in the pathway, which may be configured to filter undesirable molecules from the fluid.
[0011] In another example, a cartridge for use with a device for analyzing a colorimetric sensor array may include a substrate, an array of reactants applied to the substrate, and a pathway extending across the array of reactants, the pathway configured to receive fluid from a target area, wherein the substrate may be configured to filter undesirable molecules from the fluid.
[0012] In another example, a cartridge for use with a device for analyzing a colorimetric sensor array may include a colorimetric sensor array, a pathway extending over the colorimetric sensor array, the pathway configured to receive fluid from a target area, and a filter in the pathway, the filter configured to filter undesirable molecules from the fluid.
[0013] In another example, a system may include a cartridge including a colorimetric sensor array, an input port, an output port, and a flexible membrane, the cartridge including a pathway configured to be fluidically connected to the input port, the output port, the colorimetric sensor array, and the flexible membrane; a device for analyzing the colorimetric sensor array when the cartridge is received within the device; and a pump configured to apply a force to the flexible membrane to pump fluid along the pathway and along the colorimetric sensor array.
[0014] In another example, a system may include a cartridge including a reactant array, an input port, an output port, and a pump component between the input port and the output port; and a device for analyzing the reactant array when the cartridge is received within the device, wherein the device may be configured to engage the pump component to pump fluid through a pathway in fluid communication with the input port, the output port, and the reactant array.
[0015] Alternatively or additionally to any of the embodiments in this section, the pump components may be fluidly isolated from the pathway. Alternatively or additionally to any of the embodiments in this section, the device may include an actuator configured to actuate the pump component.
[0016] Alternatively or additionally to any of the embodiments in this section, the pump component may include an impeller. Alternatively or additionally to any of the embodiments in this section, the pump component may include a piezoelectric diaphragm configured to electrically connect to the device.
[0017] Alternatively or additionally to any of the embodiments in this section, the pump component may include a flexible diaphragm that at least partially defines the pathway. Alternatively or additionally to any of the embodiments in this section, the device may include a driving component configured to engage the flexible diaphragm to pump fluid through the pathway.
[0018] Alternatively or additionally to any of the embodiments in this section, the system may further include a first valve and a second valve, wherein the first valve may be configured to open and the second valve may be configured to close in response to a first movement of the flexible diaphragm, and wherein the first valve may be configured to close and the second valve may be configured to open in response to a second movement of the flexible diaphragm.
[0019] Alternatively or additionally to any of the embodiments in this section, the pathway may be configured to be in fluid communication with the target area, and the cartridge defines the pathway so as to be in fluid communication with the target area, forming a closed loop system that returns fluid transferred to the reactant array to the target area.
[0020] Alternatively or additionally to any of the embodiments in this section, the cartridge may be a single-use component and the device may be a reusable component. Alternatively or additionally to any of the embodiments in this section, the cartridge may include one or more seals configured to seal the input and output ports to hermetically seal the reactant array within the cartridge.
[0021] Alternatively or additionally to any of the embodiments in this section, the device for analyzing a reactant array may include a pump driving component, and the pump component of the cartridge may be a pump driven component configured to be driven by the pump driving component when the cartridge is placed in the device for analyzing the reactant array.
[0022] Alternatively or additionally to any of the embodiments in this section, the cartridge may include a cartridge housing containing the reactant array and the pump component, and the device may include a device housing configured to at least partially receive the cartridge housing.
[0023] In another example, a cartridge for use with a device for analyzing a reactant array may include a reactant array, a pathway extending to the reactant array, the pathway configured to receive fluid from a target area, and a driven pump component configured to engage a driving pump component of the device for analyzing the reactant array to pump fluid through the pathway to the reactant array.
[0024] Alternatively or additionally to any of the embodiments in this section, the driven pump component may be fluidly isolated from the pathway. Alternatively or additionally to any of the embodiments in this section, the driven pump component may be selected from the group consisting of a flexible diaphragm, a rotor, a piezoelectric element, an Archimedes screw pump, and a plunger.
[0025] Alternatively or additionally to any of the embodiments in this section, the cartridge may further include a single-use component configured to prevent the reactant array from being reused.
[0026] Alternatively or in addition to any of the embodiments in this section, the single-use components may include one or more of the following types of single-use components: mechanical single-use components, electrical single-use components, optical single-use components, chemical single-use components, magnetic single-use components, and electromechanical single-use components.
[0027] Alternatively or additionally to any of the embodiments in this section, the cartridge may further include a filter in the path, which may be configured to remove undesirable molecules from the fluid.
[0028] Alternatively or additionally to any of the embodiments in this section, the reactant array may include a substrate and an array of reactants applied to the substrate, where the substrate may be a filter. In another example, a system may include a cartridge including a reactant array, an input port, an output port, and a flexible membrane, the cartridge including a pathway configured to be fluidically connected to the input port, the output port, the reactant array, and the flexible membrane; a device for analyzing the reactant array when the cartridge is received within the device; and a pump configured to apply a force to the flexible membrane to pump fluid along the pathway and along the reactant array.
[0029] Alternatively or additionally to any of the embodiments in this section, the cartridge may include pump components. The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation in the present disclosure. The following figures and detailed description more particularly exemplify these embodiments.
[0030] The present disclosure may be more fully understood from the following detailed description considered in conjunction with the accompanying drawings. [Brief explanation of the drawings]
[0031] [Figure 1] FIG. 1 is a schematic diagram of an exemplary sensing system. [Figure 2] FIG. 1 is a schematic diagram of an exemplary computing system. [Figure 3] FIG. 1 is a schematic diagram of an exemplary sensing system in a user's hand. [Figure 4] FIG. 1 is a schematic top view of an exemplary sensing system. [Figure 5A] 1A and 1B are schematic top and side views, respectively, of an exemplary sensing system; [Figure 5B] 1A and 1B are schematic top and side views, respectively, of an exemplary sensing system; [Figure 6] FIG. 1 is a schematic side view of an exemplary sensing system. [Figure 7] FIG. 1 is a schematic side view of an exemplary sensing system. [Figure 8] FIG. 1 is a schematic top view of an exemplary sensing system. [Figure 9] 1 is a schematic perspective view of an exemplary cartridge. [Figure 10] FIG. 10 is a schematic cross-sectional view of the exemplary cartridge of FIG. 9 with a sample source coupled thereto. [Figure 11] FIG. 10 is a schematic top view of the exemplary cartridge of FIG. 9 with a sample source coupled thereto. [Figure 12] FIG. 2 is a schematic top view of an exemplary cartridge. [Figure 13A]10A-10C illustrate schematic diagrams of exemplary techniques for pumping fluid through a cartridge. [Figure 13B] 10A-10C illustrate schematic diagrams of exemplary techniques for pumping fluid through a cartridge. [Figure 13C] 10A-10C illustrate schematic diagrams of exemplary techniques for pumping fluid through a cartridge. [Figure 14A] 10A-10C illustrate schematic diagrams of exemplary techniques for pumping fluid through a cartridge. [Figure 14B] 10A-10C illustrate schematic diagrams of exemplary techniques for pumping fluid through a cartridge. [Figure 15] 1 is a schematic diagram of an exemplary technique for analyzing a colorimetric sensor array. DETAILED DESCRIPTION OF THE INVENTION
[0032] While the present disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the invention is not intended to be limited to the particular embodiments described. Rather, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.
[0033] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. The term "fluid" includes both liquids and gases.
[0034] All numerical values are assumed herein to be modified by the term "about," whether expressly stated or not. The term "about" generally refers to a range of numbers that one of ordinary 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.
[0035] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.
[0036] It should be noted that references herein to "one configuration," "several configurations," "other configurations," etc. indicate that the described configurations may include one or more particular features, structures, and / or characteristics. However, such descriptions do not necessarily imply that all embodiments include the particular feature, structure, and / or characteristic. Additionally, if a particular feature, structure, and / or characteristic is described in connection with one configuration, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other configurations, whether or not explicitly described, unless expressly stated otherwise.
[0037] The following detailed description should be read with reference to the drawings, in which like 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 present disclosure. Additionally, it should be noted that in any given drawing, some features may not be shown or may be shown in schematic form for clarity and / or simplicity. Additional details regarding some components and / or method steps may be shown in more detail in other drawings. The devices and / or methods disclosed herein may provide several desirable features and advantages, as described in more detail below.
[0038] Fluids having concentrations of volatile compounds (e.g., volatile organic compounds (VOCs)) and / or gases, which may or may not be harmful, may be sensed, analyzed, and / or monitored. Sensing, analyzing, and / or monitoring of fluids using 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 hazard warnings, manufacturing process or quality control, record keeping, archival purposes, product development, product-to-consumer matching, etc.
[0039] In some cases, VOCs and / or gases are present in ambient fluids (e.g., ambient air, etc.) and can be sensed, analyzed, and / or monitored using reactive agents for real-time alerts, to treat subjects, or to collect and / or archive data for health records, regulatory compliance records, etc. Additionally, a subject (e.g., VOCs and / or gases exhaled or emitted, exhaled, effused, emitted, and / or secreted from a subject (e.g., a human, a non-human animal, food, produce, meat, a pathogen, bacteria (e.g., good and / or bad bacteria), plants, a wound, an ulcer, a surgical site, a subject's skin, a subject's mouth, a subject's nasal cavity, a subject's sinuses, a subject's rectal area, a subject's vaginal area, a subject's genital area, a subject's ear canal, a subject's pores, etc.) may be sensed, analyzed, and / or monitored to assess harmful, dangerous, or illegal substances in or at the subject or target site, the subject's lung condition, a blood disorder condition, an infection condition, a condition related to a disease or biological condition, a condition related to overall body health, a condition related to the flavor of food, a condition related to a perfume or odor, and / or other suitable condition.
[0040] Systems discussed herein for sensing, analyzing, and / or monitoring fluids (e.g., for analytes of interest) may be configured to accurately detect and record the spectral response of a colorimetric sensor array (CSA) to exposure to the fluid. The systems may employ techniques to noninvasively detect one or more analytes of interest (e.g., one or more pathogens responsible for certain human skin infections, including, but not limited to, skin infections, urinary tract infections (UTIs), vaginitis, wound infections, ulcers, etc., and / or other suitable analytes) from the fluid using the CSA to enable early detection and implementation of protocols to address one or more conditions associated with any sensed analytes of interest. In one example, improved classification of one or more analytes using the systems described herein may enable detection and identification of the causative pathogen at a very early stage of a dangerous skin infection, which may result in a high level of protection and probability of a favorable outcome for the subject.
[0041] An analytical system (e.g., a CSA analytical system) can include a housing or cartridge containing a reactant array (e.g., a CSA having a reactant array) and a device for reading or analyzing the reactant array in the cartridge before, during, and / or after the reactant array is exposed to a fluid. The device for analyzing the reactant array (e.g., a reading device) can be or include a spectrometer, an image sensor, and / or other suitable image or light collector / sensor. In some cases, the device can be configured to be a handheld or benchtop device. Furthermore, a device for analyzing a reactant array can be configured to be easy to use, minimize human error, reduce sample cross-contamination, and reduce human risk of exposure to analytes received in the device.
[0042] In operation, a housing or cartridge containing a reactant array can be placed into a device (e.g., via an opening in the device) to analyze the reactant array before, during, and / or after exposure to a fluid for optimal image / reflectometry analysis of the reactant array. That is, analysis of the reactant array in the cartridge can include analyzing the reactant array before exposure to the fluid, during exposure to the fluid, and / or after exposure to the fluid is complete. Once analysis of the reactant array in the cartridge is complete, the cartridge can be removed from the device to analyze the reactant array and discarded. Making the cartridge disposable can prevent cross-contamination and erroneous analysis of the CSA (e.g., due to previous fluid remaining in the tubing and re-flowing over the reactant array and undesirably into the body, etc.).
[0043] The cartridge may be any suitable component containing one or more reactant arrays (e.g., where the reactant arrays may be permanent or removable from the cartridge) and may be configured to expose the one or more reactant arrays to fluid from a target area or site. In one example, the cartridge may be a flow cell and may have an input port for accepting fluid (e.g., fluid from a target area or site) over and / or through the one or more reactant arrays and an output port for outputting fluid that has passed through and / or over the one or more reactant arrays. As the fluid passes through and / or over the reactant arrays, the fluid may interact with the reactant chemistries of the reactant arrays (e.g., color bars, color dots, predetermined patterns, and / or other suitable reactants), and the reactants may respond to the interaction (e.g., change color in response to the interaction and / or react in one or more other suitable ways). A spectrometer or other suitable light or image sensor may then read or otherwise analyze the reaction of the reactants to the fluid, and determine properties of the fluid based on the analysis of the reaction.
[0044] A CSA including a reactant array may include a membrane or substrate onto which or to which reactants are applied to form the reactant array. In some cases, all or at least a portion of the membrane or substrate may function as a filter to filter out molecules of no interest from the fluid flowing over and / or through the reactants of the CSA, facilitating the delivery of analyte molecules of interest to the reactants in a concentration appropriate for contacting the reactants with the analyte to be reacted. A membrane or substrate configured to act as a filter may be made from any suitable material, including, but not limited to, biopolymer-based filtration materials, adsorbent materials, and / or other suitable materials. In some examples, the membrane may be configured to interact with specific molecules to enhance reactivity between the reactants and the fluid passing through the pathway and / or to modify the incoming analyte into different components for greater sensitivity. The membrane or substrate may be sized, shaped, and / or configured differently to accommodate the filtering of different molecules. Some variables that can be adjusted to filter out undesired molecules include, but are not limited to, the substrate or membrane material, the pore size of the substrate or membrane, the pore concentration in the substrate or member, and the pore location in the substrate or membrane.
[0045] In addition to or instead of configuring the membrane or substrate of the CSA to filter molecules from fluids containing, or at least potentially containing, the analyte of interest, the cartridge of the analytical system may include one or more filters in the fluid pathway to remove undesired molecules from the fluid passing through the fluid pathway and allow desired molecules to pass through the filter. In some examples, the filters may be configured to interact with specific molecules to modify the incoming analyte into different components to enhance reactivity between the reactant and the fluid passing through the pathway and / or to provide greater sensitivity. Filters may be sized, shaped, and / or configured differently to accommodate the filtration of different molecules. Some variables that may be adjusted to configure a filter include, but are not limited to, the filter material, the filter pore size, the filter pore density, the filter pore location, etc.
[0046] To supply fluid to and remove fluid from the reactant array, the tubing may connect at its first end to a port on the cartridge and / or may be formed integrally with (e.g., as part of) the port on the cartridge. The tubing coupled to or formed integrally with the port may be coupled to a collector for analytes and / or may be in fluid communication with fluid at or from a target area (e.g., an area of interest where analytes may be located). Additionally or alternatively, to facilitate supplying fluid from the sample or target area to the CSA, a specimen containing a sample from the target area and / or a carrier containing a sample from the target area may be coupled to or inserted into the cartridge, and the sample may be obtained from the collector, although this is not required.Exemplary collectors of concentrators for collecting analytes and / or systems for collecting analytes include PCT International Publication No. WO 2022 / 072827A1, filed October 1, 2021, entitled "Devices, Methods, and Systems to Collect, Store, and Analyze Chemical Substances," which is incorporated herein by reference in its entirety for all purposes; PCT International Publication No. WO 2022 / 072827A1, filed November 5, 2021, entitled "Devices, Methods, and Systems to Collect, Store, and Analyze Chemical Substances," which is incorporated herein by reference in its entirety for all purposes; and PCT International Publication No. WO 2022 / 133276 A1, filed December 17, 2021, entitled "DEVICES, METHODS AND SYSTEMS TO COLLECT, CONCENTRATE, STORE, AND ANALYZE CHEMICAL SUBSTANCES," which are incorporated herein by reference in their entireties for all purposes.
[0047] The cartridge can be placed in a device (e.g., through an opening in the device) to analyze the reactant array before, during, and / or after exposure to fluid for optimal image / reflectometry analysis of the reactant array. That is, analysis of the reactant array in the cartridge can include analyzing the reactant array before exposure to fluid, during exposure to fluid, and / or after exposure to fluid is complete. Once analysis of the reactant array in the cartridge is complete, the cartridge and its associated or associated tubing (or specimen or carrier) can be removed from the device to analyze the reactant array and discarded or cleaned for reuse (e.g., the reactant array can be discarded and the cartridge can be cleaned). Making the cartridge and tubing disposable can prevent cross-contamination and erroneous analysis of the CSA (e.g., due to previous fluid remaining in the tubing and re-flowing over the CSA and undesirably into the human body).
[0048] To prevent contamination due to cartridge reuse, the cartridge may include a single-use feature that indicates whether the cartridge has been previously used for a fluid analysis. In some configurations, the single-use feature, if included, may be or include at least one visual or other indicator that indicates that the cartridge has been used for a fluid analysis, in which case a device configured to analyze the reactant array of the cartridge can prevent use of the cartridge if it determines from the indicator that the cartridge has been used.
[0049] The analytical system may be an open-loop system or a closed-loop system. In an open-loop system, a fluid stream (e.g., a stream of nitrogen, a gas of known relative humidity, ambient air, and / or other suitable gas) may pass over a target area (e.g., an infected area and / or other suitable target area), after which the fluid stream transports analytes (e.g., produced and / or otherwise released by bacteria) present in or from the target area to the cartridge and over and / or through a reactant array, causing the reactants on the reactant array to react with the analyte, which is then output to waste (e.g., to the atmosphere, a waste collection component, and / or other suitable component). Because the analyte passes over or through the reactant array only once, open-loop systems, as described and otherwise, may be inefficient due to the fact that not all of the analyte present in the flowing fluid interacts with the reactants on the reactant array.
[0050] To maximize interaction of the analyte with the reactants of the reactant array and minimize discharge of the analyte into the surrounding environment and / or waste container, the output or outlet of the cartridge may be connected back to the target site and / or input of the cartridge to increase the concentration of analyte on or through the reactant array. Although other configurations are possible, an exemplary closed-loop cartridge or fluid sensing system is described in PCT Publication No. WO 2022 / 099021 A1, which is incorporated herein by reference in its entirety for all purposes.
[0051] To facilitate movement of fluid from the collector, specimen, carrier, or target area (e.g., from the sample source), and / or for other suitable purposes, an in-line pump and / or a tank or cylinder of gas (e.g., N2 and / or other suitable gas) may be utilized to push and / or pull fluid from the target area or collector through the tubing and / or cartridge, forcing the fluid over and / or through the CSA. Because contamination can occur due to the use of a pump in contact with fluid within tubing and reusable tubing and / or other reusable tubing in the cartridge and / or device for analyzing the CSA, the reusable pump may be configured to be isolated from the fluid to reduce the risk of contamination.
[0052] The pump or pumping components of the pump isolated from the fluid in the tubing and / or cartridge may be configured in any suitable manner. In one exemplary configuration, at least a portion of the pump may be part of a device for analyzing a reactant array and may be configured to interact with a flexible portion of the tubing and / or a cartridge received in the device. For example, a portion of the pump may act (e.g., with peristaltic or other suitable motion) on a flexible portion of the tubing and / or a cartridge received in the device (e.g., a diaphragm) to pump fluid through the cartridge. In another example, a portion of the pump may be integrated into or part of the cartridge (e.g., a flexible diaphragm, or part of the pump and / or other part), and a portion of the pump may be integrated into or part of a device for analyzing a reactant array. For example, an impeller, propeller, Archimedes' screw pump, piezoelectric mechanism, plunger, diaphragm, and / or other suitable driven component may be integrated into the cartridge and configured to engage a drive component of a device for analyzing a reactant array. In some cases, a mandrel or rod defining or communicating with the driven component of the cartridge protrudes from the cartridge while maintaining an airtight seal around the fluid within the cartridge and engages a motor (e.g., a drive component) within the device for analyzing the reactant array, the motor being configured to move the mandrel or rod (e.g., rotationally, axially, etc.) and accordingly drive the driven component of the cartridge (e.g., rotationally, axially, etc.).Additionally or alternatively, the cartridge may include mechanical contacts (e.g., manually or automatically actuated flexible diaphragms, plugs, plug receptacles, etc.), electrical contacts (e.g., metallic components or other suitable conductive components), optical contacts, and / or magnetic contacts that engage associated mechanical contacts (e.g., flexible membranes, rigid actuators, etc.), electrical contacts, optical contacts, and / or magnetic contacts on the device for analyzing the reactant array, such that driven components of the pump (e.g., piezoelectric components, flexible diaphragms, fluid in flexible reservoirs, etc.) are actuated in response to engagement of the respective contacts and / or signals passing between the contacts. Such mechanical, electrical, optical, and / or magnetic contacts may allow for avoidance of leak points, for example, at openings in the cartridge through which the mandrel may extend.
[0053] Returning to the drawings, FIG. 1 shows a schematic diagram of an exemplary system 10 for analyzing a reactant array. System 10 may include, among other components, a cartridge 12 having a reactant array 18 and a reading device 14 (e.g., a CSA or a device for analyzing reactant array 18) configured to monitor and / or analyze the reactant array 18. In some configurations, system 10 may include a sample source 16 configured to collect, acquire, and / or provide a sample (e.g., a solid, a fluid, etc.) from a target area (e.g., a wound, pollen from a flower, an infection, breath exhaled from a subject, sweat glands, etc.) for analysis using cartridge 12 and / or reading device 14. While exemplary sizes, shapes, and configurations of cartridge 12, reading device 14, sample source 16, and their components are discussed and illustrated herein, cartridge 12, reading device 14, sample source 16, and their components may have any suitable shape, size, and / or configuration.
[0054] Cartridge 12 may have any suitable configuration and may include any suitable components configured to facilitate receiving fluid from sample source 16, sensing analytes in the fluid from sample source 16, and interfacing with reading device 14. Exemplary components of cartridge 12 include, but are not limited to, one or more reactant arrays 18, one or more input / output (I / O) ports 20, one or more fluid paths 22, one or more pump components 24, and / or one or more other suitable components and / or configurations. Components that the cartridge 12 may include, but are not shown in FIG. 1 , include a housing, a window for viewing the reactant array 18, one or more compartments, one or more gaskets or other features for hermetically sealing the one or more compartments, one or more access openings extending between the compartments and the exterior of the housing, one or more seals configured to seal the I / O ports 20, valves, caps (e.g., snap caps, screw caps, plug caps, etc.), foils, puncturable membranes, one or more doors or lids, one or more motors for pumping fluid to the reactant array 18, tubing, one or more filters, one or more diaphragms or membranes, one or more single-use components, and / or other suitable components.
[0055] 1 , cartridge 12 may include a housing, which may be configured to completely or at least partially surround or contain reactant array 18 and fluid pathway 22. The housing may be a single component having one or more openings between fluid pathway 22 and the exterior of cartridge 12, and / or may be multiple components defining openings between fluid pathway 22 and the exterior of cartridge 12.
[0056] The housing may be formed in any suitable manner, in some examples, the housing may be formed by one or more molding techniques, injection molding techniques, welding techniques, ultrasonic welding techniques, three-dimensional (3D) printing techniques, and / or other suitable techniques.
[0057] The housing of cartridge 12 may be formed from any suitable material, including, but not limited to, polymer, metal, glass, and / or other suitable types of materials.
[0058] The housing of cartridge 12 may have any suitable shape and / or size configured to receive a fluid and / or sample source and facilitate analysis of the array of reactants in cartridge 12 using reading device 14. For example, cartridge 12 may include a cubic shape, an elongated shape, a rectangular shape, an oval shape, a rounded shape, a circular shape, a spherical shape, and / or other suitable shapes.
[0059] The reactive agent array 18 may be any suitable array of one or more reactive agents (e.g., analyte-sensitive materials), and the reactive agents of the reactive agent array 18 may be formed from any suitable material. In some cases, the reactive agent array 18 may be part of or form a colorimetric sensor array (CSA). The cartridge 12 (e.g., the housing of the cartridge 12) may be configured to completely or at least partially contain or enclose the reactive agent array 18 (e.g., to contain a CSA that includes the reactive agent array 18).
[0060] The reactant materials of the reactant array 18 may be reversible (e.g., reusable), semi-reversible, or non-reversible (e.g., single-use). In some examples, the reactant materials may be optically responsive chemical materials (e.g., chemically responsive materials) that change color in response to the detection of one or more analytes (e.g., volatile compounds, gases, liquids, and / or other fluids) in a fluid to which the reactant is exposed, although other suitable materials are contemplated. Examples of suitable materials for the reactant include, but are not limited to, dyes from the following classes: Lewis acid / base dyes (e.g., metal-containing dyes), Bronsted 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 types of dyes. One example of a reactant material may be a silver nanoparticle material. Other suitable materials for the reactant are contemplated, including printed dyes or reactant materials other than optically responsive chemical materials.
[0061] The reactants of the reactant array 18 may be applied to a substrate. If the reactant array 18 forms or is part of a CSA, the substrate may or may not be part of the CSA. Additionally or alternatively, the substrate may be the cartridge 12 (e.g., the housing of the cartridge and / or other suitable component of the cartridge) or a component configured to be received within the cartridge 12 (e.g., within one or more of the compartments of the cartridge 12).
[0062] The reactants of the reactant array 18 may be applied to the substrate in any suitable manner. In one example, the reactants may be applied to the substrate by printing the reactants (e.g., reactant material) onto the substrate. If printed, any suitable printing technique may be utilized, including, but not limited to, pin transfer, inkjet, silkscreen, and / or other suitable application techniques.
[0063] The reactive agents may be applied to the substrate randomly and / or to form one or more patterns. Exemplary configurations of reactive agents in a reactive agent array applied to a substrate include, but are not limited to, a grid pattern of rows and columns, concentric rings, color matching of the color of the printed dye material with the color of the substrate material prior to interaction with the analyte, a pattern that results in a distinguishable shape when the analyte-sensitive material reacts with a particular analyte, other suitable configurations, and / or combinations thereof.
[0064] The one or more I / O ports 20 may be any suitable type of port, and the input and output ports may be similar or different from one another. The one or more input ports may be any suitable port configured to receive fluid from the sample source 16 and facilitate fluidly coupling the sample source 16 to the fluid pathway 22. The one or more output ports may be any suitable port configured to output fluid from the fluid pathway 22 and facilitate fluidly coupling the fluid pathway 22 to a waste location (e.g., the environment, a waste container, etc.) and / or the sample source 16. In some configurations, the I / O ports 20 may be configured to couple to or be in fluid communication with tubing of at least a portion of the sample source 16, one or more carriers containing a sample, one or more specimens having a sample thereon, and / or other suitable sample source 16.
[0065] The I / O port 20 may be configured to couple to a component of the sample source 16 or a component in communication with the sample source 16 or a waste location in any suitable manner. For example, the I / O port 20 may be configured to couple to one or more components using a friction fit, luer lock, ball detent, threads, bayonet lock, O-ring, and / or other suitable coupling techniques. In some examples, the coupling between the I / O port 20 and a component of the sample source 16 or waste location or a component in communication therewith may be a fluid-tight coupling, although other suitable configurations are contemplated. In one example, a tubing set connector may be coupled to the I / O port 20 using a fluid-tight friction fit connection. In another example, a tubing set connector may be coupled to the I / O port 20 using a fluid-tight luer lock connection.
[0066] One or more seals and / or valves may be disposed at or within the I / O port 20. The seals and / or valves may be configured to fluidly seal (e.g., hermetically seal) the fluid path 22 from the surrounding environment before, during, and / or after the sample source 16 engages the I / O port 20.
[0067] 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 that may be positioned across the fluid path of the I / O port 20. One or more valves may include a slit or other access location that is biased to close and that may open upon engagement with the sample source 16. If the sample source 16 or a component in communication with the sample source 16 extends through the valve, the valve may be configured to seal around the sample source 16, although this is not required.
[0068] Instead of or in addition to utilizing a valve, one or more seals (e.g., single-use seals such as foil seals, rupturable membranes, and / or other suitable seals) may be utilized at or adjacent to I / O port 20 to seal fluid pathway 22 from the surrounding environment. In some examples, the single-use seal may extend across an opening or pathway through I / O port 20 and may be punctured or broken in response to coupling tubing or other components to I / O port 20. In some examples, the single-use seal may be a peel seal configured to be peeled from I / O port 20 prior to coupling tubing and / or other components to I / O port 20.
[0069] One or more fluid pathways 22 of cartridge 12 may extend from an input port to an output port of I / O port 20 and may or may not include a fluid pathway through I / O port 20. Fluid pathway 22 may include a tubing portion, a compartment portion, a pump portion, a combination of portions (e.g., a tubing portion and a pump portion may be the same portion of fluid pathway 22), and / or other suitable portions. In some examples, fluid pathway 22 may include a tubing portion, a pump portion, and a compartment portion, where the tubing portion may include one or more tubes or compartments that define fluid pathway 22, and fluid pathway 22 extends from an input port to a pump chamber of the pump portion extending from the tubing portion, or to a pump chamber in the pump portion, through the pump chamber, and into the cartridge portion extending to the output port. The cartridge portion or other suitable portion of fluid pathway 22 may include a reactant array 18. In some examples, fluid pathway 22 can include tubing segments and compartment segments, and the tubing segments can include one or more tubes or compartments that define fluid pathway 22 from an input port to a compartment segment that extends from the tubing segment to an output port, such that a pump can engage the tubing segment to pump fluid from the input port, through the tubing segment, onto or to the reactant array 18 in the compartment segment, and out the output port. In some examples, fluid pathway 22 can include tubing segments that extend from an input port to an output port, and the tubing segment can include one or more tubes that define fluid pathway 22, and a pump can engage the tubing segment to pump fluid from the input port, through the tubing segment, to the reactant array within the tubing segment.
[0070] Although the fluid path 22 is shown in the figures as passing through the pump components and through the reactant array 18, it is contemplated that the fluid path 22 may pass through the reactant array 18 before passing through the pump components. Additionally or alternatively, the fluid path 22 may direct fluid over the reactant array 18 from one or more directions, as desired. In some configurations, the fluid path 22 may be separated to separately flow over and / or through individual reactants of the reactant array 18.
[0071] The tubing of the tubing portion of fluid pathway 22 may be any suitable type of tubing and / or inlet compartment of cartridge 12. The tubing of the tubing portion of fluid pathway 22, if included, may be flexible, resilient, pliable, or rigid, and / or may have one or more other suitable properties. In some examples, at least a portion of the tubing portion may be a flexible, pliable, and / or elastic material, in which case the flexible, pliable, and / or elastic material may be a diaphragm or membrane that interacts with a pump component to facilitate pumping fluid through fluid pathway 22. Alternatively or additionally, at least a portion of the tubing portion may be comprised of a channel within the housing of cartridge 12. Other suitable configurations are contemplated.
[0072] The pumping portion of fluid pathway 22 may be formed in any suitable manner. In some examples, the pumping portion of fluid pathway 22 may include a pumping chamber, a diaphragm, a piston, and / or other suitable pumping components. In one example, the pump portion of fluid pathway 22 may include a pumping chamber that receives fluid from the tubing portion and supplies fluid to the compartment portion, and a pump component fluidically isolated from fluid pathway 22 may act on the diaphragm to draw fluid into and / or output fluid from the pumping chamber. If included, the pumping chamber may be at least partially defined by the housing, the diaphragm, the piston, and / or other suitable components of cartridge 12.
[0073] The compartment portion of fluid pathway 22 may include one or more compartments and may be defined completely or at least partially by the housing and / or other suitable components of cartridge 12. The one or more compartments may be sized or configured to contain or accept fluid from reactant array 18, an upstream portion of fluid pathway 22 (e.g., an input port, a tubing portion, a pump portion, etc.), and to output fluid through an output port.
[0074] Although not shown in FIG. 1 , cartridge 12 may include one or more filters within fluid pathway 22 and / or I / O port 20. One or more filters may be located in tubing, pump, compartment, and / or other portions of fluid pathway 22. In some examples, one or more filters may be configured to remove undesirable molecules from fluid passing through fluid pathway 22 and allow desirable molecules to pass through the filter. In some examples, one or more filters may be configured to interact with specific molecules to alter the incoming fluid and / or its analytes into different components to enhance reactivity between the passing fluid and reactant array 18 and / or to provide greater sensitivity at reactant array 18. Filters may be sized, shaped, doped, or impregnated with different components and / or configured in different ways to accommodate filtering out different molecules. Some variables that may be adjusted to configure a filter include, but are not limited to, the filter material, the filter pore size, the filter pore density, and the filter pore location.
[0075] One or more valves may be located in the fluid pathway 22. In some examples, valves or valve components may extend between portions of the fluid pathway 22, although other suitable configurations are contemplated. Exemplary suitable valves include, but are not limited to, check valves, one-way valves, rubber flaps, plastic flaps, ball / spring valves, umbrella valves, and / or other suitable types of valves.
[0076] The cartridge may include a pump or at least one or more pumping components 24. In some cases, the pump or at least one or more pumping components 24 of the cartridge 12 may be fluidly isolated from the fluid moving through the fluid path 22. Alternatively or additionally, the pump or at least one or more pumping components 24 may be in fluid communication with the fluid moving through the fluid path 22.
[0077] The pumping component 24 may be any suitable component configured to facilitate moving fluid along the fluid path 22. Exemplary suitable pump components 24 include, but are not limited to, a flexible diaphragm or portion of tubing defining the fluid path 22, a flexible diaphragm, an impeller, a bellows, a propeller, an Archimedes screw pump, a piezoelectric mechanism, a plunger, a piston, an axle or extension, a coupler for coupling to other pump components, and / or other suitable pump components. In some configurations, the pump component 24 may be a driven component configured to be driven by a drive component of the reading device 14. For example, a driven component (e.g., an impeller, a propeller, an Archimedes screw pump, a piezoelectric mechanism, a plunger, and / or other suitable driven component) may be integrated into the cartridge 12 and configured to engage a drive component (e.g., a motor, an actuator, a drive shaft, etc.) of the reading device 14. In some examples, a stem defining or in communication with the driven component of cartridge 12 may protrude from cartridge 12 while maintaining an airtight seal around the fluid in fluid path 22 and engage a motor or drive shaft (e.g., drive component) in reading device 14, which may be configured to drive (e.g., rotate) the stem to move the driven component of cartridge 12. Additionally or alternatively, cartridge 12 may include mechanical contacts (e.g., manually or automatically actuated flexible diaphragms, etc.), electrical contacts (e.g., metallic components or other suitable conductive components), and / or magnetic contacts that engage (e.g., directly or indirectly) with associated mechanical, electrical, and / or magnetic contacts on reading device 14, such that the driven component of cartridge 12 may be actuated in response to engagement of and / or signals passing between the respective contacts. Such mechanical, electrical, and / or magnetic contacts may make it possible to avoid leak points, for example at the opening in the cartridge through which the mandrel may extend.
[0078] Cartridge 12 may include single-use components configured to prevent contamination due to cartridge reuse. In some cases, the single-use components may be mechanical, electrical, electromechanical, optical, chemical, magnetic, and / or other suitable types of single-use features, depending on whether the cartridge 12 is used with a single-use or reusable reading device 14 to analyze the reactant array 18. In one example of a single-use component for cartridge 12, an electronic single-use component may be embedded within cartridge 12 and recognized by reading device 14 as intact or broken to indicate whether cartridge 12 is new or used. Exemplary 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. If a memory device is used as a single-use component of cartridge 12, the memory device may be accessed and modified by reading device 14 after cartridge 12 is inserted into reading device 14. If a fuse is used as a single-use component, the fuse may be destroyed (e.g., via excessive current or in other suitable manner) after the reading device 14 analyzes the reactant array 18, in which case the reading device 14 may be configured to identify the destroyed fuse and prevent the cartridge 12 having the destroyed fuse from being used in subsequent analyses. Additionally, the single-use component may be or include at least one visual indicator that can change state after use with the reading device 14 and that can be captured by an image capture sequence of the reading device 14, and if the reading device 14 determines from the indicator that the cartridge 12 has been used, the reading device 14 may prevent use of the cartridge 12.
[0079] In some cases, cartridge 12 may be reusable. For example, if reactant array 18 and / or other components (e.g., filters, etc.) of cartridge 12 are used or may be contaminated with received fluids, reactant array 18 and / or other used or contaminated components of cartridge 12 may be removed from cartridge 12, and the remaining components of cartridge 12 may be reused after cleaning, if necessary. In some cases, reactant array 18 includes reversible reactant materials, and reactant array 18 may be reused along with other components of cartridge 12.
[0080] Although cartridge 12 may include a single fluid pathway 22 extending between an input port and an output port and extending to, through, and / or over the reactant array, cartridge 12 may include multiple fluid pathways 22 each configured to carry fluid to the same or different reactant arrays 18. In one example, cartridge 12 may include a first input port, a first output port, a first fluid pathway 22 extending between the first input port and the first output port, and a first reactant array 18 within the first fluid pathway 22, as well as up to nth (e.g., integers greater than 1 and all integers between 1 and nth) input port, nth output port, nth fluid pathway 22 extending between the nth input port and the nth output port, and nth reactant array 18 within the nth fluid pathway 22. Additionally, in some configurations, multiple fluid paths 22 can share a pump component 24, and / or one or more pump components 24 may be configured to interact with the first through nth fluid paths 22 such that one or more of the first through nth fluid paths 22 has a pump component 24 dedicated to that fluid path 22. When the cartridge 12 is so configured, the cartridge 12 may be configured to be used to analyze multiple different fluids (e.g., fluids from different or the same sample) in parallel or simultaneously using one or more reading devices 14.
[0081] The sample source 16 may be configured to collect a sample 26 from a target area or to collect and / or deliver fluid from the sample 26 or target area to the cartridge 12, where the sample 26 or target area may exude or be configured to exude an analyte. In some examples, the sample source 16 may be a carrier (e.g., a container, compartment, etc.) configured to receive the sample 26, a specimen (e.g., a swab, a swab with a stick, a sponge, a sample plate, a test strip, etc.) configured to collect a sample from the target area, a collector configured to collect fluid (e.g., fluid containing an analyte) from the target area, a concentrator, and / or other suitable component configured to deliver fluid from the sample to the cartridge. In some examples, the sample source 16 may include or be coupled to tubing configured to transport fluid from the sample source 16 or target area to the cartridge 12, although other suitable configurations are contemplated.
[0082] The reading device 14 may include one or more suitable components for reading and / or analyzing the reactant array 18, which may be within the cartridge 12 or separate from the cartridge 12. Exemplary suitable components of the reading device 14 include, but are not limited to, illumination components, light collection components, one or more light or image sensors 28, one or more cartridge detectors 30, one or more controllers 32, one or more motors 34, one or more light sources, one or more lens sets, one or more pumps, one or more buttons, one or more user interfaces, one or more displays, and / or other suitable components. The controller 32, motor 34, and / or other components of the reading device 14 may be actuators for the pump component 24 of the cartridge 12. In some examples, the reading device 14 may be a benchtop device or a handheld device, each configured to be used with the cartridge 12 discussed herein or elsewhere and / or to analyze its reactant array 18. In some cases, the reading device 14 may be isolated from the sample 26 and / or fluids from the sample 26 or target area, and may be configured for reuse.
[0083] The reading device 14 may be powered using any suitable power source. Exemplary suitable power sources for powering the reading device 14 include, but are not limited to, battery power within the reading device 14, solar power at the reading device 14, wall or line power, and / or other suitable power sources. In some examples, to facilitate forming the reading device 14 in a handheld configuration, the reading device 14 may be powered by one or more batteries and / or by solar power.
[0084] The light sensor or image sensor 28 may be and / or include one or more light collectors of any suitable type. Exemplary 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 photodetector array image sensor, a photodetector array image sensor, a spectrometer, a refractometer, a charge-coupled device (CCD) image sensor, a complementary metal-oxide semiconductor (CMOS) image sensor, a contact image sensor (CIS), a color contact image sensor (CCIS), a camera, other suitable light collectors, and / or combinations of light collectors. In one example, a light collector may include or be a spectrometer configured to measure photons collected (e.g., reflected, transmitted, and / or otherwise received) from a target area. Utilizing a spectrometer can facilitate sensing wavelengths of light with high resolution in the nanometer range and can provide a continuous set of data across a range of wavelengths, thereby enabling analysis of data to identify components of the fluid to which the reactant array 18 is exposed with greater sensitivity than 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 the pixel array direction of the interferograms representing the Fourier transform of the reactant array 18, which may provide sufficient sensitivity while being compact and cost-effective.
[0085] The reading device 14 may include one or more cartridge detectors 30. In some examples, the cartridge detector 30 may be configured to detect when the cartridge 12 is in proximity to and / or accepted by the reading device 14 using mechanical, electrical, optical, magnetic, and / or combinations thereof (e.g., electromechanical, optoelectronic, etc.), or other suitable detection techniques. In one example, the cartridge detector 30 may be a pin or button or other component that physically or mechanically engages the cartridge 12 when the cartridge 12 is inserted into or placed in the reading device 14, and in response, the pin or button or other component adjusts to provide a mechanical and / or electrical indication that the cartridge 12 has been accepted (e.g., a circuit is completed, etc.). Alternatively or additionally, cartridge detector 30 may be an electronic sensor or detector and / or other suitable type of detector that may provide an indication to reading device 14 that cartridge 12 is in proximity to and / or is received within reading device 14 or is not received within reading device 14 (e.g., is properly received within cartridge 12 or is not received within cartridge 12). In some cases, the electronic sensor or detector may sense a signal (e.g., an RF signal) from cartridge 12, sense that cartridge 12 has interrupted a circuit in reading device 14 or cartridge 12, completed a circuit in reading device 14 and / or cartridge 12, and / or sense the presence of cartridge 12 in one or more other suitable manners.
[0086] In addition to or instead of cartridge detector 30, reading device 14 may include single-use components. The single-use components of reading device 14 may include features configured to electrically, mechanically, or electrically and mechanically modify cartridge 12 so that cartridge 12 is not used more than once by reading device 14 (e.g., in more than one test by reading device 14). Examples of single-use components include, but are not limited to, a component configured to write to the RFID tag of cartridge 12, a component configured to mechanically modify cartridge 12 to prevent recombination of cartridge 12 after it is removed from reading device 14, a component configured to optically modify the cartridge after it is inserted into reading device 14, a camera configured to read a code (e.g., a barcode, QR code, alphanumeric code, color code, etc.) on the surface of cartridge 12, or an RFID reader configured to read a code from the cartridge's RFID and add the code or other identifying material to a list of used cartridges in reading device 14 and / or in a memory in communication with reading device 14, a component configured to blow a fuse in cartridge 12, and / or other component configured to mark cartridge 12 as used.
[0087] The cartridge detector 30 and / or other suitable detector of the reading device 14 may be configured to detect when the sample source 16 and / or sample 26 are fluidly coupled to the cartridge 12. For example, the cartridge 12 may be inserted into the reading device 14 before the sample source 16 is fluidly coupled to the cartridge 12, and the cartridge detector 30 may detect when the sample source 16 is fluidly coupled to the cartridge 12 after the cartridge 12 is inserted into the reading device 14. Upon sensing the cartridge 12 in the reading device 14 and the sample source 16 fluidly coupled to the cartridge 12, the reading device 14 may automatically begin collecting light or images from the reactant array 18 as part of a fluid analytical test of the fluid from the sample in the sample source 16 and / or automatically request input from a user to perform one or more steps of the fluid analytical test.
[0088] The motor 34 of the reading device 14 may be any suitable type of motor. Exemplary suitable types of motor 34 include, but are not limited to, a stepper motor, an electric motor, a brushed motor, a brushless motor, an induction motor, a magnetic motor, a servo motor, and / or other suitable types of motor. The motor 34 of the reading device 14 may include a drive shaft and / or other suitable drive components configured to engage a driven component of the cartridge to pump fluid through the fluid path 22. Alternatively or additionally, the motor, drive shaft, and / or other suitable drive components of or in communication with the motor 34 may be pump components configured to engage or communicate with pump components (e.g., flexible diaphragms, motor couplers, etc.) of the cartridge 12 (e.g., defining the fluid path 22). In some examples, the motor, drive shaft, and / or other drive components of the reading device 14 may include coupling components (e.g., electrical, mechanical, and / or magnetic coupling components) configured to couple or mate with pump components of the cartridge 12.
[0089] The controller 32 of the reading device 14 may be configured to control the operation of the reading device 14 in response to receiving one or more control signals and / or usage inputs. The controller 32 may store the captured data on the reading device 14 and / or transmit the data to a remote storage component for storage, and the controller 32 may use the stored captured data to analyze the reactant array 18. Furthermore, the controller 32 may be implemented entirely on the reading device 14, partially on the reading device 14 and partially remotely, and / or entirely remotely (e.g., on a server or other suitable computing device, on the cartridge 12, on a user's mobile device, etc.).
[0090] The controller 32 of the reading device 14 may be coupled to one or more other electronic components of the system 10. For example, the controller 32 may be communicatively coupled to one or more of the illumination components (if included), the light or image sensor 28, the cartridge detector 30, the motor 34, the single-use components, and / or one or more other suitable components of the system 10, and / or to a remote component (e.g., a server, a mobile device, etc.) that may or may not be part of the system 10. In some examples, the controller 32 may be configured to receive instructions to initiate a fluid test (e.g., from a user via a user interface of the controller 32 or via a user interface in communication with the controller 32, from the cartridge detector 30, etc.) and to send coordinated control signals to one or more electronic components of the system 10.
[0091] The controller 32 may be configured to or may facilitate identification of the components of the fluid and / or the condition of the target region in contact with the reactant array 18 based on a measured (e.g., sensed and / or calculated) level or change in light (e.g., interferogram, image, reflectance, etc.) sensed or collected from the reactant array 18 using the light or image sensor 28. In some examples, the controller 32 may be configured to identify the components of the fluid and / or the condition of the target region in contact with the reactant array 18 based on one or more of the timing of the level of light from the reactant array 18, the absolute change in the level of light from the reactant array 18 between or before the time when the sample source 16 is coupled to the cartridge 12 and a predetermined or indeterminate time after the sample source 16 is coupled to the cartridge 12 (e.g., based on the response of the reactant array, analyte concentration, fluid flow rate, fluid temperature, etc.), and the level of light from the reactant array 18 relative to a predetermined or expected level of light from the reactant array 18. The controller 32 may be configured to identify components of the fluid in contact with the reactant array 18, and therefore components of the sample 26, and / or conditions at the location where the sample was taken (e.g., a wound, pollen from a flower, an infection, breath exhaled from a subject, sweat glands, etc.) based on light from the reactant array 18 received by the light or image sensor 28 in one or more additional or alternative ways.
[0092] The controller 32 and / or other components of the system 10 may be or include one or more computing devices that include or are coupled to one or more user interfaces. FIG. 2 shows a schematic diagram of an exemplary computing device 38 and user interface 40, where the computing device 38 and / or user interface 40 may be housed completely or partially within one or more housings 42 (e.g., housings that may or may not house other components of the system 10). The housing 42 may be an optional component, as represented by the dashed line defining the housing 42 shown in FIG. 2. Although various components are shown as being included in the computing device 38 and user interface 40, one or more of the shown components may be omitted and / or one or more additional or alternative components may be utilized.
[0093] 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 the operation of the system 10. The computing device 38 may be configured to control the operation of the system 10, in some cases, by establishing and / or outputting control signals to the light or image sensor 28 and / or other electronic components of the system 10 to interact with the reactant array 18, perform tests on fluid from the sample 26 in the sample source 16, and / or monitor the results of the tests. In some examples, the computing device 38 may be part of the controller 32 and may communicate with other components via a wired or wireless connection, although other suitable configurations are contemplated. If the computing device 38, or at least a portion of the computing device 38, is a separate component from the structure of the controller 32, the computing device 38 may communicate with the electronic components of the system 10 via one or more wired or wireless connections or a network (e.g., a LAN and / or a WAN). In some cases, the computing device 38 may communicate with a remote server or other suitable computing device.
[0094] An exemplary 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. Examples of other suitable components of computing device 38 not specifically shown in FIG. 2 may include, but are not limited to, communication components, a touchscreen, selectable buttons, and / or other suitable components of a computing device. As discussed, one or more components of computing device 38 may be separate from and / or incorporated into components of controller 32.
[0095] The processor 44 of the computing device 38 may include a single processor or two or more processors operating individually or in conjunction 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, a central processing unit, a microprocessor, a microcontroller, a multi-core processor, a graphical processing unit, a digital signal processor, an application specific integrated circuit (ASIC), an artificial intelligence accelerator, a field programmable gate array (FPGA), a discrete circuit, and / or other suitable types of data processing devices.
[0096] The memory 46 of the computing device 38 may include a single memory component or two or more memory components that operate independently or in conjunction with one another. Exemplary types of memory 46 may include random access memory (RAM), EEPROM, flash, suitable volatile storage, suitable non-volatile storage, persistent memory (e.g., read-only memory (ROM), hard drive, flash memory, optical disk memory, and / or other suitable persistent memory), and / or other suitable types of memory. The memory 46 may be or include a temporary and / or non-transitory computer-readable medium. The memory 46 may include instructions stored in a temporary and / or non-transitory state on a computer-readable medium, which may be executed by the processor 44 to cause the processor 44 to perform one or more of the methods and / or techniques described herein. Additionally, in some cases, the memory 46 and / or other suitable memory may store data received from the light or image sensor 28 and / or from other components of or in communication with the system 10.
[0097] I / O unit 48 of computing device 38 may include a single I / O component or two or more I / O components that operate individually or in conjunction with one another. An exemplary I / O unit 48 may be or include any suitable type of communications hardware and / or software, including, but not limited to, communications components or ports configured to communicate with electronic components of system 10 and / or with other suitable computing devices or systems. Exemplary types of I / O units 48 may include 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.
[0098] The user interface 40 may be configured to communicate with the computing device 38 via one or more wired or wireless connections. The user interface 40 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 shown, the user interface 40 may include one or more indicators (e.g., light-emitting diodes (LEDs), LED linear arrays, numbers, etc.). In some examples, the user interface 40 may be part of or include the computing device 38. Alternatively or additionally, the user interface 40 may be part of a mobile device or a remote computing system.
[0099] Display 50 may be any suitable display. Example suitable displays include, but are not limited to, a touchscreen display, a non-touchscreen display, a liquid crystal display (LCD) screen, an LED display, a head-mounted display, a virtual reality display, an augmented reality display, a mobile device display, and / or other suitable display types.
[0100] The input device 52 may be and / or include any suitable components and / or features for receiving user input via the user interface 40. Exemplary input devices 52 may include, but are not limited to, a touchscreen, a keypad, a mouse, a touchpad, a microphone, a selectable button, a selectable knob, an optical input, a camera, a gesture sensor, an eye tracker, a voice recognition control (e.g., a microphone coupled to appropriate natural language processing components), and / or other suitable input devices. In one example, the input device 52 may include a touchscreen that allows for setting settings, initiating a fluid or target area analysis test, adjusting between screens (e.g., a test screen, a data analysis screen, a results screen, etc.), and / or taking one or more other suitable actions.
[0101] Output device(s) 54 may be and / or include any suitable components and / or features for providing information and / or data to a user and / or other computing components. Exemplary output devices 54 include, but are not limited to, a display, a speaker, a vibration system, a haptic feedback system, an optical output, and / or other suitable output devices.
[0102] Figure 3 schematically illustrates an exemplary configuration of system 10 configured to be held in a user's hand 56. While system 10 can assume a variety of different handheld (and / or non-handheld) configurations, the system 10 shown in Figure 3 can include a cartridge 12 inserted into a reading device 14 through an access opening 58. Cartridge 12 can include an I / O port 20 for coupling to one or more tubes or components of or in communication with a sample source 16.
[0103] The user interface 40 of the reading device 14 shown in FIG. 3 may include a display 50 and one or more buttons 60. The user interface 40 may include additional and / or alternative components or features, including, but not limited to, one or more indicators (e.g., LEDs, linear arrays of LEDs, numbers, etc.) configured to indicate (e.g., as an alert, etc.) the results of a test, that a test has begun, that a test has completed, that a user should take action, that an action has been completed, and / or other suitable indications. Additionally or alternatively, the user interface 40 may be on or part of a remote computing device, such as a mobile device, a control station, a web page, a mobile application, and / or other suitable remote computing device. In some examples, the user interface 40 may be omitted entirely from the reading device 14, or one or more components of the user interface 40 discussed herein may be omitted from the reading device 14.
[0104] The display 50 (e.g., a touchscreen display or a non-touchscreen display), if included, may show any suitable image. In one example, the display may show an image 63 captured by the reading device 14 (e.g., captured by the light or image sensor 28). The image 63 may be a live image and / or a previously captured photograph or image. As shown schematically in FIG. 3 , the image 63 may be a live image of a CSA 66 including a reactant array 18. Additionally, the display 50 may show material other than the image 63, including, but not limited to, instructions for testing the fluid, test status (e.g., the progression of steps in the analysis of the reactant array 18), system status, results of and / or data from the analysis of the reactant array 18, marketing indicia, branding indicia, video, user pictures, artwork, etc.
[0105] If included, one or more buttons 60 may be selected by a user to cause the reading device 14 and / or cartridge 12 to perform one or more actions. For example, a user may interact with one or more buttons 60 to start a pump in the reading device 14 and / or cartridge 12, start a motor in the reading device 14, start analysis of the reactant array 18, start the light or image sensor 28 to take an image or capture light, eject the cartridge 12, mark the cartridge 12 as used, start the display 50, and / or cause the reading device 14 and / or cartridge 12 to perform one or more other suitable operations.
[0106] 4-12 schematically illustrate exemplary configurations of cartridge 12 that may be used with handheld reading device 14 and / or other configurations of reading device 14. Generally, dashed lines in the figures represent components within the housing unless expressly indicated otherwise.
[0107] The exemplary cartridge 12 may include an I / O port 20 and a housing 62 having a transparent portion 70 (e.g., a window formed from glass, polymer, and / or other suitable transparent material, etc.) through which a reading device 14 may view, collect light from, and / or image a reactant array 18 disposed within the cartridge 12. A fluid path 22 through the cartridge 12 may extend from an input port, through the cartridge 12, through and / or over the reactants 67 of the reactant array 18, and out an output port. Any of the I / O ports 20 may be an input port or an output port, depending on the direction in which fluid passes through the fluid path 22.
[0108] The system 10 may include a pump 68 for pumping fluid through the fluid pathway 22. The pump 68 may be located entirely on the cartridge 12, entirely on the reading device 14, partially on the cartridge 12 and partially on the reading device 14, or in one or more other suitable locations.
[0109] 4 schematically illustrates an exemplary configuration of the system 10 in which the cartridge 12 is inserted into the reading device 14, and the flexible, resilient, or pliable component 64 defining the fluid path 22 may be configured as part of a pump 68 (e.g., to engage a peristaltic pump with fingers 78, rollers, and / or other driving components of the pump 68 on the cartridge 12 or reading device 14). A first I / O port 20a (e.g., an input port) of the cartridge 12 may be coupled to an input tube 72 coupled to or in fluid communication with the sample source 16. A second I / O port 20b (e.g., an output port) of the cartridge 12 may be coupled to an output tube 74 coupled to or in fluid communication with a waste container 76, which may output to the environment and / or one or more other suitable locations.
[0110] 4, system 10 can be considered to have an open-loop configuration due to the fact that output from second I / O port 20b is not returned to sample source 16 and / or fluid path 22. However, system 10 can be configured in a closed-loop manner by returning output from second I / O port 20b to sample source 16, fluid path 22, and / or other suitable location in fluid communication with fluid path 22.
[0111] The I / O port 20 of the cartridge 12 may include one or more seals or valves 81 configured to fluidly seal the fluid pathway 22 from the surrounding environment. When the input and output tubing 72, 74 is engaged, the tubing 72, 74 or its connectors may open the seal or valve 81, which may then seal around the input and output tubing 72, 74. In some examples, one or more of the seals or valves 81 may be a peel seal that may be removed from the port 20 prior to connecting the input and output tubing 72, 74 to the port 20.
[0112] The input tubing 72 and the output tubing 74 may be permanent parts of the cartridge 12 (e.g., fixedly secured to the housing 62 and / or the I / O port 20) or may be removable from the cartridge 12. If the input tubing 72 and the output tubing 74 are permanent parts of the cartridge, the only component in or in fluid communication with the sample 26 that may need to be connected to the cartridge 12 is the sample source 16. Alternatively, the sample source 16 may be omitted, and one or both ends of the input and output tubing 72, 74 may be positioned at a target site and receive fluid therefrom. If the input and / or output tubing 72, 74 are part of the cartridge 12, the input and / or output tubing 72, 74 may be disposed of with the cartridge 12, thereby reducing cross-contamination to / from patients, devices, users, the environment, etc. due to the reduced utilization of components that may be accidentally reused. Additionally, by utilizing input and / or output tubing 72, 74 that is a permanent part of cartridge 12, the opportunity for human error may be reduced due to the reduced number of connections required.
[0113] To facilitate interaction with pump 68 or other suitable pump of system 10, a flexible, resilient, or compliant component 64 (e.g., a flexible diaphragm) may be exposed from and attached to housing 62 of cartridge 12 such that fingers 78 or other suitable components of pump 68 may engage flexible, resilient, and / or compliant component 64 to move fluid along fluid path 22. In addition to or instead of being attached to housing 62, flexible, resilient, or compliant component 64 may be separate from or integrated into housing 62 of cartridge 12. In some examples, the flexible, resilient, and / or compliant component 64 configured to engage fingers 78 and / or other portions of pump 68 may be one of pump components 24 of cartridge 12.
[0114] The flexible, resilient, and / or flexible component 64 may be a sheet of material that, together with the channel or housing 62 of the cartridge 12, at least partially defines the fluid pathway 22. Alternatively or additionally, the flexible, resilient, and / or flexible component 64 may be part of a tube that defines the fluid pathway 22. As shown in FIG. 4 , the flexible, resilient, or flexible component 64 may be a tube coupled to the first I / O port 20 a and the distal connector 65 of the housing 62, which may be a permanent part of the cartridge 12 or may be removable from the cartridge 12.
[0115] The reading device 14 may have any suitable components configured to drive the pump 68. In some examples, the controller 32 may be in communication with the motor 34 to drive the motor to rotate the drive shaft 80, which may result in pumping action. In the example shown in FIG. 4 , rotation of the drive shaft 80 may rotate the fingers 78, which in turn act on the flexible or pliable component 64 to drive fluid through the fluid path 22. The pump components of the reading device 14 may be fluidly isolated from the fluid pumped through the fluid path 22 of the cartridge 12. In some cases, the pump 68 may be omitted, and a similar or different pump configured to act on the flexible or pliable component 64 of the cartridge 12 may be integrated into the cartridge 12.
[0116] Fluid path 22 may have any suitable configuration configured to facilitate passage of fluid therethrough. As shown in FIG. 4 , first portion 22a (e.g., a tubing portion, an inflow portion, and / or other suitable first portion) of fluid path 22 may extend from first I / O port 20a to third portion 22c (e.g., a compartment portion, a reactant portion, an outflow portion, and / or other suitable portion), and second portion 22b (e.g., a pump portion, a diaphragm portion, and / or other suitable portion) may overlap first portion 22a at flexible, resilient, or compliant component 64. In some configurations, when fluid path 22 reaches third portion 22c (e.g., proximate the location of reactant array 18 within compartment 21 of housing 62), fluid path 22 may widen to facilitate dispersion of fluid from sample source 16. Additionally or alternatively, the fluid path 22 may include a funnel shape or configuration leading from the third portion 22c proximate the reactant array 18 into the second I / O port 20b. Other suitable configurations are contemplated.
[0117] In some exemplary configurations, cartridge 12 may include a single-use component 82, as discussed herein or elsewhere. In one example, the single-use component may be an RFID tag, and single-use component 84 of reading device 14 may receive a signal from controller 32 or other component to mark the RFID tag of cartridge 12 with an indication that the cartridge has been used in a fluid analysis test. After cartridge single-use component 82 is marked as used, single-use component 84 of reading device 14 may read or sense that cartridge 12 has been used and refuse to run a test using a previously used cartridge 12, run the test, note that cartridge 12 has been previously used, and / or take one or more other appropriate actions or no action.
[0118] 5A and 5B schematically illustrate top and side views, respectively, of an exemplary configuration of the system 10 with the cartridge 12 inserted into the reading device 14, with the pump component 24 of the cartridge 12 disposed in the fluid path 22. A first I / O port 20a (e.g., an input port) of the cartridge 12 may be coupled to an input tubing 72 coupled to or in fluid communication with the sample source 16. A second I / O port 20b (e.g., an output port) of the cartridge 12 may be coupled to an output tubing 74 coupled to or in fluid communication with the sample source 16, which may be configured to output fluid to the environment and / or one or more other suitable locations.
[0119] 5A, the system 10 can be considered to have a closed-loop configuration due to the output from the second I / O port 20b being fed back to the sample source 16 and fluid path 22. In some configurations, the system 10 can also be considered to be a closed-loop configuration when the output from the second I / O port 20b is supplied to a target area and the input to the first I / O port 20a receives fluid from the target area.
[0120] Cartridge 12 may include a filter 85 in fluid pathway 22. While FIG. 5A shows filter 85 in fluid pathway 22 (e.g., first portion 22a of fluid pathway 22) proximate first I / O port 20a, one or more filters 85 may be located at any suitable location along fluid pathway 22.
[0121] One or more filters 85 in fluid pathway 22 may be configured to remove undesirable molecules from the fluid passing through fluid pathway 22 and allow desirable molecules to pass through filter 85. Additionally or alternatively, filter 85 may be configured to interact with specific molecules to modify the incoming fluid and / or analytes therein into different components to enhance reactivity between reactive agents and the fluid passing through the pathway and / or to provide greater sensitivity. Filters 85 may be differently sized, shaped, and / or configured to accommodate enhanced filtration and / or detection of different molecules. Some variables that may be adjusted to configure a filter include, but are not limited to, filter material, filter pore size, filter pore density, filter pore location, etc.
[0122] 5A and 5B, the pump 68 may include, among other components, a motor 34 in the reading device 14 and a pump component 24 in the cartridge 12, which may be comprised of a rotating component 86 in the fluid path 22 (e.g., in the second portion 22b of the fluid path 22) at a location proximal to the third portion 22c of the fluid path 22. The rotating component 86 may be or include an impeller or propeller, although other suitable configurations are contemplated. As the rotating component 86 rotates, fluid may be advanced through the fluid path 22. Actuation of the rotating component 86 may be manual and / or automatic (e.g., initiated by a motor and / or a controller).
[0123] To facilitate maintaining a fluid-tight seal along the fluid path 22, a driven shaft 88 coupled to the rotating component 86 may extend from the rotating component 86 outside the cartridge 12 and be coupled to a drive shaft 80 extending from the motor 34 located within the reading device 14. When so configured, the drive component configured to operate the rotating component 86 of the pump 68 may be fluidly isolated from the fluid path 22. In an alternative configuration, the motor 34 may be located within the cartridge 12, and the drive shaft 80 may be directly coupled to the rotating component 86 and / or coupled to the driven shaft 88.
[0124] The driven shaft 88 and the drive shaft 80 may be coupled in any suitable manner. In some examples, the driven shaft 88 and the drive shaft 80 may be mechanically coupled to one another via a keyed relationship, or one of the driven shaft 88 and the drive shaft 80 may receive the other of the driven shaft 88 and the drive shaft 80. Additionally, the driven shaft 88 may be coupled to the drive shaft 80 in any suitable manner, including, but not limited to, via a magnetic connection. Other suitable configurations are contemplated.
[0125] FIG. 6 illustrates an exemplary configuration of system 10 having a pump 68 configuration similar to that shown in FIGS. 5A and 5B , but where the driven shaft 88 of cartridge 12 is configured to couple to rotating component 86 via a magnetic field (e.g., pump 68 has a magnetic drive system). In the example shown in FIG. 6 , driven shaft 88 may be mechanically coupled to drive shaft 80, which is in communication with motor 34. Rotating component 86 may then rotate with driven shaft 88 as driven shaft 88 rotates in response to rotation of drive shaft 80 actuated by motor 34 and / or controller 32, even though driven shaft 88 and rotating component 86 are fluidly isolated from one another and not physically coupled. When a magnetic field is used to rotate rotating component 86, the drive and / or driven components of pump 68 may be fluidly isolated from fluid path 22.
[0126] The magnetic field extending between the rotating component 86 and the drive shaft 80 may be formed in any suitable manner. In some examples, one or more magnets, wound wire coils, and / or one or more magnetic materials may be utilized to generate the magnetic field. In one example, the driven shaft 88 may include a magnet 90, and the rotating component 86 may include a magnetic material 92 such that a magnetic field may extend from the driven shaft 88 to the rotating component 86. Alternatively or additionally, the driven shaft 88 may include the magnetic material 92, the rotating component 86 may include the magnet 90, or both the driven shaft 88 and the rotating component 86 may be or include the magnet 90. In some examples, the magnetic field may be generated using a wound wire coil in communication with a power source (e.g., the controller 32 providing an electrical signal to the cartridge 12 through electrical contacts between the reading device 14 and the cartridge 12), or the magnet may be replaced with a wound wire coil, and the magnetic material may rotate in response to electrical actuation of the wound wire coil. Other suitable configurations are contemplated.
[0127] 6 may include mechanically coupling the drive shaft 80 to the rotating component 86, and a magnetic field may extend between the drive shaft 80 and the driven shaft 88. When so configured, the driven shaft 88 may include a magnet 90, and the drive shaft 80 may include a magnetic material 92, such that a magnetic field may extend from the driven shaft 88 to the drive shaft 80. Alternatively or additionally, the driven shaft 88 may include the magnetic material 92, and the drive shaft 80 may include the magnet 90, or both the driven shaft 88 and the drive shaft 80 may be or include magnets. Other suitable configurations are contemplated.
[0128] 7 shows an exemplary configuration of system 10 having a pump 68 configuration similar to that shown in FIGS. 5A and 5B , except that the driven shaft 88 of cartridge 12 is omitted and a magnetic field may extend between rotating component 86 and drive shaft 80. As shown in FIG. 7 , even though drive shaft 80 and rotating component 86 are not physically coupled, rotating component 86 may rotate with drive shaft 80 as drive shaft 80 rotates in response to actuation by motor 34 and / or controller 32. When a magnetic field is used to rotate rotating component 86, the driving component (e.g., motor 34, drive shaft 80, etc.) may be fluidly isolated from the driven component (e.g., rotating component 86, etc.) of pump 68 and fluidly isolated from fluid path 22.
[0129] The magnetic field extending between the rotating component 86 and the drive shaft 80 may be formed in any suitable manner. In some examples, one or more magnets, wound wire coils, and / or one or more magnetic materials may be utilized to generate the magnetic field. In one example, the drive shaft 80 may include a magnet 90 or a wound wire coil, and the rotating component 86 may include a magnetic material 92. Alternatively or additionally, the drive shaft 80 may include a magnetic material 92, and the rotating component 86 may include a magnet 90, or both the drive shaft 80 and the rotating component 86 may be or include magnets.
[0130] 8 schematically illustrates a top view of an exemplary configuration of system 10 with cartridge 12 inserted into reading device 14, where pump component 24 of cartridge 12 may define a portion of fluid path 22. Pump component 24 shown in FIG. 8 may at least partially define second portion 22b of fluid path 22 and may be piezoelectric diaphragm 94 of pump 68 having a piezoelectric pump configuration. The configuration of system 10 shown in FIG. 8 may function similarly to other configurations of system 10 discussed herein while using the exemplary configuration of pump 68 and fluid path 22 shown in FIG. 8.
[0131] Piezoelectric diaphragm 94 may be formed in any suitable manner to facilitate pumping fluid through fluid path 22. In some examples, piezoelectric diaphragm 94 may be formed from a membrane having one or more piezoelectric materials or from an actuator coupled to a membrane, although other suitable configurations of piezoelectric diaphragm 94 are contemplated.
[0132] The piezoelectric diaphragm 94 may be electrically coupled to a first contact 96 on the cartridge 12, which may be electrically coupled to a second contact 98 of the reading device 14 when the cartridge 12 is inserted into the reading device 14 and in communication with the controller 32. The first contact 96 and the second contact 98 may be mechanically coupled to one another to facilitate an electrical connection and / or to facilitate placement of the cartridge 12 within the reading device 14, although other suitable configurations are contemplated that do not include a mechanical connection between the first contact 96 and the second contact.
[0133] The piezoelectric diaphragm 94 may at least partially define a second portion 22b of the fluid path 22, which may extend from an inlet having a first valve 100 and an outlet having a second valve 102 to form a pump chamber 104. The first valve 100 and / or the second valve 102 may be any suitable type of valve, including, but not limited to, a valve plate, a gasket, a rubber valve, a ball and spring valve, a plastic flap, a single component configured to function as the first valve 100 and the second valve 102, and / or other suitable configurations. Other suitable configurations of the piezoelectric diaphragm 94, fluid path 22, valves 100, 102, and pump chamber 104 are contemplated.
[0134] In operation, the piezoelectric diaphragm 94 may receive an electrical signal from the controller 32 to actuate the piezoelectric diaphragm 94. In some examples, actuation of the piezoelectric diaphragm 94 may be configured to expand the volume of the pump chamber 104, which expansion may open the first valve 100, close the second valve 102, and draw fluid into the pump chamber 104 through an inlet in the first valve 100. A further electrical signal from the controller 32 may then be provided to the piezoelectric diaphragm 94, or the initial electrical signal may be removed, further actuating or relaxing the piezoelectric diaphragm 94 to decrease the volume of the pump chamber 104 compared to when the initial electrical signal was applied to the piezoelectric diaphragm 94. As a result of the decrease in the volume of the pump chamber 104, the first valve 100 closes and the second valve 102 opens, allowing fluid in the pump chamber 104 to exit the pump chamber 104 through an outlet in the second valve 102. Alternatively, in some examples, application of an initial electrical signal to the piezoelectric diaphragm 94 may be configured to decrease the volume of the pump chamber 104, causing fluid to exit the pump chamber 104 through the outlet, and removal of the initial electrical signal from the piezoelectric diaphragm 94 and / or a further electrical signal to the piezoelectric diaphragm 94 may be configured to draw fluid into the pump chamber 104 through the inlet. Other suitable configurations are contemplated.
[0135] 9-11 schematically illustrate portions of an exemplary configuration of cartridge 12, in which pump component 24 of cartridge 12 may define a portion of fluid path 22. Pump component 24 may at least partially define second portion 22b of fluid path 22 and may be diaphragm 106 of pump 68 (e.g., diaphragm 106 and motor coupler 118 of pump 68 are shown in FIGS. 10 and 11 and may be in reading device 14; motor 34 and diaphragm coupler of pump 68 are not shown). The configuration of cartridge 12 illustrated in FIGS. 9-11 may function similarly to other configurations of cartridge 12 discussed herein, while using the exemplary configuration of pump 68 and fluid path 22 illustrated in FIGS. 9-11.
[0136] Diaphragm 106 and / or other suitable diaphragms discussed herein may be formed from any suitable material, including, but not limited to, metallic, polymeric, flexible, resilient, soft, rigid, elastic, and / or other suitable materials.
[0137] 9-11 may include a housing 62 having a first component 62a (e.g., a base) and a second component 62b (a lid or cover), an I / O port 20, and a transparent portion 70 (e.g., all or at least a portion of the second component 62b of the housing 62 formed from glass, polymer, and / or other suitable transparent material) through which a reading device 14 may view, project light onto, collect light from, and / or image a reactant array 18 disposed within a compartment 21 that at least partially defines a fluid path 22 (e.g., third portion 22c). The first component 62a of the housing 62 may completely or at least partially define the compartment 21, and when a CSA 66 having a reactant array 18 is located within the compartment 21 and the sample source 16 is in fluid communication with the compartment 21, fluid from the sample source 16 may travel within the compartment 21. Although the first portion 22a of the fluid pathway 22 defined by the tube 108 is shown extending through the compartment 21, other configurations of the first portion 22a relative to the third portion 22c are contemplated.
[0138] The first component 62a of the housing 62 may include an I / O port 20 configured to engage with the sample source 16. For example, the I / O port 20 may be configured to engage with or fluidly couple to one or more components, including, but not limited to, tubing, a container containing a sample, a container (e.g., as shown in FIGS. 10 and 11 ), a container configured to collect waste, and / or other suitable components. The engagement between the sample source 16 and the I / O port 20 may be a releasable engagement or a permanent engagement.
[0139] The second component 62b may include a first portion 62b' that may cover or function as a lid for the first component 62a of the housing 62, and a second portion 62b'' configured to engage and optionally function as a cover for the sample source 16 coupled to the first component 62a of the housing 62. The second portion 62b'' of the second component 62b may extend from and pivot relative to the first portion 62b' via a living hinge 110 or other suitable hinge. In some configurations, the second portion 62b'' may include a latch 112 or other feature configured to engage the sample source 16 when the sample source 16 is coupled to the I / O port 20.
[0140] One or more valves 81 may be disposed at or within the access openings extending through the I / O ports 20. In some examples, as shown in FIG. 9 , a single valve 81 (e.g., a check valve and / or other suitable type of valve) may be located at the access opening of each I / O port 20, and the single valve 81 may include a slit 83 or other opening that is biased closed and that may open upon engagement with a sample source 16. When the port of the sample source 16 extends through the valve 81, the valve 81 may be configured to seal around the port.
[0141] The first portion 62b' of the second component 62b of the housing 62 and the first component 62a may be fixedly sealed to one another, although this is not required; the first component 62a and the second component 62b' of the housing 62 may be adjustable relative to one another to provide access to the compartment 21 and / or the CSA 66. When the first component 62a and the second component 62b are sealed to one another, the seal may be a fluid-tight (e.g., hermetic) seal.
[0142] FIG. 9 schematically illustrates a perspective view of cartridge 12 with second portion 62b″ of second component 62b adjusted to an open position to receive sample source 16 and provide access to the access opening of I / O port 20. In the open position, second portion 62b″ can be rotated upward to facilitate engagement of sample source 16 with I / O port 20. Alternatively, cartridge 12 may include sample source 16 (e.g., sample source 16 may be part of housing 62), and second portion 62b″ disposed in the open position may facilitate receipt of sample 26 into sample source 16.
[0143] 10 and 11 schematically illustrate cross-sectional and top views of the configuration of cartridge 12 shown in FIG. 9 in which sample source 16 (e.g., in a container configuration) is engaged with I / O port 20 of first component 62a of housing 62. While sample source 16 is shown as being connectable to and a separate component from housing 62, as discussed, sample source 16 may be part of housing 62 and / or may be a permanent structure of housing 62.
[0144] The sample source 16 may include one or more ports 114 configured to engage and / or extend through the I / O port 20, as shown in Figure 10. In some examples, the ports 114 may be configured to extend through a valve 81, which may seal around the port 114.
[0145] Before, during, or after the sample source 16 is in fluid communication with the I / O port 20 and / or the sample 26 is in the sample source 16, the second portion 62b" of the second component 62b may be adjusted and coupled to the sample source 16. In some examples, the second portion 62b" may be coupled to the sample source 16 via a snap connection (e.g., a permanent connection or a reversible connection) between the latch 112 and the notch 116 in the sample source 16. Although not required, the second portion 62b" coupled to the sample source 16 can serve as a cover for the sample 26 such that fluid from the sample 26 in the sample source 16 can only exit or enter the sample source 16 via the I / O port 20, such that the cartridge 12 may form a closed-loop system 10 (e.g., a closed-loop fluid path 22). The second portion 62b" of the second component 62b may form a fluid-tight seal with the sample source 16, although other suitable configurations are contemplated.
[0146] Once the sample source 16 is securely coupled to the cartridge 12 and in fluid communication with the fluid pathway 22, fluid flows from the sample 26 within the sample source 16, through the I / O port 20 coupled to the tubing 108, through the tubing 108 and a first portion 22a of the fluid pathway 22, into the pump chamber 104 and a second portion 22b of the fluid pathway 22, into the compartment 21 and a third portion 22c of the fluid pathway 22, through and over the reactant array 18, through the I / O port 20 in fluid communication with the compartment 21, and back into the sample source 16, forming a closed-loop fluid pathway 22. Alternatively, fluid may pass through the fluid pathway 22 in the opposite direction, such that fluid flows from the sample source 16, through the third portion 22c of the fluid pathway, through the second portion 22b of the fluid pathway 22, through the first portion 22a of the fluid pathway 22, and into the sample source 16. As the fluid passes to, through, and / or over the reactant array 18 of the CSA 66 in the compartment 21, the reactants 67 of the reactant array 18 may react with the fluid if an analyte of interest is detected. In some configurations, the fluid in the compartment 21 and / or the sample source 16 may pass from the sample source 16 through the fluid path 22 and return to the sample source 16 via the pump 68 (or be pumped to one or more other suitable locations).
[0147] Cartridge 12 may include, among other components of pump 68, diaphragm 106 and motor coupler 118 (e.g., diaphragm 106 and motor coupler 118 may be pump components 24, with motor coupler 118 fluidly isolated from fluid path 22). Diaphragm 106 may be a piezoelectric diaphragm, a diaphragm configured to respond to mechanical forces, a diaphragm configured to respond to pressure forces, and / or other suitable diaphragm.
[0148] In operation, the motor coupler 118 can be configured to engage or couple (e.g., mechanically, electrically, magnetically, etc.) to the motor, drive shaft, diaphragm coupler, piston, controller, and / or other components of the pump 68 at the reading device 14 or at one or more other suitable locations, such that the diaphragm 106 is actuated, the first valve 100 opens, the second valve 102 closes, and fluid is drawn through the I / O port 20 into the tube 108, through the inlet in the first valve 100, into the pump chamber 104, and then further acting on the diaphragm 106 to close the first valve 100 and open the second valve 102, forcing fluid through the outlet in the second valve 102 into the compartment 21, to, through, and / or over the reactant array 18, and out the I / O port 20 communicating with the compartment 21. The configuration of pump component 24 of pump 68 in cartridge 12 shown in Figures 9-11 may be utilized with any suitable configuration of fluid path 22, where fluid path 22 has a closed loop or an open loop configuration for circulating fluid through fluid path 22.
[0149] 12 schematically illustrates a top view of an exemplary configuration of cartridge 12, in which pump component 24 of cartridge 12 may define a portion of fluid path 22. Pump component 24 may at least partially define second portion 22b of fluid path 22 and may be diaphragm 106 of pump 68, although other suitable configurations are contemplated. The exemplary cartridge 12 shown in FIG. 2 may include one or more components, one or more I / O ports 20, and a housing 62 formed from a transparent portion 70 (e.g., a window and / or other suitable transparent portion formed from glass, polymer, and / or other suitable transparent material) through which reading device 14 may view, collect light from, and / or image reactant array 18 disposed within compartment 21.
[0150] The housing 62 may define any suitable number of compartments 21. For example, the housing 62 may define a first compartment 21a, a second compartment 21b, a third compartment 21c, and / or one or more other suitable compartments 21. As shown in FIG. 12, the second compartment 21b may form a pump chamber 104 with the diaphragm 106. The CSA 66 having the reactant array 18 may be located in the first compartment 21a or the second compartment 21b (e.g., as shown in FIG. 12).
[0151] The housing 62 may include an I / O port 20 configured to engage with the sample source 16. For example, similar to that discussed with respect to Figures 9-11, the I / O port 20 may be configured to engage with or fluidly couple to one or more components, including, but not limited to, tubing, a container containing a sample, a container (e.g., as shown in Figures 10 and 11), a container configured to collect waste, and / or other suitable components. The engagement between the sample source 16 and the I / O port 20 may be a releasable engagement or a permanent engagement.
[0152] 9-11 , to pump fluid through fluid path 22. For example, cartridge 12 may include diaphragm 106 and motor coupler 118, among other components of pump 68 (e.g., diaphragm 106 and motor coupler 118 may be pump component 24, and motor coupler 118 may be fluidly isolated from fluid path 22). Diaphragm 106 may be a piezoelectric diaphragm, a diaphragm configured to respond to a mechanical force, a diaphragm configured to respond to a pressure force, and / or other suitable diaphragm.
[0153] In operation, the motor coupler 118 may engage or couple (e.g., mechanically, electrically, magnetically, etc.) to the motor, drive shaft, diaphragm coupler, piston, controller, and / or other components of the pump 68 at the reading device 14 or at one or more other suitable locations, such that the diaphragm 106 is actuated, increasing the volume of the pump chamber 104, opening the first valve 100, closing the second valve 102, and allowing fluid to flow through the I / O port 20 and along the first portion 22a of the fluid path 22. 12 , fluid is drawn into first compartment 21 a, through an inlet in first valve 100, and into pump chamber 104, and then diaphragm 106 is actuated to decrease the volume of pump chamber 104, closing first valve 100 and opening second valve 102, allowing fluid to be forced through an outlet in second valve 102 and into third compartment 21 c, to, through, and / or over reactant array 18, and through I / O port 20 in communication with third compartment 21 c. The configuration of pump component 24 of pump 68 in cartridge 12 shown in FIG. 12 may be utilized with any suitable configuration of fluid pathway 22, having a closed-loop or open-loop configuration for circulating fluid through cartridge 12.
[0154] 13A-13C schematically illustrate exemplary techniques for applying a mechanical force to a diaphragm 106 of a pump 68, where the diaphragm 106 may be located in the cartridge 12 of the system 10 and is actuated using components fluidically isolated from the fluid path 22. A diaphragm coupler 120 in the reading device 14 may be configured to couple to a motor coupler 118 to apply a mechanical force to the diaphragm 106 (e.g., actuate the diaphragm 106) in response to motor actuation or other suitable actuation.
[0155] 13A shows a schematic diagram of a portion of cartridge 12 including a pump chamber 104 defined at least in part by a diaphragm 106 upon which forces may act to open and close first valve 100 and second valve 102. While first valve 100 and second valve 102 are shown in an exemplary configuration in FIG. 13A , other suitable configurations of valves relative to pump chamber 104 are contemplated that may change how movement of diaphragm 106 affects fluid flow through pump chamber 104.
[0156] 13B shows a motor coupler 118 coupled to a diaphragm coupler 120 of the reading device 14, which may be in communication with the motor. In response to actuation by the motor, and given the configuration of the first valve 100 and the second valve 102, the diaphragm coupler 120 may apply a mechanical force to the diaphragm 106 through the motor coupler 118 to increase the volume of the pump chamber 104, opening the first valve 100 and closing the second valve 102, and drawing fluid into the pump chamber 104.
[0157] 13C , the diaphragm 106 may apply a mechanical force to the diaphragm 106 through the motor coupler 118 to decrease the volume of the pump chamber 104, close the first valve 100, open the second valve 102, and force fluid out of the pump chamber 104 through an outlet in the second valve 102. Additionally or alternatively, the diaphragm 106 may have or be formed from an elastic material or be coupled to a bias, such that by releasing the initial force acting on the diaphragm 106 to increase the volume of the pump chamber 104, the volume of the pump chamber 104 may automatically decrease, the first valve 100 close, the second valve 102 open, and fluid may be forced out of the pump chamber 104 through the outlet in the second valve 102. In some examples, fluid exiting pump chamber 104 may travel to, through, and / or over reactant array 18, as discussed herein or elsewhere.
[0158] 13A, the stroke of the diaphragm 106 (e.g., the distance the diaphragm moves from a neutral position as shown in FIG. 13A to increase or decrease the volume of the pump chamber 104) and / or the rate of the stroke cycle may be varied to control the flow rate and velocity of fluid through the fluid path 22 and onto or through the reactant array 18; the stroke of the diaphragm 106 can determine the volume or pressure of fluid to, through, and / or over the reactant array 18, and the rate of the stroke cycle can determine the flow rate of fluid to, through, and / or over the reactant array 18. In some examples, if a first fluid reacts better with the reactants of the reactant array 18 when pressurized at a lower pressure than required for a second fluid at the reactant array 18, a smaller stroke of the diaphragm 106 may be utilized for the first fluid than for the second fluid. In some examples, if it is known that a first fluid takes longer to react with the reactant array 18 than a second fluid, the stroke cycle speed may be set to a slower speed to reduce the flow rate of the first fluid compared to when the second fluid is being analyzed.
[0159] 14A-14B schematically illustrate an exemplary technique for applying a pressure force to a diaphragm 106 of a pump 68, which may be located in the cartridge 12 of the system 10 and is actuated using components fluidly isolated from the fluid path 22. A cartridge coupler 122 in the reading device 14 may be configured to permanently or releasably couple to the housing 62 to apply a pressure force to the diaphragm 106 in response to motor actuation or other suitable actuation. While the first valve 100 and the second valve 102 are shown in exemplary configurations in FIGS. 14A and 14B, other suitable configurations of the valves relative to the pump chamber 104 are contemplated that may change how diaphragm movement affects fluid flow through the pump chamber 104.
[0160] The cartridge coupler 122 may have any suitable configuration configured to apply a pressure force to the diaphragm 106 of the cartridge 12. In some examples, the cartridge coupler 122 may include a housing 123 configured to engage the housing 62 of the cartridge 12 and a diaphragm 106 or other suitable pressure variation component configured to adjust the change in pressure applied to the diaphragm 124 of the cartridge 12. Additionally, the drive shaft 80 in communication with the motor 34 may be coupled to the diaphragm 106 such that actuating the motor moves or adjusts the position of the diaphragm 124, thereby changing the pressure applied to the diaphragm 124 of the cartridge 12.
[0161] 14A shows cartridge coupler 122 coupled to housing 62 and diaphragm 106 adjusted to a position that may reduce the pressure applied to diaphragm 124 in response to actuation of motor 34 and movement of drive shaft 80. In response to diaphragm 124 being actuated by motor 34, and given the configuration of first valve 100 and second valve 102, a reduction in force (e.g., negative pressure or vacuum force) on diaphragm 106 of cartridge 12 may increase the volume of pump chamber 104, opening first valve 100 and closing second valve 102, drawing fluid into pump chamber 104.
[0162] Upon further actuation by the motor 34, and given the configuration of the first valve 100 and the second valve 102, the drive shaft 80 may extend, causing movement of the diaphragm 124 and increasing the pressure force acting on the diaphragm 106 of the cartridge 12. The increased pressure force on the diaphragm 106 may decrease the volume of the pump chamber 104, closing the first valve 100 and opening the second valve 102, forcing fluid out of the pump chamber 104 through the outlet of the second valve 102, as shown in FIG. Additionally or alternatively, the diaphragm 106 may have or be formed from an elastic material or may be coupled to a bias such that by releasing the pressure force acting on the diaphragm 106 to increase the volume of the pump chamber 104, the volume of the pump chamber 104 automatically decreases, the first valve 100 closes, the second valve 102 opens, and fluid may be forced out of the pump chamber 104 through an outlet of the second valve 102. In some examples, the fluid exiting the pump chamber 104 may travel to, through, and / or over the reactant array 18, as discussed herein or elsewhere.
[0163] 15 schematically illustrates an exemplary method 200 that may facilitate analysis of a reactant array (e.g., a reactant array of a CSA) exposed to fluid from a sample (e.g., as part of a fluid analytical test for one or more fluids of interest). Method 200 may include inserting 202 a cartridge into a device (e.g., a reading device) configured to analyze the reactant array. In some configurations, the cartridge may include a CSA including a reactant array configured to be exposed to fluid and one or more ports configured to receive, engage with, and / or be in fluid communication with a sample to be tested or a sample source including fluid from the sample. The device may be configured to collect light from the reactant array through the cartridge, analyze the collected light instantaneously, and / or analyze changes in the collected light over time.
[0164] Further, method 200 may include actuating 204 a pump implemented at least partially on the cartridge and, optionally, at least partially on the reading device. As discussed herein or elsewhere, actuating the pump may cause fluid to be drawn from the sample source along a fluid path into the cartridge and / or through the cartridge, including through and / or over the reactant array. In some exemplary configurations, the pump may include a flexible, elastic, and / or pliable diaphragm, and actuating the pump may include applying a mechanical force, a pressure force, and / or an electrical signal to the diaphragm to actuate the pump.
[0165] In some cases, the sample source may be disposed in or in fluid communication with the cartridge, and the reactant array of the CSA may be within a compartment of the cartridge. In some examples, the sample source may contain a sample, and fluid from the sample may ooze or be released onto the reactant array. A sample may be collected from an area of interest (e.g., a wound, pollen from a flower, an infection, breath exhaled from a subject, sweat glands, etc.) by applying a specimen to the area of interest.
[0166] In some configurations, once the cartridge is inserted into the reading device and / or the pump is actuated, the reading device may mark the cartridge as used, as discussed herein or elsewhere. Additionally, a reading device that accepts a cartridge may be able to detect whether the cartridge has been previously used, as discussed herein or elsewhere, and if the cartridge and / or specimen is determined to be used, the reading device may refuse to perform a fluid analysis test that uses the specimen and / or cartridge.
[0167] Although not required, light from one or more light sources may be applied to the reactants of the reactant array. The light may be applied directly to the reactants of the reactant array and / or through a transparent portion of the substrate or cartridge. Applying light to the reactants of the reactant array as they are exposed to the fluid may facilitate collection of light from the reactant array.
[0168] The method 200 may include collecting 206 light from the reactant array of the CSA. The light from the reactant array may be collected by a reading device using a light sensor or an image sensor. In some examples, the light from the reactant array may be collected through a transparent portion of the cartridge. Although not required, the light may be collected from the reactant array while the light is irradiating the reactant array.
[0169] In some configurations, the reading device may be configured to analyze the level of wavelengths of light collected from the reactant array. The level of wavelengths of light collected from the reactant array may be measured in any suitable manner, including, but not limited to, counting photons at one or more wavelengths of collected light, measuring the amount of light collected at one or more wavelengths of collected light, the change in photon counts over time for one or more wavelengths of collected light, the change in pixel values of the image sensor over time (e.g., the change in pixel grayscale values), and / or the level of wavelengths of collected light may be measured in one or more other suitable manners.
[0170] Measurements of the levels of wavelengths of light collected from a reactant array can be used to identify components of a fluid to which the reactant array may be exposed. In some examples, if the levels of wavelengths of light collected over time match or are substantially similar to the expected wavelength levels of a reactant exposed to the known fluid or fluid component, the known fluid or fluid component can be identified as the fluid or fluid component being tested in a fluid analytical test. Exemplary techniques for measuring the levels of wavelengths of light collected from a reactant array and comparing the measurements to known measurements associated with the fluid are discussed in PCT / US2023 / 083024 (Attorney Docket No. 1519.1004111), entitled "DEVICES, METHODS, AND SYSTEM FOR MEASURING AND RECORDING SPECTRUM OF A REACTANT ARRAY," having the same filing date as the present application, and which is incorporated herein by reference in its entirety for all purposes.
[0171] 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.
[0172] Unless expressly indicated otherwise, no method or technique described herein should be construed as requiring that its steps be performed in a particular order. This applies to any anticipated non-expressive basis for interpretation, including logical considerations regarding the arrangement or operational flow of steps, simple meaning derived from grammatical construction or punctuation, and the number or type of embodiments described herein.
[0173] It should be understood that this disclosure is, in many respects, merely 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 appropriate, using any of the features of one exemplary embodiment in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.
Claims
1. 1. A system comprising: a cartridge including a reactant array, an input port, an output port, and a pump component between the input port and the output port; a device for analyzing the reactant array when the cartridge is received in the device; The device is configured to engage the pump component to pump fluid through a pathway in fluid communication with the input port, the output port, and the reactant array.
2. The system of claim 1 , wherein the pump component is fluidly isolated from the pathway.
3. The system of claim 1 or 2, wherein the device comprises an actuator configured to actuate the pump component.
4. The system of any one of claims 1 to 3, wherein the pump component comprises an impeller.
5. The system of any one of claims 1 to 4, wherein the pump component comprises a piezoelectric diaphragm configured to electrically connect to the device.
6. The system of any one of claims 1 to 5, wherein the pump component comprises a flexible diaphragm that at least partially defines the pathway.
7. The system of claim 6 , wherein the device comprises a drive component configured to engage the flexible diaphragm to pump fluid through the pathway.
8. a first valve; and Further comprising a second valve; 8. The system of claim 6 or 7, wherein in response to a first movement of the flexible diaphragm, the first valve is configured to open and the second valve is configured to close, and in response to a second movement of the flexible diaphragm, the first valve is configured to close and the second valve is configured to open.
9. 9. The system of claim 1, wherein the pathway is configured to be in fluid communication with a target area, and the cartridge forms a closed loop system that defines the pathway configured to be in fluid communication with the target area and returns fluid transferred to the reactant array to the target area.
10. The system of any one of claims 1 to 9, wherein the cartridge is a single-use component and the device is a reusable component.
11. 11. The system of claim 1, wherein the cartridge comprises one or more seals configured to seal the input and output ports to hermetically seal the reactant array within the cartridge.
12. 12. The system of claim 1, wherein the device for analyzing the reactant array includes a pump driving component, and the pump component of the cartridge is a pump driven component configured to be driven by the pump driving component when the cartridge is placed in the device for analyzing the reactant array.
13. the cartridge comprises a cartridge housing containing the reactant array and the pump component; The system of any one of claims 1 to 12, wherein the device comprises a device housing configured to at least partially receive the cartridge housing.
14. 1. A cartridge for use with a device for analyzing a reactant array, comprising: a reactant array; a pathway extending to the reactant array, the pathway configured to receive fluid from a target region; a driven pump component configured to engage a drive pump component of the device for analyzing the reactant array to pump fluid through the pathway to the reactant array; A cartridge comprising:
15. The cartridge of claim 14 , wherein the driven pump component is fluidly isolated from the pathway.
16. 16. The cartridge of claim 14 or 15, wherein the driven pump component is selected from the group consisting of a flexible diaphragm, a rotor, a piezoelectric element, an Archimedes screw pump, and a plunger.
17. The cartridge of any one of claims 14 to 17, further comprising a single-use component configured to prevent the reactant array from being reused.
18. 20. The cartridge of claim 17, wherein the single-use components comprise one or more of the following types of single-use components: mechanical single-use components, electrical single-use components, optical single-use components, chemical single-use components, magnetic single-use components, and electromechanical single-use components.
19. A cartridge according to any one of claims 14 to 18, further comprising a filter in the pathway, the filter being configured to remove undesired molecules from the fluid.
20. the reactant array comprises a substrate and an array of reactants applied to the substrate; 20. The cartridge of claim 19, wherein the substrate comprises the filter.
21. a cartridge including a reactant array, an input port, an output port, and a flexible membrane, the cartridge including a pathway configured to fluidly communicate with the input port, the output port, the reactant array, and the flexible membrane; a device for analyzing the reactant array when the cartridge is received in the device; a pump configured to apply a force to the flexible membrane to pump fluid along the pathway and along the reactant array; A system comprising:
22. 22. The system of claim 21, wherein the cartridge comprises a component of the pump.
Citation Information
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