WO2019014478A1 - Test device and system for analyzing fluid samples - Google Patents

Test device and system for analyzing fluid samples Download PDF

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Publication number
WO2019014478A1
WO2019014478A1 PCT/US2018/041875 US2018041875W WO2019014478A1 WO 2019014478 A1 WO2019014478 A1 WO 2019014478A1 US 2018041875 W US2018041875 W US 2018041875W WO 2019014478 A1 WO2019014478 A1 WO 2019014478A1
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WO
WIPO (PCT)
Prior art keywords
test device
sensor package
sensor
controller
digital signals
Prior art date
Application number
PCT/US2018/041875
Other languages
French (fr)
Inventor
Ronald B. Koo
Benjamin J. Mccarroll
Yaohua Yang
Henry Grage
Sean Cahill
Original Assignee
Maximum Integrated Products, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Maximum Integrated Products, Inc. filed Critical Maximum Integrated Products, Inc.
Publication of WO2019014478A1 publication Critical patent/WO2019014478A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/48707—Physical analysis of biological material of liquid biological material by electrical means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/06—Arrangements of multiple sensors of different types

Definitions

  • FIG. 3 is a schematic view of an electronics configuration of an embodiment of a sensor package
  • a fluid sample 201 is released through the membrane and received in the fluid reservoir 510.
  • the fluid reservoir 510 comprises or is coupled to a vacuum chamber that generates a negative pressure in the fluid reservoir 510 at the same time or at substantially the same time as the microneedles 508 are actuated to puncture the membrane (e.g., skin surface) in order to release the fluid sample 201 (e.g., blood) through the membrane.
  • a vacuum chamber may function as a passive pump.
  • the vacuum chamber may be preconfigured with a negative pressure that can be released for a single use to draw the fluid sample 201 into the fluid reservoir 510.
  • FIG. 2A an example of a packaged configuration of an embodiment of a sensor package 200 disposed on a test device substrate 102 is shown.
  • An embodiment of the sensor package 200 includes a sensor platform substrate 202, a cap structure 204, a base substrate 206, an electrode structure 210 and a plurality of conductive elements 214.
  • the sensor platform substrate 202 is disposed upon the base substrate 206. In an embodiment, the sensor platform substrate 202 is at least partially embedded within the base substrate 206. In an embodiment, the sensor platform substrate 202 defines a portion of an integrated circuit, such as for example, an application specific integrated circuit (ASIC), that is disposed upon and/or at least partially embedded within the base substrate 206. In an embodiment, the sensor platform substrate 202 and the base substrate 206 are portions of a single substrate.
  • ASIC application specific integrated circuit
  • the multiplied sense signal generated by the multiplier 246 is received at the integrator 248.
  • the integrator 248 generates a readout signal based on the received multiplied sense signal.
  • the digital processing circuitry 232 includes a frequency controller 238.
  • the frequency controller 238 is configured to adjust a frequency of the reference signal and/or the second reference signal.
  • the phase controller 240 and/or the frequency controller 238 can also be configured to control the phase or frequency parameters of digitized readout signals or fluid sample data signals output by the digital processing circuitry 232.
  • the sensor package 200 also includes biasing circuitry 254 configured to generate reference currents, bandgap references, and so forth.
  • the biasing circuitry 254 can generate references for the DAC 226, ADCs 250, and/or other electronic components of the sensor package 200.
  • each of the plurality of readout circuits 244 is placed in series with an associated row of conductive elements 214 and is configured to be selectively electrically coupled to a conductive element 214 in that row when a column corresponding to the conductive element 214 is selected by the column selection circuitry 260.
  • additional physiological data are also collected by external device 101 or entered via external device 101 or another authorized client device 318, where the network 314 and/or external device 101 can be configured to provide alerts based on one or more analyzed fluid samples 201 in addition to the additional physiological data.

Abstract

A test device includes a substrate with a sensor package disposed upon the substrate. The sensor package includes an array of conductive elements, an electrode structure proximate to the array of conductive elements, readout circuits, and analog- to-digital convertors (ADCs). A cavity is disposed between the electrode structure and the array of conductive elements. The cavity is configured to receive a fluid sample. The electrode structure is configured to transmit at least one electrical signal through the fluid sample, and the conductive elements are configured to generate corresponding sense signals. The readout circuits are configured to generate readout signals based on the sense signals, and the ADCs are configured to convert the readout signals into digital signals. The test device further includes a controller communicatively coupled to or included within the sensor package. The controller is configured to transmit information associated with the digital signals to an external device.

Description

TEST DEVICE AND SYSTEM FOR ANALYZING FLUID SAMPLES
BACKGROUND
[0001] The analysis of components in biological fluids (e.g., blood, urine, saliva, etc.) and other fluids (e.g., liquid or gas samples, etc.) is continuing to increase in importance. Biological fluid tests can be used in a health care environment to determine physiological and/or biochemical states, such as disease, mineral content, pharmaceutical drug effectiveness, and/or organ function. For example, it may be desirable to determine an analyte concentration within an individual's blood to manage a health condition, such as diabetes. Consequently, the individual may be required to go to a diagnostic laboratory or medical facility to have blood drawn and then wait (often for an extended period) for analysis results, which can be inconvenient. The individual must often schedule a follow-up visit with a healthcare provider to review the analysis results, which can also add cost. For these reasons and others, there is an increasing need for devices that can facilitate onsite (e.g., point-of-need) testing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0002] The detailed description is described with reference to the accompanying figures. The use of the same reference numbers in different instances in the description and the figures may indicate similar or identical items. Various embodiments or examples ("examples") of the present disclosure are disclosed in the following detailed description and the accompanying drawings. The drawings are not necessarily to scale. In general, operations of disclosed processes may be performed in an arbitrary order, unless otherwise provided in the claims.
[0003] FIG. 1A is a block diagram representation of an example of a test device including an embodiment of a sensor package for analyzing a fluid sample;
[0004] FIG. IB is a block diagram representation of an example of a controller configured to communicate with an embodiment of a sensor package;
[0005] FIG. 1C is a diagrammatic partial cross-sectional side elevation view illustrating a fluid collection device that includes an embodiment of a sensor package for analyzing a fluid sample; [0006] FIG. 2A is a diagrammatic partial cross-sectional side elevation view of an embodiment of sensor package configured as a sensor package;
[0007] FIG. 2B is a diagrammatic partial cross-sectional side elevation view of an embodiment of a sensor package configured as a sensor package;
[0008] FIG. 3 is a schematic view of an electronics configuration of an embodiment of a sensor package;
[0009] FIG. 4 is a partial schematic view of an electronics configuration of an embodiment of a sensor package;
[0010] FIG. 5 is a block diagram representation of an embodiment of a test device including an embodiment of a sensor package for analyzing a fluid sample;
[0011] FIG. 6 is a block diagram representation of an embodiment of a test device including an embodiment of a sensor package for analyzing a fluid sample;
[0012] FIG. 7 is a block diagram representation of an embodiment of a test device including an embodiment of a sensor package for analyzing a fluid sample;
[0013] FIG. 8 is a block diagram representation of an embodiment of a test device including an embodiment of a sensor package for analyzing a fluid sample;
[0014] FIG. 9 is a block diagram representation of an embodiment of a test device including an embodiment of a sensor package for analyzing a fluid sample;
[0015] FIG. 10 is a block diagram representation of an embodiment of a test device including an embodiment of a sensor package for analyzing a fluid sample;
[0016] FIG. 11 is a block diagram representation of an embodiment of a test device including an embodiment of a sensor package for analyzing a fluid sample;
[0017] FIG. 12 is a block diagram representation of additional sensors that may be included in an embodiment of a test device including an embodiment of a sensor package;
[0018] FIG. 13 is a block diagram representation of an embodiment of a test device including an embodiment of a sensor package for analyzing a fluid sample; [0019] FIG. 14 is a block diagram representation of an embodiment of a test device including an embodiment of a sensor package for analyzing a fluid sample;
[0020] FIG. 15 A a block diagram representation of an example system that can employ and embodiment of a test device including an embodiment of the sensor package;
[0021] FIG. 15B is a diagrammatic representation of an example system that can employ an embodiment of a test device including an embodiment of a sensor package.
[0022] FIG. 16A is a flow diagram representation of an example of a process that employs an embodiment of a test device;
[0023] FIG. 16B is a flow diagram further illustrating the example process of FIG. 16A;
[0024] FIG. 16C is a flow diagram further illustrating the example process of FIG. 16A;
[0025] FIG. 16D is a flow diagram further illustrating the example process of FIG. 16 A;
[0026] FIG. 16E is a flow diagram further illustrating the example process of FIG. 16A;
[0027] FIG. 16F is a flow diagram further illustrating the example process of FIG. 16A;
[0028] FIG. 16G is a flow diagram further illustrating the example process of FIG. 16 A;
[0029] FIG. 16H is a flow diagram further illustrating the example process of FIG. 16 A;
DETAILED DESCRIPTION
Overview
[0030] Sensor systems that allow for onsite analysis of fluid samples (e.g., biological fluids or other liquid or gas samples) are increasing in importance. For example, onsite sensor systems can be used to analyze freshly collected fluid samples rather than having to preserve the fluid samples for transport to a remotely located lab for analysis. Onsite sensor systems can also be used to obtain faster results for analyzed fluid samples, to perform analysis of fluid samples in remote areas where transportation and/or access to test equipment is limited, to perform self-tests for patients who need to have one or more of their biological samples (e.g., blood, saliva, urine, etc.) analyzed frequently (rather than having to go to a healthcare facility each time a test is needed), and so forth.
[0031] A mobile test device, system, and method for analyzing fluid samples are disclosed. The test device includes a substrate with a sensor package disposed upon the substrate. For example, the sensor package can be mounted to the substrate or embedded within (e.g., at least partially forming a layer of) the substrate. The sensor package includes at least one array of conductive elements and an electrode proximate to the array of conductive elements. The electrode and the array of conductive elements define a cavity that is configured to receive a fluid sample. The electrode is configured to transmit at least one electrical signal through the fluid sample, whereby the conductive elements generate sense signals corresponding to the electrical signal transmitted through the fluid sample. Changes in impedance due to particles in the fluid sample and/or varying densities of the fluid sample can affect the sense signal generated by respective conductive elements within the array. The sensor package further includes a plurality of readout circuits and analog-to-digital converters (ADCs). The readout circuits are configured to receive sense signals from the array of conductive elements and are further configured to generate readout signals based on the sense signals. In this manner, the test device scans a sample space defined by the array of conductive elements and generates informational signals (i.e., readout signals) associated with characteristics of the fluid sample, such as its particle content, particle morphology, particle density, particle distribution, presence/absence of an analyte, analyte concentration, and so forth. The ADCs are coupled to respective ones of the plurality of readout circuits and are configured to convert the readout signals from the plurality of readout circuits into digital signals. In some embodiments, the digital signals output by the ADCs are processed (e.g., filtered, amplified, phase and/or frequency shifted, modulated, or the like) by digital processing circuitry coupled to the ADCs. For example, the digital processing circuitry can be configured to transmit the processed digital signals or data associated with the digital signals to a controller (e.g., a controller on the test device, a mobile device controller, or the like). In an embodiment, the test device includes a controller coupled to or included within the sensor package. For example, the controller can be disposed upon or within the sensor package, or the controller may be disposed upon the test device and communicatively coupled (e.g., wired) to the sensor package. The controller is configured to receive the digital signals or data associated with the digital signals. The controller is further configured to transmit information associated with the digital signals or the data to an external device via a transceiver that is communicatively coupled with the controller and with an antenna for wirelessly transmitting the information to the external device.
[0032] In embodiments, the external device can include a mobile device (e.g., smartphone, wearable device, tablet, smartwatch, digital camera, notebook computer, media player, portable gaming device, navigation device, or the like), a desktop computer, an analysis instrument, or the like. The external device can be configured to communicate with a network (e.g., wireless network, cloud computing network, or the like). In some embodiments, the external device is configured to transmit the information to the network to be processed by the network and/or stored in a network storage (e.g., cloud storage, data storage server, etc.).
Example Implementations
[0033] Referring to FIG. 1 A, an example of a test device 100 including an embodiment of a sensor package 200 is shown. Examples of a test devices 100 include, but are not limited to, a test strip, a mobile device, a computer device, an analysis instrument, a fluid collection device, and a fluid container. Examples of mobile devices include, but are not limited to, a smartphone, a wearable device, a tablet, a digital camera, a notebook computer, a media player, and a portable gaming device. Examples of fluid collection devices include, but are not limited to, a syringe, an intravenous blood drawing device, and a push button blood collection device that employs a microneedle to draw blood through a skin surface. An example of a push button blood collection device is a TAP device manufactured by Seventh Sense Biosystems, Inc. Examples of fluid containers include, but are not limited to, a microfluidic cassette, a test tube, and a petri dish.
[0034] In an embodiment, the test device 100 includes a controller 108, a sensor package 200, a transceiver 106, a battery 110, and an antenna 104. The controller 108 is communicatively coupled to the sensor package 200 and the transceiver 106. The transceiver 106 is communicatively coupled to the antenna 104. The battery 110 is electrically coupled to the sensor package 200. [0035] In an embodiment, the sensor package 200 is a component of the test device 100. In an embodiment, the sensor package 200 is coupled to the test device 100. In another embodiment, the sensor package 200 is embedded within the test device 100. In an embodiment, the sensor package 200 is coupled to the test device substrate 102. In another embodiment, the sensor package 200 is mounted onto or otherwise attached to the test device substrate 102. In an altemative embodiment, the sensor package 200 is embedded within the test device substrate 102 such that the sensor package 200 at least partially forms a layer of the test device substrate 102. In an embodiment, the test device substrate 102 is a flexible substrate. In another embodiment, the test device substrate 102 is a rigid substrate. In an embodiment, one or more of the components of the sensor package 200 are disposed upon the test device substrate 102. In an embodiment, one or more of the sensor package 200, a controller 108, a transceiver 106, an antenna 104, and a battery 110 are coupled to the test device substrate 102. In an embodiment, one or more of the sensor package 200, a controller 108, a transceiver 106, an antenna 104, and a battery 110 are embedded within the test device substrate 102.
[0036] The sensor package 200 is configured to receive a fluid sample and scan the received fluid sample to detect one or more analytes in the fluid sample. In an embodiment, the sensor package 200 is configured to analyze a fluid sample by scanning the fluid sample to determine at least one characteristic of particles that may be present in the fluid sample. Examples of particles include, but are not limited to cells, biological structures, beads, and microparticles. Examples of characteristic of the particles include, but are not limited to an amount of a particle within the fluid sample, a spatial distribution of the particles within the fluid sample, dimensions of the particles within the fluid sample, and a concentration of particles within the fluid sample.
[0037] In an embodiment, the sensor package 200 is be configured to perform an assay. An assay is a test that is performed by adding one or more reagents to a fluid sample and analyzing the manner in which the fluid sample and/or the reagents are consequently affected. For example, functionalized beads may agglutinate or agglomerate when a certain analyte is present in the fluid sample. Functional beads typically comprise one or more reagents or are coated with one or more reagents. Examples of assays include, but are not limited to, agglutination assays, agglomeration assays, immunoassays, kinetic agglutination assays, agglomeration-of-beads assays, kinetic agglomeration-of-beads assays, coagulation assays, kinetic coagulation assays, surface antigen assays, receptor assays from biopsy procedures, circulating blood cells assays, and circulating nucleic acid assays.
[0038] The controller 108 is configured to receive fluid sample data from the sensor package 200. In an embodiment, the controller 108 is configured to communicate fluid sample data received from the sensor package 200 to an external device 101 via the transceiver 106 and antenna 104. Examples of external devices 101 include, but are not limited to, a mobile device, a computer, and an analysis instrument. In an embodiment, the controller 108 is a component of the test device 100. For example, the controller 108 can be disposed upon the test device substrate 102, is separate from the sensor package 200, and communicatively coupled to the sensor package 200. In another embodiment, the controller 108 is a component of the sensor package 200. For example, the sensor package 200 can include the controller 108 and the controller 108 is communicatively coupled with digital processing circuitry 232 of the sensor package 200. In another example, the sensor package 200 can includes a sensor controller 234 that includes controller 108 such that the sensor controller 234 may be configured to perform some or all functions/operations described herein with regard to controller 108. In an alternative embodiment, the controller 108 is a component of an external device 101 communicatively coupled to the test device 100.
[0039] In an embodiment, the transceiver 106 is disposed upon the test device substrate and is separate from the sensor package 200. In another embodiment, the transceiver 106 is included within the sensor package 200.Examples of transceivers 106 include, but are not limited to, a near-field communication (NFC) transceiver or other short range transceivers. The transceiver 106 is communicatively coupled to the antenna 104 to enable the transmission of information from the test device 100 and the receiving of information at the test device 100. In an embodiment, the transceiver 106 is configured to communicatively couple the test device 100 to an external device 101. The antenna 104 is configured to transmit information sent by the controller 108 to the external device 101. For example, the controller 108 can be configured to send information received from the sensor package 200 to the external device 101 via the transceiver 106 and the antenna 104. In an embodiment, the external device 101 may be configured to receive information from the controller 108 via a direct (e.g., wired) connection. In an embodiment, the controller 108 is configured to receive information from the external device 101 via the transceiver 106 using a direct (e.g., wired) connection).
[0040] The battery 110 is configured to power one or more components of the test device 100. In an embodiment, the battery 110 is electrically coupled to the sensor package 200, the controller 108, and the transceiver 106. In an embodiment, the battery is directly electrically coupled to one or more of the sensor package 200, the controller 108 and the transceiver 106. In an embodiment, the battery 110 is indirectly coupled to one or more of the sensor package 200, the controller 108, and the transceiver 106. In an embodiment, the battery is configured to be charged by an external device. In an embodiment, the battery 110 is configured to be inductively charged via the antenna 104. In an embodiment, the battery 110 is configured to be charged via a separate inductive charging coil. In an embodiment, an energy harvesting circuit can be electrically coupled to the antenna 104. In an embodiment, the transceiver 106 includes energy harvesting circuitry configured to charge the battery 110 with power received from one of an external charging device.
[0041] Referring to IB, an example of a controller 108 configured to communicate with the sensor package 200 is shown. A sensor controller 234 has a configuration similar to that of the controller 108. The controller 108 includes a processor 112, a memory 114, and a communications interface 116. The processor 112 provides processing functionality for the controller 108/test device 100 (or components thereof) and can include any number of microprocessors, digital signal processors, micro-controllers, circuitry, field programmable gate array (FPGA) or other processing systems, and resident or external memory for storing data, executable code, and other information accessed or generated by the controller 108/test device 100. The processor 112 can execute one or more software programs embodied in a non-transitory computer readable medium that implement techniques described herein. The processor 112 is not limited by the materials from which it is formed or the processing mechanisms employed therein and, as such, can be implemented via semiconductor(s) and/or transistors (e.g., using electronic integrated circuit (IC) components), and so forth.
[0042] The memory 114 can be an example of tangible, computer-readable storage medium that provides storage functionality to store various data and or program code associated with operation of the controller 108/test device 100, such as software programs and/or code segments, or other data to instruct the processor 112, and possibly other components of the controller 108/test device 100, to perform the functionality described herein. Thus, the memory 114 can store data, such as a program of instructions for operating the controller 108/test device 100 (including its components), and so forth. It should be noted that while a single memory 114 is described, a wide variety of types and combinations of memory (e.g., tangible, non-transitory memory) can be employed. The memory 114 can be integral with the processor 112, can comprise stand-alone memory, or can be a combination of both.
[0043] Some examples of the memory 114 can include removable and non-removable memory components, such as random-access memory (RAM), read-only memory (ROM), flash memory (e.g., a secure digital (SD) memory card, a mini-SD memory card, and/or a micro-SD memory card), magnetic memory, optical memory, universal serial bus (USB) memory devices, hard disk memory, external memory, and so forth. In implementations, the controller 108/test device 100 and/or the memory 114 can include removable integrated circuit card (ICC) memory, such as memory provided by a subscriber identity module (SIM) card, a universal subscriber identity module (USIM) card, a universal integrated circuit card (UICC), and so on.
[0044] The communications interface 116 can be operatively configured to communicate with components of the sensor package 200 and/or transceiver 106. For example, the communications interface 116 can be configured to retrieve data from storage in the sensor package 200, transmit data for storage in the sensor package 200, and so forth. The communications interface 116 can also be communicatively coupled with the processor 112 to facilitate data transfer between components of the sensor package 200 and the processor 112. It should be noted that while the communications interface 116 is described as a component of a controller 108/test device 100, one or more components of the communications interface 116 can be implemented as external components communicatively coupled to the sensor package 200 via a wired and/or wireless connection. The sensor package 200 can also be configured to connect to one or more input/output (I/O) devices (e.g., via the communications interface 116). For example, an I/O device can include, but is not limited to, a display, a mouse, atouchpad, a touchscreen, a keyboard, a microphone (e.g., for voice commands), any combination of thereof, and the like.
[0045] The communications interface 116 and/or the processor 112 can be configured to communicate with a variety of different networks, such as near-field communication (NFC) networks, a wide-area cellular telephone network, such as a cellular network, a 3G cellular network, a 4G cellular network, or a global system for mobile communications (GSM) network; a wireless computer communications network, such as a WiFi network (e.g., a wireless local area network (WLAN) operated using IEEE 802.11 network standards); an ad-hoc wireless network, an internet; the Internet; a wide areanetwork (WAN); a local area network (LAN); a personal areanetwork (PAN) (e.g., a wireless personal area network (WPAN) operated using IEEE 802.15 network standards); a public telephone network; an extranet; an intranet; and so on. However, this list is provided by way of example only and is not meant to limit the present disclosure. Further, the communications interface 116 can be configured to communicate with a single network or multiple networks across different access points. In an embodiment, a communications interface 116 can transmit information from the controller 108 to an external device (e.g., mobile device, a computer connected to a network, cloud storage, etc.). In another embodiment, a communications interface 116 can receive information from an external device (e.g., a mobile device, a computer connected to a network, cloud computing/storage network, etc.).
[0046] Referring to FIG. 1C, a block diagram representation of an embodiment of a test device 100 including an embodiment of a sensor package 200 is shown. In an embodiment, the test device 100 is a fluid collection device 500. An example of a fluid collection device 500 is a TAP device manufactured by Seventh Sense Biosystems, Inc. Examples of fluid collection devices described in U.S. Patent Nos. 8,561,795 and 8,808,202, are incorporated herein by reference. Any discussion herein regarding the test device 100 and/or components of the test device 100 thereof can also apply to the fluid collection device 500. Furthermore, as previously noted herein, the sensor package 200 and/or test device 100 components can be implemented in additional device, such as for example, including but not limited to, a mobile device, a computer, an analysis instrument, another fluid collection device, a fluid container, and any combination thereof.
[0047] An embodiment of the fluid collection device 500 includes an enclosure 502 that at least partially contains the sensor package 200, antenna 104, the transceiver 106, the controller 108, and the battery 110. In an embodiment the fluid sample collection mechanism of the fluid collection device 500 includes an actuator button 504, an actuation rod 506, one or more microneedles 508, a fluid reservoir 510, and a comfort material 512. Alternative embodiments of the fluid collection device 500 may include a fluid collection mechanism that includes fewer components or additional components that those described herein.
[0048] The one or more microneedles 508 are disposed at an end of the actuation rod 506. The actuation rod 506 is driven in response to pressing or otherwise applying pressure to the actuator button 504. The actuation rod 506 is configured to drive the one or more microneedles 508 through a membrane in order to release a fluid sample 201 from below the membrane. An example of a membrane is a skin surface. Examples of fluid samples 201 include, but are not limited to blood or other biological fluids below the membrane surface.
[0049] In an embodiment, the actuator button 504 drives the actuation rod 506 directly with a spring loaded actuator. In an embodiment, the actuator button 504 drives the actuation rod 506 directly via a magnetic actuator. In an embodiment, the actuator button 504 drives the actuation rod 506 directly via a mechanical actuator. In an embodiment, the actuator button 504 drives the actuation rod 506 directly via an electromechanical actuator.
[0050] In an embodiment, the fluid collection device 500 includes a comfort material 512 that is configured to contact the membrane (e.g., skin surface) as the one or more microneedles 508 penetrate the membrane. The use of the comfort material 512 may prevent discomfort or irritation and/or stabilize the one or more microneedles 508 as the one or more microneedles penetrate the membrane. Examples of comfort materials 512 include, but are not limited to a gel material and a pad material.
[0051] Once the one or more microneedles 508 penetrate the membrane, a fluid sample 201 is released through the membrane and received in the fluid reservoir 510. In an embodiment, the fluid reservoir 510 comprises or is coupled to a vacuum chamber that generates a negative pressure in the fluid reservoir 510 at the same time or at substantially the same time as the microneedles 508 are actuated to puncture the membrane (e.g., skin surface) in order to release the fluid sample 201 (e.g., blood) through the membrane. In an embodiment, a vacuum chamber may function as a passive pump. For example, the vacuum chamber may be preconfigured with a negative pressure that can be released for a single use to draw the fluid sample 201 into the fluid reservoir 510.
[0052] The fluid reservoir 510 can be designed to contain any amount of a fluid sample 201. For example, the fluid reservoir 210 can be designed to contain one of up to 1 microliter, up to 10 microliters, up to 100 microliters, and any range in between. At least a portion of the fluid sample 201 is transferred from the fluid reservoir 510 to the sensor package 200 for analysis.
[0053] The sensor package 200 is fluidically coupled to the fluid reservoir 510. In an embodiment, the sensor package 200 and receives the fluid sample 201 via capillary action. In an embodiment, the sensor package 200 and receives the fluid sample 201 with the assistance of a pump. An example of a pump is a microfluidic pump.
[0054] Referring to FIG. 2A, an example of a packaged configuration of an embodiment of a sensor package 200 disposed on a test device substrate 102 is shown. An embodiment of the sensor package 200 includes a sensor platform substrate 202, a cap structure 204, a base substrate 206, an electrode structure 210 and a plurality of conductive elements 214.
[0055] The plurality of conductive elements 214 are embedded within the sensor platform substrate 202. For example the plurality of conductive elements 214 may be formed within one or more layers of the sensor platform substrate 202. Examples of conductive elements 214 include, but are not limited to metal panels, metal pillars, panels formed from conductive materials, pillars formed from conductive materials, panels formed from semi-conductive materials, and pillars formed from semi- conductive materials. Indium tin oxide (ITO) may be disposed upon the sensor platform substrate 202 to reduce electrochemical effects. In an embodiment, the plurality of conductive elements 214 are uniformly arranged in a planar configuration.
[0056] In embodiment, an electrical insulator and/or protective layer is disposed upon the conductive elements 214 such that the electrical insulator and/or protective layer at least partially covers the conductive elements 214. [0057] In an embodiment, one or more of the conductive elements 214 are prepared for performing an assay. In an embodiment, one or more of the conductive elements 214 are coated with dry chemistry. Examples of dry chemistry include, but are not limited to, dry chemical reagents, microparticles, and microbeads. In an alternative embodiment, one or more of the conductive elements 214 are coated with a gel or slurry in which chemical reagents and/or microparticles are suspended. In an embodiment, the electrical insulator and/or protective layer is coated with dry chemistry. In an embodiment, the electrical insulator and/or protective layer is coated with a gel or slurry in which chemical reagents and/or microparticles are suspended.
[0058] The sensor platform substrate 202 is disposed upon the base substrate 206. In an embodiment, the sensor platform substrate 202 is at least partially embedded within the base substrate 206. In an embodiment, the sensor platform substrate 202 defines a portion of an integrated circuit, such as for example, an application specific integrated circuit (ASIC), that is disposed upon and/or at least partially embedded within the base substrate 206. In an embodiment, the sensor platform substrate 202 and the base substrate 206 are portions of a single substrate.
[0059] The sensor package 200 includes a cap structure 204. In an embodiment, the cap structure 204 is disposed upon the sensor platform substrate 202. In an embodiment, the cap structure 204 is disposed upon the base substrate 206. The cap structure 204 is disposed in relative proximity to the conductive elements 214. In an embodiment, the cap structure 204 includes a cap substrate that is mounted or otherwise coupled to the sensor platform substrate 202. In an embodiment, the cap structure 204 includes a cap substrate that is mounted on or otherwise coupled to the base substrate 206. In an embodiment, the cap structure 204 and sensor platform substrate 202 are portions of a single substrate. In an embodiment, the cap structure 204, the sensor platform substrate 202 and the base substrate 206 are portions of a single substrate.
[0060] The cap structure 204 has an inner surface 213. The electrode structure 210 is coupled to or embedded within the inner surface 213 of the cap structure 204 such that the electrode structure 210 faces the plurality of conductive elements 214 disposed within the sensor platform substrate 202. In an embodiment, an electrical insulator and/or protective layer is disposed over the electrode structure 210 such that the electrical insulator and/or protective layer at least partially covers the electrode structure 210. In an embodiment, the electrode structure 210 is prepared for performing an assay. In an embodiment, the electrode structure 210 is coated with dry chemistry. Examples of dry chemistry include, but are not limited to, dry chemical reagents, microparticles, and microbeads. In an alternative embodiment, the electrode structure 210 is coated with a gel or slurry in which chemical reagents and/or microparticles are suspended. In an embodiment, the electrical insulator and/or protective layer is coated with dry chemistry. In an embodiment, the electrical insulator and/or protective layer is coated with a gel or slurry in which chemical reagents and/or microparticles are suspended.
[0061] In an embodiment, the electrode structure 210 includes a single electrode with multiple surfaces having different distances from the inner surface 215 of the sensor platform substrate 202. The multiple surfaces allow for different sensitivities and/or can be used to filter the fluid sample 201 such each portion of the sensor area below the multi-level electrode 210 is sensitive to a different range of particle sizes. In an embodiment, the electrode structure 210 includes multiple electrodes disposed on the inner surface 213 of the cap structure 204 opposite the plurality of conductive elements 214. In an embodiment, the surfaces of each of the multiple electrodes of the electrode structure 210 has a different distance from the inner surface 215 of the sensor platform substrate 202.
[0062] In an embodiment, the cap structure 204 and the sensor platform substrate 202 define a cavity 208. In an embodiment, the cap structure 204, the sensor platform substrate 202 and the base substrate 206 define a cavity 208. The fluid sample 201 is deposited within the cavity 208 for testing. In an embodiment, the fluid sample 201 is deposited within the cavity 208 via capillary action. In an embodiment, the fluid sample
201 is disposed within the cavity with the assistance of a syringe or a pump. An example of a pump is a microfluidic pump.
[0063] The cavity 208 is disposed between the electrode structure 210 and the conductive elements 214. As described above, the electrode structure 210 is disposed upon the inner surface 213 of the cap structure 204, and the plurality of conductive elements 214 are arranged upon the inner surface 215 of the sensor platform substrate
202 that is opposite the inner surface 213 of the cap structure 204. The electrode structure 210 is configured to transmit at least one electrical test signal through the fluid sample 201 in the direction of the plurality of conductive elements 214 thereby generating a vertical electric field relative to the planar arrangement of the plurality of conductive elements 214. In other words, the generated electric field is substantially perpendicular to the inner surface 215 of the sensor platform substrate 202.
[0064] In an alternative embodiment, the plurality of conductive elements 214 are configured to transmit electrical test signals that can be received by other ones of the conductive elements 214 in order to generate horizontal electric fields relative to the receiving ones of the conductive elements 214. In other words, an electric field that is substantially parallel to the inner surface 215 of the sensor platform substrate 202 is generated.
[0065] The electrical test signal(s) generated by the electrode structure 210 passes through the fluid sample 201 disposed within the cavity 208 and at least a portion of the electrical test signal(s) is detected by the plurality of the conductive elements 214. The plurality of conductive elements 214 are configured to generate sense signals corresponding to the detected portion of electrical test signal (s).
[0066] The sensor package 200 includes one or more electrical paths 220 that enable electrical coupling between electrical components disposed on/or coupled to the sensor platform substrate 202 to other components of the test device 100. Examples of the electrical paths 220 include, but are not limited to, through-silicon vias (TSVs) and conductive traces.
[0067] The sensor platform substrate 202 includes a sensor platform connector 224. Examples of sensor platform connectors 224 include, but are not limited to, input/output (I/O) pads, I/O pins, and I/O sockets. The sensor platform connectors 224 enable electrical coupling with electronic components disposed on the sensor platform substrate 202, such as for example the conductive elements 214, via the electrical pathway 220.
[0068] The test device substrate 102 includes one or more test device connectors 103. Examples of test device connectors 224 include, but are not limited to, input/output (I/O) pads, I/O pins, and I/O sockets. Electrical coupling is provided between electrical components disposed on the sensor platform substrate 202 and the test device 100 via the sensor platform connector 224, the electrical pathway 220, the solder bump 222 and the test device connector 103.
[0069] In an embodiment, the electrode structure 210 is electrically coupled to an electrode connector 216 disposed on the sensor platform substrate 202 via a solder bump 218. Examples of the electrode connectors 216 include, but are not limited to input/output (I/O) pads, I/O pins, and I/O sockets. The electrode connector 216 is coupled to and/or defines a portion of an electrical path on sensor platform substrate 202 for electrically coupling the electrode structure 210 to other components of the sensor package 200 and/or test device 100. An example of such a component is an electrode driver circuitry configured to drive the electrode structure 210. An example of electrode driver circuitry is a digital-to-analog converter (DAC). In embodiments, where sensor platform substrate 202 and the cap structure 204 are portions of a common structure, the electrode structure 210 can be electrically coupled to the electrode driver circuitry that drives the electrode structure 210 by at least one electrical path defined on or through at least a portion of the common structure.
[0070] Referring to FIG. 2B, an example of a packaged configuration of an alternative embodiment of a sensor package 200 disposed on a test device substrate 201 is shown. The electrode structure 210 has a substantially flat or planar configuration. The substantially flat electrode structure 210 is disposed on the inner surface 213 of the cap structure 204 and the plurality or conductive elements are disposed opposite the substantially flat electrode structure 210. In other embodiments, the electrode structure 210 may be disposed on an inner sidewall of the cavity 208 with the conductive elements being disposed on an opposing inner sidewall of the cavity 208.
[0071] In another embodiment, a first section of the cavity 208 may include a first electrode structure 210 disposed on an inner surface 213 of the cap structure 204 and a first plurality of conductive elements 214 disposed on an inner surface 215 of the sensor platform substrate 202 opposite the first electrode structure and a second section of the cavity 208 may include a second electrode structure 210 disposed on an inner surface 215 of the sensor platform substrate 202 and a second plurality of conductive elements 214 disposed on an inner surface 213 of the cap structure 204 opposite the second electrode structure 210. While a number of different configurations of the electrode structure 210 with respect to a plurality of conductive elements 214 have been described, alternative configurations may be used where one or more electrode structures 210 are disposed within an inner surface of the cavity 208 with one or more sets of a plurality of conductive elements 214 disposed on an opposing inner surface of the cavity 208 with respect to the electrode structures 210.
[0072] Referring to FIG. 3 a schematic representation of an electronic configuration of an embodiment of a sensor package 200 is shown. The sensor package 200 includes digital processing circuitry 232, an array 211 of a plurality of conductive elements 214, a fluid sample detector 217, a reference signal generator 228, a phase-locked loop circuit or a delay-locked loop circuit (PLL/DLL) 230, a digital to analog converter (DAC) 226, column selection circuitry 260, a plurality of readout circuits 244, and a power manager 258. The digital processing circuitry 232 is communicatively coupled to the controller 108.
[0073] In an embodiment, the conductive elements 214 are arranged in an array 211. In an embodiment, the array 211 of conductive elements 214 is formed in an MxN matrix, where M is a number of rows of conductive elements 214 and N is a number of columns of conductive elements 214. Although a rectangular arrangement of the conductive elements 214 is shown, in other embodiments, the array 211 of conductive elements 214 can have an alternative configuration. Examples of alternative configurations include, but are not limited to a non-rectangular layout, a different polygonal layout, a hexagonal layout, an octagonal layout, a circular layout, and an elliptical layout.
[0074] The fluid sample detector 217 is communicatively coupled to the digital processing circuitry 232. The fluid sample detector 217 is coupled to and/or disposed in proximity to the array 211 of conductive elements 214. In an embodiment, the array 211 of conductive elements 214 is configured to detect the presence of a fluid sample 201 within the cavity 208 of the sensor package 200 by detecting a change in conductivity or impedance within the cavity 208. Examples of fluid sample detectors 217 include, but are not limited to a resistance sensor, an optical sensor, an electric field sensor, a magnetic field sensor, a pressure/force sensor, a thermal sensor, and a moisture sensor. Examples of optical sensors include, but are not limited to a photodiode and a photoresistor. Examples of an electric field sensor include, but are not limited to, an impendence sensor and a capacitance sensor. Examples of magnetic field sensors include, but are not limited to, a magnetic coil and a Hall effect sensor.
[0075] In an embodiment, the conductive elements 214 and/or the fluid sample detector 217 are configured to detect the presence of a fluid sample 201 in the cavity 208 of the sensor package 200. In an embodiment, the fluid sample detector 217 detects the introduction of a fluid sample 201 into the cavity 208 to enable the determination of a starting time of a reaction between the fluid sample 201 and a reagent (e.g., chemical reagent) disposed within the cavity 208 and/or the beginning of an assay performed with the fluid sample 201. The digital processing circuitry 232 receives data regarding the detection of the presence and/or the introduction of a fluid sample 201 into the cavity 208 from the fluid sample detector 217.
[0076] As discussed above, the electrode structure 210 of the sensor package 200 is configured to transmit at least one electrical test signal through the fluid sample 201 disposed within the cavity 208. The electrical test signal (or signals) are based on a reference signal generated by a reference signal generator 228. Examples of reference signal generators 228 include, but are not limited to a crystal oscillator (XO) and temperature compensated crystal oscillator (TCXO). In an embodiment, the electrode structure 210 is driven directly by the reference signal.
[0077] In an embodiment, the reference signal generator 228 is communicatively coupled to the phase-locked loop or delay-lock loop (PLL/DLL) circuit 230. The PLL/DLL 230 is configured to control a phase of the reference signal generated by the reference signal generator 228 responsive to commands received from the phase controller 240 of the digital processing circuitry 232. In an embodiment, the reference signal generated by the reference signal generator 228 is one or more of delayed, shifted, modulate and attenuated to generate a modified reference signal.
[0078] In an embodiment, the digital processing circuitry 232 receives the reference signal from the reference signal generator 228 and digitizes and/or processes the received reference signal. The digital processing circuitry 232 is communicatively coupled to the DAC 226. The DAC 226 receives the digitized and/or processed reference signal from the digital processing circuitry 232 and generates an electrode driver signal. The DAC 226 is communicatively coupled to the electrode structure 210. The electrode driver signal generated by the DAC 226 is used to drive the electrode structure 210 thereby causing the electrode structure 210 to transmit at least one electrical test signal through the fluid sample 201 disposed within the cavity 208.
[0079] In an embodiment, the digital processing circuitry 232 receives the modified reference signal from the PLL/DLL 230 and digitizes and/or processes the received modified reference signal. The DAC 226 receives the digitized and/or processed modified reference signal from the digital processing circuitry 232 and generates an electrode driver signal. The electrode driver signal generated by the DAC 226 is used to drive the electrode structure 210 thereby causing the electrode structure 210 to transmit at least one electrical test signal through the fluid sample 201 disposed within the cavity 208.
[0080] The electrical test signal(s) transmitted by the electrode structure 210 pass through the fluid sample 201 disposed within the cavity 208 of the sensor package 200. The transmitted electrical signal(s) is/are affected by changes in impedance between the electrode structure 210 and a respective conductive element 214 resulting from the presence of one or more particles 203 within the fluid sample 201 disposed within the cavity 208. The array 211 of conductive elements 214 are configured to detect the version of the electrical test signal(s) that have passed through the fluid sample 201. The conductive elements 214 generate sense signals corresponding to the version of the electrical test signal(s) that have passed through the fluid sample 201. The generated sense signals represent one or more characteristics of the fluid sample 201.
[0081] The sense signals are affected by changes in impedance between the electrode structure 210 and a respective conductive element 214 resulting from the presence of one or more particles in the fluid sample 201. For example, a conductive element 214 positioned below a portion of the fluid sample 201 having a first concentration of particles 203 or a first sized particle 203 may produce a different (e.g., more or less powerful) sense signal than another conductive element 214 positioned below a portion of the fluid sample 201 having a second (different) concentration of particles 203, no particles, or a second (different) sized particle 203 as a result of differing impedance characteristics of the respective portion of the fluid sample 201.
[0082] The column selection circuitry 260 is communicatively coupled to the digital processing circuitry 232 and to the array 211 of conductive elements 214. The column selection circuitry 260 includes one or more of switches and multiplexers. In an embodiment, the column selection circuitry 260 is configured to select individual columns of the N columns of conductive elements 214 one column at a time to read the sense signals from the conductive elements 214 in the selected column.
[0083] The plurality of readout circuits 226 are communicatively coupled to the digital processing circuitry 232 and to the array 211 of conductive elements 214. Each of the plurality of readout circuits 244 is placed in series with an associated row of conductive elements 214 and is configured to be selectively electrically coupled to a conductive element 214 in that row when a column corresponding to the conductive element 214 is selected by the column selection circuitry 260.
[0084] For example, in operation, responsive to commands received from the digital processing circuitry 232, the column selection circuitry 260 selects a first column of the N columns. The first column includes M conductive elements 214 where each of the M conductive elements 214 in the first column are disposed in one through M rows. The plurality of readout circuits 244 consist of M readout circuits, where each of the M readout circuit 244 is associated with a specific row of conductive elements 214. Each of the M readout circuits 244 receive the sense signals generated by the conductive element 214 in the row associated with the readout circuit 244 and in the selected column. All of the sense signals generated by the conductive elements 214 in a selected column are read in parallel at roughly the same time. In other words, the sense signals generated by the conductive elements 214 in a selected column are read substantially simultaneously by the associated readout circuits 244. The readout circuits 244 processe the received sense signals and generate readout signals that are transmitted to the digital processing circuitry 232.
[0085] The column selection circuitry 260 then selects a second column of the N columns. Each of the M readout circuits 244 receive the sense signals generated by the conductive element 214 in the row associated with the readout circuit 244 and in the second column. The readout circuit 244 processes the received sense signals and generates readout signals that are transmitted to the digital processing circuitry 232. This process is repeated as the column circuitry 260 successively selects each of the N columns and the readout circuits 244 receive the sense signals generated by each of the conductive elements in the selected column thereby collecting sense signals from each of the conductive elements 214 in the array 211. In an alternative embodiment, each of the conductive elements 214 in a selected column are read sequentially one at a time.
[0086] In an embodiment, each of the plurality of readout circuit 244 includes a multiplier 246 and an integrator 248. The multiplier 246 is coupled to the integrator 248. In an embodiment, the multiplier 246 is coupled in series with the integrator 248. The multiplier 246 is configured to multiply a sense signal received at the readout circuit 244 from a respective conductive element 214 by a second reference signal. The second reference signal is based upon the reference signal generated by the reference signal generator 228 that is used to drive the electrode structure 210. In an embodiment, the second reference signal is a copy of the reference signal generated by the reference signal generator 228. In an another embodiment, the second reference signal is copy of the modified reference signal generated by the PLL/DLL circuit 230.
[0087] In another embodiment, the digital processing circuitry 232 includes a phase controller 240. An example of a phase controller 240 is a PLL/DLL circuit. In an embodiment, the phase controller 240 is configured to adjust the phase of the reference
71
signal by - radians to generate the second reference signal. For example, the reference signal can comprise a sine wave and the second reference signal generated by the phase controller 240 can comprise a cosine wave, or vice versa. In another embodiment, the phase controller 240 is configured to adjust the phase of the modified reference signal
71
by - radians to generate the second reference signal.
[0088] The multiplied sense signal generated by the multiplier 246 is received at the integrator 248. The integrator 248 generates a readout signal based on the received multiplied sense signal.
[0089] In an embodiment, the digital processing circuitry 232 includes a frequency controller 238. The frequency controller 238 is configured to adjust a frequency of the reference signal and/or the second reference signal. The phase controller 240 and/or the frequency controller 238 can also be configured to control the phase or frequency parameters of digitized readout signals or fluid sample data signals output by the digital processing circuitry 232. The sensor package 200 also includes biasing circuitry 254 configured to generate reference currents, bandgap references, and so forth. For example, the biasing circuitry 254 can generate references for the DAC 226, ADCs 250, and/or other electronic components of the sensor package 200.
[0090] Each of the plurality of readout circuits 244 are coupled to an associated one of a plurality of analog-to-digital converters (ADC) 250. Each ADC 250 is configured to receive the readout signal generated by the associated readout circuit 244. The readout signal received at the ADC 250 is an analog signal. The ADC is configured to convert the analog readout signal received from the associated readout circuit 244 into a digital readout signal. The digital processing circuitry 232 is coupled to the plurality of ADCs 250 and is configured to receive the digital readout signals for further processing.
[0091] In an embodiment, the digital processing circuitry 232 is configured to output a fluid sample data signal incorporating at least a portion of one or more of the digital readout signals received from the associated ADCs 250 to the controller 108. In an embodiment, the fluid sample data signal includes at least a portion of the readout digital signals, at least one signal based on filtering, phase shifting, modulating, and/or attenuating at least one of the readout digital signals, imaging data based on at least a portion of the readout digital signals, and/or data based on aggregating, averaging, and/or comparing at least a portion of the readout digital signals. In an embodiments, the digital processing circuitry 232 is configured to store the received digital readout signals and/or the generated fluid sample data signals in a memory 236 that is coupled to the sensor controller 234. For example, the sensor controller 234 can be configured to store the digital readout signals and/or fluid sample data signals based on the digital readout signals in the memory 236 prior to transmitting the fluid sample data signals to the controller 108. In an embodiment, the fluid sample data signal is transmitted to the external device 101.
[0092] In an embodiment, each of the plurality of the ADCs 250 is coupled to a common ramp generator 252. The ramp generator 252 is configured to supply a stepped up reference voltage (e.g., a ramp signal) to the ADCs 250.
[0093] In an embodiment, the sensor package 200 includes a power manager 256. In an embodiment, the power manager 256 is configured to receive a power signal (VBATT) from the battery 110 coupled to the sensor package 200. In another embodiment, the power manager 256 is configured to receive a power signal from an external source (e.g., from device 101) via a direct (e.g., wired) connection or a wireless (e.g., inductive charging) connection. The power manager 256 includes one or more voltage regulators 258 (e.g., low-dropout regulators (LDOs)) that are configured to step up or step down the voltage of the power signal to provide one or more output voltages (e.g., VOUT 1, VOUT 2, VOUT 3, etc.) for establishing reference signals and/or powering various components of the sensor package 200 and/or components coupled to the sensor package 200, such as the controller 108, the transceiver 106, and so forth.
[0094] In an embodiment, the sensor package 100 includes the power manager 256. In an embodiment, the power manager 256 is a component of the test device 100 but is separate from the sensor package 200. For example, the power manager 256 can include a circuit (e.g., a power management integrated circuit (PMIC)) disposed upon the test device substrate 102, separate from the sensor package 200.
[0095] In an embodiment, the power manager 256 is electrically coupled to battery 110 and is configured to distribute power from the battery 110 to one or more components of the test device 100. In an embodiment, the battery 110 is pre-charged. In an embodiment, the battery 110 is configured to be charged by the external device 101.
[0096] Referring to FIG. 4, a partial schematic view of an electronics configuration of an embodiment of a sensor package 200 is shown. The sensor package 200 includes first and second arrays 211 of conductive elements 214. The first and second arrays 211 of conductive elements 214 share a common set of readout circuits 244. The sensor package 200 includes row selection circuitry 262. The row selection circuitry 262 includes one or more switches and/or one or more multiplexers between the common set of readout circuits 244 and the first and second arrays 211. The row selection circuitry 262 selectively couples each of the first and second arrays to the common set of readout circuits 244 one array at a time responsive to commands received from the digital processing circuitry 232.
[0097] Upon the coupling of the selected array 211 of conductive elements 214 with the common set of readout circuits 244, each of the plurality of readout circuits 244 is placed in series with an associated row of conductive elements 214 and is configured to be selectively electrically coupled to a conductive element 214 in that row when a column corresponding to the conductive element 214 is selected by the column selection circuitry 260.
[0098] For example, in operation, responsive to commands received from the digital processing circuitry 232, the column selection circuitry 260 selects a first column of the N columns. The first column includes M conductive elements 214 where each of the M conductive elements 214 in the first column are disposed in one through M rows. The common set of readout circuits 244 consist of M readout circuits, where each of the M readout circuit 244 is associated with a specific row of conductive elements 214. Each of the M readout circuits 244 receive the sense signals generated by the conductive element 214 in the row associated with the readout circuit 244 and in the selected column.
[0099] All of the sense signals generated by the conductive elements 214 in a selected column are read in parallel at roughly the same time. In other words, the sense signals generated by the conductive elements 214 in a selected column are read substantially simultaneously by the associated readout circuits 244. The readout circuit 244 processes the received sense signals to generate readout signals. The readout signals are transmitted to the digital processing circuitry 232.
[00100] The column selection circuitry 260 then selects a second column of the N columns. Each of the M readout circuits 244 receive the sense signals generated by the conductive element 214 in the row associated with the readout circuit 244 and in the second column. The readout circuit 244 processes the received sense signals to generate readout signals. The readout signals are transmitted to the digital processing circuitry 232. This process is repeated as the column circuitry 260 successively selects each of the N columns and the readout circuits 244 receive the sense signals generated by each of the conductive elements in the selected column thereby collecting sense signals from each of the conductive elements 214 in the array 211. In an alternative embodiment, each of the conductive elements 214 in a selected column are read sequentially one at a time. In this manner, the sensor package 200 can be configured to scan a selected array 211 of conductive elements 214, column-by-column. In an alternative embodiment, the sensor package 200 is configured to scan a selected array 211 of conductive elements 214 row-by-row in a similar manner with the row and column circuitry being reversed. [00101] Referring to FIG. 5, an embodiment of a test device 100 including an embodiment of a sensor package 200 is shown. The test device 100 includes a sensor package 200, a controller 108, a transceiver 106, an antenna 104, a battery 110, a power manager 256 and a unique identifier 103. The sensor package 200 includes one or more sensor arrays 211 (i.e. arrays of conductive elements 214), readout circuits 244, analog- to-digital converters 250, and digital processing circuitry 232. The controller 108, the transceiver 106, the antenna 104, the battery 110 and the power manager 256 are components of the test device 100 that are external to the sensor package 200. In other words, the controller 108, the transceiver 106, the antenna 104, the battery 110 and the power manager 256 are not components of the sensor package 200.
[00102] While FIG. 5 illustrates the unique identifier 103 as being associated with the test device 100, in alternative embodiments, the unique identifier 103 can be associated with the sensor package 200. Examples of unique identifiers include, but are not limited to, bar codes, QR codes, and radio frequency identifiers (RFIDs). In an embodiment, the unique identifier 103 is scannable or otherwise detectable by the external device 101. The external device 10 can use the unique identifier 103 associated with the test device 100 and/or sensor package 200 to access information associated with the test device 100 and/or sensor package 200. Examples of the information associated with the test device 100 and/or sensor package 200 that the external device 101 can access using the unique identifier 103 include, but are not limited to, model number of the test device 100 and/or sensor package 200, specifications of the test device 100 and/or sensor package 200, functionality of the test device and/or sensor package 200, expiration date of the test device 100 and/or sensor package 200, prior use data of the test device 100 and/or sensor package 200, and logged data entries associated with the test device 100 and/or sensor package 200.
[00103] In an embodiment, the test device 100 has a predetermined expiration date. In an embodiment, the sensor package 200 has a predetermined expiration date. In an embodiment, the unique identifier 103 can be used to access the predetermined expiration date of the test device 100 and/or sensor package 200. In an embodiment, the controller 108 receives information regarding the predetermined expiration date from an external device 101.
[00104] In an embodiment, the controller 108 is configured to at least partially disable the transmission of information from the test device 100 to an external device 101 based upon a determination by the controller 108 that the predetermined expiration date associated with at least one of the test device 100 and the sensor package 200 has been reached. In an embodiment, the controller 108 is configured to at least partially deactivate the sensor package 200 based upon a determination by the controller 108 that the predetermined expiration date associated with at least one of the test device 100 and the sensor package 200 has been reached. In an embodiment, the controller 108 is configured to prevent transmission of information associated with fluid sample data collected by the sensor package 200 based upon a determination by the controller 108 that the predetermined expiration date associated with at least one of the test device 100 and the sensor package 200 has been reached.
[00105] In an embodiment, the predetermined expiration date is based on when the test device 100 and/or sensor device 200 is unpacked or first used. For example, the controller 108 can be configured to begin a counter or timer when the controller 108 detects that the test device 100 and/or sensor has been unpacked. In an embodiment,
[00106] In an embodiment, the date of manufacture can be burned into the test device 100 and/or sensor package 200. For example, the date of manufacture can be physically printed and/or coded in the software or firmware of the test device 100 and/or sensor package 200. The test device 100 and/or sensor package 200 may expire after a predetermined period from the date of manufacture (e.g., 1 year from the date of manufacture). The predetermined period can be any period of time (e.g., 1 day, several days, 1 week, several weeks, 1 month, several months, 1 year, several years, etc.) and may depend on the nature of the test device 100 and/or sensor package 200. In an embodiment, the predetermined expiration date may depend on the assays that the test device 100 and/or sensor package 200 is manufactured to perform (e.g., based on the chemical reagents employed by the sensor package 200).
[00107] As discussed herein, in some embodiments, the controller 108 is configured to monitor for the expiration date/period. In other embodiments, the device 101 can be configured to determine or retrieve information associated with the expiration date/period based on a unique identifier 103 (e.g., serial number, barcode, RFID, or the like) that is scanned/detected by or manually entered into the device 101. For example, the device 101 can be configured to look up the date of manufacture in a database (e.g., a network or cloud database) and determine whether the test device 100 is still good or expired based on information received from the database.
[00108] Referring to FIG. 6, an embodiment of a test device 100 including an embodiment of a sensor package 200 is shown. The test device 100 includes a sensor package 200, a transceiver 106, an antenna 104, a battery 110, and a power manager 256. The sensor package 200 includes one or more sensor arrays 211 (i.e. arrays of conductive elements 214), readout circuits 244, analog-to-digital converters 250, digital processing circuitry 232, and the controller 108. The transceiver 106, the antenna 104, the battery 110 and the power manager 256 are components of the test device 100 that are external to the sensor package 200. In other words, the transceiver 106, the antenna 104, the battery 110 and the power manager 256 are not components of the sensor package 200.
[00109] Referring to FIG. 7, an embodiment of a test device 100 including an embodiment of a sensor package 200 is shown. The test device 100 includes a sensor package 200, a transceiver 106, an antenna 104, a battery 110, and a power manager 256. The sensor package 200 includes one or more sensor arrays 211 (i.e. arrays of conductive elements 214), readout circuits 244, analog-to-digital converters 250, and digital processing circuitry 232. The digital processing circuitry 232 includes the sensor controller 234. The controller 108 is integrated into the sensor controller 234. In an embodiment, the controller 108 is a component of the sensor controller 234. In an embodiment, the sensor controller 234 performs the functions of both the sensor controller 234 and the controller 108. The transceiver 106, the antenna 104, the battery 110 and the power manager 256 are components of the test device 100 that are external to the sensor package 200. In other words, the transceiver 106, the antenna 104, the battery 110 and the power manager 256 are not components of the sensor package 200.
[00110] Referring to FIG. 8, an embodiment of a test device 100 including an embodiment of a sensor package 200 is shown. The test device 100 includes a sensor package 200, an antenna 104, a battery 110, and a power manager 256. The sensor package 200 includes one or more sensor arrays 211 (i.e. arrays of conductive elements 214), readout circuits 244, analog-to-digital converters 250, digital processing circuitry 232, the controller 108, and the transceiver 106. The antenna 104, the battery 110 and the power manager 256 are components of the test device 100 that are external to the sensor package 200. In other words, the antenna 104, the battery 110 and the power manager 256 are not components of the sensor package 200.
[00111] Referring to FIG. 9, an embodiment of a test device 100 including an embodiment of a sensor package 200 is shown. The test device 100 includes a sensor package 200, an antenna 104, and a battery 110. The sensor package 200 includes one or more sensor arrays 211 (i.e. arrays of conductive elements 214), readout circuits 244, analog-to-digital converters 250, digital processing circuitry 232, the controller 108, the transceiver 106, and the power manager 256. The antenna 104 and the battery 110 are components of the test device 100 that are external to the sensor package 200. In other words, the antenna 104 and the battery 110 are not components of the sensor package 200.
[00112] Referring to FIG. 10, an embodiment of a test device 100 including an embodiment of a sensor package 200 is shown. The test device 100 includes a sensor package 200, an antenna 104, a battery 110, energy harvesting circuitry 118, and an energy harvesting antenna 120. The sensor package 200 includes one or more sensor arrays 211 (i.e. arrays of conductive elements 214), readout circuits 244, analog-to- digital converters 250, digital processing circuitry 232, the controller 108, the transceiver 106, and the power manager 256. The a battery 110, energy harvesting circuitry 118, and the energy harvesting antenna 120 are components of the test device 100 and are external to the sensor package 200. In other words, the a battery 110, energy harvesting circuitry 118, and the energy harvesting antenna 120 are not components of the sensor package 200.
[00113] The battery 110 is electrically coupled to the energy harvesting circuitry 118. The energy harvesting circuitry 118 is electrically coupled to the energy harvesting antenna 120. The battery 110 is charged by the energy harvesting circuitry 118. The energy harvesting circuit 118 is configured to wirelessly receive energy from the external device 101 via the energy harvesting antenna 120 and to charge the battery 110 with the energy received from the external device 101.
[00114] In an embodiment, the energy harvesting circuit 118 and the energy harvesting antenna 120 are disposed upon the test device substrate 102. In an embodiment, the energy harvesting antenna 120 is an inductive charging coil. In an embodiment, the energy harvesting antenna 120 is the antenna 104. In an embodiment, the energy harvesting antenna 120 shares one or more components with the antenna 104.
[00115] In an embodiment, the test device 100 does not include battery 110. The energy harvesting circuit 118 is configured to wirelessly receive energy from the extemal device 101 via the energy harvesting antenna 120 and to directly or indirectly power one or more components of the test device 100 components with the energy received from the extemal device 101. In an embodiment, the power manager 256 is electrically coupled to the energy harvesting circuit 118 and is configured to distribute power from the energy harvesting circuit 118 to one or more components of the test device 100 components.
[00116] Referring to FIG. 11, an embodiment of a test device 100 including an embodiment of a sensor package 200 is shown. The test device 100 includes a sensor package 200, an antenna 104, and a battery 110. The sensor package 200 includes one or more sensor arrays 211 (i.e. arrays of conductive elements 214), readout circuits 244, analog-to-digital converters 250, digital processing circuitry 232, the controller 108, the transceiver 106, and the power manager 256. The antenna 104 and the battery 110 are components of the test device 100 that are extemal to the sensor package 200. In other words, the antenna 104 and the battery 110 are not components of the sensor package 200. In an embodiment, the sensor package 200 includes one or more additional sensors 122. In an embodiment, the test device 100 includes one or more additional sensors 122. The one or more additional sensors 122 are disposed upon the test device substrate 102 separate from the sensor package 200. In an embodiment, both the sensor package 200 and the test device 100 include one or more additional sensors 122.
[00117] Referring to FIG. 12, a block diagram representation of a controller 108 communicatively coupled to the one or more additional sensors is shown. In an embodiment, the controller 108 is a component of the sensor system 200. In an embodiment, the controller 108 is a component of the test device 100 but separate from the sensor system 200.
[00118] In an embodiment, the controller 108 is communicatively coupled to the one or more additional sensors 122 that are components of the test device substrate 102 but separate from the sensor package 200. In an embodiment, the controller 108 is communicatively coupled to the one or more additional sensors 122 that are components of the sensor system 200. In an embodiment, the controller 108 is communicatively coupled to one or more additional sensors 122 that components of the sensor package 200 and to the one or more additional sensors 122 that are components of the test device 102 but not components of the sensor package 200.
[00119] Examples of the additional sensors 122 include, but are not limited to, at least one a temperature sensor 124, a moisture sensor 126, a pressure sensor 128, a motion sensor 130, a location sensor 132 and any combination thereof. An example of a temperature sensor 124 is a thermal sensor. Examples of thermal sensors include, but are not limited to a thermistor, a thermopile, and a thermal diode. An example of a moisture sensor 126 is a humidity sensor. An example of a pressure sensor 128 is a force sensor. Examples of a motion sensors 130 include, but are not limited to an accelerometer, a gyroscope, or other inertial sensor. Examples of location sensors 132 include, but are not limited to a global positioning sensor, a triangulation based sensor, an inertial positioning sensor, and any combination thereof.
[00120] The controller 108 is configured to receive measurement data from the one or more additional sensors 122. For example, the controller 108 can be configured to receive one or more of temperature measurements, moisture measurements, pressure measurements, motion measurements, and/or location/positioning measurements from the one or more additional sensors 122. In an embodiment, the measurements received from the one or more additional sensors 122 include may measurements associated with the environment surrounding the test device 100. In an embodiment, the measurements received from the one or more additional sensors 122 include may measurements associated with the test device 100. For example, the measurements received from the one or more additional sensors 122 may be associated with one or more of the sensor package 200, the cavity 208 in which the fluid sample 201 is disposed, and measurements of the fluid sample 201.
[00121] In an embodiment, the controller 108 is configured to calibrate at least one parameter associated with the test device 100 based upon at least one measurement received from the one or more additional sensors 122. In an embodiment, the controller 108 is configured to calibrate at least one parameter associated with the sensor package 200 based upon at least one measurement received from the one or more additional sensors 122. In an embodiment, the controller 108 is configured to calibrate results associated with one or more of a reaction time, a beginning of a reaction, and an ending of a reaction based on at least one measurement received from the one or more additional sensors 122. Examples of measurements received from the one or more additional sensors 122 that can be used in the calibration process include, but are not limited to, temperature measurements, moisture measurements, motion measurements, and pressure measurements. Examples of other parameters that the controller 108 may be configured to calibrate include, but are not limited to, the reference signal, the electrode structure drive signal (e.g., DAC 226 signal for driving the electrode structure 210), the second reference signal, the scan rate of the fluid sample 201, and PLL/DLL 230 parameters.
[00122] In an embodiment, the controller 108 is configured to enable or disable one or more test device 100 functionalities based upon one or more measurements received from the one or more additional sensors 122. In an embodiment, the controller 108 is configured to at least partially disable the transmission of information to from the test device 100 to the extemal device 101 based on measurements received from the one or more of the additional sensors 122.
[00123] In an embodiment, the controller 108 is configured to at least partially disable the transmission of information to from the test device 100 to the external device 101 when the measurements received from the one or more additional sensors 122 exceeds a predetermined maximum threshold for at least one of the test device 100 and/or the sensor package 200. In an embodiment, the controller 108 is configured to at least partially disable the transmission of information to from the test device 100 to the external device 101 when the measurements received from the one or more additional sensors 122 falls below a predetermined minimum threshold for at least one of the test device 100 and/or the sensor package 200. For example, the controller 108 can prevent the test device 100 from communicating analysis and/or test results associated with the fluid sample 201 if the test device 100 and/or sensor package 200 has been exposed to conditions that can affect operability of the test device 100 and/or sensor package 200.
[00124] In an embodiment, the controller 108 is configured to at least partially disable the transmission of information to from the test device 100 to the external device 101 when the temperature measurements received from at least one temperature sensor 124 exceeds a predetermined maximum operating temperature for at least one of the test device 100 and the sensor package 200. In an embodiment, the controller 108 is configured to at least partially disable the transmission of information to from the test device 100 to the external device 101 when the temperature measurements received from at least one temperature sensor 124 falls below a predetermined minimum operating temperature for at least one of the test device 100 and the sensor package 200. For example, the controller 108 can prevent the test device 100 from communicating analysis and/or test results associated with the fluid sample 201 if the test device 100 and/or sensor package 200 has been exposed to a temperature that can affect operability of the test device 100 and/or sensor package 200.
[00125] In an embodiment, the controller 108 is configured to at least partially disable the transmission of information to from the test device 100 to the external device 101 when the moisture measurements received from the at least one moisture sensor 126 exceeds a predetermined moisture/humidity level for at least one of the test device 100 and/or the sensor package 200. In an embodiment, the controller 108 is configured to at least partially disable the transmission of information to from the test device 100 to the external device 101 when the moisture measurements received from the at least one moisture sensor 126 falls below a predetermined moisture/humidity level for at least one of the test device 100 and/or the sensor package 200. For example, the controller 108 can prevent the test device 100 from communicating analysis and/or test results associated with the fluid sample 201 if the test device 100 and/or sensor package 200 has been exposed to a moisture/humidity level that can affect operability of the test device 100 and/or sensor package 200.
[00126] In an embodiment, the controller 108 is configured to at least partially disable the transmission of information to from the test device 100 to the external device 101 when the pressure measurements received from the at least one pressure sensor 128 exceeds a predetermined pressure or shock level for at least one of the test device 100 and/or the sensor package 200. In an embodiment, the controller 108 is configured to at least partially disable the transmission of information to from the test device 100 to the external device 101 when the pressure measurements received from the at least one pressure sensor 128 falls below a predetermined pressure level for at least one of the test device 100 and/or the sensor package 200. For example, the controller 108 can prevent the test device 100 from communicating analysis and/or test results associated with the fluid sample 201 if the test device 100 and/or sensor package 200 has been exposed to a pressure level that can affect operability of the test device 100 and/or sensor package 200. In an embodiment, the controller 108 can prevent the test device 100 from communicating analysis or test results associated with the fluid sample 201 if the test device 100 and/or sensor package 200 has experienced a shock, impact, or vibration that can affect operability of the test device 100 and/or sensor package 200.
[00127] In an embodiment, the controller 108 is configured to at least partially disable the transmission of information to from the test device 100 to the external device 101 when the motion measurements received from the at least one motion sensor 130 exceeds a predetermined motion and/or shock level for at least one of the test device 100 and/or the sensor package 200. In an embodiment, the controller 108 is configured to at least partially disable the transmission of information to from the test device 100 to the external device 101 when the motion measurements received from the at least one motion sensor 128 falls below a predetermined motion level for at least one of the test device 100 and/or the sensor package 200. For example, the controller 108 can prevent the test device 100 from communicating analysis and/or test results associated with the fluid sample 201 if the test device 100 and/or sensor package 200 has been exposed to a motion level that can affect operability of the test device 100 and/or sensor package 200. In an embodiment, the controller 108 can prevent the test device 100 from communicating analysis or test results associated with the fluid sample 201 if the test device 100 and/or sensor package 200 has experienced a shock, impact, or vibration that can affect operability of the test device 100 and/or sensor package 200.
[00128] In an embodiment, the expiration period associated with the test device 100 and/or the sensor package 200 is based on stored time values and/or stored moisture measurements. For example, the controller 108 can be configured to at least partially disable the test device 100 and/or sensor package 200 when the test device 100 and/or sensor package 200 has been exposed to a threshold moisture/humidity level.
[00129] Referring to FIG. 13, an embodiment of a test device 100 including an embodiment of a sensor package 200 is shown. The test device 100 includes a sensor package 200, an antenna 104, and a battery 110. The sensor package 200 includes one or more sensor arrays 211 (i.e. arrays of conductive elements 214), readout circuits 244, analog-to-digital converters 250, digital processing circuitry 232, the controller 108, the transceiver 106, the power manager 256, and an agitator 134. The antenna 104 and the battery 110 are components of the test device 100 that are external to the sensor package 200. In other words, the antenna 104 and the battery 110 are not components of the sensor package 200.
[00130] The agitator 134 is coupled to and/or in proximity to the one or more sensor arrays 211 (i.e. arrays of conductive elements 214). The agitator 134 is configured to agitate (e.g., stir, mix, shake, and/or vibrate) the fluid sample 201. Examples of the agitators 134 include, but are not limited to, an actuator (e.g., a micro-electrical mechanical system (MEMS) actuator), a stir bar (e.g., mechanical or magnetic stir bar), a vibrator (mechanical vibrator, sonic or ultrasonic vibrator (e.g., transducer), or the like), an electrical field generator that generates an electric field causing vibration and/or stirring of the fluid sample 201, a magnetic field that generates a magnetic field causing vibration and/or stirring of the fluid sample 201, any combination thereof, and so forth. When the fluid sample 201 is disposed within the cavity 208, the fluid sample 201 may come into contact with a reagent (e.g., microbeads, dry chemical reagent or a slurry) for performing an assay (e.g., an agglutination/agglomeration assay). The agitator 134 is configured to agitate the fluid sample 201 in order to improve mixing with the fluid sample 201 with the reagent and/or to initiate and/or or speed up a reaction between the fluid sample 201 and the reagent 201.
[00131] Referring to FIG 14, an embodiment of a test device 100 including an embodiment of a sensor package 200 is shown. The test device 100 includes a sensor package 200, an antenna 104, and a battery 110. The sensor package 200 includes one or more sensor arrays 211 (i.e. arrays of conductive elements 214), readout circuits 244, analog-to-digital converters 250, digital processing circuitry 232, the controller 108, the transceiver 106, and a the power manager 256. The antenna 104 and the battery 110 are components of the test device 100 that are external to the sensor package 200. In other words, the antenna 104 and the battery 110 are not components of the sensor package 200. One or more of the sensor arrays 211 include a control assay 136. The control assay 136 is used to test the sensor package 200 and/or calibrate at least one parameter of the sensor package 200.
[00132] In an embodiment, at least one array 211 of the sensor package 200 may be preloaded with the control assay 136. In an embodiment, the control assay 136 includes a mixture that can be disposed within the cavity 208 of the sensor package 200 for testing and/or calibration when the test device 100 and/or sensor package 200 is first used or at any time. In an embodiment, the controller 108 is configured to report results associated with the control assay 136 to an external device 101. In an embodiment, the controller 108 is configured to adjust one or more parameters of the test device 100 and/or sensor package 200 based on results associated with the control assay 136. In an embodiment, the controller 108 is configured to provide an alert indicating an error to the external device 101 when the control assay yields an error condition (e.g., when the control assay does not work as expected and/or yields inconclusive measurement data).
[00133] In an embodiment, the test device 100 can be at least partially disabled and/or prevented from communicating with an external device 101 based on one or more factors including, but not limited to, time related parameters, security credential validation, single and/or limited use protocols, device pairing, combinations thereof, and so forth. Examples of security credential validation include, but are not limited to device authentication and user authentication. Examples of single or limited use protocols include, but are not limited to a killbit and a register that can be set or reset by the controller 108 after a selected number of uses. Examples of device pairing include, but are not limited to a single device pairing protocol, a limited device pairing protocols, and combinations thereof.
[00134] In an embodiment, the test device 100 and/or sensor package 200 is configured for a single use or a limited number of uses. For example, the controller 108 can be configured to at least partially disable transmission of additional information from the test device 100 to the external device 101 after the controller 108 transmits the information associated with a first assay or a number of assays to the external device 101.
[00135] In an embodiment, the controller 108 is configured to pair the test device 100 with an external device 101. For example, the controller 108 can be configured to perform a pairing sequence whereby the controller 108 sends device information to and/or receives device identification information from the external device 101. In an embodiment, the controller 108 is configured to send at least one security credential to and/or receive at least one security credential from the external device 101. For example, the external device 101 may be configured to send a security credential to the test device 100 in order to pair the external device 101 with the test device 100. In an embodiment, the device 101 is configured to receive a user password, passkey, or other user security credential (e.g., biometric input, such as a fingerprint or eye scan, or the like) in order to permit pairing of the external device 101 with the test device 100. The controller 108 may be configured to at least partially disable communication with device 101 if the test device 100 fails to pair with the external device 101 (e.g., if the external device 101 fails to send a valid security credential to the test device 100 and/or if the user-entered security credential cannot be otherwise validated (e.g., by one of the external device 101, the controller 108, and/or a third party)).
[00136] In an embodiment, the controller 108 is configured to establish a secure communication path with the external device 101 via for example an encrypted tunnel, where the controller 108 is configured to encrypt information prior to transmitting the information to the external device 101. In an embodiment thee controller 108 is configured to at least partially disable communication with a second external device after the test device 100 has been paired with the external device 101. For example, the test device 100 may be configured to be paired with only one device (e.g., external device 101) or only a predetermined number of devices.
[00137] Referring to FIGS. 15A a block diagram representation of an example system 300 that can employ an embodiment of the test device 100 including an embodiment of the sensor package 200 is shown. The example system 300 includes an external device 101 configured to be communicatively coupled to the test device 100. In an embodiment, the external device 101 is configured to be coupled to a network storage 316 and one or more client devices 318, 318A, 318B via a network 314. In an embodiment, the external device 101 includes an external device controller 302 communicatively coupled to a user interface 310 and a location sensor 312.
[00138] Examples of networks 314 include, but are not limited, a wireless network, a data storage network, a management network, and a cloud computing storage network. Examples of network storage 316 include, but are not limited to a data storage server, and cloud storage. In an embodiment, the network 314 is a cloud computing network that provides access to shared storage and/or processing resources to provide services or features offered by the system 300. In an embodiment, the network 314 comprises a cloud computing resources that include one or more processors configured to determine one or more fluid sample detection and/or fluid sample measurement results based upon the information received from the test device 100. In an embodiment, the fluid sample detection and/or fluid sample measurement results received from the test device 100 at the external device 100 are transmitted from the extemal device 101 to a client device 318 via the network 314. In an embodiment, one or more software modules executable by the extemal device 101 to determine one or more fluid sample detection and/or fluid sample measurement results based upon the fluid sample data received from the test device 100 is supplied to the external device 101 via the network 314.
[00139] The external device controller 302 includes a processor 304, a memory 306 and a communications interface 308. The extemal device controller 302 is configured to control one or more components of the external device 101, facilitate communications with the test device 100 and communications with other devices via the network 314. In an embodiment, the external device controller 302 is integrated into an integrated circuit (IC) with a user interface 310. Examples of user interfaces include a screen, one or more controls, and a readout. In an embodiment, one or more of the processor 304, the memory 306, the communications interface 308, and the user interface 310 are be integrated into one system-in-package/module. . In an embodiment, one or more of the processor 304, the memory 306, the communications interface 308, and the user interface 310 are separate discrete components in the external device 101.
[00140] In an embodiment, the external device controller 302 is communicatively coupled to a location sensor 312. In an embodiment, the location sensor 312 is integrated with external device controller 302. An example of a location sensor 312 is a GPS sensor. In an embodiment, the external device 101 is configured to limit communications with the test device 100 to one or more selected area. Examples of selected areas include, but are not limited to a hospital and a lab. The controller 108 and/or the extemal device controller 302 may be configured to prevent communications between the extemal device 101 and the test device 100 when the external device 101 is outside of one of the selected areas.
[00141] The processor 304 provides processing functionality for the external device controller 302 and may include any number of processors, micro-controllers, or other processing systems and resident or external memory for storing data and other information accessed or generated by the external device controller 302. The processor 304 may execute one or more software programs which implement the techniques and modules described herein. The processor 304 is not limited by the materials from which it is formed or the processing mechanisms employed therein and, as such, can be implemented via semiconductor(s) and/or transistors (e.g., electronic Integrated Circuits (ICs)), and so forth.
[00142] The memory 306 can be an example of tangible, computer-readable storage medium that provides storage functionality to store various data associated with operation of the external device 101, such as software programs and/or code segments, or other data to instruct the processor 304, and possibly other components of the external device 101, to perform the functionality described herein. Thus, the memory 306 can store data, such as a program of instructions for operating the external device 101 (including its components), and so forth. It should be noted that while a single memory 306 is described, a wide variety of types and combinations of memory (e.g., tangible, non-transitory memory) can be employed. The memory 306 can be integral with the processor 304, can comprise stand-alone memory, or can be a combination of both.
[00143] The memory 306 may include, for example, removable and non-removable memory elements such as Random Access Memory (RAM), Read Only Memory (ROM), flash memory (e.g., a Secure Digital (SD) card, a mini-SD card, a micro-SD card), magnetic memory, optical memory, Universal Serial Bus (USB) memory devices, network storage 316, and so forth. In embodiments of the controller 302, the memory 306 may include removable Integrated Circuit Card (ICC) memory, such as memory provided by Subscriber Identity Module (SIM) cards, Universal Subscriber Identity Module (USIM) cards, Universal Integrated Circuit Cards (UICC), and so on.
[00144] The communications interface 308 can be operatively configured to communicate with components of the external device 101, the test device 100, and/or the network 314. For example, the communications interface 308 can be configured to transmit data for storage in the external device 101, retrieve data from storage in the external device 101, and so forth. The communications interface 308 can also be communicatively coupled with the processor 304 to facilitate data transfer between components of the external device 101, the test device 100, and the processor 304 (e.g., for communicating inputs to the processor 304 received from a device communicatively coupled with the external device 101). It should be noted that while the communications interface 308 is described as a component of a external device 101, one or more components of the communications interface 308 can be implemented as external components communicatively coupled to the external device 101 via a wired and/or a wireless connection. The external device 101 can also include and/or connect to one or more input/output (I/O) devices and/or a user interface 310 (e.g., via the communications interface 308), including, but not necessarily limited to a display, a screen, a mouse, a touchpad, a keyboard, and so on.
[00145] The communications interface 308 and/or the processor 304 can be configured to communicate with a variety of different networks, including, but not necessarily limited to a wide-area cellular telephone network, such as a 3G cellular network, a 4G cellular network, a near-field communication network, or a global system for mobile communications (GSM) network; a wireless computer communications network, such as a WiFi network (e.g., a wireless local area network (WLAN) operated using IEEE 802.11 network standards); an internet; the Internet; a wide area network (WAN); a local area network (LAN); a personal area network (PAN) (e.g., a wireless personal area network (WPAN) operated using IEEE 802.15 network standards); a public telephone network; an extranet; an intranet; and so on. Wired communications are also contemplated such as through USB, Ethernet, serial connections, and so forth. However, this list is provided by way of example only and is not meant to limit the present disclosure. Further, the communications interface 308 can be configured to communicate with a single network or multiple networks across different access points.
[00146] In some embodiments, the client device 318 associated with a person authorized to access information collected by the test device 100 and can be utilized to retrieve detection and/or measurement results from network storage 316 via the network 314. Examples of an authorized person include, but are not limited to a healthcare provider, authorized family member and a lab technician. The authorized person may access fluid sample based detection and/or fluid sample based measurement results associated with a patient utilizing the client device 318. [00147] In an embodiment, a patient medical record service can retrieve the fluid sample based detection and/or fluid sample based measurement results from the network storage 316 via the network 314. For example, the patient medical record service may comprise a server, that operates as a client device 318 and is communicatively coupled with the network storage 316. Examples of a client device 318 include, but are not limited to a mobile device, a server, and a desktop computer.
[00148] Referring to FIGS. 15B a diagrammatic representation of an example system 300 that can employ an embodiment of the test device 100 including an embodiment of the sensor package 200 is shown. As mentioned above, the network 314 can comprise a cloud computing network that implements a multi-user, multi-device, collaborative patient medical record management platform accessible by the external device 101 and one or more other authorized client devices 318 A and 318B. For example, the external device 101 may be a patient device and client devices 318A and 318B may be care provider and/or lab technician devices, or the like.
[00149] The system 300 can implement a multi-user, multi-device, and/or collaborative record management platform. For example, the system 300 can implement a patient medical record management platform that selectively provides access to patient history, test results, treatments, diagnostics, demographics and patient identity information stored in network storage 316. In some embodiments, patient identity information can be removed from the other data to provide useful statistical information, analysis, or geographic/demographic trends. For example, the multi-user, multi-device, collaborative patient medical record management platform can be configured to selectively provide access to one or more of the test results, treatments, diagnostics, and demographics stored by the cloud computing network 314, dissociated from the patient identity information; or the multi-user, multi-device, collaborative patient medical record management platform may selectively provide access to analysis or trends based upon one or more of the test results, treatments, diagnostics, and demographics stored by the cloud computing network 314.
[00150] The network 314 can be configured to provide a variety of services via the external device 101 (e.g., via a web portal, browser, mobile application, or the like). In some embodiments, the cloud computing network 314 and/or the external device 101 is further configured to store contextual information regarding the test device 100. For example, when the test device 100 is used to perform analysis on a sample, contextual information such as time, date, and/or location can be stored (e.g., as metadata) with the measurement or detection information. In some embodiments, the cloud computing network 314 and/or the external device 101 can be configured to track an inventory of test devices 100, where an inventory count is reduced when one of the test devices 100 is used. The cloud computing network 314 may provide an alert (e.g., via the external device 101), an option to order more test devices 100, or communicate an automated order (e.g., to the supplier) when the inventory count is reduced below a threshold inventory of test devices 100. The network 314 and/or external device 101 can also be configured to analyze information (e.g., measurement data) collected from the test device 100 over time, and can provide alerts (e.g., reports, warnings, or suggestions) based on analyzed fluid samples 201 over time. For example, the network 314 and/or external device 101 can be configured to provide suggestions on how to improve health or issue medical warnings. In some embodiments, additional physiological data (e.g., vital signs) are also collected by external device 101 or entered via external device 101 or another authorized client device 318, where the network 314 and/or external device 101 can be configured to provide alerts based on one or more analyzed fluid samples 201 in addition to the additional physiological data.
Example Process
[00151] FIGS. 16A through 16H illustrate example implementations of a process 400 that employs an embodiment of a test device 100 for analyzing fluid samples 201. In general, operations of disclosed processes (e.g., process 400) may be performed in an arbitrary order, unless otherwise provided in the claims.
[00152] As shown in FIG. 16A, the process 400 includes depositing a fluid sample 201 within a cavity 208 of a test device 100 (block 402). For example, the fluid sample 201 is deposited within the cavity 208 of the sensor package 200 on the test device 100, where the cavity 208 is defined between the array 211 of conductive elements 214 and the electrode 210. The electrode 210 transmits at least one electrical signal through the fluid sample 201 (block 404). For example, the electrode 210 can transmit at least one electrical signal based on a supplied reference signal (e.g., from reference signal generator 228). In return, the conductive elements 214 of the array 211 can generate sense signals corresponding to the electrical signal (or signals) transmitted through the fluid sample 201. The sense signals are received from the array 211 of conductive elements 214 with a plurality of readout circuits 244 (block 406). In some implementations, a readout circuit 244 may be configured to multiply a respective sense signal by a second reference signal (e.g., with multiplier 246). The readout circuit 244 may also be configured to integrate the sense signal (e.g., with integrator 248) after multiplying it by the second reference signal. The readout circuits 244 can generate readout signals corresponding to the sense signals received from the conductive elements 214. The readout signals are converted into digital signals by a plurality of ADCs 250 coupled with the readout circuits 244 (block 408). In some implementations, the digital signals are further processed by digital processing circuitry 232. Information associated with the digital signals is transmitted to an external device (e.g., device 101) via a transceiver 106 on the test device 100 (block 410). For example, controller 108 can receive the digital signals or data associated with the digital signals, and the controller 108 can then transmit the digital signals or results associated with the digital signals (e.g., measurement results, assay results, imaging data, etc.) to device 101.
[00153] In some implementations, the process 400 further includes methodology for at least partially disabling test device 100 functionality based on one or more factors that can affect performance of the test device 100. In an example implementation shown in FIG. 16B, the process 400 further includes: receiving temperature measurements from at least one additional sensor 122 on the test device 100 (block 412); and at least partially disabling the transmission of the information to the external device 101 when the temperature measurements include at least one temperature measurement that exceeds a predetermined temperature (e.g., a maximum operating temperature) or at least one temperature measurement that is below a second predetermined temperature (e.g., a minimum operating temperature) (block 414).
[00154] In an example implementation shown in FIG. 16C, the process 400 further includes: receiving moisture measurements from at least one additional sensor 122 on the test device 100 (block 416); and at least partially disabling the transmission of the information to the external device 101 when the moisture measurements include at least one moisture measurement that exceeds a predetermined moisture level (block 418).
[00155] In an example implementation shown in FIG. 16D, the process 400 further includes: receiving motion measurements from at least one additional sensor 122 on the test device 100 (block 420), and at least partially disabling the transmission of the information to the external device 101 when the motion measurements include at least one motion measurement that exceeds a predetermined shock level (block 422).
[00156] In some implementations, the process 400 further includes methodology for maintaining or improving sensor performance. In an example implementation shown in FIG. 16E, the process 400 further includes calibrating at least one parameter for the sensor package 200 based upon at least one measurement from at least one additional sensor 122 on the test device (block 424). For example, the controller 108 can be configured to calibrate results associated with reaction time, beginning/end of reaction, and so forth based on temperature, moisture, and/or motion/pressure measurements received from the additional sensor (or sensors) 122. In another example implementation, the controller 108 can be configured to calibrate parameters, such as, but not limited to, reference signal, drive signal (e.g., DAC 226 signal for driving electrode 210), second reference signal, scan rate, PLL/DLL 230 parameters, and the like.
[00157] In some implementations, the process 400 further includes methodology for at least partially disabling test device 100 functionality based on one or more factors that can affect security or reliability of information. In an example implementation shown in FIG. 16F, the process 400 further includes at least partially disabling transmission of additional information to the external device 101 after transmitting the information associated with the digital signals to the external device (block 426). In this manner, the process 400 can implement single use or limited number of uses functionality for the test device 100. In an example implementation shown in FIG. 16G, the process 400 further includes at least partially disabling the transmission of information to the external device 101 based upon a predetermined expiration date or expiration period (block 428). In some implementations, an expiration period is a predetermined period beginning when the test device 100 is unpackaged or first used. As shown in FIG. 16G, the process 400 can further include determining whether the predetermined expiration period has been reached based on stored time values and/or moisture measurements (block 430).
[00158] In some implementations, the process 400 further includes methodology for at least partially disabling test device 100 functionality based on single device registration or registration of the test device 100 to a limited number of devices. For example, as shown in FIG. 16H, the process 400 can further include: pairing the test device with the external device 101 (block 432) and at least partially disabling communication between the test device 100 and a second external device 101 after the test device 100 has been paired with the external device 101 (block 434). In this manner, a user's test results cannot be accessed by an unauthorized person after the user has paired his/her device with the test device 100. Single device or limited device pairing can also prevent reuse of spent test devices 100, thereby avoiding erroneous test/assay results that could be caused by cross-contamination.
[00159] Generally, any of the functions described herein can be implemented using hardware (e.g., fixed logic circuitry such as integrated circuits), software, firmware, manual processing, or a combination thereof. Thus, the blocks discussed in the above disclosure generally represent hardware (e.g., fixed logic circuitry such as integrated circuits), software, firmware, or a combination thereof. In the instance of a hardware configuration, the various blocks discussed in the above disclosure may be implemented as integrated circuits along with other functionality. Such integrated circuits may include all of the functions of a given block, system, or circuit, or a portion of the functions of the block, system, or circuit. Further, elements of the blocks, systems, or circuits may be implemented across multiple integrated circuits. Such integrated circuits may comprise various integrated circuits, including, but not necessarily limited to: a monolithic integrated circuit, a flip chip integrated circuit, a multichip module integrated circuit, and/or a mixed signal integrated circuit. In the instance of a software implementation, the various blocks discussed in the above disclosure represent executable instructions (e.g., program code) that perform specified tasks when executed on a processor. These executable instructions can be stored in one or more tangible computer readable media. In some such instances, the entire system, block, or circuit may be implemented using its software or firmware equivalent. In other instances, one part of a given system, block, or circuit may be implemented in software or firmware, while other parts are implemented in hardware.
[00160] It is to be understood that the present application is defined by the appended claims. Although embodiments of the present application have been illustrated and described herein, it is apparent that various modifications may be made by those skilled in the art without departing from the scope and spirit of this disclosure.

Claims

CLAIMS What is claimed is:
1. A test device, comprising:
a substrate;
a sensor package disposed upon the substrate, the sensor package including: an array of conductive elements;
an electrode structure proximate to the array of conductive elements; a cavity configured to receive a fluid sample, the cavity being disposed between the electrode structure and the array of conductive elements, the electrode structure being configured to transmit at least one electrical signal through the fluid sample;
a plurality of readout circuits configured to:
receive sense signals from the array of conductive elements, the sense signals corresponding to the at least one electrical signal transmitted through the fluid sample, and
to generate readout signals based on the received sense signals; and
a plurality of analog-to-digital converters, each of the plurality of analog-to-digital converters being electrically coupled to an associated one of the plurality of readout circuits and configured to convert the readout signals received from the associated readout circuit into digital signals; and a controller communicatively coupled to at least one component of the sensor package and configured to:
receive at least one of the digital signals and data associated with the digital signals from the sensor package, and
transmit the received at least one of the digital signals and data based the digital signals to an external device.
2. The test device of claim 1, further comprising at least one additional sensor communicatively coupled to the controller.
3. The test device of claim 2, wherein the at least one additional sensor comprises at least one of a temperature sensor, moisture sensor, a pressure sensor, a motion sensor, and a location sensor.
4. The test device of claim 2, wherein the at least one additional sensor comprises at least one temperature sensor and the controller is configured to:
receive at least one temperature measurement from the at least one temperature sensor,
determine whether the at least one received temperature measurement exceeds a first predetermined temperature or is below a second predetermined temperature, and at least partially disable the transmission of the at least one of the digital signals and data based on the digital signals to the external device based on the determination.
5. The test device of claim 2, wherein the at least one additional sensor comprises at least one moisture sensor and the controller is configured to:
receive at least one moisture measurement from the at least one moisture sensor, determine whether the at least one received moisture measurement exceeds a predetermined moisture, and
at least partially disable the transmission of the at least one of the digital signals and data based on the digital signals to the external device based on the determination.
6. The test device of claim 2, wherein the at least one additional sensor comprises at least one motion sensor and the controller is configured to:
receive at least one motion measurement from the at least one motion sensor, determine whether the at least one received motion measurement exceeds a predetermined shock value, and
at least partially disable the transmission of the at least one of the digital signals and data based on the digital signals to the external device based on the determination.
7. The test device of claim 2, wherein the controller is configured to calibrate at least one parameter for the sensor package based upon at least one measurement received from the at least one additional sensor.
8. The test device of claim 1, further comprising a power manager electrically coupled to a battery and configured to distribute power from the battery to at least one of the sensor package, the controller, and the transceiver.
9. The test device of claim 8, further comprising an energy harvesting circuit and an energy harvesting antenna, the energy harvesting circuit being configured to wirelessly receive energy from the external device via the energy harvesting antenna and to charge the battery with the energy received from the external device.
10. The test device of claim 1, further comprising an energy harvesting circuit and an energy harvesting antenna, the energy harvesting circuit configured to wirelessly receive energy from the extemal device via the energy harvesting antenna and to power at least one of the sensor package, the controller, and the transceiver with the energy received from the extemal device.
11. The test device of claim 10, further comprising a power manager electrically coupled to the energy harvesting circuit, wherein the power manager is configured to distribute power from the energy harvesting circuit to at least one of the sensor package, the controller, and the transceiver.
12. The test device of claim 1 , wherein the sensor package further comprises an agitator configured to agitate the fluid sample after the fluid sample is deposited within the cavity.
13. The test device of claim 1 , wherein the controller is configured to at least partially disable communication between the test device and the extemal device after the controller transmits at least one of the digital signals and data based on the digital signals to the external device.
14. The test device of claim 1 , wherein the controller is configured to at least partially disable the transmission of the information to the external device based upon a predetermined expiration date associated with the sensor package or the test device.
15. The test device of claim 1 , wherein the controller is configured to at least partially disable the transmission of the information to the external device based upon a predetermined expiration period associated with the sensor package or the test device, the predetermined expiration period beginning when the test device is unpackaged.
16. The test device of claim 15, wherein the controller is configured to determine whether the predetermined expiration period has been reached based upon at least one of stored time values or stored moisture measurements.
17. The test device of claim 1, further comprising a unique identifier.
18. The test device of claim 17, wherein the unique identifier comprises a scannable identifier configured to be scanned by the external device.
19. The test device of claim 1, wherein the controller is configured to pair the test device with the extemal device and to at least partially disable communication with a second extemal device after the test device has been paired with the extemal device.
20. The test device of claim 1 , wherein the controller is configured to receive a security credential from the extemal device prior to pairing the test device with the extemal device.
21. The test device of claim 1, further comprising a control assay disposed in proximity to the array of conductive elements or in proximity to a second array of conductive elements of the sensor package, wherein the controller is configured to test or calibrate at least one parameter of the sensor package based upon the control assay.
22. The test device of claim 21, wherein the controller is configured to provide an alert indicating an error to the extemal device when the control assay yields an error condition.
23. The test device of claim 1, wherein the sensor package further includes digital processing circuitry coupled to the plurality of analog-to-digital converters, the digital processing circuitry configured to receive the digital signals and output data based on the digital signals to the controller.
24. A system, comprising:
a mobile device configured to communicate with a network, the network having a network storage; and
test device configured to communicate with the mobile device, the test device, comprising:
a substrate;
a sensor package disposed upon the substrate, the sensor package including:
an array of conductive elements;
an electrode structure proximate to the array of conductive elements;
a cavity configured to receive a fluid sample, the cavity being disposed between the electrode structure and the array of conductive elements, the electrode structure being configured to transmit at least one electrical signal through the fluid sample;
a plurality of readout circuits configured to:
receive sense signals from the array of conductive elements, the sense signals corresponding to the at least one electrical signal transmitted through the fluid sample, and
to generate readout signals based on the received sense signals; and
a plurality of analog-to-digital converters, each of the plurality of analog-to-digital converters being electrically coupled to an associated one of the plurality of readout circuits and configured to convert the readout signals received from the associated readout circuit into digital signals; and
a controller communicatively coupled to at least one component of the sensor package and configured to:
receive one of the digital signals and data associated with the digital signals from the sensor package, and transmit information associated with the one of the digital signals and the data based on the digital signals to the mobile device.
25. A method for analyzing a fluid sample, comprising:
depositing a fluid sample within a cavity of a test device, the cavity being disposed between an array of conductive elements and an electrode structure of a sensor package on the test device;
transmitting at least one electrical signal through the fluid sample with the electrode structure;
receiving sense signals from the array of conductive elements at a plurality of readout circuits, the sense signals corresponding to the at least one electrical signal transmitted through the fluid sample;
generating readout signals based on the received sense signals;
converting the generated readout signals generated into digital signals via a plurality of analog-to-digital converters;
transmitting at least one of the digital signals and data based on the digital signals to an external device.
26. The method of claim 25, further comprising:
receiving temperature measurements from at least one additional sensor on the test device, and
at least partially disabling the transmission of the at least one of the digital signals and data based on the digital signals to the external device when the temperature measurements include at least one temperature measurement that exceeds a predetermined temperature.
27. The method of claim 25, further comprising:
receiving temperature measurements from at least one additional sensor on the test device, and
at least partially disabling the transmission of the at least one of the digital signals and data based on the digital signals to the external device when the temperature measurements include at least one temperature measurement that is below a predetermined temperature.
28. The method of claim 25, further comprising:
receiving moisture measurements from at least one additional sensor on the test device, and
at least partially disabling the transmission of the at least one of the digital signals and data based on the digital signals to the external device when the moisture measurements include at least one moisture measurement that exceeds a predetermined moisture level.
29. The method of claim 25, further comprising:
receiving motion measurements from at least one additional sensor on the test device, and
at least partially disabling the transmission of the at least one of the digital signals and data based on the digital signals to the external device when the motion measurements include at least one motion measurement that exceeds a predetermined shock level.
30. The method of claim 25, further comprising:
calibrating at least one parameter for the sensor package based upon at least one measurement from at least one additional sensor.
31. The method of claim 25, further comprising:
at least partially disabling communications between the test device and the external device after transmitting the at least one of the digital signals and data based on the digital signals to the external device.
32. The method of claim 25, further comprising:
at least partially disabling the transmission of the at least one of the digital signals and data based on the digital signals to the external device based upon a predetermined expiration date.
33. The method of claim 25, further comprising:
at least partially disabling the transmission of the at least one of the digital signals and data based on the digital signals to the external device based upon a predetermined expiration period, the predetermined expiration period beginning when the test device is unpackaged.
34. The method of claim 33, further comprising:
determining whether the predetermined expiration period has been reached based upon at least one of stored time values or stored moisture measurements.
35. The method of claim 25, further comprising:
pairing the test device with the external device; and
at least partially disabling communication between the test device and a second external device after the test device has been paired with the external device.
36. A test device, comprising:
an actuation rod having one or more microneedles disposed at an end of the actuation rod, the actuation rod being configured to drive the one or more microneedles into a membrane to release a fluid sample;
a fluid reservoir configured to receive the released fluid sample; and a sensor package fluidically coupled to the fluid reservoir, the sensor package including:
an array of conductive elements;
an electrode structure proximate to the array of conductive elements; a cavity fluidly coupled to the fluid reservoir and configured to receive the fluid sample, the cavity being disposed between the electrode structure and the array of conductive elements, the electrode structure being configured to transmit at least one electrical signal through the fluid sample;
a plurality of readout circuits configured to:
receive sense signals from the array of conductive elements, the sense signals corresponding to the at least one electrical signal transmitted through the fluid sample, and
to generate readout signals based on the received sense signals; and
a plurality of analog-to-digital converters, each of the plurality of analog-to-digital converters being electrically coupled to an associated one of the plurality of readout circuits and configured to convert the readout signals received from the associated readout circuit into digital signals; and a controller communicatively coupled to at least one component of the sensor package and configured to:
receive at least one of the digital signals and data based on the digital signals, and
to transmit at least one of the digital signals and data based on the digital signals to an external device.
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