# US 10,533,994 B2 · Systems and methods of sample processing and fluid control in a fluidic system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,533,994 B2 - Document ID: US10533994B2 - Status: Granted - Kind: B2 - Application number: 14/868,208 - Filed: 2015-09-28 - Published: 2016-03-17 - Granted: 2020-01-14 - Earliest claimed: 2006-03-24 - Assignees: Theranos IP Company, LLC - Applicants: Theranos IP Company, LLC - Inventors: Elizabeth A. Holmes; Shaunak Roy; Ian Gibbons; Shize Daniel Qi; Edmond Ku; Chris Todd; Melissa Takahashi; Bruce Johnson; Jeff Fenton; Keith Moravick; Uwe Springborn; Anthony Delacruz - Web page: https://patentgrep.com/patent/US10533994B2 ## CPC - G01N 33/5302: {Apparatus specially adapted for immunological test procedures} - A61B 5/1411: {by percutaneous method, e.g. by lancet} - A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase - A61B 5/150022: {for capillary blood or interstitial fluid} - A61B 5/150213: {Venting means} - A61B 5/150221: {Valves} - A61B 5/150229: {Pumps for assisting the blood sampling} - A61B 5/150251: {Collection chamber divided into at least two compartments, e.g. for division of samples (injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755)} - A61B 5/150274: {Manufacture or production processes or steps for blood sampling devices} - A61B 5/150282: {for piercing elements, e.g. blade, lancet, canula, needle} - A61B 5/150412: {Pointed piercing elements, e.g. needles, lancets for piercing the skin (blade-like piercing elements A61B5/150442)} - A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)} - A61B 5/150755: {Blood sample preparation for further analysis, e.g. by separating blood components or by mixing} - A61B 5/150778: {having complementary physical shapes for indexing or registration purposes} - A61B 5/150786: {Optical identification systems, e.g. bar codes, colour codes} - A61B 5/150854: {long distance, e.g. between patient's home and doctor's office} - A61B 5/150862: {intermediate range, e.g. within room or building} - A61B 5/15087: {short range, e.g. between console and disposable (using implanted devices A61B5/150877)} - A61B 5/150969: {Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing} - A61B 5/150984: {Microneedles or microblades} - A61B 5/412: {Detecting or monitoring sepsis} - A61B 5/685: {Microneedles} - G01N 33/536: with immune complex formed in liquid phase - G01N 33/573: for enzymes or isoenzymes - A61B 5/15142: {Devices intended for single use, i.e. disposable} - A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood - G01N 2333/46: from vertebrates - G01N 2333/91188: transferring nitrogenous groups (2.6) - G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis - Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications. ## Claims ### Claim 1 A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device. ### Claim 2 (depends on 1) The system of claim 1, wherein the metering element comprises a pin. ### Claim 3 (depends on 2) The system of claim 2, wherein the pin is configured to be movable from an open position to a closed position, wherein the pin in the closed position blocks the metering channel. ### Claim 4 (depends on 2) The system of claim 2, wherein the sample collection unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means transferring the diluent from the dilution chamber into the metering channel. ### Claim 5 (depends on 4) The system of claim 4, wherein the sample collection unit further comprises a mixing chamber in fluidic communication with the metering channel, the mixing chamber being configured to mix the predetermined portion of the sample with the diluent to yield a diluted sample. ### Claim 6 (depends on 5) The system of claim 5, wherein the sample collection unit further comprises a filter configured to filter the diluted sample before it is assayed. ### Claim 7 (depends on 1) The system of claim 1, wherein the predetermined portion of the sample is less than about 50 μl. ### Claim 8 (depends on 1) The system of claim 1, wherein the assay assembly is adapted to run an immunoassay. ### Claim 9 (depends on 8) The system of claim 8, wherein the assay assembly comprises a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent. ### Claim 10 (depends on 1) The system of claim 1, wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location. ### Claim 11 (depends on 10) The system of claim 10, wherein the actuator element is adapted to be actuated by an actuator in a device in which the cartridge can be inserted. ### Claim 12 (depends on 11) The system of claim 11, wherein the actuator element is adapted to be mechanically actuated by the actuator. ### Claim 13 (depends on 10) The system of claim 10, wherein the second location has a larger cross section than the first location. ### Claim 14 (depends on 10) The system of claim 10, wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel. ### Claim 15 (depends on 14) The system of claim 14 wherein the actuator element is substantially pin shaped and the sealing member is an O-ring adapted to be placed around the actuator element. ### Claim 16 (depends on 10) The fluidic device of claim 10, wherein the assay assembly is adapted to run an immunoassay. ### Claim 17 (depends on 10) The system of claim 10, wherein the sample of bodily fluid is less than 50 μl. ### Claim 18 (depends on 1) The system of claim 1, wherein the assay protocol is transmitted wirelessly from the external device.