Systems and methods of sample processing and fluid control in a fluidic system

• US 10,533,994 B2
• Filed: 09/28/2015
• Issued: 01/14/2020
• Est. Priority Date: 03/24/2006
• Status: Active Grant

• Current Assignee: Golden Diagnostics Corporation (FIG LLC (d/b/a Fortress Investment Group LLC))
• Original Assignee: Theranos IP Company, LLC
• Inventors: Holmes, Elizabeth A., Roy, Shaunak, Gibbons, Ian, Qi, Shize Daniel, Ku, Edmond, Todd, Chris, Takahashi, Melissa, Johnson, Bruce, Fenton, Jeff, Moravick, Keith, Springborn, Uwe, Delacruz, Anthony
• Primary Examiner(s): Mui, Christine T
• Application Number:
  US14/868,208
• Publication Number:
  US 20160077086A1
• Time in Patent Office: 1,569 Days
• Field of Search: 600538, 600502, 600501, 600500, 600 50, 422502, 422501, 422500, 422 50, 422538
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150778 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/412 : Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/685 : Microneedles
• CPC Class Codes: G01N 2333/46 : from vertebrates
• CPC Class Codes: G01N 2333/91188 : transferring nitrogenous groups (2.6)
• CPC Class Codes: G01N 2800/52 : Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/5302 : Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/536 : with immune complex formed in liquid phase
• CPC Class Codes: G01N 33/573 : for enzymes or isoenzymes
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

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

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.

2. The system of claim 1, wherein the metering element comprises a pin.

3. 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.

4. 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.

5. 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.

6. The system of claim 5, wherein the sample collection unit further comprises a filter configured to filter the diluted sample before it is assayed.

7. The system of claim 1, wherein the predetermined portion of the sample is less than about 50 μ

l.

8. The system of claim 1, wherein the assay assembly is adapted to run an immunoassay.

9. 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.

10. 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.

11. 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.

12. The system of claim 11, wherein the actuator element is adapted to be mechanically actuated by the actuator.

13. The system of claim 10, wherein the second location has a larger cross section than the first location.

14. 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.

15. 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.

16. The fluidic device of claim 10, wherein the assay assembly is adapted to run an immunoassay.

17. The system of claim 10, wherein the sample of bodily fluid is less than 50 μ

l.

18. The system of claim 1, wherein the assay protocol is transmitted wirelessly from the external device.