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

• US 9,176,126 B2
• Filed: 05/06/2014
• Issued: 11/03/2015
• Est. Priority Date: 03/24/2006
• Status: Active Grant

• Current Assignee: Golden Diagnostics Corporation (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Gibbons, Ian, Holmes, Elizabeth A., Roy, Shaunak, 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:
  US14/270,618
• Publication Number:
  US 20140329259A1
• Time in Patent Office: 546 Days
• Field of Search: 422/500, 422/50, 422/68.1, 436/180, 436/164, 436/501, 435/15, 435/4
• US Class Current: 1/1
• 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 method of detecting an analyte in a bodily fluid from a subject, comprising:

a) providing a fluidic device comprising a cartridge, said cartridge comprising a sample collection unit and an assay assembly, wherein said sample collection unit is configured to collect a sample of bodily fluid from said subject, and wherein said assay assembly comprises at least one reaction site containing a reactant adapted to reacts with said analyte;

b) metering a predetermined portion of said sample to be assayed in said sample collection unit;

c) allowing said predetermined portion of sample to react with assay reagents contained within said assay assembly to yield a signal indicative of the presence of said analyte in said sample; and

d) detecting said signal generated from said analyte collected in said sample of bodily fluid.

2. The method of claim 1, further comprising mixing said predetermined portion of said sample with a diluent in said fluidic device after the metering step.

3. The method of claim 2, wherein said mixing comprises diluting said predetermined portion of said sample with said diluent to yield a diluted sample.

4. The method of claim 3, further comprising filtering said diluted sample before allowing said predetermined portion of sample to react with assay reagents.

5. The method of claim 3, wherein said assay assembly comprises at least one reagent chamber and an actuatable valve assembly configured to control flow of the reagents out of said reagent chamber and into said at least one reaction site.

6. The method of claim 5, further comprising actuating said actuatable valve assembly to permit said reagent to flow from said reagent chamber to said reaction site.

7. The method of claim 6, wherein said actuatable valve assembly comprises an actuator pin and a sealing ball, and said actuating comprising actuating said actuator pin to displace said sealing ball.

8. The method of claim 1, further comprising the step of quantifying the amount of said analyte present in said bodily fluid after said detecting step.

9. The method of claim 8, further comprising the step of comparing the amount of said analyte present in said biologic fluid to a predetermined amount of said analyte.

10. The method of claim 1, wherein said fluidic device communicates data relating to said signal via a wireless transmitter to an external device.

11. The method of claim 1, wherein the analyte detected is indicative of at least one pharmacological parameter.

12. The method of claim 11, further comprising cross-referencing medical records of said subject with the at least one pharmacological parameter to assistant a clinician in providing an individualized medical treatment.

13. The method of claim 4, wherein said filtering comprises removing red blood cells from the diluted sample.