POINT-OF-CARE FLUIDIC SYSTEMS AND USES THEREOF

• US 20100081144A1
• Filed: 10/08/2009
• Published: 04/01/2010
• Est. Priority Date: 05/09/2005
• Status: Active Grant

• Current Assignee: Golden Diagnostics Corporation (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Qi, Shize Daniel, Kemp, Timothy M., Gibbons, Ian, Holmes, Elizabeth A., Roy, Shaunak, Wang, Chengwang, Howard, John
• Granted Patent: US 8,283,155 B2
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/150763 with identification means identification means for surgical instruments A61B90/90
• CPC Class Codes: A61B 5/150854 long distance, e.g. between patient's home and doctor's office
• 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 5/417 the bone marrow
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 : Multiple sequential chambers
• CPC Class Codes: B01L 2300/0877 : Flow chambers
• CPC Class Codes: B01L 2300/0883 : Serpentine channels
• CPC Class Codes: B01L 2300/0887 : Laminated structure
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 21/76 : Chemiluminescence; Bioluminescence
• CPC Class Codes: G01N 2500/00 : Screening for compounds of potential therapeutic value
• CPC Class Codes: G01N 33/50 : Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/53 : Immunoassay; Biospecific binding assay; Materials therefor
• CPC Class Codes: G01N 33/5302 : Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54386 : Analytical elements
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10T 436/10 : Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/11 : Automated chemical analysis
• CPC Class Codes: Y10T 436/115831 : Condition or time responsive
• CPC Class Codes: Y10T 436/12 : Condition responsive control
• CPC Class Codes: Y10T 436/143333 : Saccharide [e.g., DNA, etc.]

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 monitoring more than one pharmacological parameter useful for assessing efficacy and/or toxicity of a therapeutic agent, comprising:

a) a fluidic device comprising a cartridge, said cartridge comprising at least one sample collection unit and an assembly;

wherein said sample collection unit allows a sample of bodily fluid comprising a plurality of analytes indicative or said more than one pharamcological parameter to react with reactants contained within said assay assembly, said reaction yields detectable signals indicative of the values of the more than one pharmacological parameter from said sample of bodily fluid;

b) a reader assembly comprising a detection assembly for detecting said detectable signals; and

c) a communication assembly for transmitting said detected signals to an external device.

2. The system of claim 1, wherein the fluidic device generates the detectable signals based on a protocol transmitted from an external device.

3. The system of claim 2, wherein the protocol is transmitted wirelessly.

4. The system of claim 1, wherein the fluidic device further comprises an identifier to provide the identity of said fluidic device that is adapted to trigger the transmission of said protocol.

5. The system of claim 1, wherein said protocol varies depending on the identify of said fluidic device that is recognizable by an identifier detector.

6. The system of claim 1, wherein the sample of bodily fluid is less than about 500 ul.

7. The system of claim 1, wherein the sample of bodily fluid is less than about 50 ul.

8. The system of claim 1, wherein the reactants comprises immunoassay reagents.

10. The system of claim 8, wherein the immunoassay reagents detect a member selected from the group consisting of drug, drug metabolite, biomarkers indicative of a disease, tissue specific marker, and biomarker specific for a cell or cell type.

11. The system of claim 1, wherein the plurality of analytes are identified by distinct signals detectable over a range of 3 orders of magnitude.

12. The system of claim of claim 1, wherein the detectable signal is a luminescent signal.

13. The system of claim of claim 1, wherein the detectable signal is a chemiluminescent signal.

14. The system of claim 1, wherein the fluidic device further comprises a microneedle for obtaining the sample of bodily fluid.

15. The system of claim of claim 1, wherein the pharamcological parameter is a pharmacokinetic parameter.

16. The system of claim of claim 1, wherein the pharamcological parameter is a pharmacodynamic parameter.

17. The system of claim 1, wherein at least one of the plurality of the analytes is a biomarker indicative of a pharmacodynamic parameter.

18. The system of claim 1, wherein at least one of the plurality of the analytes is the therapeutic agent or a metabolite of the therapeutic agent that is indicative of a pharmacokinetic parameter.

19. The system of claim of claim 1, wherein said fluidic device communicates data relating to said signal via a wireless transmitter.

20. The system of claim 19, wherein said wireless transmitter comprises a cell phone.

9. The system of 8, wherein the immunoassay reagents detect a polypeptide glycoprotein, polysaccharide, lipid, nucleic acid, and a combination thereof.

21. A method of monitoring more than one pharmacological parameter useful for assessing efficacy and/or toxicity of a therapeutic agent, comprising:

a) subjecting a sample of bodily fluid from a subject administered with the pharmaceutical agent to a fluidic device for profiling said more than one pharmacological parameter, said fluidic medical device comprising

a cartridge, said cartridge comprising at least one sample collection unit, and

an assay assembly comprising reaction reagents;

b) actuating said fluidic device and directing said immunoassay reagents within said fluidic device;

c) allowing said sample of bodily fluid to react with immunoassay reagents to yield detectable signals indicative of the values of the more than one pharmacological parameter from said sample;

d) detecting said detectable signal generated from said sample of bodily fluid.

22. The method of claim 21, further comprising the step of repeating the steps of (a)-(d) at a time interval prompted by a wireless signal communicated to said subject.

23. The method of claim 21, wherein the more than one pharmacological parameter comprises both a pharmacokinetic indicator and a pharmacodynamic indicator useful for accessing efficacy and/or toxicity of the therapeutic agent.

24. The method of claim 21, wherein the pharmacological parameter is a pharmacokinetic indicator.

25. The method of claim 21, wherein the pharmacological parameter is a pharmacodynamic indicator.

26. The method of claim 21, wherein the pharmacological parameter is reflected by concentration of the therapeutic agent.

27. The method of claim 21, wherein the pharmacological parameter is reflected by concentration of a metabolite of the therapeutic agent.

28. The method of claim 21, wherein the pharmacological parameter is reflected by a biomarker affected directly or indirectly by the therapeutic agent.

29. The method of claim 21, wherein the pharmacological parameter is reflected by a biomarker that indicates an adverse reaction to the therapeutic agent.