Point-of-care fluidic systems and uses thereof

• US 8,283,155 B2
• Filed: 10/08/2009
• Issued: 10/09/2012
• Est. Priority Date: 05/09/2005
• Status: Active Grant

• Current Assignee: Golden Diagnostics Corporation (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth A., Roy, Shaunak, Howard, John, Wang, Chengwang, Gibbons, Ian, Kemp, Timothy M., Qi, Shize Daniel
• Primary Examiner(s): Turk, Neil N
• Application Number:
  US12/576,197
• Publication Number:
  US 20100081144A1
• Time in Patent Office: 1,097 Days
• Field of Search: None
• US Class Current: 435/286.1
• 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 two-way communication system for detecting an analyte in a bodily fluid from a subject, comprising:

a) a reader assembly comprising a programmable processor that is operably linked to a communication assembly;

b) an external device configured to transmit a protocol to the communication assembly;

c) a test device configured to be inserted into the reader assembly, said test device comprising;

i) a sample collection unit configured for collecting a sample of bodily fluid suspected to contain an analyte;

ii) an assay assembly containing reactants that react with said sample of bodily fluid based on the protocol transmitted from said external device to yield a detectable signal indicative of the presence and/or concentration of said analyte; and

iii) an identifier that is configured to provide the identity of said test device and is also configured to trigger the transmission of said protocol that is selected based on said identifier;

wherein the programmable processor of the reader assembly is configured to receive said protocol from said external device, wherein said protocol in turn effects (1) a reaction in said assay assembly for generating said signal, and (2) selection of a detection method for detecting said signal, and wherein said reader further comprises a detection assembly for detecting said signal which is transmitted via said communication assembly to said external device.

2. The system of claim 1 wherein the reader assembly further comprises a controller having computer-executable commands for performing the reaction at a designated point-of-care location.

3. The system of claim 1 wherein the external device further comprises a means for receiving and aggregating a plurality of signals to effect trending of the presence and/or concentration of said analyte taken at various time points over a given period of time.

4. The system of claim 3 wherein the plurality of signals are transmitted concurrently with performance of said trending.

5. The system of claim 3 wherein the plurality of signals are transmitted prior to performance of said trending.

6. The system of claim 1 wherein the system is capable of performing on-board calibration of said assay assembly.

7. The system of claim 1 wherein the sample is collected from a puncture of the skin.

8. The system of claim 1 wherein the test device further comprises a microneedle useful for collecting the sample.

9. The system of claim 1 wherein the sample collection unit collects a sample of bodily fluid which is less than about 500 uL.

10. The system of claim 1 wherein the reader assembly is configured to receive said protocol wirelessly from said external device.

11. The system of claim 1 wherein said reader assembly comprises an identifier detector that detects said identifier.

12. The system of claim 1 wherein said reactants comprise immunoassay or nucleic acid reagents immobilized within the assay assembly.

13. The system of claim 1 wherein the test device is configured to detect a plurality of analytes and said test device comprises immunoassay or nucleic acid reagents for said plurality of analytes.

14. The system of claim 13 wherein the system is configured to detect a plurality of analytes that generate distinct signals, wherein the intensities of said distinct signals vary over a range of 3 orders of magnitude.

15. The system of claim 13 wherein the system detects luminescent signals from said plurality of reactions.

16. The system of claim 1 wherein the assay assembly is configured to run a plurality of types of assays.

17. The system of claim 1 wherein the detection method further comprises detecting an optical signal from the sample.

18. The system of claim 17 wherein the optical signal is a chemiluminscent signal.

19. The system of claim 1 wherein the detection method includes collecting signals from sensors, which may be selected from one or more of the following:

temperature, conductivity, potentiometric, or amperometric.

20. The system of claim 1 wherein the external device is capable of transmitting said information concerning said signal to a patient.

21. The system of claim 1 wherein the external device transmits said information concerning said signal simultaneously to the patient and to a medical care practitioner.

22. A method for detecting an analyte in a bodily fluid of a subject, comprising:

a) providing a system of claim 1;

b) allowing a sample of bodily fluid to react with the reactants contained within said assay assembly to yield one or more detectable signal(s) indicative of the presence of said analyte; and

c) detecting said detectable signal(s).

23. The method of claim 22 further comprising quantifying the amount of said analyte present in said sample.

24. The method of claim 22 further comprising comparing the amount of said analyte to a predetermined amount of said analyte.

25. The method of claim 24 further comprising taking medical action when the amount of said analyte is statistically different than said predetermined amount.

26. The method of claim 25 wherein the medical action comprises altering a subject'"'"'s dosage of a therapeutic agent.

27. The method of claim 25 wherein the medical action comprises notifying a pharmacy that a prescription for such subject needs to be altered.

28. The system of claim 1 wherein the protocol dictates the actuation of one or more element of the device, thereby directing fluid movement.

29. The system of claim 1 wherein the transmitted information includes at least one physiological parameter of the subject.

47. The system of claim 17 wherein the external device transmits information concerning said signal simultaneously to the patient and to a medical care practitioner.

56. The system of claim 13 wherein the external device further comprises a means for receiving and aggregating a plurality of signals to effect trending of the presence and/or concentration of said plurality of analytes taken at various time points over a given period of time.

58. The system of claim 3 wherein the means comprises a processor programmed to receive and aggregate said plurality of signals.

60. The system of claim 56 wherein the means comprises a processor programmed to receive and aggregate said plurality of signals.

30. A two-way communication system for detecting an analyte in a bodily fluid from a subject, comprising:

a) a reader assembly comprising a programmable processor that is operably linked to a communication assembly;

b) an external device configured to transmit a protocol to the communication assembly;

c) a test device configured to be inserted into the reader assembly, said test device comprising;

i) a sample collection unit configured for collecting a sample of bodily fluid suspected to contain an analyte;

ii) an assay assembly configured to run a plurality of assays, said assay assembly containing reactants for conducting said plurality of assays, wherein said reactants react with said sample of bodily fluid based on the protocol transmitted from said external device to yield a detectable signal indicative of the presence and/or concentration of said analyte; and

iii) an identifier that is configured to provide the identity of said test device and is also configured to trigger the transmission of said protocol that is selected based on said identifier;

wherein the programmable processor of the reader assembly is configured to receive said protocol from said external device, wherein said protocol in turn effects a selection of at least one assay from said plurality of assays to be run with said assay assembly for generating said signal, and wherein said reader further comprises a detection assembly for detecting said signal which is transmitted via said communication assembly to said external device.

31. The system of claim 30 wherein the reader assembly further comprises a controller having computer-executable commands for performing the reaction at a designated point-of-care location.

32. The system of claim 30 wherein the external device further comprises a means for receiving and aggregating a plurality of signals to effect trending of the presence and/or concentration of said analyte taken at various time points over a given period of time.

33. The system of claim 32 wherein the plurality of signals are transmitted concurrently with performance of said trending.

34. The system of claim 32 wherein the plurality of signals are transmitted prior to performance of said trending.

35. The system of claim 30 wherein the system is capable of performing on-board calibration of said assay assembly.

36. The system of claim 30 wherein the sample is collected from a puncture of the skin.

37. The system of claim 30 wherein the test device further comprises a microneedle useful for collecting the sample.

38. The system of claim 30 wherein the sample collection unit collects a sample of bodily fluid which is less than about 500 uL.

39. The system of claim 30 wherein the reader assembly is configured to receive said protocol wirelessly from said external device.

40. The system of claim 30 wherein said reader assembly comprises an identifier detector that detects said identifier.

41. The system of claim 30 wherein said reactants comprise immunoassay or nucleic acid reagents immobilized within the assay assembly.

42. The system of claim 30 wherein the test device is configured to detect a plurality of analytes and said test device comprises immunoassay or nucleic acid reagents for said plurality of analytes.

43. The system of claim 42 wherein the system is configured to detect a plurality of analytes that generate distinct signals, wherein the intensities of said distinct signals vary over a range of 3 orders of magnitude.

44. The system of claim 42 wherein the system detects luminescent signals from said plurality of reactions.

45. The system of claim 30 further comprising a dilution chamber containing a diluents for diluting the sample of bodily fluid according to said protocol transmitted by the external device and received by the reader assembly.

46. The system of claim 30 wherein the external device is capable of transmitting information concerning said signal to a patient.

48. A method for detecting an analyte in a bodily fluid of a subject, comprising:

a) providing a system of claim 30;

b) allowing a sample of bodily fluid to react with the reactants contained within said assay assembly to yield one or more detectable signal(s) indicative of the presence of said analyte; and

c) detecting said detectable signal(s).

49. The method of claim 48 further comprising quantifying the amount of said analyte present in said sample.

50. The method of claim 48 further comprising comparing the amount of said analyte to a predetermined amount of said analyte.

51. The method of claim 41 further comprising taking medical action when the amount of said analyte is statistically different than said predetermined amount.

52. The method of claim 51 wherein the medical action comprises altering a subject'"'"'s dosage of a therapeutic agent.

53. The method of claim 51 wherein the medical action comprises notifying a pharmacy that a prescription for such subject needs to be altered.

54. The system of claim 30 wherein the protocol dictates the actuation of one or more element of the device, thereby directing fluid movement.

55. The system of claim 30 wherein the transmitted information includes at least one physiological parameter of the subject.

57. The system of claim 42 wherein the external device further comprises a means for receiving and aggregating a plurality of signals to effect trending of the presence and/or concentration of said plurality of analytes taken at various time points over a given period of time.

59. The system of claim 32 wherein the means comprises a processor programmed to receive and aggregate said plurality of signals.

61. The system of claim 57 wherein the means comprises a processor programmed to receive and aggregate said plurality of signals.