Systems and methods for improving medical treatments

• US 8,679,407 B2
• Filed: 03/24/2006
• Issued: 03/25/2014
• 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., Gibbons, Ian, Howard, John, Roy, Shaunak, Wang, Chengwang, Kemp, Timothy M.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US11/388,415
• Publication Number:
  US 20080009766A1
• Time in Patent Office: 2,923 Days
• Field of Search: 600/583, 435/14
• US Class Current: 422/68.1
• 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 method of automatically monitoring patient compliance or non-compliance with a medical treatment involving a therapeutic agent, comprising:

a) providing a sample of bodily fluid retrieved from said patient to a cartridge;

b) providing via an external device a plurality of analyte protocols for processing the sample, wherein each of the protocols measures a different analyte;

c) selecting automatically, with aid of a processor in said external device, at least one analyte protocol from said plurality of analyte protocols, wherein the selecting is determined by information associated with the cartridge;

d) allowing the sample of bodily fluid to react with one or more assay reagents from the cartridge in accordance with the at least one analyte protocol;

e) detecting, from the sample of bodily fluid, wherein at least one detectable signal indicative of the concentrations of said analyte;

f) comparing information regarding said signal with a known profile for said analyte to establish said compliance or non-compliance;

g) notifying said patient or a medical practitioner of the result of said comparison, thereby monitoring said patient compliance or non-compliance with the medical treatment involving the therapeutic agent.

2. The method of claim 1, wherein the cartridge is inserted into a reader assembly comprising a communication assembly, and wherein the comparing step of (f) is effected by transmitting via the communication assembly information regarding said signal to said external device, where comparison of said signal with a known profile associated with said analytes is performed.

3. The method of claim 2 wherein the plurality of protocols is stored on said external device.

4. The method of claim 2, wherein the detectable signal is a luminescent signal.

5. The method of claim 2, wherein the detectable signal is a chemiluminescent signal.

6. The method of claim 1, wherein said notification is transmitted electronically.

7. The method of claim 1, wherein said notification is transmitted wirelessly.

8. The method of claim 1, wherein said notification is transmitted via a handheld device.

9. The method of claim 1, the sample of bodily fluid is less than about 500 ul .

10. The method of claim 1, wherein the reactant comprises an immunoassay reagent.

11. The method of claim 1, wherein said notification indicates compliance of said patient with said medical treatment.

12. The method of claim 1, wherein said notification indicates lack of compliance of said patient with said medical treatment.

13. The method of claim 1, wherein said monitoring takes place throughout the medical treatment.

14. The method of claim 1, wherein the analyte is a biomarker.

15. The method of claim 1, wherein the analyte is a drug.

16. The method of claim 1, wherein the profile is based on the patient'"'"'s own previous pharmacodynamic, pharmacokinetic, or pharmacogenetic profiles.

17. The method of claim 1, wherein the analyte is a prodrug.

18. The method of claim 1, wherein the analyte is a drug metabolite.

19. The method of claim 1, wherein the analyte is a metabolite.

20. The method of claim 2 wherein the protocol to be run on by said reader assembly is stored on said external device.

21. The method of claim 20 further comprising transmitting the protocol from the external device to the fluidic device.

22. The method of claim 1 wherein the known profile is stored on said external device.

23. The method of claim 1 wherein the protocol is associated with said patient and comprises a time and/or date to test said sample of bodily fluid.

24. The method of claim 1 further comprising indicating that multiple doses of the therapeutic agent have been taken when a metabolite concentration detected by the reader assembly is at an elevated level compared to a known profile.

25. The method of claim 1 further comprising indicating that insufficient doses of the therapeutic agent have been taken when a metabolite concentration detected by the reader assembly is at a decreased level compared to a known profile.

26. The method of claim 1 wherein the patient is notified automatically after the signal is compared with a known profile.