Systems and methods for improving medical treatments

• US 20080009766A1
• Filed: 03/24/2006
• Published: 01/10/2008
• Est. Priority Date: 05/09/2005
• Status: Active Grant

• Current Assignee: Golden Diagnostics Corporation (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Kemp, Timothy, Holmes, Elizabeth, Gibbons, Ian, Roy, Shaunak, Wang, Chengwang, Howard, John
• Granted Patent: US 8,679,407 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 with a medical treatment involving a therapeutic agent, comprising:

a) providing a sample of bodily fluid from said patient;

b) allowing the sample of bodily fluid to react with assay reagents in a fluidic device to detect an analyte indicative of compliance or non-compliance of the medical treatment;

c) detect the presence or absence of the analyte;

d) notifying said patient or a medical practitioner of said compliance or noncompliance

2. The method of claim 1, wherein the fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows the sample of bodily fluid to react with reactants contained within said assay assembly based on a protocol transmitted from an external device to yield a detectable signal indicative of the presence of said analyte;

a reader assembly comprising a detection assembly for detecting said detectable signal; and

a communication assembly for transmitting said detected signal to an external device.

3. The method of claim 2, further comprising the step of automatically comparing said signal with a known profile associated with said medical treatment to determine if said patient is compliant or noncompliant with said medical treatment.

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

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

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

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

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

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

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

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

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

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

17. The method of claim 1, wherein the reactants comprise immunoassay reagents.

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

11. A method of alerting a patient to test a sample of bodily fluid using a fluidic device, comprising:

a) providing a protocol located on an external device to be run on said fluid device, said protocol associated with said patient and comprising a time and/or date to test said sample of bodily fluid; and

b) notifying said patient to test said bodily fluid on said time and/or date if said sample has not yet been tested.

12. The method of claim 11, wherein the fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows the sample of bodily fluid to react with reactants contained within said assay assembly based on a protocol transmitted from an external device to yield a detectable signal indicative of the presence of said analyte;

a reader assembly comprising a detection assembly for detecting said detectable signal; and

a communication assembly for transmitting said detected signal to an external device.

13. The method of claim 11, wherein said notification is transmitted electronically.

19. A business method of assisting a clinician in providing an individualized medical treatment, comprising:

a) collecting at least one pharmacological parameter from an individual receiving a medication, said collecting step is effected by subjecting a sample of bodily fluid to reactants contained in a fluidic device, which is provided to said individual to yield a detectable signal indicative of said at least one pharmacological parameter;

b) cross referencing with the aid of a computer medical records of said individual with the at least one pharmacological parameter of said individual, thereby assisting said clinician in providing individualized medical treatment.

20. The business method of claim 19, wherein the pharmacological parameter is a pharmacokinetic parameter.

21. The business method of claim 19, wherein the pharmacological parameter is a pharmacodynamic parameter.

22. The business method of claim 19, wherein the reactants comprises immunoassay reagents.

23. A business method of monitoring a clinical trial of a therapeutic agent, comprising:

a) collecting at least one pharmacological parameter from a subject in said clinical trial at a plurality of time intervals, said collecting step is effected at each time interval by subjecting a sample of bodily fluid from said subject to reactants contained in a fluidic device, wherein said fluidic device is provided to said subject to yield detectable signals indicative of the values of said at least one pharmacological parameter at a plurality of time intervals;

b) comparing the detected values to a threshold value predetermined for said pharmacological parameter;

c) notifying a clinician and/or a sponsor involved in said clinical trial when a statistically significant discrepancy exists between the detected values and the threshold value.

24. The business method of claim 23, further comprising taking a medical action based on the statistically significant discrepancy.

25. The business method of claim 24, wherein said medical action involves adjusting dosage of the therapeutic agent.

26. The business method of claim 23, further comprising taking a business decision that involves continuing, modifying, or terminating the clinical trial.

27. The business method of claim 23, wherein the fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows the sample of bodily fluid to react with reactants contained within said assay assembly based on a protocol transmitted from an external device to yield the detectable signal;

a reader assembly comprising a detection assembly for detecting said detectable signal; and

a communication assembly for transmitting said detected signal to an external device.

28. The business method of claim 27, wherein the reactants comprise immunoassay reagents.