Systems and methods for conducting animal studies

• US 8,841,076 B2
• Filed: 03/24/2006
• Issued: 09/23/2014
• 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, Kemp, Timothy M., Howard, John, Roy, Shaunak
• Primary Examiner(s): Brown, Melanie Y
• Assistant Examiner(s): Crawford, Erik B
• Application Number:
  US11/388,823
• Publication Number:
  US 20060264780A1
• Time in Patent Office: 3,105 Days
• Field of Search: 435/4, 435/6, 435/7.1, 435/283.1, 435/286.5, 435/287.1, 435/287.2, 435/287.9, 435/288.2, 435/287.3, 4352883-2885, 436/164, 436/172, 422/50, 422/57, 422/61, 422/68.1, 422/82.05, 422/82.08, 356/39, 800/3
• US Class Current: 435/7.1
• 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, comprising:

a) providing a cartridge comprising at least one sample collection unit and an assay assembly comprising a plurality of reaction sites each having a reactant contained therein;

b) reacting a first sample of biological fluid of less than about 50 ul from a subject with the reactants contained within the reaction sites of said assay assembly, wherein said assay assembly yields detectable signals generated from a plurality of analytes in the first sample that are indicative of concentrations of the plurality of analytes;

c) detecting said detectable signals with a reader assembly;

d) comparing said concentrations of said plurality of analytes with stored pharmacological data according to a bioinformatics model at an external device;

e) repeating over the course of a preclinical study the reaction and detection steps with at least a second sample of biological fluid from the same subject collected at a different time from the first sample; and

wherein said reacting step (b) occurs in accordance with a protocol transmitted from said external device that is external to the reader; and

wherein said protocol is selected by determining a plurality of protocols associated with the cartridge, and based on information about the subject, selecting one of said plurality of protocols associated with the cartridge to be run to detect said analytes.

3. The method of claim 1 or 2, wherein said cartridge interfaces with the reader assembly comprising a detection assembly for detecting said detectable signals, and a communication assembly for transmitting said detected signals to said external device.

4. The method of claim 3, wherein the protocol is transmitted wirelessly from the external device.

5. The method of claim 3, wherein the cartridge further comprises an identifier to provide the identity of said cartridge that is adapted to trigger the transmission of said protocol.

6. The method of claim 3, wherein said protocol varies depending on the identity of said cartridge that is recognizable by an identifier detector.

7. The method of claim 3, wherein the reactants comprise immunoassay reagents.

8. The method of claim 7, wherein the immunoassay reagents detect a member selected from the group consisting of:

a polypeptide, glycoprotein, polysaccharide, lipid, nucleic acid, and a combination thereof.

9. The method of claim 7, wherein the immunoassay reagents detect a member selected from the group consisting of drug, drug metabolite, biomarker indicative of a disease, tissue specific marker, and biomarker specific for a cell or cell type.

10. The method of claim 9, wherein the biomarker is a member selected from analytes listed in Table 4.

11. The method of claim 3, wherein the reactants comprise immunoassay reagents for said plurality of analytes.

12. The method of claim 3, wherein the detectable signal is a luminescent signal.

13. The method of claim 3, wherein the cartridge further comprises a microneedle for obtaining the sample of biological fluid.

14. The method of claim 3, wherein the sample of biological fluid is less than about 10 microliters.

15. The method of claim 3, wherein the sample of biological fluid is less than about 5 microliters.

16. The method of claim 3, wherein the sample of biological fluid is between about 5 microliters and about 10 microliters.

17. The method of claim 1, wherein the concentration of analytes are indicative of pharmacological parameters comprising pharmacokinetic and/or pharmacodynamic parameters.

18. The method of claim 1, wherein said assessment is carried out in real-time.

19. The method of claim 17, wherein said comparing step involves determining whether said pharmacological parameter falls outside a desired range.

20. The method of claim 3 wherein at least one pharmaceutical agent administered to said subject between the first sample and the second sample is different from a pharmaceutical agent administered before the first sample.

21. The method of claim 3 wherein said protocol effects dilution of said first sample or said second sample, thereby bringing the concentrations of the plurality of analytes into a detectable range.

22. The method of claim 1, wherein the protocol for the reacting step is selected depending on changes in a treatment regime or plan for the subject based on at least one comparison of said concentrations of said plurality of analytes with stored pharmacological data according to said bioinformatic model at said external device.

23. The method of claim 1, further comprising detecting an identifier on said cartridge;

transmitting said identifier to the external device; and

selecting the protocol to be run on said cartridge from the plurality of protocols on said external device associated with said identifier.

24. The method of claim 3, wherein prior to step b), the first sample of biological fluid is introduced into the sample collection unit and the volume of the first sample is measured therein.

25. The method of claim 24, wherein a calculation of the concentrations of the plurality of analytes in the first sample of biological fluid is calibrated to include the volume of the first sample in the calculation.

26. The method of claim 24, wherein the sample collection unit comprises conductive units which change conductivity when in contact with a biological fluid.

2. A method, comprising:

a) providing a cartridge comprising at least one sample collection unit and an assay assembly comprising a plurality of reaction sites each having a reactant contained therein;

b) reacting a first sample of biological fluid of less than about 50 ul from said subject with the reactants contained within the reaction sites of said assay assembly, wherein said assay assembly yields detectable signals generated from a plurality of analytes that are indicative of concentrations of the plurality of analytes;

c) detecting said detectable signals with a reader assembly;

d) repeating the reaction and detection steps with a second sample of biological fluid from the same subject; and

wherein said reacting step (b) occurs in accordance with a protocol transmitted from an external device that is external to the reader assembly, to yield a detectable signal indicative of the presence of said plurality of analytes, and

wherein said protocol is selected by detecting an identifier on said cartridge and selecting the protocol to be run on said cartridge from a plurality of protocols associated with said identifier.