Systems and methods for diagnosis or treatment

• US 9,268,915 B2
• Filed: 09/26/2011
• Issued: 02/23/2016
• Est. Priority Date: 09/25/2011
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (FIG LLC (d/b/a Fortress Investment Group LLC))
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth, Balwani, Sunny
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): Archer, Marie
• Application Number:
  US13/244,956
• Publication Number:
  US 20130079599A1
• Time in Patent Office: 1,611 Days
• Field of Search: 705 2- 3, 128920-925, 600300-301
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/688 using adhesives
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/74 Details of notification to user or communication with user or patient indicating measured values G01D7/00; user input means input or output arrangements for computers G06F3/00
• CPC Class Codes: A61B 8/483 involving the acquisition of a 3D volume of data
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.

Claims

1. A method for diagnosis and/or treatment of a subject with the aid of a point of care system, the method comprising:

(a) authenticating the subject at a point of care location;

(b) obtaining a three-dimensional representation of an external feature of the subject with the aid of a three-dimensional imaging device, wherein the system comprises an image recognition module for analyzing at least a portion of the three-dimensional representation of the external feature of the subject;

(c) obtaining, at the point of care location, a biological sample from the subject;

(d) loading the sample into a cartridge, the cartridge housing a plurality of reagents comprising at least a first reagent and a second reagent, wherein the first reagent is in a first fluidically isolated reagent unit and the second reagent is in a second fluidically isolated reagent unit, and wherein the plurality of reagents in the cartridge are sufficient for performing at least a first assay with the sample;

(e) loading the cartridge comprising the sample and the plurality of reagents into the point of care system, wherein the point of care system comprises i) a camera for obtaining a video image of the subject, ii) an electronic display for displaying a video image of a healthcare provider, iii) an automated pipette, wherein the pipette is configured to access the sample and reagents in the cartridge, and iv) a communications module, for transmitting information to and from the point of care system;

(f) performing the assay in the point of care system, wherein performing the assay comprises accessing and manipulating the sample and the reagents in the cartridge with the automated pipette according to a computer-implemented protocol; and

(g) displaying the video image of the healthcare provider on the display of the point of care system.

2. The method of claim 1, wherein said authenticating step comprises identifying the subject.

3. The method of claim 2, wherein identifying the subject includes verifying a fingerprint of the subject.

4. The method of claim 2, wherein identifying the subject includes verifying a genetic signature of the subject.

5. The method of claim 1, further comprising obtaining an electrical readout of the subject using a touchscreen display, wherein the electrical readout aids said healthcare provider in providing said diagnosis and/or treatment of said subject.

6. The method of claim 5, wherein obtaining said electrical readout of the subject using the touchscreen display further comprises making an electrical measurement of the subject through the touchscreen display.

7. The method of claim 1, wherein the biological sample is obtained from the subject at the location of a healthcare provider.

8. The method of claim 1, wherein the biological sample is obtained from the subject at the subject'"'"'s home.

9. The method of claim 1, wherein step (a) comprises using a biometric scan, the subject'"'"'s insurance card, the subject'"'"'s name, the subject'"'"'s driver'"'"'s license, an identification card of the subject, an image of the subject taken with the aid of a camera in the point of care system, a genetic signature of the subject, and/or a gesture of the subject to authenticate the subject.

10. The method of claim 1, further comprising combining the three-dimensional representation of said external feature of the subject with subject-specific information.

11. The method of claim 1, wherein said biological sample is obtained from said subject with the aid of said point of service system.

12. The method of claim 1, wherein the three-dimensional representation is obtained and analyzed in real time.

13. The method of claim 1, wherein said biological sample is a blood sample.