SYSTEMS AND METHODS FOR DIAGNOSIS OR TREATMENT

• US 20130079599A1
• Filed: 09/26/2011
• Published: 03/28/2013
• 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
• Granted Patent: US 9,268,915 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• 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 computer-implemented method for diagnosis and/or treatment of a subject with the aid of a point of care system, said subject being tested for a disorder with an identifiable manifestation on an external feature of said subject, the method comprising:

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

(b) obtaining, at the point of care location, an image of a three-dimensional representation of said external feature of the subject with the aid of a three-dimensional imaging device having a processor that executes a program for generating said three-dimensional representation of said external feature of the subject; and

(c) displaying, with the aid of an electronic display device in communication with said three-dimensional imaging device, said three-dimensional representation of said external feature to a remotely located healthcare provider to effect said diagnosis and/or treatment, wherein said diagnosis and/or treatment is based on said displayed three-dimensional representation of said external feature and a result of a test conducted on a biological sample obtained from said subject, and wherein said test that is conducted on said biological sample is correlated with the presence or absence of said disorder.

2. The method of claim 1, wherein said healthcare provider is selected by the subject.

3. The method of claim 1, further comprising, with the aid of said point of care system, establishing a line of communication with the healthcare provider to provide said diagnosis and/or treatment of said subject.

4. The method of claim 1, wherein said diagnosis and/or treatment is provided while the three-dimensional representation and said result are displayed to the healthcare provider.

5. The method of claim 1, wherein the three-dimensional imaging device is part of the point of care system.

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

7. The method of claim 6, wherein identifying the subject includes verifying a fingerprint of the subject.

8. 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.

9. The method of claim 1, further comprising collecting said biological sample from said subject.

10. The method of claim 9, wherein the biological sample is collected from the subject at the location of a healthcare provider.

11. The method of claim 9, wherein the biological sample is collected from the subject at the subject'"'"'s home.

12. The method of claim 1, wherein the point of care system comprises an image recognition module for analyzing at least a portion of the three-dimensional representation of the external feature of said subject for treatment.

13. 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.

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

23. The method of claim 1, wherein said test is conducted concurrent with the subject'"'"'s visit at the point of care location.

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

25. The method of claim 1, wherein said healthcare provider is located outside of the point of care location.

26. The method of claim 1, wherein the three-dimensional representation of said external feature of said subject is displayed while the subject is in the point of care location.

27. The method of claim 1, wherein the three-dimensional is obtained and displayed in real time.

28. The method of claim 6, wherein identifying the subject includes verifying a genetic signature of the subject.

29. The method of claim 9, wherein said biological sample is collected from said subject with the aid of said point of care system.

30. The method of claim 9, further comprising performing, with the aid of said point of care system, at least one procedure on said biological sample, said at least one procedure selected from the group consisting of sample processing, centrifugation, separation and chemical processing.

31. The method of claim 8, 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.

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

33. The method of claim 1, wherein said three-dimensional representation of said external feature of said subject and said result are obtained concurrently.

34. The method of claim 1, wherein said three-dimensional representation of said external feature of said subject and said result are displayed to said healthcare provider concurrently.

35. The method of claim 1, wherein said point of service system is programmed to translate a first language understood by said healthcare provider to a second language understood by said subject, and vice versa.

36. The method of claim 1, further comprising transmitting, with the aid of said point of care system at said point of care location, information concerning said diagnosis and/or treatment from said healthcare provider to said subject.

37. The method of claim 1, further comprising collecting, with the aid of a guided questionnaire provided on an electronic display of said point of care system, information selected from the group consisting of dietary consumption, exercise, health condition and mental condition of said subject, which information aids said healthcare provider in providing said diagnosis and/or treatment.

38. The method of claim 1, wherein said test is conducted with said point of care system.

39. The method of claim 1, wherein said test is an invasive procedure.

40. The method of claim 39, wherein said test comprises testing for multiple analytes in the biological sample.

14. (canceled)

16. A system for diagnosis and/or treatment of a subject, comprising:

(a) a point of service system having a three-dimensional imaging device that is programmed to (i) capture an image of said subject or a sample removed from said subject and (ii) construct a three-dimensional spatial representation of an external feature of the subject or said sample removed from the subject, and wherein the point of service system comprises a sample processing module that conducts a test on the sample removed from the subject; and

(b) a processor operatively coupled to said three-dimensional imaging device, wherein said processor is programmed to transmit (i) said three-dimensional spatial representation of said external feature or said sample, and (ii) a result of the test conducted on said sample removed from said subject, to a remote electronic display device accessible by a healthcare provider to effect said diagnosis and/or treatment.

17. The system of claim 16, wherein the point of service system comprises an image recognition module for analyzing at least a portion of the three-dimensional spatial representation of the subject for diagnosis and/or treatment of the subject.

19. The system of claim 16, wherein the remote computer system is programmed to display the retrieved three-dimensional spatial representation to said healthcare provider in real-time.

18. (canceled)

20. A computer-implemented method for diagnosis and/or treatment of a subject with the aid of a point of service system, said subject at risk of having a disorder with an identifiable manifestation on an external part of said subject, the method comprising:

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

(b) at the point of care location and with the aid of said point of service system, obtaining (i) a result of a test conducted on a biological sample of said subject, wherein said test is correlated with the presence or absence of said disorder, and (ii) an image comprising a three-dimensional representation encompassing said identifiable manifestation on said external part of said subject; and

(c) providing said result and said three-dimensional representation to a healthcare provider to effect said diagnosis and/or treatment that is based on said result and said three-dimensional representation, wherein said three-dimensional representation is provided via an electronic display device that is in communication with said point of service system.

21. The method of claim 20, wherein said healthcare provider is selected by the subject to diagnose and/or treat said subject.

22. (canceled)