Portable medical diagnostic systems and methods using a mobile device

• US 20140072189A1
• Filed: 03/15/2013
• Published: 03/13/2014
• Est. Priority Date: 09/05/2012
• Status: Active Grant

• Current Assignee: Jana Care, Inc.
• Original Assignee: Jana Care, Inc.
• Inventors: Jena, Sidhant, Depa, Michal
• Granted Patent: US 9,241,663 B2
• Time in Patent Office: Days
• US Class Current: 382/128
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/6898 Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: F04C 2270/041 Controlled or regulated
• CPC Class Codes: G01N 2021/8488 the band presenting reference patches
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04

Abstract

A system and method for analysis of colorimetric test strip strips and disease management. The system can include an accessory that is operably coupled to a mobile device, the mobile device acquiring and/or analyzing images of the colorimetric test strips. The light box accessory can be detachably attached to the mobile device, or made to remain attached to the mobile device, but with the capability of having the light box accessory removed from the field of view of the camera for general photography purposes. In other embodiments, an image containing known calibration color(s) and reagent area(s) is obtained sans the light box for comparison with a previous calibration image to model changes in ambient lighting conditions and determine a color correction function. The correction can be applied to the detected reagent area color(s) for matching between the detected reagent area color(s) and reference color(s) on the reference chart. Optionally, the information can be processed and displayed to provide feedback, as well as transmitted to a health provider for analysis.

Claims

1. A light box accessory for analyzing colorimetric strips with a mobile device, said mobile device including a central processing unit and a digital camera, the accessory comprising:

an enclosure including a proximal cover, a perimeter wall and a distal cover, the proximal cover presenting a proximal face and including structure defining a view port that passes through said proximal cover, the distal cover presenting a distal face;

an aperture structure that defines an aperture within said enclosure, said aperture defining a viewing axis that is concentric therewith, said viewing axis being substantially normal to said aperture, said view port of said proximal cover being substantially concentric about said viewing axis;

structure defining a slot for insertion of a colorimetric strip, said slot being configured for orienting said colorimetric strip to intersect said viewing axis;

an in situ calibration target disposed within said aperture structure, said in situ calibration target having predetermined color characteristics;

at least one light source disposed within said enclosure, said at least one light source being arranged for illumination of said colorimetric test strip when said colorimetric test strip is registered within said slot;

a power source disposed within said enclosure and operatively coupled with said at least one light source; and

a switch operatively coupled between said power source and said at least one light source for selective activation of said at least one light source,

wherein said accessory is configured to communicate with said central processing unit of said mobile device only through said digital camera of said mobile device.

2. The light box accessory of claim 1, wherein said aperture structure is integrally formed with at least one of said perimeter wall and said distal cover.

3. The light box accessory of claim 1, wherein said switch is accessible on the exterior of the enclosure for manual energization of said at least one light source.

4. The light box accessory of claim 1, wherein said at least one light source is a light-emitting diode.

5. The light box accessory of claim 1, wherein said power source is at least one battery.

6. The light box accessory of claim 1, further comprising a macro lens disposed within the enclosure, the macro lens being substantially concentric about the viewing axis and being located between said view port and said in situ calibration target.

7. The light box accessory of claim 1, further comprising a circuit for detection of an out-of-range condition, said circuit including a colored light source arranged to illuminate said in situ calibration target when activated.

8. The light box accessory of claim 7, wherein said said circuit is one of a low battery detection circuit and a temperature out-of-range circuit.

9. The light box accessory of claim 1, further comprising a first circuit and a second circuit, each of the first and second circuits being for detection of out-of-range conditions, each of the first and second circuits including a respective colored light source, each of the respective colored light sources being arranged to illuminate said in situ calibration target when activated.

10. The light box accessory of claim 9, wherein:

said first circuit is configured to detect a first out-of-range condition;

said second circuit is configured to detect a second out-of-range condition;

said first out-of-range condition differs from said second out-of-range condition; and

a color of said respective colored light source of said first circuit differs from a color of said respective colored light source of said second circuit.

11. A method for colorimetric analysis of colorimetric test strips that implements a color correction, the method comprising:

providing a mobile device that includes a digital camera and a central processing unit (CPU), said CPU being operatively coupled to a storage medium and configured to receive instructions from said storage medium;

configuring said storage medium to include instructions readable by said CPU, said instructions including;

capturing at least one image of a plurality of standard colors with said digital camera;

converting said at least one image of said plurality of standard colors to a plurality of initial calibration color values;

providing a colorimetric strip exposed to a test fluid, said colorimetric strip including a reactive area;

providing an in situ calibration target that includes at least one in situ calibration color thereon, said at least one in situ calibration color being unaffected by the presence of said test fluid, each of said at least one in situ calibration colors being substantially identical to a respective one of said plurality of standard colors;

obtaining a digital test image that includes both an image of said reactive area of said colorimetric strip and an image of said in situ calibration target;

analyzing portions of said digital test image known to represent said in situ calibration target to obtain a plurality of corresponding in situ quantitative color values;

comparing said corresponding quantitative color values with said initial calibration color values;

establishing a color correction function based on said corresponding in situ quantitative color values;

analyzing portions of said digital test image known to represent said reactive areas of said colorimetric strip to obtain a plurality of test color values corresponding to said reactive areas; and

applying said color correction function to said plurality of test color values; and

converting said plurality of test color values to at least one test reading.

12. The method of claim 11, wherein said plurality of standard colors are reference colors.

13. The method of claim 11 wherein said at least one image of a plurality of standard colors includes both calibration colors and reference colors.

14. The method of claim 11, further comprising linearizing said initial calibration color values and said in situ quantitative color values.

15. The method of claim 11, further comprising storing said plurality of initial calibration color values to said storage medium.

16. The method of claim 15, further comprising recalling said plurality of initial calibration color values from said storage medium before the step of comparing.