Health diagnostic systems and methods

• US 9,131,893 B2
• Filed: 10/28/2013
• Issued: 09/15/2015
• Est. Priority Date: 10/26/2012
• Status: Active Grant

• Current Assignee: Anavah Health LLC
• Original Assignee: Pixie Scientific, LLC
• Inventors: Faybishenko, Yaroslav, Faybishenko, Boris
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US14/065,360
• Publication Number:
  US 20140121487A1
• Time in Patent Office: 687 Days
• Field of Search: 600/300, 600/310, 604/361, 604/362, 128/903, 382/128, 382/162
• US Class Current: 1/1
• CPC Class Codes: A01K 23/00 Manure or urine pouches
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 2576/02 specially adapted for a particular organ or body part
• CPC Class Codes: A61B 5/0013 Medical image data A61B1/00011, A61B6/56, A61B8/56 take precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14517 for sweat
• 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 5/1477 non-invasive
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6808 : Diapers
• CPC Class Codes: A61B 5/6898 : Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/7221 : Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/7246 : using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7435 : Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61F 13/15585 : of babies' napkins, e.g. diapers A61F13/15617 - A61F13/15804 take precedence
• CPC Class Codes: A61F 13/15699 : Forming webs by bringing together several webs, e.g. by laminating or folding several webs, with or without additional treatment of the webs
• CPC Class Codes: A61F 13/15723 : Partitioning batts; Cutting
• CPC Class Codes: A61F 13/42 : with wetness indicator or alarm
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A health monitoring system, and methods of use and manufacture thereof are disclosed. The health monitoring system may include a computing system and a diagnostic test coupled to a diaper. The diagnostic test may include one or more sensors configured to produce a visual indication of one or more analytes contained in a sample produced by a subject. The diagnostic test may include a machine-readable code. The computing system may be configured to read the machine-readable code to allow an application running on the computing system to automatically perform at least one task related to a production of a data point based on the visual indication. The health monitoring system may aid in identifying a potential abnormal health condition of the subject by providing automatic longitudinal analysis of analytes contained in samples produced by the subject over a period of time.

Claims

1. A health monitoring system, comprising:

a computing system configured to interact with a first diagnostic test associated with a first diaper, the first diagnostic test having one or more sensors configured to produce a first at least quasi-quantitative indication of a first set of one or more analytes contained in a first portion of bodily waste excreted by a subject in a first interval of time;

the computing system having one or more processors, a memory, and a health monitoring system program including a plurality of instructions stored in the memory that are executed by the one or more processors to instruct a data acquisition device to acquire automatically one or more digital images of the first at least quasi-quantitative indication, the one or more digital images not including a color comparison scale, to determine and select automatically by the one or more processors a focused first digital image from the acquired one or more digital images of the first at least quasi-quantitative indication, and to analyze the first digital image by comparing data derived from the first digital image of the first at least quasi-quantitative indication to a cluster, in the memory, the cluster based in part on different levels of brightness of the first digital image, in order to produce a first data point corresponding to the first at least quasi-quantitative indication;

the computing system being further configured to interact with a second diagnostic test associated with a second diaper, the second diagnostic test having one or more sensors configured to produce a second at least quasi-quantitative indication of a second set of one or more analytes contained in a second portion of bodily waste excreted by the subject in a second interval of time; and

wherein the plurality of instructions stored in the memory are also executed by the one or more processors to instruct the data acquisition device to acquire automatically one or more digital images of the second at least quasi-quantitative indication, to determine and select automatically by the one or more processors a focused second digital image from the acquired one or more digital images of the second at least quasi-quantitative indication, and to analyze the second digital image to produce a second data point based on the second at least quasi-quantitative indication, and to send a notification to a user if both the first and second data points correspond to an abnormal health condition of the subject.

2. The system of claim 1, wherein the first and second portions of bodily waste include respective first and second portions of urine, the abnormal health condition being diabetic ketoacidosis, and the plurality of instructions stored in the memory are also executed by the one or more processors to send the notification to the user if the first and second data points indicate that both of the first and second portions of urine contain at least one analyte that comprises one or both of a ketone or/and glucose.

3. The system of claim 1, wherein the first and second portions of bodily waste include respective first and second portions of urine, the abnormal health condition being a urinary tract infection, and the plurality of instructions stored in the memory are also executed by the one or more processors to send the notification to the user if the first and second data points indicate that both of the first and second portions of urine contain at least one analyte that comprises one or both of a nitrite or/and leukocyte esterase.

4. The system of claim 1, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to visually read by the computing system a machine-readable code included in the first diagnostic test to direct the computing system to perform at least one task related to the production of the first data point.

5. The system of claim 4, wherein the at least one task includes at least one of:

determining whether the first diagnostic test has expired past a predetermined expiration date; and

determining an authenticity of the first diagnostic test.

6. The system of claim 1, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to automatically acquire and transmit data corresponding to the first and second at least quasi-quantitative indications to an online service that is configured to automatically send the notification to the user via a handheld device.

7. The system of claim 1, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to visually read by an optics system of the computing system a first machine-readable code indicia proximate the one or more sensors of the first diagnostic test to allow an application running on the computing system to perform at least one task related to a production of the first data point based on the first at least quasi-quantitative indication.

8. The system of claim 7, wherein the at least one task includes determining whether the first diagnostic test has expired past a predetermined expiration date.

9. The system of claim 8, wherein the at least one task further includes determining an authenticity of the first diagnostic test.

10. The system of claim 9, wherein the computing system includes an online service having a server and a database, the data acquisition device being a digital device having a second processor, a second memory and a camera that is configured to transmit the one or more digital images, the focused first digital image, and/or the first data point to the server for storage and/or analysis on the server.

11. The system of claim 7, further wherein the plurality of instructions stored in the memory are executed by the one or more processors to verify that each data point is associated with a unique diagnostic test and to discard any data points that correspond to a duplicated diagnostic test.

12. The system of claim 1, wherein the plurality of instructions stored in the memory are further executed by the one or more processors to:

receive and store a first digital data packet that includes a first sample reading, collected at the first interval of time, of the first diagnostic test associated with the first diaper configured to detect the first set of one or more analytes in the first portion of bodily waste excreted by the subject, wherein the first sample reading includes data corresponding to an amount of at least one analyte of the one or more analytes of the first set detected in the first diagnostic test and the first interval of time at which the first sample reading was collected;

receive and store a second digital data packet that includes a second sample reading, collected at the second interval of time different from the first interval of time, of the second diagnostic test associated with the second diaper, wherein the second sample reading includes data corresponding to an amount of at least one analyte of the one or more analytes of the second set detected and the second interval of time at which the second sample reading was collected, with the at least one analyte of the one or more analytes of the first set being the same analyte as the at least one analyte of the one or more analytes of the second set;

automatically compare the first and second sample readings against a standard for the at least one analyte that indicates normal and abnormal levels of the detected at least one analyte over different time intervals to analyze whether the first and second data readings correspond to the abnormal health condition of the subject based on the respective amounts of the at least one analyte detected in the respective first and second sample readings collected at the respective first and second intervals of time; and

automatically transmit an indication configured for receipt at least by the data acquisition device if there is an abnormal level of the detected at least one analyte based on the analysis of the first and second sample readings.

13. The system of claim 12, wherein the one or more sensors of the first diagnostic test include a first sensor corresponding to the first set of analytes being detected, and the one or more sensors of the second diagnostic test include a second sensor corresponding to the same analyte as being detected by the first sensor or a different analyte than is being detected by the first sensor.

14. The system of claim 12, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to indicate which analyte each of the first and second sensors are detecting.

15. The system of claim 1, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to automatically acquire the one or more digital images of the first at least quasi-quantitative indication in response to instructions received from reading a first machine-readable code indicia of the first diagnostic test.

16. The system of claim 15, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to individually color-correct first and second digital regions of the first digital image, the first digital region corresponding to a first region of the first diagnostic test that includes a first sensor and a uniform color reference material, the second digital region corresponding to a second region of the diagnostic test that is different from the first region and includes a second sensor and the reference material, wherein the individual color-correction is based in part on reading and analyzing a gradient in apparent color of the reference material in the first region and accordingly color correcting the first digital region, and of the reference material in the second region and accordingly color correcting the second digital region.

17. The system of claim 16, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to independently color correct the first and second digital regions, based on the respective gradient of the reference material measured in the first and second digital regions as compared to a respective deviation of each respective gradient from a standard color of the reference material.

18. The system of claim 17, wherein the first diaper includes a reference material, a first sensor, and a second sensor, further wherein the reference material surrounds at least a portion of each of the first and second sensors.

19. The system of claim 17, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to individually color-correct one or more of the first and second digital regions based at least in part on a color indication taken from a color corresponding to the first machine-readable code indicia based on the color of the first machine-readable code indicia being different than a color of the reference material and a color corresponding to true black.

20. The system of claim 17, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to read the first machine-readable code indicia and automatically acquire the one or more digital images of the first at least quasi-quantitative indication when an alignment frame indicia associated with the data acquisition device is substantially aligned with an alignment frame indication received from the first diagnostic test.

21. The system of claim 20, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to individually color-correct one or more of the first and second digital regions based at least in part on a color indication received that is associated with a color of an alignment frame of the first diagnostic test.

22. The system of claim 21, wherein the first diagnostic test includes an alignment frame, a first machine-readable code indicia, and a reference material, further wherein the color of the alignment frame of the first diagnostic test is different from the color of the first machine-readable code indicia and the color of the reference material.

23. The system of claim 20, wherein the first diagnostic test includes an alignment frame, a first sensor, a second sensor, and a first machine-readable code indicia, further wherein the first and second sensors and the first machine-readable code indicia are disposed within the alignment frame of the first diagnostic test.

24. The system of claim 17, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to determine whether the first diagnostic test has expired past a first predetermined expiration date based on information indicating a predetermined expiration date of the first diagnostic test included in the first machine-readable code indicia.

25. The system of claim 1, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to determine whether the second data point is a repeat of the first data point, and to exclude the second data point if determined to be repeated.

26. The system of claim 25, wherein the plurality of instructions stored in the memory are also executed by the one or more processors to automatically acquire the one or more digital images of the first at least quasi-quantitative indication in response to instructions received from reading a first machine-readable code indicia of the first diagnostic test and to automatically acquire the one or more digital images of the second at least quasi-quantitative indication in response to instructions received from reading a second machine-readable code indicia of the second diagnostic test, and determine if the second data point is a repeat of the first data point by comparing information received from the first and second machine-readable code indicia.

27. The system of claim 1, wherein the one or more digital images of the first at least quasi-quantitative indication includes a plurality of digital images.

28. The system of claim 1, wherein at least one of the one or more digital images of the first at least quasi-quantitative indication are acquired before the focused first digital image is determined and selected.

29. The system of claim 1, further wherein the plurality of instructions stored in the memory are executed by the one or more processors to grow the cluster by a clustering algorithm that includes k-means clustering.

30. The system of claim 1, further wherein the plurality of instructions stored in the memory are executed by the one or more processors to compare the one or more digital images of the at least quasi-quantitative indication to a standard not present in the one or more digital images.

31. A health monitoring system, comprising:

a computing system configured to interact with a first diagnostic test associated with a first diaper, the first diagnostic test having one or more sensors configured to produce a first at least quasi-quantitative indication of a first set of one or more analytes contained in a first portion of bodily waste excreted by a subject in a first interval of time;

the computing system having one or more processors, a memory, and a health monitoring system program including a plurality of instructions stored in the memory that are executed by the one or more processors to;

instruct a data acquisition device to acquire automatically one or more digital images of the first at least quasi-quantitative indication,

determine and select automatically by the one or more processors a focused first digital image from the acquired one or more digital images of the first at least quasi-quantitative indication,

individually color-correct first and second digital regions of the first digital image to generate a color-corrected first digital image, the first digital region corresponding to a first region of the first diagnostic test that includes a uniform color reference material and a first sensor of the one or more sensors of the first diagnostic test, the second digital region corresponding to a second region of the diagnostic test that is different from the first region and includes the reference material and a second sensor of the one or more sensors of the first diagnostic test, wherein the individual color-correction is based in part on reading and analyzing a gradient in apparent color of the reference material in the first region and accordingly color correcting the first digital region, and of the reference material in the second region and accordingly color correcting the second digital region, and

analyze the color-corrected first digital image to produce a first data point corresponding to the first at least quasi-quantitative indication;

the computing system being further configured to interact with a second diagnostic test associated with a second diaper, the second diagnostic test having one or more sensors configured to produce a second at least quasi-quantitative indication of a second set of one or more analytes contained in a second portion of bodily waste excreted by the subject in a second interval of time; and

wherein the plurality of instructions stored in the memory are also executed by the one or more processors to instruct the data acquisition device to acquire automatically one or more digital images of the second at least quasi-quantitative indication, to determine and select automatically by the one or more processors a focused second digital image from the acquired one or more digital images of the second at least quasi-quantitative indication, and to analyze the second digital image to produce a second data point based on the second at least quasi-quantitative indication, and to send a notification if both the first and second data points correspond to an abnormal health condition of the subject.

32. A health monitoring system, comprising:

a computing system configured to interact with a first diagnostic test associated with a first diaper, the first diagnostic test having one or more sensors configured to produce a first at least quasi-quantitative indication of a first set of one or more analytes contained in a first portion of bodily waste excreted by a subject in a first interval of time;

the computing system having one or more processors, a memory, and a health monitoring system program including a plurality of instructions stored in the memory that are executed by the one or more processors to;

instruct a data acquisition device to acquire automatically one or more digital images of the first at least quasi-quantitative indication when an alignment frame indicia associated with the data acquisition device is substantially aligned with an alignment frame indication received from the first diagnostic test,

determine and select automatically by the one or more processors a focused first digital image from the acquired one or more digital images of the first at least quasi-quantitative indication,

individually color-correct first and second digital regions of the first digital image to generate a color-corrected first digital image, the first digital region corresponding to a first region of the first diagnostic test that includes a uniform color reference material and a first sensor of the one or more sensors of the first diagnostic test, the second digital region corresponding to a second region of the diagnostic test that is different from the first region and includes the reference material a second sensor of the one or more sensors of the first diagnostic test, wherein the individual color-correction is based in part on reading and analyzing a gradient in apparent color of the reference material in the first region and accordingly color correcting the first digital region, and of the reference material in the second region and accordingly color correcting the second digital region, and

analyze the color-corrected first digital image to produce a first data point corresponding to the first at least quasi-quantitative indication;

the computing system being further configured to interact with a second diagnostic test associated with a second diaper, the second diagnostic test having one or more sensors configured to produce a second at least quasi-quantitative indication of a second set of one or more analytes contained in a second portion of bodily waste excreted by the subject in a second interval of time; and

wherein the plurality of instructions stored in the memory are also executed by the one or more processors to instruct the data acquisition device to acquire automatically one or more digital images of the second at least quasi-quantitative indication, to determine and select automatically by the one or more processors a focused second digital image from the acquired one or more digital images of the second at least quasi-quantitative indication, and to analyze the second digital image to produce a second data point based on the second at least quasi-quantitative indication, and to send a notification if both the first and second data points correspond to an abnormal health condition of the subject.