HEALTH DIAGNOSTIC SYSTEMS AND METHODS

• US 20140121487A1
• Filed: 10/28/2013
• Published: 05/01/2014
• Est. Priority Date: 10/26/2012
• Status: Active Grant

• Current Assignee: Anavah Health LLC
• Original Assignee: Pixie Scientific, LLC
• Inventors: FAYBISHENKO, Yaroslav, FAYBISHENKO, Boris
• Granted Patent: US 9,131,893 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• 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 having a processor, a memory, and a health monitoring system program including a plurality of instructions stored in the memory that are executed by the processor to;

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

receive and store a second digital data packet that includes a second sample reading, collected at a second time interval different from the first time interval, of a second diagnostic test of either the first diaper or a different diaper configured to detect the analyte, wherein the second sample reading includes data corresponding to an amount of the analyte detected and the second time interval at which the second sample was collected;

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

automatically transmit an indication if there is an abnormal level of detected analyte based on analyzing the first and second sample readings.

2. The system of claim 1, further comprising a digital optical system to acquire the first and second samples by taking a visual reading of the first and second diagnostic tests and transmitting the first and second samples respectively as part of first and second digital data packets to the computing system.

3. The system of claim 1, wherein the first diaper includes a sensor in contact with the bodily waste for detecting the analyte of the first diagnostic test and a machine-readable code, proximate the sensor, configured to enable automatic, automated acquisition of digital samples by the optical sensor for the first diagnostic test.

4. The system of claim 3, wherein the plurality of instructions stored in the memory are also executed by the processor to acquire automatically a sample reading from a diagnostic test by automatically selecting a focused digital image of the sensor acquired by the digital optical system.

5. The system of claim 3, wherein the plurality of instructions stored in the memory are also executed by the processor to receive an indication from the machine-readable code indicating one or more of a format of the first diagnostic test, whether the first diagnostic test has expired past a predetermined expiration date;

and an authenticity of the first diagnostic test.

6. The system of claim 3, further comprising 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.

7. The system of claim 6, wherein the plurality of instructions stored in the memory are also executed by the processor to indicate which analyte each of the first and second sensors are detecting.

8. The system of claim 3, wherein the computing system includes a first processor remote from a second processor, wherein at least one of the plurality of instructions are executed by the first processor and others of the plurality of instructions are executed by the second processor.

9. The system of claim 3, wherein the bodily waste is urine, the machine-readable code is a barcode proximate the sensor, and the first and second diagnostics tests are the same diagnostic test using the same reagents and substantially same concentrations of reagents.

10. A health monitoring system, comprising:

a first diaper for collecting a first portion of bodily waste produced by a subject in a first interval of time;

a first diagnostic test coupled to the first diaper, the first diagnostic test having a first set of one or more sensors configured to produce a first visual indication of one or more analytes contained in the first portion of bodily waste; and

a first machine-readable code indicia proximate the first set of one or more sensors that is configured to be read by an optics system of a computing system configured to visually read the first machine-readable code to allow an application running on the computing system to perform at least one task related to a production of a first health monitoring data point based on the first visual indication.

11. The system of claim 10, wherein the computing system includes a data acquisition device, and the at least one task includes selecting a focused first digital image acquired by the data acquisition device of the first visual indication, the computing system being configured to analyze the first digital image to produce the first health monitoring data point.

12. The system of claim 11, wherein the at least one task includes identifying a format of the first set of one or more sensors.

13. The system of claim 12, wherein the at least one task includes determining whether the first diagnostic test has expired past a predetermined expiration date.

14. The system of claim 13, wherein the at least one task includes determining an authenticity of the first diagnostic test.

15. The system of claim 14, further comprising:

a second diaper for collecting a second portion of bodily waste produced by the subject in a second interval of time different from the first interval of time; and

a second diagnostic test coupled to the second diaper, the second diagnostic test having a second set of one or more sensors configured to produce a second visual indication of one or more analytes contained in the second portion of bodily waste;

wherein the data acquisition device is configured to acquire a second digital image of the second visual indication, the computing system being configured to analyze the second digital image to produce a second health monitoring data point based on the second visual indication, and to send a notification to a user if the first and second health monitoring data points are outside a predefined range.

16. The system of claim 15, wherein the first and second portions of bodily waste are respective first and second portions of urine, and the machine-readable code is a barcode disposed on the first diagnostic test.

17. The system of claim 16, wherein the computing system includes an online service having a server and a database, the data acquisition device being a digital device having a processor, a memory and a camera that is configured to transmit the first and second digital images to the server, the server being configured to analyze the first and second images to produce the first and second health monitoring data points and to store the first and second health monitoring data points in the database.

18. A health monitoring system, comprising:

a first diaper including a first diagnostic test for producing 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;

a second diaper including a second diagnostic test for producing 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

a computing system configured to visually acquire the first and second at least quasi-quantitative indications, to analyze the first and second at least quasi-quantitative indications to produce respective first and second data points, 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.

19. The system of claim 18, wherein the first and second portions of bodily waste are respective first and second portions of urine, the abnormal health condition being dehydration, the first data point including a first level of specific gravity of the first portion of urine produced by the subject in the first interval of time, the second data point including a second level of specific gravity of the second portion of urine produced by the subject in the second interval of time, and the computing system being configured to send the notification to the user if both the first and second levels exceed a predetermined threshold level.

20. The system of claim 18, wherein the first and second portions of bodily waste are respective first and second portions of urine, the abnormal health condition being diabetic ketoacidosis, the computing system being configured 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.

21. The system of claim 18, wherein the first and second portions of bodily waste are respective first and second portions of urine, the abnormal health condition being a urinary tract infection, the computing system being configured 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.

22. The system of claim 18, wherein the first diagnostic test includes a machine-readable code configured to be visually read by the computing system to direct the computing system to perform at least one task related to the production of the first data point.

23. The system of claim 22, wherein the at least one task is selected from a group of tasks comprising:

(a) selecting a focused first digital image of the first at least quasi-quantitative indication acquired by a data acquisition device of the computing system, wherein the computing system analyzes the first digital image to produce the first data point;

(b) identifying a format of the first diagnostic test;

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

(d) determining an authenticity of the first diagnostic test.

24. The system of claim 23, wherein the machine-readable code is a barcode disposed on the first diagnostic test.

25. The system of claim 18, wherein the computing system includes a handheld computing device and an online service, the handheld computing device being configured to visually acquire and transmit the first and second at least quasi-quantitative indications to the online service, the online service being configured to send the notification to the user via the handheld device.

26. A method of manufacturing diapers, comprising:

providing an outer layer web and an inner layer web;

forming one or more cut-outs at substantially regular intervals in the outer layer web;

joining the outer layer and inner layer webs to form a package;

positioning one or more diagnostic tests in the one or more cut-outs; and

separating the package into one or more diapers.

27. The method of claim 26, further comprising sealing a transparent cover on the diagnostic tests and the outer layer web to seal the cut-outs.

28. The method of claim 26, wherein the positioning step is carried out prior to the joining step.

29. The method of claim 28, wherein the positioning step involves disposing the one or more diagnostic tests on a sheet, and substantially continuously rolling the sheet between the outer layer and inner layer webs prior to the joining step.

30. The method of claim 26, wherein the positioning step involves providing a sheet on which the one or more diagnostic tests are disposed, cutting the sheet into one or more patches, each patch including at least one of the diagnostic tests, and placing a respective patch into a respective cut-out.