MOBILE ANALYTE MONITORING SYSTEM

• US 20130303869A1
• Filed: 05/10/2013
• Published: 11/14/2013
• Est. Priority Date: 05/11/2012
• Status: Abandoned Application

• Current Assignee: Optica, Inc.
• Original Assignee: Wellsense, Inc.
• Inventors: Rebec, Mihailo V., Rebec, Slavko N., Sass, Richard G.
• Application Number:
  US13/892,151
• Publication Number:
  US 20130303869A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/6882 Anchoring means

Abstract

A mobile analyte monitoring system may include an implantable sensor and a reader device with an optical sensor. The implantable sensor may be implanted into the dermis of an animal, and may exhibit a color change in response to the presence of a target analyte or reaction product thereof. The reader device may be configured to capture an image of the implanted sensor and to determine the concentration of the target analyte based at least in part on the image. One or more portions of the implantable sensor or components thereof may be configured to facilitate calibration of the sensor, correction of an optical signal obtained from the sensor by a reader device to accommodate variations in the surrounding tissues, and/or calculation of a representative value by a reader device. The reader device may be a personal electronic device such as a cell phone, PDA, or personal computer.

Claims

1. An analyte monitoring system, comprising:

an analyte sensor having a base and an analyte reagent system coupled to the base, wherein the analyte sensor is configured to exhibit a reversible color change in response to a target analyte; and

a reader device configured to capture an image of the analyte sensor and determine a concentration of the target analyte based at least on the image.

2. The analyte monitoring system of claim 1, wherein the reader device is a mobile electronic device selected from the group consisting of a cell phone, a smart phone, a personal computer, and a personal digital assistant.

3. The analyte monitoring system of claim 1, wherein the base comprises a polymeric material impregnated with TiO₂.

4. The analyte monitoring system of claim 1, wherein the base is reflective and comprises a metal.

5. The analyte monitoring system of claim 1, wherein the analyte sensor is configured to be inserted into an animal.

6. The analyte monitoring system of claim 1, wherein the analyte sensor is configured to be inserted into the dermis of the animal.

7. The analyte monitoring system of claim 1, further comprising a medical device communicatively coupled to the reader device.

8. The analyte monitoring system of claim 7, wherein the medical device is an insulin pump.

9. The analyte monitoring system of claim 1, wherein the analyte reagent system comprises one or more of a lipophilic anion, a chromoionophore, and an ionophore.

10. The analyte monitoring system of claim 1, wherein the analyte reagent system comprises an enzyme.

11. The analyte monitoring system of claim 1, wherein the analyte sensor has a total thickness of 50 μ

m or less.

12. The analyte monitoring system of claim 9, wherein the enzyme is glucose oxidase.

13. The analyte monitoring system of claim 1, wherein the image comprises a representation of at least one analyte measurement chamber.

14. The analyte monitoring system of claim 1, wherein the analyte sensor is configured to provide a qualitative indication of analyte concentration that is visible to the user.

15. The analyte monitoring system of claim 6, wherein the animal is a human, the reader device comprises an image capture device and a smart phone in wireless communication with the image capture device, and the image capture device is configured to be retained on the animal'"'"'s body proximal to the analyte sensor.

16. A method of monitoring an analyte sensor implanted in the dermis of a subject, wherein the implanted analyte sensor includes one or more analysis regions configured to exhibit a reversible color change in response to a change in concentration of a target analyte, the computer-implemented method comprising:

receiving first image data representative of a first image of the implanted analyte sensor;

determining, based at least on the first image data, a first color value corresponding to a portion of the one or more analysis regions; and

determining a concentration of the target analyte based at least on the first color value.

17. The method of claim 16, wherein the first image of the implanted analyte sensor is captured by an optical sensor of a reader device.

18. The method of claim 17, wherein the reader device is a smart phone.

19. The method of claim 17, wherein said determining the concentration of the target analyte is performed by a third party computer system, the method further comprising communicating the concentration of the target analyte to the reader device.

20. The method of claim 17, further comprising:

receiving second image data representative of a second image of the implanted analyte sensor;

determining, based at least on the second image data, a second color value corresponding to a portion of the implanted analyte sensor;

determining a difference between the first color value and the second color value; and

determining, based at least on said difference, one or more of a correction factor, a sensor malfunction, and a time frame for replacement of the implanted analyte sensor.

21. The method of claim 17, wherein said determining the concentration of the target analyte is performed by the reader device, the method further comprising communicating the first image data, the first color value, or the concentration of the target analyte to a computing system of a manufacturer of the implanted analyte sensor.

22. The method of claim 17, wherein said determining one or more of the correction factor, the sensor malfunction, and the time frame for replacement of the implanted analyte sensor is performed by the computing system of the manufacturer of the sensor.

23. The method of claim 17, wherein the reader device includes an image capture device and a smart phone in wireless communication with the image capture device, the image capture device configured to be retained on the subject'"'"'s body proximal to the implanted analyte sensor.

24. The method of claim 23, wherein the image capture device is configured to capture images at predetermined intervals or in response to a command from the reader device.

25. The method of claim 19, further including:

receiving by the third party computer system, from the reader device, user input data regarding one or more meals or a medication; and

generating by the third party computer system, based at least on the user input data, one or more recommendations to the user regarding said medication.

33. The non-transitory computer readable medium of claim 17, wherein the instructions are further operable, upon execution by the processor, to cause the electronic device to:

capture a plurality of images of the analyte sensor; and

automatically adjust one or more image capture parameters based on one or more of the images.

34. The non-transitory computer readable medium of claim 33, wherein the plurality of images are captured as a video, and the image capture parameters are adjusted during capture of the video.

26. A non-transitory computer readable medium comprising instructions operable, upon execution by a processor of an electronic device, to cause the electronic device to:

receive a first image of an analyte sensor implanted in the dermis of a subject, wherein the implanted analyte sensor includes one or more analysis regions configured to exhibit a reversible color change in response to a change in concentration of a target analyte;

determine, based at least on the first image, a first color value corresponding to a portion of the one or more analysis regions; and

determine a concentration of the target analyte based at least on the first color value.

27. The non-transitory computer readable medium of claim 26, wherein the electronic device is a smart phone.

28. The non-transitory computer readable medium of claim 26, wherein the electronic device is a third party computer system and the first image of the implanted analyte sensor is captured by an optical sensor of a reader device.

29. The non-transitory computer readable medium of claim 28, wherein the reader device is a smart phone.

30. The non-transitory computer readable medium of claim 26, wherein the instructions are further operable, upon execution by the processor, to cause the electronic device to:

determine, based at least on the first image, a second color value corresponding to a second portion of the implanted analyte sensor;

determine a difference between the first color value and the second color value; and

determine, based at least on said difference, one or more of a correction factor, a sensor malfunction, and a time frame for replacement of the implanted analyte sensor.

31. The non-transitory computer readable medium of claim 26, wherein the instructions are further operable, upon execution by upon execution by the processor, to cause the electronic device to communicate one or more of the first image and the first color value to a third party computer system.

32. The non-transitory computer readable medium of claim 26, wherein the instructions are further operable, upon execution by the processor, to cause the electronic device to:

receive user input data regarding one or more meals or a medication; and

based at least on the user input data, generate one or more recommendations to the user regarding said medication.