SYSTEM FOR MONITORING BODY CHEMISTRY

• US 20150257687A1
• Filed: 03/13/2015
• Published: 09/17/2015
• Est. Priority Date: 03/13/2014
• Status: Abandoned Application

• Current Assignee: One Health Biosensing Incorporated
• Original Assignee: Sano Intelligence, Inc. (Informed Data Systems, Inc.)
• Inventors: Pushpala, Ashwin, Chapman, Matthew, Szmodis, Alan, Ghosh, Abhijit
• Application Number:
  US14/657,973
• Publication Number:
  US 20150257687A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/0214 Capacitive electrodes
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• 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 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6832 : using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/6849 : in combination with a needle set
• CPC Class Codes: A61B 5/685 : Microneedles
• CPC Class Codes: A61B 5/688 : using adhesives
• CPC Class Codes: A61B 5/6885 : Monitoring or controlling sensor contact pressure
• 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 5/7278 : Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7285 : for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16Y 10/60 : Healthcare; Welfare
• CPC Class Codes: G16Y 40/10 : Detection; Monitoring
• CPC Class Codes: H04W 12/037 : of the control plane, e.g. signalling traffic

Abstract

A system and method for monitoring body chemistry of a user, the system comprising: a housing supporting: a microsensor comprising a first and second working electrode, a reference electrode, and a counter electrode, and configured to access interstitial fluid of the user, and an electronics subsystem comprising a signal conditioning module that receives a signal stream, from the microsensor, wherein the electronics subsystem is configured to detect an impedance signal derived from two of the first working electrode, the second working electrode, the reference electrode, and the counter electrode; and a processing subsystem comprising: a first module configured to generate an analysis indicative of an analyte parameter of the user and derived from the signal stream and the impedance signal, and a second module configured to transmit information derived from the analysis to the user, thereby facilitating monitoring of body chemistry of the user.

Claims

1. A system for monitoring body chemistry of a user, the system comprising:

a housing comprising a first housing portion coupleable to the user and including an opening, and a second housing portion insertable into the opening of the first housing portion in a first configuration, the first housing portion supporting;

a microsensor comprising a first working electrode, a second working electrode, a reference electrode, and a counter electrode, and configured to access interstitial fluid of the user upon coupling of the housing to the user in the first configuration of the housing, and

the second housing portion supporting;

an electronics subsystem comprising a signal conditioning module configured to receive a signal stream, from the microsensor, and configured with a shifted potential different than a reference potential of the reference electrode, wherein the electronics subsystem is configured to detect an impedance signal derived from two of the first working electrode, the second working electrode, the reference electrode, and the counter electrode in response to an applied voltage near the shifted potential; and

a processing subsystem in communication with the electronics subsystem and comprising;

a first module configured to generate an analysis indicative of an analyte parameter of the user and derived from the signal stream and the impedance signal, and a second module configured to render information derived from the analysis at an electronic device associated with the user, thereby facilitating monitoring of body chemistry of the user.

2. The system of claim 1, wherein the electronics subsystem and the processing subsystem are configured to cooperate in continuously detecting a voltage parameter of the counter electrode, and wherein the electronics subsystem is configured to apply the applied voltage and detect the impedance signal when the voltage parameter of the counter electrode satisfies a voltage threshold condition.

3. The system of claim 2, wherein the processing subsystem is configured to generate a notification at the electronic device of the user, in response to detection of unsuitable impedance derived from comparison between the impedance signal and an impedance threshold condition.

4. The system of claim 2, wherein an actuator of the electronics subsystem is configured to automatically perform an action that biases the microsensor into communication with interstitial fluid of the user, in response to detection of unsuitable impedance derived from comparison between the impedance signal and an impedance threshold condition.

5. The system of claim 1, wherein the first module of the processing subsystem is configured to generate a predicted value of the analyte parameter at a future time point in the analysis, and the second module of the processing subsystem is configured to render a line graph including a predicted region, wherein the predicted region depicts the predicted value at the future time point, and a width of the predicted region indicates confidence in the predicted value.

6. The system of claim 1, further comprising an applicator configured to accelerate the second housing portion toward skin of the user, thereby causing the microsensor to penetrate skin of the user and sensing regions of the microsensor to access interstitial fluid of the user.

7. The system of claim 1, wherein the first housing portion includes a microsensor interface substrate comprising a set of concentric ring contacts configured to interface electronics of the second housing portion with filaments of the microsensor, in any rotated configuration associated with insertion of the second housing portion into the opening of the first housing portion.

8. A method for monitoring body chemistry of a user, the method comprising:

receiving a second housing portion into an opening of a first housing portion, the first housing portion supporting a microsensor including a first working electrode, a second working electrode, a reference electrode, and a counter electrode, and the second housing portion supporting an electronics subsystem configured to receive a signal stream from the microsensor;

accelerating the second housing portion toward skin of the user, thereby delivering sensing regions of the microsensor into interstitial fluid of the user;

generating an impedance signal, from two of the first working electrode, the second working electrode, the reference electrode, and the counter electrode, in response to applying an applied voltage, near a shifted potential different than a reference potential of the reference electrode, wherein the shifted potential is associated with a signal conditioning module of the electronics subsystem;

at a processing system in communication with the electronics subsystem, receiving the signal stream and the impedance signal;

at the processing system, generating an analysis indicative of an analyte parameter of the user and derived from the signal stream and the impedance signal; and

transmitting information derived from the analysis to an electronic device associated with the user, thereby facilitating monitoring of body chemistry of the user

9. The method of claim 8, further comprising:

by way of the electronics subsystem and the processing subsystem, substantially continuously detecting a voltage parameter of the counter electrode, and applying the applied voltage to generate the impedance signal whenever the voltage parameter of the counter electrode satisfies a voltage threshold condition.

10. The method of claim 8, further comprising transitioning the electronics subsystem into a first operation mode upon providing communication between the electronics subsystem and a base station, configured to charge a battery of the electronics subsystem, wherein the first operation mode permits data transfer and reception between the electronics subsystem and a mobile computing device associated with the user.

11. The method of claim 9, further comprising detecting an uncoupling state between the microsensor and the user based upon a comparison between the impedance signal and a threshold condition, and generating an alert in response to the uncoupling state.

12. The method of claim 11, further comprising activating an actuator of the electronics subsystem, wherein activating the actuator biases the microsensor into interstitial fluid of the user upon detection of the uncoupling state.

13. The method of claim 8, further comprising:

at the processing subsystem, generating a predicted value of the analyte parameter at a future time point in the analysis, and rendering a line graph including a predicted region at a display of a mobile computing device associated with the user, wherein the predicted region depicts the predicted value at the future time point, and a width of the predicted region indicates confidence in the predicted value.

14. The method of claim 13, further comprising rendering a present state of the analyte parameter, indicating a future state toward which the analyte parameter is predicted to trend, and a percent of time within a time duration at which values of the analyte parameter are within a target range.

15. The method of claim 8, wherein accelerating the second housing portion toward skin of the user comprises transitioning a plunger of an applicator from a resting state to a loaded configuration, and releasing the plunger to accelerate the second housing portion toward skin of the user, in response to release of a trigger of the applicator by the user.

16. A system for monitoring body chemistry of a user, the system comprising:

a housing supporting;

a microsensor comprising a first working electrode, a second working electrode, a reference electrode, and a counter electrode, and configured to access interstitial fluid of the user upon coupling of the housing to the user, and

an electronics subsystem comprising a signal conditioning module configured to receive a signal stream, from the microsensor, and configured with a shifted potential different than a reference potential of the reference electrode, wherein the electronics subsystem is configured to detect an impedance signal derived from two of the first working electrode, the second working electrode, the reference electrode, and the counter electrode in response to an applied voltage near the shifted potential; and

a processing subsystem in communication with the electronics subsystem and comprising;

a first module configured to generate an analysis indicative of an analyte parameter of the user and derived from the signal stream and the impedance signal, and a second module configured to transmit information derived from the analysis to the user, thereby facilitating monitoring of body chemistry of the user.

17. The system of claim 16, further comprising an applicator configured to accelerate a portion of the housing, supporting the microsensor, toward skin of the user, thereby causing the microsensor to penetrate skin of the user and sensing regions of the microsensor to access interstitial fluid of the user.

18. The system of claim 17, wherein the housing comprises a first disposable portion that supports the microsensor and a first subset of the electronics subsystem including a multiplexer and an analog front end, and wherein the housing comprises a second reusable portion that supports a second subset of the electronics subsystem.

19. The system of claim 17, wherein the housing comprises a first disposable portion that supports the microsensor, and wherein the housing comprises a second reusable portion that supports the electronics subsystem.

20. The system of claim 17, wherein the housing, the microsensor, and the electronics subsystem are configured to be disposed after a lifetime usage of less than thirty days.

21. The system of claim 16, wherein the electronics subsystem is configured to apply the applied voltage, having a sinusoidal waveform with a characteristic value centered about the shifted potential, upon detection of a voltage condition at the counter electrode.