SYSTEM FOR MONITORING BODY CHEMISTRY
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.
1 . A system, comprising:
a microsensor having two or more microneedles forming at least part of one or more electrodes, wherein the one or more electrodes are configured to generate one or more signals at least in part in response to one or more analytes of interest in interstitial fluid within a user's skin, and wherein the one or more electrodes include analyte-sensing regions located at respective distal end regions of corresponding microneedles of the two or more microneedles; and
a flexible adhesive substrate, wherein:
the flexible adhesive substrate and the microsensor are arranged such that the two or more microneedles are positioned to be inserted within the user's skin to access the interstitial fluid,
the flexible adhesive substrate is configured to be attached to a surface of the user's skin to hold the analyte-sensing regions within the user's skin at a depth less than 350 microns and separated from the surface of the user's skin.
2 . The system of claim 1 wherein the two or more microneedles includes:
a first group of the two or more microneedles configured as a working electrode;
a second group of the two or more microneedles configured as a reference electrode; and
a third group of the two or more microneedles configured as a counter electrode,
wherein the one or more signals depend at least in part on signals received from the working electrode, the reference electrode, and the counter electrode.
3 . The system of claim 1 wherein at least one microneedle of the two or m ore microneedles includes:
a substrate core having a base region connected to a base substrate for the two or more microneedles and a tip region opposite the base region;
at least one conductive material at the tip region of the substrate core; and
an insulating material configured to isolate one or more regions of the at least one conductive layer.
4 . The system of claim 3 wherein at least one of the analyte-sensing regions includes:
a sensing layer formed over the insulating material and configured to enable transduction of a concentration of an analyte of interest of the one or more analytes of interest to a signal; and
a selective coating formed over the sensing layer and having a distribution of molecules that respond to the analyte of interest.
5 . The system of claim 1 wherein one or more microneedles of the two or more microneedles are configured to sense presence of a plurality of analytes of interest of the one or more analytes of interest.
6 . The system of claim 1 , further comprising an electronics subsystem operably coupled to the microsensor, wherein the electronics subsystem is configured to receive and process the one or more signals from the microsensor.
7 . The system of claim 6 , wherein the system is configured to determine a parameter indicative of at least one health condition of the user based at least in part on the processed one or more signals.
8 . The system of claim 7 wherein the parameter includes at least one of a temporal trend in an analyte parameter, an absolute value of a metric, a change in value of a metric, an absolute value of an analyte parameter, a change in value of an analyte parameter, or any combination thereof.
9 . The system of claim 6 wherein at least one of the one or more signals is an impedance signal, and wherein the electronics subsystem controls operation of the microsensor to increase detection accuracy based on the impedance signal.
10 . The system of claim 9 wherein the electronics subsystem is programmed to detect whether the microsensor is operably coupled to the user for continuous monitoring based on the impedance signal.
11 . The system of claim 6 wherein the electronics subsystem is further configured to perform a calibration routine.
12 . The system of claim 11 wherein the calibration routine includes normalizing signals relative to a grounded portion of the microsensor.
13 . The system of claim 6 wherein the electronics subsystem is further configured to wirelessly transmit the processed one or more signals or information based at least in part on the processed one or more signals to a computing device.
14 . The system of claim 1 wherein the flexible adhesive substrate includes an opening through which the microsensor is configured to extend.
15 . The system of claim 14 wherein the flexible adhesive substrate surrounds the microsensor at least when the microsensor extends through the opening.
16 . A system, comprising:
a flexible adhesive layer configured to be coupled to a surface of a user's skin;
a microsensor configured to access interstitial fluid within the user's skin, wherein the microsensor includes:
a first portion forming a first electrode; and
a second portion forming a second electrode,
wherein the microsensor is configured to generate a signal based at least in part on one or more analytes of interest in the interstitial fluid, at least while the first or second electrodes are positioned within the user's skin;
a non-invasive sensor configured to generate an output indicative of a state of the user;
an electronics subsystem in communication with the microsensor and with the non-invasive sensor, and configured to:
receive the output from the non-invasive sensor; and
control, based at least in part on the output from the non-invasive sensor, operation of the microsensor for detecting at least one analyte of interest of the one or more analytes of interest within the user's skin.
17 . The system of claim 16 wherein the system is configured to generate a notification for the user based at least in part on the signal from the microsensor.
18 . The system of claim 17 wherein the notification includes information related to the user's eating, exercising, resting, or a combination thereof.
19 . The system of claim 16 wherein the flexible adhesive substrate includes an opening through which at least a portion of the microsensor is configured to extend.
20 . The system of claim 19 wherein the microsensor includes two or more microneedles configured to extend through the opening in the flexible adhesive layer and to penetrate the surface of the user's skin.
21 . The system of claim 20 wherein the first portion of the microsensor includes a first microneedle of the two or more microneedles forming at least a portion of the first electrode, and wherein the second portion of the microsensor includes a second microneedle of the two or more microneedles forming at least a portion of the second electrode.
22 . The system of claim 21 wherein the first microneedle includes one or more first analyte-sensing regions at distal end regions of the first microneedle, the second microneedle includes one or more second analyte-sensing regions at distal end regions of the second microneedle, a combination thereof.
23 . The system of claim 20 wherein the microsensor further includes a base substrate carrying the two or more microneedles, and wherein at least one microneedle of the two or more microneedles includes:
a substrate core having a base region connected to the base substrate and a tip region opposite the base region;
at least one conductive material formed at the tip region of the substrate core; and
an insulating material formed over the conductive material and configured to isolate one or more regions of the conductive layer.
24 . The system of claim 23 wherein a microneedle of the at least one microneedle further includes an analyte-sensing region at a distal end region of the microneedle, and wherein the analyte detecting region includes:
a sensing layer formed over the insulating material and configured to enable transduction of a concentration of the at least one analyte of interest to the signal; and
a selective coating formed over the sensing layer and having a distribution of molecules that respond to the at least one analyte of interest.
25 . The system of claim 20 wherein, when microneedles of the two or more microneedles access the interstitial fluid within the user's skin, the flexible adhesive layer is configured to hold distal end regions of the microneedles within the user's skin at a depth less than 350 microns and such that the surface of the user's skin is positioned between the flexible adhesive layer and one or more analyte-sensing regions at one or more of the distal end regions of the microneedles.
26 . The system of claim 16 wherein the electronics subsystem is further configured to (a) receive the signal from the microsensor controlled based at least in part on the output of the non-invasive sensor and (b) process the received signal to generate information.
27 . The system of claim 26 wherein the electronics subsystem is further configured to wirelessly communicate the information to a processing subsystem continuously or periodically for a period of multiple days.
28 . A system, comprising:
a microsensor having a plurality of microneedles, wherein a microneedle of the plurality forms at least a portion of an electrode configured to generate, at least in part, a signal based at least in part on an analyte of interest in interstitial fluid within a user's skin, wherein the electrode includes one or more analyte-sensing regions positioned at a distal end region of the microneedle;
an adhesive substrate including an opening through which at least a portion of the microsensor is configured to extend such that microneedles of the plurality are positioned to be inserted within the user's skin, wherein the adhesive substrate is configured (a) to attach to a surface of the user's skin and (b) to hold the one or more analyte-sensing regions within the user's skin such that the surface of the user's skin is positioned between the one or more analyte-sensing regions and at least a portion of the adhesive substrate.
29 . The system of claim 28 wherein, when the microneedles are positioned within the user's skin such that the microneedles access the interstitial fluid, the adhesive substrate is configured to hold the one or more analyte-sensing regions at a depth less than 350 microns.
30 . The system of claim 28 , further comprising:
a housing coupled to the adhesive substrate; and
an electronics subsystem positioned within the housing and operably coupled to the microsensor,
wherein the electronics subsystem is configured to generate information based at least in part on the signal, wirelessly communicate the information to a computing device, or a combination thereof.