SYSTEM FOR MONITORING BODY CHEMISTRY

• US 20170086713A1
• Filed: 12/13/2016
• Published: 03/30/2017
• 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:
  US15/377,318
• Publication Number:
  US 20170086713A1
• 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 method for coupling a system for monitoring body chemistry to a user, the method comprising:

retaining a second housing portion of the system within an opening of a first housing portion of the system, the first housing portion supporting a microsensor including a microneedle array operable as an electrode set, and the second housing portion supporting an electronics subsystem configured to receive a signal stream from the microsensor;

reversibly interfacing the second housing portion with a first portion of an applicator operable in a loading configuration;

positioning the first housing portion, with the applicator, at a body region of the user;

upon transitioning the applicator from the loading configuration to a released configuration, accelerating the second housing portion, with the electronics subsystem and the microsensor of the first housing portion, toward skin of the user, thereby delivering sensing regions of the microsensor into interstitial fluid of the user, and electronically coupling the electronics subsystem of the second housing portion with the microsensor of the first housing portion.

2. The method of claim 1, wherein accelerating the second housing portion toward skin of the user comprises, in response to a user releasing a trigger of the applicator, translating a plunger, coupled to the trigger, to produce the released configuration of the applicator.

3. The method of claim 2, wherein translating the plunger simultaneously accelerates the second housing portion and the electronics subsystem toward skin of the user, with controlled speed, along a first axis perpendicular to the skin of the user, thereby causing direct transmission of a force along the first axis from the second housing portion to the first housing portion and electronically coupling the electronics subsystem of the second housing portion with the microsensor of the first housing portion.

4. The method of claim 3, wherein causing direct transmission of the force along the first axis further comprises:

a) causing the first housing portion to move along the first axis to deliver the microneedle array of the microsensor into the interstitial fluid of the user and b) coupling the first housing portion and the second housing portion to the user.

5. The method of claim 4, wherein the first housing portion comprises an adhesive substrate that, during operation of the system, faces the skin of the user, and wherein coupling the first housing portion and the second housing portion to the user comprises coupling the adhesive substrate of the first housing portion to the user.

6. The method of claim 4, further including releasing the second housing portion from the applicator upon coupling of the first housing portion and the second housing portion to the user.

7. The method of claim 2, further including twisting a rotatable component of the applicator, thereby transitioning the plunger to produce the loading configuration of the applicator.

8. The method of claim 1, further comprising, with the applicator, controlling at least one of skin stretching and behavior at the body region of the user, thereby facilitating acceleration of the array of microneedles into skin of the user.

9. The method of claim 1, further including:

generating an impedance signal from two of;

a first working electrode, a second working electrode, a reference electrode, and a counter electrode of the electrode set;

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;

detecting proper application of the microsensor based upon 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.

10. 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 microneedle array 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 and a set of contacts operable to interface the electronics subsystem with the microsensor of the first housing portion;

an applicator operable to interface with the second housing portion in a loading configuration, and operable to transition from the loading configuration to a released configuration that releases and accelerates the second housing portion, with the electronics subsystem of the first housing portion, towards 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, coupling the set of contacts of the second housing portion with the microsensor of the first housing portion, and coupling the first and second housing portions to the user.

11. The system of claim 10, wherein the first housing portion comprises an adhesive substrate that, during operation of the system, faces the skin of the user.

12. The system of claim 11, wherein the applicator is operable to position and couple the first housing portion to the user by way of the adhesive substrate and simultaneously accelerate the microneedle array into skin of the user in the released configuration.

13. The system of claim 10, wherein the applicator includes a plunger that couples to the second housing portion in the loading configuration, and wherein, in the loading configuration, a spring coupled to the plunger is in a compressed state and retained in position with a locking mechanism.

14. The system of claim 13, wherein the applicator comprises a ram-and-catch configuration, wherein twisting of a rotatable component applicator a transitions the plunger to a spring-loaded configuration.

15. The system of claim 13, wherein, upon insertion of the microneedle array into skin of the user, with coupling of the first housing portion and the second housing portion to the user, the applicator is operable to release the second housing portion.

16. The system of claim 10, wherein the applicator comprises a region operable to laterally stretch skin of the user in cooperation with insertion of the microneedle array into skin of the user.

17. The system of claim 10, wherein the microneedle array comprises a density of less than 100 microneedles per cm², thereby facilitating insertion of the microneedle array into skin of the user by the applicator.

18. The system of claim 10, wherein the first housing portion comprises a first disposable portion that supports the microsensor, and wherein the second housing portion comprises a second reusable portion that supports the electronics subsystem.

19. The system of claim 10, 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.

20. The system of claim 12, wherein the second housing portion comprises an array of contacts coupled to the electronics subsystem, and wherein the applicator is operable to accelerate the second housing portion with the electronics subsystem towards the microsensor of the first housing portion, thereby producing electrical contact between the array of contacts of the second housing portion with the set of concentric ring contacts of the first housing portion.