System for monitoring body chemistry

• US 10,595,754 B2
• Filed: 05/22/2017
• Issued: 03/24/2020
• Est. Priority Date: 03/13/2014
• Status: Active Grant

• Current Assignee: One Health Biosensing Incorporated
• Original Assignee: Sano Intelligence, Inc. (Informed Data Systems, Inc.)
• Inventors: Pushpala, Ashwin, Pitera, Dominic, Chapman, Matthew, Gifford, Michael
• Primary Examiner(s): Berhanu, Etsub D
• Assistant Examiner(s): Catina, Michael A
• Application Number:
  US15/601,204
• Publication Number:
  US 20170251958A1
• Time in Patent Office: 1,037 Days
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• 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 2562/14 Coupling media or elements to improve sensor contact with skin or tissue
• 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 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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 5/1451 for interstitial fluid
• 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 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15188 Constructional features of reusable driving devices
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6834 using vacuum
• 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

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 sensing body chemistry of a user, the system comprising:

a first housing portion supporting a sensor operable to access interstitial fluid of the user upon coupling of the first housing to the user, the sensor exposed through a base surface of the first housing portion, and the first housing including an opening into an electrical interface with the sensor, the first housing further comprising a perforation proximal the opening;

an adhesive region coupled to the base surface and surrounding the sensor;

a covering for the adhesive region; and

a second housing portion supporting an electronics subsystem comprising a signal conditioning portion and a data transmission portion comprising an antenna, wherein the system is operable between;

a loaded mode wherein the second housing portion is seated within the opening of the first housing portion with the electronics subsystem coupled to the electrical interface and the covering is coupled to the adhesive region, wherein the second housing portion is coupled to an applicator,

a released mode wherein the sensor and the adhesive region are delivered from the applicator with the electronics subsystem of the second housing portion transmitting signals from the sensor through the antenna and the covering is uncoupled from the adhesive region, and

an uncoupled mode wherein the second housing portion is released from the first housing portion and wherein the perforation is broken to prevent subsequent coupling between the first housing portion and the second housing portion.

2. The system of claim 1, wherein the sensor comprises a first working electrode, a second working electrode, a reference electrode, and a counter electrode.

3. The system of claim 1, wherein the first housing portion comprises an o-ring co-molded with regions of the first housing portion proximal the opening.

4. The system of claim 1, wherein the covering is operable to be removed in a central-to-peripheral direction from the adhesive region.

5. The system of claim 4, wherein the covering comprises a set of leaves comprising a first leaf spanning a first portion of the adhesive region and including a first valley fold configured as a first pull-tab, and a second leaf spanning a second portion of the adhesive region and including a second valley fold overlapping the first valley fold configured as a second pull-tab.

6. The system of claim 1, further including a set of spacers about edge regions of the sensor, the set of spacers operating as a barrier that is configured to protect at least one of the sensor and skin of the user from damage.

7. The system of claim 1, wherein the antenna is decoupled from a ground plane of a printed circuit board of the electronics subsystem.

8. The system of claim 7, wherein the antenna is positioned near an edge region of the second housing portion.

9. The system of claim 1, further including a thermistor coupled to a counter electrode of the sensor, and wherein the electronics subsystem includes a circuit operable to detect temperature of skin of the user proximal the sensor, by way of the thermistor.

10. The system of claim 1, wherein the sensor comprises a microsensor.

11. A system for sensing body chemistry of a user, the system comprising:

a first housing portion supporting a sensor operable to access interstitial fluid of the user upon coupling of the first housing to the user, the sensor exposed through a base surface of the first housing portion, and the first housing including an opening into an electrical interface with the sensor, the first housing further comprising a perforation proximal the opening;

an adhesive region coupled to the base surface and surrounding the sensor; and

a second housing portion supporting an electronics subsystem comprising a data transmission portion comprising an antenna, wherein the system is operable between;

a loaded mode wherein the second housing portion is seated within the opening of the first housing portion with the electronics subsystem coupled to the electrical interface, wherein the second housing portion is coupled to an applicator, and

a released mode wherein the sensor and the adhesive region are delivered from the applicator with the electronics subsystem of the second housing portion transmitting signals from the sensor through the antenna; and

an uncoupled mode wherein the second housing portion is released from the first housing portion, wherein, in the uncoupled mode, the perforation is broken to prevent subsequent coupling between the first housing portion and the second housing portion.

12. The system of claim 11, wherein the first housing portion comprises an o-ring co-molded with regions of the first housing portion proximal the opening.

13. The system of claim 11, further comprising a covering for the adhesive region, the covering operable to be removed in a central-to-peripheral direction from the adhesive region in the loaded mode.

14. The system of claim 13, wherein the covering comprises a set of leaves comprising a first leaf spanning a first portion of the adhesive region and including a first valley fold configured as a first, pull-tab, and a second leaf spanning a second portion of the adhesive region and including a second valley fold overlapping the first valley fold configured as a second pull-tab, each of the first leaf and the second leaf including cutaways that expose the sensor.

15. The system of claim 11, wherein the sensor comprises a first working electrode, a second working electrode, a reference electrode, and a counter electrode.

16. The system of claim 15, further including a thermistor coupled to the counter electrode of the sensor, and wherein the electronics subsystem includes a circuit operable to detect temperature of skin of the user proximal the sensor, by way of the thermistor.

17. The system of claim 11, wherein the antenna is decoupled from a ground plane of a printed circuit board of the electronics subsystem, wherein the antenna is positioned near an edge region of the second housing portion.

18. The system of claim 11, further including a set of spacers about edge regions of the sensor, the set of spacers operating as a barrier that is configured to protect at least one of the sensor and skin of the user from damage.

19. The system of claim 11, wherein the sensor includes an array of filaments, each filament including:

a substrate core including a base end coupled to a substrate, a columnar protrusion having a proximal portion coupled to the base end and a distal portion, and a tip region coupled to the distal portion of the columnar protrusion and configured to provide access to interstial fluid of the user;

a conductive layer, isolated to the tip region of the substrate core and away from the base end as an active region that enables transmission of electronic signals generated upon detection of an analyte within the interstitial fluid;

an insulating layer surrounding the substrate core and exposing a portion of the conductive layer, thereby defining a boundary of the active region; and

a sensing layer, in communication with the active region, configured for at least one of amperometric sensing and potentiometric sensing of the analyte.

20. The system of claim 11, wherein the sensor comprises a microsensor.