ON-BODY MICROSENSOR FOR BIOMONITORING

• US 20170086724A1
• Filed: 12/13/2016
• Published: 03/30/2017
• Est. Priority Date: 03/14/2013
• Status: Abandoned Application

• Current Assignee: One Health Biosensing Incorporated
• Original Assignee: Sano Intelligence, Inc. (Informed Data Systems, Inc.)
• Inventors: Pushpala, Ashwin, Szmodis, Alan, Chapman, Matthew, Hall, Weldon, Miller, Scott, Hafezi, Hooman
• Application Number:
  US15/377,407
• Publication Number:
  US 20170086724A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• 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 5/14865 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 37/0015 : by using microneedles
• CPC Class Codes: C12Q 1/006 : for glucose
• CPC Class Codes: G01N 27/3271 : Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: Y10T 29/49117 : Conductor or circuit manufacturing

Abstract

A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor.

Claims

1. A sensor for sensing analytes present in a body fluid of a user, the sensor comprising:

a substrate; and

a filament comprising;

a substrate core comprising;

a columnar protrusion having a base end, coupled to the substrate, and a distal portion operable to provide access to the body fluid of the user during operation of the sensor;

a conductive layer, isolated to the distal portion of the substrate core and away from the base end as an active region operable to transmit electronic signals generated upon detection of an analyte within the body fluid;

an insulating layer surrounding the substrate core and exposing a portion of the conductive layer at the distal portion; and

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

2. The sensor of claim 1, wherein the conductive layer comprises a titanium-platinum composition.

3. The sensor of claim 2, wherein the insulating layer comprises a chemical vapor deposited oxide.

4. The sensor of claim 3, further comprising a metal contact pad coupled to the substrate.

5. The sensor of claim 1, wherein the sensing layer comprises distributions of at least two of:

tyramine, glucose oxidase, a phenylenediamine component, and an amine-decorated polymer component.

6. The sensor of claim 5, further comprising a selective layer, having a distribution of molecules that interact with the analyte, coupled to the sensing layer.

7. The sensor of claim 1, further comprising an adhesion layer, superficial to the conductive layer and the sensing layer and isolated to the tip region of the filament.

8. The sensor of claim 7, wherein the adhesion layer comprises at least one of urethane and polyvinyl alcohol.

9. The sensor of claim 1, further including an intermediate active layer, superficial to the conductive layer and deeper than the sensing layer, relative to an exterior surface of the filament, including a material for facilitating signal transduction upon detection of the analyte.

10. The sensor of claim 1, wherein the columnar protrusion has a rectangular cross section across a transverse plane defined in relation to a longitudinal axis of the columnar protrusion.

11. A sensor for sensing analytes present in a body fluid of a user, the sensor comprising:

a substrate; and

an array of filaments, each filament in the array of filaments comprising;

a substrate core comprising;

a base end, coupled to the substrate, and a distal portion operable to provide access to the body fluid of the user during operation of the sensor;

a conductive layer, isolated to the distal portion of the substrate core and away from the base end as an active region operable to transmit electronic signals generated upon detection of an analyte within the body fluid; and

an insulating layer surrounding the substrate core and exposing the active region.

12. The sensor of claim 11, wherein, for each of the array of filaments, the conductive layer comprises a titanium-platinum composition and the insulating layer comprises a chemical vapor deposited oxide.

13. The sensor of claim 11, further comprising a metal contact pad coupled to the substrate.

14. The sensor of claim 11, wherein each filament in the array of filaments further comprises:

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

15. The sensor of claim 14, wherein the sensing layer comprises a distribution of at least one of:

a phenylenediamine component and an amine-decorated polymer component.

16. The sensor of claim 15, wherein each of the array of filaments further comprises an adhesion layer configured to facilitate coupling between at least two of the substrate core, the conductive layer, the insulating layer, and the sensing layer, wherein the adhesion layer comprises polyvinyl alcohol.

17. The sensor of claim 14, wherein each of the array of filaments further comprises a selective coating, having a distribution of molecules that interact with the analyte, superficial to the sensing layer.

18. The sensor of claim 11, wherein the selective coating comprises polyvinyl alcohol with a distribution of glucose oxidase.

19. The sensor of claim 11, wherein, for each of the array of filaments, the substrate core has a rectangular cross section, the distal portion is pyramidal, the conductive layer is isolated to the tip region and isolated away from the base end.

20. The sensor of claim 19, wherein the array of filaments has a density of less than 100 filaments per cm² of the substrate.