On-body microsensor for biomonitoring

• US 10,820,860 B2
• Filed: 01/19/2017
• Issued: 11/03/2020
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: One Health Biosensing Incorporated
• Original Assignee: One Drop Biosensor Technologies, LLC
• Inventors: Pushpala, Ashwin, Chapman, Matthew, Szmodis, Alan
• Primary Examiner(s): Bloch, Michael R
• Application Number:
  US15/410,569
• Publication Number:
  US 20170128009A1
• Time in Patent Office: 1,384 Days
• Field of Search: None
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• 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 2562/12 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 2562/182 Electrical shielding, e.g. using a Faraday cage
• 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 5/150022 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 5/6849 in combination with a needle set
• 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 2037/0061 : Methods for using microneedles
• CPC Class Codes: A61M 37/0015 : by using microneedles
• 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: G01N 33/50 : Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• 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, 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 first filament comprising;

a first substrate core comprising;

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

a first electrode portion operable to sense a first analyte within the body fluid and defined by;

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

a first insulating layer surrounding the substrate core and exposing a portion of the first conductive layer at the distal portion, and

a first sensing layer coupled to the first conductive layer and operable to sense the first analyte; and

a second filament comprising;

a second substrate core comprising;

a second columnar protrusion provide access to the body fluid of the user during operation of the sensor;

a second electrode portion operable to sense a second analyte within the body fluid and defined by;

a second conductive layer,

a second insulating layer, and

a second sensing layer coupled to the second conductive layer and operable to sense the second analyte.

2. The sensor of claim 1, wherein the first conductive layer and the second conductive layer each comprise a titanium-platinum composition.

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

4. The sensor of claim 3, wherein the second insulating layer comprises a poly-silicon material composition.

5. The sensor of claim 4, wherein the first sensing layer and the second sensing layer comprise distributions of at least one of:

tyramine or a phenylenediamine component.

6. The sensor of claim 5, wherein at least one of the first sensing layer and the second sensing layer is coupled to a selective layer having a distribution of molecules that interact with at least one of the first analyte and the second analyte.

7. The sensor of claim 6, further comprising an adhesion coating comprising at least one of polyvinyl alcohol and urethane, superficial to the first sensing layer.

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

9. The sensor of claim 1, further including a metal contact pad.

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

an array of first filaments configured to penetrate the user'"'"'s skin, wherein each of the first filaments includes;

a first sensing layer configured to sense a first analyte in the interstitial fluid,

a first signal transmitting portion,

a columnar protrusion having a base end, a distal portion, and a tip region, and

a first insulating material that surrounds and electrically insulates the first signal transmitting portion to expose an active region of the first sensing layer isolated at the tip region, wherein the active region is configured to provide a signal associated with detection of the first analyte;

an array of second filaments configured to penetrate the user'"'"'s skin, wherein each of the second filaments includes;

a second sensing layer configured to sense a second analyte in the interstitial fluid, wherein the second analyte is different from the first analyte,

a second signal transmitting portion, and

a second insulating material that electrically insulates the second signal transmitting portion; and

an electronics module in communication with the array of first filaments and the array of second filaments, wherein the electronics module is configured to

detect first signals from the array of first filaments associated with detection of the first analyte, and

detect second signals from the array of second filaments associated with detection of the second analyte.

11. The sensor of claim 10 wherein the first filaments include a conductive layer that comprises a titanium-platinum composition.

12. The sensor of claim 10, wherein the first insulating material comprises a chemical vapor deposited oxide.

13. The sensor of claim 10, wherein each of the first and second insulating materials comprises a poly-silicon material composition.

14. The sensor of claim 13, wherein the first sensing layer comprises distributions of at least one of:

tyramine or a phenylenediamine component.

15. The sensor of claim 10, wherein the first filaments and the second filaments are operable to collectively detect two of:

glucose, potassium, sodium, creatinine, nitrogen, and electrolytes within the interstitial fluid.

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

17. The sensor of claim 10, wherein the tip region is part of the distal portion and is configured to facilitate access to the interstitial fluid of the user.

18. The sensor of claim 10, wherein a conductive material is coupled to the columnar protrusion, and the first sensing layer is coupled to the conductive material.

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

a substrate comprising a semiconducting material; and

a plurality of filaments that include;

a substrate core including a base end coupled to the substrate, a columnar protrusion having a proximal portion coupled to the base end and a distal portion that facilitates access to the body fluid of the user;

at least one layer defining an active region that is isolated at the distal portion, wherein the at least one layer is configured to transmit electronic signals associated with detection of an analyte;

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

at least one detection layer in communication with the active region and configured to detect the analyte.

20. The sensor of claim 19, wherein the at least one detection layer includes:

a sensing layer for generating an electronic signal associated with the analyte; and

a selective coating coupled to the sensing layer and configured to respond to the presence of the analyte.