# US 11,896,793 B2 · On-body microsensor for biomonitoring

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- Number: US 11,896,793 B2
- Document ID: US11896793B2
- Status: Granted
- Kind: B2
- Application number: 17/519,548
- Filed: 2021-11-04
- Published: 2022-02-24
- Granted: 2024-02-13
- Earliest claimed: 2013-03-14
- Assignees: One Drop Biosensor Technologies, LLC
- Applicants: One Drop Biosensor Technologies, LLC
- Inventors: Ashwin Pushpala; Alan Szmodis; Matthew Chapman; Weldon Hall; Scott Miller; Hooman Hafezi
- Web page: https://patentgrep.com/patent/US11896793B2

## CPC

- A61M 37/0015: {by using microneedles}
- 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)}
- A61B 5/14514: {using means for aiding extraction of interstitial fluid, e.g. microneedles or suction}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors}
- A61B 5/1495: Calibrating or testing of in-vivo probes
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/150282: {for piercing elements, e.g. blade, lancet, canula, needle}
- A61B 5/150427: {Specific tip design, e.g. for improved penetration characteristics}
- A61B 5/150969: {Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing}
- A61B 5/150984: {Microneedles or microblades}
- A61B 5/4839: {combined with drug delivery}
- A61B 5/685: {Microneedles}
- C12Q 1/006: {for glucose}
- 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)}
- A61B 2562/028: Microscale sensors, e.g. electromechanical sensors [MEMS]
- A61B 2562/12: Manufacturing methods specially adapted for producing sensors for in-vivo measurements
- A61B 2562/125: characterised by the manufacture of electrodes
- 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})
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/0046: {Solid microneedles}
- A61M 2037/0053: {Methods for producing microneedles}
- Y10T 29/49117: Conductor or circuit manufacturing
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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

### Claim 1

A multi-filament sensor for sensing at least one analyte in a body fluid of a user, the multi-filament sensor comprising:
a substrate; and
an analyte-sensing filament connected to the substrate and configured for insertion into the user's skin, wherein the analyte-sensing filament includes:
a conductive columnar core including a tip region;
an insulating material surrounding the conductive columnar core and exposing an active region at the tip region, wherein the insulating material forms an outermost layer of the analyte-sensing filament and is only located on the conductive columnar core between the active region and the substrate; and
at least one layer isolated to detect the at least one analyte at the tip region, wherein the at least one layer is configured to generate an electronic signal in a presence of a concentration of at least one analyte present in the body fluid, wherein the at least one layer is in communication with the active region such that the electronic signal is transmitted through the conductive columnar core.

### Claim 2 (depends on 1)

The multi-filament sensor of claim 1, wherein the at least one layer overlays conductive material of the conductive columnar core between a distal tip of the analyte-sensing filament and the insulating material.

### Claim 3 (depends on 1)

The multi-filament sensor of claim 1, wherein the at least one layer includes a sensing layer, a conductive layer, and a selective layer.

### Claim 4 (depends on 1)

The multi-filament sensor of claim 1, wherein the at least one layer extends across most of a surface of the tip region positioned distal of the insulating material.

### Claim 5 (depends on 1)

The multi-filament sensor of claim 1, wherein the tip region of the conductive columnar core includes a tapered distal tip at which analyte detection is isolated, wherein the tapered distal tip includes the at least one layer.

### Claim 6 (depends on 1)

The multi-filament sensor of claim 1, wherein the tip region of the conductive columnar core includes a pyramidal or a conical shaped distal tip that protrudes distally past the insulating material.

### Claim 7 (depends on 1)

The multi-filament sensor of claim 1, wherein the analyte-sensing filament includes a distal tip with a layer configured to prevent delamination when the analyte-sensing filament is inserted into the user's skin.

### Claim 8 (depends on 1)

The multi-filament sensor of claim 1, wherein the analyte-sensing filament has a length from 50 μm to 500 μm.

### Claim 9 (depends on 1)

The multi-filament sensor of claim 1, wherein the analyte-sensing filament includes a conductive layer extending from the substrate to the tip region.

### Claim 10 (depends on 1)

The multi-filament sensor of claim 1, wherein the insulating material extends along at least a portion of the tip region inwardly toward a tip of the analyte-sensing filament.

### Claim 11

A multi-filament sensor for sensing at least one analyte in a body fluid of a user, the multi-filament sensor comprising:
a substrate; and
a filament coupled to the substrate and including:
a substrate core including a base end coupled to the substrate and a tip region;
an insulating layer surrounding the substrate core forming an outermost layer and defining a boundary of an active region at the tip region; and
at least one layer in communication with the active region, wherein the at least one layer is configured to generate an electronic signal in response to detection of at least one analyte present in the body fluid adjacent to the tip region, and wherein the insulating layer isolates at least one layer at the tip region and is only located on the substrate core between the tip region and the substrate.

### Claim 12 (depends on 11)

The multi-filament sensor of claim 11, wherein the at least one layer includes a plurality of layers that cooperate to generate and transmit the electronic signal to the tip region, wherein the plurality of layers overlays a periphery of the insulating layer.

### Claim 13 (depends on 11)

The multi-filament sensor of claim 11, wherein the at least one layer includes a sensing layer, a conductive layer, and a selective layer.

### Claim 14 (depends on 11)

The multi-filament sensor of claim 11, wherein the at least one layer extends across most of a width of the tip region.

### Claim 15 (depends on 11)

The multi-filament sensor of claim 11, wherein the tip region of the substrate core is a pointed tip region at which analyte detection is isolated, wherein the pointed tip region includes at least one layer.

### Claim 16 (depends on 11)

The multi-filament sensor of claim 11, wherein the tip region is pyramidal or conical shaped.

### Claim 17 (depends on 11)

The multi-filament sensor of claim 11, wherein the filament has a length from 50 μm to 500 μm.

### Claim 18 (depends on 11)

The multi-filament sensor of claim 11, wherein the filament includes a conductive layer extending from the tip region along the substrate core.

### Claim 19 (depends on 11)

The multi-filament sensor of claim 11, wherein the insulating layer extends along at least a portion of the tip region toward a tip of the filament.