# US 12,109,019 B2 · Systems and methods for analyte detection

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- Number: US 12,109,019 B2
- Document ID: US12109019B2
- Status: Granted
- Kind: B2
- Application number: 18/542,386
- Filed: 2023-12-15
- Published: 2024-06-20
- Granted: 2024-10-08
- Earliest claimed: 2022-12-15
- Assignees: Adaptyx Biosciences, Inc.
- Applicants: Adaptyx Biosciences, Inc.
- Inventors: Alexander Yoshikawa; Vijit Sabnis; Pawan Kapur; Vladimir Kesler; Donald A. Ice; George M. Mihalakis
- Web page: https://patentgrep.com/patent/US12109019B2

## CPC

- A61B 5/0071: {by measuring fluorescence emission}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- 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 5/1455: using optical sensors, e.g. spectral photometrical oximeters
- A61B 5/1459: invasive, e.g. introduced into the body by a catheter
- A61B 5/14735: {comprising an immobilised reagent}
- A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase
- A61B 5/6833: {Adhesive patches}
- A61B 5/685: {Microneedles}
- A61B 5/725: {using specific filters therefor, e.g. Kalman or adaptive filters (specific diagnostics methods using using bioelectric or biomagnetic signals A61B5/316)}
- G01N 21/7703: {using reagent-clad optical fibres or optical waveguides (using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B)}
- A61B 5/14539: {for measuring pH}
- A61B 2562/0233: Special features of optical sensors or probes classified in A61B5/00
- A61B 2562/046: in a matrix array
- A61B 2562/12: Manufacturing methods specially adapted for producing sensors for in-vivo measurements
- G01N 21/645: {Specially adapted constructive features of fluorimeters}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

The present disclosure provides systems and methods to monitor analytes present in a biological sample of a subject using a piercing element coupled to a support configured to pierce a body surface of the subject, an analyte binding probe on or within the piercing to provide a change in an optical signal when contacting an analyte in the biological sample of the subject, and a detector configured to detect the optical signal.

## Claims

### Claim 1

A device for sensing an analyte in a biological sample of a subject, comprising:
a support;
a piercing element coupled to the support, wherein the piercing element is configured to pierce a body surface of the subject when the device is coupled to the body surface to bring the piercing element in contact with the biological sample;
an analyte binding probe on or within the piercing element, wherein the analyte binding probe is configured to provide a change in an optical signal when the analyte binding probe comes in contact with the analyte in the biological sample of the subject;
a light source operatively coupled to the support;
a detector operatively coupled to the support, wherein the detector is configured to detect the optical signal;
a waveguide comprising an optical excitation path and an optical emission path,
wherein the waveguide is configured to transmit light from the light source to the analyte binding probe through the optical excitation path, and
wherein the waveguide is configured to transmit light through the optical emission path from the analyte binding probe towards the detector, and wherein the optical emission path further comprises apertures in a reflective cladding layer surrounding the waveguide configured to transmit an emission light from the analyte binding probe to the detector.

### Claim 2 (depends on 1)

The device of claim 1, wherein the reflective cladding layer surrounding the waveguide is configured to reflect light back inside the waveguide and guide the light toward the piercing element.

### Claim 3 (depends on 1)

The device of claim 1, further comprising a light coupler and one or more focusing elements, wherein the one or more focusing elements are configured to focus light from the light source towards the light coupler.

### Claim 4 (depends on 3)

The device of claim 3, wherein the light coupler is configured to couple light from the light source into the waveguide.

### Claim 5 (depends on 3)

The device of claim 3, wherein the waveguide comprises a dielectric core, wherein the reflective cladding layer surrounds the dielectric core.

### Claim 6 (depends on 5)

The device of claim 5, wherein the reflective cladding layer comprises an aperture between the light source and the light coupler, and the aperture is defined by the absence of the reflective cladding layer.

### Claim 7 (depends on 1)

The device of claim 1, wherein the piercing element comprises a reflective material about a base of the piercing element, wherein the optical excitation path guides light from the light source through a protruding portion of the waveguide and to the reflective material about the base of the piercing element, wherein the reflective material about the base of the piercing element reflects the light to the analyte binding probe.

### Claim 8 (depends on 1)

The device of claim 1, wherein the optical emission path further comprises one or more focusing elements configured to focus emission light from the analyte binding probe towards the detector.

### Claim 9 (depends on 8)

The device of claim 8, wherein the one or more focusing elements comprises a first focusing element configured to focus at least part of the emission light from the analyte binding probe into a first beam, and a second focusing element configured to focus the first beam towards the detector.

### Claim 10 (depends on 9)

The device of claim 9, wherein a diameter of a second beam coming from the second focusing element is configured to be a smaller size diameter than the first beam when the second beam crosses a plane of the detector and is incident on one or more pixels of the detector, thereby improving a signal to noise ratio of the detector.

### Claim 11 (depends on 9)

The device of claim 9, further comprising an optical filter between the first beam and the detector which does not transmit a portion of light that falls on the optical filter, wherein the portion of the light blocked from transmission by the optical filter has a wavelength which is a same wavelength as the light source.

### Claim 12 (depends on 11)

The device of claim 11, wherein the first focusing element transmits light to the optical filter at an angle within approximately +/−25 degrees with respect to a surface normal vector of the filter.

### Claim 13 (depends on 1)

The device of claim 1, wherein the optical emission path is configured to reject emission light from the analyte binding probe which does not enter the waveguide at a critical angle between ±20 degrees as measured from a vector normal to a base of the piercing element.

### Claim 14 (depends on 1)

The device of claim 1, wherein the analyte binding probe is disposed in a sensing domain comprising a hydrogel matrix comprising one or more particles comprising the analyte binding probe.

### Claim 15 (depends on 1)

The device of claim 1, wherein the analyte binding probe comprises a fluorophore conjugated to an aptamer configured to bind to the analyte, wherein the aptamer is configured to undergo a conformation change resulting in a shift in the optical signal upon contacting the analyte.

### Claim 16 (depends on 15)

The device of claim 15, wherein the analyte binding probe is disposed in a sensing domain comprising a hydrogel matrix comprising one or more particles comprising the analyte binding probe.

### Claim 17 (depends on 16)

The device of claim 16, wherein the one or more particles comprise a diameter of about 1 micron to about 50 microns.

### Claim 18 (depends on 17)

The device of claim 17, wherein the piercing element comprises a plurality of microneedles, wherein a number of particles in a microneedle of the plurality of microneedles is at least 10{circumflex over ( )}3 particles.

### Claim 19 (depends on 18)

The device of claim 18, wherein a surface of the one or more particles comprises about at least 10{circumflex over ( )}6 analyte binding probes per cm{circumflex over ( )}2.