# US 12,004,811 B2 · Systems and methods for determining cross-linking distribution in a cornea and/or structural characteristics of a cornea

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- Number: US 12,004,811 B2
- Document ID: US12004811B2
- Status: Granted
- Kind: B2
- Application number: 18/078,728
- Filed: 2022-12-09
- Published: 2023-04-06
- Granted: 2024-06-11
- Earliest claimed: 2017-01-11
- Assignees: Avedro, Inc.
- Applicants: Avedro, Inc.
- Inventors: Desmond Christopher Adler; Jun A. Zhang; Mikhail Z. Smirnov; Marc D. Friedman; David Usher; Grace Elizabeth Lytle; David C. Iannetta
- Web page: https://patentgrep.com/patent/US12004811B2

## CPC

- A61B 3/1025: {for confocal scanning}
- A61B 3/107: for determining the shape or measuring the curvature of the cornea
- A61B 3/10: Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
- A61B 3/14: Arrangements specially adapted for eye photography
- A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating}
- A61F 9/0079: {using non-laser electromagnetic radiation, e.g. non-coherent light or microwaves}
- A61N 5/062: {Photodynamic therapy, i.e. excitation of an agent}
- A61B 5/0071: {by measuring fluorescence emission}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61F 2009/00872: {Cornea}
- A61N 2005/0661: {ultraviolet}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

In a corneal measurement system, an optical element focuses an excitation light to an area of corneal tissue at a selected depth. In response, a fluorescing agent applied to the cornea generates a fluorescence emission. An aperture of a pinhole structure selectively transmits the fluorescence emission from the area of corneal tissue at the selected depth. A detector captures the selected fluorescence emission transmitted by the aperture and communicates information relating to a measurement of the selected fluorescence emission captured by the detector. A controller receives the information from the detector and determines a measurement of the fluorescing agent in the area of corneal tissue at the selected depth. The system may include a scan mechanism that causes the optical element to scan the cornea at a plurality of depths, and the controller may determine a measurement of the fluorescing agent in the cornea as a function of depth.

## Claims

### Claim 1

A measurement system for a cornea, comprising:
a light source configured to emit light;
at least one optical element positioned to receive the light from the light source and configured to focus the light to an area of corneal tissue at a selected depth of the cornea, a light signal being generated at the area of corneal tissue in response to the light from the light source;
a detector positioned to capture the light signal transmitted by an aperture and configured to communicate information relating to a measurement of the light signal captured by the detector;
a scan mechanism configured to cause the at least one optical element to scan the cornea at a plurality of depths and to focus the light from the light source on a respective area of corneal tissue at each depth; and
a controller communicatively coupled to the detector and configured to receive the information from the detector and to determine, based on the information, a measurement of the light signal generated at the area of corneal tissue at the selected depth,
wherein the controller is configured to develop a three-dimensional profile of fluorescence emissions generated by the light, and wherein the controller is further configured to (1) determine that a treatment correction is required, and (2) cause the treatment correction.

### Claim 2 (depends on 1)

The measurement system of claim 1, wherein the treatment correction includes removing a blurring effect related to size of the aperture.

### Claim 3 (depends on 1)

The measurement system of claim 1, wherein the treatment correction includes adjusting variable magnification of a lens.

### Claim 4 (depends on 3)

The measurement system of claim 3, wherein the lens is a Scheimpflug lens.

### Claim 5 (depends on 1)

The measurement system of claim 1, wherein the treatment correction includes removing an image distortion due to light refraction.

### Claim 6 (depends on 1)

The measurement system of claim 1, wherein the treatment correction includes removing high frequency components of an image.

### Claim 7 (depends on 1)

The measurement system of claim 1, wherein the treatment correction includes adjusting the three-dimensional profile to accommodate movement of the cornea.

### Claim 8 (depends on 1)

The measurement system of claim 1, further comprising an illumination path for providing the light.

### Claim 9 (depends on 8)

The measurement system of claim 8, further comprising a first imaging path and a second imaging path.

### Claim 10 (depends on 9)

The measurement system of claim 9, wherein the system rotates the illumination path, the first imaging path, and the second imaging path around the cornea to develop the three-dimensional profile.

### Claim 11 (depends on 1)

The measurement system of claim 1, wherein the three-dimensional profile indicates the presence of a cross-linking agent in a volume of the corneal tissue.

### Claim 12 (depends on 1)

The measurement system of claim 1, wherein the light signal is a fluorescence emission from the area of corneal tissue.

### Claim 13 (depends on 1)

The measurement system of claim 1, wherein the light signal is reflected light from the area of corneal tissue.

### Claim 14 (depends on 1)

The measurement system of claim 1, wherein the measurement of the light signal generated at the area of corneal tissue indicates a measurement of cross-linking activity at the selected depth.

### Claim 15 (depends on 1)

The measurement system of claim 1, wherein the measurement of the light signal is determined according to a resolution of greater than 10 μm along an axis corresponding to the depth of the corneal tissue and/or a plane transverse to the axis.

### Claim 16 (depends on 1)

The measurement system of claim 1, wherein the scan mechanism is configured to cause the at least one optical element to scan, more than one time, the cornea at the plurality of depths, and the controller is further configured to determine, based on the information from the more than one scans, an amount of cross-linking activity as a function of time and depth.

### Claim 17 (depends on 1)

The measurement system of claim 1, wherein the plurality of depths extend from an anterior surface of the cornea to at least approximately 200 μm into the cornea, and adjacent depths in the plurality of depths are separated by approximately 10 μm to approximately 100 μm.