# US 2023/0056031 A1 · Medical imaging device and methods of use

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- Number: US 2023/0056031 A1
- Document ID: US20230056031A1
- Status: Published application
- Kind: A1
- Application number: 17/901,649
- Filed: 2022-09-01
- Published: 2023-02-23
- Earliest claimed: 2013-03-14
- Assignees: Lumicell, Inc.
- Applicants: Lumicell, Inc.
- Inventors: W. David Lee; Jorge Ferrer; David Benjamin Strasfeld
- Web page: https://patentgrep.com/patent/US20230056031A1

## CPC

- A61B 5/0091: {for mammography}
- A61B 5/0071: {by measuring fluorescence emission}
- A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)}
- A61B 5/0086: {using infrared radiation}
- A61B 5/4312: {Breast evaluation or disorder diagnosis (optical mammography A61B5/0091)}
- A61B 10/0041: {Detection of breast cancer (mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825)}
- A61B 90/361: {Image-producing devices, e.g. surgical cameras}
- A61K 49/0032: {Methine dyes, e.g. cyanine dyes}
- A61K 49/0056: {Peptides, proteins, polyamino acids}
- A61B 5/6886: {Monitoring or controlling distance between sensor and tissue}
- A61B 2090/306: {using optical fibres}
- A61B 2090/309: {using white LEDs}
- A61B 2090/3616: {Magnifying glass}
- A61B 2090/3941: {Photoluminescent markers}
- A61B 2505/05: Surgical care
- A61B 2560/0431: Portable apparatus, e.g. comprising a handle or case
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Embodiments related to medical imaging devices including rigid imaging tips and their methods of use for identifying abnormal tissue within a surgical bed are disclosed.

## Claims

### Claim 1

(canceled)

### Claim 2

A method for identifying abnormal tissue, comprising:
illuminating tissue with excitation light including excitation wavelengths between 620 nm and 640 nm, wherein the tissue is marked with pegulicianine;
and collecting a fluorescence signal from the surgical bed using a photosensitive detector.

### Claim 3 (depends on 2)

The method of claim 2, wherein the fluorescence signal includes fluorescence wavelengths greater than 660 nm.

### Claim 4 (depends on 3)

The method of claim 3, further comprising comparing the fluorescence signal to a fluorescence signal intensity threshold to identify abnormal tissue.

### Claim 5 (depends on 3)

The method of claim 3, further comprising indicating one or more locations of the identified abnormal tissue on a screen.

### Claim 6 (depends on 2)

The method of claim 2, wherein an intensity of the excitation light is between or equal to 10 mW/cm2 and 200 mW/cm2.

### Claim 7 (depends on 2)

The method of claim 2, wherein the photosensitive detector includes a plurality of pixels.

### Claim 8 (depends on 7)

The method of claim 7, wherein a field of view per pixel is between about 5 microns and 100 microns inclusively.

### Claim 9 (depends on 2)

The method of claim 2, wherein the excitation wavelengths are less than a wavelength cutoff threshold.

### Claim 10 (depends on 9)

The method of claim 9, wherein the fluorescence signal includes fluorescence wavelengths greater than the wavelength cutoff threshold.

### Claim 11 (depends on 10)

The method of claim 10, wherein the wavelength cutoff threshold is 660 nm.

### Claim 12 (depends on 2)

The method of claim 2, wherein the pegulicianine comprises a compound having the formula:
or a pharmaceutically acceptable salt thereof.

### Claim 13

A medical imaging device comprising:
a light source configured to illuminate tissue marked with excitation light including excitation wavelengths between 620 nm and 640 nm, wherein the tissue is marked with pegulicianine;
a photosensitive detector configured to detect a fluorescence signal from the tissue; and
a controller configured to identify abnormal tissue based on the fluorescence signal and a fluorescence signal intensity threshold for pegulicianine.

### Claim 14 (depends on 13)

The medical imaging device of claim 13, wherein the fluorescence signal includes fluorescence wavelengths greater than 660 nm.

### Claim 15 (depends on 14)

The medical imaging device of claim 14, wherein the controller is configured to compare the fluorescence signal to a fluorescence signal intensity threshold to identify the abnormal tissue.

### Claim 16 (depends on 14)

The medical imaging device of claim 14, wherein the controller is configured to indicate one or more locations of the abnormal tissue on a screen.

### Claim 17 (depends on 13)

The medical imaging device of claim 13, wherein light source is configured to emit the excitation light with an intensity of between or equal to 10 mW/cm2 and 200 mW/cm2.

### Claim 18 (depends on 13)

The medical imaging device of claim 13, wherein the photosensitive detector includes a plurality of pixels.

### Claim 19 (depends on 18)

The medical imaging device of claim 18, wherein a field of view per pixel is between about 5 microns and 100 microns inclusively.

### Claim 20 (depends on 13)

The medical imaging device of claim 13, further comprising a dichroic mirror disposed between a focal plane of the medical imaging device and the photosensitive detector, wherein the excitation wavelengths are less than a wavelength cutoff threshold.

### Claim 21 (depends on 20)

The medical imaging device of claim 20, wherein the fluorescence signal includes fluorescence wavelengths greater than the wavelength cutoff threshold.

### Claim 22 (depends on 21)

The medical imaging device of claim 21, wherein the wavelength cutoff threshold is 660 nm.

### Claim 23 (depends on 13)

The medical imaging device of claim 13, wherein the pegulicianine comprises a compound having the formula:
or a pharmaceutically acceptable salt thereof.