# US 2019/0167111 A1 · Optical speculum

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- Number: US 2019/0167111 A1
- Document ID: US20190167111A1
- Status: Published application
- Kind: A1
- Application number: 16/258,875
- Filed: 2019-01-28
- Published: 2019-06-06
- Earliest claimed: 2009-11-10
- Assignees: Illumigyn Ltd.
- Applicants: Illumigyn Ltd.
- Inventors: Lior GREENSTEIN; Gilad A. DAVARA; Gad GANON; David AVIV
- Web page: https://patentgrep.com/patent/US20190167111A1

## CPC

- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 1/00006: {of control signals}
- A61B 1/000094: {extracting biological structures}
- A61B 1/00045: {Display arrangement}
- A61B 1/00059: {provided with identification means for the endoscope}
- A61B 1/00103: {designed for single use}
- A61B 1/00105: {characterised by modular construction}
- A61B 1/018: for receiving instruments
- A61B 1/042: {characterised by a proximal camera, e.g. a CCD camera}
- A61B 1/043: {for fluorescence imaging}
- A61B 1/045: Control thereof
- A61B 1/051: {Details of CCD assembly}
- A61B 1/0607: {for annular illumination}
- A61B 1/063: {for monochromatic or narrow-band illumination}
- A61B 1/0638: {providing two or more wavelengths}
- A61B 1/0653: {with wavelength conversion}
- A61B 1/0655: {Control therefor}
- A61B 1/0684: {using light emitting diodes [LED]}
- A61B 1/303: for the vagina, i.e. vaginoscopes
- A61B 1/32: Devices for opening or enlarging the visual field, e.g. of a tube of the body
- A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating}
- A61B 5/0059: {using light, e.g. diagnosis by transillumination, diascopy, fluorescence (photoacoustic A61B5/0093; optical measurement of heart rate A61B5/02416; optical measurement of blood flow A61B5/0261; optical measurement of analytes A61B5/1455)}
- A61B 5/0071: {by measuring fluorescence emission}
- A61B 5/0082: {adapted for particular medical purposes}
- A61B 5/0084: {for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence)}
- A61B 5/725: {using specific filters therefor, e.g. Kalman or adaptive filters (specific diagnostics methods using using bioelectric or biomagnetic signals A61B5/316)}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- A61B 6/00: Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment (instruments measuring radiation intensity for application in the field of nuclear medicine, e.g. in vivo counting, G01T1/161)
- A61B 10/02: Instruments for taking cell samples or for biopsy {(A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48)}
- A61B 10/04: Endoscopic instruments, e.g. catheter-type instruments
- A61B 18/20: using laser
- A61B 18/201: {with beam delivery through a hollow tube, e.g. forming an articulated arm (through a flexible conduit A61B18/22); Hand-pieces therefor}
- A61B 90/90: Identification means for patients or instruments, e.g. tags
- A61B 2017/00057: {Light}
- A61B 2018/00559: {Female reproductive organs}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00904: {Automatic detection of target tissue}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2018/20359: {by movable mirrors, e.g. galvanometric}
- A61B 2018/20361: {with redirecting based on sensed condition, e.g. tissue analysis or tissue movement}
- A61B 2018/2075: {mixing three wavelengths}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A system for direct imaging and diagnosing of abnormal cells in a target tissue includes a disposable optical speculum and an image acquisition system having the speculum assembled on and mechanically secured thereto. The image acquisition system is arranged to capture at least one of a single image or multiple images or video of cells within the target tissue using at least one of bright field or dark field ring illumination divided into independently operated segments to obtain a plurality of data sets. An image analysis and control unit in communication with the image acquisition system analyzes the data sets and applies algorithms to the data sets for diagnosing abnormal cells.

## Claims

### Claim 1

A system for direct imaging and diagnosing of abnormal cells in a target tissue, comprising:
a disposable optical speculum; and
an image acquisition system having the speculum assembled on and mechanically secured thereto, the image acquisition system arranged to capture at least one of a single image or multiple images or video of cells within the target tissue using at least one of bright field or dark field ring illumination divided into independently operated segments to obtain a plurality of data sets; and
an image analysis and control unit in communication with the image acquisition system, the image analysis and control unit analyzing the data sets and applying algorithms to the data sets for diagnosing abnormal cells.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the disposable optical speculum covers an optical head and yet enables a free working channel for taking a manual biopsy.

### Claim 3 (depends on 1)

The system according to claim 1, wherein the image acquisition system has three separated and independent illuminations: White Bright Field (BF) illumination located near an aperture stop, White Dark Field (DF) illumination for diffusive illumination and divided into segments for independent operation, and Bright Field (BF) multi spectral illumination located behind a dichroic mirror.

### Claim 4 (depends on 1)

The system according to claim 1, wherein the image acquisition system includes one or more high resolution imaging sensors which capture different wavelength images of a whole field of the target tissue, wherein the images are injected into separate channels of the image analysis and control unit and presented separately on a screen.

### Claim 5 (depends on 1)

The system according to claim 1, wherein the disposable optical speculum is designed for single use to protect from cross-contamination and the image acquisition system is designed for multiple uses.

### Claim 6 (depends on 1)

The system according to claim 1, wherein the image acquisition system further comprises a laser ablation module with a 2-D tilted mirror system to enable accurate ablation of abnormal cells, wherein the laser ablation module uses the data sets to eliminate the diagnosed abnormal cells, and the image acquisition system is designed to stop ablation when it is detected that abnormal cells no longer exist in the image.

### Claim 7 (depends on 6)

The system according to claim 6, wherein the laser ablation module comprises an Infra Red/Green/Ultra Violet short pulse laser beam guided via a high power fiber to the target tissue using an imaging lens for focusing the pulse beam with enough pulse energy and pulse peak power to remove the abnormal cells.

### Claim 8 (depends on 1)

The system according to claim 1, wherein the disposable optical speculum includes an optical window provided with a layer of elastic material which creates a coupling between the disposable optical speculum and the image acquisition system to prevent stray light.

### Claim 9 (depends on 1)

The system according to claim 1, further comprising a locking mechanism between the disposable optical speculum and the image acquisition system to assure image acquisition without distortions.

### Claim 10 (depends on 1)

The system according to claim 1, wherein the image acquisition system further comprises a zooming lens that can be implemented by using a miniature piezo or electric motor.

### Claim 11 (depends on 1)

The system according to claim 1, wherein the image acquisition system further comprises at least one of automatic, semi-automatic and manual illumination LEDs and a laser diode (LD) adjustment.

### Claim 12 (depends on 1)

The system according to claim 1, wherein the image acquisition system comprises one of a single or dual sensor imaging system with color and monochrome CMOS or CCD, and an illumination system based on one of LEDs or laser diode (LD).

### Claim 13 (depends on 11)

The system according to claim 11, wherein the illumination system comprises bright field illumination, dark field external ring illumination, and one of a UV LED source for fluorescence or autofluorescence or a multi-spectral source.

### Claim 14 (depends on 11)

The system according to claim 11, wherein the illumination system includes a ring of white/monochromatic LEDs positioned near a lens aperture in order to optimize the delivery of light into the target tissue with minimum angle of incidence to optimize the reflection from the tissue using a second part of an objective lens.

### Claim 15 (depends on 1)

The system according to claim 1, wherein the image acquisition system achieves depth perception in an acquired image by using at least one of a large depth of field, a contiguous zoom feature to receive a sequence of different images of the same X,Y position at different focal planes, and dark field illumination applied at different illumination angles using a ring external illumination system.

### Claim 16 (depends on 1)

The system according to claim 1, wherein the disposable optical speculum integrates a light collimation element guide for dark field illumination with an optical window.

### Claim 17 (depends on 1)

The system according to claim 1, wherein the image acquisition system includes a camera apparatus comprising a camera, a lens attached to the camera, and a long pass filter which will subtract the UV/near UV light in order to obtain a fluorescence image.

### Claim 18 (depends on 11)

The system according to claim 11, wherein the illumination system includes a light source having one of an external strobe or camera electronic shutter to control the camera exposure time and prevent any saturation in the imaging system.

### Claim 19 (depends on 1)

The system according to claim 1, further comprising a detector for warning of undesired stray light generated by improper assembly of the disposable optical speculum to the image acquisition system.

### Claim 20 (depends on 1)

The system according to claim 1, wherein each disposable optical speculum includes an RFID tag to provide a unique identification for each disposable optical speculum and ensure use of a new disposable optical speculum when desired.