RU203175U1 - VIDEO FLUORESCENCE DEVICE FOR ANALYSIS OF THE INTRATUAL DISTRIBUTION OF PHOTOSENSIBILIZERS OF THE FAR RED AND NEXT INFRARED RANGE OF MALIGNANT NAVIGATIONS OF THE HEAD AND NECK - Google Patents

Abstract

The useful model relates to medical technology, namely to intraoperative fluorescence diagnostics of oncological neoplasms. The device contains a LED white light source, an emitter unit with a system of narrow-band light filters containing two semiconductor lasers with wavelengths in the ranges of 625-665 nm and 780-810 nm, operating in a continuous mode, a light delivery system with radiation input into one bundle that delivers light simultaneously from a white light source and from an emitter unit, a registration unit with a filter system, a video data processing unit with the possibility of affine transformation of an image coming from one of the monochrome video cameras, for subsequent superposition on an image from a color video camera, in real time, and with the possibility of digital processing an image from a color video camera by amplifying the red component of the RGB channel spectrum, and a block for outputting the obtained video data and a numerical value of the intensity of the fluorescent signal of the investigated tissue site, characterized in that the registration block includes two beam splitters made in the form of a dichroic mirror, focusing lens, three optical outputs connected using connectors with color and two black-and-white video cameras with light filters, while one filter transmits radiation in the spectrum range of 670-750 nm, and the other - in the range of 830-850 nm, black-and-white cameras register fluorescent images in the far red and near infrared ranges simultaneously, the output of the resulting three images occurs on a computer monitor in the overlay mode of images with adjustable intensity of each of them.

Description

AREA OF TECHNOLOGY:

The proposed useful model relates to medicine and medical technology for the diagnosis of malignant neoplasms of the head and neck. The device can be used for minimally invasive operations of the head and neck area for fluorescent navigation using two photosensitizers in the far red visible and near infrared ranges.

LEVEL OF TECHNOLOGY

Known fluorescent endoscopic device for the diagnosis of various diseases (US 2003078477 A1, publ. 04.24.2003), including a light source emitting in the wavelength range of 380-580 nm, an endoscope, a color video camera and a highly sensitive monochrome video camera, a data processing device configured combining two images; and a diagnostic image output device. The use of the utility model makes it possible to simultaneously observe the images of the reflected exciting light and the fluorescent light of the area of the investigated area, to correct the brightness and unevenness of the fluorescent radiation.

A similar fluorescent endoscope is known from US 20140171764 A1, publ. 07/19/2014. The device includes an endoscope, a continuous white light source illuminating the area under study, and at least one laser with a wavelength corresponding to the absorption peak of the photosensitizer to excite fluorescence, for example, with a wavelength of 365 nm and / or 405 nm. The device uses two video cameras with optical filters that cut off a certain part of the spectrum to form the final image and a device for processing the resulting images.

Also known is a fluorescent navigation device (WO 2008089545 A1, publ. 07/31/2008), consisting of an illumination source, an endoscope, at least one optical filter that transmits radiation that excites fluorescent luminescence, for example, in the range 390-455 nm, two color video cameras, processing and display devices capable of processing the received images and outputting the summing image.

Known image processing system for fluorescent control of surgical resection (US 10231626 B2, publ. 09/18/2014). The system contains a light source unit for supplying one or more lighting modules to the area under study, a unit for recording reflected light and fluorescence from the area under study, an optical system for directing one or more light sources and exciting fluorescence from the light source unit towards the target and for directing the reflected light, and fluorescence from the investigated area to the registration unit. A method for fluorescence control of surgical resection is also presented.

A device for visualizing images in visible and fluorescent light is known (US 20100262017 A1, publ. 14.10.2010). The device contains a source of visible light, two sources of laser radiation with different excitation wavelengths of fluorescent substances introduced into the patient's circulatory system, an electronic imaging device that captures an image of the field of view, a display that displays the first image, the second image and the third image.

Known device (US 9326666B2, publ. 03/13/2014), capable of obtaining and displaying two or more diagnostic images at two different wavelengths together with a color image of the anatomical area in the visible wavelength range. The system contains a light source providing visible light, two laser radiation sources with different excitation ranges of fluorescent preparations, a dichroic mirror that transmits the infrared wavelength range in the direction of the second dichroic mirror, a second dichroic mirror reflecting a diagnostic image having a first wavelength in the direction of the camera response to a first wavelength, and a second dichroic mirror transmitting a second diagnostic image having a second wavelength towards a camera responsive to a second wavelength, a display that displays two or more visible light images, a diagnostic image and a second diagnostic image superimposed on each other on a friend.

The described devices do not allow for fluorescence diagnostics when blood appears in the study area due to the low penetrating ability of the exciting radiation.

The closest analogue of the proposed device (prototype) is a device for fluorescent navigation in neurosurgery (RU 2661029 C1, publ. 11.07.2018).

The device allows for intraoperative fluorescence diagnostics of the tissue area under investigation in the usual color image mode and in real time. A device for fluorescence navigation for surgical removal of malignant tumors of the brain and spinal cord includes a white light source and a monochromatic radiation source that excites the fluorescence of a photosensitizer with a wavelength of 638 nm, a fiber-optic device for delivering radiation to the area under study, a means for recording backscattered radiation and fluorescent radiation of the area under study containing an optical neurosurgical operating microscope, an optical video adapter, a monochrome video camera, a color video camera, as well as a processing and display unit associated with a means for recording backscattered radiation and fluorescent radiation of the investigated area. In this case, the white light source is coupled with the first input of the fiber-optic device for delivering radiation through a light filter that cuts off the long-wavelength part of the spectrum of the red section of the visible range, the monochromatic radiation source (laser) is coupled with the second input of the fiber-optic device for delivering radiation through the filtering devices and increasing the numerical aperture of the outgoing radiation beam, the optical output of the microscope is connected to the input of the optical video adapter. The optical video adapter includes a focusing lens, a beam splitter, two optical outputs to the video camera connectors, equipped with light filter attachment devices. The beam splitter is made in the form of a dichroic mirror, a partially transparent mirror or a prism. In addition, monochrome and color video cameras are made with the possibility of synchronized or asynchronous operation. The processing and display unit is designed to combine the images obtained from a monochrome video camera and a color video camera.

As photosensitizing substances, drugs based on chlorin e6 are used. The key concept of the device being developed is the possibility of real-time video fluorescence diagnostics of malignant neoplasms containing a photosensitizer and assessment of the state of blood flow near the tumor tissue. Registration of fluorescence occurs in the "transparency window" of biological tissue, corresponding to the red part of the visible spectrum. The device allows the clinician to intraoperatively see an image on the screen in the usual color range, or at least as close as possible to that.

The disadvantages of this device are:

the inability to determine the localization of tumors of the head and neck does not allow determining the boundaries of deep-lying tumors (more than 1 cm), does not allow detecting the pathways of tumor metastasis

USEFUL MODEL DISCLOSURE

The technical problem solved by this utility model is the creation of a video fluorescent device for analyzing the interstitial distribution of photosensitizers of the far red and near infrared ranges of malignant neoplasms of the head and neck.

This problem is solved due to the fact that a video fluorescent device for analyzing the interstitial distribution of photosensitizers of the far red and near infrared ranges of malignant neoplasms of the head and neck includes an LED white light source, an emitter unit with a system of narrow-band light filters containing two semiconductor lasers with wavelengths in the 625- 665 nm and 780-810 nm, operating in continuous mode, a light delivery system with radiation input into one bundle, delivering light simultaneously from a white light source and from an emitter unit, a registration unit with a filter system, a video data processing unit with the possibility of affine image transformation, coming from one of the monochrome video cameras, for subsequent superimposition on the image from a color video camera, in real time, and with the possibility of digital processing of the image from a color video camera by amplifying the red component of the RGB channel spectrum, and the output unit receives video data and the numerical value of the intensity of the fluorescent signal of the investigated tissue site, and characterized in that the registration unit includes two beam splitters made in the form of a dichroic mirror, a focusing lens, three optical outputs connected using connectors with a color and two black-and-white video cameras with light filters , while one light filter transmits radiation in the 670-750 nm spectrum range, and the other in the 830-850 nm range, black-and-white cameras record fluorescent images in the far red and near infrared ranges simultaneously, the resulting three images are displayed on a computer monitor in overlay mode of images with adjustable intensity of each of them

In addition, the white light source is an RGB laser.

In addition, the emitter unit contains two semiconductor lasers with wavelengths in the ranges of 625-665 nm and 780-810 nm, operating in a pulsed mode.

In addition, the beam splitters in the registration unit are made in the form of a partially transparent mirror.

In addition, the beam splitters in the registration unit are made in the form of a prism.

The technical result of the claimed utility model consists in increasing the depth from which the tumor boundaries are determined, in the possibility of controlling the photodynamic effect by photobleaching of the photosensitizer in the far red visible range and in the possibility of assessing the blood supply in the area of malignant neoplasms of the head and neck using a photosensitizer in the near infrared range.

The claimed device solves the following technical problems:

determination of deep-seated tumors of the head and neck in the near infrared range;

determination of metastatic pathways by examining the vascular bed using intravenous indocyanine green;

the impossibility of simultaneous fluorescence diagnostics and visual review of the tissue area under study in the usual color image mode by the clinician;

increasing the depth of tissue probing: the impossibility of conducting fluorescent navigation in the presence of blood;

increasing the sensitivity of diagnostics of tumor tissue.

In addition, the device does not interfere with standard surgical resection with fluorescence navigation enabled. The device can work with photosensitizers approved for use in the Russian Federation, such as photolon, radachlorin, photoditazine, as well as a fluorescent marker in the near infrared spectrum with indocyanine green.

BRIEF DESCRIPTION OF DRAWINGS

The essence of the utility model is illustrated by drawings, which are included in the present description. The drawings illustrate an embodiment of the utility model and together with the above general description of the utility model and the following detailed description of the implementation serve to explain the principles of the present utility model.

FIG. 1 shows a general diagram of a video fluorescent device for analyzing the interstitial distribution of far red and near infrared photosensitizers for head and neck malignant neoplasms.

FIG. 2a is a general diagram of an emitter unit and a white light source represented as an RGB light source.

FIG. 2b shows a general diagram of the emitter unit and the white light source presented as a broadband light source.

FIG. 2c shows a general diagram of a white light source and an emitter unit with a mechanical switch between laser radiation.

FIG. 3 shows a diagram of a registration unit with three cameras.

FIG. 4a shows a fluorescent image of a stage IV left parotid tumor in the far red range after intravenous administration of chlorin e6.

FIG. 4b shows a color image of a stage IV tumor of the left parotid salivary gland.

FIG. 4c shows an image of a stage IV tumor of the left parotid salivary gland in the superimposed mode with intravenous administration of chlorin e6.

FIG. 5a shows a near infrared fluorescence image of blood vessels in a peritoneal skin graft after intravenous administration of indocyanine green.

FIG. 5b shows a fluorescent image of axillary sentinel lymph nodes in the near infrared range when injected subcutaneously.

FIG. 5c shows a fluorescent image of lymphatic vessels in the near infrared range after subcutaneous administration of indocyanine green.

DEFINITIONS AND TERMS

The term "tissue site under study" in this document means a body area within which surgery is performed, as well as any other object, for example, an experimental sample with an unknown concentration of a photosensitizer, subject to fluorescence study in order to assess the accumulation of a photosensitizer or other phosphor.

IMPLEMENTATION OF THE USEFUL MODEL

A video fluorescent device for analyzing the interstitial distribution of photosensitizers in the far red and near infrared ranges of malignant neoplasms of the head and neck includes an LED white light source (1), an emitter unit (2) containing two semiconductor lasers with wavelengths in the 625-665 nm ranges (3) and 780-810 nm (4), a radiation delivery system (5), a registration unit (6) with a filter system, a video data processing unit (7) with the possibility of affine transformation of an image coming from one of the monochrome video cameras (8, 9) for subsequent overlaying on an image from a color video camera (10), in real time, and with the possibility of digital processing of an image from a color video camera by amplifying the red component of the RGB channel spectrum, and an output unit (11) of the obtained video data and the numerical value of the intensity of the fluorescent signal of the tissue area under study

In addition, the registration unit includes two beam splitters (12, 13) made in the form of a dichroic mirror, a focusing lens (14), three optical leads (15, 16, 17) connected on one side using connectors with color (10) and two black-and-white video cameras (8, 9) with light filters that transmit radiation in the spectrum range of 670-750 nm (18) and 830-850 nm (19), and on the other, it is connected using a connector with a flexible endoscope with a rigid attachment (20 ), the resulting three images are displayed on a computer monitor (11) in the mode of overlaying images with an adjustable intensity of each of them.

The principle of operation of the video system is as follows. Light from a white light source (1) and laser radiation from an emitter unit (2), passing from lasers (3, 4) through collimators (21) and cleaning filters (22, 23), fall on a system of mirrors (24, 25, 26 , 27, 28), then onto focusing lenses (29) to the optical inputs (30, 31) of the radiation delivery system (5). In this case, a high-power white LED (32), including a collimator (21) and a filter that transmits the short-wavelength part of the spectrum up to 625 nm (33), or a set of three RGB LEDs (34, 35, 36), which includes collimators in front of each LED (21) and filters that transmit the short-wavelength part of the spectrum up to 625 nm (33). In this case, the radiation from lasers (3, 4) can be switched by an electromechanical switch (37). The radiation delivery system is a light-guiding flexible Y-shaped fiber-optic bundle (5), consisting of fibers with a diameter of 70 μm. On the side of connection to radiation sources, it has two branches and is equipped with optical connectors. One optical connector (31) is designed to input radiation from a white light source (1), equipped with a Storz / wolf connector. Another optical connector (30) is designed to input monochromatic radiation from the emitter unit (2) and is equipped with an SMA 905 optical connector. On the other hand, the fiber bundle has a connector (38) for connection to a flexible endoscope with a rigid attachment (20). A flexible endoscope with a rigid attachment (20) is used to deliver radiation to the object under study and register diffusely reflected light. Consists of a video recording channel for transmitting an image of the object under study, two experimental channels for supplying air or water. The outer part of the delivery system is made of medical grade silicone.

The diffusely reflected light is recorded by a registration unit (6), which consists of three channels (15, 16, 17) for detecting a fluorescent signal, each of which has a video camera. The light hits a beam splitter (12) with a cutoff of 652 nm. The reflected light enters a color camera (10) with a filter that transmits light in the 400-625 nm range (39). The transmitted light hits the second beam splitter (13) with a cutoff of 750 nm. The reflected light falls on a black-and-white camera (8) with a light filter that transmits radiation in the 670-750 nm range (18). Camera (8) is used to register the fluorescence of photosensitizers based on chlorin e6. The transmitted light with a spectral range of more than 750 nm falls on a black-and-white camera (9) with a filter that transmits radiation in the range of 830-850 nm (19). The camera (9) is used to register the fluorescence of the fluorescent dye indocyanine green. To display the information received from the cameras on the computer monitor (I), special software is used. By preprocessing and adding, if necessary, images in fluorescent light in the far red wavelength range of 670-750 nm, obtained from a black-and-white camera (8) with an image from a color camera (10), a fluorescent image is displayed on the monitor (11), the degree the accumulation of photosensitizers and the size of the malignant neoplasm. In fluorescent light in the near infrared wavelength range of 830-850 nm, obtained from a black-and-white camera (9), the monitor (11) displays vascular beds and possible pathways of tumor metastasis. In this case, venous thrombosis is diagnosed as a sharp interruption of the vascular bed. The visible light image from the camera (10) displays the patient's organs in a familiar color. If necessary, the fluorescent video recording system allows you to simultaneously observe the reflected and fluorescent images of the area of the investigated area, to correct the brightness and unevenness of the fluorescent radiation.

The procedure for fluorescence diagnostics using the proposed device is as follows. Two hours before the diagnosis, the patient is injected intravenously with the photosensitizer chlorin e6. The endoscope (20) of the video system is inserted into the patient's area of interest, for example, into the nasopharynx, oral cavity, auricle, etc. To determine the localization of a malignant neoplasm, a white light source (1) and a laser source (3) with excitation wavelengths in the range of 625-665 nm are switched on. The diffusely reflected light is collected by the endoscope (20) and enters the registration unit (6). In it, it is separated by means of beam splitters (12, 13) and enters the recording cameras (8, 9, 10). To inspect and diagnose the investigated area in the visible range of the spectrum, the software is switched to the mode of displaying the image from the camera (10) (Fig. 4b). To register the fluorescence of chlorin eb in the pathological tissue, the software is switched to the mode of displaying the image from the camera (8) (Fig. 4a). On it, the areas of accumulation of the photosensitizer are illuminated with white light. In this case, for fluorescent navigation, the software can be switched to the overlay mode of images from cameras (8) and (10) (Fig. 4c). Then the areas of accumulation of the photosensitizer are highlighted in a color specified by the user. By default, green, as the most contrasting with the color of human tissue.

If it is necessary to study the vascular bed in a patient, indocyanine green is injected intravenously immediately before diagnosis. The endoscope (20) is delivered to the area of interest. A white light source (1) and a laser source (4) with excitation wavelengths in the range of 780-810 nm are switched on. The software is switched to the mode of displaying the image from the camera (9) (Fig. 5a, 5b, 5c). In this case, the vessels are colored white.

Claims (4)

1. Video-fluorescent device for analyzing the interstitial distribution of photosensitizers of the far red and near infrared ranges of malignant neoplasms of the head and neck, including a LED white light source, an emitter unit with narrow-band light filters containing two semiconductor lasers with wavelengths in the ranges of 625-665 nm and 780-810 nm, a light delivery device with the introduction of radiation into one bundle, delivering light simultaneously from a white light source and from the emitter unit, connected via a connector to a flexible endoscope with a rigid attachment, a flexible endoscope with a rigid attachment for delivering radiation to the object under study and recording diffusely reflected light for transmission to the recording unit, consisting of a video recording channel for transmitting an image of the object under study, two experimental channels for supplying air or water, a unit for recording diffusely reflected light with filters, connected on one side using connectors with color and two black-and-white video cameras, and on the other - connected by means of a connector with a flexible endoscope with a rigid attachment, a video data processing unit with the possibility of affine conversion of an image coming from one of the monochrome video cameras, for subsequent superposition on an image from a color video camera, in the mode real-time, and with the possibility of digital processing of the image from a color video camera by amplifying the red component of the RGB spectrum of the channel, characterized in that the registration unit includes two beam splitters made in the form of a dichroic mirror or a prism, a focusing lens, three optical outputs connected using connectors with color and two black-and-white video cameras with light filters, with one filter transmitting radiation in the 670-750 nm spectrum range, and the other in the 830-850 nm range, black-and-white cameras record fluorescent images in the far red and near infrared ranges simultaneously , the device is made with the possible the output of the obtained video data, the numerical value of the intensity of the fluorescent signal of the investigated tissue area and the resulting three images on the computer monitor in the mode of overlaying images with adjustable intensity of each of them. 2. The device according to claim 1, characterized in that the white light source is an RGB laser. 3. The device according to claim 1, characterized in that the lasers in the emitter unit are designed to operate in a continuous or pulsed mode. 4. The device according to claim 1, characterized in that the beam splitters in the registration unit are made in the form of a partially transparent mirror or prism.

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