MOBILE DEVICE FOR ULTRAVIOLET CORNEAL CROSSLINKING

Abstract

The utility model relates to medicine, namely to ophthalmology. The device contains two UV-A light-emitting diodes (6-7) creating a light flux with a diameter of 5-12 mm, a wavelength of 370 nm and an irradiation power of 9 to 30 mW / cm2. The light-emitting diodes are connected to a unit (4) forming a UV-A radiation flux, containing an optical lens (8), a diaphragm (9) and a power supply control circuit for the light-emitting diodes, implemented by means of a microcontroller located in the control unit (2). The control unit (2) is connected to a speaker (5) and a keyboard and indication unit (3) containing a liquid crystal display and buttons for on / off, pause and selection of irradiation modes: with a power of 9 mW / cm2 - 10 minutes, with a power of 18 mW / cm2 - 5 minutes, with a power of 30 mW / cm2 - 3 minutes. Retractable stops (10) are provided to maintain focal length. The device is powered by an LR6 battery.The utility model expands the device's operational capabilities by increasing the ultraviolet radiation output, allowing for additional clinical indications and equipping it with an audible indicator of its operating mode. 2 fig.

Description

[0001] The utility model relates to medicine, namely to ophthalmology, and can be used for ultraviolet (UV) crosslinking in the treatment of corneal diseases, in particular keratitis. Traditionally, UV crosslinking is used in the treatment of degenerative diseases of the cornea, in particular keratoconus [Wollensak G., Spoerl E., Seiler T. Riboflavin / ultraviolet-a-induced collagencrosslinkingforthetreatmentofkeratoconusAm. J. Ophthalmol. 2003; 135(5): 620-627]. Data have appeared in the literature on the use of UV crosslinking technology for the treatment of keratitis using increased power of UVA radiation in the mode of: 30 mW / cm 2 for 3 minutes. In this case, the patient can be in a sitting position during the UV irradiation of the cornea [Hafezi F., Richoz O., Torres-Netto EA, Hillen M., Hafezi NL Corneal cross-linking at the slit lamp. J. Refract. Surg. 2021; 37(2): 78-82].

[0002] A device for UV binding of corneal collagen is known, consisting of an elastic holder with two UV LEDs with a wavelength of 370 nm, creating a light spot with a diameter of approximately 10 mm. The device holder is connected to a 12V power source and a control unit with a timer [Bikbova G.M., Akhmetov I.R., Bikbov M.M. Device for cross-linking of corneal collagen. Patent RU No. 72401 dated 20.04.2008].

[0003] A device for cross-linking corneal collagen with UV is known. It consists of a UV emitter on a rod, a control panel with a power supply, and a stand with caster wheels. The control panel has a liquid crystal display that displays a text display of the device's operating parameters. The emitter consists of two UV LEDs [Bikbov M.M., Bikbova G.M., Khalimov A.R. Device for Cross-linking Corneal Collagen. Patent RU No. 108963 dated 10.10.2011].

[0004] Device 2 is known for cross-linking corneal collagen with UV light. It consists of a mobile stand combined with a floor plate, on which a mobile UV emitter is mounted with a video camera and a control module in the form of an LCD touchscreen monitor. The emitter is equipped with an optical lens system with a diaphragm that forms a homogeneous ultraviolet beam with a wavelength of 370 nm, a specified diameter, and a power of up to 5 mW / cm. 2 [Bikbov M.M., Khalimov A.R., Bikbova G.M., Kharitonov S.V. Device-2 for cross-linking corneal collagen. Patent RU No. 134788 dated November 27, 2013].

[0005] A device-3 for corneal cross-linking is known, comprising a motorized UV emitter mounted on a mobile stand with a floor plate. The emitter contains a video camera, three UV LEDs, and an additional blue light LED for test setup of the device. It includes an optical lens system with a diaphragm, providing a homogeneous ultraviolet light beam with a wavelength of 370 nm and a power of up to 20 mW / cm. 2 The control unit is designed as a liquid crystal touch screen displaying the main parameters of UV exposure (time and power) [Bikbov M.M., Khalimov A.R., Usubov E.L., Kharitonov S.V. Device-3 for ultraviolet cross-linking of corneal collagen. Patent RU No. 162618 dated 20.06.2016].

[0006] A device for corneal crosslinking is known, which contains a LED source of continuous UV radiation (370 nm) with an intensity of 3 mW / cm 2, connected to a control and display unit that sets the exposure modes and duration, and is equipped with a display and a sound generator. The LED source is equipped with an attachment that creates a light spot of the required diameter [Iomdina E.N., Khandzhyan A.T., Yani E.V., Golikova V.A., Sotnikova L.F., Goncharova A.V., Brovkin A.A. Device for corneal crosslinking. Patent RU No. 199825 dated September 22, 2020].

[0007] The prototype of the utility model is a portable device for accelerated UV corneal crosslinking, comprising a power supply, a control unit with a keyboard and display, a radiation unit with an optical system and diaphragm, and stops for maintaining the focal length. Two LED emitters are capable of generating a UV light stream with a wavelength of 370 nm in the range of 6 to 18 mW / cm. 2 [Bikbov M.M., Khalimov A.R., Smirnov A.V., Aleksandrov E.I. Portable device for accelerated ultraviolet crosslinking of the cornea. Patent RU No. 236052 dated July 23, 2025].

[0008] A drawback of the prototype is its insufficient UV output. This limits its use, particularly for treating infectious keratitis, which requires higher UV intensity. Furthermore, the device lacks an audible indicator, which would provide additional monitoring of its operation.

[0009] The objective of the invention is to develop a mobile device for ultraviolet corneal crosslinking with improved performance characteristics.

[0010] The technical result is an expansion of the operational capabilities of the device due to an increase in the power of ultraviolet radiation, which allows for additional indications to be added to the clinical use of the device, and equipping it with a source of sound indication of the operating mode.

[0011] The essence of the utility model is explained by the following figures: Figure 1 shows a diagram of the claimed device, where 1 is an LR6 battery, 2 is a control unit, 3 is a keyboard and indicator unit, 4 is a radiation unit, 5 is a speaker, 6-7 are light-emitting diodes; 8 is an optical lens, 9 is a diaphragm, 10 are retractable stops; Figure 2 shows the claimed device, general view.

[0012] The proposed mobile device for UV corneal crosslinking contains two 6-7 UVA LEDs, creating a light flux with a diameter of 5-12 mm, a wavelength of 370 nm and a radiant power of 9 mW / cm 2 , 18 mW / cm 2 or 30 mW / cm 2The LEDs are connected to the block 4, which generates a flow of UV-A radiation and contains an optical lens 8, a diaphragm 9 and a power supply control circuit for the LEDs, which is implemented by means of a microcontroller located in the control unit 2. The control unit 2 is connected to the keyboard and indication unit 3, which contains a liquid crystal display and buttons for on / off, pause and selection of irradiation modes: with a power of 9 mW / cm 2 - 10 minutes, with a power of 18 mW / cm 2 - 5 minutes, with a power of 30 mW / cm 2- 3 minutes. At the same time, the control unit is connected to the speaker 5, which allows reproducing a different sound pattern for each operating mode of the device. To maintain the focal length, retractable stops 10 are provided, the diaphragm 9 provides the required light spot diameter from 5 to 12 mm. The device is equipped with an optical lens 8, which allows homogenizing the ultraviolet flow. The device is powered by a size LR6 battery 1 (Fig. 1-2). The dimensions of the device: length - 150 ± 5 mm (225 ± 5 mm with extended stops), width - 40 ± 2 mm, height - 35 ± 2 mm. In this case, the radiation power is set by means of the keyboard and indication unit 3 in the form of one of three fixed modes: 9 mW / cm 2 , 18 mW / cm 2 or 30 mW / cm 2 .

[0013] Also, to increase the safety of the procedure, a speaker is introduced into the device circuit; the operation of the device in each mode is accompanied by signals of a certain duration and frequency; at the end of the device’s operation, a special sound signal is also emitted.

[0014] The advantages of the proposed device during its operation are:

[0015] - mobility, which makes it possible to perform the corneal UV crosslinking procedure on a patient in a sitting position;

[0016] - three operating modes: power 9 mW / cm 2 - 10 minutes, with a power of 18 mW / cm 2 - 5 minutes, with a power of 30 mW / cm 2 - 3 minutes.

[0017] How to operate the device:

[0018] Turn on the device by pressing the corresponding button on the housing. On the menu screen, select the mode with the desired UVA power and duration. Aim the device at the cornea, use the diaphragm to set the desired light spot size, and apply the stops to the edges of the eye socket, having first extended them to the desired length. Press the "Start" button and, holding the device over the surgical area, wait until it stops. The device turns off automatically according to the selected irradiation duration, and a characteristic sound signal is played when the operation is complete.

[0019] The experimental model of in vivo corneal UV crosslinking was reproduced in 5 groups on 10 rabbits (20 eyes): in the 1st group (control), the standard protocol was performed (3 mW / cm 2- 30 minutes) using the UVLink floor-standing device. Using the claimed mobile device, UV crosslinking was performed in three experimental groups: the second group used an accelerated mode of 9 mW / cm 2 - 10 minutes, in 3 and 4 the keratitis treatment protocol was used, respectively 18 mW / cm 2 - 5 minutes, 30 mW / cm 2 - 3 minutes.

[0020] In the vivarium operating room, under anesthesia (Xylazine 15 mg / kg and Zoletil 15 mg / kg intramuscularly; instillation of 0.4% oxybuprocaine eye drops), corneal epithelium with a diameter of about 7-8 mm was removed. The cornea was saturated with a photosensitizer (0.1% riboflavin mononucleotide) for 30 minutes at an instillation frequency of 1 drop per 1 minute. During UV irradiation, 0.1% riboflavin was instilled at a rate of 1 drop every 2 minutes. In the postoperative period (4 days), local antibacterial and anti-inflammatory therapy was used. Daily biomicroscopy of the animals' eyes was performed for 14 days, confocal microscopy (on the 7th day).

[0021] Complete restoration of the removed corneal epithelial layer in the operated eyes of animals was completed on average within 3-4 days. In all groups, typical complications such as eye irritation and corneal edema were observed in the early postoperative period (up to 4 days). On day 7, the eyes were calm, and no corneal edema or clouding was detected. Confocal microscopy revealed no signs of damage to corneal endothelial cells in any experimental rabbit. No significant differences in the nature of crosslinking-induced complications in the postoperative period were found between the study groups.

[0022] Short-term (3 to 10 minutes) use of the proposed device significantly simplifies the corneal UV irradiation stage compared to the standard protocol (30 minutes). Accordingly, reducing the duration of UV irradiation will be more comfortable for the patient and will allow for significant savings in medication. The device has the ability to generate UV irradiation modes (9 mW / cm 2 - 10 minutes, 18 mW / cm 2 - 5 minutes and 30 mW / cm 2 - 3 minutes), required for clinical protocols for the treatment of keratitis.

[0023] Thus, the use of the claimed mobile device for ultraviolet crosslinking of the cornea of ​​the eye in UVA irradiation modes: 9 mW / cm 2 - 10 minutes, 18 mW / cm 2 - 5 minutes and 30 mW / cm 2 - 3 minutes ensures safe and effective implementation of the accelerated protocol, can be used for the treatment of keratitis.

Claims

A mobile device for ultraviolet corneal crosslinking, containing a control unit with a microcontroller, two ultraviolet LEDs that create a light flux with a diameter of 5-12 mm, a wavelength of 370 nm, connected to a control and indication unit, which includes on / off and pause buttons, a display, a keyboard and a button for selecting irradiation modes: with a power of 9 mW / cm 2 - 10 minutes, with a power of 18 mW / cm 2 - 5 minutes, diaphragm, optical lens, retractable stops, LR6 battery, characterized in that the irradiation mode selection button is equipped with an additional irradiation mode with a power of 30 mW / cm 2 - 3 minutes, and a speaker is introduced into the control unit.

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