Ophthalmological device for treating an eye, use of the device, and method for controlling and for operating the device

Abstract

The invention relates to an ophthalmological device for treating an eye (1), in particular structures inside an eyeball, preferably in the region of the anterior chamber of an eye (1). The device (18) comprises: a laser unit (19) which is designed to apply energy, in particular laser radiation (14), to structures of the eye interior, in particular the anterior stroma layer (8) of the iris (4), through the cornea (10) of the eye (1); and an irrigation unit (21, 22) for, in particular interoperative, irrigation of the eye (1) using a flushing solution (25), the irrigation unit (21, 22) being designed to generate an irrigation flow (17) of flushing solution (25) through the eye (1) without a pump.

Description

[0001] Title: OPHTHALMOLOGICAL DEVICE FOR THE TREATMENT OF A

[0002] EYE, USE OF THE DEVICE, AND METHOD

[0003] FOR CONTROLLING AND OPERATION OF THE DEVICE

[0004] Description

[0005] The invention relates to an ophthalmological device for treating an eye, in particular for treating components inside the eyeball, preferably in the region of the anterior chamber of the eye, a use of the device, and methods for controlling and operating the device.

[0006] Ophthalmological devices for treating the human or animal eye are widely known, for example for treating the eye as part of a vitrectomy, a glaucoma treatment, or, as known from US 8,206,379 B2, as part of a treatment to change the perceived iris color or to change the visually perceivable color of the eye.

[0007] Known ophthalmological devices, such as those described in US Pat. No. 8,206,379 B2, are based on the application of laser light to destroy cells or cellular material within the eye. Destroyed cells or the resulting cellular material can be metabolized and excreted from the eye, for example, via the ocular fluid and Schlemm's canal. Through the metabolization of the destroyed cells, e.g., melanocytes of the anterior stromal layer of the iris, the cells are gradually eliminated, so that with laser treatment of the iris stromal layer according to the method described in US Pat. No. 8,206,379 B2, the natural iris color, e.g., blue, green, or gray, appears after one or more weeks.

[0008] Metabolism and excretion via Schlemm's canal, as mentioned, takes a comparatively long time and carries the risk of blockage of Schlemm's canal. Devices with pump modules for rinsing the eye during ophthalmic surgery, such as those known from EP 3 308 758 B1, are comparatively complex and expensive.

[0009] Based on this, it is an object of the invention to provide an ophthalmic device for treating an eye, with which the removal of degenerated and / or detached material, of cells or cell components from the eye, in particular the anterior chamber of the eye, is possible in an efficient, simple, and comparatively cost-effective manner. Furthermore, an ophthalmic device is to be provided that enables the comparatively efficient and gentle removal of melanocyte cells from the anterior stromal layer of the iris. Furthermore, a use of the ophthalmic device, a method for controlling the ophthalmic device, and a method for setting up an operation of the ophthalmic device are to be provided.

[0010] This problem is solved by the independent claims. Further embodiments and modifications are set forth in the dependent claims and the following description.

[0011] According to one embodiment, an ophthalmological device, hereinafter referred to as device, is provided for treating a human or animal eye.

[0012] The device can, for example, be configured to apply laser radiation, in particular laser pulses, to components inside an eyeball, preferably in the region of the anterior chamber of an eye, or in other words, to apply laser radiation, in particular laser pulses, to the component of the eye, for example the anterior stromal layer of the iris. In particular, the device can be used to apply laser light, in particular laser pulses, to the anterior stromal layer of the iris of an animal or human eye in order to quasi-mechanically detach melanocyte cells and corresponding color pigments cross-linked thereto from the anterior stromal layer, i.e. to detach them from the composite of the stromal layer.According to advantageous embodiments, the device is configured to perform a method or treatment for changing the human-perceived color appearance of the iris of a human or animal eye by selectively reducing the density of pigments in the anterior stromal layer of the iris. A method and a device for changing eye color are known, for example, from EP 3 308 758 B1, the disclosure of which regarding changing eye color is hereby incorporated by reference in its entirety.

[0013] To reduce the density of pigments in the anterior stromal layer, the invention provides for the anterior stromal layer of the iris to be exposed to laser pulses in such a way that melanocyte cells and corresponding color pigments are quasi-mechanically detached or removed from the stromal layer and released into the anterior chamber of the eye. The detachment or removal of the melanocyte cells and corresponding color pigments reduces the density of the pigments and thus the externally perceptible color of the iris or eye. After removal of the pigments, the natural color of the iris appears, which can be in the blue-green-gray range. For the quasi-mechanical detachment of the melanocyte cells, special laser parameters can be used for the laser pulses, for example, wavelength X = 532 nm, pulse length 3 to 6 ns, pulse energy 1 to 3 mJ / pulse; spot diameter 200 to 300 pm. The laser pulses can be applied at a repetition rate of 80 to 100 pulses / s.Preferably, irradiation with corresponding laser pulses is carried out for a time period in the range of 4 s to 6 s, whereby several such time periods can follow one another with pauses in between. The term "quasi-mechanical" in connection with the detachment or removal of the melanocyte cells and color pigments should be understood in particular to mean that the melanocyte cells and color pigments are released into the fluid of the anterior chamber of the eye. The term "quasi-mechanical" is intended to distinguish the detachment from a laser treatment in the prior art of US Pat. No. 8,206,379 B2, in which the cells are destroyed or killed by laser irradiation and must be removed through natural metabolic and degradation processes.The device proposed herein comprises a laser unit (or laser applicator) which is designed to apply energy, in particular laser radiation, preferably in the form of laser pulses, to components of the interior of the eye, in particular the anterior stromal layer of the iris, through the cornea of ​​the eye. The laser unit can, for example, be a laser system which is designed to apply laser radiation to the iris, in particular to areas of the iris, in a point-like or grid-like manner. For example, the laser unit can comprise a laser, i.e. a laser light source, and a deflection unit, also called a laser scanner, by means of which laser radiation generated by the laser can be deflected two-dimensionally. By controlling the two-dimensional deflection of the laser radiation, it is possible to apply laser radiation to the iris or areas of the iris in a grid-like movement.

[0014] The laser unit can be configured to apply laser radiation, for example laser pulses, to the components of the eye through the cornea. In other words, the laser unit can be configured to apply laser radiation, preferably laser pulses, to the component of the eye, in particular the iris, from the outside through the cornea of ​​the eye.

[0015] For laser radiation or laser energy, the degeneration of components of the eye can be due to photodisruption. For the mechanical detachment of melanocyte cells from the anterior stromal layer of the iris, laser pulses are particularly preferred. These are applied externally, i.e., through the cornea, to the iris.

[0016] The device proposed herein further comprises an irrigation unit for irrigating the eye using a rinsing solution or rinsing fluid. The irrigation unit is preferably configured to irrigate the eye with the rinsing solution or rinsing fluid simultaneously with the application of laser radiation, in particular laser pulses. For example, the irrigation can occur simultaneously or during, or at least within a predetermined time window, from a procedure performed with the laser unit for applying laser radiation, in particular laser pulses, to an internal component of the eye, e.g., the iris.

[0017] The irrigation unit proposed herein is designed to generate an irrigation flow of rinsing solution through the eye, for example, through the anterior chamber, without the need for a pump, preferably during or as part of an application of laser radiation or laser pulses to the component of the eye. The term "pumpless" is intended to mean that the irrigation flow is generated without the use of an actively operating pump or pump unit.

[0018] An irrigation device that operates or can be operated without a pump can, on the one hand, be provided comparatively inexpensively. On the other hand, a corresponding irrigation unit based on an irrigation flow can remove the cells or (cellular) components of the eye that have degenerated / been detached by the laser unit comparatively efficiently from the interior of the eye, for example from the anterior chamber. It is not necessary for the material from the degenerated cells to be metabolized and excreted, for example, via Schlemm's canal, so that the risk of clogging of Schlemm's canal can be advantageously reduced, if not completely eliminated. In particular, experiments have shown that a quasi-mechanical detachment of the melanocyte cells of the iris upon application of laser pulses, as proposed herein, can be achieved comparatively quickly, for examplewithin 15 to 30 minutes, can lead to at least partial closure of Schlemm's canal. Irrigation during laser application can prevent this, as the melanocyte cells and detached color pigments are immediately flushed out of the anterior chamber of the eye.

[0019] The laser unit, in particular the laser light source, is configured and designed to generate and emit laser pulses, for example, for application to the iris. Preferably, the laser unit, in particular the laser light source, and the irrigation unit are configured so that the application of laser pulses, on the one hand, and the irrigation flow, on the other hand, can be generated and / or applied in a coordinated manner. For example, the application of the laser pulses can be coordinated with the irrigation flow or the irrigation volume, and vice versa.

[0020] According to embodiments, the laser unit, in particular the laser light source, and the irrigation unit can be designed such that they have a, in particular adjustable, mode of operation, or are configurable or adjustable-configurable based on already implemented software, hardware and / or firmware components for a mode of operation in which a) laser pulses are generated and emitted which, when applied through the cornea of ​​the eye to the anterior stromal layer of the iris of an eye, cause a quasi-mechanical detachment or removal of melanocyte cells from or out of the anterior stromal layer, and b) the irrigation flow is generated during the application of the laser pulses to the stromal layer and / or at least in a predetermined time window from the application of the laser pulses to the stromal layer.

[0021] The aforementioned operating mode can be used to flush detached or removed melanocyte cells out of the eye chamber, thus preventing a closure or partial closure of Schlemm's canal. Compared to the prior art method of destroying melanocyte cells by laser irradiation, the quasi-mechanical detachment of the melanocyte cells has the advantage that the result of the laser application is immediately apparent afterward. As mentioned, quasi-mechanical means that the melanocyte cells are detached from the stromal layer. The detached melanocyte cells then pass into the anterior chamber and can be flushed out by a mechanical irrigating solution stream from the irrigation unit. Quasi-mechanical detachment of the melanocyte cells can be achieved, for example, with laser pulses that have the laser parameters described below.According to one embodiment, the laser radiation is generated in the form of laser pulses and correspondingly also applied in the form of laser pulses. The laser pulses preferably have at least one of the following laser parameters: a) a laser wavelength in the range from 500 nm to 560 nm, preferably from 520 nm to 540 nm, more preferably of approximately 532 nm; b) a pulse energy in the range from 1 mJ to 7 mJ per laser pulse, preferably from 1 mJ to 3 mJ; c) a pulse duration in the range from 2 ns to 8 ns, preferably from 3 ns to 6 ns; d) a spot diameter in the range from 150 pm to 350 pm, preferably from 200 pm to 300 pm; e) a repetition rate in the range from 70 to 110 pulses / s, preferably from 80 to 100 pulses / s.

[0022] Preferably and according to embodiments, the irrigation unit comprises an inflow module for supplying the rinsing solution to the interior of the eye and an outflow module for draining fluid from the interior of the eye. The inflow module can be designed separately from the outflow module and can be handled separately. With the inflow module, for example, the interior of the eye can be fluidically connected to a rinsing solution source, and with the outflow module the interior of the eye can be fluidically connected, for example, to a rinsing solution sink. Corresponding modules can be implemented relatively easily and fluidically connected to the interior of the eye, in particular to the anterior chamber of the eye. A fluidic connection to the anterior chamber of the eye can be established, for example, through an opening passing through the cornea of ​​the eye, for example with or without a trocar.

[0023] According to embodiments, the inflow module can comprise at least one inflow hose or one inflow line, preferably at least partially flexible. A rinsing solution source is provided on the inflow hose on the inlet side, i.e., the inflow side, or the inflow hose is connected or connectable to a rinsing solution source on the inlet side. The rinsing solution source can be a vessel or a bag containing rinsing solution or rinsing liquid. The inflow hose can have a connection adapter on the inlet or inflow side for connecting to a complementary connection adapter on the rinsing solution source, e.g., a vessel or bag.

[0024] On the outlet or outflow side, the inflow tube can comprise a first applicator, for example, a needle applicator. The first applicator can be permanently or integrally connected to the inflow tube, or the first applicator can be detachably connected to the inflow tube or designed to be connectable, for example, based on corresponding adapter elements on the applicator and inflow tube.

[0025] The first applicator is designed and configured for insertion into the eye, for example through the cornea or an opening in the cornea, e.g. in the region of the sclera, and for establishing a fluidic connection, or a fluidically communicating connection, between the inflow tube or the rinsing solution source on the one hand and the interior of the eye, preferably in the region of the anterior chamber of the eye, on the other hand.

[0026] According to embodiments, the drainage module comprises at least one drainage hose or a drainage line, preferably at least partially flexible.

[0027] The drain hose may comprise a second applicator, in particular a needle applicator, on the inlet side, i.e., the inflow side. The second applicator may be permanently or integrally connected to the drain hose, or the second applicator may be detachably connected to the drain hose or designed to be connectable.

[0028] The second applicator is designed to be inserted into the eye, for example through the cornea or an opening in the cornea, e.g. in the area of ​​the sclera, and to establish a fluidic connection, or a fluidically communicating connection, between the interior of the eye on the one hand and the drainage tube or an irrigation solution sink provided on the outlet side of the drainage tube and / or connected or connectable to the drainage tube. The irrigation solution sink can be, for example, an outflow opening of the drainage tube or a container or bag coupled or connectable to an outflow-side end of the drainage tube. On the outflow side, the drainage tube can have a connection adapter for connection to a complementary connection adapter of the irrigation solution sink. On the inflow side, an adapter element for connecting the second applicator can be provided on the outflow tube.The second applicator may have a complementary adapter element.

[0029] The adapter-based inflow and outflow tubes allow for comparatively easy handling and, at the same time, efficient irrigation of the interior of the eye.

[0030] According to embodiments, the irrigation unit can be designed and operated in such a way that the pumpless irrigation flow is generated or can be generated by a hydrostatic pressure gradient and / or is generated or can be generated by capillary forces.

[0031] The hydrostatic pressure gradient can be generated, for example, between the inflow module and the outflow module, in particular between the inflow hose and the outflow hose.

[0032] In particular, the irrigation unit can be configured such that the irrigation flow is generated or can be generated by the force of gravity acting on the rinsing solution, wherein the rinsing solution source is placed vertically higher than the rinsing solution sink.

[0033] One advantage of pumpless eye irrigation over pump-based irrigation is that additional fluid pressure in the eye, caused for example by an active pump unit, can be avoided. According to embodiments, the irrigation unit can further comprise at least one adjusting means, for example a valve unit, in particular a valve such as a control valve or a pinch valve, which is designed to activate, deactivate and / or adjust a volume flow of irrigation solution or a volume flow of an irrigation flow generated or generateable by the irrigation unit, which can be guided through the eye by the irrigation unit, for example. The adjusting means can be provided for example on the inflow module, in particular on the inflow hose, or on the outflow module, in particular on the outflow hose.The adjusting means can be arranged between the irrigating solution source and the irrigating solution sink, wherein the adjusting means can be arranged upstream of the eye in the direction of the irrigation flow and downstream of the irrigating solution source or can be used in this configuration. It is also possible for the adjusting means to be arranged downstream of the eye in the direction of the irrigation flow and upstream of the irrigating solution sink or can be used in this configuration. The adjusting means can be designed, for example, in the manner of a hose clamp, e.g. a pinch valve, with which the cross-section of the inflow or outflow hose and thus the irrigation flow can be adjusted depending on the clamping or pinching state. Other types of valves such as control valves, ball valves, needle valves, etc. are also conceivable.

[0034] According to embodiments, for activating, deactivating, and / or adjusting the volume flow or the irrigation flow, the actuating means can be adjusted and / or actuated by an actuator element coupled or coupleable to the actuating means. In embodiments, it can be provided that the actuator element can be actuated by user actuation, in particular by a user actuation unit or interface, in particular a manual actuation or a foot actuation, by voice control, a gesture control, and / or automatically. Accordingly, the device can have a user actuation unit or interface, in particular a manual actuation or a foot actuation, a voice control, a gesture control, and / or an automatic adjustment mechanism. In particular, such adjustment options can achieve that the volume flow and irrigation flow can be adjusted according to needs and requirements.According to embodiments, it is possible for the actuating means, in particular the actuator element, to be automatically actuated and / or controlled depending on operating parameters of the device, in particular of the laser unit, e.g., depending on the applied laser radiation. For this purpose, a control or regulating element can be provided, for example, by which the actuator element is controlled or regulated, so that a volume flow dependent on the applied laser radiation can be generated. Other control variants, for example, according to a time profile and / or volume profile, or depending on the time and / or duration of the laser radiation exposure, are possible.

[0035] According to embodiments, the actuating means can comprise a closed position for deactivating the volume flow and at least one open position for activating or enabling a volume flow. In short, the closed position is intended to prevent an irrigation flow, and the at least one open position is intended and configured to enable an irrigation flow or a volume flow of irrigation fluid. To activate, deactivate, and / or adjust the volume flow, the actuating means can be transferred between the closed position and the at least one open position.

[0036] In embodiments, the adjusting means is designed for continuous transition between the closed position and at least one open position, or for stepwise transition between the closed position and a plurality of open positions. A continuous adjustment of the adjusting means, for example a flow cross-section for the irrigation fluid, can be understood in particular to mean that a corresponding flow cross-section can be varied continuously, for example with any intermediate positions, between the open position and the closed position. A stepwise or stepwise adjustment of the adjusting means, for example the flow cross-section, can be understood in particular to mean that a corresponding flow cross-section can be converted in steps or stages, preferably in a plurality of steps or stages, from the closed position to the open position and vice versa.The positions of the actuating means assigned to the respective steps or stages correspond to the respective open positions. In embodiments, the actuator element can be configured so that it is continuously or stepwise adjustable. Continuous adjustment of the actuating means or flow cross-section is possible, for example, with continuous adjustment, and stepwise adjustment of the actuating means or flow cross-section is possible.

[0037] According to embodiments, for example with an electrically operable or controllable actuator element, the actuator element can comprise a motor, in particular a stepper motor, for adjusting the actuating means. Mechanical actuating elements for transmitting a mechanically adjustable actuating value, e.g. manually or by a foot switch, etc., to the actuator element or the actuating means are also possible for actuator elements. Electrically or electronically operated actuator elements can be connected to a control value transmitter, which, based on a setpoint specified by a user actuation unit or interface, generates a control value for the position of the actuator element and adjusts the actuator element accordingly during operation. In particular, a corresponding control value transmitter enables user-defined, semi-automatic or automatic adjustment, e.g.based on the specifications of a user and / or based on one or more operating parameters of the device, such as applied laser radiation, start of laser irradiation, duration of laser irradiation, time interval to the start or end of the laser treatment, etc.

[0038] The valve unit can be configured for manual, semi-automatic, or automatic adjustment of the irrigation flow. In particular, according to embodiments, the valve unit can be manually adjustable and / or the valve unit can be coupled to an actuator element such that the volume flow can be automatically adjusted by the actuator element.

[0039] According to embodiments, the irrigation device can be configured to generate an irrigation flow through the anterior chamber of the eye, in particular in such a way that detached or removed cell material, in particular melanocyte cell material, can be carried out of the anterior chamber of the eye by the irrigation flow, or is carried out by the irrigation flow during operation. A treatment of the eye can, for example, provide that cells or cell material, such as melanocyte cell material of the iris, is / are detached into the anterior chamber of the eye using the laser unit. The irrigation flow, which can be provided, for example, during exposure to laser radiation by the laser unit, can flush the detached cells or the detached cell material out of the anterior chamber of the eye. It is therefore not necessary for the detached cells orThe detached cell material is broken down solely and exclusively through metabolic processes and transported away, for example, via Schlemm's canal. The particular advantage is that the result of the application of the laser pulses is essentially immediately visible afterward.

[0040] One advantage of rinsing with irrigating solution, as already mentioned, is that it can at least largely prevent blockage of Schlemm's canal or other metabolic pathways by an excess of draining cells or cellular material. A blockage of Schlemm's canal could lead to increased intraocular pressure and, in the long term, glaucoma.

[0041] According to embodiments, as mentioned, the laser unit can be designed and configured such that, during its operation, the anterior stromal layer of the iris is exposed to electromagnetic energy. The energy is preferably selected or provided in such a way that it causes degeneration, preferably detachment, of pigment cells, in particular melanocyte cells, of the anterior stromal layer. Preferably, the iris or the anterior stromal layer of the iris is exposed to laser pulses, in particular short laser pulses, in particular such that melanocyte cells of the stromal layer are quasi-mechanically detached into the anterior chamber of the eye.

[0042] Appropriate treatment of the anterior stromal layer of the iris to reduce the density of pigment cells leads to a change in the perceivable eye color, with less pigmentation making the eye or iris appear increasingly more natural, e.g., blue. According to embodiments, the laser unit can comprise a pulsed laser source (or laser light source), preferably an Nd:YAG laser. In particular, the laser can be a short-pulse laser. The laser device is preferably Q-switched.

[0043] The device proposed herein is, as mentioned, particularly suitable for changing the color appearance of the iris of a human or animal eye as perceived by humans by selectively reducing the density of pigments, in particular melanin pigments, in the anterior stromal layer of the iris. In particular with a treatment of this type, it is advantageous if the detached melanocyte cells or detached cell material are rinsed out of the anterior chamber of the eye in a gentle manner. The pumpless irrigation flow proposed here has proven particularly advantageous for this purpose. This is significantly gentler than, for example, pump-based irrigation, which can under certain circumstances cause adverse pressure peaks for the intraocular pressure, and does not lead to any significant peaks or increases in the intraocular pressure.

[0044] The irrigation solution can be, for example, a balanced salt solution (BSS) or Ringer's solution. The irrigation flow, especially for the aforementioned irrigation solutions, can be between 5 ml / min and 20 ml / min, for example. The irrigation flow is preferably adjusted to ensure a substantially laminar flow in the eye. The irrigation flow can be adjusted depending on the supplied (laser) energy, for example, depending on the energy quantity and / or the pulse frequency of the laser, for which purpose the valve unit can be adjusted or adapted accordingly.

[0045] In embodiments, the laser source can be configured for operation with a laser wavelength between 488 nm and 580 nm or a laser wavelength between 522 nm and 541 nm, in particular 532 nm. The laser unit can also be configured for operation with a laser wavelength between 976 nm and 1160 nm or between 1044 nm and 1082 nm, in particular 1064 nm, preferably with frequency doubling. In embodiments, the laser source can be configured for a pulse frequency between 3 Hz and 300 Hz and / or for a pulse length between 2 ns and 6 ns, in particular substantially 4 ns. The laser source can further be configured to generate corresponding laser pulses with a power between 0.1 MW and 0.5 MW and / or an energy of 2 mJ per pulse.

[0046] In particular, the aforementioned parameters and those mentioned further above have proven particularly suitable for mechanically detaching melanocyte cells from the anterior stromal layer into the anterior chamber of the eye, so that detached cells or cell material can be essentially immediately flushed out by the irrigation flow.

[0047] According to embodiments, the use of an ophthalmological device according to one of the embodiments described herein is provided for removing melanocyte cells from the anterior stromal layer of the iris of an eye. During use, the melanocyte cells are detached from the stromal layer, in particular mechanically or quasi-mechanically detached, by laser pulses radiated or applied to the stromal layer via the laser unit, and are flushed out of the anterior chamber of the eye essentially immediately during or immediately after the detached removal by an irrigation stream generated by the irrigation unit. As is clear from the discussion herein, the laser unit and the irrigation unit are essentially comparatively easy to operate and apply, in particular such that they can be applied and used by non-medical but trained specialist personnel.

[0048] According to one embodiment, a method for controlling an ophthalmic device according to one of the embodiments proposed herein is provided, in particular a method for controlling the device when used to change the perceivable eye color by detaching, in particular quasi-mechanically detaching, melanocyte cells from the anterior stromal layer of the iris of the eye. The control method relates to the control of the device during the detachment or detachment of melanocyte cells from the stromal layer, wherein the detached melanocyte cells are flushed out of the anterior chamber of the eye by the irrigation flow within a predetermined time window after their detachment.

[0049] According to embodiments, the time window can be in the range of 0 to 20 minutes, preferably between 0 to 10 minutes or 0 to 15 minutes, more preferably between 0 to 1 minute or 0 to 3 minutes. The irrigation unit can be adjusted so that the irrigation flow is generated or present before, during, or after the removal of melanocyte cells from the anterior stromal layer.

[0050] In particular, it can be provided that the laser unit is operated and / or operable only when the irrigation flow is generated or can be generated simultaneously with or at least immediately after the application of the laser pulses. For example, according to one embodiment, the control system can be provided or configured such that the laser radiation, in particular laser pulses, are emitted or applied only when an irrigation flow is present or can be generated within the time window.

[0051] According to one embodiment, a method is provided for establishing operation of an ophthalmic device for use in a method for changing the eye color of an eye, the device being designed according to one of the embodiments proposed herein.The method comprises the steps: a) setting up the laser unit and the laser source for emission of laser pulses with one or more of the following laser parameters: laser wavelength in the range from 500 nm to 560 nm, preferably from 520 nm to 540 nm, more preferably from about 532 nm; pulse energy in the range from 1 mJ to 7 mJ per laser pulse, preferably from 1 mJ to 3 mJ; pulse duration in the range from 2 ns to 8 ns, preferably from 3 ns to 6 ns; spot diameter in the range from 150 pm to 350 pm, preferably from 200 pm to 300 pm; repetition rate in the range from 70 to 110 pulses / s, preferably from 80 to 100 pulses / s; and b) setting up the irrigation unit in such a way that, when used, an irrigation flow suitable for rinsing the anterior chamber of the eye with rinsing solution can be generated.through which melanocyte cells released from the anterior stromal layer by the laser pulses can be flushed out of the anterior chamber of the eye (9), preferably within a predetermined time window, preferably from 0 to 10 minutes, more preferably from 0 to 3 minutes.

[0052] Exemplary embodiments of the invention will now be described in conjunction with the accompanying figures. They show:

[0053] FIG. 1 is a schematic representation of a human eye together with schematic representations for carrying out a treatment to change the eye colour

[0054] FIG. 2 is an enlarged view of a section of FIG. 1; and

[0055] FIG. 3 shows a schematic view of the eye and a schematic embodiment of a device according to the invention;

[0056] FIG. 1 shows a schematic representation of a human eye 1. The human eye 1 is an optical system with which real objects are imaged onto the retina 3 of the eye 1 via a lens 2. The incidence of light into the eye 1, and thus the amount of light falling on the retina 3, is controlled by a variable aperture formed by a comparatively thin, circular structure in the eye 1, the so-called iris 4.

[0057] Through a muscular system, the eye 1 is able to change the diameter and size of the central iris opening, i.e. the pupil 5, and thus the amount of light reaching the retina 3. The iris 4 essentially consists of two layers, the so-called stromal layer or stroma 6, which is located on the front (i.e. anterior) of the iris 4 and faces the outside of the eye 1, and a layer of pigmented epithelial cells 7, which is located on the back (i.e. posterior) of the iris 4. The pigmented epithelial cells have the task of absorbing the incoming light to such an extent that the iris actually acts as an aperture for the optical system of the eye 1, defining the diameter of the pupil 5.

[0058] The pigmented epithelial cells contain melanin as a pigment, which is an efficient light absorber, especially for light in the visible spectrum.

[0059] The anterior stromal layer 8, i.e., the layer of stroma facing the outside of the eye, i.e., the anterior chamber 9, may contain a certain number of melanocyte cells with melanin pigment. The amount or density of melanin pigment in the anterior stromal layer 8 varies from individual to individual, with the density of melanin pigment correlating with eye color.

[0060] The anterior chamber 9 is bounded externally by the cornea 10. The anterior chamber 9, defined and located between the iris 4 and the cornea 10, is filled with aqueous humor, which is formed in the ciliary body 11 of the eye 1 and secreted into the posterior chamber 12. From the posterior chamber 12, the aqueous humor flows between the iris 4 and the lens 2 into the anterior chamber 9, from where it is drained or secreted via Schlemm's canal 13 of the eye 1.

[0061] The melanin pigments contained in the melanocytes alter the absorption and reflection behavior of the iris 4, more precisely of the stroma 6. The melanin pigments, in particular the density of the melanin pigments in or at the anterior stromal layer 8, influence the perceived eye color, which is used as a synonym for the perceived color of the iris.

[0062] When there is little or no melanin in or on the anterior stromal layer 8, the perceived eye color is blue, whereas with increasing melanin density, the perceived eye color shifts toward green, hazel, and brown. The naturally occurring melanin density in the anterior stromal layer 8 is determined by the phenotype of the individual in question.

[0063] For certain reasons, including aesthetic and / or social reasons, there is a desire to change the perceived eye or iris color from brown, green, etc., to blue. Therefore, corresponding procedures have been developed to change the perceived eye or iris color by removing melanin pigments from the anterior stromal layer of the eye. For example, US Pat. No. 8,206,379 B2 and EP 3 308 758 B1 describe laser-based approaches to changing eye color.

[0064] Removal of the pigmentation of the anterior stromal layer 8 by macrophages and excretion via Schlemm's canal, as in US 8,206,379 B2, may impair the functionality of Schlemm's canal 13, which may lead to increased intraocular pressure, which in turn may lead to glaucoma.

[0065] The device according to the invention is based on a different approach, according to which the melanocyte cells are detached into the anterior chamber of the eye and flushed out by a pumpless generated irrigation stream.

[0066] It has been found according to the invention that a pumpless irrigation flow of rinsing solution is a particularly efficient, gentle and at the same time simple method of removing the cell material detached from the eye into the anterior chamber.

[0067] A method for pumpless irrigation possible with the present invention is schematically indicated and illustrated in FIG. 1. Among other things, a specific amount of energy, e.g., in the form of one or more laser pulses 14 through the cornea 10, can be applied to the anterior stromal layer 8, so that melanocyte cells 15 bound to the stroma 6 are detached into the aqueous humor contained in the anterior chamber 9 as a direct result of the impinging laser pulses 14. The detached melanocyte material is designated by reference numeral 16 in FIG. 1.

[0068] According to the invention, the detached melanocyte material 16 is flushed out of the anterior chamber 9 by a pumpless irrigation flow 17 of rinsing solution. The irrigation flow is represented in FIG. 1 by two arrows 17, which run from top to bottom relative to the vertical.

[0069] Maintaining the irrigation flow 17 of rinsing solution and applying the laser pulses 14 to ablate the melanocytes and, for example, intraoperatively flushing them out of the anterior chamber 9 have the advantage that essentially no degenerated cell material needs to be separated via Schlemm's canal.

[0070] FIG. 2 shows an enlarged view of the area of ​​the iris 4 and the stroma 6 of the eye, as shown in FIG. 1. FIG. 2 particularly shows one or more laser pulses 14 acting on the anterior stromal layer 8. As a direct result of the application of the one or more laser pulses 14, melanocyte cells 15, which under normal conditions are bound to the anterior stromal layer 8, are detached directly into the anterior chamber 9 and are flushed out by the pumpless irrigation flow 17.

[0071] Further details of an embodiment of a device 18 according to the invention are described in connection with FIG. 3.

[0072] FIG. 3 shows a schematic view of the eye 1 and, furthermore, a schematic representation of an exemplary embodiment of components of the device 18.

[0073] The device 18 comprises a laser unit 19 (or laser applicator 19) with a laser source 20 for generating predefined laser pulses 14. The laser unit 19 can be operated via a focusing device (not shown), for example, an optical system, in order to direct and apply the generated predefined laser pulses 14 to the anterior stromal layer 8 of the iris 4. The laser unit 19 can, in particular, comprise a target setting device for setting a corresponding target point / area onto which the generated laser pulses 14 are to impinge.

[0074] The predefined laser pulses 14 are generated and applied in such a way that melanocyte cells 15 of the anterior stromal layer 8 are detached directly into the aqueous humor contained in the anterior eye chamber 9 by the action of the laser pulses 14.

[0075] The laser source 20 can, for example, be a Q-switched, frequency-doubled Nd:YAG laser for generating laser pulses in the wavelength range of approximately 532 nm with a pulse length of approximately 4 ns and a pulse energy of approximately 2 mJ. The pulse frequency of the laser unit 19 can, for example, be in the range between 3 Hz and 300 Hz. The focusing device and / or the target adjustment device can be adapted and configured to generate laser spot sizes in a diameter range of approximately 500 pm.

[0076] The device further comprises an irrigation unit, which in the present example is formed by an inflow module 21 and an outflow module 22. The inflow module 21 and the outflow module 22 are configured for pumpless generation of the irrigation flow 17 through the anterior chamber 9 of the eye. The pumpless irrigation flow 17 thus generated makes it possible to gently remove ablated and excreted melanocytes and melanocyte material 16 from the anterior chamber 9 of the eye, which in particular leads to the advantages described in more detail above.

[0077] In the illustrated embodiment, the inflow module 21 comprises an inflow tube 23, to which a rinsing solution source 24, for example, a container or tube with rinsing solution 25, is connected on the inlet side. A first applicator 26, in particular a needle applicator or a hollow needle, is present or connected to the inflow tube 23 on the outlet side. The first applicator 26 is designed for insertion into the eye 1 and for establishing a fluidic connection between the inflow tube 23 or the rinsing solution source 24 and the anterior chamber 9 of the eye.

[0078] The drainage module 22 comprises a drainage tube 27, which has a second applicator 28, in particular a needle applicator or a hollow needle, on the inlet side. The second applicator 28 is designed for insertion into the eye 1 and for establishing a fluidic connection between the anterior eye chamber 9 and the drainage tube 27 or a rinsing solution sink 29 provided on the outlet side of the drainage tube 27 and / or connected or connectable to the drainage tube 27. The rinsing solution sink 29, like the rinsing solution source, can be designed, for example, as a vessel or tube.

[0079] As can be seen from FIG. 3, the irrigation unit of the illustrated embodiment is designed and operable such that the irrigation flow 17 can be generated without a pump by a hydrostatic pressure gradient between the rinsing solution source 24 and the rinsing solution sink 29. The rinsing solution source 24 is arranged vertically higher with respect to the position of the rinsing solution sink 29.

[0080] In embodiments, the irrigation unit may comprise a valve unit 30 configured to adjust a volume flow of rinsing solution 25 generated through the anterior eye chamber 9.

[0081] The irrigation unit is configured, for example, with regard to the volume flows that can be generated and the diameters of the applicators 26 and 28, such that degenerated and detached cell material 16 can be gently and simultaneously efficiently removed from the anterior chamber 9 by the irrigation flow 17 or irrigation stream through the anterior chamber 9. In summary, the proposed device is particularly suitable for efficiently and gently flushing or removing cell material from the interior of the eye, in particular the anterior chamber.

[0082] Reference symbol list

[0083] 1 eye

[0084] 2 lens

[0085] 3 Retina

[0086] 4 Iris

[0087] 5 pupil

[0088] 6 Stroma

[0089] 7 pigmented epithelial cells

[0090] 8 anterior stromal layer

[0091] 9 anterior chamber

[0092] 10 Cornea

[0093] 11 eyelash bodies

[0094] 12 posterior chamber

[0095] 13 Schlemm Canal

[0096] 14 laser pulses

[0097] 15 Melanocyte cell

[0098] 16 detached melanocyte cells / detached cell material

[0099] 17 Irrigation flow

[0100] 18 Device

[0101] 19 Laser unit

[0102] 20 Laser source

[0103] 21 Inflow module

[0104] 22 Drain module

[0105] 23 Inlet hose

[0106] 24 Rinse solution source

[0107] 25 Rinse solution

[0108] 26 first applicator

[0109] 27 Drain hose

[0110] 28 second applicator

[0111] 29 Rinse solution sink

[0112] 30 valve unit

Claims

Patent claims 1. An ophthalmological device (18) for treating an eye, in particular components inside an eyeball, preferably in the region of the anterior chamber of an eye (1), the device (18) comprising: a) a laser unit (19) configured to apply energy, in particular laser radiation (14), to components inside the eye, in particular the anterior stromal layer (8) of the iris (4), through the cornea (10) of the eye (1); and b) an irrigation unit (21, 22) for irrigating the eye (1) by means of a rinsing solution (25), preferably in conjunction with an application of the energy, the irrigation unit (21, 22) being configured to generate an irrigation flow (17) of rinsing solution (25) through the eye (1) without the need for a pump.

2. Ophthalmological device (18) according to claim 1, wherein the laser unit (19) further comprises a laser source (20), and the laser unit (19), the laser source (20) and the irrigation unit (21, 22) have a, in particular configurable-adjustable, mode of operation in which a) laser pulses (14) are generated and emitted which, when applied through the cornea (10) of an eye (1) onto the anterior stromal layer (8) of the iris (4) of the eye (1), cause melanocyte cells (15) to be released from the anterior stromal layer (8), and b) the irrigation flow (17) is generated during the application of the laser pulses (14) to the stromal layer (8) and / or at least in a predetermined time window from the application of the laser pulses (14) to the stromal layer (8).

3. Ophthalmological device (18) according to one of the preceding claims, wherein the laser radiation (14) is generated by a or the laser source (20) in the form of laser pulses (14), and the laser pulses (14) have at least one of the following laser parameters: a) a laser wavelength in the range from 500 nm to 560 nm, preferably from 520 nm to 540 nm, more preferably from about 532 nm; b) a pulse energy in the range from 1 mJ to 7 mJ per laser pulse (14), preferably from 1 mJ to 3 mJ; c) a pulse duration in the range from 2 ns to 8 ns, preferably from 3 ns to 6 ns; d) a spot diameter in the range from 150 pm to 350 pm, preferably from 200 pm to 300 pm; c) a repetition rate in the range from 70 to 110 pulses / s, preferably from 80 to 100 pulses / s.

4. Ophthalmological device (18) according to one of the preceding claims, wherein the irrigation unit (21, 22) comprises an inflow module (21) for supplying the rinsing solution (25) into the interior of the eye and an outflow module (22) for draining fluid from the interior of the eye, wherein, optionally: a) the inflow module (21) comprises an inflow tube (23), on the inlet side of which a rinsing solution source (24) is provided and / or which is connected or connectable to a rinsing solution source (24) on the inlet side, and on the outlet side comprises a first applicator (26), in particular a needle applicator, which is designed to be inserted into the eye (1) and to establish a fluidic connection between the inflow tube (23) and the outlet side.the rinsing solution source (24) and the interior of the eye, and / or b) the drainage module (22) comprises a drainage tube (27) which, on the inlet side, comprises a second applicator (28), in particular a needle applicator, which is designed to be inserted into the eye (1) and to establish a fluidic connection between the interior of the eye and the drainage tube (27) or a rinsing solution sink (29) provided on the outlet side on the drainage tube (27) and / or connected or connectable to the drainage tube (27).

5. Ophthalmological device (18) according to one of the preceding claims, wherein the irrigation unit (21, 22) is designed and operated is that the pumpless irrigation flow (17) is generated or can be generated by a hydrostatic pressure gradient and / or is generated or can be generated by capillary forces.

6. Ophthalmological device (18) according to one of the preceding claims, wherein the irrigation unit (21, 22) comprises at least one actuating means (30), in particular a valve unit (30), which is configured to activate, deactivate and / or adjust a volume flow (17) of rinsing solution (25).

7. Ophthalmological device (18) according to claim 6, wherein for activating, deactivating and / or adjusting the volume flow (17), the actuating means (30) is adjustable and / or actuatable by an actuator element coupled or coupleable to the actuating means (30), wherein, preferably, the actuator element is actuatable by a user actuation, in particular by a user actuation unit or interface, in particular a manual actuation or a foot actuation, by voice control, a gesture control, and / or automated, in particular depending on operating parameters of the device or the laser unit (19).

8. Ophthalmological device (18) according to claim 6 or 7, wherein the actuating means (30) comprises a closed position for deactivating the volume flow (17) and at least one open position for activating a volume flow (17), wherein for activating, deactivating and / or adjusting the volume flow (17) the actuating means (30) is transferable between the closed position and the at least one open position, wherein, optionally, the actuating means (30) is configured for a continuous transfer between the closed position and the at least one open position, or the actuating means (30) is configured for a step-by-step transfer between the closed position and a plurality of open positions.

9. Ophthalmological device (18) according to one of the preceding claims, wherein the irrigation device (21, 22) is configured to generate an irrigation flow (17) through the anterior chamber (9) of the eye (1), in particular such that detached cell material (16), in particular melanocyte cells (16), can be discharged from the anterior chamber (9).

10. Ophthalmological device (18) according to one of the preceding claims, wherein the laser unit (19) comprises a pulsed laser source, in particular a short-pulse laser, preferably an Nd:YAG laser, wherein the laser source is preferably Q-switched.

11. Use of an ophthalmological device (18) according to one of claims 1 to 10 for removing melanocyte cells (15) of the anterior stromal layer (8) of the iris (4) of an eye (1), wherein the melanocyte cells (15) are released from the stromal layer (8), in particular quasi-mechanically released, by laser pulses (14) applied to the stromal layer (8) via the laser unit (19), and are rinsed out of the anterior chamber of the eye (1) essentially immediately during or immediately after the release by an irrigation stream (17) generated by the irrigation unit.

12. A method for controlling an ophthalmological device (18) according to one of claims 1 to 10, in particular when used to change the eye color by mechanical removal of melanocyte cells (16) from the anterior stromal layer (8) of the iris (4) of the eye (1), wherein melanocyte cells (15) released from the stromal layer (8) are rinsed out of the anterior eye chamber (9) in a predetermined time window after being released by the irrigation flow (17) of the irrigation device (21, 22).

13. The method according to claim 12, wherein the time window is in the range of 0 to 20 minutes, preferably between 0 to 10 or 15 minutes, more preferably between 0 to 1 minute or 3 minutes.

14. Method according to one of claims 12 or 13, wherein laser radiation (14), in particular laser pulses (14), are emitted only when irrigation flow (17) is present or can be generated within the time window.

15. A method for setting up an operation of an ophthalmological device (18) according to one of claims 1 to 10 for use in a method for changing the eye color of an eye (1), comprising: a) setting up the laser unit (19) and the laser source (20) for emission of laser pulses with one or more of the following laser parameters: laser wavelength in the range from 500 nm to 560 nm, preferably from 520 nm to 540 nm, more preferably from about 532 nm; pulse energy in the range from 1 mJ to 7 mJ per laser pulse (14), preferably from 1 mJ to 3 mJ; pulse duration in the range from 2 ns to 8 ns, preferably from 3 ns to 6 ns; spot diameter in the range from 150 pm to 350 pm, preferably from 200 pm to 300 pm; Repetition rate in the range of 70 to 110 pulses / s, preferably 80 to 100 pulses / s;and b) setting up the irrigation unit (21, 22) in such a way that, when used, an irrigation flow (17) suitable for rinsing the anterior chamber of the eye (9) with rinsing solution can be generated, by means of which melanocyte cells (15) released from the anterior stromal layer (8) by the laser pulses (14) can be rinsed out of the anterior chamber of the eye (9), preferably within a predetermined time window, preferably from 0 to 10 minutes, more preferably from 0 to 3 minutes.;

Images