Retinal radiation therapy device

Abstract

The present invention relates to an apparatus for therapeutic treatment of the retina, characterized by a holding and positioning device for holding an optical lens element in a defined position and orientation in front of a patient's eye, a lens element having an illumination-transmitting concave surface for placement on a closed eyelid, and an illumination source for cooperating with the optical lens element to deliver therapeutically effective illumination to the retina through the optical lens element.

Description

[Technical Field]

[0001] The present invention relates to a device for therapeutic treatment of the retina by photobiomodulation using dosed irradiation treatment. [Background technology]

[0002] The treatment of human tissues by exposure to radiation is known and used scientifically in therapeutic approaches to the treatment of degenerative diseases and other tissue pathologies. In addition to irradiation with hard rays, such as radiotherapeutic irradiation of tumor cells, which is not considered in detail here and is not relevant to the present invention, it has recently become known that therapeutic effects can also be achieved by irradiation with wavelengths in the visible light range and adjacent wavelength ranges. Radiation is used for different tissues, for example, in wound healing of cutaneous and subcutaneous tissue.

[0003] A particular application area is the treatment of the eye, more precisely the retina, with electromagnetic radiation in the visible light range and adjacent wavelengths (here, wavelengths between 400 nm and 1500 nm). Dosage-based radiation therapy can be used to treat degenerative diseases of the retina. Retinal cells are naturally sensitive to light irradiation, especially to incorrect doses. The inventors have found that in addition to the relationship between exposure time and intensity, the wavelength range, presentation mode (e.g., pulsed or continuous irradiation, angle of incidence, and area of ​​irradiation), repetition rate, and exposure time (circadian rhythm) are also factors that can positively or negatively influence the desired therapeutic effect and potentially alter it to a cell-damaging effect. The human retina, in particular, is rich in mitochondria. Because mitochondria can have a pronounced circadian metabolic activity, the inventors have found that, in such therapeutic treatments, they have different sensitivities to specific frequencies of electromagnetic radiation at different times of the day. The sensitivity of cellular structures to electromagnetic radiation can also vary depending on an individual's age, constitution, or disease. Furthermore, because the retina is intricately interconnected by neurons (e.g., in the form of so-called on-off fields), illumination of a particular area can affect non-illuminated or less illuminated areas.

[0004] U.S. Pat. No. 10,219,944 and U.S. Patent Application Publication No. 2016 / 0067087 disclose devices that allow for the treatment of the retina of the eye with a predetermined treatment program. For this purpose, a specialized treatment device is provided that fixes the user's head in a predetermined position and mounts it on a fixed frame of the device, thereby fixing the eye position and head orientation in a defined manner, in order to perform therapeutic irradiation of the retina of both eyes. However, the drawback of this device is that it requires multiple treatment procedures to achieve a therapeutic effect. While its special structure ensures the necessary safety for performing the treatment, its special structure and associated manufacturing costs make it unsuitable for making it available to patients for a single treatment procedure, for example, by purchasing or renting it themselves. Therefore, patients must regularly visit inpatient or outpatient facilities for multiple treatment procedures. Such facilities can achieve high utilization rates, making the acquisition of such devices economical.

[0005] In principle, it is desirable to both reduce patient effort and avoid high costs to the healthcare system. In principle, one approach to avoiding the costs of outpatient or inpatient treatments would be to allow patients to perform the treatment themselves. However, on the one hand, this cannot be achieved with cost-intensive equipment, because the acquisition of such equipment would counteract the desired cost-saving effect. On the other hand, such treatments are usually not suitable for home use, as incorrect operation or imperfect setup can cause tissue damage instead of the intended treatment.

[0006] The irradiation devices for setting and defined positioning of a patient's head known from US Patent No. 10,219,944 and US Patent Application No. 2016 / 0067087 are devices suitable for use in inpatient or outpatient treatment centers, the acquisition of which is well suited for use by a large number of patients with longer intervals between treatment procedures. However, due to economic reasons and the adjustment and support work required for these devices, a doctor must be present with the patient during the treatment procedure, and therefore the devices are not suitable for cost-saving and at the same time not suitable for technically and medically safe treatment procedures over long periods of time with multiple treatment procedures carried out at intervals.

[0007] Another device for retinal radiotherapy is known from WO 2018 / 224671. This device is a system consisting of a specially made device worn by the patient like a pair of eyeglasses. The irradiation source is attached to the eyeglasses and controlled by a separate control unit belonging to the treatment system. This device is also a special device consisting of two purchased treatment devices: one special control device and the other special eyeglass-type treatment device with the irradiation source. Here too, it is not possible to carry out economically efficient and at the same time medically safe long-term treatment with multiple treatment steps spaced apart in time.

[0008] An irradiation device for the treatment of human eyes is also known from US Patent Application Publication No. 2016 / 0158486. The device taught in this document features a wide variety of designs, allowing the device to be worn near or inside the eye. Furthermore, it is described that contact with the eyelid is also envisaged as an embodiment. However, a drawback of this known teaching is the lack of information about the structure of the device and the arrangement of the components essential for effective effect. Furthermore, the device is based on distant transmission of radiation, which means that it must achieve unfavorable transmission rates and suffer from unfavorable thermal curing.

[0009] Another irradiation device worn like ski goggles is known from US Patent Application Publication No. 2013 / 0304162, which relies on remote radiation transmission through the air to the open eye, which on the one hand leads to a dependency on unavoidable eye movements during treatment, and on the other hand, the closing of the eyelids can only achieve inaccurate dosing of the irradiation intensity and total dose.

[0010] US Patent Application Publication Nos. 2017 / 0333729 and 2019 / 0232078 disclose bilateral beta-ray irradiation devices with a structure similar to a sleep mask. These devices are suitable as ancillary means for treatment, but cannot be used as therapeutic irradiation devices, since they do not provide a reliable dose of either the irradiation intensity or the total dose.

[0011] An irradiation device for the eye is known from US 2020 / 008135, which is based on the principle of transmission through air from multiple light sources with diffuse alignment of the radiation, which does not allow for therapeutic targeting of diseased tissue areas, and which is too large and cumbersome for the user to comfortably carry or use for longer treatment periods.

[0012] A technical problem in the treatment of radiation-sensitive tissues with therapeutic radiation is that excessive radiation exposure can result in tissue damage rather than the intended therapeutic effect. Such excessive radiation exposure can be caused, on the one hand, by too high a radiation source intensity, or by too short a distance between the source and the retina due to long exposure times, or by too short a repetition rate of exposure, or by a combination of these causes. Therefore, therapeutic radiation treatments can generally be performed with specialized equipment that reliably prevents these damaging causes, i.e., misalignment, manipulation, and control. Approval authorities often approve treatment only if the equipment is equipped with the appropriate safety features. On the other hand, if certain manipulation errors cannot be eliminated by the equipment itself, periodic medical supervision is required during treatment. Both effects are unfavorable for the economical implementation of long-term treatments with multiple treatment procedures spaced apart in time, posing problems for the technological development of equipment that can be used in a more economical and safe manner.

[0013] Against this background, the object of the present invention is to provide an apparatus system for radiotherapy of retinal tissue, which allows long-term treatment to be carried out in multiple treatment procedures spaced apart in time more economically than known systems, while at the same time ensuring technical safety to avoid incorrect treatments leading to tissue damage.

[0014] This problem is solved according to the invention by providing a device having the features according to claim 1.

[0015] According to the present invention, there is provided a device for use in therapeutic treatment of the retina with radiation. The device comprises, on the one hand, an irradiation source and, on the other hand, a control unit for controlling the irradiation source. This control is mainly for controlling the irradiation time and irradiation intensity. However, depending on the treatment method, other parameters such as irradiation frequency and irradiation spectra can also be controlled. The irradiation source and the control unit may be integrated into one housing or may be located separately. Signal transmission can be performed wirelessly or by wire.

[0016] The present invention is based on the recognition that retinal radiation therapy, i.e., photobiomodulation (PBM), can only be effective if it is optimally adapted to the metabolic status of the target tissue, i.e., the corresponding retinal cells being addressed. In the treatment of age-related macular degeneration (AMD), the circadian rhythm of mitochondria must be taken into account above all else. PBM treatment for AMD is particularly effective, and may only be effective if irradiation is performed in the morning, and preferably daily. In principle, this is only practical and feasible when performed at home. The treatment device according to the present invention helps to provide the patient with a daily dose in the morning. This embodiment is particularly suitable for use with patients who are lying down, allowing treatment to be performed before the patient wakes up in the morning. PBM treatment for bedridden patients or patients with general illnesses is also possible.

[0017] The device according to the present invention comprises a holding and positioning device, which serves to position an optical lens element, which is part of the present invention and is connected to the holding and positioning device, in front of a patient's eye. An objective lens is used to introduce therapeutic radiation into the patient's eye. For this purpose, the objective lens must be held in a specific position and orientation in front of the patient's eye, and this position and orientation must be reliably maintained throughout the treatment. Devices for positioning the patient's head as a whole to achieve radiation alignment and positioning are known from the prior art for this purpose. Goggle-like auxiliary devices are also known, which are intended to ensure specific axial alignment and positioning of the radiation. However, these devices have been shown to have the disadvantage that they do not allow safe irradiation of the retina with the necessary safety, even when used by patients at home without supervision by medically trained personnel, for example. In particular, patient-specific positioning and orientation present problems due to possible visual abnormalities due to different eye distances or problems maintaining accurate axial positioning and orientation relative to the visual axes of both eyes.

[0018] This problem is overcome with the device of the present invention. On the one hand, the holding and positioning device serves to hold the lens element in a defined position and orientation in front of the eye. On the other hand, the lens element has a radiolucent concave surface that matches the convex surface of the eye. On the one hand, this matching serves to allow the concave surface to be placed directly on the patient's eye, preferably geometrically adapted to rest on the closed surface of the eyelid. During treatment, this concave surface ensures a reliable positioning and orientation of the lens element. At the same time, a second effect is achieved: direct support on the eye or eyelid through irradiation-effective coupling. The contact surface of the concave surface of the lens element is preferably adapted to the shape of the eyelid surface, which varies slightly from patient to patient and also varies intra-individually depending on the viewing direction under closed eyelids. This adaptability can be achieved, for example, by the elasticity of the lens element itself, as in soft contact lenses. Conformity can also be achieved by means of a gel or other method using a rigid lens element and a resilient intermediate layer.

[0019] Another advantage is that the concave contact surface of the lens element allows for temperature conduction between the eyelid and the lens element, thereby compensating for uncomfortable heating due to irradiation and allowing for a more comfortable treatment for the patient.

[0020] The device according to the invention therefore achieves a decisive advantage over known devices which aim to achieve direct irradiation through the pupil opening and the crystalline lens of the eye when the eyelids are open in that it achieves more accurate positioning and orientation as well as more favourable radiation coupling to the eye due to the direct mechanical support of the lens element on the eyelid.

[0021] At least one irradiation source has an output of 0.01 mW / cm 2 (=0.1W / m 2) greater than 0.025mW / cm 2 Greater than 0.05mW / cm 2 Greater than 0.2mW / cm 2 Greater than or equal to 0.5mW / cm 2 Therapeutically effective radiation can be delivered at higher irradiation intensities, providing sufficient irradiation for treatment with the eyelids open. The irradiation source has a 0.1 mW / cm intensity, which is particularly suitable for treatment through closed eyelids. 2 It is particularly preferred to irradiate with an irradiation intensity greater than 1000 kJ / cm. In this context, the irradiation intensity in each case is to be understood as the irradiation intensity present from the exit surface of the device at the exit surface, which may weaken or strengthen due to divergence or contraction up to the retina, and which may be reduced in particular by absorption effects in the eyelid or in other tissue parts present between the exit surface and the retina.

[0022] In principle, a therapeutically effective treatment can be achieved at this lower limit of the irradiation intensity. The irradiation intensity is preferably less than 0.1 mW / cm. 2 Less than 0.5mW / cm 2 Less than or equal to 10mW / cm 2 Less than 1 mW / cm 2 Less than 5mW / cm 2 The exposure time should be kept below 100 seconds, so as not to exceed the permissible exposure effects on both the eye itself and the eyelid skin. It should be understood that the relationship between the permissible exposure time and the permissible exposure level follows normal scientific standards.

[0023] At least one radiation source can emit therapeutically effective radiation in the wavelength range of 450 nm to 1500 nm, preferably in four different wavelength ranges within this spectrum. These four different wavelength ranges can be between 450 nm and 500 nm, 570 nm and 600 nm, 610 nm and 730 nm, and 790 nm and 890 nm, and can be applied simultaneously or with a time lag. In particular, only two wavelength ranges can be used as core wavelengths, preferably 850±15 nm, as well as wavelength ranges around 670±15 nm and around 810±15 nm.

[0024] The at least one irradiation source is capable of irradiating with a power of 1 μW to 10 μW, preferably 100 μW to 1 W, and ideally 1 mW to 100 mW, where power is understood as the output power of the irradiation source, e.g., a diode used as irradiation source.

[0025] The lens element may be composed of multiple optically active elements or may be formed by a single optically active element. The concave surface of the lens element conforms to the shape of the eye or closed eyelid and therefore typically has a radius of 5 mm to 50 mm, ideally 10 mm to 100 mm. The concave surface may be composed of multiple segments with different radii or may include a flat portion. As mentioned above, it is preferable to conform the surface to different radii. In particular, the concave surface of the objective lens may also have a shape and radius such that a hygienic film or hygienic release liner, used as a reusable or disposable release liner, can be attached thereto to enable good hygiene and sterilization of the body-contacting surface of the device.

[0026] In preferred embodiments where the concave surface is designed to rest on the closed eyelid, the patient also has their eyelids closed, so there is no reason for them to move their eyes during treatment, achieving a therapeutic effect and reliable irradiation. These advantages outweigh the disadvantage of some attenuation and filtering of radiation through closed eyelids, resulting in an overall safer and more reliable treatment method, particularly suitable for home use by patients.

[0027] According to an alternative or preferred aspect of the present invention, the optical lens element comprises a diffuser configured to diffuse radiation from the irradiation source onto an irradiance-transmissive concave surface. According to this embodiment, the lens element comprises a diffuser. This diffuser may be formed directly by an element resting on the eye or eyelid surface, constituting the lens element itself or being part of the lens element. However, the diffuser can also be located elsewhere on the lens element. In this context, a diffuser is understood to be an optically active element that achieves a distribution effect, for example, by optical scattering or refraction. This may be, for example, a scattering element, a hologram, a lens, or a light guide, as an optical element. A typical example of such a diffusion effect is the optical effect of a frosted glass pane, which is achieved by a transparent material with a crystalline or semi-crystalline structure. The diffusion effect achieves a therapeutically appropriate radiation distribution. On the other hand, this distribution can be designed so that a larger irradiated surface is generated from punctual and / or directed irradiation, and / or so that a diffusion in the sense of undirected irradiation is generated therefrom, possibly with a preferred direction.

[0028] More preferably, the diffuser is designed as an integrating sphere or as a layer of semi-permeable material, in particular polytetrafluoroethylene. According to the inventors' findings, these particular embodiments of the diffuser are particularly suitable for integration into the device according to the invention and have been found to achieve a diffusion effect that is advantageous for therapeutic purposes.

[0029] It is further preferred if the lens is equipped with a thermal heating or cooling device, which on the one hand allows achieving a contact surface temperature that is comfortable for the patient and on the other hand prevents temperature outflow and corresponding temperature inflow from the eye or eyelid. In particular, to compensate for temperature effects occurring during treatment and to prevent heating of the lens element by radiation, the heating or cooling device can be connected to a control unit that sets a constant temperature at the eyelid or lens element.

[0030] A further embodiment of the invention comprises a set of interface elements, each of which can be attached to the concave surface of a lens element. The set comprises a first interface element having a first refractive index and a second interface element having a second refractive index different from the first refractive index. This further development allows the possibility of changing the refractive index of the lens to match the irradiated tissue material. This has proven particularly advantageous for effective coupling to the closed eyelid and avoiding excessive heating of the lens element. The interface elements can be designed as foils that can be glued to the exit surface of the lens element.

[0031] It is further preferred that the holding and positioning device is designed as a partial face mask that at least partially covers the eye area of ​​the face. Such a design of the holding and positioning device allows, on the one hand, a comfortable wearing of the device by the patient, but, on the other hand, ensures sufficient precision for the purpose of positioning and orientation, in particular allowing accurate orientation and positioning based on the concave contact surfaces of the lens elements. In particular, here, a first basic positioning and orientation of the lens elements is achieved by the holding and positioning device, but the lens elements themselves are preferably still attached to the holding and positioning device so as to be movable within limits, in order to allow a second accurate orientation and positioning based on the form-fit effect of the concave surface of the lens elements themselves.

[0032] In particular, partial face masks may be designed to rest on the skin surface adjacent to the eyes, where basic form-fit positioning is achieved by the contours of the bones below the skin surface, such as known from the frames of eyeglasses.

[0033] It is further preferred if the partial face mask is held in place on the patient's face, in particular by straps or straps guided around the head, such as eyeglass straps, or by holding elements guided around the ears, or by suction cups, which ensure good fixation and retention on the patient, sufficient for basic orientation and positioning.

[0034] According to a further preferred embodiment, it is provided that the irradiation source is attached to the holding and positioning device and is in a treatment position in the irradiation axis together with the pupil and the diffuser. According to this embodiment, the irradiation device is placed or fixed directly on the holding and positioning device. Therefore, the patient can wear this positioning and holding device comfortably and does not require connection to an external device outside the face. In order to achieve direct radiation propagation without deflection in the direction of the retina along the axis, it is preferred here that the irradiation source is located on the irradiation axis together with the pupil and the diffuser.

[0035] It is further preferred that the radiation source be arranged on the irradiation base device at a distance from the holding and positioning device and that the radiation be guided from the irradiation base device to the holding and positioning device by a flexible irradiation guide. In this embodiment, in addition to the radiation source arranged directly on the holding and positioning device, an additional second radiation source spaced apart from the holding and positioning device is also provided. The radiation of the second radiation source is conducted to the objective lens by an irradiation conductor, for example a glass fiber wire. The therapeutic radiation is constituted by the first radiation source and the second radiation source, which can act on the retina simultaneously, additively or alternately.

[0036] According to an alternative embodiment, the irradiation source is arranged on the irradiation base unit at a distance from the holding and positioning device, and the irradiation is guided from the irradiation base unit to the holding and positioning device by a flexible irradiation guide. According to this embodiment, since the irradiation device is not arranged on or fixed to the holding and positioning device, the holding and positioning device can be designed as a lightweight and compact unit. Instead, the irradiation source is arranged on an irradiation base unit that is separate from the holding and positioning device, e.g., in the form of a tabletop unit, and that does not need to be attached or worn by the patient. From this irradiation base unit, the medical radiation is guided to the objective lens by an irradiation guide. Such an irradiation guide can be designed as a single-core or multi-core light guide arrangement. In particular, separate irradiation guides can be provided to irradiate the left and right eyes and apply irradiation to two separate lens elements for the left and right eyes accordingly. This allows, on the one hand, efficient administration of the radiation power transmitted through the irradiation guide, and, on the other hand, allows different therapeutic radiation to be applied separately to the user's two eyes as needed.

[0037] According to a further preferred embodiment, at least 1 cm 2 The concave surface is designed to lie flat on the eye or closed eyelid over a contact area of ​​1 cm. 2 The flat support is achieved over a minimum area of ​​100 mm. This allows for adequate coupling of therapeutically effective radiation over a sufficiently large area and avoids undesirable irradiation effects due to high radiation concentrations. At the same time, this minimum size of the contact surface allows for safe and secure positioning of the objective lens, which is also advantageous for accurate orientation and positioning of the irradiation axis.

[0038] The device can be further advanced by an eyelid sensor signal-technically coupled to the control unit for detecting closed eyelids, and the control unit is designed to activate the irradiation device only when the eyelid sensor transmits a signal indicating closed eyelids. For this purpose, the sensor may use various physical properties, including electrochemical, mechanical, or optical elements for measuring differences in skin resistance / conductivity, contact pressure, or reflectivity. According to this embodiment, the device comprises an eyelid sensor adapted to detect whether the patient's eyelids are closed or open. Such an eyelid sensor can be designed in various ways, for example, by measuring heat conduction originating from a concave contact surface and determining the presence or absence of a planar contact with a closed eyelid based on this heat conduction. The sensor can measure the conductivity of the tissue surface on which the lens element rests, thereby determining whether this tissue surface is the surface of a closed eyelid. The eyelid sensor can also be designed as an image acquisition unit with image evaluation for detecting closed or open eyelids. The eyelid sensor can be designed as a light barrier that can distinguish between the reflection of the eyelid and the reflection of the eye surface, thus detecting closed eyelids. The eyelid sensor is signal-coupled to a control device, which can then control the exposure to radiation according to the signal from the eyelid sensor. In this way, excessive irradiation of the eye can be avoided when the eyelids are not closed, thereby avoiding overdosing of therapeutic radiation.

[0039] Alternatively, or in addition to such an eyelid sensor, the lens element may be configured to provide mechanical blockage of the closed eyelid, thereby preventing the eyelid from opening when the device is in use. This can be achieved, for example, by designing a concave contact surface to form-fit contact with the eyelid, and inhibiting opening movement of the eyelid in such form-fit contact.

[0040] The device may further comprise an input user interface and a graphic output user interface for outputting graphic information, wherein the control unit is programmed to display patient information for a subsequent therapeutic treatment via the graphic user interface during an information step and to perform a treatment step after the information step, with the irradiation time and irradiation intensity corresponding to the treatment mode input via the input user interface and / or the treatment mode output via the graphic output user interface. According to this embodiment, the device according to the invention also comprises input and output user interfaces, which may be, for example, a touch screen, a keyboard and screen, voice recognition, voice output, etc., or a combination thereof. Via these interfaces, on the one hand, a user can input data related to the treatment, and on the other hand, information related to the treatment can be output to the user. Further developments are particularly suitable for making the device suitable for home use by users and for enabling safety-related inputs and outputs via the interface so that the device can be used without medically trained personnel.

[0041] It is particularly preferred if the control unit is programmed to request user input via the input user interface in an input step between the information step and the treatment step, and to initiate the treatment step after receiving a predetermined user input. Such user input after the information step and before the treatment step provides a safety promotion and confirmation for the user, thus avoiding incorrect operation or initiation of treatment.

[0042] The control unit receives user-related personal information via the input user interface, identifies a user ID from a user ID data memory for the control unit based on the user-related personal information, and executes the predetermined treatment steps stored for the user ID in the treatment program data memory according to the user ID. According to this embodiment, the user ID is determined before treatment begins. This ensures that treatment is performed only for the intended patient and not for other persons. For example, the user ID can be determined based on a password, a fingerprint, iris recognition, etc. In particular, it is preferable to determine the user ID based on iris recognition simultaneously using an eyelid sensor designed to detect whether the eyelids are open or closed.

[0043] In this context, it is preferred that the input user interface comprises a digital image acquisition unit, and that the control unit receives image data from the digital image acquisition unit and determines the user ID based on the image data, in particular, determines the user ID based on image data representing the user's iris shape based on iris authentication.

[0044] Furthermore, it is preferred to continue the device according to the invention by arranging the control unit and the graphic output user interface in an illumination base device. The illumination base device further comprises a radiation detection device for detecting radiation emitted by the illumination source onto an optical lens element held in a holding and positioning device in front of the patient's eye. According to this embodiment, the control unit and the graphic output user interface are arranged in the illumination base device and are therefore designed integrally in one of the possibly only two structural units of the device according to the invention. This achieves on the one hand a compact structure and on the other hand an easy-to-handle device.

[0045] Furthermore, it is preferred if the control device is in the form of a smart tablet, laptop or smartphone. According to this embodiment, the control unit can be realized by software that runs as an application on the smartphone, smart tablet or laptop or the like.

[0046] It is even more preferable that the holding and carrying device has a total weight and dimensions that allow the carrying device alone to hold the device on the patient's head. According to this embodiment, the device according to the present invention can be comfortably worn on the patient's head, and the patient can move around and change positions while wearing the device, thereby establishing a comfortable treatment situation.

[0047] It is further preferred that the irradiation device has two beam exit directions spaced apart from each other in order to irradiate both eyes of the patient simultaneously. This allows both eyes to be treated simultaneously, thus shortening the treatment time. The therapeutic radiation for both eyes can be generated from a single irradiation source and distributed to both eyes by appropriate beam splitting. Alternatively, two different irradiation sources can be used, whereby each irradiation source can irradiate one eye.

[0048] The irradiation can be designed using a beam splitter or at least two independent beam sources to treat one or both eyes simultaneously. For this purpose, the eyes are separated from each other by optical isolation. The irradiation parameters and irradiation frequency for each eye can be designed differently. This allows the patient to maintain a consistent routine over a treatment period of several days and perform the treatment procedure every morning. The control unit can control the irradiation so that the eyes are irradiated in the same or different ways. For example, one eye can be irradiated with the corresponding effective therapeutic wavelength (or other parameters) only every other day, while the other eye can be irradiated with a non-therapeutically effective radiation dose, e.g., a therapeutically ineffective wavelength in the visible spectrum or a therapeutically ineffective radiation intensity. In this way, a certain placebo effect can also be used in a targeted manner.

[0049] Furthermore, it is preferred that the irradiation device comprises a first optical system including at least one first optical lens, a first optical collimator, and / or a first optical filter unit, and a second optical system spaced apart from the first optical system along the irradiation path axis and including at least one second optical lens, a second optical collimator, and / or a second optical filter unit. According to this embodiment, the irradiation device is designed to irradiate both eyes of a patient simultaneously, and for this purpose, corresponding optical devices are provided for each of the eyes. In particular, it becomes possible to treat both eyes with different therapeutic radiation, for example with respect to frequency, irradiation intensity, or other irradiation parameters.

[0050] It is further preferred that the control unit is programmed to store and control a treatment plan for the user, including at least one first and second treatment procedures, control the first treatment procedure for the user, store the completion time of the first treatment procedure, and initiate the second treatment procedure under the condition that a minimum period of time has elapsed since the completion time of the first treatment procedure. According to this further development, the control unit is programmed to intelligently and simultaneously execute error-proof treatment procedures over a longer period of time, and to execute several individual treatment steps at time intervals. In this case, appropriate programming prevents two treatment steps or treatment procedures from being executed too close to each other, which could damage the eye or at least jeopardize the success of the treatment due to excessive irradiation. This is achieved by setting a predetermined minimum period and not allowing subsequent irradiation if this minimum period has not been reached.

[0051] Furthermore, the control unit preferably receives diagnostic data characterizing the physical condition via the input user interface, generates treatment data characterizing the performed treatment procedure after the treatment procedure, transmits data packets containing the diagnostic data and the treatment data via the data transmission unit to a receiving device of an expert computer, receives command data from the transmitting device of the expert computer via the data transmission unit, and controls the irradiation device to perform the treatment procedure characterized by the command data. According to this embodiment, the device can receive diagnostic data on the one hand and generate treatment data on the other hand, and transfer these data via the data transmission unit. Thus, relevant data related to treatments performed or to be performed by the device can be directly exchanged with the expert computer, which is monitored and operated by medically trained personnel. In this way, the progress and success of the treatment can be monitored. This advanced training is particularly advantageous, making the device particularly suitable for home use by patients. Further developments also allow treatment procedures on the device to be controlled from the expert computer, thus allowing the treating physician to remotely control such treatment procedures.

[0052] Furthermore, the control unit preferably receives diagnostic data characterizing the physical condition via the input user interface, compares the diagnostic data with predetermined physical condition data stored in the electronic data memory of the control unit, and selects a subsequent treatment procedure from a plurality of treatment procedures stored in the electronic data memory of the control unit based on a match with one of the stored physical condition data. If the physical condition defined by the physical condition data is above or below the predetermined physical condition, the control unit selects the subsequent treatment procedure from the plurality of treatment procedures stored in the electronic data memory of the control unit and controls the irradiation device to execute the selected treatment procedure. According to this embodiment, the control device is programmed to detect changes in the patient's characteristics describing the health status based on the received diagnostic data, for example, by manually entering the data or by analyzing the data from the image acquisition device through image evaluation, and to select further treatment steps depending thereon. In this way, further treatment can be designed depending on the progress of the treatment, in the sense that partial success has been achieved. In this case, for example, an appropriate treatment step for the further treatment can be selected and executed from a plurality of selectable different treatment steps. Furthermore, the treatment step achieving the best results can be selected based on a comparison of the treatment success achieved with the different treatment steps, and treatment can be continued with this treatment step.

[0053] It is further preferred that the input user interface includes a digital image acquisition device and the diagnostic data includes image acquisition data describing images of the treated tissue. In such embodiments, the digital image acquisition device performs image acquisition, including images of the retinal tissue, thereby enabling direct analysis of treatment results through corresponding image evaluation. This allows direct assessment of the success of specific treatment steps, and also allows for planning of further treatment steps, such as selection of specific successful treatment steps, based on such assessment.

[0054] Preferred embodiments of the present invention will now be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0055] [Figure 1] FIG. 1 is a top view schematically illustrating a first embodiment of the present invention. [Figure 2] FIG. 10 is a top view schematically illustrating a second embodiment of the present invention. [Figure 3] FIG. 10 is a side view schematically showing a third embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0056] 1, a patient wears the device according to the present invention as a face mask 10 with their eyes closed and held in front of them by eyeglass-like support brackets 12a, 12b. The face mask 10 includes one right lens element 20 and one left lens element 30 for each of the right and left eyes in the axial direction of the eyes when the face mask 10 is worn. Six right irradiation sources 21 and six left irradiation sources 31 are incorporated into each of these lens elements. Each of these irradiation sources is integrated with a sensor that detects reflections of the emitted radiation and compares them with reference values, enabling a control unit 12 incorporated into the mask to determine whether the respective eyelids are closed or open.

[0057] The device according to this embodiment further comprises a base station 40 into which the face mask can be inserted into an adapter 41 in order to charge the rechargeable batteries 11a, 11b arranged in the face mask via corresponding contacts. The base station 40 or the face mask is further connected to a smartphone 50. The smartphone is thus in signal communication with a receiver integrated in the control unit of the face mask 10 via a Bluetooth® connection. Corresponding control software in the smartphone can be operated via the smartphone's user interface and controls the irradiation process via the irradiation sources in the lens elements 20, 30.

[0058] FIG. 2 illustrates a second embodiment of the present invention. Again, a face mask 110 is positioned over the eyes and includes lenses 120 and 130 corresponding to the axial directions of the right and left eyes. However, in this case, the lens elements 120 and 130 do not include their own illumination sources. Instead, a base station 140 is provided with a single illumination source 141 and a single illumination source 142, which are connected to the face mask via light guides 141 a and 142 a. The illumination sources 141 and 142 in the base station 140 emit radiation. The radiation is guided to the face mask 110 via the light guides 141 a and 142 a, where it is guided and coupled to the two lens elements 120 and 130, thereby effectively providing therapeutic illumination of the retina.

[0059] The base station 140 of the second embodiment further comprises a proprietary user interface 145, via which the patient can operate the device and in particular set irradiation parameters such as irradiation intensity and irradiation time.

[0060] 3 is a partial cross-sectional side view showing a third embodiment of the present invention. In this third embodiment, a face mask 210 is also applied to the face. The face mask comprises a lens element 220 including an imaging lens 221 and a diffuser 222 having a concave bearing surface 223 facing the closed eyelid 2. This concave bearing surface 223 rests directly on the closed eyelid and couples the radiation onto the eyelid. This radiation passes through the eyelid and reaches the retina 4 of the eye 1 via the lens 3, where it achieves a therapeutic effect.

[0061] In the face mask 210, radiation sources 224a-224d are positioned directly above the diffuser 222 and emit radiation into the diffuser 222, which then passes through the concave surface 223 onto the eyelids and from there onto the retina.

[0062] Additionally, in this embodiment, there is an external illumination source 227, which is connected to the face mask via a light guide 228. Radiation emitted by the external illumination source 227 is coupled to the lens element 220 via the light guide 228, enters the diffuser 222, and reaches the retina via the concave surface 223.

[0063] The external radiation source 227 is located in a base station 240 that includes a receptacle with electrical contact elements for charging the energy storage device of the face mask 210, as in the first embodiment.

Claims

1. 1. An apparatus for therapeutic treatment of the retina, comprising: at least one radiation source that delivers therapeutically effective radiation; a control unit for driving the irradiation source, the control unit being programmed to deliver therapeutically effective radiation from the irradiation source to the retina of the eye for a predetermined irradiation time and at a predetermined irradiation intensity; Equipped with a holding and positioning device for holding an optical lens element in a defined position and orientation in front of a patient's eye, said optical lens element having a radiation-transmitting concave surface for placement on a closed eyelid, said irradiation source cooperating with said optical lens element to deliver therapeutically effective radiation to the retina through said optical lens element; Device.

2. the optical lens element comprises a diffuser adapted to diffuse the radiation from the illumination source onto the radiation-transmitting concave surface.

10. The apparatus of claim 1.

3. The diffuser is designed as an integrating sphere (Ulbricht-sphere) or as a semi-transparent material, 3. The apparatus of claim 2.

4. The optical lens element is provided with a thermal heating or cooling device.

4. An apparatus according to any one of claims 1 to 3.

5. a set of interface elements; one of the sets is mountable to the radiation-transmitting concave surface of the optical lens element; The set comprises: a first interface element having a first refractive index; a second interface element having a second refractive index different from the first refractive index; Equipped with 5. An apparatus according to any one of claims 1 to 4.

6. The holding and positioning device is designed as a partial face mask that at least partially covers the eye area of ​​the face.

6. An apparatus according to any one of claims 1 to 5.

7. The partial face mask comprises: by a band worn around the head, or by a retaining element that hangs over the ear, such as a strap or eyeglass temple; or The suction cup held in place on the patient's face, 7. The apparatus of claim 6.

8. the irradiation source is secured to the holding and positioning device; 8. An apparatus according to any one of claims 1 to 7.

9. a second illumination source disposed on the illumination base device at a location remote from the holding and positioning device; the radiation is guided from the irradiation base device to the holding and positioning device by a flexible irradiation guide; 9. The apparatus of claim 8.

10. the illumination source is positioned on an illumination base device at a location remote from the holding and positioning device; the radiation is guided from the irradiation base device to the holding and positioning device by a flexible irradiation guide; 8. An apparatus according to any one of claims 1 to 7.

11. the radiation-transmitting concave surface is designed to superficially contact the eye or closed eyelid over a contact area of ​​at least 1 cm; 11. An apparatus according to any one of claims 1 to 10.

12. the optical lens element includes an eyelid sensor signal-coupled to the control unit for detecting a closed eyelid; the control unit is designed to activate the illumination source only when the eyelid sensor detects a signal indicating a closed eyelid; 12. Apparatus according to any one of claims 1 to 11.

13. a base station having a receiver for said holding and positioning device; the receiving device includes a heating means or a cooling means for heating or cooling the optical lens element; 13. An apparatus according to any one of claims 1 to 12.

14. an input user interface; a graphic output user interface for outputting graphic information; Equipped with the control unit is programmed to, at an information step, present information regarding a subsequent therapeutic treatment step to the patient via the graphical output user interface, and to perform the therapeutic step after the information step; the irradiation time and the irradiation intensity correspond to a treatment mode input via the input user interface and / or output via the graphic output user interface; 14. Apparatus according to any one of claims 1 to 13.

15. The control unit between the information step and the treatment step, an input step requests user input via the input user interface; Initiating said treatment step upon receipt of a predetermined user input; 15. The apparatus of claim 14.

16. The control unit receiving user-related personal information via the input user interface; Identifying a user ID from a user ID data store of the control unit based on the user-related personal information; Execute a predetermined treatment step stored for the user ID in a treatment program data memory in response to the user ID; 16. Apparatus according to claim 14 or 15.

17. the input user interface comprises a digital image acquisition unit; The control unit receiving image data from the digital image acquisition unit; determining a user ID based on the image data; 17. The apparatus of claim 16.

18. the control unit and the graphical output user interface are disposed on an illumination-based device; the illumination-based device further comprising an illumination guide device for directing the radiation emitted from the illumination source to the optical lens element held on a holding and positioning device in front of the patient's eye.

17. An apparatus according to any one of claims 14 to 17 and claims 9 to 10.

19. The control unit is provided in a smart tablet, a laptop, or a smartphone.

19. Apparatus according to any one of claims 1 to 18.

20. the holding and positioning device has a total weight and size that allows the holding and positioning device alone to be supported on the patient's head; 20. Apparatus according to any one of claims 1 to 19.

21. the illumination source has two beam exit directions spaced apart from one another for simultaneously illuminating both eyes of a patient; 21. Apparatus according to any one of claims 1 to 20.

22. The radiation source comprises: a first optical system including at least one first optical lens, a first optical collimator, and / or a first optical filter unit; a second optical system spaced apart from the first optical system along the illumination optical path axis and including at least one second optical lens, a second optical collimator, and / or a second optical filter unit; Equipped with 22. Apparatus according to any one of claims 1 to 21.

23. The control unit storing and controlling a treatment plan including at least a first treatment procedure and a second treatment procedure for a user; Controlling a first treatment procedure for a user; storing a completion time of the first treatment procedure; commencing a second treatment procedure under the condition that a minimum period of time has elapsed since the completion time of the first treatment procedure; 23. Apparatus according to any one of claims 1 to 22.

24. The control unit receiving diagnostic data characterizing a physical condition via an input user interface; generating treatment data after the treatment procedure that characterizes the treatment procedure performed; transmitting data packets containing said diagnostic data and said therapeutic data to a receiving device of a specialist computer via a data transmission unit; receiving command data from a transmission device of the specialized computer via the data transmission unit; controlling the radiation source to perform a treatment procedure characterized by the instruction data; 24. Apparatus according to any one of claims 14 to 23.

25. The control unit receiving diagnostic data characterizing a physical condition via an input user interface; comparing the diagnostic data with predetermined physical condition data stored in an electronic data memory of the control unit; selecting a subsequent treatment protocol from a plurality of treatment protocols stored in the electronic data memory of the control unit based on corresponding to one of the stored physical condition data, exceeding a physical condition defined in the physical condition data, or falling below a physical condition defined in the physical condition data; controlling the radiation source to perform the selected treatment procedure; 25. Apparatus according to any one of claims 14 to 24.

26. the input user interface comprises a digital image capture device; the diagnostic data includes image acquisition data describing an image of the treated tissue; 26. Apparatus according to claim 24 or 25.

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