EP4135835A1 - Appareil de traitement de la rétine par rayonnement - Google Patents

Appareil de traitement de la rétine par rayonnement

Info

Publication number
EP4135835A1
EP4135835A1 EP21717828.4A EP21717828A EP4135835A1 EP 4135835 A1 EP4135835 A1 EP 4135835A1 EP 21717828 A EP21717828 A EP 21717828A EP 4135835 A1 EP4135835 A1 EP 4135835A1
Authority
EP
European Patent Office
Prior art keywords
radiation
treatment
data
control unit
holding
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21717828.4A
Other languages
German (de)
English (en)
Inventor
Georg Gerten
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ciromed GmbH
Original Assignee
Ciromed GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ciromed GmbH filed Critical Ciromed GmbH
Publication of EP4135835A1 publication Critical patent/EP4135835A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0622—Optical stimulation for exciting neural tissue
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0626—Monitoring, verifying, controlling systems and methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/063—Radiation therapy using light comprising light transmitting means, e.g. optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0632—Constructional aspects of the apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643—Applicators, probes irradiating specific body areas in close proximity
    • A61N2005/0645—Applicators worn by the patient
    • A61N2005/0647—Applicators worn by the patient the applicator adapted to be worn on the head
    • A61N2005/0648—Applicators worn by the patient the applicator adapted to be worn on the head the light being directed to the eyes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0659—Radiation therapy using light characterised by the wavelength of light used infrared
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0662—Visible light
    • A61N2005/0663—Coloured light

Definitions

  • the invention relates to a device for the therapeutic treatment of the retina by means of photobiomodulation by means of a metered radiation treatment.
  • irradiation with hard rays which are not considered here and are not assigned to the invention, such as radiotherapeutic irradiation of tumor cells
  • irradiation with radiation of a wavelength in the range of visible light and in adjacent wavelength ranges also can achieve therapeutic effects.
  • the irradiation is used on different tissues, for example for wound healing of skin tissue and subcutaneous tissue.
  • a special field of application is the treatment of the eye, more precisely the retina or retina, by means of such radiation in the visible light range and the adjacent electromagnetic radiation, using wavelengths from 400 nm to 1500 nm).
  • a dosed radiation treatment can be used sensibly for the therapy of degenerative diseases of the retina.
  • the cells of the retina are naturally sensitive to light radiation and particularly sensitive to incorrect dosage of the radiation.
  • Relationship of the duration of exposure to optical radiation and the radiation intensity, wavelength range, mode of presentation e.g. pulsed or continuous radiation, angle of incidence and radiation area of the radiation
  • the repetition rate and the time of exposure also make the desired therapeutic effect positive or negative influence, even change into a cell-damaging effect.
  • the human retina in particular is heavily supplied with mitochondria, which can have a pronounced circadian metabolic activity and therefore, according to the inventors' knowledge, have different sensitivities for certain frequencies of electromagnetic radiation in such therapeutic treatments at different times of the day.
  • the susceptibility of cell structures to electromagnetic radiation can also vary depending on the age of the individual, his / her individual constitution or the disease.
  • the retina is interconnected in a neuronally complex manner (e.g. in the form of so-called on-off fields), so that irradiation of certain areas can affect areas that are not or less irradiated.
  • a device is previously known from US 10,219,944 B2 and US2016 / 0067087 A1 which enables the retina of the eye to be treated with a predetermined treatment program.
  • a special treatment device which picks up the user's head in a defined position, then fixes the eye position and head alignment in a defined manner by resting on a mounting frame section of the device, in order to then irradiate the retina of both eyes for therapeutic purposes.
  • the disadvantage of this device is that a large number of treatment processes are necessary for the therapeutic effect and, due to its special design, the device can ensure the necessary safety for carrying out the treatment, but is unsuitable due to its special design and the associated manufacturing costs in order to be available to the patient himself for a treatment process - for example by the patient buying or lending it himself.
  • the patient therefore has to return to an inpatient or outpatient facility for a large number of treatment processes, for which the acquisition of such a device can be cost-effective due to the high capacity utilization that can be achieved there.
  • the radiation device known from US 10,219,944 B2 and US2016 / 0067087 A1 for setting up and positioning the patient's head in a defined manner is a device suitable for use in inpatient or outpatient treatment centers longer intervals between the treatment processes.
  • the accompaniment of a doctor during the treatment process is necessary and the device is therefore not suitable for a cost-saving and at the same time technically and medically safe treatment process over a longer period of time with several treatment procedures spaced apart in time.
  • This device is a system consisting on the one hand of a specially manufactured device that is worn by the patient in the manner of a spectacle frame. Radiation sources are attached to the spectacle frame and are controlled by a separate control unit belonging to the system for the therapy treatment.
  • This device is also a special device consisting of two treatment devices to be purchased, on the one hand the special control device and on the other hand the special glasses-like treatment device with radiation source.
  • an economically efficient and at the same time medically safe implementation of a long-term therapy with several treatment processes spaced apart in time cannot be carried out.
  • An irradiation device for therapy of the human eye is also previously known from US2016 / 0158486 A1.
  • the devices taught from this document are distinguished by a great variety of configurations, so on the one hand the device can be worn close to the eye or in the eye. It is also explained that contact with the eyelid is also conceivable as an embodiment.
  • a disadvantage of this previously known teaching is that there is no information about the arrangement the components that are necessary for the construction and for an effective operation of the device.
  • the device is based on a distant transmission of the radiation and thereby achieves an unfavorable transmission rate and has to accept unfavorable thermal effects.
  • An irradiation device for the eye is previously known from US 2020/008135 A1, which is based on the principle of transmission through the air from a plurality of light sources with a diffuse orientation of the radiation. With this irradiation device, a therapeutically targeted treatment of diseased tissue areas is not possible and the device is altogether too bulky and unwieldy to be worn comfortably by the user over a longer treatment period.
  • a technical problem in the treatment of radiation-sensitive tissues with therapeutic radiation is that excessive exposure to radiation can cause tissue damage instead of the desired therapeutic effect.
  • Such a radiation exposure that is too high can be caused on the one hand by too high a radiation intensity of the radiation source or by too short a distance between the radiation source and retina by too long exposure or by too short a repetition rate of the exposure or by a combination of these causes.
  • Such therapeutic radiation treatment with special devices, which reliably prevent these causes of damage, i.e. incorrect adjustments, incorrect operation or control, is therefore regular. feasible and is often only approved for treatment by appropriate approval authorities if appropriate safety devices are available on the device. On the other hand, if certain operating errors cannot be ruled out by the device itself, regular medical supervision is necessary during the therapy.
  • a device which is used for the therapeutic treatment of the retina with radiation.
  • the device comprises, on the one hand, a radiation source and, on the other hand, a control unit which controls this radiation source.
  • This activation is primarily used to control a radiation duration and a radiation intensity. However, depending on the type of treatment, other parameters such as radiation frequencies and radiation spectra can also be controlled.
  • the radiation source and control unit can be combined in a housing or arranged separately from one another.
  • the signal transmission can be wireless or wired.
  • the invention is fundamentally based on the knowledge that radiation treatment of the retina, i.e. photobiomodulation (PBM), has an optimal effect and is possibly only effective if it is adapted to the metabolic situation of the target tissue, i.e. the corresponding cells of the retina to be addressed , is adjusted.
  • PBM therapy for AMD is particularly effective, if necessary only effective, if the radiation is carried out in the morning and in the morning best done daily. In principle, this is realistic and can only be implemented at home.
  • the therapy device according to the invention is used to provide the patient with a daily morning dose of radiation. This embodiment is particularly suitable for use on the patient lying down, so that the patient can perform the therapy in the morning before getting up.
  • PBM therapy for bedridden patients or generally ill patients is also possible.
  • the device according to the invention has a holding and positioning device.
  • This holding and positioning device is used to position an optical objective element, which is part of the invention and is connected to this holding and positioning device, in front of the eye of a patient.
  • the objective element is used to introduce the therapeutic radiation into the patient's eye.
  • the objective element must be held in a certain position and in a certain orientation in front of the patient's eye and this position and orientation must be reliably maintained during the treatment.
  • devices are known from the prior art which position the patient's head as a whole in order to achieve such an alignment and positioning of the radiation.
  • glasses-like auxiliary devices known which are intended to ensure a specific axis alignment and position of the irradiation.
  • the holding and positioning device serves on the one hand to hold the objective element in a defined position and orientation in front of the eye.
  • the objective element has a radiation-permeable, concave surface which is adapted to the convex surface of the eye.
  • This adaptation can on the one hand serve to allow the concave surface to rest directly on the patient's eye; the concave surface is preferably geometrically adapted to rest on the closed lid surface of the eyelid.
  • this concave surface is the first Effect ensures reliable positioning and alignment of the lens element.
  • the effect of the irradiation is achieved through this direct application also through the radiation-effective coupling into the eye or eyelid.
  • the contact surface of the concave surface of the objective element can preferably adapt to the surface shape of the lid.
  • the shape of the lid surface is slightly different for the individual patient and also changes intra-individually depending on the direction in which the eye is looking below the closed lid.
  • This adaptability can be implemented, for example, by an elasticity of the objective element itself, such as in the manner of a soft contact lens.
  • the adaptability can also be realized with a rigid objective element and an elastic intermediate layer in the manner of a gel or the like.
  • the concave contact surface of the lens element realizes a temperature line between the eyelid and the lens element, whereby unpleasant heating due to the radiation can be compensated and a treatment that is much more pleasant for the patient can be carried out.
  • the device according to the invention thus achieves the decisive advantage over known devices which aim to achieve irradiation directly through the pupil opening and eye lens with the eyelid open a more favorable coupling of radiation into the eye is achieved.
  • the radiation intensity is understood to mean the radiation intensity that is present from the exit surface of the device in the exit surface, which can weaken or intensify through divergence or convergence up to the retina - and in particular through absorption effects in the eyelid or in others, between the Exit surface and the tissue parts lying on the retina can still be reduced. In principle, a therapeutically effective treatment can be achieved with these lower limits of the radiation intensity.
  • the radiation intensity remains preferably below 0.1 mW / cm 2 , below 0.5 mW / cm 2 or below 10 mW / cm 2 , in particular below 1 mW / cm 2 or 5 mW / cm 2 , with an irradiation duration of up to 100s, which means that the permissible radiation effect for both the eye itself and the skin of the eyelid is not exceeded. It should be understood that the relationship between the permissible exposure time and the permissible intensity level follows the usual scientific criteria.
  • the at least one radiation source can emit therapeutically effective radiation in the wavelength range from 450 to 1500 nm, preferably in four different wavelength ranges within this spectrum. These four different wavelength ranges can be between 450 and 500nm, between 570 and 600nm, between 610 and 730nm and between 790-890nm and can be applied either simultaneously or at different times. In particular, only two ranges can be used as the core wavelength, these are preferably the ranges around 670 ⁇ 15 nm and around 810 ⁇ 15 nm and around 850 ⁇ 15 nm.
  • the at least one radiation source can emit radiation with a power between 1 pW and 10 W, preferably between 100 pW and 1W, and ideally between 1 mW and 100 mW.
  • the output power of the radiation source itself that is to say, for example, of the diodes used as the radiation source, is to be understood as power.
  • the objective element can consist of several optically effective elements or be formed by a single optically effective element.
  • the concave surface of the objective element is adapted to the geometry of the eye or the closed eyelid and therefore typically has a radius which is between 5 and 500 mm, ideally between 10 and 100 mm.
  • the concave surface can be composed of several segments with different radii or also contain planar sections. As explained above, adaptability of the surface to different radii is preferred.
  • the concave surface of the objective element can in particular also have such a geometry and such a radius that a hygiene film or hygiene separating layer, which can be used as a reusable or single-use separating layer, can be attached to it in order to ensure good product hygiene and the ability to sterilize the body contact surfaces of the device to enable.
  • the concave surface is designed to rest on the closed eyelid, because of the closed eyelid, the patient has no relevant cause to make eye movements during the treatment so that a therapeutically effective and reliable irradiation is achieved.
  • the optical objective element has a diffuser which is designed to distribute the radiation from the radiation source onto the radiation-permeable concave surface.
  • the objective element has a diffuser.
  • This diffuser can be formed directly by an element resting on the eye or the surface of the eyelid, which element represents the objective element itself or which is part of the objective element.
  • the diffuser can, however, also be arranged elsewhere in the objective element.
  • a diffuser is understood here to be an optically effective element which achieves a distribution effect through optical scattering or refraction, for example. This can be, for example, a scattering element, hologram, lens or light guide as an optical element.
  • a typical example of such a diffuser effect is an optical effect similar to a milk glass pane, as can be achieved, for example, by transparent materials with a crystalline or partially crystalline structure.
  • the diffuser effect achieves a distribution of the radiation that is favorable for therapeutic treatment.
  • this distribution can be designed in such a way that a larger radiation surface is generated from punctiform and / or directional radiation and / or diffusion in the sense of non-directional radiation, but possibly with a preferred direction, is generated therefrom.
  • the diffuser is designed as an Ulbricht sphere or as a layer of a semitransparent material, in particular polytetrafluoroethylene. According to the inventors' knowledge, these specific configurations of the diffuser have proven to be particularly suitable for integration into the device according to the invention and achieve a diffusion effect that is advantageous for therapeutic purposes.
  • the objective comprises a thermal heating or cooling device.
  • a temperature of the support surface that is comfortable for the patient can be achieved and temperature drainage from the eye or eyelid as well as corresponding temperature influx can be avoided.
  • the heating or cooling device can be connected to a control unit which sets a constant temperature in the eyelid or in the lens element in order to compensate for temperature influences occurring during the treatment and, for example, to avoid heating of the lens element by the irradiation.
  • a further development of the invention comprises a set of contact surface elements, one of which can each be fastened to the concave surface of the objective element, the set comprising: a first contact surface element with a first refractive index, and a second contact surface element with a second, different from the first refractive index Refractive index.
  • the holding and positioning device is designed as a partial face mask which at least partially covers the eye area of the face.
  • a design of the holding and positioning device on the one hand enables the device according to the invention to be carried comfortably by the patient, but also provides sufficient accuracy for the purposes of positioning and alignment, in particular a precise alignment and positioning based on the concave support surface of the object element allowed.
  • a first basic positioning and alignment of the objective element is achieved by the holding and positioning device, but the objective element itself is still movably supported within limits in the holding and positioning device for a second, precise orientation and alignment To enable positioning based on the form-fit effect of the concave surface for the lens element itself.
  • the partial face mask can in particular also be designed in such a way that it rests on the skin surface adjacent to the eyes and achieves a basic positive-locking positioning here based on the bone contours under the skin surface, as is known, for example, for spectacle frames.
  • the partial face mask is held in a predetermined position on the patient's face by means of a strap passed around the head or by means of holding elements such as straps or eyeglass temples or by means of suction cups.
  • the radiation source is fastened to the holding and positioning device, in particular lies in a treatment position in a radiation axis with the pupil and the diffuser.
  • the radiation device is arranged and fastened directly to the holding and positioning device. The patient can therefore comfortably wear this holding and positioning device and does not need a connection to an external device arranged outside the face.
  • the radiation source here preferably lies in a radiation axis with the pupil and the diffuser in order to achieve direct radiation propagation without deflection in the direction of the retina along an axis.
  • the device is developed in that a second radiation source is arranged at a distance from the holding and positioning device on a radiation base device and the radiation is guided by means of a flexible radiation conductor from the radiation base device to the holding and positioning device.
  • a second radiation source is also provided, which is at a distance from the holding and positioning device.
  • the radiation from this second radiation source is guided to the objective element by means of a radiation conductor, for example a glass fiber line.
  • the therapeutic radiation is composed of the first and second radiation sources, and these can simultaneously act additively on the retina or can act alternately.
  • the radiation source is arranged at a distance from the holding and positioning device on a radiation base device and the radiation is guided by means of a flexible radiation conductor from the radiation base device to the holding and positioning device.
  • the radiation source is not arranged and fastened on the holding and positioning device, so that the holding and positioning device can be designed as a light and compact unit.
  • the radiation source is arranged on a radiation base device that is spaced apart from the holding and positioning device is, for example, is designed as a tabletop device and that the patient does not have to attach or carry on the body. From this basic radiation device, the therapeutic radiation is then guided to the objective element by means of a radiation conductor.
  • Such a radiation guide can be designed as a single or multi-core light guide arrangement; in particular, separate radiation guides can also be provided to irradiate the left and right eyes and to apply radiation to two separate objective elements for the left and right eyes. This enables, on the one hand, an efficient dosage of the radiation power that is sent via the radiation conductor, and on the other hand, an individual exposure of the two eyes of the user with possibly different therapeutic radiation.
  • the concave surface is designed for flat support on the eye or the closed eyelid over a support surface of at least 1 cm 2 .
  • a flat support over a minimum area of 1 cm 2 is achieved by the concave support surface. This ensures a favorable coupling of therapeutically effective radiation over a sufficiently large area and avoids an unfavorable radiation effect due to possibly high radiation concentrations.
  • the contact surface of this minimum size achieves a secure, form-fitting positioning of the objective element, which is also advantageous for the exact alignment and positioning of the radiation axis.
  • the device can be developed further by means of a signal-coupled eyelid sensor to the control device for detecting the closed eyelid, the control unit being designed to activate the radiation device only when the eyelid sensor transmits a signal which signals a closed eyelid.
  • the sensor can use various physical properties and contain electrical-chemical, mechanical or optical elements, for example to measure skin resistance / conductivity, contact pressure or differences in reflectivity.
  • the device comprises an eyelid sensor which is designed to detect whether the patient's eyelid is closed or open.
  • Such an eyelid sensor can be designed differently, for example a heat transfer starting from the concave support surface can be measured and this heat transfer can be used to determine whether or not there is flat contact with the closed eyelid.
  • the sensor can also measure the conductivity of the tissue surface on which the objective element rests and, from this, conclude whether this tissue surface, the Area of the closed eyelid is.
  • the eyelid sensor can also be designed as an image acquisition unit with image evaluation in order to detect a closed or open lid.
  • the eyelid sensor can, for example, also be designed as a light barrier which can differentiate the reflection of the eyelid or the surface of the eye from one another and in this way can recognize the closed eyelid.
  • the eyelid sensor is signal-coupled to the control device. This ensures that the control device can control the effect of the radiation as a function of the signal from the eyelid sensor. For example, it can be avoided that the excessively high radiation acts on the eye when the lid is not closed, in order to avoid overdosing the therapeutic radiation as a result.
  • the objective element can also be designed to mechanically block the closed eyelid and thereby prevent the eyelid from opening when the device is used. This can be achieved, for example, in that the concave support surface is designed for form-fitting contact on the eyelid and then blocks the lid opening movement with such a form-fit support.
  • the device can be further developed by an input user interface, a graphical output user interface for outputting graphical information, the control unit being programmed to display information on a subsequent therapeutic treatment step to the patient via the graphical user interface in an information step, and the treatment step after the information step perform, wherein the radiation duration and radiation intensity correspond to a treatment input via the input user interface and / or a treatment method output via the graphic output user interface.
  • the device according to the invention also comprises an input and output user interface which can be designed, for example, as a touchscreen, as a keyboard and screen, as voice recognition and voice output or the like and combinations thereof.
  • the user can enter data relating to the therapy via these interfaces, and on the other hand, information relating to the therapy can be output to the user.
  • the training is particularly suitable to make the device suitable for home use for the user and to enable inputs and outputs serving security via the interfaces in order to enable the device to be used even without medically trained personnel. It is particularly preferred if the control unit is programmed to query a user input via the input user interface in an input step between the information step and the treatment step and to start the treatment step after receiving a predetermined user input. Such an input by the user after the information step and before the treatment step can result in a security query and confirmation from the user, thus preventing incorrect handling or an incorrect start in the treatment.
  • control unit is programmed to receive user-related personal information via the input user interface in order to use this user-related personal information to identify a user identity from a user identity data memory for the control unit and, depending on this user identity, to identify one for to carry out this user identity stored in a treatment program data memory predetermined treatment step.
  • a user identity is determined before the treatment begins. This ensures, in particular, that the treatment is only carried out for the intended patient and not for any other person.
  • the user identity can for example be based on a password, on the basis of a fingerprint, on the basis of an iris recognition or the like.
  • an eyelid sensor which is designed to detect an open or closed eyelid, is also used at the same time to determine a user identity on the basis of iris recognition.
  • the input user interface comprises a digital image acquisition unit and the control unit is programmed to receive image data from the digital image acquisition unit and to determine the user identity on the basis of the image data, in particular on the basis of image data that describe an iris geometry of the user, to determine the user identity based on an iris recognition.
  • control unit and the graphic output user interface are arranged in the basic irradiation device and the basic irradiation device further comprises a radiation guiding device which directs the radiation emitted by the radiation source onto the radiation on the holding and positioning device in front of the eye to align the patient's optical lens element held.
  • control unit and the graphical output user interface are arranged in the irradiation base device and are thus executed integrally in one of possibly only two structural units of the device according to the invention. In this way, on the one hand, a compact structure and, on the other hand, a device that is easy to handle is achieved.
  • control device is embodied in a smart tablet, laptop or smartphone.
  • control unit can be implemented by software that is executed, for example, as an application on such a smartphone, smart tablet or laptop.
  • the holding and carrying device has a total weight and dimensions which make it possible to hold the device on the patient's head solely by the carrying device.
  • the device according to the invention can be carried comfortably on the patient's head and the patient can also move with the device on, change his position and thereby set up a comfortable treatment situation.
  • the irradiation device comprises two beam exit directions which are spaced apart from one another for the simultaneous irradiation of both eyes of the patient. This makes it possible for both eyes to be treated at the same time, thereby shortening the treatment times. It can be provided that the therapeutic radiation for both eyes is derived from a single radiation source and is distributed to the two eyes by appropriate beam splitting. Alternatively, two different radiation sources can also be used, each radiation source being provided for one eye.
  • the irradiation can be designed using a beam splitter or at least 2 independent beam sources so that one eye or both eyes can be treated simultaneously.
  • the eyes are separated from each other by an optical separation.
  • the irradiation parameters and the irradiation frequency of both eyes can be designed differently for this purpose.
  • the patient can maintain a constant routine over a treatment period of several days, and in doing so, carry out a treatment process every morning.
  • the irradiation can then be carried out by the control unit in such a way that the eyes are irradiated in the same way or differently.
  • one eye can only be irradiated every 2 days with the corresponding effective therapy wavelength (or other parameters), the other eye is also illuminated, but not with a therapeutically effective radiation dose, for example a therapeutically ineffective wavelength within the visible spectrum or with a therapeutically ineffective radiation intensity.
  • a therapeutically effective radiation dose for example a therapeutically ineffective wavelength within the visible spectrum or with a therapeutically ineffective radiation intensity.
  • the irradiation device comprises a first optical system comprising at least one first optical lens, a first optical collimator and / or a first optical filter unit and a second optical system spaced from the first optical system along a radiation path axis comprising at least a second optical lens, a second optical collimator and / or a second optical filter unit.
  • the irradiation device is designed in such a way that it can irradiate the two eyes of the patient at the same time, and for this purpose corresponding optical devices are provided for each of the two eyes. In particular, this also makes it possible to treat the two eyes with different therapeutic radiation, for example with regard to the frequency, the radiation intensity or other radiation parameters.
  • control unit is programmed to store and control a treatment plan comprising at least a first and a second treatment process for a user, and to control a first treatment process for the user, to save the time of completion of the first treatment process, start the second treatment process on condition that a minimum period of time has passed since the completion time of the first treatment process.
  • control unit is programmed to carry out an intelligent and at the same time fail-safe treatment process over a longer period of time and to safely carry out several individual treatment steps at a time.
  • Appropriate programming ensures that two treatment steps or treatment measures are not carried out at such a short time interval from one another that overdosed radiation could damage the eye or at least jeopardize the success of the therapy. This is achieved by programming that provides for a predetermined minimum period and does not allow subsequent irradiation if this minimum period is not reached.
  • control unit is programmed to receive diagnostic data via the input user interface which characterize a body condition and, after a treatment process, to generate therapy data which describes the treatment process carried out characterize to send a data packet comprising the diagnostic data and the therapy data to a receiving device of an expert computer via a data transmission unit, to receive instruction data from a transmission device of the expert computer via the data transmission unit and to control the irradiation device to carry out a treatment process characterized by the instruction data.
  • the device is able to receive diagnostic data on the one hand and to generate therapy data on the other hand and to send this data via a data transmission unit.
  • This training is particularly advantageous for the particular suitability of the device according to the invention for home use by the patient.
  • the advanced training also makes it possible, starting from the expert computer, to also control treatment processes on the device and thus enable a treating doctor to remotely control such treatment processes.
  • control unit is programmed to receive diagnostic data characterizing a body condition via the input user interface, to compare the diagnostic data with predetermined body condition data stored in an electronic data memory of the control unit, based on the correspondence with one of the stored body condition data, when a body condition defined by the body condition data is exceeded or not reached, select a subsequent treatment process from a plurality of treatment processes stored in the electronic data memory of the control unit, and control the irradiation device to carry out the selected treatment process.
  • control device is programmed in such a way that it uses diagnostic data that are received, for example by entering them manually or by analyzing them from an image acquisition device by image evaluation, to record a change in the characteristics of the patient describing the state of health , in order to select the further treatment steps depending on this.
  • diagnostic data that are received, for example by entering them manually or by analyzing them from an image acquisition device by image evaluation, to record a change in the characteristics of the patient describing the state of health , in order to select the further treatment steps depending on this.
  • the further treatment can be designed and here, for example, from several different treatment steps available for selection suitable treatment step for further treatment can be selected and then carried out. It is also possible, on the basis of a comparison of therapy successes that have been achieved with different treatment steps, to select the treatment step that has achieved the best result and then to continue the treatment with this treatment step.
  • the input user interface comprises a digital image acquisition device and the diagnostic data contain image acquisition data which describe the image of a treated tissue.
  • an image acquisition is carried out by a digital image acquisition device, which includes the image of the retinal tissue and thereby enables a direct analysis of the treatment result through corresponding image evaluation.
  • the success of certain treatment steps can be evaluated directly and, on the basis of such an evaluation, the planning of further treatment steps, such as the selection of a specific, successful treatment step, can also take place.
  • Fig. 1 is a schematic plan view of a first embodiment of the invention
  • FIG. 2 is a schematic plan view of a second embodiment of the invention
  • FIG. 3 is a schematic side view of a third embodiment of the invention.
  • a patient wears the device according to the invention as a face mask 10, with his eyes closed and held in position in front of his eyes as a holding device by means of eyeglass-like retaining brackets 12a, b.
  • the face mask 10 comprises a right and a left lens element 20, 30 for the right and left eyes in the axial direction of the eyes.
  • Six right and six left radiation sources 21, 31 are integrated into these objective elements.
  • Each of these radiation sources is integral with a sensor that detects the reflection of the irradiated radiation and compares it with reference values, on the basis of which a control unit 12, which is integrated in the mask, can determine whether the lid of the respective eye is closed or open.
  • the device according to the invention according to this embodiment further comprises a base station 40, into which the face mask can be inserted in an adapter 41 in order to charge rechargeable batteries 11a, b, which are arranged in the face mask, by means of a corresponding contact.
  • the base station 40 or the face mask is further coupled with a smart phone 50.
  • the phone is by means of a Bluetooth ® - connection to a receiver which is integrated in the control unit 12 in the face mask 10, in a signal connection.
  • Corresponding control software on the smartphone can be operated via the user interface of the smartphone and controls the irradiation process through the radiation sources in the objective elements 20, 30.
  • Fig. 2 shows a second embodiment of the invention.
  • a face mask 110 is placed on the eye and comprises corresponding objective elements 120, 130 in the axial direction of the right eye and the left eye.
  • the objective elements 120, 130 do not include any radiation sources on the face mask itself.
  • a radiation source 141, 142 is present in a base station 140, which is connected to the face mask via a light guide 141a, 142a.
  • the radiation sources 141, 142 in the base station 140 emit radiation which is guided via the light guides 141a, 142a to the face mask 110, there guided to the two objective elements 120, 130 and coupled into them in order to thereby deliver the therapeutic irradiation to the retina cause.
  • the base station 140 of the second embodiment further comprises its own user interface 145, via which the patient can operate the device, in particular can set irradiation parameters such as irradiation intensity and irradiation duration.
  • Fig. 3 shows a partially sectioned side view of a third embodiment of the invention.
  • a face mask 210 is also placed on the face.
  • the face mask comprises an objective element 220 which comprises an imaging lens 221 and a diffuser 222 which has a concave support surface 223 which is directed towards the closed eyelid 2. This concave bearing surface 223 rests directly on this closed eyelid and couples radiation into the eyelid.
  • This radiation penetrates the eyelid and reaches the retina 4 of the eye through the eye lens 3 of the eye 1 in order to achieve a therapeutic effect there.
  • radiation sources 224a-d are arranged directly above the diffuser 222, which emit radiation into the diffuser 222, which radiation is radiated into the eyelid via the concave surface 223 and from there reaches the retina.
  • an external radiation source 227 which is connected to the face mask via a light guide 228.
  • the radiation emitted by the external radiation source 227 is coupled into the objective element 220 via this light guide 228 and also reaches the diffuser 222 in order to reach the retina via the concave surface 223.
  • the external radiation source 227 is arranged in a base station 240 which, as in the first embodiment, comprises a receiving device with an electrical contact element for charging an energy store in the face mask 210.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Radiation-Therapy Devices (AREA)
  • Medical Treatment And Welfare Office Work (AREA)

Abstract

La présente invention se rapporte à un appareil de traitement de la rétine par thérapie, caractérisé par un appareil de maintien et de positionnement pour maintenir un élément d'objectif optique selon une position définie et en alignement dans l'avant de l'œil d'un patient, l'élément d'objectif ayant une surface concave de transmission du rayonnement pour reposer sur la paupière fermée et la source de rayonnement interagissant avec l'élément d'objectif optique afin de déposer le rayonnement thérapeutiquement actif sur la rétine par l'intermédiaire de l'élément d'objectif optique.
EP21717828.4A 2020-04-15 2021-04-07 Appareil de traitement de la rétine par rayonnement Pending EP4135835A1 (fr)

Applications Claiming Priority (2)

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DE102020110284.4A DE102020110284A1 (de) 2020-04-15 2020-04-15 Vorrichtung zur Strahlungsbehandlung der Netzhaut
PCT/EP2021/059089 WO2021209298A1 (fr) 2020-04-15 2021-04-07 Appareil de traitement de la rétine par rayonnement

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EP4135835A1 true EP4135835A1 (fr) 2023-02-22

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US (1) US20230145284A1 (fr)
EP (1) EP4135835A1 (fr)
JP (1) JP2023522069A (fr)
KR (1) KR20230026995A (fr)
CN (1) CN115397507A (fr)
DE (1) DE102020110284A1 (fr)
WO (1) WO2021209298A1 (fr)

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JP3667268B2 (ja) * 2001-09-26 2005-07-06 得一郎 長谷川 アイマスク
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EP2422845B1 (fr) 2010-08-24 2013-04-24 Polyphotonix Limited Appareil de photothérapie à guide d'ondes
WO2013056742A1 (fr) * 2011-10-21 2013-04-25 Patrimoine De L'universite De Liege Dispositif de photo-stimulation
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KR20230026995A (ko) 2023-02-27
JP2023522069A (ja) 2023-05-26
DE102020110284A1 (de) 2021-10-21
US20230145284A1 (en) 2023-05-11
WO2021209298A1 (fr) 2021-10-21
CN115397507A (zh) 2022-11-25

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