Systems, devices, and methods for generating planning datasets for treatment of retinal tissue of patient

Abstract

The invention relates to a system for creating a planning data set (34, 35, 36, 37) for tissue treatment of a retina (16) of an eye (4) of a patient by means of a laser (2), having a camera (6, 7), which is configured to continuously capture images of the retina, having an image processing device (19), the system comprises a camera (20) configured to generate and provide current structured image data of the retina from images captured by the camera, a personal data acquisition device (21, 22) configured to acquire and / or provide personal data of a patient, and a processing device (20) configured to process the personal data of the patient. And a processing device designed to assign a planning data set for tissue treatment to the current structured image data of the retina and the personal data of the patient, the planning data being assigned to specifications, in particular patterns and rules, of the image data and the personal data of the patient being stored in the processing device.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology and is particularly advantageously applicable to the field of ophthalmology and can be used in combination with certain ophthalmoscopy instruments. Background Art

[0002] In many cases, laser therapy devices are used to treat the patient's retina, thereby enabling tissue treatment using a laser beam. The combined use of an ophthalmoscope and a laser therapy device is particularly advantageous, thereby enabling simultaneous and coordinated visualization of the retina during treatment.

[0003] The basic function of an ophthalmoscope is to provide the examiner with an image of the eye or a part of the eye. In particular, an ophthalmoscope providing an image of the retina of the eye can be combined with a device for laser treatment of the retina, if, for example, the same optical imaging device is used to at least partially guide the laser beam for visualizing the retina. In this case, the beam paths for imaging and laser treatment can be branched over part of their length, for example by a beam splitting device, and run together over another part by the same optical elements. This makes it possible to observe the retina at the same time as the laser treatment, which would be more difficult if separate imaging devices were used for observation and treatment simply for space reasons.

[0004] European patent application EP 1 875 857 A1 discloses an ophthalmoscope having imaging optics and an illumination device and an optical sensor, wherein an image of the retina of the eye can be captured by means of the optical sensor. Such an ophthalmoscope can also be used by surgeons to plan laser treatments. Summary of the invention

[0005] Against the background of the prior art, the present invention is based on the task of facilitating the generation of treatment plans for tissue treatment of the retina by means of a laser device and of systematically standardizing and improving the planning data.

[0006] According to the invention, the above object is solved by a system having the features of claim 1. The dependent claims present advantageous embodiments of such a system. To solve this problem, the invention also relates to a device and a method for creating a planning dataset, which are listed together with advantageous embodiments in the further patent claims.

[0007] The present invention therefore relates to a system for generating a planning data set for tissue treatment of the retina of a patient's eye using a laser,

[0008] - having a camera configured to continuously capture images of the retina,

[0009] - having an image processing device configured to generate and provide current structured image data of the retina from the images captured by the camera,

[0010] - having a personal data collection device configured to collect and / or provide personal data of the patient,

[0011] and a processing device which is configured to assign a planning data set for tissue treatment to the current structured image data of the retina and to the personal data of the patient, wherein specifications, in particular patterns and rules, for assigning planning data to the image data and to the personal data of the patient are stored in the processing device.

[0012] Furthermore, it may be advantageous for the system to have a modification device, which may also be referred to as a correction device, which is able to manually modify the planning dataset. Such manual modification may be performed by a technician based on his experience or additional knowledge during or in particular after the creation of the planning dataset.

[0013] The system according to the invention is configured to support the creation of a treatment plan before starting treatment of the patient's retina, which treatment plan is created in the form of a planning file or planning data. A prerequisite is that the system has a camera or, in general, an imaging system configured to continuously capture images of the retina. Such a camera can be designed as an optical color, infrared or black and white camera or scanning system, or can also have various filter options and can acquire a current image of the retina before and / or during the generation of planning data. This may be important, for example, in order to be able to compare other acquired or currently determined retinal data with the retinal state and positioning currently acquired in the system. In the context of the present invention, structured graphics or image data should be understood as all prepared pure pixel data and data derived from these or pixel data, in particular so-called vector-oriented image data. For example, the position and size of blood vessels, the position of the optic nerve and the position, size and type of macular sclerosis, i.e. soft macular sclerosis, hard macular sclerosis and reticular pseudodrusen (RPD), can be provided as structured image data and taken into account when creating the planning data set.

[0014] For example, if the patient's personal data are used, this may be in the form of a diagnosis or indication or in the form of images of the patient's retina previously taken by the system itself or by other imaging devices. These images can then be compared with the images currently recorded in the system. The personal data may also be data on treatments previously received by the patient or data on treatment status. In principle, the personal data may be all patient data that have been stored in written or electronic form, in particular in digital form, before the start of treatment or before the start of creation of the planning data set. These data may be sent to the system via an electronic interface or manual input. The personal data may be available, for example in electronic form, in a more comprehensive system, of which the system for creating a planning data set according to the invention is a subsystem or subsystem.

[0015] The advantage of a camera capturing the actual image of the retina becomes apparent when the system for generating planning data is also combined with a treatment device having a treatment laser for performing treatment using the planning data, wherein the treatment laser is adjusted relative to or aligned with the camera. The structuring of the planning data will be described in detail below.

[0016] Furthermore, an image processing device is provided, which generates structured image data of the retina based on the image data currently captured by the camera and makes them available for planning. Structured image data are, for example, data containing or representing certain objects identified in the image by image processing, or properties of the image or the retina, or properties of an image area or part of the retina. For example, structured image data can describe brightness or color distribution, intensity distribution on an infrared image, the position, shape and / or gradient of objects or object boundaries. The representation of structures in the form of such data can be varied and include, for example, pure image data, but also vector representations, such as vectors, matrices or other types of abstract representations. For example, the structured data should describe the shape, position and possible other parameters of blood vessels, neural nodes and common abnormalities on the retina in a clear form, such as vector guidance or metadata related to the geometry.

[0017] The position of objects currently identified on the retina (eg blood vessels, optic nerve or macular sclerosis) can and should be taken into account when creating a treatment plan and generating the corresponding planning data.

[0018] Furthermore, the extent to which such currently acquired structured image data is taken into account may depend on the patient's personal data etc. As mentioned above, personal data refers to data related to the patient, which already exists and is available when the system is applied to the patient.

[0019] The system may provide that certain elements of the system are available locally at the site where the patient is being treated, while other elements may be located elsewhere or difficult to locate. For example, an image processing device or a processing device used to generate planning data or a portion of such a device, such as a storage device, may be located in a different place from the treatment laser. For example, the data processing device may be located in a computer or data processing system that is larger than the laser treatment site. If the processing device needs to access a large amount of stored data, both the processing device and the storage device may be distributed across multiple computers or located in a larger central computer system. For example, it may be useful to store treatment data for many patients centrally in the form of a database or in a distributed computer system so that as much data as possible is available and accessible to the system when interpreting the personal data of a single patient or training a learning system.

[0020] For example, individual parts or modules of the system, such as a personal data acquisition device, a measurement data acquisition device, or a modification device for manually correcting planning data, or a device for inputting data describing the success of a treatment, can also be installed as applications on a mobile device. The input data is then transmitted to the mobile device via an interface that clearly defines the data format and the data transmission path (such as a hardware connection, a data bus or a radio interface) and output from the mobile device to the stationary part of the system to obtain an integrated system, wherein the stationary part also contains a camera and / or a processing device.

[0021] For example, one embodiment of such a system may provide one of a plurality of predefined patient categories for assigning the patient category to a patient based on personal data and / or currently acquired data, and provide specifications, in particular patterns and rules, for a processing device (20) for assigning planning data to currently acquired data and personal data, thereby being determined or influenced by the corresponding assigned patient category.

[0022] For example, the patient category assigned to each patient may depend on stored personal data, such as age, certain physiological parameters of the patient, such as weight, type and intensity of skin pigmentation, hair color, iris pigmentation, medical history and the type, intensity and success rate of previous treatments performed, and / or on currently measured or acquired data, such as structured image data of the retina or currently acquired physiological data and / or parameters of the patient, which may be measured in or on the eye or may also be independent of parameters of the eye, such as the patient's age, eye color, hair color, skin color, intensity of skin pigmentation, physique and current health condition.

[0023] In one embodiment, for example, only two patient categories may be provided, which are determined by a single acquired parameter, such as patients over or under 50 years old or patients with light and dark skin. However, more than two, such as 3, more than 3, more than 5 or even more than 10 categories may also be provided, and the respective assignment of these categories to patients also depends on more than one parameter, such as at least two or at least three parameters.

[0024] Depending on the patient category assigned to an individual patient, in some cases a predefined planning data set can be assigned. In other cases, saved specifications, in particular patterns and rules, can still be used to create planning data sets individually, but the patterns and rules used may depend on the assigned patient category. This makes the specifications less complex.

[0025] It is also conceivable to restrict certain categories of planning data, such as target values ​​for laser parameters or measurement data, such as target data representing the current maximum permissible temperature of the retina at the treatment site during treatment, depending on the patient category assigned to the patient, so that only some possible subsets of parameters are available for the planning dataset. In many cases, this can simplify and speed up the creation of the planning dataset after assigning a specific patient category to an individual patient.

[0026] However, it is also conceivable to create certain patient categories for patients who are determined to be problem categories and require special planning (e.g. particularly careful or small-scale planning), or to exclude or make impossible the automatic or semi-automatic creation of planning data sets. In this case, the assigned patient category can also refer to a completely expert-based treatment planning.

[0027] For example, a category of patients classified as having severe skin pigmentation and / or severe retinal pigmentation and / or dark iris color may be associated with a rule that certain laser power densities may not be exceeded.

[0028] For example, certain patient categories related to pre-existing conditions may be associated with conditions that certain retinal temperatures must not be exceeded, where the retinal temperature is monitored by collecting certain measurement data during treatment. Alternatively, target data corresponding to a desired temperature of the retina at the treatment site during treatment may be selected based on the patient category determined by previous illness or pre-treatment. Similarly, the selection of location data for laser treatment and the selection of location data for areas to exclude from laser treatment may also depend on the patient category.

[0029] Another advantageous embodiment of such a system may provide a personal data acquisition device configured to acquire and provide diagnostic data and / or prescriptive data and / or data of pre-treatments performed and / or previously known physiological data of the patient and / or existing images of the patient's retina stored external to the system.

[0030] For example, such personal data may be in the form of an electronic file, which can be entered manually or can be read in, such as a diagnosis in text or image form or an indication that already provides information about the recommended treatment. Such information may already contain data that distinguish certain locations or areas of the retina and be related to the corresponding location on the retina, such as the exact location of the site or area to be treated. However, such information can also be independent of location and describe the patient's general condition, eye or other characteristics, such as physiological data. Such data may be in the form of different types of old images of the retina, such as color images, black and white images, infrared images, fluorescent images or tomographic images, or may be age information, the patient's skin color or gender, the patient's identity or information about previous treatments that may or may not have been carried out by the system according to the invention.

[0031] Furthermore, in one embodiment, such a system can be designed in such a way that a measurement data acquisition device is provided, which has one or more sensor devices for acquiring and providing physiological data of the patient, in particular data that depends on a corresponding position on the retina and / or data that is independent of a position on the retina, and the processing device is configured to take the acquired physiological data of the patient into account when allocating planning data.

[0032] Such a measurement data acquisition device can basically be any type of device, as long as it enables the current acquisition of additional information about the patient and his physiological data. This includes sensor devices, such as cameras that record other properties in addition to the camera mentioned at the beginning, such as other imaging processes, or also use similar or identical imaging processes as the camera mentioned at the beginning to record the retina. The retinal image captured by such a camera then provides data that depends on the corresponding position of the retina. For example, the sensor device can be used to measure the temperature or temperature distribution on the retina. For example, by using the retinal image, algorithms can also be used to detect retinal diseases, which can be taken into account when creating planning data. A device for creating OCT images or a device for reflection measurement can also be provided. With the camera, in particular with the same camera configured to continuously capture retinal images, it is also possible to capture the reaction of the retina to the titration injection, i.e. the experimental application of the therapeutic laser, so that the laser parameters can be planned and controlled according to these reactions, or at least these reactions can be taken into account when generating planning data. Sensor devices that measure other physiological characteristics of the patient, such as skin color and / or brightness, skin thickness, hair color, iris color and / or color distribution, blood pressure, various blood values ​​or the like are also conceivable. For example, these sensor devices can also include cameras or optical sensors.

[0033] For example, a special embodiment of the system can also provide that the above-mentioned measurement data acquisition device can continue to operate to acquire data even after the initial generation of planning data for a laser treatment and possibly after manual correction of the planning data during the actual laser treatment. For example, such a measurement device can continuously acquire the temperature of the retina or the temperature distribution on the retina even during the treatment or during interruptions in the treatment. The measurement data obtained in this way may make it necessary or advantageous to change the planning data. Therefore, the system may need to generate further, corrected planning files based on measurement data determined after the initial creation of the planning data set and use them as the basis for further treatments.

[0034] The system may further be formed by a display module or a display device which enables a graphical representation of the planning data set within the image of the retina currently captured by the camera. In this way, the planning data can be visualized together with the graphical representation of the retinal image in order to immediately assess, for example by making it visible, the consideration of structured image data, e.g., whether certain sensitive areas of the retina, such as blood vessels or neural nodes, are excluded from treatment or whether certain areas already visible in the current image and classified as requiring treatment are appropriately considered in the treatment planning.

[0035] Furthermore, if a treatment device is integrated into the system and the current camera image is synchronized with a steering device for the treatment laser, the planning data set can also be synchronized directly with the steering device.

[0036] The system may be further enhanced by a tracking device that enables the display of the planning data set to be tracked when the image currently captured by the camera moves, in particular when it is displaced or rotated. Such displacement of the image may occur, for example, if the patient moves relative to the camera or the eye moves, in which case the tracking device ensures that the display of the planning data continues to match the currently displayed camera image. If a treatment device is integrated into the system, such tracking may also ensure that the steering device of the treatment laser remains aligned as planned.

[0037] Furthermore, in a system of the type described above, the processing device may be provided with a storage device which is configured to store the patient's personal data and the planning data set assigned thereto, and in particular also for storing physiological data associated with the above data and acquired by the measurement data acquisition device and / or for storing manual modifications made to the planning data set.

[0038] This enables the system to compare the assignment of the current planning data set to the patient's personal data with previous assignments for similar or different personal data. This can be used, for example, for a plausibility analysis. If, for example, in an earlier case, planning changes had already been made manually at a later date, these changes can also be taken into account and predicted during planning. Furthermore, if the acquired physiological data are also stored, these can also be taken into account when comparing and reconciling the planning file to be created with previous plans. The system according to the invention can thus be designed as an expert system or a learning system.

[0039] Furthermore, in such a system, the processing device may be provided with a storage device which is configured to store personal data of the patient as well as structured image data and / or images of the patient's retina generated by means of the system and a planning data set assigned thereto, in particular target values ​​of the measurement data, and in particular, is also configured to store physiological data associated with the above data and acquired by the measurement data acquisition device, and / or to store manual modifications made to the planning data set.

[0040] This embodiment of the system makes it possible to compare the assignment of the current planning data set to the patient's personal data and structured image data with a previous assignment to similar or different stored personal data and structured image data. This data can also be used for a plausibility analysis. If, in earlier cases, planning changes have been made manually at a later date, these changes can also be taken into account and anticipated during planning, for example. Furthermore, if acquired physiological data are also stored in the expert system created in this way, these can also be taken into account when comparing and coordinating the planning file to be created with previous plans.

[0041] A further development of the system can be provided, for example, by an examination device which acquires data after treatment of the retina and provides data on the effect of the treatment.

[0042] The treatment of the retina may include laser treatment, but may also include additional treatment steps with or without the use of lasers. The examination may be performed during the treatment or immediately after the treatment has been completed, in particular also within a certain minimum time after the treatment. The examination device may include a device for performing an imaging process, for example, also using the camera mentioned at the beginning to capture a current image of the retina. The examination device may also include an input device for manually entering data. It may be intended to only acquire binary information such as "treatment successful" or "treatment unsuccessful", or an assessment of the patient, such as "is there pain, yes / no" or a further assessment, such as which treatment parameters, such as laser parameters, a selected geometric treatment pattern, areas for treatment or areas excluded from treatment, are considered suboptimal by the assessor. For this purpose, certain evaluation categories, such as evaluation schemes, may be specified. Such an evaluation may also be included in the above-mentioned expert system, stored together with the saved planning data set, and taken into account when comparing the current planning data with the saved planning data.

[0043] In an implementation of the system, the planning data set generated by the system may contain planning data from one, two, three, four or five of the following categories: laser parameters, position data for laser treatment, treatment pattern, position data for areas excluded from laser treatment, and target values ​​for measurements collected by a measurement acquisition device or other device during subsequent treatment. For example, such a target value may be an average target temperature or a target temperature depending on the position on the retina, which target temperature is continuously collected during laser treatment and, for example, should be reached, maintained or not exceeded. Other treatment parameters may then be dynamically adjusted during treatment so as to reach or not exceed the specified target values. For example, rule parameters are thereby specified in the planning data set. In addition, a treatment report template may be generated as another category of planning data, namely, a table and selection and presentation of data and parameters to be reported.

[0044] The present invention can also be advantageously implemented by designing the processing device as a self-learning device, wherein an allocation function allocates planning data to personal data, in particular to structured image data, and in particular to measured physiological data of a patient, the allocation function being trained by assigning, for a patient, data from at least one of the following categories on the one hand as training data: personal data, structured image data, measured physiological data, and on the other hand, allocated planning data, in particular target values ​​for measured data, as well as manual modifications to the planning data and, in particular, treatment effect data acquired after a planned treatment has been carried out.

[0045] The planning data set generated by the system may contain planning data of one, two, three, four or five of the following categories: laser parameters, position data of laser treatment, treatment pattern, position data of areas excluded from laser treatment, target values ​​of measurement data. Laser parameters may include, for example, laser power, wavelength, pulse duration, pulse repetition rate and total number of laser pulses and the size of the laser spot on the retina and each or all conceivable subcombinations of these parameters. These laser parameters may depend on the position or area on the retina. The position data of the laser treatment may include one or more geometric areas on the retina. The retinal area excluded from treatment may also include one or more geometric areas of the retina. The treatment pattern may include a geometric pattern, such as a circle, an ellipse, a rectangle, a triangle or any free shape, wherein the laser treatment is performed with, for example, constant laser parameters, or one of the laser parameters remains unchanged. These treatment patterns may also be areas that are independently treated (i.e., irradiated) by the treatment laser after the surgeon issues a starting pulse. The treatment pattern may also simply include a geometric area that is treated by the laser at one time, for example, point by point according to a point pattern, without the surgeon having to control each individual point. Only one starting point may be controlled manually or automatically, and then the remaining treatment patterns may be automatically controlled by the laser control system. The density of the points to be treated can also be one of the parameters in the category "treatment pattern". Planning data can also be target values ​​for measurement data collected during treatment, such as the temperature on the retina to be reached or not exceeded during treatment, which can be specified as an overall average or a location-dependent value and is continuously collected / measured during treatment. The treatment system is then controlled in such a way that the target values ​​are met.

[0046] Continuously detectable optical variables, such as reflectance changes, color / spectral changes, or brightness changes of individual treatment areas detected by a camera or hyperspectral sensor, can also be assigned as target values.

[0047] Each of the above-mentioned planning data categories, or more precisely, each of the above-mentioned categories of data, can be changed manually by a person, in particular by the respective operator, if necessary restricted as described above. The operator can compare the planning data generated by the system in the first attempt with the image data or structured data currently captured by the camera and his experience and modify them according to his evaluation.

[0048] Areas to be excluded from treatment can play a special role here. Although in many cases they can be considered a supplement to the laser treatment position data, in many cases the specification of retinal areas to be excluded from treatment is less error-prone than the specification of treatment position data, in particular if, for example, the retina is to be treated uniformly except for a few areas to be excluded. In addition, areas to be excluded can be very relevant for safety, since they also include areas where laser treatment could be harmful to health. Thus, for example, areas to be excluded from treatment can also be defined based on the planning data generated by the system in such a way that they cannot be changed manually or certain obstacles have to be overcome or authorization has to be demonstrated in order to change them.

[0049] The system can be designed as a self-learning system that continuously improves the allocation algorithm that generates the planning data using the data provided to it as described above. The system can have a trained neural network, or it can have an analytical, statistical or parameter learning algorithm, which can be static, guided learning or self-learning. The allocation algorithm can also have analytical elements that cannot be changed by the learning process, which are specified by expert knowledge, such as certain conditions that the laser parameters must meet, such as power limitations or regulations that must be followed to exclude treatment locations.

[0050] For a learning process based on available treatment data, which can be performed regularly as the available treatment data expands and increases, elements of the learning process can be ranked and weighted, for example. For example, data on the success rate of a treatment determined after a laser treatment using a monitoring device can have a higher weight than manual corrections made to the planning data by the treating staff. For example, conditions can also be introduced that must be met in order for treatment data to be provided to the learning system or learning algorithm. For example, one such condition can be that certain manual parameter changes, such as laser parameters, must be made within a specified range and in a certain minimum number of cases or by a minimum number of treating staff or at a minimum number of treatment locations in order for these changes to be provided as training data to the learning system.

[0051] In addition to a system of the type described above, the invention also relates to a device for generating a planning data set for treatment of retinal tissue of an eye by means of a laser beam,

[0052] - having a camera configured to continuously capture images of the retina,

[0053] - having an image processing device which generates and provides current structured image data of the retina from the images captured by the camera,

[0054] - having a personal data collection device configured to collect and / or provide personal data of the patient,

[0055] and a processing device configured to assign a planning data set to the current structured image data of the retina and the personal data of the patient, wherein specifications, in particular patterns and rules, for assigning planning data to structured image data and personal data of the patient are stored in the processing device. The device may also advantageously have a modification device, which enables manual modification of the planning data set.

[0056] In addition to the system and the device, the present invention also relates to a method for generating a planning data set for tissue treatment of the retina of a patient's eye by means of a laser beam,

[0057] - wherein at least one image of the retina is captured by a camera,

[0058] - wherein an image processing device is used to generate and provide current structured image data of the retina based on the images captured by the camera,

[0059] - where personal data of the patient is collected and / or provided as part of a personal data collection device,

[0060] - and wherein the processing device assigns the planning data set to the current structured image data of the retina and previously known personal data of the patient according to specifications, in particular patterns and rules, stored in the processing device.

[0061] For example, the method can advantageously be designed such that the assigned planning data set is manually modified after the assignment.

[0062] Furthermore, the method can advantageously be implemented in that the physiological data of the patient are collected and provided, in particular, by a measurement data collection device and are taken into account when the processing device allocates the planning data set. Physiological data can also be collected and input by a person, in particular when they relate to easily recognizable features of the patient, such as hair or iris color.

[0063] The method can also be advantageously implemented in that the processing device is designed as a self-learning device, and an allocation function allocates the planning data to the personal data and the structured image data and, in particular, the physiological data of the patient measured by the measurement data acquisition device, the allocation function being trained by assigning the following data to it: personal data, structured image data, allocated planning data, data on manual modifications of the planning data, and, in particular, measured physiological data of the patient, or acquired physiological data and / or data on treatment effects acquired after corresponding planned treatment data has been performed on multiple patients.

[0064] In a first step, provision can be made for assigning one of a plurality of predefined patient categories to a patient based on personal data and / or currently acquired data, and for the specifications of the processing device, in particular patterns and rules, for assigning planning data to the currently acquired data and personal data, to be determined or influenced by the respectively assigned patient category.

[0065] As with the above-described system, the method may be designed in such a way that planning data of one, two, three, four or five of the following categories are generated as planning data sets: laser parameters, position data of laser treatment, treatment pattern, position data of an area excluded from laser treatment, target values ​​of measurement data.

[0066] The different types, appearances and presentation forms of the various types of planning data have been described in detail above.

[0067] The invention may also relate to a method for operating a system and / or device of the above-described type, wherein a planning data set is created and, based on the planning data set, a treatment is then performed with a therapeutic laser in a separate treatment device or a treatment device integrated into the system or device.

[0068] The success of the treatment can then be assessed using monitoring devices, for example, and data representing success can be fed into the system in digital form to enable the system to learn. BRIEF DESCRIPTION OF THE DRAWINGS

[0069] The present invention is illustrated by way of example in the drawings and explained below. In the drawings:

[0070] Figure 1 shows the main components of a device and system according to the invention having a camera integrated in an ophthalmoscope in combination with a treatment laser, an image processing device, a processing device for generating planning data and some other data acquisition and input devices,

[0071] Figure 2 A schematic diagram of a system for creating a planning data set is shown,

[0072] Figure 3 A schematic diagram showing a system for creating a planning dataset using a learning algorithm, and

[0073] Figure 4 An exemplary flow chart of a method according to the invention is shown. DETAILED DESCRIPTION

[0074] Figure 1 A device and a system according to the invention are at least partially shown with a schematic ophthalmoscope 1 which can be used in the system to carry out the method according to the invention and which combines the functionality of an ophthalmoscope and a camera with the functionality of a laser treatment of the retina.

[0075] The device has an illumination device 5 with a radiation source 5', which is configured to direct an illumination beam 14 onto the patient's eye 4 and the retina 16. This allows the retina 16 to be properly illuminated to capture an image or camera image. For example, the illumination device can be equipped with a light emitting diode or an infrared diode as a light source, or with a different type of light source providing the required wavelength spectrum. The light source can also be, for example, a UV light source.

[0076] The ophthalmoscope also has a camera 6 with an image sensor referenced 7. The sensor may be, for example, a CCD sensor. Instead of the camera 6, any other type of device may be provided, for example as a scanning device, which is suitable for detecting radiation reaching the sensor from the retina and generating an image of the retina. The purpose of operating the illumination device 5 and the camera 6 or equivalent is to achieve the most accurate possible spatially resolved measurement data from the retina 16 by capturing an image of the reflected radiation, thereby acquiring properties of the entire retina or of the target area to be treated, or being able to determine these properties from the acquired data.

[0077] The illumination beam 14 and the reflected radiation 15 are appropriately collimated or focused in a manner known per se by a suitable optical system 13 with mirrors and lenses. The optical system 13 also has a beam splitter 12, which makes it possible to direct the laser beam 11 from the treatment laser 2 onto the retina 16. Instead of a beam splitter, the different beams of the treatment laser and the illumination and / or image acquisition can also be directed parallel to each other at a certain distance.

[0078] The control unit 8 can be arranged to control the laser 2, which on the one hand controls the illumination device 5, for example triggers the illumination device 5, and on the other hand directly controls the laser 2 depending on the camera image from the camera 6. The control unit 8 can also control the deflection mirror 3, which guides the beam path of the treatment beam 11 so that individual target areas on the retina 16 can be treated. In the system according to the invention, an image processing device 19 is also provided, which allows digital processing of the image / camera image from the camera 6 and determines structured data from the image data, which are present, for example, in the form of pixel data and can be provided, for example, in the form of vector graphics or in another structured form. The image data and / or the structured image data can also be provided to the control unit 8. The image processing device 19 also provides data for a display device 17, which has a screen 18, for example, on which an image of the retina is displayed. In the display device 17, in addition to the image data of the camera 6 and / or the structured image data of the image processing device 19, planning data can also be processed and displayed together with the image data in digital or graphical form. For example, treatment areas can be marked and / or treatment patterns or laser parameters can be displayed in the current image data (i.e. in the real-time view of the retina). A tracking device is also provided in the display device or connected to the tracking device, so that if the camera image moves, i.e. the structures displayed in the camera image move, the tracking device also moves the planning data elements assigned to the image data.

[0079] Figure 1 Also shown as part of the device and system is a processing device 20 which generates a planning file or planning data for the laser treatment and uses at least personal data from a personal data memory 21 or personal data of the patient to be treated input via a first input device 22 and a structured camera image. In addition, the processing device can use measurement data from a measurement data acquisition device 23, as well as correction data or change data input by an operator via a second input device 24 after the first generation of the planning data. The measurement data device 23 can, for example, include a sensor 23b such as a color sensor, a camera 23a for objectively detecting the skin or hair color of the patient or a camera aligned with the iris of the eye to be treated for detecting the iris color, or can be connected to a sensor. The measurement data device can also use the camera 6 to measure and align it with the iris, for example, or use this camera to record data other than retinal image data. For example, such data acquisition can be directly controlled by the measurement data acquisition device 23, or can also be mediated by the image processing device 19.

[0080] The processing device may send the planning data via the image processing device 19 or directly to the display device / display module 17, where the planning data may be displayed together with the current image of the retina on a screen 18. Some of the planning data may be displayed digitally, but at least some of it may also be displayed graphically directly in the retinal image.

[0081] After the laser treatment, the success of the treatment can be assessed and reported to the processing device 20 by means of a success control device / monitoring device 25 which, among other things, receives the current image of the retina 16 from the camera 6. The processing device 20 has a learning algorithm or a self-learning device which uses the training data to improve the assignment algorithm for mapping the planning data to the output data.

[0082] According to the prior art, the type and intensity of laser treatment, i.e. the intensity and / or duration of the laser pulses as well as the timing and local distribution, are previously determined by the surgeon based on his own assessment after evaluating the retinal images. Usually a titration pulse is first directed to the retina and its effect is assessed to adjust the laser intensity.

[0083] According to the invention, planning data are assigned to personal data and image data and possibly other data in a highly autonomous and automatic manner, so that even without titration injections, planning data can be assigned to each target area on the retina in an objective, transparent and easy-to-understand manner, wherein the planning data may include different categories of data, such as laser parameters, treatment positions or areas, positions or areas excluded from treatment, and treatment patterns.

[0084] Figure 2 A system according to the invention is shown, which has an image acquisition device 26 of the retina and an image processing device 27, which provides structured image data 28 to the processing device 20. The structured data can contain, for example, identified objects, such as neural nodes, blood vessels and identified diseased tissue areas, as well as color and color intensity data and other graphically recognizable properties of the retina, such as contrast, brightness and color distribution and other comparable data. For example, color intensity and brightness values ​​can be used to determine the intensity of pigmentation of the retina, which is decisive for the absorption of laser light of certain wavelengths and the laser intensity required for treatment. In the context of the present invention, structured graphical data are to be understood as all prepared pure pixel data and data derived therefrom.

[0085] In the figure, 29 represents the personal data of the patient which are provided to the processing device 20. This can be done by electronic data transmission or manual input. Possibly, the processing device 20 can also be provided with measurement data from a sensor system or a measurement data acquisition device, which in Figure 230 in the figure. Such data may be retinal position related data, such as the currently measured temperature distribution on the retina, or data obtained from optical coherence tomography (OCT), which may indicate, for example, edema, or retinal color and / or brightness measurements. However, they may also be other measured or estimated variables that are not related to retinal position, such as the patient's skin, hair or iris color, which may be measured or estimated and entered manually.

[0086] The processing device 20 comprises an element 33 in the form of an assignment device, which comprises patterns and rules for assigning planning data to input data (current image data or structured image data, personal data, sensor detection data).

[0087] In the example shown, the dispensing device outputs the following categories of planning data: laser parameters 34, position data for treatment 35, treatment pattern for treatment 36 and data of positions excluded from treatment 37.

[0088] After the planning data have been output and, if necessary, displayed graphically, the operator can manually change one, some or all categories of planning data via the input device using element 31. The modified planning data are then typically used as a basis for the laser treatment. The modified planning data then ultimately form planning data 38 for the laser treatment, which can also be displayed in a graphical representation 39, for example together with a current image of the retina. Thus, if the patterns and rules of the allocation device 33 stored in the processing device 20 are good enough and valid, then Figure 2 The system shown in can be run in a static manner. For example, the patterns and rules can be provided as part of an expert system and updated regularly.

[0089] Figure 3 A system is shown in which the patterns and rules according to which the dispensing device 33 performs dispensing or generates planning data are continually corrected and / or improved in the processing device 20 as part of a learning algorithm.

[0090] For example, treatment planning data generated after manual corrections 31 are made to planning data originally planned by the system are fed back as part of a feedback loop 42 to a learning device 44 which analyzes the changes made to the original planning data and may also determine whether these or similar correction entries occur more frequently or only once or rarely. Taking into account certain learning specifications, such as weighting certain corrections according to certain criteria (frequency, source of certain corrections, diversity of correction sources of similar corrections, etc.), the learning device at least tends to (and if necessary repeatedly) change the stored patterns and rules until manual corrections no longer occur in a given scenario, or, for example, the correction frequency is statistically the same in different directions.

[0091] Based on the corrected planning data 38 and its graphical representation 39 , the patient is treated 40 with retinal tissue.

[0092] After the treatment 40, the success of the treatment is monitored 41, for example by or with the aid of a monitoring device. Such success monitoring may include a new image of the retina, for example in the form of newly acquired image data, but in principle may be any type of data collection of the surgeon and / or the patient. For example, the surgeon and / or the patient may answer standard questions, and the answers may be input in the form of data and passed to the processing device as an implementation of a feedback loop 43.

[0093] The final successful control of the case is achieved by monitoring the determined data and can also be used as part of a learning process controlled by the learning device 44 to improve the distribution algorithm or the pattern and rules of the distribution device 33.

[0094] The processing device 20 can be located at the laser treatment site, or it can be designed as a central device that is remote from the laser treatment site. Figure 2 and Figure 3 The other elements shown in , and the data processing and planning data set determination for a plurality of treatment stations with treatment lasers. In the process of working with a large number of treatment stations, if the processing device is set as a learning device, the processing device receives a large amount of training data, so that the distribution algorithm of the planning data can be improved quickly.

[0095] The input or transfer of personal data can typically be performed at the laser treatment site or off-site, such as at a central office or distributed computer system. Similarly, if performed without direct collection of retinal measurement data, correction input by the surgeon or other specialist and monitoring can be performed on-site at the treatment facility near the patient, remotely at a control center, or through a distributed computer system.

[0096] Figure 4 An example flow chart of a method of creating a planning file for laser treatment of the retina of an eye according to the present invention is shown.

[0097] In a first step 45, all previously known data, i.e., the patient's personal data, such as diagnosis, treatment indications, and, if applicable, treatment status (if pre-treatment has been performed), and other known physiological data are retrieved and imported into the system. This can be done by transferring the data in electronic form or manually inputting it. In a second step 46, a current image of the patient's retina, i.e., a data representation of the position-related data of the retina, is created using a camera or other imaging device. This data is processed in a third step 42 in the following manner, i.e., structures and / or objects are identified and the data is converted into structured data. In a subsequent fourth step 48, a planning data set for retinal treatment is created, thereby taking into account the personal data and structured image data using existing stored templates in the form of patterns and rules. The planning data may also contain templates for reports on the specifications, as well as the implementation and success of the treatment (if applicable). If necessary, the planning data is then corrected by the surgeon in a subsequent step 49. In one embodiment of the method, the corrected planning data can be sent in step 50 to a training process 54, which affects the process 48 of generating planning data based on existing patterns and rules, and, for this purpose, empirical data are collected and evaluated in a training management 53 and, if necessary, published as training data and weighted.

[0098] Based on the applicable planning data ( Figure 4 After the retina has been treated (not shown per se), monitoring 51 is performed in the form of a successful assessment or successful acquisition, which can be performed automatically or manually based on measurement data and / or personnel assessment. In a further step 52, the performance assessment can be introduced into the training process 54 to improve the planning data generation process 48.

[0099] The process according to the invention can be used to continuously improve the method of generating planning files / planning data for retinal laser treatments.

[0100] By using an automated system improved in this way, various known treatment methods can be planned effortlessly in a reliable, understandable and objective manner.

Claims

1. A system for generating a planning data set (34, 35, 36, 37) for tissue treatment of a retina (16) of an eye (4) of a patient by means of a laser (2), - having a camera (6, 7) configured to continuously capture images of the retina, - having an image processing device (19) configured to generate and provide current structured image data of the retina based on the images captured by the camera, - having a personal data collection device (21, 22) configured to collect and / or provide personal data of the patient, and - having a processing device (20) which is configured to assign a planning data set for tissue treatment to the current structured image data of the retina and the personal data of the patient, wherein Specifications, in particular patterns and rules, for assigning the planning data to the image data and the patient's personal data are stored in the processing device.

2. The system according to claim 1, characterized in that Based on personal data and / or currently acquired data, one of a plurality of predefined patient categories is assigned to the patient, and is characterized in that the specifications, in particular patterns and rules, for assigning planning data to currently acquired data and personal data in the processing device (20) are determined or influenced by the respectively assigned patient category.

3. The system according to claim 1 or 2, characterized in that: The personal data acquisition device (21, 22) is configured to acquire and provide diagnostic data and / or indicative data and / or data of pre-treatment performed and / or previously known physiological data of the patient and / or existing images of the patient's retina (16) stored outside the system.

4. A system according to claim 1, 2 or 3, characterised in that A measurement data acquisition device (23) is provided, which has one or more sensor devices for acquiring and providing physiological data of the patient, in particular data depending on the corresponding position on the retina, and / or data not depending on the position on the retina, and is characterized in that the processing device is configured to take into account the acquired physiological data of the patient when allocating planning data, and / or is characterized in that the system has a modification device (24) which allows manual modification of the planning data set.

5. A system according to any one of claims 1, 2, 3 or 4, characterized in that: A display module (17, 18) enables a graphical representation of the planning data set within the image of the retina (16) currently captured by the camera (6, 7).

6. The system according to claim 5, characterized in that The tracking device enables the display of the planning data set to be tracked when the image currently captured by the camera (6, 7) is displaced.

7. The system according to any one of claims 1 to 6, characterized in that The processing device (20) has a storage device (33) which is configured to store the patient's personal data and the planning data set assigned thereto, and in particular also to store physiological data associated with the above data and acquired by the measurement data acquisition device (23), and / or to store manual modifications made to the planning data set.

8. The system according to any one of claims 1 to 6, characterized in that The processing device (20) has a storage device (33) which is configured to store the patient's personal data as well as structured image data and / or images of the patient's retina (16) generated by means of the system and planning data sets (34, 35, 36, 37) assigned thereto, and in particular also to store physiological data associated in each case with the above data and acquired by means of the measurement data acquisition device (23), and / or to store manual modifications made to the planning data sets.

9. The system according to any one of claims 1 to 8, characterized in that An inspection device (25) is included, which collects and provides data on the treatment effect after the retina (16) is treated.

10. The system according to any one of claims 1 to 8, characterized in that The processing device (20) is configured as a self-learning device, wherein an assignment function assigns planning data (34, 35, 36, 37), in particular target values ​​for measured data, to personal data, in particular structured image data, and measured physiological data of the patient, the assignment function being trained by assigning, in each case for a patient, data from at least one of the following categories as training data: -Personal data -Structured image data -Measure physiological data On the other hand, the assigned planning data, in particular the target values ​​of the measurement data, as well as the manual changes to the planning data, and in particular the treatment effect data acquired after the planning treatment data are used as training data.

11. A system according to any one of claims 1 to 10, characterised in that The planning data set (34, 35, 36, 37) includes planning data of one, two, three, four or five of the following categories: laser parameters (34), position data of laser treatment (35), treatment pattern (36), position data of areas excluded from laser treatment (37), and target values ​​of measurement data.

12. A device for generating a planning data set (34, 35, 36, 37) for tissue treatment of a retina (16) of an eye (4) by means of a laser beam (11), - having a camera (6, 7) configured to continuously capture images of the retina (16), - having an image processing device (19) which generates and provides current structured image data of the retina based on the images captured by the cameras (6, 7), - having a personal data collection device (21, 22) configured to collect and / or provide personal data of the patient, - having a processing device (20) which is configured to assign a planning data set (34, 35, 36, 37) to the current structured image data of the retina and to the personal data of the patient, wherein Specifications, in particular patterns and rules, for assigning planning data to structured image data and personal data of the patient are stored in the processing device; - and having a modification device (22) which enables manual modification of the planning data set.

13. The device according to claim 12, characterized in that There is a modification device (22) which enables manual modification of the planning data set.

14. A method for generating a planning data set (34, 35, 36, 37) for tissue treatment of a retina (16) of an eye (4) of a patient by means of a laser beam (11), -in, capturing at least one image of the retina by means of a camera (6, 7), - wherein an image processing device (19) is used to generate and provide current structured image data of the retina based on the images captured by the camera, - wherein personal data of the patient are collected and / or provided as part of a personal data collection device (21, 22), - and wherein the processing device (20) assigns the planning data set to the current structured image data of the retina and previously known personal data of the patient according to specifications, in particular patterns and rules, stored in the processing device (20).

15. The method according to claim 14, characterized in that The allocated planning data sets (34, 35, 36, 37) are manually changed after allocation.

16. The method according to claim 14 or 15, characterized in that The physiological data of the patient are in particular acquired and provided by a measurement data acquisition device (23) and are taken into account when the processing device (20) allocates the planning data sets (34, 35, 36, 37).

17. The method according to any one of claims 14 to 16, characterized in that The processing device (20) is designed as a self-learning device, and an allocation function allocates planning data to the personal data and the structured image data, and in particular measured physiological data of the patient, and the allocation function is trained by assigning the following data to it: personal data, structured image data, allocated planning data (34, 35, 36, 37), data on manual modifications of the planning data, and in particular measured or acquired physiological data and / or data on the treatment effect acquired after performing the corresponding planned treatment data on each of a plurality of patients.

18. The method according to any one of claims 14 to 17, characterized in that Planning data of one, two, three, four or five of the following categories are determined as planning data sets (34, 35, 36, 37): laser parameters (34), position data of laser treatment (35), treatment pattern (35), position data of areas excluded from laser treatment (36), and target values ​​of measurement data.

19. A method for operating a system according to any one of claims 1 to 11 and / or a device according to claim 12 or 13, characterized in that: A planning data set is created and, based on the planning data set, a treatment is then carried out with a therapeutic laser in a separate treatment device or a treatment device integrated in the system or in the device.

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