EP4499005A1 - Système, appareil et procédé de création d'ensembles de données de planification pour traiter le tissu de la rétine d'un patient - Google Patents

Système, appareil et procédé de création d'ensembles de données de planification pour traiter le tissu de la rétine d'un patient

Info

Publication number
EP4499005A1
EP4499005A1 EP23715089.1A EP23715089A EP4499005A1 EP 4499005 A1 EP4499005 A1 EP 4499005A1 EP 23715089 A EP23715089 A EP 23715089A EP 4499005 A1 EP4499005 A1 EP 4499005A1
Authority
EP
European Patent Office
Prior art keywords
data
planning
retina
treatment
patient
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
EP23715089.1A
Other languages
German (de)
English (en)
Inventor
Annemarie Hoff
Arnd ROSE
Kay-Uwe Amthor
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.)
Od Os Macutherm GmbH
Original Assignee
Od Os Macutherm 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 Od Os Macutherm GmbH filed Critical Od Os Macutherm GmbH
Publication of EP4499005A1 publication Critical patent/EP4499005A1/fr
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F9/00821—Methods or devices for eye surgery using laser for coagulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T7/00—Image analysis
    • G06T7/0002—Inspection of images, e.g. flaw detection
    • G06T7/0012—Biomedical image inspection
    • 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
    • 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
    • G16H30/00—ICT specially adapted for the handling or processing of medical images
    • G16H30/20—ICT specially adapted for the handling or processing of medical images for handling medical images, e.g. DICOM, HL7 or PACS
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00844—Feedback systems
    • A61F2009/00846—Eyetracking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00861—Methods or devices for eye surgery using laser adapted for treatment at a particular location
    • A61F2009/00863—Retina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00878—Planning
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00—Indexing scheme for image analysis or image enhancement
    • G06T2207/30—Subject of image; Context of image processing
    • G06T2207/30004—Biomedical image processing
    • G06T2207/30041—Eye; Retina; Ophthalmic

Definitions

  • the invention lies in the field of medical technology and can be used particularly advantageously in the field of ophthalmology and in connection with certain ophthalmoscopes.
  • laser treatment devices are used to treat a patient's retina, which enable tissue treatment using a laser beam.
  • the combined use of an ophthalmoscope with a device for laser treatment is particularly advantageous simultaneously and coordinated to enable a visual representation of the retina even during treatment.
  • an ophthalmoscope has the function of providing an examiner with an image of an eye or parts of an eye.
  • an ophthalmoscope which provides an image of the retina of an eye, can be combined with a device for laser treatment of the retina if, for example, the same optical imaging device is used to guide the laser beam at least partially as for the visualization of the retina.
  • the beam paths for imaging and laser treatment can be branched over part of their length, for example by beam splitter devices, and run together through the same optical elements on another part. This makes it possible to observe the retina at the same time as the laser treatment, which would be significantly more difficult if there were separate imaging devices for observation and treatment for reasons of space.
  • an ophthalmoscope with imaging optics and an illumination device as well as an optical sensor is known with which images of the retina of an eye can be recorded.
  • Such an ophthalmoscope can also be used by a surgeon to plan laser treatment.
  • the present invention is based on the task of facilitating the creation of treatment plans for the tissue treatment of a retina using a laser device and of systematically standardizing and improving the planning data.
  • the invention also relates to a device and a method for creating planning data sets, which, together with advantageous embodiments, are set out in further patent claims. Accordingly, the invention relates to a system for creating planning data sets for the tissue treatment of the retina of a patient's eye using a laser,
  • an inventory data acquisition device that is set up to record and / or provide inventory data of a patient
  • a processing device that is set up to assign planning data sets for the tissue treatment to the current structured image data of the retina and the patient's inventory data, in which Processing device specifications, in particular patterns and rules, for the assignment of planning data to image data and inventory data of patients are stored.
  • the system has a change device, which can also be referred to as a correction device and which enables the manual change of a planning data set.
  • a change device which can also be referred to as a correction device and which enables the manual change of a planning data set.
  • Such manual changes can be made during or especially after the creation of a planning data set by an expert based on his or her experience or additional insights.
  • the system according to the invention is set up to support the creation of a treatment plan, which is created in the form of a planning file or planning data, before the treatment of a patient's retina begins.
  • a camera or, in general, an imaging system that is set up to continuously capture images of the retina.
  • Such a camera can be designed as an optical color, infrared or black and white camera or as a scanning system or can also have various filter options and enables the capture of current images of the Retina before and/or during planning data is generated. This can be important, for example, in order to be able to compare other recorded or currently determined retinal data with the currently recorded state and positioning of the retina in the system.
  • structured graphic or image data should be understood to mean all preparations of pure pixel data and the data derived from these or from the pixel data, in particular so-called vector-oriented image data.
  • 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 drusen, namely soft drusen, hard drusen and reticular pseudo-drusen (RPD), can be provided as structured image data and used in the creation of Planning data sets are taken into account.
  • RPD reticular pseudo-drusen
  • Inventory data can also be data from a previous treatment carried out on the patient or data on a treatment status.
  • inventory data can be all of the patient's data that is available in writing or in electronic, especially digital, form before the start of treatment or before the start of the creation of the planning data set. These can be transmitted to the system via electronic interfaces or entered manually.
  • the inventory data can, for example, be present in electronic form in a more comprehensive system, of which the system according to the invention for creating planning data sets represents a subsystem or subsystem.
  • An advantage of a camera that captures current images of the retina arises if the system for creating planning data is also combined with a treatment device that has a treatment laser that is adjusted relative to the camera or aligned with it in order to use the Planning data to carry out the treatment.
  • the structuring of the planning data is explained in detail below.
  • an image processing device is provided which generates structured image data of the retina from the currently captured image data of the camera and makes this available for planning.
  • Structured image data means, for example, data that contains or represents certain objects recognized in the images by the image processing or properties of the image or the retina or properties of image areas or parts of the retina.
  • the structured image data can describe brightness or color distributions, intensity distributions on an infrared image, the position, shape and/or progressions of objects or object boundaries.
  • the representation of such structures in the form of data can be diverse and include, for example, pure image data, but also vector representations, vectors, matrices or other types of abstracted representations.
  • the structured data should describe the shape, position and possibly other parameters of blood vessels, nerve nodes and general abnormalities on the retina in a clear form, for example vector-oriented or with metadata that relate to geometric shapes.
  • the location of objects that are currently recognized on the retina can and should be taken into account when creating a treatment plan and generating corresponding planning data.
  • inventory data is understood to mean data that relates to the patient and is already available and available when the system is used on the patient.
  • the image processing device or the processing device for generating planning data or parts of this device can be located on another Be localized as the treatment laser.
  • Data processing devices can, for example, be located in larger computers or data processing systems than are available at the location of the laser treatment. If the processing devices need access to a lot of stored data, both the processing devices and storage devices can be distributed across several computers or located in a larger, central computer system.
  • Individual parts or modules of the system can also be installed as an application on a mobile device, for example.
  • An embodiment of such a system can, for example, provide that a patient is assigned one of several predefined patient categories based on inventory data and/or currently recorded data and that specifications of the processing device (20), in particular patterns and rules, are too current for the assignment of planning data recorded data and inventory data are determined or influenced by the assigned patient category.
  • the patient category that is assigned to the respective patient can, for example, be determined by stored inventory data, such as age physiological parameters of the patient, such as weight, type and strength of skin pigmentation, hair color, pigmentation of the iris, the history of the disease and the type, intensity and success of previous treatments and / or on currently measured or recorded data, such as the structured image data of the Retina or currently recorded physiological data and/or parameters of the patient, which can either be measured in or on the eye or can also be independent of parameters of the eye, such as, for example, age of the patient, eye color, hair color, skin color, strength of skin pigmentation, body structure and current health condition.
  • stored inventory data such as age physiological parameters of the patient, such as weight, type and strength of skin pigmentation, hair color, pigmentation of the iris, the history of the disease and the type, intensity and success of previous treatments and / or on currently measured or recorded data, such as the structured image data of the Retina or currently recorded physiological data and/or parameters of the patient, which can either be measured in or on the
  • only two patient categories can be provided, which are determined by a single recorded parameter, for example patients who are younger than 50 years or older or light-skinned and dark-skinned patients.
  • more than two, for example 3, more than 3, more than 5 or even more than 10 categories can also be provided, the respective assignment of which to a patient also depends on more than one parameter, for example on at least two or at least three parameters .
  • prefabricated planning data sets can be assigned.
  • the planning data sets can still be created individually using stored specifications, in particular patterns and rules, but the patterns and rules used can depend on the assigned patient category. In this way, the specifications can be made less complex.
  • an assigned patient category could also refer to fully expert-based treatment planning.
  • a patient category into which patients with heavily pigmented skin and/or heavily pigmented retina and/or a dark iris color are classified could be linked to the rule that certain laser power densities must not be exceeded.
  • certain patient categories that concern pre-existing conditions may be linked to the condition that certain retinal temperatures, which are monitored by recording certain measurement data during treatment, must not be exceeded.
  • the target data which correspond to the desired temperature of the retina at the treatment site during the treatment, could also be selected depending on the patient category, which is determined by previous illnesses or previous treatments.
  • the selection of location data for laser treatment and the selection of location data for areas excluded from laser treatment may also depend on the patient category.
  • a further advantageous embodiment of such a system can provide that the inventory data acquisition device is set up to receive diagnostic data and/or indication data and/or data of a pretreatment carried out and/or previously known physiological data of the patient and/or existing images of the retina stored outside the system to record and provide information about the patient.
  • Such inventory data can, for example, be in the form of an electronic file, can be entered or read manually, for example a diagnosis in text or image form or an indication that already provides information about a recommended treatment.
  • Such information can already contain data that differentiates certain locations or areas of the retina and is location-dependent on the respective location on the retina, such as the exact location of locations or areas to be treated.
  • Such information can also be location-independent and describe the general condition of the patient, his eyes or other characteristics, for example physiological data of the patient.
  • physiological data may be in the form of older images of the retina of various types, for example color images, black and white images, infrared images, fluorescence images or tomography images, or may consist of age information, skin color or gender of the patient, an identity of the patient or information about previous treatments associated with or may have taken place without integration of the system according to the invention.
  • 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 recording and providing physiological data of the patient, in particular data that depend on the respective location on the retina, and / or data, which do not depend on a location on the retina, and that the processing device is set up to take the recorded physiological data of the patient into account when assigning planning data.
  • a measurement data acquisition device which has one or more sensor devices for recording and providing physiological data of the patient, in particular data that depend on the respective location on the retina, and / or data, which do not depend on a location on the retina
  • the processing device is set up to take the recorded physiological data of the patient into account when assigning planning data.
  • Such measurement data acquisition devices can in principle be all types of devices that enable the current acquisition of additional information about the patient and his physiological data.
  • These include sensor devices such as cameras that record different properties than the camera mentioned at the beginning, for example other imaging methods or similar or the same imaging methods as the camera mentioned at the beginning for recording the retina. Images of the retina captured with such cameras then provide data that depends on the respective location of the retina.
  • a sensor device can be used to measure the temperature or temperature distribution measured on the retina.
  • images of the retina can be used to detect retinal diseases using algorithms, which can be taken into account when creating planning data.
  • a device for creating an OCT image or a device for reflectometry can also be provided.
  • reactions of the retina to titration shots i.e. experimental applications of the treatment laser
  • Sensor devices are also conceivable that measure other physiological properties of the patient, such as skin color and/or lightness, skin thickness, hair color, color and/or color distribution of the iris, blood pressure, various blood values or the like. These sensor devices can also include, for example, a camera or optical sensors.
  • a special implementation of the system can, for example, also provide that the above-mentioned measurement data acquisition devices continue to be operated to acquire data during the actual laser treatment even after an initial generation of planning data for a laser treatment and possibly also after a manual correction of planning data.
  • the temperature of the retina or temperature distribution on the retina can be continuously recorded by such a measuring device even during treatment or during breaks in treatment.
  • the measurement data obtained in this way may require or make it advantageous to change the planning data. It can therefore be provided that, based on the measurement data determined after the first creation of a planning data set, the system generates a further, corrected planning file and forms the basis for further treatment.
  • the system can also be further developed, for example, by a display module or a display device that effects the graphical representation of a planning data set within an image of the retina currently captured by the camera.
  • the planning data can be can be visualized together with a graphic representation of an image of the retina, so that, for example, the consideration of the structured image data can be directly assessed by making it visible whether, for example, certain sensitive areas of the retina, such as blood vessels or nerve nodes, are excluded from the treatment or whether certain areas that are already visible in the current image and classified as requiring treatment are appropriately taken into account in the treatment plan.
  • the planning data set can also be compared directly with the steering device.
  • the system can also be further developed by a tracking device, which causes the representation of the planning data set to be updated in the event of a movement, in particular a displacement or rotation, of the recording currently captured by the camera.
  • a tracking device causes the representation of the planning data set to be updated in the event of a movement, in particular a displacement or rotation, of the recording currently captured by the camera.
  • a shift in the recording can occur, for example, when the patient moves relative to the camera or when the eye moves, and in such a case the tracking device ensures that the representation of the planning data continues to match the current camera image displayed.
  • a treatment device is integrated into the system, such tracking can also ensure that the steering device for a treatment laser remains aligned as planned.
  • the processing device has a storage device which is set up to store inventory data from patients and planning data sets assigned to them, and in particular in addition to storing data associated with the aforementioned data, through a measurement data. physiological data recorded by the recording device and/or for storing any manual changes made to the planning data sets.
  • the system can assign a current planning data set to the inventory data of a patient with previous assignments to compare similar or different inventory data. This can be used, for example, to carry out a plausibility analysis. If planning changes were made later manually in previous cases, these can also be taken into account and, for example, anticipated during planning. In addition, if recorded physiological data is also stored, this can also be taken into account when comparing and possibly aligning the planning file to be created with previous plans. Accordingly, the system according to the invention can be designed as an expert system or as a learning system.
  • the processing device has a storage device which is used to store inventory data from patients as well as structured image data and / or recordings of the patient's retina generated with the system and planning data sets assigned to these, in particular, among other things, target values for measurement data , is set up, and in particular in addition to storing physiological data associated with the aforementioned data, recorded by a measurement data acquisition device and / or for storing manual changes made to the planning data sets.
  • This embodiment of the system makes it possible to compare the assignment of a current planning data set to the inventory data of a patient and the structured image data with previous assignments for similar or different inventory data as well as structured image data that is also stored. A plausibility analysis can also be carried out with this data. If planning changes were made later manually in previous cases, these can also be taken into account and, for example, anticipated during planning. In addition, if recorded physiological data is also stored in the expert system formed in this way, these can also be taken into account when comparing and possibly comparing the planning file to be created with previous plans.
  • a further development of the system can be provided, for example, by a checking device, also called a monitoring device, which collects and provides data on the effects of the treatment after retinal treatment has been carried out.
  • a checking device also called a monitoring device
  • the treatment of the retina can include laser treatment, but also additional treatment steps with or without the use of a laser.
  • the check can be carried out immediately during the treatment or after the treatment has been completed, in particular a certain minimum time after the treatment.
  • the checking device can include a device for carrying out an imaging method, for example also using the camera mentioned at the beginning to capture current images of the retina.
  • the checking device can also include an input device for manually entering data. It can be provided that only binary information such as “treatment successful” or “treatment unsuccessful” is recorded or an assessment by the patient, such as “I have pain, yes/no” or a more detailed assessment, for example which Treatment parameters such as: B. the laser parameters, selected geometric treatment patterns, areas intended for treatment or areas excluded from treatment were, in the opinion of an assessor, suboptimal. For this purpose, certain assessment categories can be specified, such as an evaluation scheme. Such an assessment can also be included in the expert systems described above, saved together with the saved planning data sets and taken into account when comparing current planning data with saved planning data.
  • the planning data sets generated by the system may, in an implementation of the system, contain planning data from one, two, three, four or five of the following categories: laser parameters, location data for laser treatment, treatment patterns, location data for areas excluded from laser treatment, and target values for measured values that are recorded during a subsequent treatment by the measured value recording device or otherwise.
  • target values can be, for example, an average target temperature or a target temperature that depends on the location on the retina, which is continuously recorded during the laser treatment and which, for example, should be achieved, maintained or not exceeded.
  • the remaining Treatment parameters can then be dynamically adjusted during treatment so that the specified target values are achieved or not exceeded.
  • parameters for a control system are specified in the planning data sets.
  • report templates for treatment can also be created as a further category of planning data, i.e., for example, forms as well as the selection and presentation of the data and parameters to be reported.
  • the invention can further advantageously be implemented in that the processing device is designed as a self-learning device in which the assignment function, which assigns planning data to the inventory data and in particular to the structured image data and in particular to measured physiological data of a patient, is trained by assigning it to each a patient, on the one hand, at least data from at least one of the following categories: inventory data, structured image data, measured physiological data, and on the other hand, assigned planning data, in particular, among other things, target values for measurement data, as well as manual planning data changes and in particular data on an effect of the treatment recorded after the planned treatment has been carried out be specified as training data.
  • the assignment function which assigns planning data to the inventory data and in particular to the structured image data and in particular to measured physiological data of a patient, is trained by assigning it to each a patient, on the one hand, at least data from at least one of the following categories: inventory data, structured image data, measured physiological data, and on the other hand, assigned planning data, in particular, among other things, target values for measurement data, as well as manual planning
  • the planning data sets that the system generates can contain planning data from one, two, three, four or five of the following categories: laser parameters, location data for laser treatment, treatment patterns, location data for areas that are excluded from laser treatment, target values for measurement data.
  • the laser parameters can include, for example, the laser power, the wavelength, pulse duration, repetition rate of the pulses and the total number of laser pulses as well as the size of the laser's light spot on the retina as well as each of these sizes or all conceivable subcombinations. These laser parameters can depend on the location or area on the retina.
  • the location data of the laser treatment can include one or more geometric areas on the retina.
  • the areas of the retina excluded from treatment can also include one or more geometric areas of the retina.
  • the treatment patterns can include geometric patterns such as circles, ellipses, rectangles, triangles or any free shapes in which the laser treatment is to take place, for example, with constant laser parameters or in which one of the laser parameters remains the same. These treatment patterns can also be areas that are processed independently by the treatment laser after a starting impulse from the surgeon, that is, irradiated. The treatment patterns can also simply include geometric areas that the laser processes in one go, for example point by point according to a dot pattern, without the surgeon having to go to each individual point. Only a starting point can be controlled manually or automatically, and the rest of a treatment pattern can then be carried out automatically under the control of the laser control. The density of the points to be approached can also be one of the parameters of the “patterns” category.
  • Planning data can also be target values for measurement data that are recorded during the treatment, such as a temperature to be reached or not exceeded on the retina during the treatment, which can be specified overall as an average value or depending on the location and which is continuously recorded/measured during the treatment becomes.
  • the treatment system is then regulated so that the target values are met.
  • Continuously detectable optical variables such as a change in reflection, discoloration/spectral change or change in brightness of the respective treated areas recorded by a camera or a hyperspectral sensor, can also be specified as target values.
  • Each of these mentioned categories of planning data can be changed manually by a person, in particular by the respective operator, if necessary with restrictions as stated above. He can compare the planning data generated by the system in the first attempt with the image data currently captured by the camera or the structured data as well as with his experience and change it according to his assessment.
  • the areas to be excluded from treatment can play a special role. Although in many cases they can be thought of as a complementary set of location data for laser treatment, they are In many cases it is less error-prone to specify the areas of the retina to be excluded from the treatment than the location data for the treatment, especially, for example, if the retina is to be processed uniformly except for a few areas to be excluded.
  • the areas to be excluded can be very safety-relevant, as these also include areas in which laser treatment can cause health damage. It can therefore also be provided, for example, to specify the areas to be excluded from treatment according to the planning data generated by the system in such a way that they cannot be changed manually or that certain obstacles have to be overcome or authorizations have to be proven in order to change them.
  • the system can be designed as a self-learning system that continuously improves the allocation algorithm that generates planning data based on the above-mentioned data that is made available to it.
  • the system can have a neural network that is trained, or have an analytical, statistical or parametric learning algorithm, be static, guided learning or self-learning.
  • the assignment algorithm can also have analytical elements that cannot be changed by the learning process and are specified with expert knowledge, such as certain conditions that the laser parameters must meet, for example power limitations or regulations that the exclusions from treatment locations must follow.
  • the elements of the learning process can, for example, be ordered and weighted.
  • the data that is based on the treatment successes determined after the laser treatment with the monitoring device can be given a higher weighting than the manual corrections of planning data that are made by treating people.
  • conditions can also be introduced that must be met so that treatment data is made available to the learning system or the learning algorithm.
  • such a condition can This means that certain manual parameter changes, for example the laser parameters, must have been made within a defined range in a certain minimum number of cases or by a minimum number of treating people or at a minimum number of treatment locations in order for these changes to be given to the learning system as training data become.
  • the invention also relates to a device for creating planning data sets for the tissue treatment of the retina of an eye using a laser beam,
  • the device can advantageously additionally have a change device which enables the manual change of a planning data set.
  • the invention also relates to a method for creating planning data sets for the tissue treatment of the retina of a patient's eye using a laser beam,
  • planning data sets are assigned to the current structured image data of the retina and the previously known inventory data of the patient by a processing device based on specifications, in particular patterns and rules, which are stored in the processing device.
  • the method can, for example, be advantageously designed in that assigned planning data sets are changed manually after the assignment.
  • the method can be advantageously implemented in that physiological data of the patient is recorded and made available, in particular with a measurement data acquisition device, and is taken into account by the processing device when assigning planning data sets.
  • the physiological data can also be recorded and entered by a person, especially when it concerns easily recognizable characteristics of the patient, such as hair or iris color.
  • the method can also be advantageously implemented in that the processing device is designed as a self-learning device and the assignment function, which assigns planning data to the inventory data and the structured image data and in particular to physiological data of a patient measured by a measurement data acquisition device, is trained by forming it into a plurality
  • the inventory data, structured image data, assigned planning data, data of manual planning data changes and, in particular, measured or recorded physiological data and/or data on the effect of the treatment recorded after the respective planned treatment has been carried out are specified by patients.
  • a patient is assigned one of several predefined patient categories based on inventory data and / or currently recorded data and that specifications of the processing device, in particular patterns and rules, for the assignment of planning data to currently recorded data and Inventory data is determined or influenced by the assigned patient category.
  • the method can be designed in such a way that planning data from one, two, three, four or five of the following categories are generated as planning data sets: laser parameters, location data for the laser treatment, treatment patterns, location data for areas that are excluded from laser treatment, target values for measurement data.
  • the invention can also relate to a method for operating a system and / or a device of the type described above, in which a planning data set is created and then a treatment according to the is carried out in a separate treatment device or a treatment device integrated into the system or the device using a treatment laser Planning data set is carried out.
  • an assessment of the success of the treatment can be carried out using a monitoring device and data representing the success can be fed to the system in digital form in order to enable the system to learn.
  • Fig. 1 essential parts of the device and system according to the invention with an ophthalmoscope integrated and with a camera combined with a treatment laser, an image processing device, a processing device for generating planning data and several other data acquisition and input devices,
  • Fig. 3 shows schematically a system for creating planning data sets with a learning algorithm, as well
  • Fig. 4 shows an exemplary flow chart for the method according to the invention.
  • Figure 1 shows at least partially a device and a system according to the invention with a schematic ophthalmoscope 1, which can be used in the system for carrying out the method according to the invention and combines the functions of an ophthalmoscope with a camera with functions of laser treatment of the retina.
  • the device has an illumination device 5 with a radiation source 5 ', which is set up to direct an illumination beam 14 onto the eye 4 and the retina 16 of a patient. This allows the retina 16 to be suitably illuminated to capture a recording or a camera image.
  • the lighting can be equipped, for example, with a light-emitting diode or an infrared diode as a light source, or with a light source of another type that delivers a desired wavelength spectrum.
  • the light source can also be a UV light source, for example.
  • the ophthalmoscope also has a camera 6, in which an image sensor is designated 7.
  • the sensor can be a CCD sensor, for example.
  • any other type of device can also be provided, which is suitable, for example as a scanning device, for detecting radiation that passes from the retina to a sensor and for generating an image of the retina.
  • the aim of operating the lighting device 5 and the camera 6 or an equivalent device is is to obtain the most accurate, spatially resolved measurement data from the retina 16 by recording a recording of reflected radiation and thus to record the properties of the entire retina or of target areas to be treated or to be able to determine them from recorded data.
  • the illumination beam 14 and the reflected radiation 15 are suitably 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 a laser beam 11 from the treatment laser 2 onto the retina 16.
  • a beam splitter instead of a beam splitter, different beams of the treatment laser and the illumination and/or image capture can also be guided parallel to one another at a certain distance.
  • a control unit 8 can be provided, which on the one hand controls the lighting device 5, for example triggering it, and on the other hand directly controls the laser 2 on the basis of a camera image from the camera 6.
  • the control unit 8 can also control deflection mirrors 3, which direct the beam path of the treatment beam 11 and thus enable the targeted treatment of individual target areas on the retina 16.
  • an image processing device 19 is also provided, which allows digital processing of recordings/camera images from the camera 6 and determines structured data from the image data, which is present, for example, in the form of pixel data, for example in the form of a vector graphic or in a other, structured form can be provided.
  • the image data and/or structured image data can also be made available to the control unit 8.
  • the image processing device 19 also provides the data for the display device 17, which has a screen 18 on which, for example, an image of the retina is displayed.
  • planning data can also be processed in the display device 17 and displayed together with the image data in a numerical or graphical representation.
  • treatment areas can be marked and/or treatment patterns or Laser parameters are also displayed.
  • a tracking device is also provided in the display device or connected to it, which also shifts the elements of the planning data that are assigned to the image data in the event of a movement of the camera image, that is to say a movement of structures shown in the camera image.
  • the processing device 20 as part of the device and the system, which generates planning files or planning data for the laser treatment and uses at least inventory data from an inventory data memory 21 or inventory data of the patient to be treated entered by means of a first input device 22 as well as structured camera images.
  • the processing device can use measurement data from a measurement data acquisition device 23, as well as correction data or change data that can be entered by an operator using the second input device 24 after the first planning data creation.
  • the measurement data device 23 can, for example, include sensors 23b such as color sensors, a camera 23a for objectively detecting the skin or hair color of the patient or a camera aimed at the iris of the eye to be treated for detecting the iris color, or can be connected to such sensors.
  • the measurement data device can also use the camera 6 for measurements and, for example, point it at the iris or use this camera to record data other than the image data of the retina.
  • This data acquisition can, for example, be controlled directly by the measurement data acquisition device 23 or also be mediated by the image processing device 19.
  • the processing device can send planning data using the image processing device 19 or directly to the display device/display module 17, where the planning data can be displayed on a screen 18 together with current images of the retina.
  • the planning data can be partially displayed numerically, but at least partially they can also be displayed directly graphically in an image of the retina.
  • 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 can, among other things, receive current images of the retina 16 from the camera 6.
  • the processing device 20 has a learning algorithm or a self-learning device that improves the assignment algorithm for assigning planning data to output data using training data.
  • the type and intensity of the laser treatment i.e. the strength and/or duration as well as the temporal and spatial distribution of the laser pulses, was previously carried out by a surgeon based on his own assessment after assessing an image of the retina. Titration pulses were often first directed at the retina and their effect was assessed in order to scale the laser strength.
  • the largely independent, automated assignment of planning data to inventory data and image data and possibly other data according to the invention makes it possible to assign planning data to each target area on the retina in an objectified, transparent and comprehensible manner, even without titration shots, whereby the planning data is assigned to different categories of data, such as laser parameters, treatment locations or areas, locations or areas excluded from treatment and treatment patterns.
  • Figure 2 shows a system according to the invention with an image capture device 26 of the retina and an image processing device 27, which supplies structured image data 28 to the processing device 20.
  • the structured data can, for example, contain recognized objects such as nerve nodes, blood vessels and identified diseased tissue areas as well as data about the color and color intensity of the retina as well as other graphically recognizable properties such as contrasts, brightness and color distributions and other comparable data.
  • Color intensity and brightness values can be used, for example, to determine the pigmentation intensity of the retina, which is crucial for the absorption of laser light of certain wavelengths and thus crucial for the necessary laser intensity for a disease. action can be.
  • structured graphic data should be understood to mean all preparations of pure pixel data and data derived from them.
  • Inventory data of the respective patient which is provided to the processing device 20, is denoted by 29 in the figure. This can be done through electronic transmission of data or through manual entry. Potentially, the processing device 20 can also be supplied with measurement data from a sensor system or measurement data acquisition device, which is designated by 30 in FIG.
  • This data can be retinal location-dependent data, such as a currently measured temperature distribution on the retina, or data obtained from OCT (optical coherence tomography), which can indicate edema, for example, or color and/or brightness measurements of the retina. However, they can also be other measurements or estimates that are independent of a location on the retina, such as the patient's skin, hair or iris color, which can each be measured or estimated and entered manually.
  • OCT optical coherence tomography
  • the processing device 20 contains an element 33 in the form of an assignment device that contains patterns and rules for the assignment of planning data to input data (current image data or structured image data, inventory data, sensory data).
  • the allocation device outputs planning data of the categories laser parameters 34, location data 35 for the treatment, treatment patterns 36 for the treatment and data of the locations 37 excluded for the treatment.
  • the changed planning data is then usually used as the basis for the laser treatment.
  • the changed planning data then finally forms the planning data 38 for the laser treatment, which can also be displayed in the graphical representation 39, for example together with current len images of the retina.
  • the system shown in Figure 2 can function in a static manner if the patterns and rules of the assignment device 33 stored in the processing device 20 are sufficiently good and valid. Such patterns and rules can, for example, be made available as part of an expert system and also be renewed regularly.
  • FIG. 3 shows a system in which the patterns and rules according to which the assignment device 33 carries out the assignment or generation of planning data are continuously corrected and/or improved in the processing device 20 as part of a learning algorithm.
  • the planning data for the treatment which results from manual corrections 31 of the planning data originally planned by the system, is fed back to a learning device 44 as part of a feedback loop 42, which analyzes the changes in the original planning data and can also determine whether these or similar correction entries occur more frequently or only once or rarely.
  • the learning device Taking into account certain learning specifications, such as the weighting of certain corrections according to certain criteria (frequency, sources for certain corrections, diversity of correction sources for similar corrections, etc.), the learning device at least tends to change the stored patterns and rules, if necessary repeatedly, until one In a given scenario, manual corrections no longer occur or, for example, corrections statistically point in different directions with the same frequency.
  • a tissue treatment 40 of the retina takes place on the patient.
  • a success check takes place as part of a monitoring 41, for example by or with the help of a monitoring device.
  • This success control can include a new recording of the retina, for example in the form of newly recorded image data, depending on but basically any type of data collection by the surgeon and/or the patient.
  • the surgeon and/or the patient may answer standard questions, and the answers may be entered in the form of data and passed on to the processing device as an implementation of the feedback loop 43.
  • the data determined by monitoring enable a final success check for each individual case and can also be used to improve the assignment algorithm or the patterns and rules of the assignment device 33 as part of a learning process controlled by the learning device 44.
  • the processing device 20 can be present locally at the location of the laser treatment or can be designed as a central device that is located away from the other elements shown in FIGS. 2 and 3 and carries out data processing and determination of planning data sets for a plurality of treatment stations with treatment lasers. In the course of working with a large number of treatment stations, the processing device, if it is designed as a learning device, receives a large number of training data so that the allocation algorithm for the planning data can be quickly improved.
  • the entry or transmission of inventory data can in principle take place at the location of the laser treatment or non-locally, for example in a central office or in a distributed computer system.
  • correction entries by a surgeon or another expert, as well as monitoring, if it is carried out without the direct collection of retinal measurement data can be carried out on site at the treatment facility in the immediate vicinity of the patient or away from it in a central office or via a distributed computer system.
  • Figure 4 shows an exemplary flow chart for a method according to the invention for creating a planning file for a laser treatment of the retina of an eye.
  • a first step 45 all previously known data, i.e. the patient's inventory data, such as a diagnosis, a treatment indication and, if necessary, a treatment status if previous treatments have already taken place, and other known physiological data are retrieved and imported into the system. This can be done, among other things, by transporting data in electronic form or by manual entry.
  • a second step 46 a current image of the patient's retina is created using a camera or other imaging device, that is, a data representation of location-dependent retinal data.
  • This data is processed in a third step 42 such that structures and/or objects are recognized and the data is converted into structured data.
  • a planning data set for a retinal treatment is created, taking into account the inventory data and the structured image data, using existing, stored templates in the form of patterns and rules.
  • the planning data can also contain a template for a report on the specifications and implementation and, if necessary, the success of the treatment.
  • the planning data is then corrected, if necessary, in a subsequent step 49 by an operator.
  • the corrected planning data can be sent in a step 50 to a training process 54, which influences the process 48 for generating planning data according to the existing patterns and rules and, for this purpose, collects experience data within the training management 53, evaluates it and, if necessary, releases it as training data and also weighted.
  • monitoring 51 is carried out in the form of a success assessment or success recording, which can be done automatically or manually on the basis of measurement data and/or a person's assessment.
  • the success assessment can be introduced into the training process 54 in order to improve the generation process 48 of planning data.

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Abstract

L'invention concerne un système de création d'ensembles de données de planification (34, 35, 36, 37) pour traiter le tissu de la rétine (16) de l'œil d'un patient (4) au moyen d'un laser (2), comprenant : une caméra (6, 7), qui est conçue pour capturer des images de la rétine en continu ; un dispositif de traitement d'image (19), qui est conçu pour générer et rendre disponibles des données d'image structurées actuelles de la rétine à partir d'images capturées par la caméra ; un dispositif de collecte de données personnelles (21, 22), qui est conçu pour collecter et/ou fournir des données personnelles d'un patient ; et un dispositif de traitement (20), qui est conçu pour affecter des ensembles de données de planification pour le traitement de tissu aux données d'image structurées actuelles de la rétine et aux données personnelles du patient, des spécifications, en particulier des modèles et des règles, pour l'affectation de données de planification à des données d'image et des données personnelles de patients étant stockées dans le dispositif de traitement.
EP23715089.1A 2022-03-25 2023-03-24 Système, appareil et procédé de création d'ensembles de données de planification pour traiter le tissu de la rétine d'un patient Pending EP4499005A1 (fr)

Applications Claiming Priority (2)

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EP22164535.1A EP4248923A1 (fr) 2022-03-25 2022-03-25 Système, dispositif et procédé de génération des ensembles de données de planification pour le traitement tissulaire de la rétine d'un patient
PCT/EP2023/057715 WO2023180558A1 (fr) 2022-03-25 2023-03-24 Système, appareil et procédé de création d'ensembles de données de planification pour traiter le tissu de la rétine d'un patient

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EP23715089.1A Pending EP4499005A1 (fr) 2022-03-25 2023-03-24 Système, appareil et procédé de création d'ensembles de données de planification pour traiter le tissu de la rétine d'un patient

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WO2025132490A1 (fr) * 2023-12-22 2025-06-26 Od-Os Macutherm Gmbh Appareil de traitement de la rétine d'un œil
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DE502006005346D1 (de) 2006-07-07 2009-12-24 Od Os Gmbh Ophthalmoskop
US9849034B2 (en) * 2011-11-07 2017-12-26 Alcon Research, Ltd. Retinal laser surgery
EP3250166A4 (fr) * 2015-01-28 2018-09-12 Ojai Retinal Technology, LLC Procédé de restauration de la réponse aux médicaments dans un tissu d'organismes vivants
US20160278983A1 (en) * 2015-03-23 2016-09-29 Novartis Ag Systems, apparatuses, and methods for the optimization of laser photocoagulation

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US20250213394A1 (en) 2025-07-03

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