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WO2025181088A1 - Dispositifs et procédés de génération de données de commande optimisées pour une intervention chirurgicale dans un tissu de la cornée d'un œil - Google Patents

Dispositifs et procédés de génération de données de commande optimisées pour une intervention chirurgicale dans un tissu de la cornée d'un œil

Info

Publication number
WO2025181088A1
WO2025181088A1 PCT/EP2025/055050 EP2025055050W WO2025181088A1 WO 2025181088 A1 WO2025181088 A1 WO 2025181088A1 EP 2025055050 W EP2025055050 W EP 2025055050W WO 2025181088 A1 WO2025181088 A1 WO 2025181088A1
Authority
WO
WIPO (PCT)
Prior art keywords
data
control data
eye
cornea
tissue
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
PCT/EP2025/055050
Other languages
German (de)
English (en)
Inventor
Burkhard Wagner
Marcel Dusi
Jan Eulitz
Michael Bergt
Jana Gehmlich
Andreas Weyhausen
Wolf Weimer
Gregor Stobrawa
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.)
Carl Zeiss Meditec AG
Original Assignee
Carl Zeiss Meditec AG
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
Priority claimed from DE102024204044.4A external-priority patent/DE102024204044A1/de
Application filed by Carl Zeiss Meditec AG filed Critical Carl Zeiss Meditec AG
Publication of WO2025181088A1 publication Critical patent/WO2025181088A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • 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
    • A61F2009/00872—Cornea
    • 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
    • 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
    • A61F2009/00897—Scanning mechanisms or algorithms

Definitions

  • the present invention relates to a planning unit and an ophthalmic laser therapy device for calculating the severity of nerve damage during a surgical procedure or for generating optimized control data for a surgical procedure within the tissue of the cornea of an eye.
  • the present invention further relates to a corresponding computer-implemented method, a corresponding planning method, a computer program product, a data signal, a computer-readable non-volatile storage medium, and a therapy method for a surgical procedure on the cornea of an eye.
  • refractive errors in the human eye have been corrected by means of lenses in the form of glasses or contact lenses.
  • various approaches have been developed to correct refractive errors by modifying the cornea.
  • the modification alters the curvature of the cornea and thus corrects the refractive power of the eye. This is achieved, for example, by removing tissue from the cornea. This alters the refractive power of the cornea in such a way that
  • SMILE corneal modification
  • a femtosecond laser is used to create flat incisions in the cornea that enclose a lenticule-shaped piece of corneal tissue.
  • This lenticule is removed from the cornea through an access incision (also called an incision) also created with the femtosecond laser.
  • This change in curvature changes the refractive power of the cornea, thus correcting a refractive error.
  • pulsed laser radiation is used to treat the eye within the tissue - i.e. below the surface of the tissue
  • Typical (central) wavelengths of picosecond and femtosecond lasers can be around 800 nm, around 1030-1060 nm, around 1300 nm, around 1500 nm, or around 1900-2000 nm.
  • Frequency multiplication through nonlinear effects makes the corresponding wavelength ranges accessible at half, third, quarter, etc.
  • pulsed laser light with a central wavelength of 532 nm can be achieved by frequency doubling, 355 nm by frequency tripling, and 266 nm by frequency quadrupling.
  • An incision that defines a lenticule within the corneal tissue of an eye typically has a cap cut, a lenticule cut, optionally a side cut, and an access incision.
  • the cap cut delimits the lenticule - the volume of tissue to be isolated from the cornea for removal - anteriorly, towards the front of the cornea.
  • the lenticule cut delimits the lenticule posteriorly, towards the retina of the eye.
  • the lenticule cut can, for example, be created in a partial incision with a decreasing path radius (i.e., from the outside in) or with an increasing path radius (i.e., from the inside out).
  • the optional side cut (also called a side cut or lenticule side cut) delimits the lenticule laterally relative to a main optical axis of the eye and extends to both the cap cut and the lenticule cut.
  • the access incision extends to both the cap incision and the anterior aspect of the cornea. The isolated volume of tissue within the cornea can be removed through the access incision.
  • the cap cut runs towards the lenticule cut, or the lenticule cut runs towards the cap cut. It is therefore conceivable that the lenticule does not have an edge cut. or alternatively, a transition zone is formed at the edge of the lenticule instead of a lateral cut.
  • the access incision serves as an access point for separating the lenticule, which is usually still connected to the surrounding corneal tissue by material bridges, from the areas of the cornea anterior to the lenticule and from the remaining area of corneal tissue posterior to the lenticule. This can be done, for example, using a spatula-shaped tool inserted through the access incision, which can be used to remove the material bridges.
  • a lamellar dissection plane beneath the flap and cap also prevents deep stromal nerves from reaching the corneal surface vertically.
  • the cap incision is typically smaller than the area of the flap, allowing deep corneal nerves to reach the corneal surface.
  • stroma implant pockets
  • Corneal transplants such as lamellar keratoplasty, or arcuate and/or relaxing corneal incisions, also require incisions in the corneal stroma.
  • Cataract surgery also requires access to the lens.
  • LI RIO laser-induced refractive index change
  • cross-linking multiphoton absorption can generate a low-energy plasma, whereby the energy introduced into the tissue is below a threshold for photodisruption.
  • Femtosecond lasers of the aforementioned wavelengths can be used. These can be referred to as fs-LIRIC or fs-CXL.
  • Corneal cutting is preferably performed in the near-infrared range, whereas LIRIC and CXL are preferably performed at shorter wavelengths in the visible spectral range (VIS), e.g., at a central wavelength of around 400 nm.
  • LIRIC and CXL also take place within the tissue.
  • the corneal stroma can be manipulated, and the nerves contained therein can be damaged.
  • the planned treatment of the eye takes place within the tissue of the eye and not on its surface. Only access incisions can extend to the surface of the eye.
  • the object of the present invention is therefore to provide devices and methods which make it possible to damage as few nerves of the cornea as possible during interventions on the human eye (particularly within the tissue).
  • the planning unit serves to generate control data, preferably for a surgical intervention within a tissue of the cornea of an eye, for an ophthalmic laser therapy device (preferably operating within the cornea, in particular based on a femtosecond laser).
  • an ophthalmic laser therapy device comprises a laser device for providing therapeutic radiation, a focusing device for focusing the therapeutic radiation into a focus for severing or irradiating the cornea, a scanning device for shifting the focus of the therapeutic radiation in the cornea of the eye to create the cutting surface and/or to irradiate the irradiation area and/or to irradiate the tissue volume, and a control unit for controlling the laser device and/or the focusing device and/or the scanning device.
  • the planning unit further comprises a data processing device which is designed as follows:
  • start control data which represent at least one cutting surface and/or at least one irradiation surface and/or at least one tissue volume to be irradiated as well as their three-dimensional position and/or orientation in the cornea of the eye;
  • - read in provided nerve data representing a three-dimensional arrangement and/or a three-dimensional course and/or a thickness of nerves in the cornea of an eye;
  • the weighting value is based on the number and/or type and/or section length of the nerves overlapping with the at least one cut surface and/or the at least one irradiation area and/or the at least one tissue volume to be irradiated. Furthermore, the data processing device is configured to provide the weighting value.
  • the laser device may comprise at least one laser. This may, in particular, be a femtosecond laser, but also a picosecond laser or a nanosecond laser. All of these lasers enable treatment of the eye within the tissue of the eye.
  • the nerve data can represent the nerves of the eye for which the control data for the intervention is being generated. It is also conceivable that general nerve data, e.g., from measurements on (other) patients and/or test subjects, could be used. This nerve data then does not exactly represent the nerves of the eye to be treated, for which the control data is to be generated, but can serve as an aid in determining how damaging the planned intervention will be to the nerves. Furthermore, it is also possible that the nerve data merely comprises model data, which may be simulated and not based on a real measurement on an eye.
  • the weighting value can be provided optically, e.g., via a display device, or acoustically.
  • a display device e.g., a liquid crystal display
  • One possible solution is a light source that changes the displayed color depending on a comparison of the determined weighting value with a predetermined ideal weighting value.
  • a specific display of the weighting value, possibly coupled with a color coding as described above, on a display device is also conceivable.
  • the provided weighting value can be used to estimate how invasive—i.e., how damaging—the planned procedure will be for the corneal nerves right from the planning stage.
  • the weighting value may further be provided in the form of or on a scale, for example and not limited to a scale of invasiveness of the planned procedure (related to the corneal nerves) from 1 to 10.
  • a doctor can visualise the area overlapping with the at least one cut surface and/or with the at least one irradiation area and/or with the at least one tissue volume to be irradiated. Nerves are provided. Since this overlap represents nerves damaged by the procedure, this visualization can convey the invasiveness of the planned procedure to the physician, which they can use to medically evaluate the planned procedure.
  • This visualization can be purely exemplary and not restrictive, three-dimensional (3D monitor, VR glasses, etc.), two-dimensional in the form of a projection or two-dimensional in the form of a sectional representation.
  • invasiveness can be represented in a similar way, where, for example, red areas of a representation can represent a high number of transected corneal nerves per area, while green areas of a representation can represent a lower number of transected nerves.
  • the number of transected nerves per unit area can be standardized and compared with underlying reference values to calculate the determined color values of individual areas of the eye in the color representation. A color can thus be assigned to a specific value of transected nerves per area.
  • the planning unit allows at least one start parameter stored in the start control data to be modified by means of at least one user input.
  • a recalculated weighting value can be displayed.
  • the user input can be made via keyboard, mouse, touchscreen, voice input, or otherwise.
  • a modification of multiple parameters is conceivable.
  • parameters can be linked to one another, so that an increase in a first parameter causes a decrease in a second parameter.
  • the provision of the weighting value allows a user to reduce the severity of the overlap, i.e., the invasiveness of the procedure, and to protect the corneal nerves of the eye being treated by modifying at least one parameter during the planning stage. This reduces the likelihood of complications and increases patient satisfaction.
  • a previously mentioned visualization can be enabled for verification by the physician.
  • the data processing device of the aforementioned embodiments can also be designed to provide the start control data as control data without a parameter change. Likewise, the data processing device can provide control data based on the start control data and the parameters set by the user.
  • control data is preferably provided after verification by a physician. If, for example, the control data was created by an assistant and after the assistant's evaluation, an evaluation of the provided control data by a physician may be necessary before the procedure.
  • the data processing device is designed to optimize the start control data as a function of the nerve data by modifying at least one start parameter stored in the start control data and to provide the optimized control data for controlling the scanning device and/or the laser device, wherein the optimized control data represent at least one cutting area and/or at least one irradiation area and/or at least one tissue volume to be irradiated.
  • Such automatic optimization offers the possibility of supporting a physician in planning a procedure. Even with automatic optimization of the control data, the physician can always view and/or verify and/or change and/or reset the optimized parameters.
  • the evaluation based on the optimization is carried out solely based on the weighting value, which represents the invasiveness of the procedure.
  • the medical assessment of whether the planned procedure should proceed with the optimized parameters remains the responsibility of the physician.
  • a previously described manual or semi-automatic or automatic optimization of the control data by modifying the at least one start parameter can be carried out after a modification or before a modification of at least one parameter by means of user input.
  • the ophthalmic laser therapy device may have a user interface via which parameters can be changed and/or parameter intervals can be defined and/or parameters can be set as a fixed value and/or automatic optimization can be started and/or visualization can be started and/or the parameters and control data can be verified.
  • Such a user interface can comprise multiple elements, for example, a keyboard, mouse, and a display device, or it can be configured as a touchscreen, which allows both parameter input and a display.
  • the user interface can also include 3D or VR glasses and, if appropriate, 3D or VR input means and methods. For example, through gesture control, i.e., recognition of the movement and/or posture of a hand or a sensor glove.
  • the computer-implemented method according to the invention as well as the planning method for generating control data are both carried out in particular before and independently of an eye surgery to be performed.
  • the control data represents where and/or in what order and/or with what parameters a laser pulse is to be applied in the eye of a patient in order to cut a cutting surface and/or irradiate an irradiation area and/or to irradiate a tissue volume in order to correct the patient's refraction through corneal modification within the tissue.
  • control data are based on the patient's eye or cornea. This is to be understood as the theoretical location of the planned but not yet performed incisions and/or areas to be irradiated in the patient's eye.
  • start control data are read in in a first method step, which contain at least one cutting surface and/or at least one irradiation surface and/or at least one tissue volume to be irradiated as well as their three-dimensional position and/or orientation in the cornea of an eye. How this initial control data is generated is explained below in the explanation of the planning procedure or has already been explained above.
  • the start control data can be provided in a suitable computer-readable form.
  • this start control data can cause the cutting of a cut surface and/or the irradiation of an irradiation area and/or the irradiation of a tissue volume to be irradiated.
  • Control data represents a common concept in interventions, particularly in the eye, whereby the control data can be generated and optimized completely independently of the presence of a patient.
  • nerve data is imported, representing a three-dimensional arrangement and/or a three-dimensional course and/or thickness of nerves in the cornea of an eye.
  • the nerve data can be understood as a three-dimensional map of the corneal nerves in the eye to be treated, in a previously measured eye, or in a modeled eye.
  • a weighting value is generated from the start control data and the nerve data by applying a penalty and/or merit function to the number and/or type and/or section length of the nerves represented by the nerve data that overlap with the at least one cutting surface or the at least one irradiation surface.
  • all nerves that are damaged or severed according to the underlying control data can be assigned a weighting.
  • nerves with greater thickness can be assigned a higher weighting than nerves with lesser thickness.
  • nerves that are highly branched after the cut or damage can be assigned higher weightings than nerves with lesser branching.
  • the total length of the severed nerves can also be included in the weighting. It is advantageous if a higher weighting correlates with a higher numerical value.
  • the weighting value is provided. This can be understood as the degree of overlap between the structure to be created in the cornea (cutting area and/or irradiation area and/or volume to be irradiated) and the corneal nerves. It is conceivable that the weighting value will be further processed and/or prepared and/or, in particular, provided to a user, thus enabling an assessment of the severity of nerve damage to corneal nerves during the planned procedure.
  • the weighting value is optimized in a further method step by repeatedly generating it from the nerve information and from follow-up control data, which are generated in a first iteration starting from the start control data and in subsequent iterations starting from previously generated follow-up control data by modifying at least one start parameter stored in the start control data.
  • At least one starting parameter is modified, i.e., changed.
  • Which starting parameter is changed can optionally be estimated based on the starting control data and the nerve data.
  • the changed starting parameter thus changes the starting control data.
  • a linear coordinate transformation of the position of the cutting or irradiation area or the irradiation volume represented by the starting control data can be performed; thus, the planned cutting or irradiation area or the irradiation volume can simply be shifted.
  • a new weighting value can be determined.
  • the selected modification represents an improvement in the control data.
  • the direction of the modification of the selected parameter can thus be maintained. Individual possible optimization methods are listed below. However, this second modification is no longer based on the initial control data, but rather on the control data obtained, i.e., determined, in the first iteration.
  • the subsequent control data that yields the optimized weighting value and satisfies the optimality conditions can be provided as optimized control data.
  • the optimality conditions can therefore be understood as termination conditions for the optimization.
  • the computer-implemented procedure optimizes the input starting control data such that the determined optimal control data have a less negative impact on the corneal nerves during treatment than the initial control data. Complications such as dry eyes can thus be minimized as much as possible during the planning phase. The optimization is thus carried out in such a way that the number of damaged nerves, particularly those severed or harmfully irradiated (i.e., damaged by radiation), is minimized.
  • the start control data can further comprise surgical data, wherein the surgical data represent a surgical procedure to be performed on the cornea of the eye.
  • the procedure to be performed or a structure to be created in the eye can be a flap incision, a lenticule extraction, a small access lenticule extraction (SMILE), the creation of an implant pocket, a keratoplasty, a lamellar keratoplasty, an arcuate and/or relaxing corneal incision, a cataract surgical approach, a LI RIO, or a cross-linking procedure.
  • a corresponding planning unit can thus be configured to read in and further process the surgical data contained in the start control data.
  • the type of intervention is thus represented by the surgical data.
  • the type determines, in particular, which parameters can be used to calculate the weighting value.
  • the type of intervention can determine which parameters can be varied in the optimization step.
  • the start control data can further, depending on the surgical data, contain at least one predetermined set of start parameters from the list, comprising a flap thickness and/or an incision angle and/or a flap diameter and/or a flap hinge size and/or a flap hinge angle range (when cutting a flap); or a lenticule depth and/or a lenticule height and/or a position of the access incision and/or a course of the cap incision and/or a course of the lenticule incision and/or a course of the optional edge incision and/or a course of a transition zone and/or a shape of the lenticule incision and/or the cap incision and/or a shape of the lenticule and/or an eccentricity of a
  • acquisition volume and/or a shape of an acquisition volume and/or an inclination of an acquisition volume in the case of keratoplasty); or an azimuthal position of an access incision and/or a width of an access incision and/or an inclination of an access incision (when creating an access incision); a depth of an area to be processed and/or a width of an area to be processed and/or a length of an area to be processed and/or a shape of an area to be processed and/or an inclination of an area to be processed and processing parameters of the area to be processed (in the case of LIRIC or cross-linking);
  • an adapted set of parameters is thus available.
  • the respective parameters can preferably be summarized in tuples.
  • the corresponding planning unit can thus be designed to use at least one predetermined, above-mentioned set of parameters for calculating the weighting value and/or to modify it for optimizing the control data, depending on the operational data.
  • a parameter set can be selected, activated, or used which includes as parameters a lenticule depth and/or a lenticule height and/or a position of the access incision and/or a course of the cap incision and/or a course of the lenticule incision and/or a course of the edge incision and/or a course of a transition zone and/or a shape of the lenticule incision and/or the cap incision and/or a shape of the lenticule and/or an eccentricity of a incision and/or the lenticule in any combination.
  • a change in the lenticule depth depending on the nerve data can be particularly relevant.
  • each start parameter can only be modified within a parameter interval specific to each parameter stored in the start control data.
  • a flap cut cannot have an arbitrarily small diameter, since otherwise, without any restriction of the parameter flap diameter, an optimum of the weighting value would inevitably be found at a flap diameter of 0. (Because at a point not a single nerve would be cut)
  • a flap thickness is not arbitrarily variable, since a flap that is too thin could tear and a flap that is too thick could restrict access to the the underlying stromal tissue (the flap is harder to fold).
  • a flap thickness of around 100 micrometers is preferred.
  • a posterior residual stromal thickness (i.e., the remaining thickness of the stroma toward the eye chamber) represents a further limitation. It is preferably assumed that a minimum residual stromal thickness must be maintained, for which 250 micrometers is often used as a limit. Assuming lenticule depths of 100-200 micrometers purely as an example, with an average corneal thickness of 400-500 micrometers, the criterion of a residual stromal thickness greater than or equal to 250 micrometers is met for the majority of patients. The limit of 250 micrometers is preferably replaced by a residual stromal thickness of 300 micrometers.
  • a parameter interval is therefore to be understood as a limitation of the corresponding parameter to reasonable values. The parameter intervals thus represent boundary conditions for the method. When the user inputs the modification of at least one parameter, such a parameter interval can be taken into account, thus preventing modification of the corresponding parameter beyond the interval limits.
  • At least one starting parameter in the computer-implemented procedure can be set as a fixed value. This is the case, for example, if a parameter does not allow for any leeway—for example, if a flap diameter cannot be reduced or enlarged because the conditions of the eye being treated do not permit variation.
  • the nerve data represent a measurement from a high-resolution OCT and/or a measurement from a confocal microscope.
  • the measurement represented by the nerve data can have a resolution of 5 pm or less.
  • Such a resolution allows the detection of corneal nerves. More preferably, the resolution can be 2 pm or better, and even more preferably, it is better than 1 pm.
  • the selected resolution can increase the number of nerves detected by the nerve data and thus also the computational effort of the optimization.
  • the nerve data can be available in various, pre-selectable resolutions.
  • a high resolution of the nerve data can be selected, while when calculating a lenticule for a SMILE operation, a coarser resolution can be selected, thus reducing the computational effort for the significantly more extensive optimization in the case of SMILE.
  • This selection can also be used for an initial check to determine whether optimization of the control data is necessary.
  • the nerve data represent the corneal nerves of the eye underlying the planning.
  • an OCT or confocal measurement can also be representative. of another eye.
  • the nerve data represent the nerves of a modeled eye and do not originate from a real measurement.
  • Such a model can be based on a statistical evaluation of one or more or a large number of measurements.
  • the planning unit can have at least one input and/or output interface for receiving the start control data and/or the operation data and/or the nerve data and/or for providing the control data generated by the data processing device.
  • an input and/or output interface can also be used to visualize the control data and, in particular, a position and/or shape of the at least one incision area and/or the at least one irradiation area and/or the volume to be irradiated with respect to the corneal nerves and for verification by a physician.
  • the laser device can comprise a pulsed picosecond laser or a pulsed femtosecond laser.
  • a pulsed picosecond laser or a pulsed femtosecond laser.
  • nanosecond laser is also conceivable, but this is less preferred, since higher pulse energies are required to generate an optical breakthrough.
  • a branching index of individual nerves represented by the nerve data can also be taken into account when generating the weighting value, wherein the branching index represents at least a number of branches after the nerve cut or after an irradiation site. Severing or damaging highly branched nerves can thus result in a higher penalty through the penalty function.
  • thickness information of individual nerves represented by the nerve data can be taken into account when generating the weighting value, wherein the thickness information represents at least one thickness of the nerves.
  • residual length information may be taken into account when generating the weighting value, wherein the residual length information represents at least a total length of the severed or irradiated nerves represented by the nerve data.
  • the weighting value can, in particular, be a scalar. Furthermore, a weighting value can be calculated for each tuple of start parameters stored in the start control data.
  • the branching index and/or the thickness information and/or the remaining length information can also be used in the visualization of a position and/or fora of the at least one
  • the incision area and/or the at least one irradiation area and/or the tissue volume to be irradiated are processed.
  • an overlap of an area or volume of a planned procedure with thick and/or highly branched and/or long corneal nerves can be highlighted in the visualization for the physician.
  • the number of generations of subsequent control data can be limited to a predetermined limit. This can restrict the maximum number of iterations in the optimization process, so that the method terminates either when optimality conditions are met or when the limit is reached.
  • a modification of at least two, i.e., several starting parameters can advantageously be performed in parallel, and the weighting values optimized for the modified starting parameters from the parallel calculation can be combined. This allows optimization trends to be determined simultaneously (in parallel computing), which, depending on the number of parallel optimization steps, means a reduction in the calculation time for the optimization.
  • optimizing the weighting value can thus correspond in particular to finding a minimum of the weighting value depending on different tuples of parameters.
  • the artificial intelligence-based model can be a neural network, for example a CNN, a decision tree, or based on the K-Means method.
  • the artificial intelligence-based model can be trained with training data and validated with validation data. After training, the artificial intelligence-based model can evaluate the input data (start control data and neural data) based on a trained weighting matrix.
  • the artificial intelligence-based model can have an input layer, several deeper layers, and an output layer, and any number of nodes (also known as neurons) in each of these layers, which can output the weighting value and/or optimized control data.
  • the artificial intelligence-based model may include a set of instructions that can be used to train, build, or use the model.
  • the weighting matrix i.e. the weights of the individual nodes, is adjusted during training.
  • the artificial intelligence-based model and its weighting matrix will be further adapted or optimized through feedback based on a performed procedure and its success and/or complications and/or side effects that may occur.
  • the computer-implemented method may use at least one method from the list comprising the pivot method, the simplex method, the interior point method, the branch-and-bound method, the branch-and-cut method, the gradient method, the Adam algorithm, the Newton method, trust region methods, the Levenberg-Marquardt algorithm, the SQP method, augmented Lagrange method, the nearest neighbor heuristic, evolutionary algorithms; and stochastic tunneling.
  • An embodiment of the planning method according to the invention for generating control data for a surgical intervention within the tissue of the cornea of an eye provides the initial control data, the surgical data, and the nerve data and then carries out an embodiment of the computer-implemented method described above. Finally, the planning method provides the subsequent control data as optimized control data, which results in the optimized weighting value, wherein the optimized control data represent at least one cutting area and/or at least one irradiation area and/or at least one tissue volume to be irradiated.
  • the at least one cutting surface and/or at least one irradiation surface and/or at least one tissue volume to be irradiated represented by the optimized control data is optimized in its position and/or size and/or orientation and/or shape such that fewer nerves are damaged or cut than by a cutting surface or irradiation surface or tissue volume represented by the start control data.
  • the control or planning data may further include laser parameter data and/or device data and/or other patient data.
  • the additional patient data can, in particular, represent preoperative characteristics of the patient's eye to be treated.
  • a dry-eye factor is included, which represents the predominant level of moisture in the affected eye before surgery. This factor can be specified, for example, on a scale of 1 to 10. This makes it possible to tailor the planning to the individual patient. For example, and not as a limitation, optimization using the aforementioned computer-implemented procedure may be particularly interesting for patients who already suffer from dry eyes and want to minimize further worsening of dry eyes.
  • control data Since the planning process for generating control data can be performed for various ocular interventions, the provision of start control data can comprise several different process steps.
  • Cap cut data which represent a cap cut that limits the tissue volume anteriorly
  • Lenticule section data which represent a lenticule section that delimits the tissue volume posteriorly
  • Optional side cut data which represents an optional side cut that radially delimits the tissue volume with respect to the main optical axis and that extends at least to the cap cut and at least to the lenticule cut
  • Access interface data representing at least one access interface
  • Receiving position data representing a position of the receiving opening
  • Receiving history data representing an inclination or a gradient of the receiving opening
  • (F4) Generating start control data representing the at least one irradiation area from the size data, the position data and the history data.
  • an optimization as carried out for (E) can also be carried out, for example, if a different type of access to the eye is to be created.
  • an optimization according to (D) can be used with an optimization according to (E) for the case of the preparation and planning of an implantation of an intraocular lens (IOL).
  • IOL intraocular lens
  • a receiving opening for the IOL is required, as well as an access through which the IOL (preferably in a rolled-up state) can be inserted into the receiving opening.
  • the curve data which represent an inclination or a curve of the receiving opening can be set as fixed, i.e. unchangeable parameters. An optimization then takes place with regard to the position and/or size of the receiving opening for the IOL.
  • the method step of optimizing the weighting value in the planning process can comprise: in the case of (A), a modification of a parameter tuple, which includes as parameters at least a lenticule depth, a lenticule height, a lenticule diameter, a position of the access cut, an opening angle of the access cut, an angle of the access cut, a profile of the cap cut, a profile of the lenticule cut, a profile of the optional edge cut, a profile of a transition zone, an eccentricity of the cap cut and/or the lenticule cut and/or the entire lenticule, and an inclination of the lenticule; in the case of (B), a modification of a parameter tuple, which includes as parameters at least a flap thickness, an incision angle, a flap diameter, a flap-hinge size, and a flap-hinge angle range; in the case of (C), a modification of a parameter tuple which includes, as parameters, at least a depth of
  • the invention also relates to a computer program product comprising instructions which, when loaded into a data processing device, cause the device to carry out an embodiment of the planning method described above.
  • the invention further relates to a data signal that transmits the above-described computer program product.
  • the computer program product can thus be loaded from a remote PC or from a cloud and transmitted in the form of a data signal to a data processing device.
  • the computer program product can also be provided by a computer-readable non-volatile storage medium which contains or comprises the computer program product described above.
  • a computer-readable non-volatile storage medium can be a magnetic storage medium, an optical storage medium, or a storage medium based on RAM, ROM, or EEPROM.
  • the storage medium can be a CD, a DVD, a floppy disk, a magnetic tape, a hard disk (HDD or SSD), or another storage medium.
  • the planning unit according to the invention for generating control data for a surgical intervention within the tissue of the cornea of an eye may further comprise: a data processing device configured to carry out an embodiment of the planning method described above; at least one input and/or output interface for receiving the start control data, the surgical data, and the nerve data and for providing the control data generated by the data processing device.
  • the planning unit can be part of an ophthalmic laser therapy device or can be operated independently. In particular, the planning unit can be operated remotely from an operating room, so that the planning of an intervention can be carried out spatially and/or temporally separated from the site of the intervention.
  • the planning unit can be designed in the form of hardware and/or software and, for example, represent a portable device.
  • the planning unit can be, for example, a software module, a tablet, a laptop, or a handheld device that is wired. or wirelessly receive input data necessary to generate control data.
  • the planning unit can be provided as software and/or as software-as-a-service, or as a combination of software and hardware.
  • the method according to the invention for a surgical intervention on the cornea of an eye may comprise:
  • the ophthalmic laser therapy device can be designed to allow a physician to visualize the individual patient's corneal nerves during planning and to suggest an optimal location and/or positioning and/or inclination of the treatment to be performed in the eye.
  • the laser device can in particular be a femtosecond laser which is operated with a laser pulse energy above the threshold for photodisruption to create a cutting surface and is operated with a laser pulse energy below this threshold, for example for LIRIC or cross-linking.
  • the need for refractive correction can be determined through previous measurements of the patient's eye and represented by correction data.
  • This correction data is used to calculate the volume of corneal tissue to be removed using the planning procedure.
  • Various objective or subjective measurements are known to determine the need for refractive correction, which can be combined with one another. Measurements of the structure of the eye, for example, via an OCT scan, as well as measurements of intraocular pressure and the topography of the eye, can also be taken into account when determining the need for refractive correction.
  • the tissue volume is delimited or defined by cutting surfaces. These cutting surfaces are represented by the calculated cutting surface data.
  • the tissue volume i.e., the lenticule
  • Each of these cutting surfaces is represented by corresponding cutting surface data, for example, the cap cutting data, which represents a cap cutting that delimits the tissue volume anteriorly; the lenticule cutting data, which represents a lenticule cutting that delimits the tissue volume posteriorly; the optional side cutting data, which represents an optional side cutting that delimits the tissue volume radially at least in sections with respect to the main optical axis and that extends in sections at least to the cap cutting and at least to the lenticule cutting; and the access cutting data, which represents at least one access cutting.
  • the cap cutting data which represents a cap cutting that delimits the tissue volume anteriorly
  • the lenticule cutting data which represents a lenticule cutting that delimits the tissue volume posteriorly
  • the optional side cutting data which represents an optional side cutting that delimits the tissue volume radially at least in sections with respect to the main optical axis and that extends in sections at least to the cap cutting and at least to the
  • the side cut can be omitted if the cap and lenticule cuts converge.
  • the start control data are generated, which represent the cutting surface.
  • the optimal lenticule depth should be between 100-200 micrometers, since it was determined there that the number of main corneal nerves is sufficiently small.
  • the lenticule When correcting astigmatism or higher orders, it is preferable not to "impose" a round shape on the lenticule, which can protect other nerves.
  • the lenticule can also be oval.
  • the location of the access incision for lenticule extraction can be chosen to minimize transection of corneal nerves.
  • the width (opening angle) and steepness of the access incision can also be adjusted.
  • the shape of the cap incision can be chosen to ensure that as few corneal nerves as possible are severed.
  • the cap incision can be oval or irregular.
  • the shape of the transition or buffer zone can be chosen irregularly to improve nerve protection.
  • the planning unit can operate independently of an ophthalmological therapy device and can be implemented, for example, on a remote PC or a separate PC or in a cloud as software, as hardware or as a mixture of software and hardware.
  • a data processing device may be a PC, a microcontroller, an FPGA or a similarly designed device for performing calculations, for example for optimizing or generating the start control data.
  • Fig. 1-5 schematic representations of nerves in the cornea and their impairment during surgery
  • Fig. 6 is a schematic representation of a sequence of the computer-implemented method
  • FIG. 7-12 schematic representation of the optimization of different parameters of a lenticule in a SMILE operation
  • FIG. 13 is a schematic representation of an ophthalmic laser therapy device.
  • Figure 1 schematically shows a nerve network 1 in a cornea 3 of a schematically indicated eye 5.
  • the nerve network 1 is composed of different nerves 7, which may, for example, have branches 9 and different thicknesses D1, D2.
  • Figures 2 and 3 also schematically illustrate the effects of a FLAP incision and a SMILE operation on the nerves 7 shown in Figure 1.
  • a flap incision 11 performed in Figure 2 a large portion of the nerves 7 shown are severed (see detail 13 and incision 15).
  • SMILE significantly fewer nerves 7 are cut or damaged through an access incision 17 and the occurrence of complications is minimized.
  • Figures 4 and 5 also schematically depict the effects of a FLAP incision or SMILE operation on the nerves 7 of the cornea 3.
  • a lamellar dissection plane 19 beneath the flap 21 and the cap 23 prevents deep stromal nerves 7 from reaching the corneal surface 25 perpendicularly.
  • the area of a cap 23 is generally smaller than the area of a flap 21.
  • the length of the lateral incision in the Smile procedure is greatly reduced, so that nerves 7 can extend laterally into the cap 23, but not into the flap 21 (this is only possible via a hinge area 27, where the flap 21 is still connected to the remaining tissue of the cornea 3).
  • the hinge area 27 is shown in dashed lines in Figure 4.
  • Figure 6 schematically shows a sequence of the computer-implemented method according to the invention.
  • start control data 200 are read in, which represent at least one cutting surface 300 or at least one irradiation surface 310 as well as their three-dimensional position and orientation in the cornea 3 of the eye 5.
  • nerve data 210 are read in, which represent a three-dimensional arrangement and a three-dimensional course and a thickness D of nerves 7 in the cornea 3 of the eye 5.
  • a weighting value W is generated from the start control data 200 and the nerve data 210 by applying a penalty and/or merit function P to the number and/or type and/or section length of the nerves 7 represented by the nerve data 210 that overlap with the at least one cutting surface 300 or the at least one irradiation surface 310 or the tissue volume to be irradiated.
  • the computer-implemented method (in an embodiment of the method not shown) can provide the provision of the weighting value W.
  • the weighting value W is optimized by repeatedly generating it from the nerve data 210 and from subsequent control data 201, which are generated in a first iteration starting from the start control data 200 and in subsequent iterations starting from previously generated subsequent control data 201 by modifying at least one start parameter SP stored in the start control data 200.
  • a query Q is made as to whether an optimization criterion is met (branch “n”). If this is not the case, then in a process step S4.1 at least one The start parameter SP stored in the control data 200 is varied and the weighting value W is recalculated using the subsequent control data 201 thus obtained in accordance with method step S3.
  • a fifth method step S5 the subsequent control data 201 which results in the optimized weighting value is output as optimized control data 203.
  • case (A) i.e. the optimization of the control data of a SMILE operation, i.e. the extraction of a lenticule through a small access
  • case (A) i.e. the optimization of the control data of a SMILE operation, i.e. the extraction of a lenticule through a small access
  • FIG. 8 Possible optimizations are schematically illustrated in Figures 8 to 12.
  • an azimuth angle range 35 of the access incision 33 is optimized and relocated to a region in which fewer nerves 7 are destroyed, i.e., severed, by the access incision 33.
  • Figure 9 shows the case in which a transition section 37, which is shown hatched in Figures 8 and 9 and has a size 39, is optimized with respect to size 39.
  • the size 39 of the transition section 37 is smaller than in Figure 8. Furthermore, it can be seen that in the case shown in Figure 9, the optimization of the azimuth angle 35 is also retained.
  • Figure 10 shows a further optimization of the transition incision 37.
  • a shape 37A of the transition incision 37 is optimized toward an irregular transition incision 38 in order to sever fewer nerves 7.
  • FIG 11 an additional optimization of a shape 39a of a lenticule 39 has been performed.
  • the lenticule 39 is in the form of an irregular lenticule 39b.
  • Figure 12 also shows an irregular transition zone 41a.
  • a transition zone 41 extends into the plane of the drawing.
  • both the receiving opening and the access point require a suitable access.
  • Both the receiving opening and the access point can be optimized with the method according to the invention in terms of their position, size, orientation, azimuth angle range, and/or depth.
  • optimization can be carried out in a similar way to the creation of a lenticule, since this procedure also involves treating a volume of tissue, which in this case means that it is irradiated. Although the tissue volume in LIRIC remains within the tissue of the cornea, nerves 7 located in this tissue volume can still be damaged.
  • Fig. 13 schematically illustrates an embodiment of an ophthalmic laser therapy device 1.
  • a laser device 110 emits therapy light 50 in the form of a pulsed laser beam 115.
  • the laser beam 115 is deflected laterally (in the x and y directions) by a scanning device 130 and axially (z direction) by another scanning device 135.
  • the laser beam 115 can first be adjusted in the z direction by the other scanning device 135 and subsequently deflected laterally in the x and y directions by the scanning device 130.
  • a focusing device 30 focuses the pulsed laser beam 115 into a focus 77 within the tissue of the cornea 15.
  • the focus 77 is shown as an example for two positions in the cornea 3 for different settings of the lateral scanning device 130 and the axial scanning device 135.
  • a potentially advantageous fixation of the eye by means of a patient interface relative to the ophthalmic laser therapy device 1 is not shown.
  • Control unit 140 transmits the signal data to the respective devices 110, 30, 130, 135. This is indicated by arrows pointing from control unit 140 to devices 110, 30, 130, and 135, respectively.
  • Control unit 140 ensures suitably synchronous operation of laser device 110, three-dimensional scanning devices 130, 135, and, if applicable, focusing device 30.
  • the signal data can be transmitted via signal data lines 80 or wirelessly.
  • the signal data required for operation is determined in control unit 140 based on control data 90, in particular based on optimized control data 203.
  • the control unit 140 receives the optimized control data 203 in advance from the planning unit 150 as a control data set 92 via unspecified communication paths, such as control lines 94 (shown in Fig. 6 as a solid line between the planning unit 150 and the control unit 140).
  • the optimized control data 203 can also be transmitted using memory chips 96 (e.g., via USB or memory stick), magnetic storage devices 98 (e.g., floppy disks), wirelessly via radio (e.g., WLAN, UMTS, Bluetooth), or wired (e.g., USB, Firewire, RS232, CAN bus, Ethernet, etc.).
  • the planning device 150 spatially separate from the control unit 140 and to provide a corresponding data transmission channel.
  • the transmission preferably takes place before the operation of the ophthalmic laser therapy device 100, ie before control signals are transmitted to the laser device 110, the scanning devices 130, 135 and, if applicable, to the focusing device 30.
  • the control data set 92 is transmitted to the control unit 140 of the ophthalmic laser therapy device 100 via an input and/or output interface S2 of the planning device 150.
  • the optimized control data 203 represent either the various cutting surfaces 300 or the irradiation surfaces 310, such as the cap cut 29, the lenticule cut 31, an optional edge cut, as well as an access cut 33, or a tissue volume to be irradiated as well as the processing parameters to be used. Operation of the ophthalmic laser therapy device 100 is preferably blocked until a valid control data set 92 is available at the control unit 140.
  • a valid control data set 92 can be a control data set 92 that is fundamentally suitable for use with the control unit 140 of the ophthalmic laser therapy device 100. In addition, however, validity can also be linked to the passing of further tests.
  • the planning device or planning unit 150 generates the control data 90 or the control data set 92, which is provided to the control unit 140 of the ophthalmic laser therapy device 1 for carrying out the surgical procedure.
  • the refraction correction requirement R is input via an input device (not shown) and provided to the planning unit 150 via a first interface S1.
  • the refraction correction requirement R can also be input via the input and/or output interface S2.
  • the start control data 200 and the nerve data 210 can also be input via these interfaces.
  • the input device can be part of the ophthalmic laser therapy device 100 or can be designed independently.
  • the planning unit 150 comprises a calculation device C. This is connected to the first interface S1 and receives the refraction correction requirement R of the eye, the start control data 200 and the nerve data 210. In the calculation device C, the weighting value W and subsequent control data 201 are then calculated by optimization, and those subsequent control data 201 are output as optimized control data 203, which result in the optimized weighting value W.
  • the laser therapy device 100 can display the weighting value W in a suitable form, e.g. via a light source, via a display device, or by means of an acoustic output.
  • the optimized control data 203 are transmitted to the control unit 140 via the input and/or output interface S2. Using the transmitted optimized control data 203, the control unit 140 can generate signal data S1, S2, S3 and transmit them to the devices 110, 30, 130, 135, so that a cut surface can be created in the cornea 3 of the eye 5.
  • the planning unit 150 can already generate the start control data 200 as well as the optimized control data 203 regardless of whether the eye 5 is connected to the ophthalmic laser therapy device 100 or not.

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  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Optics & Photonics (AREA)
  • Surgery (AREA)
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Abstract

La présente invention concerne une unité de planification et un dispositif de thérapie laser ophtalmologique pour calculer et fournir un degré de gravité de lésions nerveuses d'une intervention chirurgicale à l'intérieur d'un tissu d'un œil, et/ou pour générer des données de commande optimisées pour une intervention chirurgicale à l'intérieur d'un tissu de la cornée d'un œil. La présente invention concerne en outre un procédé mis en œuvre par ordinateur correspondant, un procédé de planification, un produit-programme d'ordinateur, un signal de données, un support de stockage non volatil lisible par ordinateur, et un procédé de thérapie pour une intervention chirurgicale sur la cornée d'un œil. Selon l'invention, ce qui suit est également mis en œuvre : la lecture de données de commande de démarrage et de données nerveuses, la génération d'une valeur de pondération à partir des données de commande de démarrage et des données nerveuses, et la fourniture de la valeur de pondération. Facultativement, la valeur de pondération peut être optimisée, ces données de commande ultérieures étant fournies en tant que données de commande optimisées qui conduisent à la valeur de pondération optimisée.
PCT/EP2025/055050 2024-02-29 2025-02-25 Dispositifs et procédés de génération de données de commande optimisées pour une intervention chirurgicale dans un tissu de la cornée d'un œil Pending WO2025181088A1 (fr)

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DE102024204044.4A DE102024204044A1 (de) 2024-02-29 2024-04-30 Vorrichtungen und Verfahren zur Erzeugung optimierter Steuerdaten für einen operativen Eingriff innerhalb eines Gewebes der Kornea eines Auges

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Citations (2)

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Publication number Priority date Publication date Assignee Title
US20180214309A1 (en) * 2017-01-30 2018-08-02 Novartis Ag System and method for cutting a flap using polarization sensitive optical coherence tomography
CN110559087A (zh) * 2019-09-02 2019-12-13 清华大学深圳研究生院 一种角膜手术安全监控系统

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Publication number Priority date Publication date Assignee Title
US20180214309A1 (en) * 2017-01-30 2018-08-02 Novartis Ag System and method for cutting a flap using polarization sensitive optical coherence tomography
CN110559087A (zh) * 2019-09-02 2019-12-13 清华大学深圳研究生院 一种角膜手术安全监控系统

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AL-AQABA MOUHAMED A ET AL: "Corneal nerves in health and disease", PROGRESS IN RETINAL AND EYE RESEARCH, OXFORD, GB, vol. 73, 7 May 2019 (2019-05-07), XP085933368, ISSN: 1350-9462, [retrieved on 20190507], DOI: 10.1016/J.PRETEYERES.2019.05.003 *

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