Devices and methods for generating optimised control data for a surgical intervention within a tissue of the cornea of an eye

Abstract

The present invention relates to a planning unit and an ophthalmological laser therapy device for calculating and providing a degree of severity of nerve damage of a surgical intervention within a tissue of an eye, and / or for generating optimised control data for a surgical intervention within a tissue of the cornea of an eye. The present invention further relates to a corresponding computer-implemented method, a planning method, a computer program product, a data signal, a computer-readable non-volatile storage medium, and a therapy method for a surgical intervention on the cornea of an eye. According to the invention, the following is also carried out: reading in start control data and nerve data, generating a weighting value from the start control data and the nerve data, and providing the weighting value. Optionally, the weighting value can be optimised, those subsequent control data being provided as optimised control data which result in the optimised weighting value.

Description

[0001] Devices and methods for generating optimized control data for a surgical intervention within a tissue of the cornea of ​​an eye

[0002] 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.

[0003] For a long time, refractive errors in the human eye have been corrected by means of lenses in the form of glasses or contact lenses. However, for more than 20 years, 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

[0004] - taking into account the overall imaging properties of the eye - the visual impairment is reduced or even completely compensated.

[0005] The applicant has developed a particularly gentle procedure for corneal modification called SMILE. In this procedure, 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 creates a change in the curvature of the anterior surface (also called the front surface) of the cornea (i.e., at the interface between the cornea and air). This change in curvature changes the refractive power of the cornea, thus correcting a refractive error.

[0006] To create the flat incisions in the cornea, pulsed laser radiation is used to treat the eye within the tissue - i.e. below the surface of the tissue

[0007] - focused in such a way that optical breakthroughs occur in the tissue. This effect, called photodisruption, is observed particularly with picosecond and femtosecond lasers, but also with nanosecond lasers (shorter pulses result in lower fluences [in mW / cm 2 ] in focus is necessary to create optical breakthroughs). Optical breakthroughs are also achieved in media that are transparent to the laser radiation. 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. Furthermore, the corresponding wavelength ranges at half, third, quarter, etc. wavelength are accessible through frequency multiplication using nonlinear effects. For example, with an Nd:YAG laser at 1064 nm, 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.

[0008] In the tissue, various processes initiated by the laser radiation take place sequentially. Multiphoton absorption generates a plasma, which expands through the absorption of further photons in an avalanche effect. If the power density of the radiation exceeds a threshold, an optical breakthrough occurs, which creates a plasma bubble in the material. This plasma bubble grows after the optical breakthrough occurs due to expanding gases. If the optical breakthrough is not maintained, the gas generated in the plasma bubble is absorbed by the surrounding material, and the bubble disappears again. However, this process takes much longer than the formation of the bubble itself. For the sake of simplicity, the processes mentioned are summarized here under the term optical breakthrough, i.e.This term encompasses not only the actual optical breakthrough, but also the resulting effects in the material. If a large number of optical breakthroughs are created next to each other in the fabric, a flat cut (cut surface) can be created.

[0009] 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.

[0010] It is also possible for the cap cut to taper towards the lenticule cut, or for the lenticule cut to taper towards the cap cut. It is therefore conceivable for the lenticule to have no edge cut, or alternatively, for a transition zone to be formed at the edge of the lenticule instead of a side cut.

[0011] Furthermore, 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.

[0012] It is known that the risk of dry eye syndrome (Dry Eye Syndrome) is reduced after SMILE compared to other procedures. The smaller access incision used in SMILE destroys or severes significantly fewer nerves than, for example, a FLAP incision, which represents a flap-shaped, hinged volume of corneal tissue attached to a remaining bridge.

[0013] In a flap incision, a lamellar dissection plane beneath the flap and cap also prevents deep stromal nerves from reaching the corneal surface vertically. In a SMILE, the cap incision is typically smaller than the area of ​​the flap, allowing deep corneal nerves to reach the corneal surface.

[0014] However, dry eyes can also occur after a SMILE.

[0015] Furthermore, there are several other surgical procedures on the human eye that involve making incisions in the cornea (usually in the stroma). For example, implant pockets, so-called stroma, can be cut. Corneal transplants (keratoplasty), 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.

[0016] There are also surgical procedures on the eye that influence the structure of the corneal tissue using a laser, thereby varying the refractive power of the eye. These procedures can generally be summarized under the term LI RIO (laser-induced refractive index change). Last but not least, there are procedures that strengthen the cornea or reduce or stabilize corneal deformation, slowing or even preventing further deformation. These procedures can be summarized under the term cross-linking. In LIRIC and cross-linking (also: CXL), 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 also be used for this multiphoton absorption (preferably two-photon absorption) in LIRIC and CXL. In this case, the terms fs-LIRIC or fs-CXL can be used.Corneal incision 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.

[0017] What all of the above-mentioned procedures have in common is that the corneal stroma can be manipulated, and the nerves contained therein can be damaged. For all procedures, 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.

[0018] 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).

[0019] According to the invention, the object is achieved by the features of the independent claims. Preferred developments and refinements are the subject of the dependent claims.

[0020] The planning unit according to the invention 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). Such 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.

[0021] The planning unit further comprises a data processing device which is designed as follows:

[0022] - reading in provided start control data, which represent at least one cutting area and / or at least one irradiation area 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; - reading in provided nerve data, which represent a three-dimensional arrangement and / or a three-dimensional course and / or a thickness of nerves in the cornea of ​​an eye;

[0023] - generate a weighting value from the start control data and the nerve data, which represents the severity of the overlap. 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.

[0024] 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.

[0025] 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 comprise model data, which may be simulated and not based on a real measurement on an eye.

[0026] The weighting value can be provided optically, e.g., via a display device, or acoustically. 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 color coding as described above, on a display device is also conceivable. Thus, 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.

[0027] 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.

[0028] It is also conceivable for a physician to be provided with a visualization of the nerves overlapping with the at least one incision area and / or with the at least one irradiation area and / or with the at least one tissue volume to be irradiated. Since this overlap represents nerves damaged by the procedure, this visualization can convey to the physician the invasiveness of the planned procedure, which they can use to medically evaluate the planned procedure.

[0029] 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.

[0030] Analogous to known false-color representations of elevation profiles, 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. For this purpose, 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.

[0031] In a further embodiment, 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. Following a modification, a recalculated weighting value can be displayed. The user input can be made using a keyboard, mouse, touchscreen, voice input or otherwise. Furthermore, a modification of several parameters is conceivable. Furthermore, in such a modification, parameters can be linked to one another so that an increase in a first parameter causes a reduction 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 to be treated by modifying at least one parameter during the planning stage.This reduces the likelihood of complications and increases patient satisfaction.

[0032] After each modification of at least one parameter of the start control data, a previously mentioned visualization can be enabled for verification by the physician.

[0033] Furthermore, it is conceivable that all parameter changes are saved at least temporarily and can be completely reversed during the planning process.

[0034] The data processing device of the aforementioned embodiments can also be configured to provide the start control data as control data without changing the parameters. Likewise, the data processing device can provide control data based on the start control data and the parameters set by the user.

[0035] Such 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.

[0036] In a further embodiment of the planning unit, 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.

[0037] 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.

[0038] 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.

[0039] The ophthalmological laser therapy device according to the invention for a surgical intervention on the cornea of ​​an eye according to control data comprises a previously or subsequently described embodiment of the planning unit for generating control data, a control unit which is connected to the planning unit via at least one input and / or output interface for receiving the control data for controlling the ophthalmological laser therapy device, a laser device for providing therapeutic radiation, a focusing device for focusing the therapeutic radiation in a focus for severing or irradiating the cornea (within the tissue of the eye), and a scanning device for shifting the focus of the therapeutic radiation within the tissue of the cornea of ​​the eye to generate the cutting surface and / or to generate the irradiation area and / or to generate the tissue volume to be irradiated according to the control data.

[0040] In particular, 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.

[0041] 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. Furthermore, the user interface can also comprise 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.

[0042] 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. During this planning phase, no treatment or therapy of a patient is yet taking place. 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.

[0043] In the following description, the optional enhancements to the 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.

[0044] In the computer-implemented method for optimizing control data for a surgical intervention within the tissue of the cornea of ​​an eye using an ophthalmic laser therapy device, start control data are read in in a first method step. These data represent at least one incision area and / or at least one irradiation area and / or at least one tissue volume to be irradiated, as well as their three-dimensional position and / or orientation within the cornea of ​​an eye. How these start control data are generated is explained below in the explanation of the planning method or has already been explained above.

[0045] The start control data can be provided in a suitable computer-readable form. In particular, if provided to an ophthalmic laser therapy device (which allows treatment of the eye within the tissue of the eye and is particularly preferably femtosecond laser-based), 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.

[0046] Next, 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.

[0047] In the next method step, 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.

[0048] Optionally, if a cut occurs during the procedure, i.e., a severing or possible damage to corneal nerves, all nerves that are damaged or severed according to the underlying control data (start control data or modified control data) can be assigned a weighting. For example, and not limited to, nerves with greater thickness can be assigned a higher weighting than nerves with lesser thickness. Likewise, 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. A penalty function (penalty = penalty) can thus apply higher "penalties" for damaging or cutting nerves with a high weighting and can be used for optimization (here: minimization).In the next step, 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.

[0049] In a further embodiment of the computer-implemented method, 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.

[0050] In a first sub-step of optimization, 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. Purely by way of example and not by way of limitation, 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. Using this modified control data, a new weighting value can be determined.

[0051] If lower weighting values ​​represent a treatment of the cornea in which fewer corneal nerves are affected, the selected modification represents an improvement in the control data. In the subsequent sub-step, the direction of the modification of the selected parameter can thus be maintained. Individual possible optimization methods are listed below. This second modification, however, is no longer based on the initial control data, but rather on the control data obtained, i.e., determined, in the first iteration.

[0052] If the necessary optimality conditions are met, i.e. conditions that must necessarily be met when an optimum is found, the subsequent control data that result in the optimized weighting value and satisfy the optimality conditions can be provided as optimized control data. The optimality conditions are therefore to be understood as termination conditions of the optimization. The computer-implemented method therefore optimizes the entered initial control data such that the determined optimal control data have a less negative impact on the corneal nerves when the treatment is carried out than the initial control data. Complications such as dry eyes can thus be minimized as far as possible during the planning phase. The optimization is thus carried out in such a way that the number of damaged nerves, in particular those severed or harmfully irradiated (i.e. damaged by radiation), is minimized.

[0053] 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.

[0054] 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. In particular, the type of intervention can determine which parameters can be varied in the optimization step. Thus, in one embodiment of the computer-implemented method, 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 cut and / or a course of the optional edge incision and / or a course of a transition zone and / or a shape of the lenticule cut and / or the cap cut and / or a shape of the lenticule and / or an eccentricity of a cut and / or of the lenticule (in the case of a lenticule extraction); or a depth of an implant pocket and / or a width of an implant pocket and / or a length of an implant pocket and / or a curvature of an implant pocket (in the case of the creation of an implant pocket); or a depth of a receiving volume and / or a diameter of a;

[0055] 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); Depending on the type of intervention represented by the surgical data, an adapted set of parameters is thus available. The respective parameters can preferably be summarized in tuples.

[0056] 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.

[0057] For example, when planning a SMILE, 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.

[0058] Especially for the creation of a lenticule (e.g. in a SMILE), a change in the lenticule depth depending on the nerve data can be particularly relevant.

[0059] It is advantageous if each start parameter can only be modified within a parameter interval specific to each parameter stored in the start control data.

[0060] For example, a flap incision cannot have an arbitrarily small diameter, since otherwise, without restricting the flap diameter parameter, an optimum weighting value would inevitably be found at a flap diameter of 0. (Since not a single nerve would be cut at a particular point.) Likewise, a flap thickness cannot be arbitrarily varied, since a flap that is too thin could tear, and a flap that is too thick could impede access to the underlying stromal tissue (the flap is more difficult to fold over). A flap thickness is preferably in the range of 100 micrometers.

[0061] Furthermore, 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, for 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 procedure.When the user inputs the modification of at least one parameter, such a parameter interval can be taken into account so that modification of the corresponding parameter beyond the interval limits is prevented.

[0062] Consequently, it is also conceivable that at least one starting parameter in the computer-implemented procedure could be set as a fixed, invariable 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.

[0063] It is further conceivable that the nerve data represent a measurement from a high-resolution OCT and / or a measurement from a confocal microscope. In particular, 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 captured by the nerve data and thus also the computational effort of the optimization. Optionally, the nerve data can be available in various, pre-selectable resolutions.For example, when optimizing the location of a cataract surgical access point, a high resolution of the nerve data can be selected, while when calculating a lenticule for a SMILE procedure, 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.

[0064] Preferably, the nerve data represents the corneal nerves of the eye underlying the planning. However, an OCT or confocal measurement from another eye can also be representative. It is also conceivable that the nerve data represent the nerves of a modeled eye and 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.

[0065] 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. As mentioned above, such 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.

[0066] In one embodiment of the ophthalmic laser therapy device, the laser device can comprise a pulsed picosecond laser or a pulsed femtosecond laser. The use of a nanosecond laser is also conceivable, but this is less preferred, since higher pulse energies are required to generate an optical breakthrough.

[0067] In a further embodiment of the computer-implemented method, 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.

[0068] Likewise, optionally or additionally, 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.

[0069] Furthermore, optionally or additionally, 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.

[0070] 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.

[0071] The branching index and / or the thickness information and / or the residual length information can also be processed when visualizing a position and / or foreground of the at least one incision area and / or the at least one irradiation area and / or the tissue volume to be irradiated. For example, and not by way of limitation, it is conceivable that 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 for the physician in the visualization.

[0072] In the computer-implemented method, 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 is terminated either when optimality conditions are met or when the limit is reached. Depending on the optimization algorithm used, a modification of at least two, i.e., several starting parameters (depending on available resources, this can also be three, four, five, six, seven... up to all parameters of the respective tuple) can advantageously be carried out 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.

[0073] In the computer-implemented method, optimizing the weighting value can thus correspond in particular to finding a minimum of the weighting value depending on different tuples of parameters.

[0074] It can be particularly advantageous if an artificial intelligence-based model is used to optimize the weighting value. 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.

[0075] For example, in machine learning, instead of transforming input data based on predetermined rules, a transformation of that data can be used that can be derived based on an analysis of historical and / or training data. The artificial intelligence-based model can include a set of instructions that can be used to train, build, or use the model.

[0076] The weighting matrix, i.e. the weights of the individual nodes, is adjusted during training.

[0077] It is also conceivable that 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.

[0078] To optimize the weighting value, 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.

[0079] 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.

[0080] However, 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.

[0081] The control or planning data may further include laser parameter data and / or device data and / or other patient data.

[0082] The additional patient data can, in particular, represent preoperative characteristics of the patient's eye to be treated. For example, it is conceivable that a dry-eye factor is included, which represents the degree of moisture in the affected eye prevailing before the operation. This factor can be specified, for example, on a scale of 1 to 10. In this way, it can be possible to carry out a plan that is individually tailored to the respective patient. For example, purely as an example and not as a limitation, optimization using the aforementioned computer-implemented method can be particularly interesting for patients who already suffer from dry eyes and whose further worsening of dry eyes should be kept as low as possible.

[0083] 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.

[0084] (A) In the case of correction of the refraction of a cornea of ​​an eye by corneal modification using lenticule extraction:

[0085] Receiving correction data representing a need for refraction correction;

[0086] Calculating the volume of corneal tissue to be removed, based on the refractive correction required;

[0087] Calculating sectional area data representing a sectional area completely surrounding the tissue volume, wherein the sectional area data

[0088] • Cap cut data, which represent a cap cut that limits the tissue volume anteriorly,

[0089] • Lenticule section data, which represent a lenticule section that delimits the tissue volume posteriorly,

[0090] • 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, and

[0091] • Access interface data representing at least one access interface; and

[0092] Generating start control data representing the cutting surface.

[0093] (B) In case of creating a flap incision:

[0094] Receiving flap data representing a flap size;

[0095] Receiving hinge data representing the size and position of a hinge region of the flap; and receiving thickness data representing the thickness of the flap;

[0096] Calculating the cutting surfaces that create the flap using the flap data, the hinge

[0097] data and the thickness data; and

[0098] Generating start control data representing the cutting surfaces.

[0099] (C) In case of creation of an implant pocket

[0100] Receiving size data representing a size of the implant pocket;

[0101] Receiving position data representing a position of the implant pocket;

[0102] Receiving data representing an inclination or a course of the implant pocket

[0103] historical data; and

[0104] Generating start control data representing the cutting surfaces of the implant pocket from the size data, the position data and the history data.

[0105] (D) In ​​case of keratoplasty

[0106] Receiving size data representing a size of a receiving opening;

[0107] Receiving position data representing a position of the receiving opening;

[0108] Receiving history data representing an inclination or a gradient of the receiving opening; and

[0109] Generating start control data representing the cutting surface of the receiving opening from the size data, the position data and the history data

[0110] (E) In case of creating a cataract surgical access

[0111] (E1) receiving size data representing a cataract surgical access;

[0112] (E2) receiving history data representing a history of the cataract surgery access; and

[0113] (E3) Generating start control data representing the interfaces of the access from the size data and the history data.

[0114] (F) In the case of a LIRIC:

[0115] (F1) Receiving a size of an irradiation area representing

[0116] Size data;

[0117] (F2) Receiving a position of the irradiation area representing

[0118] Position data;

[0119] (F3) receiving history data representing an inclination or a gradient of the irradiation area; and

[0120] (F4) Generating start control data representing at least one irradiation area from the size data, the position data and the progression data. It should be mentioned at this point that 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. For example, 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). For such an implantation, a receiving opening for receiving the IOL and an access through which the IOL (preferably in the rolled-up state) can be inserted into the receiving opening are required. In the optimization according to (D), for example, the progression data representing an inclination or a progression of the receiving opening can be set as fixed, i.e. unchangeable parameters.Optimization then takes place with regard to the position and / or size of the aperture for the IOL.

[0121] 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 an implant pocket, a width of an implant pocket, a length of an implant pocket, and a curvature of an implant pocket; in the case of (D), a modification of a parameter tuple which includes, as parameters, at least a depth of a receiving volume, a diameter of a receiving volume, a shape of a receiving volume, and an inclination of a receiving volume; in the case of (E), a modification of a parameter tuple which includes, as parameters, at least an azimuthal position of an access incision, a width of an access incision, and an inclination of an access incision;in the case of (F), a modification of a parameter tuple which comprises as parameters at least a depth of an area to be processed, a width of an area to be processed, a length of an area to be processed, a shape of an area to be processed, an inclination of an area to be processed and processing parameters of the area to be processed;

[0122] 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.

[0123] 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.

[0124] 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.

[0125] A computer-readable non-volatile storage medium according to the invention 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.

[0126] 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.

[0127] The planning unit can be part of an ophthalmic laser therapy device or 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 separate from the site of the intervention. The planning unit can be configured 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 can receive wired or wireless 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 mixture of software and hardware.

[0128] The method according to the invention for a surgical intervention on the cornea of ​​an eye may comprise:

[0129] Implementation of the planning procedure described above;

[0130] Cutting or irradiating the cornea of ​​the eye according to the provided control data;

[0131] In the case of (A) releasing the tissue volume along the cap incision, releasing the tissue volume along the lenticule incision, optionally releasing the tissue volume along the side incision, and removing the tissue volume from the cornea of ​​the eye;

[0132] In the case of (B) separating the incisions and, if necessary, opening the flap;

[0133] In case of (C) inserting an implant into the implant pocket; in case of (D) inserting an implant into the receiving opening; in case of (E) performing cataract surgery through the cataract surgery access; and in case of (F) irradiating the cornea according to the control data on refractive index change of the tissue of the irradiation area.

[0134] 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.

[0135] 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.

[0136] 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 and subjective measurements are known to determine the need for refractive correction, and these can be combined. Measurements of the structure of the eye, for example, via an OCT measurement, as well as measurements of intraocular pressure and the topography of the eye, can also be incorporated into the refractive correction requirement.

[0137] The tissue volume is delimited or defined by cutting surfaces. These cutting surfaces are represented by the calculated cutting surface data.

[0138] As previously described, for case (A), the tissue volume (i.e., the lenticule) is composed of different cutting surfaces. 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 lateral cutting data, which represents an optional lateral 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.

[0139] As previously described, in some designs the side cut can be omitted if the cap and lenticule cuts converge.

[0140] After the individual cutting data have been calculated in the planning process, the start control data are generated, which represent the cutting surface.

[0141] 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.

[0142] When correcting astigmatism or higher orders, it is preferable not to "impose" a round shape on the lenticule, which can protect other nerves. In particular, the lenticule can also be oval.

[0143] The location of the access incision for lenticule extraction can be chosen to minimize transection of corneal nerves. In addition to the location, the width (opening angle) and steepness of the access incision can also be adjusted.

[0144] 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.

[0145] In hyperopic or presbyopic lenticules, the shape of the transition or buffer zone can be irregularly selected to improve nerve protection. In particular, the planning unit can operate independently of an ophthalmic therapy device and can be implemented, for example, on a remote PC or a separate PC or in a cloud as software, hardware, or a combination of software and hardware.

[0146] 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.

[0147] The aspects of the present invention will be explained in more detail below with reference to the accompanying drawings. The drawings show possible exemplary embodiments of the present invention purely by way of example, whereby the described features can be combined with one another or omitted as desired. Identical features or features with the same function are also identified by the same reference numerals. Repetitive descriptions of features are omitted, so that explanations of features described in previous drawings can also be applied to other drawings, unless differences are explicitly pointed out.

[0148] They show:

[0149] Fig. 1-5 schematic representations of nerves in the cornea and their impairment during surgery;

[0150] Fig. 6 is a schematic representation of a sequence of the computer-implemented method;

[0151] Fig. 7-12 schematic representation of the optimization of different parameters of a lenticule in a SMILE operation; and

[0152] 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.

[0153] Figures 2 and 3 also schematically depict the effects of a FLAP incision and a SMILE procedure on the nerves 7 shown in Figure 1. A flap incision 11 performed in Figure 2 transects a large portion of the nerves 7 shown (see detail 13 and incision 15). In the case of a SMILE, significantly fewer nerves 7 are transected or damaged by an access incision 17, minimizing the occurrence of complications.

[0154] 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. However, the area of ​​a cap 23 is generally smaller than the area of ​​a flap 21. Furthermore, 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.

[0155] Figure 6 schematically shows a sequence of the computer-implemented method according to the invention. In a first method step S1, 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.

[0156] In a second method step S2, 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.

[0157] In a third method step S3, 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.

[0158] At this area, the computer-implemented method (in an embodiment of the method not shown) can provide the provision of the weighting value W.

[0159] In the embodiment shown, in a fourth method step S4, 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.

[0160] Subsequently, a query Q is made as to whether an optimization criterion is met (branch "n"). If this is not the case, at least one start parameter SP stored in the start control data 200 is varied in a method step S4.1, and the weighting value W is recalculated using the subsequent control data 201 thus obtained, in accordance with method step S3.

[0161] If the optimization criterion is met (branch “y”), in a fifth method step S5 the subsequent control data 201 which results in the optimized weighting value is output as optimized control data 203.

[0162] In the following, case (A), ie the optimization of the control data of a SMILE operation, ie the extraction of a lenticule through a small access, will be explained purely as an example using Figures 7 to 12.

[0163] All figures show a lenticule cut 29, a cap cut 31, and the access cut 33. Figure 7 schematically shows the position of these cuts 29, 31, 33 for the case of using the start control data 200.

[0164] Possible optimizations are schematically illustrated in Figures 8 to 12. In Figure 8, an azimuth angle range 35 of the access incision 33 is optimized and relocated to a region in which fewer nerves 7 are destroyed, ie severed, by the access incision 33.

[0165] 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. In Figure 9, 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.

[0166] Figure 10 shows a further optimization of the transition incision 37. Here, a shape 37A of the transition incision 37 is optimized toward an irregular transition incision 38 in order to sever fewer nerves 7.

[0167] In Figure 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.

[0168] Figure 12 also shows an irregular transition zone 41a. In the previous figures, a transition zone 41 extends into the plane of the drawing.

[0169] All modifications and cuts shown are made within the tissue of the eye 5. All optimization steps performed can be visualized for evaluation by a physician, e.g., displayed three-dimensionally or two-dimensionally.

[0170] According to the optimization steps performed in Figures 8 to 12 based on the state of Figure 7, it is also conceivable that the parameters with which the position and / or location of the cutting surfaces 43 or irradiation surfaces 45 can be optimized for other interventions are partially identical, identical, or supplemented by additional parameters. The individual cutting or irradiation surfaces 43, 45 or a plurality of connected cutting or irradiation surfaces 43, 45 can thus be optimized according to the invention in terms of their location and / or orientation and / or size so that as few nerves 7 as possible are damaged or severed.

[0171] The optimization of the control data for a SMILE operation shown in Figures 7 to 12 can thus also be transferred to a flap incision 11, as shown in Figures 2 and 4.

[0172] When creating an implant pocket or a receiving opening for an implant during keratoplasty or lamellar keratoplasty, or even creating a receiving opening for an IOL implantation, 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.

[0173] In a treatment using LI RIO, 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.

[0174] Fig. 13 schematically illustrates an embodiment of an ophthalmic laser therapy device 1. During operation of the ophthalmic laser therapy device 100, 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. In other embodiments, 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.

[0175] A focusing device 30 focuses the pulsed laser beam 115 into a focus 77 within the tissue of the cornea 15. In Fig. 13, 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.

[0176] During operation, the laser device 110, the scanning devices 130, 135, and the focusing device 30 are controlled fully automatically via signal data transmitted from a control unit 140 to the respective devices 110, 110, 130, 135. This is indicated by arrows pointing from the control unit 140 to the devices 110, 110, 130, and 135, respectively. The control unit 140 ensures suitably synchronous operation of the laser device 110, the three-dimensional scanning devices 130, 135, and, if applicable, the focusing device 30. The signal data can be transmitted via signal data lines 80 or wirelessly. The signal data required during operation is determined in the control unit 140 based on the control data 90, in particular based on the 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 transmission of the optimized control data 203 can also take place via 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.). As an alternative to direct communication, it is also possible to arrange 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 ophthalmological laser therapy device 100, ie before control signals are sent to the laser device 110, the scanning devices 130, 135 and, if applicable,transmitted to the focusing device 30.

[0177] 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.

[0178] 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. For this purpose, it can be checked, for example, whether additional information about the ophthalmic laser therapy device 100 stored in the control data set 92, e.g. B. a device serial number 90a, or about the patient, e.g.a patient identification number 90b, match other information that was read out, for example, on the ophthalmic laser therapy device 100 or entered separately as soon as the patient is in the correct position for operation of the ophthalmic laser therapy device 100.

[0179] 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. In the embodiment shown here, 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. In other embodiments, the refraction correction requirement R can also be input via the input and / or output interface S2. Furthermore, the start control data 200 and the nerve data 210 can also be input via these interfaces.

[0180] The input device can be part of the ophthalmic laser therapy device 100 or can be designed independently.

[0181] 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.

[0182] In an embodiment not shown, 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.

[0183] 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.

[0184] It should be noted again that 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 ophthalmological laser therapy device 100 or not.

Claims

Patent claims 1. A planning unit for generating control data for an intervention within the tissue of an eye for an ophthalmic laser therapy device, wherein the ophthalmic laser therapy device comprises a laser device, a focusing device, a scanning device, and a control unit for controlling the laser device and / or the focusing device and / or the scanning device, wherein the planning unit comprises a data processing device configured to: read in provided start control data, which represent at least one cutting area and / or at least one irradiation area and / or at least one tissue volume to be irradiated, as well as their three-dimensional position and / or orientation within the tissue of the cornea of ​​the eye; read in provided nerve data, which represent a three-dimensional arrangement and / or a three-dimensional course and / or a thickness of nerves in the cornea of ​​an eye;Generate a weighting value from the initial control data and the nerve data, which represents a degree of severity of the overlap 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; and provide the weighting value; 2. Planning unit according to claim 1, which is designed to modify at least one start parameter stored in the start control data by means of at least one user input.

3. The planning unit according to claim 1 or 2, wherein the data processing device is further configured to optimize the start control data by optimizing the weighting value 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 or at least one irradiation area or at least one tissue volume to be irradiated.

4. Planning unit according to one of claims 1 to 3, wherein the start control data further comprise operation data, wherein the operation data represent a surgical procedure to be performed by the ophthalmic laser therapy device from the list of procedures comprising a flap incision, a lenticule extraction; a small access lenticule extraction (SMILE); a creation of an implant pocket; a keratoplasty; a lamellar keratoplasty; an arcuate and / or relaxing corneal incision; a cataract surgical approach; an LI RIO; and a cross-linking.

5. Planning unit according to claim 4, which is designed depending on the Operation data at least one predetermined parameter set of Starting 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; 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 edge incision and / or a course of a transition zone; or a depth of an implant pocket and / or a width of an implant pocket and / or a length of an implant pocket and / or a curvature of an implant pocket; or a depth of a receiving volume and / or a diameter of a receiving volume and / or a shape of a receiving volume and / or an inclination of a receiving volume; or an azimuthal position of an access incision and / or a width of an access incision and / or an inclination of an access incision;or a depth of an area to be worked and / or a width of an area to be worked and / or a length of an area to be worked and / or a shape of an area to be worked and / or an inclination; an area to be processed and / or processing parameters of the area to be processed; to modify.

6. Planning unit according to one of claims 1 to 5, which is further designed to modify at least one start parameter in a parameter interval specific for this start parameter and / or to set at least one start parameter invariably as a fixed value.

7. Planning unit according to one of claims 1 to 6, wherein it is designed to read in measurement data of a high-resolution OCT and / or measurement data of a confocal microscope as nerve data.

8. Planning unit according to one of claims 1 to 7, further comprising 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.

9. An ophthalmological laser therapy device for a surgical intervention within a tissue of the cornea of ​​an eye according to control data, comprising a planning unit according to one of claims 1 to 8 for generating control data, a control unit connected to the planning unit via at least one input and / or output interface for receiving the control data for controlling the ophthalmological laser therapy device, a laser device for providing therapy radiation, a focusing device for focusing the therapy radiation in a Focus for severing or irradiating the cornea, and a scanning device for shifting the focus of the therapy radiation within the tissue of the cornea of ​​the eye to generate the cutting surface and / or to generate the irradiation area and / or to generate the tissue volume to be irradiated according to the control data.

10. An ophthalmic laser therapy device according to claim 9, wherein the laser device comprises a pulsed picosecond laser and / or a pulsed femtosecond laser.

11. A computer-implemented method for optimizing control data for a surgical intervention within a tissue of the cornea of ​​an eye using an ophthalmic laser therapy device, comprising reading in start control data representing at least one cut surface and / or at least one irradiation area 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; reading in 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;Generating a weighting value from the initial control data and from 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 cut surface or the at least one irradiation area or the at least one tissue volume to be irradiated; and providing the determined weighting value; 12. The computer-implemented method of claim 11, further comprising: optimizing the weighting value by repeatedly generating the weighting value from the nerve data 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; Providing those subsequent control data as optimized control data which result in the optimized weighting value.

13. Computer-implemented method according to claim 11 or 12, wherein the nerve data represent a measurement of a high-resolution OCT and / or a measurement of a confocal microscope, which preferably have a resolution of 5 pm or less.

14. A computer-implemented method according to any one of claims 11 to 13, wherein, when generating the weighting value, a branching index of individual nerves represented by the nerve data is taken into account, wherein the branching index represents at least a number of branches after the cutting of nerves; and / or thickness information of individual nerves represented by the nerve data is taken into account, wherein the thickness information represents at least one thickness of the nerves; and / or residual length information is taken into account, wherein the residual length information represents at least one total length of the severed nerves represented by the nerve data.

15. A computer-implemented method according to any one of claims 11 to 14, wherein an artificial intelligence-based model is used to optimize the weighting value.

16. Computer-implemented method according to one of claims 11 to 15, wherein for optimizing the weighting value 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 procedure; - Augmented Lagrange method; The Nearest Neighbor Heuristic; Evolutionary algorithms;and Stochastic tunneling is used.

17. A planning method for generating control data for a surgical procedure within a tissue of the cornea of ​​an eye using an ophthalmic laser therapy device, the planning method comprising: Providing start-up control data; Providing operational data; Providing neural data; and Performing the computer-implemented method according to one of claims 11 to 16.

18. A computer program product comprising instructions which, when loaded into a data processing device, cause the device to To carry out the planning method according to claim 17.

19. Planning unit according to one of claims 1 to 8 or ophthalmological laser therapy device according to claim 9 or 10, which is designed to optimize the start control data by a computer-implemented method according to claim 12 or according to one of claims 13 to 16, if related to claim 12.

20. A computer-readable non-volatile storage medium comprising the computer program product of claim 18.

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