Therapeutic device for ophthalmic surgery

Abstract

The invention relates to a planning device for generating control data for a treatment device, which generates at least one cutting surface in the cornea and on the treatment device by means of a laser device, the treatment device having a planning device of the type mentioned. The invention also relates to a method for generating control data for such a treatment device and also to a method for ophthalmic surgery. Here, in determining the cutting surface, the cutting surface can be rotated about an axis which extends substantially parallel to the eye axis.

Description

TECHNICAL FIELD

[0001] The invention relates to a planning device for generating control data for a treatment device, which produces at least one cut in the cornea by means of a laser device. The invention also relates to a treatment device having a planning device of the aforementioned type.

[0002] The invention also relates to a method for generating control data for a treatment device, which produces at least one cut in the cornea by means of a laser device.

[0003] Finally, the invention also relates to a method for ophthalmic surgery, in which at least one cut is produced in the cornea by means of a treatment device having a laser device.

[0004] The invention also relates to a user interface for the aforementioned planning device. BACKGROUND

[0005] Different treatment methods for the purpose of refractive correction at a human eye are known from the prior art. The purpose of the surgical methods is to change the cornea in a targeted manner in order to influence the light refraction in the eye. For this purpose, various surgical methods are used. The most common method is the so-called laser in situ keratomileusis, also abbreviated as LASIK. Here, a corneal flap is separated from the corneal surface on one side and folded onto one side. The flap can be separated by means of a mechanical microkeratome or also by means of a so-called femtosecond laser keratome, for example the keratome sold by the company Intralase Corp in Irvine, USA. After the flap has been separated and folded onto one side, the application of a quasi-molecular laser is provided in the LASIK procedure, which removes the corneal tissue exposed under the flap by ablation. After the corneal tissue originally located below the corneal surface has been evaporated in this way, the corneal flap is folded back into its original position.

[0006] The use of a laser keratome for the exposure of the flap is advantageous compared to a mechanical knife, since it improves the geometric accuracy and reduces the frequency of clinically relevant complications. In particular if laser radiation is used, a flap with a more constant thickness can be produced. The cut edge is also formed precisely, thereby reducing the risk of healing disturbances caused by the cut edge and also reducing the boundary surface left after the procedure. However, the disadvantage of this method is that two different treatment devices must be used, namely a laser keratome for the exposure of the flap and a laser for the evaporation of the corneal tissue.

[0007] A method implemented by Carl Zeiss Meditec AG and abbreviated as FLEX Femtosecond Lenticule Extraction eliminates these disadvantages. In this method for lenticule extraction, a cut geometry is formed in the cornea of the eye by means of a short-pulse laser, preferably a femtosecond laser, which separates a corneal volume (so-called lenticule) in the cornea. Then, after a flap (haptic) covering the lenticule is folded to the side, the lenticule is removed manually by the operating physician. The advantage of this method is that the cut quality is improved again by using a femtosecond laser in combination with a contact lens of the curvature.

[0008] On the other hand, only one treatment device is required; the excimer laser is no longer used. This method also avoids the risks and limitations of the excimer laser.

[0009] An improved version of the FLEx method is now known in the literature as the SMILE method, in which no flap is produced, but only a small open incision serves as an access for the lenticule located under the so-called cap. The separated lenticule is removed through this small open incision, whereby the integrity of the biomechanical aspects of the anterior cornea is less damaged compared to LASIK or similar methods. In addition, the surface nerve fibers in the cornea are less divided in this way, which can have a positive effect on restoring the original sensitivity of the corneal surface. As a result, dry eye, which often requires treatment after LASIK, is reduced in its severity and duration. Other complications after LASIK, which are usually associated with the flap (e.g. flap displacement, wrinkles, epithelial growth on the flap bed), occur less frequently without a flap.

[0010] When a cut surface is produced in the cornea by means of laser radiation, the radiation effect of light is usually exploited by a single light pulse producing a light penetration with a duration of between approximately 100 fs and 100 ns. It is also known to introduce individual pulses with an energy below the light penetration threshold into the tissue or material overlappingly, so that material or tissue separation is thus achieved. This approach to producing an incision in the corneal tissue allows a variety of incisions.

[0011] A common feature of all these methods is that the success of the treatment depends on reliably associating one or more intentional incisions with the geometry of the eye to be treated, since a small deviation from the pre-set refractive correction can also result in a non-optimal correction, leading to a visual impairment.

[0012] However, in methods based on creating a cut in the cornea, such as the refractive SMILE, LASIK, photorefractive keratectomy (PRK) or therapeutic: intrastromal corneal ring (ICR), keratoplasty, other intrastromal pockets (capsules) etc., there are angular deviations between the patient's eye coordinate system and the coordinate system of the treatment device which defines the cut. Typical reasons for these deviations are:

[0013] • ring: rotation between the upright patient position and the supine patient position

[0014] • eye rotation induced by suction at the contact lens of the treatment instrument

[0015] • tilted position / head orientation of the patient relative to the instrument

[0016] • mechanical tolerances in the instrument (e.g. angular tolerance when adjusting between the cutting system and the camera for visualizing the rotation angle, other optical tolerances)

[0017] These deviations, when not taken into account, result in that not all non-rotationally symmetric parts of the cut to be performed are applied at the planned position, which can have an impact on the clinical outcome of the treatment. This includes:

[0018] • incorrectly corrected cylindrical axis

[0019] • incorrectly positioned position-dependent entry cuts, such as flap folds, SMILE incisions (flap incisions), ICR entry cuts, capsule passages.

[0020] • incorrectly corrected non-rotationally symmetric higher order components.

[0021] The prior art only discloses rotating the contact lens based on a manual comparison of the treatment image before the treatment and data detected during the preliminary examination. This method is not precise and does not provide the physician with quantitative feedback on the rotation angle which he adjusts. Furthermore, the eye is deflected from its resting state, which produces a return force. This can lead to an increased risk of suction loss (loss of suction of the contact lens at the eye) and the patient experiences discomfort. SUMMARY

[0022] It is therefore an object of the present invention to provide a planning device for generating control data, a treatment device for a refractive correction ophthalmic surgery and a method for generating control data for such a treatment device, wherein an improved refractive correction is ensured.

[0023] According to the invention, this object is solved with a planning device of the type mentioned at the outset, which has a computing unit for determining a corneal cutting surface, which enables the cutting surface to be rotated about an axis which extends essentially parallel to the eye axis when determining the cutting surface.

[0024] Thus, the physician is able to place the incision optimally in the cornea according to his experience, in particular to compensate for a twist of the patient's eye when taking the treatment position.

[0025] The object of the present application is also solved with a treatment device having a laser device which separates at least one cut in the cornea by means of laser radiation in accordance with control data, and having a planning device of the type mentioned above for generating the control data, wherein the planning device enables the cut to be rotated about an axis which extends substantially parallel to the eye axis when determining the cut.

[0026] Finally, the object of the present application is also solved with a method for generating control data of the type mentioned above, the method having: generating a control data set for a cut in the cornea for actuating the laser device, wherein the planning device enables the cut to be rotated about an axis which extends substantially parallel to the eye axis when determining the cut.

[0027] Finally, the object of the present application is also solved with a method which comprises: generating a control data set for a cut in the cornea, transmitting the control data to a treatment device and generating the cut by actuating the laser device using the control data set, wherein the cut is determined to be rotated about an axis which extends substantially parallel to the eye axis when generating the control data set.

[0028] The object of the present application is likewise solved by providing a user interface of an input means by means of which the cut is finally determined to be rotated about an axis which extends substantially parallel to the eye axis.

[0029] The present application thus relates to a device and a method by means of which the refractive surgical procedure is improved such that the physician is able to place the incision optimally in the cornea according to his experience.

[0030] Preferably, the tissue to be treated is the cornea or the lens, but also the vitreous body or other structures in the eye.

[0031] The solution according to the present application provides the possibility of a complete rotation of the incision pattern to be applied as a basis for the incision in the eye tissue by adding an angular offset to all coordinates of the incision pattern.

[0032] It is possible for the physician to determine this angle directly before the operation. This is either done manually by the physician or on the basis of an algorithm which determines and suggests the angular deviation between the diagnostic image and the treatment image. The physician is then able to fine-tune this angle.

[0033] The currently selected angle of rotation can advantageously be visualized and quantified via the treatment common view.

[0034] It is advantageous if a further angle can be added to the angle offset which is determined when adjusting the instrument in order to compensate for rotational errors due to mechanical tolerances.

[0035] Thus, the rotation of the incision pattern can be visualized at the planning time and before the start of the laser treatment and changed by the physician.

[0036] Here, the procedure according to the application can be as follows:

[0037] • acquisition of an image of the patient's eye in a diagnostic instrument

[0038] • identification of anatomical features

[0039] • planning of the expected angular position of the incision pattern with respect to the anatomical features of the patient's eye

[0040] • acquisition of an image of the patient's eye in a treatment device

[0041] • identification of anatomical features

[0042] • display of information about the deviation between the expected angular position and the currently adjusted angular position

[0043] • matching of the expected incision pattern to the actual position of the eye by rotating the incision pattern or its target coordinates

[0044] Preferably, the iris or a patient-specific structure thereof is used as anatomical feature. Alternatively, another angle-dependent feature, such as the retina, can also be used. Likewise, it is also possible to use artificial markers, such as colored dots on the cornea or the sclera.

[0045] The deviation can advantageously be indicated in numerical or graphical form.

[0046] It is particularly advantageous to adjust the rotational angle immediately after fixing the patient's eye by means of a contact lens before the treatment.

[0047] Preferably, the adjustable angular range is limited to, for example, + / - 20°.

[0048] It is also preferable for the increment of the angular adjustment to be limited downward, for example, to 1°.

[0049] Preferably, the change of the adjustment of the rotational angle is less than 3 seconds, preferably less than 1 second, between the treatment preparation or the start of the treatment.

[0050] Preferably, the adjustment of the rotational angle is achieved via a data overlay in the visual treatment observation.

[0051] It is also preferable for the adjustment scale for the rotation to be visualized by means of a data overlay in the treatment observation.

[0052] Preferably, the possibility of adjusting the rotation angle is combined with existing operating elements, particularly those used by the operator to correctly position the patient's eyes relative to one or more instruments relative to the patient's eyes. This could be, for example, a joystick, but could also be a computer mouse or a rotary encoder.

[0053] Preferably, the difference between the perspective of the visualization and / or quantification recommendations and the perspective of the current adjustment.

[0054] Preferably, the difference between the suggested angle and the currently adjusted angle is evaluated based on the adjustable limit value.

[0055] Here, it is also possible to assess the differences between the multiple suggested perspectives and the current adjusted perspective.

[0056] Preferably, the angles used in the treatment are stored with the recommended angles and treatment data after the treatment.

[0057] It goes without saying that, without departing from the scope of the invention, the features described above and below can be used not only in the specified combination, but also in other combinations or individually. Attached Figure Description

[0058] The invention will now be explained in more detail with reference to the accompanying drawings, which also disclose features essential to the invention. The drawings show:

[0059] Figure 1 A schematic diagram of a treatment device with a planning mechanism for treatment is shown during refractive correction in ophthalmic surgery.

[0060] Figure 2 It shows in Figure 1 A schematic diagram illustrating the effects of laser radiation used in the treatment equipment.

[0061] Figure 3 It shows Figure 1 Another schematic diagram of the treatment instrument regarding the introduction of laser radiation.

[0062] Figure 4 A schematic cross-sectional view through the cornea is shown to illustrate the reduction of corneal volume through refractive correction combined with ophthalmic surgery.

[0063] Figure 5 It shows about Figure 1 The schematic diagram of the treatment instrument's structure is specifically referenced from the planning device that exists there.

[0064] Figure 6 shows a schematic diagram of the cutting geometry in an example of the SMILE program.

[0065] Figure 7 a schematic diagram of a screen of a planning device is shown,

[0066] Figure 8 a schematic diagram of a screen of a treatment device is shown,

[0067] Figure 9a - c shows a preferred embodiment of a treatment device. DETAILED DESCRIPTION

[0068] Figure 1 A treatment device for ophthalmic surgery is shown and is provided with the general reference numeral 1. The treatment device 1 is designed for the introduction of a laser cut at an eye 2 of a patient 3. To this end, the treatment device 1 has a laser device 4 which emits laser radiation 6 from a laser source 5 which is aimed as focused radiation 7 into the eye 2 or the cornea. Preferably, the laser radiation 6 is pulsed laser radiation with a wavelength of between 300 nanometers and 10 micrometers. Furthermore, the pulse length of the laser radiation 6 is in the range between 1 femtosecond and 100 nanoseconds, wherein the pulse repetition rate is 500 kilohertz and 30 megahertz, preferably 1.2 to 10 megahertz, and the pulse energy is between 1 nanojoule and 10 microjoules, preferably 1 to 200 nanojoules. The treatment device 1 thus produces a cut in the cornea of the eye 2 by deflected pulsed laser radiation. A scanner 8 and a radiation intensity regulator 9 are therefore also provided in the laser device 4 or its laser source 5.

[0069] The patient 3 is on a bed 10 which can optionally be adjusted in three spatial directions in order to align the eye 2 to match the incidence of the laser radiation 6. In a preferred constructional manner, the bed 10 is motor- drivenly adjustable. Alternatively, the bed can be moved slightly and the treatment device can be correspondingly motor-drivenly adjusted. This control can be achieved in particular by means of a control instrument 11 which controls the operation of the treatment device 1 and is connected to the treatment device via a suitable data connection, for example a connection line 12. This communication can of course also take place via other paths, for example optical conductors or by radio. The control instrument 11 makes corresponding adjustments, time controls of the treatment device 1, in particular of the laser device 4, in order to achieve the corresponding functions of the treatment device 1.

[0070] The treatment device 1 also has a fixation device 15 which fixes the cornea of the eye 2 in position relative to the laser device 4. Here, the fixation device 15 can comprise a known contact lens 45, by means of which the eye cornea is placed at the contact lens by means of low pressure and is given the desired geometry. Such contact lenses are known to the person skilled in the art from the prior art, for example from DE 102 05 04 338 Al. The disclosure content of this publication is included here in its entirety as far as the description of the structure of the possible contact lens 45 of the treatment device 1 is concerned. Other changed, or improved, contact lens shapes can also have advantages for the present application and should therefore be included.

[0071] The treatment device 1 also has a camera, not shown here, which can record an image of the eye cornea 17 by means of the contact lens 45. Here, the illumination for the camera can be realized both in the visible light and in the infrared light range.

[0072] The control apparatus 11 of the treatment device 1 also has a planning device 16, which will be described in more detail later.

[0073] Figure 2 The mode of action of the incident laser radiation 6 is shown schematically. The laser radiation 6 is focused and falls as focused laser radiation 7 into the cornea 17 of the eye 2. For the focusing, a schematically drawn optical device 18 is provided. The optical device produces a focal point in the cornea 17, in which the laser radiation energy density is very high, so that in combination with the pulse length of the pulsed laser radiation 6 a nonlinear effect is produced in the cornea 17. Each pulse of the pulsed laser radiation 6 in the focal point 19 can for example generate an optical breakthrough in the eye cornea 17, which in turn triggers a plasma bubble in the Figure 2 The plasma bubble is shown here only schematically. In the formation of the plasma bubble, the tissue cutting separation includes a region which is larger than the focal point 19, although the conditions for generating the optical breakthrough are only fulfilled in the focal point 19. Therefore, the optical breakthrough is generated by each laser pulse, the energy density, i.e. the fluence of the laser radiation, must be above a certain threshold value which is related to the pulse length. This relationship is known to the person skilled in the art, for example from DE 69500997 T2. Alternatively, the tissue separation effect can also be achieved by pulsed laser radiation, wherein the focal points overlap, by emitting a plurality of laser radiation pulses in one region. The plurality of laser radiation pulses then act together to achieve the tissue separation effect. The tissue separation applied by the treatment device 1 is not further linked to the following description; it is only important that a cutting surface is produced in the cornea 17 of the eye 2.

[0074] For carrying out a refractive correction of an eye surgery, a corneal volume is removed from an inner region of the cornea 17 by means of laser radiation 6, the corneal volume being isolated by separating tissue layers there and then being made available for removal. In order to isolate the corneal volume to be removed, for example in the case of pulsed laser radiation, the position of the focal point 17 of the focused laser radiation 7 in the cornea 17 is adjusted. This is shown schematically in Figure 3 . By removing the volume, the refractive properties of the cornea 17 are changed in a targeted manner in order to thus achieve a refractive correction. The volume is therefore mainly lenticular and is referred to as a lenticule.

[0075] The elements of the treatment device 1 are only entered into Figure 3 insofar as they are required for understanding the cut surface generation. As already mentioned, the laser radiation 6 is focused in a focal point 19 of the cornea 19 and the position of the focal point 19 in the cornea is adjusted such that the focused energy from the laser radiation pulses is introduced into the tissue of the cornea 17 at different positions for cut surface generation. The laser radiation 6 is preferably provided as pulsed radiation by a laser source 5. The scanner 8 is constructed in two pieces in the configuration of Figure 3 and consists of an xy scanner 8a which, in one variant, is implemented by two electrically deflected galvanometer mirrors. The scanner 8a deflects the laser radiation 6 from the laser source 5 two-dimensionally such that there is deflected laser radiation 20 after the scanner 9. The scanner 8a thus causes an adjustment of the position of the focal point 19 which is essentially perpendicular to the main direction of incidence of the laser radiation 6 in the cornea 17. In order to adjust the depth position, in addition to the xy scanner 8a, a z scanner 8b is also provided which is designed for example as an adjustable telescope. The z scanner 8b is responsible for the z position of the position of the focal point 19, i.e. for changing the position of the focal point on the optical axis of incidence. The z scanner 8b can be arranged after or before the xy scanner 8a.

[0076] For the functional principle of the treatment device 1, the association of the individual coordinates with the spatial directions is not important, as long as the scanner 8a deflects around axes which are perpendicular to one another. Instead, it is possible to use a scanner each which adjusts the focal point 19 in a plane in which the optical radiation does not enter. It is also possible to use any non-Cartesian coordinate system for deflecting or controlling the position of the focal point 19. For example a spherical or cylindrical coordinate system. The control of the position of the focal point 19 is implemented by means of the scanners 8a, 8b under the control of a control instrument 11 which makes the corresponding adjustments to the laser source 5, the modulator 9 (not shown in Figure 3 ) and the scanners 8. The control instrument 11 is responsible for the suitable operation of the laser source 5 and the three-dimensional focal point adjustment which is exemplarily described here, such that a cut surface is finally constructed which isolates the specific corneal volume which is to be removed for the refractive correction.

[0077] The control device 11 works according to predetermined control data, which are predetermined, for example in the case of the laser device 4 described here only by way of example, as target points for the focus adjustment. The control data are generally summarized in a control data set. This provides for the predetermination of the geometry of the cutting surface to be produced, for example the coordinates of the target points as a pattern. In this embodiment, the control data set also comprises specific adjustment values for the focus position adjustment mechanism, for example for the scanner 8.

[0078] In Figure 4 The production of a cutting surface with the treatment device 1 is shown here by way of example. A corneal volume 21 in the cornea 17 is isolated by adjusting the focus point 19 in which the focused radiation 7 is focused. For this purpose, a cutting surface is produced, which is shown here by way of example as an anterior flap cutting surface 22 and a posterior lenticule cutting surface 23. These terms are understood here only by way of example and the treatment device 1 is to be created also for the general Lasik or Flex method, as already described.

[0079] It is only important here that the cutting surfaces 22 and 23 and the surrounding edge incision 25 isolate the corneal volume 21, the edge incision joining the cutting surfaces 22 and 23 together at their edges. By means of the opening incision 24 it is also possible to fold down the corneal lamella which delimits the corneal volume 21 in front, so that the corneal volume 21 is removable.

[0080] Alternatively and primarily for the present application, it is possible to use the SMILE method, in which the corneal volume 21 is removed by means of a small opening incision, as described in DE 10 2007 019813 Al. The disclosure of this document is included here in its entirety.

[0081] Figure 5 The treatment device 1 is shown schematically and according to which the meaning of the planning device 16 is to be explained in detail. The treatment device 1 has at least two devices or modules in this variant. The laser device 4 already described emits the laser radiation 6 onto the eye 2. As already described, the laser device 4 is operated here completely automatically by means of the control device 11, i.e. the laser device 4 starts the production and deflection of the laser radiation 6 according to the respective start signal and here produces the cutting surface, which is produced in the described manner and method. The laser device 5 of the control device 11 receives the control signals required for the operation, the respective control data being provided to the control device in advance. This is achieved by means of the planning device 16 shown here only by way of example as a component of the control device 11. The planning device 16 can of course also be designed to communicate independently, and wired or wirelessly, with the control device 11. It is then only important that a respective data transmission channel is provided between the planning device 16 and the control device 11. Figure 5

[0082] ​The planning device 16 generates a control data set which is provided to the control instrument 11 for performing the refractive correction of the eye surgery. Here, the planning device uses measurement data about the cornea of the eye. In the embodiment described here, these data come from the measurement device 28 which has previously measured the eye 2 of the patient 2. The measurement device 28 can of course be designed in any way and method and can transfer the corresponding data to the interface 29 of the planning device 16.

[0083] Now, the planning device 16 supports the operator of the treatment device 1 in determining the cut surface for isolating the corneal volume 21. This can be done up to a fully automatic determination of the cut surface, for example, the corneal volume 21 to be removed can be derived from the measurement data by the planning device 16, the boundary surface of the corneal volume is defined as the cut surface and the corresponding control data for the control instrument 11 are generated therefrom. The planning device 16 can provide an input feasibility at the other end of the automation degree, in which the user inputs the cut surface in the form of geometric parameters, etc. An intermediate stage provides suggestions for the cut surface, which are automatically generated by the planning device 16 and then modified by the reviser. All these concepts explained in the sections already outlined above can basically be used here in the planning device 16.

[0084] For performing the treatment, the planning device 16 generates control data for the cut surface generation, which are then used in the treatment device 1.

[0085] For clarity, Figure 6a A schematic view of a corneal cross section in a SMILE method is shown. The cornea 17 has a front hat cut 22 with an open cut 26. A back lenticule cut 23 isolates a lenticule volume 21 which can be removed through an open cut 25. For this, the lenticule 21 must first be completely separated by mechanically separating the remaining tissue bridge in the hat cut 22 and the lenticule cut 23 with a spatula-shaped instrument. Then the lenticule 21 is removed through the open cut 26. The (imaginary) axis 27 represents the symmetry axis of the cuts 22, 23, which passes through the point of passage of the plane of the cornea 17 defines the center of the cuts 22, 23, 24, 25.

[0086] Figure 6b A top view of the cornea described in Figure 6a is shown, where the meaning of the reference symbols corresponds to the meaning in Figure 6a .

[0087] Figure 7A user interface of the planning device 16 according to the application is schematically shown. In a schematic view of the patient's eye 2, the flap (or cap) incision 22 and the micro-lens incision 23 as well as the opening incision 26 are shown in a top view. Furthermore, the cylindrical axis 30 resulting from the diagnosis is shown. As diagnostic instrument one or more of the group consisting of a corneal pachymeter system, a wavefront analysis system, an optical coherence tomography system, a Placido-Scheiben topography system, a Scheimpflug topography system, a Konfocal topography system, a Niedrigkoharenz topography system, etc. are considered. For spatially correlating the cylindrical axis 30 to the anatomical structures of the eye, an image of the eye is provided (omitted in the figure for clarity) to the physician / operator with the use of the diagnosis-created anatomical landmarks, wherein the image is suitable for angular correlation (e.g. iris, retina). At the planning, the system assumes a reference angle of 0°, which is shown here as line 31 (and which here coincides with the set angle 32). The planning device calculates a proposal, which is shown here as line 33, on the basis of the respective algorithm from the diagnostic data. Both angles are also shown in numerical form in the respective displays 34, 35. The change (rotation) of the diagram is here carried out around an axis 36, which can preferably be the visual axis of the eye 2 or the instrument axis of the treatment device 1. The axis can also coincide with the axis of symmetry 27 in Figure 6a Here, the physician can make changes with respect to the proposal of the planning device 16.

[0088] Here, the input of the rotational change can be implemented, for example, in a digital manner by means of a computer mouse in the illustration of the eye or by means of a slide control, which is not shown here. After confirmation by the physician, the control data of the incisions in the cornea are calculated accordingly and transmitted to the control instrument 11.

[0089] Figure 8A user interface for directly adjusting the rotation of the pattern before treatment is schematically shown. The patient is on the bed 10 and in the lying position ready for the operation. The camera images recorded here by the contact lens 45 and the features of the anatomy used as orientation at the planning are superimposed graphically (details not shown here). In addition, the rotation angle 33 determined at the planning is also shown. By comparing the features of the anatomy used at the planning with the existing images of the camera obtained by the contact lens 45 at the eye 2, the physician can check whether the orientation of the eye 2 on which the planning was based remains unchanged when fixing the eye 2. If there are deviations from these orientations, the physician can correct the orientation by a corresponding adjustment (line 37). It is also possible that further small corrections are made by the experience of the physician. If the rotation adjusted by the physician is confirmed, then the pattern on which the incisions 22, 23 and 26 are based is recalculated accordingly and, after approval, the operation is started.

[0090] In Figures 9a to 9c a preferred embodiment of the treatment device 1 is further shown.

[0091] The treatment device 1 here has a laser swivel arm 53 surrounded by a swivel arm housing 56 and an additional examination swivel arm 64 with a surgical microscope 55, wherein a first axis 54 of the laser swivel arm 53 and a second axis 56 of the examination swivel arm 64 have a corresponding arrangement to each other at the instrument head 51 and not only the treatment screen 62 movably fixed at the swivel arm housing 56 is coupled with the movement of the swivel arm housing 56, but also the surgical microscope 65 movably fixed at the examination swivel arm 64 is coupled with the movement of the examination swivel arm 64, so that the treatment screen 62 as well as the surgical microscope 65 always remain non-inclined.

[0092] The treatment device 1 shown in this embodiment can be well used for example for the SMILE method, but also for other methods of correcting the vision of the eye or for cataract surgery.

[0093] Here, Fig. 9 shows the standby mode of the treatment device 1, wherein the swivel arms 53, 64 are in the rest position, i.e. are pivoted upwards at the instrument head 51 space-savingly "parked", and wherein the patient is for example correspondingly positioned on the patient bed 10 and can be positioned.

[0094] In contrast, in Figure 9b the laser treatment mode, i.e. the treatment mode, the laser swivel arm 53 has been introduced into the working position. In contrast, the examination swivel arm 64 is still in the rest position.

[0095] Finally, Figure 9cAn examination mode of an embodiment of the treatment device 1 using the surgical microscope 65 is shown. Here, the examination swivel arm 64 is introduced into the working position, while the laser swivel arm 53 and its swivel arm housing 56 are in the rest position.

[0096] Details are now further described below.

[0097] An embodiment of the treatment device 1 consists of an instrument base 52 and an instrument head 51 on the instrument base 52 at a height above the floor, i.e. in the z-direction, and adjustable in its position in a plane (consisting of the x- and y-directions). The instrument head 51 comprises a first part of the laser treatment optics required for performing the laser treatment. In the embodiment, the instrument head 51 also comprises a laser source required for generating the corresponding pulsed laser radiation, here a femtosecond laser source.

[0098] A second part of the laser treatment optics is rotatably mounted in the laser swivel arm 3 about a horizontal first axis 54. The laser swivel arm 53 can be pivoted about this first axis 54 from a substantially vertically upwardly projecting rest position back to a working position arranged approximately horizontally at the instrument head 51, i.e. approximately parallel to the floor.

[0099] The laser swivel arm 53 with the second laser treatment optics and the laser outlet 58 is surrounded by a housing, the swivel arm housing 56, such that the swivel arm housing 56 leaves an opening for the laser outlet 58. The swivel arm housing 56 is coaxially mounted with the laser swivel arm 53, respectively.

[0100] The swivel arm housing 56 is first pivoted together with the laser swivel arm 53 approximately 90° between an approximately vertical rest position or standby position and a horizontal working position. This movement is limited by a detent.

[0101] The laser swivel arm 53 can be moved through an angle which is overall greater than the swivel arm housing 56. Thus, the laser outlet 58 can be positioned more or less protruding out of the swivel arm housing 56 or can also be completely recessed into the swivel arm housing 56 for coupling the laser swivel arm 53 with a patient interface and a contact lens for the eye of the patient to be treated which can be detachably fixed at the laser outlet.

[0102] In the rest position of the laser swivel arm 53 and when the laser swivel arm 53 and its swivel arm housing 56 are pivoted from the rest position to the working position and from the working position to the rest position, the laser outlet 58 is recessed into the swivel arm housing 56. Thus, the laser swivel arm 53 is in a slightly tilted position compared to its swivel arm housing 56.

[0103] If the pivot arm housing 56 reaches the working position, i.e. in the horizontal, the laser pivot arm 53 is released downwards and slightly continues to pivot, so that the laser pivot arm can also reach an approximately horizontal position and the laser outlet 58 is exposed from the pivot arm housing 56. Here, the laser pivot arm 53 itself can be easily moved. In the approximately horizontal working position of the pivot arm housing 56 and the laser pivot arm 53, the treatment device is in the laser treatment mode.

[0104] The treatment screen 62 is movably fixed at the pivot arm housing 56. In this case, the treatment screen is at the same time also the screen of the video microscope 63, which shows a view of the eye 2 to be treated from the perspective of the laser outlet 58. The operator uses the video image of the video microscope 63 displayed on the treatment screen 62, for example, for approaching or fixing the contact lens 45 or another patient interface to the eye 2 to be treated and for observing the implementation of the laser incision.

[0105] As further shown in Figures 9a to 9c The camera 59 can be used for the pre-positioning of the instrument head 51, as further shown in

[0106] The graphics of the image of the camera 59 superimposed on the treatment screen 62 and / or on the planning screen 69 of the planning device 16 have already been displayed in the standby mode, i.e. in the rest position of the laser pivot arm 53, the desired position of the laser pivot arm 53 in its subsequent working position pivoted downwards. The operator can pre-position by means of the image of the instrument head 51 so that the laser pivot arm 53, after pivoting downwards to its working position, i.e. in the laser mode, is located in the best position with respect to the coarse positioning for the start of the operation and only needs fine positioning with respect to the structure of the eye 2.

[0107] A joystick 61 for controlling the coupling process to the patient is also arranged to the pivot arm housing 56. The joystick 61, the laser outlet 58 of the laser treatment optics and the video image of the eye are aligned in the working position at a perpendicular line in order to achieve equally ergonomic operation for right- and left-handed people.

[0108] Now, a typical treatment process using the treatment device 1 as described above will be described below, for example, which can be used for a SMILE treatment or for a part of a SMILE treatment:

[0109] The treatment or treatment parameters are first planned at a planning screen 69 of the planning device 16, which in this embodiment is also arranged directly at the treatment device 1. Alternatively, the planning screen 69 can also be spatially separated from the treatment device 1. During planning, the treatment device 1 is preferably in a standby position, i.e. the laser swivel arm 53 and possibly also the examination swivel arm 64 are pivoted vertically upwards in the rest position of the system.

[0110] The patient is positioned on the patient bed 10. This can be convenient due to the upwardly pivoted laser swivel arm 53.

[0111] The operator then positions the height of the instrument head 51 at this instrument head 51 by means of the joystick 60, with which a translational movement of the instrument head 51 on the instrument base 52 can be controlled. In doing so, he follows the image provided by the camera 59, which is visible on the treatment screen 62 and / or on the planning screen 69, including the superimposed marking of the downwardly pivoted laser swivel arm 53. Instead of the joystick, in a further embodiment the positioning can also be effected by input at one of the two screens 62, 69 or via a button at the treatment device 1.

[0112] The operator triggers the laser swivel arm 53 to be pivoted downwardly in and with the swivel arm housing 56 of the motor; the corresponding button for this purpose is not shown in the figures. By the pre-positioning and the still embedded laser opening 58 of the laser swivel arm, a free space is left between the laser outlet 58 and the patient's eye 2, which is advantageously between 50 mm and 150 mm in size.

[0113] If this has not yet happened with the laser swivel arm 53 in the rest position, the contact lens 45 is now placed at the laser outlet 58. The contact lens is fixedly held at the laser outlet 58 by means of low pressure. In doing so, the fixed holding is opened and closed by means of negative pressure by pressing the contact lens against the laser outlet 58, which in its embedded position is still slightly moved and triggers a switching process. This is advantageous with respect to the hitherto prevailing laser treatment systems: Here, the fixed holding of the contact lens is switched separately. As a result, the contact lens falls off when detached. In the solution described here, the operator always holds the contact lens in his hand during the switching process.

[0114] The operator then moves the laser pivoting arm 53 freely inside the pivoting arm housing 56 by means of a joystick rotation of the joystick 61 at the pivoting arm housing 56 or alternatively by means of a separate button not shown. In other embodiments, the movement can also be triggered automatically by the placed contact lens. The laser outlet 58 with the contact lens is moved here onto the spectacle. The movement path is here approximately 50 mm, a generally reasonable range for this movement path being 30 mm to 100 mm. Thus, a safety distance of approximately 30 mm to the eye is always maintained, or a generally reasonable range takes values between 10 mm and 100 mm.

[0115] Finally, a docking phase is carried out, in which the contact lens 45 is fixed: the operator controls the contact lens 45 onto the patient's eye 2 using the joystick 61 with observation by means of the video microscope 63. When the correct position has been reached, the eye is sucked to the contact lens 45 using a button at the joystick 61 to fix the eye. In one design, the correct positioning or centering of the contact lens or another patient interface on the eye can be supported by processing the video microscope images and taking into account for controlling the instrument head 51.

[0116] Thus, the actual laser treatment step can now finally be started by opening the laser radiation by means of a foot switch not shown here, the laser radiation being guided and focused in the patient's eye 2 by the laser treatment optics and the laser opening 58.

[0117] After the end of this laser treatment step, the suction of the eye 45 is released by means of a low pressure increase here, the laser pivoting arm 53 and thus also the laser outlet 58 are pivoted again into the pivoting arm housing 56, and the instrument head 51 is moved slightly upwards by a movement in the z direction. Thus, a safety distance to the eye exists again. If necessary, it is now possible to start the re-docking from this position.

[0118] However, this is usually not necessary. The contact lens 45 or the patient interface can be removed from the laser opening 58, wherein the release is achieved by a temporary pressing upwards.

[0119] The laser pivoting arm 53 now pivots upwards again with its pivoting arm housing 56, the free space above the patient is restored. Further work steps can now be carried out, or the patient can leave his position on the bed 10. The upward pivoting of the laser pivoting arm 53 and its pivoting arm housing 6 is electronic, here initiated by pressing a button. Alternatively, the laser pivoting arm 53 and its pivoting arm housing 56 can be pushed manually, a position sensor at the pivoting arm housing detects this, whereupon the motor takes over the movement.

[0120] If, however, both eyes of the patient are to be treated, the instrument head 51 is thus able to be moved on the instrument base 52 by translational movement in the x and / or y direction before the laser swivel arm 53 and its swivel arm housing 56 are swiveled upward into their rest position, so that the laser swivel arm 53 and its swivel arm housing 56 are positioned above the other eye. The second eye can then be treated in the same way by fixing the new contact lens 45 or patient interface at the laser outlet 58 and by means of low-pressure holding, and all the following steps are carried out as described above.

[0121] In this embodiment, the examination swivel arm 64 according to the treatment device 1 is also pivotably fixed at the instrument head 51 about a second axis 66, the treatment device comprising an examination device (in this case a surgical microscope 65). Such a surgical microscope is required or at least recommended for use, for example, for the second main working step of the SMILE treatment. In this embodiment, the surgical microscope 65 comprises, in addition to the necessary illumination, a camera for video recording and a slit projector for expanded viewing possibilities.

[0122] The pivot axis of the examination swivel arm 64, i.e. the second axis 66, is positioned in space in a particularly advantageous position. This allows the surgical microscope 65 at the examination swivel arm 64 to be brought into its working position from its rest position with only one swivel movement, in which the examination swivel arm 64 is likewise swiveled upward (in the same vertical position or in a tilted position).

[0123] This working position is also defined by limiting the rotational movement of the examination swivel arm 64 by means of a stop. Here, the working position has the particular property of coinciding with the working position of the laser swivel arm 53 with its second laser treatment optics and its laser outlet 58 and thus avoids a change in the position of the patient during the treatment.

[0124] If such an examination swivel arm 64 with a surgical microscope 65 is present, a complete SMILE treatment can be carried out with the treatment device 1. To this end, after the actual laser treatment step of the laser swivel arm 53 and its swivel arm housing 56 is ended as described here, a swivel upward into their rest position, the following continues:

[0125] The operator initiates the downward swivel of the examination swivel arm 64 in a motor-driven manner by pressing a button. The motor moves the examination swivel arm 64 into its working position, which rests on a stop. The working position is determined by the advantageous selection of the positions of the two pivot axes, i.e. the first axis and the second axis 66, and by the end position of the examination swivel arm 64 determined by the stop, so that the eye to be treated further is directly in the examination volume of the surgical microscope 65 after the downward swivel of the examination swivel arm 64.

[0126] As often as necessary, minor corrections can be achieved by means of a translatory movement by adjusting the position of the instrument head 51 relative to the instrument base 52. For this purpose, a joystick 60 present at the instrument base 52, a separate foot control console or a joystick present at the surgical microscope 65 is used.

[0127] If the examination swivel arm 64 is positioned accordingly to the surgical microscope 65, the micro-lens extraction is performed by the operator.

[0128] After the end of the micro-lens extraction, the examination swivel arm 64 with the surgical microscope 65 is swiveled upward in a motor-driven manner and thus back to its rest position. This can be initiated by means of a push button or, as described above, by pushing for the swivel arm housing 56 and the laser swivel arm 53. The free space above the patient is thus restored.

[0129] In this embodiment, a planning screen according to Figure 7 can be displayed on the screen 69 of the planning device 16, a treatment screen according to Figure 8 can be displayed selectively or jointly on the planning screen 69, the treatment screen 62 or be introduced into or superimposed on the image of the video microscope 63.

[0130] With this solution, the operator (doctor) can directly check the desired rotation of the cutting pattern before the solution of the treatment and, if necessary, intervene correctively when the set rotation does not correspond to the doctor's idea. In determining the planned rotation, the doctor can also take several anatomical features (e.g. iris and retina) into account.

[0131] The display of the video microscope and the treatment screen according to Figure 8 can also be realized by means of a head-up display.

[0132] When the rotation is input, the coordinate system used on the diagnostic instrument is preferably used, which is usually transformed into the coordinate system of the treatment device in the subsequent calculation of the cutting geometry.

[0133] Advantageously, the preferred rotation can be suggested from the diagnostic data by means of an algorithm, wherein the doctor can also choose among different algorithms. In an expansion, it can also be proposed that the doctor can correct the algorithm in order to match his requirements or experience. If such an algorithm takes into account treatment data of earlier treatments, this algorithm is also within the scope of the invention.

[0134] It is further noted that the treatment device 1 or the planning device 16 of course also implements the execution of the above generally described methods.

[0135] A further embodiment of the planning device is in the form of a computer program or a corresponding data carrier with a computer program, which, on a corresponding computer, implements the planning device, so that the input of the measurement data takes place at the computer via suitable data transmission means and the control data of the computer are transmitted to the control instrument 11, for which data transmission means known to the person skilled in the art can be considered.

[0136] While the application has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative or exemplary and not restrictive; it being understood that changes and modifications can be made by those skilled in the art, within the scope of the application. The application includes other embodiments not expressly described but within the scope of the application.

Claims

1. A planning device (16) for generating control data for a therapeutic apparatus (1) for eye surgery, which therapeutic apparatus generates at least one cutting surface (22, 23) of a cornea (17) by means of a laser device (4), wherein, The planning device (16) has a calculation mechanism for determining a corneal cut surface (22, 23) on the basis of diagnostic images recorded before the cornea comes into contact with the contact lens of the treatment device, wherein the calculation mechanism determines the corneal cut surface (22, 23) and generates a control data set for the laser device (4) for actuating the laser device (4), characterized in that the calculation mechanism determines the corneal cut surface (22, 23) such that the cut surface (22, 23) can be rotated about an axis (36) which extends substantially parallel to the eye axis.

2. The planning device according to claim 1, characterized in that An input mechanism is provided for a preset rotation of the cut surface.

3. The planning device according to claim 1, characterized in that The rotation is determined in relation to an anatomical feature of the eye.

4. The planning device according to claim 3, characterized in that The rotation is determined in relation to the iris or the retina.

5. A treatment device for ophthalmic surgery, having: - a laser device which produces at least one cut surface in the cornea by means of laser radiation in accordance with control data, and - a planning device for generating control data according to claim 1.

6. The therapeutic device of claim 5, wherein, The treatment device is designed such that the rotation of the cut surface can be changed before the treatment begins.

7. A method for generating control data for a therapeutic device for eye surgery, which therapeutic device produces at least one cutting plane in the cornea by means of a laser device, wherein The method is characterized by the steps of providing corneal data, determining a corneal cut surface on the basis of diagnostic images recorded before the cornea comes into contact with the contact lens of the treatment device, and generating a control data set for the laser device for actuating the laser device, wherein the corneal cut surface is determined such that the cut surface can be rotated about an axis which extends substantially parallel to the eye axis.

8. The method of claim 7, wherein, The corneal data are provided on the basis of data for a refractive correction.

9. The method of claim 7, wherein, The rotation of the cut surface can be changed.

10. A user interface which is designed such that it is provided with diagnostic images recorded before the cornea comes into contact with the contact lens of the treatment device and the rotation of the cut surface can be changed at the time of planning or before the treatment begins.

11. A computer program product having program code which, when executed on a computer, carries out the method according to any one of claims 7 to 9 or provides the user interface according to claim 10.

12. A data carrier having the computer program product according to claim 11.

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