DEVICES AND METHOD FOR PREPARING AND CARRYING OUT CORNEAL TATTOOS

Abstract

The planning device for determining control data for a treatment device enables surgical tattooing of the cornea of an eye. Based on the measurement data and functional data introduced, a substantially annular surface is defined, which is located inside the cornea and which is delimited by a circular internal edge with an interior diameter and by a circular external edge with an exterior diameter. The annular surface has a distance and an incline with regard to the surface of the cornea, and for this annular surface, a set of control data for controlling the laser device is generated which defines a pattern of target points in the cornea with perforation zones partially or completely intersecting. Upon application of the pulsed laser beam, the tissue of the cornea is cut, and the external edge of the annular surface has a constant distance relative to the external edge of the iris.

Claims

1. A planning device (P) for determining control data for a treatment device (1) for preparing a surgical tattoo of the cornea (22) of an eye (3) of a patient, the planning device (P) being designed to generate the control data for a treatment device (1) that comprises a laser device (L), which cuts the tissue of the cornea by applying a pulsed laser beam (2), the laser beam (2) being focused on target points (6) arranged in a pattern in the cornea (22), said planning device (P) comprising: an interface (S) for the introduction of measuring data regarding parameters of the eye (3) and functional data regarding the functions to be performed by the tattoo of the cornea (22) of the eye (3), wherein said interface defines, from the introduced measuring data and functional data, a globally annular surface (32) that is located inside the cornea (22) and that is limited by a globally circular interior edge (15) with an interior diameter and a globally circular exterior edge (16) with an exterior diameter, the interior diameter and the exterior diameter being positioned in an identified position and/or on an identified structure of the surface of the cornea (23) and the annular surface (32) having a distance and an incline relative to the surface of the cornea (23), and wherein said interface generates, for this globally annular surface (32), a set of control data for the control of the laser device (L), which defines, in the cornea (22), a pattern of target points (6), which are found in the annular surface (32), and which are arranged such that the annular surface (32) is made, after the application of the pulsed laser beam (2) according to the set of control data, in the form of a cutting surface, wherein the annular surface (32) containing, at each target point (6), a perforation zone (4) in which, during the application of the pulsed laser beam (2), the corneal tissue is cut, wherein the perforation zones (4) of adjacent target points (6) being able to overlap partially or completely; and wherein the exterior edge (16) of the globally annular surface (32) having, in the macroscopic sense, a constant distance relative to the exterior edge of the iris (14).

2. (canceled)

3. The planning device (P) according to claim 1, wherein the annular surface (32) after the application of the pulsed laser beam (2) has a different perforation (6) in different zones of the annular surface (32), which is preferably determined as a function of the desired degree of coloration of the tattoo in different zones of the annular surface.

4. The planning device (P) according to claim 1, wherein the annular surface (32) is designed and the pigmented dye is designed such that, after the application of the pulsed laser beam (2) and after the absorption of the pigmented dye (2) in the annular surface (32), the latter has an absorption greater than or equal to 50%, preferably an absorption greater than or equal to 80%.

5. The planning device (P) according to claim 1, wherein the annular surface (32) comprises a spared zone (17) that is preferably arranged at the exterior edge (16) of the annular surface (32); the spared zone (17) preferably having a surface area greater than 0.2 mm.sup.2.

6-7. (canceled)

8. The planning device (P) according to claim 1, wherein the center of the circular interior edge and the center of the circular exterior edge do not coincide.

9. (canceled)

10. The planning device (P) according to claim 1, wherein said interface defines, from the introduced measurement data and functional data, at least one additional globally annular surface (33), which is located inside the cornea (22), the at least two annular surfaces (32, 33) having different distances relative to the surface of the cornea (23) and the at least two annular surfaces (32, 33) being superimposed and the at least two annular surfaces (32, 33) preferably being centered relative to one another regarding their interior edges (15) or their exterior edges (16), preferably the annular surface (33), which has the smallest distance relative to the surface of the cornea (23), has the smallest gap between the exterior diameter and the interior diameter.

11. The planning device (P) according to claim 1, wherein said interface further defines, from introduced measurement data and functional data, at least one access surface (35), which goes from the surface of the cornea (23) to the annular surface (32), and wherein said interface generates, for this access surface (35), a set of control data for controlling the laser device (L), which defines, in the cornea (22), a pattern of target points (6), which are found in the access surface (35) and which are arranged such that the access surface (35) is made, after the application of the pulsed laser beam (2) according to the set of control data, in the form of an access cutting surface, the target points (6) of the access surface (35) having a radial distance relative to the center of the interior edge (15) that is greater than half of the interior diameter of the annular surface (32).

12. The planning device (P) according to claim 11, wherein the access surface (35) is oriented radially and its radial extension is smaller than the gap between half of the exterior diameter and half of the interior diameter or the access surface (35) being oriented along the exterior edge (16) or parallel to the exterior edge (16).

13-14. (canceled)

15. The planning device (P) according to claim 1, wherein the annular surface (32) is positioned using a recorded image.

16. The planning device (P) according to claim 1, further comprising: a measuring device connected to the interface that generates the measurement data from a measurement of the eye (3) and that introduces them into the planning device (P), the measurement device (M) optionally comprising one or several of the following devices: autorefractometer, refractometer, keratometer, aberrometer, wave front measuring device, optical coherence tomograph (OCT)

17. The planning device (P) according to claim 1, further comprising: a data link or data medium is provided for transmitting the set of control data from the planning device (P) to the laser device (L).

18. The planning device (P) according to claim 1, further comprising: a display device is provided for the visual representation of the control data of the set of control data and an input device for the subsequent modification of the set of control data.

19. The planning device (P) according to claim 1, wherein the planning device (P) takes into account, during the generation of the set of control data containing the pattern of the target points (6), a deformation of the cornea (22) of the eye (3), which occurs during the application of the pulsed laser beam (2), more particularly using an interface with the patient (13), optionally a contact lens or a liquid interface with the patient, such that the defined annular surface (32) finds itself in the nondeformed cornea (22).

20. A treatment device (1) for the surgical tattooing of the cornea (22) of an eye of a patient, comprising: an interface (S) for the introduction of measurement data regarding the parameters of the eye (3) and functional data regarding the functions to be fulfilled by the tattoo of the cornea (22) of the eye (3), a laser device (L) that cuts the tissue of the cornea by applying a pulsed laser beam (2), the laser beam (2) being focused on target points (6) found in a pattern of the cornea (22), and a planning device (P) according to claim 1.

21. The treatment device (1) according to claim 20, further comprising: a laser beam source for producing a pulsed laser beam, more particularly a femtosecond laser source, a lens for the focusing of the pulsed laser beam in the cornea, an x-y scanning system and a z scanning system as well as a control system.

22. A method for preparing and generating control data for a treatment device (1) allowing the surgical tattooing of the cornea (22) of an eye (3) of a patient, which comprises a laser device (L), which cuts the tissue of the cornea by applying a pulsed laser beam (2), the laser beam (L) focusing, during its operation, the laser beam (2) according to the control data on target points (6) found in a pattern in the cornea (22), the method comprising the following steps: determining measurement data regarding the parameters of the eye (3) and functional data regarding the functions to be fulfilled by the tattooing of the eye (3), defining a globally annular surface (32) from measurement data and functional data, wherein the annular surface (32) is located inside the cornea (22) and being limited by a globally circular interior edge (15) with an interior diameter and a globally circular exterior edge (16) with an exterior diameter, wherein the interior diameter and the exterior diameter is positioned at an identified point and/or in line with an identified structure on the surface of the cornea (23), and wherein the annular surface (32) has a distance and an incline relative to the surface of the cornea (23), defining a pattern of target points (6) in the cornea (22), wherein the target points (6) are located in the globally annular surface (32) and being arranged such that the annular surface (32) is made during the application of the laser beam (2) according to the control data in the form of a cutting surface, wherein the annular surface (32) contains, at each target point (6), a perforation zone (4) in which, during the application of the pulsed laser beam (2), the tissue of the cornea is cut, the perforation zones (4) of adjacent target points (6) partially or completely crossing one another, and wherein the exterior edge (16) of the globally annular surface (32) has a constant distance, in the macroscopic sense, relative to the exterior edge (14) of the iris, and generating a set of control data containing the two- or three-dimensional pattern for the control of the laser device (L).

23. The method according to claim 22, wherein the annular surface (32) is further defined or the pattern of target points (6) in the cornea (22) is defined such that at least one of the following statements is relevant: wherein the target points in the annular surface (32) are arranged such that the annular surface (32) is further designed, after the application of the pulsed laser beam (2), for the absorption of an appropriate pigmented dye; wherein the points in the annular surface (32) are arranged such that the annular surface (32) has, after the application of the pulsed laser beam (2), different perforations (4) in different zones of the annular surface (32); wherein the annular surface (32) comprises a spared zone (17), which is preferably arranged on the exterior edge (16) of the annular surface (32); the spared zone (17) preferably having a surface area greater than 0.2 mm.sup.2; wherein the annular surface (32) comprises an interior edge (15) with an interior diameter greater than 4 mm or the annular surface (32) comprises an interior edge (15) with an interior diameter smaller than 3 mm; wherein the center of the circular interior edge (15) and the center of the circular exterior edge (16) do not coincide; wherein the exterior edge (16) and/or the interior edge (15) does or do not have a smooth curve; wherein the annular surface (32) is designed, after the application of the pulsed laser beam (2), for housing an implant; wherein the annular surface (32) is defined in a lenticule (28) in the tissue of the cornea of the eye (3), which is explanted after the application of the pulsed laser beam (2); and wherein the annular surface (32) is positioned using a recorded image.

24. The method according to claim 22, wherein, from the measurement data and functional data, an additional annular surface (33) is defined, which is located inside the cornea (22), the at least two annular surfaces (32, 33) having different distances relative to the surface of the cornea (23), and the at least two annular surfaces (32, 33) overlapping each other and the at least two annular surfaces (32, 33) preferably being centered relative to one another with respect to their interior edges (15) or their exterior edges (16), preferably the annular surface (33), which has the smallest distance relative to the surface of the cornea (23), has the smallest gap between the exterior diameter and the interior diameter.

25. The method according to claim 22, wherein, from the introduced measurement data and functional data, at least one access surface (35) is defined, which goes from the surface of the cornea (23) to the annular surface (32), and, for this access surface (35), a set of control data for controlling the laser device (L) is generated, which defines, in the cornea (22), a pattern of target points (6), which are found in the access surface (35) and which are arranged such that the access surface (35) is made, after the application of the pulsed laser beam (2) according to the set of control data, in the form of an access cutting surface, the target points (6) of the access surface (35) having a radial distance relative to the center of the interior edge (15) that is greater than half of the interior diameter of the annular surface (32); also optionally characterized in that the access surface (35) is oriented radially and its radial extension is smaller than the gap between half of the exterior diameter and half of the interior diameter or the access surface (35) being oriented along the exterior edge (16) or parallel to the exterior edge (16).

26. The method according to claim 22, wherein measurement data are generated from a measurement of the eye (3), the used measurement device (M) optionally being one or several of the following devices: autorefractometer, refractometer, keratometer, aberrometer, wave front measuring device, optical coherence tomograph (OCT), and/or wherein the generated control data are transmitted to the treatment device (1); these optionally being transmitted via a data link or a data medium to the laser device (L).

27. The method according to claim 22, wherein, during the generation of the set of control data containing the pattern of the target points (6), a deformation of the cornea (22) of the eye (3) is taken into account, which occurs during the application of the pulsed laser beam (2), more particularly using an interface with the patient (13), optionally a contact lens or a liquid interface with the patient, such that the defined annular surface (32) is found in the nondeformed cornea (22).

28-29. (canceled)

30. A method for surgical tattooing of the cornea (22) of an eye (3) of a patient, with the following steps: execution of the method for preparing and generating control data for a treatment device (1) allowing the surgical tattooing of the cornea (22) of an eye (3) of a patient, which comprises a laser device (L), which cuts the tissue of the cornea by applying a pulsed laser beam (2), according to claim 22, surgical laser treatment of the cornea (22) of the eye (3) with the treatment device (1) using the generated control data, optional mechanical cutting of the tissue bridges (5) remaining with the laser treatment in the surfaces made during the surgical laser treatment, for example with a surgical tool such as a flap lifter; and injection of at least one pigmented dye into the annular surface (32), for example, using access surfaces (35).

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0098] The present invention is explained using exemplary embodiments.

[0099] FIG. 1 is a schematic view of the treatment device with a planning device.

[0100] FIG. 2 is a schematic view of elements of the treatment device, more specifically the laser device.

[0101] FIG. 3 is a schematic view of a first exemplary embodiment of a corneal tattoo with a spared zone seen from above.

[0102] FIGS. 4a and 4b are schematic views of a second exemplary embodiment of a corneal tattoo with different centering of the edges seen from above and in sectional view.

[0103] FIGS. 5a and 5b are schematic views of a third exemplary embodiment of a corneal tattoo with two annular surfaces superimposed in top view and sectional view.

[0104] FIGS. 6a and 6b are schematic views of a fourth exemplary embodiment of a corneal tattoo in a lenticule in side view and in top view, respectively.

[0105] FIG. 7a is a schematic view of penetration zones partially intersecting in a cutting surface.

[0106] FIG. 7b is a schematic view of penetration zones fully intersecting in a cutting surface.

DETAILED DESCRIPTION OF THE INVENTION

[0107] FIG. 1 schematically shows the treatment device 1. In this variant, it comprises at least two devices or modules. A laser device L emits the laser beam 2 toward the eye 3. The operation of the laser device L takes place completely automatically, that is to say, the laser device L begins, upon a corresponding start signal, to point the laser beam 2 and makes cutting surfaces in the cornea 22, which is structured in a manner that remains to be described. The control data necessary for the operation is received beforehand by the laser device L coming from a planning device P in the form of a set of control data by means of data lines not described in detail. The transmission preferably takes place before the operation of the laser device L. Of course, the communication could also take place wirelessly. In a variant with direct communication, it is also possible for the planning unit to be physically separated from the laser unit L and to provide a corresponding data transmission channel.

[0108] Preferably, the set of control data is transmitted to the treatment device 1 and preferably an operation of the laser device L is blocked until a valid set of control data reaches the laser device L. A valid set of control data can be a set of control data that in principle is suitable for use with the laser device L of the treatment device 1. However, the validity can be associated with the fact that several checks are successful, for example if, in the control data set, additional information is found regarding the treatment device 1, for example a device serial number, or the patient, for example a patient identification number, that matches other information, which is for example read on the treatment device or has been entered separately once the patient is in a correct position for the operation of the laser device L.

[0109] The planning unit generates all of the control data, which is made available to the laser unit L to perform the operation, from measurement data that have been determined for the eye to be treated, as well as functional data for functions to be performed by the tattoo of the cornea of the eye, for example a function to replace the natural iris and the performance of a pupil function. They are introduced into the planning unit using the interface S. In the illustrated example, the measurement data come from a measuring device M, which has previously measured the eye of the patient 4. Of course, the measurement device M can send the corresponding measurement data to the planning unit in any manner whatsoever.

[0110] The transmission can take place using memory chips (for example by USB key or memory stick), magnetic memories (for example, discs), by radio (for example, WLAN, UMTS, Bluetooth) or by cable (for example USB, FireWire, RS232, ADC bus, Ethernet, etc.). The same is of course valid regarding the transmission of data between the planning device P and the laser device L.

[0111] A direct radio or cable link of the measuring device M with the treatment device 1 regarding the data transmission, which can be used in a variant, has the advantage that the use of incorrect measuring data is precluded with the highest possible likelihood.

[0112] FIG. 2 introduces elements of the treatment device 1 only to the extent that they are necessary to understand the adjustment of the focus. The laser beam 2 is focused in a focal spot 7 in the cornea 22, and the position of the focal spot 7 in the cornea 22 is adjusted such that, to produce the cutting surface, energy coming from pulses of laser beams is applied in a focused manner in different locations of the tissue of the cornea 22. The laser beam 2 is provided by a laser 8 in the form of a pulsed beam. The cornea 22 of the eye 3 is fixed using an interface with the patient 13, here more particularly with a contact lens, to the treatment device 1. An x-y scanner 9, which is made, in a variant, using two galvanometric mirrors with globally orthogonal deviations, points the laser beam coming from the laser 8 in a two-dimensional manner, such that a laser beam 10 exists after the x-y scanner 9. The x-y scanner 9 therefore allows an adjustment of the focal spot 7 in a manner globally perpendicular to the main incidence direction of the laser beam 2 in the cornea 22. For the adjustment of the depth position, in addition to the x-y scanner 9, a z scanner 11 is provided, which is for example designed as an adjustable telescope. The z scanner 11 makes it possible to modify the z position of the focal spot 7, that is to say, its position on the optical axis of the incidence. The z scanner 11 can be arranged after or before the x-y scanner 9. The coordinates, called x, y, z hereinafter, refer to the deviation of the position of the focal spot 7.

[0113] For the operating principle of the treatment device 1, the assignment of the different coordinates to the spatial directions is not important, but in order to facilitate the description, hereinafter, z always designates the coordinate along the optical axis of the incidence of the laser beam 2, and x and y designate two coordinates orthogonal to one another in a plane perpendicular to the direction of incidence of the laser beam. One skilled in the art naturally knows that a three-dimensional description of the position of the focal spot 7 in the cornea 22 can also take place using other coordinate systems; more particularly, it may not involve a system of perpendicular coordinates. It is therefore not mandatory for the x-y scanner 9 to operate around axes that are perpendicular to one another, but any scanner that is able to move the focal spot 7 in a plane in which the incidence axis of the optical radiation is not located can be used. Systems of coordinates at oblique angles or on Cartesian systems of coordinates can therefore also be used.

[0114] In order to control the position of the focal spot 7, the x-y scanner 9 as well as the z scanner 11, which together define a concrete example of a three-dimensional focal spot adjusting device, are controlled by a control device 12 by means of lines, which are not described in detail. The same is valid for the laser 8. The control device 12 guarantees an appropriate synchronous operation of the laser 8 as well as the adjusting device of the focal spot, defined for example by the x-y scanner 9 as well as the z scanner 11, such that the position of the focal spot 7 in the cornea 22 is adjusted so that ultimately the annular cutting surface, which can also be curved, and which must later observe the pigmented dyes, is reached by the scanning of predetermined target points and by the application of the pulsed laser beam at these target points.

[0115] The control device 12 operates according to predetermined control data, which determine target points for the adjustment of the focal spot. The control data are generally grouped together in a set of control data. The latter determines, in one embodiment, the coordinates of the target points as pattern, the order of the target points in the set of control data defining the succession of the positions of the focal spot, and therefore ultimately a route. In one embodiment, the set of control data contains the target points in the form of concrete adjusting values for the mechanism for adjusting the position of the focal spot, for example for the x-y scanner 9 and the z scanner 11. In order to prepare the ocular surgery method, therefore before the surgical procedure strictly speaking can be carried out, the target points and preferably also their order in the pattern are defined. Prior planning of the procedure must, however, take place by determining, for the treatment device 1, the control data whose use will make it possible to obtain an optimal tattoo of the cornea for the patient 4.

[0116] FIG. 3 shows a first exemplary embodiment of a corneal tattoo that contains a spared zone 17, which can be used for an iridotomy with the YAG laser, in top view on the eye 3. In this example, the interior edge 15 has a large diameter of 5 mm and comprises a slightly irregular ridge, since the corresponding corneal tattoo 15 is used solely for cosmetic purposes. The exterior edge 16 comprises a highly irregular ridge in order to represent a natural iris with great precision in the details. After the smoothing of these irregular ridges, in the macroscopic direction, the distance between the exterior edge 16 and the exterior edge of the iris is therefore relative to the lim bus 14 is constant. The spared zone has been made in the upper part of the eye 3, which is generally covered by the eyelid, such that the spared zone 17 is difficult for an observer to see.

[0117] FIGS. 4a and 4b show a second exemplary embodiment of a corneal tattoo on a globally annular surface 32 with a different centering of the exterior edge 16 and the interior edge 15 seen in top view and sectional view. The centering 36 of the exterior edge 16 takes place relative to the limbus 14, while the interior edge 15 has been centered relative to the center 37 of the natural photopic pupil 34. In the sectional view, one can further see the position of the surface of the cornea 23, from behind the cornea 24, the epithelium 25, the endothelium 26 and the stroma 27. An access surface 35 extends from the surface of the cornea 23 toward the surface 32 in which a pigmented dye must be injected. This access surface 35 is arranged parallel and in an arc of circle relative to the exterior edge 16 of the annular surface 32.

[0118] FIGS. 5a and 5b show a third exemplary embodiment of a corneal tattoo with two superimposed annular surfaces 32, 33, that is to say, located one on top of the other, arranged at different distances relative to the surface of the cornea 23, seen in top view and in sectional view. The corneal tattoo is therefore made up of a first tattoo on a first annular surface 32 and a second tattoo on a second annular surface 33, the two tattoos being centered relative to one another regarding their exterior edges 16. The second tattoo is closer to the surface of the cornea 23, that is to say, above the first tattoo, seen from the inside of the eye toward the outside, since it is the narrowest, which has, for the same diameter of the exterior edge 16, a diameter of the interior edge 15 that is much larger than that of the first tattoo. Thus, independent access surfaces 35 (not shown here) both from the first annular surface 32 and the second annular surface 33 can also be made, since the two surfaces 32, 33 remain at least partially visible in top view.

[0119] In the exemplary embodiment shown here, the incident light can therefore pass through more than one layer of tattoo to reach the retina. Identical pigments or different pigments can be used for the tattoo. Both tattoos make it possible to obtain a common optical function, for example a stepped or variable optical absorption depending on the spectrum. The tattoo shown here with a circular interior edge 15 of a first tattoo with a very small diameter of 1.5 mm has an absorption of 70%, the second tattoo with a circular interior edge 15 of 2 mm also has an absorption of 70%. The first tattoo is at a depth of 180 m and the second tattoo is at a depth of 140 m below the surface of the cornea 23. The superposition makes it possible to obtain a stepped pupil 34 with a transmission of 100% in the inner part (diameter 1.5 mm), a transmission of 70% between 1.5 mm and 2 mm and a transmission of 9% beyond 2 mm.

[0120] FIGS. 6a and 6b show a fourth exemplary embodiment of a corneal tattoo, which has been done in a lenticule 28 to be explanted, in side view and in top view. This lenticule 28 can then be implanted in the eye 3 of a patient, in which it will simultaneously correct a corresponding vision defect. The lenticule 28 contains a colorless center 30 and is colored 29 annularly in the exterior part, in return for which it has a fine colored structure 31 that has been obtained using a different perforation 6 in different zones of the annular surface 32.

[0121] FIG. 7a shows what must be understood as zones with perforations partially crossing one another in a cutting surface: around target points 6 of the focal spot 7 of the pulsed laser beam, it results, during the application of this laser beam 2, in a perforation zone 4, the extension of which depends inter alia on the frequency of the pulsation and the power of the pulsed laser beam. The edges of the perforation zone cross one another here only partially, and tissue bridges 5 remain between the perforation zones 4.

[0122] FIG. 7b shows perforation zones 4 crossing one another completely in a cutting surface, such that no tissue bridge 5 remains any longer, and after the application of the pulsed laser beam 2, a through cutting surface, with a variable zone separated by photo-disruption, the tissue of the cornea being located between, above and below the perforation zone 4.

[0123] The features of the invention mentioned above and explained in various exemplary embodiments can be used not only in the combinations described as an example, but also in other combinations or alone, without going beyond the scope of the present invention.

[0124] A description of a device related to the features of the method is valid, regarding these features, similarly for the corresponding method, as long as the features of the method represent corresponding functional features of the described device.