DE102022116734A1 - Devices and methods for providing a solid body of a cornea for implantation of the solid body into an eye of a patient - Google Patents

Abstract

The invention relates to a treatment device (10) and a method for providing a solid body (18) for implantation into an eye of a predetermined patient. The method includes determining (S1) refractive error data of the patient's eye; determining (S2) a target condition of the solid body (18) based on the refractive error data; selecting (S3) a planned donor solid body (18) from a plurality of predetermined donor data according to a predetermined selection criterion, the selection criterion evaluating the respective nature of the donor solid body to the target condition and the donor solid body (18) is selected with the best rated quality; providing (S4) the selected and extracted donor solid (18) as a solid (18); checking (S5) whether an actual condition of the solid body (18) provided differs from the target condition; modifying (S6) the solid body (18) provided if the actual condition differs from the target condition; and providing (S7) the solid body (18) with the desired properties for implantation into the cornea of the predetermined patient.

Description

The invention relates to a method for providing a solid body of a cornea, which can also be referred to as a lenticule, for an eye treatment, in particular an implantation into an eye of a predetermined human or animal patient. In other words, the invention relates to a method for providing a solid body or lenticule for implantation thereof into an eye of the predetermined human or animal patient. The invention also relates to a control device that is designed to carry out the method, a treatment device with such a control device and at least one ophthalmological laser, a computer program and a computer-readable medium.

A solid body or lenticule is understood to mean a portion of the cornea of the eye, for example a tissue disk. The interfaces of the lenticule or solid body can, for example, form a biconvex, biconcave, plano-convex or plano-concave solid body. The lenticule or solid can optionally be lens-shaped or bean-shaped. The lenticule or solid body can be shaped symmetrically or asymmetrically.

Lenticule extraction to change corneal refraction is a common method in ophthalmology. There are various concepts dedicated to the implantation of corneal inlays or onlays.

The DE 10 2013 218 415 A1 describes a planning device for generating control data for a treatment device. The US 10,251,785 B2 describes a planning unit that generates control data for an eye surgery treatment device that creates at least one cutting surface in a cornea of the eye using a laser unit.

During lenticule extraction, small and very large refraction adjustments are usually difficult. So-called “higher-order aberrations” (“HOAs”), such as spherical aberration, coma and trefoil, as well as presbyopia (presbyopia), such as multifocal presbyopia, are extremely difficult.

In the prior art, for example, to increase the corneal volume, a pocket is cut into the cornea and a synthetic lenticule or a donor lenticule is implanted. When using donor lenticules, the use of which is subject to high restrictions, small refractive adjustments are difficult, and here too, treatment of aberrations and presbyopia are extremely difficult to treat.

From, for example, the US 2019/038399 A1 , US 2019/175333 A1 , US 2020/046559 A1 and WO 2019/084557 A1 Methods are known that rely on donor corneas to form and extract tissue. Modifications of inlays and onlays using LIRIC are, for example, from the US 2009/143858 A1 known. Here, too, one relies on donor lenticules and synthetic polymers, and here too large refraction adjustments are difficult.

From the DE 10 2016 208 012 A1 a planning device for generating control data for a treatment device is known. The planning device has calculation means for determining the corneal cut surfaces, the calculation means determining the corneal cuts in such a way that a lenticule is isolated from the cut surfaces, which, after being removed from the cornea, is treated in accordance with an intended refraction correction, so that after insertion into the Receiver cornea adjusts the intended refraction correction.

One object underlying the invention is to improve the provision of a volume body for implantation into the cornea.

The invention is based on the idea of providing a solid body, i.e. a lenticule, from a donor cornea, the nature of which, in particular shape and/or structure, is already as suitable as possible for correcting ametropia and can, if necessary, be modified before implantation. In order to obtain solid bodies from donors with suitable characteristics, a database can be provided, for example, in which the most important parameters are stored, and a corresponding donor solid body can then be determined from this database. The modifications of the lenticule include a change in shape and a change in the structural structure of the lenticule, i.e. a change in its shape and the structural change in the collagen tissue. By combining these modifications before implantation, refractive errors including hyperopia, myopia, presbyopia (for example due to multifocal properties), “higher-order aberrations” (“HOAs”), or more complex ones can be corrected very precisely outside the body. This combination, for example a combination of shape adjustment and LIRIC, can significantly increase effectiveness. Autologous tissue can be used, i.e. a solid body that was extracted from the cornea of the patient to whom the modified lenticule like which is implanted, or donor lenticules, i.e. foreign tissue.

The modifications can take place in different forms. The modifications include, on the one hand, a change in shape, i.e. a rough change in the refraction. In addition, for example, crosslinking can be carried out, whereby a finer change in refraction can be achieved. This means, for example, that high-order aberrations can be corrected much better, for example through multifocal changes. A combination of both modification options offers the advantage of a significantly higher degree of freedom in possible adjustments to the lenticule, and therefore a much more flexible and precise correction, such as the more precise correction of a visual defect. In other words, the combination significantly simplifies and improves the refraction adjustments.

With a refraction-neutral implant, the refractive index is not changed. An example of a correction without changing the refractive index is, for example, the correction of keratoconus as a therapeutic measure.

Another advantage of combining both modification methods is significantly greater flexibility in the design of the lenticule to be (re)implanted, and thus a much higher range of possible corrections. Such a combination means that corrections that were previously very difficult can be carried out much more easily.

The method according to the invention for providing a solid body of a cornea for the treatment of an eye of a human or animal patient comprises the following steps. The method may also be referred to as a method for preparing or providing a solid for an eye treatment, an ophthalmic surgical procedure or for a therapeutic procedure.

Ametropia data of an eye of a given human or animal patient are determined, the ametropia data describing a degree of ametropia of the eye. In particular, ametropia data can be determined for at least one eye-specific parameter, the eye-specific parameters describing an ametropia and/or a geometry of the human or animal eye that causes the ametropia. The refractive error data can, for example, describe ametropia, i.e. a deviation of the refractive power of an eyeball or a cornea from the ideal value, for example short-sightedness, far-sightedness or blindness. The determined ametropia data can, for example, describe a value of a refractive power, i.e. a specification in diopters, or, for example, a deviation of a corneal curvature or shape of the cornea from a normal value or ideal value. The determination of the ametropia data can be done, for example, by retrieving the ametropia data from a data storage or data server, or can be recorded, for example, by a measuring device that takes dimensions of the cornea and / or determines ametropia. The determination of the refractive error data can preferably be carried out by a control device, i.e. a device, a device component or a device group, which is set up to receive and evaluate signals and to provide, for example generate, control data. The control device can be designed, for example, as a tax check, computer program, computer program product or control program.

Based on the determined refractive error data, a target condition of the solid body is determined, with the determined target condition meeting a predetermined refractive error reduction criterion. The ametropia reduction criterion specifies suitability for reducing the degree of ametropia described by the ascertained ametropia data, and/or suitability for correcting the astigmatism or shape of the cornea. The target condition can indicate a planned condition of the solid body for correcting the ametropia, in particular a geometry and/or a structure. Preferably, an actual condition, which can indicate an actual geometry and/or structure of the solid, can be compared with the planned target condition when the solid is later provided in order to determine whether modifications to the solid are required.

Determining the target condition can also optionally be carried out by the control device. To determine the target condition, for example, a lenticule geometry can be determined, which can describe the dimensions of a lenticule and/or its position in the cornea and/or its structural tissue properties. In other words, the determined target condition can describe a desired shape and/or its position of the lenticule in the cornea and/or the desired collagen property.

The actual condition and the target condition can be referred to as the actual property and the target property. For example, the actual condition and the target condition can be one Actual geometry and a target geometry of the cornea, i.e. a current geometry and a desired geometry.

The specified ametropia reduction criterion is, in other words, the requirement that the identified ametropia, astigmatism and/or corneal shape be reduced or even completely eliminated by the target condition. Optionally, the specified ametropia reduction criterion can, for example, specify a minimum value of such a reduction, or a minimum probability with which, for example, the ametropia is reduced. The ametropia reduction criterion can be stored, for example, in a memory of the control device. Optionally, the ametropia reduction criterion can also simply be reduced to correcting an incorrect shape of the cornea without changing the refractive index.

As a further method step, a planned donor solid body is selected from a plurality of predetermined donor data according to a predetermined selection criterion, the donor data comprising a condition of the planned donor solid body, which is predetermined from ametropia data of donor corneas, the respective one being determined by the selection criterion The condition of the donor solid body is evaluated to the target condition and the donor solid body with the best-rated condition is selected. In other words, donor data may be available in which the nature of planned solid bodies of other patients is known from determined refractive error data, these solid bodies being referred to below as donor solid bodies. The donor data can, for example, be provided in the form of a database, with the suitability of the donor solid bodies for implantation being checked using a predetermined selection criterion.

The selection criterion can be, for example, a rule or an algorithm by means of which the donor data, in particular the planned donor solids, can be checked for the existence of one or more conditions. Preferably, the selection criterion is used to evaluate a similarity to the target properties of the solid body that is planned as an implant. In particular, the selection criterion can be used to select a donor solid that fits the patient's indication. From all donor data, those donor solid bodies that, for example, have the same and/or similar shape and/or structure can be rated higher than donor solid bodies whose parameters deviate from the target properties. For example, a ranking can be created as to which planned treatments and thus the expected donor solids best match the target properties of the solid to be implanted. Preferably, the donor solid body can then be determined whose properties best match the target properties. This selected donor solid can then be prepared for implantation in a next step. Preferably, the selection criterion can also take into account the local proximity of the donor to the recipient, with those donor solids that are closer to the recipient or patient preferably being given a higher rating. Particularly preferably, by selecting the planned donor solid body with the best-rated quality, the target quality can already be achieved, whereby the donor solid body can be implanted directly into the patient's cornea without post-processing. This has the advantage that fewer post-processing steps are necessary, which means that the solid body can be implanted more quickly and more cost-effectively.

The selected donor solid body extracted from the donor cornea is provided as a solid body. This means that the donor solid body is removed from the human or animal patient who was selected as a donor, which brings about a correction of the donor's ametropia, at the same time making the donor solid body available for insertion into the eye, in particular the cornea. of the patient to be implanted. Providing the solid body may, for example, include extracting the lenticule from the cornea per se, and/or - ex vivo - only providing the solid body, or providing or setting control data for controlling an eye laser to extract the solid body.

Furthermore, the method includes checking whether an actual condition of the solid provided differs from the target condition. This means that the provided solid body or the donor solid body can be examined to see whether an actual condition that it actually has corresponds to the planned target condition or not. This can be carried out, for example, by measuring, in particular optical measuring. The actual condition therefore represents the actual condition of the solid body provided. If the actual condition is equal to the target condition, the solid body can be used directly for implantation the cornea is provided. This process step can be used to check again whether the donor solid body provided needs to be modified again ex vivo or not.

The method further includes modifying the provided solid by changing the actual condition to the determined target condition if the actual condition differs from the target condition. The modification occurs, in other words, ex vivo. Changing the actual condition includes changing a shape of the solid body, as well as changing a structural property of the solid body, i.e. changing the fabric structure. Changing the actual condition may include, for example, modifying a shape of the lenticule as a therapeutic modification, as well as modifying the refraction by adjusting the shape and/or, for example, by LIRIC. This step is preferably only carried out as needed, for example if a deviation from the planned condition of the donor solid body to an actual condition is determined or if no donor solid body that matches the target condition can be found when selecting the donor solid body from the donor data . Particularly preferably, the actual condition of the donor solid body provided is already suitable through suitable selection from the donor data, which means that no further modification of the solid body provided needs to be carried out.

Optionally, one or more of these modification steps can be carried out by the optional control device. The optional control device can, for example, provide control data which, for example, controls a laser of an eye surgical treatment device to cut the extracted donor solid body ex vivo into the desired shape. The modification can then preferably also include transmitting the generated control data to the treatment device and/or the laser.

The method further includes providing the solid body with the desired properties for implantation of the solid body into the cornea of the predetermined patient. The solid body can then preferably be inserted, for example, into a pocket lasered into the cornea.

This results in the advantages mentioned above.

The invention also includes embodiments that result in additional advantages.

One embodiment provides that the condition of the donor solid body has a respective donor geometry, with the condition of the donor solid body that has the most similar donor geometry to a target geometry of the target condition being rated higher than donor Solid bodies whose donor geometry deviates from the target geometry. In other words, when selecting the planned donor solid from the plurality of predetermined donor data, the donor geometry can be compared with the target geometry. The target geometry is the shape that the solid body to be implanted should have in order to reduce or eliminate the ametropia. In particular, the deviation can be checked according to a geometry criterion, wherein the geometry criterion can include, for example, whether the donor solid bodies have a geometry that allows processing or modification to the target geometry. For example, solid bodies that are too small can be excluded as donor solid bodies because they do not have the target geometry from the start and cannot be edited to achieve this even through modification. On the other hand, donor solids that are larger than the target geometry can be modified, which means they can be rated with a higher value. Preferably, those donor solid bodies can be rated highest whose donor geometry is the same as the target geometry of the target quality. A suitable evaluation of the donor solid bodies can thus be obtained with a geometry that does not need to be adjusted or only needs to be adjusted minimally.

A further embodiment provides that the nature of the donor solid body has a respective structural property of the tissue, with the condition of the donor solid body which has the most similar structural property of the tissue to that of the target condition being rated higher than donor material. Solid bodies whose structural properties of the fabric deviate from the target properties. The structural property of the tissue can, for example, comprise a composition of a collagen tissue, wherein the structural property of the tissue of the donor solid body can preferably be compared according to a structural criterion with the structural property of the tissue of the target condition. The structure criterion can be used, for example, to determine a percentage of the tissue of the donor solid body that is equal to the target condition. The more the donor solid body has the same tissue content, the higher the respective donor solid body can be rated. Thus can be achieved that a required target condition can already be determined through suitable selection of the donor solid.

A further embodiment provides that control data for controlling an ophthalmological laser is provided for the selected donor solid body, through which an adjustment of the condition of the donor solid body to the target condition is carried out during the extraction of the donor solid body from the donor cornea becomes. In other words, control data can be provided which, during the extraction of the donor solid body, modify the solid body still within the donor cornea in such a way that it is adapted to the target condition. For example, a planned donor solid that is too large can be cut into suitable smaller parts, a so-called lenticule within a lenticule. The control data can preferably be provided by a treatment device or a control device that causes an ophthalmological laser to deliver laser pulses into the donor cornea in order to modify the donor solid body. This means that the modification can be carried out using an eye laser device which has a laser device which is designed to emit laser pulses in a wavelength range between 150 nm and 1400 nm, preferably between 700 nm and 1200 nm, with a respective pulse duration between 1 fs and 50 ns, in particular between 10 fs and 10 ps, and a repetition frequency greater than 10 kHz, preferably between 100 kHz and 100 MHz. This embodiment has the advantage that the donor solid body can be adjusted within the donor cornea while it is surrounded and/or held by corneal tissue. A modification can therefore be carried out even more precisely.

A further advantageous embodiment provides that the condition of the donor solid body that has been cut in the donor cornea but has not yet been extracted is measured, with control data for an ophthalmological laser for adjusting the condition of the donor solid body before its extraction depending on the measurement be generated. The control data generated in this way can then preferably be provided to a treatment device comprising an ophthalmological laser, wherein a control device of the treatment device can control the ophthalmological laser to change the nature of the donor solid body located in the donor cornea to the desired condition. The measurement can include, for example, optical coherence tomography (OCT), a confocal measurement and/or a wavefront measurement, which can determine optical properties of the donor solid in the donor cornea. This makes it possible to ensure that the donor solid body to be extracted has a condition that matches the target condition as closely as possible.

A further advantageous embodiment provides that the cornea is measured after the implantation of the solid body, with control data for an ophthalmological laser for adapting the cornea and / or the implanted solid body to fulfill the specified ametropia criterion being generated depending on the measurement. The control data generated in this way can then preferably be provided to a treatment device, in particular a control direction of the treatment device, which comprises an ophthalmological laser, so that the treatment device controls the laser in such a way that the cornea and/or the implanted solid body are changed according to the control data. By means of this embodiment, a subsequent correction of the cornea and/or the solid body can be carried out after implantation into the cornea, which results in a further improvement of the treatment.

Preferably, the actual condition of the solid body provided can relate to an actual geometry and/or a structural property of the tissue of the solid body provided, wherein modifying the solid body provided involves changing the actual geometry to a target geometry of the solid body provided and/or a Changing the structural property of the tissue includes. The determined shape with the target geometry can then fulfill the specified ametropia reduction criterion. Changing the actual condition then includes changing the shape of the extracted solid. The modification is then a change in shape. By changing the shape, a larger change in refraction can be achieved.

In a further development, the method can include determining boundary surfaces of the solid body that define the target geometry. Optionally, defining the interfaces can be carried out by the optional control device.

Ideally, changing shape can be done through an ablative or photodisruptive method, particularly laser in situ keratomileusis (LASIK). Excimer laser-based applications are particularly suitable for achieving the desired effect by changing shape. Alternatively, the chosen ablative method can also include (Trans-)PRK (photorefractive keratectomy) or, for example, a laser assisted sub-epithelial keratotectomy (LASEK). Optionally, a combination of the methods mentioned can be used to change the shape. In other words, excimer laser-based applications are preferred for shape modification.

Alternatively or additionally, modifying the volume body provided can include changing the structure or structural property of the tissue, for example changing the structural structure of the collagen. In other words, the structural structure of the tissue is changed. The tissue may preferably be the collagen tissue. The use of a laser-induced refractive index change (LIRIC) and/or a cross-linking method have proven to be particularly advantageous. If the modification only involves changing the structural properties of the tissue - i.e. without changing the shape - one can also speak of a refraction-neutral re-implantation.

In a further advantageous embodiment of the method according to the invention, the modification can be carried out using a treatment device designed as an eye laser device. The eye laser device has a laser device that includes a laser. The laser device is designed to emit laser pulses in a wavelength range between 150 nanometers (nm) and 1,400 nanometers, preferably between 700 nanometers and 1,200 nanometers; at a respective pulse duration between one femtosecond (fs) and 50 nanoseconds (ns), preferably between 10 femtoseconds and 10 picoseconds (ps); and a repetition frequency greater than 10 kilohertz (KHz), preferably between 100 kilohertz and 100 megahertz (MHz). Optionally, the control device can provide control data for controlling the eye laser device, which causes the laser device to emit the laser pulses. The modification can preferably be carried out using laser pulses in a wavelength range between 150 nanometers (nm) and 1,400 nanometers with a respective pulse duration between one femtosecond (fs) and 50 nanoseconds (ns). Excimer laser-based applications, such as LASIK, are also shown in the range from 150 nanometers to 1400 nanometers.

A laser device is understood to mean a device for controlling a photoablative ophthalmological laser. For this purpose, for example, a shortened laser and a beam focusing device can be designed such that the laser beam pulses cause photodisruption in a focus located within the organic material. Femtosecond systems are used in corneal surgery, for example to perform deep anterior lamilar keratoplastic (“DALK”) and/or penetrating keratoplasty (PKP). Such laser devices can also be used for laser in situ keratomileusis (LASIK), i.e. a short-incision lenticle extraction (“small incision lentical extraction, SMILE”), i.e. a method of refractory surgery in which a corneal lenticule is replaced by a peripheral one cut is removed.

A femtosecond laser is particularly suitable for producing solid bodies within the cornea. The use of photodisruptive lasers in the method according to the invention also has the advantage that the cornea does not have to be irradiated in a wave range below 300 nanometers. In laser technology, this area is subsumed under the term “deep ultraviolet”. This advantageously prevents these very short-wave and high-energy rays from causing unintentional damage to the cornea. Photodisruptive lasers of the type used here usually introduce pulsed laser radiation with a pulse duration between one femtosecond and one nanosecond into the corneal tissue. As a result, the power density of the respective laser pulse required for the optical breakthrough can be spatially limited, so that a high level of cutting precision is possible when producing the interfaces. A laser device is understood to mean that component of the laser device that emits the focused light, i.e. the laser.

In a further development of the aforementioned embodiment, the laser device can be designed to emit laser pulses in a wavelength range between 300 nanometers and 1400 nanometers, preferably between 700 nanometers and 1200 nanometers.

In a further preferred development, the laser device is designed to emit laser pulses with a respective pulse duration between one femtosecond and one nanosecond, in particular between ten femtoseconds and ten picoseconds.

Ideally, modifying the solid may include both changing the shape of the provided solid with an actual geometry and changing the structure of the fabric of the provided solid. With such a combination of modifications before re-implantation of the extracted solid body, refractive errors including hyperopia, myopia, presbyopia (for example). play through multifocal properties), high-order aberrations or more complex pathologies can be corrected very precisely. A further advantage of combining both methods for modification is significantly greater flexibility in the design of the lenticule to be reimplanted, and thus a much higher range of possible corrections. Such a combination means that corrections that were previously very difficult can be carried out much more easily.

The method according to the invention can preferably include re-implanting the modified volume body into the cornea of the predetermined human or animal patient, for example into the pocket of the lenticule created during the extraction, or at another location on the cornea or the cornea of the other eye. The advantages already mentioned arise.

In a preferred embodiment of the method, the predetermined donor data can include the refractive error data of the predetermined patient. In other words, a solid body that is removed from the predetermined patient at one point of the cornea and reinserted at another, i.e. the patient's own tissue, can also be taken into account as a donor solid body. This means that the volume body provided, which can be modified ex vivo for implantation, can come from the cornea of the patient into whom the volume body is then to be implanted. The solid body and thus the implant are then your own tissue, i.e. a re-implant. By extracting and then re-implanting your own lenticule, donor tissue can be dispensed with. This eliminates the high requirements for donor lenticules and significantly reduces the risk of rejection of the implanted volume. Alternatively, the solid body provided can be a solid body made from a donor cornea. This eliminates the need to extract the own lenticule. In some applications this can also be useful, for example if additional tissue is to be inserted into the cornea.

According to a further embodiment, the method may include implanting the modified solid into the cornea of the predetermined human or animal patient. The advantages already mentioned arise.

The above object is achieved by a solid body or lenticule for use in an implantation into an eye (or into the cornea of an eye) of a predetermined human or animal patient, the solid body being provided using an embodiment of the method described above. This results in the advantages mentioned above.

A second aspect of the present invention relates to a control device that is designed to carry out the method described above. This results in the advantages listed above. The control device can be designed, for example, as a control chip, control device or user program (“app”). The control device can preferably have a processor device and/or a data memory. A processor device is understood to mean a device or a device component for electronic data processing. The processor device can, for example, have at least one microcontroller and/or at least one microprocessor. A program code for carrying out the method according to the invention can preferably be stored on the optional data memory. The program code can then be designed, when executed by the processor device, to cause the control device to carry out one of the above-described embodiments of the method according to the invention. Furthermore, the control device can have access to a database in which the donor data is provided. These can then be examined for suitability as donor solids according to the selection criteria.

A third aspect of the present invention relates to a treatment device with at least one eye surgical laser for the separation of a lenticule with predefined interfaces from a human or animal eye by means of optical breakthroughs and / or ablation, and at least one control device for the laser or lasers, which is designed to carry out the steps of the method according to the first aspect of the invention.

In a further advantageous embodiment of the treatment device, the laser can be suitable for generating laser pulses in a wavelength range between 300 nm and 1400 nm, preferably between 900 nm and 1200 nm, with a respective pulse duration between 1 fs and 1 ns, preferably between 10 fs and 10 ps, and a repetition frequency greater than 10 kilohertz (KHz), preferably between 100 KHz and 100 megahertz (MHz). The use of such lasers in the method according to the invention also has the advantage that the cornea does not have to be irradiated in a wavelength range below 300 nm. In laser technology, this area is subsumed under the term “deep ultraviolet”. This advantageously prevents these very short-wave and high-energy rays from causing unintentional damage to the cornea occurs. Photodisruptive and/or ablative lasers of the type used here usually introduce pulsed laser radiation with a pulse duration between 1 fs and 1 ns into the corneal tissue. As a result, the power density of the respective laser pulse required for the optical breakthrough can be spatially limited, so that a high cutting precision is possible when producing the interfaces. In particular, the range between 700 nm and 780 nm can be selected as the wavelength range.

In further advantageous embodiments of the treatment device, the control device can have at least one storage device for at least temporarily storing at least one control data set, the control data set or sets comprising control data for positioning and/or focusing individual laser pulses in the cornea/cornea; and can have at least one beam device for beam guidance and/or beam shaping and/or beam deflection and/or beam focusing of a laser beam of the laser.

Further features and their advantages can be found in the descriptions of the first aspect of the invention, with advantageous embodiments of each aspect of the invention being viewed as advantageous embodiments of the other aspect of the invention.

A fourth aspect of the invention relates to a computer program comprising instructions that cause the control device according to the second aspect of the invention to carry out the method steps according to the first aspect of the invention.

A fifth aspect of the invention relates to a computer-readable medium on which the computer program according to the fourth aspect of the invention is stored. Further features and their advantages can be found in the descriptions of the first to fourth aspects of the invention, with advantageous embodiments of each aspect of the invention being viewed as advantageous embodiments of the other aspect of the invention.

• 1 eine schematische Darstellung des Prinzips einer augenchirurgischen Behandlungsvorrichtung;
• 2 eine schematische Darstellung einer Variante der Bereitstellung eines Volumenkörpers, insbesondere einer Erzeugung des Volumenkörpers gemäß einem Ausführungsbeispiel des erfindungsgemäßen Verfahrens; und
• 3 ein schematisches Verfahrensdiagramm gemäß einer beispielhaften Ausführungsform.

Further features of the invention emerge from the claims, the figures and the description of the figures. The features and combinations of features mentioned above in the description, as well as the features and combinations of features mentioned below in the description of the figures and/or shown in the figures alone, can be used not only in the combination specified in each case, but also in other combinations, without departing from the scope of the invention leave. Embodiments that are not explicitly shown and explained in the figures, but which emerge from the explained embodiments and can be generated by separate combinations of features are therefore also to be considered as included and disclosed by the invention. Versions and combinations of features are also to be regarded as disclosed, which therefore do not have all the features of an originally formulated independent claim. In addition, versions and combinations of features, in particular through the statements set out above, are to be regarded as disclosed, which go beyond or deviate from the combinations of features set out in the references to the claims. This shows:

• 1 a schematic representation of the principle of an eye surgical treatment device;
• 2 a schematic representation of a variant of the provision of a solid body, in particular a production of the solid body according to an exemplary embodiment of the method according to the invention; and
• 3 a schematic process diagram according to an exemplary embodiment.

In the figures, identical or functionally identical elements are provided with the same reference numerals.

The 1 shows a schematic representation of a treatment device 10 with a laser device 12, which includes an eye surgical laser, for the separation of a predefined corneal volume (corneal volume) of a cornea 14 of a human or animal eye 16, i.e. a volume body 18, which can also be referred to as a lenticule, with predefined interfaces 20, 22, preferably by means of photodisruption. It can be seen that, in addition to the laser device 12, a control device 24 can be designed for the laser device 12, so that it emits pulsed laser pulses, for example in a predefined pattern, into the cornea 14, the determined boundary surfaces 20, 22 of the solid body 18 to be formed, for example predefined patterns can be created using photodisruption. Alternatively, the control device 24 can be a control device 24 that is external to the treatment device 10.

The control device 24 can also be designed to access a database (not shown) on which donor data from planned treatments, in particular from planned extractions, are stored. The control device 24 can then determine, according to an algorithm or a selection criterion, those donor solid bodies that are best suited for implantation. Preferably the tax institution can After selecting a suitable donor solid body 18, device 24 provides control data which have interfaces 20, 22 of the donor solid body, by means of which the donor solid body can then be removed from the donor cornea.

The determined boundary surfaces 20, 22 form a solid body 18 in the exemplary embodiment shown, the position of the solid body 18 in this exemplary embodiment being chosen such that it can lie within a stroma 26 of the cornea 14, for example. Furthermore is over 1 It can be seen that the so-called Bowman membrane 30 can be formed between the stroma 26 and an epithelium 28.

Such a treatment device 10 can be used, for example, to remove a donor solid or its own lenticule, and to provide the solid 18 before the modification combination; or for cutting a pocket into which the solid body 18 can be inserted, especially after an ex vivo modification. Such a treatment device 10 can also be used for one or more ex-vivo modification steps and/or an adaptation of the solid body already inserted into the pocket of the cornea.

Furthermore, they show 1 and the 2 that the laser beam 32 generated by the laser device 12 is deflected towards a surface 36 of the cornea by means of a beam deflection device 34, such as a rotary scanner. The beam deflection device 34 is also controlled by the control device 24 in order to produce the determined interfaces 20, 22, preferably also incisions or cuts 38.

The laser device 12 shown can preferably be a photodisruptive laser which is designed to emit laser pulses in a wavelength range between 150 nanometers (nm) and 1400 nm, preferably between 700 nm and 1200 nm, with a respective pulse duration between 1 femtosecond (fs ) and 50 nanoseconds (ns), preferably between 10 fs and 10 picoseconds (ps), and a repetition frequency greater than 10 kilohertz (KHz), preferably between 100 KHz and 100 megahertz (MHz). The control device 24 can optionally also have a storage device (not shown) for at least temporarily storing at least one control data set, the control data set or sets comprising control data for positioning and/or focusing individual laser pulses in the cornea 14. The position data and/or focusing data of the individual laser pulses can be generated, for example, within the stroma 26 of the eye 16 based on a previously measured topography and/or pachymetry and/or the morphology of the cornea or the optical vision correction to be generated, preferably based on a determined actual -Geometry of the cornea 14 and preferably based on an analysis of how the solid body 18 should be designed to correct the ametropia.

The 2 shows a schematic representation of the production of the solid body 18 as an example of providing the donor solid body 18 from the donor cornea according to an exemplary embodiment of the present method. It can be seen that the determined boundary surfaces 20, 22 are generated by means of the pulsed laser beam 32, which is directed via the beam deflection device 34 in the direction of the cornea 14 or in the direction of the surface 36 of the cornea 14. The determined boundary surfaces 20, 22 can form a solid body 18. Furthermore, in the exemplary embodiment shown, the laser device 12 can generate further cuts 38 which cut the solid body 18 at a predefined angle and with a predefined geometry and can be formed up to the surface 36 of the cornea 14. The volume body 18 defined by the interfaces 20, 22 can then be extracted from the cornea 14 via the respective cut 38.

To determine ametropia data, which can, for example, indicate a value in diopters or other suitable data for describing the ametropia, the control device 24 can, for example, receive the corresponding data from a data server, or the ametropia data can be determined as data input or already existing data .

Providing the volume body 18 of the predetermined patient extracted from the donor cornea 14 can optionally include extracting the volume body 18 itself, for example controlling the laser device 12 in such a way that it is caused to do so by control data provided by the control device 24 cut out solid 18; and/or making the solid body 18 available for its ex-vivo modification.

After extraction and provision of the donor solid body as a solid body for implantation, a target quality of the solid body 18 that is different from an actual quality of the provided solid body 18 can be determined based on the refractive error data of the patient in whom the solid body 18 is to be implanted. This can be done, for example, by identifying a suitable one The shape and/or property of the desired solid body 18 can be determined, for example, by a database query, or, preferably, by an individual calculation of the target property based on the determined refractive error data. Preferably, this step of determining the target condition can be carried out by the optional control device 24.

Optionally, a three-dimensional, preferably digital model of the cornea 14 and/or the area to be corrected can be provided based on the determined refractive error data and/or the optionally determined actual condition. For example, the target condition of an area to be corrected can be determined using such a model. The target condition should meet the specified ametropia reduction criterion, i.e. the requirement that the identified ametropia is reduced or even completely eliminated by the target condition. Optionally, the ametropia reduction criterion can, for example, specify a minimum value of such a reduction, or a minimum probability with which the ametropia is reduced. The ametropia reduction criterion can, for example, be stored in the memory device.

For example, if there is an ametropia of five diopters, a correction can be provided by, for example, removing a solid body 18 at a depth of six millimeters in the optical zone.

Optionally, the actual condition can also be determined by, for example, measuring the area to be corrected using means known to those skilled in the art from the prior art and using these measurement data as refractive error data to determine the actual condition as the actual geometry. Optionally, the determined ametropia data can already describe an actual geometry. The exemplary actual geometry can be, for example, a thickness of a portion of the cornea 14, and/or a curvature of the cornea 14.

Modifying the provided solid body by changing the actual condition into the determined target condition S4 can be done, for example, by the optional control device 24 providing corresponding control data, which, for example, take into account a determined target shape or target change in shape, for example Control data for performing laser in situ keratomileusis. To modify the structural property of the tissue of the solid body 18, the target condition can be determined as known to those skilled in the art. To change the tissue structure in modification step S5, the control data can be, for example, control data for a laser for a laser-induced refractive index change and/or a cross-linking method. In the exemplary shape change, in addition, for example, boundary surfaces 20, 22 of the solid body 18 can be provided or shaped (S6), which can define the modified final shape of the solid body 18.

In 3 is a schematic process flow diagram for a method for providing a volume body 18 of a cornea 14 for an implantation of the volume body 18 into an eye 16 of a patient. In a step S1, ametropia data of the eye 16 of the patient to be treated are first determined. The determination of the ametropia data can be carried out using known methods, the ametropia data describing a degree of ametropia of the eye 16.

Based on this ametropia data, it can be determined in a subsequent step S2 which target properties the volume body 18, which is to be implanted into the eye 16, in particular the cornea 14 of the eye 16, must have in order to correct the ametropia. This can be carried out using a predetermined ametropia reduction criterion, through which the target condition can be determined. The target condition can, for example, describe a shape or geometry of the solid body and/or a structure, for example a cross-linking or a proportion of cross-linkings of a stroma of the tissue.

Subsequently, in a step S3, a suitable donor can be determined, which can provide a donor solid body whose properties match the target properties as closely as possible. For this purpose, in particular the control device 24 of the treatment device 10 can access a database which includes predetermined donor data with planned eye surgical treatments. Preferably, these treatments can include volume extractions or lenticule extractions from other patients and/or a planned vision correction of the patient into whom the volume body is to be implanted. In other words, the database can include foreign donors and also data for self-lenticule extraction.

The donor data can then be evaluated for their suitability according to a predetermined selection criterion by evaluating the respective properties of the donor solid bodies to the required target properties in accordance with the selection criterion. For this evaluation the Geometry or donor geometry of the respective donor solid body can be compared to a target geometry, so that each donor solid body can be evaluated according to predetermined criteria. For example, donor solids that are too small can be excluded, solids that are too large and can still be adapted to the target geometry using post-processing can be evaluated well, and donor solids whose donor geometry matches the target geometry exactly or only with minimal deviations can be evaluated rated very well. Accordingly, the structural nature of the tissue of the donor solid body can also be evaluated, in particular according to what proportion of the required structural property the donor solid body has compared to the target condition.

This can result in a ranking of possible donor solids, which indicates which donor solid is best suited to be implanted into the patient. Preferably, for example, the proximity of the donor to the patient can also be taken into account. This means that the donor solid body with the best-rated quality can be determined and selected.

In a step S4, the selected donor solid body 18 can be provided as a solid body for implantation into the cornea 14. For this purpose, control data can be provided for one or the treatment device 10, which causes the laser device 12 to extract the donor solid body 18 from the cornea 14 of the donor. Alternatively or additionally, control data for controlling the laser device 12 can be provided for the selected donor solid body 18, which modify the donor solid body 18 during the irradiation with laser radiation in such a way that it receives the desired properties. In other words, the donor solid body 18 can be cut to size during extraction, for example reduced in size, so that the desired condition is produced. Furthermore, one or more measurements for measuring the donor solid body and the condition can be carried out during the extraction in order to use the measurement results to adjust the donor solid body to the target condition during the extraction. For example, optical coherence tomography measurements, confocal measurements and/or wavefront measurements can be used.

After the solid body 18 has been provided, it can be checked in a step S5 whether an actual condition of the provided solid body 18 still differs from the target condition. This step can in particular be carried out ex vivo by determining the actual condition through measurements. Ideally, through the appropriate selection of the donor solid body and/or cutting, the solid body 18 already has the actual quality that matches the desired quality in the donor and can be prepared in a step S7 for implantation into the cornea 14 of the patient. However, if it is determined that the actual condition deviates from the target condition, the provided solid body 18 can be modified in a step S6, in particular by processing the solid body 18 ex vivo. An actual geometry and/or a structural property of the tissue of the solid body 18 can be modified in particular by ablative or photodisruptive methods and/or laser-induced refractive index change (LIRIC) and/or a crosslinking method. In a further example, by changing the shape and, for example, using LIRIC before (re)implanting outside the body, refractive errors including hyperopia, myopia, presbyopia (e.g. multifocal properties), HOAs, or more complex things can be corrected very precisely. By combining shape adjustment and LIRIC, for example, effectiveness can be significantly increased.

The volume body 18 modified in this way can then be prepared for implantation in step S7. Particularly preferably, the volume body 18, which is implanted into the cornea 14, can be additionally measured, in particular by means of optical coherence tomography, confocal microscopy and/or wavefront measurements, whereby additional control data for the laser device 12 can be generated depending on the measurement if the implanted volume body 18 does not meet the ametropia reduction criterion. The control data can then be used to control the treatment device 10 or the laser device 12 in such a way that the reduction in ametropia is achieved.

Overall, the examples show how implantation or re-implantation of a lenticule can be made possible. The implantation or re-implantation of one's own or foreign lenticules can be carried out after a modification of the shape (therapeutically) and/or the refraction by adapting the shape and/or, for example, by LIRIC. However, by previously selecting a suitable donor or donor solid body 18, this ex vivo modification can be reduced to a minimum, which has an advantageous effect on the treatment.

QUOTES INCLUDED IN THE DESCRIPTION

This list of documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

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• US 10251785 B2 [0004]
• US 2019038399 A1 [0007]
• US 2019175333 A1 [0007]
• US 2020046559 A1 [0007]
• WO 2019/084557 A1 [0007]
• US 2009143858 A1 [0007]
• DE 102016208012 A1 [0008]

Claims (12)

Method for providing a solid body (18) of a cornea (14) for implantation of the solid body (18) into an eye of a predetermined human or animal patient, the method comprising the following steps: - determining (S1) ametropia data of the eye of the predetermined human or animal patient, the ametropia data describing a degree of ametropia of the eye; - Determining (S2) a target condition of the solid body (18) based on the determined ametropia data, the target condition meeting a predetermined ametropia reduction criterion, which specifies suitability for reducing the degree of ametropia described by the determined ametropia data; - Selecting (S3) a planned donor solid body (18) from a plurality of predetermined donor data according to a predetermined selection criterion, the donor data comprising a condition of the planned donor solid body, which is predetermined from ametropia data of donor corneas, wherein by the selection criterion the respective condition of the donor solid body is evaluated to the target condition and the donor solid body (18) with the best-rated condition is selected; - Providing (S4) the selected donor solid body (18) extracted from the donor cornea as a solid body (18); - Check (S5) whether an actual condition of the solid body (18) provided differs from the target condition; - Modifying (S6) the provided solid body (18) by changing the actual condition into the determined target condition if the actual condition differs from the target condition; - Providing (S7) the solid body (18) with the desired properties for implantation into the cornea of the predetermined patient. Procedure according to Claim 1 , wherein the nature of the donor solid bodies has a respective donor geometry, whereby the nature of the donor solid bodies which has the most similar donor geometry to a target geometry of the target condition is rated higher than donor solid bodies, their donors -Geometry deviates from the target geometry. Method according to one of the preceding claims, wherein the nature of the donor solids have a respective structural property of the tissue, the condition of the donor solids which has the most similar structural property of the tissue to that of the target condition being rated higher than donors -Solid bodies whose structural properties of the fabric deviate from the target properties. Method according to one of the preceding claims, wherein for the selected donor solid body (18) control data for controlling an ophthalmological laser is provided, through which an adjustment of the condition of the donor solid body (18) to the target condition during the extraction of the donor Volume body (18) is carried out from the donor cornea (14). Method according to one of the preceding claims, wherein the condition of the donor solid body (18) cut in the donor cornea (14) but not yet extracted is measured, with control data for an ophthalmological laser (12) for adjusting the condition of the donor solid body (18) can be generated before its extraction depending on the measurement. Method according to one of the preceding claims, wherein the cornea is measured after the implantation of the volume body (18), with control data for an ophthalmological laser (12) for adapting the cornea and / or the implanted volume body to fulfill the predetermined ametropia reduction criterion depending on the measurement be generated. Method according to one of the preceding claims, wherein the actual condition of the provided solid body (18) relates to an actual geometry and/or a structural property of the tissue of the solid body (18), wherein modifying the provided solid body (18) involves changing the actual -Geometry to a target geometry of the provided solid body (18) and / or a change in the structural property of the tissue. Method according to one of the preceding claims, wherein the predetermined donor data includes the refractive error data of the predetermined patient. Control device (24) which is set up to carry out a method according to one of the preceding claims. Treatment device (10) with at least one ophthalmological laser (12) for separating and/or modifying a volume body (18) a cornea (14) and at least one control device (9). Claim 9 Computer program, comprising commands that cause the treatment device (10) according to Claim 10 a procedure according to one of the Claims 1 until 8th executes. Computer-readable medium on which a computer program according to 11 is stored.

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