Method and assembly for producing an ophthalmological device

Abstract

The invention relates to a method for producing an ophthalmological device (20), having the steps of: providing at least one container (1) which is transparent to electromagnetic radiation (31), and for each of at least two sub-regions (10-x) of the ophthalmological device (20): providing a liquid (2-x), which can be cured using electromagnetic radiation (31), in the at least one container (1); generating and / or providing a data set (33) of images of each sub-region (10-x) of the ophthalmological device (20), said images containing projections of the sub-region (10-x) from different directions; and - tomographically printing the curable liquid (2-x) using electromagnetic radiation (31) on the basis of the generated and / or provided data set (33) in order to produce the sub-region (10-x). The step of providing the curable liquid (2-x) and / or tomographically printing the curable liquid is carried out such that at least two of the at least two sub-regions (10-x) differ in terms of at least one property, wherein at least during the first printing process, a support structure is printed in addition to the sub-region (10x), said support structure holding in place the sub-region (10-x) and / or the ophthalmological device (20) produced until now. The invention additionally relates to an assembly (30) for producing an ophthalmological device (20).

Description

[0001] Method and arrangement for producing an ophthalmological device

[0002] The invention relates to a method and an arrangement for producing an ophthalmological device.

[0003] Ophthalmic devices, such as intraocular lenses, are traditionally manufactured primarily by turning. For this purpose, the starting material is first produced by polymerization. Blanks are then cut from the starting material. For hydrophilic intraocular lenses, the blanks are attached to a lathe using wax; for hydrophobic intraocular lenses, the blanks are frozen, particularly at approximately -20°C. A computer-controlled robot arm equipped with a diamond tip machines the intraocular lens, for example, from the blank rotating in the lathe. However, this is a complex and cost-intensive process. Another disadvantage is that a diamond tip used in turning leaves grooves on the surface of the ophthalmic device, which impair the optical quality of the ophthalmic device.

[0004] DE 102020 108 375 B3 discloses a method for producing an intraocular lens by tomographic printing. The method comprises the steps of: providing a container transparent to electromagnetic radiation, in which a liquid is arranged that can be cured with the electromagnetic radiation; irradiating the liquid with a set of images formed by the electromagnetic radiation, each of which shows an intraocular lens, wherein each of the images of the set is irradiated into the liquid at a different angle of incidence with respect to a reference plane passing through the liquid, whereby the liquid is cured and the cured liquid forms the intraocular lens, wherein an actuator, a solar module and / or a sensor is arranged in the liquid and the intraocular lens is formed around the actuator, the solar module and / or the sensor.

[0005] From WO 2019 / 043529 A1 a method for producing a three-dimensional object is known, comprising calculating a sequence of backprojections describing the three-dimensional object to be formed from different orientation angles of the object, defining a sequence of light patterns using the backprojections and irradiating a photoresponsive material capable of changing its material phase upon irradiation with light with each of the light patterns at the respective corresponding orientation angle and according to the defined sequence, thereby generating a three-dimensional distribution of changes within the photoresponsive medium that physically reproduces the three-dimensional object, thereby generating the three-dimensional object.

[0006] The invention is based on the object of improving a method and an arrangement for producing an ophthalmological device.

[0007] The object is achieved according to the invention by a method having the features of patent claim 1 and an arrangement having the features of patent claim 18. Advantageous embodiments of the invention emerge from the subclaims.

[0008] One of the basic concepts of the invention is to produce an ophthalmic device with at least two subregions, and to arrange for the provision of the curable liquids and / or the tomographic printing to be carried out in such a way that at least two of the at least two subregions differ from one another in at least one property. This allows the optical and / or mechanical and / or functional properties of ophthalmic devices, such as intraocular lenses, to be specifically adjusted. For this purpose, at least one container transparent to electromagnetic radiation is provided.For at least two subregions of the ophthalmic device, a liquid curable by means of electromagnetic radiation is then provided in the at least one container, a data set of images of the respective subregion of the ophthalmic device is generated and / or provided, wherein the images contain projections of this subregion from different directions, and the curable liquid is tomographically printed using electromagnetic radiation based on the generated and / or provided data set to form this subregion. The at least two subregions are produced or tomographically printed in particular sequentially, i.e., one after the other.In particular, a method for producing an ophthalmic device is provided, comprising: providing at least one container transparent to electromagnetic radiation, and for at least two partial regions of the ophthalmic device:.

[0009] - Providing a liquid that can be cured by means of electromagnetic radiation in the at least one container,

[0010] - generating and / or providing a data set of images of the respective sub-area of ​​the ophthalmic device, wherein the images include projections of this sub-area from different directions,

[0011] - tomographic printing of the curable liquid by means of electromagnetic radiation starting from the generated and / or provided data set to form this partial region, wherein the provision of the curable liquids and / or the tomographic printing are carried out in such a way that at least two of the at least two partial regions differ from one another in at least one property.

[0012] Furthermore, in particular, an arrangement for producing an ophthalmic device is provided, comprising at least one container transparent to electromagnetic radiation; a data processing device configured to generate and / or provide data sets from images of partial regions of the ophthalmic device, wherein the images include projections of the respective partial region of the ophthalmic device from different directions;at least one tomographic printing device configured for tomographic printing of a curable liquid provided in the at least one container for the respective sub-region by means of electromagnetic radiation based on the respectively generated and / or provided data set for forming the respective sub-region, and means for providing and / or handling the curable liquids in the at least one container, wherein the arrangement is configured and / or set up to carry out the provision of the curable liquids and / or the tomographic printing in such a way that at least two of the at least two sub-regions differ from one another in at least one property.

[0013] An advantage of the method and arrangement is that by selecting the respective curable liquids and / or by changing parameters during tomographic printing of the respective sub-area, the optical, mechanical, and / or functional properties of an ophthalmic device can be specifically modified and / or adjusted. This allows ophthalmic devices to be individually adapted to a user and their functionality to be expanded.

[0014] The electromagnetic radiation lies in particular in the optical wavelength range, in particular in the visible and / or UV wavelength range. The curable liquid can in particular have the properties described in DE 102020 108 375 B3. In particular, tomographic printing is generally carried out in the manner described in DE 10 2020 108 375 B3. The images of the data set can be calculated for generation and / or provision, for example, from a three-dimensional data set (e.g. CAD data) containing the shape of the ophthalmic device, in particular of the respective subregions. This is in particular a reverse process to that used in tomographic imaging. Tomographic imaging is used, for example, in computed tomography. Tomographic imaging can, for example, make use of a Radon transformation.Tomographic printing makes particular use of this reverse process to locally cure the curable liquid using the calculated images depending on the light patterns contained in the images of the data set.

[0015] The curable liquid comprises, in particular, a solution with a dissolved monomer and a photoinitiator, which can trigger polymerization of the monomer in a radiation-dependent manner. Furthermore, other substances can also be part of the curable liquid, such as fillers, optically excitable dyes or nanoparticles, and / or medicinal agents. In particular, it is intended that the curable liquid has a specified minimum viscosity of at least 100 mPa*s (cps).

[0016] It can be provided that the ophthalmic device is an intraocular lens. The intraocular lens can also be an accommodating intraocular lens. Furthermore, the ophthalmic device, in particular the intraocular lens, can additionally comprise an actuator, a solar module, and / or a sensor, which are arranged for insertion in the curable liquid, so that the ophthalmic device, in particular the intraocular lens, can be printed around these objects. Furthermore, the ophthalmic device, in particular the intraocular lens, can comprise an optical body and at least one haptic.

[0017] The ophthalmic device may further be one of the following: a glaucoma drainage device, an ocular stent, a surgical port, a capsular ring, a capsular tension ring, an eyeball ring, a capsular support device, a corneal implant, an iris implant (e.g., with dye particles), an iris prosthesis, a contact lens, a therapeutic contact lens with a medicinal agent, an implantable contact lens, a saddle ring, an iris expander ring, etc.

[0018] It may be provided that the ophthalmic device manufactured according to the method is subsequently post-processed, for example by turning, mechanical polishing, laser polishing and / or laser cutting, etc.

[0019] Parts of the arrangement, in particular the data processing device, can be implemented individually or collectively as a combination of hardware and software, for example as program code executed on a microcontroller or microprocessor. However, it can also be provided that parts are implemented individually or collectively as an application-specific integrated circuit (ASIC) and / or a field-programmable gate array (FPGA).

[0020] It is envisaged that, at least during the first printing, a support structure is printed in addition to the partial region, which holds the partial region and / or the previously produced ophthalmic device in position. This can increase positional accuracy during tomographic printing and thus achievable resolution. For example, a base, a pedestal and / or one or more suspensions, e.g. in the form of thin threads, can be printed as a support structure. After tomographic printing of all partial regions, the support structure is separated from the ophthalmic device again, e.g., cut off using a device designed for this purpose. The support structure is produced in particular such that its refractive index corresponds to that of the partial region(s) to be printed.This minimizes the influence of the support structure on the tomographic printing of the subregions. The support structure is added to the individual images, particularly during the creation and / or provision of the dataset, for example, by combining CAD data of the support structure with CAD data for the subregion to be printed.

[0021] In one embodiment, it is provided that the respective curable liquid is provided in the same container for at least two partial areas to be printed one after the other. This allows the same container to be used. The arrangement can therefore be designed to be more compact and space-saving. In particular, it is provided that the curable liquid for the partial area printed first is introduced into the container, for example via a supply device set up for this purpose (e.g. via a pipe system) as a means for providing and / or handling the curable liquids in the at least one container. After the tomographic printing of the partial area printed first, the curable liquid is removed from the container again, for example by means of a discharge device set up for this purpose (e.g. by means of a pipe system).The curable liquid for the subsequent sub-area to be printed is then introduced into the container, for example, via the same supply device or a separate, additional supply device configured for this purpose. After the tomographic printing of this sub-area, the curable liquid can be removed from the container via the same or an additional discharge device. If additional sub-areas are to be produced, the steps described above are repeated analogously for the respective curable liquids. The supply and discharge of the curable liquids is controlled, in particular, by means of the data processing device.

[0022] In one embodiment, it is provided that after the tomographic printing of a partial area, a position of the previously produced ophthalmic device is detected and / or determined, wherein the detected and / or determined position is taken into account when generating and / or providing a data set for a subsequently printed partial area. This can increase positioning accuracy and / or resolution during subsequent tomographic printing. In particular, the positioning accuracy of successively printed partial areas relative to one another can be increased. The position can be detected and determined, for example, using optical coherence tomography (OCT). This is particularly advantageous if a change in the curable liquids has taken place, which has changed a position of the previously printed ophthalmic device.The detected and / or determined position is taken into account when generating and / or providing the data set for the subsequent sub-area, for example by adjusting a position of the subsequent sub-area according to the detected and / or determined position of the already printed sub-area (e.g. by a translation and / or rotation movement).

[0023] In one embodiment, it is provided that after the tomographic printing of at least one of the partial regions, a surface is passivated. This creates a clearly defined separation between successively printed partial regions and prevents mixing of different partial regions. The passivation can be carried out in-situ, i.e. in the container, or outside the container. The passivation can be carried out, for example, using a suitable substance, e.g. heparin, or by plasma treatment. In-situ, the surface of the printed partial region is passivated using another molecule, e.g. heparin. The molecule can be introduced into the container as a solution, and the surface is then passivated by the molecule attaching to the surface.In principle, this can also be done outside the container, whereby the previously printed ophthalmic device is removed from the container and placed in the solution containing the molecule. For passivation by plasma treatment, the previously printed ophthalmic device is removed from the container and placed in a vacuum chamber in which the plasma treatment is carried out using a desired gas, e.g. oxygen or nitrogen. Passivation can generally be achieved by adding a reagent / inhibitor that closes the open ends on the surface of the cured liquid, for example a gas (e.g. oxygen), a liquid (e.g. nitrobenzene) or a solid (e.g. 2,2-diphenyl-1-picrylhadrazyl, also known as DPPH). When the previously printed ophthalmic device is removed from the container, a gaseous reagent or inhibitor is preferably added.a gaseous inhibitor is used; however, liquid or solid reagents can also be used in principle (e.g., by using chemical vapor deposition (OVD). Plasma activation or other types of energy transfer to the surface can enhance the effectiveness of the substances used. In one embodiment, at least two of the curable liquids are provided as a mixture in the at least one container, wherein, during the tomographic printing of at least one of these partial regions, a weight-related and / or density-related demixing and / or a mixing gradient is brought about by rotating the at least one container. As a result, different properties of the curable liquid used for tomographic printing can be set without changing the contents of the at least one container.If the container is rotated faster, a different mixing ratio of the curable liquids is established at the same location within the container. The rotation is then performed for the respective tomographic printing in such a way that the desired properties of the sub-areas are achieved in the respective cured state. Furthermore, this can also create a mixing gradient in a printed sub-area and / or in the ophthalmic device. In particular, curable liquids whose curable components (especially monomers) have different molar masses or different densities are mixed together for this purpose, so that they can be separated by the centrifugal forces occurring during rotation.For example, it may be possible to use curable liquids that have different refractive indices and, at the same time, different molar masses; a refractive index after printing can then be adjusted by a rotation speed during printing. In particular, it may also be possible for the rotation of the container to be synchronized with the tomographic printing. For example, it may be possible to use silicon oxide nanoparticles with surface-modified polyethylene glycol acrylate and butyl acrylate.

[0024] In one embodiment, at least two of the curable liquids are provided as a mixture in the at least one container, wherein during the tomographic printing of at least one of these partial regions, a charge-induced demixing is deliberately brought about by generating an electric field in the at least one container. As a result, different properties of the curable liquid used for tomographic printing can be achieved without changing the contents of the at least one container. For at least two partial regions, electric fields of different strengths are then applied during tomographic printing, which leads to a separation of the at least two curable liquids. The electric field for the respective tomographic printing is then selected such that the desired properties of the partial regions are achieved in the respective cured state.In this embodiment, it is particularly provided that the electric field is rotated during tomographic printing or that the container is not rotated. The curable liquids, in particular the monomers in the curable liquids, have a different electrical charge, so that they can be separated in the electric field. Positively charged and / or negatively charged monomers can be used, for example, 3-sulfopropyl acrylate or (3-acrylamidopropyl)trimethylammonium.

[0025] In one embodiment, at least two of the curable liquids are provided simultaneously in the at least one container as a density-dependent layer sequence. To select one of the at least two curable liquids for tomographic printing, a position of the curable liquids is changed by rotating the at least one container and the centrifugal forces generated thereby. This allows different properties of the curable liquid used for tomographic printing to be adjusted without changing the contents of the container.This embodiment utilizes the fact that a separating surface between the at least two curable liquids takes on a parabolic shape when rotating, depending on the centrifugal forces occurring, from the axis of rotation outwards, wherein the curved separating surface moves downwards at the location of the axis of rotation, but moves upwards towards the outside. The partial areas to be printed are then arranged in particular close to the axis of rotation, so that one of the at least two curable liquids can be selected and then printed there by selecting a rotation speed. For example, a first curable liquid can be printed with no rotation at all or only a low rotation speed. The rotation speed is then increased so that another curable liquid lying above it at the location of the axis of rotation migrates downwards into the area of ​​the already printed partial area.A further subregion is then produced by tomographic printing of this curable liquid. It may be provided to additionally use at least one support structure to fix the previously printed subregions in their position. More than two curable liquids may also be provided as a corresponding layer sequence. In one embodiment, it is provided that at least two of the curable liquids are immiscible and are provided simultaneously as a layer sequence in the at least one container. To select one of the at least two curable liquids for tomographic printing, a position of the curable liquids is changed by rotating the at least one container and the centrifugal forces caused thereby. This embodiment is designed in terms of functionality like the embodiment described above.In particular, at least two monomers are selected that are immiscible. Hydrophilic / hydrophobic or oleophilic / oleophobic properties can be exploited in this case.

[0026] In one embodiment, hydration is performed after tomographic printing of at least one of the partial regions. This allows properties of the partial region to be changed even after tomographic printing. In particular, the volume of the partial region can be changed, in particular increased, by hydration. In this way, a volume change can still be achieved even after implantation of the ophthalmic device in a patient's eye.

[0027] In one embodiment, the curable liquids of at least two subregions are selected such that at least one of these subregions can be hydrated in the cured state, while at least one of the other subregions cannot be hydrated. This makes it possible to change the position of anchors, for example in the form of haptics of the ophthalmic device, by means of hydration. For example, it can be provided that the subregions comprise, on the one hand, polymethyl methacrylate (PMMA) and, on the other hand, 2-hydroxyethyl methacrylate (HEMA) after curing by tomographic printing. While PMMA cannot absorb water, HEMA transforms into a hydrogel upon contact with water.This can be used to selectively swell one or more portions of the ophthalmic device while leaving another or more portions unfilled, thus altering the shape of the ophthalmic device, such as an intraocular lens. For example, if Y-shaped haptics are printed, with an inner portion made of poly-HEMA and an outer portion made of only poly-PMMA, the haptics will bend outward upon contact with water, thereby achieving improved positional stability in the eye after implantation.

[0028] In one embodiment, the same curable liquid is used for at least two partial areas, with a different light dose being selected for tomographic printing. This allows polymerization to occur with varying intensity, so that the mechanical properties of the at least two partial areas are different. The larger the light dose (i.e., the total amount of energy received relative to a volume with the unit J / cm 3), the longer the chain growth process, so that the resulting polymer chains become longer with increasing light dose. This can be used in particular to change stiffness (from soft / deformable to solid / rigid), since shorter polymer chains have a lower viscosity and are thus softer than longer polymer chains. The light dose can be changed, for example, by at least one of the following parameters: irradiation time or exposure time and / or irradiance.

[0029] In one embodiment, the data sets are generated and / or provided and / or the tomographic printing is performed in such a way that at least two subregions are geometrically intertwined. This allows subregions to be produced in such a way that their position relative to one another can only change to a predetermined extent. A change in position beyond this extent is prevented by the respective other subregion. For example, two encircling rings can form two such geometrically intertwined subregions.

[0030] In one embodiment, it is provided that the data sets are generated and / or provided and / or the tomographic printing is carried out in such a way that at least two partial areas are connected to one another by positive locking and / or frictional locking. This allows individual partial areas to be firmly connected to one another via connecting areas. This also allows the production of complex ophthalmic devices.

[0031] In one embodiment, the data sets are generated and / or provided and / or the tomographic printing is performed in such a way that at least two subregions are arranged so as to be freely movable relative to one another. This makes it possible to create subregions that do not influence each other's freedom of movement. An example of this is a smaller ring that is arranged within a larger ring, but can be removed from the larger ring because there is no mechanical connection between the rings.

[0032] In one embodiment, the curable liquids are provided and / or the tomographic printing is performed in such a way that at least two of the partial regions differ in stiffness. This makes it possible to create ophthalmic devices whose mechanical properties are adapted to an application scenario. For example, accommodating intraocular lenses can be created. This can be achieved in two ways: For example, it can be provided that the curable liquids are selected such that, after printing, different polymers are created that have different mechanical stiffness.For example, one sub-region may be tomographically printed using n-butyl acrylate (low refractive index and high flexibility / low rigidity) and another sub-region using 2-phenylethyl acrylate (high refractive index, low flexibility / high rigidity). The curable liquids can be changed to form the respective sub-regions independently of one another or mixtures of these two monomers. Alternatively, the same polymer can be formed during printing, but with a different chain length in the respective sub-regions. For example, the monomers specified above or below can be used.

[0033] Different chain lengths can be produced from the same monomer mixture (i.e., the same curable liquids are used) by changing the polymerization time (or printing time), by changing a proportion of a photoinitiator, and / or by changing the light dose.

[0034] In one embodiment, the curable liquids are provided and / or the tomographic printing is carried out in such a way that partial regions together form a gradient index lens (GRIN) or a diffractive lens. This allows the optical properties to be adjusted in a targeted manner and, in particular, with a smaller space requirement. In particular, several layers are printed successively as partial regions, each layer having a progressively changing refractive index. The refractive index increases, in particular, in each additional layer. Alternatively, the refractive index can also decrease in each additional layer.For example, a sub-region that forms the core of an intraocular lens has a refractive index of 1.5; the next sub-region for forming a first layer then has a refractive index of 1.45; the sub-region for forming a second layer has a refractive index of 1.40 and a sub-region for forming a final layer has a refractive index of 1.35. Alternatively, a reversed order of the refractive indices is possible. A range in which the refractive index can move for a GRIN intraocular lens is in particular between a maximum of 1.8 and a minimum of 1.3. The following monomers with refractive index given in parentheses can be mentioned as examples, which can be used alone or as mixtures: trifluoroethyl acrylate (1.407), butyl acrylate (1.474), furfuryl methacrylate (1.538) and diphenyl methyl methacrylate (1.593).A GRIN intraocular lens can in principle also be produced by means of a mixing gradient, as already described above for embodiments.

[0035] In this process, at least two curable liquids are mixed together, which (unmixed) have different refractive indices after curing. The refractive index can then be adjusted using the mixing gradient, i.e., by varying the respective proportion of the curable liquid.

[0036] In one embodiment, it is provided that at least the curable liquid contains at least one medicinal active ingredient for a partial region. In this way, partial regions can be functionalized such that they release the at least one medicinal active ingredient. For example, a haptic of an intraocular lens can be coated with a layer containing a medicinal active ingredient which, after implantation in the patient's eye, diffuses from the layer into the biological tissue (e.g. an antiglaucoma agent, antibiotics, etc.). For production, the at least one medicinal active ingredient is mixed into the respective curable liquid. For example, the medicinal active ingredient can be dissolved directly in the curable liquid (i.e. in a monomer solution) before tomographic printing (i.e. polymerization) is carried out.When light-induced polymerization occurs, the molecules of the medicinal agent are encapsulated in the polymer matrix. After implantation in the eye and contact with an aqueous environment (body fluid), the molecules of the medicinal agent begin to diffuse out and can act in the biological tissue. In one embodiment, the curable liquid contains electromagnetically excitable nanoparticles and / or at least one dye and / or at least one photochromic substance for at least a partial area. This allows for optical functionalization of at least a partial area of ​​the ophthalmic device. This allows, in particular, the production of iris prostheses or colored contact lenses.

[0037] The electromagnetically excitable nanoparticles and / or the at least one dye and / or the at least one photochromic substance are introduced, in particular, into at least one partial region that later forms an optical body of the ophthalmic device in the eye. Nanoparticles can be, for example, gold nanoparticles, silver nanoparticles, or silicon nanoparticles, which can fulfill several functions: (i) filtering of predetermined wavelengths (e.g., in the green or red wavelength range to provide support in cases of color blindness), (ii) improving the visibility of a surface and a body of the ophthalmic device under microscopic observation, (iii) drug delivery if the nanoparticles are loaded with therapeutic or medicinal agents.For example, gold nanoparticles can be used to cause absorption in the green wavelength range, which can help a patient with color blindness to distinguish colors. Titanium oxide nanoparticles exhibit strong absorption in the UV wavelength range and can be used as UV filters in the ophthalmic device for this purpose. Fluorescent dyes, for example, can be used as dyes, which can be used to encode a marking, or dyes that can be used for filtering. In particular, electromagnetically excitable nanoparticles and / or dyes and / or photochromic substances can be used to specifically adjust the optical properties of subregions of the ophthalmic device.

[0038] Based on the absorption properties and concentration of the nanoparticles and / or dyes used, a photoinitiator must be selected that absorbs outside the absorption range. The absorption of the photoinitiator is particularly in the UV wavelength range. The absorption of the nanoparticles can be adjusted via material composition and size. For example, spherically shaped gold nanoparticles with a size between 10 nm and 100 nm absorb in a wavelength range between 500 nm and 650 nm, while spherically shaped silver nanoparticles with a size between 50 nm and 100 nm absorb in a wavelength range between 420 nm and 600 nm. Dyes that can be used include dyes that absorb in the blue wavelength range or the infrared wavelength range, i.e., outside the UV absorption range of the photoinitiator.

[0039] Furthermore, magnetic nanoparticles can also be used. These can be used to passively move the ophthalmic device, such as an intraocular lens, or to monitor the ophthalmic device from outside the eye. Magnetic nanoparticles typically comprise iron oxide and absorb in the UV wavelength range, but when they are evenly dispersed in a monomer solution, polymerization occurs around the nanoparticles, embedding them in the polymer matrix, as the absorption coefficient of iron oxide nanoparticles is very low (~10 4 cm -1 compared to fluorescent dyes with ~10 15 cm -1 and gold / silver nanoparticles with ~10 7 - ~10 9 cm -1The same applies to other electromagnetically excitable nanoparticles, i.e., these can be used even with absorption in the UV wavelength range, provided the absorption there is so low that any influence on the photoinitiator is negligible. A photoinitiator that does not absorb above a wavelength of 550 nm can be used, for example, Irgacure® 784-7 from BASF SE, Germany. Photoinitiators specifically tailored to an application can also be used. Photoinitiators that have specific absorption wavelengths are manufactured, for example, by Spectra Photopolymers, Millbury, OH, USA, e.g., H-Nu390 (UV), H-Nu 470 (blue), H-Nu 535 (green), or H-Nu 780 (IR).

[0040] A photochromic material, in particular, exhibits self-adaptive light transmission properties. This makes it possible, in particular, to produce an iris prosthesis. In particular, a photoresponsive iris prosthesis can be produced. In particular, a partial region in the form of an inner ring that is phototropic and a partial region of an outer ring that is opaque can be produced. Further features regarding the configuration of the arrangement emerge from the description of embodiments of the method. The advantages of the arrangement are the same as those of the embodiments of the method.

[0041] The invention will be explained in more detail below using preferred embodiments with reference to the figures.

[0042] Fig. 1 is a schematic flow diagram of embodiments of the

[0043] procedure;

[0044] Fig. 2 is a schematic diagram to illustrate the process;

[0045] Fig. 3a-3c are schematic representations to illustrate an embodiment of the method;

[0046] Fig. 4a-4c are schematic representations to illustrate an embodiment of the method;

[0047] Fig. 5a-5c are schematic representations to illustrate an embodiment of the method;

[0048] Fig. 6 is a schematic representation to illustrate geometrically intertwined sub-areas;

[0049] Fig. 7 is a schematic representation to illustrate interconnected by

[0050] Sub-areas connected by form closure and / or friction closure;

[0051] Fig. 8 is a schematic representation to illustrate partial areas arranged so as to be freely movable relative to one another;

[0052] Fig. 9 is a schematic diagram illustrating one embodiment of the method (manufacturing a gradient index lens (GRIN) or a diffractive lens); Fig. 10 is a schematic diagram illustrating one embodiment of the method (incorporation of a medicinal agent);

[0053] Fig. 11 is a schematic representation of an embodiment of the arrangement for producing an ophthalmic device;

[0054] Fig. 12 is a schematic diagram illustrating an embodiment of the arrangement.

[0055] Figure 1 shows a schematic flow diagram of embodiments of the method. In a method step 100, at least one container transparent to electromagnetic radiation is provided. The container is selected in particular such that it is transparent at least to the electromagnetic radiation used in the method, particularly in the visible and UV wavelength range.

[0056] In a method step 101, method steps 101a, 101b and 101c are carried out for at least two sub-regions of the ophthalmological device.

[0057] In process step 101a, a liquid curable by means of electromagnetic radiation is provided in the at least one container. In particular, this is a liquid containing monomers and a photoinitiator, wherein the monomers can be polymerized by activating the photoinitiator. The curable liquid is poured into the container, for example.

[0058] In method step 101b, a data set of images of the respective sub-area of ​​the ophthalmological device is generated and / or provided, wherein the images contain projections of this sub-area from different directions.

[0059] In method step 101c, the curable liquid is tomographically printed using electromagnetic radiation based on the generated and / or provided data set to form this partial region. The provision of the curable liquids in method step 100a and / or the tomographic printing in method step 100c are carried out in such a way that at least two of the at least two partial regions differ from one another in at least one property. Such a property can be, for example, an optical, a functional, and / or a mechanical property.

[0060] Figure 2 shows a schematic representation to illustrate the method. By way of example, the method is used to produce an intraocular lens 20 with an optic 21 made of, for example, four materials and a haptic 22 made of, for example, two materials. A container 1 is shown, which contains a first curable liquid 2-1. The first curable liquid 2-1 comprises a monomer solution with a photoinitiator and, if appropriate, other substances. A first partial region 10-1 is printed tomographically, with the monomers polymerizing in the curable liquid and thereby curing.

[0061] After the first partial area 10-1 has been printed, a second curable liquid 2-2 is provided. This second curable liquid 2-2 comprises a monomer solution with a photoinitiator and, if necessary, other substances. A second partial area 10-2 is printed tomographically. This is then repeated n times, so that at the end of the process, an nth curable liquid 2-n is finally provided. This nth curable liquid 2-n comprises a monomer solution with a photoinitiator and, if necessary, other substances. An nth partial area 10-n is printed tomographically. After the nth pass, the intraocular lens 20 with the optics 21 made of, for example, four materials and the haptics 22 made of, for example, two materials has been created.

[0062] It can be provided that method steps 101a, 101b, and 101c (Fig. 1) are carried out for several subregions in the same container. It can therefore be provided that the respective curable liquid is provided in the same container for at least two subregions to be printed consecutively. For this purpose, the curable liquid can, for example, be exchanged for printing each subregion. The provision of the curable liquids 2-x and / or the tomographic printing are carried out in such a way that at least two (sequentially printed) of the n subregions 10-x differ from one another in at least one property.

[0063] It is intended that, at least during the first printing, a support structure is printed in addition to the partial area, which holds the partial area 10-x and / or the previously produced ophthalmic device 20 in position. In particular, such a support structure can be an additional thread for suspending and / or holding the previously produced ophthalmic device 20. A pedestal or a support can also be provided. For this purpose, the data set is adapted accordingly in method step 101b so that the images contain projections of the partial area 10-x and the support structure connected to it or arranged on it from different directions.

[0064] It can be provided that after the tomographic printing of a partial area 10-x, a position of the previously produced ophthalmic device 20 is detected and / or determined, wherein the detected and / or determined position is taken into account when generating and / or providing a data set for a subsequently printed partial area 10-x. This takes place, for example, in method step 101d (Fig. 1), in which the position of the previously produced ophthalmic device 20 is detected and determined, for example by means of optical coherence tomography or another suitable method. In the subsequent method step 101b for the next partial area 10-x, the associated data set for this partial area 10-x is adapted accordingly to take the determined position into account.

[0065] It can be provided that after the tomographic printing of at least one of the partial regions 10-x, a surface is passivated. This can be carried out, for example, in a method step 101e (Fig. 1). The passivation can be carried out by introducing it into a liquid which, for example, comprises heparin, or by plasma treatment. This prevents mixing with the subsequent partial region 10-x and enables a clearly defined or sharp transition to the next partial region 10-x. Figures 3a, 3b and 3c show schematic representations to illustrate an embodiment of the method. In this embodiment, it is provided that at least two of the curable liquids 2-1, 2-2 are provided as a mixture 3 in the container 1 (Fig.3a), wherein during the tomographic printing of at least one of these partial regions 10-1, 10-2, a weight-related and / or density-related demixing and / or a mixing gradient is induced by rotating the container 1 (Fig. 3c). If the container 1 is not rotated and remains stationary, the curable liquids 2-1, 2-2 are, on average, evenly distributed with a mixing ratio according to their respective proportion of the mixture (Fig. 3b). A tomographically printed first partial region 10-1 then depicts this mixing ratio. The mixing ratio can be changed by rotating if the curable liquids 2-1, 2-2 have a different molar mass or a different density. The extent of the demixing can be adjusted by changing the rotation speed.A second subregion 10-2, printed tomographically during rotation, then exhibits the mixing ratio of the curable liquids 2-1, 2-2 present at the printing location within the container 1. The properties of the two subregions 10-1, 10-2 can thus be specifically modified and adjusted without having to change or replace any contents in the container. Furthermore, a mixing gradient can also be generated within a subregion 10-x and / or the ophthalmic device.

[0066] Figures 4a, 4b, and 4c show schematic representations to illustrate one embodiment of the method. In this embodiment, at least two of the curable liquids 2-1, 2-2 are provided as a mixture 3 in the container 1 (Fig. 4a), wherein, during the tomographic printing of at least one of these partial regions 10-1, 10-2, a charge-induced demixing is deliberately induced by generating an electric field 4 in the container 1. In the example shown, an electric field 4 is first generated in one direction, resulting in a charge-induced demixing that is almost complete, and a first partial region 10-1 is tomographically printed starting from the curable liquid 2-1 (Fig. 4b).Subsequently, an electric field 4 is generated in the opposite direction, causing charge-induced demixing, in which the demixing occurs in the opposite direction, but which is also almost complete. In this state, a second partial region 10-2 is then tomographically printed starting from the curable liquid 2-2 (Fig. 4c). Figures 5a, 5b and 5c show schematic representations to illustrate an embodiment of the method. In this embodiment, it is provided that at least two of the curable liquids 2-1, 2-2 are provided simultaneously in the container 1 as a density-dependent layer sequence (Fig. 5a), wherein in order to select one of the at least two curable liquids 2-1, 2-2 for tomographic printing, a position of the curable liquids 2-1, 2-2 is changed by rotating the container 1 and the centrifugal forces caused thereby.In the example shown, a first partial area 10-1 is first tomographically printed using the curable liquid 2-1, which is arranged at the bottom in the resting state (Fig. 5b). Subsequently, the container 1 is rotated, causing a transition surface 15 between the curable liquids 2-1, 2-2 to deform parabolically. The transition surface 15 migrates downward at the location of the rotation axis and rises outwardly from the rotation axis. As a result, the second curable liquid 2-2 is displaced to the location where the already printed partial area 10-1 is located. In this state, a second partial area 10-2 is then tomographically printed (Fig. 5c).

[0067] It may be provided that hydration is performed after the tomographic printing of at least one of the partial regions 10-x. This can be done, for example, in a method step 102 (Fig. 1). This can also be done, in particular, after implantation of the ophthalmic device 20 if it comes into contact with or is implanted into a moist environment.

[0068] In particular, it can be provided that the curable liquids 2-x of at least two partial regions 10-x are selected such that at least one of these partial regions 10-x can be hydrated in the cured state, while at least one of these other partial regions 10-x cannot be hydrated. This allows mechanical movements to be generated, similar to those used in a bimetallic spring. For example, this allows arms for haptics to be moved in a targeted manner, particularly after an ophthalmological device 20, in particular an intraocular lens, has been implanted and comes into contact with a moist environment.

[0069] It can be provided that the same curable liquid 10-x is used for at least two partial areas 10-x, whereby a different light dose is selected during tomographic printing in process step 101c (Fig. 1). In particular, this can influence a chain length during polymerization, which leads in particular to a different mechanical stiffness. The light dose can be adjusted both by an irradiation or exposure duration and by an irradiation or exposure intensity.

[0070] It can be provided that the data sets in method step 101b are generated and / or provided and / or the tomographic printing in method step 101c is carried out in such a way that at least two partial regions 10-x are geometrically intertwined. This is illustrated schematically in Fig. 6 using two rings 13-x. The two rings 13-x are intertwined so that, although they can move within a range of motion, they cannot be separated from one another because each ring 13-x encompasses the other. The ring shape is chosen merely as an example for clarification; in principle, the intertwined partial regions 10-x can also be designed differently.

[0071] It can be provided that the data sets in method step 101b are generated and / or provided and / or the tomographic printing in method step 101c is carried out in such a way that at least two partial regions 10-x are connected to one another by positive locking and / or frictional locking. This is illustrated schematically in Fig. 7 using two rings 13-x. The two rings 13-x are firmly connected to one another via a connecting region 14. The ring shape is chosen merely as an example for clarification; in principle, the interconnected partial regions 10-x can also be designed differently.

[0072] It can be provided that the data sets in method step 101b are generated and / or provided and / or the tomographic printing in method step 101c is carried out in such a way that at least two partial regions 10-x are arranged so as to be freely movable relative to one another. This is illustrated schematically in Fig. 8 using two rings 13-x. The two rings 13-x are arranged so as to be freely movable relative to one another and have no connection to one another. The ring shape is chosen merely as an example for clarification; in principle, the partial regions 10-x that are freely movable relative to one another can also be designed differently. It can be provided that the curable liquids 2-x in method step 101a are provided and / or the tomographic printing in method step 101c is carried out in such a way that at least two of the partial regions 10-x differ in stiffness.This can be achieved in particular by adjusting a proportion of a photoinitiator in the curable liquids 2-x. In this way, in particular, a strength of activation of the polymerization in the curable liquids 2-x can be adjusted and, in particular, selected differently. Due to the different strength of the activation, chain growth is stronger or weaker, so that these form longer or shorter polymer chains, which determines the stiffness of the respective printed partial area 10-x. Furthermore, for example, the light dose used in tomographic printing can be selected differently for the partial areas 10-x. This can also influence chain growth and thus adjust a chain length. In particular, a smaller light dose is selected for one of the partial areas 10-x than for the other of the partial areas 10-x. The stiffness of the at least two partial areas 10-x is then different.

[0073] It can be provided that the curable liquids 2-x are provided in method step 101a and / or the tomographic printing in method step 101c is carried out in such a way that partial regions 10-x together form a gradient index lens (GRIN) or a diffractive lens. This is illustrated schematically in Fig. 9. Three partial regions 10-x are successively tomographically printed, the refractive index of which increases (or decreases) step by step. For this purpose, monomer solutions are provided as curable liquids 2-x. The partial regions 10-x are printed as a layer sequence, so that an ophthalmic device 20 in the form of an intraocular lens 20 is produced. The intraocular lens 20 comprises an optical body 21 with GRIN properties and a haptic 22, which is formed by means of the last partial region 10-3.

[0074] It can be provided that at least the curable liquid 2-1 for a partial region 10-1 contains at least one medicinal active ingredient s. This is illustrated schematically in Fig. 10. Shown here is a step in which a partial region 10-2 is tomographically printed as part of a haptic 22 on or onto an already printed partial region 10-1. The curable liquid 2-1 is in particular a monomer solution in which the medicinal active ingredient 5 is dissolved. During polymerization, the medicinal active ingredient 5 is enclosed in the polymer and can diffuse out of the polymer again in an aqueous environment and therefore act directly at the site of implantation. The medicinal active ingredient 5 can, for example, be an antiglaucoma agent, an antibiotic, etc.

[0075] It can be provided that the curable liquid 2-x for at least a partial area 10-x comprises electromagnetically excitable nanoparticles and / or at least one dye.

[0076] Fig. 11 shows a schematic representation of an embodiment of the arrangement 30 for producing an ophthalmic device 20. The arrangement 30 is particularly configured to carry out the method described in this disclosure. The arrangement 30 comprises at least one container 1 transparent to electromagnetic radiation 31, a data processing device 32 configured to generate and / or provide data sets 33 from images of partial regions 10-x of the ophthalmic device 20, wherein the images include projections of the respective partial region 10-x of the ophthalmic device 20 from different directions.

[0077] The arrangement 30 further comprises at least one tomographic printing device 34, which is configured for tomographic printing of a curable liquid 2-x provided in the at least one container 1 for the respective sub-area 10-x by means of electromagnetic radiation 31, based on the respectively generated and / or provided data set 33 for forming the respective sub-area 10-x. The tomographic printing device 34 comprises, in particular, an irradiation device 35, which projects the individual images through the transparent container 1 into the curable liquid 2-x by means of the electromagnetic radiation 31, thereby causing curing depending on the location. Furthermore, the printing device 34 comprises, for example, a turntable 36, with which an irradiation direction can be changed, so that the curable liquid 2-x can be irradiated from different directions (e.g.with angles of incidence between 0 and 360° with respect to a rotation axis of the turntable 36). Several irradiation devices 35 can also be provided, each of which radiates electromagnetic radiation 31 according to the respective image of the data set 33 from different directions simultaneously into the curable liquid 2-x. The arrangement 30 further comprises means 37 for providing and / or handling the curable liquids 2-x in the at least one container 1. For example, it can be provided that a liquid reservoir is provided as means 37, which is designed to hold the curable liquid 2-x for each of the partial regions 10-x of the ophthalmological device 20 and to introduce it into the container 1 and to remove it again therefrom as needed (only schematically indicated in Fig. 11). An example of this is shown schematically in Fig. 12.There, a pipe system 38 in the container 1 is used to introduce the curable liquids 2-x into the container 1 as needed and to remove them from it again, as indicated by way of example for two curable liquids 2-x for two partial regions 10-x of the ophthalmic device 20 to be printed. It can be provided that during the tomographic printing of the first partial region 10-1, a support structure (not shown) is also printed in order to fix the first partial region 10-1 in a position when changing the curable liquid 2-x. Alternatively or additionally, a position of the partial region 10-x can be detected and / or determined after the introduction of the second curable liquid 2-x, for example by means of optical coherence tomography or another suitable method, wherein the position is taken into account when generating and / or providing the data set for the second partial region 10-2.

[0078] Alternative means 37 have already been described above with reference to Figures 3a to 3c, 4a to 4c and 5a to 5c.

[0079] The arrangement 30 is designed and / or configured to provide the curable liquids 2-x and / or to perform the tomographic printing such that at least two of the at least two partial regions 10-x differ from one another in at least one property. In particular, the data processing device 32 is designed and / or configured to control the arrangement 30 accordingly.

[0080] Furthermore, the arrangement 30 is designed and / or configured to print, at least during the first printing process, in addition to the partial region (10-x), a support structure that holds the partial region (10-x) and / or the previously produced ophthalmic device (20) in position.

[0081] 1 container

[0082] 2-x hardenable liquid

[0083] 3 Mixture

[0084] 4 electric field

[0085] 5 medicinal active ingredient

[0086] 10-x sub-area

[0087] 13-x ring

[0088] 14 Connection area

[0089] 15 Transition surface

[0090] 20 ophthalmic device

[0091] 21 Optics

[0092] 22 Haptics

[0093] 30 Arrangement

[0094] 31 electromagnetic radiation

[0095] 32 Data processing facility

[0096] 33 data sets

[0097] 34 tomographic printing device

[0098] 35 Irradiation facility

[0099] 36 turntable

[0100] 37 funds

[0101] 38 pipe system

[0102] 100-102 procedural steps

Claims

Patent claims 1. A method for producing an ophthalmic device (20), comprising: providing at least one container (1) transparent to electromagnetic radiation (31), and for at least two partial regions (10-x) of the ophthalmic device (20): - Providing a liquid (2-x) which can be cured by means of electromagnetic radiation (31) in the at least one container (1), - generating and / or providing a data set (33) from images of the respective partial area (10-x) of the ophthalmological device (20), wherein the images contain projections of this partial area (10-x) from different directions, - tomographic printing of the curable liquid (2-x) by means of electromagnetic radiation (31) starting from the generated and / or provided data set (33) to form this partial region (10-x), wherein the provision of the curable liquids (2-x) and / or the tomographic printing are carried out in such a way that at least two of the at least two partial regions (10-x) differ from one another in at least one property, wherein at least during the first printing, in addition to the partial region (10-x), a support structure is printed which holds the partial region (10-x) and / or the previously produced ophthalmological device (20) in position.

2. Method according to claim 1, characterized in that at least for two partial areas (10-x) to be printed one after the other, the respective curable liquid (2-x) is provided in the same container (1).

3. Method according to one of the preceding claims, characterized in that after the tomographic printing of a partial area (10-x), a position of the previously produced ophthalmological device (20) is detected and / or determined, wherein the detected and / or determined position is taken into account when generating and / or providing a data set (33) for a partial area (10-x) to be subsequently printed.

4. Method according to one of the preceding claims, characterized in that after the tomographic printing of at least one of the partial regions (10-x), a surface is passivated.

5. Method according to one of the preceding claims, characterized in that at least two of the curable liquids (2-x) are provided as a mixture in the at least one container (1), wherein during the tomographic printing of at least one of these partial regions (10-x) a weight-related and / or density-related demixing and / or a mixing gradient is caused by rotating the at least one container (1).

6. Method according to one of the preceding claims, characterized in that at least two of the curable liquids (2-x) are provided as a mixture in the at least one container (1), wherein during the tomographic printing of at least one of these partial areas (10-x) by generating an electric field (4) in the at least one container (1) a charge-related demixing is deliberately brought about.

7. Method according to one of the preceding claims, characterized in that at least two of the curable liquids (2-x) are provided as a density-dependent layer sequence simultaneously in the at least one container (1), wherein in order to select one of the at least two curable liquids (2-x) for tomographic printing, a position of the curable liquids (2-x) is changed by rotating the at least one container (1) and centrifugal forces caused thereby.

8. Method according to one of the preceding claims, characterized in that after the tomographic printing of at least one of the partial regions (10-x), hydration is carried out.

9. Method according to one of the preceding claims, characterized in that the curable liquids (2-x) of at least two partial regions (10-x) are selected such that at least one of these partial regions (10-x) can be hydrogenated in the cured state, while at least one other of these partial regions (10-x) cannot be hydrogenated.

10. Method according to one of the preceding claims, characterized in that the same curable liquid (2-x) is used for at least two partial areas (10-x), wherein a light dose is selected differently during tomographic printing.

11. Method according to one of the preceding claims, characterized in that the data sets (33) are generated and / or provided and / or the tomographic printing is carried out in such a way that at least two partial areas (10-x) are geometrically intertwined.

12. Method according to one of the preceding claims, characterized in that the data sets (33) are generated and / or provided and / or the tomographic printing is carried out in such a way that at least two partial areas (10-x) are connected to one another by positive locking and / or non-positive locking.

13. Method according to one of the preceding claims, characterized in that the data sets (33) are generated and / or provided and / or the tomographic printing is carried out in such a way that at least two partial areas (10-x) are arranged so as to be freely movable relative to one another.

14. Method according to one of the preceding claims, characterized in that the curable liquids (2-x) are provided and / or the tomographic printing is carried out in such a way that at least two of the partial regions (10-x) differ in stiffness.

15. Method according to one of the preceding claims, characterized in that the curable liquids (2-x) are provided in such a way and / or the tomographic printing is carried out in such a way that partial areas (10-x) together form a gradient index lens (GRIN) or a diffraction lens.

16. Method according to one of the preceding claims, characterized in that at least the curable liquid (2-x) for a partial area (10-x) contains at least one medicinal active ingredient (5).

17. Method according to one of the preceding claims, characterized in that the curable liquid (2-x) comprises electromagnetically excitable nanoparticles and / or at least one dye and / or at least one photochromic substance for at least one partial area (10-x).

18. An arrangement (30) for producing an ophthalmic device (20), comprising: at least one container (1) transparent to electromagnetic radiation (31); a data processing device (32) configured to generate and / or provide data sets (33) from images of partial regions (10-x) of the ophthalmic device (20), wherein the images include projections of the respective partial region (10-x) of the ophthalmic device (20) from different directions; at least one tomographic printing device (34) configured to tomographically print a curable liquid (2-x) provided in the at least one container (1) for the respective partial region (10-x) by means of electromagnetic radiation (31) based on the respectively generated and / or provided data set (33) to form the respective partial region (10-x), and Means (37) for providing and / or handling the curable liquids (2-x) in the at least one container (1); wherein the arrangement (30) is set up and / or configured to carry out the provision of the curable liquids (2-x) and / or the tomographic printing in such a way that at least two of the at least two partial regions (10-x) differ from one another in at least one property, and, at least during the first printing, to print, in addition to the partial region (10-x), a support structure which holds the partial region (10-x) and / or the previously produced ophthalmological device (20) in position.

Images