Abstract
The invention relates to an ophthalmological implant (100) with an optically imaging element (110), a digital product identifier (130) being arranged on the optically imaging element. The invention additionally relates to a corresponding method for producing the implant and to a machine reading system (200) for detecting and decoding the digital product identifier. The aim of the invention is to provide an ophthalmological implant and a method for producing same, said method allowing a unique and complete product identifier and a check thereof using simple means at any point in time. This is achieved by an ophthalmological implant with a digital product identifier (130) which is implemented by means of an encoded point grid (135) of identifier points (57), said point grid being machine-readable in the visible light range and having one irregular semi-random character.
Claims
1.-23. (canceled)
24. An ophthalmological implant or an intraocular lens, comprising: an optically imaging element, including a central optical lens having an optically effective zone, and comprising a haptic adjoining the optically imaging element; and with a digital product identification of the ophthalmological implant, the digital product identification including a type, a refractive power, a database key or a combination thereof, being arranged on the optically imaging element, within the optically effective zone; wherein the digital product identification presents a coded point grid made of marking points that is machine-readable in the visible light range and has a pseudo-random, irregular character.
25. The ophthalmological implant as claimed in claim 24, wherein the machine-readable coded point grid made of marking points is arranged centrally within the optically effective zone of the optically imaging element.
26. The ophthalmological implant as claimed in claim 24, wherein the coded point grid is constructed from marking points such that a virtual polar or Cartesian base lattice is arranged on the optically imaging element, within the optically effective zone of the optically imaging element, that describes similar sectors or similar cells, each sector or cell having a defined base lattice point of the sector or the cell, as a result, and a real marking point of the coded point grid is arranged in each sector or each cell at a position which has an offset to the base lattice point, the offset in each sector or each cell being in one of four possible directions, which run pairwise opposite to each other, and having a defined distance to the base lattice point.
27. The ophthalmological implant as claimed in claim 26, wherein the sector or the cell with the base lattice point provides four states wherein a respective location of the marking point in one of four positions around the base lattice point.
28. The ophthalmological implant as claimed in claim 27, wherein the sector or the cell with the base lattice point provides a fifth state defined by the absence of a marking point at one of the four possible positions around the base lattice point.
29. The ophthalmological implant as claimed in claim 27, wherein further states are defined in the sector or the cell with the base lattice point by further offset directions, further defined distances of the offset of the marking point to the base lattice point or both.
30. The ophthalmological implant as claimed in claim 24, wherein a proportion of an area of the marking points to the total area of the optically imaging element is selected from a group consisting of less than 2%, less than 1%, and less than 0.5%, and wherein the proportion of the area of the marking points to the area of the optically effective zone of the optically imaging element is selected from a group consisting of less than 8%, less than 4%, and less than 2% or a combination of the foregoing.
31. The ophthalmological implant as claimed in claim 24, wherein the machine-readable coded point grid has structural marking points.
32. The ophthalmological implant as claimed in claim 24, further comprising a supplemented product identification which, in addition to the original product identification, has information for checksums and error correction methods.
33. The ophthalmological implant as claimed in claim 24, further comprising one or more reference marks at a defined distance from the machine-readable coded point grid made of marking points.
34. The ophthalmological implant as claimed in claim 24, wherein the machine-readable coded point grid made of marking points is arranged on the optically imaging element, in the optically imaging element or both.
35. The ophthalmological implant as claimed in claim 24, further comprising an alignment aid, the alignment aid being arranged within the optically effective zone and comprising or consisting of the machine-readable coded point grid made of marking points.
36. The ophthalmological implant as claimed in claim 24, further comprising a toric marker which is readable in a view from above, a toric marker which is readable in an axial view or both.
37. A machine reading system for capturing and decoding the digital product identification in the form of a coded point grid made of marking points on an ophthalmological implant as claimed in claim 1, comprising a camera system that records structures of the machine-readable coded point grid made of marking points on the ophthalmological implant, and an analyser that captures and evaluates a camera system recorded image of the structures of the machine-readable coded point grid made of marking points, and that decodes the digital product identification of the ophthalmological implant.
38. The machine reading system as claimed in claim 37, further comprising a connected database system, wherein the digital product identification contains a database key and the database key is assigned the product information of the ophthalmological implant in the database system.
39. The machine reading system as claimed in claim 37, which is part of a surgical microscope or a slit lamp.
40. A method to produce an ophthalmological implant with a digital identifier as claimed in claim 24, comprising, generating the machine-readable coded point grid made of marking points for digital product identification purposes on the ophthalmological implant, during or after the production of the ophthalmological implant.
41. The method as claimed in claim 40, wherein the production of the ophthalmological implant further comprises: either labelling the ophthalmological implant with the machine-readable coded point grid made of marking points in an early phase of production before the ophthalmological implant is complete, or labelling the ophthalmological implant with the machine-readable coded point grid made of marking points directly after the production has been completed, but still within the same step with a similar tool used to produce the ophthalmological implant.
42. The method as claimed in claim 41, further comprising introducing the machine-readable coded point grid made of marking points into the surface of the ophthalmological implant using a CNC-controlled drilling or milling tool during or after the production of the ophthalmological implant, and selecting the drilling or milling tool to have a tool diameter of less than 0.4 mm.
43. The method as claimed in claim 40, further comprising applying the machine-readable coded point grid made of marking points either by application of laser processing by ablation or disruption or by application of printing methods, using biocompatible chromophores or pigments.
44. The method as claimed in claim 40, further comprising converting a product identification or a supplemented product identification into grid coordinates for the physical product identification using a machine-readable coded point grid made of marking points.
45. The method as claimed in claim 40, further comprising, during or after the generation of the machine-readable coded point grid made of marking points for digital product identification, storing the machine-readable coded point grid in a manufacturer database which is linkable to an electronic patient file and/or another data collection point for medical or official purposes.
46. The method as claimed in claim 40, further comprising preceding the generation of the machine-readable coded point grid made of marking points for digital product identification by storing the product information of the ophthalmological implant in a database system and generating a database key relating to this product information and contained in the digital product identification.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0087] The invention is explained in more detail below by way of example on the basis of the accompanying drawings, which also disclose features essential to the invention. In detail:
[0088] FIG. 1 depicts a digital product identification as can be used in an ophthalmological implant according to the invention, here in the first example embodiment of FIGS. 2 and 2a; FIG. 1a depicts an enlarged section of this digital product identification;
[0089] FIG. 2 depicts a first example embodiment of an ophthalmological implant according to the invention, here an intraocular lens; FIG. 2a depicts an enlarged image representation of the product identification on the optically imaging element, here on the lens body of an intraocular lens;
[0090] FIG. 3 depicts a second example embodiment of an ophthalmological implant according to the invention; FIG. 3a depicts an enlarged image representation of the product identification on the optically imaging element;
[0091] FIG. 4 depicts a third example embodiment of an ophthalmological implant according to the invention; FIG. 4a depicts an enlarged image representation of the product identification on the optically imaging element;
[0092] FIG. 5 depicts a fourth example embodiment of an ophthalmological implant according to the invention; FIG. 5a depicts an enlarged image representation of the product identification on the optically imaging element;
[0093] FIG. 6 depicts a fifth example embodiment of an ophthalmological implant according to the invention; FIG. 6a depicts an enlarged image representation of the machine-readable point grid made of marking points used for digital product identification;
[0094] FIG. 7 depicts a sixth exemplary embodiment of an ophthalmological implant according to the invention; FIG. 7a depicts an enlarged image representation of the machine-readable point grid made of marking points used for digital product identification;
[0095] FIG. 8 depicts an intensity distribution directly downstream of an area marked with the coded point grid made of marking points of the sixth example embodiment;
[0096] FIG. 9 depicts the modulation transfer function for the central point grid made of marking points of the sixth example embodiment;
[0097] FIG. 10 depicts a machine reading system according to the invention for capturing and decoding of a coded point grid made of marking points on an ophthalmological implant.
[0098] FIG. 11 depicts the use of a coded marker for verification of the implant during implantation and in vivo post implantation;
[0099] FIGS. 12a to 12c depict a digital product identification with toric marker and alignment aid according to the prior art and in different example embodiments of the ophthalmological implant according to the invention;
[0100] FIGS. 13a to 13c depict digital product identifications with toric marker in the optically effective zone of the optically imaging element in further different example embodiments of the ophthalmological implant according to the invention;
[0101] FIGS. 14a to 14c depict a digital product identification with toric marker in further different example embodiments of the ophthalmological implant according to the inventionfor use from the view from above and for use in an axial view;
[0102] FIGS. 15a to 15c depict how a digital product identification in further different example embodiments of the ophthalmological implant according to the invention;
[0103] FIG. 16 depicts different arrangements of the machine-readable coded point grid made of marking points of a digital product identification;
[0104] FIGS. 17a and 17b depict a size estimation for M3 and M4 UDI codes, respectively;
[0105] FIGS. 18a to 18d depict a manufacturing method of an intraocular lens with a coded marker arranged in the volume of the optically imaging element;
[0106] FIGS. 19a to 19c depict an intraocular lens implanted in an ISO eye, having a coded marker on the surface of the optically imaging element and the halo/glare test with this and without this coded marker.
DETAILED DESCRIPTION
[0107] Firstly, FIG. 1 illustrates a digital product identification 130 as can be used in an ophthalmological implant 100 according to the invention, in order to be able to better explain its principles. FIG. 1a shows an enlarged portion of this digital product identification 130. The (machine-readable) coded point grid 135 made of marking points 57 for digital product identification 130, which is shown in FIGS. 1 and 1a, is obtained by the offset arrangement of the marking points 57 to form a polar base lattice, although the explanations also apply in principle to an arrangement of marking points 57 in a Cartesian base lattice (in which a sector 51 is then called a cell 51).
[0108] The polar base lattice shown here consists of three radial zones 52, each with twelve sectors 51. These generate the base lattice points 56, which are purely virtual in nature. The base lattice points are indexed consecutively from 0 to 35 in FIG. 1 and label the respective sector 51 (or the respective cell). Moreover, the grating contains positive and negative offset zones in the sectoral 54 and radial 53 directions. These generate four further crossing points 55 around the base lattice points 56. The marking point 57 can be located on one of these four crossing points 55the four crossing points therefore represent the possible positions of the marking point 57 in the corresponding sector 51 or in the corresponding cell 51.
[0109] FIG. 1a then shows an enlarged view of a base lattice point 56 and its surroundings or corresponding sector 51. It is apparent here that the four positions 55 are indexed around the base lattice point 56. For the base lattice point 56 with the index 1, these are the positions 1.1, 1.2, 1.3 and 1.4. In this example, the marking point 57 of the sector 51 associated with the base lattice point 56 can assume one of the four different positions 55 1.1, 1.2, 1.3 or 1.4. Thus, in this example, a single base lattice point 56 can assume four states. Hence, 4.sup.36=4 722 366 482 869 645 213 696 representable states are obtainable in the case of a total of 36 sectors with four positions 55 each (i.e., four possible states).
[0110] In order to improve the recognizability and referencing by a machine reading system 200, a plurality of reference marks 58 are moreover arranged in the vicinity of the point grid 135 made of marking points 57.
[0111] In the example of FIG. 1 explained here, the respective marking point 57 can assume one of four possible positions 55 around a base point 56. Thus, a total of 36 marking points 57 are arranged in the polar base lattice.
[0112] FIG. 2 shows a first example embodiment of an ophthalmological implant 100 according to the invention, here an intraocular lens, with a digital product identification 130; FIG. 2a shows an enlarged image representation of the product identification 130 on the optically imaging element 110, here on the lens body of an intraocular lens. This first example embodiment is a coded point grid 135 made of marking points 57, which uses a polar base lattice and has three zones 52 and twelve sectors 51 per zone 52, each with four states per sector 51. As shown in the example in FIG. 1, this results in 4.sup.36 representable states that can be used to store the digital product information. In this example embodiment, the individual point size of a marking point 57 is approximately 0.0025 mm.sup.2, and hence the proportion of the area of the marking points 57 to the total area of the optically imaging element 110 is 0.3178%.
[0113] FIG. 3 shows a second example embodiment of an ophthalmological implant 100 according to the invention; FIG. 3a shows an enlarged image representation of the product identification 130 on the optically imaging element 110 of this ophthalmological implant 100. This second example embodiment is a coded point grid 135 made of marking points 57, which uses a polar base lattice and in this case has one zone 52 with twelve sectors 51, with each sector 51 being able to describe four states. Thus, 4.sup.12=16 777 216 representable states are obtained.
[0114] In this example embodiment, the single point size of a marking point 57 is approximately 0.0025 mm.sup.2. Hence, the proportion of the area of the marking points 57 to the total area of the optically imaging element 110 is 0.1059%.
[0115] FIG. 4 illustrates a third example embodiment of an ophthalmological implant 100 according to the invention; FIG. 4a illustrates an enlarged image representation of the digital product identification 130 on the optically imaging element 110. This third example embodiment is also a polar base lattice with one zone 52 that contains twelve sectors 51. However, five states can be described by each of these sectors 51 in this case since, in addition to the four possible states that are due to the location of a marking point 57 on one of the four positions 55 that have an offset to the base lattice point 56, the absence of a marking point 57 in the corresponding sector 51 describes a further state. Hence, 5.sup.12=244 140 625 representable states are obtained.
[0116] In this example embodiment, the individual point size of a marking point 57 once again is approximately 0.0025 mm.sup.2, and hence the proportion of the area of the marking points 57 to the total area of the optically imaging element 110 is 0.1059%. Thus, although the possible storage capacity has increased, the proportion of the area of the marking points 57 to the total area of the optically imaging element 110 has remained the same in comparison with the second example embodiment.
[0117] FIG. 5 shows a fourth example embodiment of an ophthalmological implant 100 according to the invention; FIG. 5a once again shows an enlarged image representation of the product identification 130 on the optically imaging element 110 of the ophthalmological implant 100. This fourth example embodiment once again is a polar base lattice, but it has two zones 52 that contain twelve sectors 51 each. Five states can also be described by each of these sectors 51 in this case. Hence, 5.sup.12=59 604 644 775 390 625 representable states are obtained.
[0118] In this example embodiment, the individual point size of a marking point 57 once again is approximately 0.0025 mm.sup.2, and hence the proportion of the area of the marking points 57 to the total area of the optically imaging element 110 is 0.2119%.
[0119] FIG. 6 shows a fifth example embodiment of an ophthalmological implant 100 according to the invention; FIG. 6a shows an enlarged image representation of the machine-readable point grid 135 made of marking points 57 used for digital product identification 130. In this fifth example embodiment, however, use is made of a Cartesian base lattice with an extent of four cells 51 in a lateral direction x and four cells 51 in a lateral direction y (i.e., n.sub.x=4, n.sub.y=4), in which five states can be described by each cell 51, that is to say four states by the location of a marking point 57 on one of the four possible positions 55, which are offset (in each case in a different direction) from the base lattice point 56 of the cell 51, and an additional state due to the absence of a marking point 57 4.sup.16=4 294 967 296 representable states. In this embodiment, too, the single point size of a marking point 57 is approximately 0.0025 mm.sup.2. Hence, the proportion of the area of the marking points 57 to the total area of the optically imaging element 110 is 0.1413%.
[0120] FIG. 7 illustrates a sixth example embodiment of an ophthalmological implant 100 according to the invention, once again an intraocular lens, and FIG. 7a illustrates an enlarged image representation of the machine-readable point grid 135 made of marking points 57 used for digital product identification 130. In this sixth example embodiment, too, a Cartesian base lattice is used with an extent of six cells 51 in a lateral direction x and four cells 51 in a lateral direction y (nx=6, ny=4), in which four states can be described by each cell 51. Hence, 4 24=281 474 976 710 656 representable states are available for storing the (optionally supplemented) product identification 130. In this example embodiment, the single point size of a marking point 57 is approximately 0.0113 mm.sup.2. Hence, the proportion of the area of the marking points 57 to the total area of the optically imaging element 110 is 0.96%, and hence significantly higher than in the previous example embodiments.
[0121] In the sixth example embodiment of FIGS. 7 and 7a (Cartesian base lattice, n.sub.x=6, n.sub.y=4, four states), a Cartesian point grid 135 made of marking points 57 with relatively large marking points 57 in the center of an intraocular lens is illustrated as an optical worst-case example. This pattern was imported as a user defined obscuration into an eye model of a simulation program (ZEMAX) and the modulation transfer function (MTF) on the retina was determined. A small pupil with a diameter of 3.0 mm was chosen here in order to achieve the highest possible interference component in the pattern within the pupil. In this example, the marking points 57 are completely opaque absorbersin practice, black points for example. FIG. 8 shows the intensity distribution immediately downstream of the marked area. The pattern corresponds exactly to the example from FIGS. 7 and 7a. However, FIG. 9 shows that the MTF is practically unaffected by the central point grid and remains close to the diffraction limit.
[0122] Finally, FIG. 10 illustrates a machine reading system 200 according to the invention for recording and decoding a coded point grid made of marking points on an ophthalmological implant 100, for example on an intraocular lens, which machine reading system is part of a corresponding surgical microscope 250.
[0123] This example embodiment of a machine reading system 200 according to the invention comprises an illumination system 210 for illuminating a digital product identification 130 of an intraocular lens in the form of a machine-readable coded point grid made of marking points 135, a camera system 220 for recording structures of the machine-readable coded point grid made of marking points 135 which have been rendered detectable by use of the illumination, and an analysis unit 230 for capturing and evaluating an image, recorded by the camera system 220, of the structures of the machine-readable coded point grid made of marking points 135 rendered detectable by use of the illumination and for decoding of the digital product identification 130 of the intraocular lens, for example the type and the refractive power, for identifying the ophthalmological implant 100 from this image, and also a display and/or output apparatus 240 for displaying and/or outputting the decoded identification data of the ophthalmological implant 100.
[0124] In this case, this example embodiment of the machine reading system 200 according to the invention can also decode intraocular lenses which have already been implanted in a patient's eye 300.
[0125] FIG. 11 shows the use of a digital product identification 130, here a coded marker, for example in the form of the machine-readable coded point grid made of marking points 135, for verification of the ophthalmological implant 100 during implantation and in vivo post implantation. Already during the implantation and in vivo post implantation, there are many different occasions when a verification of the implant 100 and hence traceability is helpful. To this end, the ophthalmological implant 100 is capable of being connected to various pieces of equipment such as the surgical microscope 250 and various diagnostic equipment 260 via the digital product identification 130. These establish a contactless connection to the registry 270, which can be located on an internal server or in the cloud.
[0126] FIG. 12a illustrates a digital product identification 130 with toric marker 160 on an ophthalmological implant 100 according to the prior art: The digital product identification 130 is located in the region of the haptic 120 of the ophthalmological implant 100 close to the optically imaging element 110. Toric markers 160 are arranged at the edge of the optically imaging element 110.
[0127] FIG. 12b shows a digital product identification 130 with toric marker 160 according to an example embodiment of the ophthalmological implant 100 according to the invention, while FIG. 12c illustrates a digital product identification 130 with toric marker 160 and alignment aid 150 according to further example embodiments of the ophthalmological implant 100 according to the invention.
[0128] In general, a coded marker on an ophthalmological implant 100, for example on an IOL, can be any type of visually recognizable coded information that offers the above-described functions.
[0129] Examples of such coded information include, inter alia, (i) standard codes such as linear barcodes or matrix (2D) barcodes including point code, QR code, or (ii) advanced codes such as 3D matrix codes. The codes can differ in the number, size or width of the (individual) elements (e.g., pixels), the overall size of the code, the distances between the elements and the orientation of the elements within the code. The coded marker on an IOL is formed by a machine-readable pattern. Such a pattern can be recognized under different types of illumination, for example under normal white light illumination, fluorescent illumination or laser illumination.
[0130] The digital product identification 130 using coded markers is now attached to the IOL in such a way that it is recognizable during implantation and post operation. In the embodiments shown here, the coded marker is located at the edge of the optically imaging element 110 of an IOL, which is generally accessible by dilating the pupil. The coded marker, for example the machine-readable coded point grid made of marking points 135 contains information such as the specification data of the respective ophthalmological implant 100 (in the case of an IOL, for example diopter, type, manufacturer, model, material, toric axis). However, the specification data can also be represented by a unique identifier that enables the data to be retrieved from a database.
[0131] A coded marker as proposed in the invention not only enables a reliable identification of the IOL, but also, in example embodiments as illustrated in FIGS. 12b and 12c, the recognition of the IOL position during the operation. The use of a coded marker enables the provision of IOL design specification data (including IOL geometry) and actual IOL position data. The information supplied by the coded marker opens up new possibilities for computer-assisted optimization of IOL positioning. The coded marker represents geometric data of the individual implant 100, which data enable computer-aided recognition of the position of the said implant. On account of the coded nature of the marker, even a subset of the recognized features of a coded marker provides useful information relating to a more stable and precise alignment of an IOL in the eye. The coded marker includes features for error detection, error tolerance, and ideally error correction.
[0132] FIGS. 13a to 13c depict digital product identifications 130 with toric marker 160 in the optically effective zone of the optically imaging element 110 in further different example embodiments of the ophthalmological implant according to the invention 100. These figures describe embodiments of machine-readable coded point grids 135, that is to say data matrix codes or coded markers, and their variations for use within the optically effective zone 115 or the optical zone of 4.4 mm. This is advantageous for example to have easier access to the code in the implanted state, since dilation of the pupil is not required. In this case, it is necessary to ensure that no negative effects on the optical performance of the ophthalmological implant 100, for example an intraocular lens, are passed on to the patient. The solution here is to increase and/or randomize the spacing between the marking points and/or keep the size of the marking points small. In this case, FIG. 13a illustrates a conventional toric marker 160 from the prior art at the outermost edge of the optically imaging element 110 in combination with the digital product identification 130, described here according to the invention, in the form of a machine-readable coded point grid made of marking points 135 in the optically effective zone 115 of the optically imaging element 110 of the ophthalmological implant 100, while in FIG. 13b the toric marker 160 is integrated, in a manner according to the invention, into the digital product identification 130 in the form of a machine-readable coded point grid made of marking points 135 in the optically effective zone 115 of the optically imaging element 110 of the ophthalmological implant 100. In the lower of the two examples, in particular, the alignment is not only implemented on a macrostructure (the shape of the coded marker), but the marking points have an elliptical shape, with the long axis of the ellipse running parallel to the toric axis in this case.
[0133] To indicate the toricity of an intraocular lens or other lens characteristics (such as haptic or modular lens connection sites), the points can be extended in that direction. In addition, as shown in FIG. 13c, an optical data matrix code can be used to block the light in a desired manner, as is the case with pinhole IOLs to achieve greater depth of field. Here, the machine-readable coded point grid made of marking points 135 or, more generally, the data matrix codes form the optical mask, or a code is applied to the light-blocking mask of a pinhole IOL. This is advantageous because the optical disadvantages of a coded marker or data matrix code on a mask are dispensed with.
[0134] FIGS. 14a to 14c illustrate digital product identifications 130 with toric marker in further different example embodiments of the ophthalmological implant according to the inventionfor use from the view from above AO and for use in an axial view SA.
[0135] The toric marker 160, 161 is located on the surface of the optically imaging element 110 of the ophthalmological implant 100, for example an intraocular lens, or in the volume of the optically imaging element 110 (i.e., in the material). The toric marker 160, here for example in the form of a QR code, is for example readable in the view from above, AO, as shown in FIG. 14b, allowing access via a camera in production and in logistics, and via a surgical microscope 250, a slit lamp 260 or biometric equipment 260 in the implanted state. Alternatively, the toric marker 161, optionally also the data matrix code, can be read in an axial view (i.e., a side view, SA), as shown in FIG. 14c, which is accessible in the case of tomographic measurements. In this embodiment, the code is not readable in top view (view from above, AO) but has less impact on dysphotopsia when in the implanted state.
[0136] In general, toric markers 160 for toric IOLs are well established with no reports of dysphotopsia, which has the advantage that this shape and area can be used for a coded marker in the form of a data matrix code in the implanted state of an IOL with dilated pupils. This invention can be used for all IOLs, not just toric IOLs, and allows the rotation of the ophthalmological implant 100 to be tracked.
[0137] FIGS. 15a to 15c illustrate a digital product identification 130 in the form of a coded marker, for example a machine-readable coded point grid made of marking points 135, in further different example embodiments of the ophthalmological implant 100 according to the invention.
[0138] In this case, FIG. 15a shows two identical elongated coded markers in the form of QR codes on an intraocular lens 100. Since a conventional toric marker 160 contains two lines, both can be used as a UDI. Additional codes on the surface of the haptic 120 may be advantageous. All codes can have the same content, or different content to reduce the data density of a code.
[0139] FIG. 15b shows two identical elongated coded markers in the form of QR codes on an intraocular lens 100, in combination with a QR code on the haptic. FIG. 15c illustrates two non-identical elongated coded markers in the form of QR codes on an intraocular lens 100, in combination with a QR code on the haptic.
[0140] FIG. 16 shows different arrangements of the machine-readable coded point grid made of marking points 135 of a digital product identification 130.
[0141] In this case, the QR code designs are rectangular or square in UDI-compliant grid pattern, which is easier to generate than that of FIGS. 6 and 7, but retains a certain periodicity. The number of rows of data matrix codes varies between the individual examples in this case. Additional features show the alignment of the data matrix codes, improving the detection of equipment used to rotate and align the IOL during surgery. Here, additional functions of microscopes can be used to align the IOL. The codes shown here havein addition to the fact that a basic alignment on the basis of the machine-readable coded point grid made of marking points 135 is possible in principleadditional orientation boxes 151 that support the alignment of the corresponding ophthalmological implant 100.
[0142] The tables of FIGS. 17a and 17b present a size estimation for M3 and M4 UDI codes, respectively. In order to estimate the size of a coded marker, but also for example the size of a toric marker, calculations are made for different marking point sizes, the number of columns, and the number of rows. Various combinations of row sizes, column sizes, and point sizes for the top view AO and the axial view SA are shown for an M3 code (see FIG. 17a) and an M4 code (see FIG. 17b, with M4 comprising the full content of the UDI, including SN, date of manufacture, place of manufacture and expiration date, and a checksum length). There are combinations of rows, columns, and point sizes that meet the requirements of the ISO standard regarding the arrangement of a corresponding marker on the optically imaging element 110, for example in the edge region thereof. However, a small spot size of 20 m/25 m to 50 m is also advantageous in terms of resolution and contrast. The example combinations are highlighted in FIGS. 17a and 17b. An axial resolution of 5 m is possible for conventional OCT. This would be a lower limit for point sizes.
[0143] For the traceability of an ophthalmological implant 100 until production, in particular of the optically imaging element 110, within the scope of manufacture, coded markers, for example a machine-readable coded point grid made of marking points 135, can be applied in or on the material as a digital product identification 130 by laser engraving using a laser 190. FIGS. 18a to 18d describe an example variant of a manufacturing method of an intraocular lens with a coded marker as a digital product identification 130, but also as an alignment aid or as a toric marker, which is arranged in the volume of the optically imaging element 110. Here, the codes are first written into the material blank 180 (also called a blank); see FIGS. 18a and 18b. Since the code or codes are in the interior of the material, the ophthalmological implant 100 can already be tracked throughout the entire manufacturing process, including turning, milling, sterilizing, and packaging; see FIGS. 18c and 18d. In the material, the code is protected from any abrasion during diamond turning and diamond milling. In the example shown here, the code of the digital product identification 130 is where the toric markers 160 will be located in the finished product.
[0144] Another advantage is that a data matrix code in the interior of the material improves readout during production, logistics, and in the implanted state. For example, toric markers 160 on the surface of the optically imaging element 110, for example on a lens surface, at high diopters, and on the cornea, may appear deformed due to optical projection, making alignment during implantation of the ophthalmological implant 100 more difficult. Moreover, the toric markers 160 can also be used to align the material blank 180 during the production of the ophthalmological implant 100 in order to ensure toricity and haptic are on the correct axis.
[0145] It should be mentioned that the processing with regard to tilting and centering must be very precise, especially for the precisely timed alignment of a non-spherical intraocular lens. In the event of the lens not being perfectly aligned, this information must be linked to the serial number and stored both online (accessed via the database) and offline (box label).
[0146] Alternatively, the marker can also be attached directly after the processing or after the polishing of the ophthalmological implant 100. In this context, the marker can still be embedded into the material or applied to the surface.
[0147] In addition to conventional laser engraving, alternative techniques can also be used to produce the data matrix codes shown. One possibility would be the photochemical generation of metal (e.g., silver, gold) nanoparticles or silicon nanoparticles within the biomaterial matrix by way of two-photon absorption.
[0148] FIGS. 19a to 19c depict recordings of a Zeiss Lucia 621 intraocular lens implanted in an ISO eye and having a coded marker on the surface of the optically imaging element 110 (FIG. 19a) and the halo/glare test, the latter both without this coded marker (FIG. 19b) and with this coded marker (FIG. 19c). This relates to a laser engraved QR code (M4) on the IOL surface in an ISO eye used for bench testing. The code was introduced, tested, and analyzed as a 50 m standard unique device identifier (UDI) pattern directly in the center of the optically effective zone 115.
[0149] The code is clearly visible through a microscope. Modulation transfer function (MTF) values for 100 lp/mm are close to those of an IOL that has not been provided with a coded marker. Thus, only minor problems in terms of halo, glare and visual impairment can be determined in the case of this conventional laser-engraved code. Small lattice effects (small dysphotopsias) are visible due to the periodicity of the code. However, the test limits for such an ophthalmological implant 100 are met. These effects could be further minimized by positioning at the periphery of the optically imaging element 110 or further randomization of the pattern during the creation of the digital product identification 130.
[0150] Since the marking points are located in a Fourier plane, they are not projected onto the retina in focus. Here only visual acuity is reduced by the nature of the blocking of light rays in the central optical zone, which leads to a loss of contrast. About 0.5% of the light is blocked in an estimate for an M4 code (1717) with a square marking point size of 25 m and a central optical zone of 4.4 mm; this is negligible and has no impact on the MTF function. In order to reduce diffraction effects due to the periodicity of the point pattern of the code, the lattice spacing must be greater than the size of the marking points (sometime also called spot size). This is the case in the present example.
[0151] The aforementioned features of the invention, which are explained in various example embodiments, can be used not only in the combinations specified in an example manner but also in other combinations or on their own, without departing from the scope of the present invention.
[0152] A description of a piece of equipment relating to method features is analogously applicable to the corresponding method with respect to these features, while method features correspondingly represent functional features of the equipment described.
REFERENCE SIGNS
[0153] 0 to 36: Base lattice point numbers [0154] 1.1, 1.2, 1.3, 1.4: Possible positions of the marking point of the first base lattice point [0155] 51 Sector/cell [0156] 52 Radial zone [0157] 53 Radial direction [0158] 54 Sectoral direction [0159] 55 Crossing point/possible position for marking point [0160] 56 Base lattice point [0161] 57 Marking point [0162] 58 Reference mark [0163] 100 Ophthalmological implant [0164] 110 Optically imaging element [0165] 115 Optically effective zone [0166] 120 Haptic [0167] 130 Digital product identification [0168] 135 Machine-readable coded point grid made of marking points [0169] 140 Virtual polar or Cartesian base lattice [0170] 150 Alignment aid [0171] 151 Orientation box [0172] 160 Toric marker for view from above [0173] 161 Toric marker for view from the side/axial view [0174] 165 Toric axis [0175] 180 Blank/Material blank [0176] 190 Laser [0177] 200 Machine reading system [0178] 210 Illumination system [0179] 220 Camera system [0180] 230 Analysis unit [0181] 240 Output apparatus [0182] 250 Surgical microscope [0183] 260 Diagnostic equipment [0184] 270 Registry [0185] 300 Patient's eye [0186] AO View from above/lateral view [0187] SA Side view/axial view
