OPHTHALMIC IMPLANT AND METHOD FOR PRODUCING SUCH A

Description

[0001] Embodiments of the invention relate to an ophthalmic implant with a contactless electronically readable data storage unit and a method for manufacturing an ophthalmic implant with a contactless electronically readable data storage unit. The embodiments are thus particularly relevant to the field of ophthalmic implants and especially to the field of intraocular lenses.

[0002] Medical implants, and in particular ophthalmic implants such as intraocular lenses (IOLs), typically require traceability throughout the implant's entire lifespan. This requirement, defined, for example, in the European Medical Device Regulation, must be met for a medical device to be approved.

[0003] Appropriate traceability is ensured by the unique device identification (UDI), which is typically a combination of the manufacturer's ID and a serial number in the form of a global trade item number (GTIN). Additional information such as the batch number and expiration date is also required. Examples of common trade names for identifying an ophthalmic implant are shown in Figure 1 shown, which are explained in more detail in the character description.

[0004] Additional information is typically required for IOLs: This includes details of the diopter and cylindrical power, the IOL material, and the model number. To select a suitable IOL for a patient, calculation constants ("A-constants") from a database are typically needed; these are specific to a particular IOL type. For example, if the patient requires an astigmatism-correcting IOL, the implantation axis describes the rotation angle of the implant within the eye.

[0005] Since many ophthalmic implants, and especially IOLs, have a foldable structure that allows for implantation in a folded state followed by unfolding, information for identification and determining other properties is not conventionally directly associated with or attached to the ophthalmic implant. Particularly in the case of an IOL that primarily consists of a clear lens, UDI and IOL information are often not associated with the implant.

[0006] In the prior art, IOLs from the manufacturer OPHTECH GmbH are known which have a micro-QR code with product-specific information in the haptic form, e.g. a UDI and other implantation information ( https: / / www.ophtec.com / company / news?news id=947587To avoid impairing the optical function of the IOL, the micro-QR code is positioned so that this area is hidden behind the iris when implanted. This means it cannot be read when the IOL is implanted. Additionally, reading the code is also conventionally impossible when the IOL is folded in an applicator.

[0007] It is difficult to apply a highly visible code to an IOL without compromising the implant's optical performance while still ensuring it remains easily visible once implanted. Therefore, IOL information is traditionally provided via the packaging and / or a separate information sheet or card (e.g., patient card). However, this information can be lost over time as it is not attached to the IOL itself.

[0008] Fundamentally, clear and unambiguous traceability of the implant from production, through logistics, during the implantation process, in the implanted state, and, if applicable, after explantation, is necessary for claims management. Even during implantation and in vivo after implantation, there are many different situations where verification of the implant and thus traceability is helpful, such as in... Figure 2 depicted.

[0009] WO 2012 / 157623 A1 describes an active sensor whose chip for detecting intraocular pressure is arranged in the haptic space, wherein antenna windings for transmitting the measured values ​​from the eye are incorporated in the peripheral area of ​​the IOL optical body in its central plane.

[0010] EP2620802 A1 shows a contact lens which contains an antenna arrangement within the non-optical part, which serves to transmit data.

[0011] US patent 2009 / 0244477 A1 describes an ophthalmic lens that contains an energy receptor (=antenna) in its non-optical portion, coupled to a component. This component can be an RFID chip. The antenna is located within the lens.

[0012] WO 2015 / 081298 A1 describes an intraocular lens with an integrated display, which incorporates various electronic components arranged on the haptic surface. According to disclosure D1, one of the components can be a sensor, which in turn can be configured as an RFID chip.

[0013] US Patent 2006 / 267768 A1 describes a system for monitoring the usage duration of ophthalmic products, primarily contact lenses. The contact lenses can have RFID tags that can be read to retrieve information about the contact lens.

[0014] EP 2 846 182 A2 describes a system with an ophthalmic lens and an external device that can communicate wirelessly. US 2017 / 103363 A1 describes an inventory management system that can assist in identifying the IOL in a surgical application. The IOL may have sensors that provide information to a user.

[0015] The task is therefore to provide an ophthalmic implant that allows for easy manufacturing and reliable identification throughout the entire lifespan of the ophthalmic implant, especially in the implanted state.

[0016] The problem is solved by an ophthalmic implant with a data storage unit and a method for manufacturing an ophthalmic implant with a contactlessly electronically readable data storage unit, having the features of the respective independent claims. Optional embodiments are specified in the dependent claims and in the description.

[0017] A first embodiment relates to an ophthalmic implant comprising an optical part with an optical effect and a non-optical part connected or connectable to the optical part. The ophthalmic implant further comprises a data storage unit that can be read electronically without contact when the ophthalmic implant is implanted. This data storage unit contains electronically readable data by which the ophthalmic implant can be identified. The electronically readable data storage unit is mounted on the non-optical and / or the optical part and arranged such that the optical effect of the optical part is not substantially impaired by the electronically readable data storage unit.

[0018] Another embodiment relates to a method for manufacturing an ophthalmic implant. The method comprises providing an ophthalmic implant with an optical part and a non-optical part connected or connectable to the optical part, as well as applying a contactlessly electronically readable data storage unit such that the optical effect of the optical part is not substantially impaired by the electronically readable data storage unit.

[0019] An ophthalmic implant is an implant suitable for implantation into a patient's eye, specifically a human or animal eye. An ophthalmic implant can optionally be designed as an intraocular lens (IOL). This means that the ophthalmic implant can optionally function as an intraocular lens, with the optical component being a lens with refractive and / or diffractive properties. Alternatively or additionally, the ophthalmic implant can include a sensor to measure one or more parameters inside the eye, such as intraocular pressure and / or the concentration of a substance, such as sugar.

[0020] The optical component of the ophthalmic implant, which has an optical effect, can, for example, be a part of the ophthalmic implant that exhibits a refractive and / or diffractive effect. In particular, the optical component can be designed as or comprise an optical lens. It may be essential that the optical component is optically transparent and that light passing through it is not deflected, reflected, and / or absorbed by unwanted influences.

[0021] The non-optical part can be another component of the ophthalmic implant that has no optical effect. In particular, the non-optical part can be a component that does not contribute to optical imaging. The non-optical part can, especially in the case of an IOL, have or consist of one or more haptics, which serve to stabilize and / or fix the ophthalmic implant in the eye, for example, in the capsular bag. The non-optical part can also serve to transmit a force to the optical part, for example, to change its refractive effect. For instance, the eye can exert a force on the non-optical part via the ciliary muscle, which is then transmitted through the non-optical part to the optical part and / or results in a deformation of the optical part.The fact that the non-optical part is connected to the optical part means that there is mechanical contact between them. Optionally, the optical and non-optical parts can be formed as a single unit, forming the ophthalmic implant. Alternatively, the fact that the non-optical part can be connected to the optical part means that the optical and non-optical parts can be assembled, so that they are connected after assembly. Some designs are such that assembling the ophthalmic implant involves connecting the optical and non-optical parts during the implantation procedure. For example, an ophthalmic implant may be a modular and / or multi-part IOL that is assembled within the capsular bag, which involves connecting the optical and non-optical parts.

[0022] The fact that the data storage unit can be read electronically without contact means that no mechanical or electrical contact is required between a reader and the data storage unit for data retrieval. In other words, no cable connection is necessary between a reader and the data storage unit to read the data electronically. The term "contactless" refers to the absence of any contact between the data storage unit and a reader. However, according to some optional embodiments, contact may be required between tissue of the eye, such as the cornea, and the reader, yet no contact exists between the data storage unit and the reader. According to other embodiments, however, no contact between tissue of the eye and the reader is required to read data from the data storage unit contactlessly using the reader.In an optional configuration, the reader can be set up to make mechanical contact with the patient's temple while reading data from the data storage unit. The fact that the data is read electronically means that the data is in electronic form, for example, in bits and / or bytes, and can be read by a processing unit. For example, contactless electronic reading can be achieved via a wireless connection between the reader and the data storage unit. This wireless connection can be established using electromagnetic waves, which can optionally penetrate at least partially into the tissue of the eye.

[0023] The fact that the data storage unit and / or the data can be read when the ophthalmic implant is implanted does not, of course, preclude the possibility of contactless reading of the data storage unit and / or the data when the ophthalmic implant is not implanted. In fact, the data storage unit can optionally be read contactlessly even before the implantation procedure. Optionally, the data storage unit can also be read contactlessly even when enclosed in packaging. This offers the advantage that the ophthalmic implant does not need to be removed from its packaging for identification.

[0024] The fact that the optical effect of the optical part is essentially not impaired by the electronically readable data storage unit means that the data storage unit applied to the ophthalmic implant does not degrade the optical effect of the optical part, or only to such a small extent that the remaining optical effect is at least sufficient for the intended function of the ophthalmic implant.

[0025] These embodiments offer the advantage of enabling reliable and simple identification of the ophthalmic implant without the need for separate information carriers that are not connected to the implant. In particular, these embodiments allow for simple and reliable identification even when the ophthalmic implant is already implanted in the eye. Because the data is read electronically and without contact, the ophthalmic implant can be read and thus identified even when the data storage unit is partially or completely obscured by the implanted device, for example, by the iris.This in turn offers the advantage that the data storage unit can be deliberately placed in such locations and parts of the implant that are not visible or accessible from the outside after implantation.

[0026] Furthermore, the invention offers the advantage that by applying the data storage unit to the optical and / or non-optical part, the assembly consisting of the optical and non-optical parts can initially be manufactured without the data storage unit. In contrast to conventional ophthalmic implants, in which an antenna structure is integrated (e.g., cast into) an IOL, this offers the advantage that complications such as stress and undesirable temperature differences during the manufacturing of the optical and non-optical parts can be avoided.Even in cases where mechanical processing of the optical and / or non-optical components is required for the manufacture of the ophthalmic implant, the option of subsequently attaching the data storage unit offers the advantage of avoiding potential damage to the data storage unit during mechanical processing, as it can be attached after the machining is complete. Furthermore, this allows the optical and non-optical components to be inspected for defects before the data storage unit is attached, thus preventing the application of a data storage unit to a defective ophthalmic implant. This reduces scrap and, consequently, manufacturing costs.

[0027] These designs also offer the advantage that, unlike optical methods for reading data, a line of sight is not required between the reading device and the data storage unit due to the use of contactless electronic reading.

[0028] The fact that the data storage unit is mounted on the optical and / or non-optical part of the ophthalmic implant means that the data storage unit is at least partially, and optionally completely, arranged and attached to a surface of the optical and / or non-optical part. Optionally, structures for mounting the data storage unit or parts thereof may be provided in the optical and / or non-optical part. Optionally, one or more recesses may be provided on the optical and / or non-optical part in which the data storage unit, in particular a data storage element and / or an antenna structure, is at least partially arranged.According to an optional embodiment, a recess can be milled or otherwise formed in the optical and / or non-optical part, into which a data storage element, for example a chip, of the data storage unit is inserted and secured. This offers the advantage that the protrusion of the data storage unit from the surface of the optical and / or non-optical part can be reduced or avoided.

[0029] Optionally, the electronically readable data can include a unique identifier for the ophthalmic implant. This offers the advantage that the ophthalmic implant can be identified even if it is implanted in an eye and possibly at least partially obscured, for example by the iris, and / or if the ophthalmic implant is not accessible for direct physical electrical contact via an electrical conductor.

[0030] Alternatively or additionally, the electronically readable data can contain information about one or more properties of the implant, in particular an optical property, a material property, a property relating to the haptic platform, a property relating to an IOL design, and / or a property relating to a manufacturing process, such as a manufacturing date, of the ophthalmic implant. Alternatively or additionally, the electronically readable data can contain information about the A-constant of an ophthalmic implant designed as an IOL and / or information about a toric axis in the case of a toric IOL. This makes it possible to determine the suitability of the implant for an intended use or patient beyond doubt by reading the respective information.

[0031] Alternatively or additionally, the electronically readable data can contain information about the patient in whom the ophthalmic implant has been implanted or for whom the ophthalmic implant is intended. This simplifies the assignment of the ophthalmic implant and thus avoids any potential misassignments.

[0032] Alternatively or additionally, the electronically readable data may contain information about the implantation of the ophthalmic implant, such as a date of implantation and / or the name of a medical facility and / or medical personnel involved in the implantation.

[0033] Alternatively or additionally, the electronically readable data can include information provided by a sensor connected to the ophthalmic implant. For example, a sensor for measuring intraocular glucose concentration and / or a sensor for measuring intraocular pressure can be connected to the ophthalmic implant, allowing the information provided by these sensors to be read via the implant. This enables the contactless electronic readout functionality of the ophthalmic implant to be used for other purposes not necessarily directly related to the implant itself.

[0034] Alternatively or additionally, the electronically readable data can include a network address and / or access data to a network-accessible data storage device where data containing information about the ophthalmic implant and / or the patient is stored and / or can be stored. This offers the advantage that not all data or information intended to be associated with the ophthalmic implant necessarily needs to be stored on the ophthalmic implant's data storage unit, but can also be provided on an external server accessible via the network address encompassed by the data. This allows the storage capacity of the data storage unit to be kept low, as the amount of data stored on the data storage unit can be reduced to a minimum.This also offers the advantage that the data stored on the server can be easily maintained and updated if necessary, without requiring access to the data on the data storage unit itself. Another advantage is that access rights to the data stored on the server can be selectively restricted, so that, for example, only a predetermined group of authorized individuals can retrieve the data.

[0035] Optionally, the elastic modulus and / or coefficient of thermal expansion of the contactlessly electronically readable data storage unit essentially corresponds to the elastic modulus and / or coefficient of thermal expansion of the optical and / or non-optical part. "Essentially" means that any deviation between the elastic modulus and / or coefficient of thermal expansion of the data storage unit and the elastic modulus and / or coefficient of thermal expansion of the optical and / or non-optical part is so small that the data storage unit does not impair the handling of the ophthalmic implant. In particular, the elastic moduli are optionally matched in such a way that any folding and unfolding of the ophthalmic implant required for implantation can be carried out without interference from the data storage unit.Alternatively or additionally, the coefficients of thermal expansion can be coordinated in such a way that, in the event of temperature changes occurring at the ophthalmic implant, for example during sterilization, no such large mechanical stresses occur that would lead to irreversible deformation or impairment of the functionality of the ophthalmic implant.

[0036] Optionally, the contactless, electronically readable data storage unit is attached to the non-optical and / or optical part by bonding, laminating, welding, and / or overmolding. This offers the advantage that the connection between the data storage unit and the optical and / or non-optical part can be designed to be so robust that the risk of delamination and / or other forms of separation is reduced. Attaching the data storage unit to a surface of the optical and / or non-optical part has the advantage that the optical and / or non-optical part does not impede any potential thermal expansion of the data storage. This is advantageous during the sterilization phase and also for storage conditions. Furthermore, folding on the surface is less pronounced than in the core of the optical and / or non-optical part.As mentioned previously, the data storage unit can be attached, for example, by bonding (e.g., with flexible acrylic adhesive). Alternatively, it can be embedded in a polymer shell, which is optionally more flexible than the lens material (e.g., silicone), via lamination. This method does not preclude the possibility of incorporating one or more recesses into the ophthalmic implant, into which the data storage unit is at least partially inserted during application. The data storage unit can therefore optionally be recessed and encased in a drilled hole or milled recess in the optical and / or non-optical part (e.g., in three-piece IOLs).

[0037] Optionally, the contactless, electronically readable data storage unit includes a data storage element and an antenna structure. The antenna structure and the data storage element can be separate components connected to each other. Alternatively, they can be formed as a single unit, so that the antenna structure and the data storage element together form a single chip.

[0038] According to an optional embodiment, the antenna structure is arranged exclusively on a haptic surface of the non-optical part and optionally has an antenna area of ​​2 mm² to 5 mm². This offers the advantage that the antenna structure is not located on the optical part, thus completely avoiding any impairment of the optical properties or effect of the optical part by the antenna structure. Furthermore, this reduces the risk of breakage and / or other damage to the antenna structure, as the antenna structure does not extend into the area of ​​the transition between the non-optical and optical parts of the ophthalmic implant, where experience has shown that significant mechanical forces can frequently occur.In particular, significant mechanical forces can occur at the transition between the non-optical and optical components during the folding and / or implantation of the ophthalmic implant. These forces can lead to undesirable stress on the antenna structure if it is located in this area. Optionally, other electrical and / or electronic components, such as a data storage unit and / or a data storage element, can also be arranged on the non-optical part of the ophthalmic implant on which the antenna structure is located. Optionally, all electrical and / or electronic components of the data storage unit can be arranged on the same non-optical part of the ophthalmic implant as the antenna structure.

[0039] According to a further optional embodiment, the antenna structure is arranged exclusively on one or more haptics of the non-optical part and in a peripheral area of ​​the optical part, and optionally has an antenna area of ​​6 mm² to 30 mm². This offers the advantage that the antenna area can be significantly larger than with an arrangement solely on a haptic. Furthermore, because the antenna structure is arranged only in a peripheral area of ​​the optical part, any impairment of the optical performance of the optical part can be minimized.

[0040] According to a further optional embodiment, the antenna structure is arranged on the ophthalmic implant such that it runs along an outer contour of the implant and optionally has an antenna area of ​​6 mm² to 30 mm². This offers the advantage of achieving a large antenna area while minimizing the impairment of the optical function of the optical component. Furthermore, such an arrangement can be advantageous in terms of stabilizing the ophthalmic implant.

[0041] According to a further optional embodiment, the antenna structure is arranged such that it projects beyond the outer contour of the optical and non-optical parts of the ophthalmic implant, in particular beyond the optical part and the haptic(s), and optionally has an antenna area of ​​30 mm² to 100 mm². Optionally, the antenna structure is further designed to support the capsular bag of the eye when the ophthalmic implant is implanted. For this purpose, the antenna structure can optionally be self-supporting to provide suitable rigidity. Alternatively or additionally, the antenna structure can be partially or completely mounted on a capsular tension ring that serves to support the capsular bag of the eye. The non-optical part can, for example, incorporate the capsular tension ring.This offers the advantage of achieving a large antenna surface area, which can optionally exceed the surface area of ​​the ophthalmic implant. Furthermore, the antenna structure, for example, acting like a mechanical spring, can be used to at least partially expand the capsular bag. This can therefore result in beneficial synergies through the multiple functionalities of the antenna structure.

[0042] Optionally, the antenna structure is designed to mechanically reinforce and / or stabilize the optical and / or non-optical components, particularly the haptic properties of the non-optical component. These optional embodiments with their various antenna structure arrangements also offer the advantage of enabling the realization of antenna areas of different sizes. This allows, for example, the sensitivity of the antenna structure to be adapted to specific characteristics, such as the expected transmission power of a reader and / or the expected distance of the reader from the antenna structure. In principle, a larger antenna area can achieve greater sensitivity.

[0043] Optionally, the antenna structure features one or more conductive traces, which at least partially run in straight, parallel coils and / or at least partially meander and / or wave-like patterns. This provides flexibility regarding the mechanical properties of the conductive traces. In particular, meandering coils can offer the advantage that the conductive traces are stretchable and / or compressible under mechanical tension and / or compression. This can be especially advantageous for ophthalmic implants that are subject to significant deformation during implantation, such as unfolding after insertion into a capsular bag, and / or deform during intended use in the implanted state, as is the case with accommodation-deformable IOLs.Optionally, the ophthalmic implant may only contain materials that exhibit the same or similar elasticity and / or the same or similar reaction or expansion behavior under applied forces, pressures, and heat. For example, the elastic moduli of the materials in the pressure range of 0.5 MPa to 3 MPa and a Poisson's ratio of 0.3 to 0.49 may be present. The coefficients of thermal expansion may, for example, range from 0.05 mm / m / K to 0.1 mm / m / K.

[0044] Optionally, the non-optical part has at least one arm-shaped haptic, and the antenna structure is at least partially located in a region of the arm-shaped haptic that experiences the lowest mechanical stresses during normal deformation of the arm-shaped haptic. For example, an inner part of the arm of the haptic may be subject to lower mechanical stresses during deformation than the outer parts of the arm. Accordingly, arranging the antenna structure in the inner part of the arm of the haptic can offer the advantage of keeping the mechanical stresses on the antenna structure lower than would be possible with a different arrangement of the antenna structure on the haptic.

[0045] Optionally, the antenna structure is designed such that, when the ophthalmic implant is implanted in the eye, it at least partially expands the capsular bag of the eye or supports the expansion of the capsular bag by the ophthalmic implant. For example, the non-optical part can have a three-dimensional structure or haptic element intended to expand the capsular bag. Optionally, the antenna structure is designed such that, when the ophthalmic implant is implanted, the antenna structure exhibits a periodic pattern on its surface and / or edges.The periodic structuring and / or the edges can cause mechanical friction between the antenna structure on the surface of the ophthalmic implant and the capsular bag and / or another part of the ocular tissue, which makes relative movement of the ophthalmic implant and the eye, in particular mutual slippage, more difficult and thus stabilizes the positioning of the ophthalmic implant in the eye.

[0046] Optionally, the antenna structure is made of a material that inhibits cell adhesion. In particular, the antenna structure can have a surface energy that differs from that of the optical and / or non-optical components, thereby counteracting cell adhesion and / or growth. This can at least partially prevent the development of posterior capsule opacification (PCO). A suitable ratio between the surface energy of the optical and / or non-optical components and the surface energy of the antenna structure can be achieved by selecting appropriate materials for both components.

[0047] Optionally, the contactless, electronically readable data storage unit includes an RFID tag or is designed as such. This offers the advantage that the data storage unit can be powered by an external reader if required, thus eliminating the need for an integrated power supply.

[0048] Optionally, the contactless electronically readable data storage unit can be read contactlessly using a separate reader in such a way that the distance between the contactless electronically readable data storage unit and the reader during a read operation can be selected in the range of 5 mm to 300 mm, optionally 10 mm to 200 mm, or optionally 25 mm to 75 mm. This offers the advantage that the reader does not need to be brought into mechanical contact with the eye during the read operation, although this may be possible according to some embodiments.

[0049] Optionally, the contactless, electronically readable data storage unit is designed to receive and / or transmit electronic signals within a specific frequency range between 100 kHz and 6 GHz. In particular, a frequency range that is approved, suitable, and / or recommended for use in medical products can be selected for communication with a reader.

[0050] Table 1 lists examples of different frequencies and frequency bands that are typically used in various types of intracorporeal medical devices and that can optionally also be used for an ophthalmic implant according to the present disclosure. Table 1: Intracorporeal medical devices Frequency(ies) implantable medical devices 402 MHz 433 MHz 868 MHz 915 MHz 1.4 GHz 2.45 GHz Ultra-wideband (UWB) around 6 GHz ingestible medical devices 433 MHz 500 MHz 800 MHz 1.2 GHz 1.4 GHz 2.4 GHz injectable medical devices 132 kHz 2 MHz 13.56 MHz 915 MHz

[0051] Optionally, the data storage unit can be designed to use a frequency of 13.56 MHz for contactless electronic data retrieval. This frequency can represent an advantageous compromise between antenna size, working distance to the reader, and expected signal losses or attenuation in air and tissue for an ophthalmic implant.

[0052] Table 2 lists examples of various antenna designs that are typically used in different types of intracorporeal medical devices and that can optionally also be used for an ophthalmic implant according to the present disclosure. Table 2 Intracorporeal medical devices Antenna designs implantable medical devices PIFA Patch Loop Monopolies ingestible medical devices Helica Spiral PIFA injectable medical devices Loop Dipole

[0053] Optionally, the optical and / or non-optical parts can be composed of multiple elements, i.e., they can be multi-part. These multiple elements can be assembled, i.e., connected, during the implantation process, so that the connected elements form the optical or non-optical part, respectively, and in particular, the ophthalmic implant. Optionally, the ophthalmic implant can comprise multiple connectable elements that exist separately and are joined together during the implantation process. For example, one element of the implant can comprise at least one segment of the non-optical part and at least one segment of the optical part, so that the connected parts form the implant.According to an optional embodiment, one element comprises the entire non-optical part and a portion of the optical part, while the other element comprises the remaining portion of the optical part. Thus, while in the unconnected state one element forms, among other things, the entire non-optical part, the optical part is only completed when the two elements are connected. This can facilitate the implantation process. Similarly, according to another optional embodiment, one element can comprise the entire optical part and a portion of the non-optical part, while the other element comprises the remaining portion of the non-optical part.

[0054] Optionally, the ophthalmic implant is designed such that the data storage unit is arranged around the optical component of the implant. The data storage unit can include an antenna structure shaped like a ring antenna, which is arranged around the optical component and optionally encloses it. Alternatively, the data storage element can be positioned near the edge of the optical component. This offers the advantage of allowing the entire data storage unit to be arranged compactly close to the optical component. "Near the edge of the optical component" means that the distance to the edge of the optical component is no greater than approximately 1 mm.

[0055] The features and embodiments mentioned above and explained below are not only to be regarded as disclosed in the combinations explicitly mentioned, but are also covered by the disclosure content in other technically meaningful combinations and embodiments.

[0056] Further details and advantages will now be explained in more detail using the following examples and optional embodiments with reference to the figures.

[0057] They show: Figure 1: Conventional markings of ophthalmic implants designed as intraocular lenses; Figure 2: Schematic representation of various scenarios in which unambiguous identification of the ophthalmic implant may be desirable; Figures 3A to 3H: Various optional embodiments of ophthalmic implants designed as intraocular lenses, each featuring differently designed data storage units with an antenna structure; Figures 4A and 4B: Various exemplary arrangements of conductor tracks of an antenna structure of an ophthalmic implant; Figure 5: A model of the haptic of a non-optical part of an intraocular lens, which reveals the mechanical stress occurring in the haptic during intended use of the intraocular lens in its implanted state.

[0058] For the sake of simplicity, identical or similar elements in the various embodiments are designated with the same reference numerals in the following figures.

[0059] Figure 1Figure 1 shows examples of conventional markings on ophthalmic implants designed as intraocular lenses. These include a packaging label 10 for intraocular lenses and a patient implantation passport 18. Specifically, the packaging label 10 shows the manufacturing date 12 in a date format according to ISO 8601, a device identification code 14 (Device Identifier, DI, GTIN, product identifier), and a production identification code 16 (Production Identifier, PI, Application Identifiers), which includes, for example, a serial number, a lot number, and / or an expiration date. The markings shown illustrate the information typically provided for the labeling of ophthalmic implants.Furthermore, the packaging marking 10 indicates that this information is not conventionally attached directly to the ophthalmic implant, but rather to the packaging of the ophthalmic implant or to a separate patient card. These methods of attachment have the disadvantage that a clear assignment and identification of the ophthalmic implant can be lost or become impossible, especially if the ophthalmic implant has been removed from its packaging and, for example, implanted in an eye.

[0060] Figure 2Figure 1 shows a schematic representation of various scenarios in which unambiguous identification of the ophthalmic implant may be desirable. According to the scenario described, information about the ophthalmic implant is stored on a server 22 or in a cloud, which is accessible via a network. Identification of the ophthalmic implant can, for example, occur during the implantation procedure, such as using an operating microscope 24. The operating microscope can be equipped with a reader capable of electronically reading data contactlessly from a data storage unit of the ophthalmic implant. This can be used, for example, to verify the correct assignment of the ophthalmic implant to the patient and / or to obtain information about the ophthalmic implant's properties that are helpful or necessary for the implantation procedure.For example, information to identify the ophthalmic implant and / or a network address to the server can be read from the data storage unit, and further information can be obtained from the server.

[0061] Even after surgery, when the implant is already in place, various scenarios can arise in which identifying and / or retrieving information about the ophthalmic implant is advantageous. This can be particularly relevant during eye examinations. Accordingly, medical devices used for eye examinations can also be equipped with a corresponding reader to electronically and contactlessly retrieve data from the ophthalmic implant's data storage unit. Figure 2Figure 24 shows, as an example, an operating microscope 24, which can be used during the implantation procedure, as well as a biometry device 26, a slit lamp 28 and an autorefractor 30, which can be used in post-operative applications.

[0062] The Figures 3A to 3D show various optional embodiments of ophthalmic implants 100, which are designed as intraocular lenses 102 and each have differently designed data storage units 112 with an antenna structure 112b.

[0063] The ophthalmic implants 100 and intraocular lenses 102 each have an optical part 108 and a non-optical part 110. The optical part 108 is formed by an optical lens that has a refractive and / or diffractive effect. The non-optical part 110 comprises two haptics connected to the optical part 108, which have an arm-like structure and extend away from the optical part. The non-optical part has no optical effect and need not necessarily be optically transparent.

[0064] The ophthalmic implants 108 further comprise a data storage unit 112, which in turn includes a data storage element 112a and an antenna structure 112b connected to the data storage element 112a. The data storage unit 112 is mounted on the optical and / or non-optical part of the ophthalmic implant. For example, the data storage unit 112 may have been mounted after the optical and non-optical parts were completed. The data storage unit can store or contain data on the data storage element 112a, which can be read electronically without contact using a suitable reading device. This can be done, for example, by means of electromagnetic waves, which can be received and transmitted by the data storage unit 112 via the antenna structure 112b.The data storage unit 112 can also be designed to be powered via the antenna structure 112b, which is supplied contactlessly by the reader, for example, via induction. The data storage unit can be designed as or include an RFID tag or RFID chip. Such ophthalmic implants 100 offer the advantage over those with optical markings that contactless electronic reading is possible even when the data storage unit 112 is partially or completely covered in its implanted state, for example, by the iris of the eye.

[0065] The various designs which are in the Figures 3A to 3D The data storage units 112 shown differ in their design. These differ in particular in the design and / or arrangement of the antenna structure 112b, which are explained below.

[0066] According to the embodiment in Figure 3A The data storage unit 112 is arranged entirely on one of the haptics of the non-optical part 110. In particular, the data storage unit is arranged on the leading haptic of the intraocular lenses 102. As shown in Figure 3A As can be seen, the data storage element 112a and the entire antenna structure 112b are arranged on the same haptic surface. The antenna structure runs in a loop-shaped arrangement with multiple loops exclusively on this single haptic surface. An arrangement in just one loop is also possible. The antenna structure 112b can have an antenna area of ​​approximately 3.5 mm² to 4 mm². This embodiment offers the advantage that the data storage unit can be arranged exclusively on the non-optical part 110, and in particular on a single haptic surface, thus eliminating the need to arrange the data storage unit 112 on the optical part.

[0067] According to the in Figure 3B In the illustrated embodiment, the data storage unit 112 extends over both haptics of the non-optical part as well as over a peripheral area of ​​the optical part. As in the previous embodiment, the data storage element 112a is arranged on a haptic. However, the antenna structure extends over both haptics and also over the peripheral area of ​​the optical part 108, with several loops encircling the peripheral area of ​​the optical part 108. This offers the advantage of achieving a large antenna area, for example, approximately 30 mm².

[0068] According to the in Figure 3CIn the illustrated embodiment, the antenna structure 112b is arranged such that it circumscribes the contour of the intraocular lens 102 once. The antenna structure 112b circumscribes the intraocular lens only once, although multiple circumscriptions are possible. Such an arrangement offers the advantage that a large antenna area, approximately 10 mm², can be achieved while minimizing the superposition of the optical part 108 by the antenna structure 112b, limiting it to the outermost peripheral region. Furthermore, the arrangement offers the advantage that the antenna structure can contribute to the mechanical stabilization of the intraocular lens 102.

[0069] According to the in 3D figureIn the illustrated embodiment, the data storage unit 112 is mounted on the ophthalmic implant in such a way that it partially extends beyond the implant. Specifically, the data storage element 112a is mounted on one of the haptics of the intraocular lens 102, and the antenna structure 112b is attached to each of the two haptics. However, the antenna structure 112b extends significantly beyond the optical and non-optical parts and, according to the illustrated embodiment, spans a circular arc. This offers the advantage of achieving a significantly larger antenna area, approximately up to 100 mm², and consequently, high sensitivity of the data storage unit 112. Furthermore, this design of the antenna structure 112b allows the capsular bag of the eye to be stretched or mechanically stabilized by means of the antenna structure 112b in the implanted state.

[0070] The Figures 3E to 3Gfurther optional embodiments of ophthalmic implants 100 show. These are also designed as IOLs and differ from the embodiments of the Figures 3A to 3D in the form of their haptics. In other words, these ophthalmic implants 100 each have a non-optical part 110 that is shaped differently from the non-optical part 100 of the embodiments in the Figures 3A to 3D . In some embodiments of this design, the data storage unit 112 is arranged only in the non-optical part 110, and in other embodiments in both the optical part 108 and the non-optical part 110.

[0071] Figure 3HFigure 1 shows an ophthalmic implant according to a further optional embodiment, which is designed as an IOL. The non-optical part has three-dimensionally shaped haptics, which are spaced apart from one another along the optical axis. This offers the advantage that, for example, the capsular bag can be at least partially three-dimensionally stretched by means of the haptic(s) in the implanted state. The haptics can optionally be mechanically reinforced by the antenna structure 112b. This allows for a larger volume in the capsular bag and thus enables or increases the flow of aqueous humor. In other words, this allows for an "open" capsular bag.

[0072] Figure 4AFigure 1 shows exemplary arrangements of conductor tracks 114 of an antenna structure 112b of an ophthalmic implant 100. The dimensions in the plane of the ophthalmic implant are denoted by the exemplary coordinate systems x and y. According to the illustrations in Figure 4AThere are several possibilities for the arrangement of the conductor tracks 114 of the antenna structure 112b. According to one possibility, the antenna structure 112b is formed by a single, straight conductor track 114a, which results in particularly simple manufacturing of the antenna structure and a particularly small footprint on the optical part 108 and / or non-optical part 110 of the ophthalmic implant 100. This also offers the advantage of facilitating a connection between an external read / write device and the data storage unit from the front, since the coil surface is essentially perpendicular to the optical axis of the ophthalmic lens and, accordingly, perpendicular to the optical axis of the eye when implanted. "From the front" means that the read / write device is located in front of the cornea of ​​the eye.According to a further embodiment, the antenna structure 112b is formed by a single conductor track 114b, which runs in a meandering or wave-like pattern. This offers the advantage that the effective antenna area can be increased and mechanical flexibility can also be achieved with regard to possible compression and / or stretching. The latter can be particularly advantageous with regard to any folding and unfolding of the ophthalmic implant 100 that may be necessary during implantation. In a further embodiment, the antenna structure 112b is formed by several conductor tracks 114c running parallel in loops. This offers the advantage that the effective antenna area can be increased by means of multiple loops. A greater length of the antenna structure 112b and / or a greater number of loops can optionally increase the performance of the antenna structure 112b.

[0073] According to further embodiments, antenna structures can also be provided with multiple arrangements of the conductor tracks, so that the antenna structure 112b has several sections with different arrangements of the conductor track(s).

[0074] Figure 4B shows another optional embodiment, which differs from the one in Figure 4A The embodiment shown differs in that the antenna structure 112b extends only in the area of ​​a haptic of the non-optical area 110, and unlike in the one shown in Figure 4AIn the illustrated embodiment, the antenna structure 112 does not surround the optical part 108 and does not extend into the area of ​​the second haptic. This offers the advantage that the antenna structure 112 is not formed in the area of ​​the transition from the non-optical part 110 to the optical part 108, where large mechanical forces and correspondingly high loads on the antenna structure 112 can occur, particularly during the folding and unfolding of the ophthalmic implant.

[0075] In general, the orientation of the conductor tracks 114c of the antenna structure 112b is independent of the precise arrangement of the antenna structure 112b in and / or on the ophthalmic implant. This means that a straight, meandering, and / or looped orientation of the conductor tracks can be chosen regardless of whether the antenna structure extends only within a non-optical area 110 or in and / or around the optical area 108 of the ophthalmic implant 100. Antenna structures 112b are also possible in which the conductor tracks 114c exhibit different orientations in different sections. The in Figure 4A The depicted routing patterns of the conductor tracks 114c are therefore not necessarily identical to those shown in Figure 4A and Figure 4BThe arrangements of the antenna structure 112b shown as examples are coupled to the ophthalmic implant. Likewise, the routing of the conductor tracks 114c can be configured such that it also exhibits variation in the z-direction, i.e., parallel to the optical axis of the eye (in the implanted state) and / or to the optical axis of the ophthalmic implant. For example, the antenna structure 112b can also have a meandering, wavy, or looped path in the z-direction. This can be advantageous for facilitating a connection between an external read / write device and the data storage unit from the side, i.e., perpendicular to the optical axis of the eye (in the implanted state) and / or perpendicular to the optical axis of the ophthalmic implant.

[0076] Figure 5Figure 1 shows a model of the haptic of a non-optical part 110 of an intraocular lens, which reveals the mechanical stress occurring in the haptic during intended use of the intraocular lens in its implanted state. It is evident that particularly high mechanical stresses occur in the peripheral regions of the arm-shaped haptic when subjected to pressure, while an inner, central region remains largely stress-free. Accordingly, this embodiment proposes placing the antenna structure 112b in the central region of the haptic to minimize undesirable deformation of the antenna structure under mechanical stress. The right-hand side shows a detailed arrangement of the conductor track or the antenna structure 112b in the center of the haptic.For example, the antenna structure 112b can be formed by a conductor track 114 made of a copper wire with a cross-sectional area of ​​20 µm x 20 µm, which is attached to the haptic. The deformation of the conductor track during mechanical deformation of the haptic is very small in such an arrangement and, in particular, significantly smaller than the plastic deformability of the copper wire forming the conductor track 114. Reference symbol list

[0077] 10 Packaging label 12 Date of manufacture 14 Device identification code 16 Production identification code 18 Implantation passport 22 Server 24 Operating microscope 26 Biometric device 28 Slit lamp 30 Autorefractor 100 ophthalmic implant 102 intraocular lens 108 optical part 110 non-optical part 112 data storage unit 112a data storage element 112b antenna structure 114 conductor

Claims

1. Ophthalmic implant (100), comprising: - an optical part (108) with an optical effect, - a non-optical part (110) connected or connectable to the optical part (108), - a data storage unit (112) which can be read out electronically in a contactless manner when the ophthalmic implant (100) is in the implanted state and which contains data which can be read out electronically in a contactless manner, said data rendering the ophthalmic implant (100) identifiable; wherein the data storage unit (112) which can be read out electronically is applied to the non-optical (110) and / or the optical part (108) and is arranged in such a way that the optical effect of the optical part (108) is substantially not impaired by the data storage unit (112) which can be read out electronically, characterized in that a Young's modulus and / or a coefficient of thermal expansion of the data storage unit (112) which can be read out electronically in a contactless manner substantially corresponds to a Young's modulus and / or a coefficient of thermal expansion of the optical part (108) and / or the non-optical part (110).

2. Ophthalmic implant (100) according to Claim 1, wherein the data storage unit (112) which can be read out electronically in a contactless manner comprises a data storage element and an antenna structure.

3. Ophthalmic implant (100) according to Claim 2, wherein the antenna structure (112b) - is arranged exclusively on a haptic of the non-optical part (110) and optionally has an antenna area of 2 mm2 to 5 mm2; or - is arranged on one or more haptics of the non-optical part (110) and in a peripheral region of the optical part (110) and optionally has an antenna area of 6 mm2 to 30 mm2; or - is arranged on the ophthalmic implant (100) in such a way that the antenna structure (112b) extends along an outer contour of the ophthalmic implant (100) and optionally has an antenna area of 6 mm2 to 30 mm2; or - is arranged in such a way that the antenna structure (112b) extends beyond the outer contour of the optical part (108) and the non-optical part (110) of the ophthalmic implant (100) and optionally has an antenna area of 30 mm2 to 100 mm2 and is optionally designed to span the capsular bag of the eye when the ophthalmic implant (100) is in an implanted state in an eye.

4. Ophthalmic implant (100) according to Claim 2 or 3, wherein the antenna structure (112a) comprises one or more conductor paths (114), which - extend, at least in part, in straight, mutually parallel turns; and / or - extend, at least in part, in meandering fashion.

5. Ophthalmic implant (100) according to any of Claims 2 to 4, wherein the non-optical part (110) comprises at least one arm-shaped haptic and wherein the antenna structure (112b) is arranged, at least in part, in a region of the at least one arm-shaped haptic which has the lowest mechanical stresses in a customary deformation of the arm-shaped haptic during use.

6. Ophthalmic implant (100) according to any of Claims 2 to 5, wherein the antenna structure (112b) is designed such that it at least partially spans the capsular bag of the eye when the ophthalmic implant (100) is in an implanted state in an eye, and wherein the antenna structure (112b) is optionally designed such that the antenna structure has a periodic structuring of the antenna surface and / or edges when the ophthalmic implant (100) is in the implanted state.

7. Ophthalmic implant (100) according to any of Claims 2 to 6, wherein the antenna structure (112b) is designed such that it mechanically strengthens and / or stabilizes the optical part (108) and / or the non-optical part (110), in particular a haptic of the non-optical part.

8. Ophthalmic implant (100) according to any of the preceding claims, wherein the ophthalmic implant (100) is designed as an intraocular lens (102) and / or wherein the optical part (108) comprises a lens with a refractive and / or diffractive effect or is designed as such.

9. Ophthalmic implant (100) according to any of the preceding claims, wherein the non-optical part (110) comprises one or more haptics.

10. Ophthalmic implant (100) according to any of the preceding claims, wherein the data which can be read out electronically comprise one or more of the following pieces of information: - a unique identifier for identifying the ophthalmic implant (100); - a piece of information about one or more properties of the implant (100), in particular an optical property, a material property, a property relating to a haptic platform, a property relating to an IOL design, and / or a property relating to a manufacturing process for the ophthalmic implant (100); - a piece of information about the patient in whom the ophthalmic implant (100) has been implanted or for whom the ophthalmic implant (100) is intended; - a piece of information regarding the implantation of the ophthalmic implant (100); - a piece of information provided by a sensor connected to the ophthalmic implant (100); - a network address where data with information about the ophthalmic implant (100) and / or the patient are stored and / or can be stored.

11. Ophthalmic implant (100) according to any of the preceding claims, wherein the data storage unit (112) which can be read out electronically in a contactless manner is applied to the non-optical (110) and / or the optical part (108) by means of at least one of the following attachment types: adhesive bonding, laminating.

12. Ophthalmic implant (100) according to any of the preceding claims, wherein the data storage unit (112) which can be read out electronically in a contactless manner comprises an RFID tag or is designed as such.

13. Ophthalmic implant (100) according to any of the preceding claims, wherein the data storage unit (112) which can be read out electronically in a contactless manner can be read out in a contactless manner by means of a separate reader, wherein a distance during a read-out process between the data storage unit which can be read out electronically in a contactless manner and the reader can be optionally chosen in the range from 5 mm to 300 mm, optionally from 10 mm to 200 mm, optionally 25 mm to 75 mm; and / or wherein the data storage unit (112) which can be read out electronically in a contactless manner is designed to receive and / or transmit electronic signals which are located in a certain frequency range between 100 kHz and 6 GHz.

14. Ophthalmic implant (100) according to any of the preceding claims, wherein the optical part (108) and / or the non-optical part (110) are each formed of multiple elements.

15. Method for manufacturing an ophthalmic implant (100), the method comprising the following steps: - providing an ophthalmic implant (100) having an optical part (108) and a non-optical part (110) connected or connectable to the optical part (108); - applying a data storage unit (112) which can be read out electronically in a contactless manner, the application being such that the optical effect of the optical part is substantially not impaired by the data storage unit (112) which can be read out electronically, characterized in that the data storage unit (112) which can be read out electronically in a contactless manner is designed such that a Young's modulus and / or a coefficient of thermal expansion of the data storage unit (112) which can be read out electronically in a contactless manner substantially corresponds to a Young's modulus and / or a coefficient of thermal expansion of the optical part (108) and / or the non-optical part (110).