Patent Application
20240173170
The present disclosure relates to an ophthalmological patient interface for application to an eye of a patient and to a method of manufacturing the ophthalmological patient interface. In particular, the present disclosure relates to an ophthalmological patient interface and to a method of manufacturing the ophthalmological patient interface, wherein at least one of: the coupling portion or the eye fixation portion comprises a patient-specific portion.
Ophthalmological treatment devices, which use a laser for eye treatment, are known. The ophthalmological treatment device has a laser source, which produces a pulsed laser beam. The wavelength of the laser light produced by the ophthalmological treatment device is dependent on the type of eye treatment and is typically in the ultraviolet (190 nm to 230 nm) or infrared (780 nm to 1100 nm) range.
The laser beam is typically produced by a laser source arranged in a base station. The laser beam is then guided along a beam path to a laser applicator, where the laser beam is focused onto a patient's eye. The laser applicator can be movably connected to the base device, for example by way of an articulated arm, wherein the articulated arm may simultaneously serve for optical beam guidance from the laser light source to the laser applicator.
Mechanical and optical coupling of the laser applicator to the patient eye, for example to the cornea of the patient eye, is conventionally carried out by way of a patient interface, wherein the patient interface may comprise a transparent contact body, through which the laser pulses emerging from the projection lens are guided and which, by way of a mechanical contact with the cornea of the eye, fixes the latter with respect to the patient interface and the laser applicator.
The human eye and in particular the cornea of the human eye does not have a perfect spherical shape. Each eye has a different shape, which deviates at least partially from the perfect spherical shape.
The available conventional patient interfaces are standard parts available in a single size. This patient interface comprises a rotationally symmetric contact surface, which is configured to contact the eye of the patient. The rotationally symmetric contact surface has a flat circular or ring circular shape and deforms the eye of the patient to achieve the desired contact over the whole available contact surface. The standard patient interface is therefore never perfectly aligned with a specific eye of a patient. This could lead to an unstable coupling of the patient interface to the eye, an undesired decoupling of the patient interface during eye treatment or to an injury of the eye due to a strong deformation of the eye of the patient. Further, the available standard patient interface could have a contact conflict with an eye-surrounding surface of the patient. For example, a big nose or face deformities could make it impossible to apply the standard patient interface on the eye of the patient for treatment.
It is an object of the present disclosure to provide an ophthalmological patient interface for application to an eye of a patient and to provide a method of manufacturing an ophthalmological patient interface. In particular, it is an object of the present disclosure to provide an ophthalmological patient interface and a method of manufacturing the ophthalmological patient interface, which does not have at least some of the disadvantages of the prior art.
According to the present disclosure, these objects are addressed by the features of the independent claims. In addition, further advantageous embodiments follow from the dependent claims and the description.
According to the present disclosure, an ophthalmological patient interface for application to an eye of a patient is specified. The ophthalmological patient interface comprises a coupling portion configured to be arranged on a laser applicator of an ophthalmological laser treatment system, an eye fixation portion configured to be arranged on the eye of the patient and a passage, extending through the coupling portion and the eye fixation portion. The passage is configured to enable a treatment laser beam from the laser applicator to pass through the ophthalmological patient interface. The coupling portion and/or the eye fixation portion comprises a patient-specific portion, shaped individually with respect to a surface shape of the eye of the patient and/or a surface shape of a surrounding of the eye of the patient. The patient-specific portion is for example a part or a section of the coupling portion and/or the eye fixation portion or the entire coupling portion and/or the entire eye fixation portion. Further, the patient-specific portion may form the entire ophthalmological patient interface. The patient is for example a mammal, in particular a human, a dog or a cat. Further, the surface shape of the eye of the patient, which may be the basis for the patient-specific portion of the ophthalmological patient interface, may be the surface shape of a donor eye. In other words, a surface shape of a donor eye, which is for example treated by the ophthalmological laser treatment device to provide eye tissue for a cornea transplantation, determines the shape of the patient-specific portion. Another designation of patient-specific portion is patient-matched portion.
The patient-specific portion of the ophthalmological patient interface enables to position the ophthalmological patient interface perfectly aligned on the individually formed eye of the patient and/or perfectly aligned with respect to the individually formed shape of the eye surrounding surface of the patient. The ophthalmological patient interface according to the present disclosure reduces or avoids undesired detachments during treatment and reduces or avoids injuries of the eye. Further, with the ophthalmological patient interface according to the present disclosure it is possible to treat eyes of patients, which are not treatable with a standard conventional ophthalmological patient interface.
In an embodiment, the patient-specific portion is individually shaped with respect to the shape of the nose of the patient, the shape of the eye sockets of the patient and/or the shape of deformities of the face of the patient, which surround the eye. The surface shape of the surrounding of the eye of the patient comprises the shape of the nose of the patient, the shape of the eye socket of the patient and/or the shape of deformities of the face of the patient. These eye surroundings, for example, a big nose of the patient, deep eye sockets of the patient or other face deformities, for example due to an accident, may limit the usage of a standard patient interface. Using the ophthalmological patient interface comprising the patient-specific portion, which is individually shaped based on the above-mentioned surroundings of the eye of the patient, enables to extend the treatment possibilities.
In an embodiment, the patient-specific portion is individually shaped with respect to a geometrical shape of the eye of the patient, in particular with respect to a diameter of the eye of the patient, a curvature radius at a planned contact position of the eye of the patient, an irregular curvature of the cornea of the eye of the patient, an irregular curvature of the limbus of the eye of the patient and/or an irregular curvature of the sclera of the eye of the patient. The geometrical dimensions of the eye of the patient define the surface shape of the eye. In particular, the above-mentioned geometrical dimensions and irregularities define the actual patient individual surface shape of the eye of the patient. Taking into account at least some of the above-mentioned geometrical dimensions and irregularities advantageously improves the individual shape of the patient-specific portion of the ophthalmological patient interface with respect to the individual shape of the eye of the patient. For example, the patient-specific portion has at least partially the complementary shape of the individual surface of the eye, onto which the ophthalmological patient interface is designed to be placed. Thereby, corneal astigmatisms, or other malalignments or disease of the eye may be advantageously compensated.
In an embodiment, the coupling portion and the eye fixation portion are two separate parts of the ophthalmological patient interface, which are configured to be coupled together to form the ophthalmological patient interface, wherein the eye fixation portion comprises the patient-specific portion. The coupling portion and the eye fixation portion are for example coupled together via an engaging mechanism, which forms, for example, a form-fit coupling between these two parts. In an embodiment, the coupling portion is for example a standard part (off the shelf) and the individually shaped eye fixation portion, comprising the patient-specific portion, is configured to be coupled to the coupling portion to form the ophthalmological patient interface. In another embodiment, the coupling portion comprises the patient-specific portion, for example individually shaped with respect to the surface shape of the surrounding of the eye of the patient. In this embodiment, the eye fixation portion may be a standard part (off the shelf) and the coupling portion comprises the patient-specific portion. An individually shaped coupling portion and an individually shaped eye fixation portion is also conceivable.
In an embodiment, the patient-specific portion of the ophthalmological patient interface is at least partially or entirely made of bio-compatible and/or sterilizable material. In a further embodiment, the entire ophthalmological patient interface is made of a sterilizable material.
In an embodiment, the ophthalmological patient interface is at least partially made of metals, for example stainless steel or titan. In a further embodiment, the ophthalmological patient interface may comprise an oxidized metal surface.
In another embodiment, the ophthalmological patient interface is at least partially made of thermoplastics in particular of medical grade, for example: glycol-modified polyethylenterephthalat (PETG), polymethylmethacrylat (PMMA), low density polyethylene (LDPE), high density polyethylene (HDPE), polypropylene (PP), polyamide (PA), polyetheretherketon (PEEK, e.g. KetaSpire®), polyetherimide (PEI), acrylnitril-butadien-styrol-copolymer (ABS), polycarbonate (PC, e.g. Lexan®, Makrolon®), polyetheretherketon (PAEK, e.g. AvaSpire®), polyacrylamide (PARA, e.g. Ixef®), polyphenylsulfone (PPSU, e.g. Radel®), polysulfone (PSU, e.g. Udel®), polydimethyl siloxane (PDMS) or a combination thereof.
In another embodiment, the ophthalmological patient interface is at least partially made of thermoplastic elastomers, in particular of medical grade.
In another embodiment, the ophthalmological patient interface is at least partially made of a light-curing plastic (photopolymer), for example acrylic, epoxy or vinyl ester resin. These materials are for example used in a bath-based photopolymerization process for manufacturing of the patient-specific portion.
In another embodiment, the ophthalmological patient interface is at least partially made of ceramic materials, for example glass-based systems (mainly silica), glass-based systems (mainly silica) with fillers, usually crystalline (typically leucite or, more recently, lithium desilicated), Crystalline-based systems with glass fillers (mainly alumina) or polycrystalline solids (alumina and zirconia).
In an embodiment, the materials as described above are manufactured or treated in a quality that they still act as medical safe devices, therefore each raw material can be suitable by itself, but can change during manufacturing or in connection with other materials or environments, such that a safe application is no longer guaranteed.
In an embodiment, the ophthalmological patient interface is made of materials and is made using known manufacturing processes, which in combination provide a high probability that the resulting material is suitable for the required application in the patient-specific portion of the ophthalmological patient interface. The manufacturing processes may comprise finishing steps, which may turn biological incompatible materials into compatible materials. For example, tetrahydrofuran is used as solvent for ophthalmological patient interface devices during a coating process and is in its liquid form hazardous to mucosal tissue (e.g. eye tissue). Due to hardening and evaporation, the remains are totally compatible and suitable for application on eye tissue. In another embodiment, a polymer, which is in its raw form completely inert, can turn hazardous due to usual manufacturing processes with ray or gas treatment. Since polymer-deformed molecule cracks can occur and release unwanted emissions such as formaldehyde for example. Therefore, the testing and validation of the finished product is of high importance.
In an embodiment, the eye fixation portion comprises an at least partially transparent contact body, which is arranged in the passage at the eye facing end of the eye fixation portion, and which is configured to contact the cornea and/or the sclera of the eye, wherein the contact body comprises the patient-specific portion. In other words, the contact body, which forms part of the eye fixation portion, comprises the patient-specific portion. The contact body has for example an applanating or a non-applanating shape. The applanating contact body is configured to deform the surface of the eye of the patient and the non-applanating contact body is configured to conform/align with the surface of the eye of the patient. Deforming the surface of the eye, for example the surface of the cornea of the eye, is critical: deforming a surface of the eye which has deformities, for example a strong astigmatism is even more critical. The patient-specific portion of the contact body can take into account the individual shape of the surface of the eye, for example the individual irregularities of the cornea of the eye of the patient. This results in an advantageous application of the contact body on the surface of the eye, in particular using the patient-specific applanating contact body. In an embodiment, the contact body comprising the patient-specific portion is a separate part arranged at the eye fixation portion. In another embodiment, the contact body comprising the patient-specific portion is integrally formed with the eye fixation portion.
In an embodiment, the contact body is made of glass or the same material as the eye fixation portion. In an embodiment, the contact body is made of at least one of the materials described above with respect to the patient-specific portion of the ophthalmological patient interface, in particular of an at least partially transparent material.
In an embodiment, a geometrical extension of the patient-specific portion is limited to a predefined enveloping geometry at least partially surrounding the ophthalmological patient interface. The predefined enveloping geometry defines/limits for example the maximum possible extension of an eye contact surface of the eye fixation portion towards a specific direction. The enveloping geometry is for example a virtual box or sphere surrounding the ophthalmological patient interface in which the patient-specific portion may extend until it reaches the inner border of the virtual box or sphere. Other shapes of the enveloping geometry are also conceivable. For example, the enveloping geometry may also be a plane surface. The enveloping geometry does not need to completely envelop the ophthalmological patient interface; partially enveloping or partially limiting is also conceivable. In an embodiment, the enveloping geometry comprises specific predefined parameter ranges for different features of the ophthalmological patient interface. The different features are for example, suction openings, which need a minimal effective suction surface for advantageous positioning: another example is the diameter of the passage, which should, for example, not fall below a predefined minimal value. Analogously, there is a maximal diameter of the human eye. Additional parameters or parameter ranges for other features of the ophthalmological patient interface are also conceivable, for example curvature radii. Further, the enveloping geometry may be at least partially determined using an eye model, for example the Gullstrand model eye.
In an embodiment, the enveloping geometry defines or comprises representative intermediate variables or ranges, which cover predefined parameter ranges for different dimensions of the patient-specific portion. Further, individual customizations of the patient specific portion are for example, interpolations of the predefined parameter ranges or a combination of interpolations.
The approval process of different medical parts requires sometimes many different steps, in particular, in case the medical device is configured to contact the human body. It could be that each individually shaped part needs to go through the approval process. The patient-specific portion of the ophthalmological patient interface could require to go through the approval process for each individually shaped ophthalmological patient interface. The enveloping geometry enables to meet automatically the approval requirements for each patient-specific portion of the ophthalmological patient as long as it is shaped within the enveloping geometry. For example, the approval process for the ophthalmological patient interface is performed for the enveloping geometry, such that each patient-specific portion, which is arranged within the enveloping geometry, meets automatically the approval/certification requirements.
In an embodiment, the enveloping geometry has the shape of a standard ophthalmological patient interface plus a predefined extension in at least one direction, preferably in all directions, wherein the extension is in the range from 0.05 mm to 20 mm, preferably in the range from 0.1 mm to 5 mm.
In an embodiment, the enveloping geometry is determined prior to the determination of the patient specific portion. The enveloping geometry may comprise minimum and maximum dimensions, mechanical performance limits and/or other clinically relevant factors for the required application on the eye of the patient.
In an embodiment, the patient specific portion is accomplished or designed by specific techniques, in particular software-based techniques, such as scaling of at least one dimension or group of dimensions of a base model of the ophthalmological patient interface. The dimensions to be scaled are, for example, selected based on the surface shape of the eye and/or a surface shape of the surrounding of the eye of the patient. In a further embodiment, the patient-specific ophthalmological patient interface is designed using full anatomic features of the eye and/or the surrounding received from an imaging device.
In an embodiment, the dimensions to be varied of the patient-specific portions are categorized, for example, in a first and second category: the first category comprises clinically relevant dimensions, for example, dimensions, which define the eye contacting surface: the second category comprises clinically, not relevant dimensions, for example, dimensions which define a distance to surroundings of the eye. The dimensions of the first category may have different tolerance and approval requirements than the dimensions of the second category. The patient specific portion is advantageously designed using a manipulation software, which already comprises the predefined enveloping geometry and/or further limitations. Any software or procedure used to make modifications to the patient specific design based on clinical input (shape of the eye and/or shape of the surrounding) should include internal checks that prevent the operator from exceeding the pre-established device specifications, which are for example documented in a device master record.
In an embodiment, the eye fixation portion comprises a rotationally asymmetric contact surface, which is formed by the patient-specific portion, wherein the rotationally asymmetric contact surface is configured to contact the sclera and/or the cornea of the eye of the patient. Rotational symmetry, also known as radial symmetry, in geometry, is the property a shape has when it looks the same after some rotation by a partial turn. Rotational asymmetry on the contrary is, according to this embodiment, the property a shape has when it looks not the same after some rotation by a partial turn. Certain geometric objects are partially symmetrical, but still rotational asymmetric, when rotated at certain angles such as squares rotated 90°; however, the only geometric objects that are truly rotationally symmetric at any angle are spheres, circles, spheroids and solids of revolution. The rotationally asymmetric contact surface provides the advantageous possibility to apply the ophthalmological patient interface non-coaxially with the optical axis of the eye. The ophthalmological patient interface can be applied, for example, laterally next to the optical axis of the eye, which substantially increases the possible treatment surface for the treatment laser beam.
The optical axis of the eye is for example the straight line between the centers of curvature of refractive surfaces of the eye. The optical axis of the eye may further be the visual axis of the eye, which runs from the fovea centralis of the eye through the nodal point of the eye to the object of fixation. The optical axis of the eye may further be the line of sight of the eye, which is the straight line from the fixation point reaching the fovea centralis through the pupil center. The optical axis of the eye may further be the pupil axis, which is the straight line between the center of the cornea and the center of the pupil. Angular deviations of this axis are usually less than 5 degrees. The optical axis may further be a geometrical combination (best fit) between two or more of the above-mentioned different axis of the eye.
The asymmetric contact surface for a decentralized application on the eye of the patient is in particular simple an advantageous realizable by the patient-specific portion. For example, the patient of the eye may comprise a disease, like a pterygium, which is located laterally next to the cornea of the eye at a specific position. An advantageous alignment of the patient interface above the center of the pterygium, for an advantageous treatment of the pterygium, is realizable by the patient-specific portion shaped with respect to the orientation and location of the pterygium itself. In other words, the patient-specific portion of the ophthalmological patient interface is shaped based on the position and orientation of the pterygium to be treated. The asymmetric contact surface for the desired decentralized application, for example centrally above the pterygium, is in particular easily and advantageously realizable by the patient-specific portion.
In a further embodiment, the patient-specific portion is a single part, which forms part of the coupling portion or the eye fixation portion, and which is configured to be attached/mounted to the eye fixation portion or the coupling portion.
In an embodiment, the eye fixation portion of the ophthalmological patient interface comprises a suction opening configured to be fluidically connected to a negative pressure, wherein the patient-specific portion forms the shape of the suction opening. In other words, the suction opening is at least partially the patient-specific portion. For example, different surface structures of the eye of the individual patient may require to individually position the suction openings of the ophthalmological patient interface at an individual position, for an advantageous application of the ophthalmological patient interface on the eye of the patient. In a further embodiment, the ophthalmological patient interface comprises at least one additional opening extending through the eye fixation portion and/or coupling portion. The at least one additional opening is, for example, configured to enable access for instruments, or to inject or extract fluids, in particular into the passage.
In an embodiment, the eye fixation portion comprises protrusions, which are configured to penetrate tissue of the sclera or the cornea respectively of the eye of the patient, and wherein the patient-specific portion defines the shape and/or the position of the protrusion on the eye fixation portion. In an embodiment, the protrusions are spike shaped and extend from the eye fixation portion. The protrusions have for example a pyramid shape. In a further embodiment, the protrusions are arranged only on the area of the eye fixation portion, which is configured to be placed on the sclera of the eye of the patient. The sclera tissue is relatively soft compared to the cornea tissue, which is advantageous for the required penetration of the spikes in the sclera tissue to position the ophthalmological patient interface rigidly on the eye.
In an embodiment, the ophthalmological patient interface comprising the patient-specific portion, further comprises a patient identifier, which is configured to identify the ophthalmological patient interface to the patient. In other words, the patient identifier connects the individually shaped ophthalmological patient interface to the patient. The patient identifier is for example a code (QR-code, bar-code) directly integrated in the ophthalmological patient interface or attached to the ophthalmological patient interface. The code is, for example, manufactured on the ophthalmological patient interface during, prior or after the manufacturing of the patient-specific portion. In another embodiment, the patient identifier is a radio frequency identification tag, attached on the ophthalmological patient interface or on a packaging of the ophthalmological patient interface. For example, it may be required to scan or identify the ophthalmological patient interface, which is determined to be arranged on the laser applicator, prior to the eye treatment of the patient, in order to ensure that the right patient specific ophthalmological patient interface is used for the right patient. It is important to ensure that the right ophthalmological patient interface is used for the right patient. This may be in particular important because days or weeks can be in between manufacturing and using of the ophthalmological patient interface.
In a further aspect of the present disclosure, a method of manufacturing an individually shaped ophthalmological patient interface is specified. The method comprising the following steps:
The measuring device is for example an optical coherence tomography device or a triangulation device, which measures in a preparatory step the surface of the eye and/or the eye surrounding surface of the patient. The measurement data is afterwards for example sent to the computing device. The measurement device and the computing device are for example one single device. In other words, the measurement device may also act as computing device and determines the shape of the surface of the eye and/or the shape of the eye surrounding surface using the measurement data. The computing device is for example a specific processor for the determination of the shape of the surface of the eye and/or the shape of the eye surrounding surface of the patient. The shape of the eye surrounding surface is for example the shape of the nose of the patient, the shape of the eye socket of the patient and/or the shape of deformities of the face of the patient.
In an embodiment, the step of manufacturing comprises adding material, by an additive manufacturing device, for forming the patient-specific portion. The additive manufacturing device is for example a 3D printer or any other device, which is configured to manufacture the patient-specific portion by addition material. The coupling portion and/or the eye fixation portion comprising the patient-specific portion is/are for example completely additively manufactured. The additive manufacturing device is for example configured to use a binder jetting technology, a direct energy deposition technology, a material extrusion technology, a powder-bed fusion technology, a sheet lamination technology, a vat polymerization technology and/or a direct energy deposition-arc technology.
In an embodiment, the method further comprises the steps of providing a blank coupling portion and/or a blank eye fixation portion and additively manufacturing, by the additive manufacturing device, the patient-specific portion onto the blank coupling portion and/or the blank eye fixation portion, by adding material onto the blank portion(s). The blank coupling portion, the blank eye fixation portion or a blank ophthalmological patient interface is for example a standard part having a predefined shape, which is configured to be placed in the additive manufacturing device, and which is further configured such that the patient-specific portion is additively applicable by adding material on the provided blank part(s). Another word for the blank unmachined parts is blank or slug.
In an embodiment, manufacturing comprises removing material, by a removing device, for forming the patient-specific portion of the ophthalmological patient interface. The removing device is for example a grinding device, a milling device or another material cutting manufacturing device. In an embodiment, the material removing, by the removing device, is performed after the additive manufacturing, for example, as a finishing step of the patient-specific portion.
In an embodiment, the method further comprises the step of manufacturing, by the removing device, the patient-specific portion out of the blank coupling portion and/or the blank eye fixation portion, by removing material from the blank unmachined portion(s). An unmachined eye fixation portion or an unmachined coupling portion is a part, which has not been processed by the material removing manufacturing step. In an embodiment, the unmachined coupling portion and/or the unmachined eye fixation portion has at least partially the extensions and/or the shape of the enveloping geometry.
In an embodiment, the method further comprises the step of post processing of the manufactured patient specific portion of the ophthalmological patient interface. Post processing may comprise heat treatment, removing of manufacturing residues and/or final machining.
In an embodiment, the step of measuring is performed by an optical coherence tomography device, a Scheimpflug tomography device, a placido topography device, an optical biometer device, a 3D laser scanner device, a time of flight sensor, a structured illumination device and/or a combination thereof. The measuring step provides the required data of the face of the patient and/or of the eye of the patient for determining the shape of the patient-specific portion.
In an embodiment, the method further comprises the step of validating, by a certification software and/or a quality validation device at least the quality of the manufactured patient-specific portion of the individually shaped ophthalmological patient interface. For example, the certification software is configured to monitor the measuring device during the measuring step, the computing device during the determining step and/or the manufacturing device during the manufacturing step. Alternatively or additionally, the quality validation device validates the quality of the manufactured patient-specific portion, for example, by measuring the resulting patient-specific portion and comparing it to a virtual model of the patient-specific portion, for example via a variance analysis. In another embodiment, the quality validation device comprises a mold, a cast or a negative of the patient-specific portion. In this embodiment, the validation step may comprise to compare the manufactured patient-specific portion with the mold etc. for example by holding the manufactured patient-specific portion onto the mold.
In an embodiment, the step of validating, by the quality validation device, comprises mechanical testing, optical testing and/or dimensional testing of the manufactured patient-specific portion of the ophthalmological patient interface. In this embodiment, the patient specific portion is validated/approved after being manufactured. This is, compared to the surveillance of the entire manufacturing process, cheaper and less complex.
The herein described disclosure will be more fully understood from the detailed description given herein below and the accompanying drawings, which should not be considered limiting to the invention described in the appended claims. The drawings in which:
Reference will now be made in detail to certain embodiments, examples of which are illustrated in the accompanying drawings, in which some, but not all features are shown. Indeed, embodiments disclosed herein may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Whenever possible, like reference numbers will be used to refer to like components or parts.
The
The ophthalmological laser treatment system 100 comprises an ophthalmological laser treatment device 1 comprising a base station 2. The base station 2 is configured as a fixed or mobile apparatus. The ophthalmological laser treatment device 1 has a treatment laser source 21 arranged in the base station 2, which generates a treatment laser beam T. The base station 2 further includes, for example, a power supply and other auxiliary subsystems necessary for operation of the ophthalmological laser treatment device 1.
The treatment laser source 21 is configured, for example, to generate an ultraviolet or infrared treatment laser beam T having a wavelength of between 190 nm and 230 nm for ultraviolet laser beam and 780 nm to 1100 nm for infrared laser beam. For example, the treatment laser source 21 comprises an excimer or a solid-state laser, which produces such an ultraviolet treatment laser beam T. The excimer laser uses a combination of a noble gas and a reactive gas under high pressure and electrical stimulation to generate the treatment laser beam T. In particular, an excimer laser using argon as the noble gas and fluoride as the reaction gas may be used as the treatment laser source 21.
In an embodiment, the treatment laser beam T is a pulsed laser beam. In an embodiment, the treatment laser source 21 is configured to generate femtosecond laser pulses, which have pulse widths of typically from 10 fs to 1000 fs (1 fs=10{circumflex over ( )}−15 s).
The base station 2 includes a scanner 22, which is configured to steer the treatment laser beam T delivered by the treatment laser source 21 onto or into treatment points on a treatment pattern (comprising a laser trajectory).
The ophthalmological laser treatment device 1 comprises a laser applicator 5 or application head 5. The laser applicator 5 is designed to guide the treatment laser beam T into or onto an eye 91 of a patient 9 (as shown, for example, in
The ophthalmological laser treatment system 100 comprises an ophthalmological patient interface 6. The laser applicator 5 is preferably fixed onto the eye 91 by means of the ophthalmological patient interface 6, which is coupled to the eye for example using negative pressure. Different embodiments of the ophthalmological patient interface 6 of the present disclosure will be described in more detail with reference to the
Depending on the embodiment, the ophthalmological laser treatment system 100 further comprises an optical imaging device 7. The ophthalmological laser treatment device 1 comprises an arm 4 arranged between the base station 2 and the laser applicator 5. The arm 4 is configured to provide a beam path for the treatment laser beam T, such that the treatment laser beam T is guided along the inside of the arm 4 from the base station 2 to the laser applicator 5. In an embodiment, the arm 4 comprises one or more joints 41 (as shown in
The ophthalmological laser treatment system 100 optionally includes a user interface comprising, for example, one or more user input devices, such as a keyboard, and one or more output devices, such as a display 8 (as shown in
The
The
Reference is now made to the embodiments of the present disclosure as shown in the
The
Every eye 91 has an individual shape, which is determined by its surface, its different tissues, dimensions and individual diseases or disorders. The patient-specific portion 65, which is individually shaped with respect to the individual surface shape of the eye 91, provides an advantageous positioning of the ophthalmological patient interface 6 on the eye 91 due to its individually shaped patient-specific portion 65.
In a further embodiment, not shown in the figures, the eye fixation portion 62 may comprise protrusions 625 and at least one, preferably a plurality of suction openings 621.
In step S1, a measuring device 11 measures the surface of the eye 91 of the patient 9 and/or the eye surrounding surface 12 of the patient 9. The measuring device 11 may use different technologies to measure the surface of the eye 91 of the patient 9 and/or the eye surrounding surface 12 of the patient 9.
In step S2, a computing device 13 determines the shape of the surface of the eye 91 of the patient 9 and/or the shape of the eye surrounding surface 12 of the patient 9. The measured data of step S1 is, for example, transmitted from the measuring device 11 to the computing device 13, which determines for example a virtual model of the shape of the surface of the eye 91 and/or the shape of the eye surrounding surface 12 of the patient 9 using the received data. The measuring device 11 and the computing device 13 are for example a single device.
In the optional step S3, a blank coupling portion 61 and/or a blank eye fixation portion 62 is provided. For example, an ophthalmological patient interface 6 as shown in the
In step S4, a manufacturing device 14 manufactures the patient-specific portion 65 of the eye fixation portion 62 and/or the coupling portion 61, based on the determined shape of the surface of the eye 91 of the patient 9 or the shape of the eye surrounding surface 12 of the eye 9. For example, a software determines automatically or manually the desired shape of the patient-specific portion 65 using the provided data of step S2. The software creates, for example, a 3D model of the patient-specific portion 65 and/or the entire ophthalmological patient interface 6, wherein the dimensions of the patient-specific portion 65 is for example within the predefined enveloping geometry.
In step S5, a certification software 15 and/or a quality validation device 16 validates at least one quality parameter of the manufactured patient-specific portion 65 of the individually shaped ophthalmological patient interface 6. The certification software 15 compares, for example, the outer contour of the manufactured patient-specific portion 65 with a virtual model of the desired patient-specific portion 65. In case the deviations between the virtual model and the manufactured patient-specific portion 65 reach or surpass a predefined threshold value, the manufactured patient-specific portion 65 may not pass the validation step. In another embodiment, the certification software 15 may monitor the measuring device 14, the computing device 13 and/or the manufacturing device 14. The quality validation device 16 is, for example, a separate device, which is configured for a mechanical, optical and/or dimensional validation of the finished patient-specific portion 65 of the ophthalmological patient interface 6.
In the step S4a, an additive manufacturing device 141 manufactures additively the patient-specific portion 65 of the ophthalmological patient interface 6. In other words, the additive manufacturing device 141, for example a 3D printer, additively manufactures the patient-specific portion 65 of the eye fixation portion 62 and/or the coupling portion 61.
In the step S4b, a removing device 142 manufactures removably the patient-specific portion 65 of the ophthalmological patient interface 6. In other words, the removing device 142, for example a grinding or milling machine, forms the patient-specific portion 65 of the ophthalmological patient interface 6 by removing material. The steps S4a and S4b are for example performed in combination, preferably iteratively. In a further embodiment, one device comprises the additive manufacturing device 141 and the removing device 142.
In the step S4c, a post processing device 143 processes the additively and/or removably manufactured patient-specific portion 65. The post processing step S4c is for example a finishing step, which may comprise heat treatment, hardening, polishing, liquid-based surface treatment etc. The post processing step S4c may further comprise to add the patient identifier on the ophthalmological patient interface 6, for example, a QR-code is added via a laser on the ophthalmological patient interface 6. In another embodiment, the patient identifier may be additively or removably added in the steps S4a and/or S4b.
In the step S5a, the quality validation device 16, performs a mechanical validation/testing of the patient-specific portion 65 and/or of the entire ophthalmological patient interface 6, for example mechanical load testing.
In the step S5b, the quality validation device 16, performs a optical validation/testing of the optical properties of the patient-specific portion 65 and/or of the entire ophthalmological patient interface 6, for example a transparency test of the contact body 626.
In the step S5c, the quality validation device 16, performs a dimensional validation/testing of the individual dimensional properties of the patient-specific portion 65 and/or of the entire ophthalmological patient interface 6, for example, the dimensions of the passage 63 or the dimensions of the eye contact surface is measured and validated.
In the step S5d, a material control is performed, for example via sample testing. The material control is for example performed on the provided blank in step S3, on the additively manufacturing step S4a and/or on the removable manufacturing step S4b. For example, the specific material used for additively manufacturing the patient specific portion is tested prior, for example prior usage.
In the step S5e, a final quality control is performed, for example, using an additional device or software.
In an embodiment, the optionally added patient identifier is scanned prior to the step of validation of the patient-specific portion 65 in order to identify and connect the validation results with the current validated patient-specific portion 65.
It should be noted that, in the description, the sequence of the steps has been presented in a specific order, one skilled in the art will understand, however, that the order of at least some of the steps could be altered or some steps could be skipped, without deviating from the scope of the disclosure.
| Number | Date | Country | Kind |
|---|---|---|---|
| CH001429/2022 | Nov 2022 | CH | national |
