System for short-pulse laser ophthalmic surgery
Patent Information
- Application Number
- CN202310087749.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2015-10-08
- Filing Date
- 2015-10-09
- Publication Date
- 2026-09-08
- Estimated Expiration
- 2035-10-09
AI Technical Summary
[0018]最后,在当今已知的系统中OCT信号还受到在系统中的多个反射干扰
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Figure CN116172789B_ABST
Abstract
Description
[0001] This invention is a divisional application of the parent application, which is filed on October 9, 2015, with application number 201580056331.X and invention title "System for Short Pulse Laser Ophthalmic Surgery" (PCT international application PCT / EP2015 / 073390 entered the Chinese national phase). Technical Field
[0002] This invention relates to a system for short-pulse laser ophthalmic surgery, comprising a short-pulse laser source, a beam guide, an applicator head for guiding short-pulse laser radiation from the short-pulse laser source to the eye to be treated, a surgical microscope, a microscope head, a control unit, a housing, a first hinge arm disposed on the microscope head and a second hinge arm disposed on the applicator head, and interfaces on the applicator head and the microscope head for mechanical and optical connection or detachment from the applicator head and the microscope head.
[0003] The present invention also relates to a short-pulse laser system for ophthalmic surgery, comprising a short-pulse laser source, a lens system for altering the diffusion of short-pulse laser radiation from the short-pulse laser source, an x / y scanning system, a hinged arm, and an objective lens movable in the x and y directions; a patient interface for fixing the position of the eye relative to the system for short-pulse laser ophthalmic surgery; and a computer program product for encoding the control unit of the short-pulse laser system for ophthalmic surgery.
[0004] Furthermore, the present invention relates to a method for positioning the applicator head and microscope head in a short-pulse laser ophthalmic surgery system, a method for cutting guidance using a short-pulse laser system for ophthalmic surgery, and a reference method for different incisions and for intraocular lenses. Background Technology
[0005] Cataract surgery is one of the most frequently performed surgeries on the human eye and therefore focuses on continuous improvement of surgical structure or quality, efficiency, and minimization of risks during the procedure. Cataract surgery has been increasingly automated through recent research and advancements in ophthalmic femtosecond laser technology, particularly in refractive surgery, and in optical coherence tomography (OCT) as an imaging technique. Short-pulse lasers are used to "cut away" eye tissue through photolysis. This technique is hereinafter described as laser-supported cataract surgery (LCS). Based on current principles, LCS involves performing lens capsulotomy (circularly removing the anterior capsule of the lens), lens fragmentation (disintegrating the lens nucleus), corneal incisions (main channel incision and auxiliary incisions), and an arcuate incision (a circular incision for reducing corneal astigmatism), the latter of which clearly extends beyond the scope of conventional cataract surgery and touches upon the realm of refractive surgery.
[0006] As proposed in US 6,325,792 B1, a femtosecond laser pulse is focused into the lens, thereby "liquefying" the lens—corresponding to the aforementioned lens fragmentation—or, however, for cutting the lens capsule. The focal point of the femtosecond laser pulse is located here based on ultrasound imaging.
[0007] Disclosed in US 5,246,435, a short-pulse laser pulse is focused into the natural lens of the eye in a three-dimensional cutting pattern, thereby breaking the lens into multiple fragments and liquefying them through cutting and subsequent bubbles.
[0008] US 6,454,761B1 proposes using optically correlated tomography (OCT) instead of ultrasound imaging for the automatic localization of laser pulses in ophthalmic surgeries, such as cataract removal from the lens, on the cornea or other transparent structures.
[0009] Just a few years ago, the increasing maturity of femtosecond laser technology and OCT technology allowed for the combination and integration of these two technologies, as well as the establishment of femtosecond laser systems that could be as automated as possible in cataract surgery. To deflect the femtosecond pulse, a fixed objective lens and a fast-lens scanner for laterally x / y-deflecting the laser beam into the eye, along with a slowly adjustable lens for deflecting the focal position along the optical axis z of the eye, are used. Such systems are described, for example, in US 2006 / 195076A1 or US2009 / 131921A1. On the other hand, systems are also disclosed in which the objective lens moves laterally and slowly, using a lens for rapidly adjusting the focal point z-deflection along the optical axis of the eye. Such systems are disclosed in DE 10 2011085 046 A1.
[0010] Some application-related issues were addressed, particularly in the early days of LCS development, by introducing a fluid interface as the mechatronic contact between the laser system and the eye (see US2012 / 0078241A1 or US 6,019,472). Integration of the technology into the device, and to a lesser extent, into the overall workflow or working environment, was also important. In particular, the interoperability between the femtosecond laser and the surgical microscope, essential for cataract surgery, was significantly lacking in commercially available systems.
[0011] Most currently available systems are not equipped with surgical microscopes and, due to their size, are often placed outside the operating room where the actual intraocular lens (IOL) is implanted later. This usually requires time-consuming patient repositioning and bed changes. This shortcoming has only recently been recognized, and corresponding improvements have been proposed.
[0012] As proposed in DE 10 2010 022 298 A1 and US 2012 / 316544A1, a femtosecond laser is directly and constantly coupled to a surgical microscope during the surgical procedure. However, the components required for this, according to the prior art, are still too large, making such a system too bulky during IOL implantation and thus potentially limiting and hindering the surgery.
[0013] In WO 2008 / 098388 A1, for the purpose of corneal refractive ophthalmological surgery, a femtosecond laser is pushed under a surgical microscope, positioned between the surgical microscope and the patient, and directed to the eye when necessary. Here, the surgical microscope and the femtosecond laser operate sequentially to a certain extent and are independent of each other. However, they are always separate devices.
[0014] Furthermore, the established system revealed a series of deficiencies related to specific components, which negatively impacted the quality of surgical outcomes, efficiency during surgical execution, or risk reduction.
[0015] Miniature objective scanning, as described in WO 2008 / 098388 A1, is relatively time-saving in terms of z-rotation for lens capsulotomy incisions, or for lens fragmentation as shown in DE 10 2011 085 046 A1. Regarding access to the incision, it provides not only small spatial movements along the optical axis of the eye but also small lateral movements of the miniature objective, a solution that, as disclosed in US2007 / 173794A1, is very time-consuming.
[0016] Furthermore, incision guidance in systems with rapid z-rotation for lens capsulotomy is time-sensitive. While a closed track in the measurement x / y plane for lens capsulotomy is flawlessly displayed in the case of rapid galvanometer scanning systems, safety is paramount in systems with rapid z-rotation, where track closure occurs only after several seconds, allowing eye movement during this time. Even in cases involving corneal access and auxiliary incisions, the advantages of rapid z-rotation of the laser beam are not provided because a long lateral track must first be traversed.
[0017] Regarding the points mentioned above concerning systems with pure micro-objective scanning, a series of improvements are achieved for systems with combined micro-objectives and micro-scanning. The combined scanning system is relevant to incision quality and can even be considered as a pure micro-scanning system.
[0018] Finally, in currently known systems, OCT signals are also subject to multiple reflections within the system. Furthermore, established OCT solutions also suffer from faulty and slow components. Summary of the Invention
[0019] Therefore, the object of this invention is to describe a system and method for short-pulse laser ophthalmic surgery that improves the quality of surgical outcomes and typical workflows, thereby increasing the efficiency and safety of surgical procedures.
[0020] Such a system includes a short-pulse laser system comprising a short-pulse laser source, a beam guide, and an application head for directing the short-pulse laser radiation from the source to the eye to be operated on. The short-pulse laser source is a laser source that emits light discontinuously, but in pulses. This means that the light is emitted in time-defined fractions. Typically, the pulse rate of such short-pulse lasers is in the femtosecond or picosecond range. However, pulse rates in the attosecond range are also possible. Very high energies can be achieved through pulsed light emission, which is necessary for laser-tissue interactions resulting from multiple photoelectric absorptions, such as photobreakdown or plasma-induced photoevaporation. This is the case in all applications where it is not merely about removing material from the surface, but about achieving interaction in all three dimensions.
[0021] A beam guide is used to guide short-pulse laser radiation emitted by a short-pulse laser source from the system to the emission region of the short-pulse laser radiation in a predetermined manner and method. The beam guide can therefore be implemented, for example, by an optical conductor or by a mirror system. An optical guide can also be implemented integrally with these or similar components.
[0022] The applicator head, connected to the end of the beam guide opposite the short-pulse laser source, forms the emission region of the short-pulse laser radiation. Typically, it includes optical elements such as objective lenses or, in complex configurations, objectives with multiple optical components, particularly objectives with multiple lenses.
[0023] Advantageously, short-pulse laser systems also incorporate x / y deflection systems, also known as x / y scanning systems, and deflection or scanning systems or lens systems for the z-direction, or for altering diffusion. The possibility of deflecting short-pulse laser radiation in the x and y directions, and in the z-direction, into the volume of the emission region following the short-pulse laser radiation can also be achieved through multiple deflection devices for each direction, such as scanners for slow movement over a larger area and scanners for rapid movement over a smaller area. An ideal solution is particularly important for deflection in the z-direction.
[0024] Therefore, the short-pulse laser system according to the present invention is particularly suitable for use as a short-pulse laser system.
[0025] The system for short-pulse laser ophthalmic surgery also includes a surgical microscope, which has a microscope head and a support. The microscope head contains the optical elements of the surgical microscope. Using such a surgical microscope, an optical overview of the operational status can be obtained at any time. The surgical microscope is also used to align the eye to be treated accordingly relative to the system.
[0026] The system for short-pulse laser ophthalmic surgery also includes a control unit configured to control the execution of the short-pulse laser ophthalmic surgery. The control unit can be designed as a single component or multiple components. The system for short-pulse laser ophthalmic surgery is advantageously connected to the control unit via a communication path. In the case of a multiple-component control unit, all components of the control unit are also advantageously connected to each other via a communication path. Such a communication path can be implemented via appropriate cables and / or wirelessly.
[0027] Furthermore, the system for short-pulse laser ophthalmic surgery includes a housing that at least surrounds a short-pulse laser source, and first and second hinged arms disposed on or on an extension of the housing. The hinged arms include a plurality of hinge members movable relative to each other. The hinge members are arranged such that corresponding two hinge members are movably connected via at least one joint.
[0028] Advantageously, a microscope head is arranged on the end of the first articulated arm facing away from the housing. This articulated arm, together with the housing, forms the support for the surgical microscope. Again, preferably, an applicator head is arranged on the end of the second articulated arm facing away from the housing. The length of the second articulated arm, on which the applicator head is arranged, is preferably designed such that the entire working range of the microscope head arranged on the first articulated arm can be used within a semicircle of approximately 180° in front of the system used for short-pulse laser ophthalmic surgery. Thus, the length of the hinge of the second articulated arm is also designed accordingly.
[0029] Here, an interface is provided between the applicator head and the microscope head, which allows the applicator head and the microscope head to be mechanically and optically connected to each other and then disconnected again.
[0030] The interface is preferably characterized by a first structure on the first hinge arm and / or on the microscope head and a second structure on the second hinge arm and / or on the applicator head, which are either coordinated with each other according to the key lock principle or can be connected to each other through an intermediary.
[0031] The mechanical and optical connection between the applicator head and the microscope head means that, in addition to the mechanical connection and the resulting fixed relationship between the applicator head and the microscope head, they are connected in such a way that the imaging optical path of the surgical microscope extends through the applicator head. Thus, the applicator head provides an optical path for observing the structures of the eye using the surgical microscope.
[0032] According to the invention, a beam guide for short-pulse laser radiation passes through a second articulated arm. The beam guide is thus designed such that it can follow all movements of the second articulated arm and that the short-pulse laser radiation can be guided with the same quality to its output position at the applicator head in every position of the second articulated arm.
[0033] Furthermore, according to the invention, the applicator head and the microscope head can move not only independently of each other but also connected to each other in three-dimensional space. When the applicator head and the microscope head are connected, the applicator head and the microscope head are thus given the ability to move in each arbitrary direction as determined by their arrangement on the articulated arms, without those mechanical restrictions on three-dimensional space determined by the system. This correspondingly defines additional degrees of freedom in the first and second articulated arms. By the mobility of the applicator head itself, but particularly in conjunction with the microscope head, the short-pulse laser radiation or emission area can also move in three-dimensional space—in a preferred variant, also related to its radiation direction at the emission area. Thus, for example, it also enables treatment of patients in a non-lying position, or even in a lying position, however, in a reclining position.
[0034] Current systems for short-pulse laser ophthalmic surgery can not only remove tissue through plasma-induced volatilization and / or photolysis, but also bind tissue through coagulation and achieve tissue removal through the volatilization effect of short-pulse laser radiation. Only the characteristics of the short-pulse laser radiation need to be adjusted according to the intended application.
[0035] In a preferred design, the system according to the invention for short-pulse laser ophthalmic surgery further includes an optical coherence tomography (OCT) module comprising an OCT light source, an interferometer, and a detector. The OCT module is also enclosed in a housing.
[0036] A system for short-pulse laser ophthalmic surgery is particularly preferred, comprising an OCT module selectively configured to couple radiation emitted by an OCT light source into a microscope head or an applicator head. This can be achieved, for example, through one or more optical switching positions provided in the optical path of the beam emitted by the OCT light source and in the radiation returning from the target in the eye. It can be selectively configured such that the OCT module can reach the target in the eye via either the microscope head or the applicator head.
[0037] The coupling input of OCT light source radiation through the applicator head has the advantage of simple and mechanically stable superposition with therapeutic short-pulse laser radiation. Therefore, the two beam paths can be calibrated against each other. Thus, this variant is practically used for the planning and control of short-pulse laser therapy. Conversely, the coupling input of OCT light source radiation through the microscope head allows surgeons to take tomographic images of the patient's eye during and / or after surgery. For example, this technique can be used to precisely align intraocular lenses or to identify and remove free particles in the aqueous humor.
[0038] Furthermore, it is technically advantageous to use a ring mirror to integrate short-pulse laser radiation and radiation emitted from an OCT source into a system for short-pulse laser eye surgery. Here, this integration is preferably achieved such that the short-pulse laser beam is reflected by the ring mirror, while the short-coherent radiation emitted by the OCT source of the OCT module propagates along the direction of the eye through an aperture in the ring mirror, and the OCT detector detects the reflected radiation from the OCT source of the eye through the aperture in the ring mirror. The ring mirror may be movable for this purpose. Preferably, there is a 90° position where the radiation emitted by the OCT source is coupled into the beam path of the short-pulse laser radiation, wherein the ring aperture is thus positioned at a 45° position.
[0039] In a preferred system for short-pulse laser ophthalmic surgery, the first articulated arm and the second articulated arm each have at least three joints.
[0040] When three joints exist, these three joints, or at least two of all three joints, can function as ball-and-socket joints, meaning they provide the possibility of rotation not only around a single axis. Specifically, such a joint must achieve the following: two joint mechanisms are movably connected to each other via joints, and one joint mechanism can represent any angle in space relative to its adjacent joint mechanism, where the radius of action may be limited to a local area in space by other structural obstacles, but not to in-plane movement.
[0041] In a specific design, one of the three joints can have a unique axis of rotation. However, in the case where only three joints exist, all three joints can function as ball joints. In this way, it is ensured that the first and second articulated arms arranged on the housing or its extensions not only have optimal mobility when connected to each other, but also have independent mobility within the three-dimensional volume.
[0042] Conversely, if joints that provide only rotational possibilities about a single axis are used, each articulated arm with different axes of rotation achieves similar mobility using at least five joints. Three of these joints enable rotation about a vertical axis and two enable rotation about a horizontal axis, resulting in a tilting axis that causes tilting of the joint mechanism following the joint.
[0043] Preferably, in this variant – that is, in the case of using joints with the possibility of rotation about an axis – the articulated arm has six joints, each with a corresponding axis of rotation. In this case, three joints should be able to rotate about a vertical axis, and the other three joints should be able to rotate about a horizontal axis. Here, tilting is possible, for example, at the end part of the applicator head or microscope head, or after the joints of the articulated member.
[0044] In summary, each articulated arm joint should preferably achieve six degrees of freedom, given by three vertical and three horizontal rotation axes, which alternate along the articulated arm. In particular, a pair of joints with vertical rotation axes and a pair of joints with horizontal rotation axes arranged close to each other have the same function as ball joints.
[0045] Furthermore, systems for short-pulse laser ophthalmic surgery preferably have a coupling position coded in the control unit such that the connection between the applicator head and the microscope head is achieved not only in the vertical position of the applicator head but also in the vertical position of the microscope head, to avoid any mechanical tension. If the applicator head and the microscope head are connected via an interface, it is advantageous that the common tilting of these heads is possible.
[0046] Systems for short-pulse laser ophthalmic surgery are preferably designed as mobile systems. This includes a transport device. Specifically, it can be designed as a rolling system, allowing the system to be manually moved from one room to another within a room for transport, for example. In one particular design, the rolling system is powered by an electric motor to move the potentially heavy system for short-pulse laser ophthalmic surgery in a simple, precise, and ergonomic manner.
[0047] In an advantageous design of a system for short-pulse laser ophthalmic surgery, the control unit is coded to automatically track the position of the short-pulse laser radiation based on the position of the second articulated arm. This is used to correct for positional deviations in the focal point of the short-pulse laser radiation caused by elastic deformation, which depends on the position of the second articulated arm and a given weight distribution at its center, which contains the beam guide. Therefore, the position of the articulated arm is defined by the relative positions of the articulated members to each other.
[0048] Here, the position tracking of the short-pulse laser radiation is advantageously performed automatically relative to the adjustment position of the second hinge arm. The optical transmission of the short-pulse laser radiation is directed in this adjustment position, and then the deviation of each position from the adjustment position of the second hinge arm is determined, and the corresponding necessary corrections to that position are determined.
[0049] In another advantageous design of a system for short-pulse laser ophthalmic surgery, the second articulated arm has at least one means for a counterweight independent of the first articulated arm.
[0050] During surgical procedures, the second articulated arm, on which the applicator head is mounted, is connected to the first articulated arm, on which the microscope head is mounted, throughout the short-pulse laser system and therefore throughout the entire duration of use of the applicator head. However, the second articulated arm bears a relatively high weight: the applicator head can weigh several kilograms. It cannot be stably supported by the first articulated arm in every position. Therefore, independent counterweights ensure high stability and flexibility of movement. For application purposes, it may also be wise to separate the microscope head from the applicator head during treatment. In this case, both articulated arms must also have their own counterweights to avoid uncontrolled and consequently unsafe movement of the system.
[0051] Here, weight balance is achieved with respect to the first tilting axis, i.e., the first joint, which is capable of rotating about the horizontal axis. Further weight balance can be achieved with respect to another tilting axis if needed.
[0052] For example, weight balance can be achieved by a compression spring in a spring arm member that extends parallel to and moves accordingly parallel to the hinge member. The compression spring is housed therein and is pulled onto a toothed belt that is deflected by two toothed pulleys into the parallel-extending hinge member.
[0053] This independent weight balancing device for the second articulated arm is a highly advantageous variant of the design of a system for short-pulse laser ophthalmic surgery, wherein the device includes a beam guide and carries an application head as the exit position for short-pulse laser radiation. However, it is also advantageous for short-pulse laser systems for ophthalmic surgery, as described below, which include an articulated arm with a beam guide and an objective lens, to achieve weight balancing in any possible position of the articulated arm, thus ensuring that the articulated arm, whose movement determines the exit position of the short-pulse laser radiation from the short-pulse laser system, remains stable in any position and that optical positional errors are kept very low.
[0054] In another design, the system for short-pulse laser ophthalmic surgery has a parking and / or transmission position for a second articulated arm with an applicator head on the housing, the position being coordinated with the geometry of the second articulated arm and / or the applicator head. For example, structures on the applicator head and / or the second articulated arm, as well as structures on the housing, are also provided herein, which are matched to each other according to a keying principle. This is supported, for example, by encoding the corresponding position of the applicator head, determined by the movement of the second articulated arm, in the control unit of the system for short-pulse laser ophthalmic surgery.
[0055] Alternatively, the parking and / or transmission positions on the housing can also be achieved simply by encoding the corresponding positions of the applicator head in the control unit of the system for short-pulse laser eye surgery.
[0056] However, regardless of the design of the parking and / or transport positions, and especially the manner and method of achieving this, the parking and / or transport positions are characterized by being located on the housing in a position where the applicator head is removed from the work area of the system operator, i.e., the physician, making it less likely for the operator to cause contamination through accidental contact with components, and protecting the applicator from collisions with other parts of the system, but especially with its surrounding environment. However, it is also advantageous if the parking position is not too far from the operator's work area, so that the connection between the applicator head and the microscope head can be achieved even without significant physical movement by the operator.
[0057] The parking position is further advantageously designed such that the applicator head is accessible, provided that the patient interface for fixing the eye position to the system for short-pulse laser eye surgery can be coupled to the system for short-pulse laser eye surgery without spatial obstructions.
[0058] Preferably, the system for short-pulse laser ophthalmic surgery provides an operator-operated or automatically switching mechanism for releasing or connecting the interface between the applicator head and the microscope head. In one particular design, the connection between the interface between the applicator head and the microscope head is achieved via a bayonet-type connection.
[0059] Furthermore, the system for short-pulse laser eye surgery includes adjustable components on the first and / or second articulated arms and / or the applicator head and / or microscope head, which enable movement of the microscope head and / or applicator head controlled by the control unit. These adjustable components can be implemented using motors and / or other drive components.
[0060] It is also advantageous for the beam guide through the second articulated arm of the system used to perform short-pulse laser ophthalmic surgery to have a photonic crystal fiber with a hollow core. This photonic crystal fiber specifically satisfies the condition that the beam guide should follow all movements of the second articulated arm and should guide short-pulse laser radiation from any position on the second articulated arm to the exit position on the applicator head with the same quality.
[0061] Among short-pulse laser sources, femtosecond (fs) laser sources are the most commonly used in ophthalmic surgery. They have proven to be particularly suitable and controllable for these applications. Therefore, this type of femtosecond laser source can also be used in short-pulse laser ophthalmic surgical systems.
[0062] Advantageously, the system for short-pulse laser ophthalmic surgery includes a confocal detector. By recording an A-scan—a one-dimensional scan along the optical axis—and / or a B-scan—a two-dimensional scan along and perpendicular to the optical axis—on two structures of the eye, the offset and scaling factor between the OCT signal and intensity can be determined at the Z-focal position of the short-pulse laser radiation as it passes through the two structures, using the intensity distribution of the OCT signal and the confocal detector signal. Therefore, this allows for the control of the focal position of the short-pulse laser radiation using the OCT signal, and particularly the OCT image.
[0063] Preferably, the coherence length of the OCT light source in air is greater than 45 mm, and particularly preferably greater than 60 mm. This allows the entire anterior chamber of the eye to be detected in an A-scan even if the optical path to the eye is altered by lateral target movement, without having to adjust the optical path length of the reference optical path.
[0064] The aforementioned objective is further achieved by a method for positioning the applicator head and microscope head in the aforementioned system for short-pulse laser eye surgery. This method includes the following steps:
[0065] (a) First, combine the applicator head and the microscope head into an applicator microscope head unit and connect them to each other.
[0066] (b) Positioning the applicator microscope head unit on the eye to be operated on by moving the applicator microscope head unit in three-dimensional space.
[0067] (c) Lower the applicator microscope head unit until the applicator head is in a predefined position on the eye and / or the patient interface detachably mounted on the applicator head contacts the eye. Such a patient interface, also known as a “patient interface,” can be specifically achieved via an eyepiece, where the eyepiece is understood herein as a superordinate concept of various design options, such as a liquid interface, a gel interface, or a solid interface. The patient interface described below can be used here. If the patient interface contacts the eye in this step, the detachable fixed connection between the eye and the patient interface is typically created by vacuum, i.e., by drawing the eye toward the patient interface.
[0068] (d) The lens and / or capsule and / or cornea of the eye are treated by a focal point of short-pulse laser radiation, such as a femtosecond (fs) laser.
[0069] (e) After treatment, raise the microscope head unit of the applicator again.
[0070] (f) Place the applicator head of the applicator microscope head unit into the parking position of the housing. In a preferred design, the applicator head and / or the second hinged arm are locked in this parking position and held mechanically.
[0071] (g) Separation of the microscope head from the application head. This is preferably achieved through automatic disassembly after proper positioning in the parking position.
[0072] (h) Position the microscope head above the patient's eye.
[0073] (i) Further surgical procedures, such as performing lens emulsification and / or liquefaction of the lens and / or implantation of an artificial lens.
[0074] (j) Place the microscope head in a location outside the surgical area or guide it to and connect it to the application head.
[0075] This approach is particularly important in cataract surgery using short-pulse laser radiation (LCS) because, in this part of the surgical procedure, the focus of the laser radiation should be guided into the tissues of the eye through the applicator head, while also allowing for observation using a surgical microscope. In another part of the surgical procedure, only a separate surgical microscope is needed, but with the desired freedom of movement over the eye to be treated.
[0076] The aforementioned objective is also achieved through a short-pulse laser system used in ophthalmic surgery. Such a short-pulse laser system includes a short-pulse laser source that generates short-pulse laser radiation. Specifically, a femtosecond (fs) laser source can be used at this location.
[0077] The short-pulse laser system also includes a lens system that alters the diffusion of the short-pulse laser radiation generated by the short-pulse laser source, and an x / y scanning system for the short-pulse laser radiation.
[0078] The lens system for altering the spread of short-pulse laser radiation includes at least one lens, but advantageously is a system with different continuous lenses in the beam path of the short-pulse laser radiation, wherein at least one lens can be adjusted in its position. This arrangement provides the possibility of focusing the short-pulse laser radiation and the possibility of shifting the focal point of the short-pulse laser radiation along the z-direction (i.e., along the optical axis). By using the lens system for altering the spread of the short-pulse laser radiation, the z-position of the short-pulse laser radiation is also fixed in the eye to be treated.
[0079] The short-pulse laser system ultimately includes a hinged arm and an objective lens movable in the x and y directions, wherein the hinged arm, according to the invention, incorporates a beam guide. The beam guide ensures that short-pulse laser radiation emitted from the short-pulse laser source is guided to the exit position of the short-pulse laser radiation in a predetermined manner and method, where the objective lens is movable in the x and y directions. The beam guide can also be implemented through the integration of different components.
[0080] The articulated arm, with at least two joints, is movable, each joint corresponding to the function of a ball joint and accommodating at least two articulated members. For example, it can move freely in three-dimensional space. The objective lens, in one design, can also be adjusted in the z-direction.
[0081] In different designs of short-pulse laser systems used in ophthalmic surgery, the x / y scanning system includes an x / y mirror scanner for the x-direction, a gimbaled mirror scanner, or a mirror scanner for the x-direction with a downstream component for rotation about the optical axis. Therefore, the x / y mirror scanner can also consist of separate x and y scanners, which together function as the x / y scanning system.
[0082] Advantageously, multiple scanners can be provided for a given direction, such as a scanner for slow movement over a larger area and a scanner for very fast movement over a smaller area. This is particularly important in the z-direction, and therefore preferably combined with at least one lateral direction x or y along the optical axis.
[0083] Furthermore, short-pulse laser systems for ophthalmic surgery may include a patient interface for fixing the eye position to the system used for short-pulse laser eye surgery. In one design, the patient interface includes a contact lens, wherein the contact lens is understood herein as a general term for various design options such as liquid interfaces, gel interfaces, or solid interfaces. In particular, the short-pulse laser system may include the contact lens according to the invention described below.
[0084] The field of view of the movable objective lens in a short-pulse laser system for ophthalmic surgery is, for example, greater than 1.0 mm but less than 6.0 mm, and particularly advantageously greater than 1.5 mm but less than 3.0 mm. Thus, the field of view lies in a plane that can be moved in the x and / or y directions by scanning motion. The plane of view itself can also be moved along the optical axis in the z direction by scanning motion. The cross-section of the movable objective lens depends particularly on the scanning range of the x / y scanning system. Therefore, the focus of the short-pulse laser radiation can be strategically placed at any location within the three-dimensional scanning volume through the overlap of beam deflections from the movable objective lens and from the mirror scanner.
[0085] Optical components arranged in the optical path of the short-pulse laser radiation, as well as a lens system for altering the diffusion of the short-pulse laser radiation, are preferably fixed to an optical bench. The optical bench itself is fixed to a housing or interior at three points, where a hinged arm is advantageously arranged. Therefore, all deformation of the fastening surfaces within the housing does not affect the adjustment state of the optical components, but rather the position of the optical bench with its beam guide entering the hinged arm. This positional variation can be balanced by beam stabilization.
[0086] A preferred design of a short-pulse laser system for ophthalmic surgery also includes a system for stabilizing the beam path through the articulated arm, comprising a light source at one end of the articulated arm and a position-sensitive light sensor at the other end of the articulated arm.
[0087] Here, optical coupling is achieved at a certain angle relative to the optical axis of the hinge arm, that is, for example, the light source is not on the optical axis, or the light source is on the optical axis, but it emits asymmetrically in the direction of the optical axis.
[0088] Despite the different positions of the articulated arms, the beam stabilization allows for precise orientation of short-pulse laser radiation by deflection in the x and / or y directions via an x / y deflection system or a scanning system preferably positioned by means of a movable objective lens for x / y positioning of the focus point, and compensates for mechanical tolerances of the articulated arms and the orientation of the x / y scanning system.
[0089] The aforementioned objective is further achieved by a method for performing small incisions using a short-pulse laser system, particularly in corneal tissue, during ophthalmic surgery, especially the short-pulse laser system described above, the method comprising the following steps:
[0090] (a) The objective lens of the short-pulse laser system is positioned in the x and y directions, that is, in the direction perpendicular to the optical axis, such that at least a portion of the x and y focal points of the incision pattern to be projected are arranged within the field of view of the objective lens to be positioned. Here, the corresponding position of the focal point of the short-pulse laser radiation of the short-pulse laser system in the three-dimensional processing volume in which the patient's eye can be treated is determined by the focal point positions in the x-axis and z-axis directions.
[0091] (b) By using an x / y scanning system and by adjusting the focal position in the z-direction along the optical axis using a lens system and / or objective lens with varying diffusion after each x / y scan or in parallel with the x / y scan, the focal position of the incision pattern is imaged by means of an objective lens fixed in the x and y positions. Here, x / y scanning is the movement of the focal point of short-pulse laser radiation in the transverse x / y plane. The energy of the pulse of short-pulse laser radiation at its focal point is selected to achieve plasma-induced photoevaporation or photo-rupture of the tissue. By appropriately selecting the distance of the focal position to be imaged, an incision is thus created in the tissue, i.e., the effective range of the corresponding pulses at the focal position and the adjacent focal position at least contacts, and if possible partially overlaps.
[0092] (c) Repeat steps (a) and (b) for another field of view, this time positioning the objective lens in another lateral position until the entire cut pattern is produced. The entire cut pattern is produced when all focal positions of the cut pattern are imaged.
[0093] The aforementioned objective is achieved, in particular, by a method of incision guidance using a short-pulse laser system for ophthalmic surgery, preferably using the aforementioned short-pulse laser system to disintegrate the lens, the method comprising the following steps:
[0094] (a) The focal point of short-pulse laser radiation is positioned in the tissue of the lens to be treated, wherein plasma-induced photovaporization or photo-induced fracture of the lens tissue is generated by the corresponding energy at the focal point of the short-pulse laser radiation.
[0095] (b) The objective lens of the short-pulse laser system advances by a length (L) in the lateral direction within the first meridional plane of the lens, overlapping with the oscillating displacement of the focal point, to position other focal points of the short-pulse laser radiation within a subplane of the meridional plane. This oscillating displacement has a principal component along the optical axis and has an amplitude (A). Here, the oscillating displacement of the focal component can also extend independently along the optical axis, i.e., only one component extends along the optical axis. The meridional plane is understood as a plane extending parallel to the optical axis.
[0096] (c) The focus of the short pulse laser radiation is advanced along the optical axis by a height (H), wherein the height (H) is chosen such that during the repetition of step (b), the repositioned focus of the short pulse laser radiation does not overlap with the previously positioned focus.
[0097] (d) Repeat steps (b) and (c) again, wherein step (b) can be performed in the lateral direction as along the optical axis when the propulsion direction is reversed, just as in step (c), until the focal point is located in the common first meridional plane.
[0098] (e) Repeat steps (b) through (d) to position the focus in another meridional plane of the lens until the lens is so widely distributed with the focal point of the short-pulse laser radiation that the fragments generated by plasma-induced photoevaporation or photo-rupture do not exceed the maximum size. Here, the maximum size is determined by the suction capacity and the size of the capsular incision.
[0099] Preferably, in the method for guiding the incision of the broken lens, the focus of the short-pulse laser radiation is positioned, for example, only when the focus of the short-pulse laser radiation moves from the posterior side to the anterior side of the lens, wherein it is again preferred that the movement from the anterior side to the posterior side of the lens is performed faster than the movement from the posterior side to the anterior side of the lens.
[0100] However, alternatively, the focal point of short-pulse laser radiation can be positioned over the entire oscillation cycle.
[0101] Furthermore, it is preferable to maintain a distance of, for example, 10-50 μm when positioning the focal point of short pulse laser radiation on different meridional planes and on different sub-planes of the meridional plane.
[0102] Variations in the meridian plane also preferably occur in the region where meridians intersect.
[0103] The aforementioned objective is further achieved by incision guidance in capsulotomy using a short-pulse laser system for ophthalmic surgery, wherein, in particular, the opening of the capsular bag is generated, i.e., the focus of the short-pulse laser radiation is positioned at its x and y focal positions by an x / y scanning system, i.e., in n steps from 1 to N, where N is a natural number greater than or equal to 2, correspondingly generating the nth non-closed curve with first and second end regions of an arched structure of radius R and correspondingly the same orientation. The first end region of the nth non-closed curve has a first end region R En1 The second end region has a second end region R En2 Here, the radius R of the first end region is... En1 The radius R of the second end region En2 It is less than the radius R.
[0104] Furthermore, each of the end regions of the non-closed curves has one end. Here, the non-closed curves are arranged such that, for n from 2 to N, the first end region of the nth non-closed curve intersects the second end region of the (n-1)th non-closed curve, and additionally, for n equal to N, the second end region of the Nth non-closed curve intersects the first end region of the first non-closed curve, so that the ends of all end regions are arranged inside the closed curve formed by the first to nth non-closed curves.
[0105] This creates a corresponding incision by selecting the energy of the short-pulse laser radiation pulse at its focal point, enabling the separation of eye tissue through plasma-induced photoelimination or photodestruction. Furthermore, the distance to the focal point is chosen such that the so-called cavitation bubbles of the corresponding pulses at the effective range, the focal point, and adjacent focal points at which they contact can at least partially overlap, thereby enabling the creation of an incision through plasma-induced photoelimination or photodestruction.
[0106] Advantageously, the superposition of the focal point's oscillating motion along the optical axis with amplitude (A) allows for the compensation of the position of the capsule, for example, for changes in the z-direction.
[0107] Regarding the radius R, there can be a small deviation between the radii R of the n non-closed curves.
[0108] In order to generate a closed curve by means of N non-closed curves, these N non-closed curves, each having a first and a second end region, are arranged relative to each other such that the first end region of the nth non-closed curve intersects with the second end region of the (n-1)th non-closed curve and the second end region of the Nth non-closed curve intersects with the first end region of the first non-closed curve. That is, preferably starting from the second non-closed curve, the first end region of the non-closed curve to be generated is continuously generated on the second end region of the most recently created non-closed curve.
[0109] However, it is also possible to disregard the processing sequence of such adjacent non-closed curves and generate N non-closed curves, such that after generating the final non-closed curve, a pattern as described in this paper is obtained and there is a closed curve in general.
[0110] The patient interface used to position the eye into a system for short-pulse laser eye surgery also helps achieve the purpose described at the beginning. Such a patient interface includes a touch lens, but it can also be designed as a liquid interface.
[0111] The patient interface is manufactured as a single piece and is made of transparent or partially transparent material. It includes a suction ring, an outer cover, and optical elements on the upper side of the outer cover, wherein the upper side of the outer cover represents the side opposite to the suction ring.
[0112] The suction ring is positioned on the side of the patient interface facing the eye and is used to support and secure the patient interface to fit the shape of the patient's eye.
[0113] The outer cover is preferably formed in a conical shape, in the form of a truncated cone. The lower diameter facing the eye that can be used optically should be at least 10 mm, preferably greater than 13 mm, and particularly preferably greater than 14 mm.
[0114] The outer cover has at least one opening on its side, preferably two openings, and the corresponding supply line is connected to the opening via a fixing accessory or is accordingly permitted to be connected to the supply line.
[0115] One or more supply lines allow a vacuum to be created in the suction ring, for which the corresponding opening need not penetrate the entire thickness of the outer casing, but connection to the suction ring is essential. Another supply line allows liquid to enter the patient interface, for which the corresponding opening penetrates the entire thickness of the outer casing. Liquid supply to the patient interface is preferably achieved such that, with the patient interface positioned over the patient's eye, the entire volume defined by the eye shell and optics is filled with liquid, and the optics are immersed in the liquid on their eye-facing side.
[0116] In one design of the patient interface, an additional suction structure made of transparent material is arranged on the eyepiece on the side of the outer casing opposite to the suction ring, and thus positioned on the side of the outer casing opposite to the eye. This additional suction structure is used to hold the eyepiece in the application head of a system for short-pulse laser eye surgery, for example, as described above, by means of a vacuum.
[0117] In a particular design for the patient interface, the optical elements are arranged at an angle relative to the optical axis. An angled arrangement here means that they are not perpendicular to the optical axis. This is achieved by arranging the entire optical element, or only the surface of the optical element furthest from the eye, at an angle relative to the optical axis.
[0118] It is also advantageous to have a hydrophilic coating or hydrophilic surface treatment on the surface of the eye-facing optics included in the eyepiece of the patient interface. Furthermore, it is advantageous that the surface of the eye-facing optics is convex and curved. This serves to improve liquid wetting and, consequently, to prevent bubble formation in the area of the optics. Due to the convexity of the optics' surface, any bubbles that might form move to the outer edge of the optics, which is irrelevant to the optical imaging of the system.
[0119] Furthermore, it is advantageous if the surface of the optical elements, located away from the eye, contained in the eyepiece of the patient interface has an anti-reflective coating. This is used to prevent reflection of incident laser radiation.
[0120] In particular, it is advantageous if the patient interface further includes an applicator head protector. This allows the portion of the applicator head (excluding the optics) facing the eye to be covered when the patient interface is aligned with the applicator head of a system for short-pulse laser eye surgery, thereby supporting sterility.
[0121] A patient interface having an applicator head protector is advantageous, the protector having a recess that is advantageously centrally formed in the applicator head protector, and the recess is also preferably smaller than the diameter of the upper outer cover of the outer cover. This recess is used for the execution of the optical elements of the applicator head and its connection with the optical components of the eyepiece.
[0122] Advantageously, in patient interfaces that include an applicator head protector, the eyepiece and the applicator head are two separate or separable parts.
[0123] In a favorable design, the patient interface's applicator head protector has a mechanical coupling. The mechanical coupling is configured to detachably connect the applicator head protector to the applicator head of the system used for short-pulse laser eye surgery.
[0124] It is advantageous if the patient interface, particularly the outer casing of the eyepiece of the patient interface, also includes a light guide structure. The light guide structure is used for illumination by an additional light source that can be connected to the light guide structure, such as visible light with wavelengths between 350 nm and 780 nm, or, advantageously preferably, light in the infrared range with wavelengths between 781 nm and 1300 nm, to protect the eyes.
[0125] Another advantage is that the patient interface eyepiece contains at least one marking. This is advantageously positioned in the lower part of the outer cover, that is, in the area of the outer cover near the eye, and is used for orientation and alignment.
[0126] Furthermore, the optical unit comprising the short-pulse laser system and the patient interface supports the solution to the aforementioned objectives. In the optical unit comprising the short-pulse laser system and patient interface according to the invention, including a contact lens with optical elements, the depth of focus of the image is at least 3 mm, preferably greater than 5 mm, both in the state where the optical units comprising the short-pulse laser system and the patient interface are coupled to each other and in the state where they are directly arranged sequentially without coupling. Preferably, the short-pulse laser system is the short-pulse laser system according to the invention described above, and the patient interface is the patient interface according to the invention described above. Due to the depth of focus, even in the disengaged state, for example using a camera, the reference structure of the eye and the markings on the contact lens of the patient interface can be quickly detected. In the engaged state of the eye, due to the depth of focus, the reference structure of the eye and the incisions performed in the eye by the operator, particularly a physician, using the short-pulse laser system can be well identified.
[0127] The above objectives are further supported by a reference method for a system for relaxing and / or accessing an incision in short-pulse laser ophthalmic surgery, comprising the following steps:
[0128] a) Recording an image of an eye with a reference structure via a camera in a non-connected state of a patient interface, preferably including a tactile lens, on the patient's eye.
[0129] b) Connect the patient interface to the eye within seconds.
[0130] The alignment of relaxation incisions and / or entry incisions is performed using a reference structure-based recognition algorithm and provided to the operator, especially the physician, as information or treatment planning options.
[0131] The solution for the above objectives also supports a reference method for orienting an artificial lens when implanting it into the eye after the natural lens has been pulverized and removed, the method comprising the following steps:
[0132] a) The first image of the astigmatic eye is recorded using a diagnostic system designed to identify the steep axis and / or flat axis. The orientation of the steep axis and / or flat axis is stored with or associated with the image. The patient is typically seated during this recording.
[0133] b) A second image of the same astigmatic eye is generated using either a patient interface docked to the eye (i.e., a connected one) or an un-docked patient interface (which is then docked), and is compared with the first image using the system for short-pulse laser ophthalmic surgery described herein. In the second image recording, the patient is typically in a supine position. The orientation of the steep axis and / or flat axis of the astigmatic eye is transitioned from the first image to the second image using a reference algorithm.
[0134] c) Following laser treatment and using the unconnected patient interface, further reference is performed between the second and third image recordings. In the third image recording, the patient is in a supine position. The eye structures have changed between the second and third images, for example, through mild hemorrhage and / or redness on the sclera, where the steep and / or flat axes of the astigmatic lens remain aligned.
[0135] d) Record additional images and video recordings of the eye during orientation of the intraocular lens inserted into the eye and reference them to a third image recording.
[0136] e) The intraocular lens is oriented using the relationships established in the previous steps. This is advantageously facilitated by using a surgical microscope to provide orienting assistance to the surgeon.
[0137] Finally, the aforementioned objectives are also achieved through a computer program product for encoding the control unit of an ophthalmic surgical short-pulse laser system, which performs the aforementioned methods, for example...
[0138] - A method for locating the application header.
[0139] - An incision guidance method for corneal surgery using a short-pulse laser system.
[0140] - A method for guiding incisions to break up the lens of the eye using a short-pulse laser system used in ophthalmic surgery.
[0141] - A method for incision-guided incision in ophthalmic surgery using a short-pulse laser system.
[0142] -Reference methods for relaxing the incision and / or entering the incision.
[0143] - Reference method for the orientation of intraocular lenses. Attached Figure Description
[0144] The invention will now be described with reference to the illustrated embodiments. The figures show:
[0145] Figure 1 The first system for short-pulse laser ophthalmic surgery;
[0146] Figure 2: A second system for short-pulse laser ophthalmic surgery;
[0147] Figure 3 The top view shows the positions when connecting the applicator head and the microscope head;
[0148] Figure 4 The top view shows the transmission position of the articulated arm with the applicator head;
[0149] Figure 5 : A device for independent weight compensation of articulated arms;
[0150] Figure 6 Methods for using instrument heads and microscope heads in systems for positioning short-pulse laser ophthalmic surgery;
[0151] Figure 7 Short-pulse laser systems (beam generation and optics) used in ophthalmic surgery;
[0152] Figure 8 A structure used to combine short-pulse laser radiation from a short-pulse laser source and OCT radiation from an OCT source;
[0153] Figure 9a and Figure 9b Control of a short-pulse laser system used in ophthalmic surgery via signals from a confocal detector and an OCT module;
[0154] Figure 10 The movement of the focal point of short-pulse laser radiation when the eyepiece is used for lateral scanning in a short-pulse laser system;
[0155] Figure 11a : The location of the incision in the eye tissue in a small-field scenario where the x / y incision area is projected;
[0156] Figure 11b The process of focusing shift of short-pulse laser radiation in short-pulse laser systems used in ophthalmic surgery;
[0157] Figure 12a : The incision layer in the eye tissue with a large field of projected x / y cutting regions;
[0158] Figure 12b An alternative method for focus shifting of short-pulse laser radiation in short-pulse laser systems used in ophthalmic surgery;
[0159] Figure 13a and Figure 13b : Focusing of short-pulse laser radiation or guiding through an incision in the lens tissue of the eye using short-pulse laser radiation;
[0160] Figure 14a and Figure 14b : Focal guidance of the focal point of short-pulse laser radiation in the case of a lens tilted relative to the optical axis of the short-pulse laser;
[0161] Figure 15 : Focusing of the short-pulse laser radiation in the case of a lens that is slightly tilted relative to the optical axis of the short-pulse laser;
[0162] Figure 16 : The x / y projection of the focal point of short-pulse laser radiation in the case of first incision guidance using a short-pulse laser system for performing cystectomy;
[0163] Figure 17a : The x / y projection of the focal point of short-pulse laser radiation in the case of second incision guidance of a short-pulse laser system used to perform cystectomy;
[0164] Figure 17b : The x / y projection of the focal point of short-pulse laser radiation in the case of third-incision guidance of a short-pulse laser system used to perform cystectomy;
[0165] Figure 17c : The x / y projection of the focal point of short-pulse laser radiation in the case of fourth incision guidance of a short-pulse laser system used to perform cystectomy;
[0166] Figure 18 Patient interface for short-pulse laser systems used in ophthalmic surgery;
[0167] Figure 19a : A first structure for reference to the patient interface in a short-pulse laser system;
[0168] Figure 19b : A second structure for referencing the laser incision in a short-pulse laser system with reference to the patient interface;
[0169] Figure 20 Reference method for incision guidance in short-pulse laser systems used in ophthalmic surgery;
[0170] Figure 21a A third structure for reference to the laser incision in a short-pulse laser system at the patient interface;
[0171] Figure 21b : A fourth structure for referencing the laser incision in a short-pulse laser system with reference to the patient interface;
[0172] Figure 21c : A fourth structure for referencing the laser incision in a short-pulse laser system with reference to the patient interface;
[0173] Figure 22: A reference method for orientation when an artificial lens is placed in the eye. Detailed Implementation
[0174] In the examples of systems used in short-pulse laser eye surgery below, femtosecond lasers, or fs lasers, are used as the short-pulse lasers for the short-pulse laser systems and corresponding methods. These are the most commonly used short-pulse lasers in the field of laser-based ophthalmic surgery and are therefore considered optimal. However, all systems and methods described herein can also be implemented using other short-pulse lasers. Therefore, unless explicitly stated otherwise as a distinguishing feature, fs lasers are synonymous with short-pulse lasers.
[0175] The following discussion will focus on OCT, or Optical Coherence Tomography. Therefore, unless different variants of OCT are explicitly distinguished, OCT is synonymous with all of the following methods that use short optical coherence to measure distances in the eye or to detect images of the eye or images composed of them, such as temporal-domain optical coherence tomography (TD-OCT), spectrometer-based frequency-domain OCT (FD-OCT), or wavelength-tuned swept-frequency OCT (SS-OCT).
[0176] The entire system design and workflow
[0177] To improve the integration of different parts of the optimized workflow for operators, preferably doctors, especially ophthalmologists, and to improve the optimized working environment, in Figure 1 as well as Figure 2 The present invention discloses the structure 100 of the first and second systems for short-pulse laser ophthalmic surgery, which includes an fs laser system as a short-pulse laser system 200, a beam guide 230 and an applicator head 220 for guiding fs laser radiation to the eye 900 to be operated on, wherein the short-pulse laser system has a short-pulse laser source 210, which is therefore an fs laser source.
[0178] The structure 100 of the first and second systems for short-pulse laser ophthalmic surgery also includes a surgical microscope 300 having a surgical microscope head 320. Thus, the entire surgical microscope and the optics that determine its function are arranged in the microscope head 320.
[0179] Figure 1 The first system 100 for short-pulse laser ophthalmic surgery also includes an OCT module 400, which includes an OCT light source 405, an interferometer, and a detector. Figure 2 The second system can, in principle, also include such an OCT module. However, for Figure 1 and Figure 2 As far as the system components shown are concerned, the presence of an OCT module is not mandatory.
[0180] Figure 1 as well as Figure 2 The first and second systems for short-pulse laser eye surgery are controlled by a common control device 500, namely a control unit 500, which may be centrally located or distributed among multiple sub-units of the system, as shown herein. For this purpose, communication paths may be used between the control unit and the various components of the system, or communication paths may be used between the sub-units of the control unit.
[0181] Figure 1 and Figure 2 The system 100 for short-pulse laser ophthalmic surgery also includes a housing 110, which can also be referred to as a console. The housing 110 encloses the fs laser source 210 and the control device, which serves as a central control unit 500. Figure 1 In the case of the first system, the housing 110 also surrounds the OCT module 400.
[0182] The microscope head 320 is fixed at the first hinge arm 120, and the applicator head 220 is fixed at a separate second hinge arm 130, through which the light from the fs laser source 210 is supplied to the applicator head 220. For this purpose, the beam guide 230 passes through the second hinge arm 130. The first hinge arm 120 and the second hinge arm 130 are mounted on the housing 110 or an extension of the housing 110.
[0183] An interface 150 is provided at or near the applicator head 220 and the microscope head 320, through which the applicator head 220 and the microscope head 320 can be mechanically and optically connected to each other.
[0184] To enable the combination or discombination of the microscope head and the application head 220 via the interface 150, a mechanism is set up for the physician to connect or automatically connect.
[0185] The second articulated arm 130 has the same degrees of freedom as the first articulated arm 120, and simultaneously forms the support of the surgical microscope 300. The necessary degrees of freedom are generated through the corresponding number, arrangement, and design of the joints 140 of the articulated arms 120 and 130, allowing the instrument head 220 and microscope head 320 to move in three-dimensional space not only independently of each other but also interconnectedly. Figure 1 In the case of the first system 100 for a short-pulse laser ophthalmic surgery system, this is achieved by using three joints 140 with ball joint function.
[0186] exist Figure 2In the second system for short-pulse laser ophthalmic surgery, the degrees of freedom are the same as those achieved by using three joints 140 with ball joint function and by using horizontal rotation joints. The three joints rotate about the vertical axes 140-O1, 140-O2, 140-O5 and 140-L1, 140-L2, 140-L5 and the parallel support arm 145, and the horizontal rotation joints 140-O3, 140-O4 and 140-L3, 140-L4 are used for vertical movement, i.e., tilting movement. Here, the support arm refers to the hinge member of the first or second hinge arm 120, 130.
[0187] The first hinge arm 120, having a microscope head 320, also has a horizontal tilt axis 140-L6 for tilting the microscope head. This horizontal tilt axis, for the connection position + / -90°, can also be achieved via an applicator head 220, which is rotatably suspended from the horizontal axis 140-L6 of the last hinge member. In the connection position 0°, the surgical microscope head 320 can only be connected in a vertical position. This is... Figure 3 The diagram shows the positions of the applicator head 220 and the microscope head 320 when connected. Therefore, the thick arrows indicate the direction in which the physician looks into the eyepiece of the microscope head 320.
[0188] Therefore, the surgical microscope head 320 has its own manually operable tilt axis 140-O6. This tilt angle can be compensated for by the additional rotation axis 140-L6 in the applicator head 220 at the coupled position of + / -90°. This is not possible at the coupled position of 0°. Furthermore, it is essential to prevent the operator, typically a physician, from manually adjusting the tilt axis 140-O6 of the microscope head 320 after coupling to the applicator head 220. This causes the joint of the second articulated arm 130 to deform, resulting in a deviation of the optical axis of the second articulated arm 130, particularly the optical axis of the beam guide 230 contained within the second articulated arm, thereby causing a deviation in the focal position of the femtosecond laser radiation in the eye 900. This problem is solved by mechanizing the tilt axis 140-O6 of the microscope head 320. This operation is similar to manual operation, utilizing a knob on the side of the microscope head suspension. Before coupling, i.e., before the microscope head 320 and applicator head 220 are connected via interface 150, the verticality of the microscope head 320 can be checked via software. When a deviation occurs, the operator receives a request for correction, or the microscope head 320 automatically moves into a vertical position. During laser treatment of the patient's eye 900, manipulation of the tilt axis 140-O6 can be prevented via software.
[0189] Figure 2The length of the hinge member of the second hinge arm 130 is designed such that the entire working range of the surgical microscope head 320 can be used in a 180° semicircle in front of the device, i.e., in front of the system used for short-pulse laser eye surgery. The length of the hinge member forms areas on the right and left sides of the device 100 that are inaccessible in the connected state, i.e., when the microscope head 320 and the applicator head 220 are connected. However, this is compensated for by the fact that the retracted second hinge arm 130, on which the applicator head 220 is arranged, can bend to the right or left as needed. For this purpose, the applicator head 220 is manually removed from its parking housing on the parking arm 190, turned to the other side, and retracted again. The electrical locking of the parking housing is thus released using a switch at the applicator head 220. Furthermore, two handles 142 are provided to avoid a dead position, through which the second hinge arm 130 can be guided at the operation button, in which its hinge member extends in a plane. The handle 142 is preferably positioned at the hinge between the penultimate and final joints 140, or between the penultimate and final joints 140 along a corresponding vertical axis of rotation. To move the articulated arm 130 out of its fixed position again, the operator grasps the handle 142 and rotates the articulated arm 130 therefrom. The handle 142 can be coated aseptically, with the coating changed after each surgery, so that during the procedure, the second articulated arm 130 can also be grasped on the handle 142 after the surgical step if needed, without compromising asepticity.
[0190] The second articulated arm 130 has a joint 140-L3 on which an applicator head 220 is disposed. This joint is positioned high enough to allow objects to pass, for example, under the second articulated arm 130 via surgical aids. The height of the joint 140-L3 is chosen to maintain a minimum collision distance to the first articulated arm 120, where the surgical microscope head 320 is disposed. For rotation angles greater than 180°, there is a risk of collision between the two articulated arms 120, 130. To eliminate this, the rotation angle of the E-Box and the joint 140-O1 of the first articulated arm 120 is limited to + / -95° by a stop in the axis of the joint 140-O1. Despite this limitation, this is sufficient to reach an extended three-dimensional space in front of the device 100 and thus to position the patient roughly on a recliner in front of the device 100 and to perform any other steps by moving the articulated arms. In this way and method, it is possible to operate with different patient positions, and the doctor's particular preferences for patient placement and the system 100 used for short-pulse laser eye surgery can also be taken into account.
[0191] Therefore, the applicator head 220 is located between the patient and the microscope head 320, and for this reason must be designed in a very compact manner. The necessary actuators for shifting the focus of the femtosecond laser radiation in the z-direction (i.e., along the optical axis) within the eye 900 are very space-consuming, so placing them in the applicator head 220 would be impractical. Therefore, these actuators are arranged in the console, specifically in the housing 110 in front of the second articulated arm 130 that carries the applicator head 220. To transmit the wandering focus generated therein to the eye 900, relay lenses are required in each articulated member of the second articulated arm 130. These lenses are unfocused. Depending on the focus position, a wandering focus is generated in each relay. The aperture must be numerically as low as possible to avoid light penetration into or through the beam guide 230 of the second articulated arm 130 and the resulting power loss. This requires a long relay system. The lengths of the hinge components of the second hinge arm 130 are matched to the length of the relay system.
[0192] High precision is required for the optical transmission of the laser beam from the optics in housing 110 to the applicator head 220, especially considering the possibility of movement of the second hinge arm 130. During calibration, special care must be taken to ensure that the mechanical rotation axis and the laser beam axis do not deviate from each other in angle and position. Each deviation during movement of the second hinge arm 900 results in a wobbling of the laser focus in the eye 900. Furthermore, the elastic deformation resulting from the large weight of the second hinge arm 130 and the applicator head 220 disposed thereon is strongly dependent on the position of the second hinge arm 130. Therefore, the second hinge arm 130 can only be calibrated in one position. In any other position, there will be deviation. These deviations are compensated for by automatic beam tracking, which measures the deviation and subsequently corrects the position of the laser beam. This correction occurs within defined limits predetermined by the geometry of the actuator and the adjustment range. The free diameter of the optics is thus determined such that no vignetting of the laser beam occurs while fully utilizing the adjustment range. The required stiffness of the bearings and the components of the second articulated arm 130 is generated by the feasible adjustment range of automatic beam tracking. Elastic deformation should not exceed the feasibility of beam tracking. The typically required stiffness of the hinge members between joints 140-L1 and 140-L2 of the second articulated arm 130 is achieved through reinforcement, a box-shaped design, and additional steel plates on both sides of the hinge members. A high-rigidity rotary connection is used for support, which is tensioned axially using two needle roller bearings and radially using one needle roller bearing without clearance. Alternatively, angular contact ball bearings may be used in O-type configurations with a larger ball track distance.
[0193] The second articulated arm 130 provides the possibility for cables, OCT fiber optic cable 410, and vacuum hoses to pass through, which are used to guide the patient interface 600 to the patient's eye 900 and to the applicator head 220. At the transitions of joints 140-L2 / 140-L3 and 140-L4 / 140-L5, all cables are guided outside joint 140 to avoid overloading and twisting. At joint 140-L1, the cables are guided concentrically with the optics through joint 140.
[0194] According to a variant of the embodiment, the housing 110 is marked with a placement surface 190 for the applicator head 220 or is equipped with a placement structure 190 that conforms to the geometry of the applicator head 220.
[0195] For transport purposes, i.e., when the device 100 moves through a door, for example by means of a transport device 180 fixed below the device 100, the second hinge arm 130 and the applicator head 220 should not extend laterally beyond the housing 110. This is achieved by placing and locking the applicator head 220 in a parking housing arranged on a parking arm 190, the applicator head being positioned above the housing 110 and laterally deflected downward toward the post of the surgical microscope head 300, see [reference needed]. Figure 4 Therefore, the parking arm 190 also turns at approximately 60°.
[0196] To allow the applicator head 220 to enter the rest or parking position, the applicator head 220 simply turns to the side and rests on the articulated arm. The requirement for the rest or parking position differs from that for the transport position in that the overhang of the second articulated arm 130 and the applicator head 220 above the housing 110 is less critical. Delays in the transport and parking positions are achieved, for example, using force-operated latches.
[0197] The parking position preferably corresponds to the connection position used to connect the microscope head 320 and the applicator head 220. However, it should still be able to place the patient interface 600 on the applicator head 220. For this purpose, it can be accessed without restriction from both sides. This is achieved by arranging a parking housing that allows the last hinge member of the second hinge arm 130 to be positioned and stopped in front of the applicator head 220.
[0198] The parking housing is mounted on the parking arm 190 with a rotatable + / -90° rotation. The parking arm 190 is supported with a rotatable rotation of approximately 70° about the main axis 140-L1 of the second hinge arm 130. The parking housing is provided with locking postures for parking and transport positions. It includes an electromechanical locking mechanism for the hinge arm 130 of the applicator head 220, force sensors, and inductive sensors for detecting whether the applicator head 220 and the last hinge member in front of the applicator head 220 are in the parking housing. The size of the parking arm 190 and the parking housing is determined such that the applicator head 220 is suspended in front of the device 100, freely accessible from the bottom for mounting the patient interface 600, and preferably simultaneously allows for the unobstructed connection of the microscope head 320 from both sides. The length of the second hinge arm 130, on which the applicator head 220 is arranged, is determined as follows, such that the microscope head 320, which also has an auxiliary microscope head, can be connected without colliding with the second hinge arm 130, while maintaining a minimum collision distance.
[0199] In another embodiment variation, a potentially sterilizable, replaceable coating is applied to the handle 143 at the microscope head 320 for positioning the microscope head 320. By positioning the microscope head 320, the applicator head 220 is also ultimately positioned in the coupled state. The handle can also be implemented as a switch for releasing the electromagnetic brake of the first hinge arm 120, or as a purely mechanical lever for friction braking, at which the microscope head 320 is located.
[0200] In another embodiment variant, an element adjustable via a control device 500, such as a motor, is provided at the first and / or second articulated arms 120, 130, or at the applicator head 200 or at the microscope head, which enables movement of the microscope head 320 and / or applicator head 220 controlled by the control device 500.
[0201] Advantageously, spring elements are provided at one or both articulated arms 120, 130, which are coordinated with each other such that the correspondingly assigned applicator head 220 or microscope head 320 is held in a predetermined space surrounding the housing 110 and the surgical area without external force.
[0202] The applicator head 220 weighs approximately 5 kg and cannot be supported by the surgical microscope 300 or the microscope head 320. The spring balance of the first hinged arm 120, on which the microscope head 320 is mounted, already bears a load of up to 1 kg when loaded with the observer, i.e., the eyepiece and possibly a monitor. Therefore, the second hinged arm 130 on which the applicator head 220 is mounted includes a device for independent weight balancing, such as… Figure 5 As shown.
[0203] For the weight balancing of all masses to be balanced, here relative to joint 140-L3 ( Figure 5 The second articulated arm 130 is implemented in joints 140-L3 and 140-L4 ( ). Figure 5 The portion between 140-B) is implemented as a parallel support arm 145. The parallel support arm 145 is essentially composed of four joints 140-A, 140-B, 140-C, and 140-D, and four hinged members: a first rotating head 141-1, a second rotating head 141-2, a spring arm 145-1, and a strut 145-2. Weight balance is achieved by a compression spring 147 in the lower spring arm 145-1. The compression spring 147 pulls a toothed belt 148, which is deflected into the strut 145-2 via two toothed pulleys 149-1 and 149-2. There, the toothed belt 148 is attached to a fastener 146-2. The compression spring 147 generates a torque about joint 140-A, which is opposite to and compensates for the torque generated by the weight G about point A. The lever arm for compensating torque is generated by the vertical distance between the toothed belt 148 and the joint 140-A. This lever arm depends on the angular position of the spring arm 145-1. The spring constant of the compression spring 147 is determined such that position-dependent variations in these two torques are compensated. This ensures that weight compensation remains within predetermined tolerances throughout the deflection range. The counterweight G is independent of the deflection position of the articulated arm 130 for the applicator head 220. Although the distance from the center of gravity to the rotation point 140-A changes due to the deflection of the applicator head 220, this has no effect on weight compensation. The resulting change in torque is supported by the struts 145-2 suspended at the rotation points 140-C and 140-D.
[0204] In one embodiment variant, a video capture unit and an illumination unit are provided. Alternatively, these can be coupled to an optical path pointing towards or originating from the eye 900 via an applicator head 220 or a microscope head 320.
[0205] In a particular embodiment variant, the second hinged arm 130 on which the applicator head 220 is applied is implemented as a beam guide 230 via a photonic crystal fiber having a hollow core. The fs laser radiation is guided within the hollow core and within the fiber by means of a periodic photonic structure similar to a Bragg mirror. In this way, similar to the case of free radiation, only minimal pulse broadening occurs due to dispersion. Compared to guidance via the second hinged arm 130 using a mirror system, the photonic crystal fiber has the advantage of ensuring more flexible laser beam guidance and reducing the complexity of optical design. In this embodiment variant, the second hinged arm 130 on which the applicator head 220 is mounted is primarily used only for mechanically holding the applicator head 220, thus no longer affecting beam guidance through its structure itself.
[0206] The structure 100 of the system for short-pulse laser eye surgery described herein supports a method for positioning the applicator head and microscope head on the patient's eye, which is described below and referred to in conjunction with... Figure 6 The method, as described above, includes the following steps:
[0207] (a) If the applicator head 220 and the microscope head 320 are separated, they are assembled by an operator, such as a physician. To do this, the operator mounts the microscope head 320 onto the applicator head 220 at the interface 150 and locks it in place; or the mechanism automatically causes locking when the desired connection is achieved.
[0208] (b) The operator guides and positions the microscope head 320 above the eye 900 to be operated on. Therefore, the applicator head 220 is also positioned above the eye 900.
[0209] (c) The operator observes through the eyepiece of the microscope head 320 and lowers the microscope head 320, thereby lowering the applicator head 220 and, if necessary, further laterally aligning the microscope head 320 with the eye 900 until the applicator head 220 is in a predetermined position above the eye 900 or the patient interface 600, which is detachably mounted on the applicator head and includes the eyepiece 610, comes into contact with the eye 900.
[0210] (d) The operator uses an fs laser to treat eye tissue 910, i.e., to treat the lens and / or capsule and / or cornea.
[0211] (e) The operator lifts the microscope head 320, thereby lifting the applicator head 220.
[0212] (f) The operator brings the applicator head 220 to the parking position, where, in one embodiment variant, the applicator head 320 is placed on the placement surface or placement structure 190 at the housing 110.
[0213] (g) The operator releases the microscope head 320 from the applicator head 220 via a stop mechanism, or automatically when the applicator head 220 is correctly positioned on the placement structure 190. This separates the microscope head 320 from the applicator head 220.
[0214] (h) The operator positions the microscope head 90 degrees above the patient's eyes.
[0215] (i) The operator continues to perform additional lens emulsification steps and / or aspiration of liquefied lens steps and / or implantation of artificial lens steps.
[0216] (j) The operator places the microscope head 320 in a parking position outside the surgical area. In one embodiment variant, the operator attaches the microscope head to the applicator head, which is positioned on the placement surface 190 of the device 100 and locks the stop mechanism, or the stop mechanism is automatically locked when connection is achieved.
[0217] In one embodiment of the method, the control device 500 uses the acquired OCT images and / or video images to calculate control commands for the adjustable elements on the articulated arms 120, 130, or the applicator head 220 and / or microscope head 320, so that, in particular, steps (c) and / or (e), and if necessary, all subsequent steps, are automatically controlled by the control device 500, except for step (i).
[0218] In another embodiment of this method, once the microscope head 320 is locked to the applicator head 220, the device state can be determined by the control unit 500, for example, via a sensor. For instance, the FS laser can be automatically turned on and the illumination above the surgical microscope 300 can be turned off. Correspondingly, in the unlocked state, i.e., the microscope head 320 and the applicator head 220 are separated, the FS laser can be turned off and the illumination above the surgical microscope 300 can be turned on.
[0219] Structurally, the housing 110, particularly its interior, is preferably designed such that the components of the short-pulse laser system 200 enclosed by the housing, namely the short-pulse laser source 210 (here, an fs laser source) and the optical components as part of the beam guide, can be laterally moved as a whole into the container above the column 310 of the surgical microscope 300 in the assembled state. The column 310 here serves as an extension of the housing 110, representing a support structure for the first hinged arm 120, at which the microscope head 320 is arranged. Therefore, the components of the short-pulse laser system 200 enclosed by the housing 110 are placed on the footplate of the surgical microscope 300 in the assembled state and fixed in four positions. Figure 2 In the second system of short-pulse laser eye surgery, this is achieved by rigidly fixing the footplate about 6mm above the wheel as close as possible, with the wheel fixed below the footplate, which serves as the transport device 180.
[0220] To ensure the stability of the optical adjustment of the components of the short-pulse laser system 200 within the housing 110 and the second hinged arm 130, different configurations are required. The elastic deformation of the support portion of the housing 110 caused by positional changes in the first and / or second hinged arms 120, 130 should not affect the calibration state 130 of the optics between the fs laser source 210 and the entrance into the second hinged arm, on which the applicator head 220 is arranged. These elastic deformations are not negligible, especially considering that both the first hinged arm 120 with the microscope head 320 and the second linkage arm 130 with the applicator head 220, along with the independent weight-balancing device and its structure in the form of a parallel support arm 145, each weigh on the order of 50 kg. During deflection, a center of gravity displacement occurs, which can lead to deformation within a fraction of a millimeter. The elastic deformation of the second hinged arm 130, on which the applicator head 220 is arranged, or its hinged components, is balanced by its own beam stability. Conversely, the deformation of the optics of the short-pulse laser system 200 in housing 110, i.e., the deformation before entering the second hinge arm, cannot be balanced. However, the precision requirements of the console optics, i.e., the precision requirements of the optics arranged in housing 110 behind the short-pulse laser source 210 and in front of the second hinge arm 130, are in the micrometer range and cannot be maintained without special construction measures.
[0221] Therefore, to meet the requirements, the entire optical component of the short-pulse laser system 200, along with the output section of the fs laser source 210, is arranged on or screwed onto the optical bench. In the optical path of the short-pulse laser radiation, the entire optical component is located in the housing 110 in front of the entrance to the second hinge arm 130. The optical bench itself is fixed to or at the housing 110 using three points. All deformations of these fixed surfaces of the housing thus do not affect the calibration state of the components on the optical bench, but rather affect the position of the optical bench relative to the entrance to the second hinge arm 130.
[0222] The beam stabilization achieved by means of a system for stabilizing the optical channel 280 can balance changes in position. A first active mirror of this system for stabilizing the optical channel 280 is indirectly located in the optical bench. Another active mirror is located in the second hinge arm 130. Together, they form a beamwalk. The laser diode 281 in the applicator head 220 emits a laser beam through all the mirrors of the second hinge arm 130, including those of the system for stabilizing the optical channel 280, onto two quadrant receivers 282 in the housing 110, which are used to fix the optical bench. Deviations caused by deformation during movement of the second hinge arm or by movement of the optical bench are identified here and can be balanced by means of the reverse control of the active mirrors. The optics of this system for stabilizing the optical channel 280... Figure 7 As shown in the image.
[0223] As already described, the components of the short-pulse laser system 200, enclosed by a housing, are preferably fixed at four points as close as possible to the wheels 180 mounted on the footplate. The second articulated arm 130, as well as the electronics and control unit 500, are also indirectly attached thereto. Alternating forces, transmitted directly to the wheels 180 and the base plate by the deflection of either the first articulated arm 120 or the second articulated arm 130, where the microscope head 320 is located and the applicator head 220 is located, are also located at the first articulated arm. The device 100 should remain stationary during laser surgery. Changes in the force ratio at the wheels 180 due to unevenness of the base plate directly affect the calibration state of the laser optics. In static operation, this effect is balanced once before each surgery by beam stabilization. The control console is screwed onto the footplate of the surgical microscope 300 at four points. The height is adjustable at two of these four points where the components of the short-pulse laser system 200 are screwed onto the footplate of the surgical microscope 300. This balances the repeatability resulting from fixation at four points. Tension arising from anticipated unevenness between the components of the short-pulse laser system 200, typically mounted in and at the container, and the footplate of the surgical microscope 300 is thus avoided, i.e., an approximately 6 mm gap is established between the container base plate and the footplate of the surgical microscope 300.
[0224] The container is preferably composed essentially of a base plate and a cover plate, which are riveted to vertical walls to form a box. Compared to a frame design, this allows for a compact construction while easily receiving lateral tension. The container is fixedly embedded in the housing 110: the components fixed at the container also have a fixed relationship with respect to the housing 110.
[0225] The cover separates the upper optical components from the lower electronic components and cables. It is partially implemented as a sandwich to guide the cables to the electronic components within the intermediate space. On the cover, the optical bench is bolted to the output section of the fs laser source 210 and the second hinged arm 130. The plate-like construction of the container ensures sufficient stability for the optical bench, rather than for the second hinged arm 130 on which the applicator head 220 is mounted. To maintain the possibility of beam stabilization, the second hinged arm 130 must be secured in a very stable manner. This is achieved by four rigid posts directly below the screw points of the second hinged arm 130, which direct the supporting force directly into the base plate. The posts can only withstand pressure and can be achieved through double wall bending, typically consisting of metal plates. Breakage is prevented by the proper positioning of the bent edges.
[0226] The back of the container forms parallel vertical walls, which not only help to reinforce the container but also house the electronic components. The electronic components are vertical and parallel to each other and can be pulled out from the rear of the device 100 for maintenance. Space is reserved between the rear wall of the device 100 and the electronic components for wiring.
[0227] The vertical arrangement creates a natural chimney effect for warm air, which can then be used for ventilation. Therefore, openings are installed near the electronic components so that warm air from the fan can pass through them and be exhausted backward. This minimizes the impact of airflow near the surgical area on areas prone to dust generation or drying. Advantageously, a space-saving radial fan is used. A closed metal plate is positioned above the fan, separating the electronic components from the upper portion of the device's interior, where the components of the short-pulse laser system 200 are housed. This minimizes heat shielding of the short-pulse laser system 200 components relative to the lower portion.
[0228] System structure of a short-pulse laser system: beam generation and optics
[0229] To enable time-optimized corneal processing in areas such as access and / or relaxation of incisions, incisions used for lens manipulation, or capsulotomy using an FS laser, a method is disclosed that... Figure 7 The structure of a short-pulse laser system is shown in the figure.
[0230] Figure 3 An fs laser system 200 for ophthalmic surgery, particularly for cataract surgery, is shown, comprising an fs laser source 210. The pulsed laser radiation generated here is guided to and focused in the eye 900 via a lens or lens system 211 that modulates the diffusion and other focusing optics 212, an x / y mirror scanner 240, or alternatively via a gimbaled mirror scanner, or alternatively via an x-mirror scanner having elements arranged downstream thereon for rotation about the optical axis, further via a second hinged arm 130 containing a mirror, an x / y movable objective lens 225, and a patient interface 600 containing an eyepiece 610. Controlled z-shifting of the focus of the pulsed laser radiation can be achieved using the optics. The x / y mirror scanner includes an x-mirror scanner and a y-mirror scanner.
[0231] The diffusion of the pulsed laser radiation is altered by a lens or lens system 211 that changes the diffusion, and the focal position of the pulsed laser radiation is changed along the optical axis in the eye 900, i.e., the z-direction, via other fixed optical elements, such as relay optics 213 and / or movable focusing elements 212. The lens system is changed in position (the position of its lenses relative to each other and in position on the optical axis) along the optical axis – equivalent to the z-axis (z-Achse) – via an adjustment mechanism controlled by a controlled device 500.
[0232] The lateral focal position of the pulsed laser radiation is adjusted perpendicular to the optical axis, i.e., along the x and y directions, via the x / y movable lens 225. When the position of the x / y mirror scanner 240 is given, the femtosecond laser pulse is focused onto a spot with a width of approximately 5 μm within the area of the eye 900 defined by the moving area of the movable objective lens 225.
[0233] When scanning is performed using the x / y mirror scanner 240 and the objective lens 225 which is held in a fixed position, the focal position of the femtosecond laser pulse inside the eye 900 is shifted within the field of view of the objective lens 225.
[0234] When scanning is performed using the x / y mirror scanner 240 and the movable objective lens 225 is moved, superimposed motion can be obtained.
[0235] In a preferred embodiment variant, the system for stabilizing the optical channel 280 is integrated into the short-pulse laser system 200 for ophthalmic surgery via a second hinge arm 130. Figure 7 As shown, it includes a light source 281 at one end of a second hinged arm 130, which couples its light into the second hinged arm by means of a mirror, which also acts as a beam guide to guide and transmit pulsed laser radiation. The system also includes a position-sensitive sensor 282 located at the other end of the second hinged arm. Optical coupling occurs at an angle to the optical axis of the second hinged arm 130, i.e., for example, the light source 281 is not arranged on the optical axis, or for example, the light source 281 is arranged on the optical axis but emits asymmetrically along the direction of the optical axis.
[0236] Despite the different positions of the second articulated arms, this beam stabilization allows for accurate positioning of the focal point of the short-pulse laser radiation via the x / y mirror scanner 240 using the movable objective lens 224 in each x and / or y direction, and compensates for the mechanical tolerances of the second articulated arms 130 and the mirror orientation.
[0237] Therefore, the following steps are applied:
[0238] 1. Determine the position where the light beam of the light source 281 of the system used to stabilize the optical channel 280 deviates from the reference position on the azimuth resolution sensor 282, or determine the reference angular position of the hinge member of the second hinge arm. The deviance position depends on the rotation of the elements of the second hinge arm 130, i.e., the hinge members relative to each other.
[0239] 2. Information regarding the disengagement positions of the second articulated arm 130 at various locations is used to calculate control values for adjusting the x / y mirror scanner 240, which is used for focusing and positioning short-pulse laser radiation. Essentially, these disengagement positions determine the phase of the swing mirror of the x / y mirror scanner or the phase of the x / y swing direction of the gimbal. In one embodiment variant, directing laser radiation onto the eye 900 is interrupted or canceled whenever the disengagement position exceeds a predetermined value.
[0240] Furthermore, the arrangement already described above the following optics of the short-pulse laser system 200 located in front of the second hinge arm 130 on the optical bench is a measure to avoid the influence of mechanical deformation on the calibration of the laser optics.
[0241] In one embodiment of the short-pulse laser system 200 for ophthalmic surgery, the field of view of the objective lens 225, scanned by the x / y mirror scanner 240, is greater than 1 mm but less than 6 mm in cross-section. In another embodiment, it is greater than 1.5 mm but less than 3 mm.
[0242] A narrow field of view, for example, dictates a smaller lateral incision in the eye 900, making rapid movement of the x / y scanner 240 insufficient to perform a complete incision. This results in a significantly longer time to create a complete incision, necessitated by the slow movement of the objective lens 224. Therefore, the field size of the objective lens 225 should be chosen such that, for example, when the incision in the cornea 910 of the eye 900 is approximately 1.5 mm long in the x-direction and the y-width of the incision projection into the corneal tissue 910 is 2 mm, movement of the objective lens 225 is not permitted, and scanning is only required using the scanning lens of the x / y scanner 240. However, the field of view should not be too large either, otherwise the eyepiece 25 would be too heavy and therefore too slow for large-scale movements, such as during capsulotomy.
[0243] When the microscope head 320 and the applicator head 220 are connected via interface 150, the optical path for the light to be received through the microscope head 320 is guided through the applicator head 220. To ensure this, the following alternative solutions exist:
[0244] In a variant of the first embodiment, the laser optics in the applicator head 220 can be designed such that the mirror 224 has partial transparency—partially in the visible light region required for observing the eye 900 using the microscope head 320—while the short-pulse laser radiation is almost completely reflected. The mirror's function is to deflect the laser radiation from the fs laser source 210 onto the objective lens 225 in the applicator head 220. Here, another lens 335 for matching the radiation from the laser optics can be movably arranged in the optical path of the surgical microscope 300 in front of the objective lens 330 of the microscope head 320.
[0245] In an alternative solution, the laser optics, including the fully reflective mirror 224, can be moved using a slider in the applicator head 220. To observe the eye 900 using the microscope head 320, the laser optics are removed from the optical path of the surgical microscope 300 through the applicator head 220. The surgical microscope 300 cannot be used to observe the eye 900 during short-pulse laser radiation. Therefore, to enable observation, the eye 900 is observed using a camera, preferably an infrared camera 300, via a beam splitter 350 using light sensitive to the camera, which is therefore IR light.
[0246] Optical coherence tomography and navigation
[0247] To determine the processing patterns within the eye 900, optical coherence tomography (OCT) was used to measure the structure of the eye 900, particularly the structure of its anterior chamber. During OCT imaging, light from a short coherent source is scanned laterally across the eye 900, i.e., perpendicular to its optical axis. The light reflected or scattered from the eye 900 interferes with the light from a reference optical path. The interference signal, measured by a detector, is analyzed. From this signal, the axial distances of the structures within the eye 900 can then be reconstructed. Combined with the lateral scan, the structures within the eye 900 can thus be detected in three dimensions.
[0248] In order to determine the cut pattern in the eye 900 generated by the focal point of short-pulse laser radiation relative to the relevant structure of the eye 900, Figure 7 The diagram shows the construction of an OCT module 400 (optically) integrated into a short-pulse laser system 200 for ophthalmic surgery, and thus also shows its integration into a system 100 for short-pulse laser ophthalmic surgery.
[0249] In this variant of the structure, the same OCT light source 405 is selectively coupled to the surgical microscope head 320 and also to the applicator head 220. Accordingly, the light reflected from the eye 900 by the OCT light source 405 passes through the same interferometer, is superimposed with the reference light, and is detected by the same detector. This... Figure 7 As shown in the image.
[0250] To improve the integration of various components in the optimized workflow for physicians and to improve the optimized working environment, Figure 7 The present invention discloses a structure comprising an fs laser source 210, an applicator head 220, and a beam guide 230 for guiding fs laser radiation to and from the applicator head 220 and to the eye 900 to be operated on. Figure 7 In the diagram, the components of the beam guide 230 are shown only by way of example), the microscope head 320, the movable second hinged arm 130 containing the mirror, and the OCT module 400 are provided by... Figure 7 Controlled by a control device 500 (not shown), the OCT module includes an OCT light source 405, a reference optical path, an interferometer, a detector, and one or more switching points 420. The switching points 420 guide the light output from the OCT light source 405 and the light returned from the eye 900 through the OCT light source 405, passing only through the applicator head 220 in a first state and only through the microscope head 320 in a second state. This, for example, allows the OCT module to be used with the microscope head 320 for the surgical insertion of an intraocular lens (IOL), in which case the applicator head is not used and remains in a parked position, decoupled from the microscope head 320. On the other hand, it ensures that the illumination and detection optical paths of the OCT module 400, used to apply the incision with the focus of the fs laser radiation, correspond to the optical path of the fs laser radiation, thereby avoiding alignment errors. This is achieved through one or more switching points 420 without the need to integrate a separate OCT module.
[0251] To improve the integration of the OCT module 400, Figure 7 A short-pulse laser system 200 for ophthalmic surgery is shown, comprising fs laser sources 210 and 400, and an OCT module comprising a short-coherence light source 405 and an interferometer. The fs laser radiation and the radiation from the OCT short-coherence light source 405 are delivered to an applicator head 220 via a shared second hinged arm 130 containing mirrors, and then to the eye 900. After the radiation from the two sources is combined, both are laterally deflected by a shared x / y mirror scanner 240. In this configuration, the interferometer, which has a beam splitter and two mirrors, assigned to the OCT module, is positioned directly upstream of the exit position of the objective lens 225 in the optical path. Figure 7 (Not shown in the image).
[0252] The advantage of this solution is that only a single beam guide 230 (in the form of a guiding optics formed by a mirror) is needed for both the fs laser radiation directed at the applicator head 130 and the radiation from the OCT light source 405. Instead of the second hinge arm 130 containing the mirror, a photonic crystal fiber can serve as the beam guide for delivering both the fs laser radiation and the radiation from the OCT short-coherence light source 405. In this case, the hinge member of the second hinge arm 130 can be designed without the mirror.
[0253] To further improve the integration of the OCT module 400 and provide alternatives, Figure 7 Another solution is also depicted: the short-pulse laser system 200 shown here also illustrates an fs laser source 210 and an OCT module 400, which includes a short coherent light source 405 and an interferometer. The fs laser radiation is laterally deflected via an x / y mirror scanner 240 and then delivered to the applicator head 220 via a second hinged arm 130 containing a mirror. However, the radiation from the OCT short coherent light source is guided and delivered to the applicator head 220 via an optical fiber 410 instead of via the x / y mirror scanner 240. Here, the optical paths of the fs laser and the OCT light source radiation are combined in the applicator head 220 and guided into the eye 900 via a laterally movable objective lens 225.
[0254] The advantage of this solution is that none of the multiple optical elements of the second hinge arm 130 containing the mirror are arranged in the OCT optical path, and there is no longer any interference reflection in the OCT detection signal.
[0255] For the integration of OCT module 400 with OCT short coherence light source 405 and interferometer Figure 8 Further details are provided, namely that in the short-pulse laser system 200, the radiation from the fs laser source 210 and the radiation from the OCT short coherence source 405 of the OCT module 400 can be combined on a common optical axis 215 and directed toward and away from the eye 900 along a common optical path 250. For this purpose, the fs laser radiation from the fs laser source 210 is incident downstream of the fs laser beamforming optics 211 onto the ring mirror 430 and reflected at the ring mirror toward the eye 900. The radiation from the OCT short coherence source 405 of the OCT module extends in the opposite direction through an aperture arranged in the center of the ring mirror 430 toward the eye 900 and thus along the same path as the fs laser radiation. The light from the eye passing through the aperture in the ring mirror 430 is also detected by an OCT detector arranged in the OCT module 400.
[0256] This has the following advantages: a large aperture range is preferentially used to shape the fs laser radiation via the fs laser beamforming optics 211. This improves focusing. Furthermore, when the fs laser beam is focused into the lens of the eye 900, only the peripheral area in the retinal region is illuminated in the subsequent channel passing through the eye 900, thereby reducing the risk of injury to the patient due to radiation in the central macular region. In addition, the annular aperture segmentation has the advantage that the radiation from the OCT short coherence source 405, i.e., the OCT measurement and detection beam, is guided onto the optical axis 215 of the short-pulse laser system 200 without surface interference from its reflection optics. This does not occur when coupled with a dichroic filter or when coupled with a color-neutral component when the wavelengths of the OCT short coherence source 405 and the fs laser radiation are nearly identical. Color-neutral segmentation also results in additional intensity loss for both the OCT short coherence source 405 and the fs laser radiation.
[0257] In other embodiments not shown here, the radiation axis of the OCT short coherence light source 405 is not aligned with the optical axis 215 of the short-pulse laser system 200, but rather has a very small angle for this purpose. This has the advantage that other optical elements necessary for beamforming of the fs laser radiation directed at the eye 900 do not cause the OCT illumination light to return into the OCT detection optical path and thus affect the OCT signal.
[0258] To improve the calibration accuracy of the focus used for locating pulsed laser radiation in OCT imaging, Figure 7 A confocal detector 260 is shown, whose focal aperture is conjugate to the focal position of the fs laser radiation.
[0259] The confocal detector 260 also allows for the measurement of the structure of the eye when scanning the focal point of the fs laser radiation in all spatial directions.
[0260] Therefore, the following methods for controlling the short-pulse laser system 200 for ophthalmic surgery can be advantageously performed in the short-pulse laser system 200, see also [link to previous text]. Figure 9a and Figure 9b The short-pulse laser system includes both a confocal detector 260 and an OCT detector in the OCT module 400.
[0261] a) Using an OCT module 400 to take a B-scan or A-scan 450, the OCT module displays at least two structures 455-a and 456-a of the eye 900, such as the anterior and posterior sides of the cornea.
[0262] b) When the eye 900 is irradiated by fs laser radiation, the intensity change 460 of the signal from the confocal detector 260 is recorded as it passes through the same two structures 455-b and 456-b of the eye 900 at the z-focal position.
[0263] c) Calculate the offset and scaling factors from the signal z-positions obtained in the B or A scan and under intensity variation for the corresponding two structures.
[0264] d) Take OCT images to determine the desired incision location; determine the desired incision location (by referring to these OCT images).
[0265] e) Calculate and control the focus of the fs laser radiation using OCT images and the desired incision location, as well as offset and scaling factors.
[0266] By controlling the short-pulse laser system 200 in this way, it is ensured that the difference between the focal position of the structure irradiated by the fs laser beam, as measured by the confocal detector 260, and the focal position of the same structure, as measured by the OCT module 400, for example, by different wavelengths or different apertures, is used to control the fs laser incision and thus has little or no impact on the surgical procedure.
[0267] The difference between the focal positions of structures irradiated by fs laser radiation, determined by the resonant focal detector 260, and the difference between these focal positions and those of the same structure determined by the OCT module, can be used. Different wavelengths or different apertures have little or no impact on the control of the fs laser incision and the success of the surgery.
[0268] To improve the integration and optimized working environment of different components of the physician-optimized workflow, Figure 7 The paper further discloses a structure in which an fs laser source 210, a beam guide 230 for guiding fs laser radiation through an applicator head 220 to the eye 900 to be operated on, and a swept-frequency light source OCT module 400 are connected via... Figure 7 The control device 500 (not shown) controls the sweep frequency light source OCT module, which includes an OCT light source 405 and an interferometer. The applicator head 220 includes a laterally scanning movable objective lens 225. In one embodiment variant, the coherence length of the OCT light source 405 in air is greater than 45 mm, preferably greater than 60 mm.
[0269] Because of the large coherence length of the OCT light source 405, the entire anterior chamber section inside the A-scan given by the tuning of the frequency sweep light source can be detected. Even if the optical path pointing to the eye 900 is lengthened or changed due to the movement of the lateral objective lens, it is not necessary to adjust the optical path length of the reference optical path, for example, by moving the reference mirror.
[0270] This change in optical path length due to objective lens movement is as follows: Figure 10 As shown. Between objective positions 225-1 and 225-2 of objective lens 225, the focal point shifts accordingly between positions 465-1 and 465-2, which is accompanied by a change in the optical path length of the OCT illumination beam path.
[0271] To compensate for the effect of objective lens 225 movement on the OCT signal, the path difference (typically up to 6 mm when the objective lens position is different) is taken into account when calculating the A-scan from the OCT signal. Therefore, when obtaining the A-scan from the measured OCT signal, based on... Figure 7 In the structure, among other steps, the following steps are also performed:
[0272] (1) Detect the first OCT signal during the tuning of the OCT light source 405 at objective position 225-1.
[0273] (2) Detect the second OCT signal during the tuning of the OCT light source 405 at objective position 225-2.
[0274] (3) Perform Fourier transform on the first OCT signal used to obtain A scan; perform Fourier transform on the second OCT signal multiplied by a phase factor that depends on the relative position of objective position 225-2 with respect to objective position 225-1.
[0275] To compensate for the effect of objective lens 225 movement on the OCT signal, in an alternative solution, the A-scan obtained from the OCT signal is corrected by a target displacement related to the position along the measurement axis. To this end, the following steps are performed:
[0276] (1) Detect the first OCT signal during the tuning of the OCT light source 405 at objective position 225-1.
[0277] (2) Detect the second OCT signal during the tuning of the OCT light source 405 at objective position 225-2.
[0278] (3) The first OCT signal is subjected to Fourier transform to obtain the first A scan.
[0279] (4) The second OCT signal is subjected to Fourier transform to obtain the second A scan.
[0280] (5) The second A scan is performed along the measurement axis with a value related to the relative position of objective position 225-2 with respect to objective position 225-1.
[0281] Cutting guide
[0282] The aforementioned structures of the short-pulse laser ophthalmic surgical system 100 and the short-pulse laser system 200 particularly support laser-guided methods, such as... Figure 11a and 11b As shown:
[0283] If the incision 920-1 to be made in the tissue 910 of the eye 900 is located at the focal point 921-1 projected onto the x / y axes, then the incision 920-1 projected onto the x / y plane is smaller than the field of view 226 of the objective lens 225, for example, for a small and steep entry incision, such as... Figure 11a As shown, the following steps are selected for laser cutting guidance, and participants... Figure 11b :
[0284] (1) The objective lens 225 is positioned at x / y below, so that the position of the x / y focal point to be projected, that is, the position of the corresponding focal point of the fs laser radiation in x and y, is within the field of view 226.
[0285] (2) When using an x / y scanning system, i.e., an x / y mirror scanner 240, if necessary to deflect the focal position after each x / y scan or in parallel with the x / y scan, the focal position of the cut pattern is projected along the optical axis 215 by means of a lens with varying diffusion or a lens system 211 with varying diffusion, using an objective lens 225 fixed at its x / y position. This is a preferred solution, for example, for small and steep entry cuts.
[0286] If a larger or flatter notch 920-2 is required for application purposes, having a greater projected x and / or y extension than that simultaneously detectable from the field of view 226 of objective lens 225, see [reference needed]. Figure 12a As shown, objective lens 225 can be moved individually until the new horizon and the horizon 226 of the original objective lens position cover the entire cut area 920-2. For the corresponding new horizon, any missing cut portion can be supplemented by the x / y scanning system, in this case, the x / y mirror scanner 240, which, if necessary, is supplemented by changing the z-position of the focal point of the fs laser radiation. That is, working in successive other lateral positions of objective lens 225 until the complete cut 920-2 is achieved through different partial scanning areas. The x / y mirror scanner 240 for partial areas here allows, in a simple manner, to systematically and precisely traverse larger areas, particularly preferably, with a square partial area, by means of stepwise objective lens movement.
[0287] When the incision 920-2 is extremely flat in tissue 910, such as the cornea, that is, the y-extension of the projection of the focal position 921-2 of the incision 920-2 in the x / y plane cannot be fully reached by the y-scanner when the objective lens 225 is stationary, because the field of view 226 of the objective lens 225 is too small, and the length of the incision along the x-axis lies within the field of view 226, the following method is chosen instead of the partial area scanning described above, see [link to relevant documentation]. Figure 5 :
[0288] (1) The objective lens moves in the y-direction and simultaneously moves to adjust the z-focal position. 211 Lens or lens system, and
[0289] (2) Superimposed fast X-ray scanner motion.
[0290] If the cut 920-2 is extremely long and steep, it has a large extension in the x-direction and a small extension in the y-direction. In this case, it is advantageous to implement the cut by moving the objective lens 225 along the x-axis and simultaneously moving the lens used to adjust the z-focus position 211, while superimposing a fast y-scanner movement.
[0291] This method can also be applied in both directions to the general cutout 920-2, whose projection onto the focal position 921-2 in the x / y plane has an x and y extension that is greater than the field of view 226 of the objective lens 225 not only in the x direction but also in the y direction.
[0292] In the above description, z-positioning is performed by means of a lens or lens system 211 that changes the diffusion. The above-described cutting guidance is generally applicable to each type of z-focus adjustment, for example, the z-focus position is also achieved by positioning or moving the objective lens 225 along the optical axis 215 in the applicator head 220.
[0293] To minimize the fs processing pulse to disintegrate the lens 910 and ensure that subsequent emulsification does not require or requires only very small ultrasonic energy, Figure 13a and 13b A method or incision pattern is illustrated herein that weakens the lens in the eye 900 in terms of its structure. This incision-guided method includes the following steps:
[0294] (S0) Locate the focal point SP of the short-pulse laser radiation, in the example of fs laser radiation, within the lens 910 of the eye 900 to be treated. In one embodiment, the focal point SP is located within the lens 910 at a safe distance relative to the anterior and posterior capsules of the eye 900.
[0295] (S1) The objective lens 225 advances radially in the meridional plane 940-1 of the lens 910 and overlaps with the oscillating focal displacement 935 with amplitude A along the optical axes 215, 950 of the fs laser system and the eye, wherein, in the first variant, the laser pulse radiated by the fs laser is output to the eye only when the focal point moves from front to back, and in the second variant, the laser pulse radiated by the fs laser is output to the eye 900 after the entire cycle. The meridional plane 940 of the lens 910 is here given by a plane that passes through the center of the lens 910 near the optical axis 950 of the lens 910 or near the optical axis 215 of the fs laser system 200 and extends approximately parallel to the optical axes 215, 950. Thus, the cutting plane 925-1 is achieved. In the third variant, based on the first variant, the focal movement from front to back, i.e., with a smaller advance distance, i.e., a smaller lateral movement, is achieved faster than when the focal point moves from back to front. This results in the laser pulses aligning more closely together laterally between each other when the laser pulse frequency is constant, creating a harmonious cut surface 925-1.
[0296] (S2) The focal point of the fs laser radiation is advanced by a height HR along the optical axes 215, 950, where HR is selected such that the focal point of the laser pulse set in a subsequent step does not coincide with the focal point of the laser pulse set in a previous step. In one variant, a distance D of 10-50 μm is maintained between the laser focal points of the two cutting surfaces 925-1, 925-2. On the one hand, this positive distance ensures that no subsequent, unnecessary incisions are made in the cavitation bubbles generated in the later incision 925-1. On the other hand, no incisions are needed in this distance region because bubble formation results in sufficient weakening in the tissue 910, and the two cutting surfaces 925-1 and 925-2 may even merge together if necessary.
[0297] (S3) Repeat step S1 if the propulsion direction reverses in the radial direction, and repeat step S2 if necessary (this is in...). Figure 13b (Based on the size ratio present in this example, but not necessarily). In one implementation variant, these steps S1 and S2 are repeated until a safe distance relative to the posterior capsule is reached. In one variant, to completely deplete the lens, additional steps are taken, such as by simultaneously, superimposedly, pushing the laser-focused deposits with the aid of a rapid lateral scanner during the execution of steps S1 and S2.
[0298] (S4) The focal point advances radially in the meridional plane 940 with a length VR and along the optical axes 215, 960 with a length HR, so that the cut 925-x produced in subsequent steps does not radially overlap with previous cuts 925-1, 925-2, etc., or in one embodiment has a radial spacing D, preferably between 10-50 μm. Figure 13b The example provides feasible lengths VR and HR, but other lengths can also be chosen, as long as the incision 925-x that has not yet been created does not overlap with previous incisions 925-1, 925-2, etc. Repeat steps S1-S4 (see S1', S2', S3') until, in the implementation variant, the lens 910 is covered with incisions 925-1, 925-2, ... 925-x throughout this meridional plane 940, except for the minimum distance to the capsular bag and iris in one implementation variant.
[0299] (S5) Position the focus on the edge of another meridian 940-2. In a preferred embodiment, the alternation of meridians 940-1, 940-2, ... occurs in the region of the intersection of meridians 940-1, 940-2, ...
[0300] (S6) Repeat steps S1-S6 until the entire lens 910 is covered with incisions 925-1, 925-2, ... 925-x.
[0301] In addition to the cut patterns along meridional planes 940-1 and 940-2, different overall cut patterns can be achieved by positioning the basic cut patterns in steps (S1)-(S3). In this way, lattice planes covered with cut surfaces can also be achieved. In all three-dimensional patterns at cuts 925-1, 925-2, ... 925-x, the degree of weakening of the cohesive force within the lens can be adjusted by forming bubbles through the distances of the cut surfaces 925-1, 925-2, ... 925-x. Furthermore, the distances from cut 925-2 described in step S2 to other similar cuts 925-1, 925-2, ... 925-x according to step S2 can be matched to the desired degree of weakening in all three spatial directions.
[0302] In order to efficiently cut the 910-2 capsule using a fast Z-scan system during cystectomy, in Figure 14a The side view SA illustrates a method for guiding the focal point when the lens 910-1 is tilted relative to the optical axis 215 of the laser system, and... Figure 14b The top view AO is shown in the figure:
[0303] (1) Move the bag 910-2 to be cut to the x / y / z focal position of the preset starting position, after the last part 913 of the area of bag 910-2 that needs to be cut by laser for the cystectomy.
[0304] (2) The focal point of the fs laser radiation advances forward a total distance H along the z-axis 215, while the focal point of the fs laser radiation advances in the x / y plane 922 along the edge of the projection of the capsule 926 on the x / y plane 922 in the direction D1. Thus, after passing a distance H, the focal point is located in front of the capsule 910-2.
[0305] (3) The focus moves backward a total distance H1 along the z-axis 215, while the focus moves in the x / y plane 922 along the path projected onto the x / y plane 922 by the sac cut 926, where H1 is less than H, and the focus is located behind the sac 910-2 after traveling a distance H1.
[0306] (4) Repeat steps (2) and (3) until the foremost position 914 of the area 926 of the cyst 910-2 that requires pulsed fs laser radiation for cutting in order to perform cystectomy is reached.
[0307] (5) To complete the cystectomy 926, the above steps are repeated with the focal point of the fs laser radiation advancing in the opposite direction D2 along the path projected onto the x / y plane 922. (See [link to article]) Figure 14b ).
[0308] When the lens 910 is tilted slightly and a larger advance is selected in the x / y plane 922, the influence of bubble formation from previous laser pulses on the pulse to be used can be ignored. Here, the following steps are advantageous, as shown in the top view of the AO. Figure 15 :
[0309] (1) Move the 910-2 of the cyst to be cut to the x / y / z focal position SP, which is the position that needs to be cut with laser for the cystectomy relative to the area 926 of the cyst.
[0310] (2) The focal point of the fs laser radiation advances forward a total distance H along the z-axis 215, while the focal point advances in the x / y plane 922 along the edge of the projection of the capsule cut 926 onto the x / y plane 922 in the direction D1. Thus, after passing a distance H, the focal point is located in front of the capsule 910-2.
[0311] (3) The focus moves backward a total distance H1 along the z-axis 215, while the focus moves in the x / y plane 922 along the path projected onto the x / y plane 922 by the sac cut 926, in the direction D1, where in the first embodiment variant H1 is less than H, and the focus is behind the sac 910-2 after traveling a distance H1.
[0312] (4) Repeat steps (2) and (3) until the foremost position 914 of the area 926 that needs to be cut with laser for the cystectomy is reached in the cyst bag 910-2.
[0313] (5) While maintaining the advance in the x / y plane 922 in the direction D1, repeat steps (2) and (3), wherein in the first implementation variant H1 is greater than H, until the point 913 of the last part of the area 926 of the pouch 910-2 that needs to be laser-cut is reached.
[0314] (6) While maintaining the advancement in direction D1 in the x / y plane 922, repeat steps (2) and (3), wherein in the first embodiment variant H1 is now less than H, until the cystectomy 926 is completed at point SP.
[0315] In a second implementation variant, when the lens 910 is tilted less and a larger advance is selected in the x / y plane 922, the cutting path of the capsulotomy 926 can also be achieved in the opposite direction D2. See also Figure 15 :
[0316] (1) Move the capsule 910-2 to be cut to the x / y / z focal position SP, relative to the position of the area 926 that needs to be cut by laser for the capsule resection.
[0317] (2) The focal point of the fs laser radiation or other short-pulse laser radiation advances forward a total distance H along the z-axis 215, while the focal point advances in the x / y plane 922 along the edge of the projection of the capsule cut 926 onto the x / y plane 922 in the direction D2. Thus, after passing a distance H, the focal point is located in front of the capsule 910-2.
[0318] (3) The focus moves backward a total distance H1 along the z-axis 215, while the focus moves in the x / y plane 922 along the path projected onto the x / y plane 922 by the sac cut 926, where H1 is greater than H, and the focus is located behind the sac 910-2 after passing the distance H1.
[0319] (4) Repeat steps (2) and (3) until the last part of the area 926 of the cyst bag that needs to be cut with a laser for cystectomy is reached, position 913.
[0320] (5) While maintaining the advance in direction D2 in the x / y plane 922, repeat steps (2) and (3), but in the second implementation variant, H1 is less than H, until the position 943 of the foremost part of the area 926 of the pouch 910-2 that needs to be laser-cut is reached.
[0321] (6) While maintaining the advancement in direction D2 in the x / y plane 922, repeat steps (2) and (3), but where H1 is now greater than H, until the cystectomy 926 is completed at point SP.
[0322] The lens 910-1 is not only tilted but also perpendicular to axis 215. The capsulorhexis 926 can be performed using the FS laser system 200 with a rapid z-scan, i.e., a z-focus deflection speed greater than or approximately equal to the x / y focus deflection speed. This requires some time for the relative motion of the eye 900 relative to the optical axis 215 of the laser system to change. The following steps in the method for controlling laser focusing in capsulorhexis 926 ensure that, as Figure 16 As shown in the top view AO, even when the pouch 910-2 moves slightly in the x / y plane 922 or in the z-axis 215, a pouch segment is produced that remains completely separated from the remaining pouch 910-2:
[0323] (1) Position the focal point of the fs laser radiation in the x / y plane 922 and in the z position relative to the capsule 910-2.
[0324] (2) In the x / y plane 922, guide the focus in the first segment A1 with a first radius R1 along the edge of the bag 910-2 that needs to be cut.
[0325] (3) Guide the focus in the second segment A2 with the second radius R2 in the x / y plane.
[0326] (4) In the x / y plane 922, guide the focus in the third segment A3 with a third radius R3, wherein the first radius R1 and the third radius R3 are smaller than the second radius R2, such that the focus path generated by using each pulse intersects with the first segment A1 or the second segment A2.
[0327] Here, in steps 2, 3, and 4, the z-position of the focal point of the fs laser radiation changes oscillatingly with such a large oscillation amplitude that the laser pulse used during the oscillation breaks through the capsule 910-2 through a photointerruption process.
[0328] In steps 2, 3 and 4, while guiding the focus in the x / y plane 922, the z-focus position is also periodically changed for each segment A1, A2 and A3 at least once, preferably multiple times, and especially preferably more than five times in an oscillating manner.
[0329] In a fast x / y scanning system 240 for cutting 926 of a cystectomy, i.e., a system in which the x / y focus deflection speed is greater than the z focus deflection speed, the separation problem between the third segment A3 and the first segment A1 of the cystectomy incision in the x / y plane 922 is not as severe as in a fast z-scanning system due to the high movement speed of the focus in the x / y plane 922.
[0330] The simple incision geometry or beam-guided geometry described so far cannot guarantee an approximately circular capsulotomy, especially when the eye is slowly scanned laterally in the x and / or y directions in relation to movement. During significant eye movements, it is now possible that the third segment A3 encounters the first segment A1 of the capsulotomy incision just at its beginning, resulting in a noticeable indentation and thus a deviation from the approximately circular capsulotomy 926, as... Figure 16 As shown in the figure. However, circular capsulotomy is advantageous for better centering of various IOL types of intraocular lenses (IOLs) subsequently embedded in the capsular bag 910-2.
[0331] Therefore, as an alternative, it was disclosed in Figures 17a to 17c The proposed incision geometry, wherein at least two time-separated non-closed curves 927 are incised instead of a through incision, wherein each of the end regions 928-1, 928-2 is arranged inside the subsequently formed sac incision 926, i.e., inside the circular opening.
[0332] Therefore, as Figure 17a and 17b As shown, in the method of guiding the cutting of capsulotomy 926 using a short-pulse laser system 200 for ophthalmic surgery, an opening is created such that the focal point of the short-pulse laser radiation is positioned at its x and y focal points using an x / y scanning system 240. In this process, a first non-closed curve 927-1 with radius R and a second non-closed curve 927-2 with radius R are generated in two steps, along with first and second end regions 928-1 and 928-2, respectively, having arches pointing in the same direction. The first end region 928-1 of the first non-closed curve 927-1 has a first end region radius R. E11 Furthermore, the second end region 928-2 of the first non-closed curve 927-1 has a second end region radius R. E12 And the radius R of the first end region E11 and the radius R of the second end region E12 The radius is less than R, and the first end region 928-1 of the second non-closed curve 927-2 has a first end region radius R. E21Furthermore, the second end region 928-2 of the second non-closed curve 927-1 has a second end region radius R. E22 And the radius R of the first end region E21 and the radius R of the second end region E22 Smaller than radius R, all end regions 927-1, 927-2 each have an end 929, and the first end region 928-1 of the second non-closed curve 927-2 intersects with the second end 928-2 of the first non-closed curve 927-1, and the second end region 928-2 of the second non-closed curve 927-2 intersects with the first end region 928-1 of the first non-closed curve 927-1, so that the ends 929 of all end regions 928-1, 928-2 are arranged inside the closed curve formed by the first and second non-closed curves 927-1, 927-2 in the cystectomy 926.
[0333] In addition, in advantageous ways, such as Figure 17c As shown, in the method of guiding the cutting of a capsular resection using a short-pulse laser system 200 for ophthalmic surgery, an opening of the capsular bag 910-2 can be created, i.e., the focal point of the short-pulse laser radiation is positioned at its x and y focal points using an x / y scanning system 240. This allows for the generation of first, second, third, and fourth non-closed curves 927-1, 927-2, 927-3, and 927-4 with radii R in four steps. These non-closed curves each have first and second end regions 928-1 and 928-2 with correspondingly oriented arches. The first end region 928-1 of the first non-closed curve 927-1 has a first end region radius R. E11 Furthermore, the second end region 928-2 of the first non-closed curve 927-1 has a second end region radius R. E12 The first end region 928-1 of the second non-closed curve 927-2 has a first end region radius R. E21 Furthermore, the second end region 928-2 of the second non-closed curve 927-2 has a second end region radius R. E22 The first end region 928-1 of the third non-closed curve 927-3 has a first end region radius R. E31 The second end region 928-2 of the third non-closed curve 927-3 has a second end region radius R. E32 Furthermore, the first end region 928-1 of the fourth non-closed curve 927-4 has a first end region radius R. E41 The second end region 928-2 of the fourth non-closed curve 927-4 has a second end region radius R. E42 And the radius R of all end regions E11 R E12 RE21 R E22 R E31 R E32 R E41 and R E42 The radius is less than R, wherein all end regions 928-1 and 928-2 have an end 929, and the first end region 928-1 of the second non-closed curve 927-2 intersects with the second end region 928-2 of the first non-closed curve 927-1, the first end region 928-1 of the third non-closed curve 927-3 intersects with the second end region 928-2 of the second non-closed curve 927-2, and the first end region 928-1 of the fourth non-closed curve 927-4 intersects with the third non-closed curve 928-2. The second end region 928-2 of the closed curve 927-3 intersects with the second end region 928-2 of the fourth non-closed curve 927-4, and the first end region 928-1 of the first non-closed curve 927-1 intersects with the first end region 928-1 of the first non-closed curve 927-1, such that the ends of all end regions 928-1, 928-2 are arranged inside the closed curve formed by the first, second, third and fourth non-closed curves 927-1, 927-2, 927-3, 927-4 in the cystectomy 926.
[0334] If all the cutting processes of the cystectomy 926, as described herein and also possible with a greater number of non-closed curves 927-1...927-n, are distributed across multiple individually performed cuts, this results in a shorter incision length for each non-closed curve 927-1...927-n. With a given lateral scanning speed in the x and / or y directions, this results in a shorter cutting duration for a single non-closed curve 927-1...927-n. During this shorter cutting duration, eye movement results in a minimal deviation from the circular cutting curve for each individually performed cut of the non-closed curves 927-1...927-n. Lateral reorientation can be performed before the next incision. Even without such reorientation, this cut geometry is advantageous, in particular, but not limited to, for short-pulse laser systems 200, one or more of which use a focus of short-pulse laser radiation for cutting the bag to move faster along the optical axis 215 than in the lateral direction, or which have lateral sub-region scanners, because the mechanical tolerances of the lateral scanners or the scan guidance of the short-pulse laser system 200 can be better compensated.
[0335] Therefore, for each pair of intersecting non-closed curves 927-n-1 and 928-n, the following applies: the intersection point lies in the second end region 928-2 of the non-closed curve 927-(n-1) and the first end region 928-1 of the subsequent non-closed curve 927-n, and the radius of curvature R of the end regions is... En1 REn2 The radius R is smaller than that of the non-closed curves 927-n-1 and 928-n, which describes the radius of curvature of the central region between the two end regions 928-1 and 928-2 of the non-closed curves 927-1, ... 928-n.
[0336] However, the radius of curvature R of the end region En1 R En2 The requirement that it should be smaller than the radius R also includes the case where the radius of curvature R of the end region is less than or equal to the radius R of the radius of curvature. En1 R En2 It approaches R from the bottom up, that is, R En1 R En2 →R. All non-closed curves 927-n-1, 928-n have a radius R in their central region. However, slight differences in the radius R between two non-closed curves 927-n-1, 928-n are possible, but it is not impossible to produce a closed curve 926, approximately circularly fitted with radius R, through the combined action of the non-closed curves in the manner and method described above, thus satisfying the requirements for cystectomy incisions. The extension of the end regions 928-1, 928-2 between the two non-closed curves 927-n-1, 928-n can also vary.
[0337] For sub-region scanners, it is particularly advantageous that the number of individual incisions, i.e. the number of non-closed curves 927-1…928-n, is consistent with the number of sub-regions required to cover the entire area of the cystectomy 926.
[0338] Patient interface / touch-eyepiece
[0339] To simplify the operator's workflow as much as possible (for the patient interface 600, which includes the eyepiece 610 and is necessary for optical reasons), the following is shown... Figure 18 The diagram shows a structure for treating an eye 900 using a system 100 for short-pulse laser ophthalmic surgery. The structure shown includes a patient interface 600 and an applicator head 220 for the system 100 for short-pulse laser ophthalmic surgery. Figure 18 The patient interface 600 is fixed not only to the patient's eye 900 but also to the application head 100 of the system for short-pulse laser ophthalmic surgery, thereby fixing the relative position of the eye 900 with respect to the system 100 for short-pulse laser ophthalmic surgery and thus fixing the optical path pointing to the short-pulse laser radiation.
[0340] The patient interface 600 includes a tactile eyepiece 610, which in the illustrated embodiment is designed as a liquid interface. The tactile eyepiece 610 is a single piece, preferably made of a single transparent material, and includes a suction ring 612, an outer casing 611, and an optical element 620 on the upper side of the outer casing 611. It also includes two openings 613, 614, to which two leads are connected via a fixing auxiliary, or the openings facilitate the connection of the two leads, wherein each lead is connected to or is connected to one of the openings 613, 614.
[0341] The one-piece eyepiece 610, which integrates all functional components, makes operation simpler than that of the multi-piece eyepiece 610, which is assembled on the patient's eye 900. Such a multi-piece eyepiece 610 is described, for example, in US 7,955,324 B2, US 8,500,723 B2, US 2013 / 053837A1, and WO 2012 / 041347A1.
[0342] On the one hand, the two leads are used to apply negative pressure, which is applied here through the bottom opening 613, and on the other hand, they are used to introduce liquid into or remove liquid from the eyepiece 610 through the upper opening 614 when the eyepiece 610 is attached to the eye 900.
[0343] In a preferred variant, an overflow outlet 615 is further provided in the upper outer cover area of the eyepiece 610 away from the eye 900, so that excess liquid or air can leave from the eyepiece 610 during filling.
[0344] Preferably, the patient interface 600 includes a mechanically detachable coupling element 651 for mechanically securing the eyepiece 610 to the applicator head 220. Alternatively, instead of the mechanical interface with the mechanically detachable coupling element 651, the patient interface may include an eyepiece 610 with a different suction structure made of the same material as the eyepiece 610. This other suction structure holds the eyepiece 610 in place at the applicator head 220 when negative pressure is applied. Because alternative solutions are involved, this is not discussed in detail here. Figure 18 As shown in the image.
[0345] Furthermore, it is advantageous that the surface of the optical element 620, which is away from the outer casing 611 and faces the application head 200, is arranged not perpendicularly, but tilted relative to the optical axis 215.
[0346] This avoids the risk of over-illuminating the actual eye structure to be measured and causing distortion when the short coherence light source of the OCT is reflected at the surface of the optical element 620 through the eyepiece 610, directly reflected back into the OCT probe optical path and critical OCT image area, during the measurement of eye structure using optical coherence tomography (OCT). This risk arises when the surface of the optical element 620 is oriented perpendicularly to the optical axis 215.
[0347] The surface of the optical element 620 facing the outer cover 611 and therefore towards the eye 900 is preferably convexly curved. This achieves an optical effect on the one hand, and on the other hand, the formed bubble travels upward along the curved wall and at or beyond the edge of the lens, and thus outside the aperture of the short-pulse laser radiation or CT illumination and detection beam.
[0348] Furthermore, the surfaces of the optical element 620 facing the outer cover 611 and the eye 900 can be coated or surface-treated in a hydrophilic manner. This improves wetting achieved using water or other liquids such as a balanced salt solution (BSS) and the lateral migration of air bubbles.
[0349] Advantageously, the surface of the optical element 620 facing the application head 220 is coated with an anti-reflective coating, so that the high intensity of the incident short-pulse laser radiation is not reflected back into the device optics of the short-pulse laser ophthalmic surgery system 100.
[0350] Particularly advantageous for aseptic purposes is that the patient interface 600 also includes an applicator head protector 650, which preferably has a central recess. For example... Figure 18 As shown, the applicator head protector 650 can be fitted and secured together with the applicator head 220 on the side facing the eye 900. This applicator head protector prevents the applicator head 220 from contamination by liquids during surgery. The recess allows the patient interface 600 to be directly secured to the applicator head 220 together with the eyepiece 610, so that the applicator head protector 650 does not obstruct the optical path of short-pulse laser radiation between the system 100 for short-pulse laser ophthalmic surgery and the optics 620 of the eyepiece 610.
[0351] If the recess is realized at the center of the applicator head protector 650, then uniform protection of the applicator head 220 in space is achieved.
[0352] Preferably, the eyepiece 610 and the applicator head protector 650 of the patient interface 600 are made into two separate or separable components. The applicator head protector 650, separate from the eyepiece 610, has the advantages of allowing for the separate and thus better fulfillment of different requirements for the eyepiece 610, such as high precision in terms of geometry and optical characteristics, and environmental protection requirements, such as the simplest and most cost-effective implementation possible.
[0353] Advantageously, the applicator head protector 650 is connected to the applicator head 220 via a mechanically detachable connecting element 651.
[0354] Preferably, the diameter of the upper outer cover of the eyepiece 610 is larger than the recess in the applicator head protector 650. This ensures seamless protection of the applicator head surface.
[0355] To support docking, especially the lateral orientation of the applicator head 220, Figure 18 A lighting system particularly suitable for short-pulse laser ophthalmic surgery is disclosed: a light guide structure 635 is embedded in the outer casing 611 of the eyepiece 610. In the applicator head 220 of the system 100 for short-pulse laser ophthalmic surgery, a visible light source 630-1 and / or an infrared light source 630-2 are integrated. Especially during surgery using short-pulse laser radiation in the eye 900, where the short-pulse laser radiation is introduced into the eye 900 via optical elements of the applicator head 220 and thereby blocks or obstructs the light path in the microscope head 320 located above the eye, for example, the eye 900 can be illuminated with infrared light 630-2, and the infrared light reflected by the eye 900 can be guided to the camera 360 via a beam splitter prism 350, wherein the beam splitter prism selectively reflects infrared light, and the camera can be used to detect the infrared light. However, the prism 350 does not reflect visible light or wavelengths from the short-pulse laser source 210 or the OCT light source 405. Light of these wavelengths, which are not reflected by prism 350, passes through prism 350 without interference.
[0356] The advantage of this structure is that, compared to alternative illumination solutions, the additional optical elements of the applicator head 220 located in the illumination optical path do not reflect light and affect the image, as is provided in the surgical microscope 300.
[0357] Furthermore, it is advantageous to integrate a force sensor 655 in the applicator head 220, which makes contact with the eyepiece 610 when the patient interface 600 is docked. The force sensor 655, along with light sources 630-1 emitting visible light and 630-2 emitting infrared light, are advantageously connected to a control device 500, which also controls the system 100 for short-pulse laser ophthalmic surgery, or to an auxiliary control unit 500', which contacts the control device of the system 100 for short-pulse laser ophthalmic surgery via a communication path.
[0358] At this point, the above arrangement allows for the following method of automatically switching the lighting when the applicator head 220 is connected to the eye 900:
[0359] (1) Connect the visible light source 630-1.
[0360] (2) Measure the pressure and guide the pressure signal to the control device 500 via the force sensor 655.
[0361] (3) Once the pressure signal of the force sensor 655 exceeds the predetermined value, the visible light source 630-1 is turned off and the infrared light source 630-2 is turned on by the control device 500.
[0362] This automatic switching prevents the patient from being continuously exposed to visible light 630-1, which could cause injury, after the applicator head 900 is connected to the eye 900 via the patient interface 600. Illumination of the patient's eye 900 is then achieved using less damaging infrared light 630-2.
[0363] References and Records
[0364] In order to accurately adjust the transmission of preoperative measurement data during eye surgery, such preoperative measurement data includes, for example, the position of the astigmatic axis of the eye 900 or cornea 910 as measured preoperatively, or the nominal position of the incision or relaxation incision relative to the astigmatic axis of the eye 900 or cornea 910. In the prior art, these preoperative data or desired nominal positions are determined or referenced relative to preoperatively obtained reference markers. Here, artificially embedded markers, such as staining points or corneal incisions, or naturally occurring markers, such as vascular structures in the sclera or iris, are used as reference markers, or simply an overall image of the eye 900 with its current structure is used.
[0365] If the eyepiece 610 is used as in laser cataract surgery, the problem here is that these markings are often covered or affected by the eyepiece 610, especially the suction structure 612 of the eyepiece 610.
[0366] The following solution is disclosed so that reference markers 640 or references to preoperative data or nominal positions caused by the markers can be used when using the eyepiece 610.
[0367] Figure 19a A first structure is disclosed that utilizes a laser incision via a patient interface 600, referenced by a short-pulse laser system 200. This structure includes either a microscope head with an applicator head 320 / 220 or a patient interface 600 including an applicator head 220, a camera 361, and an eyepiece 610. The imaging optical path of the camera 361 is designed such that the observation area detects the central portion of the eyepiece 610, wherein the free diameter d1 of the detected portion of the eyepiece 610, not covered by the edges of the eyepiece 610, is at least 14 mm.
[0368] This large free diameter ensures such a large, undisturbed field of view that the camera 361 can clearly and distinctly visualize the markings or structures of the eye 900, and that preoperative data or references to the nominal position can be made with sufficient reliability. However, for the smaller eye 900, this eyepiece 610 as a whole may be too large for reliable practical applications.
[0369] therefore, Figure 19b A second structure is disclosed that utilizes a laser incision in the patient interface 600 for reference in an unconnected state using a short-pulse laser system 200. This structure includes a microscope head with an applicator head 320 / 220, or a patient interface 600 including an applicator head 220, a camera 361, and a stylus 610 with at least one mark 640. The imaging optical path of the camera 361 is designed such that the observation field detects the central portion of the stylus 610 and the mark 640, wherein the free visible diameter d1 of the stylus is at least 10 mm, preferably at least 11 mm, and the depth of focus h in the image is at least 5 mm when appropriately magnified.
[0370] The depth of focus of the imaging, combined with the free diameter of the eyepiece 610, ensures that even when the patient interface 600 containing the eyepiece 610 is detached, there is a clear image field with a sufficiently large diameter d2 on the eye 900 so that the reference markers for preoperative measurements of the eye 900 can be clearly detected in the field of view of the camera 361, and the markers 640 of the eyepiece 610 are equally clearly visible in the field of view on the other hand.
[0371] Using this or a similar structure, the following disclosed reference methods for creating or accessing relaxation incisions in the cornea can be implemented; see also [link to relevant documentation]. Figure 20 :
[0372] (1) When the patient interface 600 is not connected to the patient's eye 900 using the eyepiece 610, a first image of the eye 900 is captured by illumination.
[0373] (2) Record the position of the mark 640 of the eyepiece 610 relative to the reference mark of the eye 900 in the first image.
[0374] (3) Take a second image of the eye 900 while the patient interface 600 is in contact with the eyepiece.
[0375] (4) Align the short-pulse laser cut preferably achieved by femtosecond laser radiation according to the identifiable position of the mark 640 in the second image based on the record obtained in step (2).
[0376] If the desired incision relative to the reference mark in the eye 900 is determined or can be referenced through preoperative diagnosis, then the incision can be aligned with the reference mark by means of the above steps, even if the reference mark is no longer visible and is covered by the eyepiece 610.
[0377] In one variation of the structure, the free diameter of the eyepiece 610 is greater than 13 mm, and even when the eyepiece 610 is attached to the eye 900, a portion of the reference mark required for reference remains visible in the eye 900.
[0378] If the above situation applies, the above method can be further improved by supplementing steps 1-3 with the following steps:
[0379] (4) Record the position of the marker 640 of the eyepiece 610 relative to the visible reference structure of the eye 900 in the second image.
[0380] (5) Based on the position of the mark 640 of the eyepiece 610 present in the image or based on the reference mark visible in the second image, the short pulse laser cut is preferably aligned by femtosecond laser radiation, provided that the record of the position of the mark 640 relative to the visible reference mark of the eye 900 in the second image does not deviate from the record of the position of the mark 640 relative to the reference mark of the eye 900 in the first image by more than a predetermined value.
[0381] The disadvantage of the above structure is that the optical components must be designed in a complex manner over a large depth of focus.
[0382] therefore, Figure 21aA third structure is disclosed, which utilizes a laser incision in the patient interface 600 for reference in an unconnected state using a short-pulse laser system 200. This structure includes a microscope head 320 / 220 with an applicator head, or a patient interface 600 comprising an applicator head 220, two cameras 361-1 and 361-2, and a tactile eyepiece 610 having at least one mark 640. The imaging optical path of the first camera 361-1 is designed such that it clearly detects the mark 640 on the tactile eyepiece 610, and the imaging optical path of the second camera 361-2 is designed such that it clearly detects the reference structure 900 of the eye in the disconnected state. Furthermore, the visible free diameter d1 of the tactile eyepiece 610 is at least 10 mm, preferably at least 11 mm.
[0383] The difference in focal position during imaging, combined with the free diameter of the eyepiece 610, ensures that even in the disengaged state, the clear image of the second camera 361-2 on the eye 900 with a diameter of d2 is large enough to identify the reference markers of the preoperative measurements of the eye 900.
[0384] The following or similar structures disclose reference methods for relaxation or access to the incision:
[0385] (1) When the patient interface 600 is not connected to the patient eye 900, the patient interface includes a tactile lens 610 with its marking 640, a first image of the tactile lens 610 with its marking 640 is captured by a first camera 361-1, and a second image of the eye 900 with the reference marking of the eye 900 is captured almost simultaneously or concurrently by a second camera 361-2.
[0386] (2) When there is a known, predetermined correspondence between the alignment and magnification of the fields of view of cameras 361-1 and 361-2, the position of the mark 640 of the eyepiece 640 in the first image relative to the reference mark of the eye 900 in the second image is recorded.
[0387] (3) A third image of the eye 900 in the patient interface 600 in the state of docking with the eyepiece 610 containing the mark 640 is recorded by the first camera 361-1.
[0388] (4) Based on the identifiable position of the mark 640 on the eyepiece 610 in the third image and based on the record obtained in step (2), align the short-pulse laser cut, typically a femtosecond laser cut.
[0389] In the variant of the above structure and method, the first camera 361-1 is replaced by an imaging OCT system.
[0390] Instead of using two cameras 361-1 and 361-2 in parallel, a single camera 361 with continuous focus adjustment can be used.
[0391] Figure 21b A fourth structure is disclosed, which utilizes a laser incision in the patient interface 600 for reference in an unconnected state using a short-pulse laser system 200. This structure includes a microscope head with an applicator head 320 / 220, or alternatively includes an applicator head 220, a camera 361, a focusing lens 362, and a patient interface 600 with an eyepiece 610 having at least one mark 640. The imaging optical path of the camera 361 is designed such that, at a first position of the focusing lens 362, the mark 640 of the eyepiece 610 is clearly detected by the camera, and at a second position of the focusing lens 362, the reference mark of the eye 900 is clearly detected in the disconnected state. Here, the visible free diameter d1 of the eyepiece 610 is at least 10 mm, preferably at least 11 mm.
[0392] By combining the free diameter of the eyepiece 610 with the difference in focal position during imaging, it is ensured that, even in the detached state, the clear field of view of the focusing lens 362 in the second position on the eye 900, with a diameter of d2, is large enough to detect the reference mark of the eye 900.
[0393] The following or similar structures disclose reference methods for relaxation or access to the incision:
[0394] (1) A first image of the eyepiece 610 with its marking 640 is captured by camera 361 in a first position of focusing lens, and a second image of the eye 900 with its reference marking is captured by camera 361 in a second position of focusing lens after a delay, particularly preferably within a second, both of which are performed when the eyepiece containing the patient interface 600 is not connected to the patient's eye 900.
[0395] (2) When there is a known, predetermined correspondence between the alignment and magnification of the field of view of the camera 361 in the first and second positions of the focusing lens 362, the position of the mark 640 of the eyepiece 640 in the first image relative to the reference mark of the eye 900 in the second image is recorded.
[0396] (3) Record the image 3 of the eye in the docking state of the eyepiece by the camera when it is in or close to the focus position 1.
[0397] (4) Align the fs cut based on the identification mark position of the eyepiece in image 3 and the record obtained in step (2).
[0398] Overall, all the aforementioned structures and methods used for reference and documentation are complex in terms of technical equipment.
[0399] Figure 21c Therefore, a fifth structure is disclosed, which utilizes the laser incision of the patient interface 600 for reference in the unconnected state using a short-pulse laser system 200. This structure includes a microscope head with an applicator head 320 / 220, or a patient interface 600 including an applicator head 220, a camera 361, a focusing lens 362, and a tactile eyepiece 610, the eyepiece including at least one marking 640. The imaging optical path of the camera 361 is designed to clearly detect the reference structure of the eye 900 in the disconnected state, and the visible free diameter d1 of the tactile eyepiece 610 is at least 11 mm.
[0400] The difference in focal position during imaging, combined with the free diameter of the eyepiece 610, ensures that even when the eyepiece 610 is detached from the eye 900 by a distance h, the clear field of view with a diameter of d2 on the eye 900 is large enough to detect the reference mark of the eye 900.
[0401] Using this or a similar structure, the following reference methods are disclosed for relaxation or access to the incision:
[0402] (1) When the patient interface 600 is not connected to the patient's eye 900 using the eyepiece 610, the camera 361 captures a first image of the eye 900 with reference marks.
[0403] (2) Within a few seconds, the patient interface 600 is docked and fixed to the eye 900 using the eyepiece 610;
[0404] (3) Align the short-pulse laser cut based on the identifiable reference structure in the first image.
[0405] The aforementioned structures used for reference and recording also enable the orientation of the intraocular lens (IOL) based on preoperatively determined reference markers after the IOL is embedded in the capsular bag 910-2. Typically, this orientation is achieved by reference to reference markers that are identifiable in preoperative images of the eye 900 or are located within the preoperative images themselves. If these preoperative images of the eye 900 or its reference markers are recorded together with the intraoperative images or reference markers—that is, the structures contained therein correspond to each other and the deviations are determined—the orientation reference based on the preoperative images or reference markers can be transferred to the intraoperative images or their reference markers by means of recording.
[0406] However, when the patient interface 600 is docked using the eyepiece 610, the appearance of the preoperative reference markers of the eye 900 or the appearance of the eye 900 itself often changes. This can result in, for example, deformation or bleeding. Therefore, the recorded image of the eye 900 obtained preoperatively is inaccurate compared to the image of the eye 900 obtained intraoperatively during intraocular lens (IOL) orientation.
[0407] This susceptibility to error can be avoided as follows:
[0408] Using the aforementioned structure and method for reference and recording, a preoperative image relative to an image of the eye 900 is recorded. This image of the eye is used to set up a short-pulse laser incision when the patient interface 600, which includes the eyepiece 610, is docked. The image of the eye 900 used to set up the short-pulse laser incision when the patient interface 600, which includes the eyepiece 610, is docked can then be regarded as a new reference image.
[0409] Now, after the short-pulse laser surgery, i.e., after the patient interface 600 with eyepiece 610 is connected to the eye 900, and while the eyepiece 610 is detached, an image of the eye 900 is captured again. This image shows all the altered structures in the eye 900. This image can be recorded as a new reference image with the same structure. It is recorded during subsequent procedures of the surgery, i.e., during intraocular lens (IOL) implantation and during the orientation of the eye 900 using images captured during IOL orientation within the capsular bag 910-2. Thus, the desired orientation reference of the IOL, based on preoperative images of the eye 900, can be transferred via a different image recording chain to the desired orientation reference of the IOL, based on intraoperative images of the eye 900 acquired during IOL implantation.
[0410] For reference in the orientation of the intraocular lens (IOL) in prior short-pulse laser cataract surgery, especially femtosecond laser cataract surgery, the following method is disclosed; see [link to relevant documentation]. Figure 22 :
[0411] (0) Generate a first image of the astigmatic eye 900 using a (usually external) diagnostic system for detecting steep and / or flat axes and store the first image and axis 900.
[0412] (1) When the patient interface 600 with eyepiece 610 is connected to 900, that is, when it is connected according to the above method, a second image for surgical orientation is generated as a reference image or an image of the eye 900 with reference marks;
[0413] (2) After the patient interface 600 with eyepiece 610 is detached from the eye 900, and when the eyepiece 610 is not attached to the eye 900, a third eye image of the eye 900 is captured.
[0414] (3) Record the third image relative to the second image;
[0415] (4) Take a fourth image of the eye 900 during the alignment of the intraocular lens (IOL) embedded in the eye 900;
[0416] (5) Record the fourth image relative to the third image;
[0417] (6) Using the recordings in steps (3) and (5), align the intraocular lens (IOL) with the orienting aid for the physician in the surgical microscope 300.
[0418] Hereinafter, without departing from the scope of the invention, the above-described features of the invention and the features described in the various embodiments may be not only combinations of examples, but may also be used in other combinations or individually.
[0419] The description based on device characteristics is similarly applicable to the corresponding methods, and the method characteristics accordingly constitute the functional characteristics of the device.
Claims
1. A patient interface for fixing the position of the eye relative to a system for short-pulse laser ophthalmic surgery, the patient interface comprising: Eyepiece The eyepiece is a single piece made of a transparent or partially transparent material and includes a suction ring, an outer cover, and optical elements adjacent to the upper side of the outer cover. The outer cover has at least one opening, which allows connection to a corresponding supply line via a fixing auxiliary member or allows connection to a supply line accordingly. A light guide structure is embedded in the outer casing of the eyepiece. The light guide structure is configured to be separate from the optical axis of the system. The eyepiece is constructed to accommodate the light guide structure, which guides visible or infrared light into the interior of the outer casing, enabling the eye to be illuminated by the light guide structure without increasing reflection.
2. The patient interface according to claim 1, wherein, The outer cover has two openings.
3. The patient interface according to claim 1, wherein, The outer cover also has an additional suction structure made of transparent material, which is located on the eyepiece and on the side of the outer cover opposite to the suction ring.
4. The patient interface according to claim 1, wherein, The optical elements are arranged at an angle relative to the optical axis of the system used for short-pulse laser ophthalmic surgery.
5. The patient interface according to any one of claims 1 to 4, wherein, The surface of the optical element facing the eye is coated or treated with a hydrophilic coating and / or convexly curved, causing the bubble to migrate peripherally, upward and away from the optical aperture.
6. The patient interface according to any one of claims 1 to 4, wherein, The surface of the optical element facing away from the eye is coated with an anti-reflective coating.
7. The patient interface according to any one of claims 1 to 4, wherein, The patient interface also includes an application head protector.
8. The patient interface according to claim 7, wherein, The device head protector has a recess.
9. The patient interface according to claim 8, wherein, The recess is centrally formed in the head protection of the application device.
10. The patient interface according to claim 8, wherein, The recess is smaller than the diameter of the upper outer cover of the outer cover.
11. The patient interface according to claim 7, wherein, The eyepiece and the applicator head protector are two separate or separable parts.
12. The patient interface according to claim 7, wherein, The applicator head protector has a mechanical coupling configured to detachably connect the applicator head protector to the applicator head of the system used for short-pulse laser ophthalmic surgery.
13. The patient interface according to any one of claims 1 to 4, wherein, The eyepiece contains at least one mark.
14. The patient interface according to claim 13, wherein, The at least one mark is located in the lower outer cover area of the outer cover.
15. The patient interface according to any one of claims 1 to 4, wherein, The eyepiece also has an overflow outlet located in the upper outer cover area of the eyepiece, through which excess liquid or air can exit the eyepiece during filling.
16. The patient interface according to claim 2, wherein, The two openings include a first opening and a second opening, the first opening being fluidly connected to the suction ring to enable the application of a vacuum, and the second opening being fluidly connected to the interior of the outer casing to enable the addition of fluid to or removal of fluid from the interior of the outer casing.
17. The patient interface according to claim 1 or 2, wherein, The patient interface also includes an additional suction structure adjacent to the upper side of the outer casing, which allows suction to be applied to hold the eyepiece at the application head of the system for short-pulse laser ophthalmic surgery.
18. The patient interface according to any one of claims 1 to 4, wherein, The outer casing has a space constructed for receiving liquid, thereby enabling the eyepiece to be designed as a liquid interface.
Citation Information
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