OPHTHALMOLOGICAL LASER THERAPY SYSTEM
Patent Information
- Application Number
- DE502017016998
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2016-03-11
- Filing Date
- 2017-03-08
- Publication Date
- 2025-08-21
- Estimated Expiration
- 2037-03-08
AI Technical Summary
Current ophthalmic laser therapy systems require significant space and time for repositioning the patient between different treatment steps, exposing sensitive laser optics to mechanical influences, and lack efficient protection during movement.
An ophthalmic laser therapy system with a device base and a device head allowing translational movement, featuring a laser swivel arm that pivots around a horizontal axis and is enclosed in a swivel arm housing, along with an examination arm, enabling all therapy steps to be performed at a fixed patient position while protecting the laser optics.
The system minimizes space requirements, reduces repositioning time, and ensures safe, protected movement of sensitive laser optics, allowing seamless integration with examination devices without the need for large installation spaces.
Description
[0001] The present invention relates to an ophthalmological laser therapy system having a device base and a device head which can be moved relative to one another by means of a translational movement, and having a laser device which contains a laser source and a first laser therapy optics and a laser pivot arm with a second laser therapy optics and a laser exit opening.
[0002] In ophthalmic laser therapy, it is now common practice to combine a laser therapy device for creating incisions in eye tissue, or for ablating or coagulating eye tissue using laser radiation, with an examination device - either by integrating it into a common system or by installing the examination device in close proximity to the laser therapy device to enable switching between the two devices without having to move the patient to another room.
[0003] This is very advantageous, for example, in laser-assisted eye surgery for correcting refractive errors or for treating other eye diseases such as cataracts using cataract surgery, where steps for characterizing the eye structures alternate with surgical steps and steps for verifying the surgical procedure or supporting the surgical procedure. For example, the eye structures can first be characterized using optical coherence tomography (OCT) or ultrasound. Then, eye tissue can be sectioned using a pulsed laser beam—in this case, separated using photodisruption.The result can then be verified using a surgical microscope and subsequent steps, such as the suctioning of a clouded lens that has previously been cut with a laser beam and / or shattered with ultrasound in cataract surgery, can be carried out under the control of the surgical microscope.
[0004] Even for vision corrections such as "SMILE" treatment, i.e. lenticule extraction through a small incision ("Small Incision Lenticule Extraction"), two main steps must be carried out after the patient has been prepared and the eye structures have been characterized: Firstly, laser therapy, in which the patient's eye is brought into contact with the laser optics using a contact lens and laser incisions are made on the eye, and secondly, lenticule extraction, in which the surgeon removes the lenticule cut during the laser therapy under observation through a surgical microscope.
[0005] The same applies to the implantation of lenticules in a patient's eye: Here, a corresponding receiving area is first created in the eye tissue by separating it with the aid of a laser, usually in the corneal tissue of the eye, and then an implant is inserted and adjusted into the receiving area under observation, for example, using a surgical microscope.
[0006] With current procedures, these steps are performed at separate locations. For example, in the "SMILE" treatment using the "VisuMax," the laser therapy position is approximately 200 mm behind and approximately 100 mm above the lenticule extraction position.
[0007] With the aid of state-of-the-art ophthalmic laser therapy systems, the relative position between the respective treatment device and the patient must be significantly changed between the various work steps. This repositioning over a large distance leads to three major disadvantages: It requires significant technical effort to realize a large range of motion. It also requires a large amount of space—both for the installation space of the ophthalmic laser therapy system and for the area that must be kept clear for movement. The procedure takes a relatively long time because a longer repositioning time is required between work steps, as the travel speed during repositioning is low for safety reasons.
[0008] The necessary mobility for repositioning the patient or the patient's eye can be provided in the patient positioning system according to the state of the art. It can also be incorporated into the required systems, i.e., the laser system and the examination equipment. The space required for this is enormous, especially with non-integrated systems.
[0009] Another major disadvantage of these devices is the limited space for patient entry and exit due to the laser optics, which are usually located above the patient support. For this purpose, WO 2012 / 152496 A1 publishes a method in which the laser therapy optics are pivoted upwards by 90° and housed in the housing of the base unit. However, this design has the disadvantage that the laser therapy optics are relatively unprotected from external mechanical influences in their working position.
[0010] The publication US 2010 / 042081 A1 shows a laser therapy device with a device head that is laterally movable on a device base and has a laser exit opening at its end that can be pivoted around an axis, increasing the working freedom required for preparation and follow-up. However, despite the lateral mobility of the device head, the laser therapy optics remain exposed and unprotected in any position.
[0011] The publication US 2014 / 107634 A1 describes a laser therapy device with a surgical microscope mounted on one arm and a laterally movable laser therapy arm. Both arms can be easily pivoted around parallel axes, allowing the surgical microscope and laser therapy arm to be positioned one above the other so that the laser therapy can be observed with the surgical microscope. While this prevents the patient from having to reposition the device, both arms remain unprotected in the room, even when not needed. Furthermore, the device still requires a large amount of space.
[0012] The object of the present invention is therefore to describe an ophthalmological laser therapy system which allows working in the smallest possible space and without repositioning the patient, but nevertheless effectively protects the sensitive laser therapy optics, in particular a pivotable laser therapy optics.
[0013] This task is solved by an ophthalmic laser therapy system designed to perform all laser therapy steps on a patient's eye in such a way that the site of action for all steps remains fixed while allowing the surgeon maximum freedom of movement. The position of the patient's eye does not need to be changed during the entire laser therapy. The position of the patient's eye in the first step determines the position of the patient's eye in all subsequent steps and thus the site of action of the necessary devices.
[0014] Ophthalmic laser therapy refers to any therapy in which a laser beam is focused into the tissue of the eye in such a way that it alters the tissue. Ophthalmic laser therapy particularly includes surgical procedures in which a laser, preferably a pulsed laser such as a femtosecond laser, is used to "cut" eye tissue through photodisruption, to ablate an area of eye tissue, or to "glue" eye tissue together through coagulation, or to change the refractive index of the material, i.e., eye tissue or an implant, through laser radiation.
[0015] This object is achieved in particular by an ophthalmological laser therapy system which comprises a device base, a device head, a laser device and a laser swivel arm.
[0016] While the device base represents the immobile base of the ophthalmic laser therapy system during a laser therapy procedure – including the preparatory and follow-up work steps – the device head serves primarily to attach movable superstructures. It also forms the basis for the joint movement of these superstructures in space. For this purpose, the device head can be moved on the device base using a translational movement in at least one xy plane. The xy plane is a plane that runs parallel to a standing plane or floor plane of the ophthalmic laser therapy system. The ophthalmic laser therapy system is preferably configured so that a translational movement in the xy plane can be performed in any direction.
[0017] The ophthalmic laser therapy system as a whole can be permanently installed on this stand level, or it can include a transport option such as a rolling system that allows the system to be brought into a parking position before or after a corresponding laser therapy procedure.
[0018] The laser device contains a laser source and a first laser therapy optics system, which are preferably arranged in the device head. The power supply of the laser device as well as the electronics are preferably arranged in the device base. The laser source is preferably configured to generate pulsed laser radiation. In particular, a femtosecond laser source can be used here. Such a femtosecond laser source preferably generates pulses with a pulse duration of 100 fs to 600 fs, a pulse repetition rate between 100 kHz and 100 MHz, preferably 500 kHz to 5 MHz, and a pulse energy of 20 nJ to 20 µJ, preferably 100 nJ to 14 µJ.
[0019] The first laser therapy optics transmits the laser beam to a laser swivel arm with a second laser therapy optics and a laser exit aperture. The laser exit aperture is the location from which a laser beam, particularly a therapeutic laser beam, exits the ophthalmic laser therapy system and subsequently reaches its target site, for example, in ocular tissue. A patient's eye can be fixed to the laser exit aperture using a patient interface or a contact lens to establish a defined spatial relationship between the tissue to be treated and the laser exit aperture.
[0020] The term laser therapy optics, which consists of a first laser therapy optic, which is usually housed in the device head, and a second laser therapy optic in the laser swivel arm, includes not only optical imaging elements such as fixed and / or movable lenses or lens systems, but also beam guidance devices. These beam guidance devices can be fixed and / or movable beam guidance devices. Movable beam guidance devices here also include corresponding scanning systems. Galvanometer scanners are common, which can position the laser beam in a plane perpendicular to the beam axis using rotatable mirrors. However, a lens can also be moved transversely to the optical axis using a linear drive. To change the depth of focus, one or more lenses are usually moved in the beam direction using a linear drive. Linear drives for this can, for example,a servo motor with a spindle, a piezo drive or a moving coil or moving magnet drive.
[0021] Laser therapy optics are used to direct and shape the laser beam from its exit from the laser source to its target, usually the tissue of the eye. In particular, they also serve to shift the laser beam as desired according to a planned scan pattern during a laser therapy step.
[0022] In principle, an optical concept as described in WO 2006 / 102971 A2 can be used here.
[0023] The laser swivel arm is mounted on the device head so that it can pivot around a first axis. This first axis is preferably a horizontal axis, i.e., an axis that runs parallel to the xy plane.
[0024] The laser swivel arm can be pivoted between a rest position and a working position. The rest position represents a position in which the laser swivel arm is "stowed" to provide maximum working freedom for the surgeon or other equipment during work steps where no laser beam is required. Typically, the rest position is a position in which the laser swivel arm is pivoted vertically upwards. The working position, on the other hand, is a position in which the laser swivel arm is preferably positioned horizontally above the patient.
[0025] In one embodiment of this ophthalmic laser therapy system, in addition to the horizontal working position, various other working positions of the laser swivel arm are possible. For this purpose, the first and second laser therapy optics are configured accordingly. For this purpose, they contain means or an arrangement of optical elements or scanning elements such that the guidance of the laser beam through the laser swivel arm can be adapted to the desired working position of the laser swivel arm. This can be achieved, for example, by using pivoting mirrors instead of fixed mirrors, both at the entrance to the second laser therapy optics, i.e., the optics of the laser swivel arm, and in front of the laser exit opening.
[0026] The working position and the rest position can be designed as two end positions, possibly clearly identifiable with a stop.
[0027] The laser swivel arm is therefore typically a pivotable arm on the device head, which is otherwise rigid and has no other pivot axes. By combining the pivoting movement of the laser swivel arm around this first axis with the transverse movement in an xy plane, spatial movement is possible.
[0028] Furthermore, a control unit controls the ophthalmic laser therapy system, in particular the translational movement of the device head on the device base and the pivoting movement of the laser pivot arm, as well as the laser device. Controlling the laser device includes, in particular, controlling the generation of a laser beam, the corresponding steering of the laser beam by movable beam guidance means, and thus controlling a scanning movement of the focus of the laser beam. The control unit can also comprise several spatially separated control devices.
[0029] In a basic embodiment, the ophthalmic laser therapy system according to the invention is characterized in that an examination pivoting arm with an examination device is further pivotably mounted on the device head about a second axis. The examination device of the examination pivoting arm can also include a further therapy option.
[0030] The examination pivot arm is also pivotable between a rest position and a working position. In this embodiment, both the laser pivot arm and the examination pivot arm have only one working position. An examination volume is defined by the examination device and its working position. The laser pivot arm, in turn, determines a working volume of the laser beam, particularly through the position of its laser exit opening in the working position. This working volume describes a volume in which the laser beam emerging from the laser exit opening of the laser device can be focussed and achieves an effect at its focal point - for example, a separating or cutting effect in eye tissue through photodisruption. It is therefore also the volume in which the focal point of the laser beam can be moved without imaging errors or with the correction of these aberrations.
[0031] Both axes, i.e., the first axis of the laser swivel arm and the second axis of the examination swivel arm, are positioned relative to each other such that a working volume of the laser beam, when the laser swivel arm is in a working position, is a partial volume of the examination volume of the examination device on the examination swivel arm when the latter is in a working position. This partial volume can also be a non-genuine partial volume, i.e., the working volume and the examination volume are identical.
[0032] In their respective rest positions, however, the laser swivel arm is not located within the swivel range of the examination swivel arm and the examination swivel arm is not located within the swivel range of the laser swivel arm.
[0033] The second axis of the examination swivel arm is arranged so that it runs non-parallel to the first axis of the laser swivel arm. This allows for a more compact design than a system with a second axis running parallel to the first axis.
[0034] Therefore, if the ophthalmic therapy system includes a laser swivel arm and an examination swivel arm, both of which are pivotably mounted on the device head, then the two swivel arms are two single-axis arm systems whose swivel axes are preferably not parallel and preferably not perpendicular to each other. Furthermore, both axes can be arranged in the same plane. The working position of the examination swivel arm, and thus of the examination device, is derived from the working position of the laser swivel arm and, in particular, the position of the laser exit aperture.
[0035] The following areas are preferred for the position of the second axis, i.e. the pivot axis of the examination pivot arm, in relation to the position of the first axis of the laser pivot arm: an angle of the second axis to a vertical plane passing through the first axis of the laser pivot arm, from 0° to 20°, particularly preferably from 0° to 5°, an angle of the second axis to a horizontal, i.e. horizontal, plane passing through the first axis of the laser pivot arm, from 0° to 50°, particularly preferably from 20° to 40°, where a horizontal plane is a plane that runs parallel to a floor plane on which the ophthalmic laser therapy system - fixed or movable - is arranged.
[0036] Furthermore, the second axis preferably runs through a point which is 200 mm to 400 mm above the axis of rotation of the laser swivel arm, 200 mm to 500 mm in the y-direction behind the laser exit opening for a laser swivel arm in working position, i.e., running towards the device head, and less than 100 mm from the vertical plane through the first axis, i.e. the axis of rotation of the laser swivel arm.
[0037] In another basic embodiment, the ophthalmic laser therapy system according to the invention is characterized in that the laser pivot arm, with its second laser therapy optics and the laser exit aperture, is enclosed in a pivot arm housing that is separately pivotably mounted on the device head coaxially to the laser pivot arm. Thus, the laser pivot arm and pivot arm housing share the same pivot axis, albeit independently of each other.
[0038] This means that the second laser therapy optics and the adjacent laser exit opening are protectively enclosed by the pivoting arm housing. A corresponding opening is provided in the pivoting arm housing for the laser exit point or exit area.
[0039] In other words, the swivel arm housing forms an outer shell for the laser swivel arm, but is mounted separately and coaxially to the laser swivel arm. The laser swivel arm and swivel arm housing are usually swiveled simultaneously around their respective axes when moving the laser swivel arm in its swivel arm housing from a rest position (also called standby position) to its working position. This design therefore represents a true "arm-in-arm" solution.
[0040] Preferably, the laser swivel arm can be swiveled through a larger angle than the swivel arm housing. This allows the optics to be retracted into the swivel arm housing: In addition to swiveling the laser swivel arm and swivel arm housing together, for example, from the working position to the rest position or vice versa, the laser swivel arm can be "retracted" or "sunk" further into the swivel arm housing to provide additional protection during movement, but also in its rest position or, in certain situations, in its working position. On the other hand, the laser swivel arm can be "extended" slightly further from the swivel arm housing, for example, to facilitate the coupling process of the patient's eye to the ophthalmic laser therapy system using a contact lens or patient interface.For this purpose, the laser swivel arm can be swiveled in the positive and / or negative direction by a small amount, which can preferably assume a value between 1° and 30°, in particular a value between 2° and 15°, and particularly preferably a value of approximately 3°, beyond the end angle positions of the swivel arm housing.
[0041] Similar to the laser swivel arm with its swivel arm housing, the examination swivel arm can also be enclosed in a coaxially mounted examination swivel arm housing. In this case, the general term "swivel arm housing" always refers to the housing of the laser swivel arm. Therefore, if an examination swivel arm is also enclosed in a housing, this is more specifically referred to as an examination swivel arm housing.
[0042] This allows for various combinations of the design of the two pivot arms for an ophthalmic laser therapy system with a laser pivot arm and an examination pivot arm: The laser pivot arm can be a simple pivot arm mounted on the device head. However, a laser pivot arm with a pivot arm housing is much more preferred, with the laser pivot arm and pivot arm housing arranged coaxially and pivoting separately from each other. This is especially true for the laser therapy step in which a laser exit aperture is coupled to a patient's eye either via a contact lens or patient interface or is at least located in close proximity to the eye, the advantages of such an "arm-in-arm" solution for patient safety are significant.
[0043] The examination swivel arm can also be mounted either as a simple examination swivel arm on the device head of the ophthalmic laser therapy system or enclosed in a swivel arm housing. The decision is made based on which examination device the swivel arm encompasses and, if multiple examination devices are present, how these or individual elements of these devices are arranged relative to each other. The laser swivel arm and examination swivel arm can be used in any combination (both with an arm-in-arm solution, only one of them with an arm-in-arm solution, or both as simple swivel arms). Due to the design of the arm-in-arm solution, it does not require any significant additional space and does not restrict the relative arrangement of the axes of the two arms.
[0044] Depending on the application, and in particular the examination device and its spatial capabilities, it can be ensured that a working position of the laser swivel arm requires a rest position of the examination swivel arm, and vice versa. In certain cases, such as when using a surgical microscope on the examination swivel arm, this is a safety consideration, so collision-free operation is guaranteed by prohibiting simultaneous working positions of the laser swivel arm with its swivel arm housing and the examination swivel arm.
[0045] Furthermore, the laser swivel arm and the swivel arm housing each preferably have a separate weight compensation device.
[0046] This enables a very low-friction weight compensation mechanism, allowing movement with low force, i.e., a force of less than 3 N for the laser swivel arm. This eliminates the risk of crushing when coupling the patient's eye to the ophthalmic laser therapy system using a contact lens or patient interface.
[0047] It is crucial that the properties of the separate counterweights are adapted to their respective functions: The counterweight for the laser swivel arm is very precise and low-friction, limiting the force on the eye to the specified 3 N. In contrast, the counterweight of the swivel arm housing has more friction and a greater contact force in the end position to prevent unwanted deflection of the arm. Here, only the entire head needs to be prevented from being crushed, for which larger forces are permissible: The maximum permissible force on the face is approximately 65 N. Therefore, movement of the swivel arm housing with a force of less than 65 N is permitted.
[0048] To prevent crushing, the moment of inertia of the laser swivel arm and the maximum approach speed to the patient's eye, which is caused by the movement of a patient support device, such as a patient couch, or the movement of the device head, must be in a specific relationship: A moment of inertia of 1.9 kgm² and a static contact force of 1.5 N result in a maximum force on the eye of approximately 3 N at an approach speed of 30 mm / s. If the moment of inertia is reduced to a preferred value of 1.5 kgm², the maximum approach speed can be increased slightly.
[0049] If the weight compensation is achieved, for example, using a weight compensation device containing a gas spring, this enables a compact design and the integration of damping to prevent high speeds and to decelerate in the end positions. However, this is primarily suitable for weight compensation of the swivel arm housing, as it is not low-friction due to the gas seals.
[0050] When monitoring the gas spring included in the weight compensation device, the tension force of the gas spring in the suspension is checked by connecting it to a switching element, such as a switch or a light barrier, with a slightly movable connection. A sensor spring is connected to the suspension, which is stretched to a stop when the gas spring is subjected to a standard force. If, however, the force of the gas spring is too small, the sensor spring moves the gas spring's suspension back, and the switching element is opened. If the switching element is in an open position, the laser swivel arm or swivel arm housing is not allowed to pivot downwards from a rest position to a working position.
[0051] The examination swivel arm also usually contains a weight counterbalance device; if a swivel arm housing is available, this can also have a separate weight counterbalance device. This also achieves weight counterbalance that meets increased safety requirements while still allowing the use of small motors. The arms can be moved manually at any time and without great effort.
[0052] In this case, such a weight compensation device can also be designed with a gas spring and a corresponding monitoring device as described above.
[0053] In addition, additional examination or therapy swivel arms can, of course, also be pivotably mounted on the device head of the ophthalmic laser therapy system according to the same principles described here. Preferably, up to five swivel arms, each with its own swivel axis, are conceivable. These additional swivel arms, for which swiveling into different positions requires very different moments of force, also each have corresponding weight compensation devices. If the respective swivel arm includes a housing, its weight compensation is realized with a weight compensation device independent of the swivel arm.
[0054] Another particularly advantageous option is an ophthalmic laser therapy system whose device head can also be moved in the z-direction on the device base. This allows the distance between the device base and the device head to be varied. This change in distance easily alters the working height, i.e., the height of the laser exit aperture. With a preferred arrangement of the laser source in the device head, the laser source is also moved when the device head is moved in the z-direction on the device base, so no compensation is required.
[0055] In one embodiment, the ophthalmic laser therapy system comprises a pre-positioning device for pre-positioning the device head.
[0056] The pre-positioning device is arranged so that an object can be observed parallax-free within the laser beam's working volume when the laser swivel arm is in a working position. The working volume is the possible effective range of the focused laser beam when the laser swivel arm is in the working position.
[0057] This pre-positioning device preferably includes a camera. For the reasons stated here, this is advantageously mounted on the device head. This enables quick and easy pre-positioning of the device head by means of transverse movement in the xy plane in a y-direction, or, if a camera is used that provides additional depth information, also in an x-direction, and possibly also in the z-direction, relative to the device base.
[0058] In a further embodiment, the laser swivel arm and / or the swivel arm housing of the ophthalmic laser therapy system contain at least one detection device. Such a detection device serves to detect structures within a working volume of the laser swivel arm. In particular, the detection device can be a video microscope device or an OCT device.
[0059] A detection device, which is located on or in the laser swivel arm and / or the swivel arm housing of the ophthalmic laser therapy system, makes the use of a conventional surgical microscope, which is usually used in various work steps in many laser therapy procedures, optional.
[0060] The detection device can be configured as an integrated detection device, i.e., it can utilize the beam guidance means and, in particular, the laser therapy optics of the laser swivel arm. However, the detection device can also be configured as an independent detection device, which also exits through the laser exit opening and is directed from there onto a working volume, for example, in the tissue of a patient's eye. Having the same exit location for a laser beam used for therapy and a detection beam offers advantages with regard to the calibration of the beams, particularly their foci, relative to each other.
[0061] Nevertheless, it is also possible to work with a detection device that is part of the laser swivel arm and / or the swivel arm housing of the ophthalmic laser therapy system, but whose beam path or wave path is completely independent of that of the laser radiation, as long as a relationship is established between the laser radiation and the radiation or waves used by the detection device with regard to its location of use.
[0062] Further examples of detection devices that the laser swing arm and / or the swing arm housing can contain are ultrasonic sensors, microwave sensors, an optical coherence tomography device (OCT), interferometers, wavefront sensors, video sensors or a classic microscope in a very compact design.
[0063] Furthermore, it is advantageous if an input and / or output device is movably mounted on the swivel arm housing of the ophthalmic laser therapy system. Such an input and / or output device can be represented, in particular, by a therapy screen, which is preferably designed as a touchscreen for input purposes, and output is possible in text and / or graphic form.
[0064] The examination device of an examination arm of the ophthalmic laser therapy system is preferably an operating microscope (OPMI). Operating microscopes are used by the vast majority of surgeons in corresponding ophthalmic therapy procedures, particularly to observe the progress of a therapy procedure, visually verify results, or precisely perform manual steps included in the therapy procedure.
[0065] Of particular interest is also an embodiment of the ophthalmic laser therapy system that includes an input and / or output device or an examination device, characterized in that the input and / or output device is rotatable about an axis parallel to the first axis of the swivel arm housing and / or the examination device is rotatable about an axis parallel to the second axis of the examination swivel arm, and is coupled to the movement of the swivel arm housing or the examination swivel arm via a coupling device. Such a coupling device is, for example, a coupling rod or a cable pull.
[0066] This ensures that both the input and / or output device, such as a therapy monitor, and the examination device, such as a surgical microscope, always remain in a working position during the pivoting movement of the respective arm to which they are movably attached. Displays on an input and / or output device, for example, are always shown in the correct orientation preferred by an operator or surgeon. Examination devices or components that are damaged or misaligned during tilting can thus always be kept in an upright position, even when the respective pivoting arm is in a rest position.
[0067] Preferably, the first and / or the second laser therapy optics of the ophthalmological laser therapy system contain a scanning system with at least two scanners, which are movable beam guiding means, such that the first axis of the laser pivot arm is arranged in the beam axis between the scanners.
[0068] This makes the optical system insensitive to minor rotations during pivoting. For safety reasons, however, work is only carried out in the working position, i.e., only in the working position is the laser beam used for therapeutic treatment, which in this case also includes surgical treatment. In positions other than the working position, there is a risk that the scanner's deflection axes could be significantly rotated relative to each other.
[0069] Furthermore, an advantageous embodiment of the ophthalmic laser therapy system includes a position control device for controlling the position between the laser swivel arm and / or the examination swivel arm in the working position and a patient's eye. It is configured to track the position of the device head to the position of a patient's eye.
[0070] The position control device preferably comprises a force sensor and / or a light barrier. For this purpose, a force sensor can be arranged, for example, such that the second laser therapy optics or the entire laser swivel arm rests on the force sensor when the laser swivel arm is in the working position.
[0071] Pressure from the patient's eye against the second laser therapy optics or the laser exit aperture, possibly via a contact lens or patient interface, relieves the load on the force sensor. If this occurs, the position of the device head is adjusted so that the laser swivel arm moves away from the patient in the working position.
[0072] If, however, a higher pressure force is exerted on the force sensor by the patient's eye pulling on the laser swivel arm while it is fixed ("docked"), for example, while connected to the laser exit aperture via a contact lens or a patient interface, the position of the device head is changed so that the laser swivel arm, in its working position, faces the patient's eye. The change in the position of the device head is achieved by a corresponding translational movement relative to the device base.
[0073] In a preferred embodiment, regular position control is achieved by tracking the device head in the z-direction. This does not require interruption of the corresponding work step, particularly the laser therapy step. However, if defined lower or upper limits are reached, or if movement patterns are detected that are considered critical, the process is stopped, and the laser device is switched off if necessary. This is the case, for example, if the patient's eye moves so far downward that fixation of the patient's eye at the laser exit opening using the contact lens or patient interface can no longer be guaranteed.This is also the case, for example, if the patient's eye moves upwards so far or so quickly that compensation by tracking the device head in the z-direction is no longer possible, and the laser swivel arm is swiveled upwards by a corresponding pressure force from the patient's eye. It should be remembered that only a safe pressure force of less than 3N is required for this, so that the patient's eye is not damaged during this action. If the laser swivel arm is enclosed in a swivel arm housing, the laser swivel arm is first "sunk" into the swivel arm housing with a pressure force of less than 3N, which is safe for the eye, so that the swivel arm housing then rests on the face. The swivel arm housing can then be swiveled upwards together with the laser swivel arm with a pressure force of less than 65N, which is safe for the face.
[0074] Such a solution significantly simplifies the design of a patient bed or, more generally, a patient support device used to perform laser therapy on a patient's eye by positioning the patient in the working position under the pivoting arms of the ophthalmic laser therapy system. Without such a position control device and the safety concept described here, the patient bed itself would have to react when critical limits are reached: In addition to shutting down the laser therapy system, the movement of the patient bed in the critical direction would also have to be stopped immediately. However, if a position control device and the safety concept described here are used, such mechanisms on the patient bed can be dispensed with: The patient bed therefore no longer needs to be integrated into the ophthalmic laser therapy system or its functions.This allows any patient support device to be used.
[0075] An ophthalmological laser therapy method with an ophthalmological laser therapy system according to the invention comprises the following steps: A patient is positioned on a patient support device, preferably on a patient couch, next to an ophthalmic laser therapy system according to the invention described above, whose pivoting arms are in the rest position. The patient support device can be of the simplest design. It does not require any positioning devices, as would otherwise be necessary if the patient must be moved from one working volume to an examination volume or to another working volume via the position of the patient support device. For example, it can be adjusted purely manually.
[0076] The device head is pre-positioned, preferably using a pre-positioning device, such as a camera. For this purpose, a superimposed "symbolic image," i.e., a predicted position, of the lowered laser swivel arm is displayed on a therapy screen, which displays an image generated by the pre-positioning device. This allows the device head to be pre-positioned laterally in the y-direction, and, with a camera that provides depth information, also in the x-direction, and preferably also in the z-direction, i.e., vertically.
[0077] The laser swivel arm is then swiveled into a working position and further positioned over the patient's eye, preferably by means of a video microscope device contained in a swivel arm housing.
[0078] Once the laser arm is positioned over the patient's eye, the laser therapy step is performed. This step can be initiated, for example, by the operator or surgeon using a foot switch.
[0079] Once the laser therapy step is complete, the device head is preferably raised first, provided that the device head can be moved along the z-axis on the device base. The laser swivel arm is then pivoted into the rest position.
[0080] If necessary, these steps can be repeated on a second patient eye.
[0081] A preferred ophthalmic laser therapy method further includes the following steps: A pivoting arm housing, which encloses the laser pivoting arm, is pivoted into a working position synchronously with the laser pivoting arm. The laser exit opening is preferably still retracted into the pivoting arm housing.
[0082] Before positioning over the patient's eye, the laser swivel arm is swiveled further out of the swivel arm housing. The second laser therapy optics and the laser exit aperture move with a force adjusted by the weight of the laser swivel arm.
[0083] After the laser therapy step has been carried out, the laser swivel arm is swiveled into the swivel arm housing, i.e. the laser exit opening is retracted into the swivel arm housing.
[0084] The swivel arm housing is swiveled into the rest position synchronously with the laser swivel arm. The weight compensation for the laser swivel arm and the swivel arm housing is preferably carried out independently of each other.
[0085] The described ophthalmological laser therapy method may preferably further include the following steps: Placing a contact lens or a patient interface against the laser exit opening (9) and holding the contact lens or the patient interface to the laser exit opening (9) using negative pressure, wherein the negative pressure is switched on or off by the pressure of the contact lens or the patient interface against the laser exit opening (9). Suctioning the patient's eye, preferably assisted by a detection device (13), in particular by a video microscope device, while further positioning the device head (2). Releasing the suction of the contact lens or the patient interface after the laser therapy step has been performed.
[0086] A contact lens or other patient interface is applied to the laser exit opening using negative pressure, with the negative pressure being switched on or off by the pressure of the contact lens or patient interface against the laser exit opening. The contact lens or patient interface is usually applied to the laser exit opening while the laser swivel arm is still retracted, so that the pressure of the contact lens or patient interface triggers the switching process. For safety reasons, the laser swivel arm is generally never blocked when extended, so that it is always pushed back into the laser swivel arm when pressure is applied in the opposite direction, thus providing the necessary play to prevent crushing. However, resistance is required for the switching process.
[0087] In a special embodiment, such resistance can also be achieved in that the laser swivel arm has a blocking option in the extended state, which, however, is deactivated by a safety circuit after the contact lens or patient interface has been attached and before the contact lens or patient interface has been docked to the patient's eye, so that the laser swivel arm gives way to pressure at any time during or after the patient's eye has been docked and retracts again.
[0088] This makes it possible to attach the contact lens or patient interface for those ophthalmological laser therapy systems whose swivel arm housings have a large distance from the laser swivel arm due to special structures and which would make attaching the contact lens or patient interface with the laser swivel arm retracted very uncomfortable, even after the laser swivel arm has been swiveled out of the swivel arm housing.
[0089] In the sense of this description, a contact lens is a curved optical element - usually a lens element - which is usually adapted to the curvature of the cornea of the eye, or an optical element which is flat on the eye side and usually convexly curved on the laser exit opening side, which rests on the patient's eye and is intended to create a fixed relative relationship between the laser exit opening and the patient's eye, i.e. to temporarily fix the patient's eye to the ophthalmological laser therapy system.
[0090] A patient interface fulfills the same function. However, in this case, the optical element does not rest on the patient's eye. Therefore, the eye is not deformed by the optical element. Rather, the patient interface, which is usually conical in shape and secured to the eye via an outer ring—usually using a suction ring—is filled with a fluid into which the optical element is immersed with its eye-facing surface.
[0091] As a result, the cornea of the patient’s eye is not deformed or is only deformed at the outer edge.
[0092] The patient's eye is drawn in by further positioning the device head, preferably assisted by a detection device, in particular a video microscope. The patient's eye is now completely fixed to the ophthalmic laser therapy system.
[0093] After the laser therapy step has been completed, the suction of the contact lens or the patient interface is released, for example by removing the negative pressure.
[0094] The described ophthalmological laser therapy procedure may further advantageously include the following steps: Planning the treatment parameters on a planning screen (31) before placing the patient on the patient support device (500), and transferring them to an input and / or output device, in particular a therapy screen (12).
[0095] Before the patient is placed on the patient support device, the treatment parameters are planned on a planning screen and then transferred to an input and / or output device located on the swivel arm housing, for example a therapy screen.
[0096] Such a therapy screen, which serves as an input and output device, is preferably a touchscreen. The therapy screen has a simplified structure compared to the planning screen. For example, the graphic design of the screen can display only a reduced number of parameters, making the therapy screen more clearly structured than the planning screen. This helps prevent errors during the ophthalmic laser therapy procedure.
[0097] The described ophthalmic laser therapy procedure may further include the following steps: Pivoting an examination swivel arm (14) from a rest position to a working position after pre-positioning the device head (1) and / or after pivoting the laser swivel arm (3) from a working position to a rest position after carrying out the laser therapy step. Carrying out further work steps with the aid of an examination device (15).
[0098] Last but not least, it is of great help if, after pre-positioning the device head and / or after pivoting the laser pivot arm from a working position to a resting position after carrying out the laser therapy step, an examination pivot arm is pivoted from a resting position to a working position and further work steps are carried out with the aid of an examination device of the examination pivot arm.
[0099] The inventive solution to the problem, in its embodiments, thus avoids the disadvantage of repositioning the patient by arranging a laser swivel arm that can be swiveled and positioned over the patient's eye, and optionally arranging another examination swivel arm, which can, for example, contain a surgical microscope as an examination device, in a defined, movable arrangement of the two swivel arms relative to each other. This mobility enables the two swivel arms, and thus, for example, the focus of the laser beam and the surgical microscope, to be alternately positioned at the same working point in a working or examination volume (in which the patient's eye is located), for example, to switch between laser therapy and lenticule extraction during SMILE treatment.
[0100] In addition, the sensitive laser therapy optics of the laser swivel arm can be protected by an arm-in-arm design using a coaxially mounted swivel arm housing. The laser swivel arm and swivel arm housing are independently mounted and weight-compensated.
[0101] The scope of the present invention is defined by the claims.
[0102] The present invention will now be explained using exemplary embodiments. It shows: the Fig. 1a bis 1d : an ophthalmological laser therapy system according to the invention, wherein the Fig. 1a shows various sub-areas, the configurations of which lead to different embodiments of the ophthalmological laser therapy system according to the invention and in which Fig. 1b a standby mode in which Fig. 1c a laser therapy mode and in the Fig. 1d an examination mode using a surgical microscope of a first embodiment of the ophthalmic laser therapy system according to the invention is shown. Fig. 2a und 2b : the arm-in-arm principle of laser swivel arm and swivel arm housing in a preferred embodiment of an ophthalmological laser therapy system according to the invention, the Fig. 3a und 3b : a schematic representation of a device for monitoring the function of the spring of a weight compensation device. Fig. 4 : the coupling mechanism of the therapy screen to the movement of the swivel arm housing the Fig. 5 : the arrangement of individual elements of an ophthalmological laser therapy system according to the invention in the resting position with retracted optics
[0103] In the Fig. 1a First, various subareas are shown that contribute to solving the problem of this invention. Different configurations of these subareas lead to different embodiments of the ophthalmic laser therapy system 100 according to the invention.
[0104] It should first be noted that the patient bed 500 is not part of the ophthalmic laser therapy system 100 according to the invention, but is shown in the figures merely to better understand the function and, in particular, the working range of the ophthalmic laser therapy systems 100 according to the invention. However, the function of these ophthalmic laser therapy systems clearly demonstrates the advantage of being able to use patient beds 500 of a very simple design at this location.
[0105] Ophthalmic laser therapy systems 100 according to the invention are characterized by a laser pivot arm 3 pivotably mounted on the device head 1 about a horizontal axis 4, which can be pivoted back and forth between a rest position and a working position. Since this laser pivot arm 3 is pivoted above the patient for laser therapy on the patient's eye, but can be returned to a rest position in steps in which the laser pivot arm 3 is not needed in order to use the space above the working position for other purposes, the laser pivot arm 3 is protected by enclosing the laser pivot arm 3 in a pivot arm housing 6, which is pivotably mounted on the device head 1 coaxially with the laser pivot arm 3. This is the "arm-in-arm" principle 200.In addition to providing mechanical protection for the laser swivel arm 3 itself, the "arm-in-arm" principle also offers the advantage of independent weight balancing devices for the laser swivel arm 3 and the swivel arm housing 6, as well as, in particular, the possibility of distributing the weight of superstructures. Details of this arm-in-arm principle 200 are shown in the . Fig. 2a und 2b .
[0106] If, in addition to the laser swivel arm 3, one or more additional independent examination swivel arms 14 are used, these arm systems, each of which can be swiveled about an axis, are arranged relative to one another in such a way that all laser therapy steps on a patient's eye can be carried out in such a way that the site of action of all steps with the aid of the laser swivel arm 3 or one or more examination swivel arms 6 always remains fixed, thus the position of the patient's eye does not need to be changed during the entire laser therapy. The position of the patient's eye in the first step determines the position of all subsequent steps and thus the site of action of their respective necessary devices on the various swivel arms 3, 14. This is made possible by a special arrangement 300 of the swivel axes 4, 16 of the various swivel arms 3, 14 relative to one another on the device head 1 of the ophthalmic laser therapy system 100.
[0107] The pivotability of the various arms, each of which may have attachments – such as a therapy screen 12 on the pivot arm housing 6 of the laser pivot arm 3 or an examination device 15 on the examination pivot arm 14 – leads, if these attachments are fixedly mounted, to a tilting of the arms when pivoting from a working position to a rest position. However, these attachments should still be usable if necessary. For example, the therapy screen 12 is the screen that is available to a surgeon close to the work area even in the rest position and can be used by the surgeon, for example, to display information or enter data. Therefore, it should also be in a non-tilted position when in the rest position.A similar requirement for a non-tilted position, even in the rest position, may exist, for example, for a surgical microscope or other examination device with parts that would be subject to undesired movement if tilted, on an examination swivel arm 14. This is achieved by coupling such structures to the respective swivel arm 3, 14 via a coupling mechanism 400. One embodiment of such a coupling mechanism 400 is shown in FIG. Fig. 4 .
[0108] These various solutions, namely the "arm-in-arm" principle 200, the arrangement of the pivot axes 300 on the device head 1 of an ophthalmic laser therapy system 100 with a laser pivot arm 3 and at least one examination pivot arm 14, as well as a coupling mechanism 400 for attachments that should always be in a non-tilted position on pivot arms, regardless of the position of the pivot arms, can be used together or individually to achieve the object of the invention. However, the greatest benefit is achieved when these various solutions are used simultaneously.
[0109] The Fig. 1b bis 1d now show an embodiment of an ophthalmological laser therapy system 100 according to the invention, for which the "arm-in-arm" principle 200 is realized by a laser pivot arm 3, which is enclosed by a pivot arm housing 6, the ophthalmological laser therapy system 100 contains an additional examination pivot arm 14 with a surgical microscope 15, wherein the first axis 4 of the laser pivot arm 3 and the second axis 16 of the examination pivot arm 14 on the device head 1 have a corresponding arrangement 300 to one another, and both a therapy screen 12 movably attached to the pivot arm housing 6 with the movement of the pivot arm housing 6 and a surgical microscope 15 movably attached to the examination pivot arm 14 are coupled to the movement of the examination pivot arm 14 in such a way that the therapy screen 12 as well as the surgical microscope 15 always remain untilted.
[0110] An ophthalmological laser therapy system 100 as shown in this embodiment is, for example, very well suited for a SMILE procedure, but also for other procedures for correcting the vision of an eye or for cataract surgery.
[0111] The Fig. 1b a standby mode of this ophthalmological laser therapy system 100, in which all pivoting arms 3, 6, 14 are in a rest position, i.e. pivoted upwards on the device head 1, "parked" to save space, and in which, for example, a patient can be placed and positioned accordingly on the patient couch 500.
[0112] In the Fig. 1c , however, a laser therapy mode is shown, i.e., the mode in which the laser swivel arm 3 has been moved into a working position. The examination swivel arm 14, on the other hand, remains in a resting position.
[0113] The Fig. 1d Finally, FIG. 1 shows an examination mode of the exemplary embodiment of the ophthalmological laser therapy system 100 using a surgical microscope 15. The examination swivel arm 14 is moved into a working position, while the laser swivel arm 3 and its swivel arm housing 6 are in a rest position.
[0114] The details will now be described in more detail below.
[0115] The exemplary embodiment of the ophthalmic laser therapy system 100 consists of a device base 2 and a device head 1 mounted on this device base 2, which is adjustable in height above a floor plane, i.e., in the z-direction, and in its position in the plane, i.e., in the x- and y-directions. The device head 1 contains a first part of the laser therapy optics required to perform the laser therapy. In this exemplary embodiment, the device head 1 also contains the laser source required to generate a corresponding pulsed laser beam, which in this case is a femtosecond laser source.
[0116] The second part of the laser therapy optics is mounted in a laser pivot arm 3 for rotation about a horizontal first axis 4. The laser pivot arm 3 can be pivoted about this first axis 4 from a rest position, in which it projects approximately vertically upwards, to a working position, in which it is arranged approximately horizontally on the device head 1, i.e., approximately parallel to the floor plane, and back again.
[0117] The laser swivel arm 3 with its second laser therapy optics and the laser exit opening 8 is surrounded by a housing, the swivel arm housing 6, such that the swivel arm housing 6 leaves an opening for the laser exit opening 8. This swivel arm housing 6 is mounted separately, coaxially to the laser swivel arm 3.
[0118] The Fig. 2a und 2b depict details of the "arm-in-arm" principle 200 of laser swivel arm 3 and swivel arm housing 6 in an embodiment of the ophthalmological laser therapy system according to the invention.
[0119] The swivel arm housing 6 initially swivels together with the laser swivel arm 3 through an angle of approximately 90° between a roughly vertical rest or standby position and a horizontal working position. The movement is limited by stops.
[0120] The laser swivel arm 3 can be moved through a larger angle overall than the swivel arm housing 6. This allows the laser exit opening 8, to which a contact lens or a patient interface for coupling the laser swivel arm 3 to the patient's eye to be treated can be releasably attached, to protrude more or less from the swivel arm housing 6 or to be completely retracted into the swivel arm housing 6.
[0121] In the rest position of the laser swivel arm 3 as well as when swiveling the laser swivel arm 3 and its swivel arm housing 6 from a rest position to a working position as well as from the working position to a rest position, the laser outlet opening 8 will be retracted into the swivel arm housing 6, as shown in the Fig. 2a is shown. Thus, the laser swivel arm 3 is in a slightly tilted position compared to its swivel arm housing 6.
[0122] Once the swivel arm housing 6 has reached a working position, i.e., horizontal, the laser swivel arm 3 is released downwards and swiveled slightly further, so that it too reaches an approximately horizontal position and the laser exit opening 8 emerges from the swivel arm housing 6. The laser swivel arm 3 itself is easily movable due to its own weight compensation device 5. In the approximately horizontal working position of both the swivel arm housing 6 and the laser swivel arm 3, as in the Fig. 2b As shown, i.e. with the laser exit opening 8 protruding, the ophthalmic laser therapy system 100 is in laser therapy mode.
[0123] A very low-friction weight compensation device 5 of the laser pivot arm 3 enables a movement of the laser pivot arm 3 with a low force F, which for this embodiment is considerably smaller than 3N, and thus a coupling with an eye of a patient to be treated that is secure against crushing: the force for this example is 1.6 + / - 0.5N.
[0124] The swivel arm housing 6 is provided with its own weight compensation device 7. The separate coaxial mounting of the laser swivel arm 3 and the surrounding swivel arm housing 6, with separate weight compensation devices 5, 7 and a fixed downward stop 21 for the swivel arm housing 6, avoids the critical disadvantage of corresponding prior art systems with swivel arms, such as those described in US Pat. No. 8,771,262 B2. There, it is not provided that the optics, in the working position of the laser swivel arm, can be deflected upwards with a force that is harmless to the eye and independent of external influences, which are, in the inventive solution, prevented by the swivel arm housing 6.
[0125] The use of separate counterweight devices 5, 7 for the swivel arm housing 6 and the laser swivel arm 3 has several advantages: A motor-driven movement or swiveling of the respective arm 3, 6 around the first axis 4 requires relatively low-power motors. These essentially only have to overcome the system's inertia and therefore cannot build up dangerous forces on the swivel arm housing 6.
[0126] In addition, the laser swivel arm 3 and the swivel arm housing 6 can be moved manually at any time—even together. This allows for easy patient rescue in the event of a defect or power failure.
[0127] If the patient bed 500 is accidentally moved upwards, the patient cannot be crushed because the laser swivel arm 3 can be pushed upwards in its swivel arm housing 6 with a harmless force.
[0128] The counterbalance device 7 of the swivel arm housing 6 contains a gas spring 26. The use of a gas spring 26 has the following advantages: It allows for a compact design of the counterbalance device 7 and can integrate a damping function. The latter protects against excessive speeds and serves as a brake in the end positions of the swivel movement.
[0129] A gas spring 26 has high friction due to the gas seals. This is undesirable for the laser swivel arm 3, but desirable for the swivel arm housing 6. It ensures that the swivel arm housing 6 remains passively stationary in any position. For example, the swivel arm housing 6 can also be motor-driven into a kind of standby position, where it remains stationary without power. From there, the doctor can manually move it into the working position. This is advantageous when the doctor wants to exercise manual control over the arm's approach to the patient.
[0130] A gas spring 26 is therefore rarely used in the weight compensation device 5 of a laser swivel arm 3, while it represents a very preferred solution for the weight compensation device 7 of the swivel arm housing 6.
[0131] The Fig. 3a und 3b show a device for monitoring the function of the spring of such a preferred weight compensation device 7, with which a failure of the gas spring 26 can be detected. Fig. 3a a situation in which the spring force is in the desired range, while the Fig. 3b shows the situation in which the spring force is too small, for example, because, as shown here, the gas spring 26 is broken. In the latter case—i.e., in the case of problems with the gas spring 26—the mechanism prevents the swivel arm housing 6 from swiveling downwards, thus blocking the swivel mechanism.
[0132] For this purpose, the preferred weight compensation device 7 contains a gas spring 26, the tension of which is monitored in its suspension 27. This is achieved by the suspension 27 of the gas spring 26 being slightly movable and releasably connected to a switching element 28, which in this case is a pressure switch that is held closed by a corresponding pressure. Only in this closed state of the pressure switch is the pivoting mechanism of the pivot arm housing 6 released. An electromechanically releasable lock is used for this purpose.
[0133] If the spring force of the gas spring 26 is now sufficiently large, a sensor spring 25, which is also connected to the suspension 27, is stretched in a guide 30 of the sensor spring 25 up to a stop 29. The suspension 27 or an extension of the suspension 27 then holds the pressure switch 28 closed, the lock is released, and the swivel arm housing 6 can pivot about its pivot axis, i.e., about the first axis 4.
[0134] However, if the spring force of the gas spring 26 is too small, i.e., smaller than the force of the sensor spring 25, the sensor spring 25 moves the suspension 27 of the gas spring 26 back in the guide 30. The pressure switch 28 is opened, the lock remains closed, and the pivoting mechanism is not released.
[0135] The Fig. 4 shows a further advantageous aspect of an embodiment of the ophthalmological laser therapy system 100 according to the invention: Here, the coupling mechanism of the therapy screen 12 to the movement of the pivoting arm housing 6 is shown as an example of a device 400 coupled to a pivoting arm.
[0136] The therapy screen 12 is movably mounted on the swivel arm housing 6. In this case, the therapy screen 12 also serves as the screen of a video microscope 13, which shows the view from the second laser therapy optics and the laser exit aperture 8 onto the eye to be treated. The video image of this video microscope 13, which is displayed on the therapy screen 12, is used by the surgeon, for example, to approach and fixate a contact lens or other patient interface to the eye to be treated, as well as to observe the execution of the laser incisions.
[0137] Further information important for the laser therapy process is also displayed on the therapy screen 12. In this exemplary embodiment, the therapy screen 12 is designed as a touchscreen and thus also enables the input of information or navigation through the treatment process.
[0138] The therapy screen 12 is movably mounted on the swivel arm housing 6 such that it can be rotated about an axis 20 parallel to the horizontal pivot axis, i.e., the first axis 4, of the swivel arm housing 6. A coupling rod 19 ensures that the therapy screen 12 always remains in the same orientation when the laser swivel arm 3 is swiveled together with the swivel arm housing 6. This allows the therapy screen 12 to be used both in the rest position and in the working position of the laser swivel arm 3.
[0139] How to continue in the Fig. 1b bis 1d As shown, the image of a camera 9 is used to pre-position the device head 1. This camera is attached to the device head 1 and thus has a spatially fixed reference to the position of the device head 1. The position is selected so that a largely parallax-free view of the working volume of a therapy laser beam, in particular of the possible position of its focus as the working point of a therapy lens in the second laser therapy optics, is obtained.
[0140] A graphic superimposed on the image from camera 9 on the therapy screen 12 and / or on the planning screen 31 already shows, in standby mode—i.e., in the resting position of the laser swivel arm 3—the expected position of the laser swivel arm 3 in its then lowered working position. Using this image, the surgeon can pre-position the device head 1 such that, after being lowered into its working position—i.e., in laser mode—the laser swivel arm 3 is in an optimal position for the start of treatment in terms of rough positioning, and only fine positioning with respect to the structures of the eye is necessary.
[0141] A joystick 11 for controlling the coupling process to the patient is also attached to the swivel arm housing 6. Joystick 11, laser exit opening 8 of the laser therapy optics, and video image of the eye are aligned along a vertical line 23 in the working position to enable equally ergonomic operation for both right- and left-handed users.
[0142] In addition, this embodiment of the ophthalmological laser therapy system 100 according to the invention contains a force sensor that contributes to the automatic position control, which is important from a safety perspective: For this purpose, the force sensor is arranged such that the second laser therapy optics lies on the force sensor when the laser swivel arm is in the working position.
[0143] Pressure from the patient's eye against the second laser therapy optics or the laser exit opening relieves the load on the force sensor. This leads to an automatic movement of the position of the device head 1 such that the laser swivel arm 3 moves away from the patient into the working position. A greater pressure on the force sensor is created by the patient pulling, which then moves the device head 1 in the opposite direction.
[0144] The Fig. 5 now shows the gain in working space resulting from the therapy screen 12 remaining tilted in the rest position: The space 22 can be used for components of the laser device 24 in the device head 1. If the therapy screen 12 were firmly attached to the swivel arm housing 6, as shown as reference symbol 12a, the space 22 would be blocked for the therapy screen 12 pivoting there in the rest position, plus a safety distance.
[0145] The following describes a typical treatment sequence, such as can be used for a SMILE treatment or as part of a SMILE treatment, using an ophthalmological laser therapy system 100 as described above: First, the treatment or therapy parameters are planned on a planning screen 31, which in this exemplary embodiment is also arranged directly on the ophthalmological laser therapy system 100. Alternatively, the planning screen 31 can also be spatially separated from the ophthalmological laser therapy system 100. During planning, the ophthalmological laser therapy system 100 is preferably in a standby position, i.e., the laser pivot arm 3 and, if applicable, the examination pivot arm 14 are pivoted vertically upwards in the rest position on the system.
[0146] The patient is placed on the patient couch 500. This is possible comfortably thanks to the raised laser swivel arm 3.
[0147] The surgeon then positions the height of the device head 1 using a joystick 10 on the device head 1, which can be used to control the translational movement of the device head 1 above the device base 2. In doing so, the operator orients himself on the image provided by the camera 9, which is visible on the therapy screen 12 and / or on the planning screen 31, including a superimposed symbol of a downwardly pivoted laser pivot arm 3. As an alternative to the joystick, in other embodiments, positioning can also be performed by inputs on one of the two screens 12, 31 or via buttons on the laser therapy system 100.
[0148] The surgeon triggers the motorized downward pivoting of the laser pivot arm 3 together with its pivot arm housing 6; a corresponding button used for this purpose is not shown in the figures. Due to the pre-positioning and the still retracted laser exit opening 8 of the laser pivot arm, a free space remains between the laser exit opening 8 and the patient's eye, which is ideally between 50 mm and 150 mm.
[0149] If this has not already happened in the rest position of the laser pivot arm 3, a contact lens is now placed against the laser exit opening 8. The contact lens is held in place at the laser exit opening 8 by means of negative pressure. The holding function by means of negative pressure is switched on and off by pressing the contact lens against the laser exit opening 8, which is then moved slightly in its retracted position and triggers the switching process. This is advantageous compared to previously conventional laser therapy systems: There, the holding of the contact lens is switched separately. This means that the contact lens falls down when it is released. In the solution described here, however, the surgeon or operator always has the contact lens in their hand during the switching process.
[0150] The surgeon then releases the movement of the laser swivel arm 3 within the swivel arm housing 6 by rotating the joystick 11 on the swivel arm housing 6, or alternatively by using a separate button (not shown). In other embodiments, automatic triggering of the movement by the attached contact lens is also possible. The laser exit opening 8 with the contact lens moves towards the eye with the force set by the weight compensation device 5 of the laser swivel arm 3, which is less than 3N at the contact lens or at the level of the laser exit opening 8. The movement path is approximately 50 mm; a generally reasonable range for this movement path for all ophthalmic laser therapy systems 100 according to the invention is 30 mm to 100 mm. This still leaves a safety distance from the eye, which is approximately 30 mm, or generally reasonable, a value between 10 mm and 100 mm.
[0151] Finally, the docking phase occurs, i.e., the phase in which the contact lens is fixed: The surgeon uses the joystick 11, while observing via the video microscope 13, to move the contact lens to the patient's eye. Once the correct position is reached, the eye is fixed by suctioning the eye to the contact lens using a button on the joystick 11. In one embodiment, it is possible to support the correct positioning or centering of the contact lens or another patient interface on the eye by processing the video microscope image and using it to control the device head 1.
[0152] The actual laser therapy step can now be started by switching on the laser beam, which is guided through the laser therapy optics and the laser exit opening and focused in the patient's eye, using a foot switch, which is not shown here.
[0153] After completing this laser therapy step, the suction on the eye is released by increasing the pressure again, the laser swivel arm 3, and thus also the laser exit opening 8, are pivoted back into the swivel arm housing 6, and the device head 1 is raised slightly by moving it in the z-direction. This restores a safe distance from the eye. From this position, the device could be re-docked if necessary. However, this is usually not necessary. The contact lens or the patient interface can be removed from the laser exit opening 8 by briefly pressing upwards.
[0154] The laser swivel arm 3 is now swiveled back up together with its swivel arm housing 6, restoring the free space above the patient. Further procedures can now be performed, or the patient can leave their position on the patient couch 500. The swiveling up of the laser swivel arm 3 with its swivel arm housing 6 is initiated electronically, in this case by pressing a button. Alternatively, the laser swivel arm 3 with its swivel arm housing 6 can be pushed manually. A position sensor on the swivel arm housing detects this, and a motor then takes over the movement.
[0155] However, if both eyes of a patient are to be treated, the device head 1 can be moved above the device base 2 by a translational movement in the x and / or y directions before the laser pivot arm 3 with its pivot arm housing 6 is pivoted up into its rest position so that the laser pivot arm 3 with its pivot arm housing 6 is positioned over the other eye. Treatment of the second eye can then be performed in the same way by holding a new contact lens or patient interface to the laser exit opening 8 using negative pressure, and all subsequent steps are carried out as described above.
[0156] In this exemplary embodiment of an ophthalmic laser therapy system 100 according to the invention, an examination pivot arm 14 is also attached to the device head 1, pivotable about a second axis 16. This pivot arm contains an examination device, in this case a surgical microscope 15. Such a surgical microscope is required or at least recommended, for example, for the second main step of the "SMILE" treatment. In the present exemplary embodiment, the surgical microscope 15 contains, in addition to the necessary lighting, a camera for video recording and a slit projector for expanded observation options. However, the camera and slit projector can also be omitted entirely or used individually.
[0157] The pivot axis of the examination swivel arm 14, i.e., the second axis 16, is positioned in a particularly favorable spatial position. This allows the surgical microscope 15 on the examination swivel arm 14 to be moved from its rest position, in which the examination swivel arm 14 is also pivoted upwards—either in a vertical position or in an inclined position—to its working position with just one pivoting movement.
[0158] This working position is also defined by limiting the rotational movement of the examination swivel arm 14 by means of a stop. It has the special property of coinciding with the working position of the laser swivel arm 3 with its second laser therapy optics and its laser exit opening 8, thus preventing, according to the invention, a change in the patient's position during treatment.
[0159] The rest position of the examination swivel arm 14 with its surgical microscope 15 is advantageously selected so that the surgical microscope 15 is then located behind the therapy screen 12. This, on the one hand, frees up space for the patient to enter and exit the device, and, on the other hand, enables a compact ophthalmic laser therapy system 100 in standby mode.
[0160] In the exemplary embodiment described here, the second axis 16, i.e. the pivot axis of the examination pivot arm 14, is arranged particularly advantageously to the first axis 4, which is the pivot axis of the laser pivot arm 3 and its pivot arm housing 6, in order to be able to design the ophthalmological laser therapy system 100 as compactly as possible: The second axis 16 of the examination pivot arm 14 forms an angle of 0° to a vertical plane through the first axis 4 of the laser pivot arm 3 and an angle of 30° to a horizontal plane through the first axis 4 of the laser pivot arm 3.
[0161] The second axis 16 passes through a point located 320 mm above the rotation axis of the laser pivot arm 3, 320 mm behind the working position of the laser exit opening 8 and 50 mm from the vertical plane through the rotation axis of the laser pivot arm 3.
[0162] The surgical microscope 15 is mounted on the examination swivel arm 14 in a similar manner to the therapy monitor 12 on the swivel arm housing 6: it is rotatable about an axis 18 parallel to the rotation axis of the examination swivel arm 14, i.e., the second axis 16, and is rotatably connected to the device head 1 by a coupling rod 19. The coupling rod 19 has a rotation axis on the device head 1 that is parallel to the first axis 4.
[0163] The angle of the first axis 4 to the second axis 16 in space must be compensated in the holder of the surgical microscope 15, i.e. the position of the axis 18, so that the surgical microscope 15 is again untilted in space.
[0164] This ensures that the surgical microscope 15 remains in its working position regardless of the position of the examination swivel arm 14. This has several advantages: Movable attachments on the surgical microscope 15, such as a slit projector, do not slip. Furthermore, the aesthetic appearance is consistent.
[0165] Similar to the swivel arm housing 6 of the laser swivel arm 3, the examination swivel arm 14 is also equipped with a weight compensation device 7 containing a gas spring 25. This again offers the advantages already described above: The use of a low-power motor to move the examination swivel arm 14 thus provides protection against the risk of crushing the patient's head. The corresponding drive design can be kept relatively small and is more cost-effective than a solution that must compensate for the entire weight. Furthermore, the examination swivel arm 14 can also be moved manually at any time.
[0166] In the case of an examination swivel arm 14 containing a surgical microscope 15 – or other structures for which no contact with the eye is intended, i.e., which do not contain protruding optics or the like – the risk of crushing the patient's head is significant, and maximum forces or smaller forces on the patient's head of less than 65 N – as described above – can be applied. However, in other designs, in which an examination device 15 requires contact with the eye, the "arm-in-arm" principle must again be applied, and consequently, for the then inner swivel arm, which contains the examination device 15 contacting the eye, the risk of crushing the eye must be avoided by working with significantly smaller maximum forces of less than 3 N on the eye – as described above.
[0167] If such an examination swivel arm 14 with a surgical microscope 15 is available, the complete SMILE treatment can be performed with the ophthalmic laser therapy system 100 according to the invention. For this purpose, after the laser swivel arm 3 with its swivel arm housing 6 has been swiveled up into its rest position after the completion of the actual laser therapy step, as described here, the treatment continues as follows: The surgeon initiates the motorized downward swiveling of the examination swivel arm 14 by pressing a button. The motor moves the examination swivel arm 14 into its working position, where it rests on a stop.The working position is determined by the favorable choice of the position of the two pivot axes, i.e. the first axis 4 and the second axis 16, and the end position of the examination pivot arm 14 determined by the stop, such that the eye to be further treated lies in the examination volume of the surgical microscope 15 directly after the examination pivot arm 14 has been pivoted down.
[0168] Minor corrections, if necessary, can be made by adjusting the position of the device head 1 relative to the device base 2 using translational movements. This can be done using either the joystick 10 located on the device base 2, a separate foot control panel, or a joystick located on the surgical microscope 15.
[0169] Once the examination swivel arm 14 with the surgical microscope 15 is positioned accordingly, the surgeon performs the lenticule extraction.
[0170] After lenticule extraction is complete, the examination swivel arm 14 with the surgical microscope 15 is raised by motor and thus returned to its rest position. This can be initiated by pressing a button or – as described above for the swivel arm housing 6 and the laser swivel arm 3 – by pushing it. The free space above the patient is thus restored.
[0171] The features of the invention mentioned above and explained in various embodiments can be used not only in the combinations given as examples, but also in other combinations or alone, without departing from the scope of the present invention.
[0172] Process features described here may represent functional features of the device described.
Claims
1. Ophthalmological laser therapy system (100) comprising: - an equipment base (2), - an equipment head (1), - a laser device (24) that contains a laser source, a first laser therapy optical unit and a laser pivot arm (3) with a second laser therapy optical unit and a laser exit aperture (8), wherein - the equipment head (1) is displaceable on the equipment base (2) in an xy-plane by means of a translational movement and - the laser pivot arm (3) is fastened to the equipment head (1) in a manner pivotable about a first axis (4), preferably a horizontal first axis, - an examination pivot arm (14) with an examination device (15), which defines an examination volume, is fastened to the equipment head (1) in a manner pivotable about a second axis (16), - characterized in that both the laser pivot arm (3) and the examination pivot arm (14) are pivotable between a rest position and a work position, - and both axes (4, 16) are arranged relative to one another in terms of their relative position such that a work volume of a laser beam, when the laser pivot arm (3) is in the work position, is a partial volume of the examination volume of the examination device (15) on the examination pivot arm (14), when the latter is in the work position, while the laser pivot arm (3) and the examination pivot arm (15) are not arranged in the pivot region of the respective other pivot arm (3, 15) in their respective rest position, - wherein the second axis (16) of the examination pivot arm (14) extends in a non-parallel fashion relative to the first axis (4) of the laser pivot arm (3).
2. Ophthalmological laser therapy system (100) according to Claim 1, characterized in that the laser pivot arm (3) is encompassed by a pivot arm housing (6), which is fastened in a separately pivotable manner on the equipment head (1) in coaxial fashion relative to the laser pivot arm (3).
3. Ophthalmological laser therapy system (100) according to Claim 2, characterized in that the laser pivot arm (3) is pivotable by a greater angle than the pivot arm housing (6).
4. Ophthalmological laser therapy system (100) according to Claim 2 or 3, characterized in that the laser pivot arm (3) and the pivot arm housing (6) each have a separate weight balancing apparatus (5, 7).
5. Ophthalmological laser therapy system (100) according to any of Claims 1 to 4, characterized in that the equipment head (1) is also displaceable in the z-direction on the equipment base (2).
6. Ophthalmological laser therapy system (100) according to any of Claims 1 to 5, characterized in that it comprises a pre-positioning device (9) for pre-positioning of the equipment head (1), said pre-positioning device preferably containing a camera.
7. Ophthalmological laser therapy system (100) according to any of Claims 2 to 6, characterized in that the laser pivot arm (3) and / or the pivot arm housing (6) contains at least one detection device (13), in particular a video microscope apparatus or an OCT apparatus.
8. Ophthalmological laser therapy system (100) according to any of Claims 2 to 7, characterized in that an input and / or output apparatus (12), in particular a therapy screen, is movably fastened to the pivot arm housing (6).
9. Ophthalmological laser therapy system (100) according to any of Claims 1 to 8, wherein the examination device (15) is a surgical microscope.
10. Ophthalmological laser therapy system (100) according to Claim 8 or 9, characterized in that the input and / or output apparatus (12) is rotatable about an axis (17) that is parallel to the first axis (4) of the pivot arm housing (6) and / or the examination device (15) is rotatable about an axis (18) that is parallel to the second axis (16) of the examination pivot arm (14), and is coupled by way of a coupling apparatus (19) to the movement of the pivot arm housing (6) or of the examination pivot arm (14).
11. Ophthalmological laser therapy system (100) according to any of Claims 1 to 10, characterized in that the first and / or the second laser therapy optical unit contains a scan system with at least two scanners, and the first axis (4) of the laser pivot arm (3) is arranged in the beam axis between the scanners.
12. Ophthalmological laser therapy system (100) according to any of Claims 1 to 11, characterized by a position regulating apparatus for regulating the relative position between the laser pivot arm (3) and / or the examination pivot arm (14) in a work position and a patient's eye, said position regulating apparatus being configured to reposition the relative position of the equipment head (1) according to the position of a patient's eye.