EP4027958A1

EP4027958A1 - Ophthalmological laser therapy system with lighting assembly

Info

Publication number: EP4027958A1
Application number: EP20768036.4A
Authority: EP
Inventors: Frank Brückner; Burkhard Wagner; Gregor Stobrawa
Original assignee: Carl Zeiss Meditec AG
Current assignee: Carl Zeiss Meditec AG
Priority date: 2019-09-10
Filing date: 2020-09-08
Publication date: 2022-07-20
Also published as: WO2021048102A1; DE102019213693A1; CN114206279A; US20220409429A1; US12376992B2

Abstract

The invention relates to an ophthalmological laser therapy system (100) comprising a device main part (1, 2) and a laser device (24) which is arranged in the device main part (1, 2) and in a laser arm (3), said laser arm being arranged on the device main part (1, 2) and comprising a lighting assembly (50). The invention additionally relates to a planning device and a planning method for planning the laser therapy on an ophthalmological laser therapy system (100). The aim of the invention is to provide an ophthalmological laser therapy system (100) and a method with which an optimal psychological (calming) effect can be ensured for each patient. This is achieved by an ophthalmological laser therapy system (100), the laser arm (3) of which has a lighting assembly (50) with individually modifiable colors and by a corresponding planning device and a corresponding planning method.

Description

Ophthalmic laser therapy system with lighting arrangement

The present invention relates to an ophthalmic laser therapy system comprising a device base and a laser device which is arranged in the device base and in a laser arm, the laser arm being arranged on the device base and comprising a lighting arrangement. The invention further relates to a planning device and a planning method for planning a laser therapy on an ophthalmic laser therapy system.

Refractive and therapeutic laser eye surgery is a widespread and established procedure and has already been performed millions of times. Nevertheless, it represents a surgical procedure on the patient and is therefore an unusual situation for them, which leads to nervousness and uncertainty in most patients immediately before and during the treatment. The nervousness is increased by the process-related approach of the device arm (contact element with fs, smoke evacuation with excimer) to the patient's head (claustrophobic effect). In particular, this nervousness during the laser eye procedure can lead to a premature tearing of the eye from the laser device or the patient cannot fix his eye reliably, which represents a risk for the success of the treatment. Measures to calm the patient down and to cooperate are therefore very important.

One of these measures is a virtual “sky” for the patient in the lying position when parts of the laser system are close above him and therefore lie in a large part of his field of view. The state of the art for this is a patient environment permanently illuminated in blue on the patient's eye during the preparation and execution of the laser therapy, which is located on the underside of the laser arm, for example the applicant's “VisuMax” ophthalmic laser therapy system. It is assumed here that the color blue is generally perceived as not threatening and not oppressive. The psychological effect of colors on different people is different, however, and a color that is more calming to one person may be more unsettling to another. This is based on both the individual and cultural characteristics.

The object of the present invention is therefore to provide an ophthalmological laser therapy system and a method with which an optimal psychological (calming) effect can be guaranteed for each patient.

The invention is defined in the independent claims. The dependent claims relate to preferred developments.

An ophthalmic laser therapy system comprises a device base body and a laser device which contains a laser source and first laser therapy optics in the device base body and second laser therapy optics and a laser exit opening in a laser arm. The laser arm is arranged on the main body of the device.

A pulsed laser is preferably used here. The use of a femtosecond laser is particularly favorable, the laser beam of which is passed through the laser therapy optics and focused in a tissue to be processed in the eye. In the focus of the laser beam, this leads to a separation of the tissue by means of photodisruption. For this purpose, the patient and in particular the patient's eye to be treated is placed under the laser exit opening of the laser arm and finally fixed to this laser exit opening with a contact glass or a so-called patient interface.

The structure of the laser therapy system usually also contains a scanner system, which is used to shift the focus of the laser beam within the tissue to be treated, preferably in all three spatial directions, in order to “run” a processing pattern and finally to generate a desired structure. If a laser therapy system is used for a refractive correction in the cornea (cornea) of the patient's eye, this process takes time usually several tens of seconds. The fastest laser therapy systems generate the necessary "cuts" (by local separation of the tissue by means of photodisruption) in about 5 seconds. The patient should be relieved of any nervousness during this treatment time, but also during the preparation time and during the "docking" at the laser exit opening of the laser arm by means of the contact glass or the patient interface.

For this purpose, the laser arm has a lighting arrangement on the outside, i.e. on an outside of the laser arm. This lighting arrangement is preferably arranged so that the patient can feel its effect directly, for example on the underside of the laser arm, wherein the lighting arrangement can extend over the entire underside or even only part of the underside of the laser arm. The color of the lighting arrangement can be changed individually.

The lighting arrangement is preferably designed as a self-illuminating partial surface of the laser arm, which achieves the desired color effect directly over the patient.

In contrast to the prior art, according to the invention, the color of an illuminated patient environment can be changed individually for the patient. This solves the problem of the different psychological color effects on different patients and ensures that each patient is in an optimal psychological and emotional state before and during the laser treatment. This in turn minimizes the risk of treatment, since a patient in an optimal psychological and emotional state is generally willing to cooperate without restrictions and does not show any panic or defensive reactions.

In a preferred embodiment of the ophthalmological laser therapy system according to the invention, the laser arm is arranged on the device base body so as to be pivotable about an axis, preferably a horizontal axis. As a result, there is initially sufficient space to place the patient comfortably, for example, on a patient couch, but to bring the laser arm close to the patient's eye for treatment. In the case of a pivotable laser arm, the laser arm comes closer and closer to the patient when the patient is placed on the patient bed, and thus appears more threatening the closer the laser arm is brought to the patient. Such a self-luminous partial surface with an individually changeable color is particularly useful in this case.

In a further embodiment of the ophthalmic laser therapy system according to the invention, the lighting arrangement is part of a fixed patient surrounding lighting or is arranged in addition to the fixed patient surrounding lighting. The ophthalmological laser therapy system can therefore also have further light sources or lighting units. In this case, the lighting arrangement takes this general patient ambient lighting into account when implementing the individual coloring.

It is very advantageous if, in the ophthalmic laser therapy system according to the invention, the lighting arrangement, the color of which can be individually changed, can be switched off and / or the brightness of the lighting can be changed.

In this way, the color or the brightness of the patient environment can be selected or changed on a patient-by-patient basis in such a way that it shows the optimal psychological and emotional effect on the patient, or the effect of this individually changeable lighting arrangement can also be eliminated if necessary.

In advantageous embodiments of the ophthalmic laser therapy system according to the invention, the lighting arrangement has at least one of the following setting options for its individual changeability:

- Setting by the operator, preferably at any point in the workflow,

- Setting by the patient, preferably at any point in the workflow,

- setting by choosing a color in a preset color palette,

- setting by entering RGB values,

- Automatic setting depending on selected planning data or measurable patient data, - Adjustment according to the color scheme and / or the branding of the operating clinic.

The operator can, for example, ask each patient in advance of the treatment about their preferred color or determine their preferred color through indirect psychological tests and set them on the device as required.

If necessary, however, the setting can also be changed during the treatment.

Where desired, the patient can use suitable means to determine the setting himself, for example by acoustic means or by cognitive linking of the lighting arrangement with the patient.

It is also possible, in one embodiment, to vary the color and brightness of the lighting arrangement using patient data that can be checked during the laser therapy (such as the patient's blood pressure and pulse).

In a simple embodiment of the ophthalmological laser therapy system according to the invention, the number of discretely selectable colors of the lighting arrangement in a preset color palette is greater than or equal to two.

An ophthalmic laser therapy system according to the invention in which the color of the lighting arrangement can be continuously changed in the range of visible light is advantageous. It offers the best possible adaptation to the optimal individual coloring for the patient.

In a further variant of the ophthalmological laser therapy system according to the invention, this contains, in addition to the lighting arrangement, other likewise variable lighting elements which are of the same color or different colors for the patient's surroundings. In this case too, the lighting arrangement takes these lighting elements into account, possibly in a time sequence, when these additional lighting elements are not continuously in operation, when implementing the individual coloring. A planning device according to the invention for planning a laser therapy on an ophthalmic laser therapy system is set up to determine a color to be set for a lighting arrangement on a laser arm of the ophthalmic laser therapy system on a patient-by-patient basis.

Such a planning device can be part of a control device in the interior of the ophthalmic laser therapy system, which controls all components of this ophthalmic laser therapy system and can in turn be configured in one or more parts. The planning device can, however, also be an external planning device with which a sequence on an ophthalmic laser therapy system is planned in advance.

A planning method according to the invention for planning a laser therapy on an ophthalmological laser therapy system, in which a color to be set of a lighting arrangement on the laser therapy system is determined individually for the patient and is then preferably set automatically.

This determination of the patient-specific coloring can take place on the basis of one or more of the special features described above, for example:

- by planning the setting of the individual coloring in advance by selecting a color in a preset color palette and / or by entering RGB values;

- Include options for intervention by the operator, preferably at any point in the workflow;

- Include options for intervention by the patient, preferably at any point in the workflow;

- include an automatic setting and readjustment of the individual coloring depending on selected planning data or measurable patient data,

- take into account the color scheme and / or branding of the operating clinic;

- Consider ambient lighting and / or other lighting elements of different colors. The planning device according to the invention as well as the planning method according to the invention thus determine - in addition to the laser parameters such as the intensity of the laser pulses and their position - a color suitable for the respective patient for the illumination.

The present invention will now be explained on the basis of exemplary embodiments.

An exemplary embodiment of an ophthalmic laser therapy system 100 is described in greater detail in FIGS. 1a and 1b. It achieves a correction of the vision of a patient's eye by means of a laser, in particular by means of a pulsed and focused femtosecond laser beam, which is scanned at its focal point through a tissue within the eye and thereby this tissue within the eye, in particular within the cornea and / or the Separates the lens of the patient's eye. The ametropia can be corrected, for example, by separating a narrow lenticle in the cornea and then extracting the lenticle through a small opening in the cornea.

The ophthalmic laser therapy system 100 of FIGS. 1a and 1b is characterized by a laser swivel arm 3 which is attached to the device head 1 so as to be pivotable about a horizontal axis 4 and which can be swiveled back and forth between a rest position and a working position. Since this laser swivel arm 3 is swiveled over the patient for laser therapy on the patient's eye, but in steps in which the laser swivel arm 3 is not required, it can be brought back into a rest position in order to use the space above the working position for other purposes, the laser swivel arm 3 is thereby protected that the laser swivel arm 3 is surrounded by a swivel arm housing 6, which is fastened coaxially to the laser swivel arm 3 on the device head 1 so as to be pivotable (“arm-in-arm principle”).

The swivel arm housing 6 has a laser exit opening 8 which is positioned such that, when the laser swivel arm 3 is brought into the working position, it is directed at the eye of a patient to be treated, who can be placed and positioned accordingly on the patient bed 500. A lighting arrangement, here a self-luminous partial surface 50 is arranged on an underside of the laser pivot arm 3, that is to say the side of the laser pivot arm 3 facing the patient in the working position. This lighting arrangement 50 can be controlled in such a way that a patient-specific coloring takes place, which can also be changed during laser therapy.

The ophthalmic laser therapy system 100 is composed of a device base 2 and a device head that is adjustable on this device base 2 in height above a floor level, ie the z direction, and in its position in the plane, ie in the x and y directions 1. Device head 1 and device base 2 together form the device base body 1, 2. The device head 1 contains a first part of the laser therapy optics required to carry out the laser therapy. In the exemplary embodiment, the device head 1 also contains the laser source required to generate a corresponding pulsed laser beam, which here is a femtosecond laser source.

The second part of the laser therapy optics is mounted in a laser swivel arm 3 so that it can rotate about a horizontal first axis 4. The laser swivel arm 3 can about this first axis 4 from a rest position, which is shown in FIG. 1a, and in which it protrudes approximately vertically upwards, into a working position, which is shown in FIG. 1b, and in which it approximately is arranged horizontally on the device head 1, ie approximately parallel to the ground plane, and can be pivoted back.

If, in addition to the laser swivel arm 3, use is made of a further independent examination swivel arm 14, which contains, in particular, a surgical microscope 15, it is arranged so that it can be swiveled about an axis so that all work steps of a laser therapy on the eye of a patient can be carried out in such a way that the site of action of all work steps with the aid of the laser swivel arm 3 or the examination swivel arm 6 always remains fixed, so the position of the patient's eye does not have to be changed during the entire laser therapy. The position of the patient's eye in the first work step determines the position of all subsequent work steps and thus the place of action of their respective necessary devices on the various swivel arms 3, 14. This is made possible by a special one Arrangement 300 of the pivot axes 4, 16 of the various pivot arms 3, 14 to one another on the device head 1 of the ophthalmic laser therapy system 100, 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 having a corresponding arrangement 300 to one another, and both a therapy screen 12 movably attached to the swivel arm housing 6 with the movement of the swivel arm housing 6 and the surgical microscope 15, which is movably attached to the examination swivel arm 14, are coupled to the movement of the examination swivel arm 14 in such a way that the therapy screen 12 and the surgical microscope 15 are always kept unchanged stay. In principle, the examination swivel arm 14 can also be equipped with a further lighting arrangement 50, but this is not the case in the example shown here, since the distance between arm and patient is greater when the examination swivel arm 14 is in use, so the effect on the patient is much less significant is the more important prerequisite for working with the examination swivel arm 14 than for the laser swivel arm 3 and, in addition, favorable lighting conditions for the operator.

Depending on the therapy step, one of the two arms, i.e. either the laser leg arm 3 or the examination pivot arm 14, is pivoted over the patient in the working position and the other of the two arms is in the rest position (folded up). While the examination swivel arm, if it is used, remains at a greater distance from the patient, examinations generally proceed very quickly and even surgical manipulation of the patient's eye under the surgical microscope 15.

The lighting arrangement 50 is always initiated before the laser swivel arm 3 is swiveled into the working position and is only switched off again after the laser swivel arm 3 has been moved into the rest position.

The following now describes a typical course of treatment, as can be done, for example, for the separation of a lenticle in the cornea of a patient's eye and the subsequent extraction of the lenticle through a narrow opening, using an ophthalmic laser therapy system 100 described above:

The treatment or therapy parameters are initially planned on a planning screen 31, which in this exemplary embodiment is also arranged directly on the ophthalmic laser therapy system 100. Alternatively, the planning screen 31 can also be spatially separated from the ophthalmic laser therapy system 100. During the planning, the ophthalmic laser therapy system 100 is preferably in a standby position, i.e. the laser swivel arm 3 and possibly also the examination swivel arm 14 are swiveled up vertically in the rest position on the system.

The patient is placed on the patient couch 500. This is easily possible due to the swiveled up laser swivel arm 3.

The operator (that is, the surgeon, surgeon or an assistant) then positions the height of the device head 1 by means of a joystick 10 on this device head 1, with which the translational movement of the device head 1 over the device base 2 can be controlled. In doing so, it is based on the image supplied by the camera 9, which is visible on the therapy screen 12 and / or on the planning screen 31 including an overlaid symbol of a swiveled down laser swivel arm 3. As an alternative to the joystick, in other designs the positioning can also take place by means of inputs on one of the two screens 12, 31 or via buttons on the laser therapy system 100.

The operator triggers the motorized swiveling down of the laser swivel arm 3 in and together with its swivel 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 swivel arm, a free space remains between the laser exit opening 8 and the patient's eye, which is advantageously between 50 mm and 150 mm in size. Before it is pivoted down, the self-luminous partial surface 50 on the underside of the laser arm 3 is initiated with the optimal coloring determined for the corresponding patient. This is the pivoting down and coming of the laser arm from the patient as felt less uncomfortable and the subsequent therapy procedure is perceived more attentively and cooperatively by the patient. In addition, the coloring can also be adapted during the therapy process as a function of the behavior and measurable patient data, for example the pulse and / or the blood pressure.

If this has not yet happened in the rest position of the laser pivot arm 3, a contact glass is now attached to the laser outlet opening 8. The contact glass is held at the laser outlet opening 8 by means of a negative pressure.

The operator then initiates the release of the movement of the laser swivel arm 3 within the swivel arm housing 6 by means of a joystick rotation of the joystick 11 on the swivel arm housing 6, or alternatively by means of a separate button (not shown). In other versions, the movement can also be triggered automatically by the attached contact glass. The laser exit opening 8 with the contact glass moves towards the eye.

Finally, the docking phase takes place, i.e. the phase in which the contact glass is fixed: the operator controls the contact glass onto the patient's eye with the joystick 11 while observing by means of the video microscope 13. When the correct position is reached, the eye is fixed by sucking the eye on the contact glass with a button on the joystick 11. In one embodiment, it is possible to support the correct positioning or centering of the contact glass or another patient interface on the eye by processing the video microscope image and using it to control the device head 1.

The actual laser therapy step can now finally 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.

After completion of this laser therapy step, the suction of the eye is released by means of the negative pressure, in that the pressure is increased again here, the laser pivot arm 3, and thus also the laser outlet opening 8, again into the Swivel arm housing 6 is swiveled in and the device head 1 is raised a little by moving in the z-direction. This means that there is again a safety distance to the eye. The contact glass or the patient interface can be removed from the laser outlet opening 8, the release being effected by briefly pressing it upwards.

The laser swivel arm 3 is now swiveled up again together with its swivel arm housing 6, and the free space above the patient is restored. Further work steps can now be carried out, or the patient can leave his position on the patient bed 500. At this point the self-luminous sub-surface 50 is switched off again.

If, however, both eyes of a patient are to be treated, before the laser swivel arm 3 is swiveled up with its swivel arm housing 6 into its rest position, the device head 1 can be moved by a translational movement in the x and / or y direction over the device base 2 so that the laser swivel arm 3 is positioned with its swivel arm housing 6 over the other eye. The second eye can then be treated in the same way, in that a new contact lens or patient interface is held at the laser outlet opening 8 and by means of a negative pressure, and all subsequent steps are carried out as described above.

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 such that it can pivot about a second axis 16 and contains an examination device, in this case a surgical microscope 15. Such a surgical microscope is necessary or at least advisable for the second main work step of the “SMILE” treatment, for example. For this purpose, after the laser swivel arm 3 has been swiveled up with its swivel arm housing 6 into its rest position after the end of the actual laser therapy step as described here, the treatment is continued as follows:

The operator initiates the motorized pivoting down of the examination pivot arm 14 by pressing a button. The motor moves the Examination swivel arm 14 in 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, so that the eye to be treated further is determined immediately after the examination pivot arm 14 has been pivoted down Examination volume of the surgical microscope 15 is.

Minor corrections, if necessary, are possible by adjusting the position of the device head 1 relative to the device base 2 by means of translational movements. Either the joystick 10 present on the device base 2, a separate foot control panel or a joystick present on the surgical microscope 15 are used for this purpose.

If the examination swivel arm 14 with the surgical microscope 15 is appropriately positioned, the operator carries out the lenticle extraction.

After completion of the lenticle extraction, the examination swivel arm 14 with the surgical microscope 15 is swiveled up by a motor and thus swiveled back into its rest position. This can be initiated by pressing a button or - as already 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.

The features of the invention mentioned above and explained in various exemplary embodiments can be used not only in the combinations specified by way of example, but also in other combinations or alone, without departing from the scope of the present invention.

A description of a device based on method features applies analogously to the corresponding method with regard to these features, while method features correspondingly represent functional features of the device described.

Claims

1. An ophthalmic laser therapy system (100) comprising:

- A device base body (1, 2) and

- A laser device (24) which contains a laser source and a first laser therapy optics in the device base body (1, 2) and a second laser therapy optics and a laser exit opening (8) in a laser arm (3), the laser arm (3) on the device base body (1, 2) is arranged, characterized in that the laser arm (3) externally has a lighting arrangement (50), preferably a self-luminous partial surface, the color of which can be changed individually.

2. Ophthalmic laser therapy system (100) according to claim 1, wherein the laser arm (3) on the device base body (1, 2) is arranged pivotably about an axis (4), preferably a horizontal axis.

3. Ophthalmological laser therapy system (100) according to claim 1 or 2, wherein the lighting arrangement (50) is part of a patient surrounding lighting or is arranged in addition to the patient surrounding lighting.

4. Ophthalmological laser therapy system (100) according to one of claims 1 to 3, wherein the lighting arrangement (50) can be switched off and / or the brightness of the lighting can be changed.

5. Ophthalmic laser therapy system (100) according to one of claims 1 to 4, wherein the lighting arrangement (50) has at least one of the following setting options for its individual changeability:

- Setting by the operator, preferably at any point in the workflow,

- Setting by the patient, preferably at any point in the workflow,

- setting by choosing a color in a preset color palette,

- setting by entering RGB values,

6. Ophthalmic laser therapy system (100) according to one of claims 1 to 5, wherein the number of discretely selectable colors of the lighting arrangement (50) in a preset color palette is greater than or equal to two.

7. Ophthalmic laser therapy system (100) according to one of claims 1 to 5, wherein the color of the lighting arrangement (50) can be changed continuously in the range of visible light.

8. Ophthalmic laser therapy system (100) according to one of claims 1 to 7, which contains other lighting elements which are likewise variable, but which are of the same color or differently colored for patient ambient lighting.

9. Planning device for planning a laser therapy on an ophthalmic laser therapy system (100), which is set up to determine a color to be set for a lighting arrangement (50) on a laser arm (3) of the ophthalmic laser therapy system (100) on a patient-by-patient basis.

10. Planning method for planning a laser therapy on an ophthalmic laser therapy system (100), in which a color to be set of a lighting arrangement (50) on the ophthalmic laser therapy system (100) is determined individually for each patient and is then preferably set automatically.