DE102011116369A1 - Laser therapy instrument for therapeutic treatment on e.g. cornea of human eye, has moving device moving beam conducting device part out of treatment area after use of instrument such that area is freely accessed for using other instruments - Google Patents

Abstract

The instrument (1) has a beam conducting device i.e. laser swiveling arm (3), formed with an exit lens system (5) for a therapeutic laser beam. A moving device moves a part of the beam conducting device including the exit lens system into a treatment area (2) at the beginning and moves the part of the beam conducting device out of the treatment area after the use of the instrument such that the treatment area is freely accessed for using other instruments after the part of the beam conducting device including the exit lens system is moved out of the treatment area.

Description

The invention relates to a laser device for therapy on the human eye, designed for surgical procedures on the cornea, the sclera, the vitreous body or the eye lens, in particular suitable for use in alternation with other devices for eye diagnosis or eye therapy, wherein the eye or at least the Patient remains in a common treatment area throughout the use of the various devices. For intraoperative use in cataract surgery, the laser device preferably has a femtosecond laser (short: fs laser) and a phaco device.

Defective vision correction, for example by laser surgery on the cornea, requires a variety of devices whose design corresponds to their respective intended use. Thus, at the beginning of such treatment, devices suitable for diagnosis on the eye are used, such as surgical microscopes, optical arrangements for 3D measurement on the cornea or arrangements for optical coherence tomography. Depending on the result of the diagnosis, the therapeutic measures are then determined and carried out.

Before it is possible to start the actual correction of defective vision by ablation of the cornea, in the method known as LASIK, a hinged lid designated as "flap" is initially formed on the surface of the cornea, the thickness of which is substantially less than the thickness of the cornea itself For example, a "flapper" laser device known in the art as laser keratome or microkeratome is used. With this device, a series of a large number of only a few micrometers large tissue openings is created, so-called photodisruptions that form the "flap" in its entirety, with a very accurate positioning of the laser beam focus in the lateral and axial direction within the cornea is required. The treatment laser beam used for this purpose has pulse widths of less than 10 ^-12 s.

With a further optical precision device, tissue is then removed from the now exposed inner area of the cornea when the "flap" is flipped away, thereby changing the corneal curvature until the defective vision has been corrected. The tissue removal takes place for example by energy input with a pulsed treatment laser beam. The devices designed for ablation of the tissue are known as laser ablation devices. Alternatively, a method that is performed exclusively with a femtosecond laser therapy device may be used. Modern methods of lenticule extraction are known as FLEx and SMILE, but radial keratotomy (RK) or circular incisions are also possible.

The result of the processing is evaluated with a diagnostic device, such as a 3D measuring device, in order to be able to carry out, if necessary, postcorrective treatments.

All devices used are to be positioned relative to their respective task relative to the eye and claim the same, extending around the eye work or treatment area, which means that it must be released with each device change. An efficient process requires that the devices to be used for the successive process steps are available in the immediate vicinity without, however, hindering each other by blocking the work or treatment area. In addition, it is to be avoided as far as possible that the patient's eye to be treated has to be readjusted again or again in terms of therapy or diagnosis every time the device is changed.

In addition, at least temporarily, there must be sufficient space for manual work on the eye, whereby the observation is typically carried out by a surgical microscope. In addition, an ultrasound phacoemulsification device is often additionally available for use since complete emul sion of the lens by means of a femtosecond laser is not possible at cataract levels of 2 to 4. In these cases, complementary to the laser treatment, an ultrasonic phaco device must be used to complete the comminution of the lens. Subsequently, the phaco-device must be switched from the capsular bag to the irrigation / aspiration mode to remove the lens residues and the cortex. Also for these devices, if necessary, the treatment area is to be released.

Patient positioning and patient transport are also important in terms of efficient treatment. While at the same time comfort and aesthetic aspects are important for the above-described refractive surgery in addition to the highest demands on positioning accuracy, there are different requirements in cataract surgery, for example, in which case the patients must be stored safely in a partially or completely anesthetized state.

A particularly important and not to be ignored aspect in the treatment and therapy of the human eye and in particular for surgical interventions is the sterility of the Laser device or coming into contact with the hands of the surgeon and the assistant objects and parts of the laser device. However, sterilization of the entire laser device is extremely difficult and impractical.

Based on this, the invention has the object, a laser device for the treatment of the human eye, which is particularly suitable for surgical procedures on the cornea or eye lens, in terms of sterility and ergonomics educate so that during the course of complex treatments on the eye as possible interference-free and disability-free interaction with other devices for eye diagnosis or eye therapy is ensured, such as with surgical microscopes, Phakoemulsifikationsgeräten and patient recliners of various designs and manufacturers.

The laser therapy device according to the invention has the technical features specified in claim 1. Design features are specified in claims 2 to 12.

The essential advantage of the invention is that the laser arm, which carries the exit optics for the treatment laser beam, in a particularly preferred embodiment by a pivoting movement of the work or treatment area can be so far removed that this without limitation, the other of the Treatment involved devices is available.

The pivot mechanism is preferably operated motorized. By means of a manually operated control lever or switch a rapid movement is triggered under the control of the user, whereby the user can react immediately in the event of a collision.

An optional existing force limiting device also reduces an undesirable hard touch or a risk of crushing. Furthermore, proximity sensors may be provided with the aid of which a reduction in the pivoting speed is achieved when the exit optics approach the working position on the eye. Conversely, an increase in the pivoting speed during pivoting out of the treatment area or when swiveling away from the eye can thus be achieved.

The pivoting movement is advantageously carried out until the pivoting arm including the exit optics for the therapy laser beam is largely or even completely arranged in the contour of the device base body. This is not only advantageous in terms of the release of the treatment area, but also in terms of the transportability of the device, since the sensitive optical assemblies are protected on the laser arm from mechanical damage.

• a) der Schwenkarm mit einer bogenförmigen Bewegung heruntergeklappt und
• b) sich die Austrittsoptik mit einer Linearbewegung dem Patientenauge vertikal annähert.

In a preferred embodiment, the positioning of the swivel arm takes place in two stages by:

• a) the swing arm folded down with an arcuate movement and
• b) the exit optics approaches the patient's eye vertically with a linear movement.

This linear movement may comprise a parallel movement of the entire swing arm, a telescopic extension of the swing arm, or a combination of these two movements. This realizes a greater range of the swivel arm without the swivel arm having to have this overall length in its folded-in state. Thus, a compact and ergonomically favorable size can be realized.

While in a pure pivotal movement of the swing arm may be required under circumstances to move the surgical microscope (short: OPMI) from its normal operating position and then reposition, this can be avoided by the vertical approach of the exit optics to the patient's eye. A repositioning of the OPMI, d. H. Setting the centering, working distance, zoom setting, etc. is always associated with an extension of the total duration of the operation.

It is particularly advantageous that the assembly of the swivel arm has a height of less than 20 cm, as this corresponds to the normal working distance of the surgical microscope. Preferably, this module includes an optical interface, so that during the fine adjustment of the swivel arm and during the laser treatment, an overview image of the patient's eye through the OPMI is available. This optical interface includes at least one dichroic mirror so that observation (with visible light) and laser treatment (with NIR) can work in parallel. The laser arm is not only pivotable in a particularly preferred embodiment of the invention, but also in all three spatial directions X, Y and Z adjustable. The control takes place, for example, by the user by means of a joystick or via a software control, which for this purpose evaluates an image of the patient or the patient's eye taken through the exit optics for the therapy laser beam and adjusts the actual position determined in this case to a predetermined desired position ,

Also advantageous is an embodiment in which not only the laser arm, but also the Patient positioning device can be moved for the purpose of eye positioning, if desired by the user.

In order to be able to place a phacoemulsification device ergonomically in the access area of the user, the laser therapy device can be equipped with a mechanical coupling device or a special adapter for the phacoemulsification device. Such an adapter can be advantageously equipped with means for spatial alignment of the Phakoemulsifikationsgerätes. Also, means for transmitting electrical energy for the purpose of power supply and / or means for signal transmission between the laser therapy device and the coupled phacoemulsification device can be provided. The two devices can share operating and display elements in this way. In a specific embodiment, the phacoemulsification device may be a fully integrated component of the laser therapy device.

The laser therapy device can also have an interface for transmitting signals to a local information network or for receiving signals from such a network. In a particularly advantageous embodiment, there is a direct data connection to a surgical microscope, whereby again there is the possibility of sharing control and display elements.

The laser therapy device can also be equipped with a wheel or roller chassis to facilitate its transport to the treatment site. Since the laser therapy device at the place of use is very stable, as low in vibration and to be positioned in the correct vertical orientation, a motor position stabilization can be provided. In the simplest case, these are supports which can be extended vertically on the bottom side, which lift the device out of the wheel bearing, thereby fixing it and, if necessary, simultaneously performing a tilt correction. This mechanism is advantageously coupled to the control of the laser arm pivoting movement that pivoting of the laser arm in the transport configuration for medical application is not possible. In order to measure the information necessary for the tilt correction information about the inclination is a measuring device and this downstream an evaluation and control device is provided.

The invention will be explained in more detail with reference to an embodiment. In the accompanying drawings show:

1 FIG. 2: an embodiment of the laser therapy device according to the invention in a view from which different pivot positions of the laser arm can be seen,

2 : A side view of the laser therapy device in direction A to 1 with a representation of the laser arm completely swung out of the treatment area and pivoted into the housing of the laser therapy device,

3 a second embodiment of the laser therapy device according to the invention in a view from which a two-stage movement of the laser arm can be seen and

4 : A detailed view of the extended laser arm with a surgical microscope according to a laser therapy device according to 3 ,

In 1 is a preferred embodiment of the laser therapy device according to the invention 1 shown in his outlines. The laser therapy device 1 For example, it is designed for surgical interventions on the cornea of the human eye for the purpose of correcting defective vision due to tissue removal. In this regard, its use is required along with other medical optical devices such as a surgical microscope for diagnostic purposes, a flapper for opening the cornea prior to corrective surgery, or even a phacoemulsification device for ophthalmic lens surgery.

All involved devices come in alternation, ie in temporal succession, are used, the in 1 indicated treatment area 2 in which the patient or eye to be treated is positioned, each of the devices must be accessible for the period of time in which it is used.

The laser therapy device 1 has optical means for guiding and focusing the therapy laser beam, of which in 1 for the sake of clarity, only a trained as a swivel arm laser arm 3 is shown. The laser arm 3 is a pivot point in one of its end sections 4 pivotally mounted, while at its opposite end portion, the exit optics 5 is arranged for the therapy laser beam.

The pivoting is, for example, as shown here, possible at an angle of 90 °. To limit the swivel range adjustable stops are provided (not shown in the drawing).

In 1 is the laser arm 3 in a first pivot position in solid lines, sketched in dashed lines in a second pivot position. Both pivot positions define each an end position of the pivoting movement. The full line representation shows the position in which the exit optics 5 on the laser arm 3 in the treatment area 2 is pivoted in such a way that the laser beam is positioned according to the operation step to be performed in relation to the eye to be treated. This pivotal position is maintained during the period in which the laser therapy device according to the invention for the purpose of laser processing of the eye or laser processing of implants that are already in the eye is used.

When this mission is completed, the laser arm becomes 3 including the exit optics 5 from the treatment area 2 swung out, leaving the treatment area 2 is freely available for the other active or passive devices involved in the operation without the position and orientation of the patient or the eye to be treated having to be changed at all or even substantially.

It is advantageous if the swinging out of the laser arm 3 from the treatment area 2 as far as possible, until this including the exit optics 5 is completely classified in the contour of the device body, as well as from the synopsis of 1 and 2 evident.

In 3 is a further preferred embodiment of the laser therapy device according to the invention 1 shown. In this view is a two-stage movement of the laser arm 3 seen.

After the laser arm 3 with a bow-shaped movement 8th' has been dropped, will exit optics 5 with a linear movement 8th'' the patient's eye 10 in the treatment area 2 vertically approximated.

In this case, this telescopic linear movement 8th'' also as a parallel movement of the entire laser arm 3 or as a combination of these two movements. The positioning of the laser arm 3 success here, for example, with the help of the control lever 13 ,

After completion of the laser treatment, the laser arm becomes 3 including the exit optics 5 from the treatment area 2 by retracting the telescopic extension 9 and fold up 8th moved out, leaving the treatment area 2 is freely available for the other active or passive devices involved in the operation without the position and orientation of the patient or the eye to be treated having to be changed at all or even substantially.

Again, it is advantageous if the moving out of the laser arm 3 from the treatment area 2 as far as possible, until this including the exit optics 5 is completely arranged in the contour of the device body. Due to the two-stage movement, a longer range of the laser arm 3 achieved in a compact and ergonomically favorable size.

Another preferred embodiment is the 4 to take a detailed view of the laser therapy device after 3 shows. The extended laser arm 3 , in particular its telescopic extension 9 is located in the treatment area 2 and the exit optics 5 became the eye 10 vertically approximated.

A surgical microscope 11 is here so above the exit optics 5 arranged that its lens 12 the optical interface, not shown here (position 13 in 3 ), so that during fine adjustment of the laser arm 3 and during the laser treatment an overview image of the eye 10 through the surgical microscope 10 is available.

It is particularly advantageous that the assembly of the laser arm 3 or at least its telescopic extension 9 has a height D of less than 20 cm, since this is the normal working distance of the surgical microscope 11 equivalent.

As further from the 1 to 3 can be seen, is the laser therapy device according to the invention 1 against his footprint 6 optionally by means of rollers 7 which facilitate its manual transport to and from the site. To the laser therapy device 1 despite the roles 7 To be able to bring a stable position and orientation at the site, a parking brake can be provided (not shown in the drawing), which is then also advantageously coupled to the pivoting movement of the laser arm, that the pivoting of the laser arm is possible only after the position stabilization at the site.

In a further preferred embodiment, an ultrasound phaco device is integrated into the laser therapy device according to the invention. Such an ultrasonic phaco device is to be provided anyway, since complete emulsification of the lens with the aid of a femtosecond laser at cataract grades of 2 to 4 is not possible. In these cases, complementary to the laser treatment, an ultrasonic phaco device must be used to complete the comminution of the lens. Subsequently, the phaco-device must be switched from the capsular bag to the irrigation / aspiration mode to remove the lens residues and the cortex.

So far, the phaco device has been positioned away from the patient's head for ergonomic operation by the assistant and to maintain free space. Its arm had to be long enough to bridge the distance between the phaco device and the patient's head in order to avoid the repositioning of the laser system during the operation and the associated time.

An essential aspect of phacoemulsification, d. H. for irrigation / aspiration, as well as vitrectomy, the supply of irrigation fluid into the eye, on the one hand to be able to remove the lens residues effectively and on the other hand, to approximately maintain the pressure conditions in the eye and to prevent the capsular bag collapsing. In this case, the inflow of the liquid is usually determined passively by the height of the container containing the liquid, so that the pressure generated in the anterior chamber of the eye increases with the height of the container.

Particularly advantageous in this context, if the housing of the laser therapy device according to the invention is designed as a kind of rack, with various recording devices. This offers the possibility of constructing additional accessories such as the phaco device as a plug-in module, so that they can be integrated in a simple way.

The 3 shows in a preferred embodiment, in which the housing of the laser therapy device according to the invention is designed as a rack, with receiving devices for plug-in modules.

The laser therapy device according to the invention 1 in this case has the already explained elements, such as laser arm 3 with telescopic extension 9 , Exit optics 5 and control levers 14 belonging to the plug-in module of the laser source.

In addition, the laser therapy device is on 1 a phaco device designed as a plug-in module 15 present, with the over the cables 16 connected handpieces 17 , the cradle 18 for the liquid container, as well as over the hose 19 with the plug-in module 15 connected liquid container 20 , To store the handpieces 17 is also a storage space 21 provided, which can be folded down.

The cradle 18 for the liquid container 20 , which can be both a bottle and a bag, this has a mechanism for adjusting the height. The height of the container is controlled either manually or by means of a motorized unit. The necessary controls are available on the plug-in module itself or as a separate plug-in module and also firmly installed in the designed as a rack housing the laser therapy device.

Furthermore, the laser therapy device according to the invention 1 via further plug-in modules, for example for a control lever 22 or a monitor 23 dispose, with the monitor 23 for control can also be designed as a touch screen. From the monitor 23 For example, the live image of the patient's eye can be displayed.

The for controlling the laser arm 3 existing control levers 22 preferably has a reversing device, so that their operation can be done from several sides.

As already mentioned, the sterility of the laser therapy device or in the immediate vicinity of existing objects in the treatment and therapy of the human eye and especially in surgical procedures is a particularly important aspect.

Also or in particular in the design of the housing of the laser therapy device according to the invention as a rack, with recording devices for various plug-in modules, it must be ensured that the laser therapy device is completely closed even without plug-in modules, so that it is even suitable for use in the sterile surgical area.

Care must be taken to ensure that all objects in contact with the surgeon and assistant (or may be accidental) must be sterile, otherwise the risk of bacterial inflammation of the eye (endophthalmitis) which increases represents the most feared complication in cataract surgery.

However, since a sterilization of the entire laser therapy device is extremely difficult and impractical, the laser therapy device according to the invention has been designed so that only parts of the laser therapy device can be sterilized by means of an autoclave, without significantly hindering the intraoperative use of these devices.

Thus, for example, the assembly of the swivel arm, which is guided directly in front of the patient's eye has a removable cover (reference numeral 24 in 4 ), which can be removed and sterilized by autoclaving. But also the controls on the swivel arm and the laser therapy device, as well as the storage table have removable covers that are easy to sterilize.

It has proven to be advantageous that the sterilizable shells are designed differently in color than the laser therapy device and its elements themselves, as this is immediately recognized whether the device has been sterilized and prepared for the next operation.

Finally, it should be mentioned that the last approach to the eye under the required safety conditions by lifting the patient bed, lowering the laser therapy device or by moving the laser arm or even its exit optics can be done.

In addition, variant embodiments of the laser therapy device according to the invention optionally have the technical features and details mentioned above in the description of the invention in order to achieve the particular advantages associated therewith and those already described.

LIST OF REFERENCE NUMBERS

1

Laser therapy device

2

treatment area

3

laser arm

4

pivot point

5

exit optics

6

footprint

7

roll

8th

folding movement

9

telescopic extension of the laser arm 3

10

eye

11

OPMI

12

Lens of the OPMI 11

13

optical interface

14

control lever

15

Phaco machine

16

electric wire

17

handpieces

18

cradle

19

tube

20

liquid container

21

shelf

22

operating lever

23

monitor

24

removable cover

D

Working distance of the OPMI (about 20 cm)

Claims (15)

Laser therapy device, - designed for surgery on the cornea, the sclera, the vitreous body or the eye lens, in particular for use in alternation with other devices for eye diagnosis or eye therapy, wherein the treatment area in which the patient or the eye is positioned, in succession must be accessible to other devices, comprising: - a beam guiding device with an exit optics ( 5 ) for the therapy laser beam, and - a device for introducing at least a part of the beam guiding device including the exit optics ( 5 ) in the treatment area ( 2 ) at the beginning and for dispensing from the treatment area ( 2 ) after using the laser therapy device ( 1 ), so that - after the application of the part of the beam guiding device including the exit optics ( 5 ) from the treatment area ( 2 ) This is freely accessible for the use of the other devices. Laser therapy device according to claim 1, wherein the insertable and ausbringbare part of the beam guiding device as a laser arm ( 3 ) is formed, wherein - the on the laser arm ( 3 ) exit optics ( 5 ), starting from their working position on the eye, circular arc at an angle of preferably 90 degrees from the treatment area ( 2 ), and - the laser arm ( 3 ) in his out of the treatment area ( 2 ) swung out state preferably completely into the outer contour of the laser therapy device ( 1 ) is arranged. Laser therapy device according to claim 1, wherein the insertable and ausbringbare part of the beam guiding device as a laser arm ( 3 ) is formed, wherein - the on the laser arm ( 3 ) exit optics ( 5 ), starting from their working position on the eye, linear and circular arc-shaped from the treatment area ( 2 ), and - the laser arm ( 3 ) in his out of the treatment area ( 2 ) swung out state preferably completely into the outer contour of the laser therapy device ( 1 ) is arranged. Laser therapy device according to claim 3, wherein the insertable and ausbringbare part of the beam guiding device as a laser arm ( 3 ) is formed so that a parallel movement of the entire laser arm ( 3 ), whose telescopic extension or a combination of these two movements takes place. Laser therapy device according to one of the preceding claims, in which the laser arm which can be brought in and 3 ) includes an optical interface that during the fine adjustment of the laser arm ( 3 ) and the laser treatment allows observation of the patient's eye by direct inspection or by a separate optical system. Laser therapy device according to one of the preceding claims, in which - the triggering of the movement is provided manually via a hand or foot switch, and - the speed of movement of the distance between the exit optics ( 5 ) and the eye is dependent, whereby the movement within a critical distance is slower than outside the critical distance. Laser therapy device according to one of the preceding claims, in which force measuring sensors are present, which are connected to a control device for the movement in such a way that the movement is stopped when the measured force rises above a desired value. Laser therapy device according to one of the preceding claims, wherein the laser arm ( 3 ) including the exit optics ( 5 ), but at least the exit optics ( 5 ) itself, in addition to the movement in the spatial directions X, Y and Z positionable and is coupled for this purpose via a control device with a motor drive. Laser therapy device according to one of the preceding claims, equipped with an imaging system for the eye to be treated, wherein - the use of the exit optics ( 5 ) is provided for the therapy laser beam as entry optics for the imaging light, - an image evaluation device connected to the imaging system is present, and - the image evaluation device for positioning the exit optics ( 5 ) relative to the eye with the control means for driving the laser arm ( 3 ) and / or with a control device for driving a patient bed is in communication. Laser therapy device according to one of the preceding claims, equipped with an information acquisition, information transmission and information processing system for patient-related identification, diagnosis and / or therapy data coupled with the other devices for eye diagnosis or eye therapy. Laser therapy device according to one of the preceding claims, equipped with means For the change of location before and after the therapy relative to the other devices for eye diagnosis or eye therapy, in particular in the form of rollers, wheels or slide rails, - For fixed fixation during the entire therapy process, and / or - For tilt correction during fixed fixation. Laser therapy device according to claim 8, wherein the means for inclination measurement and / or inclination correction with the control means for the pivoting movement and / or for the positioning in the spatial directions X, Y, Z is connected. Laser therapy device according to one of the preceding claims, whose housing is designed as a rack to be able to record various other designed as plug-in modules devices. Laser therapy device according to claim 13, in which the phako device designed as a plug-in module has means for adjusting the height of a liquid container. Laser therapy device according to one of the preceding claims, equipped with removable means for its sterilization.

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