Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F9/00825—Methods or devices for eye surgery using laser for photodisruption
  • A61F9/00827—Refractive correction, e.g. lenticle
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F9/00825—Methods or devices for eye surgery using laser for photodisruption
  • A61F9/00836—Flap cutting
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F2009/00844—Feedback systems
  • A61F2009/00846—Eyetracking
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F2009/00861—Methods or devices for eye surgery using laser adapted for treatment at a particular location
  • A61F2009/00872—Cornea
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F2009/00878—Planning
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F2009/00897—Scanning mechanisms or algorithms

Definitions

• the invention relates to a planning device for generating control data for a treatment device which generates at least one cut surface in the cornea by means of a laser device.
• the invention further relates to a treatment device which has a planning device of the type mentioned.
• the invention further relates to a method for generating control data for a treatment device which generates at least one cut surface in the cornea by means of a laser device.
• the invention also relates to a method for eye surgery, wherein at least one cut surface is generated in the cornea by means of a treatment device with a laser device.
• the invention also relates to a user interface for a PI device mentioned above.
• a wide variety of treatment methods with the aim of correcting refraction in the human eye are known in the prior art.
• the aim of the surgical methods is to change the cornea in a targeted manner in order to influence the refraction of light in the eye.
• Several surgical methods are used for this.
• the most common method is the so-called laser in-situ keratomileusis, which is also abbreviated to LASIK.
• a corneal lamella is detached from the corneal surface on one side and folded to the side. This lamella can be loosened by means of a mechanical microkeratome, or also by means of a so-called femtosecond laser keratome, such as is sold by Intralase Corp., Irvine, USA, for example.
• the LASIK operation provides for the use of an excimer laser, which ablates the corneal tissue exposed under the lamella. After corneal tissue, which was originally below the corneal surface, has been superficially evaporated in this way, the corneal lamella is folded back into its original place.
• the use of a laser keratome to expose the lamella is advantageous over a mechanical knife, since it improves the geometric precision and the frequency of clinically relevant complications is reduced.
• the lamella can be produced with a much more constant thickness if laser radiation is used.
• the cut edge is also precisely shaped, which increases the risk of healing disorders also reduces the interface remaining after the operation.
• this method has the disadvantage that two different treatment devices have to be used, namely the laser keratome to expose the lamella on the one hand and the laser which vaporizes the corneal tissue on the other.
• a short pulse laser preferably a femtosecond laser
• a femtosecond laser forms a cut geometry in the cornea, which separates a corneal volume (so-called lenticle) in the cornea. This is then removed manually by the surgeon after the flap covering the lenticule has been folded to the side.
• the advantage of this method is, on the one hand, that the quality of the cut is further improved by using the femtosecond laser combined with a curved contact glass.
• the optical radiation effect is usually used in that an optical breakthrough is generated by individual optical pulses, the duration of which can be between approximately 100 fs and 100 ns. It is also known to cover individual pulses, the energy of which is below a threshold value for an optical breakthrough, with the tissue or material to be brought in so that a material or tissue separation is achieved. This concept of incision generation in the corneal tissue allows a wide variety of incisions.
• the invention is therefore based on the object of specifying a planning device for generating control data, a treatment device for refraction-correcting eye surgery and a method for generating control data for such a treatment device, in which an improved refraction correction is ensured.
• a planning device of the type mentioned at the outset which has calculation means for defining corneal cut surfaces which, when determining the cut surfaces, enable the cut surface to be rotated about an axis running essentially parallel to the axis of the eye.
• the doctor can optimally place the incisions in the cornea, in particular compensate for any twisting of the patient's eye when taking the treatment position.
• the object of the invention is further achieved with a treatment device which has a laser device which uses laser radiation to separate at least one cut surface in the cornea in accordance with control data, and a planning device of the type just mentioned for generating the control data, the planning device when determining the Cut surfaces enables a rotation of the cut surface about an axis running essentially parallel to the eye axis.
• the object of the invention is finally also achieved with a method for generating control data according to the type mentioned at the beginning, which comprises: generating a control data set for the corneal cut surface for controlling the laser device, the planning device rotating the cut surface by rotating the cut surface when determining the cut surfaces allows an axis running essentially parallel to the eye axis.
• the object of the invention is finally also achieved with a method which comprises: generating a control data set for the corneal cut surface, transferring the Control data for the treatment device and generation of the cut surfaces by controlling the laser device with the control data set, the determination of the cut surfaces allowing a rotation of the cut surface about an axis running essentially parallel to the eye axis when the control data set is generated.
• the object of the invention is also achieved by a user interface which provides input means with the aid of which the final determination of the cut surfaces enables a rotation of the cut surface about an axis running essentially parallel to the eye axis.
• the invention thus relates to a device and a method which improve refractive surgery in that, according to his experience, the doctor can optimally place cuts, preferably in the cornea.
• the tissue to be treated is preferably the cornea or the lens of the eye, but it can also be the vitreous body or other structures in the eye.
• the solution according to the invention offers the possibility of the complete rotation of the cutting pattern to be applied as a basis for the cuts in the eye tissue by adding an angular offset to all coordinates of the cutting pattern.
• the doctor is given the opportunity to determine this angle immediately before the operation. This is done either manually by the doctor or based on one of an algorithm that determines and suggests an angular deviation from the diagnosis image and therapy image. The doctor can then fine-tune this angle.
• the angle of rotation selected at the moment can advantageously be visualized and quantified by means of therapy monitoring.
• the process according to the invention can look like this: • Image recording of the patient's eye in the diagnostic device
• the iris or its patient-specific structure is preferably used as an anatomical feature.
• another angle-dependent feature can be used, for example the retina.
• Artificial marking by means of a colored point or the like on the cornea or the sclera is also possible.
• the deviation can advantageously be represented numerically or graphically.
• angle of rotation is set immediately before the treatment and after fixation of the patient's eye by means of a contact glass.
• the adjustable angle range is preferably limited, for example to +/- 20 °.
• the step size for the angle setting is limited downwards, for example to 1 °.
• the time interval between changing the setting of the angle of rotation and establishing readiness for treatment or the start of treatment is preferably less than 3 seconds, preferably less than 1 second.
• the setting of the angle of rotation is preferably implemented via a visualization by fading in data in the therapy observation.
• An adjustment scale for the rotation is also preferably visualized by fading in data in the therapy observation.
• the possibility of setting the angle of rotation is preferably combined with an existing operating element, in particular with an operating element that the operator can use uses correct positioning of the patient's eye relative to the device or the device to the patient's eye.
• This can be, for example, a joystick, but also a computer mouse or a rotary encoder.
• the difference between the suggested angle and the currently set angle is also preferably visualized and / or quantified.
• the difference between the suggested angle and the currently set angle is preferably evaluated with respect to an adjustable limit value.
• the difference between several suggested angles and the currently set angle can also be evaluated.
• the angle used in the treatment is preferably stored after the treatment together with the suggested angle and the treatment data.
• FIG. 1 shows a schematic representation of a treatment device with a planning device for a treatment during ophthalmic refraction correction
• FIG. 2 shows a schematic representation of the effect of the laser radiation which is used in the treatment device of FIG. 1,
• FIG. 3 shows a further schematic representation of the treatment device of FIG. 1 with regard to the introduction of the laser radiation
• FIG. 4 shows a schematic sectional illustration through the eye cornea to illustrate the removal of the corneal volume in connection with the ophthalmic refraction correction
• FIG. 5 shows a schematic representation with regard to the structure of the treatment device of FIG. 1 with particular reference to the planning device present there,
• FIG. 6 shows a schematic representation of a cutting geometry using the example of a SMILE procedure
• FIG. 7 shows a schematic representation of a screen of the planning device
• FIG. 8 shows a schematic representation of a screen of the treatment device
• a treatment device for eye surgery is shown in FIG. 1 and is provided with the general reference number 1.
• the treatment device 1 is designed for the introduction of laser cuts in an eye 2 of a patient 3.
• the treatment device 1 has a laser device 4 which emits a laser beam 6 from a laser source 5, which is directed as a focused beam 7 into the eye 2 or the eye cornea.
• the laser beam 6 is preferably a pulsed laser beam with a wavelength between 300 nanometers and 10 micrometers.
• the pulse length of the laser beam 6 is in the range between 1 femtosecond and 100 nanoseconds, with pulse repetition rates of 500 kilohertz and 30 MHz, preferably 1.2 to 10 MHz, and pulse energies between 1 nanojoule and 10 microjoules, preferably 1 to 200 nanojoules being possible.
• the treatment device 1 thus generates a cut surface in the cornea of the eye 2 by deflecting the pulsed laser radiation.
• a scanner 8 and a radiation intensity modulator 9 are therefore also provided in the laser device 4 or its laser source 5.
• the patient 3 is located on a couch 10, which can optionally be adjusted in three spatial directions in order to align the eye 2 to match the incidence of the laser beam 6.
• the couch 10 is adjustable by a motor.
• the patient bed is less mobile and the treatment device can be adjusted accordingly by means of a motor.
• the control can in particular take place by a control device 11 which basically controls the operation of the treatment device 1 and for this purpose is connected to the treatment device via suitable data connections, for example connecting lines 12. Of course, this communication can also take place in other ways, for example light guides or done by radio.
• the control device 11 makes the corresponding settings and time controls on the treatment device 1, in particular the laser device 4, and thus carries out corresponding functions of the treatment device 1.
• the treatment device 1 also has a fixing device 15 which fixes the cornea of the eye 2 in position with respect to the laser device 4. This fixing device
• contact lens 45 to which the cornea is placed by negative pressure and which gives the cornea a desired geometric shape.
• contact glasses are known to the person skilled in the art from the prior art, for example from DE 102005040338 A1. As far as the description of a design of the contact glass 45 possible for the treatment device 1 is concerned, the disclosure content of this document is fully included here.
• the treatment device 1 furthermore has a camera, not shown here, which can record an image of the eye cornea 17 through the contact glass 45.
• the lighting for the camera can take place in the visible as well as in the infrared range of light.
• the control device 11 of the treatment device 1 also has a planning device
• FIG. 2 shows schematically the mode of action of the incident laser beam 6.
• the laser beam 6 is focused and falls as the focused laser beam 7 into the cornea 17 of the eye 2.
• a schematically drawn optic 18 is provided for focusing. It causes a focus in the cornea 17 in which the laser radiation energy density is so high that, in combination with the pulse length of the pulsed laser radiation 6, a non-linear effect occurs in the cornea 17.
• each pulse of the pulsed laser radiation 6 in the focus 19 can generate an optical breakthrough in the cornea 17, which in turn initiates a plasma bubble that is only indicated schematically in FIG. 2.
• the tissue layer separation encompasses a larger area than the focus 19, although the conditions for generating the optical breakthrough are only achieved in the focus 19.
• tissue-separating effect can also be achieved by pulsed laser radiation by emitting several laser radiation pulses in one area, with the focus spots overlapping. Several laser radiation pulses then work together to achieve a tissue-separating effect.
• the type of tissue separation that the treatment device 1 uses is, however, no longer relevant for the following description; It is only essential that a cut surface is generated in the cornea 17 of the eye 2.
• a corneal volume is removed from an area within the cornea 17 by means of the laser radiation 6 by separating tissue layers there that isolate the corneal volume and then enable its removal.
• the position of the focus 17 of the focused laser radiation 7 in the cornea 17 is adjusted. This is shown schematically in FIG. 3.
• the refractive properties of the cornea 17 are specifically changed by removing the volume in order to achieve the refraction correction.
• the volume is therefore mostly lens-shaped and is referred to as a lenticle.
• the elements of the treatment device 1 are entered only to the extent that they are necessary for understanding the generation of cut surfaces.
• the laser beam 6 is bundled in a focus 19 in the cornea 19, and the position of the focus 19 in the cornea is adjusted so that focusing energy from laser radiation pulses is introduced into the tissue of the cornea 17 to generate cut surfaces at different points .
• the laser radiation 6 is preferably provided by the laser source 5 as pulsed radiation.
• the scanner 8 is constructed in two parts in the construction of FIG. 3 and consists of an xy scanner 8a, which is implemented in a variant by two essentially orthogonally deflecting galvanometer mirrors.
• the scanner 8a deflects the laser beam 6 coming from the laser source 5 in two dimensions, so that a deflected laser beam 20 is present after the scanner 9.
• the scanner 8a thus effects an adjustment of the position of the focus 19 essentially perpendicular to the main direction of incidence of the laser beam 6 in the cornea 17.
• a z-scanner 8b is provided in addition to the xy scanner 8a adjustable telescope is formed.
• the z-scanner 8b ensures that the z position of the position of the focus 19, ie its position on the optical axis of incidence, is changed.
• the z-scanner 8b can be arranged after or upstream of the xy-scanner 8a.
• any scanner can be used which is able to adjust the focus 19 in a plane in which the axis of incidence of the optical radiation does not lie.
• any non-Cartesian coordinate system can also be used to deflect or control the position of the focus 19. Examples are spherical coordinates or cylindrical coordinates.
• the position of the focus 19 is controlled by means of the scanners 8a, 8b under control by the control device 11, which makes corresponding settings on the laser source 5, the modulator 9 (not shown in FIG. 3) and the scanner 8.
• the control device 11 ensures suitable operation of the laser source 5 and the three-dimensional focus adjustment described here as an example, so that ultimately a cut surface is formed that isolates a specific corneal volume that is to be removed for refraction correction.
• the control device 11 operates according to predetermined control data which, for example, are predetermined as target points for the focus adjustment in the laser device 4, which is only described here as an example.
• the control data are usually summarized in a control data record. This results in geometric specifications for the cut surface to be formed, for example the coordinates of the target points as a pattern.
• the control data record then also contains specific values for the focus position adjustment mechanism, e.g. for the scanner 8.
• a cornea volume 21 in the cornea 17 is isolated by adjusting the focus 19 in which the focused beam 7 is bundled.
• cut surfaces are formed, which are embodied here, for example, as an anterior flap cut surface 22 and as a posterior lenticle cut surface 23. These terms are to be understood here merely as examples and are intended to establish the reference to the conventional Lasik or Flex method, for which the treatment device 1, as already described, is also designed. It is only essential here that the cut surfaces 22 and 23 as well as the circumferential edge incision 25, which bring the cut surfaces 22 and 23 together at their edges, isolate the cornea volume 21.
• a corneal lamella anteriorly delimiting the cornea volume 21 can also be folded down through an opening cut 24 so that the cornea volume 21 can be removed.
• the SMILE method can be used, in which the cornea volume 21 is removed through a small opening incision, as is described in DE 102007019813 A1.
• the disclosure content of this document is included here in its entirety
• the treatment device 1 has at least two devices or modules.
• the laser device 4 already described emits the laser beam 6 onto the eye 2.
• the operation of the laser device 4 takes place, as already described, fully automatically by the control device 11, ie the laser device 4 starts generating and deflecting the laser beam 6 in response to a corresponding start signal and generates cut surfaces that are constructed in the manner described .
• the control signals required for operation are received by the laser device 5 from the control device 11, to which the corresponding control data have previously been provided.
• the planning device 16 which is shown in FIG. 5 only as an example as a component of the control device 11.
• the planning device 16 can also be designed independently and communicate with the control device 11 in a wired or wireless manner. It is then only essential that a corresponding data transmission channel is provided between the planning device 16 and the control device 11.
• the planning device 16 generates a control data set which is made available to the control device 11 for carrying out the ophthalmic refraction correction.
• the planning device uses measurement data from the cornea of the eye. In the embodiment described here, these data originate from a measuring device 28 which previously measured the eye 2 of the patient 2. Of course, the measuring device 28 can be designed in any desired manner and transmit the corresponding data to the interface 29 of the planning device 16.
• the planning device 16 now supports the operator of the treatment device 1 in defining the cut surface for isolating the cornea volume 21.
• the planning device 16 can provide this from the measurement data
• the corneal volume 21 taken is determined, the boundary surfaces of which are defined as cut surfaces and corresponding control data for the control device 11 is generated therefrom.
• the planning device 16 can provide input options at which a user can input the cut surfaces in the form of geometric parameters, etc.
• Intermediate stages provide suggestions for the cut surfaces which the planning device 16 automatically generates and which can then be modified by an operator. In principle, all those concepts that have already been explained in the more general part of the description can be used here in the planning device 16.
• the planning device 16 In order to carry out a treatment, the planning device 16 generates control data for the generation of cut surfaces, which are then used in the treatment device 1.
• FIG. 6a shows a schematic representation of a corneal cross section in the SMILE method.
• the cornea 17 has an anterior cap incision 22 with an opening incision 26.
• the posterior lenticule cut 23 isolates the lenticule volume 21, which can be removed through the opening cut 26.
• the lenticle 21 must first be completely separated by mechanically separating any remaining tissue bridges with a spatula-shaped instrument in the cap incision 22 and lenticle incision 23.
• the lenticle 21 is then removed through the opening incision 26.
• the (imaginary) axis 27 represents the axis of symmetry of the cuts 22, 23; its point of penetration through the surface of the cornea 17 defines the centering of the cuts 22, 23, 25, 26.
• FIG. 6b shows the cornea shown in FIG. 6a in a top view, the meaning of the reference numerals corresponding to that in FIG. 6a.
• FIG. 7 schematically shows a user interface according to the invention of the planning device 16.
• the flap (or cap) cut 22 and the lenticule cut 23 as well as the opening cut 26 are shown in plan view.
• the cylinder axis 30 resulting from the diagnosis is displayed.
• Diagnostic devices come, for example, from one or more of the group keratometer system, wavefront analysis system, optical coherence tomography system, placido disk topography system. Scheimpflug topography system, confocal topography system, low coherence topography system, etc. in question.
• the doctor / surgeon is shown an image of anatomical features of the eye created with the diagnosis, which are suitable for angle assignment (e.g. iris, retina) (omitted in the figure for clarity).
• angle assignment e.g. iris, retina
• the system assumes a reference angle of 0 °, which is displayed here as line 31 (and here coincides with the set angle 32).
• the planning device calculates a proposal based on appropriate algorithms, which is displayed here as line 33. Both angles are also shown numerically in corresponding displays 34, 35.
• the change (rotation) of the cutting patterns takes place about an axis 36, which can preferably be the visual axis of the eye 2 or the device axis of the treatment device 1. It can also coincide with the axis of symmetry 27 from FIG. 6a.
• the doctor can already make a change compared to the proposal made by the planning device 16.
• the input of the change in rotation can take place, for example, numerically, by means of a computer mouse in the representation of the eye or by means of slide controls (not shown here). After confirmation by the doctor, the control data for the cuts in the cornea are calculated accordingly and transmitted to the control device 11.
• FIG. 8 schematically shows a user interface for setting the rotation of the cutting patterns immediately before the treatment.
• the patient has taken a seat on the couch 10 and is in the lying position intended for the operation.
• the camera image recorded by the contact lens 45 and the anatomical features used as orientation during planning are graphically superimposed (not shown in detail here).
• the angle of rotation 33 determined during the planning is shown.
• FIGS. 9a to 9c A preferred embodiment of the treatment device 1 is shown in greater detail in FIGS. 9a to 9c.
• the treatment device 1 has a laser swivel arm 53, which is encompassed by a swivel arm housing 56, and an additional examination swivel arm 64 with a surgical microscope 55, the first axis 54 of the laser swivel arm 53 and the second axis 56 of the examination swivel arm 64 on a device head 51 having a corresponding Have arrangement to each other, and both a therapy screen 62 movably attached to the swivel arm housing 56 with the movement of the swivel arm housing 56 and a surgical microscope 65, which is movably attached to the examination swivel arm 64, are coupled to the movement of the examination swivel arm 64 in such a way that the therapy screen 62 as well the surgical microscope 65 always remain unchanged.
• a treatment device 1 as shown in this exemplary embodiment can be used very well, for example, for a SMILE method, but also for other methods for correcting the vision of an eye or for cataract operations.
• 9a shows a standby mode of this treatment device 1, in which the swivel arms 53, 64 are “parked” in a rest position, ie swiveled upward on the device head 51, and in which, for example, a patient is placed accordingly on the patient bed 10 and can be positioned.
• FIG. 9b a laser therapy mode is shown in FIG. 9b, that is to say the mode in which the laser pivot arm 53 was brought into a working position.
• FIG. 9c shows an examination mode of the exemplary embodiment of the treatment device 1 using a surgical microscope 65.
• the examination pivot arm 64 is brought into a working position while the laser pivot arm 53 and its pivot arm housing 56 are in a rest position.
• the exemplary embodiment of the treatment device 1 is composed of a device base 52 and a device head which is adjustable on this device base 52 in height above a floor level, i.e. the z direction, and in its position in the plane, i.e. in the x and y directions 51.
• the device head 51 contains a first part of the laser therapy optics required to carry out the laser therapy.
• the device head 51 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 54.
• the laser pivot arm 53 can be pivoted about this first axis 54 from a rest position, in which it protrudes approximately vertically upwards, into a working position, in which it is arranged approximately horizontally on the device head 51, i.e. approximately parallel to the ground plane, and back.
• the laser swivel arm 53 with its second laser therapy optics and the laser exit opening 58 is surrounded by a housing, the swivel arm housing 56, so that the swivel arm housing 56 leaves an opening for the laser exit opening 58.
• This swivel arm housing 56 is mounted separately, coaxially to the laser swivel arm 53.
• the swivel arm housing 56 initially swivels together with the laser swivel arm 53 through an angle of approximately 90 ° between an approximately vertical rest position or standby position and a horizontal working position. The movement is limited by stops.
• the laser pivot arm 53 can be moved overall through a larger angle than the pivot arm housing 56.
• the laser exit opening 58 to which a contact lens or a patient interface for coupling the laser swivel arm 53 to the patient's eye to be treated can be detachably fixed, can be positioned protruding more or less far from the swivel arm housing 56 or can also be drawn completely into the swivel arm housing 56 .
• the laser outlet opening 58 will be drawn into the swivel arm housing 56.
• the laser swivel arm 53 is thus in a slightly tilted position compared to its swivel arm housing 56.
• the laser swivel arm 53 is released downwards and pivoted slightly further, so that it too comes into an approximately horizontal position and the laser outlet opening 58 emerges from the swivel arm housing 56.
• the laser pivot arm 53 itself is easy to move. In the approximately horizontal working position of both the swivel arm housing 56 and the laser swivel arm 53, the treatment device is in the laser therapy mode.
• the therapy screen 62 is movably attached to the swivel arm housing 56.
• the therapy screen 62 is also the screen of a video microscope 63, which shows the view from the laser exit opening 58 onto the eye 2 to be treated.
• the operator uses the video image of this video microscope 63, which is displayed on the therapy screen 62, for example to approach and fix a contact glass 45 or another patient interface to the eye 2 to be treated and to observe the execution of the laser cuts.
• a camera 59 can be used to preposition the device head 51. This is attached to the device head 51 and thus has a spatially fixed relationship to the position of the device head 51. The position is selected so that a largely parallax-free view of the working volume of a therapy laser beam, in particular the possible position of its focus as the working point of a therapy lens in laser therapy optics he follows.
• a graphic superimposed on the image of the camera 59 on the therapy screen 62 and / or on the planning screen 69 of the planning device 16 shows the expected position of the laser swivel arm 53 in its then swiveled down working position already in the standby mode, i.e. in the rest position of the laser swivel arm 53.
• the surgeon can pre-position the device head 51 in such a way that the laser swivel arm 53 moves into its working position after swiveling down, i.e. in the laser Mode, located in a position that is optimal in terms of coarse positioning for the start of treatment, and only fine positioning in relation to structures of the eye 2 is necessary.
• a joystick 61 for controlling the coupling process to the patient is also attached to the swivel arm housing 56.
• Joystick 61, laser exit opening 58 of the laser therapy optics and video image of the eye are aligned on a vertical line in the working position in order to enable ergonomic operation for both right and left-handers.
• a typical treatment sequence as it can be used for a SMILE treatment or as part of a SMILE treatment, for example, is described using a treatment device 1 described above:
• the treatment or therapy parameters are first planned on a planning screen 69 of the planning device 16, which in this exemplary embodiment is also arranged directly on the treatment device 1.
• the planning screen 69 can also be spatially separated from the treatment device 1.
• the treatment device 1 is preferably in a standby position, i.e. the laser swivel arm 53 and possibly also the examination swivel arm 64 are swiveled up vertically in the rest position on the system.
• the patient is placed on the patient bed 10. This is easily possible due to the swiveled up laser swivel arm 53.
• the surgeon positions the height of the device head 51 by means of a joystick 60 on this device head 51, with which the translational movement of the device head 51 over the device base 52 can be controlled. In doing so, it is based on the image supplied by the camera 59, which is visible on the therapy screen 62 and / or on the planning screen 69 including an overlaid symbol of a pivoted-down laser swivel arm 53.
• the positioning can also take place by means of inputs on one of the two screens 62, 69 or via buttons on the treatment device 1.
• the surgeon triggers the motorized pivoting of the laser pivot arm 53 into and together with its pivot arm housing 56; a corresponding button used for this purpose is not shown in the figures.
• a free space remains between the laser exit opening 58 and the patient's eye 2, which is advantageously between 50 mm and 150 mm in size.
• a contact glass 45 is now attached to the laser outlet opening 58.
• the contact glass is held at the laser outlet opening 58 by means of a negative pressure.
• the switching on and off of the holding by means of negative pressure is done in that the contact glass is pressed against the laser outlet opening 58, this is still slightly moved in its retracted position and triggers the switching process.
• This is advantageous compared to the previously common laser therapy systems: there, the holding of the contact glass is switched separately. So it happens that the contact glass falls down when it is released. In the solution described here, however, the surgeon or operator always has the contact lens in his hand during the switching process.
• the surgeon then initiates the release of the movement of the laser swivel arm 53 within the swivel arm housing 56 by means of a joystick rotation of the joystick 61 on the swivel arm housing 56, or alternatively by means of a separate button (not shown).
• the movement can also be triggered automatically by the attached contact glass.
• the laser exit opening 58 with the contact glass moves towards the eye.
• the movement path is approximately 50mm, a generally sensible range for this movement path is 30mm to 100mm. This means that there is still a safety distance to the eye that is approximately 30mm, or generally sensibly assumes a value between 10mm and 100mm.
• the docking phase takes place, i.e. the phase in which the contact lens 45 is fixed: the surgeon controls the contact lens 45 onto the eye 2 of the patient with the joystick 61 while observing by means of the video microscope 63.
• the eye is fixed by sucking the eye on the contact lens 45 with a button on the joystick 61.
• it is possible to correctly position or center the contact glass or another Support patient interfaces on the eye by processing the video microscope image and using it to control the device head 51.
• 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 58 and focused in the patient's eye 2, by means of a foot switch, which is not shown here.
• the suction of the eye 45 is released by means of negative pressure, in that the pressure is increased again here, the laser pivot arm 53, and thus also the laser outlet opening 58, are pivoted back into the pivot arm housing 56 and the device head 51 is moved in the z-direction booted up a bit. This means that there is again a safety distance to the eye. From this position it is now possible to dock again if necessary.
• the contact glass 45 or the patient interface can be removed from the laser exit opening 58, the release being effected by a short push upwards.
• the laser swivel arm 53 is now swiveled up again together with its swivel arm housing 56, 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 10.
• the pivoting up of the laser pivot arm 53 with its pivot arm housing 6 is initiated electronically, here by pressing a button.
• the laser swivel arm 53 with its swivel arm housing 56 can be pushed in manually, a position sensor on the swivel arm housing detects this, and a motor then takes over the movement.
• the device head 51 can be moved by a translational movement in the x and / or y direction over the device base 52 in such a way that the laser swivel arm 53 is positioned with its swivel arm housing 56 over the other eye.
• the second eye can then be treated in the same way by inserting a new contact lens 45 or Patient interface is held at the laser exit opening 58 and by means of negative pressure, and all subsequent steps are carried out as described above.
• an examination pivot arm 64 is also attached to the device head 51 so as to be pivotable about a second axis 66 and contains an examination device, in this case a surgical microscope 65.
• a surgical microscope is necessary or at least advisable for the second main work step of the “SMILE” treatment, for example.
• the surgical microscope 65 contains, in addition to the necessary lighting, a camera for video recording and a slit projector for expanded observation options.
• the pivot axis of the examination pivot arm 64 that is to say the second axis 66, is positioned in a particularly favorable position in space. This allows the surgical microscope 65 on the examination pivot arm 64 to be brought into its working position with just one pivoting movement from its rest position, in which the examination pivot arm 64 is also pivoted up, either in a likewise vertical position or in an inclined position.
• This working position is also defined by limiting the rotational movement of the examination pivot arm 64 by means of a stop. It has the special property of coinciding with the working position of the laser swivel arm 53 with its second laser therapy optics and its laser exit opening 58 and thus avoiding a change in the patient's position during the treatment.
• the complete SMILE treatment can be carried out with the treatment device 1.
• the treatment is continued as follows:
• the surgeon initiates the motorized pivoting down of the examination pivot arm 64 by pressing a button.
• the motor moves the inspection arm 64 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 54 and the second axis 66 and the end position of the examination pivot arm 64 determined by the stop, so that the eye to be treated further is immediately after the examination pivot arm 64 has been pivoted down Examination volume of the surgical microscope 65 is.
• the examination pivot arm 64 with the surgical microscope 65 is appropriately positioned, the lenticle extraction is carried out by the surgeon.
• the examination swivel arm 64 with the surgical microscope 65 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 56 and the laser swivel arm 53 - by pushing it. The free space above the patient is thus restored.
• the planning screen according to FIG. 7 can be displayed on the screen 69 of the planning device 16
• the treatment screen according to FIG. 8 can optionally or jointly be displayed on the planning screen 69
• the therapy screen 62 or incorporated into or superimposed on the image of the video microscope 63 become.
• surgeon can check the desired rotation of the pattern immediately before the treatment is initiated and, if necessary, take corrective action if the set rotation does not meet his expectations.
• the doctor can also use several anatomical features (e.g. iris and retina).
• anatomical features e.g. iris and retina.
• the display of the video microscope and the treatment screen according to FIG. 8 can also be carried out with the aid of a head-up display.
• the coordinate system used by the diagnostic device is preferably used, and the subsequent calculation of the cutting geometries is generally transformed into the coordinate system of the treatment device.
• a preferred rotation can advantageously be proposed from the diagnostic data by means of an algorithm, the doctor also being able to choose between different algorithms.
• the doctor can configure these algorithms in order to adapt them to his needs or experiences. It is also within the scope of the invention if such an algorithm takes the treatment data from previous treatments into account.
• treatment device 1 or the planning device 16 naturally also implements the previously generally explained method in concrete terms.
• Another embodiment of the planning device is in the form of a computer program or a corresponding data carrier with a computer program that implements the planning device on a corresponding computer, so that the input of the measurement data takes place via suitable data transmission means to the computer and the control data from this computer to the control unit 11 are transmitted, for which in turn data transmission means known to the person skilled in the art can be used.

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• Health & Medical Sciences (AREA)
• Ophthalmology & Optometry (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Optics & Photonics (AREA)
• Surgery (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Physics & Mathematics (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Laser Surgery Devices (AREA)

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• 2019
  • 2019-09-10 DE DE102019213736.9A patent/DE102019213736A1/de active Pending
• 2020
  • 2020-09-08 CN CN202080063662.7A patent/CN114423389A/zh active Pending
  • 2020-09-08 WO PCT/EP2020/075058 patent/WO2021048115A1/de unknown
  • 2020-09-08 US US17/640,924 patent/US20220409433A1/en active Pending
  • 2020-09-08 EP EP20768581.9A patent/EP4027960A1/de active Pending

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