WO2022223690A1 - Dispositif de traitement automatique au laser du réseau trabéculaire - Google Patents

Dispositif de traitement automatique au laser du réseau trabéculaire Download PDF

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Publication number
WO2022223690A1
WO2022223690A1 PCT/EP2022/060550 EP2022060550W WO2022223690A1 WO 2022223690 A1 WO2022223690 A1 WO 2022223690A1 EP 2022060550 W EP2022060550 W EP 2022060550W WO 2022223690 A1 WO2022223690 A1 WO 2022223690A1
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laser
unit
treatment
designed
eye
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PCT/EP2022/060550
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German (de)
English (en)
Inventor
Martin Hacker
Manfred Dick
Gerald Kunath-Fandrei
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Carl Zeiss Meditec Ag
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Publication of WO2022223690A1 publication Critical patent/WO2022223690A1/fr

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    • 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
    • A61F9/00821—Methods or devices for eye surgery using laser for coagulation
    • 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
    • A61F2009/00868—Ciliary muscles or trabecular meshwork
    • 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
    • A61F2009/00885—Methods or devices for eye surgery using laser for treating a particular disease
    • A61F2009/00891—Glaucoma

Definitions

  • the present invention relates to a device for automated laser processing of the trabecular meshwork, the device being based on ab-externo laser trabeculoplasty or trabeculotomy, in particular “selective laser trabeculoplasty” (SLT for short).
  • ab-externo laser trabeculoplasty SLT for short.
  • ALT argon laser trabeculoplasty
  • ab-externo laser trabeculoplasties there are also ab-internal variants, such as excimer laser trabeculotomy or trabeculostomy (ELT), in which the trabecular meshwork is ablated with a laser using an endoscopic optical fiber.
  • ab interno variants are invasive procedures that can usually only be carried out in the context of other surgical interventions with a sensible risk/benefit ratio.
  • Trabeculoplasty and trabeculomomy are treatments of the trabecular meshwork.
  • the term trabeculoplasty will also include trabeculotomy (removal of trabecular tissue) and trabeculostomy (creation of a hole in the trabecula).
  • the trabecular meshwork is a spongy network in the region of the chamber angle and also includes the juxtacanalicular tissue opposite to Schlemm’s canal.
  • the various trabeculoplasties have different mechanisms of action (mechanical, cellular, biochemical), but some are not yet fully understood.
  • ELT tissue is ablated in a hole-shaped manner using UV light at 308 nm, which is intended to achieve a direct increase in the permeability of the trabecular meshwork through the resulting openings.
  • ALT continuous laser radiation generated by means of an argon laser or laser diodes at e.g. 514 nm is used to create drainage openings through thermal interactions with the tissue, which tend to close again through scarring and through healing processes.
  • US 2020/0016002 A1 now also proposes using laser pulses in the femtosecond range at 1030 nm for athermal trabecular meshwork processing in order to cut drainage channels with it.
  • SLT is a simple and highly effective laser therapy in the area of the trabecular meshwork, which has been shown to reduce intraocular pressure in glaucoma (glaucoma). It is assumed that the treated tissue is stimulated at the cellular and biochemical level, which leads to tissue regeneration and/or release of endogenous substances, which in turn increase tissue permeability and aqueous humor outflow.
  • the SLT laser therapy uses very short light pulses with low energy and thus primarily affects only the pigmented cells of the trabecular meshwork and extracellular pigment grains (https://doi.org/10.1155/2015/ 476138).
  • pigment particles or cells may have previously become detached from the iris, for example in the case of a pigment dispersion syndrome, and then the trabecular meshwork to become clogged, as in pigmentary glaucoma.
  • these cells are either stimulated or destroyed and then renewed or broken down via a regenerative, endogenous self-healing process.
  • Pigment grains can be broken up into smaller grains, particularly at higher laser energies. These regeneration processes improve the drainage of the aqueous humor and lower the intraocular pressure.
  • melanin has an absorption coefficient that increases evenly towards shorter wavelengths, the ratio of its absorption to that of other substances occurring in the eye, such as hemoglobin, sometimes changes considerably, so that favorable wavelength bands result for selective absorption.
  • the absorption of melanin in the range of 480 - 520 is about a factor of 10 higher than that of hemoglobin.
  • the release of cytokines as a result of the laser treatment also seems to contribute to improving aqueous humor drainage, for example by increasing the permeability of tissues such as Schlemm's canal and supporting the breakdown of cell debris (Garg and Gazzard, "Selective laser trabeculoplasty; past, present, and future", doi: 10.1038/eye.2017.273).
  • the SLT it is advantageous to have such a large laser treatment zone that the approx. 300 ⁇ m wide TM viewed from the direction of the laser beam can be safely covered, for example by means of a 400 ⁇ m laser treatment zone.
  • ZEISS creates this 400 ⁇ m laser treatment zone from 52 individual spots, each approx. 50 ⁇ m in size.
  • the actual thermal damage zones are defined by the pigmented TM cells, since the absorption mainly only takes place there
  • SLT selective laser trabeculoplasty
  • the relevant area is irradiated with laser radiation of between approximately 0.01 and approximately 5 Joules/cm 2 .
  • a laser system that can be used for SLT processes is described, for example, in a device brochure from Ellex (http://www.ellex.com/de/).
  • the SLT treatment takes place at a wavelength of 532nm, with a pulse length of 3ns and a pulse energy of approx. 1mJ on a spot diameter of 400 ⁇ m in the trabecular meshwork of the eye, whereby the treatment is carried out over a circumference of 180° or even 360° can.
  • a further disadvantage of the known, selectively operating laser systems is that no patterns (spot patterns) are used which, in a structured manner, allow intracellular or cellular destruction.
  • the thermal damage zones are only covered by the occurrence of pigmented cells and extracellular pigment grains fixed.
  • different pigmentation levels of the trabecular network would also have to be taken into account in order to be able to assess the therapeutic effect of the laser treatment or adjust it by adjusting laser parameters or patterns.
  • Pattern scanning laser trabeculoplasty represents a certain advance, in which at least one pattern of a number of laser shots are applied together when the hand-held contact lens is in a position, which In particular, if a large part or the entire circle of the chamber angle is to be treated with adjacent or slightly separated laser spots, a method using beam guidance using a hand-held contact glass is very time-consuming, error-prone and tedious.
  • the object of the present invention is to develop a device for automated laser processing of the trabecular meshwork, which device can significantly simplify the rather cumbersome and time-consuming laser trabeculoplasty with contact glass. Furthermore, the device should be suitable for enabling a 360° treatment and better predictability of the achievable or evaluation of the currently achieved therapeutic effect.
  • the object is achieved by the features of the independent claims. Preferred developments and configurations are the subject matter of the dependent claims, This object is achieved with the present device for automated laser processing of the trabecular meshwork, consisting of a laser unit with a laser source and a focusing unit, a deflection unit for the controllable change in the irradiation direction of the laser beam onto the trabecular meshwork and a control unit that is designed to be the laser unit for an ab-externo laser trabeculoplasty of the eye and to control the deflection unit, solved by the fact that a contact glass is present, which is designed, when the contact glass is positioned opposite the eye, several deflections of the laser treatment beam in its anterior chamber angle and thus one up to To enable 360° treatment of the trabecular meshwork.
  • First configurations relate to the laser unit, consisting of a laser source and a focusing unit, which is preferably designed as an autofocus.
  • the laser unit is designed to enable laser trabeculoplasty using thermally stimulating, SLT or ALT treatment (i.e. femtosecond or picosecond laser) or a nanosecond laser (ns laser).
  • thermally stimulating, SLT or ALT treatment i.e. femtosecond or picosecond laser
  • ns laser nanosecond laser
  • the ns laser can be focused anterior to the trabecular meshwork in order to produce a photodisruption in the aqueous humor there.
  • the resulting pressure waves should stimulate the trabecular meshwork and reduce the intraocular pressure with a treatment that is gentle on the trabecular meshwork.
  • This treatment variant using photodisruption in the aqueous humor is independent of the absorption in the pigments and can therefore also take place at other wavelengths, for example the YAG laser wavelength of 1064 nm. As with SLT, this treatment is also planned over 360° with a spot arrangement that is as equidistant as possible.
  • the laser unit is preferably designed to enable pattern-based laser trabeculoplasty treatment, with the treatment pattern being able to be generated in different ways.
  • the treatment pattern is preferably generated from individual spots with the aid of a scanner.
  • a diffractive optical element DOE
  • DOE diffractive optical element
  • the generation of several such simultaneously radiating laser beams by optical beam splitters (splitting mirrors, dichroic mirrors, polarization splitters or fiber-optic splitters), which are then aligned by means of one or more scanners, for example realized by rotating mirrors or prisms , galvo mirrors, MEMS scanners, acousto- or electro-optical modulators or liquid crystal modulators,
  • the laser unit can also be designed to generate laser pulses with pulse lengths in the range of 50 ns-50 ⁇ s.
  • the laser unit is preferably further designed to generate a spot pattern with an outer, approximately octagonal shape from square spots placed directly next to one another.
  • the laser unit is also designed to provide light in particular with at least one wavelength in the range of 480-590 nm , for example 515 nm or 532 nm (for example using an InGaN laser diode or a frequency-doubled Nd;YAG laser),
  • a second group of configurations relates to the deflection unit for the controllable change in the irradiation direction.
  • this is designed to change the position of the laser treatment beams in such a way that they are guided in different directions into the anterior chamber angle of an eye by the multiple deflections in the contact lens in order to to enable up to 360° treatment of the trabecular meshwork.
  • the deflection unit is preferably designed to change not only the irradiation direction of the laser treatment beams but also the irradiation direction of the illumination radiation and the observation beam path.
  • Further configurations relate, for example, to the contact glass.
  • Several facet mirrors or a rotating mirror are arranged in the contact glass for the deflection of the laser treatment beams into different parts of the trabecular meshwork.
  • the surfaces present for the deflection of the laser processing beam have coatings which have a sufficiently high reflectivity for the processing laser and a spectral range suitable for illumination and observation.
  • the surfaces present for the deflection of the laser processing beam have a coating whose reflectivity for incidence conditions with s- and p-polarization at the laser wavelength are approximately the same.
  • the facet mirrors can use the total reflection at the interface between the contact glass and air or other media with a low refractive index, which offers the advantage of realizing high reflectivity over a large spectral bandwidth.
  • the disadvantage is that the total reflection is sensitive to contamination of the total reflecting surface (for example fingerprints), so that the contact glass would then have to be suitably enclosed against contamination.
  • dielectric layers or layer systems can also be used in order to achieve high reflectivity. In this case, however, it must be ensured that the layer system is designed in such a way that the reflectivity for incidence conditions with s- and p-polarization does not differ too much, since otherwise the laser power would vary during the treatment of different sections of the chamber angle.
  • metal-coated mirrors can also be used.
  • gold (NIR), silver (VIS-NIR) or aluminum (VIS) is used, but these are often soft or degrade easily, so that here too protection against contact and, if necessary, oxidation must be implemented, for example by a protective dielectric layer on the back of the reflective metal layer.
  • the laser power can be titrated to the desired one Tissue processing takes place (bubble formation or tissue discoloration) or the intensity of the backscattering of the processing laser is determined and evaluated.
  • the processing laser can also be activated in a defined weakened manner. If the pilot beam and the processing laser are calibrated to one another, the backscatter signal of the pilot laser can also be used to adjust the power of the processing laser.
  • the contact glass with its mirror facets it is necessary for the contact glass with its mirror facets to have a specified or known position in relation to the treatment device, for example by means of a suitably designed recording device for the contact glass on the treatment device or also by recognizing the position of the contact glass, for example by marking recognition,
  • At least one opto-acoustic sensor is preferably arranged on the contact glass, which is connected to the control unit for the transmission of signals for a dosimetric control of the laser unit. Preference is given to using piezoelectric sensors,
  • the contact glass has either a ring-shaped sensor or a sensor for each facet mirror,
  • the contact glass preferably has a liquid- or gel-filled contact chamber and/or a suction device.
  • the device also has an illumination unit for projecting an illumination beam into the anterior chamber angle of an eye and an image processing unit in order to generate images from the light backscattered from the anterior chamber angle, which provide additional information for the Deliver SLT treatment.
  • the image processing unit is based on an imaging or scanning optical method. It is also possible to use an image processing unit based on interferometry, such as an OCT system. Since this is image processing in the anterior chamber, it is possible in addition to the usual ones OCT wavelengths such as 780 ... 860nm or 1040 ... 1060nm to use longer-wave light, for example in the range from 1300 ...1550nm, since the short beam paths in the eye also make relatively strong absorption in the eye media acceptable.
  • the last configurations relate to the control unit, which has connections to the illumination unit and to the image processing unit and is designed to detect feature points in the images from the anterior chamber angle and to determine their position and to include them in the control of the laser processing of the trabecular meshwork.
  • Such characteristic points can be eye structures, such as Schwalbe's line, or also pigmentation variations in the trabecular meshwork, or reflux blood in Schlemm's canal, but also missing parts of the trabecular meshwork or scarring due to previous treatments or artificial trabecular meshwork implants (e.g. the iSTENT or the HYDRUS) , which are to be spared during trabeculoplasty.
  • the cross-section of Schlemm's canal or the aqueous humor collection vessels behind Schlemm's canal can also be used as feature points, since drainage improvement at the trabecular meshwork is particularly effective there where Schlemm's canal still has a sufficient cross-section in the connection to the nearest aqueous humor collection vessels.
  • the image processing unit It is possible to process feature points recorded by the image processing unit together with image and measurement data obtained pre-operatively in the control unit in order to control the laser processing of the trabecular meshwork.
  • the image data recorded by the image processing unit are preferably registered with the image data obtained preoperatively.
  • control unit is designed to use the signals from the opto-acoustic sensor and the image processing unit to carry out a titration algorithm for controlling the laser unit in order to achieve an optimal treatment result.
  • control unit is also designed based on of the signals from the image processing unit to take into account the degree of pigmentation of the trabecular meshwork to be treated when controlling the laser unit, for example by adjusting the energy, duration or number of laser pulses,
  • the contact lens can preferably be equipped with a force sensor system in order to determine IOR values, similar to Goldmann tonometry, on the basis of the defined or measured contact surface from the contact forces.
  • Transpalpebral tonometry is also very suitable, i.e. through the lid. The use of other alternative tonometry methods is not preferred, but possible, such as airpuff, rebound or shock wave tonometry.
  • the system is equipped with a device to limit the contact force of the contact lens on the patient's eye. It is possible to use a spring-loaded holder for the contact glass or to control a motorized device displacement in such a way that force values continuously recorded by the force sensors do not exceed certain limits. Also, for example, an electromechanical retraction of the contact glass away from the patient's eye to limit the force is possible. In addition, acoustic or optical warning signals for the operator can be implemented.
  • the present invention relates to a device which is intended in particular for the manual and/or automatic 360° treatment of open-angle glaucoma (90% of all glaucoma) and the rarer pseudoexfoliative glaucoma or pigmentary glaucoma.
  • the device also has an illumination unit for projecting an illumination beam into the anterior chamber angle of an eye and an image processing unit.
  • the proposed device can be used not only for automated laser processing of the trabecular meshwork, in particular for “selective laser trabeculoplasty”, but also or only for examination and diagnostic purposes.
  • FIG. 1 the device according to the invention with a contact glass with facet mirrors
  • FIG. 2 the device according to the invention with a contact glass with facet mirrors and an opto-acoustic sensor and
  • FIG. 3 the device according to the invention with a contact glass with a rotating mirror.
  • the proposed device for manual and/or automatic 360° treatment of open-angle, pseudoexfoliation or pigment glaucoma consists of a laser unit with a laser source and a focusing unit, and a control unit that is designed to use the laser unit for SLT treatment of an eye to control.
  • a movement unit for changing the irradiation direction of the laser treatment beam and a contact lens for the deflection of the laser treatment beam into the anterior chamber angle of the eye is provided.
  • the proposed device for automated laser processing of the trabecular meshwork consists of a laser unit with a laser source and a focusing unit, a deflection unit for controllably changing the direction of irradiation of the laser beam onto the trabecular meshwork, and a control unit that is designed for the laser unit to control an ab-externo laser trabeculoplasty of the eye and the deflection unit.
  • contact lens which is designed to allow multiple deflections of the laser treatment beam in its anterior chamber angle when the contact lens is positioned opposite the eye and thus allow up to 360° treatment of the trabecular meshwork.
  • the contact glass is only positioned once in relation to the eye and allows the laser treatment beam to be deflected several times into the anterior chamber angle of the eye without changing the positioning.
  • the contact glass is designed to allow the laser treatment beam to be deflected into the anterior chamber angle of the eye in at least two of the following quadrants without changes in positioning: superior, temporal, inferior and nasal.
  • the proposed device for automated laser processing of the trabecular meshwork consists of a laser unit with a laser source and a focusing unit,
  • the laser unit is designed to enable laser trabeculoplasty by means of a thermally stimulating, an SLT or an ALT treatment.
  • the laser source of the laser unit is a laser for predominantly athermal laser processing of the trabecular meshwork, for example an ultra-short pulse laser or an ns laser.
  • the laser unit has means for adjusting the polarization and/or power of the laser
  • the laser unit preferably also has a unit for projecting a pilot beam onto the trabecular meshwork,
  • the pilot beam is preferably also a laser beam which is aligned collinearly with the treatment laser beam and has the same focal position.
  • the pilot beam can be visible (for example red, yellow, green, possibly also blue), or invisible, for example with a wavelength in the NIR range, such as 780-1550 nm, when it is tracked with a camera.
  • a wavelength in the NIR range such as 780-1550 nm
  • shorter wavelengths have the advantage that the penetration depth into the tissue is lower than with longer wavelengths, so that the pilot beam spot is scattered less strongly in the depths of the tissue.
  • the pilot laser beam should sufficiently overlap the trabecular meshwork band, but if possible not hit the neighboring structures such as the Schwalbe line, the scleral spur and the ciliary body band.
  • a correct one Positioning can be easily controlled by the image processing and control unit.
  • the laser emission of the SLT treatment is activated via the control unit.
  • a centered positioning of the pilot beam point on the trabecular meshwork band is ideal,
  • the laser unit is designed to enable a pattern-based laser trabeculoplasty treatment.
  • the laser unit has either a diffractive optical element (DOE), with which several laser treatment beams are generated simultaneously for a treatment pattern for laser trabeculoplasty,
  • DOE diffractive optical element
  • the laser unit has a scanner that is fast enough to generate a treatment pattern for laser trabeculoplasty using a laser treatment beam.
  • a scanner in order to generate a treatment pattern consisting of 52 individual spots within 280ms, a scanner is required that works with a line deflection frequency of at least 20Hz ... 25Hz.
  • the spot application must be carried out in a synchronized manner during the individual line scans of the scanner without stopping.
  • a frequency-doubled, continuously working solid-state laser is provided for the laser unit, which generates pulse lengths in the range of 50 ns-50 ⁇ s, in particular 150 ns to 1 ⁇ s.
  • the pulse length is achieved by means of clocking by means of a switch-on and switch-off regime.
  • a spot pattern with an outer, approximately octagonal shape and a diameter of approx. 400 ⁇ m is preferably generated by the laser unit from square, directly adjacent individual spots with an edge length of 50 ⁇ m.
  • the individual spots have a pulse energy of 2-130 ⁇ J, in particular 25-65 m ⁇ .
  • the diameter of the laser treatment zones preferably exceeds the width of the trabecular meshwork (of approx. 300 ⁇ m, viewed from the direction of incidence of the treatment laser, otherwise approx. 550 ... 750 ⁇ m wide), so that spot patterns or alternatively used large individual spots have an outer diameter of approx. 400 ⁇ m.
  • the existing focusing unit is intended to focus the laser treatment beams onto the trabecular meshwork and is preferably designed as an autofocus unit.
  • a confocal detection of light from the pilot laser or the weakened processing laser can be used for autofocusing, which light is backscattered at the trabecular meshwork surface (possibly also other surfaces).
  • the laser focus can be brought closer to the trabecular meshwork, for example, until a backscatter signal threshold is exceeded.
  • an auto-focusing of the observation for contrast-maximizing "sharpening" of feature points or the minimization of the pilot beam laser spot size can be used to optimize the focussing of the processing laser on the target area.
  • Autofocusing based on the location of the trabecular meshwork surfaces in OCT data is also possible. However, the OCT scan position and the focus position of the treatment laser must be calibrated to each other.
  • the device has a deflection unit for the controllable change in the irradiation direction, which is designed to change the position of the laser to change the treatment beams in such a way that they are directed in different directions into the anterior chamber angle of an eye by the multiple deflections in the contact glass, in order to enable up to 360° treatment of the trabecular meshwork.
  • the deflection unit is preferably also designed to also change the direction of incidence of the illumination radiation.
  • the contact glass has several facet mirrors or a rotating mirror in the contact glass
  • the surfaces present in the contact gas for deflecting the laser processing beam preferably have a coating whose reflectivity for incidence conditions with s- and p-polarization at the laser wavelength differs by ⁇ 10%, preferably ⁇ 5% and particularly preferably ⁇ 1% .
  • the surfaces present in the contact gas for the deflection of the laser processing beam are totally reflecting for the incident laser processing beam, i.e. with an angle of incidence greater than the critical angle for total reflection.
  • the surfaces present in the contact gas for deflecting the laser processing beam preferably have coatings which have a high reflectivity of preferably >90% for the wavelength of the processing laser and a spectral range suitable for observation.
  • the contact glass preferably has a liquid- or gel-filled contact chamber.
  • the contact glass has several faceted mirrors or a mirror rotating around the device axis. This enables a very compact design, despite the flat angle of entry into the anterior chamber of the eye,
  • the contact glass should have a suction device, since the rotation can cause vibrations.
  • the vibrations can be suppressed by "balancing", i.e. using co-rotating balancing weights.
  • the contact lens has at least one opto-acoustic sensor that is connected to the control unit connected is. Accordingly, the control unit is designed to use the signals from the sensor for dosimetric control of the laser unit.
  • the contact glass preferably has a ring-shaped sensor or a sensor for each facet mirror, which makes it possible to obtain a signal that is independent of the deflection.
  • the sensor detects the pulse amplitude of the incident laser beam through direct contact with the facet mirror of the contact glass and, with a certain time delay due to the speed of sound, the smaller opto-acoustic signal from the laser spot (with possible bubble formation) within the trabecular meshwork. Both signals can be used for further evaluations can be compared with one another or used for calibration or also for regulating the laser processing.
  • the device also has an illumination unit for projecting an illumination beam into the anterior chamber angle of the eye and an image processing unit for generating images from the light backscattered from the anterior chamber angle.
  • the control unit has corresponding connections to the lighting unit and to the image processing unit for controlling them and is designed to detect feature points in the images from the anterior chamber angle and to determine their position.
  • the image processing unit is based on an imaging or scanning optical method.
  • gonioscopy ie examination of the chamber angle and in particular of the trabecular meshwork
  • a gonioscope is described in EP 3329839 A1, which 360° imaging of the trabecular meshwork, including visualization of the level of pigmentation.
  • the movement unit and the contact glass are designed in such a way that the irradiation direction of a processing laser for automated processing of the trabecular meshwork can also be changed or redirected and focused onto or into the trabecular meshwork.
  • fixation unit for projecting a fixation beam along the optical axis of the device into the eye.
  • FIG. 1 shows a first variant of the device according to the invention with a contact glass with facet mirrors
  • the eye 1 is illuminated by the illumination unit 2, with the illumination beam 2' being directed into the chamber angle 6 via the deflection unit 3 and a facet mirror 4 of the contact lens 5.
  • the treatment beam 7' is focused via the scanning unit 8, the deflection unit 3 and also via a facet mirror 4 of the contact glass 5 in the chamber angle 6 onto the trabecular meshwork. Focusing units for the observation and processing laser beam path are not shown here. Focusing for the treatment beam 7' is preferably implemented in the laser unit 7, i.e. before the laser beam is deflected by the scanning unit 8. The focusing unit for the observation beam path can be integrated into the image processing unit. In the case of an OCT system, the illumination and observation beam paths can be identical.
  • the illumination light backscattered by the chamber angle 8 is imaged on the image processing unit 9 .
  • the existing control unit 10 has connections fertilize to the lighting unit 2, to the image processing unit 3 and to the laser unit 7 for their control or for signal evaluation.
  • the fixation unit 11 projects a fixation beam 11' along the optical axis 15 of the device into the eye 1.
  • a contact gel 12 is used here as a connection between the contact lens 5 and the eye 1,
  • FIG. 2 shows an embodiment of the variant of the device according to the invention with a contact glass with facet mirrors according to FIG.
  • FIG. 3 shows a second variant of the device according to the invention, in which a contact glass with a flat, rotating mirror is used.
  • the deflection unit 3 is synchronized to the movement of the rotating mirror 14 by the control unit 10 .
  • the movement of the rotating mirror can take place continuously or in steps.
  • the contact glass 5 preferably has a ring-shaped opto-acoustic sensor (not shown), which makes it possible to obtain a signal that is largely independent of the direction of deflection.
  • OCT signals obtained in this way can not only be used to control and focus the treatment laser, but also to visualize the anterior chamber angle.
  • OCT scans are registered and aligned with one another in corresponding chamber angle directions (for example 0° and 360°) in order to compensate for movement artifacts in such an OCT representation.
  • the OCT scan can be registered to a color image of the chamber angle.
  • the locations of the laser treatment can then be displayed in the color and/or OCT visualization, since these locations correspond to the positions of the OCT scans that were recorded at the respective activation moments of the treatment laser.
  • 1D, 2D or 3D scans are possible as OCT scans, ie A scan, B or volume scans, preferably for displaying the trabecular meshwork and Schlemm's canal cross section).
  • a corresponding filter can be arranged in front of the image sensor.
  • This filter should selectively block the therapeutic laser radiation (e.g. 532nm) but have a high transmission for the wavelength of the pilot laser beam and all other wavelengths used in the system.
  • the therapeutic laser radiation e.g. 532nm
  • a fully automated system uses an OCDR or OCT scan overlaid with the SLT laser beam to detect whether the SLT laser beam is aimed at the trabecular meshwork and the SLT treatment can be triggered.
  • control unit is designed to detect feature points in the images from the anterior chamber angle and to determine their position.
  • this is the trabecular meshwork in order to align and focus the pilot and/or treatment beam on it.
  • the trabecular meshwork and the laser beam position are preferably detected in the images and their position determined.
  • a treatment pattern along the trabecular meshwork can then be calculated and executed by the control unit.
  • control unit is designed to use the signals from the opto-acoustic sensor and the image processing unit to carry out a titration algorithm for controlling the laser unit in order to achieve an optimal treatment result.
  • the laser dosimetry can be carried out by a plurality of feedback signals, for example by;
  • the contact glass is provided with at least one opto-acoustic sensor in order to continuously detect the changing reflection point on the facet mirrors or the rotating mirror element.
  • the proposed solution does not use ring-shaped sensor elements, such as those used in dosimetric retinal laser treatments.
  • the sensors are placed directly on the facet mirrors or the rotating mirror element, which allows the sensors to detect the direct acoustic amplitude from the laser point on the trabecular meshwork and thus receive a better and more clearly defined opto-acoustic signal, Bei During selective laser trabeculoplasty with this system, the opto-acoustic signal clearly shows a bubble formation threshold in order to adjust the laser energy for reliable laser therapy.
  • a contact glass known from gonioscopic imaging devices is preferably used for this purpose, in which facets are incorporated and mirrored.
  • an XY scanner can sometimes be dispensed with.
  • a diffractive optical element can be used for this, for example (DOA), This variant has the advantage that a continuous change of the reflection point is possible.
  • control unit is further designed to take into account the degree of pigmentation of the trabecular meshwork to be treated when controlling the laser unit using the signals from the image processing unit.
  • the focusing unit of the laser unit for the image processing unit to visualize the structures of the trabecular meshwork.
  • consecutive or opposing facet mirrors can be used.
  • the light exposure caused by processing lasers and illumination for observation can be distributed spatially.
  • the time interval between the observation (i.e. illumination and image processing) and the laser processing of this trabecular meshwork area activated on the basis of this observation must be limited to ⁇ t ⁇ treatment zone diameter*2E-4 s/m, For example, 80 ms for a treatment zone diameter of 400 ⁇ m.
  • a general limit of 60 ms can be acceptable if a certain disturbance of the pattern due to patient eye movements that cannot be completely avoided is acceptable.
  • the image signals obtained in this way can then be evaluated, for example, using fast computers, FPGAs or DSPs with low latency, so that the laser can be activated within the set time frame. It is also possible to track the treatment laser optimally on the trabecular meshwork using control signals obtained from the image data.
  • a device is made available with which manual and/or automatic 360° treatment of open-angle, pseudoexfoliative or pigmentary glaucoma is made possible.
  • the device is based on the automated laser processing of the trabecular meshwork, in particular the "selective laser trabeculoplasty".
  • the device is suitable for enabling a 360° treatment and a more precise prediction of the therapeutic effect that can be achieved or is currently being achieved.
  • an illumination unit for projecting an illumination beam into the anterior chamber angle of an eye and an image processing unit. This allows the device not only for the automated laser processing of the trabecular meshwork, in particular the "selective laser trabeculoplasty", but also or only for examination and diagnostic purposes.

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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)

Abstract

L'invention concerne un dispositif de traitement automatique au laser du réseau trabéculaire, ledit dispositif étant basé sur l'approche de la trabéculoplastie ou de la trabéculectomie ab externo. Le dispositif comprend une unité laser comprenant une source laser et une unité de focalisation, une unité de déviation pour modifier la direction d'émission du faisceau laser sur le réseau trabéculaire de manière commandée, et une unité de commande qui est conçue pour commander l'unité laser ou un traitement au laser ab externo de l'œil et l'unité de déviation. L'invention concerne un verre de contact qui est conçu pour permettre de multiples déviations du faisceau de traitement au laser dans l'angle de chambre antérieure de l'œil lorsque le verre de contact est positionné devant l'œil, ce qui permet un traitement jusqu'à 360° du réseau trabéculaire. L'invention concerne un dispositif qui est conçu pour un traitement automatique à 360° du glaucome en particulier. En outre, le dispositif comprend préférentiellement une unité d'éclairage pour projeter un faisceau d'éclairage dans l'angle de chambre antérieure d'un œil et une unité de traitement d'images de telle sorte que le dispositif peut également être utilisé à des fins d'examen et de diagnostic.
PCT/EP2022/060550 2021-04-23 2022-04-21 Dispositif de traitement automatique au laser du réseau trabéculaire WO2022223690A1 (fr)

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DE102021204066.7 2021-04-23
DE102021204066.7A DE102021204066A1 (de) 2021-04-23 2021-04-23 Vorrichtung zur automatisierten Laserbearbeitung des Trabekelwerkes

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11771596B2 (en) 2010-05-10 2023-10-03 Ramot At Tel-Aviv University Ltd. System and method for treating an eye

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5549596A (en) 1993-07-07 1996-08-27 The General Hospital Corporation Selective laser targeting of pigmented ocular cells
US20050096639A1 (en) * 2000-05-08 2005-05-05 Michael Slatkine Non-penetrating filtration surgery
US20080319427A1 (en) * 2007-03-13 2008-12-25 Palanker Daniel V Computer guided patterned laser trabeculoplasty
US7863894B2 (en) 2008-11-17 2011-01-04 Northrop Grumman Guidance and Electronic Co., Inc Small optics cell for miniature nuclear magnetic resonance gyroscope
EP3329839A1 (fr) 2016-12-05 2018-06-06 Nidek Co., Ltd. Appareil ophtalmique
US20200016002A1 (en) 2018-07-16 2020-01-16 ViaLase Inc. Integrated surgical system and method for treatment in the irido-corneal angle of the eye

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5549596A (en) 1993-07-07 1996-08-27 The General Hospital Corporation Selective laser targeting of pigmented ocular cells
US20050096639A1 (en) * 2000-05-08 2005-05-05 Michael Slatkine Non-penetrating filtration surgery
US20080319427A1 (en) * 2007-03-13 2008-12-25 Palanker Daniel V Computer guided patterned laser trabeculoplasty
US8568393B2 (en) 2007-03-13 2013-10-29 Topcon Medical Laser Systems, Inc. Computer guided patterned laser trabeculoplasty
US7863894B2 (en) 2008-11-17 2011-01-04 Northrop Grumman Guidance and Electronic Co., Inc Small optics cell for miniature nuclear magnetic resonance gyroscope
EP3329839A1 (fr) 2016-12-05 2018-06-06 Nidek Co., Ltd. Appareil ophtalmique
US20200016002A1 (en) 2018-07-16 2020-01-16 ViaLase Inc. Integrated surgical system and method for treatment in the irido-corneal angle of the eye

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11771596B2 (en) 2010-05-10 2023-10-03 Ramot At Tel-Aviv University Ltd. System and method for treating an eye

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