WO2019110855A1 - Procédé et système de dépigmentation de l'iris - Google Patents

Procédé et système de dépigmentation de l'iris Download PDF

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Publication number
WO2019110855A1
WO2019110855A1 PCT/ES2018/070755 ES2018070755W WO2019110855A1 WO 2019110855 A1 WO2019110855 A1 WO 2019110855A1 ES 2018070755 W ES2018070755 W ES 2018070755W WO 2019110855 A1 WO2019110855 A1 WO 2019110855A1
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Prior art keywords
energy
iris
pulse
processor
ultra
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PCT/ES2018/070755
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English (en)
Spanish (es)
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Pedro Grimaldos Ruiz
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Pedro Grimaldos Ruiz
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Publication of WO2019110855A1 publication Critical patent/WO2019110855A1/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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/203—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser applying laser energy to the outside of the body

Definitions

  • the invention is found in the technical sector of lasers for ophthalmological use, which may be clinical or surgical.
  • clinicians are lasers for the treatment of retinal, cataract and glaucoma pathologies.
  • the lasers used in ocular surgical procedures belong to refractive surgery (excimer and femtosecond), cataract surgery (femtosecond, nanolaser), glaucoma (diode), lacrimal (diode), or palpebral (C02 laser) surgery.
  • the invention relates to methods of application and use of lasers to specifically treat ocular tissues.
  • the most important indications of this technique are the pigmentary alterations of the iris, congenital or acquired. These include heterochromias inherited, unilateral or bilateral, partial or total, single or multiple nevi, and those secondary to surgeries, metabolic diseases or iatrogenic drugs (such as prostaglandins).
  • lasers of different wavelengths have been used, such as: 514, 532, 560, 577, 690, 810 and 1064, for special indications such as: iridotomies, goniotomies, pupiloplasties, synequiotomies, fibrinolysis or trabeculoplasties, taking advantage of thermoablation qualities and photodisruption of these lasers.
  • the main difficulty lies in the great complexity of the iris, which is a tissue with characteristics that make it very complicated to perform accurate, repeatable and predictable iridoplasties, without side effects.
  • the surface of the iris is irregular, its thickness is not uniform, it contains noble and delicate structures, such as nerves, blood vessels, collagen and elastin fibers, muscles and layers or pigmented cells. And if all this were not enough, the iris behaves like a diaphragm in permanent movement, depending on the ambient light. That is to say, the pupil contracts with the light and dilates in the darkness.
  • laser refractive surgery is performed on the cornea, which is a smooth surface tissue, of uniform thickness, without delicate noble structures (only collagen fibers), and above all it is immobile that always remains stable. Therefore, laser refractive surgery, despite its difficulty, has advanced very quickly, as the cornea is a much easier tissue to treat than the iris.
  • the access to the cornea is direct, while the iris is inside the eye and submerged in the aqueous humor, which forces to carry out the treatment in the eye depths and not on its surface, as in surgery refractive
  • YAG type lasers which have a characteristic emission with a wavelength of 1064 nanometers (that is, emits in the infrared), are too aggressive but very effective, and can generate side effects that must be prevented or treated.
  • thermoablative effect injure the stroma when they reach it, being able to damage their fibers irreversibly.
  • the micro pulse modes can also damage the stroma if high enough energies are used.
  • the nanosecond lasers designed for trabeculoplasties (SLT) are useful but only to treat very thin layers of tissue and, therefore, many sessions are needed over a year to treat highly pigmented iris, with the consequent medical risk and the excessive cost to the patient.
  • the solution provided by the present invention comprises a laser method of depigmentation of the iris of intracellular action, and therefore, without cell destruction or release of detritus to the aqueous humor.
  • a laser method of depigmentation of the iris of intracellular action By not causing cell death, all the complications of conventional laser iridoplasty are prevented, and thus the objectives of effectiveness, safety and predictability are achieved, without risks and quickly.
  • a first aspect of the present invention relates to a method for depigmenting a pigmented tissue from an iris of an eye comprising the following steps:
  • e emit, by a laser device, the pulse of energy determined by the processor on the pigmented tissue.
  • the pulse of energy is a pulse ultra-short, where the duration of said ultra-short pulse is of the order of picoseconds or less.
  • said pulse only affects the intracytoplasmic melanin granules, called melanosomes, breaking them into small particles easily eliminated by the body itself.
  • it advantageously avoids the typical complications of the longer pulse lasers (millisecond or nanosecond), in which the duration of the tripping exceeds the cell size of the melanocytes and causes their destruction and therefore all the complications derived from the release of detritus and subsequent inflammatory and cicatric reactions.
  • the ultrashort duration of the energy pulses of the present invention which in one of the embodiments is considered to be of the order of picoseconds or less, has an especially advantageous effect in the field of ophthalmology and in particular in iridioplasties, against the use of of nanosecond lasers,
  • the pulse width in picoseconds is of the order of 100 times shorter than the pulse width of the technology in nanoseconds, which achieves, through a photomechanical effect and at lower energy, destroying the pigment deposit in very fine particles. small that later eliminates the organism (macrophages).
  • a pulse set at 500-750 picosecond produces a very concentrated energy delivery in one trillionth of a second. In this way, the temperature increases very sharply and the pigments explode into tiny particles, which are metabolized by the body more easily.
  • the present invention contemplates a wavelength for the energy pulse in a range associated with the green color.
  • this wavelength is selective and is specifically absorbed by the melanin of the melanocytes included in the intracellular melanosomes.
  • the wavelength of the energy pulse is comprised in a range between 514nm and 532nm. More specifically, in one of the embodiments of the invention, the wavelength of the energy pulse is set at 532 nm.
  • the processor is configured to detect an eye movement, by means of an eye tracking system that provides iris position information at all times.
  • the solution provided by the present invention comprises a new laser, specifically designed for iridoplasties, which achieves the objectives of effectiveness, safety and predictability.
  • the laser of the present invention is capable of treating all types of pigmented indian lesions, whatever their thickness and density, reducing the total time of treatment to very few sessions distributed in a single week.
  • a second aspect of the present invention relates to a system for depigmenting a pigmented tissue of an iris of an eye comprising:
  • a laser device configured to emit, on the pigmented tissue of the iris of the eye, at least one pulse of energy, with parameters of duration and amount of energy determined by the processor;
  • the processor is configured to determine the duration and amount of energy of the ultrashort energy pulse based on a measure of thickness and density of the pigmented tissue respectively.
  • the processor is configured to determine an ultra-short duration of the energy pulse, where the ultra-short duration is of an order equal to or less than the picoseconds.
  • a trigger pedal in communication with the processor is contemplated to the system of the present invention, such that the actuation of the pedal results in the emission of the energy pulse.
  • the present invention contemplates a previous study of the iris by:
  • FIG. 2A and 2B a special iris analyzer, as shown in figures 2A and 2B, which studies: colorimetry, color contrast, pachymetry, densitometry and topography, as well as the physiodynamic parameters of aqueous humor and eye pressure.
  • a pneumotonometer to measure the output resistance of aqueous humor.
  • a mode A ultrasound biometer to measure the depth of the anterior chamber and the thickness of the iris.
  • An optical coherence tomography as shown in Figure 3 (anterior segment OCT), to measure the chamber angle, total white to white corneal diameter, depth of the anterior chamber and iris thickness.
  • a laser laser to quantify the levels of effect Tyndall or fiare of the aqueous humor that is to say, a laser that measures the viscosity the aqueous humor.
  • the previous study can be completed with studies of the visual field (FDT), the nerve fibers of the optic nerve (GDX), the corneal endothelium (specular microscope) and the iridian vascular plexus (fluorescein angiography or with OCT).
  • FDT visual field
  • GDX nerve fibers of the optic nerve
  • specular microscope specular microscope
  • iridian vascular plexus fluorescein angiography or with OCT.
  • the present invention includes a pattern scanner to accelerate treatments and an automatic follower of eye movements to ensure the safety of the shots.
  • the present invention varies two fundamental parameters: the energy released per pulse and the duration of the shots.
  • One of the main characteristics of one of the embodiments of the present invention is precisely the short duration of the shots, which is preferably less than nanoseconds, that is, picoseconds or lower ( Figures 1a and 1b), which causes the The laser effect is limited to intracytoplasmic melanosomes and prevents the destruction and death of the cells and the complications that this entails.
  • one of the embodiments of the invention comprises a table of treatment parameters that associates the characteristics of a given pigment with the most suitable type of laser, choosing the most suitable variables according to their thickness and density or hardness.
  • the wavelength used will depend on the particular characteristics of the pigment to be treated.
  • the present invention exploits the different properties of each laser according to its wavelength and pulse duration.
  • the wavelength confers specificity of the color of the target pigment and the duration of the pulse divides the lasers into two large groups: those of thermal effect (burn) and photodisruptor (cold shock wave).
  • brownish-green pigments require wavelengths close to green and ocher-yellowish pigments need lengths close to yellow, so that the laser energy is better absorbed.
  • Another aspect of the present invention relates to a specific laser of iridoplasties for the treatment of pigmentary alterations of the iris, such as heterochromia, nevus, benign and malignant tumors, and other cosmetic anomalies, congenital and acquired, of one eye or both, consisting of:
  • Trigger time 0-10 (nanoseconds);
  • the iridoplasties specific laser is dockable to any type of slit lamp or microscope, with any ocular image acquisition system.
  • the iridoplasties-specific laser of the present invention can use any wavelength of the visible or invisible spectrum, any energy range per pulse, and any length of time of shots, measured with: yoctoseconds, zeptoseconds, attoseconds, femtoseconds, picoseconds, nanoseconds , microseconds, milliseconds, centiseconds, deciseconds, ...
  • the present invention contemplates the possibility of incorporating any type of pattern scanner or performing simple shots with low, medium or high repetition frequency.
  • the iridoplasties specific laser comprises the modulation of the firing time to vary the depth of action.
  • the procedure is not surgical, without injuries or infections.
  • the programming of the laser is based on precise and quantifiable parameters.
  • the plan is personalized and takes into account the thickness, density and topography of each iris.
  • the method of the present invention advantageously generates an ultra-short duration trip, of the order of picoseconds or femtoseconds, which causes a mechanism of intracellular depigmentation by destruction of the intracytoplasmic melanosomes without rupture of the cell membrane and consequently without death of the melanocytes.
  • the present invention contemplates the use of a wavelength of 532nm or a wavelength close to it, which is selective for melanin (melanosomes) and therefore does not damage the rest of the iris structures, such as collagen fibers. , elastin, muscle, blood vessels, etc.
  • the variation of the energy levels used in the pulses modulates the depth of its scope, which allows acting on both deep and superficial lesions, adequately configuring the specific parameters of the laser, based on the previous study of the iris (color, thickness, density, topography), thus achieving the exact effect desired, in terms of intensity and depth.
  • accessory advantages derived from the present invention such as the possibility of depigmenting the iris of an eyeball with a single session; complete safety, which prevents the accidental application of the laser in the lens, derived from the system of automatic tracking of the movement of the eyes; the safety of using a selective wavelength of melanin (532nm); the possibility of applying it in small, irregular (nevus), partial (heterochromia) or total areas; or that the method and system of the present invention to depigment the iris respects the shape of the iris according to the previous study of its topography.
  • Figure 1A Graphically shows the differences in duration and power between nanosecond and picosecond laser devices.
  • Figure 1 B.- shows the difference in the effects of cellular destruction by thermal effect caused by the nanosecond laser versus the picosecond laser.
  • Figure 2A.- shows an iris analyzer equipment.
  • Figure 2B.- shows the summary of iris analysis performed in an embodiment of the invention, comprising: colorimetry map, color contrast, pachymetry, densitometry, topography and physiodynamic parameters.
  • Figure 3. Anterior segment OCT: total corneal diameter, depth of the anterior chamber, iris thickness and measurements of the chamber angle.
  • Figure 4. Color topography in three dimensions
  • Figure 5. 3D prediction and simulation
  • Figure 6. graphically shows the physiodynamic safety threshold.
  • Figure 7. Patient in front of the laser device of the present invention.
  • Figure 8. Samples the laser system including a slit lamp, general purpose computer with high resolution processor, live video and photography system and planning screen.
  • Figure 9. Shows the multifunctional trigger pedal.
  • the present invention relates to an intracellular system and method of depigmentation of the iris by laser, with a specific pulse duration of the shot and a specific wavelength for melanin, which causes the destruction of intracellular melanosomes, but without causing damage or cell death
  • the laser of the present invention shown in Figure 8, consists of the following components, according to one of the embodiments of the invention:
  • Pulse energy modulator 0.5-3.5 J / cm2 (or similar, since the energy level varies depending on the color of the pigmented tissue and the density of the pigment)
  • Trigger time modulator 3 nanoseconds (ns), 4 ns, 5ns, 6ns, 7ns, 8ns, 9ns and 10 ns.
  • a duration in the order of nanoseconds is more indicated for cases of very dark and dense pigment. It is even applicable to benign tumors of the iris.
  • the firing time is set in order of femtoseconds.
  • Tonometry and phonography eye pressure and output resistance.
  • OCT optical coherence tomography
  • - Iris analyzer as shown in figures 2A and 2B: map of colorimetry, contrast, thickness, density, topography and physiodynamics.
  • the personalized programming of the treatment is based on two main factors: thickness and density of the iris.
  • the planning software that generates a plan linked to the personalized topography is used.
  • the parameters of the laser to be configured are:
  • the image of the eye is captured by direct video.
  • the eye tracking system is activated.
  • the physiodynamic safety level is checked, according to a physiodynamic safety threshold represented in figure 6.
  • the laser is activated in shooting mode: from "standby” to "ready”.
  • Post-laser drops are instilled into the eye and oral and ocular medication recommended.
  • the present invention additionally comprises a method for the depigmentation of the iris based on the use of the laser described above, in which the pulses are ultra-short duration.
  • Figure 1a shows graphically the differences between a laser pulse 2 with an order of magnitude of nanoseconds (5 nanoseconds in this particular case), and a laser pulse 1 with an order of magnitude of picoseconds (750 picoseconds in particular).
  • the vertical axis represents the power
  • the horizontal axis represents the time duration of the pulse
  • Figure 1 b shows the advantageous effect achieved by the present invention in comparison with the results obtained by the solutions known from the state of the art.
  • a laser 2 with a pulse of duration in the order of nanoseconds provokes a photothermal interaction in the application zone that entails the appearance of micro cracks 3, a wide thermally affected area 4, molten material and debris 6 on the surface.
  • a laser 1 with a pulse of duration in the order of picoseconds causes a photoablation that does not involve significant microcracks or surface debris.
  • zone 7 affected by heat is minimal and does not translate more than a certain atomized vapor.
  • the method for the depigmentation of the iris based on ultrashort pulses is based on the use and configuration of the following components:
  • wavelengths contemplated by the present invention correspond to different colors of the spectrum and each corresponds to a specific profile of energy absorption.
  • the wavelengths of interest range from red to yellow and green or blue, so that the effect of the laser is absorbed by the melanin pigment of the iris, which can be reddish, yellowish, hazelnut or dark brown.
  • the second property characteristic of wavelengths is their penetration power in tissues. For example, green or blue are shallow, and red and deep infrared. Therefore, the choice of wavelength depends on the type of pigment and the depth of the pigmented tissue to be depigmented.
  • the working lengths range from 1.064nm to 514nm, although the most used vary from 514nm to 595nm, with the wavelength of 532nm being the preferred one.
  • - Power of energy 0.5-3.5 mJ / mW (or similar).
  • Ultra-short trip duration picoseconds, femtoseconds (or similar).
  • the ultrashort duration of the shots preferably of picoseconds or femtoseconds, limits the effect to melanosomes (intracellular pigment granules responsible for the color of the eyes) causing their specific destruction, but without damaging the membrane of the pigment cells (melanocytes ) so it does not cause cellular destruction, nor the corresponding inflammation, nor its healing, nor therefore the typical complications of lasers that use longer firing durations (nanoseconds or milliseconds).
  • the topography of the iris advantageously offers a map of the elevation profile of the iris. Since the laser emits a beam at a certain point, it is important to have a reference of where each point to be treated is located so that the focus of the laser is the most appropriate and therefore its effect is maximum. Taking into account the topographic map obtained, the laser is programmed to position each shot in the exact place of spatial depth.
  • the parameters of the laser can be regulated in energy, duration, wavelength, repetition, depending on the characteristics of the pigment and its topography. As these parameters are varied, different levels of effect are obtained, so that no more energy is applied than strictly necessary, a wavelength appropriate to the pigmentary color is selected and erroneous depths are avoided. Even once a treatment has been started, it is possible to correct the selected parameters in the case that, through real-time supervision by a specialist, through a high resolution screen in communication with high-resolution photography and / or video media , consider that they are not ideals.
  • Optical coherence tomography / ultrasound module to analyze the anatomy of the anterior segment and perform intraoperative or extra-operative measurements.
  • the starting point of the method of the present invention is the general ophthalmological study, with a high resolution image acquisition equipment as shown in Figure 2A, and in particular, of the characteristics of the iris and its pigmentation, from which the color, contrast, pachymetry, topography and physiodynamic parameters of the aqueous humor are extracted, as can be seen in Figure 2B that represents the "iris of Grimaldos".
  • the "iris of Grimaldos” or “Grimaldos iris analysis” is a summary of the main characteristics of the iris pigment and the physiodynamic variables of the anterior chamber, of ophthalmological clinical use prior to laser iridoplasty, and also useful for the diagnosis and follow-up of cases of ocular inflammation (iritis and uveitis), hemorrhages (hypems) or pseudoexfoliative and chronic or acute pigmentary syndromes.
  • the main data of the Iris de Grimaldos are: colorimetry map, contrast map, pachymetric map, topographic map in 2D and 3D, functional pupilometry, comparative and evolutionary studies, and physiodynamic parameters (maximum eye pressure, trabecular blocking factor and clearance of aqueous humor).
  • Optical coherence tomography to perform measurements of total diameter of the iris, pachymetry and depth of the anterior chamber.
  • the chamber angle can be assessed.
  • the planning software is used, in which the values of: area to be treated, energy power, duration of the shot, repetition rate, scanner pattern and physiodynamic security level must be selected.
  • the laser depigmentation method of the present invention is applied on the pigmented tissue of the iris, according to the following protocol:
  • a drop of post laser eye drops is instilled and the treatment is prescribed.
  • the procedure is carried out only with anesthetic drops and its total duration for each eye does not exceed one minute.

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Abstract

La présente invention concerne un système et un procédé intracellulaire de dépigmentation de l'iris par laser, avec une durée d'impulsion de tir ultracourte et de longueur d'onde spécifique pour la mélanine, qui entraîne la destruction des mélanosomes intracellulaires, mais sans entraîner de lésion ou de mort cellulaire. Pour cela, la présente invention élimine toutes les complications secondaires à la lésion tissulaire, telles que l'inflammation, la cicatrisation, l'hypertension oculaire, la repigmentation, la photophobie, la lésion musculaire, les malformations pupillaires, etc., ce qui permet que les traitements de dépigmentation de l'iris soient plus rapides (une seule session) et bilatéraux, que l'effet soit certain, prédictible et permanent.
PCT/ES2018/070755 2017-12-04 2018-11-22 Procédé et système de dépigmentation de l'iris WO2019110855A1 (fr)

Applications Claiming Priority (2)

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ESP201700790 2017-12-04
ES201700790A ES2715524A1 (es) 2017-12-04 2017-12-04 Láser exlicer específico para iridoplastias terapéuticas y cosméticas

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11278452B1 (en) * 2021-03-24 2022-03-22 Stroma Medical Corporation Systems and methods for eye imaging and position control
EP4090384A4 (fr) * 2020-01-16 2024-04-10 James W. Hill Modification de la couleur de l'oeil par transduction génique
WO2024180213A1 (fr) 2023-03-02 2024-09-06 Pedro Grimaldos Ruiz Système pour un traitement au laser de tissus oculaires pigmentés

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001028476A1 (fr) * 1999-10-21 2001-04-26 Technolas Gmbh Ophthalmologische Systeme Reconnaissance et suivi de l'iris en vue d'un traitement optique
WO2002032353A2 (fr) * 2000-10-17 2002-04-25 Ruiz Luis A Methode et appareil pour chirurgie laser de precision
US20030223037A1 (en) * 2002-05-30 2003-12-04 Visx, Incorporated Methods and systems for tracking a torsional orientation and position of an eye
US20090247997A1 (en) * 2008-04-01 2009-10-01 Amo Development, Llc Ophthalmic laser apparatus, system, and method with high resolution imaging
US20130289450A1 (en) * 2012-04-25 2013-10-31 Gregg S. Homer Method for Laser Treatment for Glaucoma

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001028476A1 (fr) * 1999-10-21 2001-04-26 Technolas Gmbh Ophthalmologische Systeme Reconnaissance et suivi de l'iris en vue d'un traitement optique
WO2002032353A2 (fr) * 2000-10-17 2002-04-25 Ruiz Luis A Methode et appareil pour chirurgie laser de precision
US20030223037A1 (en) * 2002-05-30 2003-12-04 Visx, Incorporated Methods and systems for tracking a torsional orientation and position of an eye
US20090247997A1 (en) * 2008-04-01 2009-10-01 Amo Development, Llc Ophthalmic laser apparatus, system, and method with high resolution imaging
US20130289450A1 (en) * 2012-04-25 2013-10-31 Gregg S. Homer Method for Laser Treatment for Glaucoma

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4090384A4 (fr) * 2020-01-16 2024-04-10 James W. Hill Modification de la couleur de l'oeil par transduction génique
US11278452B1 (en) * 2021-03-24 2022-03-22 Stroma Medical Corporation Systems and methods for eye imaging and position control
US20220304850A1 (en) * 2021-03-24 2022-09-29 Stroma Medical Corporation Systems and methods for eye imaging and position control
US11931295B2 (en) * 2021-03-24 2024-03-19 Stroma Medical Corporation Systems and methods for eye imaging and position control
WO2024180213A1 (fr) 2023-03-02 2024-09-06 Pedro Grimaldos Ruiz Système pour un traitement au laser de tissus oculaires pigmentés

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