WO2023192625A1 - Systèmes et méthodes de traitement ophtalmique - Google Patents

Systèmes et méthodes de traitement ophtalmique Download PDF

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Publication number
WO2023192625A1
WO2023192625A1 PCT/US2023/017176 US2023017176W WO2023192625A1 WO 2023192625 A1 WO2023192625 A1 WO 2023192625A1 US 2023017176 W US2023017176 W US 2023017176W WO 2023192625 A1 WO2023192625 A1 WO 2023192625A1
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WO
WIPO (PCT)
Prior art keywords
optical
intensity
laser
working tool
treatment system
Prior art date
Application number
PCT/US2023/017176
Other languages
English (en)
Inventor
Shlomo Assa
Eran Kaplan
Original Assignee
Ioptima Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Application filed by Ioptima Ltd. filed Critical Ioptima Ltd.
Publication of WO2023192625A1 publication Critical patent/WO2023192625A1/fr

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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
    • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • 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
    • A61F9/00802—Methods or devices for eye surgery using laser for photoablation
    • 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
    • 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
    • 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
    • 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
    • A61F2009/00865—Sclera
    • 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

Definitions

  • the present disclosure is related to radiation-based ophthalmic treatment systems and methods, e.g., laser-based devices for providing fractional treatment, or devices using any other type of radiation source for providing any other suitable type of ophthalmic treatment.
  • Some embodiments include an automated scanning system for scanning a beam to multiple locations on the eye to treat conditions of the eye.
  • Laser surgical apparatuses are used for performing treatment by irradiating a part to be treated by a laser beam.
  • a laser treatment apparatus which emits a carbon dioxide laser beam having infrared wavelengths has been used in medical and surgical treatments, such as plastic surgery treatments, for dermatological purposes and in treatment of the eye.
  • FIG 1 A schematically illustrates an embodiment of a laser system in accordance with the present invention.
  • FIG. IB is a schematic illustration of absorption coefficient of water in infra-red range of optical wavelengths.
  • FIG. 2A is a schematic illustration of an embodiment of a laser scanner and working tool in accordance with the present invention, the laser scanner and working tool being shown disassembled from one another.
  • Figure 2B is a detailed view of the exemplary working tool shown in FIG. 2A.
  • FIG. 2C is a schematic illustration of the laser scanner and working tool shown in FIG. 2A, the laser scanner and working tool being shown assembled to one another.
  • FIG. 2D shows the laser scanner and working tool shown in FIG. 2C as positioned for treatment of ocular tissue.
  • FIGS. 3A-M are a schematic illustrations of embodiments of a fractionated laser treatment pattern placed on target tissue.
  • FIGS. 4A-C are graphs schematically illustrating a laser pulse sequence in accordance with the present invention.
  • FIG. 5 is a schematic illustration of a surgical instrument for cutting and coagulating human tissue in accordance with the present invention.
  • FIG. 6 is a schematic illustration of another surgical instrument using fiber optics for cutting a coagulating human tissue in accordance with the present invention.
  • FIG. 7 is a schematic illustration of a surgical instrument using fiber optics for performing ophthalmic procedures in accordance with an exemplary embodiment.
  • FIGS 8A and 8B are schematic illustrations of a surgical instrument using fiber optics for performing ophthalmic procedures in accordance with an exemplary embodiment.
  • FIG. 9A is a schematic illustration of a surgical instrument using fiber optics for performing ophthalmic procedures in accordance with an exemplary embodiment.
  • FIG. 9B is a detailed section view of a portion of the surgical instrument shown in FIG. 9A.
  • the exemplary embodiments relate to systems and methods for performing radiation-based ophthalmic treatment.
  • FIG. 1 illustrates various components of an embodiment of a radiation-based treatment device 24 (alternately referred to herein as “device 24” for brevity).
  • the radiation-based treatment device 24 includes a radiation source 18 that is configured to generate an energy beam.
  • the quality of the energy beam is M 2 ⁇ 1.5.
  • the quality of the energy beam is M 2 ⁇ 1.4.
  • the quality of the energy beam is M 2 ⁇ 1.3.
  • the quality of the energy beam is M 2 ⁇ 1.2.
  • the radiation-based treatment device 24 includes a laser device.
  • the laser device includes a laser diode driver, a laser diode, an optical fiber resonator, and a shell.
  • the laser diode driver provides a working voltage and current regulation to the laser diode.
  • the laser diode driver drives the laser diode to generate a pump source laser.
  • the pump source laser has a wavelength of between 900 nm and 1000 nm.
  • the pump source laser has a wavelength of 915 nm.
  • the pump source laser has a wavelength of 976 nm.
  • the radiation-based treatment device 24 includes a fiber laser device.
  • the device 24 is powered with direct current (DC) that is generated by a power supply 20.
  • the power supply 20 is configured to accept standard alternating current power used in one or more countries (e.g., standard United States alternating current at 110 V and 60 Hz, standard Germany alternating current at 240 V and 50 Hz, etc).
  • the power supply 20 is operative to convert supplied alternating current to direct current.
  • the power supply 20 produces a working DC voltage of 24 V.
  • the electric energy necessary to control the entire device 24 is conditioned by a DC distribution power device 21.
  • the DC distribution power device 21 is embodied in a printed circuit device.
  • the DC distribution power device 21 supplies electric power to all components of the device 24.
  • the radiation source 18 is powered by electric energy provided by the DC distribution power device 21.
  • a command signal is provided to the radiation source 18 by a real-time CPU 22.
  • the real-time CPU 22 is controlled via a GUI computer 23.
  • the GUI Computer 23 includes a user interface that is usable by a device operator to enter desired command such as energy settings for the radiation source 18.
  • the user interface is a touch panel 10.
  • the GUI computer 23 communicates the desired settings to the real time CPU 22, which then provides the desired energy settings to the radiation source 18, thereby causing the radiation source 18 to generate the energy desired by the operator.
  • the radiation source 18 generates excess s heat that is dissipated to the surroundings to cool the device 24.
  • the device 24 includes a laser cooling device 12 that is operative to extract heat from the radiation source 18 and dissipate it to the surroundings of the device 24.
  • the laser cooling device 12 includes a cooling fan.
  • the radiation source 18 is a mid-IR fiber laser.
  • the mid-IR fiber laser operates at a wavelength that is in a range of from 2,700 nm to 3,000 nm. In some embodiments, the mid-IR fiber laser operates at a wavelength that is in a range of from 2,780 nm to 2,940 nm. In some embodiments, the mid-IR fiber laser operates at a wavelength that is in a range of from 2,780 nm to 2,910 nm. In some embodiments, the mid-IR fiber laser operates at a wavelength that is in a range of from 2,780 nm to 2,825 nm.
  • the mid-IR fiber laser operates at a wavelength that is in a range of from 2,825 nm to 2,940 nm. In some embodiments, the mid-IR fiber laser operates at a wavelength that is in a range of from 2,825 nm to 2,910 nm. In some embodiments, the mid-IR fiber laser operates at a wavelength that is in a range of from 2,910 nm to 2,940 nm. In some embodiments, the mid-IR fiber laser operates at a wavelength of 2,780 nm. In some embodiments, the mid-IR fiber laser operates at a wavelength of 2,825 nm. In some embodiments, the mid-IR fiber laser operates at a wavelength of 2,910 nm.
  • the mid-IR fiber laser operates at a wavelength of 2,940 nm.
  • the radiation source 18 is an Er:YAG laser.
  • the Er:YAG laser operates at a wavelength that is in a range of from 2,890 nm to 2,990 nm.
  • the Er:YAG laser operates at a wavelength that is in a range of from 2,910 nm to 2,970 nm.
  • the Er: YAG laser operates at a wavelength that is in a range of from 2,930 nm to 2,950 nm.
  • the Er:YAG laser operates at a wavelength that is in a range of from 2,780 nm to 2,940 nm. In some embodiments, the Er:YAG laser operates at a wavelength that is in a range of from 2,780 nm to 2,910 nm. In some embodiments, the Er:YAG laser operates at a wavelength that is in a range of from 2,780 nm to 2,825 nm. In some embodiments, the Er: YAG laser operates at a wavelength that is in a range of from 2,825 nm to 2,940 nm.
  • the Er: YAG laser operates at a wavelength that is in a range of from 2,825 nm to 2,910 nm. In some embodiments, the Er:YAG laser operates at a wavelength that is in a range of from 2,910 nm to 2,940 nm. In some embodiments, the Er:YAG laser operates at a wavelength of 2,780 nm. In some embodiments, the Er:YAG laser operates at a wavelength of 2,825 nm. In some embodiments, the Er: YAG laser operates at a wavelength of 2,910 nm. In some embodiments, the Er: YAG laser operates at a wavelength of 2,940 nm. In some embodiments, the radiation source 18 is an ErYSGG laser.
  • the ErYSGG laser operates at a wavelength that is in a range of from 2,730 nm to 2,830 nm. In some embodiments, the ErYSGG laser operates at a wavelength that is in a range of from 2,750 nm to 2,810 nm. In some embodiments, the ErYSGG laser operates at a wavelength that is in a range of from 2,770 nm to 2,790 nm. In some embodiments, the Er: YSGG laser operates at a wavelength that is in a range of from 2,780 nm to 2,940 nm. In some embodiments, the ErYSGG laser operates at a wavelength that is in a range of from 2,780 nm to 2,910 nm.
  • the ErYSGG laser operates at a wavelength that is in a range of from 2,780 nm to 2,825 nm. In some embodiments, the ErYSGG laser operates at a wavelength that is in a range of from 2,825 nm to 2,940 nm. In some embodiments, the Er: YSGG laser operates at a wavelength that is in a range of from 2,825 nm to 2,910 nm. In some embodiments, the ErYSGG laser operates at a wavelength that is in a range of from 2,910 nm to 2,940 nm. In some embodiments, the Er: YSGG laser operates at a wavelength of 2,780 nm.
  • the ErYSGG laser operates at a wavelength of 2,825 nm. In some embodiments, the ErYSGG laser operates at a wavelength of 2,910 nm. In some embodiments, the ErYSGG laser operates at a wavelength of 2,940 nm. In some embodiments, the radiation source 18 is an Er, Cr: YSGG laser. In some embodiments, the Er,Cr:YSGG laser operates at a wavelength that is in a range of from 2,730 nm to 2,830 nm. In some embodiments, the Er,Cr:YSGG laser operates a wavelength that is in a range of from 2,750 nm to 2,810 nm.
  • the Er,Cr:YSGG laser operates at awavelength thatis in a range of from 2,770 nm to 2,790 nm.
  • the radiation source 18 operates a wavelength that is in a range of from 2,000 nm to 4,000 nm. In some embodiments, the radiation source 18 operates a wavelength that is in a range of from 2,600 nm to 3,100 nm. In some embodiments, the radiation source 18 operates a wavelength that is in a range of from 2,700 nm to 3,000 nm. In some embodiments, the radiation source 18 operates a wavelength that is in a range of from 2,770 nm to 2,950 nm.
  • the radiation source 18 (e.g., a mid-IR fiber laser) emissions radiate into a laser optics module 17.
  • the laser optics module 17 is operative to collimate the laser beam.
  • the laser optics module 17 collimates the laser beam to a diameter that is between 3 mm and 10 mm.
  • the laser optics module 17 collimates the laser beam to a diameter that is between 5 mm and 9 mm.
  • the laser optics module 17 collimates the laser beam to a diameter of about 7 mm.
  • the laser optics module 17 collimates the laser beam to a diameter that is 7 mm.
  • the laser optics module 17 combines the collimated laser beam with a visible beam (e.g., an aiming beam) to enable the operator to see the location and pointing of the beam generated by the radiation source 18, as the beam generated by the radiation source 18 is invisible.
  • the visible beam is a red laser operating at about 650 nm.
  • the visible beam is a red laser operating at about 620-650 nm.
  • the visible beam is a green laser operating at about 530-540 nm.
  • the laser optics module 17 is connected to energy calibration device 13.
  • the energy calibration device 13 is a InAsSb photovoltaic detector that is optimized to measure laser radiation at 2,940 nm.
  • the energy calibration device 13 is a InAsSb photovoltaic detector that is optimized to measure laser radiation at 2,780 nm.
  • the energy calibration device 13 is operative to read a sample of the main laser beam generated by the radiation source 18 in real time to enable control of the energy per pulse is such a manner that when the energy set by the operator has been delivered and measured by the energy calibration device 13, a command will be sent to the real time CPU 22 to cut the laser pulse energy generated by the radiation source 18 as the desired set energy has been achieved.
  • the energy calibration device 13 includes a real time servo controller operative to ensure that the energy delivered by the radiation source 18 is identical to the energy set by the operator.
  • the energy calibration device 13 measures a sample of the laser energy and monitors in close loop the energy setting selected by the operator.
  • the device 24 includes a scanner servo controller 27 that is operable to drive X and Y scanner motors in an applicator 16.
  • the scanner servo controller 27 is powered by the DC distribution power 21 device, which regulates the DC voltage converted from AC voltage by the power supply 20.
  • commands to move the X and Y scanner motors are input by the operator. In some embodiments, such commands are input via the GUI computer 23 (e.g., using the touch panel 10). In some embodiments, commands input to the GUI computer 23 are transferred to the real time CPU 22, which sends command signals to the scanner servo controller 27 to move the scanners motors in the applicator 16.
  • the radiation energy is directed to a beam delivery device 14.
  • the beam delivery device 14 is a fiber optics device able to transmit the emission.
  • the beam delivery device 14 includes a plurality of rotating mirrors (e.g., 7 rotating mirrors) articulated arm.
  • the laser energy is directed to the final energy conditioning device, laser output optics 15.
  • the laser output optics 15 include collimating optics to collimate the laser beam.
  • the laser beam is collimated to a fixed diameter. In some embodiments, the diameter is 7.0 mm.
  • the laser output optics 15 includes a protective and replaceable window to prevent dust and contaminations from effecting the radiation-based device 18 from operating reliably.
  • the laser output optics 15 includes a quick disconnect connection 100 allowing the operator to replace the laser applicator 16 in use to achieve different clinical effects as will be disclosed hereinafter.
  • the operator uses a foot switch 26 to command the energy emission to be delivered at a setting that has been entered into the GUI computer 23.
  • the operator disengages the foot switch 26. Tn some embodiments, in case of emergency, the operator may stop the device 24 from operating by pressing the emergency switch 11.
  • FIG. IB illustrates the absorption coefficient of water in the infra-red radiation wavelengths. Because human tissue contains about 70% water, water absorption is a very effective tool to treat human tissue.
  • the basic mechanism of action of radiation-based devices is selective photo thermolysis, which is matching the radiation device wavelength to a light absorbing chromophore to create the selected effects.
  • the selected wavelength is 2,940 nm.
  • peak 104 is the point of peak water absorption of 11,700 cm' 1 , at a wavelength of 2,940 nm, the highest water absorption in the infrared spectrum.
  • FIG. IB also shows, at peak 103, an absorption coefficient of 114 cm' 1 for a laser operating at a wavelength of 1,927 nm, which is another fiber laser commonly used in treating human tissue. It may be seen that this absorption coefficient is 100 times less than that of an exemplary embodiment operating at 2,940 nm. As can be seen, the device corresponding to peak 103 has very low ablation efficiency and large potential unwanted thermal injuries. As another comparison, FIG. IB includes a peak 102 indicating a water absorption value of 10 cm' 1 at a wavelength of 1,550 nm. On this basis the radiation based device operating at 1,550 nm may be classified as a non-ablative device, as the water absorption coefficient is too low compared with the peak water absorption characteristics of the exemplary embodiments.
  • FIGS. 2A-2D illustrate an embodiment including a scanner 250 and a working tool 270 that is configured for use in the treatment of ocular tissue and tissue surrounding the eye and orbit.
  • FIG. 2A illustrates a scanner 250 and a working tool 270 as disassembled from one another.
  • FIG. 2B shows a detailed view of the working tool 270.
  • FIG. 2C shows the scanner 250 and the working tool 270 as assembled to one another.
  • FIG. 2D shows the assembled scanner 250 and working tool 270 as positioned for treatment of a patient’s eye.
  • the working tool 270 is configured for applications such as incision, excision, ablation, vaporization, and coagulation of ocular tissue and tissue surrounding the eye and orbit.
  • the laser (or laser energy) is transmitted continuously. In some embodiments, the laser (or laser energy) is transmitted in a pulsed manner. In some embodiments, the pulsed energy is in a range of from 0. 1 mJ to 100 mJ per pulse. In some embodiments, the pulsed energy is in a range of from 0.1 mJ to 50 mJ per pulse. In some embodiments, the pulsed energy is in a range of from 0.1 mJ to 15 mJ per pulse. In some embodiments, the pulsed energy is in a range of from 0.1 mJ to 5 mJ per pulse. In some embodiments, the pulsed energy is in a range of from 0.2 mJ to 5 mJ per pulse. In some embodiments, the pulsed energy is in a range of from 0.2 mJ to 1 mJ per pulse.
  • the working tool 270 shown in FIG. 2A may be connected to the radiation-based treatment device 24 illustrated in FIG. 1A, using the quick disconnect 100.
  • the field of treatment is defined by X and Y axes (see FIG. 2D) to denote the scanning action directions.
  • the working tool 270 enables the operator to clearly see the field of treatment via an opening 286 (see FIG. 2C) in the tip of the working tool 270.
  • the scanner 250 includes a laser focusing lens.
  • the focusing lens of the scanner 250 when in use, has a focal distance that is in a range of from of 150 mm to 300 mm. In some embodiments, the focusing lens of the scanner 250, when in use, has a focal distance that is in a range of from 150 mm to 250 mm. In some embodiments, the focusing lens of the scanner 250, when in use, has a focal distance that is in a range of from 150 mm to 200 mm. In some embodiments, the focusing lens of the scanner 250, when in use, has a focal distance that is in a range of from 200 mm to 300 mm.
  • the focusing lens of the scanner 250 when in use, has a focal distance that is in a range of from 200 mm to 250 mm. In some embodiments, the focusing lens of the scanner 250, when in use, has a focal distance that is in a range of from 150 mm to 200 mm. In some embodiments, the focusing lens of the scanner 250, when in use, has a focal distance that is in a range of from 200 mm to 220 mm. In some embodiments, the focusing lens of the scanner 250, when in use, has a focal distance of about 210 mm. In some embodiments, the focusing lens of the scanner 250, when in use, has a focal distance of 209 mm.
  • the focusing lens of the scanner 250 when in use, provides a laser focus spot size that is in a range of 100 pm to 500 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size that is in a range of 100 pm to 400 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size that is in a range of 100 pm to 300 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size that is in a range of 100 pm to 250 pm.
  • the focusing lens of the scanner 250 when in use, provides a laser focus spot size that is in a range of 100 pm to 200 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size that is in a range of 100 pm to 150 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size that is in a range of 200 pm to 500 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size that is in a range of 200 pm to 400 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size that is in a range of 200 pm to 300 pm.
  • the focusing lens of the scanner 250 when in use, provides a laser focus spot size that is in a range of 300 pm to 500 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size that is in a range of 300 pm to 400 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size that is in a range of 400 pm to 500 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size of 250 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size of 200 pm.
  • the focusing lens of the scanner 250 when in use, provides a laser focus spot size of 170 pm. Tn some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size of 150 pm. In some embodiments, the focusing lens of the scanner 250, when in use, provides a laser focus spot size of 120 pm.
  • the scanner 250 includes a first locking connector 252 that is operable to connect the scanner 250 to a mounting shaft 260 in a removable, locking manner.
  • the mounting shaft 260 is substantially similar to the mounting shaft 201 described above.
  • the scanner 250 includes a second locking connector 254 that is operable to connect the scanner 250 to the working tool 270 in a removable, locking manner.
  • the second locking connector 254 is a threaded connector.
  • the second locking connector 254 is a ratcheting connector.
  • the second locking connector 254 is another type of locking connection providing a sufficiently secure and stable connection between the scanner 250 and the working tool 270.
  • the scanner 250 includes X-axis and Y-axis scanning motors operable to move a beam in the X and Y directions with respect to target ocular tissue.
  • the scanner 250 includes an aperture 256 through which light enters the scanner 250 from the radiation-based treatment device 24.
  • the incoming laser beam entering the scanner 250 via the aperture 256 is collimated to a fixed diameter.
  • the fixed diameter is between 3 mm and 10 mm. In some embodiments, the fixed diameter is between 5 mm and 9 mm. In some embodiments, the fixed diameter is about 7 mm. In some embodiments, the fixed diameter is 7 mm.
  • the input laser beam entering the scanner 250 at the aperture 256 is reflected 90° vertically (e.g., in the Y-axis direction shown in FIG. 2D) by a permanently mounted reflecting mirror.
  • the scanner 250 includes X-axis and Y-axis scanning motors that position corresponding movable mirrors to allow the beam emitted by the working tool 270 to be positioned in the X and Y directions, respectively, at a target area.
  • an electronic control signal provided to the scanner 250 can drive both the X-axis scanning motor and the Y-axis scanning motor simultaneously to form a 2- dimensional complex laser beam motion at the target ocular tissue as the operator selects to use the radiation-based device 24 shown in FIG. 1A.
  • FIG. 2B shows a detailed view of the working tool 270.
  • the working tool 270 is made of a metal or other sterilizable material suitable for multiple uses.
  • the working tool 270 is adapted for one-time disposable use and is made of a material such as a medical-grade plastic.
  • the medical-grade plastic is suitable for recycling after use.
  • the working tool 270 has a first end 272 (e.g., a proximal end) and a second end 274 (e.g., a distal end).
  • the working tool 270 has a locking connector 276 at the first end 272.
  • the locking connector 276 is configured to lockingly connect the first end 272 of the working tool 270 to the second locking connector 254 of the scanner 250.
  • the locking connector 276 is a threaded connector, but it will be apparent to those of skill in the art that other locking mechanical connectors are also suitable.
  • the working tool 270 has a body 278 extending from the first end 272 to the second end 274.
  • the working tool 270 is configured to receive a laser beam at the first end 272 and for the laser beam to travel along the working tool 270 from the first end 272 to the second end 274 along an axis 280.
  • the working tool 270 has a tip 282 at the second end 274.
  • the tip 282 defines a focal plane 284.
  • the focal plane 284 is angled with respect to the axis 280. Tn some embodiments, the focal plane 284 is angled at an angle of 113 degrees (e.g., 23 degrees off perpendicular) with respect to the axis 280. In some embodiments, the focal plane 284 is angled with respect to the axis 280 at an angle that is in a range of from 90 degrees (e.g., perpendicular to the axis 280) to 135 degrees (e.g., 45 degrees off perpendicular).
  • the tip 282 acts as a distance gauge for a user of the working tool 270. In some embodiments, the tip 282 acts as a guide to assist a user in keeping the working tool 270 properly positioned in relation to the target tissue.
  • FIG. 3A is a schematic illustration of one embodiment of a fractionated laser treatment pattern placed on the ocular tissue that is to be treated, in accordance with the present invention.
  • the fractionated pattern defines a pre-determined plurality areas of the ocular tissue that will be treated by the laser pulsed energy and another plurality of areas between the treated areas that remain healthy and untreated ocular tissue to help the recovery process by leaving a bridge of healthy ocular tissue between the treated areas of ocular tissue.
  • FIG. 3A illustrates the X and Y coordinates that are consistent with the coordinates on FIG 2, 208.
  • the operator can select from a pre-determined plurality of patterns and sizes, to use a 15mm diameter hexagon pattern 300.
  • the red aiming beam will show the outline of the selected hexagon treatment area boundary 300.
  • the radiation-based device synchronizes the movement of the scanner motors 203 and 204 to each location 301, placing laser pulses of particular pre-set properties at each location of the predetermined plurality of locations within the outline boundary 300.
  • the pulse placement locations will start from the lowest right comer of the pattern 302, where the scanner motors 203 and 204 will hold position at 302 while the CPU controller 22 will command the system to pulse one pre-set energy pulse selected by the operator.
  • the system CPU controller 22 will command the scanner motors 203 and 204 to move the focused beam at the direction 305 consistent with move in X axis direction, from position 302 to position 303, the scanner motors 203 and 204 will hold position without any movement at location 303, and the CPU controller 22 will command the laser to pulse one pulse with a predetermined properties set by the operator.
  • the CPU controller 22 will command the scanner motors 203 and 204 to move the focused beam again at the direction 305 consistent with move in X axis direction, from position 303 to position 304, the scanner motors will hold position without any movement at location 304, and the CPU controller 22 will command the laser to pulse one pulse with a predetermined properties set by the operator.
  • the system will automatically advance to the next location along direction 305 as explained above to repeat the same process of stepping the scanner motors to move the focused laser beam to the new location, hold position in the new location while the CPU controller 22 will command the laser to deliver one pre-programed pulse energy, repeating the process until position 306 pulse duration reached the end.
  • the system will command the scanner motors 203 and 204 to move the focused laser beam in the direction 307, moving one line up in the Y direction to position 308 where the scanner motors 203 and 204 will hold position while the system will deliver a single preset pulse.
  • the CPU controller 22 will command the scanner motors 203 and 204 to move the focused laser beam along the negative x direction 310 from location 308 to location 309 repeating the same process of hold position while the laser deliver a pre-set energy pulse, and advance to the next adjacent position as explained above.
  • the entire plurality of pre-determined locations within the pattern boundaries will be delivered with the same pre-set laser pulse energy using the same step, hold position and repeat process.
  • the CPU controller 22 will resume presenting the red aiming beam outline 300 to indicate to the operator that the placement of all pre-set pulses has been completed.
  • the operator can then move the working tool 207 to the next area of the ocular tissue that needs to be treated to repeat the same process.
  • FIG. 3B is a schematic illustration of another embodiment of a fractionated laser treatment pattern placed on ocular issue to be treated, in accordance with the present invention.
  • the step, hold position and repeat process used to deliver the laser pulses to pre-program plurality of predetermined locations can be achieved by using random movement instead of cartesian movement along x and y axis as explained above with reference to FIG. 3A.
  • the first pulse location will be 311, where the scanner motors 203 and 204 will hold position at 311 while the system will pulse one pre-set energy pulse selected by the operator.
  • the system CPU controller 22 will command the scanner motors 203 and 204 to move the focused beam in synchronized movement along both x and y axis at the direction 312, from position 311 to position 313, the scanner motors 203 and 204 will hold position without any movement at location 313, while the system will pulse one preset energy pulse selected by the operator.
  • the system CPU controller 22 will command the scanner motors 203 and 204 to move the focused beam in synchronized movement along the direction 314, from position 313 to position 315, the scanner motors 203 and 204 will hold position without any movement at location 315, while the system will pulse one pre-set energy pulse selected by the operator.
  • the system CPU controller 22 will command the scanner motors 203 and 204 to move the focused beam in synchronized movement along the direction 316, from position 315 to position 317, the scanner motors 203 and 204 will hold position without any movement at location 317, while the system will pulse one pre-set energy pulse selected by the operator
  • the system CPU controller 22 will continue the step, hold position, pulse the laser and repeat to place preset energy pulses in all pre-determined plurality of fractionate locations within the pattern boundaries as explain above.
  • the randomized movement algorithm to be used is an algorithm that maximizes physical distance between pulses that are adjacent to one another in sequence to reduce any possibilities of accumulation of unwanted thermal injury, and for the other purpose to said reduce patient discomfort.
  • FIG. 3C illustrates an embodiment in which the operator can select from a variety of choices of available fractionated fdling density of pulses from either pattern 320 or pattern 321, as an example.
  • pattern 320 and pattern 321 are of identical pattern type and size.
  • the difference between patterns 320 and 321 is that the density of pattern 320 is of a higher density, that is, there are larger number of pre-determined pulses locations in pattern 320 compared with pattern 321 that has smaller number of predetermined pulse locations, therefore, pattern 321 is of a lower density.
  • FIG. 3D illustrates an exemplary embodiment in which the operator can select from a variety of available of fractionated pattern sizes having the same pulse density.
  • the operator can select a larger pattern size 330 or a smaller pattern size 332 having the same pulse density.
  • selection is done by the operator using the touch panel 10 from a list of pre-programed available sizes and available pulse densities.
  • the ability to easily change the pattern size and pulse density allows the operator the flexibility to fit the particular laser pulse selection to the characteristics of the specific ocular tissue to be treated.
  • FIG. 3E illustrates an exemplary embodiment in which the operator can select from a predetermined choice of available plurality of fractionated pattern sizes with the same pulse density.
  • the operator can select a larger pattern size 330 or a smaller pattern size 332 having the same pulse density as shown in FIG. 3D, wherein each one of the pulses 333 of FIG. 3D has a gaussian energy distribution 334 shown in FIG. 3E, that are spaced apart by a spacing distance 335 to form the predetermined shape shown in FIG. 3D.
  • the predetermined gaussian pulsed energy distribution 334 that is spaced at a predetermined distance 335 is applied to the target ocular tissue 336.
  • the gaussian pulsed energy distribution 334 will ablate the tissue 336.
  • ablating the ocular tissue 336 creates a tissue void 339 that will appear to be a shaft of removed tissue 339 spaced at the same distance 335 as the predetermined gaussian laser energy pulses are spaced. It will be apparent to those of skill in the art that the tissue voids 339 shown in the ocular tissue 336 are not shown in any particular position or to any particular scale, but, rather, are shown as a schematic representation.
  • FIG. 3F illustrates an exemplary embodiment in which an operator can select from a predetermined choice of available plurality of fractionated pattern size having the same pulse density.
  • the plurality of laser energy pulses 342 will be selected by the operator to be of a predetermined energy level to ablate a very thin layer of tissue.
  • the laser pulse energy 342 is gaussian in nature, it will ablate different thickness of tissue with respect to the beam profile.
  • the system will control the placement of pulsed energy 342 at a predetermined spacing, thereby creating a predetermined overlap 341 that is selected to produce homogeneous ablation of a layer of tissue having a defined thickness.
  • the predetermined plurality of pulsed laser energy is arranged in a ring 340 that spaces the plurality of pulses further apart to minimize any accumulation of thermal energy that can cause side effects.
  • the predetermined pluralities of pulses 342 and 344 are arranged in two rings having a predetermined energy overlap 341 to increase the predetermined area coverage choice that operator can select.
  • the predetermined plurality of pulses 342, 344 and 345 are arranged in three rings with a predetermined energy overlap 341 to increase the predetermined area coverage choice that the operator can select.
  • FIG. 3G shows an alternate view of the predetermined laser pulses 342, 344 and 345 of FIG. 3F with a predetermined overlap 341.
  • each one of the plurality of laser pulses has a gaussian energy distribution.
  • FIG. 3G illustrates a cross-sectional view of the gaussian laser pulses 346 that are spaced by a predetermined space 347 creating an energy overlap 348.
  • the energy overlap 348 will create an even energy distribution applied to target ocular tissue 336, thereby creating an even ablation crater 349 in the target ocular tissue 336.
  • the laser pulse energy is applied at water peak absorption that will ablate the target ocular tissue 336 with minimal thermal residue, including in embodiments such as the ring embodiments shown in FIG. 3F that keep the distance between adjacent pulses to the smallest distance to cover a target area.
  • application of laser pulse energy in this manner allows ablation of a thin layer of tissue with minimal residue of thermal energy, thereby preventing side effects that may arise due to excessive residual thermal energy. It will be apparent to those of skill in the art that the crater 340 shown in the ocular tissue 336 is not shown in any particular position or to any particular scale, but, rather, is shown as a schematic representation.
  • FIG. 3H illustrates an exemplary embodiment in which the operator can select from a variety of predetermined choices of available fractionated filling density of plurality of pulses arranged in a ring-form pattern having a higher density 354 or pattern having a lower density 358, as an example.
  • the pattern 354 and the pattern 358 are of identical pattern shape (e.g., hexagonal) and size, and the difference is that the laser energy density of pattern 354 is of a higher density, that is, there are larger number of pre-determined plurality of pulses arranged in ring locations in pattern 354 compared with pattern 358 that has smaller number of predetermined plurality of laser pulses arranged in a ring locations.
  • FIG. 31 illustrates an exemplary embodiment in which the operator can select from a variety of predetermined choices of available fractionated pattern sizes with identical laser energy density.
  • the operator can select a larger pattern size 360 or a smaller pattern size 362 having the same density of plurality laser energy pulses arranged in a ring, but pattern 360 which is larger in size will have more rings than pattern 362 that is smaller.
  • the pattern size can be selected by the operator from a list of pre-programed available sizes and available laser energy pulse density.
  • the ability to easily change the pattern size and laser energy pulse density provides the operator with the flexibility to fit the particular laser energy pulse selection to the ocular tissue to be treated.
  • 3J illustrates an exemplary embodiment in which the user can select from a predetermined variety of available fractionated pattern sizes with the same pattern type and size and fill the pattern with the same number of rings, in which the rings have different energy density coverage.
  • the operator can select pattern size 350 and fill it with a plurality of predetermined number of rings 351, with each ring comprising the same intensity of plurality laser pulses arranged in a ring, or can change the selection of the same size and type of pattern 350 and fill it with plurality of predetermined number rings 352, with each ring comprising identical intensity of plurality laser pulses arranged in a two-ring layout, or can change the selection of the same size and type of pattern 350 and fill it with plurality of predetermined number rings 353, with each ring comprising identical intensity of plurality laser pulses arranged in a three-ring layout.
  • each of the predetermined selections will have the same pattern type and size, and will have the same number of rings placed at the same distance from each other, but every ring will have different quantity of pulses, therefore effecting the energy density in a way that pattern with ring 351 will have the lowest density, the pattern with ring 352 will have a higher density, and the pattern with ring 353 will have a still higher density.
  • the ability to easily change the pattern size and pulse density provides the operator with the flexibility to fit the particular laser pulse selection to the target ocular tissue.
  • FIG. 3K illustrates an exemplary embodiment in which the operator can select from a predetermined variety of available fractionated pattern shapes with the same energy density.
  • the operator can select a hexagon pattern 364 with a plurality of predetermined number of rings, each ring with plurality of laser pulses 365, that are placed at a distance 366 between them, or select a square pattern 367 with a plurality of predetermined number of rings, each ring with plurality of laser pulses 365 that are placed at a distance of 366 between them, or select a triangle pattern 368 with plurality of predetermined number of rings, each ring with plurality of laser pulses 365 that are placed at a distance of 366 between them.
  • the operator can select from the exemplary patterns 364, 367, or 368 from a list of pre-programed and predetermined shapes, sizes and available laser pulse density.
  • the ability to easily change the pattern shape type, size and laser pulse density provides the operator with the flexibility to fit the particular laser pulse selection to the size, shape, and location of the target ocular tissue. It will be apparent to those of skill in the art that the specific shapes of the patterns 364, 367, and 368 are only exemplary, and that any other shape (e.g., diamonds, octagons, pentagons, etc.) may also be possible without departing from the general concepts described herein.
  • FIG. 3L illustrates an exemplary embodiment in which the operator can select from a predetermined selection of fractionated pattern sizes with the same predetermined pulse density.
  • the plurality of laser energy pulses 370 will be selected by the operator to be of predetermined energy level to ablate a very thin layer of tissue, such as discussed above with reference to FIGS. 3E-3F.
  • the ring 370 of a plurality of laser pulses is identical to ring 340 of shown in FIG. 3F, but with the addition of a pulse 371 at the exact center of the ring 370, wherein the pulse 371 has different predetermined laser pulse properties to ablate tissue to a greater depth.
  • FIG. 3M illustrates the exemplary embodiment of FIG.
  • FIGS. 4A-4C illustrate various exemplary laser pulse sequences that may be applied to target ocular tissue in accordance with an exemplary embodiment.
  • Any of the laser pulse sequences discussed herein may be applicable for application in accordance with any of the exemplary systems discussed herein. This includes, but is not limited to, embodiments in which the location of application of laser pulses is controlled by a scanner (e.g., as described above with reference to FIGS. 2A-2D) as well as embodiments in which pulses are applied to a single location in, on, or near the eye (e.g., as described hereinafter with reference to FIGS. 7-8B).
  • FIG. 4A is a graph schematically illustrating a sequence of plurality of laser pulses in accordance with an exemplary embodiment.
  • the x axis represents a time scale 403 while the Y axis illustrates fluence 401.
  • the horizontal dashed line illustrates the fluence threshold 400 for human tissue ablation, also referred to as the “ablation threshold” or “e”.
  • the fluence threshold 400 indicates that any pulse delivered to human tissue and having a fluence that is higher than e, 400, will ablate the human tissue.
  • any pulse with fluence below e, 400 will not ablate the tissue but, rather, will cause the energy to be absorbed by the human tissue and turn to heat in the human tissue, which may cause thermal injury.
  • the calculated theoretical value of e is about 0.33 joules/cm2, while different experimentally determined values of e have been reported by many scientific papers.
  • the relationship between fluence and ablation depth may be represented by the equation:
  • E indicates the pulse energy in millijoules
  • Sz indicates the laser spot size in microns.
  • the laser is a mid-IR fiber laser operating at 2,940nm with a focused laser beam diameter of 120 pm.
  • the ablation threshold is 0.23 millijoules.
  • the pulses 402 are preset to ablate human tissue to a selected depth selected by the operator programing the laser energy per pulse using the touch panel 10.
  • each of the plurality of pre-set laser pulses 402 is be delivered in a different location of the selected pattern 300 (as shown in FIG. 3 A) starting with pulse location 302 and to the next locations as described above.
  • the pulse duration of each pulse will be configured by the CPU controller 22 controlling the device 24 to deliver to the ocular tissue the exact amount of energy that is preprogramed by the operator.
  • the time duration 404 between adjacent pulses 402 is configured by the CPU controller 22 to leave sufficient time for the scanner motors 203 and 204 to move the mirror that reflects the laser beam from one location to the next before delivering the next pulse to the next location.
  • the energy of the plurality of pulses is set by the operator based on the desired depth of ablation. In some embodiments, for an ablation depth of 400 microns, the operator sets the energy of the plurality of laser pulses to be 9 millijoules per individual pulse 402, based on the formulas shown above.
  • FIG. 4B is a graph schematically illustrating a sequence of a plurality of laser pulses in accordance with an exemplary embodiment.
  • a pulse 402 e.g., as shown in FIG. 4A
  • a pulse burst 410 e.g., as shown in FIG. 4A
  • the delay 413 is be identical to the delay 404 discussed above with reference to FIG. 4A when the system is using a plurality of solid pulses 402 at each of the pre-determined plurality location withing the pattern boundaries.
  • the use of a plurality of sub-pulses 41 1 has the effect of lowering patient discomfort by spreading the energy per pulse over a longer time duration and lower accumulation of unwanted thermal injury.
  • the pulse burst 410 will include four (4) subpulses 411 with a predetermined time duration 412 between sub-pulses 411.
  • various parameters of the pulse burst 410 are set by the CPU controller 22.
  • the system in each location starting from 302 in the selected laser pattern 300 the system will deliver a burst 410 of sub pulses 411, with time delay 412 between each adjacent sub-pulses 411 for the same total energy per pulse burst 410, corresponding to the ablation depth selected by the operator in accordance with the formulas disclosed above.
  • Figure 4B illustrates a pulse burst 410 using four (4) of the sub-pulses 411
  • this quantity is only exemplary and that, in other embodiments, a pulse burst 410 may include any quantity of sub-pulses 411 greater than two (2) depending on the desired clinical results.
  • the laser operates at a wavelength of 2,940 nm, which provides peak water absorption, and as a result the ablation of human tissue is very efficient since human tissue contains over 70% of water.
  • FIG. 4C is a graph schematically illustrating a laser pulse sequence in accordance with an exemplary embodiment.
  • the pulses 402 (as shown in FIG. 4A) that are to be applied in a pattern 300 at a step and repeat process starting from 302, will be divided into a plurality of sub-pulses arranged as a pulse burst 420.
  • the pulse burst 420 shown in FIG. 4C differs from the pulse burst 410 shown in FIG. 4B and discussed above.
  • each pulse burst 420 includes eight (8) sub-pulses.
  • pulse burst 420 includes four (4) ablating sub-pulses 421, which have a fluence that is configured by the CPU controller 22 to be above the ablation threshold “e” 400. In some embodiments, the pulse burst 420 also includes four (4) coagulating sub-pulses 422, which have a fluence that is configured by the CUP controller 22 to be below the ablation threshold “e” 400.
  • the coagulating sub-pulses 422 because the coagulating sub-pulses 422 have a fluence that is below the ablation threshold “e” 400, the coagulating sub-pulses 422 do not ablate any tissue, but, rather, deposit the energy of the sub-pulses 422 by heating up the surrounding tissue to create a coagulation effect and to form a controlled localized thermal injury.
  • a predetermined first time duration 423 is present between each ablating sub-pulse 421 and the subsequent coagulating sub-pulse 422.
  • a predetermined second time duration 424 is present between each coagulating sub-pulse 422 and the subsequent ablating subpulse 421, except for the final coagulating sub-pulse 422 within each pulse burst 420.
  • a delay 425 is present before the ablating sub-pulse 421 that begins the subsequent pulse burst 420.
  • the next identical pulse burst 420 will be delivered to the next location in the pattern following the delay 425 that will be set by the CPU controller 22 to allow sufficient time for the scanner motors 203 and 204 to complete the synchronized motion to direct the focus laser energy to the next location in the pattern 300.
  • Figure 4C illustrates a pulse burst 420 using four (4) of the ablating sub-pulses 421 and four (4) of the coagulating sub-pulses 422, it will be apparent to those of skill in the art that this quantity is only exemplary and that, in other embodiments, a pulse burst 420 may include any quantity each of the ablating sub-pulses 421 and the coagulating sub-pulses 422 greater than two (2) depending on the desired clinical results.
  • the ablation threshold “e” is less than 1.8 joules/cm 2 . In some such embodiments, the ablation threshold “e” is in a range of from 0.01 joules/cm 2 to 1.8 joules/cm 2 . In some such embodiments, the ablation threshold “e” is in a range of from 0.1 joules/cm 2 to 1.8 joules/cm 2 . In some such embodiments, the ablation threshold “e” is in a range of from 0.5 joules/cm 2 to 1.8 joules/cm 2 .
  • the ablation threshold “e” is in a range of from 1 joules/cm 2 to 1.8 joules/cm 2 . In some such embodiments, the ablation threshold “e” is in a range of from 1.4 joules/cm 2 to 1.8 joules/cm 2 . In some such embodiments, the ablation threshold “e” is in a range of from 1.5 joules/cm 2 to 1.8 joules/cm 2 . In some such embodiments, the ablation threshold “e” is in a range of from 1.6 joules/cm 2 to 1.8 joules/cm 2 .
  • the ablation threshold “e” is in a range of from 1.7 joules/cm 2 to 1.8 joules/cm 2 . In some such embodiments, the ablation threshold “e” is in a range of from 1.4 joules/cm 2 to 1.7 joules/cm 2 . In some such embodiments, the ablation threshold “e” is in a range of from 1.5 joules/cm 2 to 1.7 joules/cm 2 . In some such embodiments, the ablation threshold “e” is in a range of from 1.6 joules/cm 2 to 1.7 joules/cm 2 .
  • the ablation threshold “e” is in a range of from 1.4 joules/cm 2 to 1 .6 joules/cm 2 . Tn some such embodiments, the ablation threshold “e” is in a range of from 1.5 joules/cm 2 to 1.6 joules/cm 2 . In some such embodiments, the ablation threshold “e” is in a range of from 1.4 joules/cm 2 to 1.5 joules/cm 2 . In some such embodiments, the ablation threshold “e” is in a range of from 1.55 joules/cm 2 to 1.65 joules/cm 2 . In some such embodiments, the ablation threshold “e” is about 1.6 joules/cm 2 . In some such embodiments, the ablation threshold “e” is 1.6 joules/cm 2 .
  • the pulse burst 420 is structured to include any plurality of subpulses in similar combination without limitation to the number of pulses in the burst.
  • a pulse burst 420 includes “n” number of ablative pulses and “N” number of coagulate pulses arranged in any other order.
  • the blending of ablating pulses 421 and coagulating pulses 422 in a pulse burst 420 has the effect of preventing bleeding when the exemplary device is used to cut tissue by coagulating the cut blood vessels, thereby preventing contamination and helping the cut to heal faster.
  • the blending of ablating pulses 421 and coagulating pulses 422 in a pulse burst 420 has the effect of allowing the ablating pulses 421 to be delivered deeper into the target tissue, allowing delivery of a blend of a preprogramed controlled amount of thermal injury that will reduce bleeding and will generate maximal natural healing following the treatment, leading to effective recovery without risk of complications due to too much un-wanted thermal injury.
  • FIG. 5 is a schematic illustration of a surgical instrument for cutting and coagulating ocular tissue in accordance with an exemplary embodiment.
  • the embodiment shown in FIG. 5 includes a working tool 500 that will be moved over target tissue 54 by the operator.
  • the working tool 500 is suitable for use for applications such as cutting and coagulation.
  • a mounting shaft 50 connects the assembly to applicator mount quick disconnect 100, as shown in FIG. 1A.
  • the laser beam enters at an aperture 56 and propagates through a focusing lens 51.
  • a working tool shaft 52 is usable by the operator to hold the device.
  • the operator places a tip pointer 55 in contact with the target ocular tissue 54 to direct the focused laser energy 53 to the target ocular tissue 54.
  • the operator can select any of the three different pre-programed pulse types (e.g., as described above with reference to FIGS. 4A, 4B, and 4C) to cut and ablate ocular tissue while moving the working tool 500 manually.
  • the instrument shown in FIG. 5 enables the operator to cut target ocular tissue efficiently and without thermal damage, allowing treatment of sensitive ocular tissue that can be easily damaged by any unwanted thermal injury.
  • FIG. 6 is a schematic illustration of an exemplary embodiment of a working tool 600 using fiber optics for cutting and coagulating ocular tissue in accordance with the present invention.
  • the working tool 600 shown in FIG. 6 includes fiber optics to enable the operator to deliver laser energy to target ocular tissue.
  • the working tool 600 shown in FIG. 6 includes a mounting shaft 61 to connect with the quick disconnect 100 of the device 24.
  • the laser beam 60 propagates through focusing optics 67 with the laser energy focused on the face of fiber optics 66.
  • a fiber optics connector 63 is mounted on a housing 62 and can be aligned the fiber optics center line to be concentric with the laser focus beam 68.
  • the fiber optics 66 is mounted inside a stainless-steel metal tube 64 to protect the fiber optics 66 from breaking during use by the operator during treatment of target tissue.
  • the fiber optics 66 has a core diameter of 140 pm, providing a spot size of 170 pm treat ocular tissue as the focused scanner beam.
  • the working tool 600 shown in FIG. 6 provides the operator with the ability to access and deliver laser energy to target ocular tissue in tight locations.
  • using the blended pulses described above with reference to FIG. 6C may increase the effectiveness of ablative tissue treatment in areas with tight access without depositing unwanted thermal damage, and the apparatus can deliver a pre-programmed amount of coagulation and thermal damage to achieve the desired clinical results even in places with very challenging physical access.
  • FIG. 7 is a schematic illustration of an exemplary optical working tool 700 configured for use with the device 24 of FIG. 1 A and adapted for use in the ablation of ocular tissue.
  • the optical working tool 700 includes an optical fiber 702 that is suitable for forming a hole in ocular tissue by ablation.
  • the optical fiber 702 comprises sapphire.
  • the optical fiber 702 comprises glass, quartz glass, hollow-core silica, hollow-core photonic crystal fiber, fluoride, ZBLAN (e.g., a fluoride glass including ZrF4, BaF2, LaFs, AIF3, and NaF), and/or germanium.
  • ZBLAN e.g., a fluoride glass including ZrF4, BaF2, LaFs, AIF3, and NaF
  • the optical fiber 702 has a diameter that is from 100 pm to 500 pm. Tn some embodiments, the optical fiber 702 has a diameter that is from 100 pm to 300 pm. In some embodiments, the optical fiber 702 has a diameter that is from 300 pm to 500 pm. In some embodiments, the optical fiber 702 has a diameter that is from 100 pm to 400 pm. In some embodiments, the optical fiber 702 has a diameter that is from 100 pm to 200 pm. In some embodiments, the optical fiber 702 has a diameter that is from 100 pm to 180 pm. In some embodiments, the optical fiber 702 has a diameter that is from 120 pm to 160 pm. In some embodiments, the optical fiber 702 has a diameter that is about 140 pm.
  • the optical fiber 702 has a diameter that is 140 pm. In some embodiments, the optical fiber 702 has a distal end 704 that is polished so as to facilitate contact with target tissue (e.g., so as to provide good contact for delivery of pulses without abrading the target tissue). In some embodiments, the distal end 704 includes a fiber tip that is formed of a different material than is the remainder of the optical fiber 702. Tn some embodiments, the fiber tip includes a biocompatible material. In some embodiments, the fiber tip is rigid. In some embodiments, the fiber tip includes sapphire. In some embodiments, the fiber tip includes silica.
  • the optical fiber 702 includes a germanium oxide glass core, a glass cladding, a polymeric coating (e.g., a polyamide coating), and a thermoplastic external coating, and includes a tip including fused silica or sapphire.
  • the optical fiber 702 includes a hollow-core waveguide having an inner reflector (e.g., a silver iodide reflector) covered by a silica tube and an acrylate buffer.
  • a hollow-core waveguide includes a window at the distal end (e.g., made from diamond or zinc selenium) to prevent water entry.
  • the optical fiber 702 is encased in a protective tube 706.
  • the protective tube 706 comprises stainless steel.
  • the protective tube 706 comprises stainless steel.
  • the stainless steel of the protective tube 706 is from 30 gauge (e.g., having an inner diameter of 0.159 mm) to 20 gauge (e.g., having an inner diameter of 0.603 mm), as measured using the American wire gauge (“AWG”) system.
  • AWG American wire gauge
  • the protective tube 706 comprises AWG 23 stainless steel.
  • the protective tube 706 comprises another biocompatible material, such as a biocompatible polymer.
  • the protective tube 706 connects to a tube connector 708 and the optical fiber 702 continues into the tube connector 708. Tn some embodiments, the optical fiber 702 and the protective tube 706 have a total combined length L between the distal end 704 and the tube connector 708. In some embodiments, the length L is selected to provide sufficient clearance for the optical working tool 700 to be used for treatments on the eye, while allowing the position of the optical fiber 702 to be controlled by a user. In some embodiments, the length L is between 30 millimeters and 50 millimeters. In some embodiments, the length L is between 39 millimeters and 45 millimeters. In some embodiments, the length L is between 40 millimeters and 44 millimeters.
  • the length L is about 42 millimeters. In some embodiments, the length L is 42 millimeters.
  • the optical fiber 702 ends at a subminiature assembly (“SMA”) 905 connector 710 that joins the tube connector 708. In some embodiments, the SMA 905 connector 710 is operable to join the optical working tool 700 to the quick disconnect connector 100 of the device 24. Tn some embodiments, the optical working tool 700 is designed to be single-use. In some embodiments, the optical working tool 700 is distributed in a singleuse sterile pouch.
  • SMA subminiature assembly
  • FIG. 8A shows an embodiment of an exemplary optical working tool 800 configured for use with the device 24 of FIG. 1 A and adapted for use in the ablation of ocular tissue.
  • the optical working tool 800 includes an optical fiber 802 that is suitable for forming a hole in ocular tissue by ablation.
  • the optical fiber 802 may have any of the properties discussed above with reference to the optical fiber 702 of the optical working tool 700.
  • the optical fiber 802 has a distal end 804 that is polished so as to facilitate contact with target tissue (e.g., so as to provide good contact for delivery of pulses without abrading the target tissue).
  • the optical fiber 802 is encased in a protective tube 806.
  • the protective tube may have any of the properties discussed above with reference to the protective tube 706.
  • the protective tube 806 connects to a housing 808 and the optical fiber 802 continues into the housing 808.
  • the housing includes a movement mechanism 810 that is configured to control movement of the optical fiber 802.
  • the optical fiber 802 ends at a subminiature assembly (“SMA”) 905 connector 812 that joins the housing 808.
  • SMA 905 connector 812 is operable to join the optical adapter structure 800 to the quick disconnect 100 of the device 24.
  • the optical working tool 800 is designed to be single-use. In some embodiments, the optical working tool 800 is distributed in a single-use sterile pouch.
  • FIG. 8B shows the optical working tool 800 as coupled to the quick disconnect 100 of the device 24.
  • the quick disconnect 100 includes a focusing lens that is configured to convey the laser beam from the device 24 to the optical fiber 802.
  • the focusing lens of the quick disconnect 100 when in use, has a focal length that is in a range of from 20 mm to 100 mm.
  • the focusing lens of the quick disconnect 100 when in use, has a focal length that is in a range of from 20 mm to 80 mm.
  • the focusing lens of the quick disconnect 100 when in use, has a focal length that is in a range of from 20 mm to 60 mm.
  • the focusing lens of the quick disconnect 100 when in use, has a focal length that is in a range of from 30 mm to 50 mm. In some embodiments, the focusing lens of the quick disconnect 100, when in use, has a focal length that about 40 mm. In some embodiments, the focusing lens of the quick disconnect 100, when in use, has a focal length that is about 39 mm. In some embodiments, the focusing lens of the quick disconnect 100, when in use, has a focal length that is 39 mm.
  • the focusing lens of the quick disconnect 100 when in use, generates a laser spot size that is in a range of from 10 pm to 100 pm. In some embodiments, the focusing lens of the quick disconnect 100, when in use, generates a laser spot size that is in a range of from 10 pm to 75 pm. In some embodiments, the focusing lens of the quick disconnect 100, when in use, generates a laser spot size that is in a range of from 10 pm to 50 pm. In some embodiments, the focusing lens of the quick disconnect 100, when in use, generates a laser spot size that is in a range of from 20 pm to 40 pm.
  • the focusing lens of the quick disconnect 100 when in use, generates a laser spot size that is about 30 pm. In some embodiments, the focusing lens of the quick disconnect 100, when in use, generates a laser spot size that is 30 pm.
  • FIGS. 9A and 9B show an embodiment of an exemplary optical working tool 900 configured for use with the device 24 of FIG. 1A and adapted for use in the ablation of ocular tissue.
  • FIG. 9A shows the entire working tool 900 and FIG. 9B shows a section view of a tip region of the working tool 900.
  • the optical working tool 900 includes an optical fiber 902 that is suitable for forming a hole in ocular tissue by ablation.
  • the optical fiber 902 may have any of the properties discussed above with reference to the optical fiber 702 of the optical working tool 700.
  • the optical fiber 902 has a distal end 904 that is polished so as to facilitate contact with target tissue (e.g., so as to provide good contact for delivery of pulses without abrading the target tissue).
  • the optical fiber 902 is encased in a protective jacket 906.
  • the protective jacket 906 comprises a polymer.
  • the polymer includes a UV-cured acrylate, polytetrafluoroethylene (“PTFE”), polyether ether ketone (“PEEK”), or a combination including more than one of the above.
  • the protective j acket 906 has an outer diameter OD1.
  • the outer diameter OD1 is between 1 millimeter and 1.5 millimeter. Tn some embodiments, the outer diameter OD1 is between 1.2 millimeter and 1.3 millimeter. In some embodiments, the outer diameter OD1 is about 1.25 millimeter.
  • the outer diameter OD1 is about 1.27 millimeter. In some embodiments, the outer diameter OD1 is 1.27 millimeter.
  • the protective jacket 906 connects to a tube connector 908 and the optical fiber 902 continues into the tube connector 908. In some embodiments, the optical fiber 902 and the protective jacket 906 have a total combined length LI between the distal end 904 and the tube connector 908. In some embodiments, the length LI is selected to provide sufficient clearance for the optical working tool 900 to be used for treatments on the eye, while allowing the position of the optical fiber 902 to be controlled by a user. In some embodiments, the length LI is between 500 millimeters and 1500 millimeters.
  • the length LI is between 750 millimeters and 1250 millimeters. In some embodiments, the length LI is about 1000 millimeters. In some embodiments, the length LI is 1000 millimeters.
  • the optical fiber 902 ends at an SMA 905 connector 910 that joins the tube connector 908. In some embodiments, the SMA 905 connector 910 is operable to join the optical working tool 900 to the quick disconnect connector 100 of the device 24.
  • a portion of the optical fiber 902 near the distal end 904 protrudes from the protective jacket 906.
  • a rigid tube 912 encases a portion of the optical fiber 902 protruding from the protective jacket 906.
  • the rigid tube 912 comprises a metal.
  • the rigid tube 912 comprises a biocompatible metal.
  • the rigid tube 912 comprises stainless steel.
  • a portion of the rigid tube 912 extends into the protective jacket 906.
  • the rigid tube 912 has an outer diameter OD2. In some embodiments, the outer diameter OD2 is between 0.5 millimeter and 1 millimeter.
  • the outer diameter OD2 is between 0.6 millimeter and 0.8 millimeter. In some embodiments, the outer diameter OD2 is between 0.65 millimeter and 0.75 millimeter. In some embodiments, the outer diameter 01)2 is about 0.7 millimeter. In some embodiments, the outer diameter OD2 is 0.7 millimeter. In some embodiments, the portion of the rigid tube 912 protruding from the protective jacket 906 has a length L2. In some embodiments, the length L2 is between 10 millimeters and 30 millimeters. Tn some embodiments, the length /.2 is between 15 millimeters and 25 millimeters. In some embodiments, the length L2 is about 20 millimeters. In some embodiments, the length L2 is 20 millimeters.
  • a portion of the optical fiber 902 including the distal end 904 protrudes from the protective jacket 906.
  • the portion of the optical fiber 902 protruding from the protective j acket 906 has a length L3.
  • the length L3 is between 0.1 millimeter and 2 millimeters. In some embodiments, the length L3 is between 0.5 millimeter and 1.5 millimeter. In some embodiments, the length L3 is about 1 millimeter. In some embodiments, the length L3 is 1 millimeter.
  • the optical working tool 900 includes a meniscus 914.
  • the meniscus 914 is positioned at the end of the protective tube 912 and seals space between the inner wall of the protective tube 912 and the optical fiber 902. In some embodiments, the meniscus 912 prevents any air space from existing between the protective tube 912 and the optical fiber 902, and thereby protects the optical fiber 902 from the external environment. In some embodiments, the meniscus 914 comprises an epoxy resin.
  • the optical working tool 900 is designed to be single-use. In some embodiments, the optical working tool 900 is distributed in a single-use sterile pouch.
  • the optical working tool 700, 800, or 900 is usable in conjunction with the device 24 for performing radiation-based treatment (e.g., laser treatment) in ophthalmic applications (e g., on or within the eye).
  • radiation-based treatment e.g., laser treatment
  • ophthalmic applications e.g., on or within the eye.
  • a clinician couples the optical working tool 700 to the device 24 by coupling the SMA 905 connector 710, 812, or 910 to the quick disconnect 100, configures the device 24 to provide desired radiation (e.g., pulse intensity, duration, etc., such as the pulse bursts 420 shown in FIG.
  • the working tools 270, 500, 600, 700, 800, and 900 used in conjunction with the device 24, are suitable for use in the performance of radiation-based (e.g., laser-based) ophthalmic procedures.
  • ophthalmic procedures include, but are not limited to, the incision, excision, vaporization, ablation and coagulation of ocular tissue.
  • a system including the device 24 and one of the working tools described herein is suitable for use in the performance of radiation-based (e.g., laser-based) ophthalmic procedures
  • the optical working tool 700, 800, or 900 together with the device 24 is suitable for use in the performance of ophthalmic procedures that involve formation of a hole in tissue of the eye.
  • the working tool 700, 800, or 900 together with the device 24 is suitable for use in such procedures including glaucoma treatment procedures that involve formation of a hole through the trabecular meshwork or through the sclera to generate a drainage channel.
  • the optical working tool 700, 800, or 900 together with the device 24 is suitable for use in such procedures that are performed using an ab-interno approach (e.g., advancing a probe across the eye and forming a channel from within the eye) or an ab-extemo approach (e.g., forming a channel from outside the eye).
  • the optical working tool 700, 800, or 900 together with the device 24 is suitable for performance of minimally- invasive glaucoma surgery (“MTGS”) in accordance with the above techniques.
  • MTGS minimally- invasive glaucoma surgery
  • the optical working tool 700, 800, or 900 together with the device 24 is suitable for use in a procedure for performing MIGS without leaving a stent in the eye to maintain the shape of a drainage channel.
  • the optical working tool 700, 800, or 900 together with the device 24 enables a practitioner to create a round drainage path having consistent size that will not require an implant (e.g., a stent) to maintain, thereby avoiding the risk of implant migration or blockage.
  • the device 24 is operated in a manner so as to apply the pulse bursts 420 described above with reference to FIG. 4C in the performance of ophthalmic procedures such as MIGS, and the pulse bursts 420 generate a drainage path with minimal bleeding and enhanced healing.
  • the following embodiments illustrate the use of the system for animal experiments in living rabbits, and the wavelength of the fiber laser is 2940 u m. The surgical procedure is as follows:
  • the laser power, laser beam focus, overlap, and repeat delay were verified.
  • the overlap rate is 50%-70%.
  • the cornea was protected with a wet sponge.
  • the laser beam was applied to the scleral wall in an area that included the Schlemm's Canal until the outer wall of the Schlemm's Canal was ablated.
  • the charred tissue was wiped after ablation every 1-3 laser scans, scanning proceeded until percolation was achieved and percolation zone length measured at least 2.5mm.
  • the cw pulse time is 70-300 microseconds, further to 70-250 microseconds, further to 70-220 microseconds, further to 170 microseconds to 220 microseconds, further to 70 microseconds or 170 microseconds or 220 microseconds or 250 microseconds.
  • the pulse energy is 2.5-5 mJ/pulse, and further, the pulse energy is 4-4.7 mJ/pulse, and further, 2.5-4.7mJ/pulse.
  • the overlap rate is 50% to 70%.
  • Various exemplary embodiments have been described herein with reference to user interface and interaction accomplished through user interface elements such as a touch panel 10 and a foot switch 26.
  • user interface elements such as a touch panel 10 and a foot switch 26.
  • any other type of user interface element or combination of interface elements e.g., a handheld controller; a computer interface including a keyboard, mouse, touchpad, and/or other pointing element; a voice controller; a software control application running on a tablet, mobile phone, or other mobile device; etc.
  • a handheld controller e.g., a handheld controller; a computer interface including a keyboard, mouse, touchpad, and/or other pointing element; a voice controller; a software control application running on a tablet, mobile phone, or other mobile device; etc.

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

Abstract

La présente invention concerne des systèmes et des méthodes de traitement ophtalmique à base de rayonnement, par exemple, des dispositifs à base de laser pour fournir un traitement fractionnaire, ou des dispositifs utilisant n'importe quel autre type de source de rayonnement pour fournir tout autre type approprié de traitement ophtalmique. Certains modes de réalisation comprennent un système de balayage automatisé pour balayer un faisceau vers de multiples emplacements sur l'œil pour traiter des affections de l'œil.
PCT/US2023/017176 2022-03-31 2023-03-31 Systèmes et méthodes de traitement ophtalmique WO2023192625A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5336215A (en) * 1993-01-22 1994-08-09 Intelligent Surgical Lasers Eye stabilizing mechanism for use in ophthalmic laser surgery
US6899707B2 (en) * 2001-01-29 2005-05-31 Intralase Corp. Applanation lens and method for ophthalmic surgical applications
US20110190741A1 (en) * 2008-08-25 2011-08-04 Thomas Deisinger Coupling of an eye to a laser device
US20120022510A1 (en) * 2009-03-05 2012-01-26 Cynosure, Inc. Thermal surgery safety apparatus and method
US20220118277A1 (en) * 2020-10-19 2022-04-21 FA Corporation Laser surgical apparatus for performing treatment by irradiating a part to be treated by a variable pulsed laser beam
US20220175449A1 (en) * 2020-12-07 2022-06-09 FA Corporation Aesthetic laser apparatus for performing treatment by irradiating a human skin to be treated by a variable pulsed laser beam

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5336215A (en) * 1993-01-22 1994-08-09 Intelligent Surgical Lasers Eye stabilizing mechanism for use in ophthalmic laser surgery
US6899707B2 (en) * 2001-01-29 2005-05-31 Intralase Corp. Applanation lens and method for ophthalmic surgical applications
US20110190741A1 (en) * 2008-08-25 2011-08-04 Thomas Deisinger Coupling of an eye to a laser device
US20120022510A1 (en) * 2009-03-05 2012-01-26 Cynosure, Inc. Thermal surgery safety apparatus and method
US20220118277A1 (en) * 2020-10-19 2022-04-21 FA Corporation Laser surgical apparatus for performing treatment by irradiating a part to be treated by a variable pulsed laser beam
US20220175449A1 (en) * 2020-12-07 2022-06-09 FA Corporation Aesthetic laser apparatus for performing treatment by irradiating a human skin to be treated by a variable pulsed laser beam

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