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EP-4218694-B1 - METHODS AND SYSTEMS FOR COMBINED SONIC AND LASER APPLICATIONS FOR THE EYE

EP4218694B1EP 4218694 B1EP4218694 B1EP 4218694B1EP-4218694-B1

Inventors

  • NEWTON, ARTHUR
  • MCWHIRTER, JOHN
  • GRAY, GARY
  • TEUMA, VALAS E.
  • CONNAUGHTON, Alan
  • Morley, Dustin
  • CURATU, George
  • ANDERSON, SCOTT
  • MCPHERSON, DALE

Dates

Publication Date
20260506
Application Date
20210101

Claims (12)

  1. An integrated laser-ultrasound system (1400), comprising: a. a first housing (1401), a second housing (1406), a graphical user interface, GUI (1413) and a means for optically connecting (1405) the first housing and the second housing; wherein the second housing is moveably associated with the first housing; b. an assembly, the assembly comprising: i. a therapeutic laser (204) for providing a therapeutic laser beam along a laser beam delivery path, comprising a therapeutic laser control system (212); ii. a phacoemulsification system (205) for providing therapeutic ultrasonic energy, comprising a phacoemulsification system control system (211); iii. wherein at least a portion of the therapeutic laser and the phacoemulsification system are located within the first housing (1401); c. an integration control system (208) in control communication with the therapeutic laser control system (212), the phacoemulsification system (211) and the GUI (1413, 209); d. a safety interlock, whereby the laser system is prevented from firing the therapeutic laser when the phacoemulsification system is in operation; e. a beam shaping and directing assembly (400) comprising a z-focus, a scanner and a lens; wherein the beam shaping and directing assembly is contained in the second housing; f. wherein the means for optically connecting the first housing and the second housing is in optical communication with the therapeutic laser and the beam shaping and directing assembly; g. an arm (1407) attached to the second housing and in optical communication with the beam shaping and directing assembly: i. the arm having a distal end and a proximal end, wherein the distal end is adjacent the second housing; ii. the proximal end having a laser delivery head (1408); iii. the laser delivery head comprising an optical element on the laser beam delivery path for receiving and directing the laser beam along the laser beam delivery path through an opening in the laser delivery head; iv. wherein the arm contains a portion of the laser beam delivery path; whereby the arm places the laser delivery head in optical communication with the beam shaping and directing assembly; v. the laser head comprising a means for determining the shape and position of a structure of the eye; wherein the means for determining the shape and position (1412) is in control communication with the integration control system, the therapeutic laser control system, or both; h. wherein the system is configured to be located at an angle (630) with respect to a patient position, wherein the angle is defined by a longitude axis of the arm and a patient axis; wherein the angle comprises the angles of about 45°, about 90°, about 135°, and about 180°.
  2. The system of claim 2, wherein the system comprises a foot switch in control communication with one or more of the integration control system, the therapeutic laser control system, and the phacoemulsification control system, and preferably wherein the foot switch is wireless.
  3. The system of claims 1 or 2, wherein the system is configured to provide two therapeutic laser beams having different pulse durations, and preferably wherein both therapeutic laser beams are configured to ablate tissue, cut tissue, or both.
  4. The system of claims 1, 2, or 3, wherein: a. the integration control system, the therapeutic laser control system or both have a plurality of predetermined laser delivery patterns; b. the integration control system, the phacoemulsification control system or both have, a plurality of predetermined phacoemulsification procedures; and, c. the system is configured to determine information about a cataract in a lens of an eye, and recommend, at least in part, a laser-phaco combined therapy based upon the determined information about the cataract; wherein the laser-phaco combined therapy comprises: i. at least one of the plurality of predetermined laser delivery patterns; and, ii. at least one of the plurality of predetermined phacoemulsification producers.
  5. The system of claim 4, wherein the determined information is a grade of the cataract.
  6. The systems of any of the foregoing claims comprising an iris registration system.
  7. The systems of any of the foregoing claims 1 to 6, wherein the therapeutic laser is selected from the group of lasers consisting of a femtosecond laser and a picosecond laser.
  8. The systems of any of the foregoing claims, wherein the system is non-handed.
  9. The systems of any of the foregoing claims, wherein the system comprises a phaco tray and a phaco cassette and is non-handed.
  10. The systems of any of the foregoing claims 1 to 9, wherein associated with the opening is a means for closing the opening during operation of the phaco system, when the laser head is in a retracted position, or both.
  11. A method of using an integrated laser-phaco system (200) comprising: a graphical user interface, GUI (209); a therapeutic laser (204) for providing a therapeutic laser beam along a laser beam delivery path, comprising a therapeutic laser control system (212); a phacoemulsification system (205) for providing therapeutic ultrasonic energy, comprising a phacoemulsification system control system (211); an integration control system (208) in control communication with the therapeutic laser control system, the phacoemulsification system and the GUI, to determine, provide or both, a laser-phaco combined therapy for a cataractous eye of a patient, the method comprising: a. the system evaluating information about a cataract in a lens of the cataractous eye of the patient, whereby a determined information about the cataract is provided; b. the system determining a recommended laser-phaco combined therapy, based at least in part, upon the determined information about the cataract; wherein the recommended laser-phaco combined therapy comprises a predetermined laser delivery pattern, and a predetermined phacoemulsification procedure; c. the system displaying on the GUI the menu items relating to the recommended laser-phaco combined therapy; d. the system receiving a selection of the recommended laser-phaco combined therapies for deliver to the lens of the eye of the patient.
  12. A method of servicing or upgrading a control software operating the integration control system (208) of any of the systems of claims 1 to 10, the method comprising providing a maintenance service, up grading the software or both, for any of the systems of claims 1 to 10.

Description

BACKGROUND OF THE INVENTION Field of the Invention The present invention relates to systems and methods for treating the structures of the eye, including animal, mammal and human eyes. In particular, embodiments of the present inventions relate to systems and methods for the combined use of sonic energy, including ultrasonic, and light energy, including laser, for addressing conditions of the eye. The anatomical structures of the natural human eye are shown in general in FIG. 11, which is a cross sectional view of the eye. The sclera 131 is the white tissue that surrounds the lens 103 except at the cornea 101. The cornea 101 is the transparent tissue that comprises the exterior surface of the eye through which light first enters the eye. The iris 102 is a colored, contractible membrane that controls the amount of light entering the eye by changing the size of the circular aperture at its center (the pupil). The ocular or natural crystalline lens 103, a more detailed picture of which is shown in FIGS. 11A, (utilizing similar reference numbers for similar structures) is located just posterior to the iris 102. The terms ocular lens, natural crystalline lens, natural lens, natural human crystalline lens, and lens (when referring to the prior terms) are used interchangeably herein and refer to the same anatomical structure of the human eye. Generally, the ocular lens changes shape through the action of the ciliary muscle 108 to allow for focusing of a visual image. A neural feedback mechanism from the brain allows the ciliary muscle 108, acting through the attachment of the zonules 111, to change the shape of the ocular lens. Generally, sight occurs when light enters the eye through the cornea 101 and pupil, then proceeds through the ocular lens 103 through the vitreous 110 along the visual axis 104, strikes the retina 105 at the back of the eye, forming an image at the macula 106 that is transferred by the optic nerve 107 to the brain. The space between the cornea 101 and the retina 105 is filled with a liquid called the aqueous 117 in the anterior chamber 109 and the vitreous 110, a gel-like clear substance, in the chamber posterior to the lens. FIG. 11A illustrates, in general, components of and related to the lens 103 for a typical 50-year old individual. The lens 103 is a multi-structural system. The lens 103 structure includes a cortex 113, and a nucleus 129, and a lens capsule 114. The capsule 114 is an outer membrane that envelopes the other interior structures of the lens. The lens epithelium 123 forms at the lens equatorial 121 generating ribbon-like cells or fibrils that grow anteriorly and posteriorly around the ocular lens. The nucleus 129 is formed from successive additions of the cortex 113 to the nuclear regions. The continuum of layers in the lens, including the nucleus 129, can be characterized into several layers, nuclei or nuclear regions. These layers include an embryonic nucleus 122, a fetal nucleus 130, both of which develop in the womb, an infantile nucleus 124, which develops from birth through four years for an average of about three years, an adolescent nucleus 126, which develops from about four years until puberty which averages about 12 years, and the adult nucleus 128, which develops at about 18 years and beyond. The embryonic nucleus 122 is about 0.5 mm in equatorial diameter (width) and 0.425 mm in Anterior-Posterior axis 104 (AP axis) diameter (thickness). The fetal nucleus 130 is about 6.0 mm in equatorial diameter and 3.0 mm in AP axis 104 diameter. The infantile nucleus 124 is about 7.2 mm in equatorial diameter and 3.6 mm in AP axis 104 diameter. The adolescent nucleus 126 is about 9.0 mm in equatorial diameter and 4.5 mm in AP axis 104 diameter. The adult nucleus 128 at about age 36 is about 9.6 mm in equatorial diameter and 4.8 mm in AP axis 104 diameter. These are all average values for a typical adult human lens approximately age 50 in the accommodated state, ex vivo. Thus this lens (nucleus and cortex) is about 9.8 mm in equatorial diameter and 4.9 mm in AP axis 104 diameter. Thus, the structure of the lens is layered or nested, with the oldest layers and oldest cells towards the center. The lens is a biconvex shape as shown in FIGS. 11 and 11A. The anterior and posterior sides of the lens have different curvatures and the cortex and the different nuclei in general follow those curvatures. Thus, the lens can be viewed as essentially a stratified structure that is asymmetrical along the equatorial axis and consisting of long crescent fiber cells arranged end to end to form essentially concentric or nested shells. The ends of these cells align to form suture lines in the central and paracentral areas both anteriorly and posteriorly. The older tissue in both the cortex and nucleus has reduced cellular function, having lost their cell nuclei and other organelles several months after cell formation. Compaction of the lens occurs with aging. The number of lens fibers that gro