Integrated system for composite laser-ultrasonic wave phacoemulsification suction treatment

Abstract

To provide a system and method for a treatment of an eye structure which uses a combination of an acoustic energy containing ultrasonic wave and an optical energy containing a laser for a treatment of eye disease.SOLUTION: Provided is an integrated system and method for a laser surgery and an ultrasonic phacoemulsification suction surgery. A reconfiguration system performs a laser treatment in a laser form, is reconfigured into the ultrasonic phacoemulsification suction form to perform the ultrasonic phacoemulsification, and reconfigured to return to the laser form. A right-left system offers a precise position and use around the patient. A composite laser-ultrasonic treatment is determined including an integrated image formation, a grading of cataract, and a femto-ultrasonic phacoemulsification suction treatment. An integrated control / measurement system recommends and transmits a predefined laser shot pattern and a predefined ultrasonic phacoemulsification suction treatment to address an eye disease including a cataract.SELECTED DRAWING: Figure 21

Description

[Technical Field]

[0001] This application claims the benefit of priority and filing date under 35 U.S.C. §119(e)(1) to U.S. Provisional Application No. 62 / 956,731, filed January 3, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] The present invention relates to systems and methods for treating ocular structures, including the eyes of animals, mammals, and humans. In particular, embodiments of the present invention relate to systems and methods for using a combination of sonic energy, including ultrasound, and optical energy, including laser, to address ocular conditions. [Background technology]

[0003] The anatomy of the natural human eye is shown schematically in FIG. 11, which is a cross-sectional view of the eye. The sclera 131 is the white tissue surrounding the lens 103, except for the cornea 101. The cornea 101 is the transparent tissue that makes up the outer surface of the eye and through which light first enters the eye. The iris 102 is a colored, contractile membrane that regulates the amount of light entering the eye by varying the size of the circular opening in its center (the pupil). The eye's or natural lens 103, a detailed view of which is shown in FIG. 11A (using similar reference numerals for similar structures), is located immediately behind the iris 102. The terms eye's lens, natural lens, natural lens, natural human lens, and crystalline lens are used interchangeably herein to refer to the same anatomical structure of the human eye.

[0004] Generally, the eye's lens changes shape through the action of the ciliary muscles 108 to enable focusing of visual images. A natural feedback mechanism from the brain allows the ciliary muscles 108 to change the shape of the eye's lens, acting through their attachment at the zonules 111. Generally, vision occurs when light enters the eye through the cornea 101 and pupil, travels along the visual axis 104, passes through the eye's lens 103, and through the vitreous body 110, striking the retina 105 at the back of the eye, forming an image on the macula 106 that is transmitted to the brain by the optic nerve 107. The space between the cornea 101 and retina 105 is filled with a gel-like, clear substance called aqueous humor 117 in the anterior chamber 109 and in the chamber in front of the lens in the vitreous body 110.

[0005] FIG. 11A generally illustrates the components of a lens 103 in a typical 50-year-old person. The lens 103 is a multi-structure system. The lens 103 structures include the cortex 113, the nucleus 129, and the lens capsule 114. The capsule 114 is an outer membrane that encases the other inner structures of the lens. The lens epithelium 123 forms a ribbon of cells or fibers that grow anteriorly and posteriorly around the lens of the eye at the lens's equator 121. The nucleus 129 is formed from successive additions of the cortex 113 to the nuclear region. The successive layers within the lens, including the nucleus 129, are characterized by several layers, nuclei, or nuclear regions. These layers include the embryonic nucleus 122 and fetal nucleus 130, which develop in utero; the infantile nucleus 124, which develops for an average of about three years from birth to four years of age; the adolescent nucleus 126, which develops from about four years of age until puberty, averaging about 12 years of age; and the adult nucleus 128, which develops beyond about 18 years of age.

[0006] The fetal nucleus 122 has an equatorial diameter (width) of approximately 0.5 mm and a diameter (thickness) along the anterior-posterior axis 104 (AP axis) of 0.425 mm. The fetal nucleus 130 has an equatorial diameter of approximately 6.0 mm and a diameter along the AP axis 104 of 3.0 mm. The infantile nucleus 124 has an equatorial diameter of approximately 7.2 mm and a diameter along the AP axis 104 of 3.6 mm. The adolescent nucleus 126 has an equatorial diameter of approximately 9.0 mm and a diameter along the AP axis 104 of 4.5 mm. The 36-year-old adult nucleus 128 has an equatorial diameter of approximately 9.6 mm and a diameter along the AP axis 104 of 4.8 mm. These are all average values ​​for a typical lens of an adult approximately 50 years old in a confined state in vitro. Thus, this lens (nucleus and cortex) has an equatorial diameter of approximately 9.8 mm and a diameter along the AP axis 104 of 4.9 mm. Thus, the structure of the lens is layered or nested, with older layers and cells towards the center.

[0007] The lens, as shown in Figures 11 and 11A, has a biconvex shape. The anterior and posterior sides of the lens have different curvatures, and the cortex and separate nucleus generally follow those curvatures. Thus, the lens appears asymmetric along its equatorial axis and essentially a stratified structure, consisting of long, crescent-shaped fiber cells arranged end-to-end to form essentially concentric or nested shells. The ends of these cells are arranged to form sutures anteriorly and posteriorly in the central paracentral region. Older tissues, both the cortex and nucleus, lose their nuclei and other organelles several months after cell formation, and cellular function declines.

[0008] Lens compression occurs with age. The number of lens fibers grown each year remains relatively constant throughout life. However, lens size does not increase as much as would be predicted by new fiber growth. From birth to age 3, the lens grows from 3.6 mm to 7.2 mm, a 20% increase in just 3 years. Then, over the next approximately 10 years, growth increases from 7.2 mm to 9 mm, a 25% increase. However, this is over a 9-year period, three times longer. Over the next approximately 20 years, from age 12 to age 36, the lens grows from 9 mm to 9.6 mm, a 6.7% increase over 24 years. While this period is believed to be a relatively constant rate of fiber growth, it represents a dramatically slower growth rate. Finally, over the last approximately 20 years, from age 36 to age 54, the lens grows only a fraction of its youthful growth, from 9.6 to 9.8 mm, a 2.1% increase. Although there are shape effects that require more lens fibers to fill the larger outer shell, the size of the old lens is significantly smaller than predicted by fiber growth rate models that take shape effects into account. Fiber compaction, including nuclear fiber compaction, may explain these observations.

[0009] In general, presbyopia is a loss of accommodative width. In general, refractive errors are typically due to changes in the axial length of the eye. Myopia occurs when the eye is too long and the focal point is in front of the retina. Hyperopia occurs when the eye is too short and the focal point is behind the retina. In general, cataracts are areas of the eye's lens that are opaque enough to interfere with vision.

[0010] Presbyopia often manifests as abnormalities in near vision, particularly the inability to read small print in dim light after about age 40-45. Presbyopia, or the loss of accommodation range with age, is related to the eye's inability to change the shape of the lens, allowing for shifts in focus between near and far objects, and occurs in virtually 100% of the population. Accommodation range shows a steady decline with age through the fourth decade of life.

[0011] As used herein, unless otherwise stated, recitation of ranges of numerical values ​​herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within that range. Unless otherwise stated, each separate value within a range is incorporated herein as if it were individually referenced.

[0012] In general, the term "about," as used herein, unless otherwise specified, is meant to encompass a variation or range of ±10%, the experimental or instrumental error associated with obtaining the stated value, and preferably a larger variation or range thereof.

[0013] As used herein, unless otherwise specified, the terms "phacoemulsification," "phaco," and "phacoemulsification system" are to be given the broadest possible meaning and refer to similar general devices and procedures, and generally to the use of ultrasonic energy to drive a needle or tip to ablate, disrupt, separate, and emulsify tissue, including ocular tissue such as the lens and cataract. Such procedures and systems may also include components and methods for aspiration, irrigation, or both.

[0014] As used herein, unless otherwise specified, the terms "femtosecond laser," "femtosecond laser beam," "femtosecond pulse," and similar terms are used to refer to the pulse time and pulse length (also referred to as pulse width) of a laser beam, and are intended to refer to pulses of less than 1 picosecond (1×10 -12 seconds) to 1 femtosecond (fs) (1×10 -15 This refers to all lasers and laser beams with pulse widths up to 1000 Hz (up to 1000 Hz).

[0015] As used herein, unless otherwise specified, the terms "picosecond laser," "picosecond laser beam," "picosecond pulse," and similar terms are used to refer to the pulse width and pulse length (also referred to as pulse width) of a laser beam, and include pulses of 1 picosecond (ps) (1×10 -12 seconds) to 1 nanosecond (ns) (1 × 10 -9 This refers to all lasers and laser beams with pulse widths up to 1000 Hz (up to 1000 Hz).

[0016] As used herein, unless otherwise specified, the terms "distal" and "proximal" have the following meanings: With respect to lasers, laser beams, and laser components, distal means the side, location, or position closer to the laser beam source. With respect to phacoemulsification systems, distal means the side, location, or position closer to the ultrasonic energy source. With respect to lasers, laser beams, and laser components, proximal means the side, location, or position along the laser beam path that is farther away from the laser beam source and therefore closer to the patient during surgery. With respect to phacoemulsification systems, proximal means the side, location, or position along the energy transmission path that is farther away from the ultrasonic energy source and therefore closer to the patient during surgery. Conversely, the distal end of a laser component or phacoemulsification component is away from the patient during operation of those systems.

[0017] In addition to being a diagnostic tool, ultrasonic energy has therapeutic applications. It is focused and directed at cutting devices, tools, or tips, and combinations and variations thereof, to cut, soften, or emulsify tissue, creating mist and vapor, and causing them to move, e.g., vibrate or vibrate. Phacoemulsification is a medically recognized technique that uses ultrasonic energy for lens removal. Phacoemulsification generally involves creating a corneal incision, a scleral incision, or one or more or both of these. A phacoemulsification handpiece is inserted through one of these incisions and typically comprises a needle driven by ultrasound to, for example, emulsify (i.e., liquefy) the lens and break down cataracts into smaller pieces. The emulsified pieces can then be subsequently removed using the same or another handpiece. The surgeon can then insert an implant into the eye through the incision.

[0018] Generally, a therapeutic laser procedure on an eye involves placing a patient on a bed or patient support, aligning the eye with the laser beam path of a laser system, and attaching a patient interface between the laser system and the eye. The therapeutic laser beam is delivered in a laser beam pattern to perform therapeutic laser surgery on the eye, particularly on structures of the eye or structures associated with the eye, to address eye conditions. For example, laser procedures for addressing cataracts, presbyopia, refractive errors (both congenital and induced), and other eye conditions are known in the art.

[0019] Typical medical ultrasound devices and systems found in operating rooms and medical offices, particularly phacoemulsification systems, are stand-alone systems with their own power supplies, control systems, monitors, control and command inputs, housings, cabinets, and bases. Similarly, typical medical therapeutic laser devices and systems found in operating rooms and medical offices are stand-alone systems with their own power supplies, control systems, monitors, control and command inputs, housings, cabinets, and bases. Summary of the Invention [Problem to be solved by the invention]

[0020] The art has identified a need for combining ultrasound devices with other therapeutic devices, such as lasers, and while some rudimentary combinations have been offered, it is believed that this need remains largely unmet. To date, no one has successfully integrated a therapeutic ultrasound system with another system, such as a therapeutic laser delivery system, to provide a compact, effective medical system that meets the needs and desires of both regulatory authorities and physicians. In particular, prior to the present invention, it is believed that no one has successfully integrated an ophthalmic phacoemulsification system with a therapeutic ophthalmic laser system to provide a compact, effective medical system that meets the needs and desires of both regulatory authorities and physicians. Meeting these needs and desires involves more than simply combining two systems, as has been proposed in the art. These needs are met by the present invention, embodiments of which provide an integrated ultrasound-laser, and in particular, a phacoemulsification-laser system, that is a compact, effective, and ergonomic medical system that meets the needs and desires of both regulatory authorities and physicians.

[0021] This Background section is intended to introduce various aspects of the art that may be related to embodiments of the present invention. Thus, the preceding discussion in this section provides a framework for a better understanding of the invention and should not be construed as admissions of prior art.

[0022] There are long-standing unmet needs to address and improve, individually or in combination, the size of systems within operating rooms and medical offices, the ergonomics of operating rooms, surgical systems, and instruments, the time required to effectively perform procedures, and patient comfort, among other issues. These long-standing needs continue to exist, particularly in the field of ophthalmology, including addressing cataracts, refractive problems, presbyopia, and eye diseases, disorders, and injuries in the treatment and treatment of other ocular and nearby structures. The present application addresses these and other needs by providing, inter alia, the products, devices, and processes described in the specification, drawings, and claims. [Means for solving the problem]

[0023] A laser ultrasound system is provided, comprising: a therapeutic laser system; a phacoemulsification system for providing therapeutic ultrasound energy; and means for measuring the shape, position, or both, of an ocular structure.

[0024] The present invention provides laser systems, methods, and apparatus having one or more of the following features: the laser is selected from the group consisting of a femtosecond laser and a picosecond laser; the means for measuring the shape, position, or both of an ocular structure is a Scheimpflug camera means; the means for measuring the shape, position, or both of an ocular structure is a Scheimpflug camera means; the therapeutic laser system comprises an assembly supporting a movable arm including a laser beam path and a laser head, whereby the assembly is positioned relative to a patient position at an angle defined by a longitudinal axis of the arm and a patient axis, the angle including all angles in the range of about 45° to about 270°; the therapeutic laser system comprises an assembly supporting a movable arm including a laser beam path and a laser head, whereby the assembly is positioned relative to a patient position at an angle defined by a longitudinal axis of the arm and a patient axis, the angle including all angles in the range of about 45° to about 270°; the therapeutic laser system is the therapeutic laser system comprises an assembly supporting a movable arm including a laser beam path and a laser head, whereby the assembly is positioned relative to a patient's position at an angle defined by a longitudinal axis of the arm and a patient axis, the angle including all angles within the range of about 45° to about 270°; the therapeutic laser system comprises an assembly supporting a movable arm including a laser beam path and a laser head, whereby the assembly is positioned relative to a patient's position at an angle defined by a longitudinal axis of the arm and a patient axis, the angle including all angles within the range of about 45° to about 270°; a PID having a meniscus inverter; providing two therapeutic laser beams having different pulse widths; the Scheimpflug camera means comprises n cameras, where at least n-1 cameras have an unobstructed view of the patient's eye at any patient angle between 30° and 320°; the Scheimpflug camera means comprises n cameras, where n is 5; the Scheimpflug camera means comprises n cameras, where n is 6;the Scheimpflug camera means has n cameras, the cameras having an angular separation of at least 40°; the means for measuring the shape, position, or both of an ocular structure is an optical coherence tomography system; the means for measuring the shape, position, or both of an ocular structure further comprises an optical coherence tomography system;

[0025] Additionally, there is provided a laser ultrasound system comprising: a therapeutic laser system; a phacoemulsification system for providing therapeutic ultrasound energy; a control system; and means for measuring a shape, a position, or both, of an ocular structure, the means for measuring being adapted to provide information to the control system for grading a cataract, wherein at least a portion of the therapeutic laser system, the phacoemulsification system, and the control system share a common housing; the control system is in control communication with the therapeutic laser system, the phacoemulsification system, and the means for measuring; and the control system is adapted to determine a grade of the cataract based at least in part on the information provided by the means for measuring, whereby the control system is adapted to determine a combination of therapeutic laser and phacoemulsification treatments based in part on the determined grade of the cataract.

[0026] Further provided are laser systems, methods, and apparatus having one or more of the following features: said means for measuring the shape, position, or both of an ocular structure comprises a Scheimpflug imaging system; said means for measuring the shape, position, or both of an ocular structure comprises an optical coherence tomography system; said means for measuring the shape, position, or both of an ocular structure comprises a Scheimpflug camera means; said Scheimpflug camera means comprises n cameras, at least n-1 of which have an unobstructed view of the patient's eye at any patient angle between 30° and 320°; said Scheimpflug camera means comprises n cameras, at least n-1 of which have an unobstructed view of the patient's eye at any patient angle between 45° and 270°. the Scheimpflug camera means comprises n cameras, n being 5 or 6; the Scheimpflug camera means comprises n cameras, n being 5 or 6; the Scheimpflug camera means comprises n cameras, the cameras having an angular separation of at least 40°; the therapeutic laser system comprises an assembly supporting a movable arm including a laser beam path and a laser head, whereby the assembly is positioned at an angle, relative to a patient position, defined by a longitudinal axis of the arm and a patient axis, the angle being from about 30° to about 320°; providing two therapeutic laser beams having different pulse widths.

[0027] Still further provided is a laser ultrasound system comprising: a therapeutic laser system comprising: an arm having a proximal end, a laser head attached to the proximal end of the arm, and electronics for operating the therapeutic laser system; and a phacoemulsification system for providing therapeutic ultrasound energy, the phacoemulsification system having electronics for operating the phacoemulsification system, wherein the laser head is electrically isolated from the electronics for the phacoemulsification system, the electronics for the therapeutic laser system, or both.

[0028] Additionally, a laser system is provided, comprising: a therapeutic laser for providing a therapeutic laser beam; and an optical assembly for defining a laser beam path, the laser beam path being greater than 300 mm, thereby allowing the therapeutic laser beam pattern to be transmitted along the laser beam path without being magnified.

[0029] Further provided are laser systems, methods and apparatus having one or more of the following features: such that the laser is selected from the group consisting of a picosecond laser and a femtosecond laser; such that the laser is selected from the group consisting of a picosecond laser and a femtosecond laser, and further comprising an integrated phacoemulsification system.

[0030] Additionally, there is provided a laser system comprising: a therapeutic laser for providing a therapeutic laser beam; and an optical assembly for defining a laser beam path, the laser beam path being longer than 300 mm, thereby enabling a therapeutic laser beam pattern to be transmitted along the laser beam path without wavefront error.

[0031] Also provided is a laser system comprising: a therapeutic laser for providing a therapeutic laser beam; and an optical assembly for defining a laser beam path, the laser beam path being greater than 300 mm, thereby enabling a therapeutic laser beam pattern to be transmitted along the laser beam path without aberrations.

[0032] The present invention provides laser systems, methods, and apparatus having one or more of the following features: a means for measuring the shape, position, or both of an ocular structure, the means being selected from the group consisting of a Scheimpflug imaging system and an optical coherence tomography system; an iris registration system; a surgical microscope integrated into the system to receive one or more of images, data, or information from the laser system, the surgical microscope displaying the received images, data, or information during the laser procedure, the phacoemulsification procedure, or both; a 3D display system integrated into the system to receive one or more of images, data, or information from the laser system, the 3D display system displaying the received images, data, or information during the laser procedure, the phacoemulsification procedure, or both. a surgical microscope and an iris registration system, the surgical microscope integrated into the system to receive one or more of the images, data, or information from the laser system, the surgical microscope displaying the received images, data, or information during the laser procedure, the phacoemulsification procedure, or both; a 3D display system and an iris registration system, the 3D display system integrated into the system to receive one or more of the images, data, or information from the laser system, the 3D display system displaying the received images, data, or information during the laser procedure, the phacoemulsification procedure, or both.

[0033] Also provided are laser systems, methods and apparatus having one or more of the following features: the laser is a femtosecond laser; the laser is a picosecond laser; comprises a means for grading cataracts; is ambidextrous; comprises a phacoemulsification tray and a phacoemulsification cassette and is ambidextrous; comprises a wireless foot switch adapted to control the laser, the phacoemulsification, or both; comprises a laser head defining an opening, a therapeutic laser beam path extending through the opening, the opening associated with means for closing the opening during operation of the phacoemulsification system, when the laser head is in a retracted position, or both.

[0034] Still further, methods are provided for servicing, updating software, operating, or performing surgical procedures using any of these systems.

[0035] Still further provided is a method of using an integrated laser phacoemulsification system, comprising: evaluating information about a cataract in a lens of a patient's cataractous eye; and determining a recommended combined laser phacoemulsification treatment based at least in part on the evaluation of the information about the cataract, the recommended combined laser phacoemulsification treatment comprising a predetermined laser transmission pattern and phacoemulsification procedure.

[0036] Additionally provided is a method of using an integrated laser phacoemulsification system, comprising: evaluating information about a cataract in a lens of a patient's cataractous eye; and determining a recommended laser-phacoemulsification combination treatment based at least in part on the evaluation of the information about the cataract, the recommended laser-phacoemulsification combination treatment having a predetermined laser transmission pattern and phacoemulsification procedure; and displaying menu items associated with the recommended laser-phacoemulsification combination treatment on a GUI.

[0037] Also provided is a method of using an integrated laser phacoemulsification system, comprising: evaluating information about a cataract in a lens of a patient's cataractous eye; and determining a recommended combined laser phacoemulsification treatment based at least in part on the evaluation of the information about the cataract, the recommended combined laser phacoemulsification treatment having a predetermined laser transmission pattern and phacoemulsification procedure; and displaying menu items associated with the recommended combined laser phacoemulsification treatment on a GUI; and selecting the recommended combined laser phacoemulsification treatment.

[0038] Also provided is a method of using an integrated laser phacoemulsification system, comprising: evaluating information about a cataract in a lens of a patient's cataractous eye; and determining a recommended laser phacoemulsification combination treatment based at least in part on the evaluation of the information about the cataract, the recommended laser phacoemulsification combination treatment having a predetermined laser delivery pattern and a phacoemulsification procedure; displaying menu items associated with the recommended laser phacoemulsification combination treatment on a GUI; selecting the recommended laser phacoemulsification combination treatment; selecting one of the predetermined laser delivery pattern or the phacoemulsification procedure; and the system determining a new recommended laser phacoemulsification combination treatment based on the selection.

[0039] Also provided is a method of using an integrated laser phacoemulsification system, comprising: evaluating information about a cataract in a lens of a patient's cataractous eye; and determining a recommended laser phacoemulsification combination treatment based at least in part on the evaluation of the information about the cataract, the recommended laser phacoemulsification combination treatment having a predetermined laser delivery pattern and a phacoemulsification procedure; displaying menu items associated with the recommended laser phacoemulsification combination treatment on a GUI; selecting the recommended laser phacoemulsification combination treatment; selecting one of the predetermined laser delivery pattern or the phacoemulsification procedure; the system determining a new recommended laser phacoemulsification combination treatment based on the selection; and selecting the new recommended laser phacoemulsification combination treatment.

[0040] Also provided are laser systems, methods, and apparatuses having one or more of the following features: displaying menu items related to the recommended laser-phacoemulsification combined treatment on a GUI; selecting the recommended laser-phacoemulsification combined treatment; selecting one of the predetermined laser transmission patterns or the phacoemulsification procedures, and the system determining a new recommended laser-phacoemulsification combined treatment based on the selection; and selecting the new recommended laser-phacoemulsification combined treatment. [Brief explanation of the drawings]

[0041] [Figure 1] 1 is a perspective view of an embodiment of a laser ultrasound system according to the present invention;

[0042] [Figure 2] FIG. 1 is a perspective view of an embodiment of a femto-phacoemulsification system according to the present invention.

[0043] [Figure 3] FIG. 1 is a perspective view of an embodiment of a femto-phacoemulsification system according to the present invention.

[0044] [Figure 4] 1A-1C are schematic diagrams of embodiments of optics and optical paths for a femtosecond laser system and an embodiment of a femto-phacoemulsification system according to the present invention.

[0045] [Figure 4A] 5 is a schematic diagram of an embodiment of the therapeutic and scanning laser optics and optical paths of the embodiment of FIG. 4.

[0046] [Figure 4B] 5 is a schematic diagram of an embodiment of the Scheimpflug optics and optical path of the embodiment of FIG. 4.

[0047] [Figure 4C] FIG. 5 is a schematic diagram of an embodiment of an IR camera with a view along the optical path of the therapeutic laser (down the pipe) optics and optical path of the embodiment of FIG. 4.

[0048] [Figure 4D] 5 is a schematic diagram of an embodiment of a color camera with a view along the optical path of the therapeutic laser (linear) optics and optical path of the embodiment of FIG. 4.

[0049] [Figure 4E] 1 is a schematic diagram of an embodiment of an optical system and path according to the present invention;

[0050] [Figure 4F] 1 is a schematic diagram of an embodiment of an optical system and path according to the present invention;

[0051] [Figure 4G] 1 is a schematic diagram of an embodiment of an optical system and path according to the present invention;

[0052] [Figure 5]1 is a perspective view of a system according to the present invention;

[0053] [Figure 5A] 1 is a top view of a portion of an embodiment of a system according to the present invention.

[0054] [Figure 5B] 1 is a perspective view of an embodiment of a positioning assembly according to the present invention; FIG.

[0055] [Figure 5C] 1 is a perspective view of an embodiment of a positioning assembly according to the present invention; FIG.

[0056] [Figure 5D] 1 is a side view of an embodiment of the system according to the present invention in one position; [Figure 5E] 1 is a side view of an embodiment of the system according to the present invention in one position; [Figure 5F] 1 is a side view of an embodiment of the system according to the present invention in one position; [Figure 5G] 1 is a side view of an embodiment of the system according to the present invention in one position; [Figure 5H] 1 is a side view of an embodiment of the system according to the present invention in one position;

[0057] [Figure 5I] 1 is a perspective view of an embodiment of an articulated light pipe according to the present invention;

[0058] [Figure 6] 1 is a top view of an embodiment of a system arrangement according to the present invention;

[0059] [Figure 7] 1 is a top view of an embodiment of a system arrangement according to the present invention;

[0060] [Figure 8] FIG. 1 is a top view of an embodiment of a Scheimpflug assembly according to the present invention.

[0061] [Figure 9] FIG. 1 is a top view of an embodiment of a Scheimpflug assembly according to the present invention.

[0062] [Figure 10A] 1 is a perspective view of an embodiment of a proximal assembly and docking system according to the present invention. FIG. [Figure 10B] FIG. 10 is another perspective view of an embodiment of a proximal assembly and docking system according to the present invention.

[0063] [Figure 11] 1 is a cross-sectional view of the human eye.

[0064] [Figure 11A] FIG. 12 is a cross-sectional view of the lens of the eye of FIG. 11.

[0065] [Figure 12A] 1 is a perspective view of an embodiment of a patient interface device (PID) according to the present invention.

[0066] [Figure 12B] FIG. 12B is an exploded perspective view of the PID of FIG. 12A.

[0067] [Figure 12C] FIG. 12B is a perspective view of the PID of FIG. 12A from above.

[0068] [Figure 12D] FIG. 12B is a cross-sectional view of the PID of FIG. 12A.

[0069] [Figure 12E] FIG. 12B is a perspective view of the PID of FIG. 12A.

[0070] [Figure 12F] FIG. 12B is a cross-sectional view of the PID of FIG. 12A.

[0071] [Figure 12G] 12B is a perspective view of the installation of the PID of FIG. 12A in an embodiment of a laser ultrasound system in accordance with the present invention.

[0072] [Figure 12H] FIG. 12B is a perspective view of the PID of FIG. 12A mounted in an embodiment of a laser ultrasound system in accordance with the present invention.

[0073] [Figure 12I] 1 is a perspective view of an embodiment of a locking mechanism for attaching a PID to an embodiment of a laser ultrasound system in accordance with the present invention. FIG.

[0074] [Figure 12J] FIG. 12I is a perspective view of the locking mechanism of FIG. 12I from another side.

[0075] [Figure 13] 1 is a perspective view of an embodiment of a PID according to the present invention. FIG.

[0076] [Figure 14] FIG. 1 is a perspective view of an embodiment of a femto-phacoemulsification system according to the present invention.

[0077] [Figure 14A] 1 is a perspective view of an embodiment of a femto-phacoemulsification system with a surgical microscope according to the present invention. FIG.

[0078] [Figure 15] FIG. 15 is a transparent perspective view of a portion of the femto-phacoemulsification system of FIG. 14.

[0079] [Figure 15A] FIG. 15 is a perspective view of the horizontal and vertical movement mechanisms of the femto-phacoemulsification system of FIG.

[0080] [Figure 15B] FIG. 15B is a perspective view of the mechanism of FIG. 15A in an extended position according to the present invention.

[0081] [Figure 16A] FIG. 15 is a top view of the system of FIG. 14 in a fully retracted position in an operating room in accordance with the present invention.

[0082] [Figure 16B] 15 is a plan view of the system of FIG. 14 in a partially extended laser operating configuration (first position) in an operating room in accordance with the present invention.

[0083] [Figure 16C] FIG. 15 is a top view of the system of FIG. 14 in a fully extended laser operating configuration in an operating room in accordance with the present invention.

[0084] [Figure 17A] 17A and 17B are photographs showing specific extended and retracted positions of the extendable assembly of the system of Fig. 14. Fig. 17A shows an intermediate extended position for testing and calibrating the laser system. [Figure 17B] 17A and 17B are photographs showing specific extended and retracted positions of the extendable assembly of the system of Fig. 14. Fig. 17B shows a first surgical extension position for therapeutic laser surgery. [Figure 17C] 17A-17C are photographs showing specific extended and retracted positions of the extendable assembly of the system of Figure 14. Figure 17C shows a second surgical extension position (fully extended) for therapeutic laser surgery.

[0085] [Figure 18] 1 is a schematic diagram of an embodiment of a fixed optical path according to the present invention;

[0086] [Figure 19] 1 is a schematic diagram of an embodiment of a color down-the-pipe (DTP) light path in accordance with the present invention.

[0087] [Figure 20] FIG. 1 is a cross-sectional perspective view of an embodiment of a PID according to the present invention.

[0088] [Figure 20A] FIG. 21 is an exploded perspective view of the PID of FIG. 20.

[0089] [Figure 20B] FIG. 21 is a perspective view of the PID of FIG. 20.

[0090] [Figure 21] FIG. 1 is a perspective view of an embodiment of a femto-ultrasound phacoemulsification system in an extended position according to the present invention.

[0091] [Figure 21A] FIG. 22 is a perspective view of the system of FIG. 21, showing the system in a retracted position from another side.

[0092] [Figure 21B] FIG. 22 is a plan view of the tray assembly of the system of FIG. 21.

[0093] [Figure 21C] FIG. 22 is a perspective view of a portion of the system of FIG. 21.

[0094] [Figure 21D] 22 is a perspective view of the lock engagement device of the system of FIG. 21 in an open position. FIG.

[0095] [Figure 21E] FIG. 22 is a perspective view of the lock engagement device of the system of FIG. 21 in a closed position.

[0096] [Figure 22] FIG. 1 is a perspective view of an embodiment of a femto-ultrasound phacoemulsification system with a wireless foot switch in an extended position according to the present invention.

[0097] [Figure 22A] 23 is a schematic diagram of a control bus for the Femto-system of FIG. 22 in accordance with the present invention.

[0098] [Figure 23A] 1 is an image of an embodiment of a GUI screen display, information, and menu according to the present invention. [Figure 23B] 1 is an image of an embodiment of a GUI screen display, information, and menu according to the present invention. [Figure 23C] 1 is an image of an embodiment of a GUI screen display, information, and menu according to the present invention. [Figure 23D] 1 is an image of an embodiment of a GUI screen display, information, and menu according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0099] Generally, embodiments of the present invention provide systems and methods for treating ocular conditions involving the cornea, lens, and other structures of the eye and associated structures, and in particular for delivering laser energy, ultrasound energy, or both to the eye to treat, mitigate, ameliorate, and reverse those conditions.

[0100] In general, embodiments of the present invention relate to ergonomic systems, integrated systems, and combinations and variations thereof that enable, among other things, the use of ultrasound and laser beams to diagnose, treat, and perform treatment of disorders of the human eye and associated structures, in which laser and ultrasound components are integrated into a single device adapted to manipulate, control, and deliver therapeutic ultrasound and laser energy to the eye. In embodiments, these integrated devices may have an integrated interactive control system; an integrated patient information system; an integrated billing system; an integrated electronic medical record; integrated interactive operation, control, transmission, voice command, voice recognition, and voice control menus between the laser and ultrasound system and combinations of these systems; integrated interactive protocol and safety systems between the laser and ultrasound system; integrated interactive input systems for surgeons and physicians to input information and commands into the device; integrated interactive monitoring systems, displays, or both; integrated common power sources and power management; integrated thermal load (e.g., high temperature) management; non-interfering energy generation and transmission systems; and combinations and variations of these and other features.

[0101] In one embodiment, these integrated devices or systems are associated with a patient support bed to form a further system. In a preferred embodiment, these devices and patient support bed are adapted to allow multiple means of accessing a patient's left and right eyes by the surgeon without the need to move or reposition the patient. Thus, this preferred embodiment of the system allows the surgeon to easily position the patient based on the surgeon's personal preference to proceed with the procedure on one or both eyes without having to reposition the patient or reconfigure the laser, ultrasound, or both. In this way, improved patient comfort, improved ergonomics for the surgeon, increased efficiency, increased efficiency, reduced time to complete a complete procedure on a patient (e.g., both eyes), and combinations of these and other advantages are achieved.

[0102] In one embodiment, these integrated devices or systems are associated with a phacoemulsification tray or phacoemulsification cassette that can be oriented and operated from either side of the system, thus allowing the surgeon to access and use the cassette components from any of the possible surgeon-patient orientations provided by the system.

[0103] In one embodiment, these integrated devices or systems allow the surgeon to transition from laser surgery to phacoemulsification surgery or between them without having to move the patient, without having to reposition the surgeon relative to the system, or preferably both.

[0104] In an embodiment, a patient is placed on a patient support, such as a support bed, and the system is moved to a position near the patient. The system can be positioned by the surgeon in any of several orientations described herein. The laser system and ultrasound system are then used to perform the procedure on the patient.

[0105] Embodiments of the system may include one or more and all of the features of the above-described embodiments and embodiments in the preceding and following paragraphs.

[0106] These system embodiments, such as those of the integrated phacoemulsification-laser system, are adapted to address various eye conditions and perform various procedures on the eye, including, for example, capsulotomy; custom-shaped non-circular or non-elliptical capsulotomy; lens cutting, fragmentation, division, and removal; cataract cutting, division, separation, and removal; lens and cataract tissue emulsification; corneal cutting and incision; corneal flap and pocket construction; limbal relaxing incision; addressing and correcting refractive error (congenital or induced); removal of residual skin material; lens epithelial cell removal; vitreous aspiration and cutting in connection with anterior vitrectomy; addressing bipolar coagulation; and intraocular lens implantation.

[0107] These system embodiments, such as those of the integrated phacoemulsification-laser system, are adapted to address various ocular conditions and perform and enable various procedures, including keratoplasty, radial keratotomy (RK), astigmatic keratotomy (AK), and limbal relaxing incisions (LRI), as well as combinations and variations thereof. These incisions can be made with a laser before or after the phacoemulsification procedure and lens insertion. RK can include micro-RK, micro-RK / AK, and traditional RK, with micro-RK being preferred. For micro-RK, radial incisions can be used in an optical zone that is preferably about 5.00 mm or larger, although smaller zones are contemplated. The incision length is typically about 2.50 mm. Typical incision parameters are shown in Table 1. Typically, one, two, three, or more incisions are made in the cornea in a micro-RK procedure. Table 1 TIFF2025157356000002.tif59163

[0108] In one embodiment of these systems, the associated patient support bed is an intelligent patient support bed having position measurement devices (e.g., positioning devices, RFID, optical, accelerometer, sensor, position device, etc.) in communication with the laser-ultrasound device to provide the precise position of the patient, particularly the position of the patient's head, relative to the laser beam transmission components, laser beam paths, laser docking components, ultrasound components, combined laser-ultrasound devices, and combinations and variations thereof.

[0109] In one embodiment of these systems, there is an intelligent headrest that can be associated with a general patient support, such as a patient support bed, that has position measurement devices (e.g., positioning devices, RFID, optical, accelerometer, sensors, position devices, etc.) that communicate with the laser-ultrasound device to provide the precise position of the patient, particularly the position of the patient's head, relative to the laser beam transmission components, laser beam path, laser docking components, ultrasound components, combined laser-ultrasound device, and combinations and variations thereof.

[0110] In one embodiment of these systems, there is an associated patient intelligent device, such as a patient tag, band, or cap that can be associated with the patient's head or neck, for example worn by or placed on the patient, that has a position measurement device (e.g., positioning device, RFID, optical, accelerometer, sensor, location device, etc.) that communicates with the laser-ultrasound device to provide the patient's precise location, particularly the patient's head location, relative to the laser beam delivery component, laser beam path, laser docking component, ultrasound component, combined laser-ultrasound device, and combinations and variations thereof.

[0111] In embodiments, the patient intelligent device may also have networking capabilities, storage capabilities, identity verification capabilities, and combinations and variations thereof. For example, the patient intelligent device may be used to verify the patient's identity or to verify identity in conjunction with other biometric systems, such as retinal imaging or iris scanning. In this manner, the patient intelligent device may also communicate with laser systems, medical billing information, electronic patient medical records, and health and information management systems as required or requested by the surgeon, insurance, patient, or others, and combinations and variations thereof.

[0112] This patient position measurement device, also referred to as a patient orientation / position tracking system, measures the patient's position relative to the position of the laser and laser beam path, e.g., the patient's head position, and can be an electromagnetic tracking system such as the Polhemus Patriot® 6-DOF. Embodiments of such tracking systems are disclosed and taught in U.S. Patent Nos. 5,307,072, 6,369,594, 6,400,139, 6,624,626, 7,710,395, 6,762,600, 7,292,948, 7,873,491, and 8,013,595, the entire disclosures of which are incorporated herein by reference. Such devices are also referred to as patient locators or patient position devices or systems.

[0113] In one embodiment, a laser ultrasound system, particularly a laser phacoemulsification system, is configured such that a therapeutic laser beam is transmitted to one or both of a patient's eyes in a therapeutic laser beam pattern such that a phacoemulsification procedure is performed on one or both of a patient's eyes without the need for the patient or surgeon to move from their respective positions relative to the laser phacoemulsification system.

[0114] In one embodiment, the size of the device, for example, an embodiment of an integrated phacoemulsification-laser device, is significantly reduced compared to the size of the two systems placed side-by-side or simply in a common housing or cabinet, allowing for a smaller operating room footprint than the combined space required for separate laser and ultrasound systems. This provides a significant advantage in the art, as it is believed that, prior to the present invention, fully integrated laser-ultrasound systems have not been used in operating rooms or received regulatory approval. The reduced size of this embodiment provides several improvements in the art in terms of efficiency, capacity, and both. Some benefits from this smaller-sized device embodiment include the ability to replace two systems, eliminating the need to move the patient, the system, or both during patient treatment, and eliminating the need to move the patient from one operating room to another (when the laser and ultrasound systems are in separate rooms). This smaller-sized device embodiment also allows for use in, for example, smaller operating rooms, greatly facilitating mobility for surgeons and other professionals working in the operating room. This also provides benefits such as easier cleaning of the operating room and freeing up space for other systems, such as diagnostic equipment and microscopes, to be placed in the operating room.The problems associated with integrating ultrasound and laser systems into a single device having this small footprint and small overall volume (height, width, length) without interference between the devices, maintaining the ability of each device to operate as intended, and maintaining the required efficacy of each device, and solutions to those problems, are believed to have not been identified, addressed, or solved by those skilled in the art prior to embodiments of the present invention.

[0115] In these system embodiments, the change or switch time from one mode of operation to another is preferably rapid. Thus, the device can change from one mode to another, e.g., from laser mode to phacoemulsification mode, in about 45 seconds to about 10 seconds, from about 30 seconds to about 5 seconds, less than 1 minute, less than 30 seconds, less than 15 seconds, less than 10 seconds, less than 5 seconds, or less than 2 seconds. It will be appreciated that additional patient preparation time may be required after the device mode is changed and before a particular procedure can be performed.

[0116] The ability to change between laser and phacoemulsification procedures or operations without the need for the patient, the system, the surgeon, and preferably all of them to be repositioned relative to one another provides additional benefits and advantages, for example, this ability to quickly and unobtrusively change between femto and phacoemulsification modes or operations allows the patient to be fully prepared for both procedures before entering the operating room, and the patient can be draped before entering the operating room.

[0117] In embodiments of these laser ultrasound systems, such as integrated phacoemulsification-laser systems, the system (not including the patient bed) has a volume of approximately 50 cubic feet (ft 3 ), approximately 40 cubic feet (ft 3 ) less than 35ft 3 Less than 30ft 3 Less than 25ft 3 Less than 200ft 3 Less than 31ft 3 Less than 28 to 33 feet 3and combinations and variations thereof, as well as greater and lesser values ​​of floor space volume. In embodiments, the volume of the device may be adjustable, in which case the device volume is referred to as the minimum volume unless otherwise specified. The device may have a height of about 45 inches (in) to about 75 in, about 65 in, about 60 in, about 50 in, about 55 in, less than 60 in, less than 58 in, about 52 in to about 58 in, and combinations and variations thereof, as well as greater and lesser sizes. (In embodiments in which the arm, extension, or component can be moved to a vertical or near-vertical position for storage or other purposes, the height should be measured when the component is in an operable configuration or position, e.g., typically in a horizontal or near-horizontal position.) In embodiments, the height of the device may be adjustable, in which case the height of the device is referred to as the minimum height unless otherwise specified. The device can have a length of about 30 inches to about 50 inches, about 33 inches, about 38 inches, about 40 inches, less than about 45 inches, less than 40 inches, about 34 inches to about 38 inches, about 36 inches, and combinations and variations thereof, as well as larger and smaller sizes. In embodiments, the length of the device can be adjustable, for example, by a movable arm assembly, tray, or carriage, in which case the length of the device is the shortest length unless otherwise specified. The device can have a width of about 15 inches to about 40 inches, about 20 inches, about 25 inches, about 30 inches, less than about 45 inches, less than about 30 inches, about 22 inches to about 27 inches, about 20 inches to about 30 inches, and combinations and variations thereof, as well as larger and smaller sizes. In embodiments, the width or length of the device can be adjustable, for example, by a movable arm, assembly, tray, or carriage, in which case the width of the device is the shortest width unless otherwise specified. These device embodiments reduce the device footprint, i.e., the area of ​​floor space occupied by the device, to approximately 400 in 2 Approximately 1,300 inches from 2 , approximately 400in 2 Approximately 600 inches from 2 , approximately 400in2 Approximately 500 inches from 2 , approximately 450 in 2 Approximately 700 inches from 2 , approximately 450 in 2 , approximately 500 in 2 , approximately 550 in 2 , approximately 600 in 2 , approximately 1,200 in 2 Less than approximately 1,100 inches 2 Less than 1,000 inches 2 Less than 1,000 inches 2 Less than 950 inches 2 , approximately 900 in 2 , approximately 800 in 2 , approximately 850 in 2 Approximately 950 inches from 2 , and combinations and variations thereof, as well as larger and smaller sizes. In embodiments, the width, length, or both of the device may be adjustable, for example, by a movable arm, assembly, tray, or carriage, in which case the footprint of the device will be the smallest unless otherwise specified. The length and width of the device may be the same, e.g., the footprint may be square or circular in shape, or the length and width may differ, e.g., the footprint may be rectangular or oval. It should be understood that other shapes for the footprint are also contemplated, such as, for example, a star shape, an "L" shape, an "H" shape, etc.

[0118] Typically, a phacoemulsification device is about 20 inches by about 25 inches, or about 500 inches. 2 (i.e., a "standard phacoemulsification footprint"). Thus, embodiments of the integrated phacoemulsification-laser system have a footprint of 500 in 2The present invention can have a footprint that is about 70% or less, about 80% or less, about 90% or less, about 100% or less, about 110% or less, about 120% or less, about 130% or less, about 140% or less, about 150% or less, and even smaller than the footprint of the conventional two-device system. This synergy achieved by embodiments of the present invention, which have two treatment functions with two devices in a slightly larger area than one device, provides significant benefits and advantages in operating rooms and medical suites, particularly with respect to workflow, available room for patient treatment (e.g., smaller rooms may be utilized), patient and staff comfort, and efficiency.

[0119] Additionally, even in situations where the phacoemulsification system has a smaller than normal footprint, the combined laser ultrasound system of the present invention can occupy less space than a separate laser and such a small footprint ultrasound system.

[0120] In these system embodiments, further synergies are realized through the use of custom trays and devices to hold and position the various surgical tools, instruments, kits, and equipment used in laser therapy procedures, laser diagnostic procedures, phacoemulsification procedures, lens insertion, and any refractive procedure. These custom surgical trays and kits can be single-use disposable and removably secured to the device (or held by or within the device housing), or they can be one-piece trays that hold disposable or reusable tools and instruments, and combinations and variations thereof.

[0121] In these system embodiments, the laser procedure is optimized to provide the most efficient, e.g., lowest, phacoemulsification energy to remove a particular lens material. Thus, laser parameters such as femto energy, laser shot spacing, line spacing, etc., and phacoemulsification parameters such as phacoemulsification energy, BSS (balanced salt solution) flow, fluidics, etc., are optimized in a highly integrated and predetermined manner, resulting in integrated control, monitoring, and storage capabilities of the system and device.

[0122] In embodiments of these systems with two laser pulse widths, additional advantages and benefits include the reduction in the need and use of instruments such as diamond blades and knives, thereby reducing costs, reducing the risk of infection, and reducing procedure time.

[0123] It should be understood that this specification contemplates that embodiments of the system may include one or more and all of the features of the above-described embodiments and paragraphs in various combinations as would be understood by one of ordinary skill in the art based on the teachings and disclosure of this specification and the embodiments in the following paragraphs.

[0124] 1 shows a perspective view of an embodiment of a laser ultrasound system 100. The system 100 is an apparatus having a first housing 101 and a second housing 102. The housings 101 and 102 contain power components, control components, operating components, analytical prediction and diagnostic equipment, position measurement and location equipment, laser beam generating components, and ultrasound generating components. In a preferred embodiment, the ultrasound generating components are components of an ultrasound phacoemulsification system, and the laser beam generating components provide a laser beam having a pulse length of about 10 ps, ​​5 ps, 2 ps, or less.

[0125] These components may be distributed in whole or in part between the two housings 101, 102 to, among other things, optimize space, avoid interference between components, manage heat and vibration, and provide more efficient control and operation of the system 100. The two housings 101, 102 may be stand-alone housings on the same base or frame 150, may have communication, control, power, optical, and other connections therebetween, may be a single identical housing, may be subdivided or divided into third, fourth, etc. housings or sub-housings, and combinations and variations thereof.

[0126] An optical conduit 105 connects the housing 102 to the housing 106. The housing 106 contains a scanning device and beam shaping optics for the therapeutic laser beam, and the scanning device, optics, or both can also be used to monitor and diagnose the laser beam and light path. In embodiments, it is understood that these components of the housing 106 can be located wholly or partially within one of the other housings 102, 101, and similarly, components from the housings 102, 101 can be located within the housing 106. The housing 106 can be integrated with or part of the housings 102, 101. The housing 106 can be subdivided or divided into one or more housings or sub-housings, as well as combinations and variations thereof. In a currently preferred embodiment, the housing 106 houses and isolates the scanner and beam shaping optics. The scanner and beam shaping optics or other components that may be contained within the housing 106 are in control communication with the controller and operating system of the system 100. The control communication connection allows information regarding the operation of the devices to be communicated to and from the devices, information acquired or received by the devices to be communicated to and from the devices, and control information, instructions, or commands, as well as other data and information, to be communicated to the devices, and combinations and variations thereof. The devices can be in direct control communication connection with each other, or indirect control communication connection with each other, for example, by being in control communication connection with a central, e.g., controller of system 100, monitor 109, which may also have control functionality, and combinations and variations thereof. The devices can also be in direct and indirect control communication connection with each other.

[0127] The light conduit 105 can be a light pipe (e.g., a hollow pipe or channel having an inner reflective surface such that the laser beam is transmitted through the free space within the hollow pipe, which can have a partial vacuum, can have ambient atmosphere, can contain an inert gas, and combinations and variations thereof), an articulated light pipe, a telescoping light pipe, a flexible light pipe, an optical fiber, one or more optical fibers, a hollow conduit, a beam guide, and combinations and variations thereof, and other laser beam transmitting structures.

[0128] The housing 106 includes an arm 107 that can move, extend, and retract in the directions of arrows 107a and 107b. The arm 107 and housing 106 are moved vertically, as indicated by arrow 107a, by an elevator device 110. The arm 107 includes an assembly or device 108 for measuring the shape and position of the eye and structures within the eye. At its proximal end, i.e., the end furthest along the laser beam path and therefore furthest from the laser beam source, below the device 108, the arm 107 includes a patient interface device (PID) (not shown in this view). The arm 107 includes a monitor 109 that moves on an articulating arm in the direction of arrow 109a. The monitor provides information about the treatment, system status, laser status, ultrasound status, cataract density, ultrasound settings, laser pattern settings, etc., and can receive input and commands from the surgeon. The monitor is in control communication with, and may include part or all of, the control system of the system 100. The monitor is in control communication connection with the laser control system and the ultrasound control system either directly or through the control system of system 100, through monitor 109, and combinations and variations thereof. The monitor and its articulating arm may be located on other structures of system 100 or may be freestanding. One, two, or additional monitors may be used. The monitor may have 3D viewing or display capabilities.

[0129] Arm 107 forms or contains a laser beam transmission structure, such as a hollow tube, that provides free space for transmission of the laser beam. In embodiments, arm 107 can contain a free-space beam path or optical fiber for transmitting the laser beam, for example, to a scanner located at the proximal end of the tube, i.e., the end near housing 106, rather than the distal end. Arm 107 can also be or contain any laser beam transmission structure of the type described for use as optical conduit 105. The tube can also contain optics. In the embodiment of FIG. 1 , arm 107 contains an uncollimated laser beam, and thus arm 107 is shown as containing an uncollimated laser beam and laser beam path; in other words, arm 107 contains, surrounds, or contains a “non-collimated space” along the laser beam path. Arm 107 can contain or surround a collimated space in which the laser beam on the laser beam path is collimated. The arm can contain a space containing optics. The arm can accommodate both collimated and non-collimated spaces. The arm 107, in embodiments, can pivot, rotate, telescope, articulate from a distal point, and combinations and variations thereof. The proximal end of the laser beam path within the arm 107 includes mirrors or optics for directing the laser beam through the PID to and into the patient's eye.

[0130] System 100 has two components 103, 104 for connecting cables and wires to ultrasound, aspirators, other tools, and combinations and variations thereof. In one embodiment, these components are adapted to connect to a phacoemulsification tool or phacoemulsification cassette system. Components 103 and 104 are shown on housing 102; they may be on housing 101, or elsewhere on the system, or may be part of a phacoemulsification cassette inserted into system 100.

[0131] In embodiments, the laser system has an external, internal, or both cooler, such as a cooling fluid that is channeled into or out of the laser housing.

[0132] System 100 has a height indicated by arrow 120, a length indicated by arrow 121, and a width indicated by arrow 122. The width and length define the footprint of system 100, and the volume is defined by height 120, length 121, and width 122. Therapeutic Lasers and Systems - Overview

[0133] Any laser adapted to provide a laser beam that is useful, safe, and effective for the treatment of the eye, its structures, and adjacent tissues can be used to provide the therapeutic laser beam. Tunable lasers, tunable lasers, and combinations and variations of these lasers can be used, e.g., variable pulse width, variable pulse rate, variable power, and variable wavelength. Multiple therapeutic lasers can be used. The therapeutic laser can be a pulsed laser, such as a femtosecond or picosecond laser, a longer or shorter pulse, a continuous laser, and combinations thereof.

[0134] Therapeutic lasers can have wavelengths in the IR and UV spectrum, as well as other wavelengths. Therapeutic laser beams can have wavelengths from about 300 nm to about 2,500 nm, from about 1,000 nanometers (nm) to about 1,300 nm, 1020 nm, about 1020 nm, 1030 nm, about 1030 nm, 1040 nm, about 1040 nm, 1050 nm, about 1050 nm, and about 1020 to about 1050 nm, as well as combinations and variations thereof, and other wavelengths.

[0135] The therapeutic lasers can have pulse widths of about 1 fs to about 100 ps, ​​about 200 fs to about 500 ps, ​​about 300 fs to about 100 ps, ​​about 300 fs to about 10 ps, ​​about 300 fs to about 2,000 fs, and combinations and variations of these, as well as longer and shorter pulse widths. The system can have one or more "short pulse width" therapeutic lasers with pulse widths of 300 fs, about 300 fs, 350 fs, about 350 fs, 400 fs, about 450 fs, 500 fs, about 500 fs, about 300 fs to about 600 fs, and combinations and variations thereof. The system can have one or more "long pulse width" therapeutic lasers having pulse widths of 1000 fs, about 1000 fs, 1200 fs, about 1,200 fs, 1,300 fs, about 1,300 fs, 1,500 fs, about 1,500 fs, about 1,200 fs to about 1,600 fs, and combinations and variations thereof.

[0136] These dual beam embodiments, i.e., those with at least both short and long pulse duration therapeutic laser beams, have various advantages and benefits, which may include reducing the need and use of instruments such as diamond blades and knives, thereby reducing costs, reducing the risk of infection, and reducing procedure times.

[0137] The therapeutic laser beam can have a pulse repetition rate of about 50 kilohertz (kHz) to about 5 megahertz (MHz), about 50 kHz to about 2 MHz, about 50 kHz to about 1 MHz, about 50 kHz to about 750 kHz, about 100 kHz to about 200 kHz, about 150 kHz to about 350 kHz, about 100 kHz, about 150 kHz, about 200 kHz, about 300 kHz, and combinations and variations thereof, as well as greater and lesser repetition rates.

[0138] The therapeutic laser beam can have an average power at a particular pulse repetition rate of about 1 Watt (W) to about 8 W, about 2.5 W to about 5 W, about 3 W to about 4.5 W, 3 W to 5 W, less than 6 W, less than 5 W, any power that results in laser-induced photodisruption (LIOB) and / or photoablation, as well as combinations and variations thereof, and lower and higher powers.

[0139] These system embodiments can also perform subthreshold treatments, diagnostics, and combinations and variations thereof. Thus, a therapeutic laser beam can be delivered to the eye at a power or in a manner below the point at which LIOB occurs. A therapeutic laser beam can be delivered to the eye at a power or in a manner below the point at which photoablation occurs. In one embodiment of such treatments, subthreshold laser treatments can be performed, photoablation-induced laser treatments can be performed, and phacoemulsification can be performed, as well as combinations and variations of some or all of these treatments, without moving the patient or the device.

[0140] The therapeutic laser beam can have a pulse energy of about 1 nanojoule (nJ) to about 2 millijoules (mJ), about 1 nJ to about 1 mJ, about 2 microjoules (μJ) to about 70 μJ, about 5 μJ to about 45 μJ, about 2 μJ to about 35 μJ, about 10 μJ to about 30 μJ, less than 45 μJ, less than 35 μJ, any pulse energy that results in photodisruption, LIOB, or both, and combinations and variations thereof, and lower and higher energies.

[0141] The therapeutic laser beam of the system can have one or more of the beam characteristics described above, such as wavelength, duration, repetition rate, power, and pulse energy, as well as combinations and variations thereof.

[0142] A Yb:YAG laser generating ultrashort laser pulses at a wavelength of 1030 nm can be used as a therapeutic laser. Typically, therapeutic lasers provide a beam with a wavelength that penetrates the cornea, aqueous humor, and lens. The beam can have a short pulse length, energy, and beam size to cause photodisruption, LIOB, or both of targeted ocular tissues, such as the cornea, limbus, lens capsule, lens, cataract tissue, opacified tissue, and other tissues. Thus, as used herein, the term "laser shot" or "shot" refers to a laser beam pulse delivered, by itself or in combination with other pulses, to a location where a therapeutic effect, such as LIOB, is to be produced. As used herein, the term "photodisruption" essentially refers to the laser converting a substance into a gas. In embodiments, wavelengths of approximately 300 nm to 2500 nm can be used. Pulse widths of approximately 1 femtosecond to 100 picoseconds can be used. Energy of approximately 1 nanojoule to 1 millijoule can be used. The pulse rate (also called pulse repetition frequency (PRF) or pulses per second measured in Hertz) can be from about 1 kHz to several GHz. Generally, in commercial laser devices, the lower the pulse rate, the higher the pulse energy. Various laser types can be used to have a therapeutic effect, such as photodisruption of ocular tissue, LIOB, or both, depending on the pulse length and energy density, as well as other factors.Thus, examples of such lasers include: Delmar Photonics Inc.'s Trestles-20, which is a titanium-sapphire (Ti:sapphire) oscillator with a wavelength in the range of 780 to 840 nm, a pulse width of less than 20 femtoseconds, a PRF of about 100 MHz, and a power of 2.5 nanojoules; Clark CPA-2161 IMRA FCRA (fiber chirped pulse resonator), which is an amplified Ti:sapphire oscillator with a wavelength of 775 nm, a pulse width of less than 150 femtoseconds, a PRF of about 3 kHz, and a power of 850 microjoules; amplification: fiber chirped pulse amplification); Microjoule D-series D-400-HR, a Yb:YAG oscillator / amplifier with a wavelength of 1045 nm, a pulse width of less than 1 picosecond, a PRF of about 5 MHz, and 100 nanojoules; Coherent Staccato, a Yb:YAG oscillator / amplifier with a wavelength of 1030 nm, a pulse width of about 1.5 picoseconds, a PRF of about 80 kHz, and 30 microjoules; and Coherent Rapid, a Yb:YAG oscillator / amplifier with a wavelength of 1030 nm, a pulse width of about 1.5 picoseconds, a PRF of about 80 kHz, and 30 microjoules, and includes one or more amplifiers achieving an average power output of approximately 2.5 to 10 watts at a PRF of 25 kHz to 650 kHz, and may further include a multi-pulsing capability capable of gating two separate 50 MHz pulse trains, and includes the IMRA, a Yb:YAG oscillator / amplifier with a wavelength of 1045 nm, a pulse width of less than 100 picoseconds, a PRF of about 200 kHz, and 4 microjoules. These and other similar lasers can be used as therapeutic lasers to generate therapeutic laser beams.

[0143] Embodiments of laser systems, methods, and apparatus for performing laser surgery on the eye are disclosed and taught in U.S. Patent Application Nos. 2016 / 0302971, 2015 / 0105759, and 2014 / 0378955, and U.S. Patent Nos. 8,262,646 and 8,708,491, the entire disclosures of which are incorporated herein by reference. Laser Beam Delivery - Overview

[0144] In general, an optical system embodiment for delivering a therapeutic laser beam to the lens of the eye should be capable of delivering a series of shots to the lens in a precise, predetermined pattern in the x, y, and z dimensions. The optical system should also provide a predetermined beam spot size to ensure that the laser energy reaching the lens or other target tissue causes photodisruption, LIOB, or both. Thus, the optical system may include, but is not limited to, an xy scanner, a z-focusing device, and focusing optics. The focusing optics may be conventional focusing optics, planar imaging optics, telecentric optics, and combinations and variations thereof, each with corresponding computer-controlled focusing and calibration in the x, y, and z dimensions. For example, the xy scanner may be a pair of closed-loop galvanometers with position-sensing feedback. Examples of such xy scanners include the Cambridge Technology Inc. Model 6450, the SCANLAB hurrySCAN, and the AGRES Rhino scanner. Examples of such z-focusing devices include the piezo apex alignment unit model ESee Zfocus control from Physik International, and the varrioSCAN from SCANLAB. Laser Control System - Overview

[0145] Generally, embodiments of a control system for delivering a therapeutic laser beam can be a computer, controller, software, hardware, and combinations and variations thereof, capable of selecting and controlling, among other things, scanning parameters and laser firing. These components can typically be at least partially associated with a circuit board connected to an xy scanner, a z-focuser, a laser, and combinations and variations thereof. Among other things, the laser control system can include a program for directing the laser with one or more laser shot patterns. The laser control system can also integrate with a system control system and further have the ability to function with or operate as an integrated system with an ultrasound control, monitor, or control panel. The system controller, laser controller, ultrasound controller, and combinations and variations thereof can also control other components of the system, as well as maintain data, acquire data, analyze data and images, prepare and recommend charts and treatments, and perform calculations. The control system can include a program for directing the laser with one or more laser shot patterns. Position and shape measurement - outline

[0146] Generally, in embodiments, an assembly or device for measuring the shape and position of the eye and structures therein can be an optical coherence tomography (OCT) device, a Scheimpflug device with a single movable camera, multiple fixed cameras, combinations and variations thereof, and other types of devices for making such measurements. In embodiments, the device measures the relative position of the lens or other structures of the eye or portions of tissue adjacent to the eye from a laser, e.g., an optical head. In embodiments, this distance is kept constant, e.g., by a PID. In embodiments, the device measures the position of the lens and other structures in all three dimensions relative to the scanning coordinates for the laser transmission pattern. This can be accomplished by several methods and devices. For example, x-y centering of the lens can be achieved by viewing the lens with a co-bore sighed camera system and display and manually aligning the viewing optics with the patient's eye at a known center. The z-position can be measured by optical triangulation or distance measurement devices using laser and CCD systems, such as the Micro-Epsilon Opto NCDT1401 laser sensor, the Aculux Laser Ranger LR2-22, and combinations and variations thereof. Three-dimensional display and measurement equipment can also be used to measure the x, y, and z-position of the lens. For example, Vision Engineering's Hawk 3-axis non-contact measurement system can be used to perform these measurements. Another example of equipment that can be used to measure the lens position is a three-dimensional measurement equipment. This equipment includes one or more cameras that can view the reference and the lens, and can include a light source that illuminates the lens. Such a light source can be a structured light source, such as a slit illumination designed to generate three-dimensional information based on its shape.Additionally, one, two, three, four, or more light sources can be positioned around the eye and electronically activated to provide multiple perspective and planar images of the eye, particularly the cornea and lens, with multiple planar slices that are integrated to provide data for positioning and placement information for the laser system around those structures. Examples of assemblies, methods, and apparatus for measuring the shape of the eye and structures, and their position relative to the laser, laser shot pattern, and laser beam are disclosed and taught in U.S. Patent Application Nos. 2018 / 0085256, 2016 / 0302971, 2015 / 0105759, 2012 / 0330290, 2016 / 0030244, and U.S. Patent Nos. 9,180,051 and 8,708,491, the entire disclosures of which are incorporated herein by reference. An iris registration device for measuring eye position is taught and disclosed in U.S. Patent Application Publication No. 2015 / 0105759, the entire disclosure of which is incorporated herein by reference. Generally, an image (optical image) travels from the eye, PID, or other structure back to the device or system along an optical path, such as an image path through free space, optical components (lens, mirrors, fibers, etc.), and both. Patient Interface - Overview

[0147] An additional component of these system embodiments can be a laser-patient interface, or PID. It should be noted that all or some of the PIDs are typically not part of the system but are preferably single-use (e.g., disposable) devices added to the system for each patient prior to or during laser treatment setup. In embodiments, this interface provides for maintaining a fixed x, y, and z position between the lens and the laser during treatment, which includes a measurement step for measuring the x, y, and z positions and a transmission step for transmitting the laser to the lens in a shot pattern. The interface device can include an optically transparent applanator. One example of this interface is a suction-ring applanator, which can be circular or elliptical, fixed against the outer surface of the eye and positioned relative to the laser optic housing, thereby fixing the distance between the laser, eye, and lens. Reference marks for three-dimensional viewing and measurement equipment can also be placed on the applanator. Additionally, the interface between the lower surface of the applanator and the cornea can be observed, and such observation can serve as a reference. A further example of a laser-patient interface is a device with a lower ring with suction capabilities for attaching the interface to the eye. The interface further has a flat bottom surface that presses against the eye to flatten the shape of the eye. The flat bottom surface is composed of a material through which the laser beam propagates, and preferably, but not necessarily, a material that transmits an optical image of the eye in the visible light spectrum. The upper ring has structure that engages a housing for the laser optics, structure that is a known distance along the path of the laser beam from the laser and is fixed relative to the laser, and combinations and variations thereof. Examples of patient interface devices, systems for engaging a PID to an eye, and systems for engaging a PID to a laser system are taught and disclosed in U.S. Patent Application Nos. 2011 / 0190739, 2017 / 0290703, 2010 / 0022994, 2011 / 0022035, and 2015 / 0088175, the entire disclosures of which are incorporated herein by reference.

[0148] During testing and calibration, a laser beam, preferably a therapeutic laser beam, can be transmitted through a window in the PID. Ultrasound / phacoemulsification - Overview

[0149] Any ultrasound generating device, such as an ultrasound driver, horn, or other device for producing ultrasound energy, adapted to provide ultrasound energy that is useful, safe, and effective for the treatment of the eye, its structures, and adjacent tissues, and their disorders, can be used to provide the ultrasound energy for the system. In particular, some or all of the components of any phacoemulsification system, preferably approved by a medical device regulatory agency, can be used or reconfigured for use in embodiments of the system.

[0150] Generally, embodiments of the integrated system and method can perform phacoemulsification, for example, to emulsify or liquefy the lens, break up the cataract into smaller pieces, and combinations and variations thereof, which involves making a corneal incision, preferably a scleral incision using a therapeutic laser beam (and combinations and variations thereof), and inserting a phacoemulsification handpiece, typically consisting of an ultrasonically driven needle. Preferably, the ultrasonic treatment is performed on the lens, lens material, or cataract material that has been cut, fragmented, softened, or combinations and variations thereof by the laser beam. The emulsified pieces can then be removed using the same or a separate handpiece. The surgeon can then insert an implant, such as an intraocular lens (IOL), into the eye through the incision.

[0151] In embodiments, the phacoemulsification frequency of vibration of the tip of the phacoemulsification needle can be greater than 20 kHz, greater than 30 kHz, greater than 40 kHz, about 30 kHz to about 50 kHz, about 30 kHz to about 45 kHz, less than about 50 kHz, about 35 kHz to about 45 kHz, about 35 kHz, about 40 kHz, about 45 kHz, 35 kHz 40 kHz, 45 kHz, combinations and variations thereof, as well as higher and lower frequencies.

[0152] In embodiments, the stroke, or longitudinal movement, length of the phacoemulsification needle can be from about 28.1 μm to about 95.25 μm, from about 25 μm to about 160 μm, from about 50 μm to about 90 μm, from about 50 μm to about 150 μm, from about 25 μm to about 110 μm, from about 35 μm to about 100 μm, from about 20 μm to about 60 μm, from about 80 μm to about 150 μm, combinations and variations thereof, as well as greater and lesser distances.

[0153] Generally, phacoemulsification systems can have pulse rates from about 20 pulses per second to about 150 pulses per second, combinations and variations thereof, and greater and lesser values. These systems can have burst widths from about 30 milliseconds to about 4 milliseconds, combinations and variations thereof, and greater and lesser values.

[0154] In an embodiment of the system, a phacoemulsification handpiece is generally connected to an irrigation source and an aspiration pump. The aspiration pump is disposed in the system housing. The handpiece includes a distal tip for insertion into the anterior chamber of a patient's eye, the distal tip emitting ultrasonic energy or vibrating at ultrasonic frequencies to cut, emulsify, and combinations and variations thereof, of the lens. The handpiece further includes an irrigation port proximal to the distal tip connected via an irrigation line to the irrigation source, and an aspiration port at the distal tip connected via an aspiration line to the aspiration pump. Fluid from the irrigation source, typically a saline bottle, is irrigated into the eye via the irrigation line and irrigation port, and the irrigation fluid and emulsified lens material are aspirated from the eye via the aspiration port and aspiration line by the aspiration pump.

[0155] Other ophthalmic medical techniques that ultrasound systems are designed to perform also typically include ophthalmic irrigation and aspiration. Such procedures involve the destruction, adjustment, or removal of ocular features using emulsification, irrigation, and aspiration. Thus, the ultrasonic power delivered by the surgical console, the flow of fluid to or from the patient via the irrigation or aspiration console, and the consequent demands for control of the preceding phacoemulsification handpiece are selected and controlled by the system, by the surgeon, and combinations and variations thereof.

[0156] The phacoemulsification components, e.g., subassemblies, of the system embodiments typically include a control system, e.g., a programmable microprocessor, and a console with operator-selected presets to control, e.g., aspiration speed, vacuum level, and ultrasound power level; in embodiments, the console is a system monitor. The phacoemulsification handpiece can be interconnected to the system by an electrical cable to power and control the piezoelectric transducer that effects emulsification. Tubing allows irrigation fluid to be provided to and aspiration fluid removed from the eye through the handpiece under control of the console.

[0157] In an embodiment, phase angles and other characteristics associated with the operation of the handpiece are constantly identified and measured during operation of the handpiece in order to adjust the drive control circuitry to achieve optimal phase angles, or otherwise effect energy transmission from the phacoemulsification handpiece into tissue, etc. Automatic tuning of the handpiece is achieved by monitoring the handpiece's electrical signals and adjusting the frequency and other characteristics to maintain uniformity of selected parameters.

[0158] In an embodiment, the control system addresses the power control requirements for a phacoemulsification handpiece based on the phase angle between the voltage applied to the handpiece's piezoelectric transducer and the current drawn by the piezoelectric transducer, the amplitude of the power pulses delivered to the handpiece, or both. Typical configurations are tailored to specific handpieces; for example, power is applied continuously or in a series of solid bursts under the control of the surgeon. For example, the system may apply power for 150 ms and then turn it off for 350 ms, repeating this on / off sequence for the required duration of power application. The application of power for the 150 ms period can be defined by the constant application of a 25 kHz to 50 kHz sinusoid. In some situations, the surgeon or operator may apply a power burst for a certain time interval, turn off the power, and then reapply it at the initial power setting or another power setting. The frequency and duration of the bursts are typically controllable as is the length of the stream of bursts applied to the affected area. The time interval during which no power is applied allows time for the broken pieces to be removed by suction, such as that provided by the handpiece or an auxiliary suction device.

[0159] In embodiments of the system, the control method for delivery of ultrasound power can generally be in several modes, such as variable mode, predetermined variable mode, panel mode, and linear mode. Variable mode provides the surgeon or operator with maximum flexibility in selecting the conditions for ultrasound treatment and can be viewed as manual. Predetermined variable mode is a mode in which the control system determines the optimal range of ultrasound treatment based on the laser treatment performed, the grade of the cataract, and other information acquired by the system before, during, and after the laser treatment procedure. Thus, in this mode, the system works in conjunction with the laser control system and the phacoemulsification control system to predetermine, make available, and recommend, preferably optimize, the range and set the phacoemulsification procedure. Generally, panel mode provides precise, fixed values, typically based on user selection. Generally, linear mode allows only the simplest form of linear adjustment, from 0% to 100%. In embodiments, intermediate adjustments, or adjustments outside the system's recommended options or ranges for ultrasound therapy delivery, are not made freely available, e.g., they are limited, at least in part to minimize the need for and inherent risks of manual adjustments.

[0160] The phacoemulsification ultrasound probe delivers energy to the eye used to fragment the remaining cataract lens material after laser fragmentation or cutting to facilitate emulsification and aspiration of the remaining pieces. The phacoemulsification ultrasound probe delivers energy to the eye used to fragment the cataract in locations where laser fragmentation of the cataract has not yet occurred, such as in locations where the surgeon does not use a laser to fragment the lens or cataract, opting instead to perform a laser capsulotomy and laser incision for insertion of the phacoemulsification probe. The phacoemulsification ultrasound probe delivers energy to the eye used to fragment the cataract by vibrating at a fixed frequency; this energy is delivered when a control switch, such as a foot pedal, is depressed into a predetermined position, which can control the firing and transmission of the therapeutic laser beam and pattern; other types of control switches, buttons, triggers, sounds, etc., can also be used. In an embodiment, to increase the magnitude of the ultrasound output, a machine increases the stroke length of the probe.

[0161] Generally, the probe can transmit power in a longitudinal manner, a lateral manner, and combinations and variations thereof. In the longitudinal manner, the phacoemulsification needle moves back and forth. In the lateral manner, ultrasonic power is also transmitted by lateral movement of the probe, which can increase cutting efficiency by, for example, reducing repulsion of the lens material.

[0162] Generally, there are two types of lateral motions in phacoemulsification. In torsional lateral motion, the phacoemulsification tip vibrates in a rotational fashion along its major axis. In transverse lateral motion, the phacoemulsification tip moves in an elliptical path. Generally, based on the type of motion, torsional usually works better with angled phacoemulsification needles, while transverse usually works equally well with either straight or angled needles. Combining transverse phacoemulsification with traditional longitudinal phacoemulsification can aid in cutting efficiency, as cataract material is emulsified in multiple directions.

[0163] While phacoemulsification is described as transmitting ultrasonic energy, it should be understood that it is the stroke of the metal phacoemulsification needle that creates the mechanical impact when it strikes the target material, such as the cataract material that the laser acts on. Generally, the needle also creates cavitation and implosion when a microcavity is created immediately in front of the phacoemulsification needle. Fluid and particle waves propagate within the cataract material, ultimately generating heat as a side effect. It is important to avoid selecting phacoemulsification power settings that result in increased heat generation, as excessive heat generation can burn the cornea and damage delicate ocular structures. Unrestricted flow through the surrounding irrigation sleeve is also crucial, as the constant cooling effect of the balanced salt solution moving around the phacoemulsification probe helps prevent heat generation.

[0164] In embodiments of the system, during surgery, the system controller, phacoemulsification controller, and combinations and variations thereof can monitor, record, and analyze average phacoemulsification power as a percentage of maximum, the total time the phacoemulsification power was delivered, and other conditions and factors. In embodiments, a common monitor can display these values ​​as "U / S AVE" (short for "ultrasound average") and "EPT" (short for "elapsed phaco time"), as well as other parameters and characteristics. The total energy delivered to the eye is the product of the phacoemulsification power multiplied by the time the power is on (known as absolute phaco time (APT)). The system control, phacoemulsification control, and combinations and variations thereof can automatically calculate the APT by multiplying the "U / S AVE" by the "EPT," allowing the surgeon to compare the total ultrasound energy transmitted in different situations.

[0165] In embodiments, to maximize APT reduction, the surgeon must reduce phacoemulsification time, average phacoemulsification power, and combinations and variations thereof. Average phacoemulsification power can be reduced by selecting parameters on the monitor, restricting control switch positions, or lowering the maximum phacoemulsification power level on the device. Phacoemulsification time can be reduced by applying ultrasonic power only when cataract fragments are located at the phacoemulsification tip and vacuum suction alone is insufficient to aspirate the fragments. Additionally, phacoemulsification time can be reduced by delivering shorter pulses or bursts of phacoemulsification power instead of continuous ultrasonic power, or by reducing the duty cycle (on:off ratio of pulses). This method of distributing ultrasonic power into smaller packets of pulses and bursts is called phacoemulsification power modulation.

[0166] In embodiments, the basic power settings are continuous, pulse, and burst. In a continuous power setting, the energy delivery is continuous with a change in power, which is controlled by the position of a control switch, e.g., the amount of depression of a foot pedal.

[0167] In embodiments, the system provides combinations and variations thereof, as well as output settings that provide hybrid or mixed levels of these output modes, as output changes can be more precisely determined and provided in a predetermined manner by the control system operating in conjunction with the phacoemulsification control system and in situations involving surgeon input.

[0168] In embodiments, in pulse mode, the pulse output increases linearly with the position of the control switch, e.g., how far the foot pedal is depressed. The farther it is positioned, e.g., the further it is depressed, the greater the output of each sequence of pulses of energy. A feature of embodiments operating in pulse mode is that each pulse of delivered energy is followed by an "off" time, a time interval during which no energy is delivered between pulses of increasing energy. By alternating between "on" and "off" pulse times, heat is reduced and half the energy is delivered to the eye.

[0169] In embodiments, in burst mode, each burst has the same power output, but the interval between each burst decreases as the control switch is advanced, e.g., the foot pedal is depressed. In embodiments, the further the control switch is advanced, e.g., the further the foot pedal is depressed, the shorter the "off" time between each burst. Thus, in embodiments, at the maximum control switch position, e.g., at maximum foot pedal depression, the bursts of energy are a continuous delivery of energy.

[0170] In embodiments, burst mode can provide phacoemulsification assisted by aspiration of the lens nucleus. The surgeon uses the vacuum and fluidics of the phacoemulsification device to aspirate the cataract and delivers small bursts of phacoemulsification power only when needed. Preferably, the control system can be programmed or recommended to make these bursts of phacoemulsification power very short (on the order of a few milliseconds), so that hundreds of tiny bursts can be efficiently delivered and the total phacoemulsification time can still be, for example, less than one second.

[0171] The system provides embodiments in which the programmable range of pulse and burst phacoemulsification settings and other settings is expanded significantly beyond previous systems, with the same features as previous systems and embodiments. Unlike any previous system, embodiments of the system can have recommended phacoemulsification settings predetermined based on the laser pattern or treatment delivered by the laser system, and can deliver those settings instantly without the need for movement by the surgeon or patient.

[0172] In embodiments, the phacoemulsification control system, alone or in conjunction with a system control system, can provide various active monitoring and control functions such as monitoring intraocular pressure (IOP) and adjusting the system's functions to maintain IOP at a desired pressure; monitoring and controlling vacuum levels; optimizing power settings; and predicting pressure changes and proactively responding to occlusion breaks. Sensors for providing this information and data for monitoring and automatic control of the phacoemulsification system's operating parameters can be within the system, on various pumps and devices, based on current or other electrical loads, or in or on the handpiece.

[0173] Examples of performance characteristics and components that can be used in the phacoemulsification-laser system include the Alcon CENTURION® Vision system, the Alco ACTIVE SENTRY® Handpiece, and the INTREPID® Hybrid Tip. In embodiments, the phacoemulsification handpiece can have an integrated fluid pressure sensor that senses pressure in real time and communicates with the system control system, the control system, or both. Examples of different performance characteristics and components that can be used in the phacoemulsification-laser system include the AMO WHITESTAR SIGNATURE® PRO phacoemulsification system.

[0174] Features of phacoemulsification systems and subsystems, methods of using them, and their components are disclosed and taught in U.S. Patent Nos. 8,20,565, 9,549,850, 9,549,851, 9,849,030, 9,877,865, 9,931,447, 9,937,077, 10,258,505, 10,314,953, 10,111,990, and U.S. Patent Application Nos. 2019 / 0133824, 2019 / 0021906, 2019 / 0099526, 2017 / 0266046, and 2017 / 0112668, the entire disclosures of which are incorporated herein by reference.

[0175] Ultrasound-Laser Hybrid - Overview

[0176] These embodiments include any hybrid laser ultrasound system, particularly a hybrid phacoemulsification laser system, and a hybrid phacoemulsification femtosecond laser system ("femto-phacoemulsification" or "phacoemulsification-femto", which are used interchangeably unless otherwise specified). These embodiments may have or utilize one or more embodiments, features, functions, parameters, components, systems, and one or more features of the general techniques and example systems disclosed herein of therapeutic laser systems, laser beam delivery, laser control systems, position and shape measurement, patient interface, and ultrasound / phacoemulsification.

[0177] In preferred embodiments of laser ultrasound systems, particularly laser-phacoemulsification systems, and more particularly femto-phacoemulsification systems, the system has two therapeutic laser beams provided by the same or different laser sources, one being a short pulse width laser beam and the other being a long pulse width laser beam.

[0178] Generally, short pulsed lasers are intended for performing procedures on the cornea, such as corneal ablation, limbal relaxation keratotomy, etc. Generally, long pulsed laser beams are intended for performing procedures on the lens, such as capsulotomy, lens fragmentation, cataract fragmentation, etc.

[0179] These embodiments having multiple types of different therapeutic laser beams, e.g., short pulse width and long pulse width therapeutic laser beams, can have or utilize one or more embodiments, features, functions, parameters, components, or systems of the therapeutic laser systems, laser beam delivery, laser control systems, position and shape measurement, patient interfaces, and general ultrasound / phacoemulsification techniques disclosed herein, and one or more features of the example systems.

[0180] A system, such as a femto-phacoemulsification system, can have multiple therapeutic laser beams, e.g., one, two, three, four, or more beams with different characteristics. These laser beams can travel the same laser beam path and thus propagate through the same optical components and interfere with each other, or they can propagate along different laser beam paths and thus propagate through different optical components and interfere with each other, as well as combinations and variations thereof. For example, a system can include a first beam having a first pulse width and a first power or energy, a second beam having a second pulse width and a second power or energy, and a third beam having a third pulse width and a third power or energy. The first, second, and third pulse widths, the first, second, and third powers, and the first, second, and third energies can be the same, different, and combinations and variations thereof.

[0181] In one embodiment, the multiple therapeutic laser beam laser system is associated (integrally or modularly) with another therapeutic device, such as an ultrasound device, a diagnostic device, and combinations and variations thereof.

[0182] In one embodiment, where the long pulse width and short pulse width laser beams are provided by the same therapeutic laser source, the switching time between pulse lengths is less than about 3 seconds, less than about 2 seconds, less than about 1.5 seconds, between about 3 seconds and 1 second, about 2 seconds, about 3 seconds, and combinations and variations thereof, and longer or shorter times.

[0183] Although preferred embodiments of the present invention are directed to laser-ultrasound, and particularly femto-ultrasound phacoemulsification systems, it should be understood that laser system improvements and embodiments thereof may find value and be used alone without being part of a laser ultrasound system.

[0184] These embodiments of the system offer important advantages over the prior art: the system provides an optimal laser energy pattern, allows for evaluation of the eye without moving the patient after delivery, and performs the phacoemulsification procedure with minimal time delay (less than 1 minute, less than 30 seconds, less than 15 seconds), thereby achieving the important goal of using as little phacoemulsification energy as possible during cataract surgery, and preferably in a predetermined manner for every patient. example

[0185] The following examples are provided to illustrate various embodiments of the system, system components, processes, assemblies, applications, and materials of the present invention. These examples are for illustrative purposes and may be prophetic and should not be viewed as limiting or restricting the scope of the invention.

[0186] The embodiments of these Examples 1 through 46 may comprise or utilize one or more embodiments, processes, methods, features, functions, parameters, components, or systems of the general techniques of therapeutic lasers and systems, laser beam delivery, laser control systems, position and shape measurement, patient interfaces, ultrasound / phacoemulsification, and phacoemulsification-femto hybridization disclosed herein, and respective combinations and variations thereof; and further, one or more embodiments, processes, methods, features, functions, parameters, components, or systems provided in one or more other examples and other embodiments provided herein.

[0187] Example 1

[0188] 2 illustrates a perspective, partial cutaway view of an embodiment of a femto-phacoemulsification laser system 200. System 200 includes a laser subsystem 204 and a phacoemulsification subsystem 205 housed within a common housing 206. Laser subsystem 204 includes a therapeutic laser beam source, and in embodiments, a slow pulse width and a long pulse width therapeutic laser beam source. Laser subsystem 204 includes a laser that defines a therapeutic laser beam path along which the therapeutic laser beam is transmitted, and optical components positioned or disposed along the laser beam path. These components may include z-focusing optics and an x-y scanner.

[0189] System 200 includes an arm 201 that encases the therapeutic laser beam path and other optical paths. In an embodiment, arm 201 also houses or carries control and power cables for imaging and positioning device 203 and a docking assembly (not shown in this view). Arm 201 includes a therapeutic laser beam delivery head 202 at its proximal end. Laser delivery head 202 includes a position and shape measurement device, which can be an OCT system or a Scheimpflug system as in the example, as well as combinations and variations thereof, and other shape and position measurement devices. The laser delivery head includes a docking and alignment system that interfaces with the PID to dock to the patient's eye.

[0190] System 200 has a common power supply 207 for laser subsystem 204 and phacoemulsification subsystem 205. The common power supply 207 provides all power for the entire system, eliminating the need for auxiliary power supplies or sources. This allows the systems to be plugged into a single power supply in the operating room.

[0191] System 200 includes a common control system 208. Common control system 208 includes controls that operate the control software or execute instructions. In a preferred embodiment, common control system 208 is control communicatively connected to one or more, preferably all of: a laser subsystem control system and controls 212; a phacoemulsification subsystem control system and controls 211; an operator interface 209; an emergency stop 210; and a network that may be configured, for example, with a patient's medical record system, accounting system, and combinations and variations thereof.

[0192] Typically, the docking system and imaging and position measurement equipment are controlled by the laser subsystem control system. In an embodiment, they are controlled in whole or in part directly by a common control system 208.

[0193] In one embodiment, the laser control system and the phacoemulsification control system may be partially or fully integrated into a single common control system, such that in one embodiment, only one control system or a single control system is present in the femto-phacoemulsification system.

[0194] Example 2

[0195] 3 shows an embodiment of a femto-ultrasound phacoemulsification system along the lines of Example 1, where like numerals refer to like components. In the embodiment of FIG. 3, an xy scanner 301 is located on the laser delivery head 202.

[0196] Example 3

[0197] 4 and 4A-4D show schematic diagrams of the light paths and optical configurations for embodiments of the present laser system, laser ultrasound system, and particularly femto-ultrasound phacoemulsification system.

[0198] Optical system 430 includes four optical systems, 400, 401, 402, and 403, each with different wavelengths, powers, and light for different purposes. Optical system 400 is for the therapeutic laser beam and includes optical components to define a therapeutic laser beam path through which the therapeutic laser beam is transmitted. Optical system 403 is for an imaging and position measurement device, such as a Scheimpflug device, which, among other things, measures the shape and position of ocular structures and directly correlates the therapeutic laser beam with the laser beam path. This system 403 provides an imaging path. Optical system 401 is for a camera, preferably an IR camera, and as can be seen, this beam path extends along, i.e., coincides with, the therapeutic laser beam path 400 for most of its path. This system 401 provides an imaging path. The two paths are combined with a beam splitter; the Vario (Z-axis laser deflection optics) for the therapeutic laser is not part of the camera beam path 401. Optical system 402 is for an auxiliary camera, preferably a color camera. This system 402 shares some of the therapeutic laser beam path. This system 402 provides the imaging path.

[0199] These systems also include an IR-DTP ("Down The Pipe"; e.g., configured to look along the laser beam path) camera 480, beam splitter cubes 481, 482 (R: 880(S); T: 880(P), 1030(S+P)), galvanometer mirror 483, DTP relay 491, vario 484, 1x telescope 485, F-Theta lens 486, color DTP camera 487, beam splitter cube 489 (R: 880, 1030; T: visible), and Scheimpflug camera assembly 490.

[0200] Telescope 485 has a pair of telecentric 120 mm lenses 493, 494. Scheimpflug camera assembly 490 has an image plane 470 with a 15 degree tilt angle, a Thorlabs lens (30 mm) 471, an aperture stop (44 mm) 472, and a folding mirror 473. IR-DTP camera 480 has an aperture stop (3 mm) 450. Color DTP camera 487 has an aperture stop (2 mm) 451.

[0201] Sections or portions of these optics 400, 401, 402, 403 can be disposed or housed in various housings and components of embodiments of the laser system, laser ultrasound system, and femto-ultrasound phacoemulsification system. Thus, as shown in Figure 4 for illustrative purposes, portions of the optics can be enclosed or housed within a distal housing 420 (such as, for example, housing 503 of Figure 5, or housing 106 of Figure 1), an arm 421 (such as, for example, arm 201 of Figure 3, light pipe 504 of Figure 5, or arm 107 of Figure 1), and a laser head or proximal housing 423, e.g., a proximal assembly or laser head (such as, for example, the proximal end of arm 107 of Figure 1, head 202 of Figure 2, or head 505 of Figure 5). These optical systems 400, 401, 402, 403 can also be positioned between or housed within distal housing 420, arm or connector 421a, and proximal housing, e.g., proximal assembly or laser head 423a, as shown in the configuration of Figure 4E. These optical systems 400, 401, 402, 403 can also be positioned between or housed within distal housing 420b, arm 421b, and proximal housing 423b, e.g., proximal assembly or laser head, as shown in the configuration of Figure 4F. Other placement and housing or enclosure configurations for these optical systems are also contemplated.

[0202] 4G, optical system 430 has four pupils 461, 462, 463, and 464. In this embodiment, the pupils are conjugate telecentric pupils. Note that only three of the four pupils are along the therapeutic laser beam path.

[0203] Example 3A

[0204] The embodiment of Example 3 simultaneously has a treatment laser and a scanning laser to illuminate the ocular structures so that optical components such as from 403 can take images to determine where the ocular structures are located. Additionally, there is an eye fixation light source to assist the patient in fixating during the docking process. The path for this fixation light source and its light is via a beam splitting cube between 402 and 403 in Figure 4G.

[0205] Example 4A

[0206] The femto-phacoemulsification system includes an imaging and localization device, which is an ultrasound-based imaging system. In one embodiment, the imaging and localization device is an optical coherence tomography (OCT) system that can measure the shape of the lens and ocular structures and their positions relative to the therapeutic laser and the therapeutic laser beam. The OCT system is integrated with and in control communication with the laser subsystem control system, the phacoemulsification subsystem control system, the femto-phacoemulsification system control system, and combinations and variations thereof.

[0207] The OCT system can also be used in the embodiments of, for example, Figures 1, 2, 3, 5, 14, and other embodiments.

[0208] Example 4B

[0209] The embodiments of Figures 1, 2, 3, 5, and 14 include and utilize a Scheimpflug camera system as an imaging and position measurement device. A Scheimpflug camera system is a completely different system than an OCT system. A Scheimpflug camera operates in a significantly different manner, functions in a different manner, and provides significantly different outputs, such as results, than an OCT system. The Scheimpflug system of the present invention is believed to be superior to OCT in determining the position and shape of ocular structures.

[0210] The Scheimpflug camera system is integrated with and in control communication with a laser subsystem control system, a phacoemulsification subsystem control system, a femto-phacoemulsification system control system, and combinations and variations thereof.

[0211] The Scheimpflug camera system is also in control communication connection with a foot switch, preferably a wireless foot switch, via a bus such as the communication bus shown in Figure 22A.

[0212] Example 5A

[0213] In one embodiment of the femto-phacoemulsification system, the phacoemulsification subsystem has the following components, features, and an integrated peristaltic and venturi pump system, allowing the surgeon to independently select either pump mode for phacoemulsification and vitrectomy procedures. Features of the phacoemulsification subsystem include: a twin pump system, peristaltic and venturi; high-vacuum occlusion; and high-speed vitrectomy. The phacoemulsification subsystem is capable of and performs the following procedures: diathermy, irrigation, sculpting, flop and chop, vit, and visco. The user interface and software provide menu items and monitor areas for these and other phacoemulsification procedures. The interface can have GUI screens and menus such as the types shown in Figures 23A through 23D.

[0214] Example 5B

[0215] In one embodiment of the femto-phacoemulsification system, the phacoemulsification subsystem includes the Alcon CENTURION® Vision System, the Alco ACTIVE SENTRY® Handpiece, and the INTREPID® Hybrid components.

[0216] Example 5C

[0217] In one embodiment of the femto-phacoemulsification system, the phacoemulsification subsystem comprises components of an AMO WHITESTAR SIGNATURE® PRO phacoemulsification system.

[0218] Example 6

[0219] In embodiments of laser ultrasound systems, particularly femto-phacoemulsification systems, the system has a safety interlock. The safety interlock is preferably in a common control system and is located in or as part of the laser control system, the phacoemulsification control system, and combinations and variations thereof. The safety interlock prevents the therapeutic laser from firing when the phacoemulsification system is operating. In one embodiment, the interlock system has three stages or gates: (i) the phacoemulsification system is de-energized—laser is operational; (ii) the phacoemulsification system is on and warming up but not operational or running—laser is operational; and (iii) the phacoemulsification is operational or running—laser cannot fire.

[0220] In one embodiment, stage (iii) allows the laser to operate when the phacoemulsification system is operational but not operating, and in this embodiment, the treatment laser is locked out, i.e., unable to fire or transmit a laser beam, only when the phacoemulsification system is operating, i.e., transmitting ultrasound energy.

[0221] Example 6A

[0222] In one embodiment, the three stages or gates in the interlock system are: (i) phacoemulsification system and femto system are powered on and ready / warm up; (ii) phacoemulsification system is on and ready but not operational - laser is operational; (iii) phacoemulsification is operational or running - laser cannot fire.

[0223] Example 7

[0224] 5 shows a perspective view of a femto-phacoemulsification laser device or system 500. The system has a lower or main housing 501 (only partially shown in the figure). The lower housing 501 contains the phacoemulsification system, a location for the phacoemulsification cartridge, the cartridge during treatment, a therapeutic laser for generating the therapeutic laser beam, and a control system. A sliding mechanism 502 is disposed on the main housing 501. The sliding mechanism 502 provides movement of an upper or movable housing 503. The movable housing 503 is moved by the sliding mechanism 502 in the direction of arrow 502a, i.e., laterally horizontally, i.e., toward and away from the patient.

[0225] The sliding mechanism may be controlled, for example, by a joystick, or may be automatically or manually moved, for example, by a motor, where the motor may be rotatable, or a combination thereof. The motor may have a set or predetermined position and be in control communication with the smart headrest to accurately position or position the laser delivery head 505 on the patient headrest and thereby on the patient and their eye undergoing surgery.

[0226] The upper or movable housing 503 contains the laser focusing z-optics, xy scanning optics, and other beam processing or handling components. The housing 503 also contains other optics and light paths as described in Example 3.

[0227] Housing 503 is in optical communication with the therapeutic laser via articulated light pipe 507. The articulated light pipe provides a free-space laser beam path that directs a laser beam from lower housing 501 into housing 503 and transmits the therapeutic laser beam along the laser beam path to the optical components within housing 503. In this embodiment, as shown in more detail in FIG. 5I, articulated light pipe 507 has six joints, each with a reflective surface on the inside. Preferably, light pipe 507 maintains the therapeutic laser and housing 501 in optical communication with housing 503 and the optical components within housing 503 in all possible positions and orientations of housing 503.

[0228] Housing 503 has arm 504, which is a rigid, hollow light pipe that houses or contains one or more optical paths, including the therapeutic laser beam path and other paths, as described in Example 3. Arm 504 connects housing 503 to laser delivery head 505, maintaining these components in optical communication. Arm 504 can also carry control and communication cables, optical fibers or wires that transmit control signals and are configured between the components of the laser head and the control system. Laser head 505 is located at the proximal end of arm 504, and housing 503 is located at the distal end of arm 504.

[0229] The laser head has a position and shape measurement device 506, which is a Scheimpflug device with five cameras (in one embodiment six fixed cameras, in one embodiment a single movable camera).

[0230] Example 8

[0231] 5A through 5H, various views of an embodiment of a position adjustment mechanism for use with the system of FIG. 5 are shown (like numbers have like meanings and refer to like components).

[0232] 5A, position adjustment mechanism 510 is generally located on the other side of housing 503, away from arm 507. A portion of mechanism 510 may be located below housing 503 and on or within housing 501.

[0233] 5B shows lateral movement assembly 531, which is part of position adjustment mechanism 510. Lateral movement assembly 531 includes first and second plates 520 and 521 that are movably and mechanically associated with motors 523 and 522, for example, by drive gears or wheels. Plates 520 and 521 are moved in a lateral movement arc, i.e., in the direction of arrow 502a, relative to fixed post 512. Fixed post 512 is attached to a free-moving assembly, such as assembly 513. Lateral movement assembly 531 is mechanically associated with housing 501 and can be housed on, or preferably within, housing 501.

[0234] Example 9

[0235] 5C, there is shown a lateral movement assembly 511 having a four-bar linkage that is part of position adjustment mechanism 510a and provides movement in the direction of arrow 502a. Lateral movement assembly 511 is mechanically associated with housing 501 and may be housed on, or preferably within, housing 501.

[0236] It is understood that lateral movement assembly 510 of Example 8 can be used with position adjustment mechanism 510a of Example 9, and vice versa. It is understood that free movement assembly 513 can be used with either lateral movement assembly 511 or lateral movement assembly 531. It is understood that other free movement type mechanisms and electromechanical devices, and lateral type movement mechanisms and electromechanical devices can be used.

[0237] Assembly 511 is attached to fixed post 512. This assembly moves fixed post 502 in the direction of arrow 502a. Fixed post 512 is connected to free-moving assembly 513. Free-moving assembly 513 provides arcuate, lateral, vertical, and combinations of movement of housing 503, as generally indicated by the set of arrows 513a. Assembly 513 is a parallelogram linkage.

[0238] Assembly 513 may be motorized, have a fixed position, or may be manipulated by hand, for example, by holding arm 504, housing 503, or other portion and changing the position of housing 503. In one embodiment, housing 503, arm 504, and laser head 505 are counterbalanced to allow housing 503 to move with forces less than 10 lbs, less than 7 lbs, less than 5 lbs, and less than 2 lbs, about 2 to about 7 lbs, about 4 to about 6 lbs, and combinations and variations thereof. Preferably, once moved, housing 503 remains in that position until a force sufficient to move it is applied. (For simplicity, arm 504 and laser head 505 are not shown in FIG. 5C.)

[0239] Figures 5D through 5H show several positions of the housing 503 positioned by the free-travel assembly 513. The position of Figure 5H is ideal for storing the system and cleaning the operating room, while the position of Figure 5E is for performing laser surgery on a patient.

[0240] Example 10

[0241] In one embodiment, a laser ultrasound system, particularly a femto-ultrasound phacoemulsification system, has a patient bed or support attached to the system.

[0242] Example 11

[0243] In one embodiment, the patient support, e.g., a bed, is not attached to the laser ultrasound system, particularly the femto-phacoemulsification system. The patient support and the femto-phacoemulsification system are fully positionable relative to each other without any physical constraints between them. Thus, the femto-phacoemulsification system can be positioned in any position and orientation relative to the patient support (with the patient's head naturally within reach of the arms and phacoemulsification tube). An orientation / position tracking system using A / C electromagnetic fields, gyroscopes, accelerometers, and magnetometers is used to determine the orientation of the patient's head relative to the therapeutic laser and the therapeutic laser beam path. This orientation tracking system can measure the angle of the arm, e.g., the angle of arm 504 in the system of FIG. 5, within ±5 degrees, ±3 degrees, ±2 degrees, and larger or smaller angles. Using this angle, the therapeutic laser beam transmission pattern is preferably adjusted by a control system to transmit the laser beam pattern at the correct angular orientation relative to the patient's eye.

[0244] In one embodiment, a Polhemus Patriot™ 6-DOF tracking sensor is placed on the patient headrest with the transducer mounted on the system frame near the front of the transmission system. This provides sufficient information to determine the orientation of the headrest relative to the laser transmission system. This orientation / position tracking system is further described in Appendix A, the entire disclosure of which is incorporated herein by reference.

[0245] Example 12

[0246] The electromagnetic tracking system is used in a stand-alone therapeutic laser system that does not include a phacoemulsification subsystem. The stand-alone therapeutic laser system has a patient support that is not attached to the laser system. The electromagnetic tracking system measures the angle of orientation of the patient's eye relative to the laser system. The laser system configures the laser transmission pattern to match the measured angle.

[0247] Example 13

[0248] The systems of Examples 11 and 12 have a flexible or positionable mechanical attachment between the patient support and the therapeutic system. An electromagnetic tracking system is used to measure the position, particularly the angle of the patient's eye, relative to the therapeutic system. The laser system configures the laser transmission pattern to match the measured angle.

[0249] Example 14

[0250] The components of the electromagnetic tracking system, such as gyroscopes, accelerometers, and magnetometers, are positioned in various arrangements within the patient support, within the patient head support, on the patient, and within the therapeutic system, with the gyroscopes, accelerometers, and magnetometers positioned within one or more of these components.

[0251] Example 15

[0252] In one embodiment, a combination of devices such as a gyroscope, accelerometer, and digital compass are placed on the patient headrest and two magnetometers are located within the femto-ultrasound phacoemulsification system, providing sufficient devices to measure the orientation, e.g., patient angle, relative to the laser arm and the laser beam path and pattern.

[0253] A compass based positioning system using a system gyroscope, accelerometer, and magnetometer is used to measure the position of the patient's head, particularly the eye on which surgery will be performed, relative to the therapeutic laser and the therapeutic laser beam path. This compass based positioning system can measure the angle of an arm, such as the angle of arm 504 of the system of FIG. 5, to within ±5 degrees, ±3 degrees, ±2 degrees, and greater or less accuracy. Using this angle, the therapeutic laser beam transmission pattern is adjusted, preferably by a control system, to deliver the laser beam pattern at the correct angular orientation relative to the patient's eye.

[0254] In one embodiment, a gyroscope and accelerometer are placed in the patient headrest and two magnetometers are located within the femto-ultrasound phacoemulsification system, providing sufficient equipment to measure the orientation, e.g., patient angle, relative to the laser arm and the laser beam path and pattern.

[0255] Components of the compass based position measurement system, such as gyroscopes, accelerometers, and magnetometers, are positioned in various arrangements within the patient support, within the patient head support, on the patient, and within the therapeutic system, with the gyroscopes, accelerometers, and magnetometers positioned within one or more of these components.

[0256] The systems of Examples 11 and 12 have a flexible or positionable mechanical attachment between the patient support and the therapeutic system. A compass based position measurement system is used to measure the position, particularly the angle of the patient's eye, relative to the therapeutic system. The laser system configures the laser transmission pattern to match the measured angle.

[0257] The compass based position measurement system is used in a stand-alone therapeutic laser system that does not include a phacoemulsification subsystem. The stand-alone therapeutic laser system has a patient support that is not attached to the laser system. The compass based position measurement system measures the angle of orientation of the patient's eye relative to the laser system. The laser system configures its laser transmission pattern to match the measured angle.

[0258] Example 16

[0259] The headrest, or other remote component of the tracking system, e.g., the electromagnetic tracking system (i.e., not part of the therapeutic system), has a separate charging station, enclosure, or rechargeable battery that can be charged on the therapeutic system.

[0260] Example 17

[0261] In one embodiment of the femto-phacoemulsification system, the control system recommends, for example, the degree of match, cataract grade, laser power and pattern, and ultrasound velocity, power, and phase angle, as well as fluid, flow rates, and other characteristics associated with the handpiece and the phacoemulsification procedure. In this manner, the system, as a fully integrated device, recommends and predetermines all energy and fluid flow rates delivered to the eye as part of the treatment. In one embodiment, the phacoemulsification handpiece is adjusted by the system controller to optimize the phacoemulsification procedure based on a prior laser treatment based on a prior cataract grading. The system provides a single system that can quickly, and without the need for patient movement or system relocation, measure the shape and position of the cornea (e.g., anterior and posterior surfaces), the structure of the eye's lens (e.g., anterior capsule, posterior capsule), grade the cataract type or density, perform laser capsulorhexis and laser fragmentation of the lens, and perform phacoemulsification of the laser-fragmented lens material to remove it for insertion of an IOL. The system is adapted to use information obtained from each previous step of the procedure to optimize the next step of the procedure. In this manner, the system provides a fully integrated, predetermined total energy delivery and energy delivery profile to the eye during the ophthalmic procedure. In embodiments, the total energy delivery and energy delivery profile are based on the grade of cataract being treated. The total energy delivery and energy delivery profile include both laser energy and ultrasound energy.

[0262] Example 18

[0263] In an embodiment, the femto-phacoemulsification system provides a predetermined, variable mode to the surgeon or practitioner performing the procedure, where the system, in conjunction with the laser control system and the phacoemulsification control system, predetermines, enables, recommends, and preferably optimizes ranges and settings for the phacoemulsification procedure. This embodiment can also "learn" based on the surgeon's selections and preferences, providing specifically optimized ranges based on the surgeon's skill level and input.

[0264] Example 19

[0265] In embodiments, the femto-phacoemulsification system provides an adjustable mode that allows for more variability or predetermined variability, such as providing a range of adjustments to the ultrasound based on the laser beam pattern or laser treatment delivered to the lens by the system, preferably based on the cataract grade, which may be measured by or provided to the system, and other factors. The system then provides recommended ranges and adjustments to the treatment, including: (i) recommended torsional lateral motion, transverse axial lateral motion, or no lateral motion; (ii) recommended laser patterns that increase fragmentation and lower phacoemulsification power to combat intraocular heating; and (iii) recommended duty cycles.

[0266] Duty cycle and duty cycle recommendations can include the selection of a mode, such as pulsed mode, in which phacoemulsification power pulses and rest periods are alternated, with a default ratio of 50:50. This is called a 50% duty cycle, with each cycle consisting of 50% of the time power on followed by 50% of the time power off. The default ratio can be modified by changing the ratio of the time interval between ultrasound energy and rest. For example, 40% is 40 milliseconds on and 60 milliseconds off, giving a 40:60 ratio. When is a higher or lower duty cycle preferable? The answer depends on the surgical phase. For nucleus sculpting, such as with the divide-and-conquer technique, surgeons need to deliver enough energy to carve the grooves. This requires a duty cycle of approximately 40% to 60%. Once the surgeon achieves a break that creates a groove in the nucleus and results in a quadrant, a lower duty cycle is used during phacoemulsification-assisted aspiration of the quadrant. During removal of this quadrant, a lower duty cycle of 20% to 40% can be used because the primary force of aspiration is fluid, not ultrasound.

[0267] Example 20

[0268] In embodiments, the phacoemulsification subsystem is used to simply separate the laser cut material, for example, when the laser cuts the material to a size smaller than the opening of the phacoemulsification needle.

[0269] Example 21

[0270] Laser ultrasound systems, particularly femto-phacoemulsification systems, have an integrated microscope.

[0271] Example 22

[0272] Adapters are used in the phacoemulsification-femto system housing to accommodate or use multiple companies or types of phacoemulsification pucks and phacoemulsification cassettes. The adapters have the necessary hardware adapters and software to provide complete, effective, and approved operation of the system. The adapters can be part of the housing, a separate insert or component for the housing, or part of or integral with the cassette.

[0273] Example 23

[0274] FIG. 6 shows a top view of a laser ultrasound system, particularly a femto-ultrasound phacoemulsification system for use in performing a laser-ultrasound therapeutic procedure. The femto-ultrasound phacoemulsification system 610 is positioned at an angle between a side position and a top position. The laser delivery head can extend to the patient for laser surgery and retract from the patient for ultrasound treatment, as indicated by arrow 620. A headrest 612 and patient support 613 are positioned relative to the femto-ultrasound phacoemulsification system. The system and patient support include a positioning system, e.g., an electromagnetic positioning system, that measures the angle 630, angle 630a, or both of the laser system relative to the patient headrest, i.e., the patient. The angle is measured as the angle between the longitudinal axis 631 of the arm and the longitudinal axis 632 of the patient's head, as determined by the patient's headrest.

[0275] Three positions of the surgeon are shown: top 641 and side 640, 642. It can be seen that regardless of the surgeon's preference for these positions, the laser arm does not interfere with the procedure.

[0276] Additionally, the laser head can be quickly and easily repositioned to access and perform laser procedures on both of a patient's eyes without having to reposition the patient support or the femto-phacoemulsification system.

[0277] In embodiments, the laser system can be positioned at an angle 630 of about 30 degrees to about 320 degrees, and any angle within this range. The only limitation to this angle is the area in which the patient support is located. The surgeon can be positioned in a top position or either side position, among others.

[0278] Example 24

[0279] FIG. 7 illustrates some of these possible configurations and surgeon placements, all of which provide the surgeon with full access to either eye of the patient for each of these configurations. Thus, the laser ultrasound system 610 can be positioned at a 45-degree angle 656, a 90-degree angle (i.e., side) 855, a 135-degree angle 654, a 180-degree angle (i.e., top) 653, a 225-degree angle 852, a 270-degree angle (i.e., side) 851, and a 315-degree angle 650. It should be understood that the laser ultrasound system can be positioned at any angle between those shown in the figure, thus providing perfect alignment, e.g., a "clockwise rotation" of the laser ultrasound system around each of the patient's eyes. In this manner, the system is ambidextrous in that the system configuration is the same for the surgeon in both left- and right-hand positions.

[0280] Example 25

[0281] Figure 8 shows an embodiment of a Scheimpflug shape and position measurement assembly for use in the laser delivery head of the system. This embodiment is a five-camera configuration with cameras 5001, 5002, 5003, 5004, and 5005 spaced 40 degrees apart. This arrangement allows the system to operate in any of the configurations of Examples 23 and 24. In some configurations and for some patients, one or two cameras may be obstructed, and the system will still operate and provide reliable images for shape and position measurements.

[0282] Example 26

[0283] Figure 9 shows an embodiment of a Scheimpflug shape and position measurement assembly for use in the laser delivery head of the system. This embodiment is a six-camera configuration with cameras 6001, 6002, 6003, 6004, 6005, and 6006 spaced 40 degrees apart. This arrangement allows the system to operate in any of the configurations of Examples 23 and 24. In some configurations and for some patients, one, two, or three cameras may be obstructed, and the system will still operate and provide reliable images for shape and position measurements.

[0284] Example 27 10A and 10B show perspective views of the proximal laser assembly with its docking system at different angles. In FIG. 10B, the head cover has been removed to reveal the Scheimpflug camera, e.g., 1001. The proximal laser assembly 1000 is attached to the proximal end of an arm 1040, which is a light pipe that surrounds the treatment laser beam path and the active laser beam. The assembly 1000 includes an automated docking system 1010 having a drive assembly 1011 connected to a docking ring 1020 that docks to or forms part of the PID. The docking system 1010 is preferably controlled by a control system and can be operated in whole or in part by the surgeon using a joystick. The control system also controls the operation of the docking system and can include load sensors, speed control, and other safety control systems.

[0285] Example 28

[0286] Embodiments of the therapeutic laser beam for use in the system and treatment have high quality beam characteristics. The laser beam has an M 2 The factor may be:

[0287] Example 29

[0288] In embodiments of the system, the transition from femto to phacoemulsification, including undocking the laser, moving the laser arm out of the way, and preparing for insertion of the phacoemulsification tool (and, in embodiments, inserting the phacoemulsification tool into the eye), takes less than 5 minutes, less than 4 minutes, 3 minutes or less, 2 minutes or less, about 3-5 minutes, about 3-4 minutes, about 2-4 minutes, and longer or shorter times.

[0289] Example 30

[0290] In one embodiment, the bed placement flexibility for the femto-phacoemulsification system, which has a footprint of 32 x 22 inches, allows the device to be placed anywhere around a patient up to 6 feet 3 inches tall. This system provides a truly bimanual system, which allows for full rotation of the laser around each eye and also allows for a top and side approach by the surgeon.

[0291] Example 31

[0292] Components associated with the laser systems of various embodiments, such as the example embodiments above, are used in stand-alone laser systems that do not have an integrated phacoemulsification system.

[0293] Example 32

[0294] In one embodiment of these devices, the floor footprint, i.e., the device envelope formed by the outer housing, is 5 square feet (22 in x 33 in = 726 square inches / 144 = 5 square feet). The height of this device is 57 in to 65 in. The laser arm and its optical head move primarily horizontally. The arm does not rotate about a pivot point. When stored, the arm fits completely within the device envelope (i.e., 22 in x 33 in). The laser arm and its optical head move up to 33 inches in "X" relative to the stated setting of their normal position. Once in the normal position, the motion platform can move + / - 2 inches in X, + / - 2 inches in Y, and +5 / - 3 inches in Z for fine adjustment to the patient. (In this example, X is the longitudinal axis of the device, Y is the transverse axis of the device, and Z is the vertical axis of the device.) Thus, in this embodiment, the arm moves in X and Y, and when stored, the arm and its optical head fit entirely within the footprint of the device. The housing is not adjustable, so its width and lateral dimensions do not change.

[0295] Example 33

[0296] Figure 14 shows a perspective view of an embodiment of a femto-ultrasound phacoemulsification system 1400. Figures 15, 15A, 15B, 16A, 16B, 16C, 17A, 17B, and 17C illustrate various components and configurations of the system of Figure 14. Like numbers in these figures refer to like components.

[0297] The femto-ultrasound phacoemulsification laser system 1400 has a housing 1401 that forms a base 1403 for the system 1400. A translation mechanism housing 1402 is attached to the housing 1401 on the base 1403. The housing 1402 contains a mechanism for horizontal movement (i.e., extension and retraction) of an extendable assembly 1409. A translation slide stage 1410 is extended and retracted by a horizontal translation mechanism 1420. The translation slide stage 1410 supports an optical assembly and scanner housing 1406. The housing 1406 also contains a vertical translation mechanism 1425 and a vertical translation translation slide stage 1411.

[0298] The extendable assembly 1409 includes a housing 1406, an arm 1407, and a laser beam delivery head 1408, with the arm 1407 containing the various optical and control cables for the system. The laser beam delivery head 1408 includes a shape and position measurement device 1412 and a PID 1470.

[0299] System 1400 is shown in Figure 17 with one monitor 1413. The system may have one or two additional monitors (as shown in Figures 16A to 16C). The system may have an integrated microscope (not shown in these figures).

[0300] 15 shows an extensible assembly 1409 attached to a translational slide stage 1410. The stage 1410 has an extensible / retractable base 1424 and a flexible extensible / retractable cover 1422. The stage 1410 provides horizontal movement for the assembly 1409. The stage 1410 is disposed within and partially forms the top surface of a housing 1402. The housing 1402 is attached to the housing 1401.

[0301] 15A in conjunction with FIG. 15, horizontal movement mechanism 1420 is housed within housing 1402. Mechanism 1420 can be attached directly to housing 1402, housing 1401, and combinations and variations thereof. Housing 1402 also contains reel 1423 that holds (i.e., winds and unwinds) flexible cover 1422. Housing 1402 also contains rollers 1421 on which flexible cover 1422 moves.

[0302] FIG. 15A shows horizontal movement mechanism 1420 with cover 1402 removed. Mechanism 1420 includes a motor, drive mechanism, sensors, and controls. Mechanism 1420 includes horizontal slide mechanism 1426, a pair of slide rails, one inside the other. Supports 1428 connect the inner rail to vertical slide mechanism 1427, which form pair of vertical movement mechanisms 1425 (see FIG. 15). FIG. 15B shows the rail assembly of FIG. 15A in a first, extended position, which is the position for performing laser surgery.

[0303] FIG. 16A is a top view of the system 1400 of FIG. 14 with three monitors, with the system 1400 positioned in an operating room or patient treatment room. The system 1400 is fully retracted, e.g., parked or positioned. In the parked position, the extensible assembly 1409 does not extend beyond the base 1403. Thus, in this position, the extensible assembly 1409 does not extend beyond (i.e., is completely within) the system's footprint or perimeter, dashed line 1480. The system 1400 is shown in relation to a patient bed 1490 and a person.

[0304] 16B shows the system in an extended position (first position or first extended position) for performing therapeutic laser surgery. While the system is shown oriented at a 90 degree angle relative to the patient, it should be understood that the system can be positioned at any angle relative to the patient. For example, the system can be positioned at any of the angles in examples 23 and 24. An extendable assembly 1409 extends horizontally beyond the housing of the system to position the laser head over the patient.

[0305] FIG. 16C shows the system in a fully extended position for performing therapeutic laser surgery. The system is shown oriented at a 135-degree angle relative to the patient. The fully extended position maintains the system housing far enough away from the patient to provide proper, comfortable, and ergonomic access to the patient by the practitioner. The extendable assembly 1409 extends horizontally beyond the system housing to position the laser head above the patient. Comparing FIG. 16C to FIG. 16B, the assembly 1409 in the fully extended position in FIG. 16C is longer, i.e., the laser head is farther from the base than in the first extended position in FIG. 16B.

[0306] 17A-17C are a series of photographs showing specific extended and retracted positions for the extendable assembly of the system of FIG. 14. FIG. 17A shows an intermediate extended position for testing and calibration of the laser system. FIG. 17B shows a first operative extended position for therapeutic laser surgery. FIG. 17C shows a second operative extended position (fully extended) for therapeutic laser surgery.

[0307] Thus, the system can have four predetermined positions: a parked position where the laser head and extendable assembly are within the footprint of the device; an intermediate position where only the laser head extends horizontally beyond the footprint of the device; a first extended position where a laser treatment action can be administered to the patient; and a second or fully extended position where a laser treatment action can be administered to the patient. The four predetermined positions can be controlled by stops that are machine-based, control software-based, and combinations and variations thereof. The system can also have various other lengths of extension from the intermediate position to the fully extended position, which can be predetermined or simply determined by the operator, and combinations and variations thereof.

[0308] The housing encloses a power component, a control component, an operating component, an analytical prediction and diagnostic device, a position measurement and location device, a laser beam generating component, and an ultrasound generating component. In a preferred embodiment, the ultrasound generating component is a component of an ultrasound phacoemulsification system, and the laser beam generating component provides a laser beam having a pulse length of about 2 ps or less.

[0309] These components may be distributed in whole or in part between the two housings 1401, 1402, among other reasons: to optimize space, to avoid interference between components, to deal with heat and vibration, and to provide more efficient control and operation of the system 1400. The two housings 1401, 1402 may be stand-alone housings on the same base or frame, may have communication, control, power, optical, and other connections therebetween, may be a single identical housing, or may be subdivided or divided into third, fourth, etc. housings or sub-housings, as well as combinations and variations thereof.

[0310] Connector 1505 is an optical conduit connecting housing 1401 to housing 1406. Housing 1406 houses the scanning device and beam shaping optics for the therapeutic laser beam; the scanning device, optics, or both may also be used to monitor and diagnose the laser beam and light path. (Housing 1406 also houses a vertical movement mechanism.) It is understood that, in embodiments, these components of housing 1406 may be located wholly or partially within one of the other housings, and similarly, components from other housings may be located within housing 1406. Housing 1406 may be subdivided or divided into one or more housings or sub-housings, as well as combinations and variations thereof. In a currently preferred embodiment, housing 1406 houses and isolates the scanner and beam shaping optics. The scanner and beam shaping optics, or other components housed within housing 1406, are in control communication with the controller and operating system of system 1400. The devices may be in direct control communication with one another, or indirect control communication with one another, for example, by being in control communication with a central, e.g., controller of system 1400, monitor 1413 which may have control functionality, and combinations and variations thereof. The devices may also be in direct and indirect control communication with one another.

[0311] The light conduit 1405 can be a light pipe (e.g., a hollow pipe or channel having an inner reflective surface such that the laser beam is transmitted through the free space within the hollow pipe, which can have a partial vacuum, can have ambient atmosphere, can contain an inert gas, and combinations and variations thereof), an articulated light pipe, a telescoping light pipe, a flexible light pipe, an optical fiber, one or more optical fibers, a hollow conduit, a beam guide, and combinations and variations thereof, other laser beam transmission structures.

[0312] The housing 1406 is attached to an arm 1407. The arm 1407 and housing 1406 move vertically via a vertical movement mechanism 1425. The arm 1407 carries an assembly or device 1412 for measuring the shape and position of the eye and structures therein. At its proximal end, i.e., the end furthest along the laser beam path and therefore furthest from the laser beam source, the arm 1407 carries a patient interface device (PID) 1470 below the device 1412. The housing 1406 carries a monitor 1413. The monitor is movable, for example, on an articulating arm. The monitor provides information such as treatment, system status, laser status, ultrasound status, cataract density, ultrasound settings, laser pattern settings, etc., and can receive input and commands from the surgeon. The monitor is in control communication with, and may include part or all of, the control system of the system 1400. The monitor is in control communication with the laser control system and the ultrasound control system either directly or via the control system of system 1400, via monitor 1409, and combinations and variations thereof. The monitor and its articulating arm may be located on other structures of system 1400 or may be freestanding. One, two, or additional monitors may be used. The monitor may have 3D viewing or display capabilities.

[0313] Arm 1407 forms or contains a laser beam transmission structure, such as a hollow tube, that provides free space for transmission of the laser beam. In embodiments, arm 1407 can include a free-space beam path or optical fiber for transmitting the laser beam, for example, to a scanner located at the proximal end of the tube, i.e., the end near housing 106, rather than the distal end. Arm 1407 can also be or include any laser beam transmission structure of the type described for use as optical conduit 1405. The tube can also include optics. In the embodiment of FIG. 14 , arm 1407 includes an uncollimated laser beam, and thus arm 1407 is shown as including an uncollimated laser beam and laser beam path; in other words, arm 1407 includes, surrounds, or contains “uncollimated space” along the laser beam path. Arm 1407 can contain or surround a collimated space in which the laser beam on the laser beam path is collimated. The arm can accommodate a space with optics. The arm can accommodate both collimated and non-collimated spaces. The arm 1407, in embodiments, can pivot, rotate, telescope, articulate from a distal point, and combinations and variations thereof. The proximal end of the laser beam path within the arm 1407 includes mirrors or optics for directing the laser beam through the PID and toward and into the patient's eye.

[0314] Example 33A

[0315] The femto-phacoemulsification system of Example 33 includes a surgical microscope 1457. The surgical microscope described in this example can be used with other examples and embodiments of the system herein.

[0316] Example 34

[0317] In an embodiment, the laser system has an external, internal, or both cooler.

[0318] Example 35

[0319] 12A-12J illustrate a PID (Patient Interface Device) for attachment to and use with any of the laser ultrasound systems, as well as for use with a stand-alone laser system. Like numbers correspond to like elements in FIGS. 12A-12J. This example embodiment of a PID 1200, as shown in FIGS. 12A-12J, has the following components: 1201 PID arm 1202 Upper Window 1204 Eyepiece 1204a Eyepiece outer skirt 1204b Inner skirt of eyepiece 1205 Upper ring 1206 Lower Ring 1207a Snap 1207b Snap 1207c Snap 1208a Bumper 1208b bumper 1208c bumper 1209 Meniscus Inverter 1210 Container Ring 1211 Upper ring side wall 1212 Channel for filling with saline solution 1213 Vacuum port 1220 Mounting Block 1221 Arm 1221a Arm lock position 1222 Receiving Clamp 1223 Engagement Ball 1224 slots (kinematic slots) 1225 Arrows showing arm movement 1226 Arrow indicating block engagement movement 1250 eyes 1260 Laser-Ultrasound Device

[0320] The patient interface device is attached to the eye as a single assembly. After being attached to the laser head, the entire device is positioned and engages the surface of the eye. The PID arm is attached to the laser system via a clamping mechanism.

[0321] During docking, the suction cup of the PID arm is gently placed on the surface of the cornea, and the suction ring contacts the surface of the eye, applying a vacuum to prevent relative eye movement, thereby stabilizing its position relative to the PID for precise laser treatment.

[0322] Three spherical features on the PID arm engage kinematic slot features on the clamping mechanism. During positioning engagement, a spring force is applied to the PID arm by the balls. Once the PID is in place, a lever moves the CAM mechanism, loading the balls against the PID and locking the kinematic mount in place.

[0323] A suction cup interface, or "ocular interface," is attached to the eye over the anterior surface of the eye. A glass window defines the first plane of the patient interface device, which is a positional reference for the first refractive surface used by software algorithms to calculate the precise location of the focal point of light emitted from the illumination or laser beam.

[0324] There are three snaps to hold the window in place. Three overmolded bumpers press the window tightly against the snap undercuts. The fluid chamber in the PID arm is designed with a circular wall that extends proximally to the window. This ensures that the fluid meniscus inverts before contacting the window while filling the fluid chamber. Proper contact between the fluid and the window, i.e., from the center of the window outward toward the periphery, prevents bubbles from becoming trapped under the window, which could cause laser beam disturbances.

[0325] The fluid chamber in the PID arm extends into a reservoir ring into which excess fluid drains from the chamber, which also acts as a barrier to prevent the saline solution (BSS) in the chamber from contacting the patient's skin, which could cause the saline solution to wick away by capillary action.

[0326] The PID arm has a flexible mounting ring at its base that conforms the interface to the front of the patient's eye. The mounting ring includes flexible annular outer and inner skirts made of silicone that engage the surface of the eye when the eyepiece is secured. The inner and outer skirts define an annular suction channel that functions as a vacuum communication channel.

[0327] In another design, the PID arm has a vacuum port on its side that is used to generate suction in the annular suction channel and ensures the ocular interface is securely attached to the patient's eye. A second port next to the first is connected to medical-grade tubing that fills the ocular interface chamber with physiological saline solution (BSS).

[0328] Example 35A

[0329] 13 shows a perspective view of a PID 1300. The PID 1300 has a PID arm 1301, an upper (distal) window 1302 which may be glass and preferably is highly transmissive to the therapeutic laser, and a lower (proximal) glass window 1303 which may be glass and preferably is highly transmissive to the therapeutic laser.

[0330] Example 36

[0331] 18 and 19 show the optical assemblies and paths for the fixed light and the direct-to-point (DTP), e.g., therapeutic laser beam delivery path along a portion of the path to the eye, and the optical assemblies and paths for viewing the eye with a camera, respectively. In a preferred embodiment, the fixed light path and the DTP visual path are largely coincident.

[0332] Example 37

[0333] In one embodiment, a laser ultrasound system, such as a femto-phacoemulsification system, includes a laser adapted to perform a posterior capsulotomy and laser surgery on the posterior lens capsule. The system further includes predetermined phacoemulsification parameters that are accessible and enabled and are integrated with and optimized for the laser surgery. The system can have a menu based control system through the use of a GUI with screens such as those shown in Figures 23A through 23D.

[0334] Example 38

[0335] The patient locator system for laser, laser-ultrasound, and femto-ultrasound phacoemulsification systems can have built-in markers that can be placed on the body, headrest, or both, and does not require line-of-sight for continuous tracking. The markers create magnetic fields that output both position and orientation data without the need for post-analysis calculations. Accurate, high-quality data is delivered at an update rate of 50 Hz per marker. Add markers (e.g., four per system). The system is further described in Table 2.

[0336] Table 2 TIFF2025157356000003.tif151166

[0337] Example 39

[0338] Laser, laser-ultrasound, and femto-phacoemulsification systems can have a surgical microscope integrated into the system. The microscope can be attached to the system housing and is preferably integrated within the system. In this manner, the microscope is connected to a system control system (e.g., a femto-phacoemulsification control system) for information, data, and control communications. Thus, for example, the surgical microscope and system are adapted so that the microscope accepts commands and views (digital overlays) from the therapeutic laser system, particularly the optics and data systems, during laser, e.g., femto, mode; laser procedures, e.g., femto procedures; phacoemulsification modes, e.g., phacoemulsification procedures; idle, warm-up, or observation modes (phacoemulsification, laser, or both are active but no procedure is occurring); and combinations thereof.

[0339] In one embodiment, the surgical microscope is replaced or augmented by a 3D vision system. The 3D display system can be any system that displays to a surgeon, other practitioner, or observer, three-dimensional images of ocular structures, such as the cornea, lens, PID interfaces in contact with the eye, IOLs, and combinations and variations thereof, as well as other structures and devices. The 3D display system can be, for example, a wearable 3D attachable aid (such as a BEYEONICS Surgical device), a 3D monitor, a monitor and glasses-based system, a heads-up display system, and combinations and variations thereof. The 3D display system can record the procedure in 3D and can provide 3D images of the procedure in real time to a remote location, such as a location different from where the laser system is located.

[0340] Example 40

[0341] Laser, laser-ultrasound, e.g., femto-ultrasound phacoemulsification systems can have a "smart" footswitch associated with the system. The footswitch is integrated into the system control system. The footswitch can turn the laser and ultrasound phacoemulsification on and off based on the mode of the system. The footswitch can be integrated into menu systems, GUIs, and voice commands in a manner that allows the footswitch to be used to select procedures through menu-style items on the GUI, such as the menu items shown in Figures 23A through 23D. The footswitch can also be integrated into speaking-and-listening control and menu selection systems, such as "Alexa" and other types of voice command systems.

[0342] The footswitch can be wired, i.e., have a control cable connecting it to the laser-phacoemulsification system. Preferably, the footswitch is wirelessly connected in control communication with the control system laser, phacoemulsification, integrated unit, one or more thereof, and all thereof.

[0343] The communication bus can be used for foot switches and other devices and systems. As shown in FIG. 22A, the bus is terminated at each end, allowing multiple devices to be turned off without the need for a supervisory computer. In this manner, all devices can communicate with each other (e.g., control communication connections, information communication connections, or both). In a preferred embodiment, both the phacoemulsification and femtocomputer use foot switches to turn on the bus. The foot switches can send message packets that are processed by the controls for both computers, e.g., the laser system and the phacoemulsification system. The main femtocomputer can use some of the foot switch controls to fire the laser or change modes. Other foot switch controls can be simultaneously used by the phacoemulsification computer to perform other operations, such as phacoemulsification energy, irrigation, or vacuum aspiration.

[0344] In one embodiment, the bus is a broadcast type bus such as a CanBus.

[0345] In an embodiment, TCP / IP may be used. However, commercially available footswitches are typically not TCP / IP based. Bluetooth or hardwired footswitches may also be used, but are less preferred.

[0346] Example 41

[0347] 20, 20A, and 20B show an embodiment of a PID 2000. This PID has four components, significantly reducing assembly cost and complexity compared to more complex PIDs and facilitating cleaning. The PID can be disposable or reusable. The PID 2000 has an integrated, e.g., single, arm 2001 having an engagement means, e.g., clip 2010, for attachment to a system (e.g., laser, laser-ultrasound, femto-ultrasound phacoemulsification, etc.). The PID 2000 further has two ports 2007 and 2008 that can be used for fluid transfer and vacuum aspiration. Preferably, port 2008 is used for vacuum aspiration and port 2007 is used for BSS delivery. The PID 2000 has a window 2002 disposed in a retaining ring 2003 and held in place by clips 2004a, 2004b, and 2004c. A single annular vacuum ring 2005 engages the proximal end of retaining ring 2003. Annular vacuum ring 2005 is in fluid communication with ports 2007 and 2008. Annular vacuum ring 2005 is preferably a single piece. Annular vacuum ring 2005 engages and retains flexible eye-engaging ring 2006, which is in fluid communication with both ports 2007, 2008.

[0348] The PID 200 includes a window support and fluid management system, which includes pins 2020a, 2020b, and 2020c (preferably integral, i.e., part of a single ring 2003). The pins support the window 2002 on the proximal (bottom) side of the window, while clips 2002a, 2002b, and 2002c engage the sides and distal (top) of the window 2002. The pins hold the window over two fluid channels: an outer fluid channel 2021 and an inner channel 2022. These channels are separated by an annular protrusion, e.g., a ring or ridge 2055. In one embodiment, the tall outer channel 2021 (and thus the height of the ring 2055) is slightly shorter than the pins, e.g., about 1 mm, about 0.7 mm, or about 0.5 mm lower than the top of the pins. The inner and outer channels act as a fluid containment system that keeps the fluid in contact with the bottom surface of the window while allowing bubbles to escape and excess fluid to spill into the outer fluid channel 2021 .

[0349] Example 42

[0350] 21, 21A, 21B, 21C, 21D, and 21E show various views and components of an embodiment of a femto-phacoemulsification laser system 2100. Like reference numerals refer to like structures. System 2100 includes a laser subsystem and a phacoemulsification subsystem housed within a common housing. The laser subsystem includes a therapeutic laser beam source, in embodiments, a slow pulse width and a long pulse width therapeutic laser beam source. The laser subsystem includes a laser that defines a therapeutic laser beam path along which the therapeutic laser beam is transmitted, and optical components positioned or arranged along the laser beam path. These components may include z-focusing optics and an x-y scanner.

[0351] Femto-phacoemulsification system 2100 includes a first housing 2101 and an optical assembly / scanner housing 2102 that is movably mechanically and optically associated with first housing 2101. Housing 2101 is part of an extendable / retractable assembly 2103 that provides horizontal movement. Assembly 2103 also includes a base 2105 that is mechanically associated with housing 2101 but is not movable relative to housing 2101.

[0352] The optical assembly and scanner housing 2102 has an arm 2105 that houses the laser beam path and a portion of the optical path, providing transport of the laser beam and optical image. A laser transmission and image head 2016 is mechanically and optically associated with the arm 2105. Vertical movement of the head 2016 is controlled by a joystick 2107 (and can be done by itself or in cooperation with a control system, or by a GUI). Vertical movement can be accomplished by any of the various devices disclosed herein.

[0353] The head 2016 includes a position measurement device 2108 and a patient interface device 2109 .

[0354] A laser beam movable connector device, such as an articulated hollow pipe 2110 , transmits the laser beam for the laser in housing 2101 to the optics and beam handling device in housing 2102 .

[0355] The system has an opening 2114 for holding and storing a phacoemulsification tray assembly 2112. The phacoemulsification tray assembly has a frame 2122 for holding a haptic tray 2121 and an engagement pin 2113.

[0356] System 2100 has two openings 2111 (left side) and 2120 (right side) for receiving and holding pin 2113 and phacoemulsification tray assembly 2122. In this manner, system 2100 is ambidextrous, allowing for use in a particular manner on both the right and left hand sides, and the tray and tray assembly are ambidextrous, allowing for use on both the left and right side of the system.

[0357] System 2100 includes a phacoemulsification cassette 2115 and ports 2116 for connecting phacoemulsification related components (eg, air, VIT, DIA, control cables, etc.).

[0358] System 2100 has two monitors 2117, 2118, which are preferably graphic user interfaces (GUIs) for displaying information and menus and receiving input, such as commands, from a system operator. The GUIs can display control menus and information menus such as those shown in Figures 23A through 23D.

[0359] The system 2100 includes an emergency stop 2119 .

[0360] In this example embodiment, the position measurement device 2108 has five Scheimpflug camera assemblies, e.g., 2123, 2124, 2125, and 2126. The head 2106 has a laser transmission aperture 2128. The laser beam path and image path pass through this aperture. The aperture has a clear window through which the laser beam and image can pass, and also has a cap, iris, or other closing device that closes the window when the laser is not in use, such as when the device is in a retracted position, or when the phacoemulsification system is operating.

[0361] PID 2109 can be, for example, the PID of Example 41. PID 2109 is attached to laser head 2106 and laser system 2100 via PID securing and engaging device 2127. Device 2127 has a locking lever tab 2129 that is movable between a locked position (shown in FIG. 21E) and an unlocked position (shown in FIG. 21D).

[0362] Arm 2105 houses the treatment laser beam path and other optical paths. In embodiments, arm 2105 also houses and carries control and power cables for the imaging and positioning equipment and docking assembly (not shown in this view).

[0363] System 2100 has a common power supply for the laser subsystem and the phacoemulsification subsystem. The common power supply provides all power for the entire system, eliminating the need for auxiliary power supplies or sources. This allows the systems to be plugged into a single power supply in the operating room.

[0364] System 2100 has a common control system with an emergency stop button or switch 2119. The common control system has controls that operate the control software or execute instructions. In a preferred embodiment, the common control system is control communicatively connected to one or more, preferably all of: the control system and controls of the laser subsystem; the control system and controls of the phacoemulsification subsystem; connected in control communicatively to an operator interface; connected in control communicatively to the emergency stop 2119; and connected in control communicatively to a network that may be, for example, a patient's medical record system, an accounting system, and combinations and variations thereof.

[0365] In one embodiment, the docking system (preferably with a joystick) and the imaging and position measurement equipment can be controlled by the laser subsystem control system. In an embodiment, they can be directly controlled, in whole or in part, by a common control system. In one embodiment, the laser control system and the phacoemulsification control system can be partially or fully integrated into a single common control system. Thus, in one embodiment, only one control system or a single control system is present in the femto-phacoemulsification system. In one embodiment, in this example, the system uses the bus communication system of example 40, which is also depicted in FIG. 22A.

[0366] Example 43

[0367] 22A shows system 2100 of Example 42 with the addition of a footswitch 2130. The footswitch is connected in control communication with the system's computer, e.g., controller, and the system's devices by wireless communication line 2131.

[0368] This example embodiment uses the bus communication system of example 40, also shown in Figure 22A.

[0369] Example 44

[0370] In one embodiment, the integrated laser ultrasound system includes a first housing, a second housing, a GUI, and a means for optically connecting the first and second housings. The second housing is movably associated with the first housing. The laser ultrasound system includes an assembly having a therapeutic laser for providing a therapeutic laser beam along a laser beam transmission path. The laser has a therapeutic laser control system. The laser ultrasound system also includes a phacoemulsification system for providing therapeutic ultrasound energy, the system having a phacoemulsification system control system. At least a portion of the therapeutic laser and the phacoemulsification system, preferably all of these two systems, are disposed within the first housing.

[0371] The integrated laser ultrasound system is in control communication with at least one, and preferably all, of an integrated control system, a therapeutic laser control system, an ultrasound phacoemulsification system, and a GUI.

[0372] The integrated laser ultrasound system also includes a safety interlock adapted to prevent the laser system from firing the therapeutic laser when the phacoemulsification system is operating. The safety interlock is connected in control communication with one or more of the integrated control system and the laser control system. The safety interlock can also be connected in control communication with the phacoemulsification control system.

[0373] The integrated laser ultrasound system also includes a beam shaping and directing assembly including a Z focus, a scanner, and a lens. The beam shaping and directing assembly is housed within a second housing. Preferably, the entire assembly is housed within the second housing.

[0374] The means for optically communicating the first and second housings is in optical communication with the therapeutic laser and the beam shaping and directing assembly, and can be an articulated hollow light pipe, a fiber, or any of the other means for transmitting laser energy disclosed herein.

[0375] The integrated laser ultrasound system also includes an arm mounted in the second housing and in optical communication with the beam shaping and directing assembly. The arm has a distal end and a proximal end, the distal end of which is adjacent to the second housing and preferably mechanically attached to the second housing, and in some embodiments is integral with the second housing. The system includes a laser delivery head mounted adjacent to the proximal end of the arm and preferably attached to the proximal end of the arm. The laser delivery head includes an optical element in the laser beam transmission path. The optical element can be, for example, a mirror that receives the laser beam and directs it along the laser beam transmission path through an opening in the laser delivery head. Thus, for example, the optical element can bend the beam 90 degrees from horizontal to vertical. The optical element can also include a lens that receives, shapes, and transmits the laser beam. The lens can be before or after the mirror in the optical path.

[0376] Preferably, the arm includes, e.g., houses, a portion of the laser beam delivery path, particularly the portion from the beam shaping and directing assembly to the laser head, such that the arm places the laser delivery head in optical communication with the beam shaping and directing assembly.

[0377] Preferably, the system includes a means for measuring the shape and position of an ocular structure, which may be a Scheimpflug assembly, an OCT assembly, or both. The means is preferably located in or on, or forms part of, the laser delivery head. The means for measuring the shape and position is in control communication with one or more, and all, of the integrated control system, the therapeutic laser control system, and the phacoemulsification control system. Preferably, the means is in communication with at least the integrated control system, the laser control system, or both.

[0378] The system is also adapted to be positioned around the patient at a number of rotational angles or positions. Preferably, the system is adapted to be positioned at an angle relative to the patient position, where the angle is defined by the longitudinal axis of the arm and the patient axis; the angles include angles of about 45°, about 90°, about 135°, and about 180°.

[0379] In one embodiment of this system, it has one or more of the following features: it is adapted to provide two therapeutic laser beams with different pulse widths; it has an iris registration system; and the therapeutic laser is a femtosecond laser, a picosecond laser, or both.

[0380] Example 44A

[0381] The system of Example 44 includes a foot switch in control communication with one or more of the integrated control system, the therapeutic laser control system, and the phacoemulsification control system, which may also be adapted to provide two therapeutic laser beams with different pulse widths.

[0382] Example 44B

[0383] The systems of Examples 44 and 44A may also include an integrated control system, a therapeutic laser control system, or both, that includes a plurality of predetermined laser transmission patterns. These predetermined laser transmission patterns may be contained within the control system or may reside on a memory device associated with and accessible by the control system. The integrated control system, the phacoemulsification control system, or both, of the system may also include a plurality of phacoemulsification treatments. These phacoemulsification treatments may include, for example, parameters (e.g., power) and procedure types (e.g., chop) described in the "Ultrasound / Phacoemulsification—Overview" section of this specification.

[0384] The system can further determine information about a cataract in the lens of the eye. A shape and position measuring device on the laser head provides data, e.g., an optical image, to form the basis for determining the determined information. A separate imaging system can also be used to provide this data. One or more control systems make decisions based on the data. The determined information is, for example, preferably the grade of the cataract. For example, this can be one of three grades or one of four grades.

[0385] The system is adapted to recommend a combined laser-phacoemulsification treatment, the recommendation being based in whole or in part on the determined information about the cataract.

[0386] The combined laser-phacoemulsification treatment is preferably a two-component treatment: a laser component that is at least one of a plurality of predetermined laser transmission patterns, and a phacoemulsification component that has at least one of a plurality of predetermined phacoemulsification treatments.

[0387] Example 45

[0388] A method of using an integrated laser-phacoemulsification system to perform combined laser-phacoemulsification treatment on an eye with cataracts, the integrated laser-phacoemulsification system having a GUI, a therapeutic laser having a therapeutic laser control system for providing a therapeutic laser beam along a laser beam transmission path, a phacoemulsification system having a phacoemulsification system control system for providing therapeutic ultrasound energy, and an integrated control system in control communication with the therapeutic laser control system, the phacoemulsification system, and the GUI.

[0389] The system can be used to determine information about the cataract of a cataractous lens, and preferably the determined information is the grade of the cataract.

[0390] Thus, the system can be used to determine and determine a combined laser-phacoemulsification treatment that is preferably a two-component treatment: a laser configuration that is at least one of a plurality of predetermined laser transmission patterns, and a phacoemulsification configuration that has at least one of a predetermined phacoemulsification treatment.

[0391] The system can be used to recommend, and does recommend, a combined laser-phacoemulsification treatment determined based on the determined information for cataract. Preferably, the system displays the recommended combined laser-phacoemulsification treatment on the GUI, preferably as a menu item associated with the recommended combined laser-phacoemulsification treatment on the GUI.

[0392] The system is commanded, preferably by GUI menu, but also by voice or foot switch, to recommend a combined therapy; only one of the two configurations of the combined therapy; redetermination of one or both of the two configurations of the combined therapy; and combinations and variations thereof. The system executes these commands.

[0393] The system is instructed to perform and delivers the determined and recommended combined laser-phacoemulsification treatment to the patient's eye lens, which may be a two or more component treatment, and one or more instructions may be envisioned and required to deliver the steps of the treatment.

[0394] Example 46

[0395] Generally, when performing a procedure using laser-ultrasound, e.g., laser-phacoemulsification, femto-phacoemulsification, or an embodiment of an integrated system, the laser procedure is performed first, the system is reconfigured, and then the ultrasound procedure and phacoemulsification are performed. Thus, generally, after the patient is prepared, the laser procedure is performed first. These laser procedures include capsulorhexis, lens fragmentation, and corneal incisions and procedures, as well as other laser procedures described herein and known to those skilled in the art. The integrated system is quickly reconfigured by moving the arm and laser head away from the patient. Thus, the system transitions from the laser configuration to the ultrasound, e.g., phacoemulsification, configuration to perform the ultrasound procedure, e.g., phacoemulsification. In this manner, phacoemulsification is performed on the eye and on the lens material that was cut or fractured by the laser from the same system, i.e., the integrated system. Once the phacoemulsification procedure is completed, the patient is removed, and the integrated system is quickly reconfigured back to the laser configuration. The system is rapidly and repeatedly transitioned, or reconfigured, between the laser and phacoemulsification modes.

[0396] It should be understood that, although not presently preferred, the system has the capability to perform a laser procedure on the same or a different eye of the same patient after an ultrasound procedure, such as phacoemulsification, has been performed.

[0397] In addition to and in furtherance of the above examples, there is provided a laser system comprising: a therapeutic laser system having a housing; a patient position measurement system having a first component and a second component; wherein the first component is mechanically associated with the therapeutic laser system; and the second component is not mechanically associated with the therapeutic laser system, whereby the second component is independent of and free to move relative to the therapeutic laser system; and wherein the first component, the second component, or both are adapted to measure the relative position of the second component with respect to the first component.

[0398] Further provided is a laser ultrasound system comprising: a therapeutic laser system; a phacoemulsification system for providing therapeutic ultrasound energy; and a safety interlock adapted to prevent the laser system from firing a laser during operation of the phacoemulsification system.

[0399] Still further, a laser ultrasound system is provided, comprising: a therapeutic laser system; a phacoemulsification system for providing therapeutic ultrasound energy; and a microscope integrated within the system.

[0400] Still further, a laser ultrasound system is provided, comprising: a therapeutic laser system; a phacoemulsification system for providing therapeutic ultrasound energy; and a Scheimpflug camera means for measuring the shape, position, or both, of an ocular structure.

[0401] Also provided are these laser systems, laser ultrasound systems, laser-phacoemulsification systems, femto-phacoemulsification systems, methods, and devices having one or more of the following features: the laser system has an integrated ultrasound system; the ultrasound system is housed within a therapeutic laser housing; the ultrasound system is a phacoemulsification system; the ultrasound system has a laser safety interlock that prevents the laser from firing when the ultrasound system is in use; the therapeutic laser system is a femtosecond laser system; the ultrasound system is a phacoemulsification system; the patient position measurement system has a device selected from the group consisting of an A / C electromagnetic tracking system, an electromagnetic tracking system, a gyroscope, an accelerometer, and a magnetometer; the patient position measurement system has a device selected from the group consisting of a compass, a laser location measurement device, an ultrasound location measurement device, and an RFID device; the therapeutic laser system has an arm extending from the housing; the therapeutic laser system has an arm extending from the housing and a laser transmission head at the proximal end of the arm; the measured relative position is in two-dimensional space; the measured relative position is in three-dimensional space. the patient position measurement system is located within original space; the patient measurement system has at least 95% accuracy; the patient measurement system has at least 98% accuracy; the patient measurement system has at least 99% accuracy; the system is configured to measure the angle of the arm relative to a longitudinal patient axis and adjust the therapeutic laser beam pattern based at least in part on the angle; the angle is measured to within ±5 degrees accuracy; the angle is measured to within ±3 degrees accuracy; the angle is measured to within ±2 degrees accuracy; the second component of the patient position measurement system is housed within the patient headrest; the therapeutic laser system has a charging station for the second component of the patient position measurement system; the system has a PID; the PID has a meniscus inverter; the PID has arms, the arms defining a vacuum channel and a saline channel; the system has an optical system defining four pupils, the laser beam path extending through two of the pupils; the pupils are conjugate telecentric pupils.

[0402] Still further, there is provided a laser ultrasound system comprising: an assembly having a therapeutic laser for providing a therapeutic laser beam along a laser beam path; an ultrasound phacoemulsification system for providing therapeutic ultrasound energy; an arm attached to the assembly; the arm having a distal end and a proximal end, the distal end attached to the assembly; the proximal end having a laser transmission head; the arm housing a portion of the laser beam transmission path; the assembly positioned at an angle relative to a patient position, the angle being defined by a longitudinal axis of the arm and a patient axis; and the angle being between 30 degrees and 320 degrees.

[0403] Furthermore, these laser systems, laser ultrasound systems, laser-ultrasound phacoemulsification systems, femto-ultrasound phacoemulsification systems, methods, and devices are provided with one or more of the following features: the angle is selected from the group of angles consisting of 45°, 90°, 135°, 180°, 225°, 270°, and 315°; the arm is adapted to move precisely about a pivot point on the assembly; the arm is adapted to move horizontally and the arm is extendable and retractable from the assembly; the arm, the laser head, or both are adapted to move vertically; the laser beam in the laser beam path within the arm is not collimated; the laser beam in the laser beam path within the arm is in an optical fiber; the optical system has four pupils, the laser beam path extending through the four pupils; the pupils are conjugate telecentric pupils; the laser system has means for measuring patient position relative to the assembly; the means for measuring patient position has a first component and a second component; the first component is adapted to measure patient position relative to the laser ultrasound system. the second component is not attached to the therapeutic laser system and is independent of the therapeutic laser system, allowing the second component to move freely relative to the therapeutic laser system; the first component, the second component, or both are adapted to measure the relative position of the second component with respect to the first component; the therapeutic laser ultrasound system has a charging station for the second component of the patient positioning system; the laser system and the phacoemulsification system are integrated; the laser system and the phacoemulsification system are contained within a housing; the assembly is contained within a housing; the phacoemulsification system has a laser safety interlock that prevents the laser from firing when the phacoemulsification system is in use; the therapeutic laser is a femtosecond laser.

[0404] Still further provided is a laser ultrasound system comprising: a therapeutic laser for providing a therapeutic laser beam along a laser beam path; an ultrasound phacoemulsification system for providing therapeutic ultrasound energy; and an optical system defining four pupils, the laser beam path extending through at least two of the pupils.

[0405] Further provided are these laser systems, laser ultrasound systems, laser-phacoemulsification systems, femto-phacoemulsification systems, methods, and devices with one or more of the following features: the pupil is a conjugate telecentric pupil; the therapeutic laser and phacoemulsification system are integrated; the therapeutic laser and phacoemulsification system are contained within a housing; the phacoemulsification system has a laser safety interlock that prevents the laser from firing when in use; and the therapeutic laser is a femtosecond laser.

[0406] Also provided is a laser ultrasound system having means for providing first and second therapeutic laser beams; the system having an optical system defining a laser beam path; the first and second laser beam paths extending along the laser beam path; the first therapeutic laser beam having a pulse width of about 1,000 fs to about 2,000 fs; the system having a laser beam delivery pattern for performing lens ablation with the first therapeutic laser beam; the second therapeutic laser beam having a pulse width of about 100 fs to about 500 fs; the system having a laser beam delivery pattern for performing corneal ablation with the second therapeutic laser beam; and a phacoemulsification system for providing the therapeutic ultrasound energy.

[0407] Furthermore, these laser systems, laser ultrasound systems, laser-ultrasound phacoemulsification systems, femto-ultrasound phacoemulsification systems, methods, and devices are provided with one or more of the following features: the wavelength of the first laser beam is 1030 nm; the wavelength of the second laser beam is 1030 nm; the wavelength of the first laser beam is 1030 nm and the wavelength of the second laser beam is 1030 nm; and the repetition rate is 320 kHz or less.

[0408] Further provided are these laser systems, laser ultrasound systems, laser-ultrasound phacoemulsification systems, femto-ultrasound phacoemulsification systems, methods, and devices having one or more of the following features: a Scheimpflug camera means; the Scheimpflug camera means having n cameras, at least one of which has an unobstructed view of the patient's eye at any patient angle between 30° and 320°; n is 5; n is 6; the cameras have an angular separation of at least 40°.

[0409] Additionally provided is a laser ultrasound system having a first configuration for providing a therapeutic laser beam to a patient; and a second configuration for performing a phacoemulsification procedure on the patient; wherein transitioning from the first configuration to the second configuration requires less than five minutes.

[0410] Further provided are these laser systems, laser ultrasound systems, laser-phacoemulsification systems, femto-phacoemulsification systems, methods, and devices with one or more of the following features: laser to phacoemulsification transition time is less than 3 minutes; laser to phacoemulsification transition time is less than 2 minutes; laser to phacoemulsification transition time is less than 1 minute; laser to phacoemulsification transition time is less than 45 seconds; laser to phacoemulsification transition time is about 30 seconds; laser to phacoemulsification transition time is about 1 minute to 30 seconds.

[0411] Further provided are these laser systems, laser ultrasound systems, laser-phacoemulsification systems, femto-phacoemulsification systems, methods, and devices with one or more of the following features: femto laser to phacoemulsification transition in less than 3 minutes; femto laser to phacoemulsification transition in less than 2 minutes; femto laser to phacoemulsification transition in less than 1 minute; femto laser to phacoemulsification transition in less than 45 seconds; femto laser to phacoemulsification transition in about 30 seconds; femto laser to phacoemulsification transition in about 1 minute to 30 seconds.

[0412] Still further provided is a laser ultrasound system having an assembly defining a footprint and volume; the assembly comprising: a therapeutic laser system; and an ultrasound phacoemulsification system for providing therapeutic ultrasound energy; the laser ultrasound system having a footprint of less than 1,500 square inches.

[0413] Further provided are these laser systems, laser ultrasound systems, laser-phacoemulsification systems, femto-phacoemulsification systems, methods, and devices having one or more of the following features: a footprint of about 33 inches by about 22 inches; a footprint of about 35 inches or less by about 35 inches or less; a footprint of about 35 inches or less by about 22 inches or less; a footprint of about 400 to about 800 square inches; a volume of about 40 ft 3 less than 35 ft 3 less than 30 ft 3 less than 25 ft 3 Less than 20 ft 3 is less than.

[0414] 1. A laser ultrasound system comprising: a therapeutic laser system having: an arm having a proximal end; a laser head attached to the proximal end of the arm; and electronics for operating the therapeutic laser system; and a phacoemulsification system for providing therapeutic ultrasound energy having electronics for operating the phacoemulsification system; wherein the laser head is electrically isolated from the electronics for the phacoemulsification system and the electronics for the therapeutic laser system.

[0415] A laser system is provided, comprising: a therapeutic laser beam for providing a therapeutic laser beam; and an optical assembly for defining a laser beam path; wherein the laser beam path is longer than 300 mm; and the laser beam pattern is transmitted along the laser beam path without expansion.

[0416] Additionally, there is provided a laser system comprising: a treatment laser beam for providing a treatment laser beam; and an optical assembly for defining a laser beam path; wherein the laser beam path is longer than 300 mm; and the laser beam pattern is transmitted along the laser beam path without wavefront error.

[0417] Additionally, there is provided a laser system comprising: a therapeutic laser beam for providing a therapeutic laser beam; and an optical assembly for defining a laser beam path; wherein the laser beam path is longer than 300 mm; and the laser beam pattern is transmitted along the laser beam path without aberrations.

[0418] Further provided are these laser systems, laser ultrasound systems, laser-phacoemulsification systems, femto-phacoemulsification systems, methods, and devices with one or more of the following features: the laser is a femtosecond laser, and further has an integrated phacoemulsification system.

[0419] Also provided are these laser systems, laser ultrasound systems, laser-ultrasound phacoemulsification systems, femto-ultrasound phacoemulsification systems, methods, and devices that have one or more of the following features: an iris registration device;

[0420] Also provided are these laser systems, laser ultrasound systems, laser-phacoemulsification systems, femto-phacoemulsification systems, methods, and devices with one or more of the following features: data and information is exchanged between the ultrasound system and the laser system; the information is the cataract grade; and the information from the laser system is used to provide the recommended ultrasound energy.

[0421] Also provided are these laser systems, laser ultrasound systems, laser-ultrasound phacoemulsification systems, femto-ultrasound phacoemulsification systems, methods, and devices having one or more of the following features: data and information is exchanged between the ultrasound system and the laser system; the information is cataract grade.

[0422] Also provided are these laser systems, laser ultrasound systems, laser-ultrasound phacoemulsification systems, femto-ultrasound phacoemulsification systems, methods, and devices having one or more of the following features: comprising an OCT imaging means.

[0423] Additionally, these laser systems, laser ultrasound systems, laser-ultrasound phacoemulsification systems, femto-ultrasound phacoemulsification systems, methods, and devices are provided with one or more of the following features: the system has a footprint size selected from the group consisting of less than 35 x less than 35 inches, 35 x 25 inches, about 35 x 25 inches, about 33 x 22 inches, and about 400 square inches to about 800 square inches.

[0424] Further provided are these laser systems, laser ultrasound systems, laser-ultrasound phacoemulsification systems, femto-ultrasound phacoemulsification systems, methods, and devices having one or more of the following features: a cap on the laser head positioned in the laser beam path to protect the optical components when the laser is not in an operational configuration.

[0425] Methods for performing laser surgery and phacoemulsification surgery using either a laser system, a laser ultrasound system, a laser-phacoemulsification system, or a femto-phacoemulsification system are provided.

[0426] Also provided are these laser systems, laser ultrasound systems, laser-phacoemulsification systems, femto-phacoemulsification systems, methods, and devices having one or more of the following features: a surgical microscope is mounted to the system housing and connected to a control system by a data communication connection, a control communication connection, or both; the surgical microscope is integrated into the system housing; and the surgical microscope accepts commands, views (e.g., digital overlay) from a therapeutic laser system in either a laser, e.g., femto, or ultrasound, e.g., phacoemulsification mode and procedure.

[0427] Also provided are these laser systems, laser ultrasound systems, laser-phacoemulsification systems, femto-phacoemulsification systems, methods, and devices with one or more of the following features: A three-dimensional (3D) display system is mounted on the system housing and connected to the control system by a data communication connection, a control communication connection, or both; the 3D display system is integrated into the system housing; the 3D system accepts commands, views (e.g., digital overlays) from the therapeutic laser system in either a laser, e.g., femto, or ultrasound, e.g., phacoemulsification mode and procedure. Heading and embodiment

[0428] The use of headings in this specification is for purposes of clarity and reference and should not be understood as limiting in any way. Accordingly, the process schemes and disclosures set forth under the headings should be read in the context of the entire specification, including the various examples. The use of headings in this specification should not limit the scope of protection afforded to the present invention.

[0429] It should be noted that it is not necessary to provide or address the theory underlying the subject matter of the embodiments of the present invention or any novel and innovative processes, laser surgeries, laser patterns, enhanced and improved structures, or other beneficial features and characteristics associated therewith. Nevertheless, various theories are provided in this specification to further advance the art in this field. The theories presented in this specification, unless expressly stated, do not in any way restrict, limit, or narrow the scope of protection afforded to the claimed invention. These theories may not be required or implemented to utilize the present invention. It is further understood that the present invention may lead to novel and previously unknown theories explaining the function-characteristics of embodiments of the methods, laser patterns, laser surgeries, ocular functions, devices, and systems of the present invention. Such subsequently developed theories do not limit the scope of protection afforded to the present invention.

[0430] The various embodiments of the devices, systems, laser shot patterns, activities, and operations described herein can be used with, within, or by various measurement, diagnostic, surgical, and treatment laser systems, as well as the embodiments thereof disclosed in the drawings and this specification. The various embodiments of the devices, systems, laser shot patterns, activities, and operations described herein can be used: with other measurement, diagnostic, surgical, and treatment systems that may be developed in the future; with existing measurement, diagnostic, surgical, and treatment laser systems that may be improved in part based on the teachings of this specification; and with other types of measurement, diagnostic, surgical, and treatment systems. Additionally, the various embodiments of the devices, systems, laser shot patterns, activities, and operations described herein can be used with each other in a variety of different combinations. Thus, for example, the configurations provided in the various embodiments of this specification can be used with each other. For example, components of an embodiment having A, A', and B and components of an embodiment having A", C, and D can be used with each other in various combinations in accordance with the teachings of this specification, such as A, C, D, and A, or A", C, and D. Thus, the scope of protection given to the present invention should not be limited to the specific embodiment, configuration, or arrangement described in a particular embodiment, example, or embodiment of a particular drawing.

[0431] The present invention may be embodied in other configurations from the specific disclosure herein without departing from the spirit or essential characteristics thereof. The described embodiments are to be considered in all respects only as illustrative and not restrictive.

Claims

1. 1. A laser ultrasound system comprising: A therapeutic laser system a phacoemulsification system for providing therapeutic ultrasound energy; a control system; a means for measuring the shape, position, or both of an ocular structure, the means for measuring adapted to provide information to the control system for grading a cataract; Equipped with 10. A laser ultrasound system wherein the means for measuring includes a plurality of Scheimpflug cameras arranged such that when the view of some of the Scheimpflug cameras is obstructed, other Scheimpflug cameras of the plurality can still measure the shape, position, or both, of an eye structure.

2. A laser ultrasound system as described in claim 1, wherein the multiple Scheimpflug cameras are spaced apart from each other at intervals of 40 degrees.

3. A laser ultrasound system as described in claim 1 or 2, wherein the plurality of Scheimpflug cameras comprises five or six Scheimpflug cameras.

4. The therapeutic laser system, the phacoemulsification system, and at least a portion of the control system share a common housing; the control system is in control communication with the therapeutic laser system, the phacoemulsification system, and the means for measuring; the control system is adapted to determine a grade of the cataract based at least in part on the information provided by the means for measuring; 4. The laser ultrasound system of claim 1, whereby the control system is adapted to determine a combination of therapeutic laser treatment and phacoemulsification treatment based in part on the determined grade of cataract.

5. A laser ultrasound system as described in any one of claims 1 to 4, wherein the therapeutic laser system is configured to provide two therapeutic laser beams having different pulse widths.

6. A laser ultrasound system as described in any one of claims 1 to 5, comprising a surgical microscope integrated with the laser ultrasound system and adapted to receive one or more images, data or information from the laser ultrasound system, and the surgical microscope adapted to display the received images, data or information during a laser procedure, an ultrasound phacoemulsification procedure, or both.

7. A laser ultrasound system as described in any one of claims 1 to 5, comprising a 3D display system integrated with the laser ultrasound system and adapted to receive one or more images, data, or information from the laser ultrasound system, and the 3D display system adapted to display the received images, data, or information during a laser procedure, an ultrasound phacoemulsification procedure, or both.

8. A laser ultrasound system as described in any one of claims 1 to 7, comprising a wireless foot switch adapted to control the therapeutic laser system, the ultrasound phacoemulsification system, or both.

9. A laser ultrasound system as described in any one of claims 1 to 8, comprising a laser head defining an opening, a therapeutic laser beam path extending through the opening, and the opening associated with means for closing the opening when the ultrasound phacoemulsification system is in operation, when the laser head is in a retracted position, or both.

10. A laser ultrasound system as described in claim 9, wherein the multiple Scheimpflug cameras are arranged around the opening.

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