Integrated systems for predetermined combination laser-phacoemulsification therapies

Abstract

To provide a compact and effective medical system that meets both regulatory and medical practitioner's requirements and needs by integrating a therapeutic ultrasound system with other systems, such as a therapeutic laser delivery system.SOLUTION: Provided is a laser ultrasound system that includes an assembly comprising a therapeutic laser system and a phacoemulsification system. The treatment laser system and the phacoemulsification system have a common power supply, a common control system, and a common GUI, and are electrically, optically, and mechanically isolated from each other so as not to electrically, optically, and mechanically interfere with the operation of the systems. The footprint of the assembly is less than 9,677 cm2 (1,500 square inches).SELECTED DRAWING: Figure 7

Description

[Technical field]

[0001] This application claims the benefit of priority under 35 U.S.C. §119(e)(1) to the filing date of 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 treat ocular disorders. [Background technology]

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

[0004] Generally, the eye's lens changes shape through the action of the ciliary muscle 108 to allow for focusing of visual images. A natural feedback mechanism from the brain allows the ciliary muscle 108 to act through its attachment at the zonules 111 to change the shape of the eye's lens. Generally, vision occurs when light enters the eye through the cornea 101 and pupil, travels along the visual axis 104, through the eye's lens 103, through the vitreous body 110, and strikes 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 the retina 105 is filled in the anterior chamber 109 and in the chamber in front of the lens of the vitreous body 110 with a gel-like, transparent substance called aqueous humor 117.

[0005] FIG. 11A generally illustrates the components of a lens 103 of a typical 50-year-old person. The lens 103 is a multi-structure system. The structures of the lens 103 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 equator 121 of the lens. The nucleus 129 is formed from successive additions of the cortex 113 to the nuclear region. The successive layers within the lens that comprise the nucleus 129 are characterized into several layers, nuclei, or nuclear regions. These layers include the embryonic nucleus 122 and fetal nucleus 130 that develop in utero, the infantile nucleus 124 that develops for an average of about three years from birth to the age of four years, the adolescent nucleus 126 that develops from about the age of four until puberty, which averages about 12 years of age, and the adult nucleus 128 that develops beyond the age of about 18 years.

[0006] The fetal nucleus 122 has an equatorial diameter (width) of approximately 0.5 mm and a diameter at the anterior-posterior axis 104 (AP axis) of 0.425 mm (thickness). The fetal nucleus 130 has an equatorial diameter of approximately 6.0 mm and a diameter at the AP axis 104 of 3.0 mm. The infant nucleus 124 has an equatorial diameter of approximately 7.2 mm and a diameter at the AP axis 104 of 3.6 mm. The adolescent nucleus 126 has an equatorial diameter of approximately 9.0 mm and a diameter at the AP axis 104 of 4.5 mm. The adult nucleus 128 at age 36 has an equatorial diameter of approximately 9.6 mm and a diameter at the AP axis 104 of 4.8 mm. These are all average values ​​for a typical lens of an adult approximately 50 years of age in in vitro containment. Thus, this lens (nucleus and cortex) has an equatorial diameter of approximately 9.8 mm and a diameter at 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 is biconvex in shape, as shown in Figures 11 and 11A. 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 to be a substantially stratified structure, composed of long crescent-shaped fiber cells arranged end-to-end to form substantially concentric or nested shells that are asymmetric along the equatorial axis. The ends of these cells are arranged to form sutures anteriorly and posteriorly in the central paracentral region. Older tissues, both cortex and nucleus, have lost their nuclei and other organelles several months after cell formation, and cell function is declining.

[0008] Compression of the lens occurs with age. The number of lens fibers that grow each year remains relatively constant throughout life. However, the size of the lens does not increase as much as would be predicted from the growth of new fibers. From birth to age 3, the lens grows from 3.6 mm to 7.2 mm, or 20% in only 3 years. Then, over the next roughly 10 years, growth goes from 7.2 mm to 9 mm, or 25%, but this is over a period of 9 years, which is three times as long. Over the next roughly 20 years, from age 12 to age 36, the lens grows from 9 mm to 9.6 mm in 24 years, or 6.7%, showing a dramatically slower growth rate while there is believed to be a relatively constant rate of fiber growth during this period. Finally, over the last roughly 20 years, from age 36 to age 54, over 18 years, the lens grows only a fraction of its growth during youth, from 9.6 to 9.8 mm, or 2.1%. Although there are shape effects that require more lens fibers to fill the larger outer shell, the size of the old lens is much smaller than predicted by a fiber growth rate model that takes shape effects into account. Fiber compaction, including nuclear fiber compaction, is thought to explain such 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 is when the eye is too long and the focal point is in front of the retina. Hyperopia is 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 an abnormality in near vision, especially the inability to read small text in dim lighting after about age 40-45. Presbyopia, or loss of accommodation range with age, is related to the inability of the eye to change the shape of the lens allowing for shifts in focus between far and near, 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 the range. Unless otherwise stated, each separate value within a range is incorporated herein as if it were individually referred to.

[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 larger variations or ranges thereof.

[0013] As used herein, unless otherwise indicated, 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 refer 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, and 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 refer to pulse lengths 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 100 Hz (up to 100 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 a pulse width 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 100 Hz (up to 100 Hz).

[0016] As used herein, unless otherwise specified, the terms "distal" and "proximal" have the following meanings: For lasers, laser beams, and laser components, distal means the side, location, or position closer to the laser beam source. For phacoemulsification systems, distal means the side, location, or position closer to the ultrasonic energy source. For 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 thus closer to the patient during surgery. For phacoemulsification systems, proximal means the side, location, or position along the energy transmission path that is farther away from the ultrasonic energy source and thus closer to the patient during surgery. Conversely, the distal end of the 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 used to focus and direct the cutting device, tool or tip, and combinations and variations thereof to cut, soften or emulsify tissue to produce mist and vapor, causing them to move, e.g., vibrate or vibrate. In general, phacoemulsification is a medically recognized technique that uses ultrasonic energy for lens removal. Generally, phacoemulsification involves making a corneal incision, a scleral incision, and one or more and both of these. A phacoemulsification handpiece is inserted through one of these incisions and typically comprises a needle that is driven by ultrasonic waves to, for example, emulsify (i.e., liquefy) the lens and break up the cataract into smaller pieces. The emulsified pieces can then be subsequently removed using the same handpiece or another handpiece. The surgeon can then insert an implant into the eye through the incision.

[0018] In general, a therapeutic laser treatment of an eye includes placing a patient on a bed or patient support, aligning the eye with a 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, and in particular on or in association with an eye structure, to address an eye condition. For example, laser treatments 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 currently 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 currently 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 demonstrated a need for combining ultrasound devices with other therapeutic devices such as lasers, and while some rudimentary combinations have been provided, it is believed that this need has largely gone unmet. To date, no one has been successful in integrating a therapeutic ultrasound system with another system, such as a therapeutic laser delivery system, to provide a compact, effective medical system that meets both the needs and desires of regulatory authorities and physicians. In particular, it is believed that prior to the present invention, no one has been successful in integrating an ophthalmic phacoemulsification system with an ophthalmic therapeutic laser system to provide a compact, effective medical system that meets both the needs and desires of regulatory authorities and physicians. Meeting these needs and desires involves more than simply combining the 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, particularly a phacoemulsification-laser system, that is a compact, effective, and ergonomic medical system that meets both the needs and desires of regulatory authorities and physicians.

[0021] This Background section is intended to introduce various aspects of art that may be related to embodiments of the present invention. Thus, the preceding descriptions in this section are intended to provide a framework for a better understanding of the present 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 others. These long-standing needs continue to exist, among others, in the field of ophthalmology, including addressing cataracts, addressing refractive problems, addressing presbyopia, and addressing eye diseases, disorders, and injuries in the treatment and treatment of other ocular and nearby structures. The present application addresses these and other needs, among others, by providing the products, apparatus, and processes described in the specification, drawings, and claims. [Means for solving the problem]

[0023] 1. A laser ultrasound system comprising: an assembly defining a footprint and volume, the assembly comprising: a therapeutic laser system adapted to provide a therapeutic laser beam; and a phacoemulsification system adapted to provide therapeutic ultrasound energy, the therapeutic laser system and the phacoemulsification system having a common power source, control system, and GUI for receiving commands and displaying information, the therapeutic laser system and the phacoemulsification system being electrically, optically, and mechanically isolated such that operation of either system does not interfere with operation of the other, the footprint being less than 1,500 square inches.

[0024] Also provided are laser systems, methods and apparatus having one or more of the following features: the footprint is about 33 inches by about 22 inches; the footprint is about 35 inches or less by about 35 inches or less; the footprint is about 35 inches or less by about 22 inches or less; the footprint is about 400 square inches to about 800 square inches; the volume is less than about 40 cubic feet; the volume is less than about 30 cubic feet; the volume is less than about 20 cubic feet; a PID with a meniscus inverter.

[0025] Also provided are laser systems, methods and apparatus having one or more of the following features: the laser system and the phacoemulsification system are integrated whereby the therapeutic laser system and the phacoemulsification system share a common power source, control system and GUI for receiving commands and displaying information; and the therapeutic laser system and the phacoemulsification system are electrically, optically and mechanically isolated such that operation of either system does not interfere with operation of the other system.

[0026] Still further, there are provided laser systems, methods and apparatus having one or more of the following features: the laser system and the phacoemulsification system are contained within a housing; the laser system and the phacoemulsification system are contained within a housing; a laser safety interlock that prevents the laser from firing when the phacoemulsification system is in use; 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 a laser procedure, a phacoemulsification procedure, or both; a 3D display system integrated into the system to display images from the laser system, the 3D display system displaying the images, data or information during a laser procedure, a phacoemulsification procedure, or both; the 3D display system is adapted to receive one or more of images, data, or information during a laser procedure, a phacoemulsification procedure, or both, and the 3D display system is adapted to display the received images, data, or information; the therapeutic laser system is adapted to provide two therapeutic laser beams having different pulse widths, both therapeutic laser beams cauterizing tissue, cutting tissue, or both; the therapeutic laser system comprises an optical assembly for defining a laser beam path, the laser beam path being longer than 300 mm, and a therapeutic laser beam pattern is transmitted along the laser beam path without magnification; the therapeutic laser system comprises an optical assembly for defining a laser beam path, the laser beam path being longer than 300 mm, and a therapeutic laser beam pattern is transmitted along the laser beam path without wavefront error.

[0027] Additionally, there are provided laser systems, methods and apparatus having one or more of the following features: comprising an iris registration system; comprising means for measuring the shape, position, or both of an ocular structure; said means for measuring the shape, position, or both of an ocular structure comprising a Scheimpflug imaging system; said means for measuring the shape, position, or both of an ocular structure comprising an optical coherence tomography system; said means for measuring the shape, position, or both of an ocular structure is a Scheimpflug camera means; said Scheimpflug camera means comprising n cameras, at least n-1 of the cameras having an unobstructed view of the patient's eye at any patient angle between 30° and 320°.

[0028] Further provided is an integrated reconfigurable laser ultrasound system comprising a therapeutic laser system, a phacoemulsification system, and a rigid laser beam delivery arm mechanically associated with a housing, the integrated reconfigurable laser ultrasound system having two predefined configurations, a first configuration for providing a therapeutic laser beam to a patient and a second configuration for performing a phacoemulsification procedure on the patient, the first configuration being different from the second configuration, and adapted to transition from the first configuration to the second configuration in less than five minutes and from the second configuration to the first configuration in less than five minutes.

[0029] Additionally, laser systems, methods and apparatus are provided having one or more of the following features: an assembly having a therapeutic laser system for providing and directing the therapeutic laser beam along a laser beam path, and a phacoemulsification system for providing therapeutic ultrasonic energy for performing the phacoemulsification procedure, the therapeutic laser system and the phacoemulsification system being operatively associated with a common control system; and 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 delivery head and including a portion of the laser beam delivery path, the arm being movable to a first position corresponding to the first configuration and to a second position corresponding to the second configuration; in the first position the arm extends proximally away from the assembly; the assembly further comprising: the arm is housed within a housing, and in the first position the arm extends proximally away from the housing; the arm is pivotally attached to the assembly at a distal end of the arm, and the proximal end of the arm is pivoted upward in the second position and horizontal in the first position; the proximal end of the arm includes a means for measuring a shape, a position, or both of an ocular structure; the distal end of the arm is in optical communication with a scanner disposed on the laser beam path; the means for measuring a shape, a position, or both of an ocular structure is selected from the group consisting of an optical coherence tomography system, a Scheimpflug camera means, and a Scheimpflug imaging system; the eye comprises a means for measuring a shape, a position, or both of an ocular structure, and the means for measuring is selected from the group consisting of an optical coherence tomography system, a Scheimpflug camera means, and a Scheimpflug imaging system.

[0030] Additionally, there are provided laser systems, methods and devices adapted for rapid reconfiguration, i.e., transition between laser mode and phacoemulsification mode, having one or more of the following characteristics: the transition is about 3 minutes or less; the transition is about 2 minutes or less; the transition is about 1 minute or less; the transition is less than 45 seconds; the transition is about 30 seconds; the transition is about 1 minute to 30 seconds.

[0031] Also provided are laser systems, methods and apparatus having one or more of the following features: the proximal end of the arm comprises a laser head defining an opening, a therapeutic laser beam path extending through the opening, the opening associated with a means for closing the opening when the arm is in the second position, thereby protecting the therapeutic laser system from damage; the system defines a footprint and volume, the footprint being less than 1,500 square inches; the system defines a footprint and volume, the footprint being less than 1,000 square inches; the system defines a footprint and volume, the footprint being about 33 inches by about 22 inches; the system defines a footprint and volume, the footprint being about 35 inches by 50 inches or less. the volume is less than about 35 cubic feet; the volume is less than about 30 cubic feet; the system has a footprint size selected from the group of sizes consisting of less than 35 inches by less than 35 inches, less than 35 inches by 25 inches, about 35 inches by 25 inches, about 35 inches by 25 inches, about 33 inches by 22 inches, and about 400 square inches to about 800 square inches; the system has a footprint size selected from the group of sizes consisting of less than 35 inches by less than 35 inches, less than 35 inches by 25 inches, about 35 inches by 25 inches, about 33 inches by 22 inches, and about 400 square inches to about 800 square inches; the therapeutic laser is selected from the group consisting of a femtosecond laser and a picosecond laser.

[0032] Still further, an integrated reconfigurable laser ultrasound system is provided, comprising: a therapeutic laser system; an ultrasound phacoemulsification system; a therapeutic laser beam path having a path length; a rigid laser beam delivery arm; and a housing, the arm having a distal end and a proximal end, the arm including a portion of the therapeutic laser beam path, the distal end being optically associated with the therapeutic laser and the proximal end being optically associated with a laser delivery head, the therapeutic laser being selected from the group consisting of a picosecond laser and a femtosecond laser, the system being operable to reconfigure the therapeutic laser into two predetermined configurations, i.e., That is, an integrated reconfigurable 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 in the first configuration the laser delivery head is a first distance from the housing and in the second configuration the laser delivery head is a second distance from the housing, the first distance being different from the second distance, and the path length being the same for the first configuration and the second configuration, thereby transitioning between the first configuration and the second configuration.

[0033] Further provided are laser systems, methods and apparatus having one or more of the following features: a scanner on the therapeutic laser beam path, the scanner mechanically and optically associated with the distal end of the arm, thereby defining a scanner-head distance between the scanner and the laser head, the scanner-head distance being the same for the first configuration and the second configuration; a predetermined third configuration for providing a therapeutic laser beam to the patient, in which the laser delivery head is a third distance from the housing, the third distance being different from the first distance and the second distance, and the path length being the same for the third configuration, thereby transitioning between the first configuration, the second configuration and the third configuration; a predetermined third configuration for providing a therapeutic laser beam to the patient, in which the laser delivery head is a third distance from the housing, the third distance being different from the first distance and the second distance, and the path length being the same for the third configuration, thereby transitioning between the first configuration, the second configuration and the third configuration.

[0034] Further provided are laser systems, methods and devices having one or more of the following features: ambidextrous: includes a phacoemulsification tray and a phacoemulsification cassette, and is ambidextrous; includes a wireless foot switch adapted to control the laser, the phacoemulsification, or both.

[0035] Additionally, methods are provided for servicing, updating software, operating, and / or performing surgical procedures using any of these systems. [Brief description of the drawings]

[0036] [Figure 1] FIG. 1 is a perspective view of an embodiment of a laser ultrasound system in accordance with the present invention.

[0037] [Diagram 2] FIG. 1 is a perspective view of an embodiment of a femto-phacoemulsification system according to the present invention.

[0038] [Diagram 3] FIG. 1 is a perspective view of an embodiment of a femto-phacoemulsification system according to the present invention.

[0039] [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 in accordance with the present invention.

[0040] [Figure 4A] FIG. 5 is a schematic diagram of an embodiment of the therapeutic and scanning laser optics and optical paths of the embodiment of FIG.

[0041] [Figure 4B] 5 is a schematic diagram of an embodiment of the Scheimpflug optics and optical path of the embodiment of FIG. 4.

[0042] [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.

[0043] [Figure 4D] FIG. 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.

[0044] [Figure 4E] 1 is a schematic diagram of an embodiment of an optical system and a path according to the present invention.

[0045] [Figure 4F] 1 is a schematic diagram of an embodiment of an optical system and a path according to the present invention.

[0046] [Figure 4G] 1 is a schematic diagram of an embodiment of an optical system and a path according to the present invention.

[0047] [Diagram 5] FIG. 1 is a perspective view of a system according to the present invention.

[0048] [Figure 5A] FIG. 2 is a top view of a portion of an embodiment of a system according to the present invention.

[0049] [Figure 5B] FIG. 1 is a perspective view of an embodiment of a positioning assembly according to the present invention.

[0050] [Figure 5C] FIG. 1 is a perspective view of an embodiment of a positioning assembly according to the present invention.

[0051] [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;

[0052] [Figure 5I] 1 is a perspective view of an embodiment of an articulated light pipe according to the present invention; FIG.

[0053] [Figure 6] FIG. 1 is a top view of an embodiment of a system arrangement according to the present invention.

[0054] [Figure 7] FIG. 1 is a top view of an embodiment of a system arrangement according to the present invention.

[0055] [Figure 8] FIG. 1 is a top view of an embodiment of a Scheimpflug assembly in accordance with the present invention.

[0056] [Figure 9] FIG. 1 is a top view of an embodiment of a Scheimpflug assembly in accordance with the present invention.

[0057] [Figure 10A] FIG. 1 is a perspective view of an embodiment of a proximal assembly and docking system according to the present invention. [Figure 10B] FIG. 1 is a perspective view of an embodiment of a proximal assembly and docking system according to the present invention.

[0058] [Figure 11] 1 is a cross-sectional view of the human eye.

[0059] [Figure 11A] FIG. 12 is a cross-sectional view of the eye lens of FIG.

[0060] [Figure 12A] FIG. 1 is a perspective view of an embodiment of a Patient Interface Device (PID) according to the present invention.

[0061] [Figure 12B] FIG. 12B is an exploded perspective view of the PID of FIG. 12A.

[0062] [Figure 12C] FIG. 12B is a top perspective view of the PID of FIG. 12A.

[0063] [Figure 12D] FIG. 12B is a cross-sectional view of the PID of FIG. 12A.

[0064] [Figure 12E] FIG. 12B is a perspective view of the PID of FIG. 12A.

[0065] [Figure 12F] FIG. 12B is a cross-sectional view of the PID of FIG. 12A.

[0066] [Figure 12G] FIG. 12B is a perspective view of the installation of the PID of FIG. 12A into an embodiment of a laser ultrasound system in accordance with the present invention.

[0067] [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.

[0068] [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.

[0069] [Figure 12J] FIG. 12I is a perspective view of the locking mechanism of FIG. 12I from another side.

[0070] [Figure 13] FIG. 1 is a perspective view of an embodiment of a PID according to the present invention.

[0071] [Figure 14] FIG. 1 is a perspective view of an embodiment of a femto-phacoemulsification system according to the present invention.

[0072] [Figure 14A] FIG. 1 is a perspective view of an embodiment of a femto-phacoemulsification system with a surgical microscope in accordance with the present invention.

[0073] [Figure 15] FIG. 15 is a transparent perspective view of a portion of the femto-phacoemulsification system of FIG.

[0074] [Figure 15A]FIG. 15 is a perspective view of a horizontal movement mechanism and a vertical movement mechanism of the femto-phacoemulsification system of FIG.

[0075] [Figure 15B] FIG. 15B is a perspective view of the mechanism of FIG. 15A in an extended position according to the present invention.

[0076] [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.

[0077] [Figure 16B] FIG. 15 is a top 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.

[0078] [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.

[0079] [Figure 17A] 17A-17C 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-17C 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 FIG 14. FIG 17C shows a second surgical extension position (fully extended) for therapeutic laser surgery.

[0080] [Figure 18] 1 is a schematic diagram of an embodiment of a fixed optical path according to the present invention;

[0081] [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;

[0082] [Figure 20] FIG. 1 is a cross-sectional perspective view of an embodiment of a PID according to the present invention.

[0083] [Figure 20A] FIG. 21 is an exploded perspective view of the PID of FIG.

[0084] [Figure 20B] FIG. 21 is a perspective view of the PID of FIG.

[0085] [Figure 21] FIG. 1 is a perspective view of an embodiment of a femto-phacoemulsification system in an extended position according to the present invention.

[0086] [Figure 21A] FIG. 22 is a perspective view of the system of FIG. 21, showing the system in a retracted position from another side.

[0087] [Figure 21B] FIG. 22 is a plan view of the tray assembly of the system of FIG. 21.

[0088] [Figure 21C] FIG. 22 is a perspective view of a portion of the system of FIG. 21.

[0089] [Figure 21D] FIG. 22 is a perspective view of the lock engagement device of the system of FIG. 21 in an open position.

[0090] [Figure 21E] FIG. 22 is a perspective view of the lock engagement device of the system of FIG. 21 in a closed position.

[0091] [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.

[0092] [Figure 22A] FIG. 23 is a schematic diagram of a control bus for the Femto-system of FIG. 22 in accordance with the present invention.

[0093] [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 PREFERRED EMBODIMENTS

[0094] Generally, embodiments of the present invention provide systems and methods for addressing ocular conditions including the cornea, lens, and other structures of the eye and associated with the eye, and in particular for delivering laser energy, ultrasound energy, or both to the eye to address, mitigate, ameliorate, and reverse such conditions.

[0095] In general, embodiments of the present invention relate to ergonomic and integrated systems that, among other things, enable the diagnosis, treatment, and combinations and variations thereof of diseases of the human eye and associated structures using ultrasound and laser beams, 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 delivery systems; and combinations and variations of these and other features.

[0096] 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 the left and right eyes of a patient 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 preferred method to begin treatment of one or both eyes without having to reposition the patient or reconfigure the laser, ultrasound, and / or both. In this way, improved patient comfort, improved ergonomics for the surgeon, improved efficiency, increased capacity, reduced time to complete a full procedure on a patient (e.g., both eyes), and combinations of these variants and other advantages are obtained.

[0097] 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 that the system provides.

[0098] 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 the surgeon reposition relative to the system, and preferably without both.

[0099] In an embodiment, a patient is placed on a patient support, such as a support bed, and the system is moved to a position adjacent to the patient, the system can be positioned by the surgeon in any of a number of orientations described herein, and the laser system and ultrasound system are used to perform the procedure on the patient.

[0100] Embodiments of the system may include one or more and all of the features of the above-mentioned embodiments and the embodiments in the preceding and following paragraphs.

[0101] These system embodiments, such as the embodiments of the integrated phacoemulsification-laser system, are adapted to address a variety of eye conditions and to perform a variety of procedures on the eye, including, for example, capsulotomy; custom shaped non-circular or non-elliptical capsulotomy; lens cutting, fracturing, segmenting, and removal; cataract cutting, segmenting, separating, and removal; lens and cataract tissue emulsification; corneal cutting and incision; construction of corneal flaps and corneal pockets; limbal relaxing incisions; addressing and correcting refractive errors (congenital or induced); removal of residual skin material; removal of lens epithelial cells; vitreous aspiration and cutting in conjunction with anterior vitrectomy; addressing bipolar coagulation; and intraocular lens implantation.

[0102] These system embodiments, such as the integrated phacoemulsification-laser system embodiments, are adapted to address a variety of ocular conditions and perform and enable a variety of 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 by 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 the optical zone, which is preferably about 5.00 mm or greater, although smaller zones are contemplated. The length of the incision is typically about 2.50 mm. Typical parameters of the incision are shown in Table 1. Typically, one, two, three, or more incisions are made in the cornea in a micro-RK procedure. Table 1 TIFF2025041786000002.tif59170

[0103] 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, accelerometers, sensors, position devices, etc.) in communication with the laser-ultrasound device to provide the precise location of the patient, particularly the patient's head position, relative to the laser beam delivery components, laser beam paths, laser docking components, ultrasound components, combined laser-ultrasound devices, and combinations and variations thereof.

[0104] 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, accelerometers, sensors, position devices, etc.) that communicate with the laser-ultrasound device to provide the precise location of the patient, particularly the patient's head, relative to the laser beam delivery components, laser beam paths, laser docking components, ultrasound components, combined laser-ultrasound devices, and combinations and variations thereof.

[0105] 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, e.g., worn by or placed on the patient, and has location measurement devices (e.g., positioning devices, RFID, light, accelerometers, sensors, location devices, etc.) that communicate with the laser-ultrasound device to provide the precise location of the patient, particularly the location of the patient's head, relative to the laser beam delivery components, the laser beam path, the laser docking components, the ultrasound components, the combined laser-ultrasound device, and combinations and variations thereof.

[0106] 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 identity of the patient, or in conjunction with other biometric systems such as retinal imaging or iris scanning to verify identity. In this manner, the patient intelligent device may also communicate with the laser system, 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.

[0107] This position measuring device for the patient, also referred to as an orientation / position tracking system for the patient, measures the position of the patient relative to the position of the laser and the laser beam path, e.g., the position of the patient's head, and can be, for example, 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 disclosures of which are incorporated herein by reference in their entireties. Such devices are also referred to as patient locators, or patient position devices or systems.

[0108] In one embodiment, a laser ultrasound system, and in particular a laser phacoemulsification system, is configured such that a therapeutic laser beam is delivered 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 relative positions to the laser phacoemulsification system.

[0109] 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 when 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 fully integrated laser-ultrasound systems have not been used or approved by regulatory agencies in operating rooms prior to the present invention. 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 are the ability to replace two systems, eliminating the need to move the patient, the system, or both during the patient's 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, making it much easier for surgeons and other professionals working in the operating room to move around. It also provides benefits such as reduced cleaning of the operating room and freeing up space to place other systems in the operating room, such as diagnostic equipment, microscopes, etc. 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 the embodiments of the present invention.

[0110] In these system embodiments, the time to change or switch from one mode of operation to another is preferably rapid, such that 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, 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, 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.

[0111] 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 configurations 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.

[0112] In embodiments of these laser ultrasound systems, such as integrated phacoemulsification-laser devices, the device (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 at its 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, as well as combinations and variations thereof, as well as greater and lesser sizes. (In embodiments where 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 device height is at its minimum volume unless otherwise specified. The device can have a length of about 30 in to about 50 in, about 33 in, about 38 in, about 40 in, less than about 45 in, less than 40 in, about 34 in to about 38 in, about 36 in, 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 in to about 40 in, about 20 in, about 25 in, about 30 in, less than about 45 in, less than about 30 in, about 22 in to about 27 in, about 20 in to about 30 in, 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 From about 1,300 in 2 , about 400in 2 About 600in from 2 , about 400in2 About 500in from 2 , about 450in 2 About 700in from 2 , about 450in 2 , about 500in 2 , about 550in 2 , about 600in 2 , about 1,200in 2 Less than 1,100in 2 Less than 1,000in 2 Less than 1,000in 2 Less than 950in 2 , about 900in 2 , about 800in 2 , about 850in 2 From about 950in 2 , and combinations and variations thereof, as well as larger and smaller sizes. In embodiments, the width, length, and 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 is 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 be different, e.g., the footprint may be rectangular or oval. It is understood that other shapes for the footprint may also be envisioned, such as, for example, a star shape, an "L" shape, an "H" shape, etc.

[0113] Typically, a phacoemulsification device is about 20 inches by about 25 inches, so about 500 inches. 2 (i.e., a "standard phacoemulsification footprint"). Thus, embodiments of the integrated phacoemulsification-laser system have a typical phacoemulsification footprint of 500 in 2The present invention may 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 smaller than the footprint of the conventional two-device system. This synergy achieved by embodiments of the present invention having 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.

[0114] Also, 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.

[0115] 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, 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.

[0116] In embodiments of these systems, 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, and phacoemulsification parameters such as phacoemulsification energy, BSS (balanced salt solution) flow, fluidics, etc. are optimized in a highly integrated and predefined manner, providing integrated control, monitoring, and storage capabilities of the system and device.

[0117] Further advantages and benefits of these system embodiments having dual laser pulse widths include reduced need and use of instruments such as diamond blades and knives, thus reducing costs, reducing risk of infection, and reducing procedure times.

[0118] 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 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.

[0119] 1, a perspective view of an embodiment of a laser ultrasound system 100 is shown. 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, motion 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, and less.

[0120] These components may be wholly and partially distributed 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 standalone housings on the same base or frame 150, may have communication, control, power, optical, and other connections between them, may be a single and identical housing, may be subdivided or split into third, fourth, etc. housings or sub-housings, and combinations and variations thereof.

[0121] There is an optical conduit 105 connecting the housing 102 to the housing 106. The housing 106 includes a scanning device and beam shaping optics for the therapeutic laser beam, and the scanning device, optics, and 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 entirely 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 integral 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 presently preferred embodiment, the housing 106 contains and isolates the scanner and beam shaping optics. The scanner and beam shaping optics or other components that may be included 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 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 the 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.

[0122] 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 the surrounding atmosphere, can include 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 transmission structures.

[0123] The housing 106 has an arm 107 that can move, extend and retract in the directions of arrows 107a and 107b. The arm 107 and the housing 106 move vertically as shown by arrow 107a by an elevator device 110. The arm 107 has an assembly or device 108 for measuring the shape and position of the eye and structures therein. At its proximal end, i.e., at the end furthest along the laser beam path and thus furthest from the laser beam source, below the device 108, the arm 107 has a patient interface device (PID) (not shown in this view). The arm 107 has a monitor 109 that moves on an articulated arm in the direction of arrow 109a. 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 the control system of the system 100 and may include part or all of the control system of the system 100. The monitor is in control communication 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.

[0124] The arm 107 forms or contains a laser beam transmission structure, such as a hollow tube, that provides free space for the transmission of the laser beam. In an embodiment, the arm 107 can contain a beam path or optical fiber in free space for transmitting the laser beam, for example, to a scanner located at the proximal end of the tube, i.e., the end near the housing 106, rather than at the distal end. The arm 107 can also be or be provided with any laser beam transmission structure of the type described for use as the optical conduit 105. The tube can also contain optics. In the embodiment of FIG. 1, the arm 107 contains an uncollimated laser beam, and thus the arm 107 is shown as containing an uncollimated laser beam and laser beam path, in other words the arm 107 contains, surrounds, or contains a "non-collimated space" along the laser beam path. The arm 107 can contain or surround a collimated space where the laser beam on the laser beam path is collimated. The arm can contain a space that contains 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 in the arm 107 includes mirrors or optics to direct the laser beam through the PID to and into the patient's eye.

[0125] 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 could be on housing 101, or could be elsewhere on the system, or could be part of a phacoemulsification cassette inserted into system 100.

[0126] In an embodiment, the laser system has an external, internal, or both cooler, such as a cooling fluid that is flowed into or out of the laser housing.

[0127] 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

[0128] 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, for example, pulse widths can be changed, pulse repetition rates can be varied, power can be changed, and wavelengths can be changed. Multiple therapeutic lasers can be used. The therapeutic laser can be a pulsed laser, such as a femtosecond or picosecond laser, longer or shorter pulses, a continuous laser, and combinations thereof.

[0129] Therapeutic lasers can have wavelengths in the IR and UV spectra, as well as other wavelengths. Therapeutic laser beams can have wavelengths of about 300 nm to about 2,500 nm, 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.

[0130] 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 wavelengths, as well as longer and shorter 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 of these. 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.

[0131] These dual beam embodiments, i.e., those with at least both short and long pulse width therapeutic laser beams, have various advantages and benefits, which may include, for example, reducing the need and use of instruments such as diamond blades and knives, thus reducing costs, reducing the risk of infection, and reducing procedure times.

[0132] 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.

[0133] Therapeutic laser beams 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.

[0134] These system embodiments can also perform sub-threshold 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, sub-threshold laser treatments can be performed, photoablation induced laser treatments can be performed, and phacoemulsification can be performed, and combinations and variations of some or all of these treatments can be performed without moving the patient or the device position.

[0135] The therapeutic laser beam can have pulse energies from about 1 nanojoule (nJ) to about 2 millijoule (mJ), from about 1 nJ to about 1 mJ, from about 2 microjoules (μJ) to about 70 μJ, from about 5 μJ to about 45 μJ, from about 2 μJ to about 35 μJ, from 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.

[0136] 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.

[0137] A Yb:YAG laser generating ultrashort laser pulses at a wavelength of 1030 nm can be used as a therapeutic laser. In general, therapeutic lasers provide a beam with a wavelength that penetrates the cornea, aqueous humor, and lens. The beam can be of short pulse length and energy and beam size to cause photodisruption, LIOB, or both of targeted ocular tissues, such as the cornea, limbus, lens capsule, lens, cataractous tissue, opacified tissue, and other tissues. Thus, as used herein, the term "laser shot" or "shot" refers to a laser beam pulse that is delivered by itself or in combination with other pulses to a location where a therapeutic effect, such as a LIOB, is caused. As used herein, the term "photodisruption" essentially means that a substance is turned into a gas by the laser. In embodiments, wavelengths of about 300 nm to 2500 nm can be employed. Pulse widths of about 1 femtosecond to 100 picoseconds can be employed. Energy of about 1 nanojoule to 1 millijoule can be employed. The pulse rate (also called the 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 2.5 nanojoules; Clark CPA-2161IMRA FCRA (fiber chirped pulse radiator) 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 850 microjoules; amplification: fiber chirped pulse amplification); Microjoule D-series D-400-HR, a Yb: fiber oscillator / amplifier with a wavelength of 1045 nm, less than 1 picosecond pulse width, a PRF of about 5 MHz, and 100 nanojoules; Coherent Staccato, a Yb:YAG with a wavelength of 1030 nm, about 1.5 picosecond pulse width, a PRF of about 80 kHz, and 30 microjoules; and Coherent Rapid, a Yb:YAG with a wavelength of 1030 nm, about 1.5 picosecond pulse width, and includes one or more amplifiers achieving an average output power 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 an IMRA, a Yb: fiber oscillator / amplifier with a wavelength of 1045 nm, less than 100 picosecond pulse width, 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.

[0138] 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, as well as U.S. Patent Nos. 8,262,646 and 8,708,491, the disclosures of which are incorporated herein by reference in their entireties. Laser Beam Delivery - Overview

[0139] In general, an embodiment of an optical system for delivering a therapeutic laser beam to the lens of the eye should be capable of providing a series of shots to the lens in a precise, predefined pattern in the x, y, and z dimensions. The optical system should also provide a predetermined beam spot size to cause photodisruption, LIOB, or both with the laser energy reaching the lens or other target tissue. Thus, the optical system may include, but is not limited to, an xy scanner, a z focuser, 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 calibrated 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, SCANLAB hurrySCAN, and AGRES Rhino scanners. Examples of such z-focusing devices include the piezo apex alignment unit model ESee Zfocus control from Phsyik International, and the varrioSCAN from SCANLAB. Laser Control System - Overview

[0140] In general, an embodiment of a control system for delivering a therapeutic laser beam can be a computer, controller, software, hardware, and combinations and variations thereof, which can select and control, 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 to direct the laser with one or more laser shot patterns. The laser control system also has the ability to integrate a system control system and function with or operate as an integrated system with an ultrasound control, monitor, or control panel. The system control, laser control, ultrasound control, 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 suggest tables and treatments, and perform calculations. The control system can include a program to direct the laser with one or more laser shot patterns. Position and shape measurement - outline

[0141] 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), Scheimpflug device with a single movable camera, multiple fixed cameras, combinations and variations thereof, and other types of devices for making such measurements. The device, in embodiments, 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, xy centering of the lens can be accomplished by viewing the lens with a CO-bore sighed camera system and display and manually aligning the viewing optics to the known center of the patient's eye. The z-position can be measured by optical triangulation or distance measuring devices using laser and ccd systems, such as Micro-Epsilon opto NCDT1401 laser sensor, 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 positions of the lens. For example, Vision Engineering's Hawk 3-axis non-contact measurement system can be used to make these measurements. A further example of equipment that can be used to measure the position of the lens is a three-dimensional measurement equipment. This equipment includes a camera or multiple 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 the 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, in multiple planar slices that are integrated to provide data for position and location information for the laser system around those structures. Examples of assemblies, methods, and apparatus for measuring the shape of the eye and structures, as well as their position relative to the laser, laser shot patterns, and laser beams, are disclosed and taught in U.S. Patent Application Publication Nos. 2018 / 0085256, 2016 / 0302971, 2015 / 0105759, 2012 / 0330290, 2016 / 0030244, 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 (lenses, mirrors, fibers, etc.), and both. Patient Interface - Overview

[0142] A further 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 one-time use devices (e.g., disposable) that are added to the system for each patient prior to or during laser treatment. In embodiments, this interface provides for the x, y, z positions between the lens and the laser to remain fixed during the treatment, which includes a measurement step to measure the xyz positions and a transmission step to transmit the laser in a shot pattern to the lens. The interface device can include an optically transparent applanator. One example of this interface is a suction ring applanator device, which can be circular or elliptical, fixed against the outer surface of the eye and positioned against the laser optics housing, and fixes the distance between the laser, eye, and lens. Reference marks for 3D viewing and measurement equipment can also be placed on this applanator device. Also, the interface between the lower surface of the applanator device 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 to affix 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 constructed 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 the housing for the laser optics, structure that is a known distance along the path of the laser beam from the laser and 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.

[0143] During testing and calibration, a laser beam, preferably a therapeutic laser beam, can be transmitted through a window in the PID. Ultrasound / phacoemulsification - Overview

[0144] Any ultrasound generating device adapted to provide ultrasonic energy that is useful, safe and effective for the treatment of the eye, its structures, and adjacent tissues, and diseases thereof, such as an ultrasonic driver, horn, or other device for producing ultrasonic energy, can be used to provide ultrasonic energy for the system. In particular, some or all of the components of any ultrasound phacoemulsification system, preferably approved by a medical device regulatory agency, can be used or reconfigured for use in embodiments of the system.

[0145] Generally, embodiments of the integrated system and method may perform phacoemulsification, for example, to emulsify or liquefy the lens, break up the cataract into smaller pieces, and combinations and variations thereof, including making a corneal incision, a scleral incision, preferably using a therapeutic laser beam, 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, disrupted, softened, and combinations and variations thereof, by the laser beam. The emulsified pieces may then be removed using the same or a different handpiece. The surgeon may then insert an implant, for example, an intraocular lens, IOL, into the eye through the incision.

[0146] 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, from about 30 kHz to about 50 kHz, from about 30 kHz to about 45 kHz, less than about 50 kHz, from 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.

[0147] In embodiments, the length of the stroke, longitudinal movement, 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.

[0148] Generally, phacoemulsification systems can have pulse rates from about 20 pulses / second to about 150 pulses / second, combinations and variations thereof, and larger and smaller values.These systems can have burst widths from about 30 milliseconds to about 4 milliseconds, combinations and variations thereof, and larger and smaller values.

[0149] 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 a housing of the system. 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 of the lens. The handpiece further includes an irrigation port proximal to the distal tip connected via an irrigation line to an irrigation source, and an aspiration port at the distal tip connected via an aspiration line to an 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.

[0150] Other medical techniques on the eye that ultrasound systems are adapted to perform also typically include irrigation and aspiration of the eye. Such procedures include the destruction, adjustment, or removal of eye features using emulsification, irrigation, and aspiration. Thus, the ultrasonic power delivered by the surgical console, the flow of fluids to or from the patient via the irrigation or aspiration console, and the natural requirements of control of the onward phacoemulsification handpiece are selected and controlled by the system, by the surgeon, and combinations and variations thereof.

[0151] 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 an embodiment the console is a system monitor. A phacoemulsification handpiece can be interconnected to the system by an electrical cable to power and control the piezoelectric transducer that effects the emulsification. Tubing allows irrigation fluid to be provided to the eye and aspiration fluid to be removed from the eye through the handpiece under control of the console.

[0152] 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 and otherwise effect energy transmission from the phacoemulsification handpiece into tissue, etc. Automatic tuning of the handpiece is accomplished by monitoring the electrical signals of the handpiece and adjusting frequencies and other characteristics to maintain uniformity of selected parameters.

[0153] In an embodiment, the control system handles the power control requirements for the phacoemulsification handpiece based on the phase angle between the voltage applied to the piezoelectric transducer of the handpiece and the current drawn by the piezoelectric transducer, the amplitude of the power pulses provided to the handpiece, and both. A typical configuration is tailored to the particular handpiece, 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 off power for 350 ms, repeating this on / off series for the required time of power application. The application of power for the 150 ms period mentioned above may be defined by the constant application of a sine wave of 25 kHz to 50 kHz. In some circumstances, the surgeon or operator may apply a power burst for a certain time interval, turn off the application of power, and reapply 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.

[0154] In an embodiment of the system, the control method for the delivery of ultrasonic power can generally be in several modes, such as variable mode, predefined variable mode, panel mode, and linear mode. The variable mode gives the surgeon or operator maximum flexibility for the selection of the conditions of the ultrasonic treatment, which may be viewed as manual. The predefined variable mode is a mode in which the control system determines the optimal range of ultrasonic 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 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, the panel mode provides precise, fixed values, typically based on the user's selection. Generally, the 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 delivery of ultrasound therapy, 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.

[0155] The phacoemulsification ultrasound probe delivers energy to the eye that is 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 that is used to fragment the cataract in places where laser fragmentation of the cataract has not yet been performed, such as in places where the surgeon does not use a laser to fragment the lens or cataract, choosing to perform a laser capsulotomy and laser incision for insertion of the phacoemulsification probe. The phacoemulsification ultrasound probe delivers energy to the eye that is used to fragment the cataract by vibrating at a fixed frequency, which is delivered when a control switch, such as a foot pedal, is pressed into place that can control the firing and transmission of the therapeutic laser beam and patterns, and other types of control switches, buttons, triggers, sounds, etc. can be used. In an embodiment, to increase the magnitude of the ultrasound output, the machine increases the stroke length of the probe.

[0156] 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 the efficiency of cutting, for example, by reducing repulsion of the lens material.

[0157] 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 as well as with either straight or angled needles. Combining transverse motion phacoemulsification with traditional longitudinal phacoemulsification can aid in cutting efficiency as cataract material is emulsified in multiple directions.

[0158] Although 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 shock when it strikes the target material, e.g., the cataract material that the laser acts upon. Generally, the needle also creates cavitation and implosion when a micro-cavity is created just in front of the phacoemulsification needle. Fluid and particle waves propagate into the cataract material, ultimately creating heat as a side effect. It is important to avoid selecting phacoemulsification power settings that create increased heat generation, since excessive heat generation can burn the cornea and damage delicate ocular structures. Unrestricted flow through the surrounding irrigation sleeve is also very important, as the constant cooling effect of the balanced salt solution moving around the phacoemulsification probe helps prevent heat generation.

[0159] In embodiments of the system, during surgery, the system control, phacoemulsification control, and combinations and variations thereof can monitor, record, and analyze the average phacoemulsification power, as a percentage of maximum, the total time the phacoemulsification ultrasound 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 display 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 the 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 delivered in different situations.

[0160] In an embodiment, to maximize the reduction in APT, the surgeon needs to reduce the phacoemulsification time, the average phacoemulsification power, and combinations and variations thereof. The average phacoemulsification power can be reduced by selecting parameters on the monitor, or by limiting the position of the control switch, or by lowering the maximum phacoemulsification power level on the device. The phacoemulsification time can be reduced by applying ultrasonic power only when a cataract piece is located at the tip of the phacoemulsifier and vacuum alone is insufficient to aspirate the piece. In addition, the phacoemulsification time can be reduced by delivering shorter pulses or bursts of phacoemulsification power instead of continuous ultrasonic power, or by lowering the duty cycle (ratio of pulses on:off). This method of distributing ultrasonic power into smaller packets of pulses and bursts is called phacoemulsification power modulation.

[0161] In an embodiment, 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.

[0162] 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 a control system operating in conjunction with the phacoemulsification control system and in situations involving surgeon input.

[0163] In an embodiment, 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 further it is positioned, e.g., the further it is depressed, the greater the output of each sequence of pulses of energy. A feature of an embodiment of operation in pulse mode is that after each pulse of delivered energy there is an interval of time, an "off" time, during which no energy is delivered between pulses of increasing energy. By alternating between "on" and "off" pulse times, less heat is delivered and half the energy is delivered to the eye.

[0164] In an embodiment, 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 an embodiment, the further the control switch is advanced, e.g., the more the foot pedal is depressed, the less "off" time there is between each burst. Thus, in an embodiment, at the maximum control switch position, e.g., maximum foot pedal depression, the bursts of energy are a continuous delivery of energy.

[0165] In an embodiment, burst mode can provide phacoemulsification assisted by aspirating the lens nucleus. The surgeon uses the vacuum and fluidics of the phacoemulsification device to aspirate the cataract and only delivers small bursts of phacoemulsification power when necessary. 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 is still, for example, less than a second.

[0166] The system provides embodiments in which the programmable range of pulse and burst phacoemulsification settings and other settings have the same features as previous systems and embodiments, but are significantly expanded beyond prior systems. Unlike any prior 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 instantaneously deliver those settings without the need for the surgeon or patient to move.

[0167] In embodiments, the phacoemulsification control system, alone or in conjunction with the 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 to proactively respond to occlusion breakup. Sensors to provide this information and data for monitoring and automatic control of the operating parameters of the phacoemulsification system can be within the system, on various pumps and devices, based on current or other electrical loads, or in or on the handpiece.

[0168] Examples of performance characteristics and components that can be used in the phaco-laser system include the Alcon CENTURION® Visionsystem, the Alco ACTIVE SENTRY® Handpiece, and the INTREPID® Hybrid Tip. In embodiments, the phaco handpiece can have a built-in 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 phaco-laser system include the AMO WHITESTAR SIGNATURE® PRO phaco system.

[0169] 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 disclosures of which are incorporated herein by reference in their entireties.

[0170] Ultrasound-Laser Hybrid - Overview

[0171] These embodiments include any hybrid laser ultrasound system, particularly hybrid phacoemulsification laser systems, and hybrid phacoemulsification femtosecond laser systems ("femto-phacoemulsification" or "phacoemulsification-femto", which are used interchangeably unless otherwise noted). These embodiments may have or utilize one or more of the embodiments, features, functions, parameters, components, systems, and features of the general techniques and systems in the examples disclosed herein of therapeutic laser systems, laser beam delivery, laser control systems, position and shape measurement, patient interfaces, and ultrasound / phacoemulsification.

[0172] In a preferred embodiment of the laser ultrasound system, particularly the laser-phacoemulsification system, and more particularly the femto-phacoemulsification system, the system has two therapeutic laser beams provided by the same or different laser sources, one a short pulse width laser beam and the other a long pulse width laser beam.

[0173] Generally, short pulsed lasers are intended for performing procedures on the cornea, such as corneal ablation, limbal relaxation tomography, etc. Generally, long pulsed laser beams are intended for performing procedures on the lens, such as capsulotomy, lens fragmentation, cataract fragmentation, etc.

[0174] 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.

[0175] A system, such as a femto-phacoemulsification system, can have multiple therapeutic laser beams, such as 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, and 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, the 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.

[0176] 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.

[0177] 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, about 3 seconds to 1 second, about 2 seconds, about 3 seconds, and combinations and variations thereof, and longer or shorter times.

[0178] Although the preferred embodiments of the present invention are directed to laser-ultrasound, and in particular femto-ultrasound phacoemulsification systems, it should be understood that improvements to the laser system and embodiments thereof may be of value and may be used alone without being part of a laser ultrasound system.

[0179] These embodiments of the system provide important advantages over the prior art: the system provides an optimal laser energy pattern, allows evaluation of the eye without moving the patient following delivery, and can perform 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

[0180] 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 limiting the scope of the invention.

[0181] The embodiments of these Examples 1 to 46 may have 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 of the other examples and other embodiments provided herein.

[0182] Example 1

[0183] 2 shows 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 xy scanner.

[0184] The system 200 has an arm 201 that encases the therapeutic laser beam path and other optical paths. In an embodiment, the arm 201 also houses or carries the control and power cables for the imaging positioning device 203 and the docking assembly (not shown in this view). The arm 201 has a therapeutic laser beam delivery head 202 at its proximal end. The laser delivery head 202 has a position and shape measurement device, which can be an OCT system or a Scheimpflug system in this example, as well as combinations and variations thereof, and other shape and position measurement devices. The laser delivery head has a docking and alignment system that interfaces with the PID to dock to the patient's eye.

[0185] The system 200 has a common power supply 207 for the laser subsystem 204 and the 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.

[0186] The system 200 includes a common control system 208. The common control system 208 includes controls that operate the control software or execute instructions. In a preferred embodiment, the 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; a human operator interface 209; an emergency stop 210; and a network that may be, for example, a patient's medical record system, an accounting system, and combinations and variations thereof.

[0187] Typically, the docking system and the imaging and position measurement equipment are controlled by a laser subsystem control system. In an embodiment, they are controlled in whole or in part directly by a common control system 208.

[0188] 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, there is only one control system or a single control system in the femto-phacoemulsification system.

[0189] Example 2

[0190] 3 shows an embodiment of a femto-phacoemulsification system along the lines of Example 1, with like numbers indicating like components. In the embodiment of FIG. 3, an xy scanner 301 is disposed on the laser delivery head 202.

[0191] Example 3

[0192] 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 the femto-ultrasound phacoemulsification system.

[0193] The optical system 430 has four optical systems, 400, 401, 402, 403, which have different wavelengths, powers and light for different purposes. The optical system 400 is for the therapeutic laser beam, comprises optical components and defines the therapeutic laser beam path along which the therapeutic laser beam is transmitted. The optical system 403 is for an imaging and position measuring device, e.g. a Scheimpflug device, which measures, among other things, the shape and position of the eye structures and directly relates the therapeutic laser beam to the laser beam path. This system 403 provides an image path. The optical system 401 is for a camera, preferably an IR camera, which, as can be seen, runs along, i.e. coincides with, the therapeutic laser beam path 400 for most of its path. This system 401 provides an image path. The two paths are combined with a beam splitter, and the Vario (Z-axis laser deflection optics) for the therapeutic laser is not part of the camera beam path 401. The 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 an imaging path.

[0194] 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, 1× telescope 485, F-Theta lens 486, color DTP camera 487, beam splitter cube 489 (R: 880, 1030; T: visible), and a Scheimpflug camera assembly 490.

[0195] 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.

[0196] Sections or portions of these optics 400, 401, 402, 403 can be disposed or housed in various housings and components of the laser system embodiments, laser ultrasound systems, and femto-ultrasound phacoemulsification system embodiments. Thus, as shown in FIG. 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 FIG. 5, or housing 106 of FIG. 1), an arm 421 (such as, for example, arm 201 of FIG. 3, light pipe 504 of FIG. 5, or arm 107 of FIG. 1), and a laser head or proximal housing 423, such as a proximal assembly or laser head (such as, for example, the proximal end of arm 107 of FIG. 1, head 202 of FIG. 2, or head 505 of FIG. 5). These optics 400, 401, 402, 403 can also be positioned between or housed within the 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 optics 400, 401, 402, 403 can also be positioned between or housed within the 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 optics are also contemplated.

[0197] 4G, optical system 430 has four pupils 461, 462, 463, 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.

[0198] Example 3A

[0199] The embodiment of Example 3 has both a treatment laser and a scanning laser to illuminate the ocular structures so that optical components such as from 403 can take images to know where the ocular structures are located. In addition, 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 this light is via a beam splitting cube between 402 and 403 in FIG. 4G.

[0200] Example 4A

[0201] The femto-phacoemulsification system has 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, which can measure the shape of the lens and ocular structures and their position relative to the therapeutic laser and 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.

[0202] The OCT system can also be used, for example, in the embodiments of Figures 1, 2, 3, 5, 14 and other embodiments.

[0203] Example 4B

[0204] The embodiments of Figures 1, 2, 3, 5, and 14 include and use 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 way, functions in a different manner, and provides significantly different output, results, than, for example, an OCT system. The Scheimpflug system of the present invention is believed to be superior to OCT in measuring the position and shape of structures in the eye.

[0205] 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.

[0206] 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.

[0207] Example 5A

[0208] In one embodiment of the femto-phacoemulsification system, the phacoemulsification subsystem has the following components, features, and an integrated system of peristaltic and venturi pumps that allows the surgeon to independently select either pump mode for phacoemulsification and vitrectomy procedures. Features of the phacoemulsification subsystem include: Twin pump system, peristaltic and venturi; high vacuum occlusion; high speed vitrectomy. The phacoemulsification subsystem is capable of and performs the following procedures: diathermy, irrigation, sculpting, flop and chop, vit, visco. The user interface and software provides 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.

[0209] Example 5B

[0210] In one embodiment of the femto-phacoemulsification system, the phacoemulsification subsystem includes the Alcon CENTURION® VisionSystem, the Alco ACTIVE SENTRY® Handpiece, and the INTREPID® Hybrid components.

[0211] Example 5C

[0212] In one embodiment of the femto-phacoemulsification system, the phacoemulsification subsystem includes components of an AMO WHITESTAR SIGNATURE® PRO phacoemulsification system.

[0213] Example 6

[0214] In an embodiment of a laser ultrasound system, particularly a femto-phacoemulsification system, the system has a safety interlock. The safety interlock is preferably in a common control system and is located in or 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 - the laser is operational; (ii) the phacoemulsification system is on and warming up but not operational or running - the laser is operational; (iii) the phacoemulsification is operational or running - the laser cannot fire.

[0215] In one embodiment, stage (iii) allows the laser to operate when the phacoemulsification system is operational but not operating, 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 ultrasonic energy.

[0216] Example 6A

[0217] 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.

[0218] Example 7

[0219] In Fig. 5, a perspective view of a femto-phacoemulsification laser device or system 500 is shown. The system has a lower or main housing 501 (only partially shown in the figure). The lower housing 501 contains the phacoemulsification system, a place for the phacoemulsification cartridge, the cartridge during treatment, a therapeutic laser for generating a therapeutic laser beam, and a control system. A sliding mechanism 502 is arranged in the main housing 501. The sliding mechanism 502 provides for the movement of an upper or movable housing 503. The movable housing 503 is moved by the sliding mechanism 502 in the direction of the arrow 502a, i.e. laterally horizontally, i.e. towards and away from the patient.

[0220] The sliding mechanism is controlled, for example, by a joystick. It can be automatically or manually moved, for example, by a motor, or a combination thereof, where, for example, the motor can be rotatable. The motor can have a set or predetermined position and be in control communication connection with the smart headrest, for accurately positioning or positioning the laser delivery head 505 on the patient headrest and thus on the patient and his eye undergoing surgery.

[0221] 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.

[0222] The housing 503 is in optical communication with the therapeutic laser via an articulated light pipe 507. The articulated light pipe provides a free space laser beam path that directs a laser beam from the lower housing 501 into the housing 503 and transmits the therapeutic laser beam along the laser beam path to the optical components within the housing 503. In this embodiment, as shown in more detail in FIG. 5I, the articulated light pipe 507 has six joints, with a reflective surface on the inside of each joint. Preferably, the light pipe 507 maintains the therapeutic laser and housing 501 in optical communication with the housing 503 and the optical components within the housing 503 in all possible positions and orientations of the housing 503.

[0223] The housing 503 has an 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. The arm 504 connects the housing 503 to the laser delivery head 505 to maintain those components in optical communication. The 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. The laser head 505 is located at the proximal end of the arm 504 and the housing 503 is located at the distal end of the arm 504.

[0224] 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).

[0225] Example 8

[0226] 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).

[0227] 5A, the position adjustment mechanism 510 is generally located on the other side of the housing 503, away from the arm 507. A portion of the mechanism 510 may be located below the housing 503 and on or in the housing 501.

[0228] 5B shows a lateral movement assembly 531 that is part of the position adjustment mechanism 510. The lateral movement assembly 531 includes a first plate 520 and a second plate 521 that are movably and mechanically associated with motors 523 and 522, for example by drive gears or wheels. The plates 520, 521 are moved in a lateral movement arc, i.e., in the direction of arrow 502a, relative to a fixed post 512. The fixed post 512 is attached to a free moving assembly, such as assembly 513. The lateral movement assembly 531 is mechanically associated with the housing 501 and may be housed on, or preferably within, the housing 501.

[0229] Example 9

[0230] 5C, there is shown a lateral movement assembly 511 having a four bar linkage that is part of a position adjustment mechanism 510a and provides movement in the direction of arrow 502a. The lateral movement assembly 511 is mechanically associated with the housing 501 and may be housed on or preferably within the housing 501.

[0231] 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, as well as lateral type movement mechanisms and electromechanical-devices, can be used.

[0232] 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 movement of housing 503 in arcuate, lateral, vertical, and combinations thereof, as generally indicated by the collection of arrows 513a. Assembly 513 is a parallelogram linkage.

[0233] The assembly 513 may be motorized, have a fixed position, or may be manipulated by hand, for example by holding the arm 504, the housing 503, or other portion and changing the position of the housing 503. In one embodiment, the housing 503, the arm 504, and the laser head 505 are counterbalanced to allow the housing 503 to move with less than 10 lbs of force, less than 7 lbs of force, less than 5 lbs of force, and less than 2 lbs of force, from about 2 to about 7 lbs of force, from about 4 to about 6 lbs of force, and combinations and variations thereof. Preferably, once moved, the housing 503 will remain in that position until a force sufficient to move it is applied. (For simplicity, the arm 504 and the laser head 505 are not shown in FIG. 5C.)

[0234] Figures 5D through 5H show several positions of the housing 503 positioned by the free-moving assembly 513. The position of Figure 5H is ideal for storing the system and cleaning the operating room. The position of Figure 5E is for performing laser surgery on a patient.

[0235] Example 10

[0236] In one embodiment, a laser ultrasound system, and in particular a femto-ultrasound phacoemulsification system, has a patient bed or support attached to the system.

[0237] Example 11

[0238] In one embodiment, the patient support, e.g., bed, is not attached to the laser ultrasound system, particularly the femto-phacoemulsification system. The patient support and the femto-phacoemulsification system are perfectly positionable relative to each other without any physical constraint between them. Thus, the femto-phacoemulsification system can be positioned in any position and orientation relative to the patient support (with the patient head naturally within reach of the arm 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 the arm 504 of the system of FIG. 5, within ±5 degrees, within ±3 degrees, within ±2 degrees, and larger or smaller angles. Using this angle, the therapeutic laser beam transmission pattern is adjusted, preferably by a control system, so that the laser beam pattern is transmitted at the correct angular orientation relative to the patient's eye.

[0239] In one embodiment, a Polhemus Patriot™ 6 degree of freedom 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.

[0240] Example 12

[0241] 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.

[0242] Example 13

[0243] 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, and in particular the angle of the patient's eyes, relative to the therapeutic system. The laser system configures the laser transmission pattern to match the measured angle.

[0244] Example 14

[0245] 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.

[0246] Example 15

[0247] 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-phacoemulsification system, providing sufficient device to measure the orientation, e.g., patient angle, relative to the laser arm and the laser beam path and pattern.

[0248] A compass based positioning system using system gyroscopes, accelerometers, and magnetometers is used to measure the position of the patient's head, and in particular the eye on which surgery is to be performed, relative to the therapeutic laser and the therapeutic laser beam path. This compass based positioning system can measure the angle of the arm, for example the angle of arm 504 of the system of FIG. 5, to within ±5 degrees, ±3 degrees, ±2 degrees, and greater or less. 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.

[0249] In one embodiment, a gyroscope and accelerometer are placed on the patient headrest and two magnetometers are located within the femto-phacoemulsification system, providing sufficient apparatus to measure the orientation, e.g., patient angle, relative to the laser arm and the laser beam path and pattern.

[0250] 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.

[0251] 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 eyes, relative to the therapeutic system. The laser system configures the laser transmission pattern to match the measured angle.

[0252] 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 the patient's eye orientation relative to the laser system. The laser system configures the laser transmission pattern to match the measured angle.

[0253] Example 16

[0254] The headrest, or other remote component of the tracking system, such as an electromagnetic tracking system (i.e., not part of the therapeutic system), may have a separate charging station, housing, or rechargeable battery that is rechargeable on the therapeutic system.

[0255] Example 17

[0256] In one embodiment of the femto-phacoemulsification system, the control system recommends, for example, the degree of match, cataract grade, laser power and pattern, as well as the ultrasound speed, power, and phase angle, as well as fluid, flow rates, and other features associated with the handpiece and the phacoemulsification procedure. In this way, the system recommends and predetermines all energy and fluid flow rates delivered to the eye as part of the treatment as a fully integrated device. 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 location movement, measure the shape and location of the cornea, e.g., anterior and posterior surfaces, the ocular lens, e.g., anterior capsule, posterior capsule structures, 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 treatment to optimize the next step of the treatment. In this way, the system provides a fully integrated and pre-defined total energy delivery and energy delivery profile to the eye during the ophthalmic treatment. In an embodiment, the total energy delivery and energy delivery profile is based on the grade of cataract being treated. The total energy delivery and energy delivery profile includes both laser and ultrasound energy.

[0257] Example 18

[0258] In an embodiment, the femto-phacoemulsification system provides a predefined, variable mode for the surgeon or practitioner performing the procedure, in which the system, in conjunction with the laser control system and the phacoemulsification control system, predefines, 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 to provide specifically optimized ranges based on the surgeon's skill level and input.

[0259] Example 19

[0260] In an embodiment, the femto-phacoemulsification system provides an adjustable mode that allows for more variability or predetermined variability, such as providing a range of adjustments of the ultrasound based on the laser beam pattern or laser treatment delivered to the lens by the system, preferably the cataract grade, which can also be measured by or provided to the system, and other factors, and the system provides recommended ranges and adjustments for the treatment, including: (i) recommended torsional lateral motion, transverse axis lateral motion, or no lateral motion; (ii) recommended laser patterns that increase fragmentation and lower phacoemulsification power to address heating within the eye; and (iii) recommended duty cycle.

[0261] Duty cycle and duty cycle recommendations can include the selection of a mode, such as a pulsed mode, where phacoemulsification power pulses and rest periods are repeated, with a default ratio of 50:50. This is called a 50% duty cycle, where each cycle consists of 50% of the time power on followed by 50% of the time power off. The default ratio can be changed by changing the ratio of the time intervals 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 face of the procedure. For nucleus sculpting, such as with the divide-and-conquer technique, the surgeon needs to deliver enough energy to carve the grooves. This requires a duty cycle of approximately 40% to 60%. Once the surgeon has achieved a break that creates a groove in the nucleus resulting in a quadrant, a smaller 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 and not ultrasound.

[0262] Example 20

[0263] In an embodiment, the phacoemulsification subsystem is used simply to separate the laser cut material, for example, when the laser cuts the material to a size smaller than the opening of the phacoemulsification needle.

[0264] Example 21

[0265] Laser ultrasound systems, particularly femto-phacoemulsification systems, have an integrated microscope.

[0266] Example 22

[0267] Adapters are used in the housing of the phacoemulsification-femto system 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.

[0268] Example 23

[0269] FIG. 6 shows a top view of a laser ultrasound system, particularly a femto-phacoemulsification system for use in performing a laser-ultrasound treatment procedure. The femto-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 to perform the laser procedure and can be removed from the patient for ultrasound treatment, as shown by arrow 620. A headrest 612 and a patient support 613 are positioned relative to the femto-phacoemulsification system. The system and the patient support have a positioning system, for example 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, particularly the headrest.

[0270] Three positions of the surgeon are shown: top 641 and sides 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.

[0271] 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.

[0272] 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 of 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.

[0273] Example 24

[0274] Some of these possible configurations and surgeon positioning are shown in FIG. 7, all of which provide the surgeon with full access, for each of these configurations, to either eye of the patient. 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 angular position between those shown in the figure. Thus, perfect alignment, e.g., "clockwise rotation" of the laser ultrasound system around each of the patient's eyes, is provided. In this manner, the system is said to be ambidextrous in that the system configuration is the same for the surgeon in left-hand and right-hand positions.

[0275] Example 25

[0276] 8 is 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, 5005 spaced 40 degrees apart. This arrangement allows the system to operate in any of the configurations of Examples 23 and 24. For some configurations and for some patients one or two cameras may be obstructed and the system will still operate to provide reliable images for shape and position measurements.

[0277] Example 26

[0278] 9 is 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, 6006 spaced 40 degrees apart. This arrangement allows the system to operate in any of the configurations of Examples 23 and 24. For some configurations and some patients, one or two or three cameras may be blocked and the system will still operate and provide reliable images for shape and position measurements.

[0279] Example 27 In Fig. 10A and 10B, a perspective view of the proximal laser assembly with docking system is shown at different angles. In Fig. 10B, the head cover is removed to reveal a 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 surrounding the treatment laser beam path and the laser beam in operation. The assembly 1000 comprises an automated docking system 1010 with 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 fully or partially operated by the surgeon using a joystick. The control system also controls the operation of the docking system and can comprise load sensors, speed control, and other safety control systems.

[0280] Example 28

[0281] Embodiments of the therapeutic laser beam for use in the present system and treatment have high quality beam characteristics. The laser beam has an M 2 The factor may be:

[0282] Example 29

[0283] 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), can take 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.

[0284] Example 30

[0285] In one embodiment, the bed placement flexibility for the femto-phacoemulsification system has a footprint of 32 x 22 inches, allowing the device to be placed anywhere around a patient up to 6 feet 3 inches tall. This system provides a truly bimanual system that provides full rotation of the laser around each eye and also provides a top and side approach by the surgeon.

[0286] Example 31

[0287] The components associated with the laser systems of various embodiments, such as the example embodiments above, may be used in a stand-alone laser system that does not have an integrated phacoemulsification system.

[0288] Example 32

[0289] In one embodiment of these devices, the floor footprint, i.e., the device envelope formed by the outer housing, is 5 sq. ft. (22 in x 33 in = 726 sq. in. / 144 = 5 sq. ft.). 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 the 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 the 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 fits entirely within the footprint of the device. The housing is not adjustable, so its width and lateral dimensions do not change.

[0290] Example 33

[0291] 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 show various components and configurations of the system of Figure 14. Like numbers in these figures refer to like components.

[0292] 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 includes a mechanism for horizontal translation (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 includes a vertical translation mechanism 1425 and a vertical translation translation slide stage 1411.

[0293] The extendable assembly 1409 includes a housing 1406, an arm 1407, which contains the various optical and control cables for the system, and a laser beam delivery head 1408. The laser beam delivery head 1408 includes a shape and position measurement device 1412 and a PID 1470.

[0294] 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).

[0295] 15 shows an extensible assembly 1409 mounted 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 of the assembly 1409. The stage 1410 is disposed within and partially forms the top surface of a housing 1402. The housing 1402 is mounted to the housing 1401.

[0296] 15A in conjunction with FIG 15, horizontal movement mechanism 1420 is housed within housing 1402. Mechanism 1420 may be attached directly to housing 1402, housing 1401, and combinations and variations thereof. Housing 1402 also contains a reel 1423 that holds (i.e., winds and unwinds) flexible cover 1422. Housing 1402 also contains rollers 1421 on which flexible cover 1422 moves.

[0297] FIG 15A shows the horizontal movement mechanism 1420 with the cover 1402 removed. The mechanism 1420 includes a motor, drive mechanism, sensors, and controls. The mechanism 1420 includes a horizontal slide mechanism 1426, which is a pair of slide rails, one inside the other. Supports 1428 connect the inner rail to a vertical slide mechanism 1427, which form a 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 a position for performing laser surgery.

[0298] 16A is a top view of the system 1400 of FIG. 14 with three monitors, where the system 1400 is positioned in an operating room or patient treatment room. The system 1400 is fully retracted, e.g., parked and positioned. In the parked position, the extensible assembly 1409 does not extend out from the base 1403. Thus, in this position, the extensible assembly 1409 does not extend beyond (i.e., is completely within) the footprint or perimeter of the system, dashed line 1480. The system 1400 is shown in relation to a patient bed 1490 and a person.

[0299] 16B shows the system in an extended position (first position or first extended position) for performing therapeutic laser surgery. Although 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 of examples 23 and 24. The extendable assembly 1409 extends horizontally beyond the housing of the system to position the laser head above the patient.

[0300] 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 keeps the housing of the system 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 housing of the system to position the laser head above the patient. Comparing FIG. 16C to FIG. 16B, the assembly 1409 in the fully extended position of FIG. 16C is longer, i.e., the laser head is farther from the base than in the first extended position of FIG. 16B.

[0301] Figures 17A-17C are a series of photographs showing specific extended and retracted positions for the extendable assembly of the system of Figure 14. Figure 17A shows an intermediate extended position for testing and calibration of the laser system. Figure 17B shows a first operative extended position for therapeutic laser surgery. Figure 17C shows a second operative extended position (fully extended) for therapeutic laser surgery.

[0302] Thus, the system can have four predefined 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 predefined 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 other lengths can be predetermined or simply determined by the operator, and combinations and variations thereof.

[0303] 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.

[0304] These components can be fully or partially distributed between the two housings 1401, 1402, among others for the following reasons: to optimize space, to avoid interference between the components, to deal with heat and vibration, to provide more efficient control and operation of the system 1400. The two housings 1401, 1402 can be standalone housings on the same base or frame, can have communication, control, power, optical and other connections between them, can be a single and identical housing, can be subdivided or split into third, fourth etc. housings or sub-housings, as well as combinations and variations thereof.

[0305] 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, and the scanning device, optics, and both can also be used to monitor and diagnose the laser beam and light path. (Housing 1406 also houses the vertical movement mechanism.) It is understood that in embodiments, these components of housing 1406 can be located in whole or in part within one of the other housings, and similarly, components from other housings can be located within housing 1406. Housing 1406 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, 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 are in direct control communication with each other, or indirect control communication with each other, for example, by being in control communication with a central, e.g., controller of system 1400, monitor 1413 that may have control functionality, and combinations and variations thereof. The devices can also be in direct and indirect control communication with each other.

[0306] The light conduit 1405 can be a light pipe (e.g., a hollow pipe or channel with 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 the surrounding atmosphere, can include 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.

[0307] The housing 1406 is attached to an arm 1407. The arm 1407 and the housing 1406 are moved vertically by 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. The arm 1407 carries a patient interface device (PID) 1470 at its proximal end, i.e., at the end furthest along the laser beam path and thus furthest from the laser beam source, below the device 1412. The housing 1406 carries a monitor 1413. The monitor is movable, for example, on the articulated arm. The monitor provides information such as treatment, system status, laser status, ultrasound status, cataract density, ultrasound settings, laser pattern settings, and can receive input and commands from the surgeon. The monitor is in control communication with the control system of the system 1400 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 through the control system of the system 1400, through the monitor 1409, and combinations and variations thereof. The monitor and its articulating arm may be located on other structures of the system 1400 or may be freestanding. One, two, or additional monitors may be used. The monitor may have 3D viewing or display capabilities.

[0308] The arm 1407 forms or contains a laser beam transmission structure, such as a hollow tube, that provides free space for the transmission of the laser beam. In an embodiment, the arm 1407 can contain a beam path or optical fiber in free space to transmit the laser beam, for example, to a scanner located at the proximal end of the tube, i.e., the end near the housing 106, rather than at the distal end. The arm 1407 can also be or be provided with any laser beam transmission structure of the type described for use as the optical conduit 1405. The tube can also include optics. In the embodiment of FIG. 14, the arm 1407 contains an uncollimated laser beam, and thus the arm 1407 is shown as including an uncollimated laser beam and laser beam path, in other words the arm 1407 includes, surrounds, or contains a "non-collimated space" along the laser beam path. The 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 in the arm 1407 includes mirrors or optics to direct the laser beam through the PID and toward and into the patient's eye.

[0309] Example 33A

[0310] 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 of the system and other embodiments of the system herein.

[0311] Example 34

[0312] In an embodiment, the laser system has an external, internal, or both cooling.

[0313] Example 35

[0314] 12A-12J show a PID (Patient Interface Device) for attachment to and use with any of the present laser ultrasound systems, as well as for use with a stand-alone laser system. Like numbers correspond to like features in FIGS. 12A-12J. This example embodiment of a PID 1200 has the following components, as shown in FIGS. 12A-12J: 1201 PID Arm 1202 Top 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 Arrows indicating the engagement movement of blocks 1250 eyes 1260 Laser-Ultrasound Device

[0315] The patient interface device is attached to the eye as a single assembly. The entire device, once attached to the laser head, is positioned to engage the surface of the eye. The PID arm is attached to the laser system via a clamping mechanism.

[0316] 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.

[0317] Three spherical features on the PID arm engage with kinematic slot features on the clamping mechanism. During positioning engagement, a spring force is exerted on the PID arm by the balls. Once the PID is in place, a lever moves the CAM mechanism to load the balls against the PID and lock the kinematic mount in place.

[0318] The suction cup interface, or "ocular interface," is attached to the eye, over the front 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 that is used by the software algorithm to calculate the exact location of the focal point of light emanating from the illumination or laser beam.

[0319] There are three snaps to hold the window. Three overmolded bumpers press the window tightly into 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 while filling the fluid chamber, the fluid meniscus inverts before contacting the window. Proper contact of the fluid with the window, i.e., from the center of the window outward toward the periphery, prevents bubbles from being trapped under the window that could cause laser beam disturbances.

[0320] 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 flow away by capillary action.

[0321] The PID arm has a flexible attachment ring at its base that conforms the interface to the front of the patient's eye. The attachment ring includes flexible annular outer and inner skirts formed 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.

[0322] In another form of design, the PID arm has a vacuum port on its side that is used to generate suction in an annular suction channel and also allows the ocular interface to be attached snugly to the patient's eye. A second port next to the first is connected to medical grade tubing to fill the ocular interface chamber with physiological saline solution (BSS).

[0323] Example 35A

[0324] 13 shows a perspective view of a PID 1300. The PID 1300 has a PID arm 1301, an upper (distal) window 1302 which can be glass and is preferably highly transparent to the therapeutic laser, and a lower (proximal) glass window 1303 which can be glass and is preferably highly transparent to the therapeutic laser.

[0325] Example 36

[0326] 18 and 19 show the optical assemblies and paths for fixed light and straight-through (DTP), e.g., paths along a portion of the therapeutic laser beam delivery 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.

[0327] Example 37

[0328] In one embodiment, a laser ultrasound system, such as a femto-phacoemulsification system, has a laser adapted to perform a posterior capsulotomy and laser surgery on the posterior capsule. The system further has predefined phacoemulsification parameters accessible and enabled, 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.

[0329] Example 38

[0330] 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. Magnetic fields are created by the markers to output both position and orientation data without the need for post-mortem analytical 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.

[0331] Table 2 TIFF2025041786000003.tif151170

[0332] Example 39

[0333] Laser, laser-ultrasound, and femto-phacoemulsification systems can have a surgical microscope integrated into the system. The microscope can be attached to the housing of the system and is preferably integrated within the system. In this way, the microscope is informationally, data-wise, and control-wise connected to a system control system (e.g., femto-phacoemulsification control system). Thus, for example, the surgical microscope and system are adapted such that the microscope receives commands and views (digital overlay) from the therapeutic laser system, particularly the optics and data system, during laser, e.g., femto, mode, laser procedure, e.g., femto procedure, phacoemulsification mode, e.g., phacoemulsification procedure, idle, warm-up, or observation mode (phacoemulsification, laser, or both are active but no procedure is being performed), and combinations thereof.

[0334] 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 the surgeon, or other practitioner, or observer, a three-dimensional image of the ocular structures, such as the cornea, the crystalline lens, the PID interface in contact with the eye, the IOL, and combinations and variations thereof, and other structures and devices. The 3D display system can be, for example, a wearable 3D attachable aid (such as the BEYEONICS Surgical device), a 3D monitor, a monitor and glasses-based system, a head-up display system, and combinations and variations thereof. The 3D display system can record the procedure in 3D and can provide a 3D image of the procedure in real time to a remote location, such as a location different from where the laser system is located.

[0335] Example 40

[0336] Laser, laser-ultrasound, e.g., femto-ultrasound phacoemulsification systems can have a "smart" foot switch associated with the system. The foot switch is integrated into the system control system. The foot switch can turn the laser and ultrasound phacoemulsification on / off based on the mode of the system. The foot switch can be integrated into menu systems, GUIs, voice command in a manner that allows the foot switch to be used to select a procedure in a menu-type item on the GUI, such as the menu items shown in Figures 23A through 23D. The foot switch can also be integrated into speaking-listening control and menu selection systems, such as "ALEXA" or other types of voice command systems.

[0337] The foot switch can be wired, i.e., have a control cable connecting it to the laser-phacoemulsification system. Preferably, the foot switch is wirelessly connected in control communication with the control system laser, phacoemulsification, integrated unit, one or more of them, and all of them.

[0338] 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 and multiple devices can be turned off without the need for a supervisory computer. In this way, all devices can communicate with each other (e.g., control communication connection, information communication connection, and both). In a preferred embodiment, both the phacoemulsification and femto computers 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 femto computer can use some of the foot switch controls to perform laser firing or mode change operations. Other foot switch controls can be used simultaneously by the phacoemulsification computer to perform other operations such as phacoemulsification energy, irrigation, or vacuum aspiration.

[0339] In one embodiment, the bus is a broadcast type bus, such as a CanBus.

[0340] 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.

[0341] Example 41

[0342] 20, 20A, 20B show an embodiment of a PID 2000. The PID has four components, which greatly reduces the cost and complexity of assembly compared to more complex PIDs, and facilitates cleaning. The PID can be disposable or reusable. The PID 2000 has an integrated, e.g., single arm 2001, which has 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, 2008 that can be used for fluid transfer and vacuum aspiration. Preferably, 2008 is used for vacuum aspiration and 2007 is used for delivery of the BSS. The PID 2000 has a window 2002, which is placed in a retaining ring 2003 and held in place by clips 2004a, 2004b, 2004c. A single annular vacuum suction ring 2005 engages the proximal end of the retention ring 2003. The annular vacuum suction ring 2005 is in fluid communication with ports 2007 and 2008. The annular vacuum suction ring 2005 is preferably a single piece. The annular vacuum suction ring 2005 engages and retains a flexible eye engaging ring 2006, which is in fluid communication with both ports 2007, 2008.

[0343] The PID 200 has a window support and fluid management system, which includes pins 2020a, 2020b, 2020c (preferably integral, i.e., part of a single ring 2003). The pins support the window 2002 on the proximal (lower) side of the window, while clips 2002a, 2002b, 2002c engage the sides and distal (upper) of the window 2002. The pins hold the window over two fluid channels, an outer fluid channel 2021 and an inner channel 2022. The 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 lower than the pins, e.g., about 1 mm, about 0.7 mm, 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 over into the outer fluid channel 2021.

[0344] Example 42

[0345] 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. The 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 disposed along the laser beam path. These components may include z-focusing optics, and an xy scanner.

[0346] The femto-phacoemulsification system 2100 includes a first housing 2101 and an optical assembly and scanner housing 2102 that is movably and mechanically and optically associated with the first housing 2101. The housing 2101 is part of an extendable / retractable assembly 2103 that provides horizontal movement. The assembly 2103 also includes a base 2105 that is mechanically associated with the housing 2101 but is not movable relative to the housing 2101.

[0347] The optics 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 by itself or in cooperation with a control system, or by a GUI). Vertical movement can be accomplished by any of a variety of devices disclosed herein.

[0348] The head 2016 has a position measuring device 2108 and a patient interface device 2109 .

[0349] A laser beam moveable connector device, such as an articulated hollow pipe 2110 , conveys the laser beam for the laser in housing 2101 to the optics and beam handling device in housing 2102 .

[0350] 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.

[0351] 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 and can be adapted for use in a particular manner on both right and left hand sides, and the tray and tray assembly are ambidextrous and can be used on both the left and right side of the system.

[0352] System 2100 includes a phacoemulsification cassette 2115 and ports 2116 for connecting phacoemulsification related components (eg, air, VIT, DIA, control cables, etc.).

[0353] System 2100 has two monitors 2117, 2118, which are preferably graphic user interfaces (GUIs) for displaying information and menus and receiving input, e.g., commands, from a system operator. The GUIs can display control menus and information menus such as those shown in Figures 23A through 23D.

[0354] The system 2100 includes an emergency stop unit 2119 .

[0355] In this example embodiment, the position measurement device 2108 has five Scheimpflug camera assemblies, e.g., 2123, 2124, 2125, 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, e.g., when the device is in a retracted position or when the phacoemulsification system is operating.

[0356] The PID 2109 can be, for example, the PID of Example 41. The PID 2109 is attached to the laser head 2106 and laser system 2100 via a PID securing and engaging device 2127. The 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).

[0357] The arm 2105 houses the therapeutic laser beam path and other optical paths. In an embodiment, the arm 2105 also houses and carries control and power cables for the imaging and positioning equipment and the docking assembly (not shown in this view).

[0358] 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.

[0359] The 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; control communicatively connected to an operator interface; control communicatively connected to the emergency stop 2119; and control communicatively connected to a network that may be, for example, a patient's medical record system, accounting system, and combinations and variations thereof.

[0360] In one embodiment, the docking system (preferably with a joystick) and the imaging and position measurement equipment are controllable 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 an embodiment, the laser control system and the phacoemulsification control system can be partially or fully integrated into a single common control system. Thus, in an embodiment, there is only one control system or a single control system 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.

[0361] Example 43

[0362] 22A shows system 2100 of Example 42 with the addition of a foot switch 2130. The foot switch is in control communication with the system's computer, e.g., controller, and the system's devices by wireless communication line 2131.

[0363] This example embodiment uses the bus communication system of example 40, also shown in FIG. 22A.

[0364] Example 44

[0365] 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 housing and the second housing. 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, and preferably all of these two systems, are disposed within the first housing.

[0366] The integrated laser ultrasound system is in control communication 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.

[0367] 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 in control communication with one or more of the integrated control system and the laser control system. The safety interlock can also be in control communication with the phacoemulsification control system.

[0368] The integrated laser ultrasound system also includes a beam forming and directing assembly including a Z focus, a scanner, and a lens. The beam forming and directing assembly is housed within a second housing. Preferably, the entire assembly is housed within the second housing.

[0369] The means for optically communicating the first housing with the second housing is in optical communication with the therapeutic laser and the beam shaping and directing assembly, which may be an articulated hollow light pipe, a fiber, or any of the other means for transmitting laser energy disclosed herein.

[0370] The integrated laser ultrasound system also includes an arm mounted to 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 being adjacent to the second housing and preferably mechanically attached to the second housing, and in embodiments integral with the second housing. The system includes a laser delivery head 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 on the laser beam delivery path. The optical element can be, for example, a mirror that receives the laser beam and directs it along the laser beam delivery 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 lenses can be before or after the mirror in the optical path.

[0371] Preferably, the arm includes, e.g., houses, a portion of the laser beam delivery path, in particular 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.

[0372] 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 at least communication with the integrated control system, the laser control system, or both.

[0373] 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°.

[0374] In one embodiment of this system, it has one or more of the following features: it is adapted to provide two therapeutic laser beams having different pulse widths; it has an iris registration system; the therapeutic laser is a femtosecond laser, a picosecond laser, or both.

[0375] Example 44A

[0376] 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. These systems can also be adapted to provide two therapeutic laser beams with different pulse widths.

[0377] Example 44B

[0378] The systems of Example 44 and Example 44A may also have an integrated control system, a therapeutic laser control system, or both, that has a plurality of predefined laser transmission patterns. These predefined laser transmission patterns may be contained within the control system or may be located on a memory device associated with and accessible by the control system. The integrated control system, phacoemulsification control system, or both of the systems may also have a plurality of phacoemulsification treatments. These phacoemulsification treatments may include, for example, parameters (e.g., power) and procedure types (e.g., chop) as described in the "Ultrasound / Phacoemulsification-Overview" section of this specification.

[0379] The system may further be adapted to 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, forming the basis for determining the determined information. A separate imaging system may 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 may be one of three grades or one of four grades.

[0380] 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.

[0381] The combined laser-phacoemulsification treatment is preferably a two component treatment: a laser component that is at least one of a plurality of predefined laser transmission patterns, and a phacoemulsification component that has at least one of a predefined phacoemulsification treatments.

[0382] Example 45

[0383] A method of using an integrated laser-phacoemulsification system to perform a 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 ultrasonic energy, and an integrated control system in control communication with the therapeutic laser control system, the phacoemulsification system, and the GUI.

[0384] The system can be used to determine, and does determine, information about the cataract of a cataractous lens, preferably the determined information is the grade of the cataract.

[0385] 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 predefined laser transmission patterns, and a phacoemulsification configuration that has at least one of a predefined phacoemulsification treatment.

[0386] 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.

[0387] 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; redetermining one or both of the two configurations of the combined therapy; and combinations and variations thereof. The system executes these commands.

[0388] The system is instructed to perform, and performs, the determined and recommended combined laser-phacoemulsification treatment on 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 perform the steps of the treatment.

[0389] Example 46

[0390] Generally, when performing a procedure using the laser-ultrasound, e.g., laser-phacoemulsification, femto-phacoemulsification, embodiment of the integrated system, the laser procedure is performed first, the system is reconfigured, and 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 fracturing, 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 is transitioned 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 has been 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.

[0391] It should be understood that, although not presently preferred, the system has the capability of performing a laser procedure on the same or a different eye of the same patient after an ultrasound procedure, such as phacoemulsification, has been performed.

[0392] 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 the therapeutic laser system and is free to move relative to the therapeutic laser system; and wherein the first component, the second component, or both are adapted to measure a relative position of the second component with respect to the first component.

[0393] 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.

[0394] Still further, a laser ultrasound system is provided that includes a therapeutic laser system; a phacoemulsification system for providing therapeutic ultrasound energy; and a microscope integrated within the system.

[0395] Still further, a laser ultrasound system is provided that includes 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 ocular structures.

[0396] 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; 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 positioning 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 positioning system has a device selected from the group consisting of a compass, a laser location device, an ultrasound location 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 a 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 measurement system is within original space; the patient measurement system has at least an accuracy of at least 95%; the patient measurement system has an accuracy of at least 98%; the patient measurement system has an accuracy of at least 99%; the system is adapted 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; the angle is measured to within ±3 degrees; the angle is measured to within ±2 degrees; 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 an arm, the arm 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.

[0397] 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 delivery head; the arm housing a portion of the laser beam delivery path; the assembly is positioned at an angle relative to a patient position, the angle being defined by a longitudinal axis of the arm and a patient axis; the angle being between 30 degrees and 320 degrees.

[0398] Further still, 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 in the arm is not collimated; the laser beam in the laser beam path in the arm is in an optical fiber; the optical system has optics defining four pupils, the laser beam path extending through the four pupils; the pupils are conjugate telecentric pupils; the 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 such that the second component is independent of the therapeutic laser system and is free to move relative to the therapeutic laser system; the first component, the second component, or both are adapted to measure a 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.

[0399] Still further, a laser ultrasound system is provided, 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.

[0400] 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 the phacoemulsification system is in use; the therapeutic laser is a femtosecond laser.

[0401] Also provided is a laser ultrasound system having a 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 2000 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.

[0402] 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: 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; the repetition rate is 320 kHz or less.

[0403] Further still, these laser systems, laser ultrasound systems, laser-ultrasound phacoemulsification systems, femto-ultrasound phacoemulsification systems, methods, and devices are provided having one or more of the following features: a Scheimpflug camera means; the Scheimpflug camera means has n cameras, at least one of the cameras having an unobstructed view of the patient's eye at every patient angle between 30° and 320°; n is 5; n is 6; the cameras have an angular separation of at least 40°.

[0404] Additionally, a laser ultrasound system is provided 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.

[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: transition from laser to phacoemulsification is less than 3 minutes; transition from laser to phacoemulsification is less than 2 minutes; transition from laser to phacoemulsification is less than 1 minute; transition from laser to phacoemulsification is less than 45 seconds; transition from laser to phacoemulsification is about 30 seconds; transition from laser to phacoemulsification is about 1 minute to 30 seconds.

[0406] 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: transition from femto laser to phacoemulsification in less than 3 minutes; transition from femto laser to phacoemulsification in less than 2 minutes; transition from femto laser to phacoemulsification in less than 1 minute; transition from femto laser to phacoemulsification in less than 45 seconds; transition from femto laser to phacoemulsification in about 30 seconds; transition from femto laser to phacoemulsification in about 1 minute to 30 seconds.

[0407] 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.

[0408] 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 square inches to about 800 square inches; a volume of about 40 ft 3 Less than 35 ft 3 Less than 30 ft in volume 3 Less than 25 ft 3 Less than 20 ft 3 is less than.

[0409] 1. A therapeutic laser 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.

[0410] 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 magnification.

[0411] Additionally, a laser system is provided 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.

[0412] Additionally, 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 aberration.

[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: the laser is a femtosecond laser, and further having an integrated phacoemulsification system.

[0414] 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: an iris registration device is included.

[0415] 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 grade of the cataract; the information from the laser system is used to provide the recommended ultrasound energy.

[0416] 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 the grade of cataract.

[0417] 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.

[0418] 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; the footprint size is selected from the group consisting of less than 35 by less than 35 inches, 35 by 25 inches, about 35 by 25 inches, about 33 by 22 inches, and about 400 square inches to about 800 square inches.

[0419] Further still, 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: a cap on the laser head disposed in the laser beam path to protect the optical components when the laser is not in an operational configuration.

[0420] Methods are provided 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.

[0421] 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 via a data communication connection, a control communication connection, or both; the surgical microscope is integrated into the system housing; 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.

[0422] 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 three-dimensional (3D) display system is mounted to 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 the laser, e.g., femto, or ultrasound, e.g., phacoemulsification mode and procedure. Heading and embodiment

[0423] It should be understood that the use of headings in this specification is for purposes of clarity and reference, and is not limiting in any manner. Thus, the process configurations 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.

[0424] It is noted that it is not necessary to provide or address the theory underlying the subject matter of the embodiments of the present invention or novel and innovative processes, laser surgeries, laser patterns, improved and improved structures, or other beneficial features and characteristics related thereto. 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 that explain the function-characteristics of the 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.

[0425] The various embodiments of the devices, systems, laser shot patterns, activities, and operations described herein can be used with, in, or by various measurement, diagnostic, surgical, and treatment laser systems, as well as the embodiments thereof disclosed in the drawings and herein. 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 upon based on the teachings of this specification; and with other types of measurement, diagnostic, surgical, and treatment systems. Also, 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 interchangeably 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 embodiments, configurations, or arrangements depicted in a particular embodiment, example, or embodiment of a particular drawing.

[0426] 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. an assembly defining a footprint and volume; b. the assembly comprises: i. a therapeutic laser system adapted to provide a therapeutic laser beam; ii. a phacoemulsification system adapted to provide therapeutic ultrasound energy; iii. the therapeutic laser system and the phacoemulsification system have a common power source, a common control system, and a common GUI for receiving commands and displaying information; iv. the therapeutic laser system and the phacoemulsification system are electrically, optically, and mechanically isolated such that operation of either system does not electrically, optically, and mechanically interfere with operation of the other system; c. The footprint is 9,677 cm ２ (1,500 square inches).

2. 10. The laser ultrasound system of claim 1, wherein the footprint is approximately 33 inches by 22 inches.

3. 10. The laser ultrasound system of claim 1, wherein the footprint is about 35 inches or less by about 35 inches or less.

4. 10. The laser ultrasound system of claim 1, wherein the footprint is about 35 inches or less by about 22 inches or less.

5. The installation area is approximately 2,581 cm ２ (1,400 square inches) to approximately 5,161 cm ２ 2. The laser ultrasound system of claim 1, wherein the surface area is 800 square inches.

6. The volume is about 1.13 m ３ 6. The laser ultrasound system of claim 1, wherein the volume of the laser ultrasound system is less than 40 cubic feet.

7. The volume is about 0.85 m ３ 6. The laser ultrasound system of claim 1, wherein the volume of the laser ultrasound system is less than 30 cubic feet.

8. The volume is about 0.057 m ３ 6. The laser ultrasound system of claim 1, wherein the volume of the laser ultrasound system is less than 20 cubic feet.

9. 9. The laser ultrasound system of claim 1, comprising a PID with a meniscus inverter.

10. 10. The laser ultrasound system of claim 1, wherein the therapeutic laser system and the phacoemulsification system are contained within a housing.

11. 11. The laser ultrasound system of claim 1, further comprising a laser safety interlock that prevents the therapeutic laser beam from being emitted when the phacoemulsification system is in use.

12. 12. The laser ultrasound system of claim 1, further comprising a surgical microscope integrated into the laser ultrasound system and adapted to receive one or more of images, data or information from the therapeutic laser system, the surgical microscope adapted to display the received images, data or information during a laser procedure, a phacoemulsification procedure, or both.

13. 13. The laser ultrasound system of claim 1, further comprising a 3D display system integrated with the laser ultrasound system and adapted to receive one or more of images, data, or information from the therapeutic laser system, the 3D display system adapted to display the received images, data, or information during a laser procedure, an ultrasound phacoemulsification procedure, or both.

14. 14. The laser ultrasound system of any one of claims 1 to 13, adapted to provide two therapeutic laser beams having different pulse widths, both therapeutic laser beams adapted to ablate tissue, cut tissue, or both.

15. 15. The laser ultrasound system of claim 1, wherein the therapeutic laser system comprises an optical assembly for defining a laser beam path, the laser beam path being longer than 300 mm, such that the therapeutic laser beam pattern is transmitted along the laser beam path without magnification.

16. 15. The laser ultrasound system of claim 1, wherein the therapeutic laser system comprises an optical assembly for defining a laser beam path, the laser beam path being longer than 300 mm, and wherein a therapeutic laser beam pattern is transmitted along the laser beam path without wavefront error.

17. 17. The laser ultrasound system of claim 1, further comprising an iris registration system.

18. 18. The laser ultrasound system of any one of claims 1 to 17, comprising means for measuring the shape, position, or both of an eye structure.

19. 20. The laser ultrasound system of claim 18, wherein the means for measuring the shape, position, or both of an ocular structure comprises a Scheimpflug imaging system.

20. 20. The laser ultrasound system of claim 18, wherein the means for measuring shape, position, or both of an ocular structure comprises an optical coherence tomography system.

21. 20. The laser ultrasound system of claim 18, wherein the means for measuring the shape, position, or both of an ocular structure is a Scheimpflug camera means.

22. 22. The laser ultrasound system of claim 21, wherein the Scheimpflug camera means comprises n cameras, at least n-1 of the cameras having an unobstructed view of the patient's eye at every patient angle between 30° and 320°.

23. An integrated reconfigurable laser ultrasound system comprising a therapeutic laser system, a phacoemulsification system, and a rigid laser beam delivery arm mechanically associated with a housing, the system being configured to reconfigure the laser beam in one of two predefined configurations, namely: a. a first configuration for providing a therapeutic laser beam to a patient; b. a second configuration for performing a phacoemulsification procedure on the patient; c. the first configuration is different from the second configuration; An integrated reconfigurable laser ultrasound system adapted to transition from the first configuration to the second configuration in less than five minutes and from the second configuration to the first configuration in less than five minutes.

24. a. An assembly comprising: i. a therapeutic laser system for providing and directing said therapeutic laser beam along a laser beam path; ii. a phacoemulsification system for providing therapeutic ultrasound energy for performing the phacoemulsification procedure; iii. an assembly, wherein the therapeutic laser system and the phacoemulsification system are operatively associated with a common control system; b. an arm attached to the assembly, i. a distal end and a proximal end, said distal end being attached to said assembly; ii. the proximal end has a laser delivery head; iii. An arm including a portion of the laser beam path; Further equipped with 24. The laser ultrasound system of claim 23, wherein the arm is movable to a first position corresponding to the first configuration and is movable to a second position corresponding to the second configuration.

25. 25. The laser ultrasound system of claim 24, wherein in the first position the arm extends proximally away from the assembly.

26. 25. The laser ultrasound system of claim 24, wherein the assembly is contained within a housing, and in the first position the arms extend proximally away from the housing.

27. 25. The laser ultrasound system of claim 24, wherein the arm is pivotally attached to the assembly at a distal end of the arm, and the proximal end of the arm is pivoted upward in the second position and horizontal in the first position.

28. 28. The laser ultrasound system of any one of claims 24-27, wherein the proximal end of the arm includes a means for measuring the shape, position, or both of an ocular structure.

29. 29. The laser ultrasound system of any one of claims 24 to 28, wherein the distal end of the arm is in optical communication with a scanner positioned on the laser beam path.

30. 30. The laser ultrasound system of claim 28, wherein the means for measuring the shape, position, or both of an ocular structure is selected from the group consisting of an optical coherence tomography system, a Scheimpflug camera means, and a Scheimpflug imaging system.

31. 25. The laser ultrasound system of claim 24, comprising means for measuring a shape, a position, or both of an ocular structure, said means for measuring being selected from the group consisting of an optical coherence tomography system, a Scheimpflug camera means, and a Scheimpflug imaging system.

32. 32. The laser ultrasound system of any one of claims 24-31, wherein the therapeutic laser system, the ultrasound phacoemulsification system, and at least a portion of the common control system are contained within a housing.

33. 33. The laser ultrasound system of claim 32, wherein in the first position the arm extends proximally away from the assembly.

34. 25. The laser ultrasound system of claim 24, wherein the assembly is contained within a housing, and in the first position the arm extends horizontally proximally away from the housing.

35. 33. The laser ultrasound system of claim 32, wherein the arm is pivotally attached to the assembly at a distal end of the arm, and the proximal end of the arm is pivoted upwardly in the second position.

36. 33. The laser ultrasound system of claim 32, wherein the proximal end of the arm includes a means for measuring a shape, a position, or both of an ocular structure.

37. 33. The laser ultrasound system of claim 32, wherein the distal end of the arm is in optical communication with a scanner positioned on the laser beam path.

38. 37. The laser ultrasound system of claim 36, wherein the means for measuring the shape, position, or both of an ocular structure is selected from the group consisting of an optical coherence tomography system, a Scheimpflug camera means, and a Scheimpflug imaging system.

39. 39. The laser ultrasound system of any one of claims 24 to 38, wherein the proximal end of the arm comprises 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 arm is in the second position, thereby protecting the therapeutic laser system from damage.

40. 40. The laser ultrasound system of any one of claims 23-39, wherein the transition is about 3 minutes or less.

41. 40. The laser ultrasound system of any one of claims 23-39, wherein the transition is about 2 minutes or less.

42. 40. The laser ultrasound system of any one of claims 23-39, wherein the transition is about 1 minute or less.

43. 40. The laser ultrasound system of any one of claims 23 to 39, wherein the transition is less than 45 seconds.

44. 40. The laser ultrasound system of any one of claims 23 to 39, wherein the transition is about 30 seconds.

45. 40. The laser ultrasound system of any one of claims 23 to 39, wherein the transition is about 1 minute to 30 seconds.

46. The laser ultrasound system defines a footprint, the footprint being 9,677 cm ２ 46. ​​The laser ultrasound system of any one of claims 23 to 45, wherein the laser ultrasound system has an area of ​​less than 1,500 square inches.

47. The laser ultrasound system defines a footprint, the footprint being 6,452 cm ２ 46. ​​The laser ultrasound system of any one of claims 23 to 45, wherein the surface area is less than 1,000 square inches.

48. 46. ​​The laser ultrasound system of any one of claims 23-45, wherein the laser ultrasound system defines a footprint, the footprint being approximately 33 inches by approximately 22 inches.

49. 46. ​​The laser ultrasound system of any one of claims 23-45, wherein the laser ultrasound system defines a footprint, the footprint being about 35 inches or less by about 35 inches or less.

50. The laser ultrasound system defines a volume, the volume being approximately 0.99 m ３ 50. The laser ultrasound system of any one of claims 23 to 49, wherein the volume is less than 35 cubic feet.

51. The laser ultrasound system defines a volume, the volume being approximately 0.85 m ３ 50. The laser ultrasound system of any one of claims 23 to 49, wherein the volume is less than 30 cubic feet.

52. 52. The laser ultrasound system of any one of claims 1 to 51, wherein the therapeutic laser system comprises a femtosecond laser or a picosecond laser.

53. 1. An integrated reconfigurable laser ultrasound system, comprising: a. a therapeutic laser system, a phacoemulsification system, a therapeutic laser beam path having a path length, a rigid laser beam delivery arm, and a housing, the arm having a distal end and a proximal end, the arm including a portion of the therapeutic laser beam path, the distal end optically associated with the therapeutic laser system, and the proximal end optically associated with a laser delivery head; b. the therapeutic laser system comprises a picosecond laser or a femtosecond laser; c. The laser ultrasound system is available in two predefined configurations: i. a first configuration for providing a therapeutic laser beam to a patient; ii. a second configuration for performing a phacoemulsification procedure on the patient; d. in said first configuration said laser delivery head is a first distance from said housing and in said second configuration said laser delivery head is a second distance from said housing, said first distance being different from said second distance; e. the path length is the same for the first configuration and the second configuration; f. an integrated reconfigurable laser ultrasound system thereby adapted to transition between said first configuration and said second configuration.

54. 54. The laser ultrasound system of claim 53, comprising a scanner on the therapeutic laser beam path, the scanner being mechanically and optically associated with the distal end of the arm, thereby defining a scanner-head distance between the scanner and the laser transmission head, the scanner-head distance being the same for the first configuration and the second configuration.

55. a third predetermined configuration for providing a therapeutic laser beam to said patient; in the third configuration, the laser delivery head is at a third distance from the housing, the third distance being different from the first distance and the second distance; the path length is the same for the third configuration; 54. The laser ultrasound system of claim 53, whereby to transition between said first configuration, said second configuration, and said third configuration.

56. a third predetermined configuration for providing a therapeutic laser beam to said patient; in the third configuration, the laser delivery head is at a third distance from the housing, the third distance being different from the first distance and the second distance; the scanner-head distance is the same for the first configuration, the second configuration, and the third configuration; the path length is the same for the third configuration; 55. The laser ultrasound system of claim 54, whereby to transition between said first configuration, said second configuration, and said third configuration.

57. 57. The laser ultrasound system of any one of claims 1 to 56, which is ambidextrous.

58. 57. The laser ultrasound system of any one of claims 1 to 56, comprising a phacoemulsification tray and a phacoemulsification cassette, and being bilateral.

59. 59. The laser ultrasound system of any one of claims 1-58, comprising a wireless foot switch adapted to control the therapeutic laser system, the phacoemulsification system, or both.

60. 60. A method of repairing a laser ultrasonic system according to any one of claims 1 to 59.

61. 60. A method for updating software of a laser ultrasound system according to any one of claims 1 to 59.

62. 60. A method of operating a laser ultrasound system according to any one of claims 1 to 59.

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