Patient interface devices and methods and systems for combined acoustic and laser applications

Abstract

A patient interface device (PID) for contacting an eye surface and having a meniscus conversion component. A pin, clip and ridge configuration for holding a window and holding an open BSS reservoir in the PID. A PID for an integrated system and method for performing laser and phacoemulsification procedures. A PID for a reconfigurable system for performing laser surgery in a laser configuration and then reconfigured to a phacoemulsification configuration to perform phacoemulsification and then reconfigured back to the laser configuration.

Description

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

[0002] This invention relates to systems and methods for treating structures of the eye (including the eyes of animals, mammals, and humans). In particular, embodiments of the invention relate to systems and methods for using a combination of acoustic energy (including ultrasound) and light energy (including lasers) to address eye conditions. Background Technology

[0003] The anatomical structure of the natural human eye is Figure 11 The image broadly illustrates a cross-sectional view of the eye. The sclera 131 is the white tissue surrounding the lens 103 (except at the cornea 101). The cornea 101 is a transparent tissue encompassing the outer surface of the eye through which light first enters. The iris 102 is a colored, constrictible membrane that controls the amount of light entering the eye by changing the size of its central circular opening (pupil). The lens or natural lens 103 (a more detailed image of which is shown in...) Figure 11A As shown in the figure, similar structures (using similar reference numerals) are located exactly behind the iris 102. The terms eye lens, crystalline lens, natural human lens, and lens (when referring to the preceding terms) are used interchangeably herein and refer to the same anatomical structure of the human eye.

[0004] Normally, the lens of the eye changes shape through the action of the ciliary muscle 108 to allow focusing of visual images. Neural feedback mechanisms from the brain allow the ciliary muscle 108 to change the shape of the lens via attachments to the suspensory ligaments 111. Vision occurs when light enters the eye through the cornea 101 and pupil, then travels along the visual axis 104 through the vitreous humor 110 and across the lens 103 to reach the retina 105 at the back of the eye, where it forms an image at 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 with a fluid called aqueous humor 117 in the anterior chamber 109 and vitreous humor 110 (a gel-like transparent substance) in the posterior chamber of the lens.

[0005] Figure 11AThe components of the lens 103 and lens-related components of a typical 50-year-old individual are shown in general. The lens 103 is a multi-structure system. The structure of the lens 103 includes the cortex 113, the nucleus 129, and the lens capsule 114. The capsule 114 is the outer membrane surrounding the other internal structures of the lens. The lens epithelium 123 forms at the lens equator 121, thereby producing bands of cells or proto-optic fibers that grow around the anterior and posterior aspects of the eye's lens. The nucleus 129 is formed by the continuous addition of the cortex 113 to the nuclear region. The continuous layers in the lens (including the nucleus 129) can be characterized as several layers, one or more nuclear regions. These layers include the embryonic nucleus 122, the fetal nucleus 130 (both develop in utero), the infant nucleus 124 (develops from birth to four years of age, averaging about three years), the adolescent nucleus 126 (from about four years of age until puberty, averaging about 12 years of age), and the adult nucleus 128 (develops from about 18 years of age and beyond).

[0006] The equatorial diameter (width) of embryonic nucleus 122 is approximately 0.5 mm, and the diameter (thickness) of its anteroposterior axis 104 (AP axis) is approximately 0.425 mm. The equatorial diameter of fetal nucleus 130 is approximately 6.0 mm, and the diameter of its AP axis 104 is approximately 3.0 mm. The equatorial diameter of infant nucleus 124 is approximately 7.2 mm, and the diameter of its AP axis 104 is approximately 3.6 mm. The equatorial diameter of adolescent nucleus 126 is approximately 9.0 mm, and the diameter of its AP axis 104 is approximately 4.5 mm. The equatorial diameter of adult nucleus 128 (approximately 36 years old) is approximately 9.6 mm, and the diameter of its AP axis 104 is approximately 4.8 mm. These are average values ​​for a typical adult human lens in an in vitro adapted state at approximately 50 years of age. Therefore, the equatorial diameter of this lens (nucleus and cortex) is approximately 9.8 mm, and the diameter of its AP axis 104 is approximately 4.9 mm. Therefore, the structure of the lens is layered or nested, with the oldest layer and the oldest cells facing the center.

[0007] The lens is like Figure 11 and Figure 11A The lens is biconvex in shape. The anterior and posterior sides of the lens have different curvatures, and the cortex and different nuclei generally follow these curvatures. Therefore, the lens can be viewed as a layered structure that is essentially asymmetrical along its equatorial axis and consists of long, crescent-shaped fiber cells arranged end-to-end in essentially concentric or nested shells. The ends of these cells align to form suture lines in the central and near-central regions of both the anterior and posterior sides. Older tissue cells in both the cortex and nuclei are less functional, losing their nuclei and other organelles several months after cell formation.

[0008] The lens undergoes compaction with age. The number of lens fibers grown each year throughout its lifespan is relatively constant. However, the lens size does not grow as large as one might expect from the growth of new fibers. From birth to age 3, the lens grows from 6 mm to 7.2 mm, or a 20% increase in just 3 years. Then, in the next decade or so, it grows from 7.2 mm to 9 mm, or a 25% increase; however, this is more than three times the timeframe of 9 years. In the next 20 years, from age 12 to 36, the lens grows from 9 mm to 9.6 mm, or a 6.7% increase in 24 years, indicating a significant slowdown in the observed growth rate, which we consider to be relatively stable during this period. Finally, in the last 20 years described, from age 36 to 54, the lens grows at only a fraction of its youthful growth rate, increasing from 9.6 to 9.8 mm, or a 2.1% increase, in 18 years. Despite the geometric effects that necessitate more lens fibers to fill the larger housing, the size of the old lens was much smaller than predicted by fiber growth rate models that account for these geometric effects. Fiber compaction, including core fiber compaction, is thought to explain these observations.

[0009] In general, presbyopia is a loss of accommodative range. In general, refractive errors are usually due to changes in the axial length of the eye. Myopia (nearsightedness) occurs when the eye is too long, causing the focal point to fall in front of the retina. Hyperopia (farsightedness) occurs when the eye is too short, causing the focal point to fall behind the retina. Cataracts are typically areas of cloudiness in the lens that can interfere with vision.

[0010] Presbyopia most commonly manifests as nearsightedness, making it difficult to read small print, especially in dim lighting after age 40-45. Presbyopia, or the loss of accommodative amplitude with age, is related to the eye's inability to change the shape of its natural lens, causing the eye to shift focus between near and far objects—a phenomenon that occurs in virtually 100% of people. Accommodative amplitude has been shown to steadily decline with age in the fifth decade of life.

[0011] As used herein, unless otherwise stated, descriptions of numerical ranges are intended only as a shorthand for individually referring to each individual value falling within that range. Unless otherwise stated herein, each individual value within a range is incorporated into this specification as if it were individually referenced herein.

[0012] In general, unless otherwise stated, the term “about” as used herein is intended to cover a variance or range of ±10% (the experimental or instrumental error associated with obtaining the value), and preferably the larger of these.

[0013] As used herein, unless otherwise specified, the terms "phacoemulsification / phaco" and "phacoemulsification system" will be given their broadest possible interpretation, referring to the same general equipment and procedure that typically involves using ultrasonic energy to drive a needle or tip to, for example, cut, break, separate, and emulsify tissue, including ocular tissues such as the lens and cataracts. Such procedures and systems may also include components and methods for aspiration, irrigation, and both.

[0014] As used herein, unless otherwise expressly stated, the terms "femtosecond laser," "femtosecond laser beam," "femtosecond pulse," and similar terms refer to pulse duration, and therefore also to the pulse length (also known as pulse width) of the laser beam, and imply a pulse duration of less than 1 picosecond (less than 1 x 10⁻⁶). -12 (seconds) to include 1 femtosecond (fs) (1x10) -15 All lasers and laser beams (seconds).

[0015] As used herein, unless otherwise expressly stated, the terms "picosecond laser," "picosecond laser beam," "picosecond pulse," and similar terms refer to the pulse duration, and therefore also to the pulse length (also known as the pulse width) of the laser beam, and signify a pulse duration of 1 picosecond (ps) (1 x 10^6 picoseconds). -12 (seconds) to 1 nanosecond (ns) (1 x 10^6) -9 All lasers and laser beams (seconds).

[0016] As used herein, unless otherwise explicitly stated, the terms "distal" and "proximal" have the following meanings: For lasers, laser beams, and laser components, distal refers to the side, site, or location closer to the laser beam source. For phacoemulsification systems, distal refers to the side, site, or location closer to the ultrasound energy source. For lasers, laser beams, and laser components, the term proximal refers to the side, site, or location away from the laser beam source along the laser beam path; and therefore, closer to the patient during operation. For phacoemulsification systems, the term proximal means the side, site, or location away from the ultrasound energy source along the energy delivery path; and therefore, closer to the patient during operation. Conversely, the distal end of a laser component or phacoemulsification component is farther from the patient during operation of those systems.

[0017] In addition to its diagnostic uses, ultrasound energy has therapeutic applications. Ultrasound energy can be focused, guided, and used to move (e.g., oscillate or vibrate) cutting devices, tools, or tips to cut, soften, or emulsify tissue, producing mists and vapors, as well as combinations and variations thereof. Generally, phacoemulsification is a medically recognized technique for removing the lens using ultrasound energy. Typically, phacoemulsification involves making a corneal incision, a scleral incision, and one or more of these, or both. A phacoemulsification head, usually consisting of an ultrasound-driven needle, is inserted through one of these incisions to emulsify (i.e., liquefy) the natural lens, break up cataracts into smaller pieces, as well as combinations and variations thereof. The emulsified fragments can then be removed using the same head or another head. The surgeon can then insert an implant into the eye through the incision.

[0018] Typically, laser treatment procedures for the eye involve positioning the patient on a bed or patient support, aligning the eye with the laser beam path of the laser system, and attaching a patient interface between the laser system and the eye. A therapeutic laser beam is then delivered in a laser beam pattern (mode) to perform therapeutic laser operations on the eye, and particularly on structures of the eye or eye-related structures, thereby addressing the eye condition. Therefore, laser surgery for addressing, for example, cataracts, presbyopia, refractive errors (natural and induced), and other eye conditions is known in the art.

[0019] To date, typical medical ultrasound equipment and systems, and especially phacoemulsification systems, used in operating rooms and medical facilities have been stand-alone systems with their own power supplies, control systems, monitors, control and command inputs, housings, cabinets, and bases. Similarly, to date, typical medical laser therapy equipment and systems used in operating rooms and medical facilities have been stand-alone systems with their own power supplies, control systems, monitors, control and command inputs, housings, cabinets, and bases.

[0020] Although the need to combine ultrasound devices with other therapeutic devices (e.g., lasers) has been expressed in the art, and some basic combinations have been provided, it is believed that this need remains largely unmet. To date, it is believed that no one has successfully integrated a therapeutic ultrasound system with another system (e.g., a therapeutic laser delivery system) to provide a compact, efficient medical system that meets regulatory and medical practitioner requirements and needs. In particular, prior to this invention, it is believed that no one has successfully integrated an ophthalmic phacoemulsification system with an ophthalmic therapeutic laser system to provide a compact, efficient, and ergonomic medical system that meets regulatory and medical practitioner requirements and needs. Meeting these two requirements and needs involves more than just a simple combination of the two systems already suggested in the art. These needs are met by the present invention, embodiments of which provide integrated ultrasound-laser, and particularly phacoemulsification-laser / phaco-laser, systems that are compact, efficient, and ergonomic medical systems that simultaneously meet regulatory and medical practitioner requirements and needs.

[0021] The background section of this invention is intended to introduce various aspects in the art that may be associated with embodiments of the invention. Therefore, the foregoing discussion in this section provides a framework for a better understanding of the invention and should not be construed as an admission of prior art. Summary of the Invention

[0022] There has long been an unmet need to address and improve the size of operating room and medical room systems, the ergonomics of operating rooms, surgical systems and equipment, the time required for efficient procedure execution, and patient comfort. These long-standing needs have existed and continue to exist, among other things, in the field of ophthalmology, including addressing cataracts, refractive errors, presbyopia, eye diseases, conditions, and injuries, as well as other surgeries and procedures for conditions of the eye and surrounding structures. This invention addresses these and other needs, particularly by providing articles of manufacture, apparatus, and methods as set forth in this specification, drawings, and claims.

[0023] Therefore, a patient interface device (PID) for ophthalmic surgery is provided, comprising: a ridged arm having a top end and a bottom end; the bottom end having an annular structure; the annular structure having a top side, a bottom side, and an opening configured for transmitting a therapeutic laser beam; a first port and a second port; wherein the port is in fluid communication with at least one of the opening, the top side, and the bottom side; the top side of the annular structure having: a plurality of pins extending upward from a surface of the top side and defining a pin height; a plurality of clips extending upward from a surface of the top side and having clip engagement surfaces thereby defining a clip engagement surface height; wherein the clip engagement surface height is greater than the pin height; an annular wall extending upward from a surface of the top side and defining a wall height; and wherein the annular wall partially defines a first annular channel and a second annular channel.

[0024] Furthermore, these systems, methods, and apparatuses are provided having one or more of the following features: a window, wherein the window defines a window height; and wherein the window is held between a clamping surface and a pin; and wherein the window is located above an opening; a window, wherein the window defines a window height; and wherein the window is held between a clamping surface and a pin; and wherein the window is located above an opening, and wherein the bottom of the window is at a height higher than the top of the annular wall; an annular vacuum ring structure attached to the bottom side of an annular structure; and wherein the annular vacuum ring is in fluid communication with at least one of the ports; an annular vacuum ring structure having a bottom side; an annular vacuum ring structure attached to an annular wall. The annular vacuum ring structure has a bottom side; and wherein the annular vacuum ring structure is in fluid communication with at least one of the ports; the annular vacuum ring structure has a bottom side; a flexible eye-engaging ring has an inner annular skirt and an outer annular skirt, and thus defines a flexible annular vacuum channel configured to engage with an eye; the flexible eye-engaging ring is attached to the bottom side of the annular vacuum ring structure and is in fluid communication with at least one of the ports; and the flexible eye-engaging ring has an inner annular skirt and an outer annular skirt, and thus defines a flexible annular vacuum channel configured to engage with an eye; the flexible eye-engaging ring is attached to the bottom side of the annular vacuum ring structure and is in fluid communication with at least one of the ports.

[0025] In addition, these systems, methods, and apparatuses are provided having one or more of the following features: wherein the pin height is equal to or lower than the wall height; wherein the pin height is lower than the wall height; wherein the pin height is about 1 mm lower than the wall height; wherein the ridged arm is an integral structure; wherein the annular vacuum ring structure is an integral structure; wherein the annular structure is an integral structure; wherein the flexible eye-jointing ring is an integral structure; wherein the tip of the arm is attached to one of the laser ultrasound, laser ultrasound emulsification, and femtosecond laser ultrasound emulsification systems of the present invention; wherein the tip of the arm is attached to the laser head of one of the laser ultrasound, laser ultrasound emulsification, and femtosecond laser ultrasound emulsification systems of the present invention.

[0026] Additionally, a patient interface device (PID) for ophthalmic surgery is provided, comprising: an arm having a top end and a bottom end; a structure supporting a window at the bottom end of the arm; and a meniscus inverter.

[0027] Furthermore, a laser ultrasound system is provided, comprising: an assembly having: a therapeutic laser for providing a therapeutic laser beam along a laser beam path; an ultrasonic emulsification system for providing therapeutic ultrasound energy; an arm connected to the assembly; the arm having a distal end and a proximal end, wherein the distal end is attached to the assembly; wherein the proximal end has a laser transmission head; wherein the arm includes a portion of the laser beam transmission path; and having any of these PIDs.

[0028] Additionally, a laser ultrasound system is provided, comprising: a therapeutic laser for providing a therapeutic laser beam along a laser beam path; an ultrasonic emulsification system for providing therapeutic ultrasound energy; optics defining four pupils in the system, wherein the laser beam path extends through at least two pupils; and any one of these PIDs.

[0029] In addition, a laser ultrasound system is provided, comprising: a therapeutic laser system; an ultrasonic emulsification system for providing therapeutic ultrasonic energy; and a safety interlock that prevents the laser system from emitting laser energy during operation of the ultrasonic emulsification system.

[0030] Furthermore, a laser ultrasound system is provided, comprising: means for providing a first therapeutic laser beam and a second therapeutic laser beam; the system having optics defining a laser beam path; the first laser beam path and the second laser beam path traveling along the laser beam path; wherein the first therapeutic laser beam has a pulse width of about 1,000 fs to about 2,000 fs; the system having a laser beam transmission mode for performing lens cutting with the first therapeutic laser beam; wherein the second therapeutic laser beam has a pulse width of about 100 fs to about 500 fs; the system having a laser beam transmission mode for performing corneal cutting with the second therapeutic laser beam; an phacoemulsification system for providing therapeutic ultrasound energy; and having any one of these PIDs.

[0031] In addition, these systems, methods, and apparatuses are provided having one or more of the following features: wherein the system is non-handled; wherein the system has an phacoemulsification tray, an phacoemulsification box, and is non-handled; wherein the system has a wireless foot switch configured to control a laser, phacoemulsification, or both; and wherein the system has a wireless foot switch; and wherein the system includes a laser head defining an opening through which a therapeutic laser beam path passes, and associated with the opening are means for closing the opening when the laser head is in a retracted position during operation of the phacoemulsification system, or both.

[0032] In addition, methods for using any of these systems to repair, upgrade software, operate, or perform surgery are provided.

[0033] In addition, a laser transmission method is provided, the method comprising transmitting a laser beam through a window of a PID according to any one of claims 2 to 13.

[0034] Furthermore, these systems, methods, and apparatuses are provided in which a PID (Potential Injector) generates and maintains an open fluid (e.g., BSS) reservoir below the lower surface of the window and in contact with the upper surface of the eye. The open reservoir has an outer annular wall (ridge) with a diameter larger than the window diameter, thus forming an opening (e.g., annular opening) between the wall and the window for the fluid (e.g., BSS) to flow out of the reservoir. The top of the wall is lower than the bottom of the window, thereby inverting the meniscus of the fluid (e.g., BSS). The top of the wall may be about 1 mm, about 0.7 mm, and about 0.5 mm lower than the bottom of the window. In this way, the fluid is in complete contact with the lower side of the window and no air bubbles are trapped below the window. In this way, the meniscus is inverted because its outer edge points downwards, i.e., like an inverted bowl. Therefore, the outer edge is lower than (i.e., close to) the center of the meniscus.

[0035] Furthermore, these systems, methods, and apparatuses are provided in which the PID is located below the lower surface of the window and in contact with the upper surface of the eye, creating and maintaining an open fluid (e.g., BSS) reservoir. The top of the annular wall forming the reservoir is higher than the bottom of the window, thus preventing the meniscus from being inverted. Therefore, the outer edge of the meniscus points upwards. Attached Figure Description

[0036] Figure 1 This is a perspective view of an embodiment of the laser ultrasound system according to the present invention.

[0037] Figure 2 This is a perspective view of an embodiment of the femtosecond laser ultrasonic emulsification system according to the present invention.

[0038] Figure 3 This is a perspective view of an embodiment of the femtosecond laser ultrasonic emulsification system according to the present invention.

[0039] like Figure 4 This is a schematic diagram of an embodiment of an optical system and optical path for a femtosecond laser system and an embodiment of a femtosecond laser ultrasonic emulsification system according to the present invention.

[0040] Figure 4A yes Figure 4 A schematic diagram of an embodiment of a treatment and scanning laser optical system and optical path.

[0041] Figure 4B yes Figure 4A schematic diagram of an embodiment of the Scheimpflug optical system and optical path.

[0042] Figure 4C This is a schematic diagram of an embodiment of an IR camera, showing the optical path along the therapeutic laser (down the tube) optical system and Figure 4 The optical path of the embodiment is observed.

[0043] Figure 4D This is a schematic diagram of an embodiment of a color camera, showing the optical path along the therapeutic laser (down the tube) optical system and Figure 4 The optical path of the embodiment is observed.

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

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

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

[0047] Figure 5 This is a perspective view of an embodiment of the system according to the present invention.

[0048] Figure 5A This is a top view as part of an embodiment of the system according to the present invention.

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

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

[0051] Figures 5D to 5H This is a side view of the position of an embodiment of the system according to the present invention.

[0052] Figure 5I This is a perspective view of an embodiment of the articulated optical tube according to the present invention.

[0053] Figure 6 This is a top view of an embodiment of the system configuration according to the present invention.

[0054] Figure 7 This is a top view of an embodiment of the system configuration according to the present invention.

[0055] Figure 8 This is a top view of an embodiment of the Sham component according to the present invention.

[0056] Figure 9 This is a top view of an embodiment of the Sham component according to the present invention.

[0057] Figure 10A and Figure 10B This is a perspective view of an embodiment of the near-end component and docking system according to the present invention.

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

[0059] Figure 11A yes Figure 11 A cross-sectional view of the lens of the eye.

[0060] Figure 12A This is a perspective view of an embodiment of the patient interface device (PID) according to the present invention.

[0061] Figure 12B yes Figure 12A A magnified perspective view of the PID.

[0062] Figure 12C yes Figure 12A Top perspective view of the PID.

[0063] Figure 12D yes Figure 12A A cross-sectional view of the PID.

[0064] Figure 12E yes Figure 12A A perspective view of the PID.

[0065] Figure 12F yes Figure 12A A cross-sectional view of the PID.

[0066] Figure 12G It is Figure 12A A perspective view of how the PID is attached to an embodiment of the laser ultrasound system according to the present invention.

[0067] Figure 12H This is an embodiment of the laser ultrasound system according to the present invention. Figure 12A A perspective view of the PID.

[0068] Figure 12I This is a perspective view of an embodiment of a locking mechanism for attaching a PID to a laser ultrasound system according to the present invention.

[0069] Figure 12J Observing from different perspectives Figure 12I A perspective view of the locking mechanism.

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

[0071] Figure 14 This is a perspective view of an embodiment of the femtosecond laser ultrasonic emulsification system according to the present invention.

[0072] Figure 14A This is a perspective view of an embodiment of a femtosecond laser ultrasonic emulsification system with a surgical microscope according to the present invention.

[0073] Figure 15 yes Figure 14 A transparent perspective view of a part of a femtosecond laser ultrasonic emulsification system.

[0074] Figure 15A yes Figure 14 Perspective view of the horizontal and vertical motion mechanism of the femtosecond laser ultrasonic emulsification system.

[0075] Figure 15B It is in the extended position according to the present invention. Figure 15A A perspective view of the structure.

[0076] Figure 16A According to the present invention, it is in the operating room and in the fully retracted position. Figure 14 The system's floor plan.

[0077] Figure 16B According to the present invention, the laser operation configuration (first position) is performed in the operating room and is in a partially extended position. Figure 14 The system's floor plan.

[0078] Figure 16C This is the laser operation configuration according to the present invention, located in the operating room and in a fully extended position. Figure 14 The system's floor plan.

[0079] Figures 17A-17C It is a series of photos that show Figure 14 The specific position of the system's extendable components when they extend and retract. Figure 17A The neutral extension position is shown for testing and calibration of the laser system. Figure 17B The first operating extension position for the treatment laser operation is shown. Figure 17C The second operating extension position (fully extended) for the treatment laser operation is shown.

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

[0081] Figure 19 This is a schematic diagram of an embodiment of the color down-the-tube (DTP) optical path according to the present invention.

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

[0083] Figure 20A yes Figure 20 A magnified perspective view of the PID.

[0084] Figure 20B yes Figure 20 A perspective view of the PID.

[0085] Figure 21 This is a perspective view of an embodiment of a femtosecond laser ultrasonic emulsification system in the extended position according to the present invention.

[0086] Figure 21A yes Figure 21 A perspective view of the system, retracted and shown from the other side.

[0087] Figure 21B yes Figure 21 A plan view of the system's tray components.

[0088] Figure 21C yes Figure 21 A perspective view of a part of the system.

[0089] Figure 21D yes Figure 21 A perspective view of the system's locking engagement device in the open position.

[0090] Figure 21E yes Figure 21 A perspective view of the system's locking engagement device in the closed position.

[0091] Figure 22 This is a perspective view of an embodiment of the femtosecond laser ultrasonic emulsification system with a wireless foot switch according to the present invention in the extended position.

[0092] Figure 22A It is used in accordance with the present invention Figure 22 A schematic diagram of the control bus of a femtosecond laser ultrasonic emulsification system.

[0093] Figures 23A-23D These are images of an embodiment of a GUI screen display, information, and menu according to the present invention. Detailed Implementation

[0094] In general, embodiments of the present invention provide systems and methods for addressing conditions of the eye (including the cornea, natural lens, and other structures of the eye and structures associated with the eye), and particularly for delivering laser energy, ultrasonic energy, and both to the eye to address, alleviate, improve, and reverse these conditions.

[0095] In general, embodiments of the present invention relate to ergonomic systems, integrated systems, and combinations and variations thereof, particularly providing the ability to diagnose and treat conditions of the human eye and its related structures using ultrasound and laser beams, and combinations and variations thereof. In embodiments of the systems of the present invention, laser and ultrasound components are integrated into a single device configured to operate therapeutic ultrasound and laser energy, control and transmit the therapeutic ultrasound and laser energy to the eye. Examples of these integrated devices include: integrated and interactive control systems; integrated patient information systems; integrated billing systems; integrated electronic medical records; integrated and interactive operation, control, transmission, voice commands, voice recognition, and voice control menus between laser and ultrasound systems, and combinations thereof; integrated and interactive protocols between laser and ultrasound systems, including safety systems; integrated and interactive input systems for surgeons and practitioners to input information and instructions into the device; integrated and interactive monitoring systems, displays, and both; integrated and shared power supplies and power management; integrated thermal load (e.g., thermal) management; interference-free energy production and transmission systems; and combinations and variations thereof.

[0096] In one embodiment, these integrated devices or systems are associated with a patient support bed and form another system. In a preferred embodiment, these devices and the patient support bed are configured to allow the surgeon to access the patient's left and right eyes via multiple pathways without requiring patient movement or repositioning. Therefore, preferred embodiments of this system allow the surgeon to easily position the patient according to their preferred method of accessing one or both eyes without repositioning the patient or reconfiguring the laser, ultrasound, and both. In this way, patient adaptability is enhanced, surgeon ergonomics is improved, efficiency is increased, effectiveness is enhanced, the time to complete the entire procedure on the patient (e.g., both eyes) is reduced, and combinations and variations of these, along with other benefits, can be obtained.

[0097] In embodiments, these integrated devices or systems are associated with an phacoemulsification tray or phacoemulsification cassette configured for orientation and operation from either side of the system. In this way, the surgeon can access and use the cassette's components from any possible surgeon-patient orientation provided by the system.

[0098] In embodiments, these integrated devices or systems provide surgeons with the ability to switch between laser and ultrasound manipulation without moving the patient, without changing the surgeon's position relative to the system, and preferably without either.

[0099] In this embodiment, the patient is positioned on a patient support (e.g., a support bed). The system is then moved to a location near the patient. The system can be positioned by the surgeon in any of the multiple orientations described in this specification. The surgery is then performed on the patient using a laser system and an ultrasound system.

[0100] Embodiments of the system of the present invention may include one or more and all features of the foregoing embodiments and paragraphs and the embodiments in the following paragraphs.

[0101] Examples of these systems (such as integrated phacoemulsification laser systems) are configured and capable of addressing a variety of ocular conditions and performing various procedures on the eye, including, for example: capsulotomy; custom-shaped non-circular and non-elliptical capsulotomy; lens cutting, fragmentation, slicing, and removal; cataract cutting, fragmentation, separation, and removal; emulsification of the lens and cataract tissue; corneal cutting and incision; creation of corneal flaps and corneal microcapsules; creation of limbal laxity incisions; resolution and correction of refractive errors (natural and induced); removal of residual cortical material; removal of lens epithelial cells; vitreous aspiration and cutting associated with anterior vitrectomy; resolution of bipolar coagulation problems; and intraocular lens injection.

[0102] Examples of these systems (e.g., integrated phacoemulsification laser systems) are configured and capable of addressing a wide range of ocular conditions and performing various surgeries, including corneal transplantation, radial keratotomy (RK), astigmatic keratotomy (AK), and limbal relaxation incision (LRI), as well as combinations and variations thereof. These incisions can be made by laser before or after phacoemulsification and lens implantation. RK includes micro-RK, micro-RK / AK, and conventional RK, with micro-RK being preferred. For micro-RK, radial incisions are preferably used for optical areas larger than approximately 5.00 mm, but smaller areas can also be considered. The incision length is typically approximately 2.50 mm. Typical parameters for the incisions are shown in Table 1. Typically, one, two, three, or more incisions are made on the cornea during micro-RK surgery.

[0103] Table 1

[0104] Radial cut parameters scope Preferred value default value unit optical zone 4.00-6.25 5.00 5.00 mm Minimum gap to AK 0.00-0.50 0.20 0.20 mm Desired radial length 0.50-2.50 2.00 2.00 mm Minimal residual interstitium 100-300 150 150 μm depth 20-90 80 80 ％ Entry overcut (+) -0.20-+0.20 0.06 0.06 mm

[0105] In embodiments of these systems, the associated patient support bed is a smart patient support bed. This smart patient support bed has positioning devices (e.g., positioning devices, RFID, optical elements, accelerometers, sensors, etc.) that communicate with laser-ultrasound equipment to provide the accurate position of the patient (and especially the patient's head) relative to the laser beam delivery components, laser beam path, laser docking components, ultrasound components, combined laser-ultrasound equipment, and combinations and variations thereof.

[0106] In embodiments of these systems, there is an associated smart headrest that can be associated with any standard patient support, such as a patient support bed. This smart headrest has positioning devices (e.g., positioning devices, RFID, optics, accelerometers, sensors, etc.) that communicate with the laser-ultrasound equipment to provide the accurate position of the patient (and especially the patient's head) relative to the laser beam delivery components, the laser beam path, the laser docking components, the ultrasound components, combined laser-ultrasound equipment, and combinations and variations thereof.

[0107] In embodiments of these systems, there is an associated patient smart device, such as a patient tag, band, or cap, which may be associated with the patient's head or neck, for example, worn by the patient or placed on the patient's body. This patient smart device has location-determining devices (e.g., positioning devices, RFID, optical elements, accelerometers, sensors, positioning equipment, etc.) that communicate with the laser-ultrasound equipment to provide the accurate position of the patient (and especially the patient's head) relative to the laser beam delivery components, the laser beam path, the laser docking components, the ultrasound components, combined laser-ultrasound equipment, and combinations and variations thereof.

[0108] In embodiments, the patient smart device may also have networking capabilities, storage capabilities, identification capabilities, and combinations and variations thereof. For example, the patient smart device may be used to verify patient identity, or in conjunction with other biometric systems (such as retinal imaging or iris scanning) to verify identity. Furthermore, and in this way, the patient smart device may communicate with laser systems, medical billing information, electronic patient records, and health and information management systems required or requested by surgeons, insurance companies, patients, and other combinations and variations thereof.

[0109] This device for patient positioning, also known as a patient orientation / position tracking system, determines the position of a patient (e.g., the patient's head) relative to a laser and the laser beam path, and the positioning device can be, for example, an electromagnetic tracking system, such as the Polhemus Patriot. TM 6-DOF. Embodiments of this tracking system are disclosed and taught in U.S. Patent Nos. 5,307,072, 6,369,594, 6,400,139, 6,624,626, 7,710,395, 6,762,600, 7,292,948, 7,873,491, and 8,013,595, the entire disclosure of each of which is incorporated herein by reference. Such a device may also be referred to as a patient locator or patient positioning device or system.

[0110] In embodiments, the laser ultrasound system, and in particular the laser phacoemulsification system, is configured such that the therapeutic laser beam can be transmitted in a therapeutic laser beam pattern to one or both eyes of the patient, and that phacoemulsification can be performed on one or both eyes of the patient without requiring the patient or surgeon to move from their relative position to the laser phacoemulsification system.

[0111] In embodiments, the size of embodiments of the present invention (e.g., integrated phacoemulsification laser devices) is significantly reduced compared to the size of two devices placed side-by-side or only within a common housing or cabin, thus providing a smaller footprint in the operating room compared to the total space required for separate laser and ultrasound systems. This provides a significant advance in the art, as prior to this invention, fully integrated laser-ultrasound systems from Juxin had not been used in operating rooms or received regulatory approval. The reduced size of this embodiment provides several improvements over the prior art, including efficiency, effectiveness, and both. The ability to switch between the two systems without moving the patient, the systems, or both during patient treatment, and without transferring the patient from one operating room to another (in this case, where the laser and ultrasound systems are in different rooms), is one benefit of this smaller device embodiment. This smaller device embodiment also provides the ability to be used in more, for example, smaller, operating rooms, while making it easier for surgeons and other professionals working in the operating room to move around. It also offers advantages in terms of operational cleanup and freeing up space to provide the ability to install other systems (e.g., diagnostic equipment and microscopes) in the operating room. The problems associated with integrating ultrasound and laser systems into a single device with such a small footprint and small overall volume (height, width, length) without interference between devices, the ability to keep each device operating as intended, and the ability to maintain the required effectiveness of each device, as well as the solutions to those problems, were believed to have not been identified, undertaken to solve, or resolved prior to the embodiments of the present invention.

[0112] In embodiments of these systems, the time required to change or switch from one operating mode to another preferably occurs very quickly. Therefore, the device can switch from laser mode to phacoemulsification mode in approximately 45 seconds to approximately 10 seconds, approximately 30 seconds to approximately 5 seconds, less than 1 minute, less than 30 seconds, less than 15 seconds, less than 10 seconds, less than 5 seconds, and less than 2 seconds. It should be understood that additional patient preparation time may be required after the device mode has been changed before a specific procedure can be performed.

[0113] The ability to switch between laser and phacoemulsification procedures or operations without requiring the patient, system, surgeon, and preferably all of these to be repositioned relative to each other offers additional benefits and advantages. For example, this ability to quickly and discreetly switch between femtosecond laser and phacoemulsification configurations or operations allows the patient to be fully prepared for both procedures before entering the operating room. Furthermore, the patient can even be covered with a curtain before entering the operating room.

[0114] In embodiments of these laser ultrasound systems, such as integrated phacoemulsification laser devices, the footprint (excluding the patient bed) is less than approximately 50 cubic feet (ft). 3 Less than approximately 40 cubic feet (ft) 3 (less than approximately 35ft) 3 Less than approximately 30 ft 3 Less than approximately 25 feet 3 Less than approximately 200 ft 3 Approximately 31 ft 3 Approximately 28 ft 3 Approximately 33ft 3And combinations and variations thereof, as well as larger and smaller values. In embodiments, the volume of the device may be adjustable, in which case the volume of the device will be the minimum volume, unless otherwise explicitly stated. The height of the device may be from about 45 inches (in) to about 75 in, about 65 in, about 60 in, about 50 in, about 55 in, less than 60 in, less than 58 in, about 52 in to about 58 in, and combinations and variations thereof, as well as larger and smaller dimensions. (In embodiments where the arm, extension, or component can be moved to a vertical or approximately 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 horizontal or approximately horizontal). In embodiments, the height of the device may be adjustable, in which case the height of the device will be the minimum height, unless otherwise explicitly stated. The length of the device may be from 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 dimensions. In embodiments, the length of the device may be adjustable, for example, via a movable arm assembly, tray, or bracket, in which case the device length will be the shortest length unless otherwise explicitly stated. The width of the device may be from 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, from about 22 in to about 27 in, from 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 may be adjustable, for example, via a movable arm, assembly, tray, or bracket, in which case the device width will be the shortest width unless otherwise explicitly stated. The device footprint (i.e., the area occupied by the device) of these embodiments may be about 400 in. 2 Up to approximately 1,300 inches 2 Approximately 400 inches 2 up to about 600 inches 2 Approximately 400 inches 2 approximately 500 inches 2 Approximately 450 inches 2 approximately 700 inches 2 Approximately 450 inches 2 Approximately 500 inches 2 Approximately 550 inches 2 Approximately 600 inches 2 Less than approximately 1,200 inches 2 Less than approximately 1,100 inches 2 Less than approximately 1,000 inches 2 Approximately 1,000 inches 2 Approximately 950 inches2 Approximately 900 inches 2 Approximately 800 inches 2 Approximately 850 inches 2 Approximately 950 inches 2 And combinations and variations thereof, as well as larger and smaller sizes. In embodiments, the width and length of the device, and both, can be adjustable, for example, via movable arms, components, trays, or brackets, in which case the device's footprint will be minimal, unless explicitly stated otherwise. The length and width of the device can be the same, for example, a square or circular footprint, or they can be different, for example, a rectangular or elliptical footprint. It should be understood that other footprint shapes are conceivable, such as star-shaped, "L"-shaped, "H"-shaped, etc.

[0115] Typically, ultrasonic emulsification equipment occupies an area of ​​approximately 20 inches x 25 inches, and therefore has a footprint of approximately 500 inches. 2 The footprint area (i.e., the "standard ultrasonic emulsification footprint area"). Therefore, the footprint area of ​​the embodiment of the ultrasonic emulsification laser integrated system is compared to 500 inches. 2 Typical phacoemulsification floor space can be approximately 70% and less, approximately 80% and less, approximately 90% and less, approximately 100% and less, approximately 110% and less, approximately 120% and less, approximately 130% and less, approximately 140% and less, or approximately 150% and less. This synergy achieved through embodiments of the invention (i.e., having two devices and therefore two therapeutic functions in an area only slightly larger than one device) provides significant benefits and advantages in operating rooms and medical rooms for workflow, available rooms for patient care (e.g., smaller rooms can now be used), patient and staff comfort and efficiency, etc.

[0116] Furthermore, even when the ultrasonic emulsification system has a smaller footprint than typical systems, the combined laser-ultrasound system of the present invention can be configured to occupy less space than a single laser and such a small-footprint ultrasound system.

[0117] In embodiments of these systems, further synergy is achieved through the use of custom-designed trays and devices for holding and positioning various surgical tools, instruments, kits, and equipment used in laser therapeutic procedures, laser diagnostic procedures, phacoemulsification procedures, lens implantation, and any refractive surgery. These custom-designed surgical trays and kits can be single-use, disposable items detachably attached to (or held by or retained within) the device housing; they can be integral trays housing disposable or reusable tools and instruments; and combinations and variations thereof.

[0118] In embodiments of these systems, laser surgery is optimized to provide the most effective, for example, lowest ultrasonic energy, for removing specific lens material. Therefore, considering the integrated control, monitoring, and storage capabilities of the systems and devices of the present invention, laser parameters such as femtosecond laser energy, laser emission spacing, and line spacing, as well as ultrasonic parameters such as ultrasonic emulsification energy, BSS (balanced salt solution) flow rate, and fluid dynamics, can be optimized and performed in a highly integrated and predetermined manner.

[0119] In embodiments of these systems with dual laser pulse widths, further advantages and benefits include the ability to reduce the need for and use of equipment such as diamond blades and cutting tools. This results in reduced costs, infection risks, and surgical time.

[0120] It should be understood that embodiments of the system of the present invention are contemplated in this specification to include one or more and all features of the embodiments and paragraphs described above and the following paragraphs (in various combinations as understood by those skilled in the art in view of the teachings and disclosure of this specification).

[0121] Go to Figure 1 The image shows a perspective view of an embodiment of a laser ultrasound system 100. System 100 is a device having a first housing 101 and a second housing 102. Housings 101 and 102 include power supply components, control components, operating components, analysis, prediction and diagnostic equipment, location determination and positioning equipment, a laser beam generating component, and an ultrasound generating component. In a preferred embodiment, the ultrasound generating component is a component of an ultrasonic emulsification system, and the laser beam generating component provides laser beams with pulse lengths of approximately 10 ps, ​​5 ps, 2 ps, and shorter.

[0122] These components can be distributed, wholly or partially, between the two housings 101, 102, for reasons including: optimizing space to avoid interference between components, managing heat and vibration, and providing more efficient control and operation of system 100. The two housings 101, 102 can be independent housings on the same base or frame 150, and can have communication, control, power, optical, and other connections between them. They can be separate, identical housings, or they can be subdivided or divided into a third or sub-housing, or a fourth or sub-housing, etc., as well as combinations and variations thereof.

[0123] An optical conduit 105 connects housing 102 to housing 106. Housing 106 includes a scanning device and beam-shaping optics for a therapeutic laser beam, which, along with the optics, can also be used to monitor and diagnose the laser beam and optical path. It should be understood that, in embodiments, these components of housing 106 may be wholly or partially located within one of the other housings 102, 101, and similarly, components from housings 102, 101 may be located within housing 106. Housing 106 may be integrated with or part of housings 102, 101. Housing 106 may be subdivided or divided into one or more housings or sub-housings, as well as combinations and variations thereof. In a preferred embodiment of the invention, housing 106 includes and isolates the scanner and beam-shaping optics. The scanner and beam-shaping optics, or other components that may be included in housing 106, communicate with the controller and operating system of system 100. Control communication refers to the transmission of information about device operation to and from devices, the transmission of information acquired or received by devices to and from devices, and the transmission of control information, instructions, or commands to devices, as well as combinations and variations thereof, and other data and information. Devices can directly control each other through communication, or they can indirectly control each other through communication, such as through communication with a central control, such as the system 100 controller, monitor 109 (which may also have control capabilities), and combinations and variations thereof. These devices can also directly and indirectly control each other through communication.

[0124] The optical guide tube 105 can be an optical tube (e.g., a hollow tube or channel with an internal reflective surface, through which a laser beam is transmitted via free space within the hollow tube, which may have a partial vacuum, contain ambient air, contain an inert gas, and combinations and variations thereof), an articulated optical tube, a telescopic optical tube, a flexible optical tube, an optical fiber, one or more optical fibers, a hollow guide tube, a beam guide, and combinations and variations thereof with other laser beam transmission structures.

[0125] The housing 106 has an arm 107 that can move, extend, retract, and in combinations and variations thereof in the directions of arrows 107a and 107b. The arm 107 and housing 106 move vertically via a lifting device 110, as shown by arrow 107a. The arm 107 has a component or device 108 for determining the shape and position of the eye and structures within the eye. At its proximal end, i.e., the end furthest along the laser beam path and therefore furthest from the laser beam source, and below device 108, the arm 107 has a patient interface device (PID) (not shown in the figure). The arm 107 has a monitor 109 that moves on the articulated arm in the direction of arrow 109a. The monitor can provide information such as surgery, system status, laser status, ultrasound status, cataract density, ultrasound settings, laser mode settings, and can receive input and instructions from the surgeon. The monitor communicates controllly with the control system of system 100, and the monitor may also comprise part or all of the control system of system 100. The monitor communicates directly with the laser control system and the ultrasonic control system, or through the control system of system 100, through monitor 109, and combinations and variations thereof. The monitor and its articulated arm may be located on other structures within system 100 or may be stand-alone. One, two, or additional monitors may be used. The monitor may have 3D viewing or display capabilities.

[0126] Arm 107 forms or includes a laser beam transmission structure, such as a hollow tube providing free space for the transmission of the laser beam. In embodiments, arm 107 may include a beam path in free space or an optical fiber for transmitting the laser beam to, for example, a scanner located at the proximal end of the tube rather than the distal end, i.e., the proximal end housing 106. Arm 107 may also be or include any laser beam transmission structure of the type described for use as an optical guide 105. The tube may also contain optics. Figure 1 In this embodiment, arm 107 contains an uncollimated laser beam, and therefore arm 107 can be referred to as containing an uncollimated laser beam and a laser beam path; in other words, arm 107 contains, surrounds, or includes an “uncollimated space” along the laser beam path. Arm 107 may accommodate or surround a collimated space, i.e., the space in which the laser beam on the laser beam path is collimated. It may accommodate a space containing optics. It may accommodate both collimated and uncollimated spaces. Arm 107 in the embodiment can pivot, rotate, extend, hinge, and combinations and variations thereof from its distal end. The proximal end of the laser beam path in arm 107 includes a mirror or optics to guide the laser beam through the PID and to reach and enter the patient's eye.

[0127] System 100 has two ports 103 and 104 for connecting cables and lines to ultrasound, aspiration, other tools, and combinations and variations thereof. In embodiments, these ports are configured to connect to an ultrasonic emulsification tool or ultrasonic emulsification cassette system. Ports 103 and 104 are shown on housing 102, and it should be understood that they may be on housing 101, or elsewhere on the system, or may be part of an ultrasonic emulsification cassette already inserted into system 100.

[0128] In this embodiment, the laser system has external cooling, internal cooling, or both. For example, cooling fluid flows into and out of the laser housing.

[0129] System 100 has a height as indicated by arrow 120, a length as indicated by arrow 121, and a width as indicated by arrow 122. The width and length define the floor area of ​​system 100, while the volume is defined by the height 120, the length 121, and the width 122.

[0130] Treatment Lasers and Systems - General

[0131] Any laser configured to provide a therapeutic laser beam that has proven useful, safe, and effective for treating the eye, its structures, and adjacent tissues and their conditions can be used. Tunable lasers, adjustable lasers, and combinations and variations thereof can be used; for example, the pulse width, pulse rate, power, and wavelength can be varied. More than one therapeutic laser can be used. The therapeutic laser can be a pulsed laser, such as a femtosecond laser or a picosecond laser, as well as longer and shorter pulses, continuous lasers, and combinations thereof.

[0132] Therapeutic lasers can have infrared, ultraviolet, and other wavelengths. The wavelength of the therapeutic laser beam can be from about 300 nm to about 2,500 nm, from about 1,000 nanometers (nm) to about 1,300 nm, 1020 nm, about 1020 nm, 1030 nm, about 1030 nm, 1040 nm, about 1040 nm, 1050 nm, about 1050 nm, and from about 1020 nm to about 1050 nm, as well as these and other combinations and variations.

[0133] The pulse duration of the therapeutic laser can be approximately 1 fs to approximately 100 ps, ​​approximately 200 fs to approximately 500 ps, ​​approximately 300 fs to approximately 100 ps, ​​approximately 300 fs to approximately 10 ps, ​​approximately 300 fs to approximately 2,000 fs, and combinations and variations of these durations, as well as longer and shorter durations. The pulse width of one or more “short pulse duration” therapeutic lasers in this system can be 300 fs, approximately 300 fs, 350 fs, approximately 350 fs, 400 fs, approximately 450 fs, 500 fs, approximately 500 fs, approximately 300 fs to approximately 600 fs, and combinations and variations of these. The pulse duration of one or more “long pulse duration” therapeutic lasers in this system can be 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.

[0134] These dual-beam embodiments, i.e., therapeutic laser beams having at least both short and long pulse durations simultaneously, offer several advantages and benefits, including, for example, the ability to reduce the need for and use of equipment such as diamond blades and cutting tools. This results in reduced costs, infection risks, and surgical time.

[0135] The pulse repetition frequency of the therapeutic laser beam can be approximately 50 kHz to approximately 5 MHz, approximately 50 kHz to approximately 2 MHz, approximately 50 kHz to approximately 1 MHz, approximately 50 kHz to approximately 750 kHz, approximately 100 kHz to approximately 200 kHz, approximately 150 kHz to approximately 350 kHz, approximately 100 kHz, approximately 150 kHz, approximately 200 kHz, approximately 300 kHz, and variations and combinations thereof, as well as larger or smaller repetition frequencies.

[0136] The average output power of the therapeutic laser beam at a specific pulse repetition frequency can be from about 1 watt (W) to about 8 W, from about 2.5 W to about 5 W, from about 3 W to about 4.5 W, from about 3 W to 5 W, less than 6 W, less than 5 W, any power that causes laser-induced optical breakdown (LIOB), photo-induced breakage, or both, as well as combinations and variations thereof, and lower and higher powers.

[0137] Embodiments of these systems can also perform sub-threshold treatments, diagnoses, and combinations and variations thereof. Thus, the therapeutic laser beam can be delivered to the eye at a power or in a manner lower than the point at which photo-induced breakage occurs. The therapeutic laser beam can be delivered to the eye at a certain power or in a manner lower than the power at the point at which photo-induced breakage occurs. Therefore, in embodiments of the surgical procedure of the present invention, sub-threshold laser surgery can be performed, laser surgery inducing photo-induced breakage can be performed, and phacoemulsification can be performed, and some or all combinations and variations of these procedures can be performed without moving the patient or the device.

[0138] The pulse energy of the therapeutic laser beam can be from about 1 nanojoule (nJ) to about 2 millijoules (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 causes photo-fragmentation, LIOB, or both, as well as combinations and variations thereof, and lower and higher energies.

[0139] The therapeutic laser beam of this system may have one or more of the above-mentioned beam characteristics, such as wavelength, duration, repetition frequency, power and pulse energy, as well as combinations and variations thereof.

[0140] Yb:YAG lasers capable of generating ultrashort laser pulses with a wavelength of 1030 nm can be used as therapeutic lasers. Typically, therapeutic lasers provide beams with wavelengths that can penetrate the cornea, aqueous humor, and lens. The beam can have short pulse lengths, along with energy and beam size, to produce photorupture, LIOB, or both of target ocular tissues, such as the cornea, limbus, lens capsule, lens, cataract tissue, opacified tissue, and other tissues. Therefore, as used herein, the term laser irradiation or irradiation refers to a laser beam pulse delivered to a location that produces a therapeutic effect (e.g., LIOB) by itself or in combination with other pulses. As used herein, the term photorupture essentially refers to the conversion of matter into a gas by a laser. In embodiments, wavelengths from approximately 300 nm to 2500 nm can be used. Pulse widths from approximately 1 femtosecond to 100 picoseconds can be used. Energy from approximately 1 nanojoule to 1 millijoule can be used. Pulse frequencies (also known as pulse repetition frequency (PRF) and pulses per second measured in Hertz) can range from approximately 1 kHz to several GHz. Typically, lower pulse rates correspond to higher pulse energies in commercial laser devices. Depending on pulse length, energy density, and other factors, various laser types can be used to produce therapeutic effects, such as photoinduced destruction of eye tissues, LIOB, or both. Therefore, examples of such lasers include: DelmarPhotonics Inc. Trestles-20, a Ti:sapphire (Ti:sapphire) oscillator with a wavelength range of 780 nm to 840 nm, a pulse width of less than 20 femtoseconds, a PRF of approximately 100 MHz, and 2.5 nanojoules; Clark CPA-2161, an amplified Ti:sapphire oscillator with a wavelength of 775 nm, a pulse width of less than 150 femtoseconds, a PRF of approximately 3 kHz, and 850 microjoules; IMRA FCPA (fiber chirped pulse amplifier) ​​μjewel D series D-400-HR, a Yb:fiber oscillator / amplifier with a wavelength of 1045 nm, a pulse width of less than 1 picosecond, a PRF of approximately 5 MHz, and 100 nanojoules; Coherent Staccato, a YB:Yag oscillator with a wavelength of 1030 nm, a pulse width of approximately 1.5 picoseconds, a PRF of approximately 80 kHz, and 30 microjoules; and Coherent... Rapid, which is YB:Yag, has a wavelength of 1030nm and a pulse width of approximately 1.5 picoseconds, and may include one or more amplifiers to achieve an average power of approximately 2.5 to 10 watts at a PRF of 25kHz to 650kHz, and also includes multi-pulse capabilities that can gate two separate 50MHz pulse sequences, as well as IMRAFCPPA (fiber chirped pulse amplifier) ​​pJewel D series D-400-NC, which is Yb: fiber optic oscillator / amplifier, has a wavelength of 1045nm, a pulse width of less than 100 picoseconds, a PRF of approximately 200kHz, and 4 microjoules.These and other similar lasers can be used as therapeutic lasers and generate therapeutic laser beams.

[0141] Embodiments of laser systems, methods, and apparatus for performing laser operations on the eye are disclosed and taught in U.S. Patent Application Publications 2016 / 0302971, 2015 / 0105759, 2014 / 0378955 and U.S. Patents 8,262,646 and 8,708,491, the entire disclosure of each of which is incorporated herein by reference.

[0142] Laser Beam Transmission - General Purpose

[0143] In general, embodiments of optics used to deliver a therapeutic laser beam to the natural lens of the eye should be able to provide a series of irradiations to the natural lens in precise and predetermined patterns along the x, y, and z dimensions. The optics should also provide a predetermined beam spot size to induce photo-fracture, LIOB, or both upon the arrival of the laser energy in the natural lens or other target tissue. Therefore, the optics can include, but are not limited to: xy scanners; z-focusing devices; and focusing optics. Focusing optics can be conventional focusing optics, plan optics, telecentric optics, and combinations and variations thereof, each with corresponding computer-controlled focusing to achieve calibration in the x, y, and z dimensions. For example, an xy scanner can be a pair of closed-loop galvanometers with position detector feedback. Examples of such xy scanners are the Cambridge Technology Inc. 6450, the SCANLAB hurrySCAN, and the AGRES Rhino Scanner. Examples of such z-focusing devices are the Phsyik International Peizo focusing unit model ESee Z-focus control and the SCANLAB varrioSCAN.

[0144] Laser Control System - General Purpose

[0145] In general, embodiments of a control system for transmitting a therapeutic laser beam can be any computer, controller, software and hardware, and combinations and variations thereof, capable of selecting and controlling XYZ scanning parameters and laser emission, etc. These components are typically associated, at least in part, with circuit boards that interface with XY scanners, Z-focusing devices, lasers, and combinations and variations thereof. Among other things, the laser control system may include procedures for guiding the laser through one or more laser emission modes. The laser control system also has the further capability of integrating with a system control system and functioning in conjunction with an ultrasound controller and monitor or control panel, or otherwise operating as an integrated system. System controllers, laser controllers, ultrasound controllers, and combinations and variations thereof can also control other components of the system, as well as maintain data, acquire data, analyze data and images, prepare and recommend forms and treatments, and perform calculations. The control system may include procedures for guiding the laser through one or more laser emission modes.

[0146] Position and shape determination - general

[0147] Typically, in embodiments, the components or devices used to determine the shape and location of the eye and its internal structures can be optical coherence tomography (OCT), SAM devices with a single movable camera, multiple fixed cameras, combinations and variations thereof, and other types of devices for such determinations. In embodiments, the device determines the relative distance of portions of the lens or other structures of the eye or tissue adjacent to the eye to a laser (e.g., an optical head). In embodiments, this distance is kept constant by, for example, a PID. In embodiments, the device determines the position of the lens and other structures relative to the scan coordinates of the laser transmission pattern in all three dimensions. This can be achieved through several methods and devices. For example, the xy coaxiality of the lens can be achieved by observing the lens via a co-bore-sighed camera system and a display, or by using a direct-viewing optics and then manually positioning the patient's eye to a known center. The z-position can then be determined using optical triangulation or distance measurement devices with laser and CCD systems (e.g., the miniature Epsilon opto NCDT 1401 laser sensor, the Aculux Laser Ranger LR2-22, and combinations and variations thereof). The x, y, and z positions of a lens can also be determined using 3D observation and measurement devices. For example, these determinations can be made using Vision Engineering's Hawk 3-axis non-contact measurement system. Another example of a device that can be used to determine lens position is a 3D measurement device. This device will include one or more cameras that can observe a reference object and the natural lens, and will also include a light source for illuminating the natural lens. This light source can be a structured light source, such as slit illumination designed to generate 3D information based on geometry. Alternatively, one, two, three, four, or more light sources can be positioned around the eye and electronically activated to provide multiple views, planar images of the eye (particularly the cornea and lens) on multiple planar slices, which can then be integrated to provide data on the position and orientation information of these structures in relation to the laser system. Examples of components, methods, and devices for determining the shape of the eye and its structure and its position relative to a laser, laser irradiation pattern, and laser beam are disclosed and taught in U.S. Patent Publications and Patent Nos. 2018 / 0085256, 2016 / 0302971, 2015 / 0105759, 2012 / 0330290, 2016 / 0030244, 9,180,051, and 8,708,491, the entire disclosure of each of which is incorporated herein by reference. An iris positioning device for determining the position of the eye is taught and disclosed in U.S. Patent Publication No. 2015 / 0105759, the entire disclosure of which is incorporated herein by reference.Typically, an image (optical image) is returned to a device or system from the structure of the eye, PID, or other structures along an optical path (e.g., along an image path that can be accessed through free space, optical components (lenses, mirrors, optical fibers, etc.), and both).

[0148] Patient Interface - General

[0149] Another component of embodiments of these systems may be a laser patient interface or PID. It should be noted that all or part of the PID is typically not part of the system, but rather preferably a single-use device (e.g., disposable) added to the system for each patient before or during preparation for laser surgery. In embodiments, the interface provides a fixed x, y, z position between the natural lens and the laser during surgery, including both a measurement step to determine the x, y, z position and a transmission step to deliver the laser to the lens in an irradiation mode. The interface device may include an optically transparent applanator. One example of such an interface is a suction ring applanator, which is fixed close to the outer surface of the eye and then positioned close to the laser optics housing, thereby fixing the distance between the laser, the eye, and the natural lens. Reference markers for 3D observation and measurement devices may also be placed on this applanator. Furthermore, the interface between the lower surface of the applanator and the cornea may be observable, and this observation may serve as a reference. Another example of a laser patient interface is a device with a lower ring that has suction capability for securing the interface to the eye. The interface also has a flat bottom that presses against the eye, flattening the shape of the eye. This flat bottom is constructed of a material that transmits the laser beam and, preferably, though not essential, transmits an optical image of the eye within the visible spectrum. The upper ring has structures for engaging with the housing of the laser optics, structures that are at a known distance from the laser along the path of the laser beam and fixed relative to the laser, and combinations and variations thereof. Examples of patient interface devices, systems for engaging the PID with the eye, and systems for engaging the PID with a laser system are disclosed and taught in U.S. Patent Application Publications Nos. 2011 / 0190739, 2017 / 0290703, 2010 / 0022994, 2011 / 0022035, and 2015 / 0088175, the entire disclosure of which is incorporated herein by reference.

[0150] During testing and calibration, the laser beam, and preferably the therapeutic laser beam, can be transmitted through the window of the PID.

[0151] Ultrasonic / Ultrasonic Emulsification - General Purpose

[0152] Ultrasonic energy can be provided to the system of the present invention using any ultrasound generator configured to provide useful, safe, and effective ultrasonic energy for treating the eye, its structures, and adjacent tissues and their conditions, such as an ultrasound driver, horn, or other device that generates ultrasonic energy. In particular, in embodiments of the system of the present invention, some or all components of any phacoemulsification system (preferably approved by a medical device regulatory authority) can be used or reconfigured.

[0153] Typically, in embodiments of the integrated systems of the present invention and the methods they can perform, phacoemulsification includes preferably using a therapeutic laser beam to make a corneal incision, a scleral incision (and combinations and variations thereof), and inserting a phacoemulsification head (which typically consists of an ultrasound-driven needle) to emulsify, i.e., liquefy the natural lens, break the cataract into smaller pieces, and combinations and variations thereof. Preferably, the ultrasound procedure is performed on a lens, lens material, or cataract material that has already been cut, sliced, softened, and combinations and variations thereof by the laser beam. The emulsified fragments can then be removed using the same head or another head. The surgeon can then insert an implant, such as an intraocular lens (IOL), into the eye through the incision.

[0154] In embodiments, the ultrasonic emulsification frequency of the vibration of the tip of the ultrasonic emulsification needle can be greater than 20 kHz, greater than 30 kHz, greater than 40 kHz, about 30 kHz to about 50 kHz, about 30 kHz to about 45 kHz, less than about 50 kHz, about 35 kHz to about 45 kHz, about 35 kHz, about 40 kHz, about 45 kHz, about 35 kHz, about 40 kHz, about 45 kHz, and combinations and variations thereof, as well as higher and lower frequencies.

[0155] In embodiments, the longitudinal travel length of the ultrasonic needle can be approximately 28.1 μm to approximately 95.25 μm, approximately 25 μm to approximately 160 μm, approximately 50 μm to approximately 90 μm, approximately 50 μm to approximately 150 μm, approximately 25 μm to approximately 110 μm, approximately 35 μm to approximately 100 μm, approximately 20 μm to approximately 60 μm, approximately 80 μm to approximately 150 μm, and combinations and variations thereof, as well as larger and smaller distances.

[0156] Typically, the pulse frequency of an ultrasonic emulsification system can be from approximately 20 pulses per second to approximately 150 pulses per second, as well as combinations and variations thereof, and higher and lower values. Furthermore, the burst pulse width of these systems can be from approximately 30 milliseconds to approximately 4 milliseconds, as well as combinations and variations thereof, and higher and lower values.

[0157] In embodiments of the system of the present invention, the phacoemulsification head is typically coupled to an irrigation source and an aspiration pump. The aspiration pump is located within the housing of the system. The head includes a distal tip for insertion into the anterior chamber of the patient's eye, which emits ultrasonic energy or vibrates at ultrasonic frequencies to cut and emulsify the lens or natural lens, and combinations and variations thereof. The head also includes an irrigation port near the distal tip, coupled to the irrigation source via an irrigation line, and an aspiration port at the distal tip, coupled to the aspiration pump via an aspiration line. Fluid from the irrigation source (typically a high-level saline solution) is flushed 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 tube by the aspiration pump.

[0158] Other medical techniques for the eye that can be configured to be performed by an ultrasound system typically include emulsification, eye irrigation, and aspiration. Such procedures may or may not include the use of emulsification, irrigation, and aspiration to destroy, alter, or remove features of the natural eye. Therefore, the ultrasound power delivered by the surgical console, the fluid flow into and out of the patient via the irrigation or aspiration console, and the subsequent need to control the phacoemulsification head to deliver the above, are all selected and controlled by the system, by the surgeon, and by combinations and variations thereof.

[0159] The ultrasonic emulsification components, such as sub-assemblies, of this system typically include a control system, such as a programmable microprocessor, and a console (in this embodiment, a system monitor) with operator-selected presets for control (e.g., aspiration rate, vacuum level, and ultrasonic power level). The ultrasonic emulsification head is interconnected to the system via cables for powering and controlling the piezoelectric transducers that provide emulsification. A conduit provides irrigation fluid to the eye, and the aspirated fluid can be extracted from the eye via the head controlled from the console.

[0160] In this embodiment, the phase angle and other aspects related to the operation of the phacoemulsification head are constantly determined and measured during head operation, such as to adjust the drive circuitry, achieve an optimal phase angle, and otherwise influence energy transfer from the phacoemulsification head to the tissue. Automatic tuning of the head to maintain consistency with selected parameters can be provided by monitoring the head's electrical signals and adjusting the frequency and other aspects.

[0161] In embodiments, the control system meets the power control requirements of the phacoemulsification head based on the phase angle between the voltage applied to the piezoelectric transducer of the head and the current drawn by the piezoelectric transducer, the amplitude of the power pulses supplied to the head, and both. Typical arrangements can be adjusted for specific heads, and power can be applied, for example, either continuously or as a series of solid bursts controlled by the surgeon. For example, the system can supply power for 150 ms, then stop supplying power for 350 ms, and can repeat this on / off sequence for the necessary duration of power application. Power application during the aforementioned 150 ms period can be defined as a constant application of a 25 kHz to 50 kHz sine wave. In some cases, the surgeon or operator may apply power bursts for a period of time, then stop applying power, and then reapply at an initial or another power setting. The frequency and duration of the bursts are generally controllable, as is the length of the bursts applied to the affected area. The periods of no power application allow for the removal of fragments using aspiration (e.g., provided by the head or auxiliary aspiration devices).

[0162] In embodiments of the system of the present invention, the control method for ultrasound power transmission can typically employ several modes, such as variable, pre-variable, panel, and linear. Variable mode provides the greatest flexibility for the surgeon or operator in selecting ultrasound treatment conditions and can be considered manual. Pre-variable mode is a mode in which the control system determines the optimal range of ultrasound treatment based on the laser treatment provided, the level of cataract, and other information obtained by the system before, during, and after the laser treatment procedure. Therefore, in this mode, the system works in conjunction with the laser controller system and the phacoemulsification control system to pre-determine and provide, recommend, and preferably optimize the range and settings of the phacoemulsification procedure. Typically, panel mode provides strictly fixed values ​​at user selection. Typically, linear mode only allows the simplest form of linear adjustment from 0% to 100%. In embodiments, intermediate adjustments, or adjustments outside the options or ranges recommended by the system to provide ultrasound treatment, are not arbitrarily available; for example, they are limited, in part to minimize the need for manual adjustments and the inherent risks.

[0163] Phacoemulsification uses an ultrasonic probe to deliver energy into the eye to break up remaining cataract lens material after laser fragmentation or cutting, facilitating the emulsification and aspiration of any remaining fragments. Phacoemulsification also delivers energy into the eye to break up cataracts that have not undergone laser fragmentation, for example, when a surgeon chooses to perform laser capsulotomy and a laser incision to insert the phacoemulsification probe, but without using a laser to break up the lens or cataract. Phacoemulsification also delivers energy into the eye to break up the cataract; this is achieved by vibrating at a fixed frequency when a control switch (e.g., a foot pedal) is pressed to a predetermined position. The same control switch can control the emission or delivery of the therapeutic laser beam and mode; other types of control switches, buttons, triggers, audio, etc., can be used. In an embodiment, to increase the amount of ultrasonic power, the machine increases the probe's stroke length.

[0164] Typically, the probe can transmit power in a longitudinal, transverse, or combination and variation of these methods. The ultrasonic emulsification needle moves longitudinally back and forth. In the latter case, ultrasonic power is also transmitted through the transverse movement of the probe and can improve cutting efficiency, for example, by reducing the repulsive forces of the lens material.

[0165] In general, there are two types of lateral motion in phacoemulsification: torsional lateral motion, in which the phacoemulsification tip oscillates rotationally along its main axis; and transverse lateral motion, in which the phacoemulsification tip moves along an elliptical path. Generally, based on their type of motion, torsion is usually more effective with angled phacoemulsification needles, while transverse motion is generally equally effective with straight or angled needles. Combining lateral motion phacoemulsification with traditional longitudinal phacoemulsification can improve cutting efficiency because cataract material is emulsified in more than one direction.

[0166] Although current technology describes phacoemulsification as the transmission of ultrasonic energy, it should be understood that the stroke of the phacoemulsification needle generates mechanical shock when it strikes the target material (e.g., laser-induced cataract material). Typically, cavitation and implosion also occur at the needle tip because micropores are created just in front of the phacoemulsification needle. Fluid and particle waves propagate into the cataract material and ultimately generate heat as a byproduct. It is crucial to avoid selecting phacoemulsification power settings that lead to excessive heat buildup, as such settings can burn the cornea and damage the delicate structures of the eye. Unrestricted flow of the surrounding flushing cannula is also important, as the continuous cooling effect of the balanced salt solution moving around the phacoemulsification probe helps prevent heat buildup.

[0167] In embodiments of the system of the present invention, during surgery, the system controller, the phacoemulsification controller, and combinations and variations thereof can monitor, record, and analyze the average phacoemulsification power (given as a percentage of the maximum value) and the total time during phacoemulsification power transmission, as well as other conditions and factors. In embodiments, common monitors can display these values ​​as “U / S AVE” (representing “ultrasound average”) and “EPT” (representing “phacoemulsification elapsed time”) as well as other parameters and characteristics. The total energy transmitted to the eye is the product of the phacoemulsification power multiplied by the power-on time, called the absolute phacoemulsification time (APT). The system controller, the ultrasound controller, and combinations and variations thereof can automatically calculate the APT by multiplying “U / S AVE” by “EPT” so that the surgeon can compare the total ultrasound energy transmitted under different conditions.

[0168] In embodiments, to minimize APT, surgeons need to reduce phacoemulsification time, average phacoemulsification power, and combinations and variations thereof. Average phacoemulsification power can be reduced by selecting parameters on the display, limiting the position of a control switch, or lowering the maximum phacoemulsification power level on the machine. Phacoemulsification time can only be reduced by applying ultrasonic power when the cataract fragment is located at the phacoemulsification tip and vacuum alone is insufficient to aspirate the fragment. Furthermore, phacoemulsification time can be reduced by providing shorter pulses or bursts of phacoemulsification power instead of continuous ultrasonic power, or by reducing the duty cycle (the ratio of on to off pulses). This method of breaking down ultrasonic power into smaller pulses and burst packets is called ultrasonic power modulation.

[0169] In the embodiments, the basic power setting can be continuous, pulsed, or bursty. In a continuous power setting, energy delivery is continuous as the power changes, controlled by the position of a control switch (e.g., the amount of pressure applied to the foot pedal).

[0170] In embodiments, the system provides combinations and variations of these, as well as power settings that provide hybrid or mixed levels of these power modes, because power variations can be determined and controlled more accurately by the control system in conjunction with the phacoemulsification control system, and in some cases with surgeon input.

[0171] In an embodiment, in pulse mode, the pulse power increases linearly by controlling the position of the switch (e.g., how far the foot pedal is pressed down). The farther it is placed (e.g., pressed down), the greater the power of each successive energy pulse. A feature of the embodiment of pulse mode operation is that after each energy pulse transmission, there is a period of time during which no energy is transmitted, i.e., an "off" period, between the increasing energy pulses. Alternating between equal "on" and "off" pulse times reduces heat and transfers half the energy to the eye.

[0172] In an embodiment, in burst mode, each burst pulse has the same power, but the interval between each burst pulse decreases as the control switch is pushed forward (e.g., the foot pedal is pressed down). In an embodiment, the further the control switch is pushed forward (e.g., the foot pedal is pressed down), the shorter the "off" time period between each burst pulse will be. Therefore, in an embodiment at the maximum control switch position (e.g., at the maximum foot pedal press), the burst of energy becomes a continuous transmission of energy.

[0173] In one embodiment, the burst mode can provide phacoemulsification-assisted aspiration of the lens nucleus. The surgeon uses the vacuum and fluid of the phacoemulsification machine to aspirate the cataract and then delivers burst pulses of phacoemulsification power only when necessary. Because a, preferably controlled, system can program or recommend these very short (as fast as milliseconds) burst pulses of phacoemulsification power, hundreds of tiny burst pulses can be delivered efficiently, still less than, for example, one second of total phacoemulsification time.

[0174] The system of the present invention provides the following embodiments in which the programmability range of pulsed and burst pulse phacoemulsification settings, as well as other settings, has the same characteristics as existing systems, and significantly expands upon existing systems in the embodiments. Unlike any existing system, embodiments of the system of the present invention provide the ability to have predetermined and recommended phacoemulsification settings based on the laser mode or treatment transmitted by the laser system, and these settings can be provided immediately without the need for surgeon or patient movement.

[0175] In embodiments, the ultrasonic emulsification control system, alone or in combination with the system control system, can perform various active monitoring and control functions, such as: monitoring intraocular pressure (IOP) and adjusting system functions to maintain IOP at a desired pressure; monitoring and controlling vacuum levels; optimizing power settings; and predicting pressure changes and actively responding to occlusion interruptions. Sensors providing this information and data for monitoring and autonomous control of the ultrasonic emulsification system's operating parameters can be located within the system, on various pumps and devices (based on current or other electrical loads), or in or on the machine head.

[0176] Examples of performance characteristics and components that can be used in the ultrasonic laser system of this invention are Alcon. Visual system and Alco ACTIVE Nose and Mixing tip. In embodiments, the ultrasonic emulsification head may have a built-in fluid pressure sensor that detects pressure in real time and communicates with the system control system, the ultrasonic emulsification system control system, or both. Examples of various features and components that can be used in the ultrasonic laser system of this invention are AMO WHITESTAR. PRO ultrasonic emulsification system.

[0177] Features, methods of use, and components of ultrasonic emulsification systems and subsystems are disclosed and taught in U.S. Patent Nos. 8,020,565, 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 Publications Nos. 2019 / 0133824, 2019 / 0021906, 2019 / 0099526, 2017 / 0266046, and 2017 / 0112668, the entire disclosure of each of which is incorporated herein by reference.

[0178] Ultrasonic-Laser Combination - Universal

[0179] These embodiments include any combination of laser-ultrasound systems, and in particular, combinations of phacoemulsification laser systems and combinations of phacoemulsification femtosecond laser systems (“femtosecond laser phacoemulsification” or “phacoemulsification femtosecond laser” are used interchangeably unless explicitly stated otherwise). These embodiments may have or utilize one or more of the following embodiments, features, functions, parameters, components, or systems of therapeutic lasers and systems, laser beam delivery, laser control systems, position and shape determination, patient interfaces, and ultrasound / phacoemulsification, as well as the general teachings disclosed in this specification and one or more features of the systems in the examples.

[0180] In a preferred embodiment of a laser ultrasound system, and particularly a laser phacoemulsification system, and even more particularly a femtosecond laser phacoemulsification system, the system has two therapeutic laser beams, which may be provided by the same or different laser sources, one being a laser beam with a short pulse duration and the second being a laser beam with a long pulse duration.

[0181] Short-pulse-duration lasers are typically used for corneal surgeries, such as corneal incisions and limbal laxity incisions. Long-pulse-duration laser beams are typically used for lens surgeries, such as capsulotomy, lens fragmentation, and cataract fragmentation.

[0182] These embodiments, which have various types of different therapeutic laser beams (e.g., short pulse duration and long pulse duration), may have or utilize one or more of the following embodiments, features, functions, parameters, components, or systems of therapeutic lasers and systems, laser beam transmission, laser control systems, position and shape determination, patient interfaces, and ultrasound / phacoemulsification: the general teachings disclosed in this specification, and one or more features of the systems in the examples.

[0183] Systems, such as femtosecond laser phacoemulsification systems, can have multiple therapeutic laser beams, for example, one, two, three, four, or more beams with different characteristics. These laser beams can follow the same laser beam path and thus pass through and interact with the same optical components; they can travel through different laser beam paths and thus pass through and interact with different optical components; and combinations and variations thereof. For example, the system can have a first laser beam with a first pulse duration and a first power or energy, a second laser beam with a second pulse duration and a second power or energy, and a third laser beam with a third pulse duration and a third power or energy. The first pulse duration, second pulse duration, and third pulse duration, the first power, the second power, and the third power, and the first energy, the second energy, and the third energy can be the same, different, and combinations and variations thereof.

[0184] In embodiments, the multi-therapeutic laser beam system is associated (integrated or modularized) with another therapeutic device, such as an ultrasound device, a diagnostic device, and combinations and variations thereof.

[0185] In embodiments where long-pulse-duration and short-pulse-duration laser beams are provided by the same therapeutic laser source, the switching time between pulse lengths is less than about 3 seconds (sec), 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, as well as longer and shorter times.

[0186] Although preferred embodiments of the invention are directed toward laser ultrasound, and particularly femtosecond laser ultrasound emulsification systems, it should be understood that improvements and embodiments of the invention for laser systems are valuable and can be used alone rather than as part of a laser ultrasound system.

[0187] These embodiments of the present invention provide significant advantages over the prior art. Because the present invention system can provide an optimal laser energy mode, allowing for eye assessment (after transmission), and then without moving the patient, and then performing phacoemulsification surgery with minimal time delay (less than 1 min, less than 30 sec, less than 15 sec), the important goal of using as little ultrasound phacoemulsification energy as possible during cataract surgery can be achieved, and preferably in a predetermined manner for all patients.

[0188] Example

[0189] The following examples are provided to illustrate various embodiments of the systems, components, processes, compositions, applications, and materials of the present invention. These examples are for illustrative purposes, may be predictive, and should not be considered limiting, nor do they otherwise limit the scope of the invention.

[0190] These examples 1 to 46 may have or utilize one or more of the following embodiments, processes, methods, features, functions, parameters, components, or systems: therapeutic lasers and systems, laser beam transmission, laser control systems, position and shape determination systems, patient interfaces, ultrasound / phacoemulsification, and phacoemulsification-femtosecond laser combinations, as well as one or more of the embodiments, processes, methods, features, functions, parameters, components, or systems provided in one or more other examples and embodiments provided in this specification.

[0191] Example 1

[0192] Go to Figure 2 A partial cross-sectional perspective view of an embodiment of a femtosecond laser phacoemulsification laser system 200 is shown. System 200 has a laser subsystem 204 and an phacoemulsification subsystem 205 contained within a common housing 206. Laser subsystem 204 includes a therapeutic laser beam source, and in embodiments includes slow-pulse-duration and long-pulse-duration therapeutic laser beam sources. Laser subsystem 204 includes a laser defining a therapeutic laser beam path along which it travels, and optical components placed or positioned along the laser beam path. These components will include z-axis focusing optics and an xy scanner.

[0193] System 200 has an arm 201 that houses the path of the therapeutic laser beam and other optical paths. In an embodiment, arm 201 also houses or carries control and power cables for the imaging and positioning device 203, as well as docking components (not shown in the figure). Arm 201 has a therapeutic laser beam transmission head 202 at its proximal end. Laser transmission head 202 has position and shape determination devices (which may be an OCT system or a SAM system as described in this invention), and combinations and variations of these and other position and shape determination devices. The laser transmission head has a docking and positioning system that, together with the PID, docks with the patient's eye.

[0194] System 200 has a common power supply 207 for both the laser subsystem 204 and the ultrasonic emulsification subsystem 205. The common power supply 207 provides all power to the entire system, eliminating the need for auxiliary power supplies or individual power sources. This allows the system to be plugged into a single power source within the operating room.

[0195] System 200 has a common control system 208. The common control system 208 has controller operation control software or operating instructions. In a preferred embodiment, the common control system 208 communicates control with one or more, and preferably all of, the following: the control system and controller 212 in the laser subsystem; the control system and controller 211 in the ultrasonic emulsification subsystem; control communication with the operator interface 209; control communication with the emergency stop 210; and network communication with, for example, patient record systems, accounting systems, and combinations and variations of these configurations.

[0196] Typically, the docking system, as well as the imaging and positioning devices, are controlled by the laser subsystem control system. In this embodiment, they may be controlled, in whole or in part, directly by the common control system 208.

[0197] In this embodiment, the laser control system and the ultrasonic control system are partial and can be fully integrated into a single common control system. Therefore, in this embodiment, the femtosecond laser ultrasonic emulsification system has only one control system or a single control system.

[0198] Example 2

[0199] Turning Figure 3 An embodiment of a femtosecond laser ultrasonic emulsification system is shown along the line of Example 1, with the same numbers denoteing the same components. Figure 3 In this embodiment, the xy scanner 301 is located in the laser transmission head 202.

[0200] Example 3

[0201] Turning Figure 4 and Figures 4A to 4D The diagram illustrates the optical path and optical configuration of embodiments of the laser system, laser ultrasound system, and particularly femtosecond laser ultrasonic emulsification system of the present invention.

[0202] Optical system 430 has four optical systems 400, 401, 402, and 403, which may have different wavelengths, powers, and be used for different purposes. Optical system 400 is used for the treatment laser beam and includes optical components and defines the treatment laser beam path along which the treatment laser beam travels. Optical system 403 is used for an image and position determination device, such as a SAM device, which determines the shape and position of the eye structure among other things and is directly related to the treatment laser beam and the laser beam path. System 403 provides an image path. Optical system 401 is used for a camera, preferably an IR camera, and as can be seen from the figure, the beam path travels along most of the treatment laser beam path 400, i.e., coincides with it. System 401 provides an image path. The two paths are combined at a beam splitter, and the Vario (Z-axis laser deflection optics) used for the treatment laser is not part of the camera beam path 401. Optical system 402 is used for a second camera, preferably a color camera. System 402 shares some of the treatment laser beam path. System 402 provides an image path.

[0203] These systems also include an IR DTP ("down-to-the-pipe", e.g., configured to observe along the path of the laser beam) camera 480, beam splitter cubes 481, 482 (R: 880(S); T: 880(P), 1030(S+P)), a galvanometer 483, a DTP relay 491, a zoomer 484, a 1x telescope 485, an F-θ lens 486, a color DTP camera 487, a beam splitter cube 489 (R: 880, 1030; T: visible), and a Sham camera assembly 490.

[0204] Telescope 485 has a pair of telecentric 120mm lenses 493 and 494. The Sham camera assembly 490 has an image plane 470 with a 15-degree tilt angle, a Thorlabs lens (30mm) 471, an aperture stop (4.4mm) 472, and a folding mirror 473. The IR DTP camera 480 has an aperture stop (3mm) 450. The color DTP camera 487 has an aperture stop (2mm) 451.

[0205] Segments or portions of these optical systems 400, 401, 402, 403 may be located in or contained within various housings and components of embodiments of the laser system, the laser ultrasound system, and the femtosecond laser ultrasonic emulsification system. Therefore, by description, as... Figure 4 As shown, a portion of the optical system may be housed or contained within the distal housing 420 (e.g., Figure 5 The outer casing 503, or Figure 1 The outer casing 106), arm 421 (e.g. Figure 3 Arm 201, Figure 5 504 or light tube Figure 1Arm 107) and laser head or proximal housing 423 (e.g., proximal assembly or laser head (e.g.) Figure 1 The proximal end of arm 107, Figure 2 The first 202, or Figure 5 The optical systems 400, 401, 402, and 403 may also be distributed between and contained within the distal housing 420a, arm, or connector 421a and the proximal housing (e.g., the proximal assembly or laser head 423a), such as... Figure 4E The configuration is shown. These optical systems 400, 401, 402, and 403 can also be distributed between and contained within the distal housing 420b, arm 421b, and proximal housing (e.g., proximal assembly or laser head 423b), as shown. Figure 4F The configuration is shown. Other distribution and inclusion or accommodating arrangements for these optical systems are also envisioned.

[0206] Turning Figure 4G The visible optical system 430 has four pupils 461, 462, 463, and 464. In this embodiment, the pupils are conjugate telecentric pupils. Notably, only three of the four pupils are along the path of the therapeutic laser beam.

[0207] Example 3A

[0208] Example 3 is consistent with the therapeutic laser, i.e., a scanning laser that illuminates the structures of the eye so that optical components such as 403 can capture images to determine the location of the eye structures. Additionally, an eye-fixing light source is present to help stabilize the patient during the insertion process. The fixing light source and path are via... Figure 4G The bundled cube between 402 and 403 in the diagram.

[0209] Example 4A

[0210] The femtosecond laser phacoemulsification system has an image and position determination device based on an ultrasound imaging system. In one embodiment, the image and position determination device is an optical coherence tomography (OCT) system, which can determine the shape and position of the lens structure and eye structure relative to the treatment laser and the treatment laser beam. The OCT system is integrated with and controls the laser subsystem control system, the phacoemulsification subsystem control system, the femtosecond laser phacoemulsification system control system, and combinations and variations thereof.

[0211] For example, OCT systems can also be used in Figure 1 , 2 Examples of embodiments 3, 5, 14, and others.

[0212] Example 4B

[0213] Figure 1 , 2Embodiments 3, 5, and 14 have and use a Sham camera system as their image and position determination device. The Sham camera system is entirely different from the OCT system. The Sham camera has a very different operating mode, operates in a different manner, and provides very different outputs (e.g., results) than the OCT system. The Sham system of the present invention is considered superior to OCT in determining the position and shape of the eye structure.

[0214] The SAM camera system and laser subsystem control system, ultrasonic emulsification subsystem control system, femtosecond laser ultrasonic emulsification system control system, and their combinations and variants are integrated and controlled for communication.

[0215] The SAM camera system can also communicate with a foot switch, preferably a wireless foot switch. Control communication can be achieved via a bus, for example... Figure 22A The communication bus shown.

[0216] Example 5A

[0217] In embodiments of the femtosecond laser phacoemulsification system, the phacoemulsification subsystem comprises the following components and is characterized by an integrated system of peristaltic and Venturi pumps, allowing the surgeon to independently select either pump mode for phacoemulsification or vitrectomy. The phacoemulsification subsystem features: a dual-pump system, a peristaltic pump and a Venturi pump; high-vacuum occlusion; and high-speed vitrectomy. The phacoemulsification subsystem is capable of performing the following procedures: diathermy, irrigation, sculpting, flop and chop therapy, VIT therapy, and viscoelasticity supplementation (visco). The user interface and software provide menu items and monitoring fields for these and other phacoemulsification procedures. The interface may have a GUI screen and menus, such as... Figures 23A to 23D The type shown.

[0218] Example 5B

[0219] In an embodiment of the femtosecond laser ultrasonic emulsification system, the ultrasonic emulsification subsystem has features from Alcon Visual system and Alco ACTIVE Nose and Hybrid components.

[0220] Example 5C

[0221] In an embodiment of the femtosecond laser ultrasonic emulsification system, the ultrasonic emulsification subsystem has features from AMO WHITESTAR. Components of the PRO ultrasonic emulsification system.

[0222] Example 6

[0223] In embodiments of the laser ultrasound system, and particularly for femtosecond laser phacoemulsification systems, the system has a safety interlock. The safety interlock is preferably located in a common control system, but may also be located in, or as part of, the laser control system, the phacoemulsification control system, and combinations and variations thereof. The safety interlock prevents the phacoemulsification system from emitting therapeutic lasers while in operation. In embodiments, the interlock system has three levels or gates: (i) phacoemulsification system power off – laser can be operated; (ii) phacoemulsification system is on and preheating, but not operational or not operating – laser can be operated; and (iii) phacoemulsification is operational or running – laser cannot be emitted.

[0224] In this embodiment, level (iii) will allow the laser to operate when the phacoemulsification system is operational but not in operation. In this embodiment, the therapeutic laser will only be locked, i.e., unable to emit or propagate a laser beam, when the phacoemulsification system is in operation, i.e., transmitting ultrasonic energy.

[0225] Example 6A

[0226] In the embodiment, the three levels or gates in the interlocking system are: (i) the ultrasonic emulsification system and the femtosecond laser system are powered on, started / preheated; (ii) the ultrasonic emulsification system is turned on and ready but not operational—the laser can be operated; and (iii) the ultrasonic emulsification is operational or running—the laser cannot be emitted.

[0227] Example 7

[0228] Turning Figure 5 The figure shows a perspective view of a femtosecond laser phacoemulsification device or system 500. The system has a lower housing or main housing 501 (shown only partially in the figure). The lower housing 501 contains the phacoemulsification system, a phacoemulsification cassette and its location during the procedure, a treatment laser for generating the treatment laser beam, and a control system. A sliding mechanism 502 is located within the main housing 501. The sliding mechanism 502 provides movement of an upper housing or movable housing 503. The movable housing 503 is moved by the sliding mechanism 502 in the direction of arrow 502a (i.e., laterally, horizontally, or toward and away from the patient).

[0229] The sliding mechanism can be moved automatically by a motor controlled, for example, by a joystick; it can also be moved manually or in combination, for example, when the motor can rotate freely. The motor can have a set or predetermined position and can communicate with the smart headrest to precisely position or place the laser transmission head 505 above the patient's headrest and thereby operate on the patient and the patient's eyes.

[0230] The upper or movable housing 503 contains laser focusing optics in the z-direction, xy-scanning optics, and other beam processing or handling components. Housing 503 may also contain other optical systems and optical paths as discussed in Example 3.

[0231] Housing 503 is in optical communication with the therapeutic laser via a hinged optical tube 507. The hinged optical tube provides a free-space laser beam path that guides the laser beam from the lower housing 501 to housing 503 and transmits the therapeutic laser beam along this path to the optical components within housing 503. In this embodiment, as seen in more detail in 5I, the hinged optical tube 507 has six joints, each with a reflective surface on its inner side. Preferably, the optical tube 507 maintains optical communication between the therapeutic laser and housing 501 with housing 503 and the optical components within it in all possible positions and orientations of housing 503.

[0232] The housing 503 has an arm 504, which is a rigid hollow optical tube that houses or contains one or more optical paths, including a therapeutic laser beam path, and other paths as discussed in Example 3. The arm 504 connects the housing 503 to the laser transmission head 505 and maintains optical communication between these components. The arm 504 may also carry control and communication cables, optical fibers, or wires for transmitting control and information between 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.

[0233] The laser head has a position and shape determination device 506, which is a SAM device with five cameras. (In one embodiment, there are six fixed cameras. In another embodiment, there is a single movable camera.)

[0234] Example 8

[0235] Go to Figures 5A to 5H It shows the relationship with Figure 5 Various views and embodiments of the position adjustment mechanism used in the system (the same numbers have the same meaning and refer to the same parts).

[0236] Go to Figure 5A The position adjustment mechanism 510 is typically located on the opposite side of the housing 503 away from the arm 507. Parts of the mechanism 510 may be located below the housing 503 and above or inside the housing 501.

[0237] Figure 5BA lateral movement assembly 531, which is part of the position adjustment mechanism 510, is shown. The lateral movement assembly 531 has a first plate 520 and a second plate 521, which are mechanically and movably associated with motors 523 and 522 via, for example, drive gears or wheels. For the stationary post 512, plates 520, 521 move in an arcuate manner, which translates to lateral movement, i.e., in the direction of arrow 502a. The stationary post 512 is attached to a free-moving assembly, such as assembly 513. The lateral movement assembly 531 is mechanically associated with and can be housed on, and preferably within, housing 501.

[0238] Example 9

[0239] Go to Figure 5C The diagram shows a lateral movement assembly 511 with a four-bar linkage, which is part of the position adjustment mechanism 510a; and provides movement in the direction of arrow 502a. The lateral movement assembly 511 is mechanically associated with and can be housed on the housing 501, and preferably housed within the housing.

[0240] It should be understood that the lateral movement component 511 of Example 8 can be used with the position adjustment mechanism 510a of Example 9, and vice versa. It should be understood that the free movement component 513 can be used with either the lateral movement component 511 or the lateral movement component 531. It is understood that other free movement type machinery and electromechanical devices, as well as lateral movement type machinery and electromechanical devices, can be used.

[0241] Component 511 is attached to fixed post 512. This component moves fixed post 502 in the direction of arrow 502a. Fixed post 512 is connected to free-moving component 513. Free-moving component 513 provides movement of housing 503 in an arcuate, lateral, vertical, and combinations thereof, as generally indicated by the combination of arrows 513a. Component 513 is a parallelogram linkage mechanism.

[0242] Component 513 may be electrically powered, may have a predetermined position, or may be manually operated, for example, by gripping arm 504, housing 503, or other parts, and by changing the position of housing 503. In embodiments, housing 503, arm 504, and laser head 505 are balanced such that housing 503 can be moved with forces less than 10 pounds, less than 7 pounds, less than 5 pounds, less than 2 pounds, about 2 to about 7 pounds, about 4 to about 6 pounds, and combinations and variations thereof. Preferably, once moved, housing 503 will remain in its positioned position until subjected to a force sufficient to move it. (For simplicity, arm 504 and laser head 505 are not shown in the original text.) Figure 5C (as shown in the image)

[0243] Figures 5D to 5H The freely movable component 513 is shown to allow the housing 503 to be placed in some of its positions. Figure 5H The location was conceived for system storage and operating room cleaning. Figure 5E The location is used to perform laser surgery on the patient.

[0244] Example 10

[0245] In embodiments, the laser ultrasound system, and particularly the femtosecond laser phacoemulsification system, has a patient bed or support attached to the system.

[0246] Example 11

[0247] In this embodiment, the patient support, such as a bed, is not attached to the laser ultrasound system, and particularly the femtosecond laser phacoemulsification system. The patient support and the femtosecond laser phacoemulsification system can be completely positionable relative to each other, with no physical constraints between them. Therefore, the femtosecond laser phacoemulsification system can be positioned relative to the patient support in any location or orientation (provided, of course, the patient's head is within reach of the arm and the phacoemulsification tube). A orientation / position tracking system using an A / C electromagnetic field, gyroscope, accelerometer, and magnetometer is used to determine the orientation of the patient's head relative to the treatment laser and the treatment laser beam path. This orientation tracking system can determine the arm (e.g., Figure 5 The angle of the system's arm 504 is within a precision range of ±5 degrees, ±3 degrees, and ±2 degrees, as well as larger and smaller. This angle is used to adjust the therapeutic laser beam transmission pattern (preferably by the control system), thereby transmitting the laser beam pattern to the patient's eye at the correct directional angle.

[0248] In the embodiment, Polhemus Patriot TM A 6-DOF tracking sensor is located in the patient's headrest, with the transmitter 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.

[0249] Example 12

[0250] Electromagnetic tracking systems are used in stand-alone therapeutic laser systems that do not have an phacoemulsification subsystem. These stand-alone systems have a patient support not connected to the laser system. The electromagnetic tracking system determines the orientation angle between the patient's eye and the laser system. The laser system is configured with a laser transmission mode to meet the determined angle.

[0251] Example 13

[0252] The systems in Examples 11 and 12 have flexible or positionable mechanical attachments between the patient support and the treatment system. An electromagnetic tracking system is used to determine the position, and specifically the angle, of the patient's eye relative to the treatment system. The laser system is configured with a laser transmission mode to meet the determined angle.

[0253] Example 14

[0254] Components of the electromagnetic tracking system (e.g., gyroscopes, accelerometers, and magnetometers) are arranged in various ways on the patient support, the patient head support, the patient themselves, and in the treatment system, wherein the gyroscopes, accelerometers, and magnetometers are located in one or more of these components.

[0255] Example 15

[0256] In this embodiment, a combination of devices such as a gyroscope, accelerometer, and digital compass is located in the patient's headrest, and two magnetometers are located within the femtosecond laser phacoemulsification system. This provides sufficient equipment to determine orientation (e.g., the angle between the patient and the laser arm) as well as the laser beam path and pattern.

[0257] A compass-based positioning system using gyroscopes, accelerometers, and magnetometers is used to determine the position of the patient's head, and particularly the eye to which surgery will be performed, relative to the treatment laser and the path of the treatment laser beam. This compass-based positioning system can also determine the position of the arm (e.g., Figure 5 The angle of the system's arm 504 is within a precision range of ±5 degrees, ±3 degrees, and ±2 degrees, as well as larger and smaller. This angle is used to adjust the therapeutic laser beam transmission pattern (preferably by the control system), thereby transmitting the laser beam pattern to the patient's eye at the correct directional angle.

[0258] In this embodiment, a gyroscope and accelerometer are located in the patient's headrest, and two magnetometers are located within the femtosecond laser phacoemulsification system. This provides sufficient equipment to determine orientation (e.g., the angle between the patient and the laser arm) as well as the laser beam path and pattern.

[0259] The components of the compass-based position determination system (such as gyroscopes, accelerometers, and magnetometers) are arranged on the patient support, the patient head support, the patient themselves, and in various arrangements within the treatment system, wherein the gyroscopes, accelerometers, and magnetometers are located in one or more of these components.

[0260] The systems in Examples 11 and 12 have flexible or positionable mechanical attachments between the patient support and the treatment system. A compass-based positioning system is used to determine the position of the patient's eye relative to the treatment system, and specifically the angle. The laser system is configured with a laser transmission mode to meet the determined angle.

[0261] A compass-based positioning system is used in stand-alone therapeutic laser systems that do not have an phacoemulsification subsystem. The stand-alone therapeutic laser system has a patient support not connected to the laser system. The compass-based positioning system determines the orientation angle between the patient's eye and the laser system. The laser system is configured with a laser transmission mode to meet the determined angle.

[0262] Example 16

[0263] The headrest or other remote components of the tracking system (such as an electromagnetic tracking system) (i.e., not part of the treatment system) have rechargeable batteries that can be charged at a separate charging station, in a storage container, or on the treatment system.

[0264] Example 17

[0265] In embodiments of a femtosecond laser phacoemulsification system, the control system recommends, for example, matching, cataract grade, laser power and mode, and ultrasound rate, power, phase angle, flow rate and jet rate, as well as other aspects related to the phacoemulsification head and the phacoemulsification operation. In this way, the system recommends and pre-determines all energy and fluid flow rates delivered to the eye as part of the treatment in a fully integrated device. In embodiments, the phacoemulsification head is adjusted by the system controller to optimize the phacoemulsification procedure based on a prior laser surgery, which in turn is based on a prior cataract grade. This system provides a single system capable of rapidly and without requiring patient or system movement to determine the shape and position of corneal structures (e.g., anterior and posterior surfaces), the lens of the eye, such as the anterior and posterior capsules, grading the type or density of the cataract, performing laser capsulotomy, and laser fragmentation of the lens, and then phacoemulsifying the laser-fractured lens material to remove it for IOL insertion. The system is configured to optimize the next step in the procedure using information obtained from each prior step of the surgery. In this way, the system delivers a fully integrated and predetermined total energy delivery and energy delivery profile to the eye during ophthalmic surgery. In this embodiment, the total energy delivery and energy delivery profile are based on the grade of the cataract being treated. The total energy delivery and energy delivery profile include laser energy and ultrasound energy.

[0266] Example 18

[0267] In this embodiment, the femtosecond laser phacoemulsification system provides a predetermined, variable mode for the surgeon or practitioner performing the procedure. Therefore, in this mode, the system works in conjunction with the laser controller system and the phacoemulsification control system to predetermine and provide, recommend, and preferably optimize the scope and settings of the phacoemulsification procedure. This embodiment can also "learn" based on the surgeon's choices and preferences to provide a customized optimal range according to the surgeon's practice and input.

[0268] Example 19

[0269] In embodiments, the femtosecond laser phacoemulsification system provides adjustable modes that offer greater variability and predetermined variability, for example, by providing the ultrasound adjustment range based on the laser beam mode or the laser treatment delivered to the lens, the cataract grade (preferably determined by the system or available to the system), and other factors. The system can then provide recommended ranges and adjustments for the procedure, including: (i) recommending torsional lateral movement, transverse lateral movement, or no lateral movement; (ii) recommending a laser mode to increase fragmentation and thereby reduce phacoemulsification power to manage heat buildup in the eye; and (iii) a recommended duty cycle.

[0270] Duty cycle and duty cycle recommendations can include, for example, selecting a mode such as pulse mode, which alternates between phacoemulsification power pulses and rest periods, with a default ratio of 50:50. This is called a 50% duty cycle because each complete cycle consists of 50% of the time being powered on and then 50% of the time being powered off. This default ratio can be changed to alter the ratio of ultrasound energy to rest intervals. For example, 40% produces 40ms on and 60ms off, resulting in a ratio of 40:60. When is a higher or lower duty cycle preferred? The answer depends on the stage of the procedure. To shape the cell nucleus, for example using a divide-and-conquer technique, the surgeon needs to deliver enough energy to cut the groove. This requires a duty cycle of approximately 40% to 60%. Once the surgeon has placed the groove in the nucleus and achieved the opening that leads to the quadrant, a lower duty cycle can be used during phacoemulsification-assisted aspiration in the quadrant. For this quadrant removal, a lower duty cycle of 20% to 40% can be used because the primary force for aspiration is fluid rather than ultrasound.

[0271] Example 20

[0272] In this embodiment, the ultrasonic emulsification subsystem is used only to separate laser-cut materials, for example, when the laser-cut material is smaller than the opening of the ultrasonic emulsification aspiration needle.

[0273] Example 21

[0274] Laser ultrasonic emulsification systems, and especially femtosecond laser ultrasonic emulsification systems, have integrated microscopes.

[0275] Example 22

[0276] The adapter is used within the housing of an ultrasonic emulsification femtosecond laser system to fit or use ultrasonic emulsification packages and cartridges from multiple companies or of different types. The adapter contains the necessary hardware and software to provide complete, effective, and approved operation of the system. The adapter can be part of the housing, a separate insert or component for the housing, or it can be part of or integrated with the cartridge.

[0277] Example 23

[0278] Go to Figure 6 This diagram illustrates a plan view of a laser ultrasound system, specifically a femtosecond laser phacoemulsification system positioned for performing laser ultrasound therapeutic procedures. The femtosecond laser phacoemulsification system 610 is positioned at an angle between a temporal and superior position. The laser delivery head can extend to the patient to perform laser surgery and move away from the patient, as indicated by arrow 620, to perform ultrasound surgery. A headrest 612 and a patient support 613 are positioned relative to the femtosecond laser phacoemulsification system. The system and patient support have a positioning system, such as an electromagnetic positioning system, that determines the laser system relative to the patient's headrest and thus determines the patient's angle 630, angle 630a, or both. The measured angle is the angle between the longitudinal axis 631 of the arm and the longitudinal axis 632 of the patient (specifically, the patient's head, as determined by the headrest).

[0279] Three positions for the surgeon are shown: upper 641 and temporal 640, 642. As can be seen, the laser arm does not interfere with the surgery regardless of the surgeon's preferred position.

[0280] Furthermore, the laser head can be easily repositioned to reach and perform laser surgery over the patient's eyes without requiring repositioning of the patient support or the femtosecond laser phacoemulsification system.

[0281] In this embodiment, the laser system can be positioned at an angle ranging from approximately 30 degrees to approximately 320 degrees, and any angle 630 within that range. The only limitation on this angle is the area where the patient support is located. Among other things, the surgeon can position it in a superior or either temporal position.

[0282] Example 24

[0283] Go to Figure 7 The diagram illustrates several of these possible configurations and surgeon positions, all of which provide complete access for the surgeon. For each of these configurations, this complete access is to either of the patient's eyes. Thus, the laser ultrasound system 610 can be located at: 45 degrees 656, 90 degrees (i.e., temporal) 655, 135 degrees 654, 180 degrees (i.e., superior) 653, 225 degrees 652, 270 degrees (i.e., temporal) 651, and 315 degrees 650. It should be understood that the laser ultrasound system can be located at any angular position between those shown in the diagram. Thus, full-position positioning is provided, for example, a “clock” of the laser ultrasound system around each of the patient's eyes. In this way, the system can be considered non-manual, as the system configuration is identical for both left-hand and right-hand positions for the surgeon.

[0284] Example 25

[0285] Figure 8 This is an embodiment of the Sham shape and position determination component for the laser transmission head used in the system of the present invention. This embodiment is a 5-camera configuration, wherein cameras 5001, 5002, 5003, 5004, and 5005 are spaced 40 degrees apart. This arrangement allows the system to operate in any configuration as described in Examples 23 and 24. Even in some configurations and for some patients, one or two cameras may be obstructed, the system will still operate and provide reliable images for shape and position determination.

[0286] Example 26

[0287] Figure 9 This is an embodiment of the Sham shape and position determination component for the laser transmission head of the system of the present invention. This embodiment is a 6-camera configuration, wherein cameras 6001, 6002, 6003, 6004, 6005, and 6006 are spaced 40 degrees apart. This arrangement allows the system to operate in any configuration as described in Examples 23 and 24. Even in some configurations and for some patients, one, two, or three cameras may be obstructed, the system will still operate and provide reliable images for shape and position determination.

[0288] Example 27

[0289] Turning Figure 10A and Figure 10B This shows perspective views of the near-end laser assembly with a docking system from different angles. Figure 10B In the image, the head cover is removed, revealing a SAM camera, such as 1001a. A proximal laser assembly 1000 is attached to the proximal end of an arm 1040, which is a light tube housing the path of the therapeutic laser beam and the laser beam during operation. Assembly 1000 has an automated docking system 1010 with a drive assembly 1011 connected to a docking ring 1020, which docks to and forms part of a PID. The docking system 1010 is preferably controlled by a control system and can be operated wholly or partially by a surgeon using a joystick. The control system also controls the operation of the docking system and may include a load sensor, speed control, and safety and control systems.

[0290] Example 28

[0291] Embodiments of the therapeutic laser beam used in the system and therapy of the present invention have high-quality beam characteristics. The laser beam may have an M0 of 1 to approximately 2.5, less than 2, less than 1.5, and less than 1.2. 2 factor.

[0292] Example 29

[0293] In embodiments of the system of the present invention, the transition from femtosecond laser to ultrasonic emulsification, including disengaging the laser, removing the laser arm, and preparing the ultrasonic emulsification tool for insertion (and in embodiments, inserting the ultrasonic emulsification tool into the eye), may take less than 5 minutes, less than 4 minutes, 3 minutes and 2 minutes, and less, about 3-5 minutes, about 3-4 minutes, about 2-4 minutes, and longer and shorter times.

[0294] Example 30

[0295] In this embodiment, the femtosecond laser phacoemulsification system, with a 32-inch x 22-inch footprint, offers bed arrangement freedom that allows the device to be positioned anywhere around a patient who is 6'3" or smaller. This system provides truly agile operation. This agile system provides full-time laser access around each eye, as well as temporal and superior proximity for the surgeon.

[0296] Example 31

[0297] Various embodiments (e.g., examples of the laser system components) are used in stand-alone laser systems that do not have an integrated ultrasonic emulsification system.

[0298] Example 32

[0299] In embodiments of these devices, the footprint, i.e., the device housing formed by the outer casing, is 5 square feet (22 inches x 33 inches = 726 square inches / 144 = 5 square feet). The height of the device varies from 57 inches to 65 inches. The laser arm and its optical head move primarily horizontally. The arm does not rotate about a pivot point. During storage, the arm is fully fitted to the device housing (i.e., 22 inches x 33 inches). The maximum travel of the laser arm and its optical head in the "X" direction is 33 inches for initial setting of the nominal position. Once in the nominal position, the motion platform can move + / - 2 inches in the X direction, + / - 2 inches in the Y direction, and +5 / - 3 inches in the Z direction for fine-tuning relative to the patient. (In this example, X is the long axis of the device, Y is the transverse axis of the device, and Z is the longitudinal axis of the device.) Therefore, in this embodiment, the arm moves in the X and Y directions such that the entire arm and its optical head are fitted within the device footprint during storage. The housing is not adjustable, and therefore its width and lateral dimensions do not change.

[0300] Example 33

[0301] Go to Figure 14 The image shows a perspective view of an embodiment of the femtosecond laser ultrasonic emulsification system 1400. Figure 15 , Figure 15A , Figure 15B , Figure 16A , Figure 16B, Figure 16C , Figure 17A , Figure 17B , Figure 17C It shows Figure 14 The system's various components and configurations. The same numbers in these diagrams represent the same components.

[0302] The femtosecond laser ultrasonic emulsification system 1400 has a housing 1401 forming a base 1403. Above the base 1403 and attached to the housing 1401 is a motion mechanism housing 1402. The housing 1402 includes mechanisms for horizontal movement (i.e., extension and retraction) of an extendable component 1409. A transition slide 1410 extends and retracts via a horizontal motion mechanism 1420. The transition slide 1410 supports an optical component and a scanner housing 1406. The housing 1406 also includes a vertical motion mechanism 1425 and a vertical motion transition slide 1411.

[0303] The extendable component 1409 includes a housing 1406, an arm 1407, and a laser beam delivery head 1408, wherein the arm contains various optical paths of the system and control cables. The laser beam delivery head 1408 includes a shape and position determination device 1412 and a PID 1470.

[0304] In Figure 17, system 1400 is shown with one monitor 1413. The system may have one or two additional monitors (such as...). Figures 16A to 16C (As shown in the figures). The system can have an integrated microscope (not shown in these figures).

[0305] exist Figure 15 The image shows an extendable component 1409 attached to a conversion slide 1410. The slide 1410 has an extendable / retractable base 1424 and a flexible extendable / retractable cover 1422. The slide 1410 provides horizontal movement for the component 1409. The slide 1410 is positioned within a housing 1402 and partially forms the top surface of the housing. The housing 1402 is attached to the housing 1401.

[0306] Go to Figure 15A ,as well as Figure 15 A horizontal movement mechanism 1420 is contained within a housing 1402. Mechanism 1420 can be directly attached to housing 1402, housing 1401, and combinations and variations thereof. Housing 1402 also includes a reel 1423 that holds (i.e., winds and unwinds) a flexible cover 1422. Housing 1402 also includes a roller 1421 on which the flexible cover 1422 moves.

[0307] Figure 15AA horizontal movement mechanism 1420 for removing cover 1402 is shown. Mechanism 1420 includes a motor, drive mechanism, sensor, and controller. Mechanism 1420 has a horizontal sliding mechanism 1426, which is a pair of interlocking slide rails. Support 1428 connects the inner rails to a vertical sliding mechanism 1427, which forms part of the vertical movement mechanism 1425 (see [link to diagram]). Figure 15 ). Figure 15B The image shows the first extended position (the position for laser operation). Figure 15A Guide rail assembly.

[0308] Figure 16A It has 3 monitors Figure 14 A plan view of system 1400. System 1400 is located in an operating room or patient treatment room. System 1400 is in a fully retracted (e.g., parked) position. In the parked position, the extendable component 1409 does not extend from the base 1403. Therefore, in this position, the extendable component 1409 does not extend beyond (i.e., it is entirely within) the system's footprint or housing 1480. System 1400 is shown relative to the patient bed 1490 and the person.

[0309] Figure 16B The system is shown in an extended position (first position or first extended position) for performing therapeutic laser operations. Although the system is shown at a 90-degree angle 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 angle as in Examples 23 and 24. The extendable component 1409 extends horizontally beyond the system housing to position the laser head above the patient.

[0310] Figure 16C A system for performing laser treatment procedures is shown in its fully extended position. The system is shown at a 135-degree angle to the patient. The fully extended position maintains a sufficient distance between the system housing and the patient, providing the practitioner with appropriate, comfortable, and ergonomic access. An extendable component 1409 extends horizontally beyond the system housing to position the laser head above the patient. (Comparison) Figure 16C and Figure 16B This indicates that it is in Figure 16C The fully extended position of component 1409 is longer, that is, compared to the position in Figure 16B In the first extended position, the laser head is further away from the base.

[0311] Figures 17A-17C It is a series of photos that show Figure 14 The specific position of the system's extendable components when they extend and retract. Figure 17A The neutral extension position is shown for testing and calibration of the laser system. Figure 17B The first operating extension position for the treatment laser operation is shown. Figure 17C The second operating extension position (fully extended) for the treatment laser operation is shown.

[0312] Therefore, the system can have four predetermined positions: a parking position, where the laser head and expandable components are located within the equipment's footprint; a neutral position where only the laser head extends horizontally beyond the equipment's footprint; a first extended position where laser treatment activities can be performed on the patient; and a second or fully extended position where laser treatment activities can be performed on the patient. These four predetermined positions can be controlled by stops, mechanical-based methods, software-based methods, and combinations and variations thereof. The system can also be configured to have any number of other extended lengths, from neutral to fully extended, either predetermined or determined individually by the operator, as well as combinations and variations thereof.

[0313] The housing includes a power supply unit, a control unit, an operating unit, an analysis, prediction, and diagnostic device, a positioning and location device, a laser beam generating unit, and an ultrasound generating unit. In a preferred embodiment, the ultrasound generating unit is a component of the ultrasonic emulsification system, and the laser beam generating unit provides a laser beam with a pulse length of approximately 2 ps or less.

[0314] These components can be distributed, wholly or partially, between the two housings 1401, 1402, among other reasons: to optimize space, thereby avoiding interference between components, managing heat and vibration, and providing more efficient control and operation of system 1400. The two housings 1401, 1402 can be independent housings on the same base or frame, and can have communication, control, power, optical, and other connections between them. They can be separate, identical housings, or they can be subdivided or divided into a third or sub-housing, or a fourth or sub-housing, etc., as well as combinations and variations thereof.

[0315] Connector 1505 is an optical conduit connecting housing 1401 and housing 1406. Housing 1406 includes a scanning device and beam-shaping optics for a therapeutic laser beam, which, along with the optics, can also be used to monitor and diagnose the laser beam and optical path. (Housing 1406 also includes a vertical motion mechanism.) It should be understood that, in embodiments, these components of housing 1406 may be wholly or partially located in one of the other housings, and similarly, components from other housings may be located in housing 1406. Housing 1406 may be subdivided or divided into one or more housings or sub-housings, as well as combinations and variations thereof. In a preferred embodiment of the invention, housing 1406 includes and isolates the scanner and beam-shaping optics. The scanner and beam-shaping optics or other components that may be included in housing 1406 may communicate with the controller and operating system of system 1400. Devices may communicate directly with each other, or they may communicate indirectly with each other, for example, through communication with a central control, such as the system 1400 controller, monitor 1413 (which may also have control capabilities), and combinations and variations thereof. These devices can also control and communicate with each other directly and indirectly.

[0316] The optical guide tube 1405 can be a light tube (e.g., a hollow tube or channel with an internal reflective surface, through which a laser beam is transmitted via free space within the hollow tube, which may have a partial vacuum, contain ambient air, contain an inert gas, and combinations and variations thereof), an articulated light tube, a telescopic light tube, a flexible light tube, an optical fiber, one or more optical fibers, a hollow guide tube, a beam guide, and combinations and variations thereof with other laser beam transmission structures.

[0317] The housing 1406 is attached to the arm 1407. The arm 1407 and housing 1406 are movable in the vertical direction via a moving mechanism 1425. The arm 1407 has a component or device 1412 for determining the shape and position of the eye and structures within the eye. At its proximal end, i.e., the end furthest along the laser beam path and therefore furthest from the laser beam source, and below the device 1412, the arm 1407 has a patient interface device (PID) 1470. The housing 1406 has a monitor 1413. The monitor is movable, for example, on the articulated arm. The monitor can provide information such as surgery, system status, laser status, ultrasound status, cataract density, ultrasound settings, laser mode settings, and can receive input and instructions from the surgeon. The monitor communicates controllly with the system 1400 control system; the monitor may also comprise part or all of the system 1400 control system. The monitor communicates controllly with the laser control system and ultrasound control system directly, or through the system 1400 control system, through the monitor 1413, and combinations and variations thereof. The monitor and its articulated arm can be located on other structures within system 1400 or can be stand-alone. One, two, or additional monitors can be used. The monitor may have 3D viewing or display capabilities.

[0318] Arm 1407 forms or includes a laser beam transmission structure, such as a hollow tube providing free space for the transmission of the laser beam. In embodiments, arm 1407 may include a beam path in free space or an optical fiber for transmitting the laser beam to, for example, a scanner located at the proximal end of the tube rather than the distal end, i.e., the proximal end housing 1406. Arm 1407 may also be or include any laser beam transmission structure of the type described as used as an optical guide 1405. The tube may also contain optics. Figure 14 In this embodiment, arm 1407 contains an uncollimated laser beam, and therefore arm 1407 can be referred to as containing an uncollimated laser beam and a laser beam path; in other words, arm 1407 contains, surrounds, or accommodates an “uncollimated space” along the laser beam path. Arm 1407 can accommodate or surround a collimated space, i.e., the space in which the laser beam on the laser beam path is collimated. It can accommodate a space containing optics. It can accommodate both collimated and uncollimated spaces. Arm 1407 in this embodiment can pivot, rotate, extend, hinge, and combinations and variations thereof from its distal end. The proximal end of the laser beam path in arm 1407 includes a mirror or optics to guide the laser beam through the PID and to reach and enter the patient's eye.

[0319] Example 33A

[0320] The femtosecond laser phacoemulsification system of Example 33 features a surgical microscope 1457. It should be understood that the surgical microscope depicted in this example can be used with other examples of systems and other embodiments of the systems described in this specification.

[0321] Example 34

[0322] In the embodiments, the laser system has external cooling, internal cooling, or both.

[0323] Example 35

[0324] Turning Figures 12A to 12J The diagram illustrates a PID (Patient Interface Device) that is attached to and used with any of the laser ultrasound systems of this invention, and is also intended for use with stand-alone laser systems. Figures 12A to 12J In this context, the same numbers correspond to the same structure. In this example, and as... Figures 12A to 12J As shown, an embodiment of PID 1200 has the following components:

[0325] 1201 PID Arm

[0326] 1202 Upper Window

[0327] 1204 Eyepiece;

[0328] 1204a Eyepiece outer skirt

[0329] 1204b Eyepiece Inner Skirt

[0330] 1205 IUD insertion

[0331] 1206 Lower IUD

[0332] 1207a Buckle

[0333] 1207b buckle

[0334] 1207c buckle

[0335] 1208a shock absorber

[0336] 1208b shock absorber

[0337] 1208c shock absorber

[0338] 1209 Meniscus Conversion Component

[0339] 1210 Liquid Storage Ring

[0340] 1211 Upper Ring Sidewall

[0341] 1212 Channel for brine filling

[0342] 1213 Vacuum port

[0343] 1220 Attachment Block

[0344] 1221 Arm

[0345] Locking position of arm 1221a

[0346] 1222 Receiver Clip

[0347] 1223 Joining ball

[0348] 1224 slot (motion slot)

[0349] 1225 shows the arrow indicating arm movement.

[0350] 1226 shows the arrow indicating the movement of the block engagement.

[0351] 1250 eyes

[0352] 1260 Laser Ultrasonic Equipment

[0353] The patient interface device is attached to the eye as a single component. The entire device is positioned and engaged with the surface of the eye after attachment to the laser head. The PID arm is attached to the laser system via a clamping mechanism.

[0354] During the docking process, the suction cup of the PID arm is gently placed on the corneal surface, so that the suction ring contacts the surface of the eye. Then, a vacuum is activated to suppress the relative movement of the eye, thereby stabilizing its position relative to the PID for precise laser treatment.

[0355] Three spherical features on the PID arm engage with motion slot features on the clamping mechanism. During positioning engagement, spring force is applied to the PID arm by the balls. Once the PID is in place, the control lever activates the CAM mechanism to load the balls onto the PID and lock the motion support in place.

[0356] The suction cup interface, or "eye shield," covers the front surface of the eye and attaches to it. A glass window defines the first plane of the patient interface device. It serves as a position reference for the first refractive surface used by software algorithms to calculate the precise location of the focal point of light emitted from an illumination or laser beam.

[0357] Three snap-fit ​​windows secure the unit. Three encased molded shock absorbers push the windows firmly into the snap-fit ​​undercut. The fluid chamber of the PID arm is designed with a circular wall extending close to the window. This allows the fluid meniscus to invert during fluid chamber filling before contacting the window. Proper fluid contact with the window, i.e., from the center outwards to the periphery, helps prevent air bubbles from accumulating below the window, which could cause interruptions in the laser beam.

[0358] The fluid chamber of the PID arm extends into a reservoir ring, through which additional fluid from the chamber drains. This also acts as a barrier, preventing the saline solution (BSS) in the chamber from contacting the patient's skin and thus causing it to drain away via capillary action.

[0359] The PID arm has a flexible attachment ring at its base, suitable for interface connection with the anterior surface of the patient's eye. The attachment ring comprises a flexible annular outer skirt and an inner skirt made of silicone, which engage with the eye surface when the eye patch is secured. The inner and outer skirts define an annular suction channel for a vacuum communication channel.

[0360] In other aspects of the design, the PID arm has a vacuum port on its side, which is used to generate suction in the annular suction channel and allow the goneck interface to adhere neatly to the patient's eye. A second port next to the first port connects to medical-grade tubing to fill the goneck interface chamber with saline solution (BSS).

[0361] Example 35A

[0362] Go to Figure 13 The diagram shows a perspective view of the PID 1300. The PID 1300 has a PID arm 1301, an upper (distal) window 1302, and a lower (proximal) glass window 1303. The upper (distal) window may be glass and preferably has high transmittance to the therapeutic laser, and the lower (proximal) glass window may be glass and preferably has high transmittance to the therapeutic laser.

[0363] Example 36

[0364] Turning Figure 18 and Figure 19 The diagrams illustrate the fixed-light optical components and path, as well as the down-the-tube (DTP) path, for example, a portion of the path along which the therapeutic laser beam is transmitted to the eye, the optical components, and the path for observing the eye with a camera. In a preferred embodiment, most of the fixed-light path and the DTP observation path overlap.

[0365] Example 37

[0366] In an embodiment, the laser ultrasound system (e.g., a femtosecond laser phacoemulsification system) has a laser configured for posterior capsulotomy and laser manipulation of the posterior lens capsule. The system also has predetermined phacoemulsification parameters that are accessible, usable, integrated with, and optimized for laser operation. The system can be configured using lasers with features such as... Figures 23A to 23D The GUI shown on the screen is for a menu-based control system.

[0367] Example 38

[0368] Patient positioning devices for laser, laser ultrasound, and femtosecond laser phacoemulsification systems can have independent markers that can be placed on the body, headrest, or both, and do not require continuous line-of-sight tracking. Magnetic fields are generated by the markers and output position and orientation data without the need for subsequent analysis calculations. Accurate, high-quality data is provided at an update rate of 50 Hz per marker. Markers can be added (e.g., four per system). The system is further described in Table 2.

[0369] Table 2

[0370]

[0371] Example 39

[0372] Laser, laser ultrasound, and femtosecond laser phacoemulsification systems can have a surgical microscope integrated with the system. The microscope can be attached to the system housing, and is preferably integrated into the system. In this way, the microscope communicates information, data, and control with the system control system (e.g., a femtosecond laser phacoemulsification control system). Thus, for example, the surgical microscope and system are configured for the microscope to receive commands and views (digital overlays) from the therapeutic laser system, and particularly the optics and data systems. This communication occurs during laser (e.g., femtosecond laser mode), during laser surgery (e.g., during femtosecond laser surgery), during phacoemulsification mode (e.g., during phacoemulsification surgery), during idle, warm-up, or observation modes (phacoemulsification, laser, or both activated but without surgery), and during combinations thereof.

[0373] In this embodiment, the surgical microscope is replaced by or enhanced by a 3D vision system. The 3D observation system can be any system that displays three-dimensional images of eye structures (including, for example, the cornea, lens, PID interface and contact with the eye, IOL, and combinations and variations of these and other structures and devices) to a surgeon or other practitioner or observer. For example, the 3D observation system can be a wearable 3D attachable assistive device (e.g., the BEYEONICS Surgical device), a 3D monitor, a monitor-and-glasses based system, a heads-up display system, and combinations and variations thereof. The 3D observation system can 3D record the process and can provide remote 3D images of the process in real time to remote locations, such as different locations where a laser system is located.

[0374] Example 40

[0375] Laser and laser-ultrasound systems, such as femtosecond laser-assisted ultrasonic emulsification systems, can feature a "smart" foot switch associated with the system. This foot switch is integrated with the system's control system. It can turn the laser and ultrasonic emulsification on and off according to the system's mode. The foot switch can also be integrated with menu systems, GUIs, and voice commands to allow for program selection, such as menu-driven items on the GUI. Figures 23A to 23D The menu items are shown. The foot switch can also be integrated with speech and hearing control and menu selection systems (such as "ALEXA" or other types of voice command systems).

[0376] The foot switch can be wired, i.e., it has a control cable that connects the foot switch to the laser ultrasonic emulsification system. Preferably, the foot switch is wireless and communicates with the control system for the laser, ultrasonic emulsification, integrated unit, one or more of these, and all of them.

[0377] Communication buses can be used for foot switches and other devices and systems. For example... Figure 22A As shown, the bus terminates at each end, and multiple devices can then shut it down without a monitoring computer. In this way, all devices can exchange information with each other (e.g., for control communications, information communications, and both). In a preferred embodiment, both the ultrasonic emulsification and femtosecond laser computers are connected to foot switches on the bus. The foot switches can broadcast message packets, which can be processed by two computers (e.g., controllers) for the laser system and the ultrasonic emulsification system. The main femtosecond laser computer can use some foot switch controls to emit the laser or perform mode-changing operations. The ultrasonic emulsification computer can simultaneously use other foot switch controls to perform other operations, such as controlling ultrasonic emulsification energy, rinsing, or vacuuming.

[0378] In this embodiment, the bus is a broadcast bus, such as a CanBus.

[0379] In this embodiment, TCP / IP can be used. However, commercially available foot switches are typically not TCP / IP based. Bluetooth or hardwired foot switches can also be used, but are less preferred.

[0380] Example 41

[0381] Turning Figure 20 , Figure 20A , Figure 20BAn embodiment of the PID 2000 is shown. Compared to more complex PIDs, the PID has four components, significantly reducing assembly costs and complexity, and making cleaning easier. The PID can be single-use or reusable. The PID 2000 has an integrated, for example, integral arm 2001 with engagement devices, such as clips 2010, for attachment to a system (e.g., laser, laser ultrasound, femtosecond laser ultrasound emulsification, etc.). The PID 2000 also has two ports 2007 and 2008, which can be used for fluid delivery and vacuum. Preferably, 2008 is used for vacuum and 2007 is used for BSS delivery. The PID 2000 has a window 2002 located in a retaining ring 2003 and secured in place by clips 2004a, 2004b, and 2004c. An integral annular vacuum ring 2005 engages the proximal end of the retaining ring 2003. The annular vacuum ring 2005 is in fluid communication with ports 2007 and 2008. The annular vacuum ring 2005 is preferably an integral part. The annular vacuum ring 2005 is engaged with and holds the flexible eye engagement ring 2006, which is in fluid communication with one or both of the ports 2007 and 2008.

[0382] PID 200 has a window support and a fluid management system, which has pins 2020a, 2020b, and 2020c (which are preferably integrated, i.e., integral part of ring 2003). The pins support the window 2002 on the proximal (lower) side of the window, while clips 2002a, 2002b, and 2002c engage the side and distal (top) ends of the window 2002. The pinned window is held above two fluid channels, an external fluid channel 2021 and an internal channel 2022. The channels are separated by annular arms (e.g., rings or ridges 2055). In an embodiment, the height of the external channel 2021 (and therefore the height of the ring 2055) is slightly lower than the pins, for example, about 1 mm, about 0.7 mm, or about 0.5 mm lower than the top of the pins. The internal and external channels serve as a fluid storage system, maintaining fluid contact with the bottom side of the window while allowing air bubbles to escape and excess fluid to overflow into the external fluid channel 2021.

[0383] Example 42

[0384] Turning Figure 21 , Figure 21A , Figure 21B , Figure 21C , Figure 21D , Figure 21EVarious views and components of an embodiment of a femtosecond laser phacoemulsification laser system 2100 are shown. Similar numerals refer to similar structures. System 2100 has a laser subsystem and an phacoemulsification subsystem contained within a common housing. The laser subsystem includes a therapeutic laser beam source and, in embodiments, includes slow pulse duration and long pulse duration therapeutic laser beam sources. The laser subsystem includes a laser that defines the therapeutic laser beam path along which it travels and optical components placed or positioned along the laser beam path. These components will include z-axis focusing optics and an xy scanner.

[0385] The femtosecond laser ultrasonic emulsification system 2100 has a first housing 2101 and an optical assembly and scanner housing 2102, which are movably, 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, which is mechanically associated with the housing 2101 and is immovable relative to the housing 2101.

[0386] The optical assembly and scanner housing 2102 has an arm 2105 that houses portions of the laser beam path and optical path, and thus provides transmission of the laser beam and optical image. Mechanically and optically associated with the arm 2105 is a laser transmission and imaging head 2106. Vertical movement of the head 2106 is controlled by a joystick 2107 (and can be performed independently or in conjunction with a control system, and can also be performed via a GUI). Vertical movement can be achieved using any of the various devices disclosed in this specification.

[0387] The head 2106 has a positioning device 2108 and a patient interface device 2109.

[0388] A laser beam movable connector device, such as a hinged hollow tube 2110, transmits a laser beam for a laser in housing 2101 to optics and beam processing equipment in housing 2102.

[0389] The system has an opening 2114 for holding and storing the ultrasonic emulsification tray assembly 2112. The ultrasonic emulsification tray assembly has a frame 2122 for holding the support tray 2121 and the engagement pin 2113.

[0390] System 2100 has two openings 2111 (left side) and 2120 (right side) for receiving and retaining pin 2113 and thus ultrasonic emulsification tray assembly 2122. In this way, system 2100 is non-manual, so it can be configured to be used on both the left and right sides in the same way, and the tray and tray assembly are non-manual because they can be used on both the left and right sides of the system.

[0391] The system 2100 has an ultrasonic emulsification chamber 2115 and a port 2116 for connecting ultrasonic emulsification related components (e.g., air, VIT, DIA, control cable, etc.).

[0392] System 2100 has two monitors 2117 and 2118, which are preferably graphical user interfaces (GUIs) that display information and menus and accept input such as instructions from a system operator. The GUI can display control and information menus, for example... Figures 23A to 23D Those shown.

[0393] System 2100 has an emergency stop component 2119.

[0394] In this embodiment, the positioning and determining device 2108 has six or five SAM camera assemblies, such as 2123, 2124, 2125, and 2126. The head 2106 has a laser transmission opening 2128. The laser beam path and image path pass through this opening. The opening may have a transparent window that allows the laser beam and image to pass through, and it may also have 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 the retracted position or when the ultrasonic emulsification system is running).

[0395] For example, PID 2109 can be the PID of Example 41. PID 2109 is connected to laser head 2106 via PID locking and engagement device 2127, and thus to laser system 2100. Device 2127 has a locking position (e.g., Figure 21E (as shown) and unlock position (as shown) Figure 21D The movable locking lever tab 2129 is shown between the two.

[0396] Arm 2105 accommodates the therapeutic laser beam path and other optical paths. In an embodiment, arm 2105 also accommodates or carries control and power cables for imaging and positioning devices, as well as docking assemblies (not shown in the figure).

[0397] System 2100 has a common power supply for both the laser subsystem and the ultrasonic emulsification subsystem. This common power supply provides all power to the entire system, eliminating the need for auxiliary power supplies or individual power sources. This allows the system to be plugged into a single power source within the operating room.

[0398] System 2100 has a common control system, which includes an emergency stop button or switch 2119. The common control system has controller operation control software or operating instructions. In a preferred embodiment, the common control system communicates control with one or more, and preferably all of, the following: the control system and controller in the laser subsystem; the control system and controller in the phacoemulsification subsystem; control communication with the operator interface; control communication with the emergency stop 2119; and network communication with, for example, patient record systems, accounting systems, and combinations and variations of these configurations.

[0399] In this embodiment, the docking system (preferably with a joystick) and the imaging and positioning devices are controlled by the laser subsystem control system. In this embodiment, they may be wholly or partially controlled directly by a common control system. In this embodiment, the laser control system and the ultrasonic control system are partial and may be fully integrated into a single common control system. Therefore, in this embodiment, only one control system or a single control system exists in the femtosecond laser ultrasonic emulsification system. In this example embodiment, the system uses the bus communication system of Example 40, which is also depicted in 22A.

[0400] Example 43

[0401] Go to Figure 22A The example illustrates system 2100 of example 42, to which a foot switch 2130 is added. The foot switch communicates with a system computer, such as a controller and system devices, via wireless communication line 2131.

[0402] This example implementation uses the bus communication system of Example 40, which also... Figure 22A Described in the text.

[0403] Example 44

[0404] In one embodiment, the integrated laser ultrasound system has a first housing, a second housing, a GUI, and means for optically connecting the first and second housings. The second housing is movably associated with the first housing. The laser ultrasound system has a component 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 has an phacoemulsification system for providing therapeutic ultrasound energy, and this system has an phacoemulsification system control system. At least a portion of, and preferably all of, the therapeutic laser and the phacoemulsification system are located within the first housing.

[0405] The integrated laser ultrasound system has an integrated control system that communicates with at least one, and preferably all, of the therapeutic laser control system, the phacoemulsification system, and the GUI.

[0406] This integrated laser-ultrasound system also features a safety interlock that prevents the laser system from emitting therapeutic laser light during phacoemulsification system operation. The safety interlock communicates with one or more controls within the integrated control system and the laser control system. The safety interlock device can also communicate with the phacoemulsification control system.

[0407] This integrated laser ultrasound system also includes a beam shaping and directing assembly, comprising a z-focusing element, a scanner, and a lens. The beam shaping and directing assembly is housed within a second housing. Preferably, the entire assembly is housed within the second housing.

[0408] The device for optically connecting the first and second housings communicates optically with the therapeutic laser and beam shaping and directing components. This device for optical connection can be a hinged hollow tube, an optical fiber, or any other device disclosed in this specification for transmitting laser energy.

[0409] The integrated laser ultrasound system also has an arm connected to a second housing and in optical communication with a beam shaping and directing assembly. The arm has a distal end and a proximal end, wherein the distal end is adjacent to the second housing and is preferably mechanically attached, and in embodiments integrated with the second housing. The system has a laser transmission head adjacent to and preferably attached to the proximal end of the arm. The laser transmission head has optical elements located in the laser beam transmission path. These optical elements can be, for example, mirrors, which receive and guide the laser beam along the laser beam transmission path through an opening in the laser transmission head. Thus, for example, the optical element can redirect the beam from horizontal to vertical by 90 degrees. The optical element may also include lenses that receive, shape, and transmit the laser beam. These lenses may be before or after the mirror in the optical path.

[0410] As preferably configured, the arm includes, for example, a portion accommodating a laser beam transmission path, particularly the portion from the beam shaping and directing assembly to the laser head. In this way, the arm positions the laser transmission head in optical communication with the beam shaping and directing assembly.

[0411] Preferably, the system has means for determining the shape and position of eye structures, which may be a SAM assembly, an OCT assembly, or both. This means is preferably located in, on, or formed part of the laser transmission head. The means for determining shape and position communicates with an integrated control system, a therapeutic laser control system, an phacoemulsification control system, and one or more controls in all of these systems. Preferably, the means communicates with at least the integrated control system, the laser control system, or both.

[0412] The system is also configured to be positioned around the patient at multiple clock angles or locations. Preferably, the system is configured to be angularly positioned relative to the patient's location, wherein the angle is defined by the longitude axis of the arm and the patient's axis; wherein the angle includes angles of approximately 45°, approximately 90°, approximately 135°, and approximately 180°.

[0413] In an embodiment of the system, it has one or more of the following features: it is configured to provide two therapeutic laser beams with different pulse durations; it has an iris positioning system; the therapeutic laser is a femtosecond laser, a picosecond laser, or both.

[0414] Example 44A

[0415] The system in Example 44 has a foot switch that communicates with one or more of the controls in the integrated control system, the therapeutic laser control system, and the phacoemulsification control system. These systems can also be configured to provide two therapeutic laser beams with different pulse durations.

[0416] Example 44B

[0417] The systems of Examples 44 and 44A may also have an integrated control system, a therapeutic laser control system, or both with multiple predetermined laser transmission modes. These predetermined laser transmission modes may be contained within one or more control systems, or may reside in a memory device associated with and accessible by the control systems. Further, the integrated control system, the phacoemulsification control system, or both have multiple predetermined phacoemulsification procedures. These predetermined phacoemulsification procedures will include, for example, parameters (e.g., power) and procedure types (e.g., chop), which are detailed in the Ultrasound / Phacoemulsification - General section of this specification.

[0418] The system is also configured to determine information about cataracts within the lens of the eye. A shape and position determination device on the laser head can provide data, such as optical images, to form the basis for the determination. This data can also be provided by a separate imaging system. One or more control systems then make a determination based on the data. The determined information is, for example, and preferably, the grade of the cataract. For example, this could be one of three grades or one of four grades.

[0419] The system is configured to recommend a combination of laser and ultrasound therapy. This recommendation is based, in whole or in part, on definitive information about the cataract.

[0420] Laser-phacoemulsification combination therapy, preferably a two-component therapy. Therefore, it includes a laser component, which is at least one of a plurality of predetermined laser transmission modes; and an phacoemulsification component, which includes at least one of a plurality of predetermined phacoemulsification procedures.

[0421] Example 45

[0422] A method for providing laser-phacoemulsification combined therapy for cataract eyes using an integrated laser-phacoemulsification system. The integrated laser-phacoemulsification system includes a GUI; a therapeutic laser for providing a therapeutic laser beam along a laser beam transmission path, having a therapeutic laser control system; a phacoemulsification system for providing therapeutic ultrasonic energy, having a phacoemulsification system control system; and an integrated control system communicating with the therapeutic laser control system, the phacoemulsification system, and the GUI control.

[0423] Therefore, this system can be used to determine and ascertain information about cataracts in the lens of a cataract. Preferably, the determined information is the grade of the cataract.

[0424] Therefore, this system can be used to identify and determine laser-ultrasound combination therapy. This laser-ultrasound emulsification combination therapy is preferably a two-component therapy. Thus, it includes a laser component, which is at least one of a plurality of predetermined laser transmission modes; and an ultrasound emulsification component, which has at least one of a plurality of predetermined ultrasound emulsification procedures.

[0425] This system can be used to recommend and suggest laser-ultrasound combination therapies based on determined cataract information. Preferably, the system displays the recommended laser-phacoemulsification combination therapy on a GUI; and more preferably, it is displayed as a menu item on the GUI associated with the recommended laser-phacoemulsification combination therapy.

[0426] The system can then be instructed, preferably via a GUI menu, but also via voice or a foot switch, to perform: a recommended combination therapy; only one of the two components of the combination therapy; to redefine one or both of the two components of the combination therapy; and combinations and variations thereof. The system executes these instructions.

[0427] The system can then be instructed to perform and execute a defined and recommended laser-ultrasound combination therapy on the lens of the patient's eye. Because this is a two- or multi-part therapy, one or more instructions may be considered and may be required to perform the steps of the treatment.

[0428] Example 46

[0429] Typically, when performing surgery using embodiments of the laser ultrasound of this invention (e.g., laser ultrasound, femtosecond laser phacoemulsification, integrated system), a laser procedure is performed first, the system is reconfigured, then an ultrasound procedure is performed, followed by phacoemulsification. Therefore, and typically, the laser procedure is performed first after the patient is ready. These laser procedures may include capsulotomy, lens fragmentation, and corneal incision and surgery, as well as other laser procedures discussed herein and known to those skilled in the art. The integrated system is then rapidly reconfigured by removing the arm and laser head from the patient. Thus, the system is switched from a laser configuration to an ultrasound configuration, such as a phacoemulsification configuration, and then an ultrasound procedure, such as phacoemulsification, is performed. In this way, phacoemulsification is performed on the eye and lens materials, which are first cut or fragmented by a laser from the same system (i.e., the integrated system). After the phacoemulsification procedure is completed, the patient is removed, and the integrated system is rapidly reconfigured back to the laser configuration. The system can be rapidly and repeatedly switched between laser and phacoemulsification configurations, i.e., reconfigured.

[0430] It should be understood that, although not preferred by the present invention, the system has the ability to perform laser surgery on the same patient, the same or different eyes after an ultrasound procedure such as phacoemulsification has been performed.

[0431] In addition to the foregoing examples and to further these examples, a laser system is also provided, comprising: a therapeutic laser system having a housing; a patient position determination system; having a first component and a second component; the first component being mechanically associated with the therapeutic laser system; the second component not being associated with the therapeutic laser system, thereby the second component being independent of the therapeutic laser system and thus moving independently relative to the therapeutic laser system; and wherein the first component, the second component, or both are configured to determine the relative position of the second component with respect to the first component.

[0432] In addition, a laser ultrasound system is provided, comprising: a therapeutic laser system; an ultrasonic emulsification system for providing therapeutic ultrasonic energy; and a safety interlock that prevents the laser system from emitting laser energy during operation of the ultrasonic emulsification system.

[0433] Furthermore, a laser ultrasound system is provided, comprising: a therapeutic laser system; an ultrasonic emulsification system for providing therapeutic ultrasonic energy; and a microscope integrated into the system.

[0434] In addition, a laser ultrasound system is provided, comprising: a therapeutic laser system; an phacoemulsification system for providing therapeutic ultrasound energy; and a SAM camera device for determining the shape, position, and both of the eye structures.

[0435] Furthermore, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtosecond laser phacoemulsification systems, methods, and apparatuses are provided, possessing one or more of the following features: the laser system has an integrated ultrasound system; the ultrasound system is contained within a therapeutic laser housing; the ultrasound system is a phacoemulsification system; a laser safety interlock is provided, thereby preventing laser emission when using the ultrasound system; 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 positioning device, an acoustic positioning device, and an RFID device; the therapeutic laser system has an arm extending from the housing; the therapeutic laser system has an arm extending from the housing and a laser transmission head at the proximal end of the arm; the determined relative position is in two-dimensional space; The determined relative position is in three-dimensional space; wherein the patient positioning system has at least 95% accuracy; wherein the patient positioning system has at least 98% accuracy; wherein the patient positioning system has at least 99% accuracy; wherein the system is configured to determine the angle of the arm relative to the longitudinal axis of the patient, and adjust the treatment laser beam pattern at least in part based on this angle; wherein the angle is determined within ±5 degrees of accuracy; wherein the angle is determined within ±3 degrees of accuracy; wherein the angle is determined within ±2 degrees of accuracy; wherein a second component of the patient positioning system is contained in the patient's headrest; wherein the treatment laser system has a charging station for the second component of the patient positioning system; wherein the system has a PID; wherein the PID has a meniscus conversion component; wherein the PID includes an arm and wherein the arm defines a vacuum channel and a saline channel; wherein the system has optics defining four pupils, and wherein the laser beam path extends through two of the pupils; and wherein at the pupils are conjugate telecentric pupils.

[0436] Furthermore, a laser ultrasound system is provided, comprising: an assembly having: a therapeutic laser for providing a therapeutic laser beam along a laser beam path; an phacoemulsification system for providing therapeutic ultrasound energy; an arm connected to the assembly; the arm having a distal end and a proximal end, wherein the distal end is attached to the assembly; wherein the proximal end has a laser transmission head; the arm includes a portion of the laser beam transmission path; wherein the assembly is positioned at an angle relative to a patient position, wherein the angle is defined by the longitude axis of the arm and the patient axis; and wherein the angle is from 30 degrees to 320 degrees.

[0437] Furthermore, these laser systems, laser ultrasound systems, laser ultrasonic emulsification systems, femtosecond laser ultrasonic emulsification systems, methods, and apparatuses are provided, having one or more of the following features: wherein the angle is selected from an angle group consisting of 45°, 90°, 135°, 180°, 225°, 270°, and 315°; wherein the arm is configured to move in an arc around a pivot point on the assembly; wherein the arm is configured to move horizontally, thereby being extendable from and retractable into the assembly; wherein the arm, laser head, or both are configured to move vertically; wherein the laser beam in the laser beam path within the arm is uncollimated; wherein the laser beam in the laser beam path within the arm is located within an optical fiber; having optics defining four pupils, and wherein the laser beam path extends through the four pupils; wherein at the pupils are conjugate telecentric pupils; having optics for determining phase For a device for determining the patient position of a component; wherein the device for determining the patient position has a first component and a second component; wherein the first component is mechanically associated with a laser ultrasound system; wherein the second component is not attached to a therapeutic laser system, thereby the second component is independent of the therapeutic laser system and thus moves independently relative to the therapeutic laser system; and wherein the first component, the second component, or both are configured to determine the relative position of the second component with respect to the first component; wherein the therapeutic laser ultrasound system has a charging station for the second component of the patient position determination system; wherein the laser system and the phacoemulsification system are integrated; wherein the laser system and the phacoemulsification system are contained within a housing; wherein the component is contained within the housing; having a laser safety interlock so that the laser cannot be emitted when the phacoemulsification system is in use; and wherein the therapeutic laser is a femtosecond laser.

[0438] Furthermore, a laser ultrasound system is provided, comprising: a therapeutic laser for providing a therapeutic laser beam along a laser beam path; an ultrasonic emulsification system for providing therapeutic ultrasound energy; and an optics having four pupils defined, wherein the laser beam path extends through at least two pupils.

[0439] Furthermore, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtosecond laser phacoemulsification systems, methods, and apparatuses are provided, having one or more of the following features: wherein a conjugate telecentric pupil is present at the pupil; wherein the therapeutic laser and the phacoemulsification system are integrated; wherein the therapeutic laser and the phacoemulsification system are contained within a housing; wherein a laser safety interlock is provided, thereby preventing laser emission when using the ultrasound system; and wherein the therapeutic laser system is a femtosecond laser system.

[0440] Furthermore, a laser ultrasound system is provided, comprising: means for providing a first therapeutic laser beam and a second therapeutic laser beam; the system having optics defining a laser beam path; the first laser beam path and the second laser beam path traveling along the laser beam path; wherein the first therapeutic laser beam has a pulse width of about 1,000 fs to about 2,000 fs; the system having a laser beam transmission mode for performing lens cutting with the first therapeutic laser beam; wherein the second therapeutic laser beam has a pulse width of about 100 fs to about 500 fs; the system having a laser beam transmission mode for performing corneal cutting with the second therapeutic laser beam; and an phacoemulsification system for providing therapeutic ultrasound energy.

[0441] Furthermore, these laser systems, laser ultrasound systems, laser ultrasonic emulsification systems, femtosecond laser ultrasonic emulsification systems, methods, and apparatuses are provided, having one or more of the following features: wherein the wavelength of the first laser beam is 1030 nm; wherein the wavelength of the second laser beam is 1030 nm; wherein the wavelength of the first laser beam is 1030 nm and the wavelength of the second laser beam is 1030 nm; wherein the repetition frequency is 320 kHz or lower.

[0442] Furthermore, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtosecond laser phacoemulsification systems, methods, and apparatuses are provided, having one or more of the following features: having a SAM camera device; wherein the SAM camera device has n cameras, wherein at least n-1 cameras have an obstructed field of view of the patient's eye at any patient angle from 30 degrees to 320 degrees; wherein n is 5; wherein n is 6; and wherein the cameras have a separation of at least 40 degrees.

[0443] Furthermore, a laser ultrasound system is provided, comprising: a first configuration for providing a therapeutic laser beam to a patient; a second configuration for performing phacoemulsification surgery on the patient; and wherein the transition from the first configuration to the second configuration takes less than 5 minutes.

[0444] Furthermore, these laser systems, laser ultrasound systems, laser ultrasonic emulsification systems, femtosecond laser ultrasonic emulsification systems, methods, and apparatuses are provided, having one or more of the following characteristics: wherein the transition from laser to ultrasonic emulsification is less than 3 minutes; wherein the transition from laser to ultrasonic emulsification is less than 2 minutes; wherein the transition from laser to ultrasonic emulsification is less than 1 minute; wherein the transition from laser to ultrasonic emulsification is less than 45 seconds; wherein the transition from laser to ultrasonic emulsification is approximately 30 seconds; wherein the transition from laser to ultrasonic emulsification is approximately 1 minute to 30 seconds.

[0445] Furthermore, these laser systems, laser ultrasound systems, laser ultrasonic emulsification systems, femtosecond laser ultrasonic emulsification systems, methods, and apparatuses are provided, having one or more of the following characteristics: wherein the transition from femtosecond laser to ultrasonic emulsification is less than 3 minutes; wherein the transition from femtosecond laser to ultrasonic emulsification is less than 2 minutes; wherein the transition time from femtosecond laser to ultrasonic emulsification is less than 1 minute; wherein the transition from femtosecond laser to ultrasonic emulsification is less than 45 seconds; wherein the transition from femtosecond laser to ultrasonic emulsification is approximately 30 seconds; wherein the transition from femtosecond laser to ultrasonic emulsification is approximately 1 minute to 30 seconds.

[0446] Furthermore, a laser ultrasound system is provided, comprising: a component defining a floor area and volume; the component comprising: a therapeutic laser system; and an phacoemulsification system for providing therapeutic ultrasound energy; and wherein the floor area is less than 1,500 square inches.

[0447] Furthermore, these laser systems, laser ultrasound systems, laser ultrasonic emulsification systems, femtosecond laser ultrasonic emulsification systems, methods, and apparatuses are provided, having one or more of the following characteristics: a footprint of approximately 33 inches by approximately 22 inches; a footprint of approximately 35 inches or less by approximately 35 inches or less; a footprint of approximately 35 inches or less by approximately 22 inches or less; a footprint of approximately 400 square inches to approximately 800 square inches; or a volume of less than approximately 40 ft. 3 The volume of which is less than approximately 35 ft 3 The volume of which is less than approximately 30 ft 3 The volume of which is less than approximately 25 ft 3 Furthermore, the volume of which is less than approximately 20 ft. 3 .

[0448] Furthermore, a laser ultrasound system is provided, comprising: a therapeutic laser system; the therapeutic laser system having: an arm having a proximal end; a laser head connected to the proximal end of the arm; and electronic equipment for operating the therapeutic laser system; an phacoemulsification system for providing therapeutic ultrasound energy, having electronic equipment for operating the phacoemulsification system; and a laser head electrically isolated from the electronic equipment for the phacoemulsification system and the electronic equipment for the therapeutic laser system.

[0449] Furthermore, a laser system is provided, comprising: a therapeutic laser beam for providing a therapeutic laser beam; and optics for defining a laser beam path; wherein the laser beam path is longer than 300 mm; thereby the laser beam pattern is transmitted along the laser beam path without laser beam pattern amplification.

[0450] In addition, a laser system is provided having: a therapeutic laser beam for providing a therapeutic laser beam; and optics for defining the laser beam path; wherein the laser beam path is longer than 300 mm; thereby the laser beam pattern is transmitted along the laser beam path without wavefront error.

[0451] In addition, a laser system is provided having: a therapeutic laser beam for providing a therapeutic laser beam; and optics for defining the laser beam path; wherein the laser beam path is longer than 300 mm; thereby the laser beam pattern is transmitted along the laser beam path without optical separation.

[0452] Furthermore, these laser systems, laser ultrasound systems, laser ultrasonic emulsification systems, femtosecond laser ultrasonic emulsification systems, methods, and apparatuses are provided, having one or more of the following features: wherein the laser is a femtosecond laser, and also has an integrated ultrasonic emulsification system.

[0453] In addition, these laser systems, laser ultrasound systems, laser ultrasonic emulsification systems, femtosecond laser ultrasonic emulsification systems, methods and apparatus are provided, having one or more of the following features: having an iris positioning device.

[0454] In addition, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtosecond laser phacoemulsification systems, methods, and apparatuses are provided, having one or more of the following features: data and information exchange between the ultrasound system and the laser system; wherein the information includes a cataract grade; and wherein information from the laser system is used to provide a recommended ultrasound energy.

[0455] In addition, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtosecond laser phacoemulsification systems, methods, and apparatuses are provided, having one or more of the following features: wherein data and information exchange occurs between the ultrasound system and the laser system; and wherein the information includes a cataract grade.

[0456] In addition, these laser systems, laser ultrasound systems, laser ultrasonic emulsification systems, femtosecond laser ultrasonic emulsification systems, methods and apparatus are provided, having one or more of the following features: having an OCT imaging device.

[0457] In addition, these laser systems, laser ultrasound systems, laser ultrasonic emulsification systems, femtosecond laser ultrasonic emulsification systems, methods and apparatus are provided, having one or more of the following features: wherein the system has a floor area size; and the floor area size is selected from the group consisting of less than 35 x less than 35 inches, less than 35 x 25 inches, about 35 x 25 inches, about 33 x 22 inches and about 400 square inches to about 800 square inches.

[0458] Furthermore, these laser systems, laser ultrasound systems, laser ultrasonic emulsification systems, femtosecond laser ultrasonic emulsification systems, methods, and apparatuses are provided, having one or more of the following features: having a cap on a laser head located in the laser beam path, thereby protecting the optical components when the laser is not in an operable configuration.

[0459] Furthermore, methods are provided for performing laser operations and ultrasonic emulsification operations using any of these laser systems, laser ultrasound systems, laser ultrasonic emulsification systems, and femtosecond laser ultrasonic emulsification systems.

[0460] Furthermore, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtosecond laser phacoemulsification systems, methods, and apparatuses are provided, having one or more of the following features: wherein a surgical microscope is attached to the system housing and communicates with the control system via data communication, control communication, and both; wherein the surgical microscope is integrated with the system housing; wherein the surgical microscope can receive commands or views (e.g., digital overlay) from a laser treatment system (e.g., femtosecond laser) or ultrasound (e.g., phacoemulsification modes and surgery).

[0461] In addition, these laser systems, laser ultrasound systems, laser phacoemulsification systems, femtosecond laser phacoemulsification systems, methods, and apparatuses are provided, having one or more of the following features: wherein a three-dimensional (3-D) observation system is attached to the system housing and communicates with the control system via data communication, control communication, and both; wherein the 3-D observation system is integrated with the system housing; wherein the 3-D system can receive commands and views (e.g., digital overlays) from a laser treatment system (e.g., femtosecond laser) or ultrasound (e.g., phacoemulsification modes and surgery).

[0462] Title and Examples

[0463] It should be understood that the headings used in this specification are for clarity and reference purposes only, and not for any purpose of limitation. Therefore, the process compositions and disclosures described under these headings should be read in conjunction with the entire contents of this specification (including various examples). The use of headings in this specification should not limit the scope of protection provided by this invention.

[0464] Note that no theory is required to provide or resolve novel and inventive processes, laser operation and laser modes, enhanced and improved vision, or other beneficial features and characteristics that serve as the basis for the subject matter of or are associated with embodiments of the invention. However, various theories are provided in this specification to further advance the art in this field. The theories presented in this specification, unless expressly stated otherwise, are in no way intended to limit, restrict, or narrow the scope of the claimed invention. Many of these theories are not necessary for or practiced with respect to the invention. It should also be understood that the invention may lead to new and previously unknown theories to explain the functional features of embodiments of the methods, laser modes, laser operation, eye function, devices, and systems of the invention; and these subsequently developed theories should not limit the scope of the invention.

[0465] The various embodiments of the devices, systems, laser emission modes, activities, and operations presented in this specification, in addition to those disclosed in the figures and this specification, can be used with, in, or by various measurement, diagnostic, surgical, and therapeutic laser systems. The various embodiments of the devices, systems, laser emission modes, activities, and operations presented in this specification can be used with: other measurement, diagnostic, surgical, and therapeutic systems that may be developed in the future; existing measurement, diagnostic, surgical, and therapeutic laser systems that may be partially modified according to the teachings of this specification; and other types of measurement, diagnostic, surgical, and therapeutic systems. Furthermore, the various embodiments of the devices, systems, laser emission modes, activities, and operations presented in this specification can be used with each other in different and various combinations. Therefore, for example, the configurations provided in the various embodiments of this specification can be used with each other. For example, components of embodiments having A, A', and B according to the teachings of this specification and components of embodiments having A”, C, and D can be used with each other in various combinations, such as A, C, D and A, A”C, and D. Therefore, the scope of protection of this invention should not be limited to the specific embodiments, configurations, or arrangements illustrated in the specific embodiments, examples, or figures.

[0466] This invention may be embodied in forms other than those specifically disclosed herein without departing from their spirit or essential characteristics. The described embodiments are to be regarded in all respects as illustrative rather than restrictive.

Claims

1. A patient interface apparatus for ophthalmic surgery, the apparatus comprising: a. a spine-armed arm (2001) having a top end and a bottom end; i. the bottom end comprising an annular structure (2003); ii. the annular structure (2003) having a top side, a bottom side, and an opening configured for transmission of a therapeutic laser beam; iii. a first port (2007) and a second port (2008); wherein the first port (2007) and the second port (2008) are in fluid communication with at least one of the opening, the top side, and the bottom side, wherein the first port (2007) bounds a first channel, the second port (2008) bounds a second channel; b. the top side of the annular structure (2003) comprising: i. a plurality of pins (2020a, 2020b, 2020c) extending upward from a surface of the top side and bounding a pin height; ii. a plurality of clips (2002a, 2002b, 2002c) extending upward on a surface of the top side and having a clip engagement surface, thereby bounding a clip engagement surface height; iii. wherein the clip engagement surface height is greater than the pin height; iv. an annular wall (2055) extending upward from a surface of the top side and bounding an annular wall (2055) height; and, v. wherein the annular wall (2055) partially bounds a first annular channel (2021) and a second annular channel (2022).

2. The patient interface apparatus of claim 1, comprising a window (2002), wherein the window bounds a window height; and wherein the window is held between the clip engagement surface and the pins; and, wherein the window is positioned above the opening.

3. The patient interface apparatus of claim 1, comprising an annular vacuum ring structure (2005) attached to a bottom side of the annular structure (2003); and, wherein the annular vacuum ring structure (2005) is in fluid communication with at least one of the ports; the annular vacuum ring structure (2005) having a bottom side.

4. The patient interface apparatus of claim 2, comprising an annular vacuum ring structure (2005) attached to the bottom side of the annular structure (2003); and, wherein the annular vacuum ring structure (2005) is in fluid communication with at least one of the ports; the annular vacuum ring structure (2005) having a bottom side.

5. The patient interface apparatus of claim 3, comprising a flexible eye engagement ring (2006) having an inner annular skirt and an outer annular skirt, and thereby bounding a flexible annular vacuum channel configured to engage with an eye; the flexible eye engagement ring (2006) attached to a bottom side of the annular vacuum ring structure (2005) and in fluid communication with at least one of the ports.

6. The patient interface apparatus of claim 4, comprising a flexible eye engaging ring (2006) having an inner annular skirt and an outer annular skirt and thereby defining a flexible annular vacuum channel configured to engage with an eye; the flexible eye engaging ring (2006) attached to an underside of the annular vacuum ring structure (2005) and in fluid communication with at least one of the ports.

7. The patient interface apparatus of any one of claims 1 to 6, wherein the pin (2020a, 2020b, 2020c) height is equal to or lower than the annular wall (2055) height.

8. The patient interface apparatus of any one of claims 1 to 6, wherein the pin (2020a, 2020b, 2020c) height is lower than the annular wall (2055) height.

9. The patient interface apparatus of any one of claims 1 to 6, wherein the pin (2020a, 2020b, 2020c) height is 1 mm lower than the annular wall (2055) height.

10. The patient interface apparatus of any one of claims 1 to 6, wherein the ridged arm (2001) is a unitary structure.

11. The patient interface apparatus of claim 3 or 4, wherein the annular vacuum ring structure (2005) is a unitary structure.

12. The patient interface apparatus of any one of claims 1 to 6, wherein the annular structure (2003) is a unitary structure.

13. The patient interface apparatus of claim 5 or 6, wherein the flexible eye engaging ring (2006) is a unitary structure.

14. An integrated laser-ultrasound system comprising the patient interface apparatus of any one of claims 1 to 13, wherein the top end of the arm is attached to the system.

15. An integrated laser-ultrasound system comprising the patient interface apparatus of any one of claims 1 to 13, wherein the top end of the arm is attached to a laser head of the system.

16. A laser-ultrasound system comprising: a. an assembly comprising: i. a therapeutic laser for providing a therapeutic laser beam along a laser beam path; ii. a phacoemulsification system for providing therapeutic ultrasound energy; b. an arm connected to the assembly; i. the arm having a distal end and a proximal end, wherein the distal end is attached to the assembly; ii. wherein the proximal end has a laser delivery head; iii. wherein the arm contains a portion of the laser beam path; and, c. the patient interface apparatus of any one of claims 1 to 13.

17. A laser-ultrasound system comprising: a. a therapeutic laser for providing a therapeutic laser beam along a laser beam path; b. a phacoemulsification system for providing therapeutic ultrasound energy; c. optics defining four pupils in the system, and wherein the laser beam path extends through at least two of the pupils; and, d. the patient interface apparatus of any one of claims 1 to 13.

18. A laser-ultrasound system comprising: a. a device for providing a first therapeutic laser beam and a second therapeutic laser beam; b. the system has optics that bound a laser beam path; c. the first therapeutic laser beam and the second therapeutic laser beam travel along the laser beam path; d. wherein the first therapeutic laser beam has a pulse width of 1,000 fs to 2000 fs; the system includes a laser beam delivery mode for performing a lens cut with the first therapeutic laser beam; e. wherein the second therapeutic laser beam has a pulse width of 100 fs to 500 fs; the system includes a laser beam delivery mode for performing a corneal cut with the second therapeutic laser beam; f. a phacoemulsification system for providing therapeutic ultrasonic energy; and, g. a patient interface device according to any one of claims 1 to 13.

19. The system according to any one of claims 14 to 18, wherein the system is non- handed.

20. The system according to any one of claims 14 to 18, wherein the system includes a phacoemulsification tray, a phacoemulsification cassette and is non-handed.

21. A method of servicing, upgrading software, testing or calibrating a system according to claim 14 or 15.

22. The system according to any one of claims 14 to 18, including a wireless footswitch configured to control the laser, the phacoemulsification or both.

23. The system according to any one of claims 14 to 18, wherein the system includes a laser head that bounds an opening through which a therapeutic laser beam path passes, and associated with the opening is a device for closing the opening during operation of a phacoemulsification system or when the laser head is in a retracted position, or both during operation of the phacoemulsification system and when the laser head is in a retracted position.

24. A method of testing or calibrating a laser system, the method including transmitting a laser beam through a window of a patient interface device according to any one of claims 2 to 13.

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