Patent Application
20230181368
Embodiments of this invention relate generally to laser-assisted ophthalmic procedures, and more particularly, to systems and methods for lenticular incisions in the cornea.
Vision impairments such as myopia (near-sightedness), hyperopia and astigmatism can be corrected using eyeglasses or contact lenses. Alternatively, the cornea of the eye can be reshaped surgically to provide the needed optical correction. Eye surgery has become commonplace with some patients pursuing it as an elective procedure to avoid using contact lenses or glasses to correct refractive problems, and others pursuing it to correct adverse conditions such as cataracts. And, with recent developments in laser technology, laser surgery is becoming the technique of choice for ophthalmic procedures.
Different laser eye surgical systems use different types of laser beams for the various procedures and indications. These include, for instance, ultraviolet lasers, infrared lasers, and near-infrared, ultra-short pulsed lasers. Ultra-short pulsed lasers emit radiation with pulse durations as short as 10 femtoseconds and as long as 3 nanoseconds, and a wavelength between 300 nm and 3000 nm.
Prior surgical approaches for reshaping the cornea include laser assisted in situ keratomileusis (hereinafter “LASIK”), photorefractive keratectomy (hereinafter “PRK”) and corneal lenticule extraction.
In the LASIK procedure, an ultra-short pulsed laser is used to cut a corneal flap to expose the corneal stroma for photoablation with ultraviolet beams from an excimer laser. Photoablation of the corneal stroma reshapes the cornea and corrects the refractive condition such as myopia, hyperopia, astigmatism, and the like. In a PRK procedure where no flap is created, the epithelium layer is first removed, and some stroma material is then removed by an excimer laser. The epithelium layer will grow back within a few days after the procedure.
In a corneal lenticule extraction procedure, instead of ablating corneal tissue with an excimer laser following the creation of a corneal flap, the technique involves tissue removal with two or more femtosecond laser incisions that intersect to create a lenticule for extraction. The extraction of the lenticule changes the shape of the cornea and its optical power to accomplish vision correction. Lenticular extractions can be performed either with or without the creation of a corneal flap. With the flapless procedure, a refractive lenticule is created in the intact portion of the anterior cornea and removed through a small incision. Methods for corneal lenticule extraction using a fast-scan-slow-sweep scheme of a surgical ophthalmic laser system are described in U.S. Pat. Appl. Pub. No. 20160089270, entitled “Systems And Methods For Lenticular Laser Incision,” published Mar. 31, 2016, and U.S. Pat. Appl. Pub. No. 20200046558, entitled “High Speed Corneal Lenticular Incision Using A Femtosecond Laser,” published Feb. 13, 2020.
Embodiments of the present invention provide a lenticular incision method using a pulsed laser which can reduce unnecessary laser energy exposure in the center area of the patient's field of view and reduce the time required for forming the incision.
In one aspect, embodiments of the present invention provides an ophthalmic surgical laser system which includes: a laser source configured to generate a pulsed laser beam comprising a plurality of laser pulses; a laser delivery system configured to deliver the pulsed laser beam to a target tissue in a subject's eye; a high frequency scanner configured to scan the pulsed laser beam back and forth at a predefined frequency; an XY-scanner configured to deflect the pulsed laser beam, the XY-scanner being separate from the high frequency scanner; a Z-scanner configured to modify a depth of a focus of the pulsed laser beam; and a controller configured to control the laser source, the high frequency scanner, the XY-scanner and the Z-scanner to successively form a plurality of sweeps which collectively form at least one lenticular incision of a lens in the subject's eye, the lens having a curved surface that defines an apex and a Z axis passing through the apex, wherein each sweep is formed by: controlling the high frequency scanner to deflect the pulsed laser beam to form a scan line, the scan line being a straight line having a predefined length and being tangential to a parallel of latitude of the lens, the parallel of latitude being a circle on the surface of the lens that is perpendicular to the Z axis and has a defined distance to the apex, controlling the XY-scanner and the Z-scanner to move the scan line along a meridian of longitude of the lens, the meridian of longitude being a curve that passes through the apex and has a defined angular position around the Z axis, and controlling the laser source to periodically blank the pulsed laser beam when the scan line is located within a central area of the lens, wherein the plurality of sweeps are successively formed one after another along the respective meridians of longitude which are different from one another.
In another aspect, embodiments of the present invention provide a method for creating a lenticular incision using an ophthalmic surgical laser system, the method including the steps of: generating, by a laser source, a pulsed laser beam comprising a plurality of laser pulses; delivering the pulsed laser beam to a target tissue in a subject's eye; scanning, by a high frequency scanner, the pulsed laser beam back and forth at a predefined frequency; deflecting, by an XY-scanner, the pulsed laser beam, the XY-scanner being separate from the high frequency scanner; modifying, by a Z-scanner, a depth of a focus of the pulsed laser beam; and controlling, by a controller, the laser source, the high frequency scanner, the XY-scanner and the Z-scanner to successively form a plurality of sweeps which collectively form at least one lenticular incision of a lens in the subject's eye, the lens having a curved surface that defines an apex and a Z axis passing through the apex, including forming each sweep by: controlling the high frequency scanner to deflect the pulsed laser beam to form a scan line, the scan line being a straight line having a predefined length and being tangential to a parallel of latitude of the lens, the parallel of latitude being a circle on the surface of the lens that is perpendicular to the Z axis and has a defined distance to the apex, controlling the XY-scanner and the Z-scanner to move the scan line along a meridian of longitude of the lens, the meridian of longitude being a curve that passes through the apex and has a defined angular position around the Z axis, and controlling the laser source to periodically blank the pulsed laser beam when the scan line is located within a central area of the lens, wherein the plurality of sweeps are successively formed one after another along the respective meridians of longitude which are different from one another.
This summary and the following detailed description are merely exemplary, illustrative, and explanatory, and are not intended to limit, but to provide further explanation of the invention as claimed. Additional features and advantages of the invention will be set forth in the descriptions that follow, and in part will be apparent from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the structure particularly pointed out in the written description, claims and the appended drawings.
The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages will be facilitated by referring to the following detailed description that sets forth illustrative embodiments using principles of the invention, as well as to the accompanying drawings, in which like numerals refer to like parts throughout the different views. Like parts, however, do not always have like reference numerals. Further, the drawings are not drawn to scale, and emphasis has instead been placed on illustrating the principles of the invention. All illustrations are intended to convey concepts, where relative sizes, shapes, and other detailed attributes may be illustrated schematically rather than depicted literally or precisely.
Embodiments of this invention are generally directed to systems and methods for laser-assisted ophthalmic procedures, and more particularly, to systems and methods for corneal lenticule incision.
Referring to the drawings,
Laser 14 may comprise a femtosecond laser capable of providing pulsed laser beams, which may be used in optical procedures, such as localized photodisruption (e.g., laser induced optical breakdown). Localized photodisruptions can be placed at or below the surface of the tissue or other material to produce high-precision material processing. For example, a micro-optics scanning system may be used to scan the pulsed laser beam to produce an incision in the material, create a flap of the material, create a pocket within the material, form removable structures of the material, and the like. The term “scan” or “scanning” refers to the movement of the focal point of the pulsed laser beam along a desired path or in a desired pattern.
In other embodiments, the laser 14 may comprise a laser source configured to deliver an ultraviolet laser beam comprising a plurality of ultraviolet laser pulses capable of photodecomposing one or more intraocular targets within the eye.
Although the laser system 10 may be used to photoalter a variety of materials (e.g., organic, inorganic, or a combination thereof), the laser system 10 is suitable for ophthalmic applications in some embodiments. In these cases, the focusing optics direct the pulsed laser beam toward an eye (for example, onto or into a cornea) for plasma mediated (for example, non-UV) photoablation of superficial tissue, or into the stroma of the cornea for intrastromal photodisruption of tissue. In these embodiments, the surgical laser system 10 may also include a lens to change the shape (for example, flatten or curve) of the cornea prior to scanning the pulsed laser beam toward the eye.
User interface input devices 62 may include a keyboard, pointing devices such as a mouse, trackball, touch pad, or graphics tablet, a scanner, foot pedals, a joystick, a touch screen incorporated into a display, audio input devices such as voice recognition systems, microphones, and other types of input devices. In general, the term “input device” is intended to include a variety of conventional and proprietary devices and ways to input information into controller 22.
User interface output devices 64 may include a display subsystem, a printer, a fax machine, or non-visual displays such as audio output devices. The display subsystem may be a flat-panel device such as a liquid crystal display (LCD), a light emitting diode (LED) display, a touchscreen display, or the like. The display subsystem may also provide a non-visual display such as via audio output devices. In general, the term “output device” is intended to include a variety of conventional and proprietary devices and ways to output information from controller 22 to a user.
Storage subsystem 56 can store the basic programming and data constructs that provide the functionality of the various embodiments of the present invention. For example, a database and modules implementing the functionality of the methods of the present invention, as described herein, may be stored in storage subsystem 56. These software modules are generally executed by processor 52. In a distributed environment, the software modules may be stored on a plurality of computer systems and executed by processors of the plurality of computer systems. Storage subsystem 56 typically comprises memory subsystem 58 and file storage subsystem 60.
Memory subsystem 58 typically includes a number of memories including a main random access memory (RAM) 70 for storage of instructions and data during program execution and a read only memory (ROM) 72 in which fixed instructions are stored. File storage subsystem 60 provides persistent (non-volatile) storage for program and data files. File storage subsystem 60 may include a hard disk drive along with associated removable media, a Compact Disk (CD) drive, an optical drive, DVD, solid-state memory, and/or other removable media. One or more of the drives may be located at remote locations on other connected computers at other sites coupled to controller 22. The modules implementing the functionality of the present invention may be stored by file storage subsystem 60.
Bus subsystem 54 provides a mechanism for letting the various components and subsystems of controller 22 communicate with each other as intended. The various subsystems and components of controller 22 need not be at the same physical location but may be distributed at various locations within a distributed network. Although bus subsystem 54 is shown schematically as a single bus, alternate embodiments of the bus subsystem may utilize multiple busses.
Due to the ever-changing nature of computers and networks, the description of controller 22 depicted in
As should be understood by those of skill in the art, additional components and subsystems may be included with laser system 10. For example, spatial and/or temporal integrators may be included to control the distribution of energy within the laser beam. Ablation effluent evacuators/filters, aspirators, and other ancillary components of the surgical laser system are known in the art, and may be included in the system. In addition, an imaging device or system may be used to guide the laser beam.
In preferred embodiments, the beam scanning can be realized with a “fast-scan-slow-sweep” scanning scheme, also referred herein as a fast-scan line scheme. The scheme consists of two scanning mechanisms: first, a high frequency fast scanner is used to scan the beam back and forth to produce a short, fast scan line (e.g., a resonant scanner 21 of
In a preferred embodiment shown in
where R is greater than L. R is the radius of curvature of the surface dissection 620, and L is the length of the fast scan.
While the above maximum deviation analysis is for a spherical surface, this scanning method may also be used to create a smooth cut having a non-spherical shape, such as an ellipsoidal shape, etc. In such a case, the parallel of latitude and/or the meridian of longitude may not be circular.
In an exemplary case of myopic correction, the radius of curvature of the surface dissection may be determined by the amount of correction, ΔD, using the following equation (Equation (2)):
where n=1.376, which is the refractive index of cornea, and R1 and R2 (may also be referred herein as Rt and Rb) are the radii of curvature for the top surface and bottom surface of a lenticular incision, respectively. For a lenticular incision with R1=R2=R (the two dissection surface are equal for them to physically match and be in contact), we have (Equation (3)):
Using such a “fast-scan-slow-sweep” scanning scheme, each sweep of the fast scan line forms a bent band, the bent band being the equivalent of bending a flat rectangle such that its long sides form arched shapes (the shape of the meridian of longitude) while its short sides remain straight. In the top view in
U.S. Pat. Appl. Pub. No. 20200046558 describes corneal lenticule incision method which addresses this redundant cutting problem by using a variable sweeping speed along the meridian, so that in each sweep, the sweeping speed is the slowest at the edge of the lenticule and the fastest near the apex.
Preferred embodiments of the present invention address the redundant cutting problem by applying rapid laser blanking in the central area of the lenticule. This technique maintains the desired tissue-bridge free cutting performance, and effectively reduces the excessive bubbles generated during lenticule incisions.
More specifically, in preferred embodiments of the present invention, the laser is periodically blanked in the central area of the lenticule during each sweep. The generation of the fast scan lines is unchanged, and the sweeping speed for each sweep may be constant or variable. As schematically illustrated in
As shown in
The periodic laser blanking scheme is accomplished by the ophthalmic laser system under the control of the controller, based on the following control parameters:
(1) Laser blanking Enable or Disable. When this parameter is disabled, no blanking is performed.
(2) Laser blanking zone diameter, e.g. in mm.
(3) Laser blanking On-Off period, e.g. in ms.
(4) Laser blanking duty cycle, i.e., the percentage of time within each laser blanking On-Off period that laser blanking is On.
These parameters, along with other parameters of the laser system, determine the amount of laser energy reduction in the central area of the lenticule incision.
In one particular example, the resonant scanner frequency is 7910 Hz; i.e., the system generates 15820 scan lines per second, each scan line being 63 μs (0.063 ms) in duration, or about 16 scan lines per ms. The laser repetition rate is 10M pulses per second, so each scan line has approximately 632 laser pulses. The laser blanking On-Off mode can be switched within nanoseconds, but the laser pulse behavior transient time is about 30 μs (0.03 ms); thus, for each On-Off transition, about half scan line will be in this transient time and will therefore cut poorly. Near the lenticule center, the XY scanning speed is about 32-40 mm/s, or more generally, about 10-100 mm/s. When the blanking zone diameter is 1.5 mm, the time inside the blanking zone in each sweep is about 40 ms, i.e., about 630 scan lines inside the zone. When the blanking On-Off period is 1 ms and the blanking duty cycle is 5%, each laser blanking signal On time duration is about 0.05 ms (50 μs). Taking into consideration the transient time mentioned above, the total time during which adequate cutting does not occur (the uncut time) is about 80 μs. As a result, in this example, for every 16 scan lines, there will be 1-1.5 uncut line due to laser blanking.
The parameters for additional examples are shown in Table 1 in
More generally, for the periodic laser blanking method, the blanking duty cycle may be 5-95%, preferably 15-25%, and more preferably 20%; the blanking On-Off period may be 1-50 ms, preferably 2.5-7.5 ms, and more preferably 5 ms. When the period is 5 ms and the duty cycle is 20%, the actual blanking time per period is about 1 ms. In a preferred embodiment, each 1 ms corresponds to approximately 32 μm of uncut length of the sweep. Generally speaking, uncut length should not be too long, e.g., longer than 32 μm. The approximately 1 ms uncut time (approximately 32 μm uncut length) gives more evenly distributed cut-uncut-cut-uncut regions. This will reduce or eliminate tissue bridges. The resulting percentage of actual uncut time may be 5 to 95%, preferably 10 to 30%, more preferable, 20%; the blanking zone radius may be 0.25-2.5 mm, preferably 0.5-1.0 mm, more preferably 0.75 mm.
The blanking of laser pulses in a high-repetition-rate laser system may be achieved in various ways. For example, a pulse picker (e.g., an acoustic-optical modulator, AOM) may be used to selectively pick some laser pulses and block other laser pulses. To maintain beam quality and avoid wavefront aberration, the pulse picking is done before light amplification. However, simply blocking the pulses before the amplifier of the laser system may create a problem of “giant pulses.” Namely, if in the blanking-on time period, there is no laser pulse passing through the amplifier, then the first laser pulse in the blanking-off time period immediately following the blanking-on time period will experience extra gain when it passes through the amplifier and will become a “giant pulse.” This is undesirable because giant pulses may cause abnormally large tissue effect.
Thus, in preferred embodiments of the present invention, the laser pulses are not blocked before the amplifier; rather, in the blanking-on time period, the laser is switched to a higher repetition rate, lower pulse energy mode, to generate laser pulses at a higher pulse repetition rate but a lower pulse energy. The lower pulse energy is such that at the locations they are delivered to the tissue, the pulse energy is below the tissue's photodisruption threshold (the energy at which the a laser pulse starts to photodisrupt the tissue), and therefore will not result in any tissue cutting. Meanwhile, because these more numerous lower pulse energy pulses pass through the amplifier, the amplifier is not in an idle state during the blanking-on period and therefore, it will not generate the “giant pulse” in the blanking-off period. This method can realize fast blanking for the laser incision procedures. In one particular example, a 10 MHz repetition rate is used to perform normal laser cutting, and laser blanking is realized by switching from the 10 MHz to a 40 MHz repetition rate. Note that the pulse energy is automatically reduced when the repetition rate is increased, because the total energy, which is determined by the pump current, is maintained the same. Under the given pump current, i.e., pump energy, the more pulses are produced, the less energy each pulse will have.
From the above descriptions, it can be seen that the term “laser blanking” in this disclosure does not require the laser pulses to be blocked; it only requires the absence of laser pulses with pulse energies at or above the photodisruption threshold (at the location the pulses are delivered to the tissue). This laser blanking technique may be referred to as “tissue cutting blanking” to emphasize the blanking effect on tissue cutting. Of course, “laser blanking” can also be accomplished by completely blocking the laser pulses, e.g., by using an acoustic-optical modulator.
In some embodiments, the overall lenticular incision procedure is performed in the following steps:
1. Calculate the radius of curvature of the lenticule based on the amount of optical correction, e.g., using Equation (3) for a myopic correction.
2. Select the diameter for the lenticular incision to be extracted.
3. Select laser and optical system parameters, including the laser blanking parameters.
4. Perform bottom surface dissection. In doing so, the fast scan line is preferably kept tangential to the parallels of latitude, and the trajectory of the slow sweep drawn by X, Y, and Z scanning devices moves along the meridians of longitude near south pole in a sequence of 1A to 1B (first sweep of lenticular cut), 2A to 2B (second sweep of lenticular cut), 3A to 3B (third sweep of lenticular cut), and so on, applying periodic laser blanking in the central area for each sweep, until the full bottom dissection surface is generated.
5. Perform the lenticule side (edge) incision.
6. Perform the top surface dissection in a similar manner as the bottom dissection is done.
7. Perform the entry incision.
The laser system 10 first performs side incision to provide a vent for gas that can be produced in the lenticular surface dissections, and for tissue extraction later on (Action Block 1140). The laser system 10 then performs the bottom lenticular surface dissection (Action Block 1150) and the top lenticular surface dissection (Action Block 1160). The bottom and top lenticular surface dissection are performed using a fast-scan-slow-sweep scheme along the meridians of longitude, with periodic laser blanking in the central area, as described above. The lenticular tissue is then extracted (Action Block 1170). Alternatively, the side incision may be performed after the bottom and top lenticular surface dissections.
The above described embodiments solve the problem of redundant energy deposit near the central area by reducing the number of laser pulses delivered in the central area.
All patents and patent applications cited herein are hereby incorporated by reference in their entirety.
The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. The term “connected” is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
While certain illustrated embodiments of this disclosure have been shown and described in an exemplary form with a certain degree of particularity, those skilled in the art will understand that the embodiments are provided by way of example only, and that various variations can be made without departing from the spirit or scope of the invention. Thus, it is intended that this disclosure cover all modifications, alternative constructions, changes, substitutions, variations, as well as the combinations and arrangements of parts, structures, and steps that come within the spirit and scope of the invention as generally expressed by the following claims and their equivalents.
