This invention relates to ophthalmic laser surgeries, and in particular, it relates to flap cutting in LASIK (laser-assisted in situ keratomileusis) surgery using an ultrafast resonant scanning femtosecond laser.
Femtosecond lasers are used to cut flaps in the corneal stroma as the first step of LASIK (laser-assisted in situ keratomileusis) surgeries. A flap is typically formed by a bed cut which is parallel to the anterior corneal surface and a vertical side cut around the periphery of the bed cut expect for an uncut hinge region.
When using femtosecond lasers to cut a flap in the corneal stroma as a part of a LASIK procedure, the interaction of the laser pulses with the tissue can sometimes create excessive gas bubbles which can interfere with the continued cutting of the tissue, creating tissue bridges and rough bed cut surfaces.
The present invention is directed to a method and related apparatus for incising a corneal flap in LASIK surgery that substantially obviates one or more of the problems due to limitations and disadvantages of the related art.
Embodiments of this invention provide flap cutting patterns including intrastromal pockets that can be implemented with a resonant scanning femtosecond laser. These flap cutting patterns will allow for gas bubbles to collect and vent posterior to and outside of the flap bed cut.
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 and claims thereof as well as the appended drawings.
To achieve the above objects, the present invention provides a method implemented in an ophthalmic surgical laser system for incising a cornea of a patient's eye to form a corneal flap, the method including: controlling a laser delivery system of the ophthalmic surgical laser system to deliver a pulsed laser beam to the cornea; controlling a high frequency scanner of the ophthalmic surgical laser system to scan the pulsed laser beam back and forth to form a laser scan line; and controlling a scan line rotator, an XY-scanner and a Z-scanner of the ophthalmic surgical laser system to move the laser scan line in the cornea to form the corneal flap, including forming a pocket cut, forming a bed of the flap, and forming a side cut of the flap, wherein the bed is located in a horizontal plane at a first depth from an anterior corneal surface, the bed defining a hinge line, wherein the side cut extends from the bed upwards to the anterior corneal surface to form a side of the flap, the side cut surrounding an entire periphery of the bed except the hinge line, and wherein the pocket cut includes a ramp region and a pocket region connected to each other, wherein the pocket region is located at a second depth from the anterior corneal surface which is deeper than the first depth, wherein the pocked region has a shape of a rectangle, or multiple rectangles joined to each other, or a segment of a ring in a top view, and wherein the ramp region extends between the first depth and the second depth and is connected to both the bed and the pocket region.
In preferred embodiments, the pocket cut is formed first, the bed is formed after the pocket cut, and the side cut is formed after the bed.
In another aspect, the present invention provides a method implemented in an ophthalmic surgical laser system for incising a cornea of a patient's eye to form a corneal flap, the method including: controlling a laser delivery system of the ophthalmic surgical laser system to deliver a pulsed laser beam to the cornea; controlling a high frequency scanner of the ophthalmic surgical laser system to scan the pulsed laser beam back and forth to form a laser scan line; and controlling a scan line rotator, an XY-scanner and a Z-scanner of the ophthalmic surgical laser system to move the laser scan line in the cornea to form the corneal flap, including forming a bed of the flap and forming a side cut of the flap, wherein the bed is located in a horizontal plane at a first depth from an anterior corneal surface, the bed defining a hinge line, wherein the side cut extends from the bed upwards to the anterior corneal surface to form a side of the flap, the side cut surrounding an entire periphery of the bed except for the hinge line, and wherein the step of forming the bed includes: forming a hinge cut along the hinge line by scanning the laser scan line along the hinge line; forming a first ring cut along a periphery of the bed except for an area of the hinge cut by scanning the laser scan line along a circumference of the bed; forming a bed cut by scanning the laser scan line in overlapping parallel raster scan passes, the bed cut overlapping at least a part of the hinge cut and the first ring cut and covering all areas of the bed not covered by the hinge cut and the first ring cut; and forming a second ring cut overlapping the first ring cut by scanning the laser scan line along the circumference of the bed.
In preferred embodiments, the bed cut is formed after both the hinge cut and the first ring cut, and the second ring cut is formed after the bed cut. The hinge cut and the first ring cut are formed using a first laser pulse energy, and the bed but, the second ring cut, and the side cut are formed using a second laser pulse energy which is higher than the first laser pulse energy.
In another aspect, the present invention provides a method implemented in an ophthalmic surgical laser system for incising a cornea of a patient's eye to form a corneal flap, the method including: controlling a laser delivery system of the ophthalmic surgical laser system to deliver a pulsed laser beam to the cornea; controlling a high frequency scanner of the ophthalmic surgical laser system to scan the pulsed laser beam back and forth to form a laser scan line; and controlling a scan line rotator, an XY-scanner and a Z-scanner of the ophthalmic surgical laser system to move the laser scan line in the cornea to form the corneal flap, including forming a bed of the flap and forming a side cut of the flap, wherein the bed is located in a horizontal plane parallel to an anterior corneal surface of the cornea, wherein the side cut extends from the bed upwards to the anterior corneal surface to form a side of the flap, and wherein the step of forming the side cut includes forming a plurality of side cut layers in a sequence, each side cut layer extending within a depth range relative to the anterior corneal surface, wherein all except one of the plurality of side cut layers are located entirely within the cornea without reaching the anterior corneal surface, and wherein the plurality of side cut layers are aligned with each other and connect with each other to form the side cut.
In preferred embodiments, the depth ranges of adjacent side cut layers overlap each other, and the plurality of side cut layers are formed in a sequence from deeper side cut layers to shallower side cut layers. Each of the plurality of side cut layers is formed by placing the laser scan line tangent to a circumference of the side cut, moving the laser scan line in a vertical direction, simultaneously moving the laser scan line around the circumference, and simultaneously rotating the scan line to keep it tangent to the circumference.
In another aspect, the present invention provides an ophthalmic surgical laser system, which includes: a laser delivery system configured to deliver a pulsed laser beam to a cornea of a patient's eye; a high frequency scanner configured to scan the pulsed laser beam back and forth at a predefined frequency to form a laser scan line; a scan line rotator configured to rotate an orientation of the laser scan line; an XY-scanner and a Z-scanner configured to move the laser scan line in lateral and depth directions; and a controller operatively coupled to and programmed to control the scan line rotator, the XY-scanner and the Z-scanner to scan the laser scan line in the cornea to form a corneal flap, including to perform various steps in any of the above described methods.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed.
FIGS. 2A1-2B5 schematically illustrate a cutting sequence in the first embodiment.
A previous technique for managing gas bubble formation during bed cut uses an intrastromal pocket cut, as shown in
While effective, this cut is difficult to implement with a resonant scanning femtosecond laser. As described in more detail later, and shown in
To solve the problem of excessive bubble formation when cutting a flap bed using an ultrafast raster scanning femtosecond laser, embodiments of the present invention provide a flap cutting procedure, where a pocket is first cut in a region posterior to the intended bed cut surface in a manner that can be conveniently executed by scanning the lase scan line. This pocket is made so that it connects to the bed cut or ring cut and will allow gas bubbles to collect in the pocket rather than collecting at the incision interface of the flap.
The pocket cut 101 includes a pocket region 101A and a ramp region 101B. The ramp region 101B is aligned along the hinge line of the flap in the top view, and extends from a depth slightly above the bed level (e.g., 2 to 20 μm above the bed level) to a depth about 70 to 150 μm below the bed level. The pocket region 101A extends substantially horizontally from the lower end of the ramp region 101B for about 150 to 400 μm. The pocket cut 101 preferably extends along the entire length of the hinge line, or along a part of the length of the hinge line. The ramp region 101B may be vertical, or alternatively be inclined (e.g., within 0-170 degrees from the vertical direction). Overall, the pocket cut 101 has a rectangular shape when viewed from the top, and also has a rectangular shape in a side view when viewed along a direction perpendicular to the hinge line.
The cutting sequence is described in more detail with reference to FIGS. 2A1-2B5 (both top and perspective views for each step). The pocket cut 101 is made first, with the ramp region connecting to the bed level of the bed cut to be formed, along the hinge line, as shown in FIGS. 2A1 and 2B1. The pocket cut may be made by placing the laser scan line parallel to the hinge line and scanning the scan line along the intended surface of the pocket cut using the XY scanner and the Z scanner. The scanning direction is radially inwardly for the pocket region 101A and in a deep-to-shallow direction for the ramp region 101B. Multiple passes may be executed side-by-side (preferably with edge overlaps) to form the entire pocket.
Then, a cutting pass is made at the bed level, located across the hinge portion along the hinge line, forming the hinge cut 102 which connects to the pocket cut, as shown in FIGS. 2A2 and 2B2. A low energy ring cut 103 is made at the bed level along the periphery of the bed circle except for the hinge portion, to create the peripheral edge of the flap bed, as shown in FIGS. 2A3 and 2B3. The ring cut 103 is made by placing the laser scan line in a radial direction at the required distance from the center of the bed, so that its outer end is located at the circumference of the bed circle, and scanning the scan line using the XY scanner along the circumferential direction while using the scan line rotator to rotate the scan line direction to keep it in the radial direction. The order of the hinge cut 102 and ring cut 103 may be reversed. Both cuts are made at laser pulse energy levels that are lower than the other cutting steps, e.g., at 90% (or more generally, from 85% to 95%) of the pulse energy of the other cutting steps. These lower energy cuts generate less bubbles and less distortion of the tissue. In preferred embodiments, the pulse energy for the pocket cut, the bed cut, the second ring cut, and the side cut is 40 to 90 nJ.
Then, the bed cut 104 is made by creating overlapping parallel raster scan passes of the laser scan line, covering substantially the entire bed circle (at least all the areas not covered by the ring cut 103) except for the arc segment of the hinge, as shown in FIGS. 2A4 and 2B4. Preferably, adjacent parallel raster scan passes overlap with each other in the width direction by at least 50% of their widths, so that in effect, each point is covered by at least two passes. Note that one of the scan passes preferably overlaps with the low energy hinge cut 102. The second ring cut 105 is then made in the same area of the first ring cut 103 to ensure tissue separation at the edges of the bed, as shown in FIGS. 2A5 and 2B5. The second ring cut 105 is made in the same way as the first ring cut 103 but at the normal pulse energy.
The hinge cut 102, first ring cut 103, bed cut 104, and second ring cut 105 overlap each other so that any given point within the bed is covered by at least two passes, which minimize residual uncut tissue bridges. Moreover, the cutting sequence of the hinge cut 102, first ring cut 103, bed cut 104, and second ring cut 105 ensures that a venting channel is always present that connects the current cutting point through earlier-formed cuts to the pocket, so that the gas formed at the current cutting point always has somewhere to escape to, thereby voiding opaque bubble layer formation.
Lastly, a side cut 106 is made, as shown in
The cutting order described above, which cuts the ring cut and hinge cut twice, the first time at lower energy, has the advantage of avoiding tissue bridges. Tissue bridges prevent bubbles from traveling to the pocket, and presents problems for flap separation. The low energy hinge cuts 102 and low energy ring cut 103 generate less bubbles and less distortion of tissue.
The pocket cut 302/303 is made by placing the laser scan line parallel to the hinge line (i.e., in
In a particular example, the flap diameter D is 9.0 mm, the pocket width Wp is 250 μm, and the hinge angle ΘH is 55°. The scan line length Ls is about 900 μm, and five parallel scans are used to form the entire length of the pocket 302, 303. Other appropriate scan line lengths may be used. More generally, the flap diameter D may be between 5 and 10 mm, the pocket width Wp may be between 150 and 400 μm, and the hinge angle ΘH may be between 45 and 90 degrees.
To form the corneal flap in this embodiment, the pocket cut 302, 303 is formed first as described above; then the bed cut and side cut are formed in that sequence, for example using the raster scanning method described in the first embodiment. This flap procedure, including the pocket 302, 303, is design so that it can be made with an ultrafast resonant scanning femtosecond laser.
The pocket region cut 403 is made by scanning the laser scan line in a similar manner as forming the ring cut in the first embodiment, but the scan line is located at the pocket depth and the required distance from the center of the bed circle, and the scan spans only the required angular range. Each ramp region segment 4021, 4022, etc. is made by placing the laser scan line parallel to the hinge line, and scanning the scan line along the depth profile of that tamp region in a similar manner as forming the ramp region in the second embodiment. As indicated earlier, different ramp regions start at different positions and have different slopes. In one example, the laser scan line is set to approximately 400 μm long when cutting the pocket region, and set to 900 μm long when cutting each ramp region; five ramp regions are formed by five scan passes, as illustrated in
The values of the flap diameter D, pocket width Wp, and hinge angle ΘH are similar to those in the second embodiment.
To form the corneal flap in this embodiment, the pocket region is formed first, followed by the ramp regions to connect the pocket region to the bed level. Then the bed cut and side cut are formed in that sequence, for example using the raster scanning method described in the first embodiment. This flap procedure, including the pocket and ramps, is design so that it can be made with an ultrafast resonant scanning femtosecond laser.
In alternative embodiments (not shown in the drawings), the pocket region and ramp region in the second embodiment (
In other alternative embodiments, the ramp region 302 or 502 is still formed in the same manner described earlier, but the pocked region 303 or 503 is formed by a single scan of the laser scan line placed at the pocket level and perpendicular to the hinge, and moved in a direction parallel to the hinge.
The pocket region 703 is located at a level below the bed level and has the shape of a segment of a ring in the top view, concentric with the bed and located approximately within the hinge portion. In the illustrated embodiment, the inner and outer radii of the pocket region 703 are respectively larger than the inner and outer radii of the ring cut 704 (the pocket width is indicated by the double-arrowed line), but this is not required. The pocket region 703 is made by scanning a laser scan line along an arc at the pocket level in a manner similar to forming the pocket region 403 in the third embodiment shown in
In some embodiment, the pocket region 703 may be formed in a two-pass scan, starting from the center of the hinge portion (and outsider of the bed area) and moving counter-clockwise (or clockwise) in the first pass, and then moving in the clockwise (or counter-clockwise) direction from one end of the hinge portion to the other end in the second pass.
The ramp region 702 connects the pocket region 703 to the ring cut 704 at the bed level. In the top view, the ramp region 702 has the shape of a segment of a ring, concentric with the ring cut and having the same inner and outer radii (and hence the same width) as the ring cut, and located within the hinge portion. The two circumferential ends of the ramp region 702 are respectively connected to the pocket region 703 and the ring cut 704. The ramp region 702 is formed by placing the laser scan line in a radial direction, at a location near one end of the pocket region 703 but at a depth slightly below the pocket region to ensure connectivity. The scan line is then moved by the XY scanner along an arc toward the other end of the hinge region, simultaneously rotated by the scan line rotator to keep it in the radial direction, and simultaneously moved by the Z scanner upwards toward the bed level, to a position where it connects with a circumferential end of the ring cut at the bed level (see
To form the corneal flap in this embodiment, the pocket region 703 is formed first, followed by the ramp region 702, then by the bed cut (including the ring cut) and then the side cut using the method described earlier. This flap procedure is design so that it can be made with an ultrafast resonant scanning femtosecond laser.
It can be seen that in the first to fifth embodiments (
In the first to tenth embodiments described above, the pocket depth Dp is comparable to flap thickness (i.e. the bed depth), such as from 0.5 to 1.5 times the flap thickness.
In each embodiment, one or more of the following parameters may be varied: laser scan line length for both the pocket and ramp, pocket width, scan line overlaps, pocket depth, bed depth, and cutting order.
In the flap cutting procedures according to the above embodiments, the pockets allow the gas bubbles to move into the pockets and out of the laser path of the subsequent cut. It is not essential for the bubbles to move all the way back to the pocket, however, so long as they move backward to earlier cut areas. Thus, for example, in a ring, bed, side cut cutting order, when cutting the side cut, it is not essential for the gas bubbles to move into the pocket; rather, it is sufficient if they move back to the ring or bed cut.
In conventional flap procedures, the flap cut is executed by forming a ring cut (at the bed level) first, followed by a side cut, then by a bed cut. The side cut is a single layer which is created by moving the laser scan line sinusoidally in Z and XY directions between the top of the side cut (at or slightly above anterior corneal surface) and the bottom of the side cut (at or slightly below the bed level), tangent to the side-cut path (the circle in the top view). One problem with this side cut method is that, because the scan line reaches the anterior corneal surface in each sinusoidal period of the scan, gas bubbles generated during the cut will escape from cornea and be trapped between the cornea and the patient interface lens; such gas bubbles may move sideways into a center areas of the flap, which may interfere with the subsequent bed cut. The patient interface is a device used to mechanically couple the patient's eye to the laser surgical system; the patient interface typically has a lens that contacts and applanates the cornea during the procedure.
In the flap procedure according to the eleventh embodiment of the present invention, the cutting sequence is to form a bed 1201 first, which includes a ring cut and a bed cut executed in either order, then form a side cut 1202 after the bed is completed. Moreover, the side cut 1202 is formed using a multi-layer technique.
More specifically, the side cut 1202 is formed one layer at a time, where each layer 1202-1, 1202-2, 1202-3, etc. is a part of the overall side cut but extends only in a depth range that is a sub-range of the entire depth range of the side cut. All but the top layer are completely located within the cornea and do not reach the anterior corneal surface. The layers are aligned with each other along the entire depth range and connect with each other to form the side cut. The adjacent layers preferably overlap each other in the depth direction (i.e., their sub-ranges overlap each other). In one example, the layer thickness, i.e. the size of the depth sub-range, is about 25 μm, and the overlap between two adjacent layers is about 10 μm. More generally, the layer thickness may be from 10 to 40 μm, and the layer overlap may be from 2 to 15 μm. The bottom-most layer may extend below the bed level and the top-most layer may extend above the anterior corneal surface, to ensure proper separation of the flap. The number of side cut layers is determined by the total depth of the side cut, the thickness of each layer and the amount of overlap between adjacent layers. The example illustrated in
The side cut layers are formed in a sequence from posterior to anterior (i.e. deeper to shallower relative to the anterior corneal surface), preferably changing layers at the corner of the hinge to start the subsequent side cut layer. The top of the last side cut layer that is located completely inside the cornea is preferably within less than 20 μm from the top surface of epithelium in order to manage the bubbles generated within the ring cut, bed cut and side cut.
The side cut may be perpendicular to the anterior corneal surface, or at a non-right angle relative to the anterior corneal surface.
As shown in
where H is the layer thickness, fz is the Z scan frequency, fs is the resonant scan frequency that produces the scan line, Δz is a scan line-to-line separation parameter, H is the layer thickness, Vc is the speed of the XY scan in the circumferential direction, and ΔB is a band-to-band separation of the band in the circumferential direction in one period of the Z scan. Preferably, during the anterior to posterior half of each sinusoidal period, the laser beam is fast blanked, e.g. blocked by using an acousto-optic modulator of the laser system, in order to manage the generated bubbles in the corneal tissue.
In one particular example for creating the layered side cut, the Z scan frequency was 120 Hz, the scan line length was 600 μm, the scan line overlap was 25%, the glass overcut at the anterior corneal surface was 90 μm, the side cut angle was 120° , and the flap diameter was 8.0 mm.
In the embodiment of
In embodiments of the present invention described above, the execution sequences for the various cuts that form the pocket, the flap bed and flap side ensure that a venting channel is always present that connects the current cutting point through earlier-formed cuts to the bottom part of the pocket, so that the gas formed at the current cutting point always has somewhere to escape to, thereby voiding opaque bubble layer formation.
Ophthalmic laser systems that may be used to implement the above-described flap formation procedures are described in more detail now with reference to
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 a near infrared laser beam comprising a plurality of 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 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.
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 (e.g., the resonant scanner 21 of
As described earlier, the flap procedures in various embodiments of the present invention utilize the fast-scan-slow-sweep scanning scheme to form various cuts of the flap. The controller of the laser system controls the various components of the system to form the above-described cuts.
It will be apparent to those skilled in the art that various modification and variations can be made in the corneal flap procedure and related apparatus of the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover modifications and variations that come within the scope of the appended claims and their equivalents.
This application is a continuation of U.S. patent application Ser. No. 17/457419, filed Dec. 2, 2021, which claims priority to U.S. Provisional Patent Application No. 63/121,073, filed on Dec. 3, 2020, the entire contents of which are hereby incorporated by reference.
Number | Date | Country | |
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63121073 | Dec 2020 | US |
Number | Date | Country | |
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Parent | 17457419 | Dec 2021 | US |
Child | 18439724 | US |