Ablation systems and methods for treating presbyopia

Abstract

According to some embodiments, an ophthalmic surgical system for treating presbyopia includes controllable components and a computer. The controllable components include a light source for generating a light beam and a scanner for guiding the focus of the beam. The computer determines an ablation profile to remove tissue from the central and peripheral regions of the cornea of ​​the first eye in a pair of eyes. The ablation profile is designed to: remove tissue from the central region to create a protrusion to provide near vision, and remove tissue from the peripheral region to correct to emmetropia.

Description

Technical Field

[0001] This disclosure generally relates to ophthalmic surgical systems and methods, and more particularly to ablation systems and methods for treating presbyopia. Background Technology

[0002] The eye's lens changes shape to focus light onto the retina, allowing us to see both near and far objects. In youth, the lens is soft and flexible, easily changing shape. Presbyopia typically occurs after age 40, when the lens becomes more rigid and less able to reshape. This causes the eye to focus light behind the retina rather than directly on it when viewing near objects, thus reducing near vision.

[0003] There are approximately 1.7 billion people worldwide suffering from presbyopia, with about one-third of the population in the United States affected. Treatments for presbyopia include lenses (e.g., eyeglasses and contact lenses), implants (e.g., intraocular lenses (IOLs), scleral implants, and corneal inlays), and multifocal refractive surgery. However, current treatments do not always provide satisfactory results in certain situations. Summary of the Invention

[0004] In some embodiments, an ophthalmic surgical system for treating presbyopia includes controllable components and a computer. The controllable components include a light source for generating a light beam and a scanner for guiding the focus of the beam. The computer determines an ablation profile to remove tissue from the central and peripheral regions of the cornea of ​​a first eye in a pair of eyes. The ablation profile is designed to: remove tissue from the central region to create a bulge for near vision, and remove tissue from the peripheral region to correct for emmetropia. The computer instructs one or more of the controllable components to ablate the cornea of ​​the first eye according to the ablation profile.

[0005] The embodiments may exclude the following features or may include one, some, or all of the following features:

[0006] The protrusion can have any suitable size. For example, the protrusion can be spherical with a diameter of 0.5 to 4 millimeters and / or a height of 3 to 50 micrometers, such as 20 to 40 micrometers.

[0007] If the peripheral area is designed to treat myopia, the ablation contour removes a thicker portion of the cornea in the inner part of the peripheral area than in the outer part.

[0008] If the peripheral region is designed to treat farsightedness, the ablation contour removes a thicker portion of the cornea in the outer part of the peripheral region than in the inner part.

[0009] If the first eye in a pair of eyes is a non-dominant eye and the second eye in the pair of eyes is a dominant eye, then the computer can: determine a second ablation profile designed to correct the second eye to emmetropia, and instruct one or more controllable components to ablate the cornea of ​​the second eye according to the second ablation profile.

[0010] The computer can generate a focal spot pattern that corresponds to the ablation contour and align the focal spot pattern relative to the visual axis to ablate the cornea.

[0011] A computer can: generate a focal spot pattern corresponding to an ablation contour, wherein the points of the focal spot pattern are specified to be aligned with the visual axis of the eye; determine the visual axis of the eye; and align the points of the focal spot pattern relative to the visual axis to ablate the cornea.

[0012] In some embodiments, a method for treating presbyopia includes: generating a light beam via a light source among a plurality of controllable components; guiding the focus of the light beam via a scanner among the plurality of controllable components; determining an ablation profile via a computer to remove tissue from a central and peripheral region of the cornea of ​​a first eye in a pair of eyes, the ablation profile being designed to remove tissue from the central region to create a protrusion to provide near vision, and the ablation profile being designed to remove tissue from the peripheral region to correct to emmetropia; and instructing one or more controllable components among the controllable components via a computer to ablate the cornea of ​​the first eye according to the ablation profile.

[0013] The embodiments may exclude the following features or may include one, some, or all of the following features:

[0014] The protrusion can have any suitable size. For example, the protrusion can be spherical with a diameter of 0.5 to 4 millimeters and / or a height of 3 to 50 micrometers, such as 20 to 40 micrometers.

[0015] If the peripheral area is designed to treat myopia, the ablation contour removes a thicker portion of the cornea in the inner part of the peripheral area than in the outer part.

[0016] If the peripheral region is designed to treat farsightedness, the ablation contour removes a thicker portion of the cornea in the outer part of the peripheral region than in the inner part.

[0017] If the first eye in a pair of eyes is a non-dominant eye and the second eye in the pair of eyes is a dominant eye, the method may further include: determining a second ablation profile designed to correct the second eye to emmetropia via a computer; and instructing one or more controllable components via a computer to ablate the cornea of ​​the second eye according to the second ablation profile.

[0018] The method may further include: generating a focal spot pattern corresponding to the ablation contour by computer; and aligning the focal spot pattern relative to the visual axis by computer to ablate the cornea.

[0019] The method may further include: generating a focal spot pattern corresponding to the ablation contour by computer, wherein the points of the focal spot pattern are designated to be aligned with the visual axis of the eye; determining the visual axis of the eye by computer; and aligning the points of the focal spot pattern relative to the visual axis by computer to ablate the cornea.

[0020] In some embodiments, an ophthalmic surgical system for treating presbyopia includes controllable components and a computer. The controllable components include a light source for generating a light beam and a scanner for guiding the focus of the beam. The computer determines an ablation profile to remove tissue from the central and peripheral regions of the cornea of ​​a first eye in a pair of eyes. The first eye in the pair is the non-dominant eye, and the second eye in the pair is the dominant eye. The ablation profile is designed to remove tissue from the central region to create a projection that provides near vision. The projection is spherical, with a diameter of 0.5 to 4 millimeters and a height of 3 to 50 micrometers. The ablation profile is designed to remove tissue from the peripheral region to correct for emmetropia. If the peripheral region is designed to treat myopia, the ablation profile removes a thicker portion of the cornea in the inner portion of the peripheral region than in the outer portion. If the peripheral region is designed to treat hyperopia, the ablation profile removes a thicker portion of the cornea in the outer portion of the peripheral region than in the inner portion. Computer: Generates a focal spot pattern corresponding to the ablation profile, wherein points of the focal spot pattern are designated to be aligned with the visual axis of the eye; determines the visual axis of the eye; aligns the points of the focal spot pattern relative to the visual axis to ablate the cornea; and instructs one or more controllable components to ablate the cornea of ​​the first eye according to the ablation profile. Computer: Determines a second ablation profile designed to correct the second eye to emmetropia; and instructs one or more controllable components to ablate the cornea of ​​the second eye according to the second ablation profile. Attached Figure Description

[0021] Figure 1 Examples of ophthalmic laser ablation systems according to certain embodiments are shown, which ablate corneal tissue of the eye to treat presbyopia;

[0022] Figure 2 Showing Figure 1 The system can be used to treat ablation patterns in myopia and presbyopia;

[0023] Figure 3 Showing Figure 1 The system can be used to treat ablation patterns in farsightedness and presbyopia; and

[0024] Figure 4 It is shown that, according to certain embodiments, it can be made by Figure 1 The system executes a method for ablating the cornea of ​​the eye. Detailed Implementation

[0025] Example embodiments of the disclosed devices, systems, and methods are now shown in detail with reference to the specification and accompanying drawings. The specification and drawings are not intended to be exhaustive or otherwise limit the claims to the specific embodiments shown in the drawings and disclosed in the specification. Although the drawings illustrate possible embodiments, they are not necessarily drawn to scale, and certain features may be simplified, exaggerated, removed, or partially cut out to better illustrate the embodiments.

[0026] In some embodiments, an ophthalmic surgical system ablates the first eye in a pair of eyes to treat presbyopia. The system ablates tissue from both the central and peripheral regions of the cornea. The remaining tissue has a protrusion in the central region. The resulting cornea provides near vision in the central region and distance vision in the peripheral region. In some embodiments, the first eye is a non-dominant eye. The system can also ablate a second eye to correct it to emmetropia.

[0027] Figure 1 An example of an ophthalmic laser ablation system 10 according to certain embodiments is shown, which ablates corneal tissue of eye 22 to treat presbyopia. In the illustrated example, system 10 includes a laser device 15, a camera 38, and a control computer 30 coupled as shown. Laser device 15 includes controllable components coupled as shown, such as a light source (e.g., laser source 12), a scanner 16, a focusing objective 18, and / or one or more optical elements 17. Computer 30 includes logic 36, a memory 32 (which stores computer programs 34), and a display 37 coupled as shown. For ease of explanation, the following xyz coordinate system is used: the z-direction is defined by the propagation direction of the laser beam, and the xy plane is orthogonal to the propagation direction. Other suitable xyz coordinate systems may be used.

[0028] In summary, laser source 12 generates a laser beam, and scanner 16 guides the focus of the laser beam to ablate tissue from eye 22. Computer 30 determines an ablation profile to remove tissue from the central and peripheral regions of the cornea. The ablation profile is designed to remove tissue from the central region to create a bulge for near vision, and to remove tissue from the peripheral region to correct for emmetropia. Computer 30 instructs one or more controllable components of system 10 to ablate the cornea according to the ablation profile.

[0029] In the steering system 10, the light source generates a beam of light that ablates the tissue of the eye 22 according to a focal spot pattern. The wavelength of the beam can be, for example, less than 300 nm. In the example shown, the light source is a laser source 12 that generates a laser beam that ablates the tissue of the eye 22 according to a laser focal spot pattern. The laser source 12 can be an excimer, solid-state, or other suitable laser. The focal spot pattern can define the x and y coordinates of the location to which the laser radiation pulses are to be guided. The focal spot pattern can be determined based on an ablation profile that indicates the volume of tissue to be removed at a specific x, y location on the cornea. Given the volume of tissue ablated per pulse, the number of pulses to be guided to the x, y location can be calculated based on the tissue volume defined by the ablation profile.

[0030] Scanner 16 laterally guides the focal point of the laser beam. Lateral direction refers to the direction orthogonal to the beam propagation direction, i.e., the x-direction and y-direction. Scanner 16 can laterally guide the laser beam in any suitable manner. For example, scanner 16 may include a pair of galvanometer-actuated scanner mirrors that can tilt about mutually perpendicular axes. As another example, scanner 16 may include an electro-optic crystal capable of electro-optically manipulating the laser beam.

[0031] One or more optical elements 17 direct the laser beam toward a focusing objective 18. Optical elements 17 can act (e.g., transmit, reflect, refract, diffract, collimate, adjust, shape, focus, modulate, and / or otherwise act on) the laser beam. Examples of optical elements include lenses, prisms, mirrors, diffractive optics (DOE), holographic optics (HOE), and spatial light modulators (SLM). In this example, optical element 17 is a mirror. The focusing objective 18 focuses the laser beam toward a point on eye 22. In this example, focusing objective 18 is an objective, such as an f-θ objective.

[0032] Camera 38 records images of eye 22. Examples of cameras 38 include video cameras, optical coherence tomography cameras, or eye-tracking cameras. Camera 38 transmits image data representing the recorded images of eye 22 to computer 30. Computer 30 can perform image processing on the image data to monitor the ablation of eye 22.

[0033] Computer 30 controls components of system 10 according to computer program 34. For example, computer 30 controls components (e.g., laser source 12, scanner 16, optics 17, and / or focusing lens 18) to focus the laser beam of laser device 15 onto eye 22 and ablate at least a portion of eye 22 according to an ablation profile. In some embodiments, computer 30 generates a focal spot pattern corresponding to the ablation profile. Computer 30 can generate the focal spot pattern by determining a focal spot corresponding to the tissue removed according to the ablation profile. The ablation profile indicates the volume of tissue to be removed at a specific x, y position on the cornea. Given the volume of tissue ablated per pulse, the number of pulses to be directed to the x, y position can be calculated based on the tissue volume defined by the ablation profile.

[0034] In some embodiments, computer 30 determines an ablation profile to remove tissue from both the central and peripheral regions of the cornea. The ablation profile is designed to remove tissue from the central region to create a bulge for near vision and to remove tissue from the peripheral region to correct for emmetropia. In other embodiments, computer 30 may determine the ablation profile by retrieving a profile from memory 32, wherein the ablation profile is determined as described above.

[0035] In some embodiments, computer 30 aligns a focal spot pattern relative to an axis of the eye (e.g., the optical axis or visual axis) to ablate the cornea. In some cases, specific points of the focal spot pattern are designated for alignment with that axis. Computer 30 can align a point relative to an axis by receiving a measurement or coordinate (e.g., xy coordinates) identifying the location of that axis and then aligning that point with that axis. In some embodiments, computer 30 can determine the xy coordinates of the visual axis according to the methods described in U.S. Patent Applications Nos. 63 / 010293 (filed April 15, 2020) and 63 / 033327 (filed June 2, 2020). Computer 30 can then align the specific point with the xy position of the visual axis.

[0036] In some embodiments, computer 30 treats a pair of eyes. A first eye (e.g., a non-dominant eye) is treated according to an ablation profile having protrusions for near vision correction, and a second eye (e.g., a dominant eye) is treated with a profile corrected to emmetropia. In embodiments, the dominant or non-dominant eye can be either the first or the second eye.

[0037] Figure 2 and Figure 3 They were shown respectively Figure 1Examples of ablation diagrams 50 (50a, 50b) for system 10, which can be used to treat myopic presbyopia and hyperopic presbyopia. Ablation diagrams 50 can be used for any suitable refractive surgery to reshape the cornea, such as laser-assisted in situ keratomileusis (LASIK) or laser-assisted refractive corneal reshaping (PRK). In the example, ablation diagrams 50 (50a, 50b) are used for LASIK. In the example, ablation diagram 50 shows an epithelium 51 and a cornea 52. The cornea 52 has a central region 55 and a peripheral region 57. The central region 55 is substantially centered on the axis of the eye (e.g., the visual axis or optical axis), and the peripheral region 57 extends from the central region 55 toward the edge of the cornea.

[0038] Corneal flap incision 53 represents the incision formed to create the LASIK corneal flap. Removed tissue 62 (62a, 62b) represents the tissue ablated according to the ablation contour, while remaining tissue 64 (64a, 64b) represents the tissue remaining after ablation. Ablation surface 60 (60a, 60b) represents the remaining stromal surface after the tissue has been ablated according to the ablation contour.

[0039] The ablation surface 60 of the central region 55 and the peripheral region 57 can have any suitable size and / or shape, and the computer 30 can determine the size of the ablation surface 60 in any suitable manner. In some embodiments, the computer 30 can receive information describing refractive correction and determine the size based on that information.

[0040] In an embodiment, computer 30 can calculate the size of peripheral region 57 based on information describing vision correction. In some examples, removing a thickness of 14 to 18 micrometers corresponds to approximately 1 diopter of correction. The location of the thickness (e.g., central or peripheral) depends on whether the correction is for myopia or hyperopia. Typically, myopia treatment removes a thicker portion of the cornea (e.g., ) in the inner part of the peripheral region than in the outer part. Figure 2 (ablation diagram 50a), while hyperopia treatment removes a thicker portion of the cornea in the outer part of the peripheral area than in the inner part (e.g., Figure 3 (See ablation diagram 50b). In some embodiments, ablation of the peripheral region 57 can be designed to correct myopia or hyperopia to emmetropia. Emmetropia is a visual state in which distant objects at infinity are clearly focused and the lens of the eye is in a neutral or relaxed state. Emmetropia can be in the range of +1 to -1 diopters.

[0041] In an embodiment, computer 30 can calculate the size of the protrusion 58 in the central region 55 based on information describing near vision correction. In some examples, the diameter of the protrusion 58 is 0.5 to 4 mm (e.g., 0.5 to 1 mm, 1 to 2 mm, 2 to 3 mm, and / or 3 to 4 mm), and the thickness of the center of the protrusion 58 is 3 to 50 micrometers (e.g., 3 to 10 micrometers, 10 to 20 micrometers, 20 to 25 micrometers, 25 to 30 micrometers, 30 to 35 micrometers, 35 to 40 micrometers, and / or 40 to 50 micrometers). Generally, a protrusion 58 with a larger central thickness provides greater correction for presbyopia. In an example, a protrusion 58 having a spherical shape, a diameter of 2 mm, and a central thickness of 30 micrometers increases the diopter by 2.5 to 4.0 diopters.

[0042] Figure 4 It is shown that, according to certain embodiments, it can be made by Figure 1 The system 10 performs a method for ablating the cornea of ​​the eye. The method begins at step 110, where the computer 30 receives surgical input describing the surgical procedure. The surgical input may include information that the computer 30 can use to retrieve or calculate an ablation profile describing the tissue to be removed. The surgical input may describe the patient's eye, such as spherical deviation, cylindrical deviation, the axis of the cylindrical deviation, the added power (spherical deviation for reading distance correction), and / or the x, y position of the visual axis.

[0043] In step 112, computer 30 determines the ablation contour based on the surgical input. In step 113, the ablation contour may be stored, or it may need to be calculated. If the ablation contour is stored in step 113, the method proceeds to step 114, where computer 30 retrieves the stored ablation contour. The method then proceeds to step 126, where computer 30 begins ablation of the cornea.

[0044] If no ablation profile is stored in step 113, the method proceeds to steps 116 through 122, in which computer 30 calculates the ablation profile. In step 116, computer 30 determines the ablation profile for the peripheral region. In some cases, the peripheral region may be designed to treat myopia, and the ablation profile may remove progressively thicker portions of material towards the center within the peripheral region. In other cases, the peripheral region may be designed to treat hyperopia, and the ablation profile may remove progressively thicker portions of material towards the periphery within the peripheral region. In step 122, computer 30 determines the ablation profile for the central region. The protrusion in the central region may have any suitable shape and / or size. In some examples, the diameter of the protrusion is 0.5 to 4 mm, and the thickness at the center of the protrusion is 3 to 50 micrometers.

[0045] In step 126, computer 30 aligns the focal spot pattern corresponding to the ablation contour with the axis of the eye (e.g., the visual axis or optical axis). In some embodiments, computer 30 may determine the focal spot pattern corresponding to the ablation contour. Computer 30 may receive measurements or coordinates identifying the axis position and then align the focal spot pattern with the axis. In step 128, computer 30 instructs controllable components to ablate the cornea according to the ablation contour. The method then ends.

[0046] Components of the systems and devices disclosed herein (such as control computers) may include interfaces, logic, and / or memory, any of which may include computer hardware and / or software. Interfaces may receive input to and / or send output from components and are typically used to exchange information between, for example, software, hardware, peripherals, users, and combinations thereof. User interfaces (e.g., graphical user interfaces (GUIs)) are types of interfaces that users can use to interact with a computer. Examples of user interfaces include displays, touchscreens, keyboards, mice, gesture sensors, microphones, and speakers.

[0047] Logic can perform operations on components. Logic may include one or more electronic devices that process data (e.g., execute instructions to generate outputs from inputs). Examples of such electronic devices include computers, processors, microprocessors (e.g., central processing units (CPUs)), and computer chips. Logic may include computer software that encodes instructions executable by electronic devices to perform operations. Examples of computer software include computer programs, applications, and operating systems.

[0048] Memory can store information and may include tangible, computer-readable, and / or computer-executable storage media. Examples of memory include computer memory (e.g., random access memory (RAM) or read-only memory (ROM)), mass storage media (e.g., hard disk), removable storage media (e.g., optical disc (CD) or digital video or universal disc (DVD)), databases, network storage devices (e.g., servers), and / or other computer-readable media. Specific embodiments may be directed to memory encoded with computer software.

[0049] Although this disclosure has been described with reference to certain embodiments, modifications to the embodiments (such as alterations, substitutions, additions, omissions, and / or other modifications) will be apparent to those skilled in the art. Therefore, modifications can be made to the embodiments without departing from the scope of the invention. For example, modifications can be made to the systems and devices disclosed herein. Components of the systems and devices may be integral or separate, or the operation of the systems and devices may be performed by more, fewer, or other components, as will be apparent to those skilled in the art. As another example, modifications can be made to the methods disclosed herein. These methods may include more, fewer, or other steps, and these steps may be performed in any suitable order, as will be apparent to those skilled in the art.

[0050] To assist the Patent Office and readers in interpreting the claims, the applicant notes that they do not intend for any claim or claim element to invoke 35 U.SC §112(f) unless the terms “means for…” or “steps for…” are expressly used in a particular claim. The applicant understands that the use of any other terms within the claims (e.g., “mechanism,” “module,” “device,” “unit,” “component,” “element,” “building block,” “device,” “machine,” “system,” “processor,” or “controller”) refers to structures known to a person skilled in the art and is not intended to invoke 35 U.SC §112(f).

Claims

1. An ophthalmic surgical system for treating presbyopia, the ophthalmic surgical system comprising: a plurality of controllable components, the plurality of controllable components comprising: a light source configured to generate a light beam; and a scanner configured to direct a focal point of the light beam; a computer configured to: determine an ablation profile to remove tissue from a central region and a peripheral region of a cornea of a first eye of a pair of eyes, the ablation profile designed to remove tissue from the central region to create a protrusion to provide near vision, the protrusion of the central region of the cornea having a diameter of 0.5 to 4 millimeters and a height of 3 to 50 micrometers, the ablation profile designed to remove tissue from the peripheral region to correct to emmetropia; instruct one or more of the controllable components to ablate the cornea of the first eye according to the ablation profile; determine a second ablation profile designed to correct a second eye of the pair of eyes to emmetropia; and instruct one or more of the controllable components to ablate a second central region and a second peripheral region of the cornea of the second eye according to the second ablation profile to correct the second eye to emmetropia.

2. The ophthalmic surgical system of claim 1, wherein, the protrusion is spherical.

3. The ophthalmic surgical system of claim 1, wherein, the height of the protrusion is 20 to 40 micrometers.

4. The ophthalmic surgical system of claim 1, wherein: if the peripheral region is designed to treat myopia, the ablation profile removes a thicker portion of the cornea at an inner portion of the peripheral region than at an outer portion of the peripheral region.

5. The ophthalmic surgical system of claim 1, wherein: if the peripheral region is designed to treat hyperopia, the ablation profile removes a thicker portion of the cornea at an outer portion of the peripheral region than at an inner portion of the peripheral region.

6. The ophthalmic surgical system of claim 1, wherein: the first eye of the pair of eyes is a non-dominant eye; the second eye of the pair of eyes is a dominant eye.

7. The ophthalmic surgical system of claim 1, the computer further configured to: generate a focal spot pattern corresponding to the ablation profile; and align the focal spot pattern relative to a visual axis to ablate the cornea.

8. The ophthalmic surgical system of claim 1, the computer further configured to: generate a focal spot pattern corresponding to the ablation profile, points of the focal spot pattern designated to align with a visual axis of the eye; determine the visual axis of the eye; and align the points of the focal spot pattern relative to the visual axis to ablate the cornea.

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