Systems and methods for adjusting intraocular lenses using optical coherence tomography guidance
OCT-guided laser adjustment technology solves the problem of inaccurate adjustment after AIOL and non-accommodative IOL surgery, enabling patients to achieve adaptive visual acuity and reducing their dependence on assistive glasses.
Patent Information
- Application Number
- JP2025522803
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-11-07
- Filing Date
- 2023-10-04
- Publication Date
- 2025-11-14
AI Technical Summary
Existing traditional IOLs require patients to wear glasses or other corrective eyewear for certain activities after surgery, and cannot automatically adjust the focus according to changes in distance. Although new AIOLs have a certain degree of adjustment capability, a method for safely and accurately adjusting the IOL is not yet mature.
Guided by optical coherence tomography (OCT), the composite material of the IOL is adjusted using laser. The reference optical power of the IOL is adjusted by measuring the volume change of the material, including adjusting the composite material with a laser beam and determining the optical power change by combining OCT image analysis.
It enables safe and precise adjustment of AIOLs or non-accommodative IOLs, meets clinical needs, improves patients' visual accommodation ability, and reduces reliance on assistive glasses.
Smart Images

Figure 2025537091000001_ABST
Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 382,588, filed November 7, 2022, which is incorporated herein by reference.
[0002] The present disclosure relates generally to the field of intraocular lenses, and more particularly to systems and methods for adjusting intraocular lenses (IOLs) using optical coherence tomography (OCT) guidance. [Background technology]
[0003] A cataract is a condition involving clouding of the normally clear lens of a patient's eye. Cataracts develop as a result of aging, genetic factors, trauma, inflammation, metabolic disease, or exposure to radiation. Age-related cataracts are the most common type of cataract. To treat a cataract, a surgeon removes the natural lens matrix from the patient's lens capsule and replaces it with an intraocular lens (IOL). Traditional IOLs provide one or more selected focal lengths that allow patients to see at a distance. However, after cataract surgery, patients with traditional IOLs often require glasses or other corrective eyewear to perform certain activities because the eye can no longer accommodate (i.e., change its optical power) to retain a sharp image of an object or focus on an object as its distance changes.
[0004] Newer IOLs, such as accommodating IOLs, allow the eye to restore at least some focusing ability. Accommodating IOLs (AIOLs) use the power available in the eye to change some portion of the optical system, thereby refocusing the eye to distant or near targets. Examples of AIOLs are discussed in the following U.S. patent publications: U.S. Patent Application Publication No. 2021 / 0100652, U.S. Patent Application Publication No. 2021 / 0100650, U.S. Patent Application Publication No. 2020 / 0337833, U.S. Patent Application Publication No. 2018 / 0256315, U.S. Patent Application Publication No. 2018 / 0153682, U.S. Patent Application Publication No. 2017 / 0049561, and the following issued U.S. patents: U.S. Patent No. 10,299,913, U.S. Patent No. 10,195,020, and U.S. Patent No. 8,968,396, the contents of which are incorporated herein by reference in their entireties.
[0005] AIOLs and non-accommodating IOLs may need to be adjusted after surgery or after implantation in a patient's eye. Thus, there is a need for a solution that allows a clinician or other medical professional to safely and accurately adjust an AIOL or non-accommodating IOL after surgery. Such a solution must be designed with clinical considerations in mind. [Prior art documents] [Patent documents]
[0006] [Patent Document 1] U.S. Patent Application Publication No. 2021 / 0100652 [Patent Document 2] U.S. Patent Application Publication No. 2021 / 0100650 [Patent Document 3] US Patent Application Publication No. 2020 / 0337833 [Patent Document 4] US Patent Application Publication No. 2018 / 0256315 [Patent Document 5] US Patent Application Publication No. 2018 / 0153682 [Patent Document 6] US Patent Application Publication No. 2017 / 0049561 [Patent Document 7] U.S. Patent No. 10,299,913 [Patent Document 8] U.S. Patent No. 10,195,020 [Patent Document 9] U.S. Patent No. 8,968,396 Summary of the Invention [Means for solving the problem]
[0007] Disclosed herein are systems and methods for adjusting an IOL with laser light using OCT guidance. In some embodiments, a method for adjusting an IOL using OCT includes directing a laser beam generated by a laser system to a composite material that constitutes a portion of the IOL. At least a portion of the composite material is capable of expanding in volume in response to the laser beam directed at the composite material. The method may also include measuring a volume change of the composite material by analyzing one or more OCT images of the composite material generated by the OCT imaging device, and determining a change in base power of the IOL based on the measured volume change of the composite material.
[0008] In certain embodiments, the step of determining the change in base power of the IOL further includes estimating the volume of fluid displaced from either the haptic fluid lumen to the optical fluid chamber or from the optical fluid chamber to the haptic fluid lumen in response to the measured volume change of the composite material, and determining the change in base power of the IOL by selecting from the readout table the change in base power value associated with the volume of fluid displaced.
[0009] The method may also include imaging the IOL using an OCT imaging device and determining the location of the composite material based on the OCT imaging.
[0010] In some embodiments, the IOL can include at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen. The composite material can be configured as a lumen filler that constitutes a portion of the radially inner haptic lumen wall, and the lumen filler can be configured to expand into at least a portion of the haptic fluid lumen in response to a laser beam directed at the lumen filler to reduce the volume of the haptic fluid lumen. The composite material can also be configured as a lumen expander that constitutes another portion of the radially inner haptic lumen wall, and the lumen expander can be configured to expand in response to a laser beam directed at the lumen expander to increase the volume of the haptic fluid lumen. In these embodiments, the method can further include distinguishing between the lumen filler and the lumen expander by analyzing one or more OCT images.
[0011] In some embodiments, the method can also include adjusting the pulse repetition rate of the laser beam to between about 10 kHz and about 100 kHz. In certain embodiments, the laser beam has a wavelength of between about 1030 nm and about 1064 nm. In some embodiments, the method can further include adjusting the laser energy of the laser beam to between about 0.1 μJ and about 100 μJ of laser energy per pulse.
[0012] In certain embodiments, the laser beam can be focused by a focusing objective lens having a numerical aperture of 0.2 to 0.6. The laser beam can be focused onto the composite material by the focusing objective lens.
[0013] In some embodiments, the method may also include controlling a volume change of the composite material by controlling a laser spot diameter formed by the laser beam on the composite material. The laser spot diameter may be determined by the following relationship:
number
[0014] The method may further include redirecting the laser beam at the composite material using a goniolens so that the laser beam reaches a portion of the IOL obscured by the ocular anatomy.
[0015] Another method for adjusting an IOL with OCT is also disclosed. The method may include directing a laser beam generated by a laser system to a composite material that constitutes a portion of the IOL. At least a portion of the composite material is volumetrically expandable in response to the laser beam directed at the composite material. The IOL may include an optic portion including an anterior element and a posterior element. The method may also include measuring a change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optic portion by analyzing one or more OCT images of the optic portion generated by an OCT imaging device, and determining a change in the base power of the IOL based on the measured change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optic portion.
[0016] In certain embodiments, the step of determining the change in base power of the IOL further includes selecting from a lookup table a change value in base power associated with the measured change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optic portion.
[0017] In some embodiments, the method may further include imaging the IOL including the composite material using an OCT imaging device and determining the location of the composite material based on the OCT imaging.
[0018] In some embodiments, the IOL can include at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen. The composite material can be configured as a lumen filler that constitutes a portion of the radially inner haptic lumen wall, and the lumen filler can be configured to expand into at least a portion of the haptic fluid lumen in response to a laser beam directed at the lumen filler to reduce the volume of the haptic fluid lumen. The composite material can also be configured as a lumen expander that constitutes another portion of the radially inner haptic lumen wall, and the lumen expander can be configured to expand in response to a laser beam directed at the lumen expander to increase the volume of the haptic fluid lumen. In these embodiments, the method can also include distinguishing between the lumen filler and the lumen expander by analyzing one or more OCT images.
[0019] In some embodiments, the method can also include adjusting the pulse repetition rate of the laser beam to between about 10 kHz and about 100 kHz. In certain embodiments, the laser beam can have a wavelength of between about 1030 nm and about 1064 nm. In some embodiments, the method can further include adjusting the laser energy of the laser beam to between about 0.1 μJ and about 100 μJ of laser energy per pulse.
[0020] In some embodiments, the method may also include controlling a volume change of the composite material by controlling a laser spot diameter formed by the laser beam on the composite material. The laser spot diameter may be determined by the following relationship:
number
[0021] In certain embodiments, the laser beam can be focused by a focusing objective lens having a numerical aperture of 0.2 to 0.6. The laser beam can be focused onto the composite material by the focusing objective lens.
[0022] The method may further include redirecting the laser beam at the composite material using a goniolens so that the laser beam reaches a portion of the IOL obscured by the ocular anatomy.
[0023] Yet another method for adjusting an IOL with OCT is also disclosed. The method can include directing a laser beam generated by a laser system at a composite material that constitutes a portion of the IOL. At least a portion of the composite material can expand in volume in response to the laser beam directed at the composite material. The method can also include measuring volumetric changes of structures or cavities within the IOL in response to the expansion of the composite material by analyzing OCT images of the IOL generated by the OCT imaging device. The method can further include determining a change in base power of the IOL based on the measured volumetric changes of the structures or cavities.
[0024] In some embodiments, determining the change in base power of the IOL may further include estimating the volume of fluid displaced from either the haptic fluid lumen to the optical fluid chamber or from the optical fluid chamber to the haptic fluid lumen based on the measured volume change of a structure or cavity within the IOL, and determining the change in base power by selecting a change in base power value associated with the volume of fluid displaced from a readout table.
[0025] An ophthalmic system for postoperatively adjusting an IOL is also disclosed. The system can include a laser system configured to generate a laser beam directed at a composite material comprising a portion of the IOL. At least a portion of the composite material can expand in volume in response to the laser beam directed at the composite material. The system can also include an OCT imager configured to generate one or more OCT images of the composite material comprising a portion of the IOL; an image analyzer configured to measure a volume change of the composite material by analyzing the one or more OCT images; and a computing device configured to determine a change in base power of the IOL based on the volume change of the composite material.
[0026] For example, the computing device can determine the change in base power of the IOL by estimating the volume of fluid displaced from either the haptic fluid lumen to the optical fluid chamber or from the optical fluid chamber to the haptic fluid lumen in response to the measured volume change of the composite material, and selecting from the readout table the change value in base power associated with the volume of fluid displaced.
[0027] In some embodiments, the OCT imaging apparatus can be configured to image the IOL before the laser beam is directed at the composite material, and the computing device can be configured to determine the location of the composite material based on one or more OCT images of the IOL.
[0028] In some embodiments, the IOL can include at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen. The composite material can be configured as a lumen filler that constitutes a portion of the radially inner haptic lumen wall, and the lumen filler can be configured to expand into at least a portion of the haptic fluid lumen in response to a laser beam directed at the lumen filler to reduce the volume of the haptic fluid lumen. The composite material can also be configured as a lumen expander that constitutes another portion of the radially inner haptic lumen wall, and the lumen expander can be configured to expand in response to a laser beam directed at the lumen expander to increase the volume of the haptic fluid lumen. In these embodiments, the computing device can be further configured to distinguish between the lumen filler and the lumen expander by analyzing one or more OCT images.
[0029] In some embodiments, the laser beam directed at the composite material can have a pulse repetition rate of 10 kHz to 100 kHz. In certain embodiments, the laser beam directed at the composite material can have a laser energy per pulse of about 0.1 μJ to about 100 μJ. In some embodiments, the laser beam can have a wavelength of about 1030 nm to about 1064 nm. Furthermore, in some embodiments, the laser beam can be focused by a focusing objective lens having a numerical aperture of 0.2 to 0.6.
[0030] In some embodiments, the volume change of the composite material can be controlled in part by the laser spot diameter formed by the laser beam on the composite material. The laser spot diameter can be determined by the following relationship:
number
[0031] The ophthalmic system may further comprise a patient interface including a goniolens configured to redirect the laser beam at a portion of the IOL constructed of a composite material that is hidden by the anatomical structure of the eye.
[0032] Another ophthalmic system for post-operatively adjusting an IOL is also disclosed. The system may include a laser system configured to generate a laser beam directed at a composite material comprising a portion of an intraocular lens (IOL). At least a portion of the composite material is volumetrically expandable in response to the laser beam directed at the composite material. The IOL may include an optic portion including an anterior element and a posterior element. The system may also include an optical coherence tomography (OCT) imager configured to generate one or more OCT images of the optic portion of the IOL after the laser beam is directed at the composite material, and an image analyzer configured to measure a change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optic portion by analyzing the one or more OCT images of the optic portion. The system may further include a computing device configured to determine a change in the base power of the IOL based on the measured change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optic portion.
[0033] For example, the computing device may be configured to determine the change in base power of the IOL by selecting from a lookup table a change value in base power associated with a measured change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optic portion.
[0034] In some embodiments, the OCT imaging apparatus can be configured to image the IOL before the laser beam is directed at the composite material, and the computing device can be configured to determine the location of the composite material based on one or more OCT images of the IOL.
[0035] In some embodiments, the IOL can include at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen. The composite material can be configured as a lumen filler that constitutes a portion of the radially inner haptic lumen wall, and the lumen filler can be configured to expand into at least a portion of the haptic fluid lumen in response to a laser beam directed at the lumen filler to reduce the volume of the haptic fluid lumen. The composite material can also be configured as a lumen expander that constitutes another portion of the radially inner haptic lumen wall, and the lumen expander can be configured to expand in response to a laser beam directed at the lumen expander to increase the volume of the haptic fluid lumen. In these embodiments, the computing device can be further configured to distinguish between the lumen filler and the lumen expander by analyzing one or more OCT images.
[0036] In some embodiments, the laser beam directed at the composite material can have a pulse repetition rate of 10 kHz to 100 kHz. In certain embodiments, the laser beam directed at the composite material can have a laser energy per pulse of about 0.1 μJ to about 100 μJ. In some embodiments, the laser beam can have a wavelength of about 1030 nm to about 1064 nm. Furthermore, in some embodiments, the laser beam can be focused by a focusing objective lens having a numerical aperture of 0.2 to 0.6.
[0037] In some embodiments, the volume change of the composite material can be controlled in part by the laser spot diameter formed by the laser beam on the composite material. The laser spot diameter can be determined by the following relationship:
number
[0038] The ophthalmic system may further comprise a patient interface including a goniolens configured to redirect the laser beam at a portion of the IOL constructed of a composite material that is hidden by the anatomical structure of the eye.
[0039] Yet another ophthalmic system for post-operatively adjusting an IOL is also disclosed. The system can include a laser system configured to generate a laser beam directed at a composite material comprising a portion of the IOL. At least a portion of the composite material can expand in volume in response to the laser beam directed at the composite material. The system can also include an OCT imager configured to generate an OCT image of the IOL, including structures or cavities within the IOL. The system can also include an image analyzer configured to analyze the OCT image to measure volumetric changes of the structures or cavities within the IOL in response to the expansion of the composite material. The method can further include a computing device configured to determine a change in base power of the IOL based on the measured volumetric changes of the structures or cavities.
[0040] In some embodiments, the computing device may be further configured to determine a change in base power of the IOL by estimating the volume of fluid displaced from the haptic fluid lumen to the optical fluid chamber or from the optical fluid chamber to the haptic fluid lumen based on the measured volume change of a structure or cavity within the IOL and selecting a change value in base power associated with the volume of fluid displaced from the readout table. [Brief explanation of the drawings]
[0041] [Figure 1A] FIG. 1A shows a top view of one embodiment of an IOL. [Figure 1B-1C] 1B and 1C show cross-sectional views of the IOL of FIG. 1A along section AA. [Figure 1D] FIG. 1D shows an exploded view of the IOL of FIG. 1A. [Figure 2A] FIG. 2A shows an example of a composite material used to fabricate at least a portion of an IOL. [Figure 2B] FIG. 2B illustrates one embodiment of an expandable component of a composite that increases in size in response to external energy applied to the composite. [Figure 3] FIG. 3 is a block diagram illustrating an OCT-guided laser system configured to adjust an IOL post-operatively. [Figure 4] FIG. 4 shows a top view of the IOL, with the laser spot indicating the location along the lumen filler where it can be targeted by the laser. [Figure 5A-5B] 5A and 5B show that a protrusion can be formed at the laser spot where the lumen filler is exposed to the beam of laser light. [Figures 6A-6C] Figure 6A shows that the protrusions can be formed into a shape resembling a hemisphere, Figure 6B shows that the protrusions can be formed into a shape resembling a paraboloid, and Figure 6C shows that the protrusions can be formed into a shape resembling a semi-ellipsoid. [Figure 7A-7C] Figure 7A is a cross-sectional OCT image showing protrusions formed within the haptic, Figure 7B is a cross-sectional OCT image showing a segment of lumen filler with multiple protrusions formed along the segment, and Figure 7C is a cross-sectional OCT image showing the lumen expander in an expanded configuration. [Figure 8A] FIG. 8A is a cross-sectional OCT image showing a portion of the haptics of an IOL with lumen filler and lumen expander visible in the OCT image. [Figure 8B] Figure 8B is an en face OCT image showing a top view of a portion of the haptic, with the composite material visible in the OCT image. [Figures 9A-9C] 9A and 9B are OCT images showing the change in axial thickness of the optical portion in response to fluid entering the optical fluid chamber, and FIG. 9C shows that at least one of the anterior and posterior elements can change its curvature in response to fluid entering or exiting the optical fluid chamber. [Figure 10] FIG. 10 shows a goniolens used to redirect the laser light to more precisely target the composite material without harming the iris of the eye. DETAILED DESCRIPTION OF THE INVENTION
[0042] FIG. 1A shows a top view of one embodiment of an accommodative intraocular lens (IOL) 100. For example, the accommodative IOL can be an adjustable accommodative IOL (AIOL). The IOL 100 can be implanted in a subject's eye to correct defocus aberration, corneal astigmatism, spherical aberration, or a combination thereof. The IOL 100 can include an optic portion 102 and one or more haptics 104, including first haptics 104A and second haptics 104B, coupled to the optic portion 102 and extending therefrom along the periphery. The IOL 100 can be placed in a natural capsular bag from which the natural lens has been removed.
[0043] In some embodiments, the haptics 104 can be bonded or glued to the optic portion 102 . For example, the haptics 104 can be bonded to the optic portion 102 after each is formed separately. In other embodiments, the IOL 100 can be a one-piece lens in which the haptics 104 are connected to and extend from the optic portion 102. In this exemplary embodiment, the haptics 104 are formed along with the optic portion 102 and are not glued or otherwise joined to the optic portion 102 in a subsequent step.
[0044] The IOL 100 can be implanted into a subject's natural lens capsule after the subject's natural lens has been removed. The optic portion 102 can be adapted to refract light entering the eye toward the retina when implanted in the natural lens capsule. The one or more haptics 104 can be configured to engage the lens capsule and adapted to deform in response to ciliary muscle movement (e.g., muscle relaxation, muscle contraction, or a combination thereof) in conjunction with capsule reshaping.
[0045] Each of the haptics 104 can include a haptic fluid lumen 106 that extends across at least a portion of the haptic 104. For example, the first haptic 104A can include a first haptic fluid lumen 106A that extends across at least a portion of the first haptic 104A, and the second haptic 104B can include a second haptic fluid lumen 106B that extends across at least a portion of the second haptic 104B. The haptic fluid lumen 106 (e.g., either the first haptic fluid lumen 106A or the second haptic fluid lumen 106B) can be in fluid communication with or fluidly connected to an optical fluid chamber 108 in the optical portion 102.
[0046] The optical fluid chamber 108 can be in fluid communication with one or more tactile fluid lumens 106 through one or more fluid channels 110. The fluid channels 110 can be conduits or passageways that fluidly connect the optical fluid chamber 108 to the tactile fluid lumens 106. The fluid channels 110 can be spaced apart from one another. For example, a pair of fluid channels 110 can be spaced apart by about 0.1 mm to about 1.0 mm. In some embodiments, the diameter of each of the fluid channel pairs 110 can be about 0.4 mm to about 0.6 mm.
[0047] The haptics 104 can be coupled to the optical portion 102 at a reinforcement portion 112. The reinforcement portion 112 can serve as a haptic optical interface. A pair of fluid channels 110 can be defined or formed within a portion of the reinforcement portion 112.
[0048] 1A, the optical fluid chamber 108 can be in fluid communication with the first tactile fluid lumen 106A through a first pair of fluid channels 110A. The optical fluid chamber 108 can also be in fluid communication with the second tactile fluid lumen 106B through a second pair of fluid channels 110B.
[0049] In some embodiments, the first fluid channel pair 110A and the second fluid channel pair 110B can be positioned substantially opposite each other in the optical portion 102. The first fluid channel pair 110A can be positioned substantially opposite the second fluid channel pair 110B. The first fluid channel pair 110A and the second fluid channel pair 110B can be defined or extend through a portion of the optical portion 102. The first fluid channel pair 110A and the second fluid channel pair 110B can extend or be defined through a posterior element 132 of the optical portion 102 (see, e.g., FIGS. 1B-1D).
[0050] FIG. 1A also shows that each of the haptics 104 (e.g., either the first haptic 104A or the second haptic 104B) can have a proximal attachment end 114 and a distal free end 116. A haptic fluid port 152 (see, e.g., FIG. 1C ) can be defined in the proximal attachment end 114 of the haptic 104. The haptic fluid port 152 can serve as an opening for the haptic fluid lumen 106. Fluid in the haptic fluid lumen 106 can flow out of the haptic fluid lumen 106 via the fluid channel 110 and through the haptic fluid port 152 into the optical fluid chamber 108 when the haptic 104 is coupled to the optical portion 102. Similarly, fluid in the optical fluid chamber 108 can flow out of the optical fluid chamber 108 through the pair of fluid channels 110 and through the haptic fluid port 152 into the haptic fluid lumen 106.
[0051] Each of the haptics 104 can include a radially outer haptic lumen wall 118 and a radially inner haptic lumen wall 120. The radially outer haptic lumen wall 118 (also referred to as the radially outer sidewall of the haptic 104) can be configured to face and contact the inner surface of the patient's lens capsule (e.g., see FIG. 10 ) when the IOL 100 is implanted in the lens capsule. The radially inner haptic lumen wall 120 (also referred to as the radially inner sidewall of the haptic 104) can be configured to face the outer peripheral surface 122 of the optic portion 102.
[0052] As previously described, IOL 100 can be implanted or introduced into a patient's capsular bag after the patient's natural lens has been removed from the capsule. The patient's capsular bag is connected to zonular fibers, which are connected to the patient's ciliary muscle (see, e.g., FIG. 10 ). The capsular bag is elastic, and ciliary muscle movement can deform the capsular bag via the zonular fibers. For example, when the ciliary muscle relaxes, the zonules stretch. This stretching pulls the capsular bag generally radially outward through a radially outward force. This tension on the capsular bag lengthens the capsular bag, creating space within the capsular bag. When the patient's natural lens is within the capsular bag, the natural lens is typically flattened (anterior-posterior), thereby reducing the lens's power and enabling distance vision. In this configuration, the patient's natural lens is said to be in a disaccommodative state, or not accommodative.
[0053] However, when the ciliary muscle contracts, as occurs when the eye attempts to focus on a nearby object, the radially inner portion of the muscle moves radially inward and the zonules relax. Relaxation of the zonules causes the elastic lens capsule to contract, applying a radially inward force to the lens within the capsule. When a patient's natural lens is within the capsule, the natural lens is typically more curved (e.g., the anterior portion of the lens is more curved), which allows the lens to have more power and enables the eye to focus on nearby objects. In this configuration, the patient's natural lens is said to be in an accommodative state, or to accommodate.
[0054] In embodiments in which IOL 100 is an AIOL, the radially outer haptic lumen walls 118 of the implanted AIOL can directly engage or physically contact the portions of the lens capsule that are connected to the zonules or zonular fibers. Thus, the radially outer haptic lumen walls 118 of the AIOL can be configured to respond to radially applied lens capsule deformation forces as the zonules relax and stretch as a result of ciliary muscle movement.
[0055] For example, when the ciliary muscles contract, the peripheral region of the elastic lens capsule deforms, applying a radially inward force to the radially outer haptic lumen wall 118 of each of the haptics 104. If the IOL 100 is an AIOL, the radially outer haptic lumen wall 118 can deform or otherwise change shape, and this deformation or shape change can reduce the volume of the haptic fluid lumen 106. As the volume of the haptic fluid lumen 106 decreases, fluid within the haptic fluid lumen 106 is displaced or forced into the optical fluid chamber 108. The optic portion 102 of the AIOL can change shape in response to fluid entering the optical fluid chamber 108 from the haptic fluid lumen 106. This can increase the base power or base spherical power of the AIOL, thereby enabling a patient implanted with an AIOL in their eye to focus on nearby objects. In this state, the tunable AIOL can be considered to have accommodated.
[0056] When the ciliary muscles relax, the peripheral region of the elastic lens capsule stretches radially outward, lengthening the capsule and creating more space within the capsule. The radially outer haptic lumen walls 118 of the haptics 104 can be configured to respond to this deformation of the capsule by returning to their undeformed or unstressed configuration, thereby increasing or returning the volume of the haptic fluid lumen 106 to its undeformed volume. This increase in the volume of the haptic fluid lumen 106 can cause fluid within the optical fluid chamber 108 to be drawn or otherwise exit the optical fluid chamber 108 and return to the haptic fluid lumen 106. The fluid moves out of the optical fluid chamber 108 and into the haptic fluid lumen 106 through the same fluid channels 110 formed in the optic portion 102.
[0057] The optic portion 102 of the AIOL can change shape in response to fluid exiting the optical fluid chamber 108 and entering the haptic fluid lumen 106. This reduces the base power or base spherical power of the AIOL, thereby enabling a patient implanted with the AIOL in their eye to focus on distant objects, or obtain distance vision. In this state, the AIOL can be considered disaccommodating.
[0058] If the IOL 100 is an AIOL, the radially outer haptic lumen wall 118 of the haptic 104 can be thinner than the radially inner haptic lumen wall 120 to enable the haptic 104 to retain high sensitivity to radial forces applied to the equatorial region of the haptic 104 due to capsular deformation resulting from ciliary muscle movement. As shown in FIGS. 1B and 1C , the radially inner haptic lumen wall 120 of the haptic 104 can be designed to be thicker or bulkier than the radially outer haptic lumen wall 118 to provide stiffness or resilience to the haptic 104 in the anterior-posterior direction. In certain embodiments, the radially inner haptic lumen wall 120 can be tapered in shape as the radially inner haptic lumen wall 120 approaches the optic portion 102. When designed in this manner, the haptic 104 can be less sensitive to capsular forces applied in the anterior-posterior direction. For example, when a capsular force is applied to the haptics 104 in an anterior-posterior direction, less fluid moves between the haptic fluid lumen 106 and the optical fluid chamber 108 than when the force is applied radially. Because less fluid movement occurs, the change in base power of the AIOL is also less.
[0059] 1A-1D depict IOL 100 as an AIOL, it is contemplated by the present disclosure that IOL 100 may also be a non-accommodative or statically accommodative IOL, and that OCT-guided laser system 300 may be used to adjust the base power of a non-accommodative or statically accommodative IOL. Examples of non-accommodative or statically accommodative IOLs are discussed in U.S. Patent Application Publication No. 2021 / 0100649, the contents of which are incorporated herein by reference in their entirety.
[0060] In some embodiments, IOL 100 can be designed such that a gap 124 or void space radially separates haptic lumen walls 120 radially inward of haptics 104 from an outer peripheral surface 122 of optic portion 102. This allows some of haptics 104 to change shape or expand in response to external energy, such as laser light 125 (see, e.g., FIGS. 1B and 1C ), being directed at haptics 104.
[0061] FIG. 1A also illustrates that one or more portions of each of the haptics 104 can be made of composite material 200 (e.g., FIG. 2A). As described in more detail in later sections, composite material 200 can include, or be made of, a cross-linked copolymer used to make the energy-absorbing component, multiple expandable components, and the remainder of the haptics 104. The portions of the haptics 104 made of composite material 200 can be configured to expand in response to laser light 125 directed at the composite material 200 (see, e.g., FIGS. 1B and 1C). Depending on where composite material 200 is disposed or integrated within each of the haptics 104, composite material 200 can function as a lumen filler 126 or a lumen expander 128 to occupy space within the haptic fluid lumen 106, creating more space within the haptic fluid lumen 106.
[0062] As will be described in more detail in a later section, when laser light 125 is applied to composite material 200 configured as lumen filler 126, composite material 200 can expand, where the expansion of composite material 200 can decrease the volume of haptic fluid lumen 106 and displace fluid within haptic fluid lumen 106 into optical fluid chamber 108. This can cause optic portion 102 to change shape (e.g., make the anterior or posterior elements of optic portion 102 more curved), which can lead to an increase in the base power of optic portion 102.
[0063] Alternatively, when laser light 125 is applied to composite material 200 configured as lumen expander 128, composite material 200 can expand, in which case the expansion of composite material 200 can increase the volume of haptic fluid lumen 106 and draw fluid in optical fluid chamber 108 into haptic fluid lumen 106. This can also cause optic portion 102 to change shape (e.g., cause the anterior or posterior elements of optic portion 102 to become less curved, i.e., flatten), resulting in a decrease in the base power of optic portion 102.
[0064] 1B and 1C show cross-sectional views of the IOL 100 of FIG. 1A taken along section line AA. As shown in FIG. 1B and 1C, the optic portion 102 can include an anterior element 130 and a posterior element 132. A fluid-filled optical fluid chamber 108 can be defined between the anterior element 130 and the posterior element 132.
[0065] The anterior element 130 can include a front optical surface 134 and a front inner surface 136 opposite the front optical surface 134. The posterior element 132 can include a posterior optical surface 138 and a posterior inner surface 140 opposite the posterior optical surface 138. Either the anterior optical surface 134, the posterior optical surface 138, or a combination thereof can be considered and referred to as an outer optical surface. The anterior inner surface 136 and the posterior inner surface 140 can face the optical fluid chamber 108. At least a portion of the anterior inner surface 136 and at least a portion of the posterior inner surface 140 can serve as chamber walls of the optical fluid chamber 108.
[0066] 1B and 1C, the optic portion 102 can have an optical axis 142 extending in the anterior-posterior direction through the center of the optic portion 102. The optical axis 142 can extend through the centers of both the anterior element 130 and the posterior element 132.
[0067] The thickness of the anterior element 130 may be greater at or near the optical axis 142 than at the periphery of the anterior element 130. In some embodiments, the thickness of the anterior element 130 may gradually increase from the periphery of the anterior element 130 toward the optical axis 142.
[0068] In certain embodiments, the thickness of the anterior element 130 at or near the optical axis 142 can be from about 0.45 mm to about 0.55 mm. In these and other embodiments, the thickness of the anterior element 130 near the periphery can be from 0.20 mm to about 0.40 mm. Additionally, the anterior inner surface 136 of the anterior element 130 can be less curved, or flatter, than the anterior optical surface 134.
[0069] The thickness of the posterior element 132 may be thicker at or near the optical axis 142 than at a portion of the posterior element 132 radially outward from the optical axis 142, but before reaching the raised periphery 144 of the posterior element 132. The thickness of the posterior element 132 may gradually decrease from the optical axis 142 to a portion radially outward from the optical axis 142, but before reaching the raised periphery 144. As shown in Figures 1B and 1C, the thickness of the posterior element 132 may again increase from a portion radially inward from the raised periphery 144 to a portion radially outward from the raised periphery 144.
[0070] In certain embodiments, the thickness of the posterior element 132 at or near the optical axis 142 can be about 0.45 mm to about 0.55 mm. In these and other embodiments, the thickness of the posterior element 132 radially outward from the optical axis 142 (but before reaching the raised peripheral portion 144) can be about 0.20 mm to about 0.40 mm. The thickness of the posterior element 132 near the radially outer portion of the raised peripheral portion 144 can be about 1.00 mm to about 1.15 mm. Additionally, the posterior inner surface 140 of the posterior element 132 can be less curved, i.e., flatter, than the posterior optical surface 138.
[0071] The optic portion 102 can have a base power or a base spherical power. The base power of the optic portion 102 can be configured to change based on the internal fluid pressure within the fluid-filled optical fluid chamber 108. The base power of the optic portion 102 can be configured to increase or decrease as fluid enters or exits the fluid-filled optical fluid chamber 108.
[0072] The base power of the optic portion 102 can be configured to increase when fluid enters the fluid-filled optical fluid chamber 108 from the haptic fluid lumen 106, as indicated by the curved dashed arrow in FIG. 1B. For example, the anterior element 130 of the optic portion 102 can be configured to increase its curvature in response to fluid entering the optical fluid chamber 108. Also, for example, the posterior element 132 of the optic portion 102 can be configured to increase its curvature in response to fluid entering the optical fluid chamber 108. In another embodiment, both the anterior element 130 and the posterior element 132 can be configured to increase their curvature in response to fluid entering the optical fluid chamber 108.
[0073] The base power of the optic portion 102 can be configured to decrease as fluid exits the fluid-filled optical fluid chamber 108 or is withdrawn into the haptic fluid lumen 106, as shown in FIG. 1C using the curved dashed arrow. For example, the anterior element 130 of the optic portion 102 can be configured to decrease its curvature (i.e., flatten) in response to fluid exiting the optical fluid chamber 108. Also, for example, the posterior element 132 of the optic portion 102 can be configured to decrease its curvature (i.e., flatten) in response to fluid exiting the optical fluid chamber 108. In another embodiment, both the anterior element 130 and the posterior element 132 can be configured to decrease their curvature in response to fluid exiting the optical fluid chamber 108.
[0074] 1B and 1C illustrate fluid entering optical fluid chamber 108 from haptic fluid lumen 106 with curved dashed arrows, it should be noted that fluid enters and exits optical fluid chamber 108 through apertures 146 defined along fluid channel 110 and posterior element 132. Apertures 146 can be holes or openings defined along posterior element 132 that serve as termini for fluid channels 110. When IOL 100 includes pairs of fluid channels 110, the pairs of apertures 146 that serve as ends of fluid channels 110 can be spaced apart from each other by about 0.1 mm to about 1.0 mm.
[0075] 1B and 1C, one or more portions of IOL 100 can be made of composite material 200 (see, e.g., FIG. 2A) designed to respond to external energy, such as laser light 125, applied to composite material 200. For example, one or more portions of each of haptics 104 of IOL 100 can be made of composite material 200.
[0076] Depending on where composite material 200 is positioned or integrated within each of haptics 104, composite material 200 can function as either a lumen filler 126 or a lumen expander 128. As shown in Figures 1A-1C, the same IOL 100 can include both a lumen filler 126 and a lumen expander 128.
[0077] Lumen filler 126 may be a portion of haptics 104 made of composite material 200 designed to decrease the volume of tactile fluid lumen 106 in response to external energy (e.g., laser light 125) directed at lumen filler 126. Lumen expander 128 may be a portion of haptics 104 made of composite material 200 designed to increase the volume of tactile fluid lumen 106 in response to external energy (e.g., laser light 125) directed at lumen expander 128.
[0078] 1B and 1C, each of the haptics 104 can include a channel 148. The channel 148 can be defined within a portion of the radially inner haptic lumen wall 120. For example, the channel 148 can extend partially within the radially inner haptic lumen wall 120. The channel 148 can be in fluid communication with the haptic fluid lumen 106 or can be considered part of the haptic fluid lumen 106.
[0079] In some embodiments, lumen filler 126 can be positioned aft of channel 148. In these embodiments, lumen filler 126 can replace or function as part of the aft portion of radially inner haptic lumen wall 120. Lumen filler 126 can also be positioned radially inward of the portion of haptic fluid lumen 106 that is not a channel 148.
[0080] At least a portion of the lumen filler 126 can be in fluid communication with the channel 148. For example, at least a portion of a forward portion or layer of the lumen filler 126 can be in fluid communication with or otherwise exposed to the channel 148.
[0081] 1B and 1C, in some embodiments, the radially outer side of the lumen filler 126 is not in fluid communication with the haptic fluid lumen 106. In these embodiments, the radially outer side of the lumen filler 126 is separated from the haptic fluid lumen 106 by portions of the haptics 104 that are not made of composite material 200.
[0082] The lumen expander 128 can be disposed radially inward of the channel 148. The lumen expander 128 can also be disposed forward of the lumen filler 126. More specifically, for example, the lumen expander 128 can be disposed forward of a radially inner portion of the lumen filler 126.
[0083] In some embodiments, lumen expander 128 can be disposed within channel 148. In these embodiments, lumen expander 128 can be disposed at the radially innermost end of channel 148. In certain embodiments, radially inner haptic lumen wall 120 can have a tapered shape as radially inner haptic lumen wall 120 approaches optic portion 102. Lumen expander 128 can be disposed at the radially innermost end of channel 148 near the tapered end of radially inner haptic lumen wall 120.
[0084] 1B and 1C , the radially outer side of lumen expander 128 can be in fluid communication with channel 148 and haptic fluid lumen 106. In some embodiments, lumen expander 128 does not extend completely to the radially innermost portion of radially inner haptic lumen wall 120. In these embodiments, the portion of haptics 104 that is not made of composite material 200 can serve as the radially innermost portion of radially inner haptic lumen wall 120 and can separate lumen expander 128 from outer peripheral surface 122 of optic portion 102.
[0085] In some embodiments, the lumen expander 128 may be connected or otherwise coupled to the lumen filler 126. In these and other embodiments, the lumen expander 128 and the lumen filler 126 may be or may refer to different portions of the same composite material 200. For example, the lumen filler 126 may be shaped substantially as a curved cornice, and the lumen expander 128 may be shaped substantially as a rectangular cuboid extending from the front face of the cornice.
[0086] Those skilled in the art should understand that although different color shading is used in the figures to distinguish between the lumen filler 126 and the lumen expander 128 (i.e., a darker shading pattern is used to depict the lumen expander 128 and a lighter shading pattern is used to depict the lumen filler 126), both the lumen filler 126 and the lumen expander 128 may be made of the same composite material 200 or may refer to different portions / features of the same block of composite material 200.
[0087] In other embodiments, the lumen filler 126 and the lumen expander 128 may be made of different types of composite materials 200. In these embodiments, the lumen filler 126 may be made of a first type of composite material 200, and the lumen expander 128 may be made of a second type of composite material 200. In certain embodiments, the lumen filler 126 and the lumen expander 128 may be made of different colored composite materials 200. For example, the composite material 200 may include an energy absorbing component, such as an energy absorbing pigment or dye.
[0088] As a more specific example, either the lumen filler 126 or the lumen expander 128 may be made of a composite material 200 that includes a black energy-absorbing pigment, such as graphitized carbon black. In this example, if one of the lumen filler 126 or the lumen expander 128 is made of a composite material 200 that includes graphitized carbon black, the other may be made of another type of composite material 200 that includes a red energy-absorbing pigment, such as an azo dye (e.g., Disperse Red 1 dye).
[0089] As shown in FIG. 1B , external energy, such as laser light 125, can be directed toward lumen filler 126, causing at least a portion of lumen filler 126 to expand and grow in size. As described in more detail in a later section, this expansion can manifest as a protrusion 500 growing or protruding from lumen filler 126 (see, e.g., FIGS. 5B, 7A, and 7B ). For example, when laser light 125 is directed toward a front portion or layer of lumen filler 126 that is in fluid communication with or otherwise exposed to channel 148, protrusion 500 can grow from the front portion into channel 148. Because channel 148 is in fluid communication with (or can be considered part of) haptic fluid lumen 106, the volume of haptic fluid lumen 106 can decrease in response to the formation of protrusion 500. This can cause fluid within haptic fluid lumen 106 to be pushed or otherwise displaced into optical fluid chamber 108. As a result, in response to laser light 125 being directed toward the lumen filling material 126, at least one of the anterior element 130 and the posterior element 132 can increase its curvature, and the base power of the optical portion 102 can increase.
[0090] External energy, such as laser light 125, can be directed at lumen expander 128, causing at least a portion of lumen expander 128 to expand and grow in size. As discussed in more detail in a later section, this expansion can manifest as an expansion of channel 148 (see, for example, FIG. 7C ). For example, when laser light 125 is directed at lumen expander 128, lumen expander 128 can increase in size, causing channel 148 to grow. Because channel 148 is in fluid communication with (or can be considered part of) haptic fluid lumen 106, the volume of haptic fluid lumen 106 can increase as lumen expander 128 grows. This can draw fluid within haptic fluid lumen 106 from optical fluid chamber 108 into haptic fluid lumen 106. As a result, in response to laser light 125 being directed toward lumen expander 128, at least one of anterior element 130 and posterior element 132 can decrease its curvature, and the base power of optical portion 102 can decrease.
[0091] One technical problem faced by applicants is that when IOL 100 is implanted within a patient's capsular bag, an active healing response by tissue within the capsular bag may compress or shrink the optic portion 102 of the lens, driving a higher optical power than initially expected. Another technical challenge faced by applicants is that preoperative biometry measurements performed on a patient's eye may be inaccurate, resulting in an incorrect lens power being prescribed and implanted in the patient. Yet another technical challenge faced by applicants is that the cornea or muscles within a patient's eye may change due to injury, disease, or aging. One technical solution discovered and developed by applicants is to design IOL 100 that can be adjusted postoperatively (i.e., after implantation) to account for such changes or errors.
[0092] In some embodiments, the fluid in the optical fluid chamber 108 and the haptic fluid lumen 106 can be an oil. More specifically, in certain embodiments, the fluid in the optical fluid chamber 108 and the haptic fluid lumen 106 can be a silicone oil or fluid. For example, the fluid can be a silicone oil made in part with diphenylsiloxane. In other embodiments, the fluid can be a silicone oil made in part with a ratio of two dimethylsiloxane units to one diphenylsiloxane unit. More specifically, in some embodiments, the fluid can be a silicone oil made in part with diphenyltetramethylcyclotrisiloxane or a copolymer of diphenylsiloxane and dimethylsiloxane. In another embodiment, the fluid can be a silicone oil including a branched polymer.
[0093] The fluid (e.g., silicone oil) can have an index of refraction that matches the lens body material used to fabricate the optic portion 102. When the fluid has an index of refraction that matches the lens body material, the entire optic portion 102, including the fluid, functions as a single lens. For example, the fluid can be selected to have an index of refraction of about 1.48 to 1.53 (or about 1.50 to 1.53). In some embodiments, the fluid (e.g., silicone oil) can have a polydispersity index of about 1.2 to 1.3. In other embodiments, the fluid (e.g., silicone oil) can have a polydispersity index of about 1.3 to 1.5. In other embodiments, the fluid (e.g., silicone oil) can have a polydispersity index of about 1.1 to 1.2. Other exemplary fluids are described in U.S. Patent Application Publication No. 2018 / 0153682, which is incorporated herein by reference in its entirety.
[0094] The optic portion 102 can be made, in part, of a deformable or flexible material. In some embodiments, the optic portion 102 can be made, in part, of a deformable or flexible polymer material. For example, the anterior element 130, the posterior element 132, or a combination thereof, can be made, in part, of a deformable or flexible polymer material. One or more haptics 104 (e.g., the first haptic 104A, the second haptic 104B, or a combination thereof) can be made, in part, of the same deformable or flexible material as the optic portion 102. In other embodiments, one or more haptics 104 can be made, in part, of a different material than the optic portion 102.
[0095] In some embodiments, the optic portion 102 can include or be made, in part, of a lens body material. The lens body portion can be made, in part, of a crosslinked copolymer, including a copolymer blend. The copolymer blend can include alkyl acrylate or methacrylate, fluoroalkyl (meth)acrylate, and phenyl-alkyl acrylate. It is contemplated by this disclosure, and should be understood by those skilled in the art, that these types of acrylic crosslinked copolymers can generally be copolymers of multiple acrylates, methacrylates, or combinations thereof, and the term "acrylate," as used herein, can be understood to refer to interchangeable acrylates, methacrylates, or combinations thereof, unless otherwise specified. The crosslinked copolymer used to make the lens body material can include alkyl acrylate in an amount of about 3% to 20% (wt%), fluoroalkyl acrylate in an amount of about 10% to 35% (wt%), and phenyl-alkyl acrylate in an amount of about 50% to 80% (wt%). In some embodiments, the crosslinked copolymer can include, or be made in part from, n-butyl acrylate as the alkyl acrylate, trifluoroethyl methacrylate as the fluoro-alkyl acrylate, and phenylethyl acrylate as the phenyl-alkyl acrylate. More specifically, the crosslinked copolymer used to make the lens body material can include n-butyl acrylate in an amount of about 3% to 20% (wt%) (e.g., about 12% to 16%), trifluoroethyl methacrylate in an amount of about 10% to 35% (wt%) (e.g., about 17% to 21%), and phenylethyl acrylate in an amount of about 50% to 80% (wt%) (e.g., about 64% to 67%).
[0096] The final composition of the crosslinked copolymer used to make the lens body material can also include a crosslinker, or crosslinking agent, such as ethylene glycol dimethacrylate (EGDMA). For example, the final composition of the crosslinked copolymer used to make the lens body material can also include a crosslinker, or crosslinking agent (e.g., EGDMA) in an amount of about 1.0%. The final composition of the crosslinked copolymer used to make the lens body material can also include an initiator, or initiator agent (e.g., Perkadox 16), and a UV absorber.
[0097] One or more haptics 104 can include or be made in part from a haptic material. The haptic material can include or be made in part from a cross-linked copolymer, including a copolymer blend. The copolymer blend can include an alkyl acrylate, a fluoroalkyl acrylate, and a phenyl-alkyl acrylate. For example, a cross-linked copolymer used to make a haptic can include an alkyl acrylate in an amount of about 10%-25% (wt%), a fluoroalkyl acrylate in an amount of about 10%-35% (wt%), and a phenyl-alkyl acrylate in an amount of about 50%-80% (wt%). In some embodiments, the crosslinked copolymer used to make the tactile material can include n-butyl acrylate in an amount of about 10% to 25% (wt%) (e.g., about 19% to 23%), trifluoroethyl methacrylate in an amount of about 10% to 35% (wt%) (e.g., about 14% to 18%), and phenylethyl acrylate in an amount of about 50% to 80% (wt%) (e.g., about 58% to 62%). The final composition of the crosslinked copolymer used to make the tactile material can also include a crosslinker, i.e., crosslinking agent, such as EGDMA, in an amount of about 1.0%. The final composition of the crosslinked copolymer used to make the tactile material can also include multiple photoinitiators, i.e., photoinitiators (e.g., camphorquinone, 1-phenyl-1,2-propanedione, and 2-ethylhexyl-4-(dimethylamino)benzoic acid).
[0098] In some embodiments, the refractive index of the lens body material can be from about 1.48 to about 1.53, and in certain embodiments, the refractive index of the lens body material can be from about 1.50 to about 1.53 (e.g., about 1.5178).
[0099] The anterior element 130 can be attached or otherwise adhered to the posterior element 132 via an adhesive 150 or adhesive layer. The adhesive layer can be substantially annular in shape. The adhesive 150 or adhesive layer can be disposed on the peripheral edge of the optic portion 102 between the anterior element 130 and the posterior element 132. For example, the adhesive 150 can be disposed on the raised periphery 144 of the posterior element 132.
[0100] The adhesive 150 or adhesive layer can include or be made in part of a biocompatible adhesive. The adhesive 150 or adhesive layer can include or be made in part of a biocompatible polymer adhesive.
[0101] The adhesive 150 or adhesive layer can include or be made in part from a cross-linked polymer precursor formulation that can include or be made in part from a copolymer blend, a hydroxyl-functional acrylic monomer, and a photoinitiator.
[0102] The copolymer blend can include an alkyl acrylate (e.g., n-butyl acrylate in an amount of about 41% to about 45% (wt%)), a fluoro-alkyl acrylate (e.g., trifluoroethyl methacrylate in an amount of about 20% to about 24% (wt%)), and a phenyl-alkyl acrylate (phenylethyl acrylate in an amount of about 28% to about 32% (wt%)). The hydroxyl-functional acrylic monomer can be 2-hydroxyethyl acrylate (HEA). A photoinitiator can be used to facilitate curing of the adhesive. For example, the photoinitiator can be Darocur 4265 (a 50 / 50 blend of diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide and 2-hydroxy-2-methylpropiophenone).
[0103] In some embodiments, the same adhesive 150 used to bond the anterior element 130 to the posterior element 132 can also be used to bond or secure one or more haptics 104 to the optic portion 102.
[0104] 1D also shows that each of the haptics 104 (e.g., either the first haptic 104A or the second haptic 104B) can have a proximal attachment end 114 and a closed distal free end 116. A haptic fluid port 152 can be defined in the proximal attachment end 114 of the haptic 104. The haptic fluid port 152 can serve as a chamber opening for the haptic fluid lumen 106. Fluid in the haptic fluid lumen 106 can flow out of the haptic fluid lumen 106, through the haptic fluid port 152, and into the optical fluid chamber 108 via the pair of fluid channels 110 when the haptic 104 is coupled to the optical portion 102. Similarly, fluid in the optical fluid chamber 108 can flow out of the optical fluid chamber 108, through the pair of fluid channels 110, and through the haptic fluid port 152 into the haptic fluid lumen 106. The pair of outer opening 156 and inner opening 146 can serve as the ends of the fluid channel 110 .
[0105] 1A and 1D, each of the haptics 104 can be coupled to the optic portion 102 at a reinforcement portion 112. For example, a first haptic 104A can be coupled or attached to the optic portion 102 at a first reinforcement portion 112A, and a second haptic 104B can be coupled or attached to the optic portion 102 at a second reinforcement portion 112B.
[0106] More specifically, the proximal mounting end 114 can be coupled to a protruding outer surface 154 of the posterior element 132. The protruding outer surface 154 can also be referred to as a "landing" or a "haptic mounting landing." The protruding outer surface 154 can extend radially outward from the outer circumferential surface 122 of the optic portion 102. For example, the protruding outer surface 154 can extend radially outward from the outer circumferential surface 122 of the posterior element 132 of the optic portion 102. The protruding outer surface 154 can extend radially outward from the outer circumferential surface 122 by approximately 10 micrometers to 1.0 mm, or by approximately 10 micrometers to 500 micrometers.
[0107] The proximal mounting end 114 has a substantially flat surface and can be glued or otherwise coupled to the substantially flat surface of the protruding outer surface 154. When the proximal mounting end 114 is coupled to the protruding outer surface 154, the haptic fluid ports 152 can surround the outer openings 156 of the fluid channels 110. The haptics 104 can be bonded or adhered to the optic portion 102 by a biocompatible adhesive 150. In some embodiments, the adhesive 150 can be the same adhesive used to bond or adhere the anterior element 130 to the posterior element 132.
[0108] 2A is a graphical representation of a composite material 200 comprising a composite substrate 202, an energy-absorbing component 204, and a plurality of expandable components 206. As previously mentioned, one or more portions of each of the haptics 104 can be made of the composite material 200.
[0109] The composite substrate 202 may be composed of a hydrophobic acrylic material. For example, the composite substrate 202 may be composed of phenylethyl acrylate (PEA), phenylethyl methacrylate (PEMA), or a combination thereof.
[0110] In one exemplary embodiment, the composite substrate 202 can include a methacrylate- or methacrylic-functional crosslinked polymer and a reactive acrylic monomer diluent including lauryl methacrylate (n-dodecyl methacrylate or SR313) and ADMA. By controlling the amount of lauryl methacrylate (SR313) relative to ADMA, the overall corresponding hardness (i.e., more ADMA) or softness (i.e., more SR313) of the cured composite material 200 can be controlled. The methacrylate- or methacrylic-functional crosslinked polymer can be made using a crosslinked polymer precursor formulation.
[0111] The cross-linked polymer precursor formulation can include the same copolymer blends used to fabricate the optics and haptics.
[0112] The copolymer blend can include an alkyl acrylate or methacrylate (e.g., n-butyl acrylate), a fluoro-alkyl (meth)acrylate (e.g., trifluoroethylene methacrylate), and a phenyl-alkyl acrylate (e.g., phenylethyl acrylate). For example, the copolymer blend can include n-butyl acrylate in an amount of about 41% to about 45% (wt%), trifluoroethyl methacrylate in an amount of about 20% to about 24% (wt%), and phenylethyl acrylate in an amount of about 28% to about 32% (wt%). The crosslinked polymer precursor formulation can include or be made in part from the copolymer blend, a hydroxyl-functional acrylic monomer (e.g., HEA), and a photoinitiator (e.g., Darocur 4265 or a 50 / 50 blend of diphenyl(2,4,6-trimethylbenzoyl)-phosphine oxide and 2-hydroxy-2-methylpropiophenone).
[0113] The composite substrate 202 can include a methacrylate- or methacrylate-functional crosslinked polymer (as described above) in an amount of about 50% to about 65% (e.g., about 55% to about 60%) (wt %), a reactive acrylic monomer diluent lauryl methacrylate (SR313) in an amount of about 32% to about 38% (e.g., about 32.70%) (wt %), and a reactive acrylic monomer diluent adamantyl methacrylate (ADMA) in an amount of about 5% to about 9% (e.g., about 7.30%) (wt %).
[0114] Table 1 below shows an example formulation of composite material 200.
[0115] [Table 1]
[0116] The composite material 200 can be made in several operations. A first operation can include preparing an unpigmented composite substrate 202. A second operation can include mixing the composite substrate 202 with an energy-absorbing component 204, an expandable component 206, and an initiator, such as one or more photoinitiators, thermal initiators, or combinations thereof. A third operation can include placing the uncured composite material 200 at a desired location within the haptic 104 (e.g., adjacent to the channel 148) and curing the composite material 200 in place.
[0117] For example, an unpigmented composite substrate 202 can be mixed with an energy absorbing component 204, such as a dye (e.g., Disperse Red 1 dye) or a pigment (e.g., graphitized carbon black), which is described in more detail below.
[0118] In some embodiments, the expandable component 206 can comprise between about 5.0% and about 15.0% by weight of the final composition of the composite material 200. More specifically, the expandable component 206 can comprise between about 8.0% and about 12.0% by weight (e.g., about 10.0%) of the final composition (see Table 1) of the composite material 200. In these and other embodiments, the energy-absorbing component 204 can comprise between about 0.044% and about 0.44% by weight (or about 0.55%) of the final composition of the composite material 200.
[0119] The photoinitiator can be Omnirad 2022 (bis(2,4,6-trimethylbenzoyl)phenyl-phosphine oxide / 2-hydroxy-2-methyl-1-phenyl-propan-1-one). The photoinitiator can comprise approximately 1.30 wt. % of the final composite material 200 formulation (see, e.g., Table 1). In addition, the composite material 200 can also include a thermal initiator. The thermal initiator can comprise approximately 1.00 wt. % of the final composite material 200 formulation (see, e.g., Table 1). In some embodiments, the thermal initiator can be a dialkyl peroxide, such as Luperox® peroxide. In other embodiments, the thermal initiator can be Perkadox®.
[0120] In some embodiments, the energy absorbing component 204 can absorb external energy (e.g., laser energy), convert the energy into heat, and conduct the energy to the composite substrate 202, causing the composite substrate 202 to expand.
[0121] FIG. 2B illustrates that the expandable component 206 can be expandable microspheres including an expandable thermoplastic shell 208 and a foaming agent 210 contained within the expandable thermoplastic shell 208. The microspheres can be configured to expand such that the diameter 212 of at least one of the microspheres increases by approximately 2× its original diameter. In other embodiments, the microspheres can be configured to expand such that the diameter 212 of at least one of the microspheres increases by approximately 4×, or four times, its original diameter. In other embodiments, the microspheres can be configured to expand such that the diameter 212 of at least one of the microspheres increases by approximately 2× to approximately 4× (or approximately 3.5×) its original diameter. For example, the microspheres can initially have a diameter 212 of approximately 12 μm. In response to external energy applied or directed to the composite material 200, or in response to energy transferred or transmitted to the microspheres, the diameter 212 of the microspheres can increase to approximately 40 μm.
[0122] At least one volume of the microspheres can be configured to expand by about ten times (10X) to about fifty times (50X) in response to external energy applied or directed to the composite material 200 or in response to energy transferred or transmitted to the microspheres.
[0123] In some embodiments, the blowing agent 210 can be an expandable fluid, such as an expandable gas. More specifically, the blowing agent 210 can be a branched chain hydrocarbon. For example, the blowing agent 210 can be isopentane. In other embodiments, the blowing agent 210 can be or include cyclopentane, pentane, or a mixture of cyclopentane, pentane, and isopentane.
[0124] The expandable components 206 can include different amounts of foaming agent 210. For example, some expandable components 206 can include more or greater amounts of foaming agent (e.g., more expandable gas) to allow such expandable components 206 to expand more, resulting in greater expansion of the composite material 200 including such expandable components 206.
[0125] 2B shows that each of the expandable components 206 can include a thermoplastic shell 208. FIG. 2B also shows that the thickness of the thermoplastic shell 208 can vary as the size of the expandable components 206 increases. More specifically, the thickness of the thermoplastic shell 208 can decrease as the size of the expandable components 206 increases. For example, if the expandable components 206 are expandable microspheres, the thickness of the thermoplastic shell 208 (i.e., its thickness in the radial direction) can decrease as the diameter 212 of the expandable microspheres increases.
[0126] For example, as described above, at least one of the expandable microspheres may initially have a diameter 212 of about 12 μm. In this embodiment, the thermoplastic shell 208 of the expandable microsphere may have a shell thickness of about 2.0 μm. In response to external energy applied to or directed at the composite material 200, or in response to energy transferred or transmitted to the microsphere, the diameter 212 of the microsphere may increase to about 40 μm (and expand in volume by about 10× to 50×), and the shell thickness of the microsphere may decrease to about 0.1 μm.
[0127] Although Figures 2A and 2B depict the expandable component 206 as a sphere or microsphere, the present disclosure contemplates that the expandable component 206 can be substantially shaped as an oval, ellipsoid, cube, or other polyhedron, or combinations thereof.
[0128] In some embodiments, the thermoplastic shell 208 can be made in part from a nitrile or acrylonitrile copolymer. For example, the thermoplastic shell 208 can be made in part from acrylonitrile, styrene, butadiene, methyl acrylate, or combinations thereof.
[0129] As previously mentioned, the expandable component 206 can comprise between about 8.0% and about 12% by weight of the final composition of the composite material 200. The expandable component 206 can comprise about 10% by weight of the final composition of the composite material 200.
[0130] The expandable component 206 can be dispersed or otherwise distributed within a composite matrix 202 that comprises the bulk of the composite material 200. The composite matrix 202 can act as a matrix to hold or support the expandable component 206. The composite material 200 can expand in response to the expansion of the expandable component 206 (e.g., thermoplastic microspheres). For example, the volume of the composite material 200 can increase in response to the expansion of the expandable component 206.
[0131] The composite material 200 also includes an energy absorbing component 204. In some embodiments, the energy absorbing component 204 can be an energy absorbing pigment.
[0132] In certain embodiments, the energy absorbing pigment can be an energy absorbing dye. For example, the energy absorbing dye can be an azo dye. In some embodiments, the azo dye can be a red azo dye, such as Disperse Red 1 dye. In other embodiments, the azo dye can be an orange azo dye, such as Disperse Orange dye (e.g., Disperse Orange 1), a yellow azo dye, such as Disperse Yellow dye (e.g., Disperse Yellow 1), a blue azo dye, such as Disperse Blue dye (e.g., Disperse Blue 1), or a combination thereof.
[0133] In additional embodiments, the energy absorbing pigment may be or include a pigment, for example, the energy absorbing pigment may be or include graphitized carbon black as a pigment.
[0134] Similar to the expandable component 206, the energy absorbing component 204 can be dispersed or otherwise distributed within a composite matrix 202 that comprises the bulk of the composite material 200. The composite matrix 202 can act as a matrix to hold or support the expandable component 206 and the energy absorbing component 204.
[0135] As discussed above, the energy absorbing component 204 can comprise from about 0.025% to about 1.0% by weight (or, more specifically, from about 0.045% to about 0.45% by weight) of the final formulation of the composite material 200. For example, if the energy absorbing component 204 is a dye (e.g., an azo dye such as Disperse Red 1), the energy absorbing component 204 can comprise from about 0.45% to about 1.0% by weight of the final formulation of the composite material 200. If the energy absorbing component 204 is graphitized carbon black or other type of pigment, the energy absorbing component 204 can comprise from about 0.025% to about 0.045% by weight of the final formulation of the composite material 200.
[0136] The energy absorbing component 204 (e.g., an azo dye, graphitized carbon black, or a combination thereof) can absorb or capture external energy (e.g., light energy, or more specifically, laser light) applied or directed to the composite material 200. The energy absorbing component 204 can absorb or capture the external energy and convert the energy into thermal energy or heat or transfer it to the expandable component 206.
[0137] The thermoplastic shell 208 can soften and begin to flow when thermal energy is transferred or transmitted to the expandable component 206. The thermoplastic shell 208 of the expandable component 206 can then begin to thin, i.e., decrease in thickness, in response to the thermal energy being transferred or transmitted to the expandable component 206. As the thermoplastic shell 208 begins to soften and decrease in thickness, the foaming agent 210 within the expandable component 206 can expand. The foaming agent 210 can also expand in response to the thermal energy or heat being transferred or transmitted to the expandable component 206. The expansion of the foaming agent 210 can cause the expandable component 206 (e.g., thermoplastic microspheres) to expand, i.e., increase in volume, ultimately causing the composite material 200 to expand or increase in volume.
[0138] The composite material 200 can expand, or increase in size, isotropically, causing the composite material 200 to expand in all directions. Such isotropic expansion can be utilized to cause expansion or material displacement in specific directions by placing or positioning the composite material 200 at specific locations within the haptics 104 of the IOL 100.
[0139] As previously mentioned, the external energy can be laser light 125, and the energy absorbing component 204 can absorb or capture the laser light 125 directed at the composite material 200 and convert or transfer the light energy to thermal energy or heat to the expandable component 206. The foaming agent 210 within the expandable component 206 can expand or become excited in response to the thermal energy or heat. The expandable component 206, and ultimately the composite material 200, can expand or increase in volume in response to this light energy directed at the composite material 200.
[0140] The shape change (e.g., volume increase) that occurs in the expandable component 206 can be a persistent or substantially permanent change. A persistent or substantially permanent change can mean that the expandable component 206 does not substantially return to its original shape or size after the shape change occurs (e.g., after a volume increase). As a result, any change in size or volume of the composite material 200 caused by a change in the size or volume of the expandable component 206 is also persistent or substantially permanent. As explained in more detail in the following section, this means that any structural change applied to the IOL 100 as a result of external energy or stimuli applied or otherwise directed at the composite material 200 embedded or integrated within the IOL 100 can remain persistent or substantially permanent.
[0141] The thermoplastic shell 208 of the expandable component 206 can re-harden when external energy is no longer directed or applied to the composite material 200. For example, the thermoplastic shell 208 can re-harden when the temperature near the expandable component 206 drops below a certain threshold. For example, the thermoplastic shell 208 of the expandable microspheres can harden when light energy is no longer directed at the composite material 200. Once the thermoplastic shell 208 has hardened, the expandable component 206 is locked into its new size and expanded configuration.
[0142] If the energy absorbing component 204 is an energy absorbing pigment, such as a dye or graphitized carbon, the color of at least a portion of the composite material 200 can take on the color of the energy absorbing pigment. For example, if the energy absorbing component 204 is an azo dye, such as Disperse Red 1, which has a red color, at least a portion of the composite material 200 including the energy absorbing component 204 can be colored red. Alternatively, if the energy absorbing component 204 is graphitized carbon, which has a black color, at least a portion of the composite material 200 including the energy absorbing component 204 can be colored black. Although two colors (e.g., red and black) are described in this disclosure, it is contemplated by this disclosure and would be understood by one of ordinary skill in the art that other types of colored energy absorbing pigments can also be used, such as energy absorbing yellow, orange, or blue dyes or materials.
[0143] The color of the energy-absorbing dye may be visually perceptible to a clinician or another medical professional when at least a portion of the IOL 100 is made of a composite material 200 that includes the energy-absorbing dye. The color of the energy-absorbing dye may be visually perceptible to a physician or other medical professional when the IOL 100 is implanted in a patient's eye. For example, the composite material 200 may include Disperse Red 1, which serves as the energy-absorbing dye. In this example, when the IOL 100 is implanted in a patient's eye, at least a portion of the IOL 100 may appear red to a physician or other medical professional. The color of the energy-absorbing dye may enable a physician or other medical professional to detect or determine the location or position of the composite material 200 within the IOL 100. The color of the energy-absorbing dye may also enable a clinician or another medical professional to determine where to direct the laser light 125 or stimulus to adjust the IOL 100.
[0144] However, in some cases, even when composite material 200 is made with an energy-absorbing dye, a clinician or operator may have difficulty perceiving color when IOL 100 is implanted in a subject's eye. Furthermore, if different expandable components, such as lumen filler 126 and lumen expander 128, are different colors to space the structures apart, a clinician or operator may have difficulty distinguishing the colors separately. Therefore, a solution is needed to address these challenges and ensure the safety of any post-implant adjustment procedures involving laser light.
[0145] 3 is a block diagram illustrating one embodiment of an OCT-guided laser system 300. System 300 can be used to guide a clinician during an IOL adjustment procedure, the purpose of which is to adjust the base power of an implanted IOL 100. For example, system 300 can assist a clinician in accurately locating IOL structures made of composite material 200 and targeting such structures using laser light 125. More specifically, system 300 can assist a clinician in accurately locating and targeting lumen filler 126 and lumen expander 128 using laser light 125.
[0146] System 300 can further assist clinicians in distinguishing between different IOL structures made with composite material 200 to avoid unintentionally targeting the wrong structure and causing unintended power-changing effects. For example, system 300 can assist clinicians in distinguishing between lumen filler 126 and lumen expander 128. This is important because lumen filler 126 and lumen expander 128 are often placed in close proximity to or adjacent to each other.
[0147] Additionally, system 300 can enable a clinician to measure in real time the net volume change of an IOL structure made of composite material 200 as the structure is exposed to laser light 125. These net volume change measurements can then be used to calculate or estimate the resulting power change in the optic portion 102 of IOL 100. Such real-time measurements can provide a closed feedback loop, allowing the clinician to adjust the amount of laser exposure by controlling the number of laser pulses and / or the amount of energy per laser pulse and / or the structure targeted to achieve the desired power change.
[0148] The OCT-guided laser system 300 may also include dedicated laser delivery optics (e.g., a gonio lens 1000 integrated within the patient interface 312) that allows the laser light 125 to reach specific tactile structures made of the composite material 200 positioned radially outside the optical portion 102.
[0149] As shown in FIG. 3, the OCT-guided laser system 300 may include a laser module 302, an imaging-based laser controller 304, a video microscope 306, multiple beam splitters including at least a first beam splitter 308A and a second beam splitter 308B, a focusing objective lens 310, a patient interface 312, one or more computing devices 314, and one or more displays 316.
[0150] The laser module 302 can generate and emit a beam of laser pulses to a point or focused spot within the implanted IOL 100 as directed by the imaging-based laser controller 304. The imaging-based laser controller 304 can image the anatomical features of the eye along with the device implanted therein. The imaging-based laser controller 304 can also adjust certain beam parameters of the laser beam to control where the beam is directed within the eye. The imaging-based laser controller 304 can perform these functions by sending one or more power control signals 318 and scanning control signals 320 to the laser module 302.
[0151] The beam of laser light 125 or laser beam generated by the laser module 302 may be directed into the eye by a first beam splitter 308A. A focusing objective lens 310 may focus the laser beam using one or more objective lenses, while a patient interface 312 may stabilize the patient's eye. In some embodiments, the laser module 302 may automatically generate the laser beam based on beam parameters received via a power control signal 318 and a scan control signal 320. In other embodiments, the laser module 302 may generate the laser beam based on beam parameters set at least in part by a clinician or operator via one of the computing devices 314.
[0152] The laser module 302 may include a laser engine 322, a beam attenuator 324, and a beam scanner 326. The laser engine 322 may be configured to generate an initial beam of laser pulses, the beam attenuator 324 may be configured to modify the beam of laser pulses based on beam parameters, and the beam scanner 326 may be configured to direct the beam of laser pulses to one or more points or focused spots specified by the imaging-based laser controller 304.
[0153] The laser engine 322 may comprise a solid-state laser source. More specifically, the laser engine 322 may comprise an oscillator configured to generate laser pulses (e.g., femtosecond laser pulses) having sufficient bandwidth, an amplifier configured to amplify the laser pulses to higher energies, and a compressor configured to compress the pulses to a desired pulse range (e.g., to the femtosecond pulse range). In some embodiments, the amplifier may be a diode-pumped regenerative amplifier and the compressor may be a grating compressor. For example, the laser engine 322 may include an ultrafast pulsed diode-pumped solid-state femtosecond laser.
[0154] The laser engine 322 operates in nanoseconds (10 -9 seconds), picoseconds (10 -12 seconds), or femtoseconds (10 -15 Laser pulses can be generated with durations of 1 kHz to 500 kHz. More specifically, laser pulses can be generated at pulse repetition rates of about 10 kHz to about 100 kHz. In other embodiments, laser pulses can be generated at pulse repetition rates of 0.1 kHz to 1,000 kHz.
[0155] In some embodiments, the laser beam generated by laser engine 322 can have a wavelength of about 900 nm to about 1100 nm (i.e., the near-infrared (NIR) range). For example, the laser beam generated by laser engine 322 can have a wavelength of about 1030 nm.
[0156] In alternative embodiments, the laser beam generated by laser engine 322 may be green laser light having a wavelength of approximately 480 nm to 650 nm (e.g., 532 nm). In these embodiments, laser engine 322 may comprise a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser.
[0157] The beam attenuator 324 can be a computer-controlled attenuator that adjusts the beam energy to a desired level and continuously monitors the beam energy. The beam attenuator 324 can modify one or more beam parameters of the laser beam, including pulse energy, pulse power, pulse length, pulse repetition rate, or a combination thereof. The beam attenuator 324 can also include a shutter (e.g., a mechanical / electromechanical shutter) that can shutter or block selected laser pulses and / or a polarizer assembly that can reduce the power of selected laser pulses.
[0158] The beam scanner 326 can be configured to direct or focus the beam of laser pulses to one or more focused spots at specific locations within the eye. For example, the beam scanner 326 can include multiple computer-controlled scanning mirrors that scan the laser beam into the beam expander. Each scanned position of the laser beam corresponds to an X,Y location in the focal plane of the focusing objective lens 310. The Z position of the focused laser spot can be computer-controlled by an optical zoom lens located within the beam expander.
[0159] The imaging-based laser controller 304 can include an imaging system, such as an OCT imager 328, an image analyzer 330, and laser control components 332. The OCT imager 328 can generate an imaging beam 334 used to scan the subject's eye, including any implanted devices within the eye. The imaging beam 334 can be directed into the eye by a second beam splitter 308B. Light scattered from the anatomical structures of the eye and implant structures (e.g., the haptics 104 and optic portion 102 of the IOL 100, including any structures or elements thereof) can be reflected back to the imaging-based laser controller 304 via the second beam splitter 308B and used by the OCT imager 328 to form cross-sectional images of the eye and any implants within the eye. The OCT imager 328 can generate cross-sectional images by measuring the echo time delay and intensity of backscattered or back-reflected light. OCT measurements of echo time delay are based on correlation techniques that compare backscattered or backreflected light signals with reference light signals that travel a known path length.
[0160] The OCT imager 328 may include an OCT light source that produces low-power visible wavelength light. In other embodiments, the OCT light source can produce light in the near-infrared (NIR) range (i.e., wavelengths from about 900 nm to about 1,400 nm).
[0161] For example, the OCT light source of the OCT imager 328 can be a superluminescent diode. The OCT imager 328 can also include an interferometer, such as a Michelson interferometer, a reference mirror, a galvo scanner used to scan the imaging beam 334 across the eye, and a spectrometer.
[0162] In some embodiments, the OCT imager 328 may be communicatively coupled to one or more computing devices 314, which may be used to process imaging signals or data and control various hardware components of the OCT imager 328. The OCT images generated by the OCT imager 328 may also be presented to a clinician or operator of the system 300 via one or more displays 316.
[0163] The OCT imager 328 can be a spectral domain OCT (SD-OCT), hi other embodiments, the OCT imager 328 can be a swept-source OCT (SS-OCT), a frequency domain OCT, a Fourier domain OCT, or a complex Fourier OCT.
[0164] The OCT imager 328 can generate a three-dimensional (3D) composite OCT image by combining two-dimensional (2D) cross-sectional OCT images. The 2D cross-sectional OCT images, the 3D composite OCT images, the data associated with the imaging, or a combination thereof, can be provided as input to the image analyzer 330. The image analyzer 330 can be configured to analyze the 2D cross-sectional OCT images, the 3D composite OCT images, the data associated with the imaging, or a combination thereof to determine where particular structures or features made from the composite material 200 are located within the implanted IOL 100.
[0165] If the OCT imager 328 is a spectral-domain OCT (SD-OCT), the OCT imager 328 can generate an "en face" scan (a so-called "C-scan") of the eye and any implants therein. An en face scan can be an OCT image of the eye and any implants therein taken along the coronal or anterior plane of the eye.
[0166] In some embodiments, the laser control component 332 can generate a set of X, Y, and Z coordinates that represent where the beam of laser pulses generated by the laser module 302 should be directed. The laser control component 332 can also set one or more beam parameters (e.g., pulse energy, pulse power, pulse length, pulse repetition rate, or a combination thereof) for each of the generated laser beams. The laser control component 332 can send the coordinates and beam parameters to the laser module 302 via the power control signal 318 and the scan control signal 320.
[0167] As discussed in more detail in a later section, the OCT imager 328 can image the IOL structure targeted by the laser module 302 and other structures of the IOL after the IOL structure (i.e., the target structure) made of the composite material 200 is exposed to the beam of laser light 125. For example, the OCT imager 328 can generate any combination of 2D cross-sectional OCT images or 3D composite OCT images of the IOL structure after the structure made of the composite material 200 is exposed to the beam of laser light 125. These 2D cross-sectional OCT images, 3D composite OCT images, and any data associated with the imaging can be provided as input to the image analyzer 330 to calculate volumetric changes in the IOL structure made of the composite material 200. As discussed in more detail in a later section, the image analyzer 330 can also be used to measure changes in at least one of the curvature of the anterior element 130, the curvature of the posterior element 132, and the axial thickness of the optic portion 102 of the IOL 100.
[0168] It is contemplated by this disclosure, and should be understood by one of ordinary skill in the art, that any of the measurements or calculations performed by image analyzer 330 may be performed by one or more computing devices 314 communicatively coupled to imaging-based laser controller 304. In certain embodiments, 2D cross-sectional OCT images, 3D composite OCT images, or combinations thereof, of any of the aforementioned IOL structures may be presented to a clinician or operator of system 300 via one or more displays 316 (e.g., touchscreen displays or other types of computer displays). In these embodiments, the clinician or operator can perform certain calculations by measuring the IOL structures using the OCT images presented on display 316.
[0169] The computing device 314 can also be configured to determine a change in base power of the IOL 100 based on a volumetric change of the composite material 200 in response to a beam of laser pulses directed at the composite material 200. For example, one or more processors of at least one of the computing devices 314 can be programmed to execute instructions stored in a memory or storage unit of the computing device 314 to determine a change in base power of the IOL 100 based on a volumetric change of the composite material 200.
[0170] As previously described, one or more IOL structures (e.g., lumen filler 126 and lumen expander 128) can be made of composite material 200, and a beam of laser pulses can be directed at these IOL structures. The volume change of composite material 200 can be calculated by image analyzer 330, computing device 314, or a combination thereof. As described in more detail in the following sections, in some embodiments, computing device 314 can determine the change in base power of IOL 100 by first estimating the volume of fluid (e.g., silicone oil) displaced either from haptic fluid lumen 106 to optical fluid chamber 108 or from optical fluid chamber 108 to haptic fluid lumen 106 in response to the measured volume change of composite material 200. Computing device 314 can then determine the change in base power of IOL 100 by selecting a base power change value from a lookup table associated with the volume of displaced fluid.
[0171] The computing device 314 can also be configured to determine a change in the base power of the IOL 100 based on a measured change in at least one of the curvature of the anterior element 130, the curvature of the posterior element 132, and the axial thickness of the optic portion 102 of the IOL 100. As described above, the image analyzer 330 can be configured to measure a change in at least one of the curvature of the anterior element 130, the curvature of the posterior element 132, and the axial thickness of the optic portion 102 of the IOL 100 based on OCT images (e.g., 2D cross-sectional OCT images and / or 3D composite OCT images) of the anterior element 130, the posterior element 132, and the optic portion 102 before and after the IOL structure made of the composite material 200 is exposed to the laser light 125. As described in more detail in the following sections, in some embodiments, the computing device 314 can determine the change in base power of the IOL 100 by selecting a base power change value from a readout table associated with a measured change in at least one of the curvature of the anterior element 130, the curvature of the posterior element 132, and the axial thickness of the optical portion 102.
[0172] In certain embodiments, the readout tables can be stored in a memory or storage unit of the computing device 314, the image analyzer 330, or a combination thereof. The readout tables can be constructed based on numerous laser-induced tuning experiments performed on the IOL 100 using different beam parameters. In these and other embodiments, each set of readout tables associated with an IOL 100 having a unique combination of IOL structures or IOL structures of different shapes or sizes made from the composite material 200 can be stored in the computing device 314 and / or the image analyzer 330.
[0173] In some embodiments, at least one of the image analyzer 330 and the computing device 314 may be configured to automatically distinguish between different IOL structures made of the composite material 200. For example, at least one of the image analyzer 330 and the computing device 314 may be configured to distinguish between a lumen filler 126 and a lumen expander 128 by analyzing OCT images received as input from the OCT imager 328. In other embodiments, at least one of the image analyzer 330 and the computing device 314 may provide a clinician or operator of the system 300 with a suggestion or recommendation as to whether the IOL structure is a lumen filler 126 or a lumen expander 128, and the clinician or operator may make the final decision. In further embodiments, the display 316 of the system 300 may present OCT images captured by the OCT imager 328 of different IOL structures, and the clinician or operator may determine whether the IOL structure is a lumen filler 126 or a lumen expander 128 based on the displayed OCT images.
[0174] As mentioned above, in some embodiments, the system 300 can be designed as a closed feedback loop in which the laser control component 332 is configured to generate and send power control signals / commands 318 and scan control signals / commands 320 to the laser module 302 to adjust certain beam parameters and / or target position based on changes in the base power of the IOL 100 determined by the computing device 314. In this manner, the imaging-based laser controller 304 can automatically control the laser module 302 without input from a clinician or operator.
[0175] Those skilled in the art will understand that although the various engines, modules, or components of the laser module 302 and the imaging-based laser controller 304 are shown as separate from one another, such engines, modules, or components may be integrated with one another. For example, in some embodiments, the beam attenuator 324 may be part of the laser engine 322. In other embodiments, the beam scanner 326 may be integrated with the beam attenuator 324. Furthermore, in some embodiments, the image analyzer 330 may be integrated with or part of the OCT imager 328. In other embodiments, the laser control component 332 may be integrated with or part of the image analyzer 330.
[0176] 3, the OCT-guided laser system 300 can further include a video microscope 306 capable of capturing video images of the eye and implanted IOL 100 during the IOL adjustment procedure. The OCT-guided laser system 300 can also include a focusing objective 310 having an objective with a high numerical aperture (NA). For example, in some embodiments, the numerical aperture of the objective can be approximately 0.2 to 0.6.
[0177] The OCT-guided laser system 300 may also include an interface 312 configured to interface with and stabilize the subject's eye during the adjustment procedure. In some embodiments, the patient interface 312 may refer to an assembly including a patient interface lens and certain suction components. For example, the patient interface lens can be lowered or pressed onto the subject's eye until the subject's cornea is applanated. Suction is then activated to stabilize the eye and prevent it from moving during the procedure. The patient interface 312 can be attached to the distal end of the focusing objective lens 310 and can serve as a sterile barrier between the subject's eye and the remainder of the laser system 300.
[0178] In some embodiments, the patient interface 312 may also include a gonio lens 1000. The gonio lens 1000 may be configured to redirect a laser beam at a portion of the IOL 100 made of the composite material 200 that is obscured by an anatomical structure of the eye. For example, the anatomical structure of the eye may be the iris of the eye, and the portion of the IOL 100 obscured by the iris may be the haptics 104 of the IOL 100. More specifically, the gonio lens 1000 may redirect a laser beam at a portion of the haptics 104 made of the composite material 200 (e.g., the lumen filler 126 or the lumen expander 128) that is obscured by the iris of the eye.
[0179] FIG. 4 shows a top view (also called a front view) of IOL 100, illustrating both lumen filler 126 and lumen dilator 128 positioned along haptic lumen wall 120 radially inward of haptics 104. FIG. 4 also illustrates that a beam of laser light 125 generated by laser module 302 (see, e.g., FIG. 3) can be directed to multiple locations along lumen filler 126. Each location where the laser beam contacts IOL 100 can be referred to as a laser spot 400.
[0180] As discussed in more detail in the following sections, the heated layer of composite material 200 at each laser spot 400 may expand, causing a protrusion 500 (see, e.g., FIGS. 5B, 7A, and 7B) to form in the laser spot 400. The formation of the protrusion 500 may displace fluid within the haptic fluid lumen 106 into the optical fluid chamber 108, thereby changing the base power of the optical portion 102.
[0181] In some embodiments, each laser spot 400 can be the result of a 1 second exposure to the beam of laser light 125. If the beam of laser light 125 has a pulse repetition rate of 50 kHz, the lumen filling material 126 at the laser spot 400 can be exposed to 50,000 laser pulses, each such pulse having a pulse duration in the range of several hundred femtoseconds (e.g., 500 femtoseconds).
[0182] In some embodiments, the laser engine 322 can generate or adjust the pulse repetition rate of the laser light 125 from about 1 kHz up to 500 kHz. For example, the laser engine 322 can generate or adjust the pulse repetition rate of the laser light 125 to be from about 10 kHz to about 100 kHz.
[0183] In certain embodiments, the laser engine 322 can generate or adjust the laser energy of the laser beam (i.e., the beam of laser light 125) to between about 0.1 and about 100 μJ of laser energy per pulse. For example, the laser engine 322 can generate or adjust the laser energy of the laser beam to between about 1 μJ and about 50 μJ of laser energy per pulse.
[0184] As previously mentioned, the laser module 302 can adjust the pulse repetition rate and / or laser energy based on a power control signal 318 received from the imaging-based laser controller 304 (see, e.g., FIG. 3 ). Additionally, the laser module 302 can adjust the pulse repetition rate and / or laser energy based on input received from a clinician or operator via an operator interface, such as a touchscreen display 316 or an input device communicatively coupled to the computing device 314.
[0185] 4 shows seven laser spots 400 along each lumen filler 126, it is contemplated by the present disclosure and should be understood by one of ordinary skill in the art that each lumen filler 126 (and lumen expander 128) can accommodate more than seven laser spots. For example, each lumen filler 126 and lumen expander 128 can accommodate between eight and twenty laser spots 400, or more than twenty laser spots 400.
[0186] In some embodiments, the location of each of the laser spots 400 can be pre-calculated by the computing device 314 based on OCT images of the haptics 104 taken by the OCT imager 328. For example, a target map or scanning map can be formed that indicates where each of the laser spots 400 should be placed along the haptics 104 of the IOL 100. In other embodiments, the clinician or operator can direct the laser module 302 in real time to a target location selected by the clinician or operator based on real-time OCT images provided by the OCT imager 328.
[0187] 5A and 5B show that a protrusion 500 can be formed at a laser spot 400 where the lumen filler 126 is exposed to a beam of laser light 125. As previously described, the lumen filler 126 can be made from a composite material 200. A heated layer 502 of the lumen filler 126 below the laser spot 400 can absorb the energy of the laser beam and expand in volume to form the protrusion 500. In certain embodiments, the depth of the heated layer 502 can be about 0.05 mm to about 1.0 mm (e.g., about 0.10 mm).
[0188] Because heated layer 502 is near the top or front surface of lumen filler 126, protrusions 500 can protrude or otherwise grow into channels 148 of haptics 104 (e.g., FIGS. 1B, 1C, and 7A). Because channels 148 are also in fluid communication with haptic fluid lumen 106, the formation of protrusions 500 can displace fluid (e.g., silicone oil) from haptic fluid lumen 106 into optical fluid chamber 108. The amount of fluid displaced can be substantially or approximately equivalent to the volume of protrusions 500.
[0189] One technical problem faced by applicants is how to control the growth of the protrusions 500 using the laser light 125. One technical solution discovered and developed by applicants is to control the growth of the protrusions 500 by adjusting or changing at least one of the laser energy per pulse, the pulse repetition rate, the size of the laser spot 400 or the laser spot diameter 504, and the concentration of the energy absorbing pigment or dye.
[0190] For example, the size of the protrusion 500 can be fine-tuned by adjusting the size of the laser spot 400 or the laser spot diameter 504. The laser spot diameter 504 may depend on the cone angle 506 of the laser beam and the front-to-back distance (also referred to as the depth of focus 510) separating the focal point 508 of the laser beam from the laser spot 400. As a more specific example, the laser spot diameter 504 can be determined by Equation 1 below:
number
[0191] In some embodiments, laser spot diameter 504 can be up to 1.0 mm. In other embodiments, laser spot diameter 504 can be between approximately 0.5 mm and 1.0 mm. In additional embodiments, laser spot diameter 504 can be between approximately 0.05 mm and 0.5 mm.
[0192] The protrusion 500 can also have a protrusion height 512. The protrusion height 512 can be the maximum height of the protrusion as measured from the superior or anterior surface of the lumen filler 126 to the apex of the protrusion 500. In some embodiments, the protrusion height 512 can be up to 0.1 mm. In other embodiments, the protrusion height 512 can be between about 0.05 mm and 0.1 mm. In additional embodiments, the protrusion height 512 can be between about 0.01 mm and 0.05 mm.
[0193] The volume of the protrusion 500 (and thereby the volume of displaced fluid, and ultimately the change in base power of the IOL 100) can be controlled by adjusting at least one of the laser energy per pulse, the pulse repetition rate, the cone angle 506 of the laser beam, and the depth of focus 510. Additionally, by increasing the concentration of energy absorbing pigments or dyes within the composite material 200, the composite material 200 itself can be made more responsive to the application of laser energy.
[0194] In some embodiments, the cone angle 506 of the laser beam may depend on the numerical aperture (NA) of the focusing objective lens 310 or objective lens used to focus the laser beam. For example, applicants have discovered that focusing objective lens 310 or objective lenses having a high numerical aperture objective lens, between about 0.2 and 0.6, are more effective at forming protrusion 500 and changing the base power of IOL 100.
[0195] 6A-6C illustrate various geometric shapes that protrusion 500 can take when fully formed. For example, FIG. 6A illustrates that protrusion 500 is a hemisphere (h 半球 ) can be formed. 半球 may be the protrusion height 512. If the protrusion 500 is formed as a substantially hemisphere, h 半球 may be half of the laser spot diameter 504. Also, in this example, the volume of the hemispherical protrusion 500 may be calculated using Equation 2 below: The volume of the hemispherical protrusion (V 半球 )=(2*π*(h 半球 ) 3 ) / 3[equation 2]
[0196] FIG. 6B shows that the protrusion 500 has a height dimension (h 放物面 ) and width dimension (w 放物面 ) can be formed as a paraboloid. When the protrusion 500 is formed as a substantially paraboloid, w 半球 may be substantially equal to the laser spot diameter 504, and h 放物面 may be the protrusion height 512 or the maximum height or height of the parabolic protrusion 500. In some embodiments, the maximum height / height of the paraboloid (as well as w 半球 ) can be measured automatically by the image analyzer 330 or the computing device 314 (see, for example, FIG. 3 ) based on the 2D and 3D OCT images of the protrusion 500 provided by the OCT imager 328. In other embodiments, the clinician or operator can manually measure the relevant dimensions of the protrusion 500 on-screen using specific measurement tools or features provided as part of the OCT software. Also, in this example, the volume of the parabolic protrusion 500 can be calculated using Equation 3 below: Volume of the parabolic protrusion (V 放物面 )=(π*h 放物面 *(w 放物面 ) 2 ) / 8[equation 3]
[0197] FIG. 6C shows that the protrusion 500 has a height dimension (h楕円体 ), width dimension (w 楕円体 ), and length dimension (l 楕円体 When the protrusion 500 is formed as a substantially semi-ellipsoid, w 楕円体 and / or l 楕円体 may be substantially equivalent to the laser spot diameter 504, and h 楕円体 may be the projection height 512 or the maximum height or height of the semi-ellipsoidal projection 500. In some embodiments, the maximum height / height of the semi-ellipsoidal projection, as well as w 楕円体 and l 楕円体 can be measured automatically by the image analyzer 330 or the computing device 314 (see, for example, FIG. 3 ) based on the 2D and 3D OCT images of the protrusion 500 provided by the OCT imager 328. In other embodiments, the clinician or operator can manually measure the relevant dimensions of the protrusion 500 on-screen using specific measurement tools or features provided as part of the OCT software. Also, in this example, the volume of the semi-ellipsoidal protrusion 500 can be calculated using Equation 4 below. [Equation 4] The volume of the semi-ellipsoidal protrusion (V 半楕円体 )=(π*h 楕円体 *w 楕円体 *l 楕円体 ) / 6
[0198] FIG. 7A is an OCT image showing a cross section of a portion of the haptics 104 and optic portion 102 of IOL 100. As can be seen in FIG. 7A, protrusions 500 are formed along the surface of lumen filler 126 and protrude or project into channels 148 of haptics 104. Because composite material 200 expands substantially isotropically upon exposure to the laser beam, the heated composite material 200 expands in an anterior direction toward channels 148 and in a posterior direction within lumen filler 126. FIG. 7A highlights the contour or outer boundary of this expansion.
[0199] As previously mentioned, channel 148 may be in fluid communication with haptic fluid lumen 106 such that the formation of protrusion 500 may displace fluid (e.g., silicone oil) from haptic fluid lumen 106 into optical fluid chamber 108. Applicants have discovered that the amount of fluid displaced may be substantially or approximately equivalent to the volume of protrusion 500.
[0200] In some embodiments, the volume of the protrusion 500 can be calculated in real time based on an OCT image of the protrusion 500, such as that shown in Figure 7A. For example, the shape of the protrusion 500 can be approximated by comparing its shape to known geometric shapes, such as a hemisphere, a paraboloid, or a semi-ellipsoid. Relevant dimensions of the protrusion 500 can be measured by the image analyzer 330 / computing device 314 based on the OCT image, or can be measured on a screen by a clinician or operator.
[0201] The computing device 314 can then determine the change in base power of the IOL 100 by selecting a base power change value from the readout table that is associated with the volume of displaced fluid. As previously described, the computing device 314 can use the calculated volume of the protrusion 500 as an approximation of the volume of displaced fluid. The readout table can be stored in a memory or storage unit of the computing device 314, the image analyzer 330, or a combination thereof. The readout table can be constructed based on laser-based adjustment experiments previously performed on the IOL 100.
[0202] In some embodiments, one of the readout tables can correlate a displacement of approximately 10 nanoliters (nL) to 20 nL (e.g., approximately 15 nL) of fluid from the haptic fluid lumen 106 to the optical fluid chamber 108 with an approximately +0.10 diopter (D) change in the base power of the IOL 100. In this manner, application of laser light 125 to the lumen filler 126 can be considered in addition to activation, as it increases the base power of the IOL 100.
[0203] 7B is an OCT image showing a cross-section of a segment of lumen filler 126 having multiple protrusions 500 formed along the segment. For example, protrusions 500 can be formed by targeting multiple spots along the length of lumen filler 126. Multiple spots can be targeted in one post-implantation conditioning procedure or in multiple post-implantation conditioning procedures over time. The total volume of fluid displaced (from haptic fluid lumen 106 to optical fluid chamber 108) can be calculated based on the combined volume of the multiple protrusions 500.
[0204] 7C is an OCT image showing a cross section of the haptics 104 and a portion of the optic portion 102 showing the lumen expander 128 in an expanded configuration. At least a portion of the lumen expander 128, which is comprised of the composite material 200, can expand or expand in size to enlarge the lumen expander 128. When the lumen expander 128 is in the expanded configuration, the channel height 700 of the channel 148 can increase along with the volume of the channel 148.
[0205] As described above and shown in FIG. 7C , the lumen expander 128 can be positioned radially inward of the channel 148, and a radially outer side of the lumen expander 128 can be in fluid communication with the channel 148. The lumen expander 128 can be positioned between the lumen filler 126 and the anterior portion of the radially inner haptic lumen wall 120 in the anterior-posterior direction. For example, the anterior end of the lumen expander 128 can be adjacent to and in physical contact with the anterior portion of the radially inner haptic lumen wall 120, and the posterior end of the lumen expander 128 can be adjacent to and in physical contact with the lumen filler 126. Because the composite material 200 expands substantially isotropically when exposed to the laser beam, the lumen expander 128 in the expanded configuration pushes against the lumen filler 126 and the anterior portion of the radially inner haptic lumen wall 120, increasing the channel height 700. Although some of the expansion may be in the radially inward direction (in the direction of channel 148), the decrease in volume of channel 148 caused by the radially inward expansion is negligible and is offset by the increase in volume of channel 148 caused by the increase in channel height 700 in the anterior-posterior direction.
[0206] As mentioned above, because channel 148 is in fluid communication with (or can be considered part of) haptic fluid lumen 106, the volume of haptic fluid lumen 106 can increase in response to growth of lumen expander 128. This can draw fluid within haptic fluid lumen 106 from optical fluid chamber 108 into haptic fluid lumen 106. The amount of fluid drawn back into haptic fluid lumen 106 can be substantially or approximately equivalent to the increase in the volume of channel 148.
[0207] The increase in volume of the channel 148 can be calculated by measuring the channel height 700 before and after the lumen expander 128 is exposed to the beam of laser light 125. These measurements can be made by analyzing OCT images taken from one or more cross sections of the haptic 104, with the channel 148 visible in the OCT images. OCT images can be taken before and after the lumen expander 128 is exposed to the laser light 125. The increase in volume of the channel 148 can then be calculated based on these OCT images. For example, the increase in volume of the channel 148 can be calculated based on the known static dimensions of the channel 148 and the change in the channel height 700. In other embodiments, the increase in volume of the channel 148 can be calculated by measuring the dimensions of the channel 148 based on OCT images or OCT imaging data. The dimensions of the channel 148 can be measured before and after the lumen expander 128 is exposed to the laser light 125.
[0208] The computing device 314 can then determine the change in base power of the IOL 100 by selecting a base power change value from the readout table that relates to the volume of fluid drawn from the optical fluid chamber 108 into the haptic fluid lumen 106. As described above, the computing device 314 can use the calculated increase in the volume of the channel 148 as an approximation of the volume of fluid drawn from the optical fluid chamber 108 into the haptic fluid lumen 106. The readout table can be stored in a memory or storage unit of the computing device 314, the image analyzer 330, or a combination thereof. The readout table can be constructed based on laser-based adjustment experiments previously performed on the IOL 100.
[0209] In some embodiments, one of the readout tables can correlate the transfer or displacement of fluid of approximately 10 nanoliters (nL) to 20 nL (e.g., approximately 15 nL) from the optical fluid chamber 108 to the haptic fluid lumen 106 with approximately a -0.10D change in the base power of the IOL 100. In this manner, applying laser light 125 to the lumen expander 128 can be considered a negative activation because doing so decreases the base power of the IOL 100.
[0210] Figure 8A is an OCT image showing a cross section of a portion of a haptic 104 of IOL 100 with lumen filler 126 and lumen dilator 128 visible in the OCT image. Figure 8B is an en face OCT image showing a top view of a portion of a haptic 104 of IOL 100, where segments of haptics 104 made of composite material 200 are visible in the en face OCT image.
[0211] As previously mentioned, the method of adjusting the implanted IOL 100 can include imaging the implanted IOL 100 using the OCT imager 328 prior to targeting the lumen filler 126 or lumen expander 128 with the beam of laser light 125. In some embodiments, at least one of the computing device 314 and the image analyzer 330 can automatically determine the location of the lumen filler 126 or lumen expander 128 based on one or more OCT images of the IOL 100 or OCT imaging data obtained from the OCT imager 328. In other embodiments, a clinician or operator can determine the location of the lumen filler 126 or lumen expander 128 by inspecting the OCT images of the IOL 100.
[0212] 8A and 8B, composite material 200 (in the form of either lumen filler 126 or lumen expander 128) is clearly visible in both cross-sectional and en face OCT images. This may be due to the difference in density of composite material 200 compared to the surrounding haptic material and the fluid within haptic fluid lumen 106. As previously mentioned, composite material 200 may be composed of specific energy absorbing pigments / dyes and expandable microspheres, all of which may contribute to the visibility of composite material 200 under OCT.
[0213] The computing device 314 may first use the en face OCT image to determine the X and Y coordinates of the composite material 200 and then use the cross-sectional OCT image to determine the Z or depth coordinate of the composite material 200.
[0214] The computing device 314 can also use the cross-sectional OCT images to distinguish between the lumen filler 126 and the lumen expander 128. For example, the computing device 314 can distinguish between the lumen filler 126 and the lumen expander 128 based on the position of such structures relative to other haptic structures (where the shape and size of such other haptic structures remain stationary and are well documented) and based on their positions relative to each other. As a more specific example, the lumen filler 126 can be distinguished from the lumen expander 128 based on the presence of fluid in the channel 148 immediately preceding the lumen filler 126.
[0215] One technical problem faced by applicants is how to precisely target only the lumen filler 126 or the lumen expander 128 with the laser beam without unintentionally colliding with other structures. This is particularly challenging given that both the lumen filler 126 and the lumen expander 128 are positioned along the curved region of the haptics 104, and single segments of either the lumen filler 126 or the lumen expander 128 may be positioned at different depths due to the fact that implanted IOLs 100 are often tilted at an angle (called the angle kappa) relative to the visual axis of the eye (this also applies to the subject's own natural lens). One technical solution discovered and developed by applicants is to use OCT to image the haptics 104, including the lumen filler 126 and the lumen expander 128, and determine the X, Y, and Z coordinates of the lumen filler 126 and the lumen expander 128 based on the OCT image. A scan pattern or target map can be formed that includes the X, Y, and Z coordinates of the intended laser spot along either the lumen filler 126 or the lumen expander 128. The laser beam can then be applied according to the scan pattern or target map to prevent the laser beam from unintentionally targeting the wrong expandable structure or unintentionally causing harm to the subject's eye.
[0216] 9A and 9B are pre-OCT and post-OCT images showing the change in axial thickness 900 of the optic portion 102 in response to fluid entering the optical fluid chamber 108. As previously described, the optic portion 102 can undergo shape changes in response to fluid entering and exiting the optical fluid chamber 108. For example, as shown in FIGS. 9A and 9B, the axial thickness 900 of the optic portion 102 can increase by 0.04 mm in response to a beam of laser light 125 applied to the lumen filler 126. The laser light 125 can cause the laser spot 400 along the lumen filler 126 to form a protrusion 500, which can displace fluid in the tactile fluid lumen 106 into the optical fluid chamber 108.
[0217] 9C illustrates that at least one of the anterior element 130 and the posterior element 132 can change its curvature in response to fluid entering or leaving the optical fluid chamber 108. As a more specific example, at least one of the anterior optical surface 134 of the anterior element 130 and the posterior optical surface 138 of the posterior element 132 can be configured to increase its curvature in response to fluid entering the optical fluid chamber 108, and at least one of the anterior optical surface 134 of the anterior element 130 and the posterior optical surface 138 of the posterior element 132 can be configured to decrease its curvature (or flatten) in response to fluid exiting the optical fluid chamber 108.
[0218] Axial thickness 900 may be the distance, measured along optical axis 142, separating a most anterior point along anterior optical surface 134 and a most posterior point along posterior optical surface 138. When at least one of anterior element 130 and posterior element 132 increases its curvature, axial thickness 900 of optic portion 102 may increase. Conversely, when at least one of anterior element 130 and posterior element 132 decreases its curvature, axial thickness 900 of optic portion 102 may decrease.
[0219] In some embodiments, at least one of image analyzer 330 and computing device 314 can automatically measure the change in at least one of axial thickness 900, the curvature of anterior optical surface 134, and the curvature of posterior optical surface 138 based on one or more cross-sectional OCT images of IOL 100 or OCT imaging data obtained from OCT imager 328. In other embodiments, a clinician or operator can measure the change in at least one of axial thickness 900, the curvature of anterior optical surface 134, and the curvature of posterior optical surface 138 by examining one or more cross-sectional OCT images.
[0220] In some embodiments, the computing device 314 can be configured to determine a change in base power of the IOL 100 based on a measured change in at least one of the curvature of the anterior element 130, the curvature of the posterior element 132, and the axial thickness 900 of the optic portion 102. For example, the computing device 314 can be configured to determine a change in base power of the IOL 100 by selecting from one or more lookup tables a base power change value associated with a measured change in at least one of the curvature of the anterior element 130, the curvature of the posterior element 132, and the axial thickness 900. Also, for example, the computing device 314 can be configured to determine a change in base power of the IOL 100 using a mathematical relationship that multiplies a change in axial thickness 900 by a conversion factor. As a more specific example, the conversion factor can be a change of approximately 60 D (±5 D) per millimeter change in axial thickness 900.
[0221] 10 illustrates that a goniolens 1000 can be used to redirect laser light 125 to a portion of an IOL 100 made of composite material 200 that is hidden by the anatomical structure of the eye. In some embodiments, the goniolens 1000 can be incorporated into or integrated into a patient interface 312 that physically contacts the subject's eye. In certain embodiments, numbering drops are applied to the subject's eye before the goniolens 1000 contacts the eye.
[0222] The gonio-lens 1000 can include a number of angled mirrors 1002 disposed inside a lens housing of the gonio-lens 1000. In some embodiments, the gonio-lens 1000 can include between two and six angled mirrors 1002. In other embodiments, the gonio-lens 1000 can include only one angled mirror 1002 or more than six angled mirrors 1002, such as between eight and ten angled mirrors 1002.
[0223] In some embodiments, each of the angled mirrors 1002 of the gonio lens 1000 may be positioned at a different angle within the lens housing. In other embodiments, at least two of the angled mirrors 1002 may be positioned at the same angle. For example, each of the angled mirrors 1002 may be positioned at a 58 o From 80 o The angle between the
[0224] 10 , the angled mirror 1002 of the goniolens 1000 can redirect the laser beam to a portion of the implanted IOL 100 that is obscured by the ocular anatomical structure. For example, the angled mirror 1002 of the goniolens 1000 can redirect the laser beam to a portion of the implanted IOL 100 that is obscured by the iris of the eye. As a more specific example, the angled mirror 1002 of the goniolens 1000 can redirect the laser beam to a portion of the haptics 104 of the implanted IOL 100 that is obscured by the iris of the eye (e.g., a portion of the lumen filler 126 or lumen dilator 128).
[0225] The gonio lens 1000 can contribute to improving the safety of the system 300. For example, one technical problem faced by the applicant is the risk of unintentional damage to a patient's eye due to exposure to laser energy. This risk is heightened when such laser energy must be directed at one or more haptics 104 located around the periphery of the central optic portion 102. As a more specific example, while the laser is directed at the outer peripheral region of the central optic portion 102, the patient's iris may be unintentionally exposed to the laser energy. The gonio lens 1000 can contribute to improving the safety of the system 300 by enabling the system 300 to precisely target portions of the IOL 100 located around the periphery of the central optic portion 102 without unintentional injury to the eye. For example, the gonio lens 1000 can prevent unintentional exposure of the iris to the laser beam.
[0226] This disclosure also covers the following sections: Clause 1. A method of adjusting an intraocular lens (IOL) using optical coherence tomography (OCT) guidance, comprising: directing a laser beam generated by a laser system to a composite material comprising a portion of the IOL, wherein at least a portion of the composite material volumetrically expands in response to the laser beam directed at the composite material; measuring a volumetric change of the composite material by analyzing one or more OCT images of the composite material generated by an OCT imaging device; and determining a change in base power of the IOL based on the measured volumetric change of the composite material. A method comprising:
[0227] Clause 2. The method of clause 1, further comprising imaging the IOL including the composite material using an OCT imaging device before directing the laser beam at the composite material, and determining the position of the composite material based on the OCT imaging.
[0228] Clause 3. The method of clause 2, wherein the IOL includes at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen, the composite material is configured as a lumen filler constituting a portion of the radially inner haptic lumen wall, the lumen filler being configured to expand into at least a portion of the haptic fluid lumen to reduce a volume of the haptic fluid lumen in response to a laser beam directed at the lumen filler, the composite material is also configured as a lumen expander constituting another portion of the radially inner haptic lumen wall, the lumen expander being configured to expand in response to a laser beam directed at the lumen expander to increase a volume of the haptic fluid lumen, the method further comprising distinguishing between the lumen filler and the lumen expander by analyzing one or more OCT images.
[0229] Clause 4. The method of clause 1, further comprising adjusting the pulse repetition rate of the laser beam to between about 10 kHz and about 100 kHz.
[0230] Clause 5. The method of clause 1, further comprising adjusting the laser energy of the laser beam to a laser energy of about 0.1 to about 100 μJ per pulse.
[0231] Clause 6. The method further includes controlling a volume change of the composite material by controlling a laser spot diameter formed by the laser beam on the composite material, wherein the laser spot diameter satisfies the relationship:
number
[0232] Clause 7. The method of clause 1, wherein the laser beam has a wavelength of about 1030 nm to about 1064 nm.
[0233] Clause 8. The method of clause 1, wherein the laser beam is focused by a focusing objective lens having a numerical aperture of 0.2 to 0.6, and the laser beam is focused on the composite material by the focusing objective lens.
[0234] Clause 9. The method of clause 1, further comprising redirecting the laser beam at the composite material using a goniolens so that the laser beam reaches portions of the IOL hidden by ocular anatomical structures.
[0235] Clause 10. The method of clause 1, wherein determining the change in base power of the IOL further comprises estimating the volume of fluid displaced from the haptic fluid lumen to the optical fluid chamber or from the optical fluid chamber to the haptic fluid lumen in response to the measured volume change of the composite material, and determining the change in base power by selecting from the readout table the change in base power value associated with the volume of fluid displaced.
[0236] Clause 11. A method of adjusting an intraocular lens (IOL) using optical coherence tomography (OCT) guidance, comprising: directing a laser beam generated by a laser system to a composite material comprising a portion of the IOL, at least a portion of the composite material volumetrically expanding in response to the laser beam directed at the composite material, the IOL including an optic portion including an anterior element and a posterior element; measuring a change in at least one of a curvature of the anterior element, a curvature of the posterior element, and an axial thickness of the optic portion by analyzing one or more OCT images of the optic portion generated by an OCT imaging device; and determining a change in base power of the IOL based on the measured change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optic portion. A method comprising:
[0237] Clause 12. The method of clause 11, further comprising imaging the IOL including the composite material using an OCT imaging device before directing the laser beam at the composite material, and determining the location of the composite material based on the OCT imaging.
[0238] Clause 13. The method of Clause 12, wherein the IOL includes at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen, the composite material is configured as a lumen filler constituting a portion of the radially inner haptic lumen wall, the lumen filler being configured to expand into at least a portion of the haptic fluid lumen to reduce a volume of the haptic fluid lumen in response to a laser beam directed at the lumen filler, the composite material is also configured as a lumen expander constituting another portion of the radially inner haptic lumen wall, the lumen expander being configured to expand in response to a laser beam directed at the lumen expander to increase a volume of the haptic fluid lumen, the method further comprising distinguishing between the lumen filler and the lumen expander by analyzing one or more OCT images.
[0239] Clause 14. The method of clause 11, further comprising adjusting the pulse repetition rate of the laser beam to between about 10 kHz and about 100 kHz.
[0240] Clause 15. The method of clause 11, further comprising adjusting the laser energy of the laser beam to a laser energy of about 0.1 μJ to about 100 μJ per pulse.
[0241] Clause 16. The method further includes controlling a volume change of the composite material by controlling a laser spot diameter formed by the laser beam on the composite material, wherein the laser spot diameter is determined by the relationship:
number
[0242] Clause 17. The method of clause 11, wherein the laser beam has a wavelength of about 1030 nm to about 1064 nm.
[0243] Clause 18. The method according to clause 11, wherein the laser beam is focused by a focusing objective lens having a numerical aperture of 0.2 to 0.6, and the laser beam is focused on the composite material by the focusing objective lens.
[0244] Clause 19. The method of clause 11, further comprising redirecting the laser beam at the composite material by using a goniolens so that the laser beam reaches portions of the IOL hidden by ocular anatomical structures.
[0245] Clause 20. The method of clause 11, wherein determining the change in base power of the IOL further comprises selecting from a lookup table a change value in base power associated with a measured change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optical portion.
[0246] Clause 21. An ophthalmic system, comprising: a laser system configured to generate a laser beam directed at a composite material that constitutes a portion of an intraocular lens (IOL), wherein at least a portion of the composite material volumetrically expands in response to the laser beam directed at the composite material; an optical coherence tomography (OCT) imager configured to generate one or more OCT images of the composite material that constitutes a portion of the IOL; an image analyzer configured to measure a volumetric change of the composite material by analyzing the one or more OCT images; and a computing device configured to determine a change in base power of the IOL based on the volumetric change of the composite material. ophthalmology system, including
[0247] Clause 22. An ophthalmic system as described in Clause 21, wherein the OCT imaging device is configured to image the IOL before the laser beam is directed at the composite material, and the computing device is configured to determine the position of the composite material based on one or more OCT images of the IOL.
[0248] Clause 23. The ophthalmic system described in Clause 22, wherein the IOL has at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen, the composite material is configured as a lumen filler constituting a portion of the radially inner haptic lumen wall, the lumen filler being configured to expand into at least a portion of the haptic fluid lumen to reduce a volume of the haptic fluid lumen in response to a laser beam directed at the lumen filler, the composite material is also configured as a lumen expander constituting another portion of the radially inner haptic lumen wall, the lumen expander being configured to expand in response to a laser beam directed at the lumen expander to increase a volume of the haptic fluid lumen, and the computing device is further configured to distinguish between the lumen filler and the lumen expander by analyzing one or more OCT images.
[0249] Clause 24. An ophthalmic system as described in clause 21, wherein the laser beam directed at the composite material has a pulse repetition rate of 10 kHz to 100 kHz.
[0250] Clause 25. The ophthalmic system of clause 21, wherein the laser beam directed at the composite material has a laser energy per pulse of about 0.1 μJ to about 100 μJ.
[0251] Clause 26. The volume change of the composite material is controlled in part by the laser spot diameter formed by the laser beam on the composite material, and the laser spot diameter is determined by the relationship:
number
[0252] Clause 27. An ophthalmic system as described in clause 21, wherein the laser beam has a wavelength of about 1030 nm to about 1064 nm.
[0253] 28. An ophthalmic system as described in Clause 21, further comprising a focusing objective lens having a numerical aperture of 0.2 to 0.6, wherein the laser beam is focused onto the composite material by the focusing objective lens.
[0254] Clause 29. An ophthalmic system as described in Clause 21, wherein the IOL is implanted in the subject's eye, and the system further comprises a patient interface including a goniolens configured to redirect the laser beam at a portion of the IOL constructed of a composite material that is hidden by the anatomical structure of the eye.
[0255] Clause 30. The computing device determines the change in base power of the IOL by estimating the volume of fluid displaced from the haptic fluid lumen to the optical fluid chamber or from the optical fluid chamber to the haptic fluid lumen in response to the measured volume change of the composite material and selecting from the readout table the value of the change in base power associated with the volume of fluid displaced. 22. The ophthalmic system of claim 21, configured to:
[0256] Clause 31. An ophthalmic system, comprising: a laser system configured to generate a laser beam directed at a composite material constituting a portion of an intraocular lens (IOL), at least a portion of the composite material volumetrically expanding in response to the laser beam directed at the composite material, the IOL including an optic portion including an anterior element and a posterior element; an optical coherence tomography (OCT) imaging device configured to generate one or more OCT images of the optic portion of the IOL after the laser beam is directed at the composite material; an image analyzer configured to measure a change in at least one of a curvature of the anterior element, a curvature of the posterior element, and an axial thickness of the optic portion by analyzing the one or more OCT images of the optic portion; and a computing device configured to determine a change in base power of the IOL based on the measured change in at least one of a curvature of the anterior element, a curvature of the posterior element, and an axial thickness of the optic portion. An ophthalmology system comprising:
[0257] Clause 32. An ophthalmic system as described in Clause 31, wherein the OCT imaging device is configured to image the IOL before the laser beam is directed at the composite material, and the computing device is configured to determine the position of the composite material based on one or more OCT images of the IOL.
[0258] Clause 33. The ophthalmic system of Clause 32, wherein the IOL comprises at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen, the composite material is configured as a lumen filler constituting a portion of the radially inner haptic lumen wall, the lumen filler being configured to expand into at least a portion of the haptic fluid lumen to reduce a volume of the haptic fluid lumen in response to a laser beam directed at the lumen filler, the composite material is also configured as a lumen expander constituting another portion of the radially inner haptic lumen wall, the lumen expander being configured to expand in response to a laser beam directed at the lumen expander to increase a volume of the haptic fluid lumen, and the computing device is further configured to distinguish between the lumen filler and the lumen expander by analyzing one or more OCT images.
[0259] Clause 34. An ophthalmic system as described in clause 31, wherein the laser beam directed at the composite material has a pulse repetition rate of 10 kHz to 100 kHz.
[0260] Clause 35. The ophthalmic system of clause 31, wherein the laser beam directed at the composite material has a laser energy per pulse of about 0.1 μJ to about 100 μJ.
[0261] Clause 36. The volume change of the composite material is controlled in part by the laser spot diameter formed by the laser beam on the composite material, and the laser spot diameter satisfies the following relationship:
number
[0262] Clause 37. An ophthalmic system as described in Clause 31, wherein the laser beam has a wavelength of about 1030 nm to about 1064 nm.
[0263] An ophthalmic system as described in Clause 31, further comprising a focusing objective lens having a numerical aperture of Clause 38.0.2 to 0.6, wherein the laser beam is focused onto the composite material by the focusing objective lens.
[0264] Clause 39. An ophthalmic system as described in Clause 31, wherein the IOL is implanted in the subject's eye, and the system further comprises a goniolens configured to redirect the laser beam at a portion of the IOL constructed of a composite material that is hidden by the anatomical structure of the eye.
[0265] Clause 40. The ophthalmic system of clause 31, wherein the computing device is further configured to determine a change in base power of the IOL by selecting from the readout table a change value in base power associated with a measured change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optical portion.
[0266] Clause 41. A method of adjusting an intraocular lens (IOL) using optical coherence tomography (OCT) guidance, comprising: directing a laser beam generated by a laser system to a composite material that constitutes a portion of the IOL, wherein at least a portion of the composite material expands in volume in response to the laser beam directed at the composite material; measuring volumetric changes of structures or cavities within the IOL in response to the expansion of the composite material by analyzing OCT images of the IOL generated by an OCT imaging device; and determining a change in base power of the IOL based on the measured volumetric changes of the structures or cavities. A method comprising:
[0267] Clause 42. The method of clause 41, further comprising imaging the IOL using an OCT imaging device before directing the laser beam at the composite material, and determining the position of the composite material based on the OCT imaging.
[0268] Clause 43. The method of Clause 42, wherein the IOL includes at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen, the composite material is configured as a lumen filler constituting a portion of the radially inner haptic lumen wall, the lumen filler being configured to expand into at least a portion of the haptic fluid lumen to reduce a volume of the haptic fluid lumen in response to a laser beam directed at the lumen filler, the composite material is also configured as a lumen expander constituting another portion of the radially inner haptic lumen wall, the lumen expander being configured to expand in response to a laser beam directed at the lumen expander to increase a volume of the haptic fluid lumen, the method further comprising distinguishing between the lumen filler and the lumen expander by analyzing the OCT image.
[0269] Clause 44. The method of clause 41, further comprising adjusting the pulse repetition rate of the laser beam to between about 10 kHz and about 100 kHz.
[0270] Clause 45. The method of clause 41, further comprising adjusting the laser energy of the laser beam to a laser energy of about 0.1 μJ to about 100 μJ per pulse.
[0271] Clause 46. The method further includes controlling the volume change of the composite material by controlling a laser spot diameter formed by the laser beam on the composite material, wherein the laser spot diameter satisfies the following relationship:
number
[0272] Clause 47. The method of clause 41, wherein the laser beam has a wavelength of about 1030 nm to about 1064 nm.
[0273] Clause 48. The method according to clause 41, wherein the laser beam is focused by a focusing objective lens having a numerical aperture of 0.2 to 0.6, and the laser beam is focused on the composite material by the focusing objective lens.
[0274] Clause 49. The method of clause 41, further comprising redirecting the laser beam at the composite material using a goniolens so that the laser beam reaches portions of the IOL hidden by ocular anatomical structures.
[0275] Clause 50. The method of clause 41, wherein determining the change in base power of the IOL further comprises estimating the volume of fluid displaced from the haptic fluid lumen to the optical fluid chamber or from the optical fluid chamber to the haptic fluid lumen based on the measured volume change of a structure or cavity within the IOL, and determining the change in base power by selecting from the readout table a change value for base power associated with the volume of fluid displaced.
[0276] Clause 51. An ophthalmic system comprising: a laser system configured to generate a laser beam directed at a composite material that forms a portion of an intraocular lens (IOL), wherein at least a portion of the composite material expands in volume in response to the laser beam directed at the composite material; an optical coherence tomography (OCT) imaging device configured to generate an OCT image of the IOL including structures or cavities within the IOL; an image analyzer configured to measure volumetric changes of the structures or cavities within the IOL in response to the expansion of the composite material by analyzing the OCT image; and a computing device configured to determine a change in base power of the IOL based on the measured volumetric changes of the structures or cavities.
[0277] Clause 52. An ophthalmic system as described in Clause 51, wherein the OCT imaging device is configured to image the IOL before the laser beam is directed at the composite material, and the computing device is configured to determine the position of the composite material based on the OCT imaging.
[0278] Clause 53. The ophthalmic system described in Clause 52, wherein the IOL has at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen, the composite material is configured as a lumen filler constituting a portion of the radially inner haptic lumen wall, the lumen filler being configured to expand into at least a portion of the haptic fluid lumen to reduce a volume of the haptic fluid lumen in response to a laser beam directed at the lumen filler, the composite material is also configured as a lumen expander constituting another portion of the radially inner haptic lumen wall, the lumen expander being configured to expand in response to a laser beam directed at the lumen expander to increase a volume of the haptic fluid lumen, and the computing device is further configured to distinguish between the lumen filler and the lumen expander by analyzing OCT images.
[0279] Clause 54. An ophthalmic system as described in Clause 51, wherein the laser beam directed at the composite material has a pulse repetition rate of about 10 kHz to about 100 kHz.
[0280] Clause 55. An ophthalmic system as described in Clause 51, wherein the laser beam directed at the composite material has a laser energy per pulse of about 0.1 μJ to about 100 μJ.
[0281] Clause 56. The volume change of the composite material is controlled in part by the laser spot diameter formed by the laser beam on the composite material, and the laser spot diameter satisfies the following relationship:
number
[0282] Clause 57. An ophthalmic system as described in Clause 51, wherein the laser beam has a wavelength of about 1030 nm to about 1064 nm.
[0283] Clause 58. An ophthalmic system as described in Clause 51, further comprising a focusing objective lens having a numerical aperture of 0.2 to 0.6, wherein the laser beam is focused onto the composite material by the focusing objective lens.
[0284] Clause 59. An ophthalmic system as described in Clause 51, wherein the IOL is implanted in the subject's eye, and the system further comprises a patient interface including a goniolens configured to redirect the laser beam at a portion of the IOL constructed of a composite material that is hidden by the anatomical structure of the eye.
[0285] Clause 60. The computing device determines the change in base power of the IOL by estimating the volume of fluid displaced from either the haptic fluid lumen to the optical fluid chamber or from the optical fluid chamber to the haptic fluid lumen based on the measured volume change of a structure or cavity within the IOL and selecting from the readout table the change in base power value associated with the volume of fluid displaced. 52. The ophthalmic system of clause 51, further configured to:
[0286] Although multiple embodiments have been described, those skilled in the art will appreciate that various changes and modifications can be made to the present disclosure without departing from the spirit and scope of the embodiments. The elements of the systems, devices, apparatus, and methods shown in connection with any embodiment are exemplary for a particular embodiment and can be used in combination or otherwise with other embodiments within the present disclosure. For example, the steps of any method depicted in the figures or described in this disclosure do not require the particular order or sequential order shown or described to achieve the desired results. In addition, other step operations may be provided, or steps or operations may be eliminated or omitted from a described method or process, to achieve the desired results. Furthermore, any component or portion of any apparatus or system described in the figures or disclosed herein may be removed, eliminated, or omitted to achieve the desired results. In addition, certain components or portions of systems, devices, or apparatus shown or described herein have been omitted for the sake of brevity and clarity.
[0287] Accordingly, other embodiments are within the scope of the following claims, and the specification and / or drawings are to be regarded in an illustrative rather than a restrictive sense.
[0288] Each individual variation or embodiment described and illustrated herein has distinct components and features that may be readily separated from or combined with the features of any of the other variations or embodiments. Modifications may be made to adapt a particular situation, material, composition of matter, process, process acts or steps to the objective, spirit or scope of the present invention.
[0289] Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as in the order of the recited events. Furthermore, additional steps or operations may be provided or steps or operations may be eliminated in order to achieve desired results.
[0290] Furthermore, when a range of values is provided, all intervening values between the upper and lower limits of that range, and any other stated or intervening value within that stated range, are encompassed within the invention. Optional features of the described inventive variations may be set forth and claimed independently or in combination with any one or more of the features described herein. For example, description of a range of 1 to 5 should be considered to disclose subranges of 1 to 3, 1 to 4, 2 to 4, 2 to 5, 3 to 5, etc., as well as individual numbers within that range, e.g., 1.5, 2.5, etc., and whole or partial increments therebetween.
[0291] All pre-existing subject matter (e.g., publications, patents, patent applications) mentioned herein is incorporated herein by reference in its entirety, except to the extent that such subject matter may conflict with the subject matter of the present invention, in which case the present invention shall control. The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.
[0292] Reference to a singular item includes the possibility that there are plural of the same items. More specifically, as used in this specification and the appended claims, the singular forms "a," "an," "said," and "the" include plural references unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude optional elements. As such, this statement is intended to serve as a predicate against the use of exclusive terminology such as "solely," "only," or the use of a "negative" limitation in connection with reciting claim elements. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
[0293] Reference to the phrase "at least one," when such phrase modifies more than one item or component (or an enumerated list of items or components), means any combination of one or more of those items or components. For example, the phrase "at least one of A, B, and C" means (i) A, (ii) B, (iii) C, (iv) A, B, and C, (v) A and B, (vi) B and C, or (vii) A and C.
[0294] In understanding the scope of the present disclosure, the term "comprises" and its derivatives as used herein are intended to be open-ended terms that specify the presence of stated features, elements, components, groups, integers, and / or steps, but do not exclude the presence of other, unstated features, elements, components, groups, integers, and / or steps. The above also applies to words of similar meaning, such as the terms "comprises," "has," and their derivatives. The terms "portion," "section," "portion," "member," "element," or "component," when used in the singular, can also have the dual meaning of a single part or multiple parts. As used herein, the directional terms "front, rear, above, below, vertical, horizontal, downward, transverse, lateral, and vertical" and other similar directional terms refer to the position of a device or apparatus or the direction of a device or apparatus being translated or moved.
[0295] Finally, terms of degree, such as "substantially," "about," and "approximately," as used herein, refer to the specified value or values and reasonable amounts of deviation from the specified value (e.g., deviations of up to ±0.1%, ±1%, ±5%, or ±10%, as such variations are appropriate) such that the end result is not significantly or substantially altered. For example, "about 1.0 cm" can be interpreted as meaning "1.0 cm" or "0.9 cm to 1.1 cm." When terms of degree, such as "about" or "approximately," are used to refer to numbers or values that are part of a range, the term can be used to modify both the minimum and maximum numbers or values.
[0296] The present disclosure is not intended to be limited in scope to the particular embodiments described, but is intended to encompass alternatives, modifications, and equivalents of the variations or embodiments described herein. Moreover, the scope of the present disclosure fully encompasses other variations or embodiments that may become apparent to those skilled in the art in light of the present disclosure.
Claims
1. 1. A method for adjusting an intraocular lens (IOL) using optical coherence tomography (OCT) guidance, comprising: directing a laser beam generated by a laser system at a composite material comprising a portion of the IOL, at least a portion of the composite material expanding in volume in response to the laser beam being directed at the composite material; measuring the volume change of the composite material by analyzing one or more OCT images of the composite material generated by an OCT imaging device; determining a change in base power of the IOL based on the measured volume change of the composite material; and A method comprising:
2. imaging the IOL including the composite material using the OCT imaging device before directing the laser beam at the composite material; determining a location of the composite material based on the OCT imaging; and The method of claim 1 further comprising:
3. the IOL comprises at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen; the composite material is configured as a lumen filler that constitutes a portion of the radially inner haptic lumen wall, the lumen filler configured to expand into at least a portion of the haptic fluid lumen to reduce a volume of the haptic fluid lumen in response to the laser beam directed at the lumen filler; the composite material is also configured as a lumen expander that constitutes another portion of the radially inner haptic lumen wall, the lumen expander configured to expand in response to the laser beam directed at the lumen expander to increase the volume of the haptic fluid lumen; the method further comprising distinguishing between the lumen filler and the lumen expander by analyzing the one or more OCT images. The method of claim 2.
4. The method of claim 1 , further comprising adjusting the pulse repetition rate of the laser beam to between about 10 kHz and about 100 kHz.
5. The method of claim 1 , further comprising adjusting the laser energy of the laser beam to a laser energy of about 0.1 to about 100 μJ per pulse.
6. and controlling the volume change of the composite material by controlling a laser spot diameter formed by the laser beam on the composite material, the laser spot diameter satisfying the relationship: [Equation 1] The method of claim 1 , wherein the value is determined by:
7. The method of claim 1 , wherein the laser beam has a wavelength of about 1030 nm to about 1064 nm.
8. 2. The method of claim 1, wherein the laser beam is focused by a focusing objective lens having a numerical aperture of 0.2 to 0.6, and the laser beam is focused onto the composite material by the focusing objective lens.
9. 10. The method of claim 1, further comprising redirecting the laser beam at the composite material using a goniolens such that the laser beam reaches portions of the IOL obscured by the ocular anatomy.
10. Determining the change in the base power of the IOL includes estimating a volume of fluid displaced from a haptic fluid lumen to an optical fluid chamber or from the optical fluid chamber to the haptic fluid lumen in response to the measured volume change of the composite material, and determining the change in base power by selecting from a readout table a change in base power value associated with the volume of displaced fluid. The method of claim 1 further comprising:
11. 1. A method for adjusting an intraocular lens (IOL) using optical coherence tomography (OCT) guidance, comprising: directing a laser beam generated by a laser system at a composite material that forms a portion of the IOL; at least a portion of the composite material expands in volume in response to the laser beam being directed at the composite material; the IOL comprises an optic portion including an anterior element and a posterior element; To point and measuring a change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optic portion by analyzing one or more OCT images of the optic portion produced by an OCT imaging device; determining a change in base power of the IOL based on the measured change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optic portion; A method comprising:
12. imaging the IOL including the composite material using the OCT imaging device before directing the laser beam at the composite material; determining a location of the composite material based on the OCT imaging; and The method of claim 11 further comprising:
13. the IOL comprises at least one haptic including a haptic fluid lumen and a radially inner haptic lumen wall surrounding at least a portion of the haptic fluid lumen; the composite material is configured as a lumen filler that constitutes a portion of the radially inner haptic lumen wall, the lumen filler configured to expand into at least a portion of the haptic fluid lumen to reduce a volume of the haptic fluid lumen in response to the laser beam directed at the lumen filler; the composite material is also configured as a lumen expander that constitutes another portion of the radially inner haptic lumen wall, the lumen expander configured to expand in response to the laser beam directed at the lumen expander to increase the volume of the haptic fluid lumen; the method further comprising distinguishing between the lumen filler and the lumen expander by analyzing the one or more OCT images. The method of claim 12.
14. The method of claim 11 , further comprising adjusting the pulse repetition rate of the laser beam to between about 10 kHz and about 100 kHz.
15. 12. The method of claim 11, further comprising adjusting the laser energy of the laser beam to a laser energy of about 0.1 to about 100 μJ per pulse.
16. and controlling the volume change of the composite material by controlling a laser spot diameter formed by the laser beam on the composite material, the laser spot diameter satisfying the relationship: [Equation 2] The method of claim 11 , wherein the value is determined by:
17. a laser system configured to generate a laser beam directed at a composite material comprising a portion of an intraocular lens (IOL), wherein at least a portion of the composite material expands in volume in response to the laser beam directed at the composite material; an optical coherence tomography (OCT) imaging device configured to generate one or more OCT images of the composite material that forms a portion of the IOL; an image analyzer configured to measure a volume change of the composite material by analyzing the one or more OCT images; a computing device configured to determine a change in base power of the IOL based on the volumetric change of the composite material; and ophthalmology system, including
18. 1. A laser system configured to generate a laser beam directed at a composite material comprising a portion of an intraocular lens (IOL), the laser system comprising: at least a portion of the composite material expands in volume in response to the laser beam being directed at the composite material; the IOL comprises an optic portion including an anterior element and a posterior element; a laser system; an optical coherence tomography (OCT) imaging device configured to generate one or more OCT images of the optic portion of the IOL after the laser beam is directed at the composite material; an image analyzer configured to measure changes in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optic portion by analyzing the one or more OCT images of the optic portion; a computing device configured to determine a change in base power of the IOL based on the measured change in at least one of the curvature of the anterior element, the curvature of the posterior element, and the axial thickness of the optic portion; and An ophthalmology system comprising:
19. 1. A method for adjusting an intraocular lens (IOL) using optical coherence tomography (OCT) guidance, comprising: directing a laser beam generated by a laser system at a composite material comprising a portion of the IOL, at least a portion of the composite material expanding in volume in response to the laser beam being directed at the composite material; measuring volumetric changes of structures or cavities within the IOL in response to the expansion of the composite material by analyzing OCT images of the IOL produced by an OCT imaging device; determining a change in base power of the IOL based on the measured volumetric change of the structure or cavity; A method comprising:
20. a laser system configured to generate a laser beam directed at a composite material comprising a portion of an intraocular lens (IOL), wherein at least a portion of the composite material expands in volume in response to the laser beam directed at the composite material; an optical coherence tomography (OCT) imaging device configured to generate an OCT image of the IOL, including structures or cavities within the IOL; an image analyzer configured to analyze the OCT image to determine volumetric changes of the structures or cavities within the IOL in response to the expansion of the composite material; a computing device configured to determine a change in base power of the IOL based on the measured volumetric change of the structure or cavity; An ophthalmology system comprising:
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