ACCOMMODATING INTRAOCULAR LENS AND METHODS FOR POSTOPERATIVE ADJUSTMENT OF INTRAOCULAR LENSES - Patent application

Abstract

An accommodative intraocular lens and a method for post-operatively adjusting an intraocular lens are disclosed. In one embodiment, the accommodative intraocular lens includes an optic portion and at least one haptic. At least a portion of the haptic can be fabricated in part from a composite material including an energy absorbing component and a plurality of shrinkable and / or burstable microspheres. At least one of the base powers of the optic portion can be configured to change in response to external energy being directed at the composite material.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 267,376, filed January 31, 2022, the entire contents of which are incorporated herein by reference.

[0002] TECHNICAL FIELD This disclosure relates generally to the field of intraocular lenses, and more particularly to adjustable intraocular lenses and methods for adjusting intraocular lenses. [Background technology]

[0003] A cataract is a condition involving the clouding of the normally transparent 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. In cataract treatment, surgeons remove the lens matrix from the patient's lens capsule and replace it with an intraocular lens (IOL). Traditional IOLs provide one or more selected focal lengths that allow patients to see in the distance. However, after cataract surgery, patients with traditional IOLs inserted often require glasses or other corrective eyewear to perform certain activities because the eye can no longer accommodate (or change its power) to retain a sharp image of an object or to focus on an object as the distance changes.

[0004] Newer IOLs, such as accommodating IOLs, allow the eye to regain at least some of its 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.

[0005] For all IOLs, including both AIOLs and non-accommodating IOLs, it may be necessary to adjust these lenses post-operatively or after insertion into the patient's eye. Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, a solution is needed that allows post-insertion adjustment of the IOL without additional surgery. Such a solution should allow effective negative as well as positive tuning of the IOL power. [Means for solving the problem]

[0007] Disclosed herein are accommodative intraocular lenses and methods for post-operatively adjusting intraocular lenses. In one embodiment, an intraocular lens is disclosed that includes an optic portion and one or more haptics coupled to the optic portion. At least one of the haptics can include a composite material. The composite material can include an energy absorbing component and a plurality of shrinkable and / or rupturable microspheres. The base power of the optic portion can be configured to change in response to external energy being directed to the composite material.

[0008] Each of the shrinkable and / or rupturable microspheres can include an internal phase contained within a thermoplastic shell and one or more vacuum voids. The internal phase can be configured to undergo a phase change from a gas phase to a liquid phase at a temperature below the boiling point of the internal phase. The vacuum voids can be formed when the internal phase condenses into a liquid phase within the thermoplastic shell.

[0009] In some embodiments, the internal phase can be water. In other embodiments, the internal phase can be ethylene glycol.

[0010] In some embodiments, the thermoplastic shell can be made in part of polyacrylonitrile. In other embodiments, the thermoplastic shell can be made in part of polystyrene. The thermoplastic shell can be made in part of poly(methyl methacrylate).

[0011] The thermoplastic shell can be configured to soften above the glass transition temperature of the thermoplastic shell. The thermoplastic shell can be configured to soften and disintegrate or decompose / rupture in response to external energy being directed at the composite. In the case of shrinkable microspheres, the thermoplastic shell can rebond around the internal phase.

[0012] In some embodiments, at least one of the shrinkable microspheres can be configured to reduce in diameter by about half in response to external energy being directed at the composite material. The shrinkable microspheres can be about 5% to about 25% by weight of the composite material.

[0013] The energy absorbing component can be an energy absorbing pigment. For example, the energy absorbing pigment can be a dye. As a more specific example, the dye can be an azo dye. The energy absorbing pigment can also be a pigment. For example, the pigment can be graphitized carbon black. The energy absorbing component can be configured to transfer thermal energy to the plurality of shrinkable and / or rupturable microspheres in response to external energy being directed at the composite material.

[0014] At least one of the optical portion and the one or more haptics can be made in part of a cross-linked copolymer, including a copolymer blend. The composite material can be made in part of a copolymer blend. In some embodiments, the copolymer blend can include an alkyl acrylate, a fluoroalkyl acrylate, and a phenyl-alkyl acrylate. The composite material can further include at least one of a reactive acrylic monomer diluent, a photoinitiator, and a thermal initiator.

[0015] In some embodiments, the external energy can be optical energy, for example, the optical energy can be laser light.

[0016] The change in base power can be a continuous change: The base power of the optical portion can be configured to decrease in response to external energy being directed at the composite material.

[0017] The optical portion can include a fluid-filled optical portion chamber, and at least one of the haptics can include a fluid-filled haptic fluid lumen in fluid communication with the optical portion fluid chamber. The base power of the intraocular lens can be configured to decrease in response to fluid movement between the optical portion fluid chamber and the haptic fluid lumen as a result of external energy being directed at the composite material. The base power can be configured to change in response to a change in the volume of the haptic fluid lumen as a result of external energy being directed at the composite material.

[0018] The composite material can be positioned in part within a channel formed along at least one radially inner wall of the haptic. The channel can be part of and in fluid communication with a haptic fluid lumen. A volume of the haptic fluid lumen can be configured to increase in response to external energy being directed at the composite material.

[0019] The composite material can be configured as a mass that extends into the channel. The volume of the mass can be configured to increase in response to external energy being directed at the composite material. The volume of the haptic fluid lumen can be configured to increase in response to a decrease in the volume of the mass.

[0020] A method of adjusting an intraocular lens is also disclosed. The method can include adjusting a base power of the intraocular lens by directing external energy to a composite material in at least one haptic of the intraocular lens. The composite material can include an energy absorbing component and a plurality of shrinkable and / or burstable microspheres. The base power of the intraocular lens can be adjusted when the intraocular lens is inserted into a patient's eye.

[0021] Adjusting the base power of the intraocular lens can include directing external energy to the composite material to excite the energy absorbing component such that thermal energy is transferred to the plurality of shrinkable and / or rupturable microspheres.

[0022] The shrinkable microspheres and the burstable microspheres can each include an internal phase contained within a thermoplastic shell and one or more vacuum voids. By directing external energy at the composite material, the shrinkable microspheres can be caused to shrink or the burstable microspheres can be caused to burst.

[0023] The thermoplastic shell can be configured to soften at a temperature above a glass transition temperature of the thermoplastic shell. A diameter of at least one of the shrinkable microspheres can be configured to decrease by approximately half in response to external energy being directed at the composite material.

[0024] In some embodiments, the intraocular lens can include an optical portion including a fluid-filled optical portion chamber. At least one haptic can include a fluid-filled haptic fluid lumen in fluid communication with the optical portion fluid chamber. Directing external energy to the composite material can cause fluid movement between the optical portion fluid chamber and the haptic fluid lumen. The base power of the intraocular lens can be configured to be reduced in response to fluid movement between the optical portion fluid chamber and the haptic fluid lumen.

[0025] The composite material can be partially disposed within a channel formed along a radially inner wall of at least one of the haptics. The channel can be in fluid communication with a haptic fluid lumen. A volume of the haptic fluid lumen can be configured to increase in response to external energy being directed at the composite material.

[0026] The composite material can be configured as a mass that extends into the channel. A volume of the mass can be configured to decrease in response to external energy being directed at the composite material. A volume of the haptic fluid lumen can be configured to increase in response to the decrease in volume of the mass. In some embodiments, the external energy can be light energy.

[0027] Further disclosed is an intraocular lens including an optic portion and at least one haptic coupled to the optic portion. The at least one haptic can include a first composite material. The first composite material can include an energy absorbing component and a plurality of contractible and / or rupturable microspheres. In some embodiments, a portion of the at least one haptic can be fabricated from a second composite material including an energy absorbing component and a plurality of expandable microspheres. A base power of the optic portion can be configured to decrease in response to external energy being directed to the first composite material, and a base power of the optic portion can be configured to increase in response to external energy being directed to the second composite material.

[0028] Each of the shrinkable microspheres and the rupturable microspheres of the first composite material can include an internal phase contained within a first thermoplastic shell and one or more vacuum voids. The internal phase can be configured to undergo a phase change from a gas phase to a liquid phase at a temperature below the boiling point of the internal phase. The vacuum voids can be formed when the internal phase condenses from a gas phase to a liquid phase within the first thermoplastic shell.

[0029] Each of the expandable microspheres of the second composite material can include a blowing agent contained within a second thermoplastic shell.

[0030] The optical portion can include a fluid-filled optical portion fluid chamber. At least one of the haptics can include a fluid-filled haptic fluid lumen in fluid communication with the optical portion fluid chamber. External energy can be directed at the first composite material to move fluid from the optical portion fluid chamber to the haptic fluid lumen. The base power can be configured to be reduced in response to fluid movement between the optical portion fluid chamber and the haptic fluid lumen.

[0031] In some embodiments, the first composite material can be positioned in part within a channel formed along a radially inner wall of the at least one haptic. The channel can be in fluid communication with a haptic fluid lumen. A volume of the haptic fluid lumen can be configured to increase in response to external energy being directed at the first composite material.

[0032] The first composite material can be configured as a mass extending into the channel. A volume of the mass can be configured to increase in response to external energy being directed at the first composite material. A volume of the haptic fluid lumen can be configured to increase in response to a decrease in the volume of the mass.

[0033] At least a portion of a radially inner wall of the at least one haptic can be fabricated from a second composite material, and a portion of the second composite material can be in fluid communication with the channel.

[0034] A portion of the second composite material can be configured to expand in response to external energy being directed at the second composite material, hi some embodiments, the external energy can be light energy.

[0035] Also disclosed is a size-adjustable ophthalmic material comprising an energy absorbing component and a plurality of at least one of shrinkable and burstable microspheres, the size of which can be configured to change in response to external energy being directed at the optical material.

[0036] Each of the shrinkable microspheres and the rupturable microspheres can include an internal phase contained within a thermoplastic shell and one or more vacuum voids. The internal phase can be configured to undergo a phase change from a gas phase to a liquid phase at a temperature below the boiling point of the internal phase. The vacuum voids can be formed when the internal phase condenses to a liquid phase within the thermoplastic shell.

[0037] In some embodiments, the internal phase can be water. In other embodiments, the internal phase can be ethylene glycol.

[0038] The thermoplastic shell can be made in part of polyacrylonitrile. The thermoplastic shell can also be made in part of polystyrene. The thermoplastic shell can also be made in part of poly(methyl methacrylate).

[0039] The thermoplastic shell can be configured to soften above a glass transition temperature of the thermoplastic shell. The thermoplastic shell can be configured to soften and rebond around the internal phase in response to external energy being directed at the ophthalmic material.

[0040] At least one of the shrinkable microspheres can be configured to reduce in diameter by about half in response to external energy being directed at the ophthalmic material. At least one of the shrinkable microspheres and the burstable microspheres can comprise between about 5% and about 25% by weight of the ophthalmic material.

[0041] The energy absorbing component may be an energy absorbing pigment. For example, the energy absorbing pigment may be a dye. More specifically, the dye may be an azo dye.

[0042] The energy absorbing colorant can be a pigment, for example the pigment can be graphitized carbon black.

[0043] In some embodiments, the external energy can be optical energy, for example, the optical energy can be laser light.

[0044] The energy absorbing component can be configured to transfer thermal energy to at least one of the plurality of contractible microspheres and burstable microspheres in response to external energy being directed at the ophthalmic material.

[0045] In some embodiments, the ophthalmic material may include only shrinkable microspheres, hi other embodiments, the ophthalmic material may include only burstable microspheres. [Brief description of the drawings]

[0046] [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 taken along section line AA and illustrating a first composite material within the IOL decreasing in size in response to external energy being applied to the first composite material. [Fig. 1D-1E] 1D and 1E show a cross-section of the IOL of FIG. 1A taken along section line AA and a portion of the second composite material that increases in size in response to external energy being applied to the second composite material. [Figure 1F] FIG. 1F shows an exploded view of the IOL of FIG. 1A. [Figure 2A-2B] FIG. 2A is a diagrammatic representation of a first composite material, and FIG. 2B is a diagrammatic representation of shrinkable and / or rupturable microspheres of the first composite material. [Figure 2C] FIG. 2C is a diagrammatic representation of a second composite material used to fabricate at least a portion of the haptics of the IOL. [Figure 2D] FIG. 2D is a diagrammatic representation of an expandable component of a second composite material that increases in size in response to external energy being applied to the second composite material. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] 1A illustrates a top view of an accommodative intraocular lens (IOL) 100 according to one embodiment. For example, the accommodative IOL can be an adjustable accommodative IOL (AIOL). 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, U.S. Patent No. 8,968,396, the contents of which are incorporated herein by reference in their entireties. In other embodiments not shown in the figures, accommodative IOL 100 can also be a non-accommodative or monofocal accommodative IOL.

[0048] IOL 100 can be inserted into a patient's eye to correct defocus aberration, corneal astigmatism, spherical aberration, or a combination thereof. IOL 100 can include an optic portion 102 and one or more haptics 104, including a first haptic 104A and a second haptic 104B, coupled to optic portion 102 and extending therefrom along the periphery. IOL 100 can be positioned within the natural capsular bag from which the natural lens has been removed.

[0049] In some embodiments, the haptics 104 can be coupled and bonded 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 bonded or otherwise coupled to the optic portion 102 in a subsequent step.

[0050] The IOL 100 can be inserted into a patient's natural lens capsule after the patient's natural lens has been removed. The optic portion 102 can be adapted to refract light entering the eye toward the retina when inserted into the natural lens capsule. If the IOL 100 is an AIOL, one or more haptics 104 can be configured to engage the capsule and can be adapted to deform in response to ciliary muscle movement associated with deformation of the capsule (e.g., muscle relaxation, muscle contraction, or a combination thereof).

[0051] 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 portion fluid chamber 108 in the optical portion 102.

[0052] The optical portion fluid chamber 108 can be in fluid communication with one or more haptic fluid lumens 106 through one or more fluid channels 110. The fluid channels 110 can be conduits or passages that fluidly connect the optical portion fluid chamber 108 to the haptic 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, a diameter of each of the pair of fluid channels 110 can be about 0.4 mm to about 0.6 mm.

[0053] The haptics 104 can be coupled to the optic portion 102 at a reinforcement portion 112. The reinforcement portion 112 can serve as a haptics-optical portion interface. A pair of fluid channels 110 can be defined or formed in a portion of the reinforcement portion 112.

[0054] 1A, the optical portion fluid chamber 108 can be in fluid communication with the first haptic fluid lumen 106A through a first fluid channel pair 110A. The optical portion fluid chamber 108 can also be in fluid communication with the second haptic fluid lumen 106B through a second fluid channel pair 110B.

[0055] In some embodiments, the first fluid channel pair 110A and the second fluid channel pair 110B can be positioned substantially opposite one another 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 extend or be defined 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).

[0056] 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. 1F) can be defined at 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 portion fluid chamber 108 when the haptic 104 is coupled to the optical portion 102. Similarly, fluid in the optical portion fluid chamber 108 can flow out of the optical portion fluid chamber 108 through the fluid channel 110 and through the haptic fluid port 152 into the haptic fluid lumen 106.

[0057] 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 haptics 104) can be configured to face and contact the inner surface of the patient's capsular bag when the IOL 100 is inserted therein. The radially inner haptic lumen wall 120 (also referred to as the radially inner sidewall of the haptics 104) can be configured to face the outer circumferential surface 122 of the optic portion 102.

[0058] As previously mentioned, the IOL 100 can be inserted or introduced into the patient's capsule after the patient's natural lens has been removed from the capsule. The patient's capsule is connected to the zonules, which are connected to the patient's ciliary muscles. The capsule is elastic and can be deformed by ciliary muscle movement via the zonules. For example, when the ciliary muscles relax, the zonules stretch. This stretching pulls the capsule generally radially outward with a radially outward force. This tension on the capsule lengthens the capsule and creates space within the capsule. When the patient's natural lens is within the capsule, the natural lens is typically flattened (in the anterior-posterior direction), which reduces the refractive power of the lens and allows distance vision. In this state, the patient's natural lens is said to be in a disaccommodative state, or to not accommodate.

[0059] However, when the ciliary muscle contracts, as occurs when the eye is attempting 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 to contract and exert a radially inward force on the lens within the lens. When the patient's natural lens is within the capsular bag, 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 refractive power and enables the eye to focus on nearby objects. In this state, the patient's natural lens is said to be in an accommodative state or to accommodate.

[0060] In embodiments in which IOL 100 is an AIOL, the radially outer lumen wall 118 of the inserted AIOL can directly engage or physically contact the portion of the capsule that is connected to the zonules or zonular fibers. Thus, the radially outer haptic lumen wall 118 of the AIOL can be configured to respond to radially applied capsule deformation forces as the zonules relax and stretch as a result of ciliary muscle movement.

[0061] For example, as the ciliary muscles contract, the peripheral region of the elastic lens capsule deforms, exerting a radially inward force on 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, which can reduce the volume of the haptic fluid lumen 106. The reduction in the volume of the haptic fluid lumen 106 can displace or push fluid within the haptic fluid lumen 106 into the optic portion fluid chamber 108. The optic portion 102 of the AIOL can change shape in response to fluid entering the optic portion 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 with an AIOL inserted in his or her eye to focus on nearby objects. In this state, the accommodative AIOL can be considered to have accommodated.

[0062] When the ciliary muscles relax, the peripheral region of the elastic capsule stretches radially outward, lengthening the capsule and creating more space within the capsule. The radially outer haptic lumen wall 118 of the haptics 104 can be configured to respond to this deformation of the capsule by returning to its undeformed or unstressed state. This causes the volume of the haptic fluid lumen 106 to increase or return to its undeformed volume. This increase in the volume of the haptic fluid lumen 106 causes the fluid in the optical portion fluid chamber 108 to be drawn or otherwise exit the optical portion fluid chamber 108 and return to the haptic fluid lumen 106. The fluid moves out of the optical portion fluid chamber 108 and into the haptic fluid lumen 106 through the same fluid channels 110 formed in the optical portion 102.

[0063] The optic portion 102 of the AIOL can change shape in response to fluid exiting the optic portion 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 having the AIOL inserted in their eye to focus on distant objects or obtain distance vision. In this state, the AIOL can be considered to be disaccommodating.

[0064] 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 allow the haptic 104 to retain high sensitivity to radial forces applied to the equatorial region of the haptic 104 by capsular deformation resulting from ciliary muscle movement. As shown in FIGS. 1B and 1E, 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 allow the haptic 104 to have stiffness or resilience 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 movement occurs between the haptic fluid lumen 106 and the optic portion fluid chamber 108 than when the force is applied in a radial direction. Because less fluid movement occurs, the change in base power of the AIOL is also less.

[0065] 1A-1F depict IOL 100 as an AIOL, the present disclosure also contemplates that IOL 100 can be an accommodative or monofocal adjustable IOL, and that the base plate of an accommodative or monofocal adjustable IOL can be adjusted by directing external energy (e.g., laser light) to the accommodative or monofocal adjustable IOL. Examples of accommodative or monofocal adjustable IOLs are discussed in U.S. Patent Application Publication No. 2021 / 0100649, the contents of which are incorporated herein by reference in their entirety.

[0066] In some embodiments, the IOL 100 can be designed such that a gap 124 or void space radially separates a radially inner haptic lumen wall 120 of the haptic 104 from an outer circumferential surface 122 of the optic portion 102, thereby allowing a portion of the haptic 104 to change shape or expand in response to external energy, such as laser light 125 (see, e.g., FIGS. 1D and 1E ), being directed at the haptic 104.

[0067] FIG. 1A also shows that at least one of the haptics 104 can include a contractible component 128 made of a first composite material 200 (see, e.g., FIG. 2A) and a lumen filler 126 made of a second composite material 201 (see, e.g., FIG. 2C). As described in more detail in a later section, the first composite material 200 can include or be made in part of an energy absorbing component, a plurality of contractible and / or rupturable microspheres, and a cross-linked copolymer used to fabricate the remaining portion of the haptic 104. The contractible component 128 made of the first composite material 200 can be configured to contract, i.e., decrease in size, in response to a laser light 125 (see, e.g., FIGS. 1B and 1C) being directed at the first composite material 200. The second composite material 201 can include or be made in part of an energy absorbing component, a plurality of expandable microspheres, and a cross-linked copolymer used to fabricate the remaining portion of the haptic 104. At least a portion of the lumen filler 126 made of the second composite material 201 can be configured to expand, i.e., increase in size, in response to laser light 125 (see, e.g., Figures 1D and 1E) being directed at the lumen filler 126.

[0068] When laser light 125 is applied to contractible component 128 made of first composite material 200, contractible component 128 can contract or decrease in size, and the contraction or shrinking of contractible component 128 can increase the volume of haptic fluid lumen 106, causing fluid in optic portion fluid chamber 108 to be drawn into haptic fluid lumen 106. This can also cause optic portion 102 to change shape (e.g., cause anterior or posterior elements of optic portion 102 to become less curved, i.e., flattened), resulting in a decrease in the base power of optic portion 102.

[0069] Alternatively, when laser light 125 is applied to lumen filler 126 made of second composite material 201, lumen filler 126 can expand, and the expansion of lumen filler 126 can reduce the volume of haptic fluid lumen 106 and move fluid within haptic fluid lumen 106 into optical portion fluid chamber 108. This can cause optic portion 102 to change shape (e.g., anterior or posterior elements of optic portion 102 can become more curved), which leads to an increase in the base power of optic portion 102.

[0070] 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 optic portion fluid chamber 108 can be defined between the anterior element 130 and the posterior element 132.

[0071] The anterior element 130 can include a front optical surface 134 and a front inner surface 136 opposite the anterior 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 portion 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 a chamber wall of the optical portion fluid chamber 108.

[0072] 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 axial direction of both the anterior element 130 and the posterior element 132.

[0073] 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.

[0074] 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.

[0075] The thickness of the posterior element 132 may be greater 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 be gradually reduced 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 be greater from a portion radially inward of the raised periphery 144 to a portion radially outward of the raised periphery 144.

[0076] In certain embodiments, the thickness of the posterior element 132 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 posterior element 132 radially outward from the optical axis 142 (but before reaching the raised periphery 144) can be from about 0.20 mm to about 0.40 mm. The thickness of the posterior element 132 near the radially outer portion of the raised periphery 144 can be from about 1.00 mm to about 1.15 mm. Additionally, the posterior inner surface 140 of the posterior element 132 can be less curved, or flattened, than the posterior optical surface 138.

[0077] 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 optic portion 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 optic portion fluid chamber 108.

[0078] 1B and 1C, each of the haptics 104 can include a contractible component 128 fabricated from a first composite material 200 (see, for example, FIG. 2A). The first composite material 200 can be configured to respond to external energy, such as a laser light 125, being applied to the first composite material 200.

[0079] In some embodiments, the contractible component 128 can be adhered or otherwise coupled to a portion of the radially inner haptic lumen wall 120 of each of the haptics 104. As shown in Figures 1B and 1C, the contractible component 128 can be adhered or otherwise coupled to a portion of a posterior portion of the radially inner haptic lumen wall 120. In other embodiments not shown in the figures, the contractible component 128 can be adhered or otherwise coupled to a portion of a anterior portion of the radially inner haptic lumen wall 120.

[0080] The contractible component 128 can be partially disposed within a channel 148 formed along the radially inner haptic lumen wall 120 of each of the haptics 104. The contractible component 128 can occupy the space within the channel 148 until exposed to external energy.

[0081] In other embodiments, at least a portion of the radially inner haptic lumen wall 120 can be made of the first composite material 200. For example, at least a portion of a posterior or anterior portion of the radially inner haptic lumen wall 120 can be made of the first composite material 200.

[0082] In response to external energy being directed at the contractible component 128, the contractible component 128 can contract, i.e., decrease in size. Because the contractible component 128 previously occupies space within the channel 148, decreasing the size of the contractible component 128 can increase the space available within the channel 148. Additionally, because the channel 148 is in fluid communication with the haptic fluid lumen 106, as the contractible component 128 decreases in size, the haptic fluid lumen 106 and volume can increase. This can draw fluid within the optic portion fluid chamber 108 into the haptic fluid lumen 106. As a result, at least one of the anterior element 130 and the posterior element 132 can decrease in curvature in response to the laser light 125 being directed at the contractible component 128 fabricated from the first composite material 200, and the base power of the optic portion 102 can decrease.

[0083] 1B and 1C, the contractible component 128 can initially be a mass that extends into the channel 148. The volume of the mass can decrease in response to external energy being directed at the contractible component 128. As the volume of the mass decreases, the volume of available space within the channel 148 and the volume of the haptic fluid lumen 106 can increase, thereby drawing fluid from the optical portion fluid chamber 108 into the haptic fluid lumen 106.

[0084] The base power of the optic portion 102 can be configured to decrease when fluid exits the fluid-filled optic portion fluid chamber 108 or is withdrawn into the haptic fluid lumen 106, as shown in FIG. 1C. 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 optic portion 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 optic portion 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 optic portion fluid chamber 108.

[0085] 1C illustrates fluid exiting the optic portion fluid chamber 108 and entering the haptic fluid lumen 106 using curved dashed arrows, it should be noted that fluid exits the optic portion fluid chamber 108 via the fluid channels 110 and apertures 146 defined along the posterior element 132. The apertures 146 can be holes or ports defined along the posterior element 132 that serve as termini of the fluid channels 110. When the IOL 100 includes a pair of fluid channels 110, the aperture pairs 146 that serve as ends of the fluid channels 110 can be spaced apart from each other by about 0.1 mm to about 1.0 mm.

[0086] One technical challenge faced by the applicant is that when the IOL 100 is inserted into the patient's capsular bag, the rapid healing response by the tissues in the capsular bag may squeeze or shrink a portion of the IOL 100, resulting in a higher power than originally expected. Another technical challenge faced by the applicant is that preoperative biometry measurements taken on the patient's eye may be inaccurate, resulting in an incorrect lens power being prescribed and inserted into the patient. Yet another technical challenge faced by the applicant is that the cornea or muscles in the patient's eye may change due to injury, disease, or aging. In such cases, it may be necessary to adjust the IOL inserted into the patient to account for such changes. One technical solution that the applicant has discovered and developed is to design an IOL 100 that can be adjusted postoperatively (i.e., after insertion) to reduce or reduce the power of the IOL 100 to account for such changes or errors. Such a solution should also be such that the design of such lenses is not overly complicated, yet the lenses can be manufactured in a cost-effective manner.

[0087] In some embodiments, the fluid in the optical portion fluid chamber 108 and the haptic fluid lumen 106 can be an oil. More specifically, in certain embodiments, the fluid in the optical portion fluid chamber 108 and the haptic fluid lumen 106 can be a silicone oil or a 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 units of dimethylsiloxane to one unit of diphenylsiloxane. 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 that includes a branched polymer.

[0088] The fluid (e.g., silicone oil) can have a refractive index that matches the lens body material used to fabricate the optical portion 102. When the fluid has a refractive index that matches the lens body material, the entire optical portion 102 including the fluid functions as a lens. For example, the fluid can be selected to have a refractive index 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 by reference in its entirety.

[0089] 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.

[0090] 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 cross-linked copolymer, including a copolymer blend. The copolymer blend can include an alkyl acrylate or methacrylate, a fluoroalkyl (meth)acrylate, and a phenyl-alkyl acrylate. It is contemplated by this disclosure and should be understood by those skilled in the art that these types of acrylic cross-linked copolymers can generally be copolymers of multiple acrylates, methacrylates, or combinations thereof, and the term "acrylate," as used herein, can be understood to mean interchangeable acrylates, methacrylates, or combinations thereof, unless otherwise specified. The cross-linked copolymers used to make the lens body material can include alkyl acrylates in an amount of about 3% to 20% (wt%), fluoroalkyl acrylates in an amount of about 10% to 35% (wt%), and phenyl-alkyl acrylates 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%).

[0091] The final composition of the crosslinked copolymer used to make the lens body material may 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 may 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 may also include an initiator or initiator agent (e.g., Perkadox 16) and a UV absorber.

[0092] 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 the haptic material 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 haptic 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 haptic material can also include a crosslinker, i.e., a crosslinking agent, such as EGDMA, in an amount of about 1.0%. The final composition of the crosslinked copolymer used to make the haptic material can also include a number of photoinitiators, i.e., photopolymerization initiators (e.g., camphorquinone, 1-phenyl-1,2-propanedione, and 2-ethylhexyl-4-(dimethylamino)benzoic acid).

[0093] In some embodiments, the refractive index of the lens body material can be from about 1.48 to about 1.53. 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).

[0094] The anterior element 130 may be attached or otherwise adhered to the posterior element 132 via an adhesive 150 or adhesive layer. The adhesive layer may be substantially annular in shape. The adhesive 150 or adhesive layer may be positioned on the peripheral edge of the optic portion 102, between the anterior element 130 and the posterior element 132. For example, the adhesive 150 may be positioned on the raised periphery 144 of the posterior element 132.

[0095] The adhesive 150 or adhesive layer may include or be made in part from a biocompatible adhesive. The adhesive 150 or adhesive layer may include or be made in part from a biocompatible polymer adhesive.

[0096] 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.

[0097] 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).

[0098] 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 .

[0099] 1D and 1E illustrate that one or more portions of the IOL 100 can be made of a second composite material 201 (see, e.g., FIG. 2), which is configured to respond to the application of external energy, such as a laser light 125, to the second composite material 201. The second composite material 201 can be positioned or incorporated into each of the haptics 104 in such a way that the second composite material 201 functions as the lumen filler 126. For example, the laser light 125 can be directed or otherwise directed at the lumen filler 126, causing at least a portion of the lumen filler 126 to expand and increase in size. This expansion can be manifested as a portion of the lumen filler 126 expanding or enlarging into the channel 148 (see, e.g., FIG. 1E). More specifically, this expansion can be manifested as a front portion of the lumen filler 126 enlarging or bulging into the channel 148.

[0100] Because channel 148 is in fluid communication with or otherwise exposed to haptic fluid lumen 106, the volume of haptic fluid lumen 106 can be reduced by the expansion or expansion of lumen filler 126 into channel 148. This can cause fluid in haptic fluid lumen 106 to be pushed or otherwise displaced into optic portion fluid chamber 108. As a result, in response to laser light 125 being directed into lumen filler 126, at least one of anterior element 130 and posterior element 132 can increase its curvature, and the base power of optic portion 102 can increase.

[0101] The base power of the optic portion 102 can be configured to increase when fluid enters the fluid-filled optic portion fluid chamber 108 from the haptic fluid lumen 106, as shown by the curved dashed arrow in FIG. 1E. For example, the anterior element 130 of the optic portion 102 can be configured to increase its curvature in response to fluid entering the optic portion 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 optic portion 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 optic portion fluid chamber 108.

[0102] In some embodiments, the lumen filler 126 can be positioned posterior to the channel 148. In these embodiments, the lumen filler 126 can replace or function as part of the posterior portion of the radially inner haptic lumen wall 120. The lumen filler 126 can also be positioned radially inward of the portion of the haptic fluid lumen 106 that is not the channel 148.

[0103] 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.

[0104] 1D and 1E, in some embodiments, the radially outer side of lumen filler 126 is not in fluid communication with haptic fluid lumen 106. In these embodiments, the radially outer side of lumen filler 126 is separated from haptic fluid lumen 106 by portions of haptics 104 that are not fabricated from composite material 200.

[0105] It should be noted that while Figures 1D and 1E show fluid entering the optical portion fluid chamber 108 from the haptic fluid lumen 106 with curved dashed arrows, the fluid enters the optical portion fluid chamber 108 through the fluid channel 110 and an opening 146 defined along the rear element 132.

[0106] 1A-1E also illustrate that IOL 100 can include one or more contractible components 128, luminal filler 126, or a combination thereof. For example, each of haptics 104 of IOL 100 can include both a contractible component 128 and luminal filler 126.

[0107] 1A-1E further illustrate that in some embodiments, the contractible component 128 can be positioned radially outward of the lumen filler 126. In these embodiments, the lumen filler 126 can be positioned radially inward of the contractible component 128 or radially closer to the optic portion 102.

[0108] Although not shown in the figures, in other embodiments contemplated by the present disclosure, the lumen filler 126 can be positioned radially outward of the contractible component 128, and the contractible component 128 can be positioned radially closer to the optical portion 102.

[0109] The contractible component 128 can be directly coupled to a portion of the haptic 104 that is not made of the second composite material 201. More specifically, the area of ​​the haptic 104 directly in front of or behind the contractible component 128 is not made of the second composite material 201.

[0110] 1B-1E, the contractible component 128 can be directly coupled to and positioned at a radially inner anterior or posterior portion of the haptic lumen wall 120 that is not fabricated from the second composite material 201. In this example, the contractible component 128 can protrude or otherwise extend into the channel 148.

[0111] Although not shown in the figures, in other embodiments contemplated by this disclosure, the contractible component 128 can be directly coupled to a radially outwardly facing surface of the posterior portion of the radially inner haptic lumen wall 120. In these embodiments, the contractible component 128 can protrude or otherwise extend directly into the haptic fluid lumen 106.

[0112] Although not shown in the figures, in another embodiment contemplated by the present disclosure, at least a portion of the radially inner haptic lumen wall 120 positioned radially outward of the lumen filler 126 can be made of the first composite material 200, thereby functioning as the contractible component 128.

[0113] In all such embodiments, the contractible component 128 is configured to contract, i.e., decrease in size, in response to external energy (e.g., laser light 125) being directed at the contractible component 128. This decrease in size of the contractible component 128 can free up space in the haptic fluid lumen 106, thereby drawing fluid in the fluid-filled optical portion fluid chamber 108 into the haptic fluid lumen 106, which in turn can reduce the optical power of the optic portion 102.

[0114] FIG. 1F also shows that each of the haptics 104 (e.g., 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 at the proximal attachment end 114 of the haptic 104. The haptic fluid port 152 can serve as a chamber mouth of 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 portion 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 portion fluid chamber 108 can flow out of the optical portion fluid chamber 108 through the pair of fluid channels 110 and through the haptic fluid port 152 to the haptic fluid lumen 106. The pair of outer opening 156 and inner opening 146 may serve as the terminus of the fluid channel 110 .

[0115] 1A and 1F, each of the haptics 104 can be coupled to the optical portion 102 at a reinforcement portion 112. For example, a first haptic 104A can be coupled or attached to the optical portion 102 at a first reinforcement portion 112A, and a second haptic 104B can be coupled or attached to the optical portion 102 at a second reinforcement portion 112B.

[0116] More specifically, the proximal attachment 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 attachment 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.

[0117] The proximal mounting end 114 has a substantially flat surface and can be adhered 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 port 152 can surround the outer opening 156 of the fluid channel 110. The haptics 104 can be coupled or bonded to the optic portion 102 by a biocompatible adhesive 150. In some embodiments, the adhesive 150 can be the same adhesive used to couple or bond the anterior element 130 to the posterior element 132.

[0118] 2A is a diagrammatic representation of one embodiment of a first composite material 200 including a composite substrate 202, an energy absorbing component 204, and a plurality of contractible and / or rupturable microspheres 206. As previously described, the contractible component 128 can be fabricated from the first composite material 200. In some embodiments, the contractible component 128 can be bonded or otherwise coupled to a portion of the haptic 104, such as the radially inner lumen wall 120. In other embodiments, at least a portion of the haptic 104 (e.g., a portion of the radially inner haptic lumen wall 120) can be fabricated from the first composite material 200.

[0119] The composite substrate 202 may be constructed of a hydrophobic acrylic material. For example, the composite substrate 202 may be constructed of phenyl ethylene acrylate (PEA), phenyl ethyl methacrylate (PEMA), or a combination thereof.

[0120] In one exemplary embodiment, the composite substrate 202 can include a methacrylate- or methacryl-functional crosslinked polymer and a reactive acrylic monomer diluent including lauryl methacrylate (n-dodecyl methacrylate or SR313) and 1-adamantyl methacrylate (ADMS). 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 first composite material 200 can be controlled. The methacrylate- or methacryl-functional crosslinked polymer can be fabricated using a crosslinked polymer precursor formulation.

[0121] In other embodiments, the monomer diluent may be or include phenylethyl acrylate (PEA), and in these embodiments, PEA may be used as an alternative monomer diluent to SR313.

[0122] The cross-linked polymer precursor formulation can include the same copolymer blends used to fabricate the optic portion 102 and haptics 104 .

[0123] The copolymer blend can include an alkyl acrylate or ethacrylate (e.g., n-butyl acrylate), a fluoroalkyl (meth)acrylate (e.g., trifluoroethyl 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., Darocure 4265 or a 50 / 50 blend of diphenyl(2,4,6-trimethylbenzoyl)-phosphine oxide and 2-hydroxy 2-methylpropiophenone).

[0124] The composite substrate 202 can include a methacrylate or methacrylic functional crosslinked polymer (as described above) in an amount of about 50% to about 65% (e.g., 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 %).

[0125] Table 1 below provides an exemplary formulation for the first composite material 200.

[0126] [Table 1]

[0127] In some embodiments, the first composite material 200 can be fabricated in several operations. A first operation can include preparing an unpigmented composite matrix 202. A second operation can include mixing the composite matrix 202 with an energy absorbing component 204, shrinkable and / or burstable microspheres 206, and an initiator, such as one or more photoinitiators, thermal initiators, or combinations thereof. A third apparatus can include placing the uncured first composite material 200 at a desired location within the haptic 104 (e.g., near the channel 148) and curing the first composite material 200 in place.

[0128] The unpigmented composite substrate 202 may be mixed with an energy absorbing component 204, such as a dye (e.g., Disperse Red 1 dye) or a pigment (graphitized carbon black), which is described in more detail below.

[0129] In some embodiments, the shrinkable and / or rupturable microspheres 206 can comprise between about 5.0% and about 25.0% by weight of the final formulation of the first composite material 200 (see Table 1).

[0130] 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% by weight of the final formulation of the first composite material 200 (see, e.g., Table 1). In addition, the first composite material 200 can also include a thermal initiator. The thermal initiator can comprise approximately 1.00% by weight of the final formulation of the composite material 200 (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.

[0131] In other embodiments, the energy absorbing component 204 can absorb external energy (e.g., laser energy) and convert this energy into heat. The heat energy can be transferred (e.g., through the composite matrix 202) to the shrinkable and / or burstable microspheres 206 to cause the shrinkable microspheres to shrink or the burstable microspheres to burst.

[0132] Although Figures 2A and 2B depict the contractible or rupturable microspheres 206 as spheres or microspheres, in the present disclosure, the contractible or rupturable microspheres 206 can be shaped as substantially oval, ellipsoidal, cubic, or other polyhedral shapes, or combinations thereof.

[0133] The contractible and / or rupturable microspheres 206 may be dispersed or otherwise distributed within the composite matrix 202 along with the energy absorbing component 204. The composite matrix 202 may comprise the majority of the first composite material 200. The composite matrix 202 may act as a matrix to hold or support the contractible and / or rupturable microspheres 206 and the energy absorbing component 204.

[0134] In some embodiments, the energy absorbing component 204 can be an energy absorbing pigment. 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.

[0135] In additional embodiments, the energy absorbing pigment can be or include a pigment, for example, the energy absorbing pigment can be or include graphitized carbon black as a pigment.

[0136] 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 first composite material 200 can be 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 first composite material 200, including the energy absorbing component 204, can be colored red. Further, if the energy absorbing component 204 is graphitized carbon, which has a black color, at least a portion of the first composite material 200, including the energy absorbing component 204, can be colored black.

[0137] 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, more specifically, laser light) that is applied or directed to the first 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 the energy to the contractible and / or rupturable microspheres 206.

[0138] The color of the energy absorbing dye may be visually discernible to a physician or other medical practitioner when the IOL 100 is fabricated with the first composite material 200 that includes the energy absorbing dye. The color of the energy absorbing dye may be visually discernible to a physician or other medical practitioner when the IOL 100 is inserted into a patient's eye. For example, the first composite material 200 may include Disperse Red 1, which serves as an energy absorbing dye. In this example, at least a portion of the IOL 100 may appear red to a physician or other medical practitioner when the IOL 100 is inserted into a patient's eye. The color of the energy absorbing dye may enable a physician or other medical practitioner to detect or identify the location or position of the first composite material 200 within the IOL 100. The color of the energy absorbing dye may also enable a physician or other medical practitioner to identify where to direct the laser light 125 or stimulus to prepare the IOL 100.

[0139] 2B shows that the shrinkable and / or rupturable microspheres 206 can include an internal phase 208 contained within a thermoplastic shell 212 and one or more vacuum voids 210. The shrinkable microspheres 206 can be configured to shrink, or reduce in size, such that the diameter 214 of at least one of the microspheres is reduced by approximately half of its original diameter.

[0140] For example, the contractible microspheres 206 can be initially fabricated with a diameter 214 of about 50 μm to 100 μm. In response to external energy being applied or directed to the first composite material 200, or in response to energy being transferred or transmitted to the contractible microspheres 206, the diameter 214 of the contractible microspheres 206 can decrease to about 25 μm to 50 μm.

[0141] The volume of the contractible microspheres 206 can be configured to decrease by approximately a factor of 10 in response to external energy being applied or directed to the first composite material 200 .

[0142] The internal phase 208 can be a fluid capable of undergoing one or more phase changes. In some embodiments, the internal phase 208 can be configured to undergo a phase change from a gas phase to a liquid phase at a temperature below the boiling point of the internal phase 208. When the internal phase 208 is encapsulated in a thermoplastic shell 212, it can form one or more vacuum voids 210 as the internal phase 208 condenses to a liquid phase within the thermoplastic shell 212.

[0143] In one embodiment, the internal phase 208 can be or include water, in which embodiment, the vacuum voids 210 can form when water vapor within the thermoplastic shell 212 condenses into liquid water.

[0144] In other embodiments, the internal phase 208 can be or include ethylene glycol (which has a higher boiling point than water). In another embodiment, the internal phase 208 can be or include a silicone-based fluid, such as certain cyclic siloxanes (e.g., hexamethylcyclotrisiloxane). In additional embodiments, the internal phase 208 can be or include a polydiethylsiloxane (PDMS) oligomer or certain types of hydrofluoroethers.

[0145] As previously discussed, the thermoplastic shell 212 can soften and begin to flow (see, e.g., FIG. 2A) when thermal energy is transferred or transmitted from the energy absorbing component 204 to the shrinkable microspheres 206. If the external energy is laser light 125, the energy absorbing component 204 can absorb or capture the laser light 125 directed at the first composite material 200 and convert the light energy into thermal energy or heat.

[0146] As shown in FIG. 2B, the thermoplastic shell 212 of the shrinkable microsphere 206 is heated to a temperature above the glass transition temperature (Tg shell) the thermoplastic shell 212 may also begin to thin above the glass transition temperature of the thermoplastic shell 212.

[0147] In some embodiments, the glass transition temperature of the thermoplastic shell 212 can be lower than the boiling point of the internal phase 208. In other embodiments, the glass transition temperature of the thermoplastic shell 212 can be substantially equal to or close to the boiling point of the internal phase 208.

[0148] As the thermoplastic shell 212 softens or thins, it may collapse and decrease in size due to the vacuum within the thermoplastic shell 212 as well as the external pressure surrounding the thermoplastic shell 212 .

[0149] In some embodiments, at least some of these microspheres 206 can also be configured to burst when the thermoplastic shell 212 degrades or ruptures in response to external energy being directed at the first composite material 200. In these embodiments, the internal phase 208 of the burstable microspheres 206 can be dissolved in the surrounding haptic material or silicone oil.

[0150] In some embodiments, the thermoplastic shell 212 can be, or can be made in part, of polyacrylonitrile. In some embodiments, the thermoplastic shell 212 can be, or can be made in part, of polystyrene. In another embodiment, the thermoplastic shell 212 can be, or can be made in part, of poly(methyl methacrylate). The thermoplastic shell 212 can also include a photoinitiator (e.g., a UV initiator). For example, the photoinitiator can be Omnirad 2022 (Bis(2,4,6-trimethylbenzoyl)phenyl-phosphine oxide / 2-hydroxy-2-methyl-1-phenyl-propan-1-one). The thermoplastic shell 212 can be formed when a monomer of the shell material is curved via UV curing with a photoinitiator.

[0151] As further shown in Figure 2B, in the case of the shrinkable microspheres 206, the thermoplastic shell 212 can recombine in its hardened state or become glassy again when the temperature is below the glass transition temperature of the thermoplastic shell 212 (i.e., when external energy is no longer directed at the first composite material 200). Additionally, as shown in Figure 2B, the diameter 214 of the shrinkable microspheres 206 can decrease as the thermoplastic shell 212 recombines around the liquid interior phase 208, eliminating the space previously occupied by one or more vacuum voids 210.

[0152] The change (e.g., reduction in volume) caused by the contractible microspheres 206 can be a persistent or substantially permanent change. A persistent or substantially permanent change can mean that the contractible microspheres 206 do not substantially return to their original shape or size after the change (e.g., reduction in volume) occurs. As a result, the change in size or volume of the first composite material 200 caused by the change in size or volume of the contractible microspheres 206 is also persistent or substantially permanent.

[0153] One technical challenge faced by applicant is how to design a shrinkable material that can be used in an IOL 100 that is safe for a patient when the IOL 100 is inserted in a patient's eye and that responds to external energy being directed at the shrinkable material. One technical solution that applicant has discovered and developed is a first composite material 200 disclosed herein that includes shrinkable and / or rupturable microspheres 206 having a phase-changeable internal phase 208 and vacuum voids 210 encapsulated in a thermoplastic shell 212. As will be described in more detail in a later section, when the shrinkable and / or rupturable microspheres 206 are initially formed, the internal phase 208 is in a gas phase, and the vacuum voids 210 are formed when the internal phase 208 condenses into a liquid phase within the thermoplastic shell 212.

[0154] 2C is a diagrammatic representation of one embodiment of a second composite material 201 including a composite substrate 202, an energy absorbing component 204, and a plurality of expandable components 207. As previously described, one or more portions of each of the haptics 104, such as the lumen filler 126, can be fabricated from the second composite material 201.

[0155] The composite substrate 202 can be made of a hydrophobic acrylic material. For example, the composite substrate 202 can be made of phenylethyl acrylate (PEA), phenylethyl methacrylate (PEMA), or a combination thereof.

[0156] In one exemplary embodiment, the composite substrate 202 can include a methacrylate or methacryl functional crosslinked polymer and a reactive acrylic monomer diluent including lauryl methacrylate (n-dodecyl methacrylate or SR313) and ADMS. 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. Methacrylate or methacryl functional crosslinked polymers can be fabricated using crosslinked polymer precursor formulations.

[0157] The cross-linked polymer precursor formulation can include the same copolymer blends used to fabricate the optic portion 102 and haptics 104 .

[0158] 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).

[0159] 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 %).

[0160] Table 2 below provides an exemplary formulation of the second composite material 201.

[0161] [Table 2]

[0162] In some embodiments, the second composite material 201 can be fabricated in several operations. A first operation can include preparing an unpigmented composite matrix 202. A second operation can include mixing the composite matrix 202 with an energy absorbing component 204, an expandable component 207, and an initiator, such as one or more photoinitiators, thermal initiators, or combinations thereof. A third operation can include placing the uncured second composite material 201 at a desired location in the haptic 104 (e.g., near the channel 148) and curing the second composite material 201 in place.

[0163] As previously mentioned, the second composite material 201 can be positioned radially offset from the first composite material 200 of the haptic 104 .

[0164] The 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.

[0165] In some embodiments, the expandable component 207 can comprise from about 5.0 wt% to about 15.0 wt% of the final formulation of the second composite material 201. More specifically, the expandable component 207 can comprise from about 8.0 wt% to about 12.0 wt% (e.g., about 10.0 wt%) of the final formulation (see Table 2) of the second composite material 201. In these and other embodiments, the energy absorbing component 204 can comprise from about 0.044 wt% to about 0.44 wt% (or about 0.55 wt%) of the final formulation of the composite material 200.

[0166] 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% by weight of the final composite 200 formulation (see, e.g., Table 2). In addition, the composite 200 can also include a thermal initiator. The thermal initiator can comprise approximately 1.00% by weight of the final composite 200 formulation (see, e.g., Table 2). In some embodiments, the thermal initiator can be a dialkyl peroxide, such as Luperox® peroxide. In other embodiments, the thermal initiator can be Perkadox.

[0167] In some embodiments, the energy absorbing component 204 can absorb external energy (e.g., laser energy) and convert this energy into heat. The thermal energy can be conducted to the expandable component 207 (through the composite matrix 202) causing the expandable component 207 to expand.

[0168] FIG. 2D illustrates that the expandable component 207 can be an expandable microsphere including an expandable thermoplastic shell 209 and a blowing agent 211 contained within the expandable thermoplastic shell 209. The expandable microsphere can be configured to expand such that the diameter 213 of at least one of the microspheres can increase by about 2× its original diameter. In another embodiment, the expandable microsphere can be configured to expand such that the diameter 213 of at least one of the microspheres can increase by about 4×, i.e., four times, its original diameter. In another embodiment, the expandable microsphere can be configured to expand such that the diameter 213 of at least one of the microspheres can increase by 2× to about 4× (or about 3.5×) its original diameter. For example, the expandable microsphere can initially have a diameter 213 of about 12 μm. In response to external energy being applied or directed to the second composite material 201, the diameter 213 of the expandable microsphere can increase to about 40 μm.

[0169] The volume of at least one of the expandable microspheres can be configured to expand by about ten times (10×) to about fifty times (50×) in response to external energy being applied or directed to the second composite material 201.

[0170] In some embodiments, the blowing agent 211 can be an expandable fluid, such as an expandable gas. More specifically, the blowing agent 211 can be a branched chain hydrocarbon. For example, the blowing agent 211 can be isopentane. In other embodiments, the blowing agent 211 can be or include cyclopentane, pentane, or a mixture of cyclopentane, pentane, and isopentane.

[0171] The expandable components 207 can include different amounts of blowing agent 211. For example, one expandable component 207 can include more, i.e., a larger amount, of blowing agent 211 (e.g., more expandable gas) to enable such expandable component 207 to expand more, which in turn results in a second composite material 201 that includes such expandable component 207 to expand more.

[0172] 2D illustrates that each of the expandable components 207 can include a thermoplastic shell 209. FIG 2D also illustrates that the thickness of the thermoplastic shell 209 can vary as the expandable components 207 grow. More specifically, the thickness of the thermoplastic shell 209 can decrease as the expandable components 207 grow. For example, if the expandable components 207 are expandable microspheres, the thickness of the thermoplastic shell 209 (i.e., its thickness in the radial direction) can decrease as the diameter 213 of the expandable microspheres increases.

[0173] For example, as discussed above, at least one of the expandable microspheres may initially have a diameter 213 of about 12 μm. In this embodiment, the thermoplastic shell 209 of the expandable microsphere may have a shell thickness of about 2.0 μm. In response to external energy being applied or directed to the second composite material 201, the diameter 213 of the microsphere may increase to about 40 μm (expanding in volume by about 10×-50×) and the shell thickness of the microsphere may decrease to about 0.1 μm.

[0174] Although Figures 2C and 2D depict the expandable component 207 as a microsphere, the present disclosure contemplates that the expandable component 207 can be substantially shaped as an oval, ellipsoid, cube, or other polyhedron, or combinations thereof.

[0175] In some embodiments, the thermoplastic shell 209 can be made in part from a nitrile or acrylonitrile copolymer. For example, the thermoplastic shell 209 can be made in part from acrylonitrile, styrene, butadiene, methyl acrylate, or combinations thereof.

[0176] As previously discussed, the expandable component 207 can comprise between about 8.0% and about 12% by weight of the final formulation of the second composite material 201. The expandable component 207 can comprise about 10% by weight of the final formulation of the second composite material 201.

[0177] The expandable component 207 can be dispersed or otherwise distributed within a composite matrix 202 that constitutes the majority of the second composite material 201. The composite matrix 202 can act as a matrix to hold or support the expandable component 207. The second composite material 201 can expand in response to the expansion of the expandable component 207 (e.g., expandable microspheres). For example, the volume of the second composite material 201 can increase in response to the expansion of the expandable component 207.

[0178] The second composite material 201 may also include an energy absorbing component 204. In some embodiments, the energy absorbing component 204 may be an energy absorbing pigment.

[0179] 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.

[0180] 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.

[0181] Like the expandable component 207, the energy absorbing component 204 can be dispersed or otherwise distributed within the composite matrix 202 that comprises the majority of the second composite material 201. The composite matrix 202 can act as a matrix to hold or support the expandable component 207 and the energy absorbing component 204.

[0182] The energy absorbing component 204 can comprise about 0.025% to about 1.0% by weight (or, more specifically, about 0.045% to about 0.45% by weight) of the final formulation of the second composite material 201. 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 about 0.45% to about 1.0% by weight of the final formulation of the second composite material 201. If the energy absorbing component 204 is graphitized carbon black or other type of pigment, the energy absorbing component 204 can comprise about 0.025% to about 0.045% by weight of the final formulation of the second composite material 201.

[0183] 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) that is applied to or directed at the second composite material 201. The energy absorbing component 204 can absorb or capture the external energy and convert the energy to thermal energy or heat or transfer it to the expandable component 207.

[0184] The thermoplastic shell 209 can soften and begin to flow when thermal energy is transferred or transmitted to the expandable component 207. The thermoplastic shell 209 of the expandable component 207 can then begin to thin, i.e., decrease in thickness, in response to thermal energy being transferred or transmitted to the expandable component 207. As the thermoplastic shell 209 begins to soften and decrease in thickness, the foaming agent 211 within the expandable component 207 can expand. The foaming agent 211 can also expand in response to thermal energy or heat being transferred or transmitted to the expandable component 207. The expansion of the foaming agent 211 can cause the expandable component 207 (e.g., thermoplastic microspheres) to expand, i.e., increase in volume. This can ultimately cause the second composite material 201 to expand, i.e., increase in volume.

[0185] The second composite material 201 can be isotropically expanded, i.e., increased in size, such that the second composite material 201 expands in all directions. Such isotropic expansion can be utilized to cause expansion or material displacement in a particular direction by placing or positioning the second composite material 201 at a particular location within the haptics 104 of the IOL 100.

[0186] 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 second composite material 201 and convert or transfer the light energy to thermal energy or heat to the expandable component 207. The blowing agent 211 within the expandable component 207 can expand or become excited in response to the thermal energy or heat. The expandable component 207, and ultimately the second composite material 201, can expand or increase in volume in response to this light energy being directed at the second composite material 201.

[0187] The shape change (e.g., volume increase) caused to the expandable component 207 can be a persistent or substantially permanent change. A persistent or substantially permanent change can mean that the expandable component 207 does not substantially return to its original shape or size after the shape change has occurred (e.g., after the volume increase). As a result, any change in size or volume of the second composite material 201 caused by the change in size or volume of the expandable component 207 is also persistent or substantially permanent. As will be described in more detail in the following section, this means that any structural change that occurs to the IOL 100 as a result of external energy or stimuli applied or otherwise directed to the second composite material 201 embedded or incorporated within the IOL 100 can remain persistent or substantially permanent.

[0188] The thermoplastic shell 209 of the expandable component 207 can harden again when external energy is no longer directed or applied to the second composite material 201. For example, the thermoplastic shell 209 can harden again when the temperature in the vicinity of the expandable component 207 drops below a certain threshold. For example, the thermoplastic shell 209 of the expandable microspheres can harden when light energy is no longer directed to the second composite material 201. Once the thermoplastic shell 209 has hardened, the expandable component 207 is locked into its new size and expanded state.

[0189] 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 second composite material 201 can be 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, the portion of the second composite material 201 that includes at least the energy absorbing component 204 can be red. Furthermore, if the energy absorbing component 204 is graphitized carbon, which has a black color, the portion of the second composite material 201 that includes at least the energy absorbing component 204 can be 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 colors of energy absorbing pigments can also be used, such as energy absorbing yellow, orange, or blue dyes or materials.

[0190] The color of the energy absorbing dye may be visually discernible to a physician or other medical practitioner when at least a portion of the IOL 100 is made of the second composite material 201 that includes an energy absorbing component. The color of the energy absorbing dye may be visually discernible to a physician or other medical practitioner when the IOL 100 is inserted into a patient's eye. For example, the second composite material 201 may include Disperse Red 1, which serves as an energy absorbing dye. In this example, at least a portion of the IOL 100 may appear red to a physician or other medical practitioner when the IOL 100 is inserted into a patient's eye. The color of the energy absorbing dye may enable a physician or other medical practitioner to detect or identify the location or position of the second composite material 201 within the IOL 100. The color of the energy absorbing dye may also enable a physician or other medical practitioner to identify where to direct the laser light 125 or stimulation on the IOL 100.

[0191] In some embodiments, different energy absorbing pigments may be used in the same IOL 100 to facilitate distinguishing between the first composite material 200 and the second composite material 201. For example, the first composite material 200 may include a red dye (e.g., Disperse Red 1) that serves as the energy absorbing pigment, and the second composite material 201 may include a black pigment (e.g., graphitized carbon) that serves as the energy absorbing pigment. In this example, when the IOL 100 is inserted into a patient's eye, the portion of the IOL 100 that includes the first composite material 200 appears red to a physician or other medical practitioner, and the portion of the IOL 100 that includes the second composite material 201 appears black to a physician or other medical practitioner. This color difference may enable a physician or other medical practitioner to distinguish between the first composite material 200 and the second composite material 201 within the IOL 100. More specifically, this color difference can guide a physician or other medical personnel in identifying where to aim the laser light 125 when a negative power change or a positive power change is desired.

[0192] The present disclosure also covers the following sections:

[0193] Item 1: An intraocular lens comprising an optical portion and one or more haptics coupled to the optical portion, at least one of the haptics comprising a composite material comprising an energy absorbing component and a plurality of at least one of contractible microspheres and rupturable microspheres, wherein a base power of the optical portion is configured to change in response to external energy being directed to the composite material.

[0194] Item 2: The intraocular lens of item 1, wherein each of the shrinkable microspheres and the burstable microspheres comprises an internal phase contained within a thermoplastic outer shell and one or more vacuum voids.

[0195] Item 3: The intraocular lens of item 2, wherein the internal phase is configured to undergo a phase change from a gas phase to a liquid phase at a temperature below the boiling point of the internal phase, and the vacuum void is formed when the internal phase condenses to the liquid phase within the thermoplastic outer shell.

[0196] Item 4: The intraocular lens of Item 3, wherein the internal phase is water.

[0197] Item 5: The intraocular lens of item 3, wherein the internal phase is ethylene glycol.

[0198] Item 6: The intraocular lens of Item 2, wherein the thermoplastic shell is made in part of polyacrylonitrile.

[0199] Item 7: The intraocular lens of Item 2, wherein the thermoplastic shell is made in part of polystyrene.

[0200] Item 8: The intraocular lens of Item 2, wherein the thermoplastic shell is made in part of poly(methyl methacrylate).

[0201] Item 9: The intraocular lens of item 2, wherein the thermoplastic shell is configured to soften at a temperature above the glass transition temperature of the thermoplastic shell.

[0202] Item 10: The intraocular lens of item 9, wherein the thermoplastic shell is configured to soften and collapse and rebond around the internal phase in response to external energy being directed at the composite.

[0203] Item 11: The intraocular lens of item 2, wherein a diameter of at least one of the shrinkable microspheres is configured to decrease by approximately half in response to external energy being directed at the composite material.

[0204] Item 12: The intraocular lens of item 1, wherein at least one of the shrinkable microspheres and the burstable microspheres is about 5% to about 25% by weight of the composite material.

[0205] Item 13: The intraocular lens of item 1, wherein the energy absorbing component is an energy absorbing dye.

[0206] Item 14: The intraocular lens of item 13, wherein the energy absorbing pigment is a dye.

[0207] Item 15: The intraocular lens of item 14, wherein the dye is an azo dye.

[0208] Item 16: The intraocular lens of item 13, wherein the energy absorbing dye is a pigment.

[0209] Item 17: The intraocular lens of item 16, wherein the pigment is graphitized carbon black.

[0210] Item 18: The intraocular lens of item 1, wherein at least one of the optic portion and the one or more haptics is made in part from a crosslinked copolymer including a copolymer blend, and the composite material is made in part from the copolymer blend.

[0211] Item 19: The intraocular lens of item 18, wherein the copolymer blend comprises an alkyl acrylate, a fluoroalkyl acrylate, and a phenyl alkyl acrylate.

[0212] Item 20: The intraocular lens of item 19, wherein the composite material further comprises at least one of a reactive acrylic monomer diluent, a photoinitiator, and a thermal initiator.

[0213] Item 21: The intraocular lens of Item 1, wherein the external energy is light energy.

[0214] Item 22: The intraocular lens of Item 21, wherein the light energy is laser light.

[0215] Item 23: The intraocular lens of Item 1, in which the change in base power is a sustained change.

[0216] Item 24: The intraocular lens of item 1, wherein the base power of the optic portion is configured to decrease in response to external energy being directed at the composite material.

[0217] Item 25: The intraocular lens of item 24, wherein the optic portion includes a fluid-filled optic portion chamber and at least one of the haptics includes a fluid-filled haptic fluid lumen in fluid communication with the optic chamber.

[0218] Item 26: The intraocular lens of item 25, wherein the base power is configured to decrease in response to fluid movement between the optical chamber and the haptic fluid lumen as a result of external energy being directed at the composite material.

[0219] Item 27: The intraocular lens of item 26, wherein the base power is configured to change in response to a change in volume of the haptic fluid lumen as a result of external energy being directed at the composite material.

[0220] Item 28: The intraocular lens of Item 25, wherein the composite material is partially disposed within a channel formed along a radially inner wall of at least one of the haptics, the channel being part of and in fluid communication with a haptic fluid lumen, and the volume of the haptic fluid lumen is configured to increase in response to external energy being directed at the composite material.

[0221] Item 29: The intraocular lens of Item 28, wherein the composite material is configured as a mass extending into the channel, the volume of the mass is configured to decrease in response to external energy being directed at the mass, and the volume of the haptic fluid lumen is configured to increase in response to an increase in the volume of the mass.

[0222] Item 30: The intraocular lens of item 1, wherein the energy absorbing component is configured to transfer thermal energy to at least one of the plurality of contractible microspheres and burstable microspheres in response to external energy being directed at the composite material.

[0223] Item 31: A method of adjusting an intraocular lens, comprising the step of adjusting a base power of the intraocular lens by directing external energy to a composite material in at least one haptic of the intraocular lens, the composite material including an energy absorbing component and a plurality of at least one of shrinkable microspheres and burstable microspheres.

[0224] Item 32: The method of item 31, wherein the base power of the intraocular lens is adjusted when the intraocular lens is inserted into the patient's eye.

[0225] Item 33: The method of Item 31, wherein the step of adjusting the base power of the intraocular lens further includes the step of directing external energy to the composite material to excite the energy absorbing component such that thermal energy is transferred to at least one of the plurality of contractible microspheres and rupturable microspheres.

[0226] Item 34: The method of item 31, wherein each of the shrinkable microspheres and the burstable microspheres comprises an internal phase contained within a thermoplastic outer shell and one or more vacuum voids, and wherein at least some of the shrinkable microspheres shrink and at least some of the burstable microspheres burst by directing external energy to the composite material.

[0227] Item 35: The method of item 34, wherein the thermoplastic shell is configured to soften at a temperature above a glass fiber temperature of the thermoplastic shell.

[0228] Item 36: The method of item 34, wherein a diameter of at least one of the contractible microspheres is configured to decrease by approximately half in response to external energy being directed at the composite material.

[0229] Item 37: The method of Item 31, wherein the intraocular lens includes an optical portion including a fluid-filled optical portion chamber, at least one haptic includes a fluid-filled haptic fluid lumen in fluid communication with the optical portion chamber, and wherein directing external energy to the composite material causes fluid to move between the optical portion chamber and the haptic fluid lumen, and the base power is configured to be reduced in response to fluid movement between the optical portion chamber and the haptic fluid lumen.

[0230] Item 38: The method of Item 37, wherein the composite material is partially disposed within a channel formed along a radially inner wall of at least one of the haptics, the channel being part of and in fluid communication with a haptic fluid lumen, and the volume of the haptic fluid lumen being configured to increase in response to external energy being directed at the composite material.

[0231] Item 39: The method of Item 38, wherein the composite material is configured as a mass extending into the channel, the volume of the mass is configured to decrease in response to external energy being directed at the mass, and the volume of the haptic fluid lumen is configured to increase in response to the decrease in the volume of the mass.

[0232] Item 40: The method of item 31, wherein the external energy is light energy.

[0233] Item 41: An intraocular lens comprising an optical portion and at least one haptic coupled to the optical portion, the at least one haptic comprising a first composite material comprising an energy absorbing component and a plurality of at least one of contractible microspheres and rupturable microspheres, a portion of the at least one haptic being fabricated in part from a second composite material comprising an energy absorbing component and a plurality of expandable microspheres, a base power of the optical portion configured to decrease in response to external energy being directed at the first composite material, and a base power of the optical portion configured to increase in response to external energy being directed at the second composite material.

[0234] Item 42: The intraocular lens of item 41, wherein each of the shrinkable microspheres and the burstable microspheres comprises an internal phase contained within a thermoplastic outer shell and one or more vacuum voids.

[0235] Item 43: The intraocular lens of item 42, wherein the internal phase is configured to undergo a phase change from a gas phase to a liquid phase at a temperature below the boiling point of the internal phase, and the vacuum void is formed when the internal phase condenses to the liquid phase within the thermoplastic shell.

[0236] Item 44: The intraocular lens of item 41, wherein each of the expandable microspheres includes a foaming agent contained within a thermoplastic shell.

[0237] Item 45: The intraocular lens of Item 41, wherein the optical portion includes a fluid-filled optical portion chamber, at least one haptic includes a fluid-filled haptic fluid lumen in fluid communication with the optical portion chamber, and wherein external energy is directed at the first composite material to cause fluid to move from the optical portion chamber to the haptic fluid lumen, and the base power is configured to be reduced in response to fluid movement between the optical portion chamber and the haptic fluid lumen.

[0238] Item 46: The intraocular lens of Item 45, wherein the first composite material is partially disposed within a channel formed along a radially inner wall of at least one haptic, the channel being part of and in fluid communication with a haptic fluid lumen, and the volume of the haptic fluid lumen is configured to increase in response to external energy being directed at the first composite material.

[0239] Item 47: The intraocular lens of Item 46, wherein the first composite material is configured as a mass extending into the channel, the volume of the mass is configured to decrease in response to external energy being directed at the first composite material, and the volume of the haptic fluid lumen is configured to increase in response to the decrease in the volume of the mass.

[0240] Item 48: The intraocular lens of Item 45, wherein at least a portion of a radially inner wall of at least one haptic is fabricated from a second composite material, the portion of the second composite material being fluidly connected to a channel formed along the radially inner wall, the channel being fluidly connected to the haptic fluid lumen.

[0241] Item 49: The intraocular lens of item 48, wherein a portion of the second composite material is configured to expand into the channel in response to external energy being directed at the second composite material.

[0242] Item 50: The intraocular lens of Item 41, wherein the external energy is light energy.

[0243] Item 51: A size-adjustable ophthalmic material comprising an energy absorbing component and a plurality of at least one of shrinkable microspheres and rupturable microspheres, the size of the ophthalmic material being configured to change in response to external energy being directed at the ophthalmic material.

[0244] Item 52: The ophthalmic material of item 51, wherein each of the shrinkable microspheres and the rupturable microspheres comprises an internal phase contained within a thermoplastic outer shell and one or more vacuum voids.

[0245] Item 53: The ophthalmic material of item 52, wherein the internal phase is configured to undergo a gas-to-liquid phase change at a temperature below a boiling point of the internal phase, and the vacuum void is formed when the internal phase condenses to the liquid phase within the thermoplastic shell.

[0246] Item 54: The ophthalmic material of Item 53, wherein the internal phase is water.

[0247] Item 55: The ophthalmic material of Item 53, wherein the internal phase is ethylene glycol.

[0248] Item 56: The ophthalmic material of Item 52, wherein the thermoplastic shell is made in part of polyacrylonitrile.

[0249] Item 57: The ophthalmic material of Item 52, wherein the thermoplastic shell is made in part of polystyrene.

[0250] Item 58: The ophthalmic material of Item 52, wherein the thermoplastic shell is made in part of poly(methyl methacrylate).

[0251] Item 59: The ophthalmic material of item 52, wherein the thermoplastic shell is configured to soften at a temperature above the glass transition temperature of the thermoplastic shell.

[0252] Item 60: The ophthalmic material of item 59, wherein the thermoplastic shell is configured to soften, collapse, and rebond around the internal phase in response to external energy being directed at the ophthalmic material.

[0253] Item 61: The ophthalmic material of Item 52, wherein a diameter of at least one of the shrinkable microspheres is configured to decrease by approximately half in response to external energy being directed at the ophthalmic material.

[0254] Item 62: The ophthalmic material of Item 51, wherein at least one of the shrinkable microspheres and the burstable microspheres is about 5% by weight to about 25% by weight of the ophthalmic material.

[0255] Item 63: The ophthalmic material of Item 51, wherein the energy absorbing component is an energy absorbing dye.

[0256] Item 64: The ophthalmic material of Item 63, wherein the energy absorbing pigment is a dye.

[0257] Item 65: The ophthalmic material of Item 64, wherein the dye is an azo dye.

[0258] Item 66: The ophthalmic material of Item 63, wherein the energy absorbing dye is a pigment.

[0259] Item 67: The ophthalmic material of Item 66, wherein the pigment is graphitized carbon black.

[0260] Item 68: The ophthalmic material of Item 51, wherein the external energy is light energy.

[0261] Item 69: The ophthalmic material of Item 68, wherein the light energy is laser light.

[0262] Item 70: The ophthalmic material of Item 51, wherein the energy absorbing component is configured to transfer thermal energy to at least one of the plurality of contractible microspheres and rupturable microspheres in response to external energy being directed at the ophthalmic material.

[0263] Item 71: The ophthalmic material of Item 51, wherein the ophthalmic material contains only shrinkable microspheres.

[0264] Item 72: The ophthalmic material of Item 51, wherein the ophthalmic material contains only burstable microspheres.

[0265] A number of embodiments have been described. Nevertheless, those skilled in the art will appreciate that various changes and modifications may be made to the present disclosure without departing from the spirit and scope of the embodiments. The elements of the systems, devices, apparatuses, and methods shown with any embodiment are illustrative for a particular embodiment and may 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 the described method or process to achieve the desired results. Furthermore, any components or parts of any apparatus or system described in the figures or depicted in this disclosure may be removed, eliminated, or omitted to achieve the desired results. In addition, certain components or parts of the systems, devices, or apparatuses shown or described herein have been omitted for brevity and clarity.

[0266] Accordingly, other embodiments are within the scope of the following claims, and the specification and / or drawings may be regarded in an illustrative sense rather than a restrictive sense.

[0267] 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.

[0268] Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as the order of events recited. Furthermore, additional steps or actions may be provided or steps or actions may be eliminated in order to achieve desired results.

[0269] 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 values ​​within that stated range, are encompassed within the invention. Optional features of the described invention 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 numerical values ​​within that range, e.g., 1.5, 2.5, etc., and whole or partial increments therebetween.

[0270] All existing subject matter (e.g., publications, patents, patent applications) referred to 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 subject matter present herein shall take precedence. The referenced items are provided solely for their disclosure prior to the filing date of this 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.

[0271] 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 terms such as "solely," "only," or the use of "negative" limitations in connection with the recitation of 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.

[0272] Reference to the phrase "at least one," when such phrase modifies a plurality of items or components (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.

[0273] In understanding the scope of the present disclosure, the term "comprise" 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 having similar meanings, such as the terms "comprise", "have" and their derivatives. Furthermore, the terms "portion", "section", "portion", "member", "element" or "component", when used in the singular, may also have a dual meaning of a single part or multiple parts. As used herein, the directional terms "front, rear, up, down, vertical, horizontal, below, transverse, lateral and vertical" as well as other similar directional terms refer to the location of devices or equipment or the direction of devices or equipment that are translated or moved.

[0274] 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 changed. 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 terms can be used to modify both the minimum and maximum numbers or values.

[0275] 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. In intraocular lenses, The optical part, one or more haptics coupled to the optical portion; Including, At least one of the haptics includes a composite material, the composite material including an energy absorbing component and a plurality of at least one of contractible microspheres and rupturable microspheres; An intraocular lens, wherein the base power of the optic portion is configured to change in response to external energy being directed at the composite material.

2. The intraocular lens of claim 1 , wherein the contractible microspheres and the rupturable microspheres each include an internal phase contained within a thermoplastic outer shell and one or more vacuum voids.

3. 3. The intraocular lens of claim 2, wherein the internal phase is configured to undergo a phase change from a gas phase to a liquid phase at a temperature below a boiling point of the internal phase, and the vacuum void is formed when the internal phase condenses into the liquid phase within the thermoplastic shell.

4. The intraocular lens of claim 3 , wherein the internal phase is water.

5. The intraocular lens of claim 3 , wherein the internal phase is ethylene glycol.

6. The intraocular lens of claim 2 , wherein the thermoplastic shell is made in part from polyacrylonitrile.

7. The intraocular lens of claim 2 , wherein the thermoplastic shell is made in part of polystyrene.

8. The intraocular lens of claim 2 , wherein the thermoplastic shell is made in part of poly(methyl methacrylate).

9. The intraocular lens of claim 2 , wherein the thermoplastic shell is configured to soften at a temperature above a glass transition temperature of the thermoplastic shell.

10. The intraocular lens of claim 9 , wherein the thermoplastic shell is configured to soften, collapse, and rebond around the internal phase when the external energy is directed at the composite material.

11. The intraocular lens of claim 2 , wherein a diameter of at least one of the shrinkable microspheres is configured to decrease by approximately half in response to the external energy being directed at the composite material.

12. The intraocular lens of claim 1 , wherein at least one of the shrinkable microspheres and the burstable microspheres is about 5% to about 25% by weight of the composite material.

13. The intraocular lens of claim 1 , wherein the energy absorbing component is an energy absorbing dye.

14. The intraocular lens of claim 13 , wherein the energy absorbing pigment is a dye.

15. The intraocular lens of claim 13 , wherein the energy absorbing dye is a pigment.

16. The intraocular lens of claim 1 , wherein at least one of the optical portion and the one or more haptics is made in part from a crosslinked copolymer, including a copolymer blend, and the composite material is made in part from the copolymer blend.

17. The intraocular lens of claim 1 , wherein the external energy is light energy.

18. A method for adjusting an intraocular lens, comprising the steps of: adjusting a base power of the intraocular lens by directing external energy to a composite material in at least one haptic of the intraocular lens; The composite material includes an energy absorbing component and a plurality of at least one of shrinkable microspheres and burstable microspheres.

19. An intraocular lens, The optical part, at least one haptic coupled to the optical portion; Including, the at least one haptic includes a first composite material, the first composite material including an energy absorbing component and a plurality of at least one of contractible microspheres and burstable microspheres; a portion of the at least one haptic is fabricated in part from a second composite material including the energy absorbing component and a plurality of expandable microspheres; a base power of the optical portion is configured to decrease in response to external energy being directed at the first composite material; An intraocular lens configured such that the base power of the optic portion is increased in response to the external energy being directed at the second composite material.

20. A size-adjustable ophthalmic material, comprising: An energy absorbing component; a plurality of at least one of contractible microspheres and burstable microspheres; Including, A size adjustable ophthalmic material, the size of the ophthalmic material being configured to change in response to external energy being directed at the ophthalmic material.

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