Adjustable intraocular lenses and methods for post-operatively adjusting intraocular lenses
The adjustable AIOL with a fluid-filled chamber and energy-responsive design addresses post-implantation issues by allowing non-invasive adjustment of refractive power and aberrations, enhancing optical performance and reducing the need for additional surgeries.
Patent Information
- Application Number
- JP2025075239
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-10-04
- Filing Date
- 2025-04-30
- Publication Date
- 2025-08-07
AI Technical Summary
Existing intraocular lenses (IOLs) often require additional surgery to correct mispositioning or changes in the eye's refractive power due to post-implantation issues such as tissue compression or inaccurate preoperative biometry, and they fail to effectively address higher-order aberrations like cylindrical astigmatism and spherical aberration.
An adjustable accommodating intraocular lens (AIOL) with a fluid-filled optical chamber and haptic fluid chambers, allowing for post-implantation adjustments through fluid flow and external energy application, such as laser energy, to change the base power and cylindricity in response to physiological muscle movements and environmental interactions.
Enables non-invasive adjustment of IOLs to correct refractive errors and aberrations, maintaining optical quality without additional surgery, and allowing for cost-effective manufacturing.
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Figure 2025116000000001_ABST
Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 911,039, filed October 4, 2019, the entirety of which is incorporated herein by reference.
[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of intraocular lenses, and more particularly to accommodating intraocular lenses and methods for adjusting intraocular lenses. [Background technology]
[0003] A cataract is a condition in which the normally clear lens of a patient's eye becomes cloudy. Cataracts can occur as a result of aging, genetic factors, trauma, inflammation, metabolic disorders, or exposure to radiation. Age-related cataracts are the most common type of cataract. To treat cataracts, 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 have distance vision. However, after cataract surgery, patients with traditional IOLs often require eyeglasses or other corrective eyewear for certain activities because the eye can no longer accommodate (or change refractive index) to maintain a sharp image of or focus on objects as distances change.
[0004] New IOLs, such as accommodating IOLs, allow the eye to regain at least some focusing ability. Accommodating IOLs (AIOLs) use available power in the eye to change a portion of the optical system to refocus the eye onto distant or near targets. Examples of AIOLs are disclosed in the following U.S. Patent Publications: U.S. Patent Application Publication Nos. 2018 / 0256315, 2018 / 0153682, and 2017 / 0049561, and in the following issued U.S. patent publications: U.S. Patent Nos. 10,299,913, 10,195,020, and 8,968,396, the contents of which are incorporated herein by reference in their entireties.
[0005] Even with the use of AIOLs, it may be necessary to adjust such lenses after surgery or after implantation in a patient's eye. For example, after an AIOL is implanted in the capsular bag, an active healing response by tissues within the capsular bag may compress the AIOL, resulting in a greater optical power than originally anticipated. In some cases, preoperative biometry performed on a patient's eye may be inaccurate, leading to an IOL with the wrong lens power being prescribed and implanted in the patient. Furthermore, a patient's cornea or muscles within the eye may change as a result of injury, illness, or aging. In such cases, it may be necessary to adjust the IOL or AIOL implanted in the patient to account for such changes.
[0006] In addition to low-order aberrations (e.g., focusing power), higher-order aberrations, such as cylindrical astigmatism and spherical aberration, are also commonly corrected by intraocular lenses. Cylindrical astigmatism generally occurs naturally in the cornea, and many patients with a history of cataracts also have some degree of astigmatism. While toric IOLs have been used to correct astigmatism during cataract surgery, one problem faced by all toric lens manufacturers is that the rotational asymmetry of such lenses makes it important to properly position the lens relative to the patient's existing aberrations. When mispositioning does occur, the patient's only recourse is often to undergo additional surgery to correct the mispositioning.
[0007] Therefore, there is a need for a solution that allows for post-implant adjustment of IOLs or AIOLs without additional surgery. Such a solution should not overly complicate the design of such lenses, yet still allow the lenses to be manufactured cost-effectively. Summary of the Invention
[0008] Disclosed herein are accommodating intraocular lenses, accommodating intraocular lenses, and methods for accommodating intraocular lenses and accommodating intraocular lenses. In one embodiment, the accommodating intraocular lens is disclosed as including an optic portion including an anterior component and a posterior component. The anterior component can include an anterior optical surface. The posterior component can include a posterior optical surface. A fluid-filled optical fluid chamber can be defined between the anterior and posterior components.
[0009] The optic portion can have a base power or a base spherical power. The base power of the optic portion can be configured to change based on the internal fluid pressure in a fluid-filled optical fluid chamber. The base power of the optic portion can be configured to increase or decrease when fluid flows into or out of the optical fluid chamber. The optic portion can be configured to change shape in response to fluid flowing into or out of the optical fluid chamber. In certain embodiments, an anterior component of the optic portion can be configured to change shape in response to fluid flowing into or out of the optical fluid chamber. In other embodiments, a posterior component of the optic portion can be configured to change shape in response to fluid flowing into or out of the optical fluid chamber. In further embodiments, both the anterior and posterior components of the optic portion can be configured to change shape in response to fluid flowing into or out of the optical fluid chamber.
[0010] The base power of the optic can be configured to change in response to a shape change imposed by the shape-changing optic (e.g., an anterior component, a posterior component, or a combination thereof). The shape-changing optic can be configured to change shape in response to physiological muscle movements (e.g., ciliary muscle movements) made by a patient when the adjustable accommodating intraocular lens is implanted in the patient's eye.
[0011] In some embodiments, the adjustable accommodating intraocular lens can include one or more haptics coupled to and extending from the optic portion. Each of the one or more haptics can include a haptic fluid chamber therein. The base power of the optic portion can be configured to increase as fluid flows into the optical fluid chamber from the one or more haptic fluid chambers. The base power of the optic portion can be configured to decrease as fluid flows out or is extracted from the optical fluid chamber into the one or more haptic fluid chambers.
[0012] The optical fluid chamber can be in fluid communication or fluidly connected to one or more haptic fluid chambers. The optical fluid chamber can be in fluid communication with the haptic fluid chamber through a pair of fluid channels. The fluid channels can be conduits or passages that fluidly connect the optical fluid chamber to the haptic fluid chamber. The pair of fluid channels can be spaced apart from each other. For example, the pair of fluid channels can be spaced apart by about 0.1 mm to about 1.0 mm.
[0013] In some embodiments, the pair of fluid channels can be defined and extend through a portion of the optic portion, more particularly, the pair of fluid channels can be defined and extend through the posterior component.
[0014] The one or more haptics can be coupled to the optical portion at a haptic-optical interface. The one or more haptics can be coupled to the optical portion at a reinforcement portion along the optical portion. The reinforcement portion can be part of the haptic-optical interface. The pair of fluid channels can be defined or formed within a portion of the reinforcement portion.
[0015] In some embodiments, the adjustable accommodating intraocular lens can include two haptics coupled to and extending from the optic portion. The first haptic can include a first haptic fluid chamber therein. The second haptic can include a second haptic fluid chamber therein. The first haptic can be coupled to the optic portion at a first haptic-optical interface, and the second haptic can be coupled to the optic portion at a second haptic-optical interface.
[0016] In these embodiments, the optical fluid chamber can be in fluid communication with both the first haptic fluid chamber and the second haptic fluid chamber. The optical fluid chamber can be in fluid communication with the first haptic fluid chamber via a first pair of fluid channels. The optical fluid chamber can be in fluid communication with the second haptic fluid chamber via a second pair of fluid channels.
[0017] The first pair of fluid channels can be spaced apart from one another. The first pair of fluid channels can be spaced apart by about 0.1 mm to about 1.0 mm. The second pair of fluid channels can be spaced apart from one another. The second pair of fluid channels can be spaced apart by about 0.1 mm to about 1.0 mm.
[0018] The first pair of fluid channels and the second pair of fluid channels can be enlarged and extend through a portion of the optic portion, and the first pair of fluid channels and the second pair of fluid channels can be defined and extend through the posterior component.
[0019] The optical portion can also include first and second reinforcing portions located on substantially opposite sides or substantially diametrically opposed sides of the optical portion. The first pair of fluid channels can be defined or formed within the first reinforcing portion. The second pair of fluid channels can be defined or formed within the second reinforcing portion.
[0020] The first pair of fluid channels can terminate at a first pair of openings defined within the optic portion. The first pair of fluid channels can terminate at a first pair of openings defined within the posterior component. The first pair of openings can be spaced apart by about 0.1 mm to about 1.0 mm. The second pair of fluid channels can terminate at a second pair of openings defined within the optic portion. The second pair of fluid channels can terminate at a second pair of openings within the posterior component. The second pair of openings can be spaced apart by about 0.1 mm to about 1.0 mm.
[0021] In some embodiments, the first pair of fluid channels and the second pair of fluid channels can be located on substantially opposite sides of the optical portion, and the first pair of fluid channels can be located substantially diametrically opposite the second pair of fluid channels.
[0022] In these embodiments, the first pair of apertures and the second pair of apertures can be located on substantially opposite sides of the optical portion, and the first pair of apertures can be located substantially radially opposite the second pair of apertures.
[0023] In some embodiments, at least one of the optic and peripheral portion (e.g., haptics) can be partially formed from a cross-linked copolymer, including a copolymer blend. Further, at least one of the optic and peripheral portion can be partially formed from a composite material, the composite material including an energy-absorbing component, a plurality of expandable components, and a composite base material partially formed from a copolymer blend. At least one of the base power and cylindricity of the optic can be configured to change in response to external energy directed at the composite material.
[0024] In certain embodiments, the adjustable accommodating intraocular lens can be implanted into a subject's eye, and at least one of the base power and cylindricity of the optic portion can be configured to change in response to external energy directed at the composite material when the adjustable accommodating intraocular lens is implanted into the subject's eye.
[0025] In some embodiments, the expandable component can be an expandable microsphere containing a blowing agent within an expandable thermoplastic shell. The blowing agent can be a branched chain hydrocarbon. For example, the branched chain hydrocarbon can be isopentane.
[0026] The thickness of the thermoplastic shell can be configured to change in response to external energy directed at the composite material, hi some embodiments, the thermoplastic shell can be formed in part from an acrylonitrile copolymer.
[0027] The diameter of at least one of the expandable microspheres can be configured to increase between about two times (2x) and about four times (4x) in response to external energy directed at the composite material. The volume of at least one of the expandable microspheres can be configured to expand between about ten times (10x) and about fifty times (50x) in response to external energy directed at the composite material.
[0028] The expandable component can comprise about 5% to about 15% by weight (more specifically, about 8% to about 12% by weight) of the composite. For example, the expandable component can comprise about 10% by weight of the composite.
[0029] The energy absorbing component 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 composite. In some embodiments, the energy absorbing component can be an energy absorbing colorant. For example, the color of the energy absorbing colorant can be visually perceptible to a clinician or another medical professional when the accommodating intraocular lens is implanted in the eye.
[0030] The energy absorbing colorant can be a dye. For example, the dye can be an azo dye. In some embodiments, the dye can be a red azo dye, such as Disperse Red 1 dye. The energy absorbing colorant can also include a pigment. For example, the pigment can be graphitized carbon black.
[0031] In some embodiments, at least one of the optical portion and the peripheral portion can be formed in part from a first composite material and a second composite material. The first composite material can include a first energy absorbing colorant. The second composite material can include a second energy absorbing colorant. In certain embodiments, the color of the first energy absorbing colorant can be different from the color of the second energy absorbing colorant.
[0032] In addition to the copolymer blend, the composite base material can further include at least one of one or more reactive acrylic monomer diluents, a photoinitiator, and a thermal initiator. The copolymer blend can include an alkyl acrylate, a fluoroalkyl acrylate, and a phenyl alkyl acrylate. The composite material can remain relatively fixed at one or more locations within the optic or peripheral portion during all stages of accommodation or disaccommodation of the intraocular lens.
[0033] As described above, the base power of an adjustable accommodating intraocular lens can be configured to change in response to external energy directed at a composite material comprising at least a portion of the adjustable accommodating intraocular lens. The base power of the optic portion can be configured to change in a range of about ±0.05D to about ±0.5D (e.g., more specifically, about ±0.1D to about ±0.2D) in response to pulses of external energy directed at the composite material. In some embodiments, the base power of the optic portion can be configured to change by a total of up to ±2.0D. In other embodiments, the base power of the optic portion can be configured to change by a total of up to ±5.0D.
[0034] In some embodiments, the external energy can be optical energy. The external energy can be optical energy from a laser beam. The optical energy can have a wavelength of about 488 nm to about 650 nm. For example, the optical energy can be green laser light having a wavelength of about 520 nm to about 570 nm. As a more specific example, the optical energy can be green laser light having a wavelength of about 532 nm.
[0035] External energy directed or otherwise applied to the composite material can cause a lasting change in the optical parameters of the accommodating intraocular lens. For example, external energy directed or otherwise applied to the composite material can cause a lasting change to the base power of the accommodating intraocular lens. Also, for example, external energy directed or otherwise applied to the composite material can cause a lasting change to the cylindricity of the optic portion of the accommodating intraocular lens.
[0036] In some embodiments, the optical portion can be partially formed from a composite material. In these embodiments, at least one of the base power and cylindricity of the optical portion can be configured to change in response to external energy directed at the optical portion. For example, a composite material can be disposed along a first periphery of the anterior component of the optical portion. In this example, the composite material can also be disposed along a second periphery radially opposite the first periphery. The cylindricity of the anterior optical surface can be configured to change in response to external energy directed at the first and second peripheries.
[0037] Alternatively, the composite material can also be disposed along a first periphery along a second periphery of the posterior component of the optical portion. The second periphery can be radially opposite the first periphery. The cylindricity of the posterior optical surface can be configured to change in response to external energy directed toward the first and second peripheries.
[0038] As described above, the anterior component of the optic portion can be circumferentially bonded or otherwise attached to the posterior component by an adhesive layer. In some embodiments, the adhesive layer can comprise a composite material. The base power of the optic portion can be configured to decrease in response to external energy directed at the adhesive layer. The adhesive layer can be configured to expand in response to external energy directed at the adhesive layer. The expansion of the adhesive layer can increase the volume of an optical fluid chamber within the optic portion. The increase in the volume of the optical fluid chamber decreases the internal fluid pressure within the optical fluid chamber, which can flatten or reduce the degree of curvature of the anterior component.
[0039] In other embodiments, the peripheral portion (e.g., one or more haptics) of the adjustably accommodating intraocular lens can be partially formed from a composite material. As described above, the peripheral portion can include at least one haptic that includes a fluid-filled haptic fluid chamber in fluid communication with the optic chamber. The base power of the optic portion can be configured to change in response to external energy directed toward a portion of the peripheral portion partially formed from a composite material. The external energy can cause fluid communication or movement between the fluid-filled optic chamber and the haptic fluid chamber.
[0040] For example, the base power can be configured to change in response to a change in the volume of the haptic fluid chamber. Also, for example, the base power of an accommodating intraocular lens can be configured to change in response to interactions between the peripheral portion and the lens environment surrounding the accommodating intraocular lens when the lens is implanted in the eye.
[0041] More specifically, the composite material can be configured or designed as a spacer extending radially from the haptic chamber wall. The spacer can be configured to expand in response to external energy directed at the spacer. The expansion of the spacer can cause a decrease in the volume of the haptic fluid chamber by pressing one or more haptics against one or more capsule walls.
[0042] The composite material can also be partially disposed within a haptic chamber wall surrounding the haptic fluid chamber. For example, the composite material can be at least partially disposed within a channel formed along a radially inner wall of the haptic. The volume of the haptic fluid chamber can be configured to increase in response to external energy directed at the composite material.
[0043] In other embodiments, the composite material can be located or disposed at least partially along a radially outermost portion of a radially inner wall of the haptic. The volume of the haptic fluid chamber can be configured to decrease in response to external energy directed at the composite material. In at least some of these embodiments, the composite material can expand into the haptic fluid chamber in response to external energy directed at the composite material.
[0044] In a further embodiment, the haptics of the adjustable accommodating intraocular lens can include a first haptic portion and a second haptic portion. The first haptic portion and the second haptic portion can be partially formed from a composite material. The base power of the optic portion can be configured to increase in response to external energy directed toward the first haptic portion. For example, the base power of the optic portion can be configured to increase in response to fluid flow from the haptic fluid chamber to the optical fluid chamber as a result of external energy directed toward the first haptic portion.
[0045] Additionally, the base power of the optical portion can be configured to decrease in response to external energy directed toward the second haptic portion. The base power of the optical portion can be configured to decrease in response to fluid flow from the optical fluid chamber to the haptic fluid chamber as a result of external energy directed toward the second haptic portion. At least one of the first haptic portion and the second haptic portion can be partially located within a haptic chamber wall surrounding the haptic fluid chamber.
[0046] In some embodiments, the first haptic portion can be partially formed from a first composite material, and the second haptic portion can be partially formed from a second composite material. The first composite material can include a first energy-absorbing component, and the second composite material can include a second energy-absorbing component. The composition of the first energy-absorbing component can be different from the composition of the second energy-absorbing component. For example, the first energy-absorbing component can be an energy-absorbing dye having a first color. In this example, the second energy-absorbing component can be another energy-absorbing dye having a second color different from the first color.
[0047] The first haptic portion can be radially offset from the second haptic portion. In some embodiments, the first haptic portion and / or the second haptic portion can be oriented in a pattern such that the position of the first haptic portion and / or the second haptic portion along the haptic is visually perceptible to a clinician or another medical professional.
[0048] A method for adjusting an accommodating intraocular lens is also disclosed. The method can include adjusting the base power of the accommodating intraocular lens by directing external energy to a composite material within at least one of the optic and peripheral portions of the accommodating intraocular lens. The composite material can include an energy absorbing component, a plurality of expandable components, and a composite base material formed in part from a copolymer blend.
[0049] The method can further include adjusting the base power of the accommodating intraocular lens when the accommodating intraocular lens is implanted in the subject's eye. The method can further include adjusting the cylindricity of an optical surface of the optic portion of the accommodating intraocular lens by directing external energy to composite materials disposed on diametrically opposed peripheries of the optic portion.
[0050] The method can also include directing external energy toward the composite material to impart energy to the energy absorbing component, thereby transferring thermal energy to the plurality of expandable components. In some embodiments, the plurality of expandable components can be expandable microspheres including a blowing agent contained within a thermoplastic shell. The microspheres can be expanded by directing external energy toward the composite material.
[0051] In some embodiments, the external energy can be optical energy, for example, laser light having a wavelength of about 488 nm to about 650 nm.
[0052] The method can further include adjusting the base power of the optical portion in a range of about ±0.05D to about ±0.5D (e.g., more specifically, about ±0.1D to about ±0.2D) in response to a pulse of external energy directed at the composite material.
[0053] The method can also include directing external energy toward the composite material to move fluid between the optical chamber and the haptic fluid chamber. For example, the method can include directing external energy toward the composite material to change the volume of the haptic fluid chamber. This change in the volume of the haptic fluid chamber can result in a change in the base power of the accommodating intraocular lens. The method can further include directing external energy toward the composite material to cause the lens haptics to interact with the crystalline lens environment surrounding the implanted accommodating intraocular lens, thereby adjusting the base power of the accommodating intraocular lens.
[0054] Additionally, the method can also include directing external energy at the composite material to change the volume of the optical fluid chamber, thereby adjusting the base power of the accommodating intraocular lens. This change in volume of the optical fluid chamber can result in the outflow of fluid from the optical fluid chamber, thereby changing the shape of a portion of the optic portion and decreasing the base power of the lens. [Brief explanation of the drawings]
[0055] [Figure 1A] FIG. 1A shows a top view of one embodiment of an adjustable accommodating intraocular lens. [Figure 1B] 1B and 1C show cross-sectional views of one embodiment of an adjustable accommodating intraocular lens. [Figure 1C] 1B and 1C show cross-sectional views of one embodiment of an adjustable accommodating intraocular lens. [Figure 1D] FIG. 1D shows an exploded view of one embodiment of an adjustable accommodating intraocular lens. [Figure 2A] FIG. 2A shows a composite material used to form at least a portion of an adjustable accommodating intraocular lens. [Figure 2B] FIG. 2B shows one embodiment of a composite expandable component. [Figure 3A] FIG. 3A shows a cross-sectional view of one embodiment of an adjustable accommodating intraocular lens including an expandable spacer. [Figure 3B] FIG. 3B shows a cross-sectional view of one embodiment of an adjustable accommodating intraocular lens including an expandable spacer. [Figure 4A] FIG. 4A shows a top view of another embodiment of an adjustable accommodating intraocular lens including an expandable spacer extending radially inward. [Figure 4B] FIG. 4B shows a cross-sectional view of another embodiment of an adjustable accommodating intraocular lens including an expandable spacer extending radially inward. [Figure 5A]FIG. 5A shows a cross-sectional view of another embodiment of an adjustable accommodating intraocular lens including an inflatable spreader. [Figure 5B] FIG. 5B shows a cross-sectional view of another embodiment of an adjustable accommodating intraocular lens including an inflatable spreader. [Figure 6] FIG. 6 shows a cross-sectional view of another embodiment of an adjustable accommodating intraocular lens including expandable protrusions. [Figure 7A] FIG. 7A shows a top view of another embodiment of an adjustable accommodating intraocular lens that includes both an expandable spreader and an expandable protrusion. [Figure 7B] FIG. 7B shows a cross-sectional view of another embodiment of an adjustable accommodating intraocular lens that includes both an expandable spreader and an expandable protrusion. [Figure 8] FIG. 8 shows a plan view of another embodiment of an adjustable accommodating intraocular lens that includes both an expandable spreader and an expandable protrusion implemented as discrete components along the haptics. [Figure 9A] FIG. 9A shows a plan view of another embodiment of an adjustable accommodating intraocular lens that includes both an expandable spreader and expandable protrusions arranged in a visually perceptible pattern. [Figure 9B] FIG. 9B shows a cross-sectional view of an embodiment of an adjustable accommodating intraocular lens shown along section AA of FIG. 9A. [Figure 9C] FIG. 9C shows a cross-sectional view of an embodiment of an adjustable accommodating intraocular lens shown along section BB of FIG. 9A. [Figure 10] FIG. 10 shows a cross-sectional view of the optic portion of another embodiment of an adjustable accommodating intraocular lens including an adhesive layer partially formed from a composite material. [Figure 11] FIG. 11 shows a perspective view of another embodiment of an accommodative intraocular lens configured to exhibit cylindricity in response to external energy directed at the accommodative intraocular lens. DETAILED DESCRIPTION OF THE INVENTION
[0056] 1A illustrates a plan view of one embodiment of an adjustable accommodating intraocular lens (AIOL) 100 for correcting defocus aberration, corneal astigmatism, spherical aberration, or a combination thereof. Adjustable AIOL 100 can include an optic portion 102 and a peripheral portion 103, which in this embodiment includes one or more haptics 104, including first haptic 104A and second haptic 104B, coupled to and extending peripherally from optic portion 102. Adjustable AIOL 100 is configured to be placed into the natural lens capsule after the natural lens has been removed.
[0057] When implanted within the natural lens capsule, the optic portion 102 can be adapted to refract light entering the eye onto the retina. The peripheral portion 103 (e.g., one or more haptics 104) can be configured to engage with the lens capsule and to deform in response to ciliary muscle movement associated with reshaping the lens capsule (e.g., muscle relaxation, muscle contraction, or a combination thereof). The engagement of the peripheral portion 103 (e.g., one or more haptics 104) with the lens capsule is described in more detail below in a following section.
[0058] Figures 1B and 1C show cross-sectional views of one embodiment of an adjustable AIOL 100, as shown along section AA in Figure 1A. As shown in Figures 1B and 1C, the optic portion 102 can include an anterior component 106 and a posterior component 108. A fluid-filled optical fluid chamber 110 can be defined between the anterior component 106 and the posterior component 108.
[0059] The anterior component 106 may include an anterior optical surface 112 and an anterior inner surface 114 located behind the anterior optical surface 112. The posterior component 108 may include a posterior optical surface 116 and a posterior inner surface 118 located behind the posterior optical surface 116. Either the anterior optical surface 112, the posterior optical surface 116, or a combination thereof may be considered and referred to as an outer optical surface. The anterior inner surface 114 and the posterior inner surface 118 may face the optical fluid chamber 110. At least a portion of the anterior inner surface 114 and at least a portion of the posterior inner surface 118 may function as chamber walls of the optical fluid chamber 110.
[0060] Each of one or more haptics 104 can include a haptic fluid chamber 120 therein. For example, first haptic 104A can include a first haptic fluid chamber 120A therein, and second haptic 104B can include a second haptic fluid chamber 120B therein. Haptic fluid chamber 120 (e.g., either first haptic fluid chamber 120A, second haptic fluid chamber 120B, or a combination thereof) can be in fluid communication with or fluidically connected to optical fluid chamber 110.
[0061] The optical fluid chamber 110 can be in fluid communication with one or more haptic fluid chambers 120 through a pair of fluid channels 122 (see FIG. 1A ). The fluid channels 122 can be conduits or passageways that fluidly connect the optical fluid chamber 110 to the haptic fluid chambers 120. The pair of fluid channels 122 can be spaced apart from each other. For example, the pair of fluid channels 122 can be spaced apart by about 0.1 mm to about 1.0 mm. In some embodiments, each of the pair of fluid channels 122 has a diameter of about 0.4 mm to about 0.6 mm.
[0062] In some embodiments, the pair of fluid channels 122 can be defined and extend through a portion of the optic portion 102. More specifically, the pair of fluid channels 122 can be defined and extend through the posterior component 108.
[0063] 1A shows that one or more haptics 104 of the peripheral portion 103 can be coupled to the optic portion 102 at a haptic-optical interface 124. For example, one or more haptics 104 can be coupled to the optic portion 102 at a reinforcement portion 126 (see FIG. 1D ) along the optic portion 102. The reinforcement portion 126 can be part of the haptic-optical interface 124. A pair of fluid channels 122 can be defined or formed within a portion of the reinforcement portion 126.
[0064] Optical fluid chamber 110 can be in fluid communication with first haptic fluid chamber 120A through a first pair of fluid channels 122A. Optical fluid chamber 110 can also be in fluid communication with second haptic fluid chamber 120B via a second pair of fluid channels 122B.
[0065] The two fluid channels of the first pair of fluid channels 122A can be spaced apart from each other. The two fluid channels of the first pair of fluid channels 122A can be spaced apart from each other by about 0.1 mm to about 1.0 mm. The two fluid channels of the second pair of fluid channels 122B can be spaced apart from each other. The two fluid channels of the second pair of fluid channels 122B can be spaced apart from each other by about 0.1 mm to about 1.0 mm.
[0066] In some embodiments, the first pair of fluid channels 122A and the second pair of fluid channels 122B can be located on substantially opposite sides of the optical portion 102. The first pair of fluid channels 122A can be located substantially diametrically opposite the second pair of fluid channels 122B.
[0067] The first pair of fluid channels 122A and the second pair of fluid channels 122B can be defined or extend through a portion of the optical portion 102. The first pair of fluid channels 122A and the second pair of fluid channels 122B can be defined or extend through the posterior component 108.
[0068] The design with two fluid channels 122 rather than one channel helps maintain dimensional stability during assembly, which can be important when assembling flexible, thin components. Additionally, it has been observed through experimentation that the design with two fluid channels 122 provides better optical quality across the entire range of compatibility than certain single-channel designs. The additional stiffness in the two fluid channel design results in less deflection due to pressure changes within the fluid channels.
[0069] 1D, the optic portion 102 can include a first reinforcing portion 126A and a second reinforcing portion 126B on substantially opposite sides or substantially diametrically opposed sides of the optic portion 102. A first pair of fluid channels 122A can be defined or formed within the first reinforcing portion 126A. A second pair of fluid channels 122B can be defined or formed within the second reinforcing portion 126B.
[0070] Each pair of fluid channels 122 (e.g., either the first pair of fluid channels 122A or the second pair of fluid channels 122B) can have a pair of inner openings 128 disposed at one end of the fluid channel 122 and another pair of outer openings 130 disposed at the other end of the fluid channel 122. The pair of inner openings 128 can be defined or formed on a portion of the aft component 108. As shown in FIGS. 1B-1D , the inner openings 128 can be defined or formed on a portion of a raised inner surface 132 of the aft component 108. In some embodiments, the raised inner surface 132 can be an angled or chamfered surface.
[0071] The pair of outer openings 130 can be defined or formed on a portion of a protruding outer surface 134 of the posterior component 108. The protruding outer surface 134 can be part of the reinforcement portion 126. The protruding outer surface 134 can also be part of the haptic-optical interface 124.
[0072] For example, Figure 1D shows a pair of inner openings 128 disposed at one end of a first pair of fluid channels 122A and defined along a raised inner surface 132 of the rear component 108. Figure 1D also shows a pair of outer openings 130 serving as ends of a second pair of fluid channels 122B and defined along a protruding outer surface 134 of the rear component 108. The pair of outer openings 130 of the first pair of fluid channels 122A and the pair of inner openings 128 of the second pair of fluid channels 122B are not visible in Figure 1D.
[0073] The two openings of the pair of inner openings 128 can be spaced apart from each other by about 0.1 mm to about 1.0 mm. The two openings of the pair of outer openings 130 can be spaced apart from each other by about 0.1 mm to about 1.0 mm. The pair of inner openings 128 of the first pair of fluid channels 122A can be located diametrically opposite, or on opposite sides of, the raised inner surface 132 from the pair of inner openings 128 of the second pair of fluid channels 122B.
[0074] 1D also shows that each of the haptics 104 (e.g., either the first haptic 104A or the second haptic 104B) can have an optics-mounting end 136 and a closed free end 138. A haptic fluid port 140 can be defined in the optics-mounting end 136 of the haptic 104. The haptic fluid port 140 can function as a chamber opening for the haptic fluid chamber 120. When the haptic 104 is coupled to the optical portion 102, fluid in the haptic fluid chamber 120 can flow out of the haptic fluid chamber 120 through the haptic fluid port 140 and into the optical fluid chamber 110 via the pair of fluid channels 122. Similarly, fluid within optical fluid chamber 110 can exit optical fluid chamber 110 through a pair of fluid channels 122 and can enter haptic fluid chamber 120 through haptic fluid port 140 .
[0075] 1A and 1D, the haptics 104 can be coupled to the optical portion 102 at the reinforcement portion 126. For example, a first haptic 104A can be coupled or attached to the optical portion 102 at the first reinforcement portion 126A, and a second haptic 104B can be coupled or attached to the optical portion 102 at the second reinforcement portion 126B.
[0076] More specifically, the haptic attachment end 136 can be coupled to a protruding outer surface 134 of the posterior component 108. The protruding outer surface 134 can also be referred to as a "landing" or a "haptic attachment landing." The protruding outer surface 134 can extend radially outward from an outer circumferential surface 142 of the optic portion 102. For example, the protruding outer surface 134 can extend radially outward from the outer circumferential surface 142 of the posterior component 108 of the optic portion 102. The protruding outer surface 134 can extend radially outward from the outer circumferential surface 142 by approximately 10 microns to 1.0 mm, or by approximately 10 microns to 500 microns.
[0077] The haptic attachment end 136 can have a substantially flat surface for attaching or otherwise coupling to the substantially flat surface of the protruding outer surface 134. When the haptic attachment end 136 is coupled to the protruding outer surface 134, the haptic fluid port 140 can surround the outer opening 130 of the fluid channel 122. The haptics 104 can be bonded or attached to the optic portion 102 via a biocompatible adhesive 148. In some embodiments, the adhesive 148 can be the same adhesive used to bond or attach the anterior component 106 to the posterior component 108. The adhesive 148 is described in more detail in a following section.
[0078] Each of the haptics 104 may also include a radially outer portion 144 configured to face and contact the inner surface of the patient's lens capsule when the adjustable AIOL 100 is implanted within the capsule. Each of the haptics 104 may also include a radially inner portion 146 configured to face the outer circumferential surface 142 of the optic portion 102. The engagement of the lens capsule with the radially outer portions 144 of the haptics 104 is described in more detail in a following section.
[0079] The optic portion 102 can have a base power or a base spherical power. The base power of the optic portion 102 can be configured to change based on the internal fluid pressure within the fluid-filled optical fluid chamber 110. The base power of the optic portion 102 can be configured to increase or decrease as fluid flows into or out of the fluid-filled optical fluid chamber 110.
[0080] The base power of the optical portion 102 can be configured to increase as fluid flows from one or more haptic fluid chambers 120 into the fluid-filled optical fluid chamber 110, as shown in Figure 1B. The base power of the optical portion 102 can be configured to decrease as fluid flows out or is extracted from the fluid-filled optical fluid chamber 110 into the one or more haptic fluid chambers 120, as shown in Figure 1C.
[0081] 1B uses curved dashed arrows to illustrate fluid flowing from haptic fluid chamber 120 into optical fluid chamber 110, it should be noted that fluid flows into optical fluid chamber 110 via fluid channel 122 (including through inner opening 128 and outer opening 130) and haptic fluid port 140. Also, while FIG. 1C uses curved dashed arrows to illustrate fluid flowing from optical fluid chamber 110 into haptic fluid chamber 120, it should be noted that fluid flows out of optical fluid chamber 110 via fluid channel 122 (including through inner opening 128 and outer opening 130) and haptic fluid port 140.
[0082] The optic portion 102 can be partially formed from a deformable or flexible material. In some embodiments, the optic portion 102 can be partially formed from a deformable or flexible polymer material. For example, the anterior component 106, the posterior component 108, or a combination thereof, can be partially formed from 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 partially formed from the same deformable or flexible material as the optic portion 102. In other embodiments, one or more haptics 104 can be partially formed from a different material than the optic portion 102.
[0083] In some embodiments, the optic portion 102 can include or be partially formed from a lens body material. The lens body material can be partially formed from a crosslinked 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 those skilled in the art will understand, that these types of acrylic crosslinked copolymers can generally be copolymers of acrylates, methacrylates, or combinations thereof, and that, as used herein, the term “acrylate” can be understood to refer interchangeably to acrylate, methacrylate, or combinations thereof, unless otherwise specified. The crosslinked copolymer used to form the lens body material can include an alkyl acrylate in an amount of about 3% to 20% (wt%), a fluoroalkyl acrylate in an amount of about 10% to 35% (wt%), and a phenyl alkyl acrylate in an amount of about 50% to 80% (wt%). In some embodiments, the crosslinked copolymer can include, or be partially formed from, n-butyl acrylate as the alkyl acrylate, trifluoroethyl methacrylate as the fluoroalkyl acrylate, and phenylethyl acrylate as the phenylalkyl acrylate. More specifically, the crosslinked copolymer used to form 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%).
[0084] The final composition of the cross-linked copolymer used to form the lens body material may also include a cross-linking agent or material, such as ethylene glycol dimethacrylate (EGDMA). For example, the final composition of the cross-linked copolymer used to form the lens body material may also include a cross-linking agent or material (e.g., EGDMA) in an amount of about 1.0%. The final composition of the cross-linked copolymer used to form the lens body material may also include an initiator or material (e.g., Perkadox 16) and a UV absorber.
[0085] One or more haptics 104 can include or be partially formed of a haptic material. The haptic material can include or be partially formed of 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, the cross-linked copolymer used to form the haptic material can include an alkyl acrylate in an amount of about 10% to 25% (wt%), a fluoroalkyl acrylate in an amount of about 10% to 35% (wt%), and a phenyl alkyl acrylate in an amount of about 50% to 80% (wt%). In some embodiments, the crosslinked copolymer used to form the haptic material can include n-butyl acrylate in an amount of about 10% to 25% (wt%) (e.g., about 19% to about 23%), trifluoroethyl methacrylate in an amount of about 10% to 35% (wt%) (e.g., about 14% to about 18%), and phenylethyl acrylate in an amount of about 50% to 80% (wt%) (e.g., about 58% to about 62%). The final composition of the crosslinked copolymer used to form the haptic material can also include a crosslinker or material, such as EGDMA, in an amount of about 1.0%. The final composition of the crosslinked copolymer used to form the haptic material can also include a number of photoinitiators or materials, such as camphorquinone, 1-phenyl-1,2-propanedione, and 2-ethylhexyl-4-(dimethylamino)benzoate.
[0086] In some embodiments, the refractive index of the lens body material can be from about 1.48 to about 1.53, and in particular embodiments, the refractive index of the lens body material can be from about 1.50 to about 1.53 (e.g., about 1.5178).
[0087] The optic portion 102 can be configured to deform, bend, or otherwise change shape in response to fluid flowing into or out of the optical fluid chamber 110 (see FIGS. 1B and 1C ). The optic portion 102 can be configured to deform, bend, or otherwise change shape as a result of the material composition (e.g., polymer composition) of the optic portion 102, as described above. The one or more haptics 104 can also be configured to deform or otherwise change shape in response to interaction with or engagement with the patient's lens capsule when the adjustable AIOL 100 is implanted in the patient's eye. The one or more haptics 104 can be configured to deform or otherwise change shape as a result of the material composition of the haptics 104.
[0088] In some embodiments, the front component 106 can be configured to deform, bend, or otherwise change shape (e.g., change its curvature) in response to fluid flowing into or out of the optical fluid chamber 110. In other embodiments, the rear component 108 can be configured to deform, bend, or otherwise change shape (e.g., change its curvature) in response to fluid flowing into or out of the optical fluid chamber 110. In further embodiments, both the front component 106 and the rear component 108 can be configured to deform, bend, or otherwise change shape in response to fluid flowing into or out of the optical fluid chamber 110.
[0089] In some embodiments, the fluid in optical fluid chamber 110, one or more haptic fluid chambers 120, or a combination thereof can be oil. More specifically, in certain embodiments, the fluid in optical fluid chamber 110, one or more haptic fluid chambers 120, or a combination thereof can be silicone oil or fluid. The fluid can flow between optical fluid chamber 110 and one or more haptic fluid chambers 120 in response to deformation, bending, or shape changes made by one or more haptics 104, one or more components of optical portion 102 (e.g., anterior component 106, posterior component 108, or a combination thereof), or a combination thereof.
[0090] The fluid within optical fluid chamber 110, one or more haptic fluid chambers 120, or a combination thereof, can be a silicone oil or fluid that includes or is partially formed from diphenylsiloxane. In other embodiments, the silicone oil or fluid can include or be partially formed from a ratio of one diphenylsiloxane unit to two dimethylsiloxane units. More specifically, in some embodiments, the silicone oil or fluid can be diphenyltetramethylcyclotrisiloxane. In additional embodiments, the silicone oil or fluid can include or be partially formed from a copolymer of diphenylsiloxane and dimethylsiloxane.
[0091] The fluid (e.g., silicone oil) can be refractive index matched to the lens body material used to form the optic portion 102. When the fluid is refractive index matched to the lens body material, the entire optic portion 102 containing the fluid acts as a single 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 disclosed in U.S. Patent Application Publication No. 2018 / 0153682, the entire contents of which are incorporated herein by reference.
[0092] The base power of the optic portion 102 can be configured to change in response to a shape change made by a shape-changing component of the optic portion 102 (e.g., the anterior component 106, the posterior component 108, or a combination thereof). The optic portion 102 can be configured to change shape in response to a physiological muscle movement made by the patient (e.g., ciliary muscle movement) when the adjustable AIOL 100 is implanted into the capsular bag of a patient's eye and the adjustable AIOL 100 deforms or changes shape in response to reshaping of the capsular bag associated with the ciliary muscle.
[0093] The adjustable AIOL 100 can be implanted or introduced into a patient's lens capsule after the natural lens has been removed from the capsule. The patient's lens capsule is connected to zonular fibers, which are connected to the patient's ciliary muscle. The lens capsule is elastic, and movement of the ciliary muscle can reshape the lens capsule via the zonular fibers. For example, when the ciliary muscle relaxes, the zonular fibers are stretched. This stretching pulls the lens capsule radially outward due to a radial outward force. This tension on the lens capsule stretches the lens capsule and creates space within the lens capsule. When the patient's natural lens resides within the lens capsule, the natural lens is typically flatter (in the anterior-posterior direction), which reduces the lens's power and enables distance vision. In this configuration, the patient's natural lens is said to be in a disaccommodated state or to be disaccommodated.
[0094] However, when the ciliary muscle contracts, as occurs when the eye attempts to focus on a near object, the radially inner portion of the muscle moves radially inward, causing the zonular fibers to relax. This relaxation of the zonular fibers contracts the elastic lens capsule, which imposes a radially inward force on the lens within the capsule. When a patient's natural lens resides within the capsule, the natural lens is typically more curved (e.g., the anterior portion of the lens is more curved), which increases the lens's power and enables the eye to focus on near objects. In this configuration, the patient's natural lens is said to be in an accommodated state or to be undergoing accommodation.
[0095] Therefore, any AIOLs implanted within the capsular bag must also have a mechanism that can increase the base power of the AIOL when the ciliary muscle contracts and decrease the base power of the AIOL when the ciliary muscle relaxes.
[0096] In this case, when adjustable AIOL 100 is implanted or introduced into a patient's natural capsular bag, radially outer portions 144 of haptics 104 of adjustable AIOL 100 can directly engage or physically contact the portions of the capsular bag that are connected to the zonules or zonular fibers. Thus, radially outer portions 144 of haptics 104 can be configured to respond to capsular bag reshaping forces applied radially as the zonules relax and stretch as a result of ciliary muscle movement.
[0097] When the ciliary muscles contract, the peripheral region of the elastic lens capsule reshapes and exerts a radially inward force on the radially outer portion 144 of the haptics 104 (e.g., the elastic lens capsule exerts a radially inward force on the radially outer portion 144 of the first haptic 104A and on the radially outer portion 144 of the second haptic 104B). This causes the radially outer portion 144 of the haptics 104 to deform or otherwise change shape, and this deformation or change in shape reduces the volume of the haptic fluid chamber 120. When the volume of the haptic fluid chamber 120 decreases, the fluid in the haptic fluid chamber 120 moves or is forced into the optical fluid chamber 110 in the optic portion 102. As described above, fluid travels from the haptic fluid chamber 120 through a fluid channel 122 (eg, a pair of fluid channels 122) formed within the optical portion 102 and into the optical fluid chamber 110.
[0098] The optic portion 102 (either the anterior component 106, the posterior component 108, or a combination thereof) can change shape (increase its curvature) in response to the inflow of fluid from the haptic fluid chamber 120 into the optical fluid chamber 110. This increases the base power or base spherical power of the tunable AIOL 100, thereby enabling a patient implanted with the tunable AIOL 100 in their eye to focus on near objects. The tunable AIOL 100 can also be considered to be in an accommodative state or to be undergoing accommodation.
[0099] When the ciliary muscles relax, the peripheral region of the elastic lens capsule stretches radially outward, stretching the capsule and creating more space within it. The radially outer portions 144 of the haptics 104 can be configured to respond to this reshaping of the capsule by returning to their undeformed or unstressed configuration. This causes the volume of the haptic fluid chamber 120 to increase or return to its undeformed volume. This increase in the volume of the haptic fluid chamber 120 causes fluid within the optical fluid chamber 110 to be extracted or otherwise flow out of the optical fluid chamber 110 and back into the haptic fluid chamber 120. As described above, fluid moves from the optical fluid chamber 110 into the haptic fluid chamber 120 through the same fluid channel 122 (e.g., a pair of fluid channels 122) formed within the optic portion 102.
[0100] As described above, the optic portion 102 (either the anterior component 106, the posterior component 108, or a combination thereof) can change shape (reduce its curvature or become flatter) in response to the inflow of fluid from the optical fluid chamber 110 into the haptic fluid chamber 120. This reduces the base power or base spherical power of the accommodative AIOL 100, thereby enabling a patient implanted with the accommodative AIOL 100 in their eye to focus on distant objects or provide distance vision. The accommodative AIOL 100 can also be considered to be in a disaccommodated state or to be undergoing disaccommodation.
[0101] 1B and 1C , the radially inner portion 146 of the haptic 104 can be designed to be thicker or bulkier (compared to the radially outer portion 144) to impart anterior-posterior stiffness or resilience to the haptic 104. In this way, when a capsular bag force is applied to the haptic 104 in the anterior-posterior direction, less deformation occurs compared to when the force is applied radially, resulting in less fluid movement between the haptic fluid chamber 120 and the optical fluid chamber 110. Due to the less fluid movement, the base power of the adjustable AIOL 100 changes less when an anterior-posterior force is applied to the adjustable AIOL 100. Thus, the design and material properties of the haptic 104 and the optic portion 102 can enable the adjustable AIOL 100 to maintain high sensitivity to radial forces applied to the haptic 104 by capsular bag reshaping caused by ciliary muscle movement.
[0102] In some embodiments, the anterior component 106 can be configured such that the anterior optical surface 112 changes shape from a spherical configuration to an aspherical configuration in response to fluid flowing into the optical fluid chamber 110. The aspherical configuration can correct higher-order aberrations, such as spherical aberration. Fluid can flow into the optical fluid chamber 110 from one or more haptic fluid chambers 120 coupled to the optic portion 102 in response to ciliary muscle movement.
[0103] The anterior optical surface 112 can be biased into an aspheric configuration such that the center or central portion of the anterior component 106 bends or bulges more than the outer periphery, which is held down by the adhesive 148 or adhesive layer of the anterior component 106 (see FIGS. 1B and 1C).
[0104] In other embodiments, the posterior component 108 can be configured such that the posterior optical surface 116 changes shape from a spherical configuration to an aspherical configuration in response to the flow of fluid into the optical fluid chamber 110.
[0105] The posterior optical surface 116 can be biased to an aspheric configuration such that the center or central portion of the posterior component 108 bends or bulges more than the outer periphery, which is held down by the adhesive 148 or adhesive layer of the anterior component 106.
[0106] The anterior component 106 can be attached or otherwise adhered to the posterior component 108 via an adhesive 148 or adhesive layer. The adhesive layer can be substantially annular in shape. The adhesive 148 or adhesive layer can be disposed on the periphery 150 (see FIG. 1D ) of the optic portion 102 between the anterior component 106 and the posterior component 108. For example, the adhesive 148 can be disposed on top of the raised inner surface 132 of the posterior component 108.
[0107] The adhesive 148 or adhesive layer can include or be partially formed of a biocompatible adhesive. The adhesive 148 or adhesive layer can include or be partially formed of a biocompatible polymer adhesive.
[0108] The adhesive 148 or adhesive layer can include or be formed in part from a crosslinkable polymer precursor composition, which can include or be formed in part from a copolymer blend, a hydroxyl-functional acrylic monomer, and a photoinitiator.
[0109] The copolymer blend can include an alkyl acrylate (e.g., n-butyl acrylate in an amount of about 41% to about 45% (wt%)), a fluoroalkyl 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 accelerate the cure 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).
[0110] The first step in forming the adhesive is to prepare a hydroxyl-functional polymer precursor by photopolymerizing a crosslinkable polymer precursor composition, thereby obtaining a cured composition. The second step is to chemically convert the precursor polymer pendant hydroxyl moieties, or hydroxyl pendant groups, to pendant methacrylate functional groups by reacting with methacrylic anhydride or methacryloyl chloride, thereby forming a crosslinkable polymer containing alkyl acrylate or methacrylate (e.g., n-butyl acrylate), fluoroalkyl (meth)acrylate (e.g., trifluoroethyl methacrylate), phenyl alkyl acrylate (phenyl ethyl acrylate), and 2-(2-methyl-acryloyloxy)ethyl acrylate.
[0111] The methacrylic-functional crosslinkable polymer can be blended with a reactive acrylic monomer diluent, such as 1-adamantyl methacrylate (ADMA), and with the same photoinitiator, such as Darocur 4265. For example, the final composition of adhesive 148 can include the crosslinkable polymer precursor composition in an amount of about 50% to about 85% (wt%) (e.g., about 61% to about 65%), the reactive acrylic monomer diluent in an amount of about 10% to about 40% (wt%) (32% to about 36%), and the photoinitiator, such as Darocur 4265, in an amount of about 2% to about 3% (wt%).
[0112] The adhesive 148 or adhesive layer can bond, adhere, or otherwise join the anterior component 106 to the posterior component 108. As described in more detail in the following section, the thickness of the adhesive layer can be adjusted after implantation to adjust the base power of the tunable AIOL 100.
[0113] In some embodiments, the same adhesive 148 used to bond the anterior component 106 to the posterior component 108 can also be used to bond or secure the peripheral portion 103 (e.g., one or more haptics 104) to the optical portion 102.
[0114] In certain embodiments, the anterior optical surface 112 of the anterior component 106 can be manufactured to have an aspheric optical surface before the adjustable AIOL 100 is implanted into a patient's eye. In these embodiments, the anterior optical surface 112 can be aspheric regardless of any changes in fluid pressure within the optical fluid chamber 110. In these embodiments, the anterior optical surface 112 can also maintain its asphericity across all base power changes.
[0115] In other embodiments, the posterior optical surface 116 of the posterior component 108 can be manufactured to have an aspheric optical surface before the adjustable AIOL 100 is implanted into a patient's eye. In these embodiments, the posterior optical surface 116 can be aspheric regardless of any changes in fluid pressure within the optical fluid chamber 110. In these embodiments, the posterior optical surface 116 can maintain its asphericity across all base power changes.
[0116] In some embodiments, the anterior component 106 can have a greater thickness at its center or central portion than at its peripheral portions. In certain embodiments, the posterior component 108 can also have a greater thickness at its center or central portion than at its peripheral portions.
[0117] 1B-1D, the optic portion 102 can have an optical axis 152. The optical axis 152 can extend in the anterior-posterior direction through a center or midpoint of the optic portion 102. The optical axis 152 can extend through a center or midpoint of both the anterior component 106 and the posterior component 108.
[0118] The thickness of the anterior component 106 may be greater at or near the optical axis 152 than at the peripheral portion of the anterior component 106. In some embodiments, the thickness of the anterior component 106 may gradually increase from the peripheral portion of the anterior component 106 toward the optical axis 152.
[0119] In certain embodiments, the thickness of the anterior component 106 at or near the optical axis 152 can be about 0.45 mm to about 0.55 mm. In these and other embodiments, the thickness of the anterior component 106 near the periphery can be about 0.20 mm to about 0.40 mm. This difference in thickness can contribute to the anterior optical surface 112 changing shape from a spherical configuration to an aspherical configuration when fluid flows from one or more haptic fluid chambers 120 into the fluid-filled optical fluid chamber 110.
[0120] Additionally, the anterior inner surface 114 of the anterior component 106 can have a smaller curvature or can be flatter than the anterior optical surface 112. This difference in surface curvature between the anterior inner surface 114 and the anterior optical surface 112 can also contribute to the anterior optical surface 112 changing shape from a spherical configuration to an aspherical configuration when fluid flows from one or more haptic fluid chambers 120 into the fluid-filled optical fluid chamber 110.
[0121] In other embodiments, the thickness of the posterior component 108 may be greater at or near the optical axis 152 than at a portion of the posterior component 108 radially outward from the optical axis 152 but before reaching the raised inner surface 132. The thickness of the posterior component 108 may gradually decrease from the optical axis 152 to a portion radially outward from the optical axis 152 but before reaching the raised inner surface 132. The thickness of the posterior component 108 may increase again from the beginning of the raised inner surface 132 towards the periphery 150.
[0122] In certain embodiments, the thickness of the posterior component 108 at or near the optical axis 152 can be about 0.45 mm to about 0.55 mm. In these and other embodiments, the thickness of the posterior component 108 radially outward from the optical axis 152 (but before reaching the raised inner surface 132) can be about 0.20 mm to about 0.40 mm. The thickness of the posterior component 108 near the periphery 150 can be about 1.00 mm to 1.15 mm. This difference in thickness can contribute to the posterior optical surface 116 changing shape from a spherical configuration to an aspherical configuration when fluid flows from one or more haptic fluid chambers 120 into the fluid-filled optical fluid chamber 110.
[0123] Additionally, the posterior inner surface 118 of the posterior component 108 can have a smaller curvature or can be flatter than the posterior optical surface 116. This difference in surface curvature between the posterior inner surface 118 and the posterior optical surface 116 can also contribute to the posterior optical surface 116 changing shape from a spherical configuration to an aspherical configuration when fluid flows from one or more haptic fluid chambers 120 into the fluid-filled optical fluid chamber 110.
[0124] 2A is a graphical representation of a composite material 200 including a composite base material 202, an energy-absorbing component 204, and a plurality of expandable components 206. In some embodiments, the optic portion 102 of the adjustable AIOL 100 can be formed in part from the composite material 200. In other embodiments, the peripheral portion 103 of the adjustable AIOL 100 can be formed in part from the composite material 200. In further embodiments, both the optic portion 102 and the peripheral portion 103 of the adjustable AIOL 100 can be formed in part from the composite material 200.
[0125] The composite base material 202 can include a methacrylate- or methacrylic-functional crosslinkable polymer, a reactive acrylic monomer diluent including lauryl methacrylate (n-dodecyl methacrylate, or SR313), and ADMA. By controlling the amount of lauryl methacrylate (SR313) relative to ADMA, the corresponding overall hardness (i.e., more ADMA) or softness (i.e., more SR313) of the cured composite material 200 can be controlled. The methacrylate- or methacrylic-functional crosslinkable polymer can be prepared using a crosslinkable polymer precursor composition. The crosslinkable polymer precursor composition can be the same crosslinkable polymer precursor composition used as part of the composition for the adhesive 148.
[0126] As discussed above, the optic portion 102 can include or be partially formed from a lens body material. Also, as discussed above, the peripheral portion 103 (e.g., one or more haptics 104) can include or be partially formed from a haptic material. The crosslinkable polymer precursor composition can include the same copolymer blends used to form the lens body material, haptic material, or adhesive.
[0127] The copolymer blend can include an alkyl acrylate or methacrylate (e.g., n-butyl acrylate), a fluoroalkyl (meth)acrylate (e.g., trifluoroethyl methacrylate), and a phenylalkyl acrylate (e.g., phenylethyl acrylate). For example, the copolymer blend can include about 41% to about 45% (wt%) of n-butyl acrylate, about 20% to about 24% (wt%) of trifluoroethyl methacrylate, and about 28% to about 32% (wt%) of phenylethyl acrylate. As described above, the crosslinkable polymer precursor composition can include, or be partially formed 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).
[0128] The composite base material 202 can include a methacrylate- or methacrylic-functional crosslinkable polymer (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 adomant methacrylic acid (ADMA) in an amount of about 5% to about 9% (e.g., about 7.30%) (wt%).
[0129] The composite material 200 can be prepared in multiple operations. A first operation can include preparing an unpigmented composite base material 202. A second operation can include combining the composite base material 202 with an energy absorbing component 204, an expandable component 206, and an initiator, such as one or more photoinitiators and thermal initiators, or a combination thereof. A third operation can include placing the uncured composite material 200 at a desired location within the optic portion 102 and one or more haptics 104, or a combination thereof, and curing the composite material 200 in place to form an adhered composite material 200.
[0130] For example, an unpigmented composite base material 202 can 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.
[0131] In some embodiments, the expandable component 206 can comprise about 5.0% to about 15.0% by weight of the final composition of the composite material 200. More specifically, the expandable component 206 can comprise about 8.0% to about 12.0% by weight (e.g., about 10.0% by weight) of the final composition (see Table 1) of the composite material 200. In these and other embodiments, the energy-absorbing component 204 can comprise about 0.044% to about 0.44% by weight (or about 0.55% by weight) of the final composition of the composite material 200.
[0132] The photoinitiator can be Omnirad 2022 (bis(2,4,6-trimethylbenzoyl)phenyl-phosphine oxide / 2-hydroxy-2-methyl-1-phenyl-propan-1-one). The photoinitiator can comprise approximately 1.30 wt % of the final composition of composite material 200 (see, e.g., Table 1). In addition, composite material 200 can also include a thermal initiator. The thermal initiator can comprise approximately 1.00 wt % of the final composition of 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®.
[0133] Table 1 below provides an exemplary composition for composite material 200. [Table 1]
[0134] FIG. 2B illustrates that the expandable component 206 can be an expandable microsphere including an expandable thermoplastic shell 208 and a blowing agent 210 contained within the expandable thermoplastic shell 208. The microspheres can be expandably configured such that at least one diameter 212 of the microspheres can increase to approximately twice their original diameter. In other embodiments, the microspheres can be expandably configured such that at least one diameter 212 of the microspheres can increase to approximately 4×, or approximately four times, their original diameter. In further embodiments, the microspheres can be expandably configured such that at least one diameter 212 of the microspheres can increase from approximately two to approximately four times (or approximately 3.5 times) their original diameter. For example, the microspheres can initially have a diameter 212 of approximately 12 μm. In response to external energy applied or directed to the composite material 200, or in response to energy transferred or transmitted to the microspheres, the diameter 212 of the microspheres can increase to approximately 40 μm.
[0135] The volume of at least one of the microspheres can be configured to expand from about ten times (10x) to about fifty times (50x) in response to external energy applied or directed to the composite material 20 or in response to energy transferred or transmitted to the microsphere.
[0136] In some embodiments, the blowing agent 210 can be an expandable fluid, such as an expandable gas. More specifically, the blowing agent 210 can be a branched chain hydrocarbon. For example, the blowing agent 210 can be isopentane. In other embodiments, the blowing agent 210 can be or include cyclopentane, pentane, or a mixture of cyclopentane, pentane, and isopentane.
[0137] 2B illustrates that each of the expandable components 206 can include a thermoplastic shell 208. FIG. 2B also illustrates that the thickness of the thermoplastic shell 208 can vary as the size of the expandable component 206 increases. More specifically, the thickness of the thermoplastic shell 208 can decrease as the size of the expandable component 206 increases. For example, if the expandable component 206 is an expandable microsphere, the thickness of the thermoplastic shell 208 (i.e., its thickness in the radial direction) can decrease as the diameter 212 of the expandable microsphere increases.
[0138] For example, as described above, at least one of the expandable microspheres may initially have a diameter 212 of about 12 μm. In this embodiment, the thermoplastic shell 208 of the expandable microsphere may have a shell thickness of about 2.0 μm. In response to external energy applied or directed to the composite material 200, or in response to energy transferred or transmitted to the microsphere, the diameter 212 of the microsphere may increase to about 40 μm (and the volume may expand about 10 to 50 times), and the shell thickness of the microsphere may decrease to about 0.1 μm.
[0139] Although Figures 2A and 2B depict the expandable component 206 as a sphere or microsphere, it is contemplated by this disclosure that the expandable component 206 may be substantially formed as an oval, ellipsoid, cube, or other polyhedron, or combinations thereof.
[0140] In some embodiments, the thermoplastic shell 208 may be formed in part from a nitrile or acrylonitrile copolymer. For example, the thermoplastic shell 208 may be formed in part from acrylonitrile, styrene, butadiene, methyl acrylate, or combinations thereof.
[0141] As discussed above, the expandable component 206 may comprise about 8.0% to about 12% by weight of the final composition of the composite material 200. The expandable component 206 may comprise about 10% by weight of the final composition of the composite material 200.
[0142] The expandable components 206 may be dispersed or otherwise distributed within a composite base material 202 that comprises the majority of the composite material 200. The composite base material 202 may act as a matrix to hold or support the expandable components 206. The composite material 200 may expand in response to the expansion of the expandable components 206 (e.g., thermoplastic microspheres). For example, the volume of the composite material 200 may increase in response to the expansion of the expandable components 206.
[0143] The composite material 200 also includes an energy absorbing component 204. In some embodiments, the energy absorbing component 204 can be an energy absorbing colorant.
[0144] In certain embodiments, the energy absorbing colorant 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.
[0145] In additional embodiments, the energy absorbing colorant can be or include a pigment, for example, the energy absorbing colorant can be or include graphitized carbon black as a pigment.
[0146] Similar to the expandable component 206, the energy absorbing component 204 may be dispersed or otherwise distributed within the composite base material 202 that makes up the majority of the composite material 200. The composite base material 202 may act as a matrix to hold or support the expandable component 206 and the energy absorbing component 204.
[0147] As discussed above, 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 composition of the composite material 200. For example, if the energy absorbing component 204 is a dye (e.g., an azo dye such as Disperse Red 1), the energy absorbing component 204 can comprise about 0.45% to about 1.0% by weight of the final composition of the composite material 200. If the energy absorbing component 204 is graphitized carbon black or other type of pigment, the energy absorbing component 204 can comprise about 0.025% to about 0.045% by weight of the final composition of the composite material 200.
[0148] The energy absorbing component 204 (e.g., azo dye, graphitized carbon black, or a combination thereof) can absorb or capture external energy applied or directed to the composite material 200. The energy absorbing component 204 can absorb or capture the external energy and then convert or transfer the energy to thermal energy or heat to the expandable component 206.
[0149] The thermoplastic shell 208 can soften and begin to flow when thermal energy is transferred or transmitted to the expandable component 206. The thermoplastic shell 208 of the expandable component 206 can then begin to thin or reduce in thickness in response to the thermal energy transferred or transmitted to the expandable component 206. As the thermoplastic shell 208 begins to soften and reduce in thickness, the blowing agent 210 within the expandable component 206 can expand. The blowing agent 210 can also expand in response to the thermal energy or heat transferred or transmitted to the expandable component 206. The expansion of the blowing agent 210 can cause the expandable component 206 (e.g., thermoplastic microspheres) to expand or increase in volume. This ultimately causes the composite material 200 to expand or increase in volume.
[0150] The composite material 200 can expand or increase in size in a fairly parametric, or isotropic, manner such that the composite material 200 expands in all directions. Such isotropic expansion can be utilized to create expansion or material displacement in a specific direction by placing or positioning the composite material 200 at a specific location along one or more haptics 104 or optic portion 102 of the tunable AIOL 100.
[0151] As described in more detail in the following sections, in some embodiments, the external energy can be light energy, and the energy absorbing component 204 can absorb or capture the light energy directed toward the composite material 200 and convert or transfer the light energy to thermal energy or heat to the expandable component 206. The blowing agent 210 within the expandable component 206 can expand or be energized in response to the thermal energy or heat. The expandable component 206, and thus the composite material 200, can expand or increase in volume in response to this light energy directed toward the composite material 200.
[0152] The shape change (e.g., an increase in volume) made by the expandable component 206 can be a lasting or substantially permanent change. A lasting or substantially permanent change can mean that the expandable component 206 does not substantially return to its original shape or size after the shape change occurs (e.g., after an increase in volume). As a result, any change in size or volume of the composite material 200 caused by a change in the size or volume of the expandable component 206 is also lasting or substantially permanent. As described in more detail in the following section, this means that any structural change made to the tunable AIOL 100 as a result of external energy or stimuli applied or otherwise directed to the composite material 200 embedded in or integrated within the tunable AIOL 100 can be sustained or retained substantially permanently.
[0153] The thermoplastic shell 208 of the expandable component 206 can harden again when external energy is no longer directed or applied to the composite material 200. The thermoplastic shell 208 of the expandable component 206 can harden again when the temperature in the vicinity of the expandable component 206 drops below a certain threshold. For example, the thermoplastic shell 208 of an expandable microsphere can harden when light energy is no longer directed toward the composite material 200. After the thermoplastic shell 208 has hardened, the expandable component 206 is locked in its newly sized, expanded configuration.
[0154] If the energy absorbing component 204 is an energy absorbing colorant, such as a dye or graphitized carbon, the color of at least a portion of the composite material 200 can be the color of the energy absorbing colorant. For example, if the energy absorbing component 204 is an azo dye having a red color, such as Disperse Red 1 dye, at least a portion of the composite material 200 including the energy absorbing component 204 can be colored red. Furthermore, if the energy absorbing component 204 is graphitized carbon having a black color, at least a portion of the composite material 200 including the energy absorbing component 204 can be colored black. Although this disclosure refers to two colors (e.g., red and black), it is contemplated by this disclosure and will be understood by one of ordinary skill in the art that other types of colored energy absorbing colorants can also be used, such as energy absorbing yellow, orange, or blue dyes or materials.
[0155] The color of the energy absorbing colorant can be visually perceptible to a clinician or another medical professional when the tunable AIOL 100 is formed in part from a composite material 200 that includes the energy absorbing colorant. The color of the energy absorbing colorant can be visually perceptible to a clinician or another medical professional when the tunable AIOL 100 is implanted into a patient's eye. For example, the composite material 200 can include Disperse Red 1, which functions as the energy absorbing colorant. In this example, at least a portion of the tunable AIOL 100 can appear red to a clinician or another medical professional when the tunable AIOL 100 is implanted into a patient's eye.
[0156] The color of the energy absorbing colorant can allow a clinician or another medical professional to detect or determine the placement or location of the composite material 200 within the adjustable AIOL 100. The color of the energy absorbing colorant can also allow a clinician or another medical professional to determine where to direct external energy or stimulation when adjusting the adjustable AIOL 100.
[0157] As described in more detail in the following sections, at least a portion of the tunable AIOL 100 can be formed from a composite material 200 including energy-absorbing components 204 of a first color (e.g., red), and another portion of the tunable AIOL 100 can be formed from an additional composite material 200 including energy-absorbing components 204 of a second color (e.g., black). By designing the tunable AIOL 100 in this manner, a clinician or another medical professional can direct external energy or stimulation to different portions of the tunable AIOL 100, using the different colors of the composite material 200 as guides or markers to identify different locations of such target sites. Furthermore, the different colored composite materials 200 can also serve as indicators or visual cues as to where to direct external energy or stimulation to cause specific changes to one or more optical parameters of the tunable AIOL 100 (e.g., base power, cylindricity, or a combination thereof).
[0158] One technical problem faced by applicants is how to integrate an adjustable composite material with the optic and peripheral portions (e.g., haptics) of an AIOL so that the adjustable composite material adheres to the lens material used to form the remainder of the AIOL and remains substantially fixed in a specific location within the optic or peripheral portion. One solution discovered by applicants and disclosed herein is a unique composition of the composite material that incorporates the same copolymer blend used to form the lens body material and haptic material. Moreover, the composite material is formed in part from a crosslinkable polymer precursor composition that is used in the adhesive to attach the portions of the AIOL to one another. By designing the AIOL in this way, the composite material is compatible with the remaining materials used to construct the optic and peripheral portions and remains substantially fixed in place without shifting or misalignment.
[0159] Another technical problem faced by the applicant is how to ensure that any conditioning performed on the AIOL persists long after the conditioning procedure. One solution discovered by the applicant and disclosed herein is to induce expansion of a composite material formed in part from expandable microspheres containing a blowing agent contained within a thermoplastic shell. The thermoplastic shell can soften (and reduce the thickness of the thermoplastic shell) in response to external energy directed or applied to the composite (which can be heat or thermal energy and transferred or transmitted to the expandable microspheres). The blowing agent within the thermoplastic shell can expand when the thermoplastic shell softens. The expansion of the blowing agent can expand the microspheres, which in turn can expand the composite base material that serves as the bulk of the composite. The expandable microspheres can retain their new expanded or inflated configuration after external energy is no longer applied to the composite.
[0160] Moreover, the composite material also includes an energy-absorbing component, such as an energy-absorbing dye or colorant. The energy-absorbing component can capture or absorb relatively harmless external energy or stimuli directed toward the composite material and convert or transform the external energy into thermal energy, which can then expand the thermoplastic microspheres. By designing the tunable AIOL 100 in this manner, one or more bursts or pulses of relatively harmless energy or stimuli (e.g., light energy) can be used to induce a sustained change in the shape or size of at least a portion of the tunable AIOL 100. This sustained change in the shape or size of the tunable AIOL 100 can have a lasting effect on the optical parameters of the lens, including, for example, its base power.
[0161] 3A and 3B show cross-sectional views of one embodiment of an adjustable AIOL 100 including an expandable spacer 300 formed at least in part from a composite material 200. The expandable spacer 300 can be located or otherwise disposed within the radially inner portion 146 of the peripheral portion 103 (e.g., haptics 104) of the adjustable AIOL 100.
[0162] As shown in Figures 3A and 3B, the radially inner portions 146 of the haptics 104 can be thicker or bulkier in the radial direction than the radially outer portions 144. Figures 3A and 3B also illustrate the adjustable AIOL 100 when implanted into a patient's eye, and more specifically, when placed within the patient's capsular bag 304 (illustrated using dashed lines in Figures 3A and 3B). The radially outer portions 144 of the haptics 104 can physically contact or press against the inner surface of the capsular bag 304 when the adjustable AIOL 100 is placed within the capsular bag 304.
[0163] 3A and 3B, the expandable spacer 300 can be partially located within the radially inner portion 146 of the haptic 104. In some embodiments, at least a portion of the expandable spacer 300 can protrude or extend radially inward or laterally toward the outer circumferential surface 142 of the optic portion 102. In these and other embodiments, at least a portion of the expandable spacer 300 can be located between the haptic 104 and the optic portion 102. More specifically, the expandable spacer 300 can be located between the optic portion 102 and the haptic fluid chamber 120 (e.g., radially between the optic portion 102 and the haptic fluid chamber 120).
[0164] In some embodiments, the expandable spacer 300 can be cured in place to adhere to the radially inner portion 146 of the haptic 104. For example, the expandable spacer 300 can be adhered to a groove, recess, or groove formed along the radially inner portion 146.
[0165] In other embodiments, the expandable spacer 300 can be located entirely within the radially inner portion 146 of the haptic 104. In some embodiments, a cavity, conduit, or other void can be formed within the radially inner portion 146, and the expandable spacer 300 can be introduced into such cavity, conduit, or void and cured in place.
[0166] In further embodiments, the expandable spacer 300 can be directed to a portion of the peripheral portion 103 (e.g., the haptics 104) formed from the composite material 200. For example, the expandable spacer 300 can refer to a portion of the radially inner portion 146 of the haptics 104 formed from the composite material 200.
[0167] Although Figures 3A and 3B illustrate the expandable spacer 300 as having a rectangular cross-sectional profile, it is contemplated by this disclosure, and will be understood by those skilled in the art, that the cross-sectional profile of the expandable spacer 300 may be substantially elliptical, circular, triangular, or other polygonal.
[0168] 3A and 3B also illustrate that the optical parameters of the tunable AIOL 100 can be affected by directing or otherwise applying external energy 302 to the expandable spacer 300 to induce a shape change in the expandable spacer 300 (e.g., by expanding the expandable spacer 300).
[0169] In some embodiments, the external energy 302 can be optical energy. More specifically, the external energy 302 can be laser light. In particular embodiments, the laser light can have a wavelength of about 488 nm to about 650 nm. The external energy 302 can be one or more bursts or pulses of laser light.
[0170] In some embodiments, the laser light can be green laser light. The green laser light can have a wavelength of about 520 nm to about 570 nm. In one example embodiment, the external energy 302 can be green laser light having a wavelength of about 532 nm.
[0171] For example, the laser light may be laser light emitted by an ophthalmic laser, for example, the laser light may be laser light emitted by a retinal coagulation laser.
[0172] When the external energy 302 is light energy, the energy absorbing component 204 can absorb or otherwise capture the light energy and convert it into thermal energy, thereby expanding the expandable component 206 within the composite material 200.
[0173] 3B , external energy 302 can expand the expandable spacer 300. The expansion of the expandable spacer 300 can cause the spacer 300 to press against the outer circumferential surface 142 of the optic portion 102. For example, the expanded expandable spacer 300 can press against the posterior component 108 of the optic portion 102. Due to the relatively thick or bulky peripheral portion of the posterior component 108 between the outer circumferential surface 142 and the raised inner surface 132, the expanded expandable spacer 300 primarily applies a radially outward force or a lateral outward force to the haptics 104.
[0174] 3B illustrates that the haptics 104 can be biased or pressed against the sides of the lens capsule 304. More specifically, the expanded expandable spacer 300 can bias or press the radially inner portions 146 of the haptics 104 radially outward. For example, FIG. 3B illustrates the radially outward displacement of the radially inner portions 146 of the haptics 104 using solid lines to indicate the position of the radially inner portions 146 after expansion or dashed lines to indicate the position of the radially inner portions 146 before expansion. Given the limited amount of space within the lens capsule 304, this radially outward displacement of the radially inner portions 146 of the haptics 104 can compress or squeeze the chamber walls of the haptic fluid chamber 120 against each other, thereby reducing the volume of the haptic fluid chamber 120.
[0175] As described above, both one or more haptic fluid chambers 120 and optical fluid chamber 110 can be filled with a fluid (e.g., silicone oil). Reducing the volume of haptic fluid chamber 120 allows at least a portion of the fluid in one or more haptic fluid chambers 120 to flow from one or more haptic fluid chambers 120 into optical fluid chamber 110. Moreover, as described above, one or more haptic fluid chambers 120 can be in fluid communication with optical fluid chamber 120 via multiple fluid channels 122 (including a first pair of fluid channels 122A, a second pair of fluid channels 122B, or a combination thereof; see FIG. 1A ). Although the fluid flow between the haptic fluid chamber 120 and the optical fluid chamber 110 is illustrated in FIG. 3B using curved arrows drawn using dashed lines, those skilled in the art will understand that fluid flows from one or more haptic fluid chambers 120 to the optical fluid chamber 120 via multiple fluid channels 122.
[0176] As described above, the base power of the optical portion 102 can be configured to change based on the internal fluid pressure within the fluid-filled optical fluid chamber 110. The base power of the optical portion 102 can be configured to increase when fluid flows into the optical fluid chamber 110 from one or more haptic fluid chambers 120.
[0177] The optic portion 102 can also be configured to change shape in response to the flow of fluid into the optical fluid chamber 110. In certain embodiments, the anterior component 106 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in response to the flow of fluid into the optical fluid chamber 110. In other embodiments, the posterior component 108 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in response to the flow of fluid into the optical fluid chamber 110. In further embodiments, both the anterior component 106 and the posterior component 108 can be configured to change shape in response to the flow of fluid into the optical fluid chamber 110. The base power of the optic portion 102 can be configured to increase in response to one or more shape changes made by the anterior component 106, the posterior component 108, or a combination thereof.
[0178] 3A and 3B , when the expandable spacer 300 is positioned between the optic portion 102 and one or more haptic fluid chambers 120, application of external energy 302 to the expandable spacer 300 can cause interaction between one or more haptics 104 and the lens environment surrounding the one or more haptics 104 (e.g., the sides of the lens capsule 304). This interaction between the one or more haptics 104 and the lens environment can result in an increase in the base power of the tunable AIOL 100.
[0179] For example, adjusting the base power of the adjustable AIOL 100 can include directing or applying external energy 302 (e.g., optical energy at about 520 nm to about 570 nm) to the adjustable AIOL 100 implanted in the patient's eye. More specifically, the external energy 302 can be applied or directed to an expandable spacer 300 formed in part from the composite material 200. The expandable spacer 300 can expand in response to the application of the external energy 302. The expansion of the spacer 300 can press or urge one or more haptics 104 radially or laterally outward against the sides of the lens capsule 304. This can compress or squeeze the walls of the haptic fluid chamber 120 together, thereby reducing the volume of the haptic fluid chamber 120. Fluid in one or more haptic fluid chambers 120 can then flow into optical fluid chamber 110 in response to this decrease in volume of one or more haptic fluid chambers 120. The base power of optical portion 102 can increase in response to this flow of fluid into optical fluid chamber 110.
[0180] In some embodiments, a burst or pulse of external energy 302 (e.g., light energy) directed toward the expandable spacer 300 can increase the base power of the tunable AIOL 100 by about +0.10 D to about +0.20 D (e.g., about +0.125 D). For example, a pulse of green laser light directed toward the expandable spacer 300 can increase the base power of the tunable AIOL 100 by about +0.10 D to about +0.20 D (e.g., about +0.125 D). In some embodiments, the base power of the tunable AIOL 100 can increase a total of about +1.0 D to about +5.0 D (e.g., about +2.0 D) in response to a burst or pulse of external energy 302 directed toward the expandable spacer 300.
[0181] 4A and 4B are plan and cross-sectional views of one embodiment of an adjustable AIOL 100 including an expandable spacer 300 extending radially inward toward the optical portion 102 and occupying a gap space 400 between one or more haptics 104 and the optical portion 102.
[0182] 4A , the adjustable AIOL 100 can be implanted within a patient's capsular bag 304 (see FIGS. 3A and 3B ). The haptics 104 of the adjustable AIOL 100 can be curved around the periphery of the optic portion 102, with the free ends of the haptics 104 positioned approximately diametrically opposite the optic portion 102.
[0183] 4A, the expandable spacer 300 can also be curved such that a radially inner portion of the expandable spacer 300 follows or matches the curvature of the optic portion 102. The expandable spacer 300 can extend along substantially the entire length of each haptic 104.
[0184] 4B illustrates that the expandable spacer 300 can extend radially inward from the radially inner portion 146 of the haptic 104 toward the optic portion 102. In some embodiments, the expandable spacer 300 can be formed as a fin-like protrusion extending radially inward from the radially inner portion 146 of the haptic 104. In other embodiments, the expandable spacer 300 can be formed substantially as discontinuous segments of an annulus disposed at least partially between the optic portion 102 and the haptic 104.
[0185] 4B, the expandable spacer 300 can have a height in the anterior-posterior direction. The anterior-posterior height of the expandable spacer 300 can be significantly smaller than the anterior-posterior height of the haptics 104. Moreover, the expandable spacer 300 is relatively unconstrained in the anterior-posterior direction such that any expansion of the spacer 300 primarily imparts a radially outward force or pressure to the haptics 104. Such expansion imparts a relatively small force or pressure to the haptics 104 in the anterior-posterior direction.
[0186] In some embodiments, expandable spacer 300 can have a spacer anterior-posterior height of about 0.10 mm to about 1.00 mm. Expandable spacer 300 can also have a spacer radial width. The spacer radial width can be about 0.50 mm to about 1.0 mm. In comparison, haptic fluid chamber 120 can have a haptic fluid chamber anterior-posterior height of about 2.0 mm to about 3.0 mm. Moreover, haptic fluid chamber 120 can have a haptic fluid chamber radial width of about 0.8 mm to about 1.1 mm.
[0187] 5A and 5B show cross-sectional views of another embodiment of an adjustable AIOL 100 including an expandable spreader 500 formed at least partially from a composite material 200. The expandable spreader 500 can be located or disposed within a radially inner portion 146 of the peripheral portion 103 (e.g., one or more haptics 104, as shown in FIGS. 5A and 5B). The radially inner portion 146 of the one or more haptics 104 can be thicker or bulkier in the radial direction than the radially outer portion 144.
[0188] 5A and 5B, the inflatable spreader 500 can be disposed within a channel 502 or opening defined within the radially inner portion 146 of the haptic 104. In some embodiments, the channel 502 or opening can extend along the entire length of the haptic 104. In other embodiments, the channel 502 or opening can extend partially along the length of the haptic 104. The channel 502 or opening can be in fluid communication with the haptic fluid chamber 120.
[0189] In some embodiments, the expandable spreader 500 can occupy all of the space within the channel 502 or opening except for the gap 504 or void between the expandable spreader 500 and the outer periphery 142 of the optic portion 102. In further embodiments, the gap 504 or void can be replaced with haptic material.
[0190] In other embodiments, the expandable spreader 500 can occupy at least a portion of the space within the channel 502 (e.g., the expandable spreader 500 is disposed within a radially intermediate portion of the channel 502 or opening). In these embodiments, a gap 504, or void, or additional haptic material can separate (e.g., radially separate) the expandable spreader 500 from the outer circumferential surface 142 of the optic portion 102. In all such embodiments, the expandable spreader 500 can be positioned or located such that expansion of the expandable spreader 500 does not substantially press or push the radially inner portions 146 of the haptics 104 or the expandable spreader 500 against the outer peripheral surface 142 of the optic portion 102 (which prevents the one or more haptics 104 from being pressed against the sides of the lens capsule 304, which would not cause deformation of the one or more haptics 104 or affect the volume of the one or more haptic fluid chambers 120). For example, the expandable spreader 500 can be positioned or located such that expansion of the expandable spreader 500 does not compress or squeeze the haptic chamber walls of the haptic fluid chambers 120 against each other (or result in a decrease in the volume of the haptic fluid chambers 120).
[0191] In some embodiments, the expandable spreader 500 can be attached to the radially inner portion 146 of the haptic 104 by being cured in place within the channel 502 or opening. For example, the expandable spreader 500 can be attached to a location or position in the middle portion of the channel 502 or opening.
[0192] In further embodiments, the expandable spreader 500 can point to a portion of the peripheral portion 103 (e.g., a portion of the haptics 104) formed from the composite material 200. For example, the expandable spreader 500 can point to a portion of the radially inner portion 146 of the haptics 104 formed from the composite material 200.
[0193] Although FIGS. 5A and 5B illustrate the inflatable spreader 500 as having a rectangular cross-sectional profile, it is contemplated by this disclosure, and will be understood by those skilled in the art, that the cross-sectional profile of the inflatable spreader 500 may be substantially elliptical, circular, triangular, or other polygonal.
[0194] 5A and 5B illustrate that external energy 302 can be directed or otherwise applied to the expandable spreader 500 to induce a shape change in the expandable spreader 500 (e.g., to expand the expandable spreader 500), which can affect the optical parameters of the tunable AIOL 100.
[0195] In some embodiments, the external energy 302 is light energy, such as laser light. In particular embodiments, the laser light can have a wavelength of about 488 nm to about 650 nm. The external energy 302 can be one or more bursts or pulses of laser light. In some embodiments, the laser light can be green laser light.
[0196] If the external energy 302 is light energy, the energy absorbing component 204 may absorb or otherwise capture the light energy and convert it to thermal energy, which may cause the expandable component 206 within the composite material 200 to expand.
[0197] 5B, external energy 302 can expand the expandable spreader 500. The expansion of the expandable spreader 500 can push the spreader 500 against the channel walls 506 of the channel 502 defined in the radially inner portion 146 of the haptic 104.
[0198] 5B illustrates that expanded spreader 500 can expand or spread apart channel walls 506, thereby expanding or spreading apart channel 502. Moreover, expanded spreader 500 can also deform the chamber walls of haptic fluid chamber 120 by spreading apart at least a portion of the chamber walls, thereby expanding the volume of haptic fluid chamber 120.
[0199] The expanded inflatable spreader 500 can bias or spread apart the channel walls 506 of the channel 502, at least in the anterior-posterior direction, which can result in an increased volume of the haptic fluid chamber 120. For example, FIG. 5B uses solid lines to show the spread apart channel walls 506 and haptic chamber walls, and dashed lines to show the positions of the channel walls 506 and haptic chamber walls before expansion. 5B also illustrates that the gap 504 or void between the spreader 500 and the optic portion 102 allows the spreader 500 to expand or increase in size without being pressed or compressed against the outer circumferential surface 142 of the optic portion 102 (which prevents the one or more haptics 104 from being pressed against the sides of the lens capsule 304, thereby not causing deformation of the one or more haptics 104 or affecting the volume of the one or more haptic fluid chambers 120). In other embodiments, additional haptic material can separate the spreader 500 from the outer circumferential surface 142 of the optic portion 102 such that expansion of the spreader 500 only spreads the channel walls 506 and chamber walls apart, but does not press the radially outer portions 144 of the one or more haptics 104 against the sides of the lens capsule 304.
[0200] As described above, both one or more haptic fluid chambers 120 and optical fluid chamber 110 can be filled with a fluid (e.g., silicone oil). Increasing the volume of haptic fluid chamber 120 can allow at least a portion of the fluid in optical fluid chamber 110 to flow from optical fluid chamber 110 into one or more haptic fluid chambers 120. Moreover, as described above, one or more haptic fluid chambers 120 can be in fluid communication with optical fluid chamber 120 via multiple fluid channels 122 (including a first pair of fluid channels 122A, a second pair of fluid channels 122B, or a combination thereof; see FIG. 1A ). Although the fluid flow between the haptic fluid chamber 120 and the optical fluid chamber 120 is illustrated in FIG. 5B using curved arrows drawn using dashed lines, those skilled in the art will understand that fluid flows from the optical fluid chamber 110 to one or more haptic fluid chambers 120 via multiple fluid channels 122.
[0201] As described above, the base power of the optical portion 102 can be configured to change based on the internal fluid pressure within the fluid-filled optical fluid chamber 110. The base power of the optical portion 102 can be configured to decrease when fluid flows from the optical fluid chamber 110 into one or more haptic fluid chambers 120.
[0202] The optic portion 102 can also be configured to change shape in response to fluid being discharged from the optical fluid chamber 110. In certain embodiments, the anterior component 106 of the optic portion 102 can be configured to change shape (e.g., decrease its curvature) in response to fluid being discharged from the optical fluid chamber 110. In other embodiments, the posterior component 108 of the optic portion 102 can be configured to change shape (e.g., decrease its curvature) in response to fluid being discharged from the optical fluid chamber 110. In further embodiments, both the anterior component 106 and the posterior component 108 can be configured to change shape in response to fluid being discharged from the optical fluid chamber 110. The base power of the optic portion 102 can be configured to decrease in response to one or more shape changes made by the anterior component 106, the posterior component 108, or a combination thereof.
[0203] 5A and 5B, applying external energy 302 to the expandable spreader 500 (e.g., when the expandable spreader 500 is positioned within a channel 502 or opening defined in the radially inner portion 146 of one or more haptics 104) can increase the volume of one or more haptic fluid chambers 120. This increase in the volume of one or more haptic fluid chambers 120 can extract fluid from the optical fluid chamber 110 and can reduce the base power of the tunable AIOL 100.
[0204] For example, a method for decreasing the base power of adjustable AIOL 100 can include directing or applying external energy 302 (e.g., optical energy at about 520 nm to about 570 nm) to an expandable spreader 500 embedded within adjustable AIOL 100 implanted in a patient's eye. More specifically, external energy 302 can be applied or directed to expandable spreader 500 formed in part from composite material 200. Expandable spreader 500 can expand in response to the application of external energy 302. The expansion of spreader 500 can expand the volume of one or more haptic fluid chambers 120. Fluid within optical fluid chamber 110 can then flow into one or more haptic fluid chambers 120 in response to this increase in the volume of one or more haptic fluid chambers 120. The base power of optic portion 102 can decrease in response to this fluid outflow from optical fluid chamber 110.
[0205] In some embodiments, a burst or pulse of external energy 302 (e.g., light energy) directed toward the inflatable spreader 500 can decrease the base power of the adjustable AIOL 100 by about −0.10D to about −0.20D (e.g., about −0.125D). For example, a pulse of green laser light directed toward the inflatable spreader 500 can decrease the base power of the adjustable AIOL 100 by about −0.10D to about 0.20D (e.g., about 0.125D). In some embodiments, the base power of the adjustable AIOL 100 can decrease a total of about −1.0D to about −5.0D (e.g., about −2.0D) in response to a burst or pulse of external energy 302 directed toward the inflatable spreader 500.
[0206] 6 shows a cross-sectional view of another embodiment of an adjustable AIOL 100 including an expandable protrusion 600 formed at least partially from a composite material 200. The expandable protrusion 600 can be located or otherwise positioned along a portion of the radially inner portion 146 of the peripheral portion 103 (e.g., one or more haptics 104) of the adjustable AIOL 100.
[0207] 6, haptic 104 (e.g., either first haptic 104A or second haptic 104B) can include a haptic chamber wall that surrounds haptic fluid chamber 120. For example, haptic chamber wall can include radially inner wall 602 and radially outer wall 604. Haptic fluid chamber 120 can be partially defined by radially inner wall 602 and radially outer wall 604.
[0208] The expandable protrusions 600 can be located or otherwise positioned along a portion of the radially inner wall 602 of the haptic 104. More specifically, the expandable protrusions 600 can be located or otherwise positioned or secured along a radially outermost portion 606 of the radially inner wall 602 of the haptic 104.
[0209] In some embodiments, the adjustable AIOL 100 can be designed such that a gap or void 608 radially separates the radially inner walls 602 of the haptics 104 from the outer peripheral surface 142 of the optic portion 102. This can ensure that when the expandable protrusions 600 are expanded, neither the expandable protrusions 600 nor the radially inner walls 602 are pressed or compressed against the outer peripheral surface 142 of the optic portion 102 (this prevents the one or more haptics 104 from being pressed against the sides of the lens capsule 304, which would neither cause deformation of the one or more haptics 104 nor affect the volume of the one or more haptic fluid chambers 120). As described above, when the radially inner portions 146 of the haptics 104 are pressed against the outer peripheral surface 142 of the optic portion 102, the haptic chamber walls can be compressed or squeezed together as a result of the radially outer walls 604 of the haptics 104 being pressed against the sides of the patient's lens capsule 304. In other embodiments, the adjustable AIOL 100 can be designed so that the radially inner walls 602 of the haptics 104 rest continuously against the outer peripheral surface 142 of the optic portion 102 or so that they rest intermittently against the outer peripheral surface 142 of the optic portion 102.
[0210] In some embodiments, for example, as shown in FIG. 6 , the entire expandable protrusion 600 can be located below (or above) the midline or haptic midline 610. The midline or haptic midline 610 can bisect the anterior-posterior height of the haptic 104. In these embodiments, in an uninflated state, no portion of the expandable protrusion 600 can extend beyond the haptic midline 610. The anterior-posterior height of the expandable protrusion 600 can be smaller than the anterior-posterior height of the radially inner wall 602.
[0211] In some embodiments, the expandable protrusions 600 can be attached to the radially inner portion 146 (e.g., the radially inner wall 602) of the haptic 104 by being cured in place. For example, the expandable protrusions 600 can be attached to a groove, recess, or groove formed along the radially outermost portion 606 of the radially inner wall 602. In these examples, the expandable protrusions 600 can make up or occupy less than half of the anterior-posterior height of the radially inner wall 602.
[0212] In further embodiments, the expandable protrusion 600 may refer to a portion of the radially inner portion 146 (e.g., a portion of the radially inner wall 602) formed from the composite material 200. For example, the expandable protrusion 600 may refer to a portion of the radially outermost portion 606 of the radially inner wall 602 formed from the composite material 200.
[0213] Although FIG. 6 illustrates the cross-sectional profile of the expandable projection 600 as having primarily straight edges and corners, it is contemplated by this disclosure, and will be understood by one skilled in the art, that the cross-sectional profile of the expandable projection 600 may also have rounded or curved edges and corners.
[0214] FIG. 6 also illustrates that external energy 302 can be directed or otherwise applied to the expandable protrusions 600 to induce a shape change in the expandable protrusions 600 (e.g., to expand the expandable protrusions 600), which can affect the optical parameters of the tunable AIOL 100.
[0215] The external energy 302 can be the same external energy 302 described above. For example, if the external energy 302 is light energy, the energy absorbing component 204 can absorb or otherwise capture the light energy and convert it to thermal energy, which can cause the expandable component 206 in the composite material 200 to expand.
[0216] 6 , external energy 302 can expand expandable protrusion 600 (as illustrated by the expanded protrusion 600 shown in dashed lines). The expansion of expandable protrusion 600 can cause protrusion 600 to intrude, stretch, or otherwise grow into fluid-filled haptic fluid chamber 120. This can move or force fluid within haptic fluid chamber 120 into optical fluid chamber 110 (via multiple fluid channels 122). Furthermore, when protrusion 600 expands and a portion of protrusion 600 intrudes, stretches, or grows into haptic fluid chamber 120, the fluid holding capacity or available volume of haptic fluid chamber 120 can be reduced.
[0217] As described above, both one or more haptic fluid chambers 120 and optical fluid chamber 110 can be filled with a fluid (e.g., silicone oil). Reducing the fluid holding capacity or available volume of haptic fluid chamber 120 can cause at least a portion of the fluid in one or more haptic fluid chambers 120 to flow from one or more haptic fluid chambers 120 to optical fluid chamber 110 and remain within optical fluid chamber 110. Although fluid communication between haptic fluid chamber 120 and optical fluid chamber 110 is illustrated in FIG. 6 using curved arrows drawn with dashed lines, one skilled in the art will understand that fluid flows from one or more haptic fluid chambers 120 to optical fluid chamber 110 via multiple fluid channels 122.
[0218] As described above, the base power of the optical portion 102 can be configured to change based on the internal fluid pressure within the fluid-filled optical fluid chamber 110. The base power of the optical portion 102 can be configured to increase as fluid flows into the optical fluid chamber 110 from one or more haptic fluid chambers 120.
[0219] The optic portion 102 can also be configured to change shape in response to the flow of fluid into the optical fluid chamber 110. In certain embodiments, the anterior component 106 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in response to the flow of fluid into the optical fluid chamber 110. In other embodiments, the posterior component 108 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in response to the flow of fluid into the optical fluid chamber 110. In further embodiments, both the anterior component 106 and the posterior component 108 can be configured to change shape in response to the flow of fluid into the optical fluid chamber 110. The base power of the optic portion 102 can be configured to increase in response to one or more shape changes made by the anterior component 106, the posterior component 108, or a combination thereof.
[0220] In some embodiments, a burst or pulse of external energy 302 (e.g., light energy) directed toward the expandable protrusions 600 can increase the base power of the tunable AIOL 100 by about +0.10D to about +0.20D (e.g., about +0.125D). For example, a pulse of green laser light directed toward the expandable protrusions 600 can increase the base power of the tunable AIOL 100 by about +0.10D to about +0.20D (e.g., about +0.125D). In some embodiments, the base power of the tunable AIOL 100 can increase by a total of about +1.0D to about +5.0D (e.g., about +2.0D) in response to a burst or pulse of external energy 302 directed toward the expandable protrusions 600.
[0221] 7A and 7B show plan and cross-sectional views, respectively, of another embodiment of an adjustable AIOL 100 that includes both an inflatable spreader 500 and an inflatable protrusion 600 that form at least a portion of each haptic 104. For example, as shown in FIG. 7A, a first haptic portion formed from inflatable spreader 500 can be positioned or attached to a portion of a haptic chamber wall, and a second haptic portion formed from inflatable protrusion 600 can be positioned or attached to another portion of the same haptic chamber wall.
[0222] In some embodiments, the first haptic portion (e.g., the expandable spreader 500) can be partially formed from a first composite material or from a first type of composite material 200 shown in FIG. 2A, and the second haptic portion (e.g., the expandable protrusion 600) can be partially formed from a second composite material or from a second type of composite material 200 shown in FIG. 2A.
[0223] In some embodiments, the first composite material can be partially formed from a first energy-absorbing component (e.g., the first type of energy-absorbing component 204 shown in FIG. 2A ), and the second composite material can be partially formed from a second energy-absorbing component (e.g., the second type of energy-absorbing component 204 shown in FIG. 2A ). For example, the first composite material can be partially formed from Disperse Red 1 dye, and the second composite material can be partially formed from graphitized carbon black. The first energy-absorbing component can have or exhibit a first color (e.g., Disperse Red 1 dye can have or exhibit a red color), and the second energy-absorbing component can have or exhibit a second color different from the first color (e.g., graphitized carbon black can have or exhibit a black color). As another example, the first energy-absorbing component can be an azo dye having a first color (e.g., Disperse Red 1 dye), and the second energy-absorbing component can be another azo dye having a second color (e.g., Disperse Orange 1 dye). This difference in color allows a clinician or another medical professional to visually distinguish between the two haptic portions.
[0224] In certain embodiments, a first composite material formed in part from a first energy absorbing component can expand in response to a first type of external energy directed at the first composite material (e.g., light energy between 520 nm and 540 nm), and a second composite material formed in part from a second energy absorbing component can expand in response to a second type of external energy directed at the second energy absorbing component (e.g., light energy between 600 nm and 650 nm). In these and other embodiments, the first energy absorbing component can have or exhibit a first color (e.g., red), and the second energy absorbing component can have or exhibit a second color different from the first color (e.g., orange or blue).
[0225] In other embodiments, the first and second composite materials may be formed in part from the same energy-absorbing components, but contain different amounts or weight percentages of these components. In other embodiments, the first and second composite materials may be formed in part from the same energy-absorbing components, but contain different amounts or weight percentages of the expandable component 206.
[0226] 7A, a first haptic portion partially formed from a first composite material can be positioned or arranged radially offset from a second haptic portion partially formed from a second composite material. For example, expandable spreader 500 can be positioned radially offset from expandable protrusions 600 on each haptic 104. More specifically, a radially innermost portion of haptic 104 can be partially formed from expandable spreader 500, and an adjacent portion of the haptic radially outward from expandable spreader 500 can be partially formed from expandable protrusions 600.
[0227] 7A, the inflatable spreader 500 can extend along a portion of the length of the haptic 104. Additionally, the inflatable protrusions 600 can also extend along a portion of the length of the haptic 104.
[0228] 7B illustrates that the same radially inner wall 602 of the haptic 104 can include both the expandable spreader 500 and the expandable protrusions 600. In the embodiment shown in FIG. 7B, the expandable spreader 500 can be formed in part from a first composite material (e.g., composite material 200 including a first energy-absorbing colorant), and the expandable protrusions 600 can be formed in part from a second composite material (e.g., composite material 200 including a second energy-absorbing colorant). The difference in color of the energy-absorbing colorant allows a clinician or another medical professional to more easily distinguish between the expandable spreader 500 and the expandable protrusions 600. In other embodiments (e.g., as shown in FIG. 9B), the expandable spreader 500 and the expandable protrusions 600 can be formed from the same composite material 200.
[0229] The expandable spreader 500 can be disposed within a channel 502 or opening formed in the radially inner wall 602. The channel 502 or opening can be in fluid communication with the haptic fluid chamber 120.
[0230] In some embodiments, the expandable spreader 500 can occupy a radially innermost portion 700 of the radially inner wall 602 of the haptic 104. In these embodiments, the expandable spreader 500 can also occupy or be disposed at a radially innermost end of the channel 502. In further embodiments, the expandable spreader 500 can refer to a portion of the haptic chamber wall of the haptic 104 that is formed from the composite material 200. For example, in these embodiments, the expandable spreader 500 can refer to a portion of the radially innermost portion 700 of the radially inner wall 602 of the haptic 104 that is formed from the composite material 200.
[0231] 7B, a void 608 or gap can separate the radially innermost portion 700 of the radially inner wall 602 of the haptic 104 from the outer circumferential surface 142 of the optic portion 102. This allows the expandable spreader 500 to expand without being forced or pressed against the outer circumferential surface 142 of the optic portion 102.
[0232] 7B , the expandable protrusion 600 can be located or otherwise positioned or secured along a radially outermost portion 606 of the radially inner wall 602 of the haptic 104. In certain embodiments, the expandable protrusion 600 can refer to a portion of the haptic chamber wall formed from the composite material 200. For example, the expandable protrusion 600 can refer to a portion of the radially outermost portion 606 of the radially inner wall 602 of the haptic 104 formed from the composite material 200.
[0233] External energy 302 directed or otherwise applied to expandable spreader 500 located along a haptic chamber wall (e.g., located along radially innermost portion 700 of radially inner wall 602 of haptic 104) can expand expandable spreader 500. The expansion of expandable spreader 500 can press spreader 500 against channel walls 506 of channels 502 and expand at least one of channels 502 and haptic fluid chambers 120. This can increase the volume of one or more haptic fluid chambers 120. This can extract fluid from optical fluid chamber 110 (via fluid channel 122) into one or more haptic fluid chambers 120 and reduce the base power of tunable AIOL 100 (e.g., by approximately −0.10D to −0.20D).
[0234] The same external energy 302, or another type of external energy 302 (e.g., optical energy of another wavelength), can also be directed or otherwise applied to expandable protrusions 600 located along the haptic chamber wall (e.g., located along the radially outermost portion 606 of the radially inner wall 602 of the haptic 104). The external energy can expand the expandable protrusions 600. Expansion of the expandable spreader 500 can cause the protrusions 600 to penetrate, stretch, or otherwise grow into the fluid-filled haptic fluid chamber 120. This can move or push fluid within the haptic fluid chamber 120 (via the multiple fluid channels 122) into the optical fluid chamber 110. A burst or pulse of external energy 302 (e.g., optical energy) directed toward the expandable protrusions 600 can increase the base power of the tunable AIOL 100 by approximately +0.10D to +0.20D.
[0235] 8 shows a plan view of another embodiment of an adjustable AIOL 100 that includes both an inflatable spreader 500 and inflatable protrusions 600 implemented as discrete components 800 along the haptics 104. In an alternative embodiment, at least one of the inflatable spreader 500 and the inflatable protrusions 600 can be replaced by an inflatable spacer 300 (see FIGS. 3A and 3B).
[0236] In some embodiments, the inflatable spreader 500 can occupy or be located along a radially innermost portion 700 (see FIG. 7B ) of the radially inner wall 602 of one or more haptics 104. The inflatable protrusion 600 can occupy or be located along a radially outermost portion 606 (see FIG. 6 ) of the radially inner wall 602 of one or more haptics 104.
[0237] At least one of the expandable spreader 500 and the expandable protrusions 600 may be implemented or configured as a discrete component 800 that is visually perceptible to a clinician or another medical professional responsible for adjusting the adjustable AIOL 100 when the adjustable AIOL 100 is implanted into a patient's eye.
[0238] Discrete components 800 can refer to the shape or configuration of inflatable spreader 500, inflatable protrusions 600, or a combination thereof. In some embodiments, discrete components 800 can have a circular profile when viewed from top to bottom or from front to back. In these embodiments, each of discrete components 800 can be formed as a substantially cylinder. In other embodiments not shown, discrete components 800 can have an oval profile, a rectangular profile, a triangular profile, a diamond or rhombus profile, a star profile, any other polygonal profile, or a combination thereof when viewed from top to bottom or from front to back. Discrete components 800 can be closely spaced apart, or each of discrete components 800 can be separated from one another by a portion of haptic material.
[0239] 8, a portion or segment of one haptic 104 can include an inflatable spreader 500, while another portion or segment of the same haptic 104 can include an inflatable protrusion 600. For example, a distal segment 802 of each haptic 104 (e.g., a segment 802 near the closed free end 138 of the haptic 104) can include an inflatable spreader 500, while a proximal segment 804 of each haptic 104 (e.g., a segment 804 near the optical portion 102) can include an inflatable protrusion 600. As shown in FIG. 8, the inflatable protrusions implemented as discrete components 800 can be radially offset or spaced apart from the inflatable spreader 500, which is also implemented as a discrete component 800.
[0240] Designing or otherwise configuring at least one of the expandable spreader 500 and the expandable protrusions 600 as discrete components 800 allows a clinician or medical professional to adjust the adjustable AIOL 100. For example, the clinician or medical professional can direct external energy 302 at one of the discrete components 800 and increase the base power of the adjustable AIOL 100 by a set amount (if the discrete component 800 is an expandable protrusion 600) or decrease the base power of the adjustable AIOL 100 (if the discrete component 800 is an expandable spreader 500). More specifically, in certain embodiments, the discrete components 800 can be sized, shaped, or arranged to allow a burst or pulse of external energy 302 applied to each of the discrete components 800 to adjust an optical parameter (e.g., base power) of the adjustable AIOL 100 by a predetermined or preset amount. For example, a burst or pulse of external energy 302 applied or directed to each of the discrete components 800 can vary the base power by approximately ±0.10D and ±0.20D (e.g., approximately ±0.125D).
[0241] Moreover, in this example, the clinician or medical professional can also further increase or decrease the base power of the adjustable AIOL 100 by directing additional bursts or pulses of external energy 302 to the same discrete component 800, or can undo or negate a previous adjustment (e.g., decrease the base power after it has been increased) by directing additional bursts or pulses of external energy 302 to a different discrete component 800.
[0242] Although FIG. 8 illustrates one or more haptics 104 including both an inflatable spreader 500 and an inflatable protrusion 600 (configured as discrete components 800), it is contemplated by this disclosure, and will be understood by those skilled in the art, that each haptic 104 may also include only an inflatable spreader 500 or only an inflatable protrusion 600 as a discrete component 800.
[0243] 7A, 7B, and 8, the tunable AIOL 100 can be configured such that the base power of the tunable AIOL 100 can be adjusted in a first manner (e.g., increasing the base power) by directing or otherwise applying external energy 302 to a first portion of a haptic 104 formed in part from the composite material 200. Additionally, the base power of the tunable AIOL 100 can be adjusted in a second manner (e.g., decreasing the base power) by directing or otherwise applying additional bursts or pulses of external energy 302 to a second portion of the same or different haptic 104 formed in part from the composite material 200. In some embodiments, the composite material 200 used to form the first portion of the haptic 104 can be or exhibit a different color than the composite material 200 used to form the second portion of the haptic 104 as a result of differences in the energy-absorbing components 204 that make up the composite material 200.
[0244] 9A shows a top view of another embodiment of an adjustable AIOL 100 that includes both an inflatable spreader 500 and inflatable protrusions 600 arranged in a visually perceptible pattern 900. The visually perceptible pattern 900 can enable a clinician or medical professional responsible for adjusting the adjustable AIOL 100 after surgery to distinguish between the inflatable spreader 500 and the inflatable protrusions 600, particularly when the inflatable spreader 500 and the inflatable protrusions 600 are formed from the same composite material 200 having the same color (as shown in FIG. 9A ). This allows the clinician or medical professional to more easily determine where to direct or apply external energy 302 on the adjustable AIOL 100 to adjust the optical parameters of the adjustable AIOL 100.
[0245] As shown in FIGS. 9A-9C , visually perceptible pattern 900 can include both continuous curved segments of expandable projections 600 and spaced branch or finger-shaped segments of expandable spreader 500 extending radially inward from the continuous curved segments. FIG. 9A also illustrates that branch or finger-shaped segments of expandable projections 600 can be separated from one another by portions of haptic material 902. Haptic material 902 can be the same haptic material used to construct the remainder of one or more haptics 104. For example, visually perceptible pattern 900 can be a comb-shaped pattern. In other embodiments, visually perceptible pattern 900 can be a wave pattern, a chain-triangle pattern, a zigzag pattern, or a combination thereof.
[0246] For example, a clinician or another medical professional can direct or otherwise apply external energy 302 to the spaced apart tines or finger-shaped segments to inflate the inflatable spreader 500 to decrease the base power of the adjustable AIOL 100. A clinician or another medical professional can also direct or otherwise apply external energy 302 to the inflatable protrusions 600, which are formed as curved portions disposed radially outward of the spaced apart tines or finger-shaped segments, to inflate the inflatable protrusions 600 to increase the base power of the adjustable AIOL 100.
[0247] FIG. 9B shows a cross-sectional view of one embodiment of the adjustable AIOL 100 shown in FIG. 9A , as viewed along section AA. As shown in FIG. 9B , this cross-section of the haptic 104 can include both an inflatable spreader 500 and inflatable protrusions 600 attached, formed, or otherwise disposed along the radially inner wall 602. The inflatable spreader 500 can be located along the radially innermost portion 700 of the radially inner wall 602, or can be located in the radially innermost portion of a channel 502 defined along the radially inner wall 602. The inflatable protrusions 600 can be located along the radially outermost portion 606 of the radially inner wall 602 of the haptic 104. The inflatable protrusions 600 can be located directly below or further posterior to the inflatable spreader 500. Furthermore, the adjustable AIOL 100 can be configured such that a void 608 or gap separates the radially inner wall 602 of the haptic 104 from the outer peripheral surface 142 of the optical portion 102, such that when the expandable spreader 500 expands, no portion of the haptic 104 is substantially pressed against or pushed up against the outer peripheral surface 142 of the optical portion 102 (this prevents one or more haptics 104 from being pressed against the sides of the lens capsule 304, which would not cause deformation of the one or more haptics 104 or affect the volume of the one or more haptic fluid chambers 120).
[0248] 9C shows a cross-sectional view of one embodiment of the adjustable AIOL shown in FIG. 9A, as viewed along cross section BB. As shown in FIG. 9C, this cross-section of haptic 104 can include only expandable protrusions 600 attached, formed, or otherwise disposed along radially inner wall 602. Expandable protrusions 600 can be located along a radially outermost portion 606 of radially inner wall 602 of haptic 104. The remainder of radially inner wall 602 can be formed from the same haptic material 902 used to construct the remainder of haptic 104.
[0249] The visually perceptible pattern 900 allows a clinician or medical professional to more easily determine where to direct or apply external energy 302 on the adjustable AIOL 100 to adjust the optical parameters of the adjustable AIOL 100. This is useful when both the expandable spreader 500 and the expandable protrusions 600 have the same color or are formed from the same composite material 200 that exhibits the same color. To increase the base power of the adjustable AIOL 100, the clinician or medical professional can direct or otherwise apply external energy 302 only to the curved portions of the expandable protrusions 600 to inflate the expandable protrusions 600. The clinician or medical professional can also direct or otherwise apply external energy 302 only to the branch or finger-shaped portions to inflate the expandable spreader 500 to decrease the base power of the adjustable AIOL 100.
[0250] One technical problem encountered by the applicant is how to integrate a composite material with the rest of the tunable AIOL without interfering with the optical quality of the lens. One solution discovered by the applicant and disclosed herein is to place or embed a composite material within or along the haptic chamber wall. More specifically, the solution discovered by the applicant is to place or embed a composite material along or within the radially inner wall of one or more haptics.
[0251] 10 shows a cross-sectional view of another embodiment of an optic portion 102 of an adjustable AIOL 100 that includes an adhesive layer 1000 formed in part from a composite material 200. In some embodiments, the adhesive layer 1000 can include the composite material 200 integrated or mixed with the adhesive 148 described above. In other embodiments, the composite material 200 is disposed or sandwiched between layers of adhesive 148.
[0252] The adhesive layer 1000 can be located or disposed along the periphery 150 of the posterior component 108 (i.e., the tops of the raised inner surfaces 132). Although Figure 10 illustrates the adhesive layer 1000 as being disposed along opposite sides of the optic portion 102, one skilled in the art will understand that the adhesive layer 1000 extends circumferentially around the entire periphery of the optic portion 102. The adhesive layer 1000 can also be referred to as being rotationally symmetric.
[0253] In some embodiments, the base power of the tunable AIOL 100 can be configured to decrease in response to external energy 302 directed or otherwise applied to the adhesive layer 1000. The adhesive layer 1000 can be configured to expand in response to external energy 302 directed to the adhesive layer 1000. The external energy 302 can be directed to the entire adhesive layer 1000 surrounding the periphery of the optic portion 102.
[0254] The expansion of the adhesive layer 1000 can cause the front component 106 to bulge, increasing the volume of the optical fluid chamber 110. This can cause the front component 106 to flatten slightly as the internal fluid pressure within the fluid-filled optical fluid chamber 110 decreases.
[0255] In some embodiments, a burst or pulse of external energy 302 (e.g., light energy) directed toward the adhesive layer 1000 can decrease the base power of the tunable AIOL 100 by about −0.10D to −0.20D (e.g., about −0.125D). For example, a pulse of green laser light directed toward the adhesive layer 1000 can decrease the base power of the tunable AIOL 100 by about −0.10D to −0.20D (e.g., about −0.125D). In some embodiments, in response to a burst or pulse of external energy 302 directed toward the adhesive layer 1000, the base power of the tunable AIOL 100 can decrease by a total of about −1.0D to about −5.0D (e.g., about −2.0D).
[0256] 11 is a perspective view of another embodiment of an adjustable AIOL 100 including an adjustable anterior component 1100 having a composite material 200 disposed or located along a circumferential portion on a radially opposite side of the anterior component 1100. As shown in FIG. 11 , the composite material 200 may be molded or configured as multiple discrete components 800 disposed on the circumferential portion on opposite sides of the anterior component 1100.
[0257] For example, the composite material 200 may be molded or configured as a plurality of discrete components 800 aligned along a first perimeter 1102 and a second perimeter 1104 of the forward component 1100. The first perimeter 1102 may be radially opposite the second perimeter 1104 or may be spaced apart from the second perimeter 1104 by approximately 180 degrees. In all such embodiments, the composite material 200 does not extend along or surround the entire circumference of the forward component 1100.
[0258] In some embodiments, the composite material 200 can be disposed or attached between the anterior optical surface 112 and the anterior inner surface 114. In other embodiments, the composite material 200 can extend or protrude partially from the anterior optical surface 112. The composite material 200 can be visually perceptible to a clinician or another medical professional when the adjustable AIOL 100 is implanted into a patient's eye. For example, the composite material 200 can be formed in part from an energy absorbing component 204 or colorant that has or exhibits a color (e.g., red or black) that is visually perceptible to a clinician or another medical professional.
[0259] A clinician or another medical professional can direct or otherwise apply external energy 302 to the composite material 200 (e.g., to all of the composite material 200 shaped or configured as discrete components 800 along the first perimeter 1102 and the second perimeter 1104). The composite material 200 can expand in response to this application of external energy 302. This expansion or swelling of the composite material 200 can cause the anterior optical surface 112 of the anterior component 1100 to flatten or exhibit a flatter curvature along a first midline of the anterior component 1100 (referred to as the flat midline 1106). The flat midline 1106 can be substantially perpendicular to another midline of the anterior component 1100 (referred to as the steep midline 1108), where the curvature of the anterior component 1100 along this other midline is substantially unaffected by the expansion of the composite material 200. In this manner, a cylindrical shape or cylindricity is induced to the anterior optical surface 112 of the anterior component 1100. This change in cylindricity of the anterior component 1100 can persist or remain substantially permanently even after the external energy 302 is no longer directed or applied to the anterior component 1100.
[0260] More specifically, in response to application of external energy 302, the radius of curvature of the anterior optical surface 112 measured along the flat midline 1106 can be greater than the radius of curvature of the anterior optical surface 112 measured along the steep midline 1108. Moreover, in response to application of external energy 302, the peripheral thickness of the anterior component 1100 along the flat midline 1106 can be greater than the peripheral thickness of the anterior component 1100 along the steep midline 1108.
[0261] In some embodiments, the anterior component 1100 can be induced to have a cylindrical power of about +0.50D to about +5.0D (e.g., about +1.50D or about +3.0D) by applying or directing external energy 302 to the composite material 200. The cylindrical power can be measured along the steep midline 1108 of the anterior component 1100.
[0262] 11 illustrates an adjustable AIOL 100 that includes an adjustable anterior component 1100 having a composite material 200, it is contemplated by the present disclosure that the adjustable AIOL 100 may also include an adjustable posterior component having a composite material 200. For example, the composite material 200 may be disposed or located along opposite radially opposing periphery portions of the posterior component. The composite material 200 may be molded or configured as multiple discrete components 800 disposed on opposite peripheries of the posterior component.
[0263] In some embodiments, composite material 200 can be disposed or attached between posterior optical surface 116 and posterior inner surface 118 (see, e.g., FIGS. 1B and 1C). In other embodiments, composite material 200 can extend or protrude partially from posterior optical surface 116. Composite material 200 can be visually perceptible to a clinician or another medical professional when adjustable AIOL 100 is implanted into a patient's eye.
[0264] A clinician or another medical professional can direct or otherwise apply external energy 302 to the composite material 200 that forms part of the periphery of the posterior component. The composite material 200 can expand in response to this application of external energy 302. This expansion or swelling of the composite material 200 can cause the posterior optical surface 116 to flatten or exhibit a flatter curvature along a flat midline of the posterior component. The flat midline can be substantially perpendicular to the steep midline of the posterior component, where the curvature of the posterior component along the steep midline is substantially unaffected by the expansion of the composite material 200. In this manner, a cylindrical shape or cylindricity is induced with respect to the posterior optical surface 116 of the posterior component. This change in cylindricity of the posterior component can persist or be substantially permanently retained even after the external energy 302 is no longer directed or applied to the posterior component.
[0265] More specifically, in response to the application of external energy 302, the radius of curvature of the posterior optical surface 116 measured along the flat midline can be greater than the radius of curvature of the posterior optical surface 116 measured along the steep midline. Moreover, in response to the application of external energy 302, the peripheral thickness of the posterior component along the flat midline can be greater than the peripheral thickness of the posterior component along the steep midline.
[0266] In some embodiments, the posterior component can be induced to have a cylindrical power of about +0.50D to about +5.0D (e.g., about +1.50D or about +3.0D) by applying or directing external energy 302 to the composite material 200. The cylindrical power can be measured along the steep midline of the posterior component.
[0267] One technical problem encountered by applicant is how to induce cylindricity or cylindrical shape in an accommodating intraocular lens without interfering with the optical quality of the lens. One solution discovered by applicant and disclosed herein is to place or embed a composite material along or within the periphery of an optical component (e.g., an anterior component, a posterior component, or a combination thereof). More specifically, the solution discovered by applicant is to place or embed a composite material along or within a portion of two diametrically opposed peripheries of at least one of the anterior and posterior components.
[0268] Disclosed herein is an intraocular lens including an optic portion and a peripheral portion coupled to the optic portion, at least one of the optic portion and the peripheral portion being formed in part from a composite material including an energy absorbing component and a plurality of expandable components, wherein the base power of the optic portion is configured to change in response to external energy directed at the composite material.
[0269] An intraocular lens as disclosed herein, wherein when the intraocular lens is implanted into a subject's eye, the base power of the optical portion is configured to change in response to external energy directed at the composite material.
[0270] 10. An intraocular lens as disclosed herein, wherein the expandable components are expandable microspheres, each of the expandable microspheres comprising a foaming agent contained within a thermoplastic shell.
[0271] An intraocular lens as disclosed herein, wherein the foaming agent is a branched chain hydrocarbon.
[0272] An intraocular lens as disclosed herein, wherein the branched chain hydrocarbon is isopentane.
[0273] An intraocular lens as disclosed herein, wherein the thickness of the thermoplastic shell is configured to change in response to external energy directed at the composite material.
[0274] An intraocular lens as disclosed herein, wherein the thermoplastic shell is formed in part from an acrylonitrile copolymer.
[0275] 1. An intraocular lens as disclosed herein, wherein a diameter of at least one of the expandable microspheres is configured to increase by about two to about four times in response to external energy directed at the composite material.
[0276] An intraocular lens as disclosed herein, wherein at least one volume of the expandable component is configured to expand approximately 10 to 50 times in response to external energy directed at the composite material.
[0277] An intraocular lens as disclosed herein, wherein the expandable component comprises about 5% to about 15% by weight of the composite material.
[0278] An intraocular lens as disclosed herein, wherein the expandable component comprises about 10% by weight of the composite material.
[0279] An intraocular lens as disclosed herein, wherein the energy absorbing component is an energy absorbing colorant.
[0280] An intraocular lens as disclosed herein, wherein the color of the energy absorbing colorant is visually perceptible to a clinician when the intraocular lens is implanted in the eye.
[0281] An intraocular lens as disclosed herein, wherein the energy absorbing colorant is a dye.
[0282] An intraocular lens as disclosed herein, wherein the dye is an azo dye.
[0283] An intraocular lens as disclosed herein, wherein the dye is Disperse Red 1 dye.
[0284] An intraocular lens as disclosed herein, wherein the energy absorbing colorant is a pigment.
[0285] An intraocular lens as disclosed herein, wherein the pigment is graphitized carbon black.
[0286] 1. An intraocular lens as disclosed herein, wherein at least one of an optical portion and a peripheral portion is formed in part from a first composite material and a second composite material, the first composite material including a first energy absorbing colorant, the second composite material including a second energy absorbing colorant, and the color of the first energy absorbing colorant is different from the color of the second energy absorbing colorant.
[0287] An intraocular lens as disclosed herein, wherein the energy absorbing component comprises from about 0.025% to about 1.00% by weight of the composite material.
[0288] An intraocular lens as disclosed herein, wherein at least one of the optical portion and the peripheral portion is formed in part from a crosslinked copolymer, including a copolymer blend, and the composite material is formed in part from the copolymer blend.
[0289] An intraocular lens as disclosed herein, wherein the copolymer blend comprises an alkyl acrylate, a fluoroalkyl acrylate, and a phenyl alkyl acrylate.
[0290] An intraocular lens as disclosed herein, wherein the composite material further comprises at least one of a reactive acrylic monomer diluent, a photoinitiator, and a thermal initiator.
[0291] An intraocular lens as disclosed herein, wherein the composite material is adhered to the cross-linked copolymer at a location within at least one of the optical portion and the peripheral portion, and the composite material remains substantially fixed in that location.
[0292] An intraocular lens as disclosed herein, wherein the base power of the optical portion is configured to vary in a range of about ±0.05D to about ±0.5D in response to a pulse of external energy directed at the composite material.
[0293] An intraocular lens as disclosed herein, wherein the base power of the optic portion is configured to vary by a total of up to ±5.0D.
[0294] An intraocular lens as disclosed herein, wherein the external energy is light energy.
[0295] An intraocular lens as disclosed herein, wherein the light energy is laser light.
[0296] An intraocular lens as disclosed herein, wherein the laser light has a wavelength of about 488 nm to about 650 nm.
[0297] An intraocular lens as disclosed herein, wherein the laser light is green laser light.
[0298] An intraocular lens as disclosed herein, wherein the green laser light has a wavelength of about 532 nm.
[0299] An intraocular lens as disclosed herein, wherein the optical portion is formed in part from a composite material and the base power is configured to change in response to external energy directed at the optical portion.
[0300] An intraocular lens as disclosed herein, wherein the peripheral portion is formed in part from a composite material, and the base power of the optical portion is configured to change in response to external energy directed toward the peripheral portion.
[0301] An intraocular lens as disclosed herein, wherein the optical portion is formed in part from a composite material, and the cylindricity of the optical surface of the optical portion is configured to change in response to external energy directed at the optical portion.
[0302] An intraocular lens as disclosed herein, wherein the change in cylindricity of the optic portion is a permanent change.
[0303] An intraocular lens as disclosed herein, wherein the change in base power is a continuous change.
[0304] An intraocular lens as disclosed herein, wherein the optical portion includes an anterior component having an anterior optical surface and a posterior component having a posterior optical surface.
[0305] An intraocular lens as disclosed herein, wherein the composite material is disposed along a first periphery of the anterior component and along a second periphery of the anterior component that is radially opposite the first periphery, and the cylindricity of the anterior optical surface is configured to change in response to external energy directed toward the first periphery and the second periphery.
[0306] An intraocular lens as disclosed herein, wherein the composite material is disposed along a first periphery of the posterior component and along a second periphery of the posterior component that is radially opposite the first periphery, and the cylindricity of the posterior optical surface is configured to change in response to external energy directed toward the first periphery and the second periphery.
[0307] An intraocular lens as disclosed herein, wherein the optical portion includes an anterior component, a posterior component, and a fluid-filled optical chamber defined between the anterior and posterior components, and the anterior component is circumferentially bonded or attached to the posterior component by an adhesive layer, the adhesive layer comprising a composite material.
[0308] An intraocular lens as disclosed herein, wherein the base power is configured to decrease in response to expansion of the adhesive layer as a result of external energy directed at the composite material in the adhesive layer.
[0309] An intraocular lens as disclosed herein, wherein the optical portion includes a fluid-filled optical chamber and the peripheral portion includes at least one haptic including a fluid-filled haptic fluid chamber in fluid communication with the optical chamber.
[0310] An intraocular lens as disclosed herein, wherein the base power is configured to change in response to fluid movement between the optical chamber and the haptic fluid chamber as a result of external energy directed at the composite material.
[0311] An intraocular lens as disclosed herein, wherein the base power is configured to change in response to a change in the volume of the haptic fluid chamber as a result of external energy directed at the composite material.
[0312] An intraocular lens as disclosed herein, wherein the intraocular lens is configured to change its base power in response to the interaction between the haptics and the lens environment surrounding the intraocular lens when the intraocular lens is implanted into the eye.
[0313] An intraocular lens as disclosed herein, wherein the composite material is configured as a spacer extending radially from the haptic chamber wall, the spacer configured to expand in response to external energy directed at the spacer, and the expansion of the spacer reduces the volume of the haptic fluid chamber by pressing the haptics against the lens environment.
[0314] An intraocular lens as disclosed herein, wherein the composite material is located partially within a haptic chamber wall that surrounds the haptic fluid chamber.
[0315] An intraocular lens as disclosed herein, wherein the composite material is at least partially disposed within a channel formed along the radially inner wall of the haptic, and the volume of the haptic fluid chamber is configured to expand in response to external energy directed toward the composite material.
[0316] An intraocular lens as disclosed herein, wherein the composite material is at least partially disposed along the radially outermost portion of the radially inner wall of the haptic, and the volume of the haptic fluid chamber is configured to decrease in response to external energy directed toward the composite material.
[0317] An intraocular lens as disclosed herein, wherein the composite material is configured to expand into the haptic fluid chamber in response to external energy directed at the composite material.
[0318] An intraocular lens as disclosed herein, wherein the energy absorbing component is configured to transfer thermal energy to a plurality of expandable components in response to external energy directed at the composite material.
[0319] Also disclosed in the present specification is an accommodating intraocular lens, comprising: an optical portion; and a haptic coupled to the optical portion, the haptic comprising a first haptic portion and a second haptic portion, wherein the first haptic portion is partially formed from a composite material comprising an energy absorbing component and a plurality of expandable components, and the second haptic portion is partially formed from a composite material, wherein the base power of the optical portion is configured to increase in response to external energy directed toward the first haptic portion, and the base power of the optical portion is configured to decrease in response to external energy directed toward the second haptic portion.
[0320] An accommodating intraocular lens as disclosed herein, wherein the optical portion includes a fluid-filled optical fluid chamber and the haptics include a fluid-filled haptic fluid chamber in fluid communication with the optical fluid chamber.
[0321] An accommodating intraocular lens as disclosed herein, wherein the base power of the optical portion is configured to increase in response to external energy directed toward the first haptic portion as a result of fluid flow from the haptic fluid chamber to the optical fluid chamber.
[0322] An accommodating intraocular lens as disclosed herein, wherein the base power of the optical portion is configured to decrease in response to external energy directed toward the second haptic portion as a result of fluid flow from the optical fluid chamber to the haptic fluid chamber.
[0323] An accommodating intraocular lens as disclosed herein, wherein at least one of the first haptic portion and the second haptic portion is partially located within a haptic chamber wall surrounding the haptic fluid chamber.
[0324] An accommodating intraocular lens as disclosed herein, wherein a first haptic portion is partially formed from a first composite material, and a second haptic portion is partially formed from a second composite material, the first composite material including a first energy absorbing component, and the second composite material including a second energy absorbing component, and the composition of the first energy absorbing component is different from the composition of the second energy absorbing component.
[0325] An accommodating intraocular lens as disclosed herein, wherein a first haptic portion is partially formed from a first composite material, a second haptic portion is partially formed from a second composite material, the first composite material includes a first energy absorbing component, and the second composite material includes a second energy absorbing component, and the composition of the first energy absorbing component is the same as the composition of the second energy absorbing component.
[0326] An accommodating intraocular lens as disclosed herein, wherein the first energy absorbing component has a first color and the second energy absorbing component has a second color different from the first color.
[0327] An accommodating intraocular lens as disclosed herein, wherein the first haptic portion is radially offset from the second haptic portion.
[0328] An accommodating intraocular lens as disclosed herein, wherein at least one of the first haptic portion and the second haptic portion is oriented in a pattern such that the position along the haptic of at least one of the first haptic portion and the second haptic portion is visually perceptible to a clinician.
[0329] Also disclosed herein is a method for adjusting an accommodating intraocular lens, the method comprising adjusting the base power of the accommodating intraocular lens by directing external energy to a composite material within at least one of the optical portion and peripheral portion of the accommodating intraocular lens, the composite material comprising an energy absorbing component and a plurality of expandable components.
[0330] A method as disclosed herein, further comprising adjusting the base power of the accommodating intraocular lens when the accommodating intraocular lens is implanted into the subject's eye.
[0331] A method as disclosed in the present specification, further comprising adjusting the cylindricity of the optical surface of the optical portion of the accommodating intraocular lens by directing external energy to a composite material disposed on a periphery located radially opposite the optical portion.
[0332] The method disclosed herein further includes directing external energy to the composite material to impart energy to the energy absorbing component, thereby transferring thermal energy to the plurality of expandable components.
[0333] The method disclosed herein, wherein the plurality of expandable components are expandable thermoplastic microspheres, and wherein external energy is directed toward the composite material to expand the thermoplastic microspheres.
[0334] A method as disclosed herein, wherein the external energy is light energy.
[0335] 10. The method disclosed herein, wherein the light energy is laser light having a wavelength of about 488 nm to about 650 nm.
[0336] The method disclosed herein, further comprising adjusting the base power of the optical portion in a range of about ±0.05D to about ±0.5D by directing a pulse of external energy to the composite material.
[0337] A method as disclosed herein, wherein the optical portion includes a fluid-filled optical chamber and the peripheral portion includes at least one haptic including a fluid-filled haptic fluid chamber in fluid communication with the optical chamber, and the method further includes moving fluid between the optical chamber and the haptic fluid chamber by directing external energy toward the composite material.
[0338] A method as disclosed herein, further comprising adjusting the base power of the accommodating intraocular lens by directing external energy to the composite material to change the volume of the haptic fluid chamber.
[0339] A method as disclosed herein, further comprising adjusting the base power of the accommodating intraocular lens by directing external energy to the composite material when the accommodating intraocular lens is implanted into the eye, thereby causing the peripheral portion to interact with the crystalline lens environment surrounding the accommodating intraocular lens.
[0340] A method as disclosed herein, further comprising adjusting the base power of the accommodating intraocular lens by directing external energy to the composite material to change the volume of the optical fluid chamber.
[0341] 10. The method disclosed herein, wherein at least one of the optical portion and the peripheral portion is formed in part from a crosslinked copolymer, including a copolymer blend, and the composite material is formed in part from the copolymer blend.
[0342] Numerous embodiments have been described. Nevertheless, those skilled in the art will understand that various changes and modifications can be made to the present disclosure without departing from the spirit and scope of the embodiments. The components of the systems, devices, apparatuses, and methods illustrated with any embodiment are exemplary of a particular embodiment and can be used in combination or otherwise on other embodiments within the present disclosure. For example, the steps of any method illustrated in the drawings or described in this disclosure need not be in the particular order or sequential order as illustrated or described to achieve the desired results. In addition, other step operations may be provided, or steps or operations may be removed or omitted from the described method or process to achieve the desired results. Furthermore, any component or part of any apparatus or system described in this disclosure or illustrated in the drawings may be removed, eliminated, or omitted to achieve the desired results. In addition, certain components or parts of the systems, devices, or apparatuses illustrated or described herein have been omitted for the sake of brevity and clarity.
[0343] Accordingly, other embodiments are within the scope of the following claims, and the specification and / or drawings are to be regarded in an illustrative rather than a restrictive sense.
[0344] Each individual variation or embodiment described and illustrated herein has distinct components and features that may be readily separated from or combined with features of any of the other variations or embodiments. Modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s), or process step(s) to one or more objectives, spirit, or scope of the present invention.
[0345] Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as in the recited order of events, and additional steps or operations may be provided or steps or operations may be eliminated in order to achieve desired results.
[0346] Furthermore, when a range of values is provided, all intervening values between the upper and lower limits of that range, and any other stated or intervening value within that stated range, are encompassed within the invention. Also, any optional feature of the described inventive variations may be set forth and claimed independently or in combination with any one or more features described herein. For example, reciting a range of 1 to 5 should be considered to disclose subranges such as 1 to 3, 1 to 4, 2 to 4, 2 to 5, 3 to 5, etc., as well as individual numbers within that range, e.g., 1.5, 2.5, etc., and any whole or partial increments therebetween.
[0347] All pre-existing subject matter (e.g., publications, patents, patent applications) mentioned herein is incorporated herein by reference in its entirety, except to the extent that such subject matter may conflict with the subject matter of the present invention, in which case the present invention shall control. References 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.
[0348] Reference to a singular item includes the possibility of a plural of the same item. More specifically, as used in this specification and the appended claims, the singular forms "a," "an," "said," and "the" include plural referents unless the context clearly dictates otherwise. It should be further noted that the claims may be drafted to exclude any optional element. Accordingly, this reference is intended to serve as a precondition for the use of exclusive language such as "solely," "only," and the like in connection with the recitation of claim elements, as well as a precondition for the use of a "negative" limitation. Unless otherwise specified, 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.
[0349] A reference to the phrase "at least one of," when the phrase modifies more than one item or component (or an enumerated list of items or components), means any combination of one or more of those items or components. For example, the phrase "at least one of A, B, and C" means (i) A, (ii) B, (iii) C, (iv) A, B, and C, (v) A and B, (vi) B and C, or (vii) A and C.
[0350] For purposes of understanding the scope of the present disclosure, as used herein, the term "comprise" and its derivatives are intended to be open-ended terms that specify the presence of stated features, components, members, groups, integers, and / or steps, but do not exclude the presence of other, unstated features, components, members, groups, integers, and / or steps. The same also applies to terms of similar meaning, such as "comprise," "have," and their derivatives. Furthermore, the terms "part," "section," "portion," "member," "component," or "component," when used in the singular, can have the dual meaning of a single part or multiple parts. As used herein, the directional terms "front, rear, above, below, vertical, horizontal, underneath, lateral, side, and vertical" and any other similar directional terms refer to the position of a device or piece of equipment or the orientation of a device or piece of equipment being translated or driven.
[0351] Finally, as used herein, terms of degree, such as "substantially," "approximately," and "about," refer to a stated value or value and reasonable amounts of deviation from that stated value (e.g., deviations up to ±0.1%, ±1%, ±5%, or ±10%, where such variations are appropriate) such that the end result is not significantly or substantially altered. For example, "about 1.0 cm" can be interpreted as meaning "1.0 cm" or "0.9 cm to 1.1 cm." When terms of degree, such as "approximately" or "about," are used to refer to numbers or values that are part of a range, the term can be used to modify both the minimum and maximum numbers or values.
[0352] The present disclosure is not intended to be limited in scope to the particular embodiments defined, but is intended to cover 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 be obvious to those skilled in the art in light of the present disclosure.
Claims
1. An intraocular lens, The optical part and a peripheral portion coupled to the optical portion; at least one of the optic portion and the peripheral portion is formed in part from a composite material including an energy absorbing component and a plurality of expandable components; An intraocular lens wherein the base power of the optic portion is configured to change in response to external energy directed at the composite material.
2. The intraocular lens of claim 1 , wherein the expandable components are expandable microspheres, each of the expandable microspheres including a blowing agent contained within a thermoplastic shell.
3. 3. The intraocular lens of claim 2, wherein a diameter of at least one of the expandable microspheres is configured to increase by about two to about four times in response to the external energy directed at the composite material.
4. The intraocular lens of claim 1 , wherein the energy absorbing component is an energy absorbing colorant.
5. The intraocular lens of claim 4 , wherein the energy absorbing colorant is an azo dye.
6. The intraocular lens of claim 4 , wherein the energy absorbing colorant is graphitized carbon black.
7. 5. The intraocular lens of claim 4, wherein at least one of the optical portion and the peripheral portion is formed in part from a first composite material and a second composite material, the first composite material including a first energy absorbing colorant, the second composite material including a second energy absorbing colorant, and the color of the first energy absorbing colorant being different from the color of the second energy absorbing colorant.
8. The intraocular lens of claim 1 , wherein at least one of the optical portion and the peripheral portion is formed in part from a cross-linked copolymer, including a copolymer blend, and the composite material is formed in part from the copolymer blend.
9. The intraocular lens of claim 8 , wherein the copolymer blend comprises an alkyl acrylate, a fluoroalkyl acrylate, and a phenyl alkyl acrylate.
10. The intraocular lens of claim 1 , wherein the base power of the optical portion is configured to vary between about ±0.05D and about ±0.5D in response to a pulse of external energy directed at the composite material.
11. The intraocular lens of claim 1 , wherein the base power of the optical portion is configured to vary by a total of up to ±5.0 D.
12. The intraocular lens of claim 1 , wherein the external energy is laser light having a wavelength of about 488 nm to about 650 nm.
13. The intraocular lens of claim 1 , wherein the optical portion is partially formed from the composite material, and the cylindricity of the optical surface of the optical portion is configured to change in response to the external energy directed at the optical portion.
14. The intraocular lens of claim 1 , wherein the optical portion includes an anterior component having an anterior optical surface and a posterior component having a posterior optical surface.
15. 15. The intraocular lens of claim 14, wherein the composite material is disposed along a first periphery of the anterior component and along a second periphery of the anterior component that is radially opposite the first periphery, and wherein the cylindricity of the anterior optical surface is configured to change in response to the external energy directed toward the first periphery and the second periphery.
16. 15. The intraocular lens of claim 14, wherein the composite material is disposed along a first periphery of the posterior component and along a second periphery of the posterior component that is radially opposite the first periphery, and wherein the cylindricity of the posterior optical surface is configured to change in response to the external energy directed toward the first periphery and the second periphery.
17. 2. The intraocular lens of claim 1, wherein the optical portion includes an anterior component, a posterior component, and a fluid-filled optical chamber defined between the anterior component and the posterior component, the anterior component being circumferentially bonded or attached to the posterior component by an adhesive layer, the adhesive layer including the composite material.
18. The intraocular lens of claim 1 , wherein the optical portion includes a fluid-filled optical chamber and the peripheral portion includes at least one haptic including a fluid-filled haptic fluid chamber in fluid communication with the optical chamber.
19. The intraocular lens of claim 18, wherein the base power is configured to change in response to fluid movement between the optical chamber and the haptic fluid chamber as a result of the external energy directed at the composite material.
20. The intraocular lens of claim 18, wherein the base power is configured to change in response to a change in volume of the haptic fluid chamber as a result of the external energy directed at the composite material.
21. The intraocular lens of claim 18, wherein the composite material is configured as a spacer extending radially from a haptic chamber wall, the spacer configured to expand in response to the external energy directed at the spacer, the expansion of the spacer reducing the volume of the haptic fluid chamber by pressing the haptics against the crystalline lens environment surrounding the lens.
22. The intraocular lens of claim 18 , wherein the composite material is partially disposed within a haptic chamber wall surrounding the haptic fluid chamber.
23. The intraocular lens of claim 18, wherein the composite material is at least partially disposed within a channel formed along a radially inner wall of the haptic, and the volume of the haptic fluid chamber is configured to expand in response to the external energy directed toward the composite material.
24. The intraocular lens of claim 18, wherein the composite material is at least partially disposed along the radially outermost portion of the radially inner wall of the haptic, and the volume of the haptic fluid chamber is configured to decrease in response to the external energy directed toward the composite material.
25. 25. The intraocular lens of claim 24, wherein the composite material is configured to expand into the haptic fluid chamber in response to the external energy directed at the composite material.
26. An accommodating intraocular lens, The optical part and a haptic coupled to the optical portion, the haptic including a first haptic portion and a second haptic portion; the first haptic portion is formed in part from a composite material including an energy absorbing component and a plurality of expandable components; the second haptic portion is formed in part from the composite material; a base power of the optical portion configured to increase in response to external energy directed at the first haptic portion; An accommodating intraocular lens, wherein the base power of the optic portion is configured to decrease in response to the external energy directed toward the second haptic portion.
27. 27. The accommodating intraocular lens of claim 26, wherein the optical portion includes a fluid-filled optical fluid chamber, and the haptics include fluid-filled haptic fluid chambers in fluid communication with the optical fluid chamber.
28. The accommodating intraocular lens of claim 27, wherein the base power of the optical portion is configured to increase in response to the external energy directed toward the first haptic portion as a result of fluid flow from the haptic fluid chamber to the optical fluid chamber.
29. The accommodating intraocular lens of claim 27, wherein the base power of the optical portion is configured to decrease in response to the external energy directed toward the second haptic portion as a result of fluid flow from the optical fluid chamber to the haptic fluid chamber.
30. 27. The accommodating intraocular lens of claim 26, wherein the first haptic portion is formed in part from a first composite material, the second haptic portion is formed in part from a second composite material, the first composite material includes a first energy absorbing component, and the second composite material includes a second energy absorbing component, and the composition of the first energy absorbing component is different from the composition of the second energy absorbing component.
31. 27. The accommodating intraocular lens of claim 26, wherein the first haptic portion is radially offset from the second haptic portion.
32. 1. A method for adjusting an accommodating intraocular lens, comprising: adjusting the base power of the accommodating intraocular lens by directing external energy to a composite material within at least one of an optic portion and a peripheral portion of the accommodating intraocular lens; The composite material includes an energy absorbing component and a plurality of expandable components.
33. 33. The method of claim 32, further comprising adjusting the base power of the accommodating intraocular lens when the accommodating intraocular lens is implanted in the subject's eye.
34. 33. The method of claim 32, further comprising adjusting cylindricity about an optical surface of the optical portion of the accommodating intraocular lens by directing external energy to the composite material disposed on diametrically opposite peripheral edges of the optical portion.
35. 33. The method of claim 32, wherein the external energy is laser light having a wavelength of about 488 nm to about 650 nm.
36. 33. The method of claim 32, further comprising adjusting the base power of the optical portion between about ±0.05D and about ±0.5D by directing a pulse of external energy to the composite material.
37. 33. The method of claim 32, wherein the optical portion includes a fluid-filled optical chamber and the peripheral portion includes at least one haptic including a fluid-filled haptic fluid chamber in fluid communication with the optical chamber, the method further including directing the external energy to the composite material to move fluid between the optical chamber and the haptic fluid chamber.
38. 33. The method of claim 32, further comprising adjusting the base power of the accommodating intraocular lens by directing the external energy to the composite material to change the volume of the haptic fluid chamber.
39. 33. The method of claim 32, further comprising adjusting the base power of the accommodating intraocular lens by directing the external energy to the composite material to change the volume of the optical fluid chamber.