Adjustable intraocular lens and method of postoperative adjustment of an intraocular lens

Abstract

Adjustable accommodative intraocular lenses and methods for using postoperatively accommodative accommodative intraocular lenses are disclosed. In one embodiment, the adjustable accommodative intraocular lens includes an optical portion and a peripheral portion. At least one of the optical portion and the peripheral portion may be partially made of a composite material containing an energy-absorbing component and a plurality of expandable components. At least one of the fundamental power and cylindricity of the optical portion may be configured to change in response to external energy directed to the composite material.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 911,039, filed on October 4, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates generally to the field of intraocular lenses, and more specifically to adjustable intraocular lenses and methods for adjusting intraocular lenses.

[0004] background

[0005] Cataracts are a condition involving clouding of the normally clear lens of the eye. Cataracts can occur due to aging, genetic factors, trauma, inflammation, metabolic disorders, or exposure to radiation. Age-related cataracts are the most common type. During cataract surgery, a surgeon removes the lens matrix from the patient's lens capsule and replaces it with an intraocular lens (IOL). Traditional IOLs provide one or more focal lengths that allow patients to have distance vision. However, after cataract surgery, patients using traditional IOLs often require glasses or other corrective lenses for certain activities because the eye is no longer able to adjust (or change its optical power) to maintain a clear image of an object or focus on an object as its distance changes.

[0006] Newer IOLs, such as accommodating IOLs, allow the eye to regain at least some of its focusing ability. Accommodating IOLs (AIOLs) use the forces available in the eye to change parts of the optical system in order to refocus the eye on a distant or nearby target. Examples of AIOLs are discussed in the following U.S. patent publications: U.S. Patent Publication No. 2018 / 0256315; U.S. Patent Publication No. 2018 / 0153682; and U.S. Patent Publication No. 2017 / 0049561, and in the following U.S. patents: U.S. Patent No. 10,299,913; U.S. Patent No. 10,195,020; and U.S. Patent No. 8,968,396, the contents of which are incorporated herein by reference in their entirety.

[0007] Even with AIOLs, adjustments to the lens may be necessary post-operatively or after implantation in the patient's eye. For example, once an AIOL is implanted within the capsular bag, the aggressive healing response of the tissue within the bag can compress the AIOL and drive its power higher than initially intended. In some cases, preoperative biological measurements taken on the patient's eye may be incorrect, resulting in the use and implantation of an IOL with an incorrect lens power. Furthermore, the cornea or muscles within the patient's eye may have changed due to injury, disease, or aging. In such cases, adjustments to the implanted IOL or AIOL may be necessary to address these changes.

[0008] In addition to lower-order aberrations (such as focusing ability), higher-order aberrations such as cylindrical astigmatism and spherical aberrations are also commonly corrected with intraocular lenses. Cylindrical astigmatism usually develops naturally in the cornea, and most patients with pre-existing cataracts also have some degree of astigmatism. Although toric IOLs have been used to correct astigmatism during cataract surgery, one difficulty faced by all toric IOL manufacturers is that such lenses are rotationally asymmetrical, making proper placement of the lens relative to the patient's own aberrations crucial. When misalignment occurs, the patient's only recourse is usually to undergo additional surgery to correct the misalignment.

[0009] Therefore, a solution is needed that allows for post-implantation adjustment of the IOL or AIOL without requiring additional surgery. Such a solution should not make the design of such a lens overly complex, and should still allow for cost-effective lens manufacturing.

[0010] Overview

[0011] This document discloses adjustable intraocular lenses, adjustable accommodative intraocular lenses, and methods for adjusting and accommodating intraocular lenses. In one embodiment, an adjustable accommodative intraocular lens is disclosed, comprising an optic portion including an anterior element and a posterior element. The anterior element may include an anterior optical surface. The posterior element may include a posterior optical surface. A fluid-filled optic fluid chamber may be defined between the anterior and posterior elements.

[0012] The optical component may have a base focal length or a base spherical focal length. The base focal length of the optical component can be configured to change based on the internal fluid pressure within the fluid-filled optical component fluid chamber. The base focal length of the optical component can be configured to increase or decrease as fluid enters or leaves the optical component fluid chamber. The optical component can be configured to change shape in response to fluid entering or leaving the optical component fluid chamber. In some embodiments, the front element of the optical component can be configured to change shape in response to fluid entering or leaving the optical component fluid chamber. In other embodiments, the rear element of the optical component can be configured to change shape in response to fluid entering or leaving the optical component fluid chamber. In yet another embodiment, both the front and rear elements of the optical component can be configured to change shape in response to fluid entering or leaving the optical component fluid chamber.

[0013] The base power of the optical component can be configured to change in response to shape changes borne by the shape-changing optical component (e.g., anterior element, rear element, or a combination thereof). The shape-changing optical component can be configured to change shape in response to physiological muscle movements (e.g., ciliary muscle movements) borne by the patient when an adjustable accommodative intraocular lens is implanted in the patient's eye.

[0014] In some embodiments, an adjustable accommodative intraocular lens may include one or more tactile elements connected to and extending from the optical element portion. Each of the one or more tactile elements may include a tactile element fluid chamber within the tactile element. The base power of the optical element portion may be configured to increase as fluid enters the one or more tactile element fluid chambers. The base power of the optical element portion may be configured to decrease as fluid exits the optical element fluid chambers into or from the one or more tactile element fluid chambers.

[0015] The optical component fluid chamber may be in fluid communication with or connected to one or more tactile component fluid chambers. The optical component fluid chamber may be in fluid communication with the tactile component fluid chamber via a pair of fluid channels. These fluid channels may be conduits or pathways that fluidly connect the optical component fluid chamber to the tactile component fluid chamber. The pair of fluid channels may be spaced apart from each other. For example, the pair of fluid channels may be spaced apart by about 0.1 mm to about 1.0 mm.

[0016] In some embodiments, the pair of fluid channels may be defined and extend through a portion of the optical component. More specifically, the pair of fluid channels may be defined and extend through the rear element.

[0017] The one or more tactile elements may be connected to the optical element portion at the tactile element-optical element interface. The one or more tactile elements may be connected to the optical element portion at a reinforcing portion along the optical element portion. The reinforcing portion may be part of the tactile element-optical element interface. The pair of fluid channels may be defined or formed within a portion of the reinforcing portion.

[0018] In some embodiments, the adjustable accommodative intraocular lens may include two tactile elements connected to and extending from the optical element portion. A first tactile element may include a first tactile fluid chamber within the first tactile element. A second tactile element may include a second tactile fluid chamber within the second tactile element. The first tactile element may be connected to the optical element portion at a first tactile element-optics interface, and the second tactile element may be connected to the optical element portion at a second tactile element-optics interface.

[0019] In these embodiments, the optical fluid chamber can be in fluid communication with both the first tactile fluid chamber and the second tactile fluid chamber. The optical fluid chamber can be in fluid communication with the first tactile fluid chamber via a first pair of fluid channels. The optical fluid chamber can be in fluid communication with the second tactile fluid chamber via a second pair of fluid channels.

[0020] The first pair of fluid channels may be spaced apart from each other. The first pair of fluid channels may be spaced apart from about 0.1 mm to about 1.0 mm. The second pair of fluid channels may be spaced apart from each other. The second pair of fluid channels may be spaced apart from about 0.1 mm to about 1.0 mm.

[0021] The first pair of fluid channels and the second pair of fluid channels can be defined and extend through a portion of the optical component. The first pair of fluid channels and the second pair of fluid channels can be defined and extend through the rear component.

[0022] The optical component may further include a first reinforcing portion and a second reinforcing portion, which are substantially opposite each other on opposite sides of the optical component or substantially diametrically opposed to each other. A first pair of fluid channels may be defined or formed within the first reinforcing portion. A second pair of fluid channels may be defined or formed within the second reinforcing portion.

[0023] The first pair of fluid channels may terminate at a first pair of holes defined within the optical component portion. The first pair of holes may be spaced approximately 0.1 mm to approximately 1.0 mm apart. The second pair of fluid channels may terminate at a second pair of holes defined within the optical component portion. The second pair of fluid channels may terminate at a second pair of holes defined within the rear component. The second pair of holes may be spaced approximately 0.1 mm to approximately 1.0 mm apart.

[0024] In some implementations, the first pair of fluid channels and the second pair of fluid channels may be positioned substantially on opposite sides of the optical component. The first pair of fluid channels may be positioned substantially diametrically opposite to the second pair of fluid channels.

[0025] In these embodiments, the first pair of holes and the second pair of holes can be positioned substantially on opposite sides of the optical component. The first pair of holes can be positioned substantially diametrically opposite to the second pair of holes.

[0026] In some embodiments, at least one of the optical component and the peripheral component (e.g., the haptic component) may be partially made of a crosslinked copolymer comprising a copolymer blend. Furthermore, at least one of the optical component and the peripheral component may be partially made of a composite material comprising an energy-absorbing component, multiple expandable components, and a composite base material partially made of a copolymer blend. At least one of the base focal length and cylindricity of the optical component may be configured to change in response to external energy directed to the composite material.

[0027] In some implementations, an adjustable accommodative intraocular lens can be implanted into the subject's eye. When the adjustable accommodative intraocular lens is implanted into the subject's eye, at least one of the fundamental power and cylindricity of the optics portion can be configured to change in response to external energy directed to the composite material.

[0028] In some embodiments, the expandable component may be expandable microspheres containing a foaming agent within an expandable thermoplastic shell. The foaming agent may be a branched hydrocarbon. For example, a branched hydrocarbon may be isopentane.

[0029] The thickness of the thermoplastic shell can be configured to change in response to external energy directed to the composite material. In some embodiments, the thermoplastic shell may be made in part from an acrylonitrile copolymer.

[0030] The diameter of at least one of the expandable microspheres can be configured to increase by about two times (2X) to about four times (4X) in response to external energy directed to the composite material. The volume of at least one of the expandable microspheres can be configured to expand by about ten times (10X) to about fifty times (50X) in response to external energy directed to the composite material.

[0031] The expandable component may comprise about 5% to about 15% (more specifically, about 8% to about 12%) of the composite material by weight. For example, the expandable component may comprise about 10% of the composite material by weight.

[0032] The energy-absorbing component may comprise about 0.025% to about 1.0% of the weight of the composite material (or, more specifically, about 0.045% to about 0.45%). In some embodiments, the energy-absorbing component may be an energy-absorbing colorant. For example, when an accommodative intraocular lens is implanted in the eye, a clinician or other medical professional can visually perceive the color of the energy-absorbing colorant.

[0033] Energy-absorbing colorants can be dyes. For example, dyes can be azo dyes. In some embodiments, the dye can be a red azo dye, such as Disperse Red 1. Energy-absorbing colorants can also contain pigments. For example, pigments can be graphitized carbon black.

[0034] In some embodiments, at least one of the optical component and the peripheral component may be partially made of a first composite material and a second composite material. The first composite material may contain a first energy-absorbing colorant. The second composite material may contain a second energy-absorbing colorant. In some embodiments, the color of the first energy-absorbing colorant may be different from the color of the second energy-absorbing colorant.

[0035] In addition to the copolymer blend, the composite base material may further include at least one of one or more reactive acrylic monomer diluents, photoinitiators, and thermal initiators. The copolymer blend may include alkyl acrylates, fluoroalkyl acrylates, and phenylalkyl acrylates. During all phases of accommodation or deaccommodation of the intraocular lens, the composite material may remain relatively fixed at one or more locations within the optical or peripheral portions.

[0036] As previously discussed, the base power of an adjustable accommodative intraocular lens can be configured to change in response to external energy applied to the composite material constituting at least a portion of the adjustable accommodative intraocular lens. The base power of the optics portion can be configured to change in response to a pulse of external energy applied to the composite material within a range of approximately ±0.05D to approximately ±0.5D (e.g., more specifically, between approximately ±0.1D and approximately ±0.2D). In some embodiments, the base power of the optics portion can be configured to change by a total of up to ±2.0D. In other embodiments, the base power of the optics portion can be configured to change by a total of up to ±5.0D.

[0037] In some implementations, the external energy can be light energy. The external energy can be light energy from a laser. The light energy can have a wavelength of about 488 nm to about 650 nm. For example, the light energy can be a green laser with a wavelength of about 520 nm to about 570 nm. As a more specific example, the light energy can be a green laser with a wavelength of about 532 nm.

[0038] External energy directed to or otherwise applied to the composite material can cause a continuous change in the optical parameters of the adjustable accommodative intraocular lens. For example, external energy directed to or otherwise applied to the composite material can cause a continuous change in the fundamental power of the adjustable accommodative intraocular lens. Additionally, external energy directed to or otherwise applied to the composite material can cause a continuous change in the cylindricity of the adjustable accommodative intraocular lens.

[0039] In some embodiments, the optical element portion may be partially made of a composite material. In these embodiments, at least one of the base power and cylindricity of the optical element portion may be configured to change in response to external energy directed to the optical element portion. For example, the composite material may be positioned along a first peripheral edge of the front element of the optical element portion. In this example, the composite material may also be positioned along a second peripheral edge that is diametrically opposed to the first peripheral edge. The cylindricity of the front optical surface may be configured to change in response to external energy directed to the first and second peripheral edges.

[0040] Alternatively, the composite material can also be positioned along a second peripheral edge along the first peripheral edge of the rear element of the optical component. The second peripheral edge may be diametrically opposed to the first peripheral edge. The cylindricity of the rear optical surface can be configured to change in response to external energy directed to the first and second peripheral edges.

[0041] As previously discussed, the front element of the optical component can be bonded to the rear element circumferentially by an adhesive layer or otherwise. In some embodiments, the adhesive layer may comprise a composite material. The base power of the optical component can be configured to decrease in response to external energy directed to the adhesive layer. The adhesive layer can be configured to expand in response to external energy directed to the adhesive layer. The expansion of the adhesive layer can result in an increase in the volume of the optical fluid chamber within the optical component. The increase in the volume of the optical fluid chamber can result in a decrease in the internal fluid pressure within the optical fluid chamber, thereby causing the front element to flatten or reduce its curvature.

[0042] In other embodiments, the peripheral portion of the adjustable accommodative intraocular lens (e.g., one or more tactile elements) may be partially made of a composite material. As previously discussed, the peripheral portion may include at least one tactile element comprising a fluid-filled tactile element fluid chamber in fluid communication with the optical element chamber. The base power of the optical element portion may be configured to change in response to external energy directed to multiple portions of the peripheral portion partially made of composite material. The external energy may cause fluid flow or fluid displacement between the fluid-filled optical element chamber and the tactile element fluid chamber.

[0043] For example, the base focal length can be configured to change in response to changes in the volume of the fluid chamber of the haptic. Additionally, for example, when the lens is implanted in the eye, the base focal length of an adjustable accommodative intraocular lens can be configured to change in response to the interaction between the peripheral portion and the capsule environment surrounding the adjustable accommodative intraocular lens.

[0044] More specifically, the composite material can be configured or designed as a spacer extending radially from the wall of the haptic chamber. The spacer can be configured to expand in response to external energy directed to it. The expansion of the spacer can reduce the volume of the haptic fluid chamber by pushing one or more haptic elements against one or more pocket walls.

[0045] The composite material may also be partially located within the walls of the haptic fluid chamber surrounding the haptic fluid chamber. For example, the composite material may be at least partially located within a channel formed along the radial inner wall of the haptic. The volume of the haptic fluid chamber can be configured to increase in response to external energy directed to the composite material.

[0046] In other embodiments, the composite material may be placed or positioned at least partially along the radially outermost portion of the radially inner wall of the haptic element. The volume of the fluid chamber of the haptic element may be configured to decrease in response to external energy directed to the composite material. In at least some of these embodiments, the composite material may expand into the fluid chamber of the haptic element in response to external energy directed to the composite material.

[0047] In another embodiment, the tactile element of the adjustable intraocular lens may include a first tactile element portion and a second tactile element portion. Both the first and second tactile element portions may be partially made of composite materials. The base power of the optical element portion may be configured to increase in response to external energy directed to the first tactile element portion. For example, the base power of the optical element portion may be configured to increase in response to fluid flowing from the tactile element fluid chamber to the optical element fluid chamber caused by external energy directed to the first tactile element portion.

[0048] Furthermore, the base focal length of the optical component can be configured to decrease in response to external energy directed to the second tactile component. The base focal length of the optical component can also be configured to decrease in response to fluid flowing from the optical component fluid chamber to the tactile component fluid chamber caused by the external energy directed to the second tactile component. At least one of the first and second tactile components can be partially located within the tactile component chamber wall surrounding the tactile component fluid chamber.

[0049] In some embodiments, the first tactile component portion may be partially made of a first composite material, and the second tactile component portion may be partially made of a second composite material. The first composite material may include a first energy-absorbing component, and the second composite material may include a second energy-absorbing component. The composition of the first energy-absorbing component may differ from the composition of the second energy-absorbing component. For example, the first energy-absorbing component may be an energy-absorbing dye having a first color. In this example, the second energy-absorbing component may be another energy-absorbing dye having a second color different from the first color.

[0050] The first tactile component portion may be radially offset from the second tactile component portion. In some embodiments, at least one of the first and second tactile component portions may be pattern-oriented such that the positioning of at least one of the first and second tactile component portions along the tactile component is visually perceptible to clinicians or other medical professionals.

[0051] A method for adjusting an accommodative intraocular lens is also disclosed. This method may include adjusting the fundamental focal power of the accommodative intraocular lens by directing external energy to a composite material within at least one of the optical and peripheral portions of the accommodative intraocular lens. The composite material may comprise an energy-absorbing component, multiple expandable components, and a composite base material partially made of copolymer blends.

[0052] The method may further include adjusting the baseline focal power of the accommodative intraocular lens when implanting it into the eye of a subject. The method may further include adjusting the cylindricity of the optical surface of the accommodative intraocular lens by directing external energy to a composite material disposed at the diametrically opposed peripheral edges of the optical portion.

[0053] The method may also include directing external energy to the composite material to supply energy to the energy-absorbing component, thereby transferring thermal energy to the expandable component. In some embodiments, the multiple expandable components may be expandable microspheres containing a blowing agent enclosed within a thermoplastic shell. Directing external energy to the composite material can cause the microspheres to expand.

[0054] In some implementations, the external energy can be light energy. For example, the light energy can be a laser with a wavelength of about 488 nm to about 650 nm.

[0055] The method may further include adjusting the base focal length of the optical component in response to a pulse of external energy directed to the composite material between approximately ±0.05D and approximately ±0.5D (e.g., more specifically, between approximately ±0.1D and approximately ±0.2D).

[0056] The method may also include directing external energy to the composite material to displace fluid between the optical element chamber and the tactile element fluid chamber. For example, the method may include directing external energy to the composite material to change the volume of the tactile element fluid chamber. This change in the volume of the tactile element fluid chamber can result in a change in the base power of the accommodative intraocular lens. The method may further include modulating the base power of the accommodative intraocular lens by directing external energy to the composite material to cause the tactile element of the lens to interact with the capsular environment surrounding the implanted accommodative intraocular lens.

[0057] Furthermore, the method may also include adjusting the fundamental power of the accommodative intraocular lens by directing external energy to the composite material to change the volume of the optical fluid chamber. This change in the volume of the optical fluid chamber can cause fluid to flow out of the optical fluid chamber, thereby causing a portion of the optical component to change shape and reducing the fundamental power of the lens. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] Figure 1A A top view of an embodiment of an adjustable intraocular lens is shown.

[0060] Figure 1B and 1C A cross-sectional view of an embodiment of an adjustable intraocular lens is shown.

[0061] Figure 1D An exploded view of an embodiment of an adjustable intraocular lens is shown.

[0062] Figure 2A A composite material for preparing at least a portion of an adjustable intraocular lens is shown.

[0063] Figure 2B An embodiment of the expandable component of the composite material is shown.

[0064] Figure 3A and 3B A cross-sectional view of an embodiment of an adjustable intraocular lens including an expandable spacer is shown.

[0065] Figure 4A and 4B Top and cross-sectional views of another embodiment of an adjustable intraocular lens including radially inwardly extending expandable spacers are shown.

[0066] Figure 5A and 5B A cross-sectional view is shown of another embodiment of an adjustable intraocular lens including an expandable spreader.

[0067] Figure 6 A cross-sectional view is shown of another embodiment of an adjustable intraocular lens including an expandable protrusion.

[0068] Figure 7A and 7B Top and cross-sectional views are shown, respectively, of another embodiment of an adjustable intraocular lens including both an expandable extension and an expandable protrusion.

[0069] Figure 8 A top view is shown of another embodiment of an adjustable intraocular lens, including both an expandable extension and an expandable protrusion implemented as discrete components along the tactile element.

[0070] Figure 9A A top view is shown of another embodiment of an adjustable intraocular lens, including both expandable extensions and expandable protrusions arranged in a visually perceptible pattern.

[0071] Figure 9B It shows Figure 9A The embodiment of the adjustable intraocular lens shown is a cross-sectional view taken along section AA.

[0072] Figure 9C It shows Figure 9A The embodiment of the adjustable intraocular lens shown is a cross-sectional view taken along section BB.

[0073] Figure 10 A cross-sectional view of the optical component of another embodiment of an adjustable intraocular lens, including an adhesive layer partially made of composite material, is shown.

[0074] Figure 11 A perspective view is shown of another embodiment of an adjustable intraocular lens configured to exhibit cylindricity in response to external energy directed to the adjustable intraocular lens.

[0075] Detailed Explanation

[0076] Figure 1A A top view is shown of an embodiment of an adjustable accommodative intraocular lens (AIOL) 100 for correcting defocus aberrations, corneal astigmatism, spherical aberrations, or combinations thereof. The adjustable AIOL 100 may include an optical portion 102 and a peripheral portion 103. In this embodiment, the peripheral portion 103 includes one or more tactile elements 104, including a first tactile element 104A and a second tactile element 104B connected to and extending from the periphery of the optical portion 102. The adjustable AIOL 100 is configured to be positioned within a natural capsular bag in which the natural lens has been removed.

[0077] When implanted within a natural capsule, the optical portion 102 can be adapted to refract light entering the eye onto the retina. The peripheral portion 103 (e.g., the one or more tactile elements 104) can be configured to engage the capsule and adapted to deform in response to ciliary muscle movements (e.g., muscle relaxation, muscle contraction, or a combination thereof) associated with capsule reshaping. The engagement of the peripheral portion 103 (e.g., the one or more tactile elements 104) with the capsule will be discussed in more detail in the following sections.

[0078] Figure 1B and 1C It shows along Figure 1A A cross-sectional view of the adjustable AIOL 100 embodiment obtained from section AA. (See figure) Figure 1B and 1C As shown, the optical component 102 may include a front element 106 and a rear element 108. A fluid-filled optical component fluid chamber 110 may be defined between the front element 106 and the rear element 108.

[0079] The front element 106 may include a front optical surface 112 and a front inner surface 114 opposite to the front optical surface 112. The rear element 108 may include a rear optical surface 116 and a rear inner surface 118 opposite to the rear optical surface 116. Any one of the front optical surface 112, the rear optical surface 116, or a combination thereof may be considered and referred to as an external optical surface. The front inner surface 114 and the rear inner surface 118 may face the optical fluid chamber 110. At least a portion of the front inner surface 114 and at least a portion of the rear inner surface 118 may serve as the chamber wall of the optical fluid chamber 110.

[0080] Each of the one or more tactile elements 104 may include a tactile element fluid chamber 120 within the tactile element 104. For example, a first tactile element 104A may include a first tactile element fluid chamber 120A within the first tactile element 104A, and a second tactile element 104B may include a second tactile element fluid chamber 120B within the second tactile element 104B. The tactile element fluid chamber 120 (e.g., any one of the first tactile element fluid chamber 120A, the second tactile element fluid chamber 120B, or a combination thereof) may be in fluid communication with or fluidly connected to the optical element fluid chamber 110.

[0081] The optical fluid chamber 110 can be in fluid communication with the one or more tactile fluid chambers 120 via a pair of fluid channels 122 (see [link]). Figure 1AThe fluid channel 122 may be a conduit or passage that fluidly connects the optical component fluid chamber 110 to the tactile component fluid chamber 120. The pair of fluid channels 122 may be spaced apart from each other. For example, the pair of fluid channels 122 may 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.

[0082] In some embodiments, the pair of fluid channels 122 may be defined and extend through a portion of the optical component portion 102. More specifically, the pair of fluid channels 122 may be defined and extend through the rear element 108.

[0083] Figure 1A One or more tactile elements 104 of the peripheral portion 103 are shown to be connected to the optical portion 102 at the tactile element-optical interface 124. For example, the one or more tactile elements 104 may be located along the reinforcing portion 126 of the optical portion 102 (see...). Figure 1D The reinforcement portion 126 is connected to the optical component at a location 124. The reinforcement portion 126 may be part of the tactile-optical interface 124. The fluid channel 122 may be defined or formed within a portion of the reinforcement portion 126.

[0084] The optical component fluid chamber 110 can be fluidly connected to the first tactile component fluid chamber 120A through the first pair of fluid channels 122A. The optical component fluid chamber 110 can also be fluidly connected to the second tactile component fluid chamber 120B through the second pair of fluid channels 122B.

[0085] 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.

[0086] In some embodiments, the first pair of fluid channels 122A and the second pair of fluid channels 122B can be positioned substantially on opposite sides of the optical component portion 102. The first pair of fluid channels 122A can be positioned substantially diametrically opposite to the second pair of fluid channels 122B.

[0087] The first pair of fluid channels 122A and the second pair of fluid channels 122B may be defined and extend through a portion of the optical component 102. The first pair of fluid channels 122A and the second pair of fluid channels 122B may be defined or extend through the rear element 108.

[0088] The design with two fluid channels 122 instead of one helps maintain dimensional stability during assembly, which can be important when assembling flexible and thin components. Furthermore, experiments have shown that the design with two fluid channels 122 provides better optical quality than some single-channel designs across the entire adjustment range. The additional stiffness of the two-fluid-channel design results in smaller deflection due to pressure variations within the fluid channels.

[0089] like Figure 1D As shown, the optical component portion 102 may include a first reinforcing portion 126A and a second reinforcing portion 126B, which are substantially opposite each other on opposite sides of the optical component portion 102 or substantially diametrically opposed. A first pair of fluid channels 122A may be defined or formed within the first reinforcing portion 126A. A second pair of fluid channels 122B may be defined or formed within the second reinforcing portion 126B.

[0090] The pair of fluid channels 122 (e.g., either a first pair of fluid channels 122A or a second pair of fluid channels 122B) may have a pair of inner holes 128 disposed at one end of the fluid channel 122 and another pair of outer holes 130 disposed at the other end of the fluid channel 122. The pair of inner holes 128 may be defined or formed on a portion of the rear element 108. Figure 1B-1D As shown, the inner hole 128 may be defined or formed on a portion of the raised inner surface 132 of the rear element 108. In some embodiments, the raised inner surface 132 may be an inclined or beveled surface.

[0091] The external aperture 130 may be defined or formed on a portion of the protruding external surface 134 of the rear element 108. The protruding external surface 134 may be part of the reinforcement portion 126. The protruding external surface 134 may be part of the tactile-optical interface 124.

[0092] For example, Figure 1D A pair of inner holes 128 are shown, which are located at one end of the first pair of fluid channels 122A and defined along the raised inner surface 132 of the rear element 108. Figure 1D Also shown is a pair of external holes 130 that serve as the ends of the second pair of fluid channels 122B and are defined along the protruding outer surface 134 of the rear element 108. The external holes 130 of the first pair of fluid channels 122A and the pair of internal holes 128 of the second pair of fluid channels 122B are... Figure 1D The middle is covered.

[0093] The two holes of the pair of inner holes 128 can be spaced apart from each other by about 0.1 mm to about 1.0 mm. The two holes of the pair of outer holes 130 can be spaced apart from each other by about 0.1 mm to about 1.0 mm. The pair of inner holes 128 of the first pair of fluid channels 122A can be diametrically opposite to the pair of inner holes 128 of the second pair of fluid channels 122B or positioned on opposite sides of the raised inner surface 132.

[0094] Figure 1D It is also shown that each of the haptic elements 104 (e.g., any one of the first haptic element 104A or the second haptic element 104B) may have an optical attachment end 136 and a closed free end 138. A haptic fluid port 140 may be defined at the optical attachment end 136 of the haptic element 104. The haptic fluid port 140 may serve as a chamber opening of the haptic fluid chamber 120. When the haptic element 104 is connected to the optical portion 102, fluid within the haptic fluid chamber 120 may flow out of the haptic fluid chamber 120 through the haptic fluid port 140 and enter the optical fluid chamber 110 via the pair of fluid channels 122. Similarly, fluid within the optical fluid chamber 110 may flow out of the optical fluid chamber 110 through the pair of fluid channels 122 and enter the haptic fluid chamber 120 through the haptic fluid port 140.

[0095] like Figure 1A and 1D As shown, the tactile element 104 can be connected to the optical element portion 102 at the reinforcing portion 126. For example, the first tactile element 104A can be connected to or attached to the optical element portion 102 at the first reinforcing portion 126A, and the second tactile element 104B can be connected to or attached to the optical element portion 102 at the second reinforcing portion 126B.

[0096] More specifically, the haptic attachment end 136 can be connected to the protruding outer surface 134 of the rear element 108. The protruding outer surface 134 can also be referred to as a "platform" or "haptic attachment platform". The protruding outer surface 134 can extend radially outward from the outer peripheral surface 142 of the optical element portion 102. For example, the protruding outer surface 134 can extend radially outward from the outer peripheral surface 142 of the rear element 108 of the optical element portion 102. The protruding outer surface 134 can extend radially outward from the outer peripheral surface 142 by about 10 micrometers to 1.0 mm or about 10 micrometers to 500 micrometers.

[0097] The haptic attachment end 136 may have a substantially flat surface for adhesive or otherwise attaching to the substantially flat surface of the protruding outer surface 134. When the haptic attachment end 136 is attached to the protruding outer surface 134, the haptic fluid port 140 may surround the outer aperture 130 of the fluid channel 122. The haptic element 104 may be attached or adhered to the optical element portion 102 via a biocompatible adhesive 148. In some embodiments, the adhesive 148 may be the same adhesive used to attach or adhere the front element 106 to the rear element 108. The adhesive 148 will be discussed in more detail in the following sections.

[0098] Each of the tactile elements 104 may further include a radially outer portion 144 configured to face and contact the inner surface of the patient's pocket when the adjustable AIOL 100 is implanted within the pocket. Each of the tactile elements 104 may further include a radially inner portion 146 configured to face the outer peripheral surface 142 of the optical element portion 102. The engagement of the pocket with the radially outer portion 144 of the tactile element 104 will be discussed in more detail in the following sections.

[0099] The optical component 102 may have a base focal length or a base spherical focal length. The base focal length of the optical component 102 may be configured to change based on the internal fluid pressure within the fluid-filled optical component fluid chamber 110. The base focal length of the optical component 102 may be configured to increase or decrease as fluid enters or leaves the fluid-filled optical component fluid chamber 110.

[0100] The base focal length of the optical component 102 can be configured to increase as fluid enters the fluid-filled optical component fluid chamber 110 from one or more tactile fluid chambers 120, such as... Figure 1B As shown in the diagram, the base focal length of the optical component 102 can be configured to decrease as fluid leaves the fluid-filled optical component fluid chamber 110 and enters or is extracted from the fluid-filled optical component fluid chamber 110 into one or more tactile component fluid chambers 120, as... Figure 1C As shown in the image.

[0101] It should be noted that, although Figure 1B The curved dashed arrows illustrate the fluid entering the optical fluid chamber 110 from the haptic fluid chamber 120, via fluid channels 122 (including through inner holes 128 and outer holes 130) and the haptic fluid port 140. It should be noted that, although... Figure 1C The curved dashed arrows indicate the fluid leaving the optical fluid chamber 110 and entering the tactile fluid chamber 120, but the fluid leaves the optical fluid chamber 110 via fluid channels 122 (including through inner holes 128 and outer holes 130) and tactile fluid ports 140.

[0102] The optical component portion 102 may be partially made of a deformable or flexible material. In some embodiments, the optical component portion 102 may be partially made of a deformable or flexible polymeric material. For example, the front element 106, the rear element 108, or a combination thereof may be partially made of a deformable or flexible polymeric material. The one or more tactile elements 104 (e.g., a first tactile element 104A, a second tactile element 104B, or a combination thereof) may be made of the same deformable or flexible material as the optical component portion 102. In other embodiments, the one or more tactile elements 104 may be partially made of a material different from that of the optical component portion 102.

[0103] In some embodiments, the optical component 102 may comprise or be partially made of a lens body material. The lens body material may be partially made of a crosslinked copolymer comprising a copolymer blend. The copolymer blend may comprise alkyl acrylates or alkyl methacrylates, fluoroalkyl (meth)acrylates, and phenylalkyl acrylates. This application takes into consideration, and it will be understood by those skilled in the art, that these types of acrylic crosslinked copolymers can generally be copolymers of various acrylates, methacrylates, or combinations thereof, and unless otherwise stated, the term "acrylate" as used herein is to be understood to mean interchangeably acrylates, methacrylates, or combinations thereof. The crosslinked copolymer used to prepare the lens body material may comprise about 3% to 20% (wt%) of alkyl acrylates, about 10% to 35% (wt%) of fluoroalkyl acrylates, and about 50% to 80% (wt%) of phenylalkyl acrylates. In some embodiments, the crosslinked copolymer may comprise, or be partially composed of, butyl acrylate as an alkyl acrylate, trifluoroethyl methacrylate as a fluoroalkyl acrylate, and phenylethyl acrylate as a phenylalkyl acrylate. More specifically, the crosslinked copolymer used to prepare the lens body material may comprise about 3% to 20% (by weight) (e.g., about 12% to 16%) of butyl acrylate, about 10% to 35% (by weight) (e.g., about 17% to 21%) of trifluoroethyl methacrylate, and about 50% to 80% (by weight) (e.g., about 64% to 67%) of phenylethyl acrylate.

[0104] The final composition of the crosslinked copolymer used to prepare the lens substrate material may also contain a cross-linker or cross-linking agent, such as ethylene glycol dimethacrylate (EGDMA). For example, the final composition of the crosslinked copolymer used to prepare the lens substrate material may also contain about 1.0% of a cross-linker or cross-linking agent (e.g., EGDMA). The final composition of the crosslinked copolymer used to prepare the lens substrate material may also contain an initiator or initiating agent (e.g., Perkadox 16) and a UV absorber.

[0105] One or more tactile elements 104 may comprise or be partially made of a tactile element material. The tactile element material may comprise or be partially made of a crosslinked copolymer comprising a copolymer blend. The copolymer blend may comprise alkyl acrylates, fluoroalkyl acrylates, and phenylalkyl acrylates. For example, the crosslinked copolymer used to prepare the tactile element material may comprise about 10% to 25% (wt%) of alkyl acrylates, about 10% to 35% (wt%) of fluoroalkyl acrylates, and about 50% to 80% (wt%) of phenylalkyl acrylates. In some embodiments, the crosslinked copolymer used to prepare the tactile element material may comprise about 10% to 25% (wt%) (e.g., about 19% to about 23%) of n-butyl acrylate, about 10% to 35% (wt%) (e.g., about 14% to about 18%) of trifluoroethyl methacrylate, and about 50% to 80% (wt%) (e.g., about 58% to about 62%) of styrene acrylate. The final composition of the crosslinked copolymer used to prepare the tactile material may also contain about 1.0% of a cross-linker or cross-linking agent, such as EGDMA. The final composition of the crosslinked copolymer used to prepare the tactile material may also contain a variety of photoinitiators or photoinitiating agents (e.g., camphorquinone, 1-phenyl-1,2-propanedione, and 2-ethylhexyl 4-(dimethylamino)benzoate).

[0106] In some embodiments, the refractive index of the lens body material may be from about 1.48 to about 1.53. In some embodiments, the refractive index of the lens body material may be from about 1.50 to about 1.53 (e.g., about 1.5178).

[0107] Optical component 102 can be configured to deform, bend, or otherwise change shape in response to fluid entering or leaving optical component fluid chamber 110 (see [link]). Figure 1B and 1C The optical component 102 can be configured to deform, bend, or otherwise change shape due to the material composition (e.g., polymer composition) of the optical component 102 previously discussed. When the adjustable AIOL 100 is implanted in a patient's eye, one or more tactile elements 104 can also be configured to deform or otherwise change shape in response to interaction or engagement with the patient's capsular region. One or more tactile elements 104 can be configured to deform or otherwise change shape due to the material composition of the tactile element 104.

[0108] In some embodiments, the front element 106 may be configured to deform, bend, or otherwise change shape (e.g., change its curvature) in response to fluid entering or leaving the optical fluid chamber 110. In other embodiments, the rear element 108 may be configured to deform, bend, or otherwise change shape (e.g., change its curvature) in response to fluid entering or leaving the optical fluid chamber 110. In still other embodiments, both the front element 106 and the rear element 108 may be configured to deform, bend, or otherwise change their shape in response to fluid entering or leaving the optical fluid chamber 110.

[0109] In some embodiments, the fluid within the optical fluid chamber 110, one or more haptic fluid chambers 120, or a combination thereof, may be oil. More specifically, in some embodiments, the fluid within the optical fluid chamber 110, one or more haptic fluid chambers 120, or a combination thereof, may be silicone oil or a silicone fluid. The fluid may flow between the optical fluid chamber 110 and one or more haptic fluid chambers 120 in response to deformation, bending, or shape change borne by one or more components of the one or more haptic elements 104, one or more components of the optical portion 102 (e.g., front element 106, rear element 108, or a combination thereof), or a combination thereof.

[0110] The fluid within the optical component fluid chamber 110, one or more tactile component fluid chambers 120, or combinations thereof, may be a silicone oil or silicone fluid comprising or partially composed of diphenylsiloxane. In other embodiments, the silicone oil or silicone fluid may comprise or partially comprise a ratio of two dimethylsiloxane units to one diphenylsiloxane unit. More specifically, in some embodiments, the silicone oil or silicone fluid may be diphenyltetramethylcyclotrisiloxane. In further embodiments, the silicone oil or silicone fluid may comprise or partially comprise a copolymer of diphenylsiloxane and dimethylsiloxane.

[0111] A fluid (e.g., silicone oil) may be matched to the refractive index of the lens host material used to fabricate the optical component portion 102. When the fluid is matched to the refractive index of the lens host material, the entire optical component portion 102 containing the fluid acts as a single lens. For example, the fluid may be selected such that it has a refractive index of about 1.48 to about 1.53 (or about 1.50 to 1.53). In some embodiments, the fluid (e.g., silicone oil) may have a polydispersity index of about 1.2 to 1.3. In other embodiments, the fluid (e.g., silicone oil) may have a polydispersity index of about 1.3 to 1.5. In other embodiments, the fluid (e.g., silicone oil) may have a polydispersity index of about 1.1 to 1.2. Other example fluids are described in U.S. Patent Publication No. 2018 / 0153682, which is incorporated herein by reference in its entirety.

[0112] The base power of the optical component 102 can be configured to change in response to shape changes borne by shape-changing components of the optical component 102 (e.g., front element 106, rear element 108, or a combination thereof). The optical component 102 can be configured to change shape in response to physiological muscle movements (e.g., ciliary muscle movements) borne by the patient when the adjustable AIOL 100 is implanted within the capsular bag of the patient's eye, and the adjustable AIOL 100 deforms or changes shape in response to capsular reshaping associated with the ciliary muscle.

[0113] After the natural lens has been removed from the capsular bag, an adjustable AIOL 100 can be implanted or introduced into the patient's capsular bag. The patient's capsular bag is connected to suspensory ligament fibers, which are connected to the patient's ciliary muscle. The capsular bag is elastic, and ciliary muscle movement can reshape the capsular bag via the suspensory ligament fibers. For example, when the ciliary muscle relaxes, the suspensory ligaments are stretched. This stretching pulls the capsular bag in a generally radially outward direction due to radially outward forces. This pulling of the capsular bag causes it to elongate, creating space within the capsular bag. When the patient's natural lens is present in the capsular bag, the natural lens typically becomes flatter (in the anterior-posterior direction), which reduces the lens's optical power, allowing for distance vision. In this configuration, the patient's natural lens is considered to be in a state of disaccommodation or undergoing disaccommodation.

[0114] 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 suspensory ligaments to relax. This relaxation allows the elastic capsule to contract and exert a radially inward force on the lens within the capsule. When the patient's natural lens is present within the capsule, it typically becomes more curved (e.g., the anterior portion of the lens becomes more curved), giving the lens greater power and allowing the eye to focus on near objects. In this configuration, the patient's natural lens is considered to be in a state of accommodation or undergoing accommodation.

[0115] Therefore, any AIOL implanted within the capsular bag should also have a mechanism that allows the AIOL's base focal length to increase when the ciliary muscle contracts and to decrease when the ciliary muscle relaxes.

[0116] In the present case, when the adjustable AIOL 100 is implanted or otherwise introduced into a patient's natural pocket, the radially outer portion 144 of the tactile element 104 of the adjustable AIOL 100 can directly engage or physically contact the portion of the pocket connected to the suspensory ligament or suspensory ligament fibers. Therefore, the radially outer portion 144 of the tactile element 104 can be configured to respond to a pocket reshaping force applied radially during suspensory ligament relaxation and stretching due to ciliary muscle movement.

[0117] When the ciliary muscle contracts, the peripheral region of the elastic capsule reshapes and applies a radially inward force to the radially outer portion 144 of the tactile element 104 (e.g., the elastic capsule applies a radially inward force to the radially outer portion 144 of the first tactile element 104A and the radially outer portion 144 of the second tactile element 104B). The radially outer portion 144 of the tactile element 104 then deforms or otherwise changes shape, and this deformation or shape change results in a reduction in the volume of the tactile fluid chamber 120. As the volume of the tactile fluid chamber 120 decreases, fluid within the tactile fluid chamber 120 is moved or pushed into the optical fluid chamber 110 within the optical portion 102. As previously discussed, fluid moves from the tactile fluid chamber 120 into the optical fluid chamber 110 through fluid channels 122 (e.g., a pair of fluid channels 122) formed within the optical portion 102.

[0118] The optical component 102 (any of the front element 106, the rear element 108, or a combination thereof) can change shape (increase its curvature) in response to fluid entering the optical component fluid chamber 110 from the tactile fluid chamber 120. This increases the base power or base spherical power of the adjustable AIOL 100 and allows a patient with the adjustable AIOL 100 implanted in the patient's eye to focus on near objects. The adjustable AIOL 100 can also be considered to be in a state of accommodation or has undergone accommodation.

[0119] When the ciliary muscle relaxes, the peripheral region of the elastic capsule is stretched radially outward and the capsule elongates, creating more space within it. The radially outer portion 144 of the haptic element 104 can be configured to respond to this capsule reshaping by returning to its undeformed or unstressed configuration. This results in an increase in the volume of the haptic element fluid chamber 120 or a return to its undeformed volume. This increase in the volume of the haptic element fluid chamber 120 causes fluid within the optical element fluid chamber 110 to be extracted or otherwise drained from the optical element fluid chamber 110 and returned to the haptic element fluid chamber 120. As previously discussed, fluid moves out of the optical element fluid chamber 110 and into the haptic element fluid chamber 120 through the same fluid channels 122 (e.g., a pair of fluid channels 122) formed within the optical element portion 102.

[0120] As previously discussed, the optical component 102 (any of the front element 106, the rear element 108, or a combination thereof) can change shape (reduce its curvature or become flatter) in response to fluid leaving the optical component fluid chamber 110 and entering the tactile component fluid chamber 120. This reduces the fundamental focal power or fundamental spherical power of the adjustable AIOL 100 and allows a patient with the adjustable AIOL 100 implanted in the patient's eye to focus on distant objects or provide distance vision. The adjustable AIOL 100 can also be considered to be in a state of disaccommodation or has undergone disaccommodation.

[0121] like Figure 1B and 1C As shown, the radially inner portion 146 of the haptic element 104 can be designed to be thicker or larger (relative to the radially outer portion 144) to provide stiffness or resilience to the haptic element 104 in the front-to-back direction. Thus, when a bag force is applied to the haptic element 104 in the front-to-back direction, less deformation and less fluid movement occur between the haptic element fluid chamber 120 and the optical element fluid chamber 110 than when a force is applied in the radial direction. Because of the less fluid movement, the fundamental focus of the adjustable AIOL 100 changes less when a force is applied to it in the front-to-back direction. Therefore, the design and material properties of the haptic element 104 and the optical element portion 102 allow the adjustable AIOL 100 to maintain a high sensitivity to radial forces applied to the haptic element 104 by bag reshaping caused by ciliary muscle movement.

[0122] In some embodiments, the front element 106 may be configured such that the front optical surface 112 changes shape from a spherical surface configuration to a non-spherical surface configuration in response to fluid entering the optical fluid chamber 110. The non-spherical surface configuration can correct for higher-order aberrations, such as spherical aberration. Fluid may enter the optical fluid chamber 110 from one or more tactile fluid chambers 120 connected to the optical portion 102 in response to ciliary muscle movement.

[0123] When the center or central portion of the front element 106 bends or protrudes further than the outer periphery of the front element 106 held downward by the adhesive 148 or adhesive layer, the front optical surface 112 can be pressed into a non-spherical surface configuration (see [link]). Figure 1B and 1C ).

[0124] In other embodiments, the rear element 108 may be configured such that the rear optical surface 116 changes shape from a spherical surface configuration to a non-spherical surface configuration in response to fluid entering the optical fluid chamber 110.

[0125] When the center or central portion of the rear element 108 bends or protrudes further than the outer periphery of the front element 106 held downward by the adhesive 148 or adhesive layer, the rear optical surface 116 can be pressed into a non-spherical surface configuration.

[0126] The front element 106 may be attached to or otherwise adhered to the rear element 108 via adhesive 148 or an adhesive layer. The adhesive layer may be substantially annular. Adhesive 148 or the adhesive layer may be positioned at the peripheral edge 150 of the optical portion 102 between the front element 106 and the rear element 108 (see [link to relevant documentation]). Figure 1D For example, adhesive 148 may be positioned on top of the raised inner surface 132 of the rear element 108.

[0127] Adhesive 148 or adhesive layer may contain or be partially made of a biocompatible adhesive. Adhesive 148 or adhesive layer may contain or be partially made of a biocompatible polymer adhesive.

[0128] Adhesive 148 or the adhesive layer may contain or be partially made from a crosslinkable polymer precursor formulation. The crosslinkable polymer precursor formulation may contain or be partially made from a copolymer blend, a hydroxy-functionalized acrylic monomer, and a photoinitiator.

[0129] The copolymer blend may contain alkyl acrylates (e.g., about 41% to about 45% (wt%) of n-butyl acrylate), fluoroalkyl acrylates (e.g., about 20% to about 24% (wt%) of trifluoroethyl methacrylate), and phenylalkyl acrylates (about 28% to about 32% (wt%) of styrene acrylate). The hydroxyl-functionalized acrylic monomer may be 2-hydroxyethyl acrylate (HEA). A photoinitiator may be used to promote the curing of the adhesive. For example, the photoinitiator may be Darocur 4265 (a 50 / 50 blend of diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide and 2-hydroxy-2-methylphenylacetone).

[0130] The first step in preparing the adhesive is to prepare a hydroxyl-functionalized polymer precursor by photopolymerizing a crosslinkable polymer precursor formulation, thereby obtaining a cured composition. The second step is to chemically convert the side hydroxyl portion or hydroxyl side groups of the precursor polymer into side methacrylate functional groups by reacting it with methacrylic anhydride or methacryloyl chloride, thereby forming a methacrylate-functionalized polymer or a methacrylate-functionalized crosslinkable polymer comprising alkyl acrylate or alkyl methacrylate (e.g., n-butyl acrylate), fluoroalkyl (e.g., trifluoroethyl methacrylate), phenylalkyl acrylate (ethyl phenyl acrylate), and 2-(2-methacryloyloxy)ethyl acrylate.

[0131] The methacrylic acid-functionalized crosslinkable polymer can be blended with a reactive acrylic monomer diluent such as 1-adamantyl methacrylate (ADMA) and the same photoinitiator (e.g., Darocur 4265). For example, the final composition of adhesive 148 may contain about 50% to about 85% (by weight) (e.g., about 61% to about 65%) of the crosslinkable polymer precursor formulation, about 10% to about 40% (by weight) (32% to about 36%) of the reactive acrylic monomer diluent, and about 2% to about 3% (by weight) of the photoinitiator (e.g., Darocur 4265).

[0132] Adhesive 148 or an adhesive layer can bond, adhere, or otherwise attach the anterior element 106 to the rear element 108. As will be discussed in more detail in the following sections, the thickness of the adhesive layer can be adjusted post-implantation to adjust the base power of the adjustable AIOL 100.

[0133] In some embodiments, the same adhesive 148 used to bond the front element 106 to the rear element 108 can also be used to bond or fix the peripheral portion 103 (e.g., one or more tactile elements 104) to the optical portion 102.

[0134] In some embodiments, the anterior optical surface 112 of the anterior element 106 may be manufactured to have an aspherical optical surface before the adjustable AIOL 100 is implanted into the patient's eye. In these embodiments, the anterior optical surface 112 may be aspherical regardless of any changes in fluid pressure within the optical fluid chamber 110. In these embodiments, the anterior optical surface 112 may also maintain its asphericity across all changes in fundamental power.

[0135] In other embodiments, the posterior optical surface 116 of the posterior element 108 may be manufactured to have an aspherical optical surface before the adjustable AIOL 100 is implanted into the patient's eye. In these embodiments, the posterior optical surface 116 may be aspherical, independent of any changes in fluid pressure within the optical fluid chamber 110. In these embodiments, the posterior optical surface 116 may maintain its asphericity across all changes in fundamental power.

[0136] In some embodiments, the front element 106 may have a thickness at its center or central portion greater than its periphery. In some embodiments, the rear element 108 may also have a thickness at its center or central portion greater than its periphery.

[0137] like Figure 1B-1D As shown, the optical component portion 102 may have an optical axis 152. The optical axis 152 may extend through the center or center point of the optical component portion 102 in a front-to-back direction. The optical axis 152 may extend through the center or center point of both the front element 106 and the rear element 106.

[0138] The thickness of the front element 106 at or near the optical axis 152 may be greater than the thickness at the periphery of the front element 106. In some embodiments, the thickness of the front element 106 may gradually increase from the periphery of the front element 106 toward the optical axis 152.

[0139] In some embodiments, the thickness of the front element 106 at or near the optical axis 152 may be from about 0.45 mm to about 0.55 mm. In these and other embodiments, the thickness of the front element 106 near the periphery may be from about 0.20 mm to about 0.40 mm. This thickness difference can help change the shape of the front optical surface 112 from a spherical surface configuration to a non-spherical surface configuration as fluid enters the fluid-filled optical component fluid chamber 110 from one or more tactile component fluid chambers 120.

[0140] Furthermore, the front inner surface 114 of the front element 106 may have a smaller curvature or be flatter than the front optical surface 112. The difference in surface curvature between the front inner surface 114 and the front optical surface 112 may also help to change the shape of the front optical surface 112 from a spherical surface configuration to a non-spherical surface configuration when fluid enters the fluid-filled optical fluid chamber 110 from one or more tactile fluid chambers 120.

[0141] In other embodiments, the thickness of the rear element 108 at or near the optical axis 152 may be greater than the portion of the rear element 108 radially outward from the optical axis 152 but before reaching the inner surface 132 of the protrusion. The thickness of the rear element 108 may gradually decrease from the optical axis 152 to the portion radially outward from the optical axis 152 (but before reaching the inner surface 132 of the protrusion). The thickness of the rear element 108 may increase again from the inner surface 132 of the protrusion to the peripheral edge 150.

[0142] In some embodiments, the thickness of the rear element 108 at or near the optical axis 152 may be from about 0.45 mm to about 0.55 mm. In these and other embodiments, the thickness of the rear element 108 radially outward from the optical axis 152 (but before reaching the inner surface 132 of the protrusion) may be from about 0.20 mm to about 0.40 mm. The thickness of the rear element 108 near the peripheral edge 150 may be from about 1.00 mm to 1.15 mm. This thickness difference can help change the shape of the rear optical surface 116 from a spherical surface configuration to a non-spherical surface configuration as fluid enters the fluid-filled optical component fluid chamber 110 from one or more tactile component fluid chambers 120.

[0143] Furthermore, the rear inner surface 118 of the rear element 108 may have a smaller curvature or be flatter than the rear optical surface 116. The difference in surface curvature between the rear inner surface 118 and the rear optical surface 116 may also help to change the shape of the rear optical surface 116 from a spherical surface configuration to a non-spherical surface configuration when fluid enters the fluid-filled optical fluid chamber 110 from one or more tactile fluid chambers 120.

[0144] Figure 2AThis is an illustration of a composite material 200 comprising a composite base material 202, an energy-absorbing component 204, and various expandable components 206. In some embodiments, the optical portion 102 of the adjustable AIOL 100 may be partially made of the composite material 200. In other embodiments, the peripheral portion 103 of the adjustable AIOL 100 may be partially made of the composite material 200. In still other embodiments, both the optical portion 102 and the peripheral portion 103 of the adjustable AIOL 100 may be partially made of the composite material 200.

[0145] The composite base material 202 may comprise a methacrylate-functionalized or methacrylic acid-functionalized crosslinkable polymer and a reactive acrylic monomer diluent, including lauryl methacrylate (dodecyl methacrylate or SR313) and ADMA. By controlling the amounts of lauryl methacrylate (SR313) and ADMA, the overall corresponding hardness (i.e., more ADMA) or softness (i.e., more SR313) of the cured composite material 200 can be controlled. The methacrylate-functionalized or methacrylic acid-functionalized crosslinkable polymer can be prepared using a crosslinkable polymer precursor formulation. The crosslinkable polymer precursor formulation may be the same as the crosslinkable polymer precursor formulation used as part of the formulation of the adhesive 148.

[0146] As previously discussed, the optical component 102 may comprise or be partially made of the lens body material. Additionally, as previously discussed, the peripheral component 103 (e.g., one or more haptic components 104) may comprise or be partially made of haptic component material. The crosslinkable polymer precursor formulation may comprise the same copolymer blend used to prepare the lens body material, haptic component material, or adhesive.

[0147] The copolymer blend may comprise alkyl acrylates or alkyl methacrylates (e.g., n-butyl acrylate), fluoroalkyl (meth)acrylates (e.g., trifluoroethyl methacrylate), and phenylalkyl acrylates (e.g., ethyl styrene). For example, the copolymer blend may comprise 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 ethyl styrene. As previously discussed, the crosslinkable polymer precursor formulation may comprise or be partially composed of the copolymer blend, a hydroxyl-functionalized 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-methylphenylacetone).

[0148] The composite base material 202 may contain about 50% to about 65% (e.g., about 55% to about 60%) (by weight) of a crosslinkable polymer that is methacrylate-functionalized or methacrylic acid-functionalized (as discussed above), about 32% to about 38% (e.g., about 32.70%) (by weight) of a reactive acrylic monomer diluent lauryl methacrylate (SR313), and about 5% to about 9% (e.g., about 7.30%) (by weight) of a reactive acrylic monomer diluent adamantyl methacrylate (ADMA).

[0149] Composite material 200 can be prepared by several operations. A first operation may include preparing an uncolored composite base material 202. A second operation may include mixing the composite base material 202 with an energy-absorbing component 204, an expandable component 206, and an initiator such as one or more photoinitiators, thermal initiators, or combinations thereof. A third operation may include placing the uncured composite material 200 at a desired location within an optical component portion 102, one or more tactile components 104, or a combination thereof, and curing the composite material 200 in place to form an adhered composite material 200.

[0150] For example, the uncolored 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). The energy-absorbing component 204 will be discussed in more detail below.

[0151] In some embodiments, the expandable component 206 may comprise about 5.0% to about 15.0% of the final formulation of the composite material 200 by weight. More specifically, the expandable component 206 may comprise about 8.0% to about 12.0% (e.g., about 10.0%) of the final formulation of the composite material 200 by weight (see Table 1). In these and other embodiments, the energy-absorbing component 204 may comprise about 0.044% to about 0.44% (or about 0.55%) of the final formulation of the composite material 200 by weight.

[0152] The photoinitiator may be Omnirad 2022 (bis(2,4,6-trimethylbenzoyl)phenylphosphine oxide / 2-hydroxy-2-methyl-1-phenyl-prop-1-one). The photoinitiator may comprise about 1.30% by weight of the final formulation of composite material 200 (see, for example, Table 1). Additionally, composite material 200 may also contain a thermal initiator. The thermal initiator may comprise about 1.00% by weight of the final formulation of composite material 200 (see, for example, Table 1). In some embodiments, the thermal initiator may be a dialkyl peroxide, such as... Peroxide. In other embodiments, the thermal initiator may be Perkadox.

[0153] Table 1 below provides example formulations of composite material 200:

[0154] Table 1: Formulation of composite materials (wt%)

[0155]

[0156] Figure 2B The expandable component 206 is shown to be expandable microspheres comprising an expandable thermoplastic shell 208 and a foaming agent 210 contained within the expandable thermoplastic shell 208. The microspheres can be configured to expand such that the diameter 212 of at least one of the microspheres can increase to about 2 times the original diameter. In other embodiments, the microspheres can be configured to expand such that the diameter 212 of at least one of the microspheres can increase to about 4 times or four times the original diameter. In yet another embodiment, the microspheres can be configured to expand such that the diameter 212 of at least one of the microspheres can increase to about 4 times (or about 3.5 times) the original diameter. For example, the microspheres may initially have a diameter 212 of about 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 about 40 μm.

[0157] The volume of at least one of the microspheres can be configured to expand by about ten times (10X) to about 50 times (50X) in response to external energy applied to or directed to the composite material 20 or in response to energy transferred or transmitted to the microspheres.

[0158] In some embodiments, the blowing agent 210 may be an expandable fluid, such as an expandable gas. More specifically, the blowing agent 210 may be a branched hydrocarbon. For example, the blowing agent 210 may be isopentane. In other embodiments, the blowing agent 210 may be or comprise cyclopentane, pentane, or a mixture of cyclopentane, pentane, and isopentane.

[0159] Figure 2B It is shown that each of the expandable components 206 may contain a thermoplastic shell 208. Figure 2B It is also shown that the thickness of the thermoplastic shell 208 can vary with the increase of the size of the expandable component 206. More specifically, the thickness of the thermoplastic shell 208 can decrease with the increase of the size of the expandable component 206. For example, when 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 with the increase of the diameter 212 of the expandable microsphere.

[0160] For example, as previously discussed, 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 expands between about 10X and 50X), and the shell thickness of the microsphere may decrease to about 0.1 μm.

[0161] although Figure 2A and 2B Expandable component 206 is shown as a sphere or microsphere, but this application contemplates that expandable component 206 can be substantially shaped as an oval, ellipsoid, cuboid or other polyhedron, or a combination thereof.

[0162] In some embodiments, the thermoplastic shell 208 may be made in part from a nitrile or an acrylonitrile copolymer. For example, the thermoplastic shell 208 may be made in part from acrylonitrile, styrene, butadiene, methyl acrylate, or combinations thereof.

[0163] As previously discussed, the expandable component 206 may comprise about 8.0% to about 12% of the final formulation of composite material 200 by weight. The expandable component 206 may comprise about 10% of the final formulation of composite material 200 by weight.

[0164] The expandable component 206 can be dispersed or otherwise distributed within the composite base material 202 that constitutes the bulk of the composite material 200. The composite base material 202 can act as a matrix that holds or supports the expandable component 206. The composite material 200 can expand in response to the expansion of the expandable component 206 (e.g., thermoplastic microspheres). For example, the volume of the composite material 200 can increase in response to the expansion of the expandable component 206.

[0165] The composite material 200 also includes an energy-absorbing component 204. In some embodiments, the energy-absorbing component 204 may be an energy-absorbing colorant.

[0166] In some embodiments, the energy-absorbing colorant may be an energy-absorbing dye. For example, the energy-absorbing dye may be an azo dye. In some embodiments, the azo dye may be a red azo dye, such as Disperse Red 1. In other embodiments, the azo dye may be an orange azo dye such as Disperse Orange (e.g., Disperse Orange 1), a yellow azo dye such as Disperse Yellow (e.g., Disperse Yellow 1), a blue azo dye such as Disperse Blue (e.g., Disperse Blue 1), or a combination thereof.

[0167] In another embodiment, the energy-absorbing colorant may be a pigment or contain pigments. For example, the energy-absorbing colorant may be or contain graphitized carbon black as a pigment.

[0168] Similar to expandable component 206, energy-absorbing component 204 can be dispersed or otherwise distributed within the composite base material 202 that constitutes the bulk of composite material 200. Composite base material 202 can act as a matrix that retains or supports expandable component 206 and energy-absorbing component 204.

[0169] As previously discussed, the energy-absorbing component 204 may comprise from 0.025% to about 1.0% (or more specifically, from about 0.045% to about 0.45%) of the final formulation of the composite material 200. For example, when the energy-absorbing component 204 is a dye (e.g., an azo dye, such as Disperse Red 1), the energy-absorbing component 204 may comprise from about 0.45% to about 1.0% of the final formulation of the composite material 200. When the energy-absorbing component 204 is graphitized carbon black or other types of pigment, the energy-absorbing component 204 may comprise from about 0.025% to about 0.045% of the final formulation of the composite material 200.

[0170] Energy-absorbing component 204 (e.g., azo dye, graphitized carbon black, or a combination thereof) can absorb or capture external energy applied to or directed to composite material 200. Energy-absorbing component 204 can absorb or capture external energy and then convert or transfer the energy into heat or thermal energy to expandable component 206.

[0171] When heat is transferred or transported to the expandable component 206, the thermoplastic shell 208 can soften and begin to flow. The thermoplastic shell 208 of the expandable component 206 can then begin to thin or decrease in thickness in response to the heat transferred or transported to it. As the thermoplastic shell 208 begins to soften and decrease in thickness, the foaming agent 210 within the expandable component 206 can expand. The foaming agent 210 can also expand in response to the heat transferred or transported to the expandable component 206. The expansion of the foaming agent 210 can cause the expandable component 206 (e.g., thermoplastic microspheres) to expand or increase in volume. This ultimately results in the composite material 200 expanding or increasing in volume.

[0172] The composite material 200 can expand or increase in size in an isotropic manner, such that the composite material 200 expands in all directions. By placing or positioning the composite material 200 at a specific location along one or more tactile elements 104 or optical elements 102 of the adjustable AIOL 100, such isotropic expansion can be used to produce expansion or material displacement in a specific direction.

[0173] As will be discussed in more detail below, in some embodiments, the external energy may be light energy, and the energy-absorbing component 204 may absorb or capture the light energy directed to the composite material 200 and convert or transfer the light energy into heat energy or heat in the expandable component 206. The foaming agent 210 within the expandable component 206 may expand or become energetic in response to the heat energy or heat. The expandable component 206 and the final composite material 200 may expand or increase in volume in response to the light energy directed to the composite material 200.

[0174] Shape changes (e.g., volume increases) borne by expandable component 206 can be persistent or substantially permanent. A persistent or substantially permanent change can mean that expandable component 206 does not substantially revert to its original shape or size after a shape change (e.g., after a volume increase). Therefore, any changes in the size or volume of composite material 200 caused by changes in the size or volume of expandable component 206 are also persistent or substantially permanent. As will be discussed in more detail in the following sections, this means that any structural changes made to the adjustable AIOL 100 due to external energy or stimuli applied or otherwise directed to the composite material 200 embedded or integrated within the adjustable AIOL 100 can be sustained or substantially permanent.

[0175] 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. The thermoplastic shell 208 of the expandable component 206 can also harden again when the temperature in the region surrounding the expandable component 206 drops below a certain threshold. For example, the thermoplastic shell 208 of the expandable microspheres can harden when light energy is no longer directed to the composite material 200. After the thermoplastic shell 208 hardens, the expandable component 206 is locked into its new size and expanded structure.

[0176] When the energy-absorbing component 204 is an energy-absorbing colorant such as a dye or graphitized carbon, at least a portion of the composite material 200 may exhibit the color of the energy-absorbing colorant. For example, when the energy-absorbing component 204 is an azo dye such as Disperse Red 1 with a red hue, at least a portion of the composite material 200 containing the energy-absorbing component 204 may be colored red. Furthermore, when the energy-absorbing component 204 is graphitized carbon with a black hue, at least a portion of the composite material 200 containing the energy-absorbing component 204 may be colored black. Although two colors (e.g., red and black) are mentioned in this application, it is contemplated and understood by those skilled in the art that other types of energy-absorbing colorants, such as energy-absorbing yellow, orange, or blue dyes or materials, may also be used.

[0177] When the adjustable AIOL 100 is partially made of a composite material 100 containing an energy-absorbing colorant, the color of the energy-absorbing colorant can be visually perceptible to clinicians or other medical professionals. When the adjustable AIOL 100 is implanted in a patient's eye, the color of the energy-absorbing colorant can be visually perceptible to clinicians or other medical professionals. For example, the composite material 200 may contain Disperse Red 1, which acts as an energy-absorbing colorant. In this example, when the adjustable AIOL 100 is implanted in a patient's eye, at least a portion of the adjustable AIOL 100 can appear red to clinicians or other medical professionals.

[0178] The color of the energy-absorbing colorant allows clinicians or other medical professionals to detect or determine the position or orientation of the composite material 200 within the adjustable AIOL 100. The color of the energy-absorbing colorant also allows clinicians or other medical professionals to determine where to direct external energy or stimulation to adjust the adjustable AIOL 100.

[0179] As will be discussed in more detail below, at least a portion of the adjustable AIOL 100 may be made of a composite material 200 containing an energy-absorbing component 204 of a first color (e.g., red), and another portion of the adjustable AIOL 100 may be made of a separate composite material 200 containing an energy-absorbing component 204 of a second color (e.g., black). By designing the adjustable AIOL 100 in this way, clinicians or other medical professionals can use the different colored composite materials 200 as guides or markers to direct external energy or stimuli to different portions of the adjustable AIOL 100 to distinguish different locations of such target sites. Furthermore, the differently colored composite materials 200 can also serve as indicators or visual cues of where external energy or stimuli should be directed to cause certain changes in one or more optical parameters (e.g., basal power, cylindricity, or combinations thereof) of the adjustable AIOL 100.

[0180] One technical problem faced by the applicant is how to integrate an adjustable composite material into the optical and peripheral portions (e.g., haptic components) of an AIOL, such that the adjustable composite material adheres to the lens material used to prepare the rest of the AIOL and remains substantially fixed at certain locations within the optical or peripheral portions. One solution discovered by the applicant and disclosed herein is a unique composition of the composite material incorporating the same copolymer blend used to prepare the lens body material and the haptic component material. Furthermore, the composite material is partially prepared in a crosslinkable polymer precursor formulation used in the adhesive used to adhere the portions of the AIOL to each other. By designing the AIOL in this way, the composite material is compatible with the rest of the material used to construct the optical and peripheral portions and remains substantially fixed in its position without migration or displacement.

[0181] Another technical challenge faced by the applicant is how to ensure that any conditioning applied to AIOL persists for an extended period after the conditioning process. One solution discovered and disclosed herein is to induce expansion in a composite material partially composed of expandable microspheres containing a foaming agent enclosed within a thermoplastic shell. The thermoplastic shell can soften in response to external energy directed or applied to the composite material (and the thickness of the thermoplastic shell can decrease) (this can lead to heat or thermal energy transfer or transport to the expandable microspheres). The foaming agent within the thermoplastic shell can expand as the thermoplastic shell softens. The expansion of the foaming agent causes the microspheres to expand, which in turn causes the composite base material, which acts as the body of the composite material, to expand. Even after external energy is no longer applied to the composite material, the expandable microspheres can retain their newly expanded or inflated structure.

[0182] Furthermore, the composite material also contains energy-absorbing components, such as energy-absorbing dyes or colorants. These energy-absorbing components can capture or absorb relatively harmless external energy or stimuli directed to the composite material and convert or transfer this external energy into heat, which can then cause the thermoplastic microspheres to expand. By designing the adjustable AIOL 100 in this way, one or more bursts or pulses of relatively harmless energy or stimuli (e.g., light energy) can be used to induce a persistent change in the shape or size of at least a portion of the adjustable AIOL 100. This persistent change in the shape or size of the adjustable AIOL 100 can have a lasting effect on the optical parameters of the lens, including, for example, its fundamental power.

[0183] Figure 3A and 3BA cross-sectional view is shown of an embodiment of an adjustable AIOL 100 including an expandable spacer 300 made at least partially of composite material 200. The expandable spacer 300 may be positioned or otherwise disposed in a radially inner portion 146 of the peripheral portion 103 (e.g., tactile element 104) of the adjustable AIOL 100.

[0184] like Figure 3A and 3B As shown, the radially inner portion 146 of the tactile element 104 may be radially thicker or larger than the radially outer portion 144. Figure 3A and 3B The adjustable AIOL 100 is also shown implanted in the patient's eye, more specifically, positioned within the patient's capsular bag 304 (in... Figure 3A and 3B (Shown in dashed lines). When the adjustable AIOL 100 is positioned within the pouch 304, the radially outer portion 144 of the tactile element 104 can physically contact or rest against the inner surface of the pouch 304.

[0185] like Figure 3A and 3B As shown, the expandable spacer 300 may be partially positioned within the radially inner portion 146 of the tactile element 104. In some embodiments, at least a portion of the expandable spacer 300 may project or extend radially inward or laterally toward the outer peripheral surface 142 of the optical element portion 102. In these and other embodiments, at least a portion of the expandable spacer 300 may be positioned between the tactile element 104 and the optical element portion 102. More specifically, the expandable spacer 300 may be positioned between the optical element portion 102 and the tactile element fluid chamber 120 (e.g., radially positioned therebetween).

[0186] In some embodiments, the expandable spacer 300 can be adhered to the radially inner portion 146 of the tactile element 104 by being cured into place. For example, the expandable spacer 300 can be adhered to a groove, recess, or recess formed along the radially inner portion 146.

[0187] In other embodiments, the expandable spacer 300 may be positioned entirely within the radially inner portion 146 of the tactile element 104. In some embodiments, cavities, conduits, or other void spaces may be formed within the radially inner portion 146, and the expandable spacer 300 may be introduced into the cavity, conduit, or void space and cured into place.

[0188] In another embodiment, the expandable spacer 300 may refer to a portion of the peripheral portion 103 (e.g., tactile element 104) made of composite material 200. For example, the expandable spacer 300 may refer to a portion of the radially inner portion 146 of the tactile element 104 made of composite material 200.

[0189] although Figure 3A and 3B The expandable spacer 300 is shown as having a rectangular cross-sectional profile, but it is contemplated and should be understood by those skilled in the art that the cross-sectional profile of the expandable spacer 300 may be substantially shaped as an ellipse, a circle, a triangle or other polygon.

[0190] Figure 3A and 3B It is also shown that external energy 302 can be directed or otherwise applied to the expandable spacer 300 to cause a change in the shape of the expandable spacer 300 (e.g., to enlarge the expandable spacer 300) to affect the optical parameters of the adjustable AIOL 100.

[0191] In some embodiments, the external energy 302 can be optical energy. More specifically, the external energy 302 can be a laser. In some embodiments, the laser can have a wavelength of about 488 nm to about 650 nm. The external energy 302 can be one or more pulses or clusters of laser light.

[0192] In some embodiments, the laser can be a green laser. A green laser can have a wavelength of about 520 nm to about 570 nm. In one example embodiment, the external energy 302 can be a green laser with a wavelength of about 532 nm.

[0193] For example, the laser could be emitted by an ophthalmic laser. For example, the laser could be emitted by a retinal coagulation laser.

[0194] 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 heat energy to cause the expandable component 206 in the composite material 200 to expand.

[0195] like Figure 3BAs shown, external energy 302 can cause the expandable spacer 300 to expand. The expansion of the expandable spacer 300 can cause it to press against the outer peripheral surface 142 of the optical component portion 102. For example, the enlarged expandable spacer 300 can press against the rear element 108 of the optical component portion 102. Because the periphery of the rear element 108 is relatively thicker or larger between the outer peripheral surface 142 and the raised inner surface 132, the expanded expandable spacer 300 primarily applies a radially outward or laterally outward force to the tactile element 104.

[0196] Figure 3B The tactile element 104 is shown to be biased or pushed against the side of the pouch 304. More specifically, the enlarged, inflatable spacer 300 can be radially biased outward or pushed against the radially inner portion 146 of the tactile element 104. For example, Figure 3B The radially outward displacement of the radially inner portion 146 of the haptic element 104 is shown, with solid lines indicating the position of the radially inner portion 146 after expansion and dashed lines indicating the position of the radially inner portion 146 before expansion. Given the limited amount of space within the pouch 304, this radially outward displacement of the radially inner portion 146 of the haptic element 104 can cause the chamber walls of the haptic element fluid chamber 120 to compress or squeeze together, thereby reducing the volume of the haptic element fluid chamber 120.

[0197] As previously discussed, one or more haptic fluid chambers 120 and optical fluid chambers 110 may be filled with fluid (e.g., silicone oil). Reducing the volume of the haptic fluid chamber 120 may cause at least some of the fluid within the one or more haptic fluid chambers 120 to flow from the one or more haptic fluid chambers 120 to the optical fluid chamber 120. Furthermore, as previously discussed, the one or more haptic fluid chambers 120 may be accessible through a plurality of fluid channels 122 (including a first pair of fluid channels 122A, a second pair of fluid channels 122B, or combinations thereof, see [link to relevant documentation]). Figure 1A It is in fluid communication with the optical component fluid chamber 120. Although in Figure 3B The curved arrows depicted in dashed lines illustrate the fluid flow between the haptic fluid chamber 120 and the optical fluid chamber 120. However, 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.

[0198] As previously discussed, the base power of the optical component 102 can be configured to change based on the internal fluid pressure within the fluid-filled optical component fluid chamber 110. The base power of the optical component 102 can be configured to increase as fluid enters the optical component fluid chamber 110 from one or more haptic component fluid chambers 120.

[0199] The optical element portion 102 may also be configured to change shape in response to fluid entering the optical fluid chamber 110. In some embodiments, the front element 106 of the optical element portion 102 may be configured to change shape (e.g., increase its curvature) in response to fluid entering the optical fluid chamber 110. In other embodiments, the rear element 108 of the optical element portion 102 may be configured to change shape (e.g., increase its curvature) in response to fluid entering the optical fluid chamber 110. In yet another embodiment, both the front element 106 and the rear element 108 may be configured to change shape in response to fluid entering the optical fluid chamber 110. The fundamental power of the optical element portion 102 may be configured to increase in response to one or more shape changes borne by the front element 106, the rear element 108, or a combination thereof.

[0200] like Figure 3A and 3B As depicted, when the expandable spacer 300 is located between the optical portion 102 and one or more tactile fluid chambers 120, applying external energy 302 to the expandable spacer 300 can cause an interaction between one or more tactile elements 104 and the sac environment (e.g., the side of the sac 304) surrounding the one or more tactile elements 104. This interaction between the one or more tactile elements 104 and the sac environment can result in an increase in the base power of the adjustable AIOL 100.

[0201] For example, adjusting the base power of the adjustable AIOL 100 may include directing or applying external energy 302 (e.g., light energy from about 520 nm to about 570 nm) to the adjustable AIOL 100 implanted in the patient's eye. More specifically, the external energy 302 may be applied or directed to an expandable spacer 300, which is partially made of composite material 200. The expandable spacer 300 may expand in response to the application of external energy 302. The expansion of the spacer 300 may cause one or more tactile elements 104 to be radially or laterally pushed outward or biased against the side of the pocket 304. This may cause the walls of the tactile element fluid chamber 120 to be compressed or squeezed together, resulting in a reduction in the volume of the tactile element fluid chamber 120. Fluid within the one or more tactile element fluid chambers 120 may then flow into the optical element fluid chamber 110 in response to this reduction in the volume of the one or more tactile element fluid chambers 120. The base focal length of the optical component 102 can increase in response to the fluid flowing into the optical component fluid chamber 110.

[0202] In some embodiments, a pulse group or pulse of external energy 302 (e.g., light energy) directed to the expandable spacer 300 can cause an increase in the base focal 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 directed to the expandable spacer 300 can cause an increase in the base focal power of the adjustable AIOL 100 by about +0.10D to about +0.20D (e.g., about +0.125D). In some embodiments, the base focal power of the adjustable AIOL 100 can increase in total by about +1.0D to about +5.0D (e.g., about +2.0D) in response to a pulse group or pulse of external energy 302 directed to the expandable spacer 300.

[0203] Figure 4A and 4B These are top and cross-sectional views of an embodiment of the adjustable AIOL 100, which includes an expandable spacer 300 extending radially inward toward the optical component portion 102 and occupying a gap space 400 between one or more tactile components 104 and the optical component portion 102.

[0204] When according to Figure 4A When the structure shown is positioned, the adjustable AIOL 100 can be implanted into the patient's pocket 304 (see...). Figure 3A and 3B The tactile element 104 of the adjustable AIOL 100 can be bent around the periphery of the optical element portion 102, wherein the free end of the tactile element 104 is almost on the opposite side of the optical element portion 102.

[0205] like Figure 4A As shown, the expandable spacer 300 may also be curved, such that the radially inward portion of the expandable spacer 300 follows or matches the curvature of the optical portion 102. The expandable spacer 300 may extend along almost the entire length of each of the tactile elements 104.

[0206] Figure 4B An expandable spacer 300 is shown extending radially inward from the radially inner portion 146 of the tactile element 104 toward the optical portion 102. In some embodiments, the expandable spacer 300 may be formed as a fin-like protrusion extending radially inward from the radially inner portion 146 of the tactile element 104. In other embodiments, the expandable spacer 300 may be substantially shaped as a discontinuous segment of a ring at least partially located between the optical portion 102 and the tactile element 104.

[0207] like Figure 4BAs shown, the expandable spacer 300 can have a front-to-back height. The front-to-back height of the expandable spacer 300 can be significantly smaller than the front-to-back height of the tactile element 104. Furthermore, the expandable spacer 300 is relatively unconstrained in the front-to-back direction, such that any expansion of the spacer 300 primarily applies a radially outward force or pressure to the tactile element 104. Such expansion applies a relatively small force or pressure to the tactile element 104 in the front-to-back direction.

[0208] In some embodiments, the expandable spacer 300 may have a front-to-back height of about 0.10 mm to about 1.00 mm. The expandable spacer 300 may also have a radial width. The radial width may be about 0.50 mm to about 1.0 mm. In contrast, the haptic fluid chamber 120 may have a front-to-back height of about 2.0 mm to about 3.0 mm. Furthermore, the haptic fluid chamber 120 may have a radial width of about 0.8 mm to about 1.1 mm.

[0209] Figure 5A and 5B A cross-sectional view is shown of another embodiment of the adjustable AIOL 100 including an expandable extension 500 made at least partially of composite material 200. The expandable extension 500 may be positioned or otherwise disposed on the peripheral portion 103 (e.g., one or more tactile elements 104, such as...). Figure 5A and 5B In the radial inner portion 146 (shown), one or more tactile elements 104 may have radially thicker or larger radially than the radial outer portion 144.

[0210] like Figure 5A and 5B As shown, the expandable extension 500 can be positioned within a channel 502 or opening defined within a radially inner portion 146 of the haptic member 104. In some embodiments, the channel 502 or opening can extend along the entire length of the haptic member 104. In other embodiments, the channel 502 or opening can extend partially along the length of the haptic member 104. The channel 502 or opening can be in fluid communication with the fluid chamber 120 of the haptic member.

[0211] In some embodiments, the expandable extension 500 may occupy all the space within the channel 502 or opening, except for the gap 504 or void space between the expandable extension 500 and the outer peripheral surface 142 of the optical component portion 102. In other embodiments, the gap 504 or void space may be replaced with a tactile component material.

[0212] In other embodiments, the expandable extension 500 may occupy at least some space within the channel 502 (e.g., the expandable extension 500 is positioned in the radially intermediate portion of the channel 502 or opening). In these embodiments, the gap 504 or void space or additional tactile material may separate the expandable extension 500 from the outer peripheral surface 142 of the optical portion 102 (e.g., radially). In all such embodiments, the expandable extension 500 may be positioned such that expansion of the expandable extension 500 does not cause the radially inner portion 146 of the tactile element 104 or the expandable extension 500 to substantially impact or abut against the outer peripheral surface 142 of the optical portion 102 (thus preventing one or more tactile elements 104 from being pushed against the sides of the pouch 304, which could cause deformation of one or more tactile elements 104 and affect the volume of one or more tactile fluid chambers 120). For example, the expandable extension 500 may be positioned such that the expansion of the expandable extension 500 does not cause the haptic chamber walls of the haptic fluid chamber 120 to be squeezed together or compressed (or does not cause a reduction in the volume of the haptic fluid chamber 120).

[0213] In some embodiments, the expandable extension 500 can be adhered to the radially inner portion 146 of the tactile element 104 by being cured to a suitable location within the channel 502 or opening. For example, the expandable extension 500 can be adhered to a portion or location of the middle portion of the channel 502 or opening.

[0214] In another embodiment, the expandable extension 500 may refer to a portion of the peripheral portion 103 made of composite material 200 (e.g., a portion of the tactile element 104). For example, the expandable extension 500 may refer to a portion of the radially inner portion 146 of the tactile element 104 made of composite material 200.

[0215] although Figure 5A and 5B The expandable extension 500 is shown as having a rectangular cross-sectional profile, but it is contemplated and should be understood by those skilled in the art that the cross-sectional profile of the expandable extension 500 may be substantially shaped as an ellipse, a circle, a triangle or other polygon.

[0216] Figure 5A and 5B It is shown that external energy 302 can be directed or otherwise applied to the expandable extension 500 to cause a change in the shape of the expandable extension 500 (e.g., to enlarge the expandable extension 500) to affect the optical parameters of the adjustable AIOL 100.

[0217] In some embodiments, the external energy 302 is optical energy, such as a laser. In some embodiments, the laser may have a wavelength of about 488 nm to about 650 nm. The external energy 302 may be one or more pulses or clusters of laser light. In some embodiments, the laser may be a green laser.

[0218] 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 heat energy to cause the expandable component 206 in the composite material 200 to expand.

[0219] like Figure 5B As shown, external energy 302 can cause the expandable extension 500 to expand. The expansion of the expandable extension 500 can cause the extension 500 to press against the channel wall 506 of the channel 502 defined within the radially inner portion 146 of the tactile member 104.

[0220] Figure 5B The enlarged extension 500 is shown to expand or unfold the channel wall 506 to expand or unfold the channel 502. Furthermore, the enlarged extension 500 can also expand the volume of the haptic fluid chamber 120 by deforming the chamber walls of the haptic fluid chamber 120 by unfolding at least some of the chamber walls.

[0221] The expandable extension 500 can bias or push open the channel wall 506 of the channel 502, at least in the front-to-back direction. This can result in an increase in the volume of the haptic fluid chamber 120. For example, Figure 5B The expanded channel wall 506 and haptic chamber wall are shown in solid lines, and the positioning of the channel wall 506 and haptic chamber wall before expansion is shown in dashed lines. Figure 5B It is also shown that the gap 504 or void space between the extension 500 and the optical portion 102 allows the extension 500 to expand or increase in size without causing the extension 500 to impact or push against the outer peripheral surface 142 of the optical portion 102 (thus preventing one or more tactile elements 104 from being pushed against the sides of the pouch 304, which could cause deformation of one or more tactile elements 104 and affect the volume of one or more tactile fluid chambers 120). In other embodiments, additional tactile material may separate the extension 500 from the outer peripheral surface 142 of the optical portion 102, such that the expansion of the extension 500 only expands the channel wall 506 and the chamber wall, and does not cause the radially outer portions 144 of one or more tactile elements 104 to push against the sides of the pouch 304.

[0222] As previously discussed, one or more haptic fluid chambers 120 and optical fluid chambers 110 may be filled with fluid (e.g., silicone oil). Increasing the volume of the haptic fluid chamber 120 may cause at least some of the fluid within the optical fluid chamber 110 to flow from the optical fluid chamber 110 into one or more haptic fluid chambers 120. Furthermore, as previously discussed, one or more haptic fluid chambers 120 may be accessible via a plurality of fluid channels 122 (including a first pair of fluid channels 122A, a second pair of fluid channels 122B, or combinations thereof, see [link to relevant documentation]). Figure 1A It is in fluid communication with the optical component fluid chamber 120. Although in Figure 5B The curved arrows depicted in dashed lines illustrate the fluid flow between the haptic fluid chamber 120 and the optical fluid chamber 120. However, 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.

[0223] As previously discussed, the base power of the optical component 102 can be configured to change based on the internal fluid pressure within the fluid-filled optical component fluid chamber 110. The base power of the optical component 102 can be configured to decrease as fluid flows from the optical component fluid chamber 110 into one or more haptic component fluid chambers 120.

[0224] The optical element portion 102 may also be configured to change shape in response to fluid exiting the optical fluid chamber 110. In some embodiments, the front element 106 of the optical element portion 102 may be configured to change shape (e.g., reduce its curvature) in response to fluid exiting the optical fluid chamber 110. In other embodiments, the rear element 108 of the optical element portion 102 may be configured to change shape (e.g., reduce its curvature) in response to fluid exiting the optical fluid chamber 110. In yet another embodiment, both the front element 106 and the rear element 108 may be configured to change shape in response to fluid exiting the optical fluid chamber 110. The fundamental power of the optical element portion 102 may be configured to decrease in response to one or more shape changes borne by the front element 106, the rear element 108, or a combination thereof.

[0225] like Figure 5A and 5BAs depicted, applying external energy 302 to the expandable extension 500 (e.g., when the expandable extension 500 is positioned within a channel 502 or opening defined within a radially inner portion 146 of one or more haptic elements 104) can cause an increase in the volume of one or more haptic element fluid chambers 120. This increase in the volume of one or more haptic element fluid chambers 120 can draw fluid out of the optical element fluid chamber 110 and result in a reduction in the base focal length of the adjustable AIOL 100.

[0226] For example, a method of reducing the base power of an adjustable AIOL 100 may include directing or applying external energy 302 (e.g., light energy from about 520 nm to about 570 nm) to an expandable extension 500 embedded within the adjustable AIOL 100 implanted in a patient's eye. More specifically, the external energy 302 may be applied or directed to the expandable extension 500, which is partially made of composite material 200. The expandable extension 500 may expand in response to the application of external energy 302. The expansion of the extension 500 may cause an increase in the volume of one or more tactile fluid chambers 120. Fluid within the optical fluid chamber 110 may then flow into one or more tactile fluid chambers 110 in response to this increase in the volume of the one or more tactile fluid chambers 120. The base power of the optical portion 102 may decrease in response to the fluid flowing out of the optical fluid chamber 110.

[0227] In some embodiments, a pulse group or pulse of external energy 302 (e.g., light energy) directed to the expandable extender 500 can cause a reduction in the base focal 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 directed to the expandable extender 500 can cause a reduction in the base focal power of the adjustable AIOL 100 by about -0.10D to about -0.20D (e.g., about -0.125D). In some embodiments, the base focal power of the adjustable AIOL 100 can be reduced in total by about -1.0D to about -5.0D (e.g., about -2.0D) in response to a pulse group or pulse of external energy 302 directed to the expandable extender 500.

[0228] Figure 6 A cross-sectional view is shown of another embodiment of the adjustable AIOL 100 including an expandable protrusion 600 made at least partially of composite material 200. The expandable protrusion 600 may be positioned or otherwise positioned along a portion of the radially inner portion 146 of the peripheral portion 103 of the adjustable AIOL 100 (e.g., the one or more tactile elements 104).

[0229] like Figure 6As shown, the tactile element 104 (e.g., either the first tactile element 104A or the second tactile element 104B) may include a tactile element chamber wall surrounding the tactile element fluid chamber 120. For example, the tactile element chamber wall may include a radially inner wall 602 and a radially outer wall 604. The tactile element fluid chamber 120 may be partially defined by the radially inner wall 602 and the radially outer wall 604.

[0230] The expandable protrusion 600 may be positioned or otherwise provided along a portion of the radial inner wall 602 of the tactile member 104. More specifically, the expandable protrusion 600 may be positioned or otherwise provided or fixed along the radial outermost portion 606 of the radial inner wall 602 of the tactile member 104.

[0231] In some embodiments, the adjustable AIOL 100 can be designed such that the gap or void space 608 radially separates the radially inner wall 602 of the tactile element 104 from the outer peripheral surface 142 of the optical element portion 102. This ensures that when the expandable protrusion 600 expands, neither the expandable protrusion 600 nor the radially inner wall 602 impacts or pushes against the outer peripheral surface 142 of the optical element portion 102 (thus preventing one or more tactile elements 104 from being pushed against the sides of the pouch 304, which could cause deformation of one or more tactile elements 104 and affect the volume of one or more tactile element fluid chambers 120). As previously discussed, when the radially inner portion 146 of the tactile element 104 pushes against the outer peripheral surface 142 of the optical element portion 102, the tactile element chamber walls can be compressed or squeezed together because the radially outer wall 604 of the tactile element 104 presses against the sides of the patient's pouch 304. In other embodiments, the adjustable AIOL 100 may be designed such that the radial inner wall 602 of the tactile element 104 continuously rests against the outer peripheral surface 142 of the optical element portion 102, or intermittently rests against the outer peripheral surface 142 of the optical element portion 102.

[0232] In some implementations, for example, Figure 6 As shown, the entire expandable protrusion 600 can be positioned below (or above) the centerline or haptic centerline 610. The centerline or haptic centerline 610 bisects the front-to-back height of the haptic member 104. In these embodiments, a portion of the expandable protrusion 600 in its unexpanded state cannot extend beyond the haptic centerline 610. The front-to-back height of the expandable protrusion 600 can be less than the front-to-back height of the radial inner wall 602.

[0233] In some embodiments, the expandable protrusion 600 can be adhered to the radially inner portion 146 of the tactile element 104 (e.g., the radially inner wall 602) by being cured into place. For example, the expandable protrusion 600 can adhere to a cavity, groove, or recess formed along the radially outermost portion 606 of the radially inner wall 602. In these cases, the expandable protrusion 600 can occupy or occupy less than half the front-to-back height of the radially inner wall 602.

[0234] In another embodiment, the expandable protrusion 600 may refer to a portion of the radially inner portion 146 made of composite material 200 (e.g., a portion of the radially inner wall 602). For example, the expandable protrusion 600 may refer to a portion of the radially outermost portion 606 of the radially inner wall 602 made of composite material 200.

[0235] although Figure 6 The cross-sectional profile of the expandable protrusion 600 is shown as having primarily straight edges and corners; however, it is contemplated by this application and should be understood by those skilled in the art that the cross-sectional profile of the expandable protrusion 600 may also have rounded or curved edges and corners.

[0236] Figure 6 It is also shown that external energy 302 can be directed or otherwise applied to the expandable protrusion 600 to cause a change in the shape of the expandable protrusion 600 (e.g., to enlarge the expandable protrusion 600) to affect the optical parameters of the adjustable AIOL 100.

[0237] External energy 302 can be the same external energy 302 as previously disclosed. For example, when external energy 302 is light energy, energy absorbing component 204 can absorb or otherwise capture light energy and convert it into heat energy to cause expandable component 206 within composite material 200 to expand.

[0238] like Figure 6 As shown, external energy 302 can cause the expandable protrusion 600 to expand (as depicted by the enlarged protrusion 600 shown in dashed lines). The expansion of the expandable protrusion 600 can cause it to encroach upon, extend, or otherwise grow into the fluid-filled haptic fluid chamber 120. This can cause fluid within the haptic fluid chamber 120 (through the plurality of fluid channels 122) to shift or be pushed into the optical fluid chamber 110. Furthermore, when the protrusion 600 expands and a portion of it encroaches upon, extends, or grows into the haptic fluid chamber 120, the fluid-carrying capacity or usable volume of the haptic fluid chamber 120 can be reduced.

[0239] As previously discussed, one or more haptic fluid chambers 120 and optical fluid chambers 110 can both be filled with fluid (e.g., silicone oil). Reducing the fluid carrying capacity or available volume of the haptic fluid chamber 120 can cause at least some of the fluid within one or more haptic fluid chambers 120 to flow from one or more haptic fluid chambers 120 to the optical fluid chamber 120 and remain there. Although in Figure 6 The curved arrows depicted in dashed lines illustrate the fluid flow between the haptic fluid chamber 120 and the optical fluid chamber 120. However, 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.

[0240] As previously discussed, the base power of the optical component 102 can be configured to change based on the internal fluid pressure within the fluid-filled optical component fluid chamber 110. The base power of the optical component 102 can be configured to increase as fluid enters the optical component fluid chamber 110 from one or more haptic component fluid chambers 120.

[0241] The optical element portion 102 may also be configured to change shape in response to fluid entering the optical fluid chamber 110. In some embodiments, the front element 106 of the optical element portion 102 may be configured to change shape (e.g., increase its curvature) in response to fluid entering the optical fluid chamber 110. In other embodiments, the rear element 108 of the optical element portion 102 may be configured to change shape (e.g., increase its curvature) in response to fluid entering the optical fluid chamber 110. In yet another embodiment, both the front element 106 and the rear element 108 may be configured to change shape in response to fluid entering the optical fluid chamber 110. The fundamental power of the optical element portion 102 may be configured to increase in response to one or more shape changes borne by the front element 106, the rear element 108, or a combination thereof.

[0242] In some embodiments, a pulse group or pulse of external energy 302 (e.g., light energy) directed to the expandable protrusion 600 can cause an increase in the base focal 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 directed to the expandable protrusion 600 can cause an increase in the base focal power of the adjustable AIOL 100 by about +0.10D to about +0.20D (e.g., about +0.125D). In some embodiments, the base focal power of the adjustable AIOL 100 can increase in total by about +1.0D to about +5.0D (e.g., about +2.0D) in response to a pulse group or pulse of external energy 302 directed to the expandable protrusion 600.

[0243] Figure 7A and 7B Top and cross-sectional views of another embodiment of the adjustable AIOL 100, including both an expandable extension 500 and an expandable protrusion 600 constituting at least a portion of each of the tactile elements 104, are shown. For example, as Figure 7A As shown, a first tactile part made of expandable extension 500 can be positioned or adhered to a portion of the tactile part chamber wall, and a second tactile part made of expandable protrusion 600 can be positioned or adhered to another portion of the same tactile part chamber wall.

[0244] In some embodiments, the first tactile component portion (e.g., the expandable extension 500) may be partially composed of a first composite material or Figure 2A The first type of composite material 200 shown is made of, and the second tactile component portion (e.g., the expandable protrusion 600) may be partially made of the second composite material or Figure 2A The second type of composite material 200 shown is made of.

[0245] In some embodiments, the first composite material may be partially composed of a first energy-absorbing component (e.g., Figure 2A The first type of energy-absorbing component 204 shown is made of the second composite material, and the second composite material may be partially made of the second energy-absorbing component (e.g., Figure 2A The second type of energy-absorbing component (204) shown is made of [material name missing]. For example, the first composite material may be made partially of Disperse Red 1 dye, and the second composite material may be made partially of graphitized carbon black. The first energy-absorbing component may have or exhibit a first color (e.g., Disperse Red 1 dye may have or exhibit red), and the second energy-absorbing component may have or exhibit a second color different from the first color (e.g., graphitized carbon black may have or exhibit black). Alternatively, as another example, the first energy-absorbing component may be an azo dye having a first color (e.g., Disperse Red 1 dye), and the second energy-absorbing component may be another azo dye having a second color (e.g., Disperse Orange 1 dye). This color difference can allow clinicians or other medical professionals to visually distinguish the two tactile components.

[0246] In some embodiments, a first composite material, partially made of a first energy-absorbing component, may expand in response to a first type of external energy directed to the first composite material (e.g., light energy of 520 nm to 540 nm), and a second composite material, partially made of a second energy-absorbing component, may expand in response to a second type of external energy directed to the second energy-absorbing component (e.g., light energy of 600 nm to 650 nm). In these and other embodiments, the first energy-absorbing component may have or exhibit a first color (e.g., red), and the second energy-absorbing component may have or exhibit a second color different from the first color (e.g., orange or blue).

[0247] In other embodiments, the first composite material and the second composite material may be made partially of the same energy-absorbing component, but contain different amounts or weight percentages of such component. In other embodiments, the first composite material and the second composite material may be made partially of the same energy-absorbing component, but contain different amounts or weight percentages of expandable component 206.

[0248] like Figure 7A As shown, a first tactile element portion, partially made of a first composite material, can be placed or positioned radially offset from a second tactile element portion, partially made of a second composite material. For example, an expandable extension 500 can be positioned radially offset from an expandable protrusion 600 on each of the tactile elements 104. More specifically, the radially innermost portion of the tactile element 104 can be partially made of the expandable extension 500, and adjacent portions of the tactile element radially outward from the expandable extension 500 can be partially made of the expandable protrusion 600.

[0249] In addition, such as Figure 7A As shown, the expandable extension 500 can extend along a portion of the length of the tactile member 104. Furthermore, the expandable protrusion 600 can also extend along a portion of the length of the tactile member 104.

[0250] Figure 7B The same radial inner wall 602 of the tactile element 104 shown may include both an expandable extension 500 and an expandable protrusion 600. Figure 7B In the illustrated embodiment, the expandable extension 500 may be partially made of a first composite material (e.g., composite material 200 containing a first energy-absorbing colorant), and the expandable protrusion 600 may be partially made of a second composite material (e.g., composite material 200 containing a second energy-absorbing colorant). The color difference in the energy-absorbing colorant can allow clinicians or other medical professionals to more easily distinguish between the expandable extension 500 and the expandable protrusion 600. In other embodiments (e.g., as...) Figure 9BAs depicted in the illustration, the expandable extension 500 and the expandable protrusion 600 can be made of the same composite material 200.

[0251] The expandable extension 500 can be positioned within a channel 502 or opening defined within a radial inner wall 602. The channel 502 or opening can be in fluid communication with the tactile fluid chamber 120.

[0252] In some embodiments, the expandable extension 500 may occupy the radially innermost portion 700 of the radially inner wall 602 of the tactile element 104. In these embodiments, the expandable extension 500 may also occupy or be disposed at the radially innermost end of the channel 502. In another embodiment, the expandable extension 500 may refer to a portion of the tactile element chamber wall of the tactile element 104 made of composite material 200. For example, in these embodiments, the expandable extension 500 may refer to a portion of the radially innermost portion 700 of the radially inner wall 602 of the tactile element 104 made of composite material 200.

[0253] like Figure 7B As shown, the gap 608 or clearance separates the radially innermost portion 700 of the radially inner wall 602 of the tactile element 104 from the outer peripheral surface 142 of the optical element portion 102. This allows the expandable extension 500 to expand without impacting or pushing against the outer peripheral surface 142 of the optical element portion 102.

[0254] like Figure 7B As further shown, the expandable protrusion 600 may be positioned or otherwise provided or fixed along the radially outermost portion 606 of the radially inner wall 602 of the tactile element 104. In some embodiments, the expandable protrusion 600 may refer to a portion of the tactile element chamber wall made of 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 of the tactile element 104 made of composite material 200.

[0255] External energy 302 directed or otherwise applied to the expandable extender 500 positioned along the wall of the haptic chamber (e.g., along the radially innermost portion 700 of the radially inner wall 602 of the haptic element 104) can cause the expandable extender 500 to expand. The expansion of the expandable extender 500 can cause the extender 500 to press against the channel wall 506 of the channel 502, and expand at least one of the channel 502 and the haptic fluid chamber 120. This can result in an increase in the volume of one or more haptic fluid chambers 120. This can then (via fluid channel 122) draw fluid from the optical fluid chamber 110 into one or more haptic fluid chambers 120, and result in a reduction in the base power of the adjustable AIOL 100 (e.g., a reduction of approximately -0.10D to -0.20D).

[0256] The same external energy 302 or another type of external energy 302 (e.g., light energy of another wavelength) may also be directed or otherwise applied to the expandable protrusion 600 located along the wall of the haptic chamber (e.g., along the radially outermost portion 606 of the radially inner wall 602 of the haptic 104). The external energy may cause the expandable protrusion 600 to expand. The expansion of the expandable extension 500 may cause the protrusion 600 to intrude into, extend, or otherwise grow into the fluid-filled haptic fluid chamber 120. This may cause fluid displacement within the haptic fluid chamber 120 or (through the plurality of fluid channels 122) into the optical fluid chamber 110. A pulse group or pulse of external energy 302 (e.g., light energy) directed to the expandable protrusion 600 may cause an increase in the base power of the adjustable AIOL 100 by approximately +0.10D to +0.20D.

[0257] Figure 8 A top view is shown of another embodiment of the adjustable AIOL 100 including both an expandable extender 500 and an expandable protrusion 600 implemented along a discrete component 800 of the tactile element 104. In an alternative embodiment, at least one of the expandable extender 500 and the expandable protrusion 600 may be replaced by an expandable spacer 300 (see [link to alternative embodiment]). Figure 3A and 3B ).

[0258] In some embodiments, the expandable extension 500 may occupy or be positioned along the radially innermost portion 700 of the radially inner wall 602 of one or more tactile elements 104 (see [link]). Figure 7B The expandable protrusion 600 may occupy or be positioned along the radially outermost portion 606 of the radially inner wall 602 of one or more tactile elements 104 (see [link]). Figure 6 ).

[0259] At least one of the expandable extension 500 and the expandable protrusion 600 may be implemented or configured as a discrete component 800 that is visually perceptible to a clinician or other medical professional responsible for adjusting the adjustable AIOL 100 when the adjustable AIOL 100 is implanted in a patient's eye.

[0260] Discrete component 800 may refer to the shape or configuration of expandable extension 500, expandable protrusion 600, or combinations thereof. In some embodiments, discrete component 800 may have a circular profile when viewed from top to bottom or from front to back. In these embodiments, each of the discrete components 800 may be substantially shaped as a cylinder. In other embodiments not shown in the figures, discrete component 800 may have an elliptical profile, a rectangular profile, a triangular profile, a rhomboid or oblique square 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 may be spaced close together, or each of the discrete components 800 may be separated from each other by portions of tactile material.

[0261] In addition, such as Figure 8 As shown, a portion or segment of a haptic element 104 may include an expandable extension 500, while another portion or segment of the same haptic element 104 may include an expandable protrusion 600. For example, the distal segment 802 of each of the haptic elements 104 (e.g., the segment 802 closer to the closed free end 138 of the haptic element 104) may include an expandable extension 500, and the proximal segment 804 of each of the haptic elements 104 (e.g., the segment 804 closer to the optical portion 102) may include an expandable protrusion 600. Figure 8 As shown, the expandable protrusion implemented as a discrete component 800 may be radially offset or radially separated from the expandable extension 500, which is also implemented as a discrete component 800.

[0262] Designing or otherwise configuring at least one of the expandable extension 500 and the expandable protrusion 600 as a discrete component 800 allows clinicians or medical professionals to fine-tune the adjustment of the adjustable AIOL 100. For example, a clinician or medical professional can direct external energy 302 to one of the discrete components 800 to increase the base power of the adjustable AIOL 100 (when the discrete component 800 is the expandable protrusion 600) or decrease the base power of the adjustable AIOL 100 (when the discrete component 800 is the expandable extension 500) by a set amount. More specifically, in some embodiments, the size, shape, or location of the discrete components 800 may allow a pulse group or pulse of external energy 302 applied to each of the discrete components 800 to adjust the optical parameters (e.g., base power) of the adjustable AIOL 100 by a predetermined or preset amount. For example, a pulse group or pulse of external energy 302 applied to or directed to each of the discrete components 800 can cause a change in base focal length of about ±0.10D to ±0.20D (e.g., about ±0.125D).

[0263] Furthermore, in this example, clinicians or medical professionals may direct additional pulses or bursts of external energy 302 to the same discrete component 800 to further increase or decrease the base focal length of the adjustable AIOL 100, or direct additional pulses or bursts of external energy 302 to different discrete components 800 to eliminate or cancel previous adjustments (e.g., to decrease the base focal length after an increase has been caused).

[0264] although Figure 8 One or more tactile elements 104 are shown, including both an expandable extension 500 and an expandable protrusion 600 (configured as a discrete component 800). However, it is contemplated in this application and should be understood by those skilled in the art that each of the tactile elements 104 may also include only the expandable extension 500 or only the expandable protrusion 600 as a discrete component 800.

[0265] like Figure 7A , 7BAs shown in Figure 8, the adjustable AIOL 100 can be configured such that the base focal length of the adjustable AIOL 100 can be adjusted in a first manner (e.g., increasing the base focal length) by directing or otherwise applying external energy 302 to a first portion of the tactile element 104, which is partially made of composite material 200. Furthermore, the base focal length of the adjustable AIOL 100 can be adjusted in a second manner (e.g., decreasing the base focal length) by directing or otherwise applying additional pulses or bursts of external energy 302 to a second portion of the same or different tactile element 104, which is partially made of composite material 200. In some embodiments, the composite material 200 used to prepare the first portion of the tactile element 104 may be or exhibit a different color than the composite material 200 used to manufacture the second portion of the tactile element 104 due to differences in the energy-absorbing components 204 constituting the composite material 200.

[0266] Figure 9A A top view is shown of another embodiment of an adjustable AIOL 100 including both an expandable extension 500 and an expandable protrusion 600 arranged in a visually perceptible pattern 900. The visually perceptible pattern 900 allows clinicians or medical professionals responsible for adjusting the adjustable AIOL 100 postoperatively to distinguish between the expandable extension 500 and the expandable protrusion 600, especially when the expandable extension 500 and the expandable protrusion 600 are made of the same composite material 200 having the same color (e.g., ...). Figure 9A (As shown in the diagram). This allows clinicians or medical professionals to more easily determine where to direct or apply external energy 302 to the adjustable AIOL 100 in order to adjust the optical parameters of the adjustable AIOL 100.

[0267] like Figures 9A-9C As shown, the visually perceptible pattern 900 may include continuous curved segments of expandable protrusions 600 and spaced branches or finger-like segments of expandable extensions 500 extending radially inward from the continuous curved segments. Figure 9A It is also shown that branches or finger-like segments of the expandable protrusion 600 can be separated from each other by portions of the tactile material 902. The tactile material 902 can be the same tactile material used to construct the rest of one or more tactile elements 104. For example, the visually perceptible pattern 900 can be a comb pattern. In other embodiments, the visually perceptible pattern 900 can be a wave pattern, a chain-like triangle pattern, a zigzag pattern, or a combination thereof.

[0268] For example, a clinician or other medical professional may direct or otherwise apply external energy 302 to spaced branches or finger segments to cause the expandable extension 500 to expand, thereby reducing the base focal length of the adjustable AIOL 100. A clinician or medical professional may also direct or otherwise apply external energy 302 to an expandable protrusion 600 shaped as a curved portion positioned radially outward of spaced branches or finger segments to cause the expandable protrusion 600 to expand, thereby increasing the base focal length of the adjustable AIOL 100.

[0269] Figure 9B It shows Figure 9A The illustrated embodiment of the adjustable AIOL 100 is shown in a cross-sectional view taken along section AA. Figure 9B As shown, this cross-section of the tactile element 104 may include an expandable extension 500 and an expandable protrusion 600 adhered, formed, or otherwise positioned along a radially inner wall 602. The expandable extension 500 may be positioned along the radially innermost portion 700 of the radially inner wall 602, or positioned at the radially innermost end of the channel 502 defined along the radially inner wall 602. The expandable protrusion 600 may be positioned along the radially outermost portion 606 of the radially inner wall 602 of the tactile element 104. The expandable protrusion 600 may be positioned below or further rear of the expandable extension 500. Furthermore, the adjustable AIOL 100 can be configured such that the gap space 608 or the gap separates the radial inner wall 602 of the tactile element 104 from the outer peripheral surface 142 of the optical element portion 102, such that the expansion of the expandable extension 500 does not cause any part of the tactile element 104 to substantially impact or push upward against the outer peripheral surface 142 of the optical element portion 102 (thus preventing one or more tactile elements 104 from being pushed against the side of the pouch 304, which could cause deformation of one or more tactile elements 104 and affect the volume of one or more tactile fluid chambers 120).

[0270] Figure 9C It shows Figure 9A The illustrated embodiment of the adjustable AIOL 100 is shown in a cross-sectional view taken along section BB. Figure 9C As shown, this cross-section of the tactile element 104 may include only an expandable protrusion 600 adhered, formed, or otherwise positioned along the radial inner wall 602. The expandable protrusion 600 may be positioned along the radially outermost portion 606 of the radial inner wall 602 of the tactile element 104. The remaining portion of the radial inner wall 602 may be made of the same tactile element material 902 used to construct the rest of the tactile element 104.

[0271] The visually perceptible pattern 900 allows clinicians or medical professionals to more easily determine where to direct or apply external energy 302 to the adjustable AIOL 100 in order to adjust the optical parameters of the adjustable AIOL 100. This can be useful when both the expandable extension 500 and the expandable protrusion 600 are made of the same composite material 200 having or exhibiting the same color. Clinicians or medical professionals can direct or otherwise apply external energy 302 only to the expandable protrusion 600, which is shaped as a curved portion, to cause the expandable protrusion 600 to expand, thereby increasing the base power of the adjustable AIOL 100. Clinicians or medical professionals can also direct or otherwise apply external energy 302 only to the branch or finger-shaped portion to cause the expandable extension 500 to expand, thereby decreasing the base power of the adjustable AIOL 100.

[0272] One technical problem faced by the applicant is how to integrate the composite material with the rest of the adjustable AIOL without interfering with the optical quality of the lens. One solution discovered and disclosed herein is to position or embed the composite material within or along the walls of the haptic chamber. More specifically, the applicant's solution involves positioning or embedding the composite material along or within the radial inner walls of one or more haptic elements.

[0273] Figure 10 A cross-sectional view of the optical component portion 102 of another embodiment of an adjustable AIOL 100, including an adhesive layer 1000 partially made of composite material 200, is shown. In some embodiments, the adhesive layer 1000 may comprise composite material 200 integrated or blended with the adhesive 148 previously discussed. In other embodiments, composite material 200 may be positioned or sandwiched between layers of adhesive 148.

[0274] The adhesive layer 1000 can be positioned or disposed along the peripheral edge 150 of the rear element 108 (i.e., the top of the raised inner surface 132). Although Figure 10 The adhesive layer 1000 is shown positioned along opposite sides of the optical component portion 102; however, those skilled in the art will understand that the adhesive layer 1000 extends circumferentially around the entire periphery of the optical component portion 102. The adhesive layer 1000 may also be described as rotationally symmetric.

[0275] In some embodiments, the base power of the adjustable 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 optical component portion 102.

[0276] The expansion of the adhesive layer 1000 can raise the front element 106 and increase the volume of the optical fluid chamber 110. When the internal fluid pressure within the fluid-filled optical fluid chamber 110 decreases, this can cause the front element 106 to flatten slightly.

[0277] In some embodiments, a pulse group or pulse of external energy 302 (e.g., light energy) directed to the adhesive layer 1000 can cause a reduction in the base focal length of the adjustable AIOL 100 by about -0.10D to -0.20D (e.g., about -0.125D). For example, a pulse of green laser directed to the adhesive layer 1000 can cause a reduction in the base focal length of the adjustable AIOL 100 by about -0.10D to -0.20D (e.g., about -0.125D). In some embodiments, the base focal length of the adjustable AIOL 100 can be reduced in total by about -1.0D to about -5.0D (e.g., about -2.0D) in response to a pulse group or pulse of external energy 302 directed to the adhesive layer 1000.

[0278] Figure 11 A perspective view of another embodiment of an adjustable AIOL 100 is shown, including an adjustable front element 1100 having a composite material 200 positioned or placed along a diametrically opposed peripheral portion of the front element 1100. Figure 11 As shown, the composite material 200 can be shaped or configured as a plurality of discrete parts 800 arranged on opposite peripheral edges of the front element 1100.

[0279] For example, composite material 200 may be shaped or configured as a plurality of discrete parts 800 arranged along a first peripheral edge 1102 and a second peripheral edge 1104 of the front element 1100. The first peripheral edge 1102 may be positioned diametrically opposite to or separated from the second peripheral edge 1104 by approximately 180 degrees. In all such embodiments, composite material 200 does not extend along or surround the entire periphery of the front element 1100.

[0280] In some embodiments, the composite material 200 may be located or adhered between the anterior optical surface 112 and the anterior inner surface 114. In other embodiments, the composite material 200 may partially extend from or protrude from the anterior optical surface 112. When the adjustable AIOL 100 is implanted in a patient's eye, the composite material 200 may be visually perceptible to a clinician or other medical professional. For example, the composite material 200 may be partially made of an energy-absorbing component 204 or a colorant having or exhibiting a color (e.g., red or black) that is visually perceptible to a clinician or other medical professional.

[0281] Clinicians or other medical professionals may direct or otherwise apply external energy 302 to the composite material 200 (e.g., to all composite materials 200 shaped or configured as discrete parts 800 along the first peripheral edge 1102 and the second peripheral edge 1104). The composite material 200 may expand in response to the application of external energy 302. This expansion or bulging of the composite material 200 may cause the front optical surface 112 of the front element 1100 to flatten or exhibit a flatter curvature along a first meridian of the front element 1100 (referred to as the flat meridian 1106). The flat meridian 1106 may be substantially perpendicular to another meridian of the front element 1100 (referred to as the steep meridian 1108), wherein the curvature of the front element 1100 along this other meridian is substantially unaffected by the expansion of the composite material 200. In this way, a cylindrical or cylindrical shape is created on the front optical surface 112 of the front element 1100. Even after external energy 302 is no longer directed or applied to the front element 1100, this change in the cylindricity of the front element 1100 can persist or remain substantially permanent.

[0282] More specifically, in response to the application of external energy 302, the radius of curvature of the front optical surface 112, measured along the flat meridian 1106, can be greater than the radius of curvature of the front optical surface 112, measured along the steep meridian 1108. Furthermore, in response to the application of external energy 302, the peripheral thickness of the front element 1100 along the flat meridian 1106 can be greater than the peripheral thickness of the front element 1100 along the steep meridian 1108.

[0283] In some embodiments, applying or directing external energy 302 to the composite material 200 can cause the front element 1100 to have a cylindrical focal length of about +0.50D to about +5.0D (e.g., about +1.50D or about +3.0D). The cylindrical focal length can be measured along the steep meridian 1108 of the front element 1100.

[0284] although Figure 11An adjustable AIOL 100 is shown, including an adjustable front element 1100 with composite material 200; however, it is contemplated that the adjustable AIOL 100 may also include an adjustable rear element with composite material 200. For example, composite material 200 may be positioned or placed along diametrically opposed peripheral portions of the rear element. Composite material 200 may be shaped or configured as a plurality of discrete parts 800 arranged on opposing peripheral edges of the rear element.

[0285] In some embodiments, the composite material 200 may be located or adhered between the rear optical surface 116 and the rear inner surface 118 (see, for example, Figure 1B and 1C In other embodiments, the composite material 200 may extend or protrude partially from or from the rear optical surface 116. When the adjustable AIOL 100 is implanted in a patient's eye, the composite material 200 may be visually perceptible to clinicians or other medical professionals.

[0286] Clinicians or other medical professionals may direct or otherwise apply external energy 302 to the composite material 200, which forms part of the peripheral edge of the rear element. The composite material 200 may expand in response to the application of external energy 302. This expansion or bulging of the composite material 200 may cause the rear optical surface 116 to flatten or exhibit a flatter curvature along a flat meridian of the rear element. The flat meridian may be substantially perpendicular to a steep meridian of the rear element, wherein the curvature of the rear element along the steep meridian is substantially unaffected by the expansion of the composite material 200. In this way, a cylindrical or cylindrical shape is created on the rear optical surface 116 of the rear element. This change in the cylindricity of the rear element may persist or be substantially permanent even after the external energy 302 is no longer directed or applied to the rear element.

[0287] More specifically, in response to the application of external energy 302, the radius of curvature of the rear optical surface 116 measured along a flat meridian can be greater than the radius of curvature of the rear optical surface 116 measured along a steep meridian. Furthermore, in response to the application of external energy 302, the peripheral thickness of the rear element along a flat meridian can be greater than the peripheral thickness of the rear element along a steep meridian.

[0288] In some embodiments, applying or directing external energy 302 to the composite material 200 can cause the rear element to have a cylindrical focal length of about +0.5D to about +5.0D (e.g., about +1.5D or about +3.0D). The cylindrical focal length can be measured along the steep meridian of the rear element.

[0289] One technical problem faced by the applicant is how to introduce cylindricity or cylindricality into an accommodative intraocular lens without interfering with the optical quality of the lens. One solution discovered and disclosed herein by the applicant is to position or embed a composite material along or within the peripheral edge of an optical element (e.g., anterior element, posterior element, or a combination thereof). More specifically, the applicant's solution involves positioning or embedding a composite material along or within a portion of or within one of the two diametrically opposed peripheral edges of at least one of the anterior and posterior elements.

[0290] This document discloses an intraocular lens comprising: an optical element portion; a peripheral portion connected to the optical element portion; wherein at least one of the optical element portion and the peripheral portion is partially made of a composite material comprising an energy-absorbing component and a plurality of expandable components, and wherein the base focal length of the optical element portion is configured to change in response to external energy directed to the composite material.

[0291] As disclosed herein, the basic focal power of the optics portion is configured to change in response to external energy directed to the composite material when the intraocular lens is implanted into the eye of a subject.

[0292] As disclosed herein, the intraocular lens contains expandable components that are expandable microspheres, each of which contains a foaming agent contained within a thermoplastic shell.

[0293] As disclosed in this article, the intraocular lens contains a branched hydrocarbon as the foaming agent.

[0294] As disclosed in this article, the intraocular lens contains isopentane as a branched hydrocarbon.

[0295] As disclosed herein, the thickness of the thermoplastic shell is configured to change in response to external energy directed to the composite material.

[0296] As disclosed herein, the intraocular lens has a thermoplastic shell partially made of an acrylonitrile copolymer.

[0297] As disclosed herein, in an intraocular lens, the diameter of at least one of the expandable microspheres is configured to increase by about 2X to about 4X in response to external energy directed to the composite material.

[0298] As disclosed herein, the volume of at least one of the expandable components is configured to expand by about 10X to about 50X in response to external energy directed to the composite material.

[0299] As disclosed herein, the intraocular lens contains an expandable component comprising approximately 5% to approximately 15% of the weight of the composite material.

[0300] As disclosed herein, the intraocular lens contains an expandable component that comprises approximately 10% of the weight of the composite material.

[0301] As disclosed in this article, the energy-absorbing component of the intraocular lens is an energy-absorbing colorant.

[0302] As disclosed in this article, the color of the energy-absorbing colorant is visually perceptible to clinicians when the intraocular lens is implanted into the eye.

[0303] As disclosed in this article, the energy-absorbing colorant in the intraocular lens is a dye.

[0304] As disclosed in this article, the intraocular lens contains an azo dye.

[0305] The intraocular lens disclosed herein contains Disperse Red 1 dye.

[0306] As disclosed in this article, the energy-absorbing colorant in the intraocular lens is a pigment.

[0307] As disclosed in this article, the intraocular lens contains graphitized carbon black as the pigment.

[0308] As disclosed herein, an intraocular lens, wherein at least one of the optical portion and the peripheral portion is partially made of a first composite material and a second composite material, wherein the first composite material contains a first energy-absorbing colorant and the second composite material contains a second energy-absorbing colorant, wherein the color of the first energy-absorbing colorant is different from the color of the second energy-absorbing colorant.

[0309] As disclosed herein, the intraocular lens contains an energy-absorbing component comprising approximately 0.025% to approximately 1.00% of the weight of the composite material.

[0310] As disclosed herein, an intraocular lens wherein at least one of the optical portion and the peripheral portion is made in part from a crosslinked copolymer comprising a copolymer blend, and wherein the composite material is made in part from a copolymer blend.

[0311] As disclosed herein, intraocular lenses contain copolymer blends comprising alkyl acrylates, fluoroalkyl acrylates, and phenylalkyl acrylates.

[0312] As disclosed herein, the intraocular lens, wherein the composite material further comprises at least one of a reactive acrylic monomer diluent, a photoinitiator, and a thermal initiator.

[0313] As disclosed herein, an intraocular lens in which a composite material is adhered to a crosslinked copolymer at a location within at least one of the optical and peripheral portions, and wherein the composite material remains substantially fixed at that location.

[0314] As disclosed herein, the fundamental focal power of the optics portion is configured to change between approximately ±0.05D and approximately ±0.5D in response to a pulse of external energy directed to the composite material.

[0315] As disclosed herein, the basic focal power of the optics portion is configured to vary by a total of up to ±5.0D.

[0316] As disclosed in this article, the external energy in the intraocular lens is light energy.

[0317] As disclosed in this article, the intraocular lens contains laser light.

[0318] As disclosed in this article, the intraocular lens contains a laser with a wavelength of approximately 488 nm to approximately 650 nm.

[0319] The intraocular lens disclosed in this article uses a green laser.

[0320] As disclosed in this article, the intraocular lens contains a green laser with a wavelength of approximately 532 nm.

[0321] As disclosed herein, the intraocular lens has an optic portion partially made of composite material, and its base power is configured to change in response to external energy directed to the optic portion.

[0322] As disclosed herein, the intraocular lens has a peripheral portion partially made of composite material, and the base power of the optical portion is configured to change in response to external energy directed to the peripheral portion.

[0323] As disclosed herein, an intraocular lens in which the optics portion is partially made of a composite material, and in which the cylindricity of the optical surface of the optics portion is configured to change in response to external energy directed to the optics portion.

[0324] As disclosed in this article, the cylindricity of the optical components in the intraocular lens is a continuous change.

[0325] As disclosed in this article, the change in the basal focal length of the intraocular lens is a continuous change.

[0326] As disclosed herein, the intraocular lens includes an anterior element having an anterior optical surface and a posterior element having a posterior optical surface.

[0327] As disclosed herein, an intraocular lens wherein a composite material is positioned along a first peripheral edge of an anterior element and along a second peripheral edge of an anterior element that is diametrically opposed to the first peripheral edge, and wherein the cylindricity of the anterior optical surface is configured to change in response to external energy directed to the first and second peripheral edges.

[0328] As disclosed herein, an intraocular lens wherein a composite material is positioned along a first peripheral edge of a posterior element and along a second peripheral edge of the posterior element that is diametrically opposed to the first peripheral edge, and wherein the cylindricity of the posterior optical surface is configured to change in response to external energy directed to the first and second peripheral edges.

[0329] As disclosed herein, an intraocular lens includes an anterior element, a posterior element, and a fluid-filled optical chamber defined therebetween, wherein the anterior element is circumferentially bonded or adhered to the posterior element by an adhesive layer, and wherein the adhesive layer comprises a composite material.

[0330] As disclosed herein, the intraocular lens in which the base focal length is configured to decrease in response to the expansion of the adhesive layer caused by external energy of the composite material directed into the adhesive layer.

[0331] As disclosed herein, an intraocular lens includes an optical component portion comprising a fluid-filled optical component chamber, and a peripheral portion comprising at least one tactile component comprising a fluid-filled tactile component fluid chamber in fluid communication with the optical component chamber.

[0332] As disclosed herein, the intraocular lens in which the base power is configured to change in response to fluid displacement between the optical chamber and the tactile fluid chamber caused by external energy directed to the composite material.

[0333] As disclosed herein, the intraocular lens in which the base focal length is configured to change in response to a change in the volume of the tactile fluid chamber caused by external energy directed to the composite material.

[0334] As disclosed herein, the intraocular lens has a base focal length configured to change in response to the interaction between a tactile element and the capsule environment surrounding the intraocular lens when the intraocular lens is implanted in the eye.

[0335] As disclosed herein, an intraocular lens in which a composite material is configured as a spacer extending radially from the wall of the tactile chamber, wherein the spacer is configured to expand in response to external energy directed to the spacer, and wherein the expansion of the spacer reduces the volume of the tactile fluid chamber by pushing the tactile element against the capsular environment.

[0336] As disclosed herein, the intraocular lens contains a composite material partially located within the tactile chamber wall surrounding the tactile fluid chamber.

[0337] As disclosed herein, an intraocular lens in which the composite material is at least partially located within a channel formed along the radial inner wall of the tactile element, wherein the volume of the fluid chamber of the tactile element is configured to expand in response to external energy directed to the composite material.

[0338] As disclosed herein, an intraocular lens in which the composite material is positioned at least partially along the radially outermost portion of the radially inner wall of the tactile element, wherein the volume of the fluid chamber of the tactile element is configured to decrease in response to external energy directed to the composite material.

[0339] As disclosed herein, an intraocular lens in which a composite material is configured to expand into a tactile fluid chamber in response to external energy directed to the composite material.

[0340] As disclosed herein, an intraocular lens in which an energy-absorbing component is configured to transfer thermal energy to multiple expandable components in response to external energy directed to the composite material.

[0341] This document also discloses an adjustable intraocular lens comprising: an optical element portion; and a tactile element connected to the optical element portion, wherein the tactile element includes a first tactile element portion and a second tactile element portion, wherein the first tactile element portion is partially made of a composite material comprising an energy-absorbing component and a plurality of expandable components, wherein the second tactile element portion is partially made of a composite material, wherein the base power of the optical element portion is configured to increase in response to external energy directed to the first tactile element portion, and wherein the base power of the optical element portion is configured to decrease in response to external energy directed to the second tactile element portion.

[0342] As disclosed herein, an accommodative intraocular lens includes an optical component comprising a fluid-filled optical fluid chamber, and a tactile component comprising a fluid-filled tactile fluid chamber in fluid communication with the optical fluid chamber.

[0343] As disclosed herein, the accommodative intraocular lens has a base focal length in which the optical portion is configured to increase in response to external energy directed to the first tactile portion caused by fluid flowing from the tactile fluid chamber to the optical fluid chamber.

[0344] As disclosed herein, the accommodative intraocular lens has a base focal length in which the optical portion is configured to decrease in response to external energy directed to the second tactile portion caused by fluid flowing from the optical fluid chamber to the tactile fluid chamber.

[0345] As disclosed herein, an accommodative intraocular lens, wherein at least one of a first tactile portion and a second tactile portion is partially located within the tactile chamber wall surrounding the tactile fluid chamber.

[0346] As disclosed herein, an accommodative intraocular lens is provided, wherein a first tactile element is partially made of a first composite material, and a second tactile element is partially made of a second composite material, wherein the first composite material contains a first energy-absorbing component, wherein the second composite material contains a second energy-absorbing component, and wherein the composition of the first energy-absorbing component differs from the composition of the second energy-absorbing component.

[0347] As disclosed herein, an accommodative intraocular lens is wherein a first tactile element is partially made of a first composite material, and a second tactile element is partially made of a second composite material, wherein the first composite material contains a first energy-absorbing component, wherein the second composite material contains a second energy-absorbing component, and wherein the composition of the first energy-absorbing component is the same as the composition of the second energy-absorbing component.

[0348] As disclosed herein, an accommodative intraocular lens has a first energy-absorbing component having a first color, and a second energy-absorbing component having a second color different from the first color.

[0349] As disclosed herein, the accommodative intraocular lens has a first tactile portion that is radially offset from the second tactile portion.

[0350] As disclosed herein, in an accommodative intraocular lens, at least one of a first tactile element portion and a second tactile element portion is oriented in such a pattern that at least one of the first tactile element portion and the second tactile element portion is visually perceptible to a clinician along the position of the tactile element.

[0351] This article also discloses a method for adjusting an accommodative intraocular lens, comprising: adjusting the base focal length of the accommodative intraocular lens by directing external energy to a composite material within at least one of the optical portion and the peripheral portion of the accommodative intraocular lens, wherein the composite material comprises an energy-absorbing component and a plurality of expandable components.

[0352] The method disclosed herein further includes adjusting the baseline focal length of the accommodative intraocular lens when implanting the accommodative intraocular lens into the eye of the subject.

[0353] The method disclosed herein further includes adjusting the cylindricity of the optical surface of the optical element portion of the accommodative intraocular lens by directing external energy to a composite material disposed at the diametrically opposed peripheral edges of the optical element portion.

[0354] The method disclosed herein further includes directing external energy to the composite material to supply energy to the energy-absorbing component, thereby transferring thermal energy to multiple expandable components.

[0355] As disclosed in this paper, the various expandable components are expandable thermoplastic microspheres, wherein external energy is directed to the composite material to cause the thermoplastic microspheres to expand.

[0356] The method disclosed in this paper uses light energy as the external energy source.

[0357] The method disclosed herein uses light energy that is a laser with a wavelength of about 488 nm to about 650 nm.

[0358] The method disclosed herein further includes adjusting the fundamental focal length of the optical component between approximately ±0.05D and approximately ±0.5D by directing a pulse of external energy to the composite material.

[0359] As disclosed herein, the optical component portion includes a fluid-filled optical component chamber, and the peripheral portion includes at least one tactile component including a fluid-filled tactile component fluid chamber in fluid communication with the optical component chamber, wherein the method further includes directing external energy to the composite material to displace fluid between the optical component chamber and the tactile component fluid chamber.

[0360] The method disclosed herein further includes modulating the basal focal length of the accommodative intraocular lens by directing external energy to the composite material to change the volume of the tactile fluid chamber.

[0361] The method disclosed herein further includes, when the accommodative intraocular lens is implanted in the eye, modulating the base focal length of the accommodative intraocular lens by directing external energy to the composite material to cause the peripheral portion to interact with the capsule environment surrounding the accommodative intraocular lens.

[0362] The method disclosed herein further includes adjusting the base power of the accommodative intraocular lens by directing external energy to the composite material to change the volume of the fluid chamber of the optics.

[0363] As disclosed herein, at least one of the optical portion and the peripheral portion is partially made of a crosslinked copolymer comprising a copolymer blend, and the composite material is partially made of a copolymer blend.

[0364] Numerous embodiments have been described. However, those skilled in the art will understand that various changes and modifications can be made to this application without departing from the spirit and scope of the embodiments. Elements of the systems, apparatuses, devices, and methods shown with any embodiment are exemplary for particular embodiments and can be combined with or otherwise used with other embodiments within this application. For example, the steps of any method depicted in the drawings or described in this application do not require a specific order or sequence shown or described to achieve the desired result. Additionally, other steps may be provided, or steps or operations may be eliminated or omitted from the described method or process to achieve the desired result. Furthermore, any component or part of any device or system described in this application or depicted in the drawings may be removed, eliminated, or omitted to achieve the desired result. Additionally, for brevity and clarity, certain components or parts of the systems, apparatuses, or devices shown or described herein have been omitted.

[0365] Therefore, other embodiments are within the scope of the following claims, and the description and / or drawings are to be regarded as illustrative rather than restrictive.

[0366] Each of the various variants or embodiments described and illustrated herein has discrete components and features that can be readily separated from or combined with features of any other variant or embodiment. Modifications may be made to suit the specific circumstances, materials, composition, methods, one or more methodological actions, or steps to one or more objects, spirit, or scope of the invention.

[0367] The methods described herein can be performed in any logically possible order of the events, and in any logical sequence of events. Furthermore, additional steps or operations may be provided, or steps or operations may be eliminated to achieve the desired result.

[0368] Furthermore, where a numerical range is provided, every intermediate value between the upper and lower limits of that range, as well as any other specified value or intermediate value within that range, is included within the scope of this invention. Additionally, any optional features of the described variations of the invention may be set forth and claimed independently or in combination with any one or more of the features described herein. For example, the description of the range 1 to 5 should be considered as having disclosed 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, such as 1.5, 2.5, etc., and any wholly or partially increments therein.

[0369] All existing subjects (e.g., publications, patents, patent applications) mentioned herein are incorporated herein by reference in their entirety, unless such subject matter may conflict with the subject matter of this invention (in which case the content herein shall prevail). The referenced items are provided only for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that this invention does not claim prior material rights due to prior invention.

[0370] References to a single item include the possibility that multiple identical items exist. More specifically, unless the context clearly indicates otherwise, the singular forms “a / an,” “the,” and “the” as used herein and in the appended claims include plural referents. It should also be noted that claims may be drafted to exclude any optional elements. Therefore, this statement is intended to serve as a priori basis for the use of exclusive terms such as “solely,” “only,” etc., or the use of “negative” limitations associated with the recitation of the elements of the claims. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0371] Regarding the phrase "at least one of...", when this phrase modifies multiple items or components (or a list of items or components), it refers to any combination of one or more of these items or components. For example, the phrase "at least one of A, B, and C" refers to: (i) A; (ii) B; (iii) C; (iv) A, B, and C; (v) A and B; (vi) B and C; or (vii) A and C.

[0372] In understanding the scope of this application, the term "comprising" and its derivatives, as used herein, are intended to be open-ended terms that specify the presence of said features, elements, parts, groups, integers, and / or steps, but do not exclude the presence of other unstated features, elements, parts, groups, integers, and / or steps. The foregoing also applies to words with similar meanings, such as the terms "including," "having," and their derivatives. Additionally, the terms "part," "section," "portion," "member," "element," or "component," when used in the singular, can have a dual meaning of a single part or multiple parts. As used herein, the following directional terms "forward, backward, above, downward, vertical, horizontal, below, lateral, sideways, and vertically," and any other similar directional terms, refer to those directions in which a device or piece of equipment is positioned or translated or moved.

[0373] Finally, degree terms such as “substantially,” “about,” and “approximately” as used herein refer to a specified value or a specified value and a reasonable amount of deviation from the specified value (e.g., a deviation of at most ±0.1%, ±1%, ±5%, or ±10%, as such variation is appropriate) that makes the final result not significantly or substantially altered. For example, “about 1.0 cm” can be interpreted as referring to “1.0 cm” or “0.9 cm to 1.1 cm.” When degree terms such as “about” or “approximately” are used to refer to numbers or values ​​that are part of a range, the term can be used to modify both the minimum and maximum numbers or values.

[0374] This application is not intended to limit the scope to the specific forms set forth herein, but rather to cover alternatives, modifications, and equivalents to the variations or embodiments described herein. Furthermore, the scope of this application fully encompasses other variations or embodiments that may become apparent to those skilled in the art in light of this application.

Claims

1. An accommodative intraocular lens, comprising: Optical components; The peripheral portion connected to the optical component; At least one of the optical component and the peripheral component is partially made of a composite material comprising an energy-absorbing component and multiple expandable components, wherein the expandable components are expandable microspheres, each of which contains a foaming agent contained within a thermoplastic shell, and The base focal length of the optical component is configured to change in response to external energy directed to the composite material.

2. The adjustable intraocular lens of claim 1, wherein the diameter of at least one of the expandable microspheres is configured to increase by 2 to 4 times in response to external energy directed to the composite material.

3. The accommodative intraocular lens as described in claim 1, wherein the energy-absorbing component is an energy-absorbing colorant.

4. The adjustable intraocular lens as described in claim 3, wherein the energy-absorbing colorant is an azo dye.

5. The adjustable intraocular lens as described in claim 3, wherein the energy-absorbing colorant is graphitized carbon black.

6. The adjustable intraocular lens of claim 3, wherein at least one of the optical portion and the peripheral portion is partially made of a first composite material and a second composite material, wherein the first composite material contains a first energy-absorbing colorant and the second composite material contains a second energy-absorbing colorant, wherein the color of the first energy-absorbing colorant is different from the color of the second energy-absorbing colorant.

7. The accommodative intraocular lens of claim 1, wherein at least one of the optical portion and the peripheral portion is made of a crosslinked copolymer comprising a copolymer blend, and wherein the composite material is made of the copolymer blend in part.

8. The adjustable intraocular lens of claim 7, wherein the copolymer blend comprises alkyl acrylate, fluoroalkyl acrylate, and phenylalkyl acrylate.

9. The adjustable intraocular lens of claim 1, wherein the base power of the optical component is configured to change between ±0.05 D and ±0.5 D in response to a pulse of external energy directed to the composite material.

10. The adjustable intraocular lens of claim 1, wherein the base power of the optical component is configured to change by a total of up to ±5.0 D.

11. The adjustable intraocular lens of claim 1, wherein the external energy is a laser having a wavelength of 488 nm to 650 nm.

12. The accommodative intraocular lens of claim 1, wherein the optic portion is partially made of the composite material, and wherein the cylindricity of the optical surface of the optic portion is configured to change in response to the external energy directed to the optic portion.

13. The adjustable intraocular lens of claim 1, wherein the optical component comprises an anterior element having an anterior optical surface and a posterior element having a posterior optical surface.

14. The adjustable intraocular lens of claim 13, wherein the composite material is positioned along a first peripheral edge of the anterior element and along a second peripheral edge of the anterior element that is diametrically opposed to the first peripheral edge, and wherein the cylindricity of the anterior optical surface is configured to change in response to external energy directed to the first peripheral edge and the second peripheral edge.

15. The adjustable intraocular lens of claim 13, wherein the composite material is positioned along a first peripheral edge of the posterior element and along a second peripheral edge of the posterior element that is diametrically opposed to the first peripheral edge, and wherein the cylindricity of the posterior optical surface is configured to change in response to external energy directed to the first peripheral edge and the second peripheral edge.

16. The accommodative intraocular lens of claim 1, wherein the optical component comprises an anterior element, a posterior element, and a fluid-filled optical chamber defined therebetween, wherein the anterior element is circumferentially bonded or adhered to the posterior element by an adhesive layer, and wherein the adhesive layer comprises the composite material.

17. The accommodative intraocular lens of claim 1, wherein the optical element portion comprises a fluid-filled optical element chamber, and the peripheral portion comprises at least one tactile element, the tactile element comprising a fluid-filled tactile element fluid chamber in fluid communication with the optical element chamber.

18. The accommodative intraocular lens of claim 17, wherein the base power is configured to change in response to fluid displacement between the optical chamber and the tactile fluid chamber caused by the external energy directed to the composite material.

19. The accommodative intraocular lens of claim 17, wherein the base power is configured to change in response to a change in the volume of the tactile fluid chamber caused by external energy directed to the composite material.

20. The accommodative intraocular lens of claim 17, wherein the composite material is configured as a spacer extending radially from the wall of the tactile chamber, wherein the spacer is configured to expand in response to external energy directed to the spacer, and wherein the expansion of the spacer reduces the volume of the tactile fluid chamber by pushing the tactile element against the capsule environment surrounding the accommodative intraocular lens.

21. The adjustable intraocular lens of claim 17, wherein the composite material is partially located within the tactile chamber wall surrounding the tactile fluid chamber.

22. The accommodative intraocular lens of claim 17, wherein the composite material is at least partially located within a channel formed along the radial inner wall of the tactile element, wherein the volume of the fluid chamber of the tactile element is configured to expand in response to external energy directed to the composite material.

23. The accommodative intraocular lens of claim 17, wherein the composite material is positioned at least partially along the radially outermost portion of the radially inner wall of the tactile element, wherein the volume of the fluid chamber of the tactile element is configured to decrease in response to the external energy directed to the composite material.

24. The accommodative intraocular lens of claim 23, wherein the composite material is configured to expand into the tactile fluid chamber in response to external energy directed to the composite material.

25. An accommodative intraocular lens, comprising: Optical components; and A tactile element connected to the optical component portion, wherein the tactile element includes a first tactile element portion and a second tactile element portion. The first tactile component is partially made of a composite material containing energy-absorbing components and various expandable components. The second tactile element is partially made of the same composite material. The base focal length of the optical component is configured to increase in response to external energy directed to the first tactile component. The base focal length of the optical component is configured to decrease in response to the external energy directed to the second tactile component.

26. The adjustable intraocular lens of claim 25, wherein the optical element portion includes a fluid-filled optical fluid chamber, and the tactile element includes a fluid-filled tactile fluid chamber in fluid communication with the optical fluid chamber.

27. The accommodative intraocular lens of claim 26, wherein the base power of the optical component is configured to increase in response to external energy directed to the first tactile component caused by fluid flowing from the tactile fluid chamber to the optical fluid chamber.

28. The accommodative intraocular lens of claim 26, wherein the base power of the optical component is configured to decrease in response to the external energy directed to the second tactile component caused by fluid flowing from the optical component fluid chamber to the tactile component fluid chamber.

29. The accommodative intraocular lens of claim 25, wherein the first tactile element is partially made of a first composite material, wherein the second tactile element is partially made of a second composite material, wherein the first composite material comprises a first energy-absorbing component, wherein the second composite material comprises a second energy-absorbing component, and wherein the composition of the first energy-absorbing component is different from the composition of the second energy-absorbing component.

30. The adjustable intraocular lens of claim 25, wherein the first tactile portion is radially offset from the second tactile portion.

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