Adjustable intraocular lenses and methods of post-operatively adjusting intraocular lenses

Abstract

To provide adjustable intraocular lenses, and methods of adjusting the intraocular lenses post-operatively.SOLUTION: In one embodiment, the adjustable intraocular lens can comprise an optic portion and a peripheral portion. The peripheral portion can comprise a composite material comprising an energy absorbing constituent and a plurality of expandable components. A base power of the optic portion may change in response to an external energy directed at the composite material.SELECTED DRAWING: Figure 3B

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62 / 911,039, filed October 4, 2019, the contents of which are incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to the field of intraocular lenses, and more particularly to accommodative intraocular lenses and methods for adjusting intraocular lenses after surgery. [Background technology]

[0003] A cataract is a clouding of the normally clear lens inside a patient's eye. Cataracts can occur due to causes such as aging, genetics, trauma, inflammation, metabolic abnormalities, or radiation exposure. Age-related cataracts are the most common type of cataract. To treat cataracts, surgeons remove the patient's lens matrix from the lens capsule and replace it with an intraocular lens (IOL).

[0004] However, some patients may not be satisfied with the refractive results of current IOL surgery. In some cases, the preoperative biometry performed on the patient's eye may be in error, resulting in an IOL with an incorrect lens power being prescribed and implanted in the patient's eye. In other cases, when the IOL is implanted in the capsular bag, an aggressive healing response by cells in the capsular bag may affect the optical power of the IOL. Furthermore, the cornea or muscles in the patient's eye may change as a result of injury, disease, or aging. In such cases, it may be necessary to adjust the IOL implanted in the patient to accommodate such changes.

[0005] Therefore, to address the issues listed above, a solution is needed to adjust the IOL after implantation without additional surgery, which should not be overly complicated and allow the IOL to be manufactured cost-effectively. Summary of the Invention

[0006] Disclosed herein are accommodative intraocular lenses and methods for post-operative adjustment of intraocular lenses. Such accommodative intraocular lenses may also be referred to as accommodative fixed focus intraocular lenses or non-accommodative fluidically accommodative intraocular lenses.

[0007] In an embodiment, an intraocular lens is disclosed that includes an optic and a peripheral portion connected to the optic. The peripheral portion may include a composite material including an energy absorbing component and a plurality of expansile elements. The base power of the optic may change in response to external energy directed at the composite material. The base power of the optic may be insensitive to forces applied to the peripheral portion by the capsular bag when the intraocular lens is implanted in the capsular bag.

[0008] In some embodiments, the expandable elements may be expandable microspheres, each of which may include a blowing agent encapsulated within a thermoplastic shell, the thickness of which may vary in response to external energy directed at the composite.

[0009] In certain embodiments, the blowing agent may be a branched chain hydrocarbon, for example, the branched chain hydrocarbon may be isopentane, and the thermoplastic shell may be comprised, in part, of an acrylonitrile copolymer, for example.

[0010] In some embodiments, as a result of external energy directed at the composite material, the diameter of the at least one expandable microsphere may increase between about 2 and about 4 times. The volume of the at least one expandable element may expand between about 10 and 50 times in response to external energy directed at the composite material.

[0011] In some embodiments, the intumescent element may comprise between about 5% and about 15% by weight of the composite material. For example, the intumescent element may comprise about 10% by weight of the composite material.

[0012] In some embodiments, the energy absorbing component may be an energy absorbing colorant, the color of which may be visually perceptible when the intraocular lens is implanted in the eye.

[0013] In some embodiments, the energy absorbing colorant may be a dye. For example, the dye may be an azo dye. More specifically, the dye may be Disperse Red 1.

[0014] In some embodiments, the energy absorbing colorant may be an energy absorbing pigment. For example, the energy absorbing pigment may be graphitized carbon black. In certain embodiments, the energy absorbing component may comprise between about 0.025% and about 1.00% by weight of the composite material.

[0015] In some embodiments, the periphery may be made in part of a cross-linked copolymer, including a copolymer blend. In these embodiments, the composite material may also be made in part of a copolymer blend.

[0016] The composite material may be cured to become a cross-linked copolymer in position within the perimeter. The composite material may be generally fixed in position.

[0017] The base power of the optic may vary from about ±0.05 D to about ±0.5 D in response to a pulse of external energy directed at the composite material. For example, the base power of the optic may vary by about 0.1 D in response to a pulse of external energy directed at the composite material.

[0018] The base power of the optic may vary by a total of about ±1.0 D to about ±2.0 D. The change in base power may be a permanent change.

[0019] In some embodiments, the external energy may be light energy. In these embodiments, the light energy may be laser light. The laser light may have a wavelength between about 488 nm and about 650 nm. For example, the laser light may be green laser light. The green laser light may have a wavelength of about 532 nm.

[0020] In other embodiments, the laser light may have a wavelength between about 946 nm and about 1120 nm. For example, the laser light may have a wavelength of about 1030 nm. Also, for example, the laser light may have a wavelength of about 1064 nm.

[0021] In some embodiments, the laser light may be a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser, hi other embodiments, the laser light may be generated by a femtosecond laser.

[0022] The energy absorbing component transfers thermal energy to the plurality of intumescent elements in response to external energy directed at the composite material.

[0023] In some embodiments, the composite material may be separate peripheral elements, where directing external energy to one separate peripheral element results in a change in the base power of the optic, and directing external energy to another separate peripheral element also results in a change in the base power of the optic, hi certain embodiments, the periphery may comprise between 20 and 40 peripheral elements.

[0024] The optic portion of the IOL may comprise an optical fluid chamber, and the periphery may comprise at least one peripheral fluid chamber in fluid communication with the optical fluid chamber, hi some embodiments, the peripheral fluid chamber is curved, and the peripheral fluid chamber follows the curvature of the optic portion.

[0025] The peripheral fluid chamber may have a chamber height, which may be between about 0.1 mm and about 0.3 mm.

[0026] In some embodiments, the composite material may be a chamber expansion portion. The chamber expansion portion may expand in response to external energy directed at the chamber expansion portion. Expansion of the chamber expansion portion may increase the volume of the surrounding fluid chamber. The base power of the optic portion may decrease in response to external energy directed at the chamber expansion portion. The chamber expansion portion may be an expandable strut extending from the front chamber wall to the rear chamber wall.

[0027] In some embodiments, the composite material may be a space-filling portion or piston. The space-filling portion or piston may expand in response to external energy directed at the space-filling portion or piston. Expansion of the space-filling portion or piston may decrease the volume of the surrounding fluid chamber. The space-filling portion or piston may be a pad extending from either the anterior chamber wall or the posterior chamber wall. The base power of the optic may increase in response to external energy directed at the space-filling portion or piston.

[0028] The base power may change in response to the movement of fluid between the optical fluid chamber and the peripheral fluid chamber as a result of external energy being directed at the composite material.

[0029] In certain embodiments, the perimeter may include a first composite material and a second composite material. In these embodiments, the first composite material may include a first energy absorbing component and the second composite material may include a second energy absorbing component. The first energy absorbing component may be a different color than the second energy absorbing component.

[0030] In some embodiments, the periphery can be at least one haptic and the peripheral bladder can be defined within the haptic. In these embodiments, the peripheral bladder can extend only partially within the haptic.

[0031] The haptic may comprise a proximal haptic portion and a distal haptic portion. The distal haptic portion may comprise a distal haptic arm that is not connected to the optical portion except through the proximal haptic portion.

[0032] In some embodiments, the haptic distal arm may include a twist or bend.

[0033] The peripheral fluid chamber may be defined within a proximal haptic portion, and the chamber section of the proximal haptic portion may be unconnected or separated from the optic portion by a gap or space. The haptic may be connected to the optic portion by a distal connection portion disposed distally from the proximal end of the haptic and the chamber section.

[0034] In some embodiments, the proximal ends of the haptics may be connected to and extend from the sides of the optic. In these embodiments, the sides may have a side height of about 0.65 mm.

[0035] The peripheral portion may have a first haptic with a first haptic fluid chamber and a second haptic with a second haptic fluid chamber. The optical portion may have an optical fluid chamber.

[0036] The first haptic fluid chamber may be in fluid communication with the optical fluid chamber via a first fluid channel. The second haptic fluid chamber may be in fluid communication with the optical fluid chamber via a second fluid channel. The first fluid channel may be disposed generally diametrically opposite from the second fluid channel.

[0037] In some embodiments, the optical fluid chamber, the first haptic fluid chamber, and the second haptic fluid chamber may comprise a total volume of fluid between about 10 μL and about 20 μL. Each of the first haptic fluid chamber and the second haptic fluid chamber may comprise about 0.5 μL of fluid. In certain embodiments, about 15 nL of fluid may be exchanged between either the first haptic fluid chamber or the second haptic fluid chamber and the optical fluid chamber in response to a pulse of external energy being directed at the composite material. In some embodiments, the fluid may be silicone oil.

[0038] In another embodiment, an intraocular lens is disclosed that includes an optic and a peripheral portion connected to the optic. The peripheral portion may include a first peripheral element and a second peripheral element. The first peripheral element may be comprised of a composite material including an energy absorbing component and a plurality of expandable elements. The second peripheral element may also be comprised of a composite material including an energy absorbing component and a plurality of expandable elements. The base power of the optic may increase in response to external energy being directed to the first peripheral element, and the base power of the optic may decrease in response to external energy being directed to the second peripheral element. However, the base power of the optic may not be responsive to forces applied to the peripheral portion by the capsular bag when the intraocular lens is implanted in the capsular bag.

[0039] In some embodiments, the optics may include an optical fluid chamber and the peripheral portion may include at least one peripheral fluid chamber in fluid communication with the optical fluid chamber. The base power may change in response to movement of fluid between the optical fluid chamber and the peripheral fluid chamber as a result of external energy being directed at the first peripheral element or the second peripheral element.

[0040] In some embodiments, the first peripheral element may be a space-filling portion. The space-filling portion may expand in response to external energy directed at the space-filling portion. Expansion of the space-filling portion may reduce the volume of the peripheral fluid chamber. For example, the space-filling portion may be an inflatable pad extending from either the front or rear chamber wall.

[0041] In some embodiments, the second peripheral element may be a chamber expansion portion or a jack. The chamber expansion portion or the jack may expand in response to external energy directed at the chamber expansion portion or the jack. Expansion of the chamber expansion portion or the jack may increase the volume of the peripheral fluid chamber. For example, the chamber expansion portion or the jack may be an expansible strut extending from the chamber front wall to the chamber rear wall.

[0042] In certain embodiments, the first peripheral element and the second peripheral element may be disposed within the same peripheral fluid chamber. In these embodiments, the second peripheral element may be disposed distal to the first peripheral element within the same peripheral fluid chamber. Also, in these embodiments, the first peripheral element may be disposed proximate to the second peripheral element within the same peripheral fluid chamber. The first peripheral element may be disposed closer to the fluid channel connecting the optical fluid chamber to the peripheral fluid chamber than the second peripheral element.

[0043] The first peripheral element and the second peripheral element may be independent peripheral elements, and directing external energy to one independent peripheral element may cause a change in the base power of the optical portion, and directing external energy to another independent peripheral element may also cause a change in the base power of the optical portion.

[0044] In some embodiments, one peripheral fluid chamber may comprise at least 10 first peripheral elements. In these and other embodiments, the same or a different peripheral fluid chamber may comprise at least 10 second peripheral elements.

[0045] Also disclosed is a method of post-operatively adjusting an intraocular lens. The method may include adjusting the base power of the intraocular lens by directing external energy to a composite material within a periphery of the intraocular lens. The periphery may be connected to an optic disposed radially inward of the periphery. The composite material may include an energy absorbing component and a plurality of expansile elements. The base power of the intraocular lens may be insensitive to forces applied to the periphery by the capsular bag when the intraocular lens is implanted within the capsular bag.

[0046] The optic portion may include an optical fluid chamber, and the peripheral portion may include at least one peripheral fluid chamber in fluid communication with the optical fluid chamber. The base power of the intraocular lens may change in response to a transfer of fluid between the optical fluid chamber and the peripheral fluid chamber as a result of the external energy being directed to the composite material. In some embodiments, approximately 15 nL of fluid may be exchanged between the peripheral fluid chamber and the optical fluid chamber in response to a pulse of external energy being directed to the composite material.

[0047] In some embodiments, adjusting the base power of the intraocular lens may further include increasing the base power by directing external energy to a composite material that is a space-filling portion located within a peripheral fluid chamber defined within the periphery.

[0048] The method may further include reducing the base power by directing external energy to another instance of the composite material, the chamber expansion portion located within the perimeter.

[0049] In some embodiments, adjusting the base power of the intraocular lens may further include reducing the base power by directing external energy to a composite material that is a chamber expansion portion located within a peripheral fluid chamber defined within the periphery. Reducing the base power may further include directing external energy to another instance of the composite material that is a space-filling portion located within the peripheral fluid chamber.

[0050] In certain embodiments, adjusting the base power of the intraocular lens may further include directing a pulse of external energy to a first peripheral element within a peripheral fluid chamber defined within the periphery and directing an additional pulse of external energy to a second peripheral element within the same peripheral fluid chamber, the first peripheral element may be comprised of a composite material and the second peripheral element may be comprised of the same composite material.

[0051] In additional embodiments, adjusting the base power of the intraocular lens may further include directing a pulse of external energy to a first peripheral element within a first peripheral fluid chamber defined in the peripheral portion and directing an additional pulse of external energy to a second peripheral element within a second peripheral fluid chamber defined in the peripheral portion. The first peripheral element may be comprised of a composite material and the second peripheral element may be comprised of the same composite material. The first peripheral fluid chamber may be in fluid communication with the second peripheral fluid chamber via an optical fluid chamber defined in the optical portion.

[0052] In some embodiments, adjusting the base power in a first direction further comprises directing external energy to a first composite material, and adjusting the base power in a second direction further comprises directing external energy to a second composite material. The first composite material may include a first energy absorbing component having a first color. The second composite material may include a second energy absorbing component having a second color different from the first color. [Brief description of the drawings]

[0053] [Figure 1A] FIG. 1A is a plan view of an embodiment of an accommodative intraocular lens (IOL) with a portion of the anterior portion of the accommodative IOL removed to better depict the components within the IOL. [Figure 1B] FIG. 1B shows an accommodative IOL implanted within a subject's capsular bag. [Figure 2A] FIG. 2A is a perspective view of an accommodative IOL. [Figure 2B] FIG. 2B is a perspective view of an accommodative IOL with a portion of the anterior portion of the accommodative IOL removed to better depict the components within the IOL. [Figure 3A] FIG. 3A is a cross-sectional view of the accommodative IOL along line AA of FIG. 2A. [Figure 3B] FIG. 3B is a cross-sectional view of the accommodative IOL along line BB of FIG. 2A. [Figure 3C] FIG. 3C shows external energy directed at a first peripheral element of an accommodating IOL. [Figure 3D] FIG. 3D shows external energy directed at a second peripheral element of the accommodating IOL. [Figure 4A] FIG. 4A shows a composite material used to make at least a portion of an accommodative intraocular lens. [Figure 4B] FIG. 4B illustrates one embodiment of an expandable element of an accommodative intraocular lens. [Diagram 5] FIG. 5 is a plan view of another embodiment of an accommodative IOL with a portion of the anterior portion of the accommodative IOL removed to better depict the components within the IOL. [Figure 6] FIG. 6 is a plan view of an accommodative IOL having a light-splitting lens surface profile. [Figure 7] FIG. 7 illustrates one embodiment of a method for post-operative adjustment of an IOL. [Figure 8] FIG. 8 illustrates another embodiment of a method for post-operative adjustment of an IOL. [Figure 9] FIG. 9 illustrates yet another embodiment of a method for post-operative adjustment of an IOL. [Figure 10] FIG. 10 illustrates an additional embodiment of a method for post-operative adjustment of an IOL. Detailed Description

[0054] 1A is a plan view of an embodiment of an adjustable, fixed focus intraocular lens (IOL) 100 with a portion of the anterior portion of the accommodative IOL 100 removed to better depict the components within the IOL. As shown in FIG 1A, the accommodative IOL 100 may include an optic portion 102 and a peripheral portion 103. The peripheral portion 103 may include one or more haptics 104, including a first haptic 104A and a second haptic 104B, extending peripherally from or connected to the optic portion 102.

[0055] For example, accommodating IOL 100 may be a one-piece lens (see, e.g., FIGS. 1A-3B ) in which peripheral portion 103 is connected to and extends from optic portion 102. In this embodiment, peripheral portion 103 is formed with optic portion 102 and is not bonded or connected to optic portion 102 in a subsequent step.

[0056] In other embodiments, the peripheral portion 103 is connected and bonded to the optic portion 102. For example, the peripheral portions 103 may be bonded to the optic portion 102 after each is formed separately.

[0057] The optical portion 102 may include an optical fluid chamber 106 (see also, e.g., FIGS. 2B, 3A, and 3B) and one or more peripheral fluid chambers 108 in fluid communication with the optical fluid chamber 106. The one or more peripheral fluid chambers 108 may be defined within the peripheral portion 103. For example, at least one peripheral fluid chamber 108 may extend into the interior of the peripheral portion 103.

[0058] In some embodiments, at least one peripheral fluid chamber 108 may extend only partially into the interior of the periphery 103. For example, at least one peripheral fluid chamber 108 may extend only one-third, one-half, or three-quarters into the interior of the periphery 103. Also, for example, at least one peripheral fluid chamber 108 may extend only partially into between one-third and one-half of the periphery 103, or between one-half and three-quarters of the periphery 103.

[0059] In certain embodiments, the at least one peripheral fluid chamber 108 may extend only partially into one of the haptics 104 of the periphery 103. For example, the at least one peripheral fluid chamber 108 may extend into one-third, one-half, or three-quarters of the haptics 104. Also, for example, the at least one peripheral fluid chamber 108 may extend between one-third and one-half of the haptics 104, or between one-half and three-quarters of the haptics 104.

[0060] 1A, the peripheral portion 103 may include two haptics 104 (e.g., first haptic 104A and second haptic 104B). In this embodiment, the peripheral fluid chamber 108 may extend into each of the two haptics 104. The peripheral fluid chamber 108 may extend into only a portion of the haptics 104.

[0061] The one or more peripheral fluid chambers 108 may also be referred to as one or more haptic fluid chambers. When the peripheral portion 103 includes the first haptics 104A and the second haptics 104B, the peripheral portion 103 may include one peripheral fluid chamber 108 referred to as the first haptic fluid chamber and another peripheral fluid chamber 108 referred to as the second haptic fluid chamber.

[0062] At least one haptic 104 (e.g., first haptic 104A, second haptic 104B, or a combination thereof) may be curved. In these embodiments, the peripheral fluid chamber 108 (e.g., the haptic fluid chamber) may be curved. The peripheral fluid chamber 108 may follow the curvature of the haptic 104. When at least a section of the haptic 104 follows the curvature of at least a portion of the optical portion 102, the peripheral fluid chamber 108 may also follow the curvature of at least a portion of the optical portion 102.

[0063] The peripheral fluid chamber 108 may be in fluid communication with the optical fluid chamber 106 or may be fluidly connected to the optical fluid chamber 106 via a fluid channel 110. The fluid channel 110 may be a passage or conduit connecting the peripheral fluid chamber 108 to the optical fluid chamber 106. The fluid channel 110 may be defined along a posterior element 300 of the optic portion 102 (see, e.g., FIGS. 3A and 3B).

[0064] The fluid channel 110 may also refer to a gap or an opening defined along a side surface 111 or lateral surface of the optical portion 102 (see also, for example, Figures 2A, 2B, 3A, 3B). The fluid channel 110 may be curved. The fluid channel 110 may be formed as a generally annular section.

[0065] The peripheral fluid chambers 108 may be in fluid communication with the optical fluid chamber 106, or may be fluidly connected to the optical fluid chamber 106 via a single fluid channel 110. If the accommodable IOL 100 comprises multiple peripheral fluid chambers 108, each of the peripheral fluid chambers 108 may be in fluid communication with the optical fluid chamber 106, or may be fluidly connected to the optical fluid chamber 106 via a single fluid channel 110.

[0066] In other embodiments, the peripheral fluid chamber 108 may be in fluid communication with the optical fluid chamber 106 or may be fluidly connected to the optical fluid chamber 106 via multiple (e.g., two or more) fluid channels. In these embodiments, the two or more fluid channels 110 may be separated by a channel divider or dividing wall.

[0067] When peripheral portion 103 includes first haptics 104A having a first haptic fluid chamber and second haptics 104B having a second haptic fluid chamber, the first haptic fluid chamber can be in fluid communication or fluid connection with optical fluid chamber 106 via a first fluid channel, and the second haptic fluid chamber can be in fluid communication or fluid connection with optical fluid chamber 106 via a second fluid channel. In these embodiments, the first fluid channel can be disposed generally diametrically opposite from the second fluid channel (e.g., FIGS. 1A, 1B, 2B, and 3A).

[0068] 1A illustrates that when peripheral portion 103 is implemented as one or more haptics 104, each of haptics 104 may have a haptic proximal portion 112 and a haptic distal portion 114. A peripheral fluid chamber 108, or haptic fluid chamber, may be defined within haptic proximal portion 112.

[0069] At least a section of the haptic proximal portion 112 may be curved. At least a section of the haptic proximal portion 112 may follow the curvature of at least a portion of the optic portion 102.

[0070] The haptic distal portion 114 may include a haptic distal arm 116. The haptic distal arm 116 may be unconnected to the optic portion 102 except for the connection via the haptic proximal portion 112.

[0071] The haptic distal arm 116 may have a twist or bend 118 defined along the haptic distal arm 116. The twist or bend 118 may cause the haptic distal arm 116 to compress or bend in response to deformation of the capsular bag. The haptic distal arm 116 may terminate in a haptic distal end 120 that is free or unconnected.

[0072] When peripheral portion 103 includes two haptics 104 (e.g., first haptic 104A and second haptic 104B), accommodating IOL 100 can have an uncompressed haptic length 122 measured from haptic distal end 120 of first haptic 104A to haptic distal end 120 of second haptic 104B. Uncompressed haptic length 122 can be between about 12.0 mm and about 14.0 mm. For example, uncompressed haptic length 122 can be about 13.0 mm.

[0073] The haptic distal end 120 of each haptic 104 may be a closed end of the haptic 104 that is not connected to the optic portion 102. The haptic distal end 120 may include a bulbous feature or a small knob at the end of the haptic distal end 120.

[0074] 1A, the optic 102 may have an optic diameter 124. The optic diameter 124 may be between about 5.0 mm and 8.0 mm. For example, the optic diameter 124 may be about 6.0 mm.

[0075] The haptics 104 may be connected to the optics 102 at a proximal end 126 of the haptics 104. The haptics 104 may also be connected to the optics 102 at a distal connection 128. The distal connection 128 may be a portion of the haptics 104 that is disposed distal to the distal end of the peripheral fluid chamber 108 or the haptic fluid chamber.

[0076] A section of the haptic 104 between the proximal end 126 and the distal connection 128 (referred to herein as the chamber section 129) may be physically separated from the optics 102. The chamber section 129 includes at least a section of the peripheral fluid chamber 108 between a radially inner chamber wall 132 and a radially outer chamber wall 134. For example, the radially inner chamber wall 132 of the chamber section 129 may be separated from the optics 102 by an elongated gap or space. The elongated gap or space may be a curved gap 130 as shown in FIG. 1A.

[0077] The curved gap 130 allows the peripheral fluid chamber 108 or haptic fluid chamber to expand or deform without the radially inner chamber wall 132 colliding with or exerting pressure on the side 111 adjacent the chamber section 129 of the optical portion 102 (see also, e.g., Figures 2A, 2B, 3A, and 3B).

[0078] 1A, the radially outer chamber wall 134 may be thicker or larger than the radially inner chamber wall 132. In some embodiments, the radially outer chamber wall 134 may be thicker or larger than both the radially inner chamber wall 132 and the surrounding fluid chamber 108.

[0079] A thicker or larger radially outer chamber wall 134 may provide stiffness or resilience to the chamber compartment 129 when a radial force is applied to the chamber compartment 129 due to contraction or deformation of the lens capsule. For example, a thicker or larger radially outer chamber wall 134 may make the chamber compartment 129 in the peripheral portion 103 less sensitive to radial forces applied to the peripheral portion 103 by deformation of the lens capsule due to ciliary muscle movement.

[0080] In some embodiments, the distal connection 128 may not be fixed or connected to the adjacent portion of the optic 102, so that most of the haptics 104 are free to move for purposes of folding and unfolding during implantation of the IOL 100. Once the IOL 100 is implanted within the capsular bag, the distal connection 128 may rest or rest against the adjacent portion of the optic 102, stabilizing the haptics 104 and preventing them from twisting or moving around due to contraction or deformation of the capsular bag. In other embodiments, the haptics 104 may also be connected to the optic 102 at the distal connection 128.

[0081] 1A, the peripheral fluid chamber 108 terminates before reaching the haptic distal portion 114. In some embodiments, the haptic distal arm 116 may be made of the same material as the haptic chamber wall.

[0082] One technical problem faced by applicants is how to design a fluid-filled IOL that is insensitive or insensitive to the radial force exerted by the capsular bag on the fluid-filled IOL, which can be adjusted by a clinician or other medical personnel after surgery. One solution that applicants have found is the accommodative IOL disclosed herein, which has a peripheral fluid chamber that extends only partially within the haptics of the accommodative IOL, the chamber section of the haptics having a radially outer chamber wall that is thicker than the radially inner chamber wall, and the radially inner chamber wall separated from the optic by an elongated gap or space. The haptics may also be connected to the optic by a distal connection disposed distal to the proximal end of the haptics and the chamber section.

[0083] The perimeter 103 may include, or at least a portion of, a composite material 400 (see, e.g., FIG. 4A). As discussed in more detail in a later section, the composite material 400 may include an energy absorbing component 404 and a plurality of inflatable elements 406 (see, e.g., FIGS. 4A and 4B).

[0084] In some embodiments, the composite material 400 may be a plurality of space-filling portions 310 (see, e.g., FIGS. 3A and 3B) or a piston. One or more of the space-filling portions 310 may expand in response to external energy 318 (see, e.g., FIG. 3C) directed at the one or more space-filling portions 310. The expansion of the one or more space-filling portions 310 may reduce the volume of the peripheral fluid chamber 108 that contains the one or more space-filling portions 310. At least one space-filling portion 310 may be a pad extending from either the front chamber wall 314 or the rear chamber wall 316 of the peripheral fluid chamber 108 (see, e.g., FIG. 3B).

[0085] In these and other embodiments, the composite material 400 may be a plurality of chamber expansions 312 (see, e.g., FIG. 3B) or jacks. One or more of the chamber expansions 312 may expand in response to external energy 318 (see, e.g., FIG. 3D) directed at the one or more chamber expansions 312. Expansion of the one or more chamber expansions 312 may increase the volume of the peripheral fluid chamber 108 that contains the one or more chamber expansions 312. At least one chamber expansion 312 may be an expansible strut extending from a front chamber wall 314 to a rear chamber wall 316 of the peripheral fluid chamber 108 (see, e.g., FIG. 3B).

[0086] The base power or optical / refractive power of the optic 102 may change in response to external energy 318 (see, e.g., FIGS. 3C and 3D) directed at the composite material 400. However, the base power of the optic 102 may be unresponsive or insensitive to forces exerted by the capsular bag on the peripheral portion 103 when the accommodating IOL 100 is implanted within the capsular bag.

[0087] The base power of the optic 102 may change in response to the movement of fluid between the optical fluid chamber 106 and the peripheral fluid chamber 108 as a result of the external energy 318 being directed at the composite material 400 .

[0088] The composite material 400 of the perimeter 103 may be formed, shaped, or configured as a plurality of independent perimeter elements 136. For example, each of the perimeter elements 136 may be separated from neighboring or adjacent perimeter elements 136 by a space or gap.

[0089] The peripheral element 136 may be disposed or positioned within the peripheral fluid chamber 108. In some embodiments, the peripheral element 136 may occupy the entire length of the peripheral fluid chamber 108. In other embodiments, the peripheral element 136 may occupy the entire length of the peripheral fluid chamber 108.

[0090] In some embodiments, directing external energy 318 at one of the peripheral elements 136 may cause that particular peripheral element 136 to deform or expand, generally without affecting the other peripheral elements 136. For example, directing external energy 318 at one of the peripheral elements 136 may cause that particular peripheral element 136 to deform or expand, without the other peripheral elements 136 undergoing a similar deformation or expansion.

[0091] A pulse or set amount of external energy 318 may be directed to one peripheral element 136 to change the base power of the optic 102. In these embodiments, an additional pulse or additional set amount of external energy 318 may be directed to another peripheral element 136 to cause another change in the base power of the optic 102.

[0092] In some embodiments, the periphery 103 may include between 20 and 40 periphery elements 136. In other embodiments, the periphery 103 may include between 10 and 20 periphery elements 136. In additional embodiments, the periphery 103 may include between 40 and 60 periphery elements 136.

[0093] In certain embodiments, a peripheral fluid chamber 108 may include 20 peripheral elements 136. In other embodiments, a peripheral fluid chamber 108 may include between 10 and 20 peripheral elements 136. In further embodiments, a peripheral fluid chamber 108 may include between 20 and 30 peripheral elements 136. In additional embodiments, a peripheral fluid chamber 108 may include between 5 and 10 peripheral elements 136.

[0094] The peripheral element 136 may comprise one or more first peripheral elements 138, one or more second peripheral elements 140, or a combination thereof. The first peripheral element 138 and the second peripheral element 140 may be disposed or located within the same peripheral fluid chamber 108.

[0095] In some embodiments, a single peripheral fluid chamber 108 may include at least 10 first peripheral elements 138. In other embodiments, a single peripheral fluid chamber 108 may include between 5 and 10 first peripheral elements 138, or between 10 and 20 first peripheral elements 138.

[0096] In these and other embodiments, a single peripheral fluid chamber 108 may include at least 10 second peripheral elements 140. In other embodiments, a single peripheral fluid chamber 108 may include between 5 and 10 second peripheral elements 140, or between 10 and 20 second peripheral elements 140.

[0097] 1A, one peripheral fluid chamber 108 may include ten first peripheral elements 138 and ten second peripheral elements 140. Additionally, the accommodative IOL 100 may include two haptics 104, each having a haptic fluid chamber including ten first peripheral elements 138 and ten second peripheral elements 140.

[0098] The first peripheral element 138 may be disposed proximate to the second peripheral element 140 within the peripheral fluid chamber 108 (i.e., the second peripheral element 140 may be disposed deeper within the peripheral fluid chamber 108). For example, the first peripheral element 138 may be disposed closer to the fluid channel 110 connecting the optical fluid chamber 106 to the peripheral fluid chamber 108 than the second peripheral element 140. One reason for disposing the second peripheral element 140 (e.g., the chamber expansion portion 312 or the jack) deeper or more distally within the peripheral fluid chamber 108 is to minimize pressure on the optics 102 (which may create unwanted aberrations) since expansion of the second peripheral element 140 affects the entire cross-section of the peripheral fluid chamber 108.

[0099] In other embodiments, at least some of the second peripheral elements 140 may be disposed closer to or closer to the fluid channel 110 than the first peripheral elements 138. In further embodiments, the second peripheral elements 140 may be interleaved with the first peripheral elements 138 such that the elements form an alternating pattern.

[0100] 1A, the peripheral elements 136 (including the first peripheral element 138, the second peripheral element 140, or a combination thereof) may be arranged in a single row (e.g., a single curved row) along the length of the peripheral fluid chamber 108. In other embodiments not shown but contemplated by this disclosure, the peripheral elements 136 may be arranged in a zigzag, curved pattern, or a two or three row pattern, i.e., two or more adjacent rows of peripheral elements 136.

[0101] The base power of the optics 102 may change in response to movement of fluid between the optical fluid chamber 106 and the peripheral fluid chamber 108 as a result of external energy 318 being directed at the peripheral element 136. For example, in response to external energy 318 being directed at the peripheral element 136, fluid may flow out of the peripheral fluid chamber 108 and into the optical fluid chamber 106, or out of the optical fluid chamber 106 and back into the peripheral fluid chamber 108.

[0102] The base power of the optic 102 may change in a first direction in response to external energy 318 directed at the first peripheral element 138. The base power of the optic 102 may also change in a second direction, opposite the first direction, in response to external energy 318 directed at the second peripheral element 140.

[0103] For example, the base power of the optic 102 may increase in response to external energy 318 directed at the first peripheral element 138. As a more specific example, fluid in the peripheral fluid chamber 108 may flow into the optical fluid chamber 106 in response to external energy being directed at the first peripheral element 138.

[0104] Also, for example, the base power of the optic 102 may decrease in response to external energy 318 directed at the second peripheral element 140. As a more specific example, fluid in the optical fluid chamber 106 may flow into the peripheral fluid chamber 108 in response to external energy being directed at the second peripheral element 140.

[0105] As discussed in more detail in a later section, the first peripheral element 138 may be a space-filling portion 310 (see, e.g., FIGS. 3A and 3B ) or a piston. The space-filling portion 310 may expand in response to external energy 318 directed at the space-filling portion 310. The expansion of the space-filling portion 310 may reduce the volume of the peripheral fluid chamber 108, which may result in fluid moving from the peripheral fluid chamber 108 to the optical fluid chamber 106.

[0106] The second peripheral element 140 may be a chamber expansion portion 312 (see, e.g., FIGS. 2B, 3A, and 3B) or a jack. The chamber expansion portion 312 may expand in response to external energy 318 directed at the chamber expansion portion 312. The expansion of the chamber expansion portion 312 may increase the volume of the peripheral fluid chamber 108.

[0107] In some embodiments, the fluid within the optical fluid chamber 106 and the peripheral fluid chamber 108, or a combination thereof, may be oil. More specifically, in certain embodiments, the fluid within the optical fluid chamber 106, the peripheral fluid chamber 108, or a combination thereof may be silicone oil or fluid.

[0108] The fluid within the optical fluid chamber 106, the peripheral fluid chamber 108, or a combination thereof may be a silicone oil or fluid that includes or consists in part of diphenylsiloxane and dimethylsiloxane. In other embodiments, the silicone oil or fluid may include or consist in part of one unit of diphenylsiloxane for every two units of dimethylsiloxane. In a particular embodiment, the silicone oil may include about 20 mol % diphenylsiloxane and about 80 mol % dimethylsiloxane.

[0109] More specifically, in some embodiments, the silicone oil may include diphenyltetramethylcyclotrisiloxane. In additional embodiments, the silicone oil or fluid may include or consist in part of a diphenylsiloxane and dimethylsiloxane copolymer.

[0110] The fluid (e.g., silicone oil) may be index matched to the lens body material used to fabricate the optic 102. When the fluid is index matched to the lens body material, the entire optic 102 including the fluid behaves as a single lens. For example, the fluid may be selected to have a refractive index between about 1.48 and 1.53 (or between about 1.50 and 1.53). In some embodiments, the fluid (e.g., silicone oil) may have a polydispersity index between about 1.2 and 1.3. In other embodiments, the fluid (e.g., silicone oil) may have a polydispersity index between about 1.3 and 1.5. In other embodiments, the fluid (e.g., silicone oil) may have a polydispersity index between about 1.1 and 1.2. Examples of other fluids are described in U.S. Patent Application Publication No. 2018 / 0153682, the contents of which are incorporated herein by reference.

[0111] 1B illustrates that the adjustable fixed focus IOL 100 may be implanted in the natural capsular bag after the natural lens has been removed. When implanted in the natural capsular bag, the optic 102 may be adapted to refract light that enters the eye and reaches the retina. One or more haptics 104 (e.g., first haptic 104A and second haptic 104B) may engage the capsular bag to hold the adjustable IOL 100 in place within the capsular bag.

[0112] 2A is a perspective view of an accommodative IOL 100. As previously discussed, the optical fluid chamber 106 and the peripheral fluid chamber 108 may be filled with a fluid (e.g., silicone oil). The base power of the optic 102 may change based on the fluid pressure inside the fluid-filled optical fluid chamber 106.

[0113] The shape of the optic portion 102 may also change in response to fluid entering the optical fluid chamber 106. In certain embodiments, the shape of the anterior element 200 of the optic portion 102 may change in response to fluid entering or leaving the optical fluid chamber 106. For example, the curvature of the anterior element 200 may increase in response to fluid entering the optical fluid chamber 106. Also, for example, the curvature of the anterior element 200 may decrease in response to fluid leaving the optical fluid chamber 106.

[0114] In other embodiments, the posterior element 300 (see, e.g., FIGS. 3A and 3B ) of the optic portion 102 may change shape (e.g., increase in curvature or decrease in curvature) as fluid enters and leaves the optical fluid chamber 106. In further embodiments, both the anterior element 200 and the posterior element 300 may deform as fluid enters and leaves the optical fluid chamber 106.

[0115] The base power of the optic 102 may be increased or decreased depending on the deformation of the anterior element 200, the posterior element 300, or a combination thereof. By increasing the curvature of the anterior element 200, the posterior element 300, or a combination thereof, the base power of the optic 102 may be increased, resulting in better near vision. By decreasing the curvature of the anterior element 200, the posterior element 300, or a combination thereof, the base power of the optic 102 may be decreased, resulting in better distance vision.

[0116] For example, the base power of the optics 102 may increase as fluid flows from the peripheral fluid chamber 108 (e.g., the haptic fluid chamber) into the optical fluid chamber 106. Fluid may flow out of the peripheral fluid chamber 108 into the optical fluid chamber 106 as the volume of the peripheral fluid chamber 108 decreases in response to the expansion of the one or more first peripheral elements 138. The one or more first peripheral elements 138 may expand in response to external energy 318 being directed at the first peripheral elements 138.

[0117] Also, for example, the base power of the optic 102 may decrease as fluid flows out or is drawn out of the fluid-filled optical fluid chamber 106 into the peripheral fluid chamber 108. Fluid may flow out of the optical fluid chamber 106 into the peripheral fluid chamber 108 as the volume of the peripheral fluid chamber 108 increases in response to the expansion of the one or more second peripheral elements 140. The one or more second peripheral elements 140 may expand in response to external energy 318 being directed at the second peripheral elements 140.

[0118] 2B is a perspective view of accommodative IOL 100 with a portion of the anterior portion of accommodative IOL 100 removed to better depict components within the IOL. Accommodative IOL 100 may include a peripheral portion 103 that includes a number of peripheral elements 136 within a peripheral fluid chamber 108. For example, a portion of peripheral portion 103 may be formed as peripheral elements 136.

[0119] 2B, the optical fluid chamber 106 may be in fluid communication with each of the peripheral fluid chambers 108 through a fluid channel 110. The fluid channel 110 may be a conduit or passageway connecting the peripheral fluid chamber 106 to the optical fluid chamber 108 or the haptic fluid chamber. Although only a single fluid channel 110 is shown connecting the optical fluid chamber 106 to each peripheral fluid chamber 108, it is contemplated that multiple fluid channels (e.g., two fluid channels) may connect the optical fluid chamber 106 to each peripheral fluid chamber 108.

[0120] The base power of the optic 102 may change (e.g., increase or decrease) in response to external energy 318 directed at the peripheral elements 136. As previously discussed, each of the peripheral elements 136 may be comprised of a composite material 400.

[0121] As discussed in more detail in a later section, each of the first peripheral elements 138 may be a space-filling portion 310 (see also, e.g., FIGS. 3A, 3B, and 3C). The space-filling portion 310 may expand in response to external energy directed at the space-filling portion 310. The expansion of the space-filling portion 310 may reduce the volume of the peripheral fluid chamber 108, which may result in fluid moving from the peripheral fluid chamber 108 to the optical fluid chamber 106.

[0122] Each of the second peripheral elements 140 may be a chamber expansion portion 312 (see also FIGS. 3B and 3D). The chamber expansion portion 312 may expand in response to external energy directed at the chamber expansion portion 312. Expansion of the chamber expansion portion 312 may cause the peripheral fluid chamber 108 to expand and increase the volume of the peripheral fluid chamber 108, which may result in fluid flowing from the optical fluid chamber 106 to or from the peripheral fluid chamber 108.

[0123] The optical fluid chamber 106 and the peripheral fluid chamber 108 may contain or hold a total volume of fluid (e.g., silicone oil) between about 10 μL and about 20 μL. For example, the optical fluid chamber 106 and the peripheral fluid chamber 108 may contain a total volume of fluid (e.g., silicone oil) of about 15 μL.

[0124] In the embodiment shown in FIG. 2B, the peripheral portion 103 may include a first haptic 104A and a second haptic 104B. The first haptic 104A may include a first haptic fluid chamber, and the second haptic 104B may include a second haptic fluid chamber. Each of the first haptic fluid chamber and the second haptic fluid chamber may be considered one of the peripheral fluid chambers 108. In this embodiment, each of the haptic fluid chambers (e.g., each of the first haptic fluid chamber and the second haptic fluid chamber) may include or hold a volume of fluid between about 0.3 μL and 0.6 μL (or about 0.5 μL).

[0125] In some embodiments, between about 10 nanoliters (nL) and 20 nL of fluid may be exchanged or moved between a peripheral fluid chamber 108 (e.g., the first haptic fluid chamber or the second haptic fluid chamber) and the optical fluid chamber 106 in response to a pulse of external energy 318 being directed at one of the peripheral elements 136. More specifically, about 15 nL of fluid may be exchanged or moved between one or more of the peripheral fluid chambers 108 (e.g., the first haptic fluid chamber or the second haptic fluid chamber) and the optical fluid chamber 106 in response to a pulse of external energy 318 being directed at one of the peripheral elements 136.

[0126] In some embodiments, the base power of the optic 102 may change between about 0.05 diopters (D) to about 0.5 D in a positive or negative direction in response to a pulse of external energy 318 directed at one of the peripheral elements 136. For example, the base power of the optic 102 may change by about 0.1 D in response to a pulse of external energy 318 directed at one of the peripheral elements 136.

[0127] The change in base power of the optic 102 may be a permanent or substantially permanent change. A permanent or substantially permanent change may mean that the peripheral element 136 does not return to approximately its original shape or size after the change occurs.

[0128] In certain embodiments, the base power of the optic 102 may vary in the positive or negative direction by a total of between about 1.0 D and about 2.0 D. In these embodiments, the total power change may be defined by the total number of peripheral elements 136, the size and / or expansion characteristics of the peripheral elements 136, the chamber volumes of the peripheral fluid chambers 108 and / or the optical fluid chambers 106, the volume of oil within those chambers, or a combination thereof.

[0129] In other embodiments, the base power of the optic 102 may vary in the positive or negative direction by a total of about 2.0D to about 3.0D. In additional embodiments, the base power of the optic 102 may vary in the positive or negative direction by a total of about 3.0D to about 5.0D. In further embodiments, the base power of the optic 102 may vary in the positive or negative direction by a total of about 5.0D to about 10.0D.

[0130] In some embodiments, the optic 102 may have an optical power in an unfilled or as-manufactured state (i.e., the optical power of the optic 102 when the optical fluid chamber 106 is empty or unfilled) of between about 11D and 13D (a "zero power" lens). For example, the optic 102 may have an optical power in an unfilled or as-manufactured state of about 12D. The optical power of the optic 102 may increase as the optical fluid chamber 106 fills with fluid (e.g., silicone oil).

[0131] The optical fluid chamber 106 may be filled until the base power of the filled optic 102 (contributed by both the fluid and the lens surface of the optic 102) is between about 15D (low power IOLs) and about 30D (high power IOLs). For example, the optical fluid chamber 106 may be filled until the base power of the filled optic 102 is about 20D.

[0132] The accommodative IOL 100 implanted within the subject's capsular bag may have a base power of between about 15D and about 30D (e.g., about 20D). When the accommodative IOL 100 is implanted within the subject's capsular bag, a clinician or medical professional may direct external energy 318 (e.g., laser light) to the peripheral element 136 to increase or decrease the base power of the optic 102.

[0133] For example, the accommodative IOL 100 may have a base power of approximately 20 D when implanted in a subject's eye. If a power correction is desired, such as increasing the power of the lens, the clinician or medical professional may direct external energy 318 to each of the first peripheral elements 138 to increase the base power of the optic 102 in steps of between approximately +0.1 D and +0.2 D, resulting in a final base power of between approximately 21 D (a total change of +1.0 D) and 22 D (a total change of +2.0 D).

[0134] In other embodiments, the clinician or medical professional may direct external energy 318 to each of the first peripheral elements 138 to incrementally increase the base power of the optical portion 102 between approximately +0.1D and +0.2D, resulting in a final base power of between approximately 22D (a total change of +2.0D) and 25D (a total change of +5.0D).

[0135] As another example, the accommodative IOL 100 may have a base power of approximately 25 D when implanted in a subject's eye. If a power correction is desired, such as decreasing the power of the lens, the clinician or medical professional may direct external energy 318 to each of the second peripheral elements 140 to incrementally decrease the base power of the optic 102 by approximately -0.1 D to -0.2 D, resulting in a final base power of approximately 24 D (a total change of -1.0 D) to 23 D (a total change of -2.0 D).

[0136] In other embodiments, the clinician or medical professional may direct external energy 318 to each of the second peripheral elements 140 to incrementally reduce the base power of the optical portion 102 by between approximately -0.1D and -0.2D, resulting in a final base power of between approximately 23D (a total change of -2.0D) and 20D (a total change of -5.0D).

[0137] In some embodiments, the accommodating IOL 100 may have an optical sensitivity of between about 100 nL and 200 nL (e.g., about 150 nL) of fluid movement per diopter. That is, when between about 100 nL and 200 nL (e.g., about 150 nL) of fluid moves between the peripheral fluid chamber 108 and the optical fluid chamber 106, the base power of the optic portion 102 may change by about 1.0 D. As a more specific example, when between about 100 nL and 200 nL (e.g., about 150 nL) of fluid flows from the peripheral fluid chamber 108 to the optical fluid chamber 106 as a result of the external energy 318 being directed at the first peripheral element 138, the base power of the optic portion 102 may increase by +1 D. Furthermore, when external energy 318 is directed at the second peripheral element 140, resulting in between about 100 nL and 200 nL (e.g., about 150 nL) of fluid flowing or being drawn from the optical fluid chamber 106 to the peripheral fluid chamber 108, the base power of the optical portion 102 may decrease by -1.0D.

[0138] In certain embodiments, each of the peripheral fluid chambers 108 may include ten first peripheral elements 138 and ten second peripheral elements 140. In these embodiments, directing external energy 318 to each of the first peripheral elements 138 or each of the second peripheral elements 140 may cause between about 10 nL and 20 nL (e.g., about 15 nL) of fluid to be moved or exchanged between the optical fluid chamber 106 and the peripheral fluid chamber 108. For example, directing external energy 318 to one of the first peripheral elements 138 may cause the first peripheral element 138 to expand and reduce the volume of the peripheral fluid chamber 108 containing the first peripheral element 138. This may cause between about 10 nL and about 20 nL (e.g., about 15 nL) of fluid to flow from the peripheral fluid chamber 108 into the optical fluid chamber 106. Also, for example, directing external energy 318 toward one of the second peripheral elements 140 may cause the second peripheral element 140 to expand, increasing the volume of the peripheral fluid chamber 108 containing the second peripheral element 140. This may cause between about 10 nL and about 20 nL (e.g., about 15 nL) of fluid to flow from the optical fluid chamber 106 into the peripheral fluid chamber 108.

[0139] The accommodating IOL 100 may change the base power of the optic portion 102 by between about 0.05 D and 0.5 D as a result of the exchange or movement of fluid. As a more specific example, the base power of the optic portion 102 may change by about 0.1 D when about 15 nL of fluid is transferred or exchanged between the optical fluid chamber 106 and the peripheral fluid chamber 108.

[0140] Figure 3A is a cross-sectional view of the accommodative IOL 100 along line AA in Figure 2A. The optic portion 102 may comprise an anterior element 200 and a posterior element 300. A fluid-filled optical fluid chamber 106 may be defined between the anterior element 200 and the posterior element 300.

[0141] The anterior element 200 may have an anterior optical surface and an anterior inner surface opposite the anterior optical surface. The posterior element 300 may have a posterior optical surface and a posterior inner surface opposite the posterior optical surface. Any of the anterior optical surface, the posterior optical surface, or a combination thereof may be considered and referred to as an optical outer surface. The anterior inner surface and the posterior inner surface may face the optical fluid chamber 106. At least a portion of the anterior inner surface and at least a portion of the posterior inner surface may serve as a chamber wall of the optical fluid chamber 106. In some embodiments, the peripheral portion 103 (e.g., haptics 104) may be connected to or extend from at least a portion of the posterior element 300 of the optic portion 102.

[0142] As will be discussed in more detail in a later section, the accommodating IOL 100 may have a lens surface profile or pattern (e.g., a light-splitting lens profile or pattern) defined on the outer optical surface. For example, the lens surface profile may comprise a diffractive surface profile or pattern, or a shift-changing structure or profile. The lens surface profile or pattern allows the accommodating IOL 100 to adapt to different use cases, such as providing a focus for one particular distance (short focus) or providing a focus for multiple distances. For example, the lens surface profile or pattern defined on the outer optical surface may configure the accommodating IOL 100 as an accommodating short focus IOL, an accommodating multifocal IOL (e.g., an accommodating bifocal or trifocal IOL), or an accommodating extended depth of focus (EDOF) IOL.

[0143] The optic 102 may deform or bend in response to fluid entering or leaving the optical fluid chamber 106. In some embodiments, the anterior element 200 may deform or bend (e.g., change curvature) as fluid enters or leaves the optical fluid chamber 106. In other embodiments, the posterior element 300 may deform or bend (e.g., change curvature) as fluid enters or leaves the optical fluid chamber 106. In further embodiments, both the anterior element 200 and the posterior element 300 may deform or bend as fluid enters or leaves the optical fluid chamber 106. The base power of the optic 102 may change in response to deformation by a deformation component of the deforming optic 102 (e.g., the anterior element 200, the posterior element 300, or a combination thereof).

[0144] A portion of the optic 102 may be made of a deformable or pliable material. In some embodiments, a portion of the optic 102 may be made of a deformable or pliable polymeric material. For example, the anterior element 200, the posterior element 300, or a combination thereof may be made of a portion of a deformable or pliable polymeric material. At least a portion of the peripheral portion 103, such as one or more haptics 104 (e.g., the first haptic 104A, the second haptic 104B, or a combination thereof), may be made of the same deformable or pliable material as the optic 102. In other embodiments, a portion of the one or more haptics 104 may be made of a different material than the optic 102.

[0145] In some embodiments, the portions of the optical portion 102 and peripheral portion 103 that are not composed of the composite material 400 may comprise or be partially composed of polymers or cross-linked copolymers, including copolymer blends.

[0146] For example, in some embodiments, the copolymer mixture may include alkyl acrylates or methacrylates, fluoroalkyl (meth)acrylates, and phenyl alkyl acrylates, or combinations thereof. These types of acrylic crosslinked copolymers are generally copolymers of multiple acrylates or methacrylates, as contemplated by this disclosure and understood by those skilled in the art. As used herein, the term "acrylate" means acrylate or methacrylate, unless otherwise specified.

[0147] For example, the portions of the optic 102 and peripheral 103 not comprised of the composite material 400 may be comprised of a hydrophobic acrylic material. For example, the hydrophobic acrylic material may include a hydrophobic acrylate / methacrylate copolymer. In some embodiments, the hydrophobic acrylic material may include a combination of phenylethyl acrylate (PEA) and phenylethyl methacrylate (PEMA).

[0148] In some embodiments, the crosslinked copolymer may include an alkyl acrylate in an amount of about 3% to 20% (wt%), a fluoroalkyl acrylate in an amount of about 10% to 35% (wt%), and a phenyl alkyl acrylate in an amount of about 50% to 80% (wt%). In some embodiments, the crosslinked copolymer may include or consist in part of n-butyl acrylate as the alkyl acrylate, trifluoroethyl methacrylate as the fluoroalkyl acrylate, and phenylethyl acrylate as the phenyl alkyl acrylate. More specifically, the crosslinked copolymer may include n-butyl acrylate in an amount of about 3% to 20% (wt%) (e.g., between about 12% and 16%), trifluoroethyl methacrylate in an amount of about 10% to 35% (wt%) (e.g., between about 17% and 21%), and phenylethyl acrylate in an amount of about 50% to 80% (wt%) (e.g., between about 64% and 67%).

[0149] The final composition of the crosslinked copolymer may also include a crosslinking agent such as ethylene glycol dimethacrylate (EGDMA). For example, the final composition of the crosslinked copolymer may also include a crosslinking agent (e.g., EGDMA). The final composition of the crosslinked copolymer may also include an initiator (e.g., Perkadox 16, camphorquinone, 1-phenyl-1,2-propanedione, and 2-ethylhexyl-4-((dimenthylamino)benzoate) and a UV absorber.

[0150] In some embodiments, the refractive index of the material used to construct the optic 102 may be between about 1.48 and about 1.53. In certain embodiments, the refractive index of the material used to construct the optic 102 may be between about 1.50 and about 1.53.

[0151] In some embodiments, the portions of the optic 102 and peripheral 103 that are not comprised of the composite material 400 may include a reactive (polymerizable) UV absorber and a reactive blue light absorber. For example, the reactive UV absorber may consist of or include 2-(2'-hydroxy-3'-methallyl-5'-methylphenyl)benzotriazole, available as o-Methallyl Tinuvin P ("oMTP") from Polysciences, Inc., Warrington, Pennsylvania, 3-(2H-benzo[d][1,2,3]triazol-2-yl)-4-hydroxyphenylethyl methacrylate, and 2-(3-(tertiarybutyl)-4-hydroxy-5-(5-methoxy-2H-benzo[d][1,2,3]triazol-2-yl)phenoxy)ethyl methacrylate. In certain embodiments, the reactive UV absorber may be present in an amount of about 0.1% to 5% (wt%). When present, the reactive UV absorbers are typically present in an amount of about 1.5% to 2.5% (wt %), or about 1.5% to 2% (wt %).

[0152] In certain embodiments, the reactive blue light absorbing agent mixture may be as described in US Patent No. 5,470,932, US Patent No. 8,207,244, and US Patent No. 8,329,775, the contents of which are incorporated herein by reference. For example, the blue light absorbing dye may be N-2-[3-(2'-methylphenylazo)-4-hydroxyphenyl]ethyl methacrylamide. When present, the blue light absorbing agent is typically present in an amount of about 0.005% to 1% (wt%), or about 0.01% to 0.1% (wt%).

[0153] Figure 3B is a cross-sectional view of the accommodative IOL along line BB of Figure 2A. As shown in Figure 3B, the peripheral fluid chamber 108 may have a chamber height 302. In some embodiments, the chamber height 302 may be about 0.1 mm. In other embodiments, the chamber height 302 may be between about 0.1 mm and 0.3 mm.

[0154] In other embodiments, the chamber height 302 may be between about 0.3 mm and 1.0 mm. In further embodiments, the chamber height 302 may be between about 1.0 mm and 1.5 mm.

[0155] 3B also shows that the side 111 of the optic 102 may have a side height 304 (measured in an anterior to posterior direction). In some embodiments, the side height 304 may be between about 0.50 mm and 0.75 mm. For example, the side height 304 may be about 0.65 mm. In other embodiments, the side height 304 may be between about 0.40 mm and 0.50 mm or between about 0.75 mm and 1.25 mm.

[0156] The perimeter 103 may also have a perimeter height 306 (also referred to as haptic height or thickness). In some embodiments, the perimeter height 306 may be between about 0.50 mm and 0.60 mm. In other embodiments, the perimeter height 306 may be between about 0.60 mm and 0.65 mm or between about 0.45 mm and 0.50 mm.

[0157] 3B, a side height 304 of a side 111 of the optic 102 may be greater than a peripheral height 306. For example, when the peripheral 103 includes one or more haptics, the thickness or height (measured in an anterior to posterior direction) of the haptics may be less than the thickness or height of the optic 102 along all portions of the optic 102.

[0158] In some embodiments, the perimeter height 306 or thickness (measured in a front-to-back direction) may be generally uniform such that no portion of the perimeter 103 is taller or thicker than other portions of the perimeter 103. When the perimeter 103 includes multiple haptics 104, all of the haptics 104 may have the same height or thickness.

[0159] 3B also shows that the anterior element 200 may have a anterior element thickness 308 (measured in the anterior-to-posterior direction). In some embodiments, the anterior element thickness 308 may be between about 0.15 mm and about 0.25 mm. For example, the anterior element thickness 308 may be about 0.20 mm.

[0160] 3A and 3B also show that the first peripheral element 138 may be a space-filling portion 310. The space-filling portion 310 may expand in response to external energy 318 directed at the space-filling portion 310. The expansion of the space-filling portion 310 may cause the volume of the peripheral fluid chamber 108 to decrease.

[0161] As a more specific example, the space-filling portion 310 may be implemented as an inflatable pad extending from at least one of the front chamber wall 314 and the rear chamber wall 316. The base power of the optic 102 may increase in response to external energy 318 being directed at the space-filling portion 310, causing the volume of the space-filling portion 310 to increase and displace fluid out of the peripheral fluid chamber 108.

[0162] 3B also shows that the second peripheral element 140 may be a chamber expansion portion 312. The chamber expansion portion 312 may expand in response to external energy 318 directed at the chamber expansion portion 312. The expansion of the chamber expansion portion 312 may increase the volume of the peripheral fluid chamber 108.

[0163] As a more specific example, the chamber expansion portion 312 may be implemented as an expansible strut extending from the chamber anterior wall 314 to the chamber posterior wall 316. Expansion of the expansible strut may increase the volume of the peripheral fluid chamber 108. The base power of the optic portion 102 may decrease in response to external energy 318 being directed at the expansible strut, causing the chamber expansion portion 312 to stretch and the volume of the peripheral fluid chamber 108 to increase.

[0164] FIG. 3C illustrates that external energy 318 may be directed at the space-filling portion 310 of the accommodating IOL 100 to induce deformation of the space-filling portion 310 .

[0165] The first peripheral element 138 may be comprised of a composite material 400. The first peripheral element 138 may be disposed within the peripheral fluid chamber .

[0166] In some embodiments, the composite material 400 used to fabricate the first peripheral element 138 may be cured within the peripheral fluid chamber 108 along with the remaining materials that make up the peripheral fluid chamber 108. In these embodiments, the first peripheral element 138 may be cured in-situ within the peripheral fluid chamber 108.

[0167] In other embodiments, the first peripheral element 138 may be adhered to the interior wall or surface of the peripheral fluid chamber 108 using an adhesive. The adhesive may be allowed to harden to secure the first peripheral element 138 to the interior wall or surface of the peripheral fluid chamber 108.

[0168] First peripheral element 138 may be a space-filling portion 310. In some embodiments, space-filling portion 310 may be implemented as an inflatable, disk-shaped pad (see, e.g., FIGS. 2B, 3A, and 3B). Although the figures show space-filling portion 310 as a flattened cylinder or disk, it is contemplated herein that space-filling portion 310 may be generally a sphere, hemisphere, ovoid, ellipsoid, rectangular prism, or other polyhedron, or combinations thereof.

[0169] The space-filling portion 310 may extend from, be adhered to, or be connected to either the front chamber wall 314 or the rear chamber wall 316. In some embodiments, when the peripheral fluid chamber 108 includes multiple space-filling portions 310, at least one of the space-filling portions 310 may extend from, be adhered to, or be connected to the front chamber wall 314 and another of the space-filling portions 310 may extend from, be adhered to, or be connected to the rear chamber wall 316.

[0170] In other embodiments, the space-filling portion 310 may extend from the interior sidewall 320 and may be adhered or connected to the interior sidewall 320 .

[0171] 3C, the space-filling portion 310 may expand in response to a burst of external energy 318 directed at the space-filling portion 310. The expansion of the space-filling portion 310 may reduce the internal volume of the peripheral fluid chamber 108 and may cause fluid to move from the peripheral fluid chamber 108 to the optical fluid chamber 106. The base power of the optic portion 102 may increase in response to the external energy 318 directed at the space-filling portion 310.

[0172] 3C illustrates that the space-filling portion 310 may be sized such that the space-filling portion 310 does not contact the chamber interior wall 320. FIG. 3C also illustrates that a separation distance 322 or gap may be maintained between the space-filling portion 310 and each of the chamber interior walls 320 even when external energy 318 is directed at the space-filling portion 310 and causes the space-filling portion 310 to expand. This ensures that the expanded space-filling portion 310 does not expand the peripheral fluid chamber 108 or to an extent that would counteract the effect of the expansion of the space-filling portion 310 decreasing the volume of the peripheral fluid chamber 108. Furthermore, because the front-to-back height of the space-filling portion 310 is much less than the chamber height 302, the expanded space-filling portion 310 does not contact the chamber front wall 314.

[0173] In some embodiments, the external energy 318 may be light energy. More specifically, the external energy 318 may be laser light. The external energy 318 may be a burst of laser light.

[0174] In certain embodiments, the laser light may have a wavelength between about 488 nm and about 650 nm. For example, the laser light may be a green laser light. The green laser light may have a wavelength between about 520 nm and about 570 nm. In one example embodiment, the external energy 318 may be a green laser light having a wavelength of about 532 nm.

[0175] For example, the laser light may be laser light emitted by an ophthalmic laser. For example, the laser light may be laser light emitted by a retinal coagulation laser.

[0176] In a particular embodiment, the laser light may be a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. As a more specific example, the laser light may be a pulsed Nd:YAG laser operated in Q-switching mode and frequency doubled to generate laser light at 532 nm.

[0177] In other embodiments, the laser light may be emitted by a femtosecond laser or an infrared or near infrared laser. For example, the laser light emitted by such lasers may have a wavelength between about 1030 nm and 1064 nm.

[0178] As discussed in more detail in a later section, when the external energy 318 is light energy, the energy absorbing component 404 (see FIG. 4A ) in the composite material 400 may absorb or capture the light energy, convert the light energy to thermal energy, and deliver the thermal energy to the expansile element 406 (see FIGS. 4A and 4B ) in the composite material 400 to cause the expansile element 406 to expand.

[0179] As previously discussed, in some embodiments, in response to expansion of one of the space-filling portions 310, approximately 15 nL of fluid may flow (through the fluid channel 110) from the peripheral fluid chamber 108 to the optical fluid chamber 106. In these and other embodiments, the base power of the optic portion 102 may change by approximately +0.1 D in response to a pulse of external energy 318 directed at one of the space-filling portions 310.

[0180] FIG. 3D illustrates that external energy 318 may be directed to the second peripheral element 140 of the accommodative IOL 100 to induce deformation of the second peripheral element 140 .

[0181] The second peripheral element 140 may be made of the composite material 400. The second peripheral element 140 may be disposed within the peripheral fluid chamber .

[0182] In some embodiments, the composite material 400 used to fabricate the second peripheral element 140 may be cured within the peripheral fluid chamber 108 along with the remaining materials that make up the peripheral fluid chamber 108. In these embodiments, the second peripheral element 140 may be cured in-situ within the peripheral fluid chamber 108.

[0183] In other embodiments, the second peripheral element 140 may be adhered to the interior wall or surface of the peripheral fluid chamber 108 using an adhesive. The adhesive may be allowed to harden to secure the second peripheral element 140 to the interior wall or surface of the peripheral fluid chamber 108.

[0184] The second peripheral element 140 may be a chamber expansion portion 312. In some embodiments, the chamber expansion portion 312 may be implemented as an expansible strut extending from a chamber front wall 314 to a chamber rear wall 316 (see, e.g., FIG. 3B). Although the figures show the chamber expansion portion 312 as a generally elongated cylinder, it is contemplated herein that the chamber expansion portion 312 may be a generally elongated oval, elongated ellipsoid, elongated rectangular prism, or other polyhedron, cone, truncated cone, or combinations thereof.

[0185] As a more specific example, the chamber expansion portion 312 may be implemented as an expansible strut extending from the front chamber wall 314 to the rear chamber wall 316. Expansion of the expansible strut may increase the volume of the peripheral fluid chamber 108 by pushing against one or both of the interior chamber wall 314 and the rear chamber wall 316 to increase the chamber height 302. The base power of the optic portion 102 may decrease in response to external energy 318 directed at the expansible strut.

[0186] 3D, the chamber expansion portion 312 may expand in response to a burst of external energy 318 directed at the chamber expansion portion 312. The expansion of the chamber expansion portion 312 may increase the volume of the peripheral fluid chamber 108, causing fluid to flow from the optical fluid chamber 106 into the peripheral fluid chamber 108. The base power of the optic portion 102 may decrease in response to the external energy 318 directed at the chamber expansion portion 312.

[0187] The external energy 318 may be the same as the previously disclosed external energy 318. For example, the external energy 318 may be light energy.

[0188] 3D illustrates that the chamber expansion portion 312 may be sized such that (even when expanded) the chamber expansion portion 312 does not contact the chamber inner wall 320. This ensures that the enlarged chamber expansion portion 312 can expand the peripheral fluid chamber 108 from front to rear, temporarily, without exerting pressure on the radially inner chamber wall 132 (which would translate into pressure on the sides of the optic 102, thereby unintentionally affecting the optical power).

[0189] As previously discussed, in some embodiments, approximately 15 nL of fluid may flow from the optical fluid chamber 106 to the peripheral fluid chamber 108 (through the fluid channel 110) in response to a pulse of external energy 318 being directed at one of the chamber expansion portions 312. In these and other embodiments, the base power of the optic portion 102 may change by approximately -0.1 D in response to one of the chamber expansion portions 312 expanding due to the external energy 318 being directed at the chamber expansion portion 312.

[0190] Although Figures 1A, 1B, 2B and 5 show each peripheral fluid chamber 108 (e.g., each haptic fluid chamber) having both a space-filling portion 310 and a chamber expansion portion 312, it is contemplated in the present disclosure that each of the peripheral fluid chambers 108 may also have only a space-filling portion 310 or only a chamber expansion portion 312, and this should be understood by one of ordinary skill in the art.

[0191] One technical problem faced by applicants is how to provide a clinician or other medical practitioner with the ability to bidirectionally fine-tune the optical power of an implanted IOL (i.e., provide the clinician with the ability to increase or decrease the optical power of an implanted IOL post-operatively). One solution that applicants have discovered is the peripheral elements disclosed herein, which include space-filling portions and chamber expansion portions, e.g., made of a composite material. As a more specific example, each peripheral fluid chamber (or haptic fluid chamber) may include multiple space-filling portions, chamber expansion portions, or both space-filling portions and chamber expansion portions. Each peripheral element may be configured such that the optical portion of the accommodative IOL changes by approximately 0.1D in response to a burst of external energy directed at the peripheral element.

[0192] 4A is a diagrammatic representation of a composite material 400 including a composite substrate 402, an energy absorbing component 404, and a plurality of inflatable elements 406. As previously discussed, at least a portion within or a component of the perimeter 103 may be comprised of the composite material 400.

[0193] The composite substrate 402 may include a hydrophobic acrylic material. For example, the composite substrate 402 may include phenylethyl acrylate (PEA), phenylethyl methacrylate (PEMA), or a combination thereof.

[0194] In one embodiment, the composite substrate 402 may include a methacrylic or methacrylate functional crosslinkable polymer and a reactive acrylic monomer diluent including lauryl methacrylate (n-dodecyl methacrylate or SR313) and ADMA. By controlling the amount of lauryl methacrylate (SR313) relative to ADMA, the overall corresponding hardness (i.e., more ADMA) or softness (i.e., more SR313) of the cured composite material 400 may be controlled. The methacrylate or methacrylic functional crosslinkable polymer may be formed using a crosslinkable polymer precursor composition.

[0195] The crosslinkable polymer precursor composition may include the same copolymer blends used to fabricate the optics and haptics.

[0196] The copolymer mixture may include an alkyl acrylate or methacrylate (e.g., n-butyl acrylate), a fluoroalkyl (meth)acrylate (e.g., trifluoroethyl methacrylate), and a phenylalkyl acrylate (e.g., phenylethyl acrylate). For example, the copolymer mixture may include n-butyl acrylate in an amount of, for example, about 41% to about 45% (wt%), trifluoroethyl methacrylate in an amount of, for example, about 20% to about 24% (wt%), and phenylethyl acrylate in an amount of, for example, about 28% to about 32% (wt%). The crosslinkable polymer precursor composition may include or consist in part of the copolymer mixture, a hydroxyl-functional acrylic monomer (e.g., HEA), and a photoinitiator (e.g., Darocur 4265, or a 50:50 mixture of diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide and 2-hydroxy 2-methylpropiophenone).

[0197] The composite substrate 402 may include a methacrylate- or methacrylic-functional crosslinkable polymer (as described above) in an amount of about 50% to about 65% (e.g., about 55% to about 60%) (wt %), a reactive acrylic monomer diluent lauryl methacrylate (SR313) in an amount of about 32% to about 38% (e.g., about 32.70%) (wt %), and a reactive acrylic monomer diluent adamantyl methacrylate (ADMA) in an amount of about 5% to about 9% (e.g., about 7.30%) (wt %).

[0198] Table 1 below provides examples of compositions of composite material 400. Table 1. Composition of composite materials (wt%) [Table 1]

[0199] The composite material 400 can be made in several operations. A first operation may include providing an unpigmented composite matrix 402. A second operation may include mixing the composite matrix 402 with an energy absorbing component 404, an expandable element 406, and an initiator, such as one or more photoinitiators, thermal initiators, or combinations thereof. A third operation may include placing the uncured composite material 400 into a desired location within the periphery 103 (e.g., the peripheral fluid chambers 108 and / or haptics 104) and curing the composite material 400 in place.

[0200] For example, an unpigmented composite substrate 402 may be mixed with an energy absorbing component 404, such as a dye (e.g., Disperse Red 1) or pigment (e.g., graphitized carbon black), which is discussed in more detail below.

[0201] In some embodiments, the intumescent element 406 may comprise about 5.0% to about 15.0% by weight of the final composition of the composite material 400. More specifically, the intumescent element 406 may comprise about 8.0% to about 12.0% (e.g., about 10.0%) by weight of the final composition (see Table 1) of the composite material 400. In these and other embodiments, the energy absorbing component 404 may comprise about 0.044% to about 0.44% (or about 0.55%) by weight of the final composition of the composite material 400.

[0202] The photoinitiator may be Omnirad 2022 (bis(2,4,6-trimethylbenzoyl)phenylphosphine oxide / 2-hydroxy-2-methyl-1-phenyl-propan-1-one). The photoinitiator may comprise approximately 1.30% by weight of the final composition of the composite 400 (see, e.g., Table 1). In addition, the composite 400 may also include a thermal initiator. The thermal initiator may comprise approximately 1.00% by weight of the final composition of the composite 400 (see, e.g., Table 1). In some embodiments, the thermal initiator may be a dialkyl peroxide, such as Luperox® peroxide. In other embodiments, the thermal initiator may be Perkadox.

[0203] In some embodiments, an energy absorbing component (e.g., a dye or pigment) may be located or disposed adjacent to the unpigmented composite substrate 402. In this embodiment, the energy absorbing component 404 may absorb the external energy 318 (e.g., laser energy), convert the energy to heat, or conduct the energy to the composite substrate 402 to expand the composite substrate 402. One additional advantage of this approach is that the energy absorbing component 404 may be more independently made and may be an easier target for the laser or other external energy 318 to be aimed at by the clinician or surgeon.

[0204] FIG. 4B illustrates that the expandable element 406 may be an expandable microsphere including an expandable thermoplastic shell 408 and a blowing agent 410 contained within the expandable thermoplastic shell 408. The microsphere may expand such that the diameter 412 of at least one of the microspheres increases to about two times its original diameter. In other embodiments, the microsphere may expand such that the diameter 412 of at least one of the microspheres increases to about four times its original diameter. In further embodiments, the microsphere may expand such that the diameter 412 of at least one of the microspheres increases between about two and about four times (or about 3.5 times) its original diameter. For example, the microsphere may initially have a diameter 412 of about 12 μm. In response to external energy being applied or directed to the composite material 400 or energy being transmitted or transferred to the microsphere, the diameter 412 of the microsphere may increase to about 40 μm.

[0205] In response to external energy being applied or directed to the composite material 400 or in response to energy being transferred or transmitted to the microspheres, the volume of at least one of the microspheres may be configured to increase between about 10 times and about 50 times.

[0206] In some embodiments, the blowing agent 410 may be an expanding fluid, such as an expanding gas. More specifically, the blowing agent 410 may be a branched chain hydrocarbon. For example, the blowing agent 410 may be isopentane. In other embodiments, the blowing agent 410 may include cyclopentane, pentane, or a mixture of cyclopentane, pentane, and isopentane.

[0207] The inflatable elements 406 may include different amounts of blowing agent 410. For example, some inflatable elements 406 may include more blowing agent or greater amounts (e.g., more expanding gas) to allow such inflatable elements 406 to expand more, and therefore allow the composite material 400 including the inflatable elements 406 to expand more.

[0208] Figure 4B illustrates that each expandable element 406 may include a thermoplastic shell 408. Figure 4B also illustrates that the thickness of the thermoplastic shell 408 may vary as the size of the expandable element 406 increases. More specifically, the thickness of the thermoplastic shell 408 may decrease as the size of the expandable element 406 increases. For example, if the expandable elements 406 are expandable microspheres, the thickness (i.e., radial thickness) of the thermoplastic shell 408 may decrease as the diameter 412 of the expandable microspheres increases.

[0209] For example, as previously discussed, at least one of the expandable microspheres may initially have a diameter 412 of about 12 μm. In this embodiment, the thermoplastic shell 408 of the expandable microsphere may have a thickness of about 2.0 μm. In response to external energy being applied or directed to the composite material 400, or energy being transferred or transmitted to the microsphere, the diameter 412 of the microsphere may increase to about 40 μm (and expand in volume between about 10-50 times) and the thickness of the microsphere shell may decrease to about 0.1 μm.

[0210] Although the expansile elements 406 are shown in FIGS. 4A and 4B as spheres or microspheres, it is contemplated in the present disclosure that the expansile elements 406 may be formed generally as ovoids, ellipsoids, rectangular prisms, or other polyhedrons, or combinations thereof.

[0211] In some embodiments, the thermoplastic shell 408 may be comprised in part of a nitrile or acrylonitrile copolymer. For example, the thermoplastic shell 408 may be comprised in part of acrylonitrile, styrene, butadiene, methyl acrylate, or combinations thereof.

[0212] As previously discussed, the intumescent element 406 may comprise between about 8.0% and about 12% by weight of the final composition of the composite material 400. The intumescent element 406 may comprise about 10% by weight of the final composition of the composite material 400.

[0213] The inflatable elements 406 may be dispersed or distributed throughout the composite matrix 402, which forms the bulk of the composite material 400. The composite matrix 402 may act as a substrate to hold or support the inflatable elements 406. The composite material 400 may expand in response to the expansion of the inflatable elements 406 (e.g., thermoplastic microspheres). For example, the volume of the composite material 400 may increase in response to the expansion of the inflatable elements 406.

[0214] The composite material 400 also includes an energy absorbing component 404. In some embodiments, the energy absorbing component 404 may be an energy absorbing colorant.

[0215] In certain 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 On Range 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.

[0216] In additional embodiments, the energy absorbing colorant may be or include a pigment, for example, the energy absorbing colorant may be graphitized carbon black or include graphitized carbon black as a pigment.

[0217] Like the intumescent element 406, the energy absorbing component 404 may be dispersed or distributed throughout the composite matrix 402, which forms the bulk of the composite material 400. The composite matrix 402 may act as a substrate to hold or support the intumescent element 406 and the energy absorbing component 404.

[0218] As previously discussed, the energy absorbing component 404 may comprise between about 0.025% and about 1.0% (or, more specifically, between about 0.045% and about 0.45%) of the weight of the final composition of the composite material 400. For example, if the energy absorbing component 404 is a dye (e.g., an azo dye such as Disperse Red 1), the energy absorbing component 404 may comprise between about 0.45% and about 1.0% of the weight of the final composition of the composite material 400. If the energy absorbing component 404 is graphitized carbon black or other type of pigment, the energy absorbing component 404 may comprise between about 0.025% and about 0.045% of the weight of the final composition of the composite material 400.

[0219] The energy absorbing component 404 (e.g., an azo dye, graphitized carbon black, or a combination thereof) may absorb or capture external energy applied or directed to the composite material 400. The energy absorbing component 404 may absorb or capture the external energy and convert or transfer the energy to the intumescent element 406 into thermal energy or heat.

[0220] As thermal energy is transferred or transmitted to the expansile element 406, the thermoplastic shell 408 may soften and begin to flow. In response to the thermal energy being transferred or transmitted to the expansile element 406, the thermoplastic shell 408 of the expansile element 406 may begin to thin or decrease in thickness. As the thermoplastic shell 408 begins to soften and decrease in thickness, the blowing agent 410 in the expansile element 406 may expand. The blowing agent 410 may also expand in response to the thermal energy or heat being transferred or transmitted to the expansile element 406. The expansion of the blowing agent 410 may cause the expansile element 406 (e.g., thermoplastic microspheres) to expand or increase in volume, which ultimately causes the composite material 400 to expand or increase in volume.

[0221] The composite material 400 may expand or increase in volume isotropically such that the composite material 400 expands in all directions. Such isotropic expansion may be utilized to create expansion or material displacement in a particular direction by placing or positioning the composite material 400 at a particular location within the peripheral fluid chamber 108 along the haptic(s) 104 or optic 102 of the accommodating IOL 100.

[0222] As discussed in more detail in a later section, in some embodiments, the external energy may be light energy, and the energy absorbing component 404 may absorb or capture the light energy directed at the composite material 400 and convert or transfer the light energy to thermal energy or heat to the intumescent element 406. The blowing agent 410 within the intumescent element 406 may expand or become activated in response to the thermal energy or heat. The intumescent element 406, and ultimately the composite material 400, may expand or increase in volume in response to this light energy being applied to the composite material 400.

[0223] The deformation (e.g., increase in volume) of the expandable element 406 may be a permanent or generally permanent change. A permanent or generally permanent change means that the expandable element 406 does not return to approximately its original shape or size after the change (e.g., increase in volume) occurs. As a result, the change in size or volume of the composite material 400 caused by the change in size or volume of the expandable element 406 is also permanent or generally permanent. As will be discussed in more detail in a later section, the above means that the structural changes made to the accommodating IOL 100 as a result of external energy or stimuli directed at the composite material 400 integrated within the accommodating IOL 100 may remain permanent or generally permanent.

[0224] The thermoplastic shell 408 of the inflatable element 406 may harden again when external energy is no longer directed at the composite material 400. For example, the thermoplastic shell 408 may harden again when the temperature surrounding the inflatable element 406 drops below a certain threshold. For example, the thermoplastic shell 408 of the expandable microspheres may harden when light energy is no longer directed at the composite material 400. After the thermoplastic shell 408 hardens, the inflatable element 406 is locked into its new size and expanded configuration.

[0225] If the energy absorbing component 404 is an energy absorbing colorant, such as a dye or graphitized carbon, the color of at least a portion of the composite material 400 may be the color of the energy absorbing colorant. For example, if the energy absorbing component 404 is an azo dye, such as Disperse Red 1, having a red color, at least a portion of the composite material 400 including the energy absorbing component 404 may be red. Furthermore, if the energy absorbing component 404 is graphitized carbon, having a black color, at least a portion of the composite material 400 including the energy absorbing component 404 may be black. Although this disclosure refers to two colors (e.g., red and black), it is contemplated and should be understood by one of ordinary skill in the art that energy absorbing colorants having other types of colors may also be used, such as energy absorbing yellow, orange, or blue dyes or materials.

[0226] When at least a portion of the accommodating IOL 100 is comprised of a composite material 400 that includes an energy absorbing colorant, the color of the energy absorbing colorant may be visually perceptible by a clinician or other medical practitioner. When the accommodating IOL 100 is implanted in a patient's eye, the color of the energy absorbing colorant may be visually perceptible by a clinician or other medical practitioner. For example, the composite material 400 may include Disperse Red 1, which acts as an energy absorbing colorant. In this example, when the accommodating IOL 100 is implanted in a patient's eye, at least a portion of the accommodating IOL 100 may appear red to a clinician or other medical practitioner.

[0227] The color of the energy absorbing colorant may allow a clinician or other medical practitioner to detect or determine the position or location of the composite material 400 within the accommodating IOL 100. The color of the energy absorbing colorant may also allow a clinician or other medical practitioner to determine where to direct external energy or stimulation to adjust within the accommodating IOL 100.

[0228] One technical problem faced by applicants is how to integrate a composite material into the periphery (e.g., haptics) of an accommodating IOL so that the composite material is bonded to the materials used in the rest of the accommodating IOL and generally fixed in a specific location within the periphery. One solution discovered by applicants and disclosed herein is the unique composition of composite material 400, which incorporates the same copolymer blend used to make the rest of the lens. By designing the accommodating IOL in this way, composite material 400 is compatible with the rest of the materials used to construct the periphery and generally stays in place without migrating.

[0229] Another technical problem faced by applicants is how to ensure that adjustments made to an accommodative IOL are sustained long after the adjustment procedure is over. One solution discovered by applicants and disclosed herein is to stimulate the expansion of a composite material made in part of expandable microspheres and including a blowing agent within a thermoplastic shell. In response to external energy being directed or applied to the composite material (which may result in heat or thermal energy being transferred or transmitted to the expandable microspheres), the thermoplastic shell may soften (and the thickness of the thermoplastic shell may decrease). The blowing agent within the thermoplastic shell may expand as the thermoplastic shell softens. The expansion of the blowing agent may cause the microspheres to expand, which may result in the expansion of the composite matrix, which serves as the bulk of the composite material. The expandable microspheres may maintain their new, expanded or expanded configuration even when external energy is no longer applied to the composite material.

[0230] Additionally, the energy absorbing components of the composite material 400 may capture or absorb relatively harmless external energy or stimuli directed at the composite material and may convert or convey the external energy into energy that allows the thermoplastic microspheres to expand. By designing the accommodative IOL 100 in this manner, relatively harmless energy or stimuli (e.g., light energy) may be used to induce a permanent change to the shape or size of at least a portion of the accommodative IOL 100. This permanent change to the shape or size of the accommodative IOL 100 may have a lasting effect on the optical parameters of the lens, including, for example, the base power.

[0231] 5 is a plan view of another embodiment of an adjustable fixed focus IOL 100 with a portion of the anterior portion of the adjustable IOL 100 removed to better depict the components within the IOL. As shown in FIG. 5, the first peripheral element 138 may be comprised of a first composite material including a first energy absorbing component having a first color, and the second peripheral element 140 may be comprised of a second composite material including a second energy absorbing component having a second color different from the first color. This color difference may be visually perceptible to a clinician or other medical practitioner, allowing the clinician or other medical practitioner to visually distinguish between the two types of peripheral elements 136.

[0232] For example, the first energy absorbing component may be an energy absorbing dye. As a more specific example, the energy absorbing dye may be an azo dye, such as a red azo dye (e.g., Disperse Red 1). In this example, the second energy absorbing component may be another energy absorbing dye, such as a yellow azo dye or another lighter colored dye.

[0233] In other examples, the first energy absorbing component may be or include a pigment, such as graphitized carbon black (which exhibits a black color). In these examples, the second energy absorbing component may be an energy absorbing dye (e.g., a red azo dye).

[0234] In additional examples, the second energy absorbing component may be or include a pigment, such as graphitized carbon black (which exhibits a black color). In these examples, the first energy absorbing component may be an energy absorbing dye (e.g., a red azo dye).

[0235] In other embodiments, the first composite material and the second composite material may comprise portions of the same energy absorbing components or colorants, but may contain different amounts or weight percentages of the components or colorants.

[0236] In certain embodiments, a first peripheral element 138 made of a first composite material (and having a first color) may expand or deform in response to a first type of external energy (e.g., light energy between 520 nm and 540 nm) directed to the first composite material, and a second peripheral element 140 made of a second composite material (and having a second color different from the first color) may expand or deform in response to a second type of external energy (e.g., light energy between 600 nm and 650 nm) directed to the second composite material.

[0237] By designing the accommodative IOL 100 in this manner, a clinician or other medical practitioner can utilize the different colors of the composite material as guides or markers to direct external energy or stimuli to different target locations along the periphery 103. Additionally, the composite materials having different colors may also act as indicators or visual cues of where to direct external energy or stimuli to effect specific changes in the base power of the optic 102.

[0238] For example, accommodating IOL 100 may be configured such that the base power of accommodating IOL 100 can be adjusted in a first manner (e.g., the base power can be increased) by directing or applying external energy to a first peripheral element 138 made of a first composite material (having a first color). The base power of accommodating IOL 100 can also be adjusted in a second manner (e.g., the base power can be decreased) by directing or applying an additional burst or pulse of external energy to a second peripheral element 140 made of a second composite material (having a second color different from the first color).

[0239] 6 is a plan view of another embodiment of an accommodating IOL 100 having an optic 102 with a light-dividing lens surface profile 600. The periphery 103 of the accommodating IOL 100 is shown in dashed lines to emphasize the optic 102.

[0240] One technical problem faced by applicants is how to design a fluid-filled IOL that may be used by patients seeking different types of vision assistance. One solution discovered by applicants is the accommodative IOL disclosed herein, where different lens surface profiles having both rotational symmetry and a toric profile that corrects astigmatism can be defined on the outer optical surface (e.g., anterior optical surface) of the optic, allowing the same accommodative IOL structure to be adapted as an accommodative parfocal IOL, an accommodative bifocal IOL, an accommodative trifocal IOL, or an accommodative EDOF IOL in both toric and non-toric shapes.

[0241] 6, the optic 102 of the accommodating IOL 100 may include a light-dividing lens surface profile 600 defined on a lens surface of the optic 102. In some embodiments, the light-dividing lens surface profile 600 may include a central diffractive region or structure including a plurality of diffractive zones or steps. In these and other embodiments, the diffractive zones may decrease radially outward such that the zone width at the periphery of the lens is smaller than the zone width near the center of the lens.

[0242] The light-splitting lens surface profile 600 may split light into multiple focal points. In these embodiments, the accommodative IOL 100 may be considered an accommodative multifocal IOL or a non-accommodative fluidic accommodative multifocal IOL. Even though the light-splitting lens surface profile 600 may split light into multiple focal points, each focal point is fixed and the fluidic accommodative multifocal IOL may be considered non-accommodative.

[0243] In some embodiments, the light-splitting lens surface profile 600 may split light into two focal points (e.g., to provide near and far vision). In these embodiments, the accommodating IOL 100 may be considered an accommodating bifocal IOL or a non-accommodating fluidic accommodating bifocal IOL. In these embodiments, even though the light-splitting lens surface profile 600 may split light into two focal points, each focal point is fixed and the fluidic accommodating bifocal IOL may be considered non-accommodating.

[0244] The light-splitting lens surface profile 600 may also split light into three focal points (e.g., to provide near, intermediate, and far vision). In these embodiments, the accommodative IOL 100 may be considered an accommodative trifocal IOL or a non-accommodative fluidically accommodative trifocal IOL.

[0245] 6, the optic 102 of the accommodative IOL 100 may have a uniformly curved (e.g., spherical) lens surface that provides a single distance focusing capability, or an aspheric lens surface. In these embodiments, the accommodative IOL 100 may be considered an accommodative monofocal IOL or a non-accommodative fluidically accommodative monofocal IOL.

[0246] 6, the optic 102 of the accommodating IOL 100 may have a lens surface profile or pattern that provides an extended depth or focus, or a single extended focus. In these embodiments, the accommodating IOL 100 may be considered an extended depth of focus (EDOF) IOL or a non-accommodating fluidically accommodating EDOF IOL.

[0247] It is contemplated herein that the unique peripheral portion 103 disclosed herein may be compatible with optics 102 having various lens surface profiles. Thus, by directing external energy (e.g., laser light) to peripheral element 136 of composite material 400 within peripheral portion 103, the focusing ability or focal length provided by such lens surface profile may be adjusted.

[0248] Any of the accommodative monofocal IOLs, accommodative multifocal IOLs, and accommodative EDOF IOLs may have a toric lens profile.

[0249] 7 illustrates one embodiment of a method 700 for post-operatively adjusting an IOL 100. The method 700 may include, in operation 702, increasing the base power of the IOL 100 by post-operatively directing external energy 318 to a space-filling portion 310 of the composite material 400 located within a peripheral fluid chamber 108 defined within the periphery 103 of the IOL 100. The method 700 may also include, in operation 704, decreasing the base power by directing external energy 318 to another instance of the composite material 400 located within the peripheral fluid chamber 108, the chamber expansion portion 312.

[0250] 8 illustrates another embodiment of a method 800 for post-operatively adjusting an IOL 100. The method 800 may include, at operation 802, adjusting the base power of the IOL 100 by post-operatively directing a pulse of external energy 318 to a first peripheral element 138 in a peripheral fluid chamber 108 defined in the periphery 103 of the IOL 100. The method 800 may also include, at operation 804, further adjusting the base power by directing an additional pulse of external energy 318 to a second peripheral element 140 in the peripheral fluid chamber 108.

[0251] For example, the first peripheral element 138 may be a space-filling portion 310, and directing external energy 318 to the space-filling portion 310 may cause the space-filling portion 310 to expand, decreasing the volume of the peripheral fluid chamber 108 and causing fluid to move from the peripheral fluid chamber 108 to the optical fluid chamber 106 (resulting in an increase in the base power of the optic portion 102). The second peripheral element 140 may be a chamber expansion portion 312, and directing external energy 318 to the chamber expansion portion 312 may cause the chamber expansion portion 312 to expand, increasing the volume of the peripheral fluid chamber 108 and causing fluid to move from the optical fluid chamber 106 to the peripheral fluid chamber 108 (resulting in a decrease in the base power of the optic portion 102).

[0252] Alternatively, external energy 318 may be first directed to the chamber expansion portion 312 to decrease the base power of the optical portion 102, and external energy 318 may then be directed to the space-filling portion 310 to increase the base power of the optical portion 102.

[0253] 9 illustrates yet another embodiment of a method 900 for post-operatively adjusting an IOL 100. The method 900 may include, at operation 902, adjusting a base power of the IOL 100 by directing a pulse of external energy to a first peripheral element 138 in a first peripheral chamber 108 (e.g., a first haptic chamber) defined in the periphery 103 of the IOL 100. The method 900 may further include, at operation 904, adjusting the base power of the IOL 100 by directing an additional pulse of external energy to a second peripheral element 140 or another instance of the first peripheral element 138 in a second peripheral chamber 108 (e.g., a second haptic chamber) of the periphery 103 of the IOL 100.

[0254] The first peripheral element 138 may be a space-filling portion 310, and directing external energy 318 to the space-filling portion 310 may cause the space-filling portion 310 to expand, decreasing the volume of the first peripheral fluid chamber and moving fluid from the first peripheral fluid chamber to the optical fluid chamber 106 (resulting in an increase in the base power of the optic portion 102). The second peripheral element 140 may be a chamber expansion portion 312, and directing external energy 318 to the chamber expansion portion 312 may cause the chamber expansion portion 312 to expand, increasing the volume of the second peripheral fluid chamber and moving fluid from the optical fluid chamber 106 to the second peripheral fluid chamber (resulting in a decrease in the base power of the optic portion 102).

[0255] In some embodiments, a pulse of external energy 318 may be first directed to the chamber expansion portion 312 in the first peripheral fluid chamber to decrease the base power of the optical portion 102, and an additional pulse of external energy 318 may then be directed to the space-filling portion 310 in the second peripheral fluid chamber to increase the base power of the optical portion 102.

[0256] 10 illustrates an additional embodiment of a method 1000 for post-operatively adjusting an IOL 100. The method 1000 may include, at operation 1002, adjusting the base power of the IOL 100 in a first direction by directing external energy 318 to a first composite material. The first composite material may include a first energy absorbing component having a first color. The method 1000 may further include, at operation 1004, adjusting the base power of the IOL 100 in a second direction by directing external energy to a second composite material. The second composite material may include a second energy absorbing component having a second color different from the first color.

[0257] For example, a first composite material may be formed as a space-filling portion 310. In this example, a first energy absorbing component of the first composite material may be an azo dye having a first color (e.g., red). Also, in this example, a second composite material may be formed as a chamber expansion portion 312, and a second energy absorbing component of the second composite material may be an energy absorbing pigment, such as graphitized carbon black or an azo dye, having a second color (e.g., blue or yellow) different than the first color.

[0258] In other embodiments, a first composite material may be formed as the chamber expansion portion 312 and a first energy absorbing component of the first composite material may be an azo dye having a first color (e.g., red). In these embodiments, a second composite material may be formed as the space-filling portion 310 and a second energy absorbing component of the second composite material may be an energy absorbing pigment such as graphitized carbon black or an azo dye having a second color different from the first color (e.g., blue or yellow).

[0259] In one or more of the methods disclosed herein, adjusting the base power of the IOL 100 may include adjusting the base power of the optic 102 by between about ±0.05 D and about ±0.50 D by directing a pulse of external energy 318 to the composite material 400 to expand the composite material 400. For example, adjusting the base power of the IOL 100 may include adjusting the base power of the optic 102 by about ±0.10 D by directing a pulse of external energy 318 to the composite material 400 to expand the composite material 400.

[0260] For example, the base power of the optic portion 102 may be adjusted by between about ±0.05D and about ±0.50D as a result of a transfer or exchange of fluid between the optical fluid chamber 106 and one of the peripheral fluid chambers 108 due to a change in the volume of the peripheral fluid chamber 108 as a result of an expansion of the peripheral element 136 caused by a pulse of external energy 318 being directed at the peripheral element 136. As a more specific example, the base power of the optic portion 102 may be increased by between about +0.05D and about +0.50D as a result of fluid flowing from one of the peripheral fluid chambers 108 into the optical fluid chamber 106 due to a decrease in the volume of the peripheral fluid chamber 108 as a result of an expansion of the first peripheral element 138 caused by a pulse of external energy 318 being directed at the first peripheral element 138. As another more specific example, an increase in the volume of the peripheral fluid chambers 108 as a result of expansion of the second peripheral element 140 caused by a pulse of external energy 318 being directed at the second peripheral element 140 may cause fluid to flow out of the optical fluid chamber 106 and into one of the peripheral fluid chambers 108, resulting in a decrease in the base power of the optical portion 102 of between approximately -0.05D and approximately -0.50D.

[0261] In one or more of the methods disclosed herein, adjusting the base power of the IOL 100 may include adjusting the base power of the IOL 100 a total of between about ±1.0 D and about ±2.0 D by directing pulses of external energy 318 to multiple peripheral elements 136.

[0262] In one or more methods disclosed herein, directing the external energy 318 to the composite material 400 may further include directing light energy to the composite material 400. For example, directing the external energy 318 to the composite material 400 may further include directing a laser light to the composite material 400. As a more specific example, directing the external energy 318 to the composite material 400 may further include directing a green laser light to the composite material 400.

[0263] In one or more of the methods disclosed herein, directing external energy 318 to the composite material 400 may include directing laser light having a wavelength between about 488 nm and about 650 nm to the composite material 400. In other embodiments, directing external energy 318 to the composite material 400 may further include directing laser light having a wavelength between about 946 nm and about 1120 nm to the composite material 400.

[0264] One drawback of currently available photochromic IOLs (such as photochromic lenses) is that the photochromic procedure takes time to be effective, may require multiple visits to the clinic, and clinicians must frequently purchase expensive new equipment to perform such photochromic processes. One advantage of the fixed focus adjustable IOL 100 disclosed herein is that such fixed focus adjustable IOL 100 allows for post-operative correction of refractive error in seconds rather than hours. This allows the patient to provide almost instantaneous feedback regarding the refractive error correction. Furthermore, the IOL 100 disclosed herein can be adjusted using commercially available lasers (e.g., 532 nm laser photocoagulation devices) commonly found in most clinics. Furthermore, patients do not need to wear UV-protective glasses during the healing period, and refractive error correction can be achieved months or even years after the initial implantation surgery.

[0265] The intraocular lens disclosed herein comprises an optic and a peripheral portion connected to the optic, the peripheral portion comprising a composite material including an energy absorbing component and a plurality of expandable elements, the base power of the optic changes in response to external energy directed at the composite material, and the base power of the optic is insensitive to forces applied to the peripheral portion by the capsular bag when the intraocular lens is implanted in the capsular bag.

[0266] In the intraocular lenses disclosed herein, the expandable elements are expandable microspheres, each of which includes a blowing agent encapsulated within a thermoplastic shell.

[0267] The intraocular lenses disclosed herein have a thermoplastic shell that changes thickness in response to external energy directed at the composite material.

[0268] In the intraocular lens disclosed in Specification 2, the foaming agent is a branched chain hydrocarbon.

[0269] In the intraocular lenses disclosed herein, the branched chain hydrocarbon is isopentane.

[0270] The intraocular lens disclosed herein has a thermoplastic shell made in part from an acrylonitrile copolymer.

[0271] The intraocular lenses disclosed herein have at least one expandable microsphere that increases in diameter by between about 2-fold and about 4-fold as a result of external energy being directed at the composite material.

[0272] The intraocular lenses disclosed herein have at least one expandable element that expands in volume between about 10-50 times in response to external energy directed at the composite material.

[0273] The intraocular lenses disclosed herein include an expandable element that comprises between about 5% and about 15% by weight of the composite material.

[0274] The intraocular lenses disclosed herein include an expandable element that is about 10% by weight of the composite material.

[0275] In the intraocular lenses disclosed herein, the energy absorbing component is an energy absorbing colorant.

[0276] In the intraocular lenses disclosed herein, the color of the energy absorbing colorant is visually perceptible when the intraocular lens is implanted in the eye.

[0277] In the intraocular lenses disclosed herein, the energy absorbing colorant is a dye.

[0278] In the intraocular lenses disclosed herein, the dye is an azo dye.

[0279] In the intraocular lenses disclosed herein, the dye is Disperse Red 1.

[0280] In the intraocular lenses disclosed herein, the energy absorbing colorant is an energy absorbing dye.

[0281] In the intraocular lenses disclosed herein, the energy absorbing pigment is graphitized carbon black.

[0282] The intraocular lenses disclosed herein include an energy absorbing component between about 0.025% and about 1.00% by weight of the composite material.

[0283] The intraocular lenses disclosed herein have a periphery comprised in part of a crosslinked copolymer including a copolymer blend, and a composite comprised in part of the copolymer blend.

[0284] The intraocular lenses disclosed herein are constructed such that the composite material is cured to become a cross-linked copolymer at locations within the periphery, generally locking the composite material in place.

[0285] The intraocular lenses disclosed herein have an optic base power that varies from about ±0.05D to about ±0.5D in response to a pulse of external energy directed at the composite material.

[0286] The intraocular lenses disclosed herein have a base power of the optic that changes by approximately 0.1 D in response to a pulse of external energy directed at the composite material.

[0287] The intraocular lenses disclosed herein have an optic base power that varies from about ±1.0D to about ±2.0D total.

[0288] The intraocular lenses disclosed herein provide a permanent change in base power.

[0289] In the intraocular lens disclosed in this specification, the external energy is light energy.

[0290] In the intraocular lens disclosed herein, the light energy is laser light.

[0291] In the intraocular lenses disclosed herein, the laser light has a wavelength between about 488 nm and about 650 nm.

[0292] In the intraocular lens disclosed in the present specification, the laser light is green laser light.

[0293] The intraocular lenses disclosed herein have a wavelength of green laser light of about 532 nm.

[0294] In the intraocular lenses disclosed herein, the laser light has a wavelength between about 946 nm and about 1120 nm.

[0295] In the intraocular lenses disclosed herein, the laser light has a wavelength of about 1030 nm.

[0296] In the intraocular lenses disclosed herein, the laser light has a wavelength between about 1030 nm and 1064 nm.

[0297] In the intraocular lens disclosed in the present specification, the laser light is emitted by a femtosecond laser.

[0298] In the intraocular lenses disclosed herein, the laser light is generated by a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser.

[0299] In the intraocular lenses disclosed herein, an energy absorbing component transfers thermal energy to a plurality of expansile elements in response to external energy directed at the composite material.

[0300] The intraocular lenses disclosed herein are configured such that the composite material is formed into separate peripheral elements, such that directing external energy to one separate peripheral element causes a change in the base power of the optic, and directing external energy to another separate peripheral element also causes a change in the base power of the optic.

[0301] The intraocular lenses disclosed herein have a periphery with between 20 and 40 peripheral elements.

[0302] The intraocular lenses disclosed herein have an optic portion that includes an optical fluid chamber and a peripheral portion that includes at least one peripheral fluid chamber that is in fluid communication with the optical fluid chamber.

[0303] The intraocular lenses disclosed herein have a curved peripheral fluid chamber, which follows the curvature of the optic.

[0304] The intraocular lenses disclosed herein have a peripheral fluid chamber having a chamber height, the chamber height being between about 0.1 mm and about 0.3 mm.

[0305] In the intraocular lens disclosed in the present specification, the composite material is a chamber expansion portion that expands in response to external energy directed at the chamber expansion portion, and the expansion of the chamber expansion portion increases the volume of the surrounding fluid chamber.

[0306] The intraocular lenses disclosed herein have a base power that decreases in response to external energy directed at the expansion chamber.

[0307] The intraocular lenses disclosed herein are expandable struts with chamber expansion portions extending from the anterior chamber wall to the posterior chamber wall.

[0308] In the intraocular lenses disclosed herein, the composite material is a space-filling portion that expands in response to external energy directed at the space-filling portion, the expansion of the space-filling portion decreasing the volume of the surrounding fluid chamber.

[0309] In the intraocular lenses disclosed herein, the space-filling portion is a pad that extends from either the anterior or posterior chamber wall.

[0310] The intraocular lenses disclosed herein have a base power in the optic that increases in response to external energy directed at the space-filling portion.

[0311] The intraocular lenses disclosed herein change base power in response to the movement of fluid between the optical and peripheral fluid chambers as a result of external energy being directed at the composite material.

[0312] The intraocular lenses disclosed herein have a periphery with at least one haptic, a peripheral fluid chamber defined within the haptic, and the peripheral fluid chamber extending only partially within the haptic.

[0313] The intraocular lenses disclosed herein have at least one haptic comprising a haptic proximal portion and a haptic distal portion, the haptic distal portion comprising a haptic distal arm that is not connected to the optical portion except through the connection via the haptic proximal portion.

[0314] The intraocular lenses disclosed herein include a twist or bend in the haptic distal arms.

[0315] The intraocular lenses disclosed herein have a peripheral fluid chamber defined within the proximal haptic portion, the chamber section of the proximal haptic portion not connected to the optic portion.

[0316] The intraocular lenses disclosed herein have at least one haptic connected to the optic by a proximal end of the haptic and a distal connection portion disposed distally from the chamber compartment.

[0317] The intraocular lenses disclosed herein have proximal ends of the haptics connected to and extending from a lateral side of the optic, the lateral side having a lateral height, the lateral height being approximately 0.65 mm.

[0318] The intraocular lens disclosed herein has a peripheral portion having a first haptic with a first haptic fluid chamber and a second haptic with a second haptic fluid chamber, and an optical portion having an optical fluid chamber.

[0319] The intraocular lens disclosed in the present specification has a first haptic fluid chamber in fluid communication with the optical fluid chamber via a first fluid channel, a second haptic fluid chamber in fluid communication with the optical fluid chamber via a second fluid channel, and the first fluid channel is positioned diametrically opposite the second fluid channel.

[0320] The intraocular lenses disclosed herein include an optical fluid chamber, a first haptic fluid chamber, and a second haptic fluid chamber that contain a total volume of fluid between about 10 μL and about 20 μL.

[0321] The intraocular lenses disclosed herein include a first haptic fluid chamber and a second haptic fluid chamber each containing approximately 0.5 μL of fluid.

[0322] The intraocular lenses disclosed herein provide for an exchange of approximately 15 nL of fluid between either the first or second haptic fluid chamber and the optical fluid chamber upon expansion of the composite material.

[0323] In the intraocular lenses disclosed herein, the fluid is silicone oil.

[0324] The intraocular lenses disclosed herein have a peripheral portion comprising a first composite material and a second composite material, the first composite material comprising a first energy absorbing component, the second composite material comprising a second energy absorbing component, and the first energy absorbing component having a color different from the color of the second energy absorbing component.

[0325] The intraocular lens disclosed herein also comprises an optic portion and a peripheral portion connected to the optic portion, the peripheral portion comprising a first peripheral element and a second peripheral element, the first peripheral element being comprised of a composite material including an energy absorbing component and a plurality of expandable elements, the second peripheral element being comprised of a composite material including an energy absorbing component and a plurality of expandable elements, a base power of the optic portion increasing in response to external energy directed to the first peripheral element, a base power of the optic portion decreasing in response to external energy directed to the second peripheral element, and a base power of the optic portion being insensitive to forces applied to the peripheral portion by the capsular bag when the intraocular lens is implanted within the capsular bag.

[0326] The intraocular lenses disclosed herein have an optic portion that includes an optical fluid chamber and a peripheral portion that includes at least one peripheral fluid chamber that is in fluid communication with the optical fluid chamber.

[0327] The intraocular lenses disclosed herein change base power in response to movement of fluid between the optical fluid chamber and the peripheral fluid chamber as a result of external energy being directed at the first peripheral element or the second peripheral element.

[0328] In the intraocular lenses disclosed herein, the first peripheral element is a space-filling portion that expands in response to external energy directed at the space-filling portion, the expansion of the space-filling portion decreasing the volume of the peripheral fluid chamber.

[0329] The intraocular lenses disclosed herein are inflatable pads with space-filling portions extending from either the anterior or posterior chamber walls.

[0330] In the intraocular lens disclosed in the present specification, the second peripheral element is a chamber expansion portion that expands in response to external energy directed at the chamber expansion portion, and the expansion of the chamber expansion portion increases the volume of the peripheral fluid chamber.

[0331] The intraocular lenses disclosed herein are expandable struts with chamber expansion portions extending from the anterior chamber wall to the posterior chamber wall.

[0332] The intraocular lenses disclosed herein include a first peripheral element and a second peripheral element disposed within the same peripheral fluid chamber.

[0333] The intraocular lenses disclosed herein have a second peripheral element disposed distal to the first peripheral element within the same peripheral fluid chamber.

[0334] The intraocular lenses disclosed herein have a first peripheral element disposed adjacent to a second peripheral element within the same peripheral fluid chamber, the first peripheral element being disposed closer to the fluid channel connecting the optical fluid chamber to the peripheral fluid chamber than the second peripheral element.

[0335] The intraocular lenses disclosed herein have a first peripheral element and a second peripheral element formed as independent peripheral elements, and directing external energy to one independent peripheral element causes a change in the base power of the optical portion, and directing external energy to the other independent peripheral element also causes a change in the base power of the optical portion.

[0336] The intraocular lens disclosed herein has a peripheral fluid chamber that includes at least ten first peripheral elements.

[0337] The intraocular lens disclosed herein has a peripheral fluid chamber that includes at least ten second peripheral elements.

[0338] In the intraocular lenses disclosed herein, the expandable elements are expandable microspheres, each of which includes a blowing agent encapsulated within a thermoplastic shell.

[0339] In the intraocular lenses disclosed herein, the energy absorbing component is an energy absorbing colorant.

[0340] The intraocular lenses disclosed herein have an optic base power that varies from about ±0.05D to about ±0.5D in response to a pulse of external energy directed at the first peripheral element or the second peripheral element.

[0341] The intraocular lenses disclosed herein have a base power of the optic that changes by approximately 0.1 D in response to a pulse of external energy directed at the first peripheral element or the second peripheral element.

[0342] The intraocular lenses disclosed herein have an optic base power that varies from about ±1.0D to about ±2.0D total.

[0343] In the intraocular lenses disclosed herein, the external energy is light energy.

[0344] In the intraocular lenses disclosed herein, the light energy is laser light.

[0345] The method of post-operatively adjusting an intraocular lens disclosed herein also includes adjusting the base power of the intraocular lens by directing external energy to a composite material within a peripheral portion of the intraocular lens, the peripheral portion being connected to an optic portion disposed radially inward from the peripheral portion, the composite material including an energy absorbing component and a plurality of expandable elements, and the base power of the intraocular lens is insensitive to forces applied to the peripheral portion by the capsular bag when the intraocular lens is implanted within the capsular bag.

[0346] The methods disclosed herein include an optical portion comprising an optical fluid chamber, a peripheral portion comprising at least one peripheral fluid chamber in fluid communication with the optical fluid chamber, and a base power of the intraocular lens that changes in response to movement of fluid between the optical fluid chamber and the peripheral fluid chamber as a result of external energy being directed at the composite material.

[0347] The method disclosed herein results in approximately 15 nL of fluid being exchanged between the peripheral fluid chamber and the optical fluid chamber in response to the expansion of the composite material.

[0348] The method disclosed herein further includes adjusting the base power of the intraocular lens by directing external energy to a composite material, which is a space-filling portion located within a peripheral fluid chamber defined within the periphery, to increase the base power.

[0349] The methods disclosed herein further include reducing the base power by directing external energy to another instance of the composite material, a peripherally located chamber expansion portion.

[0350] The method disclosed herein further includes adjusting the base power of the intraocular lens by directing external energy to a composite material, which is a chamber expansion portion located within a peripheral fluid chamber defined within the peripheral portion, thereby decreasing the base power.

[0351] The methods disclosed herein further include reducing the base power by directing external energy to another instance of the composite material, the space-filling portion located within the surrounding fluid chamber.

[0352] The method disclosed herein further includes adjusting the base power of the intraocular lens by directing a pulse of external energy to a first peripheral element within a peripheral fluid chamber defined in the peripheral portion, the first peripheral element being made of a composite material, and directing an additional pulse of external energy to a second peripheral element within the same peripheral fluid chamber, the second peripheral element being made of a composite material.

[0353] The method disclosed herein further includes adjusting the base power of the intraocular lens by directing a pulse of external energy to a first peripheral element within a first peripheral fluid chamber defined in the peripheral portion, the first peripheral element being made of a composite material, and directing an additional pulse of external energy to a second peripheral element within a second peripheral fluid chamber defined in the peripheral portion, the second peripheral element being made of a composite material.

[0354] In the method disclosed herein, a first peripheral fluid chamber is in fluid communication with a second peripheral fluid chamber through an optical fluid chamber defined within the optic portion.

[0355] The method disclosed herein includes a composite material comprising a first composite material and a second composite material, the method further including adjusting the base power in a first direction by directing external energy to the first composite material, the first composite material including a first energy absorbing component having a first color, and adjusting the base power in a second direction by directing external energy to the second composite material, the second composite material including a second energy absorbing component having a second color different from the first color.

[0356] In the method disclosed herein, the expandable elements are expandable microspheres, each of which comprises a blowing agent encapsulated within a thermoplastic shell.

[0357] The methods disclosed herein further include varying the base power of the intraocular lens between about ±0.05D and about ±0.50D by directing a pulse of external energy to the composite material.

[0358] The methods disclosed herein further include adjusting the base power of the intraocular lens by about ±0.10 D by directing a pulse of external energy to the composite material.

[0359] The methods disclosed herein further include varying the base power of the intraocular lens by a total of about ±1.0 D to about ±2.0 D by directing multiple pulses of external energy to the composite material.

[0360] In the methods disclosed herein, directing external energy to the composite material may further include directing light energy to the composite material.

[0361] In the methods disclosed herein, directing external energy to the composite material further comprises directing a laser light to the composite material.

[0362] In the methods disclosed herein, directing external energy to the composite material further comprises directing a green laser light to the composite material.

[0363] In the methods disclosed herein, directing external energy to the composite material further comprises directing laser light having a wavelength between about 488 nm and about 650 nm to the composite material.

[0364] In the methods disclosed herein, directing external energy to the composite material further includes directing laser light having a wavelength between about 946 nm and about 1120 nm to the composite material.

[0365] A number of embodiments have been disclosed. Nevertheless, it will be understood by those skilled in the art that various changes and modifications may be made to the present disclosure without departing from the spirit and scope of the embodiments. The systems, devices, equipment, and methods shown with the embodiments are illustrated for certain embodiments and may be used in combination with or with other embodiments within the present disclosure. For example, the steps of the methods shown in the figures or described within the present disclosure do not require the specific order or sequential order shown or described to achieve the desired results. In addition, other operational steps may be provided to achieve the desired results, and steps or operations may be deleted or omitted from the described method or process. Furthermore, components or portions of the devices or systems described in the present disclosure or shown in the figures may be removed, deleted, or omitted to achieve the desired results. In addition, certain components or portions of the systems, devices, or equipment shown or described herein have been omitted for brevity and clarity.

[0366] Accordingly, other embodiments are within the scope of the following claims, and the specification and / or figures may be regarded as illustrative rather than restrictive.

[0367] Each modification or embodiment described and illustrated herein has independent components and functions which may be readily separated or combined with the functions of the other modifications or embodiments. Modifications may be made to adapt a particular situation, material, composition of matter, process, process acts or steps to the objective, spirit or scope of the present invention.

[0368] For methods recited herein, the recited events may be carried out in any order that is logically possible, in addition to the recited order of events, and additional steps or operations may be provided or steps or operations may be omitted in order to achieve desired results.

[0369] Furthermore, when a range of values ​​is provided, all values ​​between the upper and lower limits of that range, as well as any other values ​​within the stated or stated range, are encompassed within the scope of the invention. Also, any optional features of the described inventive modifications may be disclosed and claimed independently or together with any one or more of the features described herein. For example, a description of a range from 1 to 5 should be considered to disclose subranges of 1 to 3, 1 to 4, 2 to 4, 2 to 5, 3 to 5, etc., as well as the individual numbers within the range, such as 1.5, 2.5, etc., and whole or partial increments of numbers therebetween.

[0370] All existing subject matter (e.g., publications, patents, patent applications) mentioned herein is hereby incorporated by reference in its entirety, except to the extent that the subject matter conflicts with the subject matter of the present invention, in which case the content of this specification shall take precedence. The referenced items are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.

[0371] Reference to a singular item includes the possibility of a plural of the same item. More specifically, in this specification and the appended claims, the singular forms "a," "an," and "said" also include plural references unless the context clearly indicates otherwise. It is further noted that the claims may be drafted to exclude optional elements. Accordingly, this statement is intended to serve as a predicate for the use of exclusive terminology such as "solely," "solely," or "negative" limitations in connection with the recitation of claim elements. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0372] The phrase "at least one of," when used to modify a plurality of items or components (or an enumerated list of items or components), is meant to indicate a combination of one or more of those items or components. For example, "at least one of A, B, and C" means (i) A, (ii) B, (iii) C, (iv) A, B, and C, (v) A and B, (vi) B and C, or (vii) A and C.

[0373] In understanding the scope of the present disclosure, "comprises" and its derivatives, as used herein, are intended to be open-ended terms specifying the mentioned features, elements, components, groups, integers, and / or steps, but not excluding other unmentioned features, elements, components, groups, integers, and / or steps. The same also applies to terms of similar meaning, such as "include," "have," and their derivatives. Also, the terms "part," "portion," "part," "member," "element," or "component," when used in the singular, have the dual meaning of one part and multiple parts. As used herein, the directional terms "front, back, up, down, vertically, horizontally, below, across, laterally, and longitudinally" and other similar directional terms refer to the location of a device or equipment, or the direction in which a device or equipment is moved or moved.

[0374] Finally, terms indicating degree, such as "generally," "about," and "approximately," as used herein, refer to a particular value or a reasonable amount of variation from the specified value such that the particular value and end result do not change significantly or substantially (e.g., up to ±0.1%, ±1%, ±5%, or ±10%, where such variation is appropriate). For example, "about 1.0 cm" may be interpreted to mean "1.0 cm" or "between 0.9 cm and 1.1 cm." Terms indicating degree, such as "about" or "approximately," are used to indicate numbers or values ​​that are part of a range, and the terms may be used to modify the lowest and highest numbers or values.

[0375] The present disclosure is not intended to be limited in scope to any particular form, but is intended to cover alternatives, modifications, and equivalents of the modifications or embodiments described herein. Moreover, the scope of the present disclosure fully encompasses other modifications or embodiments that may become apparent to those skilled in the art in view of the present disclosure.

Claims

1. An optical section; a peripheral portion connected to the optical portion, the periphery comprises a composite material including an energy absorbing component and a plurality of intumescent elements; the base power of the optic changes in response to external energy directed at the composite material; the base power of the optical portion is insensitive to forces applied to the peripheral portion by the lens capsule when the intraocular lens is implanted in the lens capsule; Intraocular lens.

2. The intraocular lens of claim 1 , wherein the expandable elements are expandable microspheres, each of the expandable microspheres including a blowing agent encapsulated within a thermoplastic shell.

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

4. The intraocular lens of claim 1 , wherein the energy absorbing component is graphitized carbon black.

5. The intraocular lens of claim 1 , wherein said peripheral portion is comprised in part of a cross-linked copolymer including a copolymer blend, and said composite material is comprised in part of said copolymer blend.

6. 2. The intraocular lens of claim 1, wherein the base power of the optic varies between 0.05D and 0.5D in a positive or negative direction in response to the pulse of external energy directed at the composite material.

7. The intraocular lens of claim 1 , wherein the external energy is laser light having a wavelength between 488 nm and 650 nm.

8. The intraocular lens of claim 1 , wherein the external energy is laser light having a wavelength between 946 nm and 1120 nm.

9. The intraocular lens of claim 1 , wherein the external energy is laser light emitted by a femtosecond laser.

10. The intraocular lens of claim 1, wherein the composite material is formed as independent peripheral elements, and wherein directing the external energy to one independent peripheral element causes a change in the base power of the optical portion, and directing the external energy to another independent peripheral element further causes a change in the base power of the optical portion.

11. The intraocular lens of claim 1 , wherein the optic portion comprises an optical fluid chamber, and the peripheral portion comprises at least one peripheral fluid chamber in fluid communication with the optical fluid chamber.

12. The intraocular lens of claim 11, wherein the composite material is a chamber expansion portion that expands in response to the external energy directed to the chamber expansion portion, and the expansion of the chamber expansion portion increases the volume of the surrounding fluid chamber.

13. The intraocular lens of claim 12 , wherein the base power of the optic decreases in response to the external energy directed at the chamber expansion portion.

14. The intraocular lens of claim 12 , wherein the chamber expansion portion is an expandable strut extending from the anterior chamber wall to the posterior chamber wall.

15. The intraocular lens of claim 11 , wherein the composite material is a space-filling portion that expands in response to the external energy directed at the space-filling portion, and the expansion of the space-filling portion reduces the volume of the peripheral fluid chamber.

16. The intraocular lens of claim 15 , wherein the base power of the optic increases in response to the external energy directed at the space-filling portion.

17. The intraocular lens of claim 11 , wherein the peripheral portion is at least one haptic, the peripheral fluid chamber is defined within the haptic, and the peripheral fluid chamber extends only partially within the haptic.

18. The intraocular lens of claim 1 , wherein the peripheral portion is a first haptic having a first haptic fluid chamber and a second haptic having a second haptic fluid chamber, and the optical portion is provided with an optical fluid chamber.

19. The intraocular lens of claim 18, wherein the first haptic fluid chamber is fluidly connected to the optical fluid chamber via a first fluid channel, the second haptic fluid chamber is fluidly connected to the optical fluid chamber via a second fluid channel, and the first fluid channel is positioned diametrically opposite the second fluid channel.

20. 20. The intraocular lens of claim 18, wherein the optical fluid chamber, the first haptic fluid chamber, and the second haptic fluid chamber contain a total volume of fluid between 10 μL and 20 μL.

21. 21. The intraocular lens of claim 20, wherein each of the first haptic fluid chamber and the second haptic fluid chamber comprises 0.5 μL of the fluid.

22. The intraocular lens of claim 20, wherein 15 nL of the fluid is exchanged between either the first haptic fluid chamber or the second haptic fluid chamber and the optical fluid chamber in response to expansion of the composite material.

23. 2. The intraocular lens of claim 1, wherein the peripheral portion comprises a first composite material and a second composite material, the first composite material comprising a first energy absorbing component, the second composite material comprising a second energy absorbing component, and the first energy absorbing component having a color different from the color of the second energy absorbing component.

24. An optical section; a peripheral portion connected to the optical portion, the peripheral portion comprising a first peripheral element and a second peripheral element; the first peripheral element is made of a composite material including an energy absorbing component and a plurality of intumescent elements; the second peripheral element is comprised of the composite material including the energy absorbing component and the plurality of intumescent elements; a base power of the optic increases in response to external energy directed at the first peripheral element; the base power of the optic decreases in response to the external energy directed at the second peripheral element. Intraocular lens.

25. 25. The intraocular lens of claim 24, wherein the optic portion comprises an optical fluid chamber, and the peripheral portion comprises at least one peripheral fluid chamber in fluid communication with the optical fluid chamber.

26. 26. The intraocular lens of claim 25, wherein the first peripheral element is a space-filling portion that expands in response to the external energy directed at the space-filling portion, and the expansion of the space-filling portion reduces the volume of the peripheral fluid chamber.

27. The intraocular lens of claim 25, wherein the second peripheral element is a chamber expansion portion that expands in response to the external energy directed at the chamber expansion portion, and the expansion of the chamber expansion portion increases the volume of the peripheral fluid chamber.

28. 26. The intraocular lens of claim 25, wherein the first peripheral element and the second peripheral element are disposed within the same peripheral fluid chamber.

29. 29. The intraocular lens of claim 28, wherein the second peripheral element is disposed distal to the first peripheral element within the same peripheral fluid chamber.

30. The intraocular lens of claim 28, wherein the first peripheral element is arranged in the same peripheral fluid chamber adjacent to the second peripheral element, and the first peripheral element is arranged closer to a fluid channel connecting the optical fluid chamber to the peripheral fluid chamber than the second peripheral element.

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