Adjustable intraocular lenses and postoperative adjustment methods for 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 Patent Application No. 62 / 911,039, filed on October 4, 2019, the contents of which are incorporated herein by reference in their entirety.

[0002] The present disclosure relates generally to the field of intraocular lenses, and more specifically to adjustable intraocular lenses and methods for adjusting an intraocular lens after surgery.

BACKGROUND ART

[0003] Cataract is an eye condition in which the normally clear lens inside a patient's eye becomes cloudy. Cataracts develop due to causes such as aging, genetics, trauma, inflammation, metabolic abnormalities, or radiation exposure. Age-related cataracts are the most common type of cataract. For cataract treatment, surgeons remove the patient's lens substrate from the lens capsule and replace it with an intraocular lens (IOL).

[0004] However, some patients may not be satisfied with the refractive correction results of current IOL surgery. In some cases, there may be errors in the biometry performed on the patient's eye before surgery, in which case an IOL with an incorrect lens power is prescribed and implanted into the patient's eye. In other cases, when the IOL is implanted in the lens capsule, an aggressive healing response by cells within the lens capsule can affect the optical power of the IOL. Furthermore, the cornea or muscles in the patient's eye may change as a result of injury, illness, or aging. In such cases, it may become necessary to adjust the IOL implanted in the patient to accommodate such changes.

[0005] Accordingly, to address the problems noted above, there is a need for a solution to adjust an IOL after implantation without performing additional surgery. Such a solution should not be overly complex and should allow the IOL to be manufactured in a cost-effective manner.

SUMMARY OF THE INVENTION

[0006] This specification discloses adjustable intraocular lenses and methods for adjusting intraocular lenses postoperatively. Such adjustable intraocular lenses may also be referred to as adjustable fixed-focus intraocular lenses or non-adjustable fluid-adjustable intraocular lenses.

[0007] In one embodiment, an intraocular lens is disclosed comprising an optical portion and a peripheral portion connected to the optical portion. The peripheral portion may include a composite material comprising an energy-absorbing component and a plurality of expandable elements. The base power of the optical portion may change in response to external energy directed toward the composite material. The base power of the optical portion does not need to respond to the force applied to the peripheral portion by the lens capsule when the intraocular lens is implanted in the lens capsule.

[0008] In some embodiments, the expandable elements may be expandable microspheres. Each expandable microsphere may contain a foaming agent enclosed within a thermoplastic resin shell. The thickness of the thermoplastic resin shell may vary depending on the external energy directed at the composite material.

[0009] In certain embodiments, the foaming agent may be a branched-chain hydrocarbon. For example, the branched-chain hydrocarbon may be isopentane. Also, for example, the thermoplastic resin shell may be made partly of an acrylonitrile copolymer.

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

[0011] In some embodiments, the expandable element may contain composite material in an amount between approximately 5% and approximately 15% by weight. For example, the expandable element may contain composite material in an amount between approximately 10% by weight.

[0012] In some embodiments, the energy-absorbing component may be an energy-absorbing colorant. The color of the energy-absorbing colorant 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 Thread 1.

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

[0015] In some embodiments, a portion of the peripheral portion may be made of a crosslinked copolymer containing a copolymer mixture. In these embodiments, the composite material may also consist of a copolymer mixture in part.

[0016] The composite material may harden and become a cross-linked copolymer at a location within the periphery. The composite material may be generally fixed in that position.

[0017] The base power of the optical element may vary between approximately ±0.05D and approximately ±0.5D in response to the pulse of external energy directed at the composite material. For example, the base power of the optical element may vary by approximately 0.1D in response to the pulse of external energy directed at the composite material.

[0018] The base power of the optical element may vary between approximately ±1.0D and approximately ±2.0D. The change in base power may be permanent.

[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 approximately 488 nm and approximately 650 nm. For example, the laser light may be green laser light. The green laser light may have a wavelength of approximately 532 nm.

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

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

[0022] The energy-absorbing component transfers thermal energy to multiple expandable elements in response to external energy directed at the composite material.

[0023] In some embodiments, the composite material may consist of independent peripheral elements, and directing external energy to one independent peripheral element causes a change in the base frequency of the optical section, and directing external energy to another independent peripheral element also causes a change in the base frequency of the optical section. In certain embodiments, the peripheral section may comprise between 20 and 40 peripheral elements.

[0024] The optical section of the IOL may include an optical fluid chamber, and the peripheral section may include at least one peripheral fluid chamber that is in fluid communication with the optical fluid chamber. In some embodiments, the peripheral fluid chamber is curved and follows the curvature of the optical section.

[0025] The surrounding fluid chamber may have a chamber height. The chamber height may be between approximately 0.1 mm and approximately 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 toward the chamber expansion portion. Expansion of the chamber expansion portion may increase the volume of the peripheral fluid chamber. The base power of the optical portion may decrease in response to external energy directed toward the chamber expansion portion. The chamber expansion portion may be an expandable strut extending from the chamber anterior wall to the chamber posterior wall.

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

[0029] In certain embodiments, the peripheral portion 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 color of the first energy absorbing component may be different from the color of the second energy absorbing component.

[0030] In some embodiments, the peripheral portion may be at least one haptic, and the peripheral fluid chamber may be defined within the haptic. In these embodiments, the peripheral fluid chamber may extend only to a portion within the haptic.

[0031] The haptic may include a haptic proximal portion and a haptic distal portion. The haptic distal portion may include a haptic distal arm that is not connected to the optical portion except for the connection via the haptic proximal portion.

[0032] In some embodiments, the haptic distal arm may be twisted or bent.

[0033] The peripheral fluid chamber may be defined within the proximal part of the haptic, and the chamber compartment of the proximal part of the haptic may be connected to or separated from the optical part by gaps or spaces. The haptic may be connected to the optical part by a distal connection located distal to the proximal end of the haptic and the chamber compartment.

[0034] In some embodiments, the proximal end of the haptic may be connected to and extend from the side of the optical unit. In these embodiments, the side may have a side height of approximately 0.65 mm.

[0035] The peripheral portion may consist of a first haptic having a first haptic fluid chamber and a second haptic having a second haptic fluid chamber. The optical portion may also consist of 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 positioned approximately diametrically opposite the second fluid channel.

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

[0038] In another embodiment, an intraocular lens is disclosed comprising an optical portion and a peripheral portion connected to the optical portion. The peripheral portion may comprise a first peripheral element and a second peripheral element. The first peripheral element may consist of a composite material comprising an energy-absorbing component and a plurality of expandable elements. The second peripheral element may also consist of a composite material comprising an energy-absorbing component and a plurality of expandable elements. The base power of the optical portion may increase in response to external energy directed to the first peripheral element, and the base power of the optical portion may decrease in response to external energy directed to the second peripheral element. However, the base power of the optical portion does not have to respond to the force applied to the peripheral portion by the lens capsule when the intraocular lens is implanted in the lens capsule.

[0039] In some embodiments, the optical section may include an optical fluid chamber, and the peripheral section may include at least one peripheral fluid chamber that is in fluid communication with the optical fluid chamber. The base frequency may change in response to fluid movement between the optical fluid chamber and the peripheral fluid chamber as a result of external energy being directed towards a first peripheral element or a 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 towards it. The expansion of the space-filling portion may reduce the volume of the peripheral fluid chamber. For example, the space-filling portion may be an expandable pad extending from either the front wall or the rear wall of the chamber.

[0041] In some embodiments, the second peripheral element may be a chamber expansion section or a jack. The chamber expansion section or jack may expand in response to external energy directed toward it. The expansion of the chamber expansion section or jack may increase the volume of the peripheral fluid chamber. For example, the chamber expansion section or jack may be an expandable column extending from the front wall of the chamber to the rear wall.

[0042] In certain embodiments, the first and second peripheral elements may be located within the same peripheral fluid chamber. In these embodiments, the second peripheral element may be located distal to the first peripheral element within the same peripheral fluid chamber. In these embodiments, the first peripheral element may also be located near the second peripheral element within the same peripheral fluid chamber. The first peripheral element may be located closer to the fluid channel connecting the optical fluid chamber to the peripheral fluid chamber compared to the second peripheral element.

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

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

[0045] A method for adjusting an intraocular lens after surgery is also disclosed. The method may include adjusting the base power of the intraocular lens by directing external energy to a composite material within the peripheral portion of the intraocular lens. The peripheral portion may be connected to an optical portion that is radially inward. The composite material may include an energy-absorbing component and multiple expandable elements. The base power of the intraocular lens does not have to respond to the force applied to the peripheral portion by the lens capsule when the intraocular lens is implanted in the lens capsule.

[0046] The optical portion may include an optical fluid chamber, and the peripheral portion may include at least one peripheral fluid chamber that is in fluid communication with the optical fluid chamber. The base power of the intraocular lens 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 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 pulses 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 which is a space-filling portion located within a peripheral fluid chamber defined within the peripheral region.

[0048] The method may further include reducing the base frequency by directing external energy to another example of the composite material, which is a chamber expansion region located within the periphery.

[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 which is a chamber expansion portion located within a peripheral fluid chamber defined within the peripheral region. Reducing the base power may further include directing external energy to another example of the composite material which 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 peripheral region, 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 made of a composite material, and the second peripheral element may be made 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 in a first peripheral fluid chamber defined within the peripheral region, and directing an additional pulse of external energy to a second peripheral element in a second peripheral fluid chamber defined within the peripheral region. The first peripheral element may be made of a composite material, and the second peripheral element may be made 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 within the optical region.

[0052] In some embodiments, adjusting the base frequency in a first direction further includes directing external energy towards a first composite material, and adjusting the base frequency in a second direction includes directing external energy towards a second composite material. The first composite material may contain a first energy-absorbing component having a first color. The second composite material may contain a second energy-absorbing component having a second color different from the first color. [Brief explanation of the drawing]

[0053] [Figure 1A] Figure 1A is a plan view of an embodiment of an adjustable intraocular lens (IOL), with a portion of the anterior part of the adjustable IOL removed to better illustrate the components within the IOL. [Figure 1B] Figure 1B shows an adjustable IOL implanted in the lens capsule of the subject. [Figure 2A] Figure 2A is a perspective view of an adjustable IOL. [Figure 2B] Figure 2B is a perspective view of an adjustable IOL, with a portion of the front part of the adjustable IOL removed to better depict the components within the IOL. [Figure 3A] Figure 3A is a cross-sectional view of the adjustable IOL along AA in Figure 2A. [Figure 3B] Figure 3B is a cross-sectional view of the adjustable IOL along BB in Figure 2A. [Figure 3C] Figure 3C shows the external energy directed towards the first peripheral element of the tunable IOL. [Figure 3D] Figure 3D shows the external energy directed towards the second peripheral element of the adjustable IOL. [Figure 4A] Figure 4A shows the composite material used to fabricate at least a portion of an adjustable intraocular lens. [Figure 4B] Figure 4B shows one embodiment of the expandable element of an adjustable intraocular lens. [Figure 5] Figure 5 is a plan view of another embodiment of the adjustable IOL, with a portion of the front part of the adjustable IOL removed to better depict the components within the IOL. [Figure 6] Figure 6 is a plan view of an adjustable IOL with an optical splitting lens surface profile. [Figure 7] Figure 7 shows one embodiment of a method for adjusting an IOL after surgery. [Figure 8] Figure 8 shows another embodiment of a method for adjusting an IOL after surgery. [Figure 9] Figure 9 shows yet another embodiment of a method for adjusting an IOL after surgery. [Figure 10] Figure 10 shows an additional embodiment of a method for adjusting an IOL after surgery. Detailed explanation

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

[0055] For example, the adjustable IOL 100 may be an integrated lens (see, for example, Figures 1A to 3B) in which the peripheral portion 103 is connected to and extends from the optical portion 102. In this embodiment, the peripheral portion 103 is formed together with the optical portion 102 and is not bonded or connected to the optical portion 102 in a subsequent step.

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

[0057] The optical unit 102 may include an optical fluid chamber 106 (see also, for example, Figures 2B, 3A, and 3B) and one or more peripheral fluid chambers 108 that are in fluid communication with the optical fluid chamber 106. 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 into only a portion of the interior of the peripheral portion 103. For example, at least one peripheral fluid chamber 108 may extend into only one-third, one-half, or three-quarters of the interior of the peripheral portion 103. Alternatively, for example, at least one peripheral fluid chamber 108 may extend only partially into the interior between one-third and one-half of the peripheral portion 103, or between one-half and three-quarters of the interior of the peripheral portion 103.

[0059] In certain embodiments, at least one peripheral fluid chamber 108 may extend into only a portion of the interior of one of the haptic 104 of the peripheral portion 103. For example, at least one peripheral fluid chamber 108 may extend into one-third, one-half, or three-quarters of the interior of the haptic 104. Alternatively, for example, at least one peripheral fluid chamber 108 may extend into between one-third and one-half of the haptic 104, or between one-half and three-quarters of the interior of the haptic 104.

[0060] As shown in Figure 1A, the peripheral portion 103 may comprise two haptics 104 (for example, a first haptic 104A and a second haptic 104B). In this embodiment, the peripheral fluid chamber 108 may extend into the interior of each of the two haptics 104. The peripheral fluid chamber 108 may extend into only a portion of the haptic 104.

[0061] One or more peripheral fluid chambers 108 may also be referred to as one or more haptic fluid chambers. When the peripheral portion 103 comprises a first haptic 104A and a second haptic 104B, the peripheral portion 103 may comprise 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., a first haptic 104A, a second haptic 104B, or a combination thereof) may be curved. In these embodiments, the peripheral fluid chamber 108 (e.g., a haptic fluid chamber) may also be curved. The peripheral fluid chamber 108 may be aligned with the curvature of the haptic 104. When at least one section of the haptic 104 aligns with the curvature of at least a portion of the optical section 102, the peripheral fluid chamber 108 may also align with the curvature of at least a portion of the optical section 102.

[0063] The peripheral fluid chamber 108 may be in fluid communication with the optical fluid chamber 106, or it 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 the rear element 300 of the optical section 102 (see, for example, Figures 3A and 3B).

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

[0065] The peripheral fluid chamber 108 may be in fluid communication with the optical fluid chamber 106, or it may be fluidly connected to the optical fluid chamber 106 via a single fluid channel 110. If the adjustable IOL 100 has multiple peripheral fluid chambers 108, each of the peripheral fluid chambers 108 may be in fluid communication with the optical fluid chamber 106, or it 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 it may be fluidly connected to the optical fluid chamber 106 via a plurality of (e.g., two or more) fluid channels. In these embodiments, the two or more fluid channels 110 may be separated by channel dividers or divider walls.

[0067] When the peripheral portion 103 comprises a first haptic 104A having a first haptic fluid chamber and a second haptic 104B having a second haptic fluid chamber, the first haptic fluid chamber may be in fluid communication or fluid connection with the optical fluid chamber 106 via a first fluid channel, and the second haptic fluid chamber may be in fluid communication or fluid connection with the optical fluid chamber 106 via a second fluid channel. In these embodiments, the first fluid channel may be positioned approximately diametrically opposite to the second fluid channel (for example, Figures 1A, 1B, 2B, and 3A).

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

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

[0070] The haptic distal section 114 may include a haptic distal arm 116. The haptic distal arm 116 does not have to be connected to the optical section 102, except for the connection via the haptic proximal section 112.

[0071] The haptic distal arm 116 may have a defined twist or bend 118 along the haptic distal arm 116. The twist or bend 118 may cause the haptic distal arm 116 to be compressed or bent in response to deformation of the lens capsule. The haptic distal arm 116 may terminate at a haptic distal end 120 that is free or disconnected.

[0072] When the peripheral portion 103 comprises two haptics 104 (for example, a first haptic 104A and a second haptic 104B), the adjustable IOL 100 may have an uncompressible haptic length 122 measured from the distal end 120 of the first haptic 104A to the distal end 120 of the second haptic 104B. The uncompressible haptic length 122 may be between approximately 12.0 mm and approximately 14.0 mm. For example, the uncompressible haptic length 122 may be approximately 13.0 mm.

[0073] The distal end 120 of each haptic 104 may be the closed end of the haptic 104 that is not connected to the optical unit 102. The distal end 120 of the haptic may have a bulbous feature or a small node at its end.

[0074] As shown in Figure 1A, the optical section 102 may have an optical section diameter 124. The optical section diameter 124 may be between approximately 5.0 mm and 8.0 mm. For example, the optical section diameter 124 may be approximately 6.0 mm.

[0075] The haptic 104 may be connected to the optical unit 102 at its proximal end 126. The haptic 104 may also be connected to the optical unit 102 at its distal connection 128. The distal connection 128 may be part of the haptic 104, distally located at 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 chamber section 129) may be physically separated from the optical section 102. Chamber section 129 includes at least a section of the peripheral fluid chamber 108 between the radially inner chamber wall 132 and the radially outer chamber wall 134. For example, the radially inner chamber wall 132 of chamber section 129 may be separated from the optical section 102 by an elongated gap or space. The elongated gap or space may be a curved gap 130 as shown in Figure 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 pressurizing the side surface 111 adjacent to the chamber compartment 129 of the optical unit 102 (see also, for example, Figures 2A, 2B, 3A, and 3B).

[0078] As shown in Figure 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 thick or large, radially outer chamber wall 134 may provide rigidity or elasticity 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 thick or large, radially outer chamber wall 134 may make the chamber compartment 129 of the peripheral portion 103 less sensitive to the radial force applied to the peripheral portion 103 due to deformation of the lens capsule by the movement of the ciliary muscle.

[0080] In some embodiments, the distal connector 128 may not be fixed to or connected to an adjacent portion of the optical portion 102, and as a result, most of the haptic 104 may move freely for the purpose of folding and unfolding during IOL 100 implantation. Once the IOL 100 is implanted in the lens capsule, the distal connector 128 can lean against or contact an adjacent portion of the optical portion 102, stabilizing the haptic 104 and preventing it from twisting or moving around due to contraction or deformation of the lens capsule. In other embodiments, the haptic 104 may also be connected to the optical portion 102 by the distal connector 128.

[0081] As shown in Figure 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 the applicant is how to design a fluid-filled IOL that is adjustable by a clinician or other healthcare professional after surgery, and that is unresponsive to or insensitive to radial forces applied to the fluid-filled IOL by the lens capsule. One solution discovered by the applicant is the adjustable IOL disclosed herein, which has a peripheral fluid chamber extending only to a portion of the haptic of the adjustable IOL, and the chamber compartment of the haptic has a radially outer chamber wall that is thicker than the radially inner chamber wall, and a radially inner chamber wall separated from the optical part by an elongated gap or space. The haptic may also be connected to the optical part by a distal connector located distal to the proximal end of the haptic and the chamber compartment.

[0083] The peripheral portion 103 may include a composite material 400 (see, for example, Figure 4A), or at least a portion of the peripheral portion 103 may be made of the composite material 400. As will be discussed in more detail in later chapters, the composite material 400 may include an energy-absorbing component 404 and a plurality of expandable elements 406 (see, for example, Figures 4A and 4B).

[0084] In some embodiments, the composite material 400 may be a plurality of space-filling portions 310 (see, for example, Figures 3A and 3B) or pistons. One or more of the space-filling portions 310 may expand in response to external energy 318 directed towards one or more space-filling portions 310 (see, for example, Figure 3C). The expansion of one or more space-filling portions 310 may reduce the volume of the surrounding fluid chamber 108 that houses one or more space-filling portions 310. At least one space-filling portion 310 may be a pad extending from either the front wall 314 or the rear wall 316 of the surrounding fluid chamber 108 (see, for example, Figure 3B).

[0085] In these and other embodiments, the composite material 400 may be a plurality of chamber expansion sections 312 (see, for example, Figure 3B) or jacks. One or more of the chamber expansion sections 312 may expand in response to external energy 318 directed towards one or more chamber expansion sections 312 (see, for example, Figure 3D). The expansion of one or more chamber expansion sections 312 may increase the volume of the surrounding fluid chamber 108 that houses one or more chamber expansion sections 312. At least one chamber expansion section 312 may be an expandable column extending from the front wall 314 to the rear wall 316 of the surrounding fluid chamber 108 (see, for example, Figure 3B).

[0086] The base power or optical / refractive power of the optical unit 102 may change in response to the external energy 318 directed at the composite material 400 (see, for example, Figures 3C and 3D). However, the base power of the optical unit 102 may not respond to, or may be insensitive to, the force applied to the peripheral portion 103 by the lens capsule when the adjustable IOL 100 is implanted in the lens capsule.

[0087] The base frequency of the optical unit 102 may change in accordance with 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 towards the composite material 400.

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

[0089] The peripheral element 136 may be located inside or installed 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 to one of the peripheral elements 136 may cause that particular peripheral element 136 to deform or expand without significantly affecting the other peripheral elements 136. For example, directing external energy 318 to one of the peripheral elements 136 may cause that particular peripheral element 136 to deform or expand without the other peripheral elements 136 undergoing similar deformation or expansion.

[0091] To change the base frequency of the optical unit 102, a pulse or a set amount of external energy 318 may be directed to one peripheral element 136. In these embodiments, an additional pulse or a set additional amount of external energy 318 may be directed to another peripheral element 136 to cause a different change in the base frequency of the optical unit 102.

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

[0093] In certain embodiments, one peripheral fluid chamber 108 may have 20 peripheral elements 136. In other embodiments, one peripheral fluid chamber 108 may have between 10 and 20 peripheral elements 136. In further embodiments, one peripheral fluid chamber 108 may have between 20 and 30 peripheral elements 136. In additional embodiments, one peripheral fluid chamber 108 may have 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 elements 138 and the second peripheral elements 140 may be arranged or installed within the same peripheral fluid chamber 108.

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

[0096] In these and other embodiments, one peripheral fluid chamber 108 may comprise at least 10 second peripheral elements 140. In other embodiments, one peripheral fluid chamber 108 may comprise 5 to 10 second peripheral elements 140 or 10 to 20 second peripheral elements 140.

[0097] In the embodiment shown in Figure 1A, one peripheral fluid chamber 108 may comprise 10 first peripheral elements 138 and 10 second peripheral elements 140. Furthermore, the adjustable IOL 100 may comprise two haptics 104, each having a haptic fluid chamber containing 10 first peripheral elements 138 and 10 second peripheral elements 140.

[0098] The first peripheral element 138 may be positioned near the second peripheral element 140 within the peripheral fluid chamber 108 (i.e., the second peripheral element 140 may be positioned deeper within the peripheral fluid chamber 108). For example, the first peripheral element 138 may be positioned closer to the fluid channel 110 connecting the optical fluid chamber 106 to the peripheral fluid chamber 108 compared to the second peripheral element 140. One reason for positioning the second peripheral element 140 (e.g., chamber expansion section 312 or jack) deeper or distaler within the peripheral fluid chamber 108 is to minimize the pressure on the optical section 102 (which may produce unwanted aberrations) because the 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 positioned closer to or in a more immediate vicinity of the fluid channel 110 than the first peripheral elements 138. In further embodiments, the second peripheral elements 140 may be interspersed with the first peripheral elements 138 so that the elements form an alternating pattern.

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

[0101] The base frequency of the optical unit 102 may change in accordance with 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 towards the peripheral element 136. For example, in response to the external energy 318 being directed towards the peripheral element 136, the fluid may flow out of the peripheral fluid chamber 108 and into the optical fluid chamber 106, or it may flow out of the optical fluid chamber 106 and return to the peripheral fluid chamber 108.

[0102] The base frequency of the optical unit 102 may change in a first direction in response to the external energy 318 directed towards the first peripheral element 138. The base frequency of the optical unit 102 may also change in a second direction, which is the opposite direction to the first direction, in response to the external energy 318 directed towards the second peripheral element 140.

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

[0104] Furthermore, for example, the base frequency of the optical unit 102 may decrease in response to the external energy 318 directed towards the second peripheral element 140. As a more specific example, the fluid in the optical fluid chamber 106 may flow into the peripheral fluid chamber 108 in response to the external energy directed towards the second peripheral element 140.

[0105] As will be discussed in more detail in later chapters, the first peripheral element 138 may be a space-filling section 310 (see, for example, Figures 3A and 3B) or a piston. The space-filling section 310 may expand in response to external energy 318 directed toward it. The expansion of the space-filling section 310 may reduce the volume of the peripheral fluid chamber 108, and as a result, fluid may move from the peripheral fluid chamber 108 to the optical fluid chamber 106.

[0106] The second peripheral element 140 may be a chamber expansion section 312 (see, for example, Figures 2B, 3A, and 3B) or a jack. The chamber expansion section 312 may expand in response to external energy 318 directed toward it. The expansion of the chamber expansion section 312 may increase the volume of the peripheral fluid chamber 108.

[0107] In some embodiments, the fluid inside 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 inside the optical fluid chamber 106, the peripheral fluid chamber 108, or a combination thereof may be silicone oil or a fluid.

[0108] The fluid inside the optical fluid chamber 106, the peripheral fluid chamber 108, or a combination thereof may be a silicone oil or fluid containing or consisting in part of diphenylsiloxane and dimethylsiloxane. In other embodiments, the silicone oil or fluid may contain or consist in part of the above in a ratio of 1 unit of diphenylsiloxane to 2 units of dimethylsiloxane. In certain embodiments, the silicone oil may contain about 20 mol% diphenylsiloxane and about 80 mol% dimethylsiloxane.

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

[0110] The fluid (e.g., silicone oil) may be index-matched to the material of the lens body used to fabricate the optical unit 102. When the fluid is index-matched to the material of the lens body, the entire optical unit 102 containing 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] Figure 1B shows that an adjustable fixed-focus IOL 100 may be implanted in the natural lens capsule after the natural lens has been removed. When implanted in the natural lens capsule, the optical portion 102 may be adapted to refract light entering the eye and reaching the retina. One or more haptics 104 (e.g., a first haptic 104A and a second haptic 104B) may engage with the lens capsule to hold the adjustable IOL 100 in a fixed position within the lens capsule.

[0112] Figure 2A is a perspective view of the adjustable 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 degree of the optical section 102 may be changed based on the fluid pressure inside the fluid-filled optical fluid chamber 106.

[0113] The shape of the optical section 102 may also change in response to the inflow of fluid into the optical fluid chamber 106. In certain embodiments, the shape of the front element 200 of the optical section 102 may change in response to the inflow and outflow of fluid into the optical fluid chamber 106. For example, the curvature of the front element 200 may increase in response to the inflow of fluid into the optical fluid chamber 106. Alternatively, for example, the curvature of the front element 200 may decrease in response to the outflow of fluid from the optical fluid chamber 106.

[0114] In other embodiments, the shape of the rear element 300 of the optical unit 102 (see, for example, Figures 3A and 3B) may change (for example, the curvature may increase or decrease) in response to the inflow and outflow of fluid into the optical fluid chamber 106. In further embodiments, both the front element 200 and the rear element 300 may deform as fluid flows into and out of the optical fluid chamber 106.

[0115] The base refractive power of the optical unit 102 may increase or decrease depending on the deformation of the front element 200, the rear element 300, or a combination thereof. Increasing the curvature of the front element 200, the rear element 300, or a combination thereof can increase the base refractive power of the optical unit 102, resulting in a better field of view for near objects. Decreasing the curvature of the front element 200, the rear element 300, or a combination thereof can decrease the base refractive power of the optical unit 102, resulting in a better field of view for far objects.

[0116] For example, the base frequency of the optical section 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 one or more first peripheral elements 138. One or more first peripheral elements 138 may expand in response to external energy 318 being directed toward the first peripheral elements 138.

[0117] Furthermore, for example, the base frequency of the optical section 102 may decrease as fluid flows out of or is drawn out of the optical fluid chamber 106, which is filled with fluid, 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 one or more second peripheral elements 140. One or more second peripheral elements 140 may expand in response to external energy 318 being directed toward the second peripheral elements 140.

[0118] Figure 2B is a perspective view of the adjustable IOL 100, with a portion of the front part of the adjustable IOL 100 removed to better depict the components within the IOL. The adjustable IOL 100 may have a peripheral portion 103 containing a plurality of peripheral elements 136 within a peripheral fluid chamber 108. For example, portions of the peripheral portion 103 may be formed as peripheral elements 136.

[0119] As shown in Figure 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 passage connecting the peripheral fluid chamber 106 to the optical fluid chamber 108 or the haptic fluid chamber. Although only a single fluid channel 110 connecting the optical fluid chamber 106 to each peripheral fluid chamber 108 is shown, in this disclosure, multiple fluid channels (e.g., two fluid channels) may connect the optical fluid chamber 106 to each peripheral fluid chamber 108.

[0120] The base frequency of the optical unit 102 may change (e.g., increase or decrease) in response to the external energy 318 directed towards the peripheral elements 136. As previously discussed, each of the peripheral elements 136 may be made of composite material 400.

[0121] As will be discussed in more detail in later chapters, each of the first peripheral elements 138 may be a space-filling section 310 (see also, for example, Figures 3A, 3B, and 3C). The space-filling section 310 may expand in response to external energy directed toward it. The expansion of the space-filling section 310 may reduce the volume of the peripheral fluid chamber 108, and as a result, fluid may move 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 section 312 (see also Figures 3B and 3D). The chamber expansion section 312 may expand in response to external energy directed toward it. The expansion of the chamber expansion section 312 may cause the peripheral fluid chamber 108 to expand, increasing its volume, which may result in fluid flowing from the optical fluid chamber 106 into or out of the peripheral fluid chamber 108.

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

[0124] In the embodiment shown in Figure 2B, the peripheral portion 103 may include a first haptic 104A and a second haptic 104B. The first haptic 104A may have a first haptic fluid chamber, and the second haptic 104B may have a second haptic fluid chamber. Each of the first and second haptic fluid chambers may be considered as one of the peripheral fluid chambers 108. In this embodiment, each of the haptic fluid chambers (for example, the first haptic fluid chamber and each of the second haptic fluid chambers) may contain or hold a fluid with a volume between approximately 0.3 μL and 0.6 μL (or approximately 0.5 μL).

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

[0126] In some embodiments, the base frequency of the optical unit 102 may vary in the positive or negative direction between approximately 0.05 diopters (D) and approximately 0.5 D in response to a pulse of external energy 318 directed towards one of the peripheral elements 136. For example, the base frequency of the optical unit 102 may vary by approximately 0.1 D in response to a pulse of external energy 318 directed towards one of the peripheral elements 136.

[0127] The change in the base frequency of the optical unit 102 may be permanent or nearly permanent. A permanent or nearly permanent change may mean that, after the change occurs, the peripheral element 136 does not return to its roughly original shape or size.

[0128] In certain embodiments, the base frequency of the optical unit 102 may vary in a positive or negative direction between approximately 1.0D and approximately 2.0D in total. In these embodiments, the variation in total frequency 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 optical fluid chambers 106, the volume of oil in those chambers, or a combination thereof.

[0129] In other embodiments, the base frequency of the optical unit 102 may vary in the positive or negative direction between a total of about 2.0D and about 3.0D. In additional embodiments, the base frequency of the optical unit 102 may vary in the positive or negative direction between a total of about 3.0D and about 5.0D. In further embodiments, the base frequency of the optical unit 102 may vary in the positive or negative direction between a total of about 5.0D and about 10.0D.

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

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

[0132] The adjustable IOL 100 implanted in the target lens capsule may have a base power between approximately 15D and approximately 30D (e.g., approximately 20D). When the adjustable IOL 100 is implanted in the target lens capsule, a clinician or healthcare professional may direct external energy 318 (e.g., laser light) to the peripheral elements 136 to increase or decrease the base power of the optical unit 102.

[0133] For example, the adjustable IOL 100 may have a base power of approximately 20D when implanted in the eye of the subject. If a power correction is desired, such as increasing the power of the lens, the clinician or healthcare professional may gradually increase the base power of the optical unit 102 between approximately +0.1D and +0.2D, directing the external energy 318 to each of the first peripheral elements 138 so that the final base power is between approximately 21D (a total change of +1.0D) and 22D (a total change of +2.0D).

[0134] In other embodiments, a clinician or healthcare professional may gradually increase the base power of the optical unit 102 between approximately +0.1D and +0.2D, directing the external energy 318 to each of the first peripheral elements 138 such that the final base power is between approximately 22D (a total change of +2.0D) and 25D (a total change of +5.0D).

[0135] As another example, the adjustable IOL 100 may have a base power of approximately 25D when implanted in the target eye. If a power correction that reduces the lens power is desired, the clinician or healthcare professional may gradually decrease the base power of the optics 102 between approximately -0.1D and -0.2D, directing the external energy 318 to each of the second peripheral elements 140 such that the final base power is between approximately 24D (a total change of -1.0D) and 23D (a total change of -2.0D).

[0136] In other embodiments, a clinician or healthcare professional may gradually decrease the base power of the optical unit 102 between approximately -0.1D and -0.2D, directing the external energy 318 to each of the second peripheral elements 140 such that the final base power is between approximately 23D (a total change of -2.0D) and 20D (a total change of -5.0D).

[0137] In some embodiments, the adjustable IOL 100 may have optical sensitivity to fluid movement between approximately 100 nL and 200 nL (e.g., approximately 150 nL) per diopter. That is, when fluid between approximately 100 nL and 200 nL (e.g., approximately 150 nL) moves between the peripheral fluid chamber 108 and the optical fluid chamber 106, the base degree of the optical section 102 may change by approximately 1.0 D. In a more specific example, when fluid between approximately 100 nL and 200 nL (e.g., approximately 150 nL) flows from the peripheral fluid chamber 108 to the optical fluid chamber 106 as a result of external energy 318 being directed to the first peripheral element 138, the base degree of the optical section 102 may increase by +1 D. Furthermore, when the external energy 318 is directed towards the second peripheral element 140, resulting in the outflow or withdrawal of fluid between approximately 100 nL and 200 nL (for example, approximately 150 nL) from the optical fluid chamber 106 to the peripheral fluid chamber 108, the base degree of the optical unit 102 may decrease by -1.0D.

[0138] In certain embodiments, each of the peripheral fluid chambers 108 may comprise 10 first peripheral elements 138 and 10 second peripheral elements 140. In these embodiments, by directing external energy 318 towards each of the first peripheral elements 138 or each of the second peripheral elements 140, fluid between approximately 10 nL and 20 nL (e.g., approximately 15 nL) may be moved or exchanged between the optical fluid chamber 106 and the peripheral fluid chamber 108. For example, by directing external energy 318 towards one of the first peripheral elements 138, the first peripheral element 138 may expand, reducing the volume of the peripheral fluid chamber 108 housing the first peripheral element 138. This may cause fluid between approximately 10 nL and 20 nL (e.g., approximately 15 nL) to flow from the peripheral fluid chamber 108 into the optical fluid chamber 106. Furthermore, for example, by directing external energy 318 towards one of the second peripheral elements 140, the second peripheral element 140 may expand, increasing the volume of the peripheral fluid chamber 108 that houses the second peripheral element 140. This may cause fluid between approximately 10 nL and approximately 20 nL (for example, approximately 15 nL) to flow from the optical fluid chamber 106 into the peripheral fluid chamber 108.

[0139] The adjustable IOL 100 may have a base power of the optical section 102 that changes between approximately 0.05D and 0.5D as a result of fluid exchange or movement. More specifically, when approximately 15 nL of fluid is moved or exchanged between the optical fluid chamber 106 and the peripheral fluid chamber 108, the base power of the optical section 102 may change by approximately 0.1D.

[0140] Figure 3A is a cross-sectional view of the adjustable IOL 100 along AA in Figure 2A. The optical section 102 may comprise a forward element 200 and a rear element 300. An optical fluid chamber 106 filled with fluid may be defined between the forward element 200 and the rear element 300.

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

[0142] As will be discussed in detail in later chapters, the adjustable IOL 100 may have a lens surface profile or pattern (e.g., an optical splitting lens profile or pattern) defined on its optical outer surface. For example, the lens surface profile may comprise a diffraction surface profile or pattern, or a transport change structure or profile. The lens surface profile or pattern allows the adjustable IOL 100 to adapt to different use cases, such as providing a focus for one specific distance (short focus) or providing a focus for multiple distances. For example, the lens surface profile or pattern defined on the optical outer surface may configure the adjustable IOL 100 as an adjustable short-focus IOL, an adjustable multifocal IOL (e.g., an adjustable bifocal or trifocal IOL), or an adjustable extended depth of field (EDOF) IOL.

[0143] The optical section 102 may deform or bend in response to the inflow and outflow of fluid into the optical fluid chamber 106. In some embodiments, the front element 200 may deform or bend (e.g., change its curvature) as fluid flows into and out of the optical fluid chamber 106. In other embodiments, the rear element 300 may deform or bend (e.g., change its curvature) as fluid flows into and out of the optical fluid chamber 106. In further embodiments, both the front element 200 and the rear element 300 may deform or bend as fluid flows into and out of the optical fluid chamber 106. The base degree of the optical section 102 may change in response to the deformation caused by the deformation components of the deformable optical section 102 (e.g., the front element 200, the rear element 300, or a combination thereof).

[0144] Part of the optical section 102 may be made of a deformable or flexible material. In some embodiments, part of the optical section 102 may be made of a deformable or flexible polymer material. For example, the front element 200, the rear element 300, or a combination thereof may be made of a deformable or flexible polymer material in part. At least a portion of the peripheral section 103, such as one or more haptics 104 (e.g., a first haptic 104A, a second haptic 104B, or a combination thereof), may be made of the same deformable or flexible material as the optical section 102. In other embodiments, part of one or more haptics 104 may be made of a different material from the optical section 102.

[0145] In some embodiments, portions of the optical section 102 and peripheral section 103 that are not made of the composite material 400 may include a polymer containing a copolymer mixture or a crosslinked copolymer, or a portion of them may be made of such polymers.

[0146] For example, in some embodiments, the copolymer mixture may include alkyl acrylates or methacrylates, fluoroalkyl (meth)acrylates, and phenylalkyl acrylates, or combinations thereof. It should be considered and understood by those skilled in the art that these types of acrylic crosslinked copolymers are generally copolymers of multiple acrylates or methacrylates. As used herein, the term “acrylate” means acrylate or methacrylate unless otherwise specified.

[0147] For example, the optical portion 102 and peripheral portion 103 that are not made of composite material 400 may be made 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 contain about 3% to 20% (wt%) of an alkyl acrylate, about 10% to 35% (wt%) of a fluoroalkyl acrylate, and about 50% to 80% (wt%) of a phenylalkyl acrylate. In some embodiments, the crosslinked copolymer may contain, or consist in part of, n-butyl acrylate as the alkyl acrylate, trifluoroethyl methacrylate as the fluoroalkyl acrylate, and phenylethyl acrylate as the phenylalkyl acrylate. More specifically, the crosslinked copolymer may contain about 3% to 20% (wt%) (e.g., between about 12% and 16%) of n-butyl acrylate, about 10% to 35% (wt%) (e.g., between about 17% and 21%) of trifluoroethyl methacrylate, and about 50% to 80% (wt%) (e.g., between about 64% and 67%) of phenylethyl acrylate.

[0149] The final composition of the crosslinked copolymer may also contain a crosslinking agent such as ethylene glycol dimethacrylate (EGDMA). For example, the final composition of the crosslinked copolymer may also contain a crosslinking agent (e.g., EGDMA). The final composition of the crosslinked copolymer may also contain initiators (e.g., Percadox 16, camphaquinone, 1-phenyl-1,2-propanedione, and 2-ethylhexyl-4-((dimentylamino)benzoate)) and UV absorbers.

[0150] In some embodiments, the refractive index of the material used to fabricate the optical unit 102 may be between approximately 1.48 and approximately 1.53. In certain embodiments, the refractive index of the material used to fabricate the optical unit 102 may be between approximately 1.50 and approximately 1.53.

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

[0152] In certain embodiments, the reactive blue light absorber mixture may be one of those described in U.S. Patent No. 5,470,932, U.S. Patent No. 8,207,244, and U.S. Patent No. 8,329,775, the contents of which are incorporated herein by reference. For example, the blue light absorber dye may be N-2-[3-(2'-methylphenylazo)-4-hydroxyphenyl]ethyl methacrylamide. If present, the blue light absorber 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 adjustable IOL along BB in 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 approximately 0.3 mm and 1.0 mm. In yet another embodiment, the chamber height 302 may be between approximately 1.0 mm and 1.5 mm.

[0155] Figure 3B also shows that the side surface 111 of the optical unit 102 may have a side height 304 (measured from front to back). In some embodiments, the side height 304 may be between approximately 0.50 mm and 0.75 mm. For example, the side height 304 may be between approximately 0.65 mm. In other embodiments, the side height 304 may be between approximately 0.40 mm and 0.50 mm or between approximately 0.75 mm and 1.25 mm.

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

[0157] As shown in Figure 3B, the side height 304 of the side surface 111 of the optical section 102 may be greater than the peripheral height 306. For example, when the peripheral section 103 includes one or more haptics, the thickness or height (measured from front to back) of the haptics may be less than the thickness or height of the optical section 102 along all parts of the optical section 102.

[0158] In some embodiments, the peripheral height 306 or thickness (measured from front to back) may be generally uniform so that no part of the peripheral 103 is higher or thicker than any other part of the peripheral 103. When the peripheral 103 comprises multiple haptics 104, all haptics 104 may have the same height or thickness.

[0159] Figure 3B also shows that the front element 200 may have a front element thickness 308 (measured from front to rear). In some embodiments, the front element thickness 308 may be between approximately 0.15 mm and approximately 0.25 mm. For example, the front element thickness 308 may be approximately 0.20 mm.

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

[0161] As a more specific example, the space-filling section 310 may be implemented as an expandable pad extending from at least one of the chamber front wall 314 and the chamber rear wall 316. The base frequency of the optical section 102 may increase in response to external energy 318 being directed towards the space-filling section 310, and as a result, the fluid moves out of the surrounding fluid chamber 108 due to the increase in the volume of the space-filling section 310.

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

[0163] As a more specific example, the chamber expansion section 312 may be implemented as an expandable support extending from the front wall 314 to the rear wall 316 of the chamber. The expansion of the expandable support may increase the volume of the surrounding fluid chamber 108. The base frequency of the optical section 102 may decrease in response to the external energy 318 being directed towards the expandable support, resulting in the expansion of the chamber expansion section 312 and an increase in the volume of the surrounding fluid chamber 108.

[0164] Figure 3C shows that external energy 318 may be directed towards the space-filling portion 310 of the adjustable IOL 100 to induce deformation of the space-filling portion 310.

[0165] The first peripheral element 138 may be made of composite material 400. The first peripheral element 138 may be located inside the peripheral fluid chamber 108.

[0166] In some embodiments, the composite material 400 used to fabricate the first peripheral element 138 may be cured inside the peripheral fluid chamber 108 together with the remaining material constituting the peripheral fluid chamber 108. In these embodiments, the first peripheral element 138 may be cured in situ inside the peripheral fluid chamber 108.

[0167] In other embodiments, the first peripheral element 138 may be bonded to the inner wall or surface of the peripheral fluid chamber 108 using an adhesive. The adhesive may be cured to fix the first peripheral element 138 to the inner wall or surface of the peripheral fluid chamber 108.

[0168] The first peripheral element 138 may be a space-filling portion 310. In some embodiments, the space-filling portion 310 may be implemented as an expandable disc-shaped pad (see, for example, Figures 2B, 3A, and 3B). Although the space-filling portion 310 is shown in the figures as a flat cylinder or disk, in this specification it is considered that the space-filling portion 310 may be a sphere, hemisphere, oval, ellipsoid, cuboid, or other polyhedron, or a combination thereof.

[0169] The space-filling portion 310 may extend from either the front wall 314 or the rear wall 316 of the chamber, and may be bonded to or connected to them. In some embodiments, if the peripheral fluid chamber 108 comprises a plurality of space-filling portions 310, at least one of the space-filling portions 310 may extend from, bond to, or be connected to the front wall 314 of the chamber, and another space-filling portion 310 may extend from, bond to, or be connected to the rear wall 316 of the chamber.

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

[0171] As shown in Figure 3C, the space-filling section 310 may expand in response to bursts of external energy 318 directed towards the space-filling section 310. The expansion of the space-filling section 310 may reduce the internal volume of the peripheral fluid chamber 108, and fluid may move from the peripheral fluid chamber 108 to the optical fluid chamber 106. The base frequency of the optical section 102 may increase in response to the external energy 318 directed towards the space-filling section 310.

[0172] Figure 3C shows that the space-filling section 310 may be sized such that it does not come into contact with the interior wall 320. Figure 3C also shows that even when external energy 318 is directed towards the space-filling section 310 and it expands, a separation distance 322 or gap may be maintained between the space-filling section 310 and the interior wall 320, respectively. This ensures that the expanded space-filling section 310 does not expand the surrounding fluid chamber 108, nor does it expand the surrounding fluid chamber 108 to the extent that it cancels out the volume reduction effect of the expansion of the space-filling section 310. Furthermore, since the height of the space-filling section 310 from front to rear is much smaller than the chamber height 302, the expanded space-filling section 310 does not come into contact with the front wall 314 of the chamber.

[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 approximately 488 nm and approximately 650 nm. For example, the laser light may be green laser light. The green laser light may have a wavelength between approximately 520 nm and approximately 570 nm. In one example, in an embodiment, the external energy 318 may be green laser light having a wavelength of approximately 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 certain embodiments, the laser beam may be a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. More specifically, the laser beam may be a pulsed Nd:YAG laser operating in Q-switching mode with its 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 a laser may have a wavelength between approximately 1030 nm and 1064 nm.

[0178] As will be discussed in more detail in later chapters, if the external energy 318 is light energy, the energy-absorbing component 404 (see Figure 4A) in the composite material 400 may absorb or capture the light energy to convert it into thermal energy and transport the thermal energy to the expandable element 406 (see Figures 4A and 4B) in the composite material 400 to expand the expandable element 406.

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

[0180] Figure 3D shows that external energy 318 may be directed towards the second peripheral element 140 of the adjustable IOL 100 in order to induce deformation of the second peripheral element 140.

[0181] The second peripheral element 140 may be made of a composite material 400. The second peripheral element 140 may be located inside the peripheral fluid chamber 108.

[0182] In some embodiments, the composite material 400 used to fabricate the second peripheral element 140 may be cured inside the peripheral fluid chamber 108 together with the remaining material constituting the peripheral fluid chamber 108. In these embodiments, the second peripheral element 140 may be cured in situ inside the peripheral fluid chamber 108.

[0183] In other embodiments, the second peripheral element 140 may be bonded to the inner wall or surface of the peripheral fluid chamber 108 using an adhesive. The adhesive may be cured to fix the second peripheral element 140 to the inner wall or surface of the peripheral fluid chamber 108.

[0184] The second peripheral element 140 may be a chamber expansion section 312. In some embodiments, the chamber expansion section 312 may be implemented as an expandable support extending from the front wall 314 of the chamber to the rear wall 316 (see, for example, Figure 3B). Although the figure shows the chamber expansion section 312 as a generally elongated cylinder, in this specification, the chamber expansion section 312 may be generally an elongated oval, elongated ellipsoid, elongated cuboid, or other polyhedron, cone, frustocone, or a combination thereof.

[0185] As a more specific example, the chamber expansion section 312 may be implemented as an expandable support extending from the front wall 314 to the rear wall 316 of the chamber. The expansion of the expandable support may increase the volume of the surrounding fluid chamber 108 by pushing one or both of the interior wall 314 and the rear wall 316 to increase the chamber height 302. The base degree of the optical section 102 may decrease in accordance with the external energy 318 directed towards the expandable support.

[0186] As shown in Figure 3D, the chamber expansion section 312 may expand in response to a burst of external energy 318 directed towards the chamber expansion section 312. The expansion of the chamber expansion section 312 may increase the volume of the surrounding fluid chamber 108, and as a result, fluid may flow out from the optical fluid chamber 106 into the surrounding fluid chamber 108. The base frequency of the optical section 102 may decrease in response to the external energy 318 directed towards the chamber expansion section 312.

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

[0188] Figure 3D shows that the chamber expansion section 312 may be sized such that it does not come into contact with the inner chamber wall 320 (even during expansion). This ensures that the expanded chamber expansion section 312 expands the surrounding fluid chamber 108 from front to back, temporarily without applying pressure to the inner chamber wall 132 in the radial direction (which would be converted into pressure applied to the side of the optical section 102, resulting in an unintended effect on the optical degree).

[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 towards one of the chamber expansion sections 312. In these and other embodiments, the base frequency of the optical section 102 may change by approximately -0.1 D in response to one of the chamber expansion sections 312 expanding as a result of the external energy 318 being directed towards it.

[0190] Figures 1A, 1B, 2B, and 5 show each peripheral fluid chamber 108 (e.g., each haptic fluid chamber) having both a space-filling section 310 and a chamber expansion section 312. However, in this disclosure, each peripheral fluid chamber 108 may also have only a space-filling section 310 or only a chamber expansion section 312, and this should be understood by those skilled in the art.

[0191] One technical problem faced by the applicant is how to provide clinicians or other healthcare professionals with the ability to fine-tune the optical intensity of an implanted IOL in both directions (i.e., to provide clinicians with the ability to increase or decrease the optical intensity of an implanted IOL after surgery). One solution discovered by the applicant is a peripheral element disclosed herein, which includes, for example, space-filling and chamber-expanding sections made of composite materials. In a more specific example, each peripheral fluid chamber (or haptic fluid chamber) may comprise multiple space-filling sections, chamber-expanding sections, or both space-filling and chamber-expanding sections. Each peripheral element may be configured such that the optical section of the tunable IOL changes by about 0.1 D in response to bursts of external energy directed toward the peripheral element.

[0192] Figure 4A is a schematic representation of a composite material 400 comprising a composite substrate 402, an energy-absorbing component 404, and a plurality of expandable elements 406. As previously discussed, at least a portion of the peripheral portion 103 or a component of the peripheral portion 103 may be made of the composite material 400.

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

[0194] In one embodiment, the composite substrate 402 may include a methacrylate-functional or methacrylate-functional crosslinkable polymer and a reactive acrylic monomer diluent containing 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., high ADMA) or softness (i.e., high SR313) of the cured composite material 400 can be controlled. The methacrylate-functional or methacrylate-functional crosslinkable polymer may be made using a crosslinkable polymer precursor composition.

[0195] The crosslinkable polymer precursor composition may contain the same copolymer mixture used in the production of the optical unit and the haptic.

[0196] The copolymer mixture may contain alkyl acrylates or methacrylates (e.g., n-butyl acrylate), fluoroalkyl (meth)acrylates (e.g., trifluoroethyl methacrylate), and phenylalkyl acrylates (e.g., phenylethyl acrylate). For example, the copolymer mixture may contain, for example, about 41% to about 45% (wt%) of n-butyl acrylate, for example, about 20% to about 24% (wt%) of trifluoroethyl methacrylate, and for example, about 28% to about 32% (wt%) of phenylethyl acrylate. The crosslinkable polymer precursor composition may contain, or be composed in part of, the copolymer mixture, a hydroxyl-functionalized acrylic monomer (e.g., HEA), and a photopolymerization initiator (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 contain about 50% to about 65% (e.g., about 55% to about 60%) (wt%) of the (as described above) methacrylate-functional or methacrylic-functional crosslinkable polymer, about 32% to about 38% (e.g., about 32.70%) (wt%) of the reactive acrylic monomer diluent lauryl methacrylate (SR313), and about 5% to about 9% (e.g., about 7.30%) (wt%) of the reactive acrylic monomer diluent adamantry methacrylate (ADMA).

[0198] Table 1 below shows examples of the composition of composite material 400. Table 1 Composition of Composite Materials (wt%) [Table 1]

[0199] The composite material 400 can be prepared by several operations. The first operation may include preparing an uncolored composite substrate 402. The second operation may include mixing the composite substrate 402 with an energy-absorbing component 404, an expandable element 406, and one or more initiators such as a photopolymerization initiator, a thermal initiator, or a combination thereof. The third operation may include placing the uncured composite material 400 at a desired location within the peripheral portion 103 (e.g., peripheral fluid chamber 108 and / or haptic 104) and curing the composite material 400 in place.

[0200] For example, the uncolored composite substrate 402 may be mixed with an energy-absorbing component 404 such as a dye (e.g., Disperse Red 1) or pigment (graphitized carbon black). The energy-absorbing component 404 will be discussed in more detail later.

[0201] In some embodiments, the expandable element 406 may account for about 5.0% to about 15.0% by weight in the final composition of the composite material 400. More specifically, the expandable element 406 may account for about 8.0% to about 12.0% (e.g., about 10.0%) by weight in the final composition of the composite material 400 (see Table 1). In these and other embodiments, the energy-absorbing component 404 may account for about 0.044% to about 0.44% (or about 0.55%) by weight in 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 account for about 1.30% by weight of the final composition of composite material 400 (see, for example, Table 1). In addition, composite material 400 may also contain a thermal initiator. The thermal initiator may account for about 1.00% by weight of the final composition of composite material 400 (see, for example, 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 Parkadox.

[0203] In some embodiments, the energy-absorbing component (e.g., a dye or pigment) may be located adjacent to or placed on the uncolored composite substrate 402. In this embodiment, the energy-absorbing component 404 may absorb external energy 318 (e.g., laser energy), convert the energy into heat, or conduct energy to the composite substrate 402 to cause it to expand. One additional advantage of this method is that the energy-absorbing component 404 can be fabricated more independently and can be more easily targeted by a clinician or surgeon to deliver laser or other external energy 318.

[0204] Figure 4B shows that the expandable element 406 may be an expandable microsphere comprising an expandable thermoplastic resin shell 408 and a foaming agent 410 contained within the expandable thermoplastic resin shell 408. The microsphere may expand such that the diameter 412 of at least one of the microspheres increases to about twice 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 twice 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 to or directed to the composite material 400, or to energy being transmitted to or sent to the microsphere, the diameter 412 of the microsphere may increase to about 40 μm.

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

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

[0207] The expandable element 406 may contain different amounts of blowing agent 410. For example, some expandable elements 406 may contain more or a greater amount of blowing agent (e.g., more expandable gas) so that such expandable element 406 can expand more, and as a result the composite material 400 containing the expandable element 406 can expand more.

[0208] Figure 4B shows that each expandable element 406 may include a thermoplastic shell 408. Figure 4B also shows that the thickness of the thermoplastic shell 408 may change as the size of the expandable element 406 increases. More specifically, it shows that the thickness of the thermoplastic shell 408 may decrease as the size of the expandable element 406 increases. For example, if the expandable element 406 is an expandable microsphere, the thickness of the thermoplastic shell 408 (i.e., the radial thickness) may decrease as the diameter 412 of the expandable microsphere 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 resin shell 408 of the expandable microsphere may have a thickness of about 2.0 μm. In response to external energy being applied to or directed to the composite material 400, or to energy being transmitted to or sent to the microsphere, the diameter 412 of the microsphere may increase to about 40 μm (and its volume may expand between about 10 and 50 times), and the thickness of the microsphere's shell may decrease to about 0.1 μm.

[0210] In Figures 4A and 4B, the expandable element 406 is shown as a sphere or microsphere; however, in this disclosure, the expandable element 406 may be formed as a generally oval, ellipsoidal, rectangular parallelepiped, or other polyhedron, or a combination thereof.

[0211] In some embodiments, the thermoplastic resin shell 408 may be made partly of a nitrile or acrylonitrile copolymer. For example, the thermoplastic resin shell 408 may be made partly of acrylonitrile, styrene, butadiene, methyl acrylate, or a combination thereof.

[0212] As previously discussed, the expandable element 406 may account for between approximately 8.0% and approximately 12% of the weight of the final composition of the composite material 400. The expandable element 406 may account for approximately 10% of the weight of the final composition of the composite material 400.

[0213] The expandable element 406 may be dispersed or distributed in a composite substrate 402 that forms the majority of the composite material 400. The composite substrate 402 may function as a base for holding or supporting the expandable element 406. The composite material 400 may expand in response to the expansion of the expandable element 406 (e.g., microspheres made of thermoplastic resin). For example, the volume of the composite material 400 may increase in response to the expansion of the expandable element 406.

[0214] The composite material 400 also contains 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 Orange 1), a yellow azo dye such as Disperse Yellow (e.g., Disperse Yellow 1), a blue azo dye such as Disperse Blue (e.g., Disperse Blue 1), or a combination thereof.

[0216] In additional embodiments, the energy-absorbing colorant may be a dye or contain a dye. For example, the energy-absorbing colorant may be graphitized carbon black or contain graphitized carbon black as a dye.

[0217] Similar to the expandable element 406, the energy-absorbing component 404 may be dispersed or distributed in the composite substrate 402 that forms the majority of the composite material 400. The composite substrate 402 may function as a base for holding or supporting the expandable element 406 and the energy-absorbing component 404.

[0218] As previously discussed, the energy-absorbing component 404 may occupy between approximately 0.025% and 1.0% (or more specifically, between approximately 0.045% and 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 Thread 1), the energy-absorbing component 404 may occupy between approximately 0.45% and 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 types of dyes, the energy-absorbing component 404 may occupy between approximately 0.025% and 0.045% of the weight of the final composition of the composite material 400.

[0219] The energy-absorbing component 404 (e.g., azo dye, graphitized carbon black, or a combination thereof) may absorb or capture external energy directed at or to the composite material 400. The energy-absorbing component 404 may absorb or capture external energy and convert or transport the energy to the expandable element 406 as thermal energy or heat.

[0220] When thermal energy is transmitted to or sent to the expandable element 406, the thermoplastic resin shell 408 may soften and begin to flow out. In response to the transmission or sending of thermal energy to the expandable element 406, the thermoplastic resin shell 408 of the expandable element 406 may shrink or begin to decrease in thickness. As the thermoplastic resin shell 408 softens and begins to decrease in thickness, the foaming agent 410 in the expandable element 406 may expand. The foaming agent 410 may also expand in response to the transmission or sending of thermal energy or heat to the expandable element 406. The expansion of the foaming agent 410 may cause the expandable element 406 (e.g., a thermoplastic resin microsphere) to expand or increase in volume. This ultimately causes the composite material 400 to expand or increase in volume.

[0221] The composite material 400 may expand isotropically or increase in volume so that it expands in all directions. Such isotropic expansion may be utilized to produce expansion or material displacement in a specific direction by positioning or locating the composite material 400 at a specific position within the peripheral fluid chamber 108 along the haptic(s) 104 or optical section 102 of the adjustable IOL 100.

[0222] As will be discussed in more detail in later chapters, in some embodiments the external energy may be light energy, and the energy-absorbing component 404 may absorb or capture the light energy directed to the composite material 400 and convert or transport the light energy to the expandable element 406 as thermal energy or heat. The foaming agent 410 within the expandable element 406 may expand or be activated in response to the thermal energy or heat. The expandable element 406 and ultimately the composite material 400 may expand or increase in volume in response to this light energy being directed to the composite material 400.

[0223] The deformation (e.g., volume increase) of the expandable element 406 may be permanent or nearly permanent. Permanent or nearly permanent means that after the change (e.g., volume increase) occurs, the expandable element 406 does not return to its approximately original shape or size. Consequently, 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 nearly permanent. As will be discussed in more detail in later chapters, the above means that structural changes made to the adjustable IOL 100 as a result of external energy or stimulation directed at the composite material 400 integrated within the adjustable IOL 100 may be permanent or nearly permanent.

[0224] The thermoplastic resin shell 408 of the expandable element 406 may harden again when external energy is no longer directed towards the composite material 400. For example, the thermoplastic resin shell 408 may harden again when the temperature around the expandable element 406 drops below a certain threshold. For example, the thermoplastic resin shell 408 of the expandable microsphere may harden when light energy is no longer directed towards the composite material 400. After the thermoplastic resin shell 408 hardens, the expandable element 406 is locked in its new size and post-expansion configuration.

[0225] If the energy-absorbing component 404 is a dye or an energy-absorbing colorant such as 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 Thread 1 which has red color, at least a portion of the composite material 400 containing the energy-absorbing component 404 may be red. Furthermore, if the energy-absorbing component 404 is graphitized carbon which has black color, at least a portion of the composite material 400 containing the energy-absorbing component 404 may be black. Although two colors (e.g., red and black) are mentioned in this disclosure, it is conceivable to those skilled in the art that other types of energy-absorbing colorants having other colors, such as energy-absorbing yellow, orange, or blue dyes or materials, may also be used.

[0226] If at least a portion of the adjustable IOL 100 consists of a composite material 400 containing an energy-absorbing colorant, the color of the energy-absorbing colorant may be visually perceptible to a clinician or other healthcare professional. When the adjustable IOL 100 is implanted in the patient's eye, the color of the energy-absorbing colorant may be visually perceptible to a clinician or other healthcare professional. For example, the composite material 400 may contain Disperse Red 1, which acts as an energy-absorbing colorant. In this example, when the adjustable IOL 100 is implanted in the patient's eye, at least a portion of the adjustable IOL 100 may appear red to a clinician or other healthcare professional.

[0227] The color of the energy-absorbing colorant may allow a clinician or other healthcare professional to detect or determine the location or position of the composite material 400 within the adjustable IOL 100. The color of the energy-absorbing colorant may also allow a clinician or other healthcare professional to determine where to direct the external energy or stimulus for adjusting within the adjustable IOL 100.

[0228] One technical challenge faced by the applicant is how to integrate the composite material into the peripheral portion (e.g., haptic) of the adjustable IOL so that it adheres to the materials used for the rest of the adjustable IOL and is largely fixed in a specific position within the peripheral portion. One solution discovered by the applicant and disclosed herein is a unique composition of composite material 400 that incorporates the same copolymer mixture used to fabricate the rest of the lens. By designing the adjustable IOL in this way, composite material 400 becomes compatible with the remaining materials used to constitute the peripheral portion and remains largely in place without shifting.

[0229] Another technical problem faced by the applicant is how to ensure that adjustments made to an adjustable IOL persist long after the adjustment procedure is complete. One solution discovered by the applicant and disclosed herein is to promote the expansion of a composite material containing a foaming agent within a thermoplastic resin shell, which is partly composed of expandable microspheres. Depending on whether external energy is directed to or applied to the composite material (which may result from the transmission or application of heat or thermal energy to the expandable microspheres), the thermoplastic resin shell may soften (and the thickness of the thermoplastic resin shell may decrease). The foaming agent within the thermoplastic resin shell may expand as the thermoplastic resin shell softens. The expansion of the foaming agent may cause the microspheres to expand, and as a result, the composite substrate, which functions as the majority of the composite material, may expand. Even when external energy is no longer applied to the composite material, the expandable microspheres may maintain their new, enlarged or expanded configuration.

[0230] Furthermore, the energy-absorbing component of the composite material 400 may capture or absorb relatively harmless external energy or stimuli directed at the composite material, and may convert or transport the external energy into energy that can cause the thermoplastic resin microspheres to expand. By designing the adjustable IOL 100 in this way, relatively harmless energy or stimuli (e.g., light energy) can be used to induce a permanent change in the shape or size of at least some part of the adjustable IOL 100. This permanent change in the shape or size of the adjustable IOL 100 may have a continuous effect on the optical parameters of the lens, including, for example, the base power.

[0231] Figure 5 is a plan view of another embodiment of the adjustable fixed-focus IOL 100, with a portion of the front part of the adjustable IOL 100 removed to better depict the components within the IOL. As shown in Figure 5, the first peripheral element 138 may consist of a first composite material containing a first energy-absorbing component having a first color, and the second peripheral element 140 may consist of a second composite material containing 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 healthcare professional, thereby enabling the clinician or other healthcare professional 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. More specifically, 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 a dye such as graphitized carbon black (which exhibits a black color), or may contain one. 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 a dye such as graphitized carbon black (which exhibits a black color), or may contain one. 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 a portion of the second composite material consist of the same energy-absorbing component or colorant, but these components or colorants may be present in different amounts or weight percentages.

[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 toward 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 toward the second composite material.

[0237] By designing the adjustable IOL 100 in this way, clinicians or other healthcare professionals can use the different colors of the composite material as guides or markers to direct external energy or stimuli to different target sites along the peripheral portion 103. Furthermore, the composite material with different colors may also serve as an indicator or visual cue for where to direct external energy or stimuli to cause a specific change in the base power of the optical portion 102.

[0238] For example, the adjustable IOL 100 may be configured such that the base frequency of the adjustable IOL 100 is adjustable by a first method (e.g., the base frequency is increaseable), which is to direct or strike an external energy onto a first peripheral element 138 made of a first composite material (having a first color). The base frequency of the adjustable IOL 100 may also be adjusted by a second method (e.g., the base frequency is decreaseable), which is to direct or strike an additional burst or pulse of external energy onto a second peripheral element 140 made of a second composite material (having a second color different from the first color).

[0239] Figure 6 is a plan view of another embodiment of the adjustable IOL 100 having an optical section 102 with an optical splitting lens surface profile 600. To highlight the optical section 102, the peripheral portion 103 of the adjustable IOL 100 is shown with a dashed line.

[0240] One technical challenge faced by the applicant is how to design a fluid-filled IOL that may be used by patients seeking different types of visual aids. One solution discovered by the applicant is the adjustable IOL disclosed herein, in which different lens surface profiles having both rotational symmetry and a toric profile for astigmatism correction can be defined on the optical outer surface (e.g., the front optical surface) of the optical part, and the same adjustable IOL structure can be adapted as an adjustable short-focus IOL, adjustable bifocal IOL, adjustable trifocal IOL, or adjustable EDOF IOL in both toric and non-toric shapes.

[0241] As shown in Figure 6, the optical section 102 of the adjustable IOL 100 may have an optical segmentation lens surface profile 600 defined on the lens surface of the optical section 102. In some embodiments, the optical segmentation lens surface profile 600 may have a central diffraction region or structure comprising a plurality of diffraction regions or steps. In these, and other embodiments, the diffraction regions may decrease radially outward such that the width of the regions at the periphery of the lens is smaller than the width of the regions near the center of the lens.

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

[0243] In some embodiments, the optical splitting lens surface profile 600 may split light into two focal points (for example, to obtain near and far fields of view). In these embodiments, the adjustable IOL 100 may be considered as an adjustable bifocal IOL or a non-adjustable fluid-adjustable bifocal IOL. In these embodiments, even if the optical splitting lens surface profile 600 can split light into two focal points, each focal point is fixed, and the fluid-adjustable bifocal IOL may be considered non-adjustable.

[0244] The light-splitting lens surface profile 600 may also split light into three focal points (for example, to obtain near, intermediate, and far fields of view). In these embodiments, the adjustable IOL 100 may be considered as an adjustable trifocal IOL or a non-adjustable fluid-adjustable trifocal IOL.

[0245] In other embodiments not shown in Figure 6, the optical section 102 of the adjustable IOL 100 may have a uniformly curved (e.g., spherical) lens surface or an aspherical lens surface that provides the ability to focus to a single distance. In these embodiments, the adjustable IOL 100 may be considered as an adjustable single-focus IOL or a non-adjustable fluid-adjustable single-focus IOL.

[0246] In additional embodiments not shown in Figure 6, the optical section 102 of the adjustable 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 adjustable IOL 100 may be considered an adjustable depth of focus extension (EDOF) IOL or a non-adjustable fluid adjustable EDOF IOL.

[0247] In this specification, it is considered that the unique peripheral portion 103 disclosed herein may be compatible with optical portions 102 having various lens surface profiles. Accordingly, the focusing ability or focal length provided by such lens surface profiles may be adjusted by directing external energy (e.g., laser light) to the peripheral element 136 made of composite material 400 within the peripheral portion 103.

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

[0249] Figure 7 shows one embodiment of a method 700 for adjusting IOL 100 postoperatively. Method 700 may also include increasing the base degree of IOL 100 by directing external energy 318 postoperatively to a composite material 400 which is a space-filling portion 310 located within a peripheral fluid chamber 108 defined within the peripheral portion 103 of IOL 100 in operation 702. Method 700 may also include decreasing the base degree by directing external energy 318 to another example of the composite material 400 which is a chamber expansion portion 312 located within the peripheral fluid chamber 108 in operation 704.

[0250] Figure 8 shows another embodiment of method 800 for postoperative adjustment of IOL 100. Method 800 may include adjusting the base degree of IOL 100 by directing pulses of external energy 318 postoperatively to a first peripheral element 138 in a peripheral fluid chamber 108 defined within the peripheral portion 103 of IOL 100 in operation 802. Method 800 may also include further adjusting the base degree by directing additional pulses of external energy 318 to a second peripheral element 140 in the peripheral fluid chamber 108 in operation 804.

[0251] For example, the first peripheral element 138 may be a space-filling section 310, and by directing external energy 318 towards the space-filling section 310, the space-filling section 310 expands, the volume of the peripheral fluid chamber 108 decreases, and the fluid moves from the peripheral fluid chamber 108 to the optical fluid chamber 106 (as a result, the base frequency of the optical section 102 increases). The second peripheral element 140 may be a chamber expansion section 312, and by directing external energy 318 towards the chamber expansion section 312, the chamber expansion section 312 expands, the volume of the peripheral fluid chamber 108 increases, and the fluid moves from the optical fluid chamber 106 to the peripheral fluid chamber 108 (as a result, the base frequency of the optical section 102 decreases).

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

[0253] Figure 9 shows yet another embodiment of method 900 for adjusting IOL 100 postoperatively. Method 900 may include adjusting the base degree of IOL 100 by directing a pulse of external energy to a first peripheral element 138 in a first peripheral fluid chamber 108 (e.g., a first haptic fluid chamber) defined within the peripheral portion 103 of IOL 100 in operation 902. Method 900 may further include adjusting the base degree of IOL 100 by directing an additional pulse of external energy to a second peripheral element 140 or another example of the first peripheral element 138 in a second peripheral chamber 108 (e.g., a second haptic fluid chamber) in the peripheral portion 103 of IOL 100 in operation 904.

[0254] The first peripheral element 138 may be a space-filling section 310, and by directing external energy 318 towards the space-filling section 310, the space-filling section 310 expands, the volume of the first peripheral fluid chamber decreases, and the fluid may move from the first peripheral fluid chamber to the optical fluid chamber 106 (as a result, the base frequency of the optical section 102 increases). The second peripheral element 140 may be a chamber expansion section 312, and by directing external energy 318 towards the chamber expansion section 312, the chamber expansion section 312 expands, the volume of the second peripheral fluid chamber increases, and the fluid may move from the optical fluid chamber 106 to the second peripheral fluid chamber (as a result, the base frequency of the optical section 102 decreases).

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

[0256] Figure 10 shows an additional embodiment of method 1000 for postoperative adjustment of IOL 100. Method 1000 may include adjusting the base frequency of IOL 100 in a first direction by directing external energy 318 to a first composite material in operation 1002. The first composite material may contain a first energy-absorbing component having a first color. Method 1000 may further include adjusting the base frequency of IOL 100 in a second direction by directing external energy to a second composite material in operation 1004. The second composite material may contain a second energy-absorbing component having a second color different from the first color.

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

[0258] In other embodiments, the first composite material may be formed as a chamber expansion portion 312, and the first energy-absorbing component of the first composite material may be an azo dye having a first color (e.g., red). In these embodiments, the second composite material may be formed as a space-filling portion 310, and the second energy-absorbing component of the second composite material may be an energy-absorbing dye 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 IOL 100 may include adjusting the base power of the optical unit 102 between approximately ±0.05D and approximately ±0.50D by directing pulses of external energy 318 to the composite material 400 in order to expand the composite material 400. For example, adjusting the base power of IOL 100 may include adjusting the base power of the optical unit 102 by approximately ±0.10D by directing pulses of external energy 318 to the composite material 400 in order to expand the composite material 400.

[0260] For example, the base frequency of the optical unit 102 may be adjusted between approximately ±0.05D and approximately ±0.50D as a result of the movement 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 resulting from the expansion of the peripheral element 136 caused by pulses of external energy 318 being directed toward the peripheral element 136. In a more specific example, the base frequency of the optical unit 102 may increase between approximately +0.05D and approximately +0.50D as a result of fluid flowing into the optical fluid chamber 106 from one of the peripheral fluid chambers 108 due to a decrease in the volume of the peripheral fluid chamber 108 resulting from the expansion of the first peripheral element 138 caused by pulses of external energy 318 being directed toward the first peripheral element 138. As a more specific example, the base frequency of the optical section 102 may decrease by approximately -0.05D to approximately -0.50D as a result of the expansion of the second peripheral element 140 caused by a pulse of external energy 318 being directed toward the second peripheral element 140, resulting in an increase in the volume of the peripheral fluid chamber 108, which causes fluid to flow out of the optical fluid chamber 106 and into one of the peripheral fluid chambers 108.

[0261] In one or more of the methods disclosed herein, adjusting the base frequency of IOL 100 may include adjusting the base frequency of IOL 100 within a total range of approximately ±1.0D to approximately ±2.0D by directing pulses of external energy 318 to a plurality of peripheral elements 136.

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

[0263] In one or more of the methods disclosed herein, directing the 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 the 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 become effective, may require multiple visits to the clinic, and clinicians frequently have to purchase expensive new equipment to perform such photochromic procedures. One advantage of the fixed-focus adjustable IOL 100 disclosed herein is that such a fixed-focus adjustable IOL 100 allows for correction of refractive errors after surgery in seconds rather than hours. This allows patients to provide feedback on refractive error correction almost instantaneously. Furthermore, the IOL 100 disclosed herein can be adjusted using commercially available lasers commonly found in most clinics (e.g., 532nm laser photocoagulation devices). In addition, patients do not need to wear glasses for UV protection during the healing period, and refractive error correction can be performed months or even years after the initial implantation surgery.

[0265] The intraocular lens disclosed herein comprises an optical portion and a peripheral portion connected to the optical portion, wherein the peripheral portion comprises a composite material including an energy-absorbing component and a plurality of expandable elements, the base power of the optical portion changes in response to external energy directed toward the composite material, and the base power of the optical portion does not respond to the force applied to the peripheral portion by the lens capsule when the intraocular lens is implanted in the lens capsule.

[0266] The intraocular lenses disclosed herein are expandable microspheres, each expandable microsphere containing a foaming agent enclosed within a thermoplastic resin shell.

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

[0268] The intraocular lenses disclosed in this specification 2 use a branched-chain hydrocarbon as the foaming agent.

[0269] The intraocular lenses disclosed herein have isopentane as the branched-chain hydrocarbon.

[0270] The intraocular lenses disclosed herein have a thermoplastic resin shell in which a portion of the shell is made of an acrylonitrile copolymer.

[0271] The intraocular lenses disclosed herein result in an increase in the diameter of at least one expandable microsphere between approximately 2 and 4 times as a result of external energy being directed to the composite material.

[0272] The intraocular lenses disclosed herein expand between approximately 10 to 50 times the volume of at least one expandable element in response to external energy directed at the composite material.

[0273] The intraocular lenses disclosed herein include a composite material in which the expandable element is between approximately 5% and approximately 15% by weight.

[0274] The intraocular lenses disclosed herein include a composite material with an expandable element accounting for approximately 10% of its weight.

[0275] In the intraocular lens disclosed in the present specification, the energy-absorbing component is an energy-absorbing colorant.

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

[0277] In the intraocular lens disclosed in the present specification, the energy-absorbing colorant is a dye.

[0278] In the intraocular lens disclosed in the present specification, the dye is an azo dye.

[0279] In the intraocular lens disclosed in the present specification, the dye is Disperse Red 1.

[0280] In the intraocular lens disclosed in the present specification, the energy-absorbing colorant is an energy-absorbing pigment.

[0281] In the intraocular lens disclosed in the present specification, the energy-absorbing pigment is graphitized carbon black.

[0282] In the intraocular lens disclosed in the present specification, the energy-absorbing component comprises the composite material in a weight percentage between about 0.025% and about 1.00%.

[0283] In the intraocular lens disclosed in the present specification, the peripheral part consists in part of a crosslinked copolymer including a copolymer mixture, and the composite material consists in part of the copolymer mixture.

[0284] In the intraocular lens disclosed in the present specification, the composite material is cured to become a crosslinked copolymer at a position within the peripheral part, and the composite material is substantially fixed in place.

[0285] In the intraocular lens disclosed in the present specification, the base power of the optical part varies between about ±0.05D and about ±0.5D in response to pulses of external energy directed at the composite material.

[0286] The intraocular lens disclosed in the present specification has a base power of the optical part that changes by about 0.1D in response to pulses of external energy directed to the composite material.

[0287] The intraocular lens disclosed in the present specification has a base power of the optical part that varies in total between about ±1.0D and about ±2.0D.

[0288] In the intraocular lens disclosed in the present specification, the change in base power is a permanent change.

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

[0290] In the intraocular lens disclosed in the present specification, the light energy is laser light.

[0291] In the intraocular lens disclosed in the present specification, 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] In the intraocular lens disclosed in the present specification, the green laser light has a wavelength of about 532 nm.

[0294] In the intraocular lens disclosed in the present specification, the laser light has a wavelength between about 946 nm and about 1120 nm.

[0295] In the intraocular lens disclosed in the present specification, the laser light has a wavelength of about 1030 nm.

[0296] In the intraocular lens disclosed in the present specification, 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] The intraocular lenses disclosed herein are emitted by a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser.

[0299] The intraocular lenses disclosed herein have an energy-absorbing component that transfers thermal energy to multiple expandable elements in response to external energy directed at the composite material.

[0300] The intraocular lenses disclosed herein are formed from a composite material 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 another independent peripheral element also causes a change in the base power of the optical portion.

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

[0302] The intraocular lens disclosed herein comprises an optical portion having an optical fluid chamber and a peripheral portion having 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, the peripheral fluid chamber conforming to the curvature of the optical portion.

[0304] The intraocular lenses disclosed herein have a peripheral fluid chamber with a chamber height, which is between approximately 0.1 mm and approximately 0.3 mm.

[0305] The intraocular lens disclosed herein has a chamber expansion portion made of a composite material, which expands in response to external energy directed toward 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 in the optical portion that decreases in response to external energy directed towards the chamber expansion portion.

[0307] The intraocular lens disclosed herein is an expandable stud in which the ventricular expansion portion extends from the anterior ventricular wall to the posterior ventricular wall.

[0308] In the intraocular lens disclosed in the present specification, the composite material is a space-filling portion, the space-filling portion expands in response to external energy directed to the space-filling portion, and the expansion of the space-filling portion reduces the volume of the peripheral fluid chamber.

[0309] In the intraocular lens disclosed in the present specification, the space-filling portion is a pad extending from either the chamber anterior wall or the chamber posterior wall.

[0310] In the intraocular lens disclosed in the present specification, the base power of the optical portion increases in response to external energy directed to the space-filling portion.

[0311] In the intraocular lens disclosed in the present specification, the base power changes 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 to the composite material.

[0312] In the intraocular lens disclosed in the present specification, the peripheral portion is at least one haptic, the peripheral fluid chamber is defined within the haptic, and the peripheral fluid chamber extends only to a part of the interior of the haptic.

[0313] In the intraocular lens disclosed in the present specification, at least one haptic comprises a haptic proximal portion and a haptic distal portion, and the haptic distal portion comprises a haptic distal arm that is not connected to the optical portion except via the connection through the haptic proximal portion.

[0314] In the intraocular lens disclosed in the present specification, the haptic distal arm comprises a twist or a bend.

[0315] In the intraocular lens disclosed in the present specification, the peripheral fluid chamber is defined within the haptic proximal portion, and the chamber section of the haptic proximal portion is not connected to the optical portion.

[0316] In the intraocular lens disclosed in the present specification, at least one haptic is connected to the optical portion by a distal connection portion disposed distally from the proximal end of the haptic and the chamber section.

[0317] The intraocular lens disclosed herein has a haptic whose proximal end is connected to the lateral surface of the optical portion, extending from there, and the lateral surface has a lateral height of approximately 0.65 mm.

[0318] The intraocular lens disclosed herein comprises a first haptic having a first haptic fluid chamber and a second haptic having a second haptic fluid chamber in its peripheral portion, and an optical portion comprising an optical fluid chamber.

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

[0320] The intraocular lens disclosed herein comprises an optical fluid chamber, a first haptic fluid chamber, and a second haptic fluid chamber, each containing a fluid with a total volume between approximately 10 μL and approximately 20 μL.

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

[0322] In the intraocular lens disclosed herein, approximately 15 nL of fluid is exchanged between either the first or second haptic fluid chamber and the optical fluid chamber in response to the expansion of the composite material.

[0323] The intraocular lenses disclosed herein use silicone oil as the fluid.

[0324] The intraocular lens disclosed herein comprises a peripheral portion comprising a first composite material and a second composite material, wherein the first composite material comprises a first energy-absorbing component, and the second composite material comprises a second energy-absorbing component, and the color of the first energy-absorbing component is different from the color of the second energy-absorbing component.

[0325] The intraocular lens disclosed herein also comprises an optical portion and 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 comprising a composite material comprising an energy-absorbing component and a plurality of expandable elements, the second peripheral element comprising a composite material comprising an energy-absorbing component and a plurality of expandable elements, the base power of the optical portion increases in response to external energy directed toward the first peripheral element, the base power of the optical portion decreases in response to external energy directed toward the second peripheral element, and the base power of the optical portion does not respond to the force applied to the peripheral portion by the lens capsule when the intraocular lens is implanted in the lens capsule.

[0326] The intraocular lens disclosed herein comprises an optical portion having an optical fluid chamber and a peripheral portion having at least one peripheral fluid chamber that is in fluid communication with the optical fluid chamber.

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

[0328] The intraocular lens disclosed herein has a first peripheral element which is a space-filling portion that expands in response to external energy directed toward the space-filling portion, and the expansion of the space-filling portion reduces the volume of the peripheral fluid chamber.

[0329] The intraocular lenses disclosed herein are expandable pads in which the space-filling portion extends from either the anterior or posterior wall of the cervix.

[0330] The intraocular lens disclosed herein has a second peripheral element which is a chamber expansion portion that expands in response to external energy directed toward the chamber expansion portion, and the expansion of the chamber expansion portion increases the volume of the peripheral fluid chamber.

[0331] The intraocular lens disclosed herein is an expandable stud in which the ventricular expansion portion extends from the anterior wall to the posterior wall of the ventricular cavity.

[0332] The intraocular lens disclosed herein has a first peripheral element and a second peripheral element arranged in the same peripheral fluid chamber.

[0333] The intraocular lens disclosed herein has a second peripheral element positioned distal to the first peripheral element within the same peripheral fluid chamber.

[0334] The intraocular lens disclosed herein has a first peripheral element positioned in the vicinity of a second peripheral element within the same peripheral fluid chamber, and the first peripheral element is positioned closer to the fluid channel connecting the optical fluid chamber to the peripheral fluid chamber than the second peripheral element.

[0335] The intraocular lens disclosed herein has a first peripheral element and a second peripheral element formed as independent peripheral elements, and a change in the base power of the optical part occurs when external energy is directed to one independent peripheral element, and a change in the base power of the optical part also occurs when external energy is directed to the other independent peripheral element.

[0336] The intraocular lens disclosed herein comprises a peripheral fluid chamber comprising at least 10 first peripheral elements.

[0337] The intraocular lens disclosed herein comprises one peripheral fluid chamber with at least 10 second peripheral elements.

[0338] The intraocular lenses disclosed herein are expandable microspheres, each expandable microsphere containing a foaming agent enclosed within a thermoplastic resin shell.

[0339] The intraocular lenses disclosed herein have an energy-absorbing colorant as their energy-absorbing component.

[0340] The intraocular lenses disclosed herein have a base power of the optical portion that varies between approximately ±0.05D and approximately ±0.5D in response to pulses of external energy directed to a first peripheral element or a second peripheral element.

[0341] The intraocular lens disclosed herein has an optical base power that changes by approximately 0.1 D in response to an external energy pulse directed to a first peripheral element or a second peripheral element.

[0342] The intraocular lenses disclosed herein have a total base power of the optical portion that varies between approximately ±1.0D and approximately ±2.0D.

[0343] The intraocular lenses disclosed herein have an external energy of light energy.

[0344] The intraocular lenses disclosed herein use laser light as their light energy.

[0345] The postoperative adjustment method for an intraocular lens disclosed herein also includes adjusting the base power of the intraocular lens by directing external energy to a composite material within the peripheral portion of the intraocular lens, the peripheral portion being connected to an optical portion radially inward, the composite material comprising an energy-absorbing component and multiple expandable elements, and the base power of the intraocular lens is not responsive to the force applied to the peripheral portion by the lens capsule when the intraocular lens was implanted in the lens capsule.

[0346] The method disclosed herein comprises an optical section comprising an optical fluid chamber and a peripheral section comprising at least one peripheral fluid chamber that is in fluid communication with the optical fluid chamber, wherein the base power of the intraocular lens changes 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 to the composite material.

[0347] In the method disclosed herein, approximately 15 nL of fluid is 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 an intraocular lens by directing external energy to a composite material which is a space-filling portion located within a peripheral fluid chamber defined in the peripheral region, thereby increasing the base power.

[0349] The method disclosed herein further includes reducing the base degree by directing external energy to another example of the composite material, which is a chamber expansion portion located in the periphery.

[0350] The method disclosed herein further includes adjusting the base power of an 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 region, thereby reducing the base power.

[0351] The method disclosed herein further includes reducing the base frequency by directing external energy to another example of a composite material which is a space-filling portion located within a peripheral fluid chamber.

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

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

[0354] The method disclosed herein involves a first peripheral fluid chamber being in fluid communication with a second peripheral fluid chamber via an optical fluid chamber defined within the optical section.

[0355] A method disclosed herein comprises a composite material comprising a first composite material and a second composite material, the method further comprising directing external energy toward the first composite material to adjust the base frequency in a first direction, wherein the first composite material comprises a first energy-absorbing component having a first color, and directing external energy toward the second composite material to adjust the base frequency in a second direction, wherein the second composite material comprises a second energy-absorbing component having a second color different from the first color.

[0356] The method disclosed herein involves an expandable element being an expandable microsphere, each expandable microsphere containing a foaming agent enclosed within a thermoplastic resin shell.

[0357] The method disclosed herein further includes varying the base power of an intraocular lens between approximately ±0.05D and approximately ±0.50D by directing pulses of external energy onto a composite material.

[0358] The method disclosed herein further includes adjusting the base power of an intraocular lens by approximately ±0.10 D by directing pulses of external energy onto a composite material.

[0359] The method disclosed herein further includes directing multiple pulses of external energy onto a composite material to change the base power of an intraocular lens between a total of approximately ±1.0D and approximately ±2.0D.

[0360] The method disclosed herein further includes directing external energy to the composite material, and also includes directing light energy to the composite material.

[0361] The method disclosed herein further includes directing external energy to the composite material by directing laser light to the composite material.

[0362] The method disclosed herein further includes directing external energy to the composite material with green laser light.

[0363] The method disclosed herein further includes directing external energy onto the composite material with laser light having a wavelength between about 488 nm and about 650 nm.

[0364] The method disclosed herein further includes directing external energy onto the composite material with laser light having a wavelength between approximately 946 nm and approximately 1120 nm.

[0365] Numerous embodiments are disclosed. Nevertheless, it will be understood by those skilled in the art that various changes and modifications can be made to this disclosure without departing from the spirit and scope of the embodiments. Systems, apparatus, devices, and methods shown with the embodiments are illustrative for specific embodiments and may be used in combination with other embodiments in this disclosure or in other embodiments. For example, the steps of a method shown in the figures or described in this disclosure do not require a specific order or sequence shown or described in order to achieve the desired result. In addition, other operating steps may be provided to achieve the desired result, and steps or operations may be removed or omitted from the described method or process. Furthermore, components or parts of apparatus or systems described in this disclosure or shown in the figures may be removed, deleted or omitted to achieve the desired result. In addition, certain components or parts of systems, apparatus or devices shown or described herein have been omitted for brevity and clarity.

[0366] Therefore, other embodiments are within the scope of the claims below, and the specification and / or drawings may be considered more descriptive than restrictive.

[0367] Each modification or description and embodiment described herein has independent components and functions, and they may be readily separated or combined with the functions of other modifications or embodiments. Modifications may be made to suit the purpose, spirit or scope of the invention for specific situations, materials, compositions, processes, actions or steps of a process.

[0368] The methods described herein may be performed in any logically possible order, in addition to the order in which the events are listed. Furthermore, additional steps or operations may be provided, or steps or operations may be omitted, in order to achieve the desired result.

[0369] Furthermore, if a range of values ​​is provided, all values ​​between the upper and lower limits of that range, and other values ​​indicated or within the indicated range, are included within the scope of the invention. Additionally, optional functions of modifications to the described invention may be disclosed independently or in conjunction with any one or more of the functions described herein. For example, a description of the range 1 to 5 should be considered to disclose sub-ranges such as 1 to 3, 1 to 4, 2 to 4, 2 to 5, 3 to 5, etc., as well as independent numbers within the range, such as 1.5, 2.5, etc., and whole or partial increases of the numbers in between.

[0370] All existing subject matter (e.g., publications, patents, patent applications) referenced herein is incorporated herein by reference unless the subject matter conflicts with the subject matter of the present invention (in which case the content of this specification shall prevail). The referenced items are provided only for disclosures prior to the filing date of this application. Nothing in this specification shall be construed as acknowledging that the present invention has no prior rights to such materials by prior invention.

[0371] A reference to a singular item includes the possibility that there may be multiple instances of that item. More specifically, in this specification and the appended claims, the singular forms “a,” “an,” and “the foregoing” also include references to the plural unless the context clearly indicates otherwise. It should be further noted that claims may be constructed to exclude optional elements. Accordingly, this statement is intended to serve as a prior art for the use of exclusive terms such as “solely,” “only,” or “negative” limitations in relation to the detail of elements of a claim. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person of ordinary skill in the art to which this invention belongs.

[0372] The phrase "at least one" means that when this phrase modifies multiple articles or components (or an enumerated list of articles or components), it indicates one or more combinations of those articles 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] For understanding the scope of this disclosure, “equipment” and its derivatives are intended to be open-ended terms, as used herein, to specify the functions, elements, components, groups, integers, and / or steps mentioned, but not to exclude other functions, elements, components, groups, integers, and / or steps not mentioned. The same applies to similar terms such as “includes,” “has,” and their derivatives. Also, when the terms “part,” “section,” “part of,” “component,” “element,” or “component” are used in the singular, they have a dual meaning of one part and multiple parts. As used herein, directional terms “forward, backward, up, down, vertically, horizontally, below, across, sideways, and vertically” and other similar directional terms indicate the position of the device or equipment, or the direction in which the device or equipment is moved or moved.

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

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

Claims

1. The Department of Optics, It comprises a peripheral portion connected to the optical portion, The peripheral portion includes a composite material containing an energy-absorbing component and multiple expandable elements. The base frequency of the optical unit is configured to change in accordance with the external energy directed at the composite material. The aforementioned expandable element is an expandable microsphere, and each of the expandable microspheres contains a foaming agent enclosed within a thermoplastic resin shell. Adjustable fixed-focus intraocular lens.

2. The adjustable fixed-focus intraocular lens according to claim 1, wherein the base power of the optical section is configured to change between approximately 0.05 D and approximately 0.5 D in the positive or negative direction in response to pulses of external energy directed at the composite material.

3. The adjustable fixed-focus intraocular lens according to claim 1, wherein the external energy is laser light having a wavelength between approximately 488 nm and approximately 1120 nm.

4. The adjustable fixed-focus intraocular lens according to claim 1, wherein the volume of the expandable element changes in response to the external energy directed toward the composite material, and the external energy is femtosecond laser light.

5. The adjustable fixed-focus intraocular lens according to claim 1, wherein the composite material is formed as independent peripheral elements, and a change in the base power of the optical part occurs when the external energy is directed to one independent peripheral element, and a further change in the base power of the optical part occurs when the external energy is directed to another independent peripheral element.

6. The adjustable fixed-focus intraocular lens according to claim 1, wherein the optical portion comprises an optical fluid chamber, and the peripheral portion comprises at least one peripheral fluid chamber that is in fluid communication with the optical fluid chamber.

7. The composite material is configured as a chamber expansion section, and the chamber expansion section is configured to expand in response to the external energy directed towards the chamber expansion section, and the volume of the surrounding fluid chamber increases due to the expansion of the chamber expansion section. The base frequency of the optical unit is configured to decrease in accordance with the external energy directed towards the chamber expansion unit. The adjustable fixed-focus intraocular lens according to claim 6, wherein the chamber expansion portion is configured as an expandable support extending from the anterior wall of the chamber to the posterior wall of the chamber.

8. The composite material is configured as a space-filling portion, and the space-filling portion is configured to expand in response to the external energy directed towards the space-filling portion, and the volume of the surrounding fluid chamber decreases due to the expansion of the space-filling portion. The adjustable fixed-focus intraocular lens according to claim 6, wherein the base power of the optical portion is configured to increase in response to the external energy directed towards the space-filling portion.

9. The adjustable fixed-focus intraocular lens according to claim 6, wherein the peripheral portion is configured as at least one haptic, the peripheral fluid chamber is defined within the haptic, and the peripheral fluid chamber extends only to a portion of the haptic.

10. The Department of Optics, 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. The second peripheral element is made of a composite material. The base power of the optical unit is configured to increase in response to the external energy directed towards the first peripheral element, and the first peripheral element is configured to expand in response to the external energy directed towards the first peripheral element. The base frequency of the optical unit is configured to decrease in response to the external energy directed towards the second peripheral element, and the second peripheral element is configured to expand in response to the external energy directed towards the second peripheral element. The optical section comprises an optical fluid chamber, and the peripheral section comprises at least one peripheral fluid chamber that is in fluid communication with the optical fluid chamber. The first peripheral element and the second peripheral element are arranged in the same peripheral fluid chamber. The second peripheral element is located distal to the first peripheral element within the same peripheral fluid chamber. Intraocular lens.

11. The aforementioned composite material includes an energy-absorbing component and a plurality of expandable elements. The intraocular lens according to claim 10.

12. The intraocular lens according to claim 11, wherein the base power is configured to change in accordance with the movement of fluid between the optical fluid chamber and the peripheral fluid chamber.

13. The intraocular lens according to claim 10, wherein the first peripheral element is configured as a space-filling portion, and the space-filling portion is configured to expand in response to the external energy directed toward the space-filling portion.

14. The intraocular lens according to claim 10, wherein the second peripheral element is configured as a chamber expansion portion, and the chamber expansion portion is configured to expand in response to the external energy directed toward the chamber expansion portion.

15. The intraocular lens according to claim 14, wherein the chamber expansion portion is configured as an expandable support column.

16. The intraocular lens according to claim 10, wherein the first peripheral element and the second peripheral element are configured as independent peripheral elements, and a change in the base power of the optical part occurs when the external energy is directed to one independent peripheral element, and a further change in the base power of the optical part occurs when the external energy is directed to another independent peripheral element.

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