Multi-piece accommodative intraocular lens and methods of making and using the same

Abstract

An accommodative intraocular lens (AIOL) for implantation in the capsular bag of a patient's eye comprises first and second components coupled together to define an internal fluid chamber and an external fluid reservoir. An internal region of the AIOL provides optical power utilizing one or more shaping fluids in the internal fluid chamber or the shape of the first or second component. The fluid reservoir comprises a bellows region having one or more folds extending circumferentially around the optical axis of the eye. The bellows cooperates with the lens capsule, and a compliant fold region between the internal and external bellows portions allows the profile of the AIOL to deflect as the eye accommodates for near vision. Fluid is transferred between the internal fluid chamber and the external fluid reservoir to provide optical power changes. A third lens component coupled to the first or second component provides additional optical power.

Description

[0001] This application is a divisional application of the Chinese invention patent application with application number 201780087361.6 filed on December 22, 2017 and entitled “Multi-piece accommodative intraocular lens and methods for manufacturing and using the same”.

[0002] Cross-reference to related applications

[0003] This application claims priority to U.S. Provisional Application No. 62 / 438,969, filed on December 23, 2016, entitled “Multi-piece Accommodating IOL,” U.S. Provisional Application No. 62 / 544,681, filed on August 11, 2017, entitled “Multi-piece Accommodating IOL,” and U.S. Provisional Application No. 62 / 549,333, filed on August 23, 2017, entitled “Multi-piece Accommodating IOL,” the contents of which are incorporated herein by reference in their entirety. Background Art

[0004] The present disclosure relates to medical devices and methods. In particular, the present disclosure relates to accommodating intraocular lenses (hereinafter referred to as "AIOLs" or "AIOL" in the singular).

[0005] Cataracts affect a large portion of the adult population worldwide, causing clouding of the natural crystalline lens and resulting in loss of vision. Patients with cataracts can be treated by removal of the natural lens and surgical implantation of a synthetic intraocular lens (IOL).

[0006] Millions of IOL implants are performed annually worldwide. In the United States, 3.5 million cataract surgeries are performed, and more than 20 million are performed annually worldwide.

[0007] Although IOL implantation surgery can be effective in restoring vision, conventional IOLs have several disadvantages. For example, many existing IOLs cannot change focus (called accommodation) like the native lens. Other disadvantages of conventional IOLs include refractive errors that occur after implantation and require glasses for distance vision correction, or in other cases, the IOL can effectively provide good distance vision, but the patient needs glasses for intermediate and near vision.

[0008] Several multifocal IOLs have been developed to address these shortcomings, but they can also have disadvantages. For example, although multifocal IOLs generally perform well for reading and distance vision, in at least some cases, such multifocal IOLs can cause significant glare, halos, and visual artifacts.

[0009] AIOLs have been proposed to provide accommodative optical power in response to the distance at which a patient is viewing an object. However, such AIOLs are generally still under development and have various disadvantages. For example, existing AIOLs may provide inadequate accommodation or produce suboptimal refractive correction of the eye after implantation. The amount of accommodation of existing AIOLs may also decrease after implantation, at least in some cases. Existing AIOLs may also be too large to be inserted through a small incision in the eye and may require the incision to be larger than ideal. Moreover, at least some existing AIOLs may be unstable when placed in the eye, which may lead to improper accommodation and other errors.

[0010] There is a need for an improved implantable intraocular lens that adapts to the natural mechanisms that control the focus of the eye and overcomes at least some of the above-mentioned deficiencies. Ideally, such an improved AIOL would provide increased accommodation when implanted, provide refractive stability, introduce few, if any, perceptible visual artifacts, and allow the optical power of the eye to change from distance vision to near vision in response to the distance at which the patient views an object. Summary of the invention

[0011] Embodiments of the present disclosure provide improved AIOLs and methods for making and using AIOLs. In many embodiments, the AIOL includes an adjustable structure that includes an internal fluid chamber and an external fluid reservoir that is continuously arranged around the internal fluid chamber. The adjustable structure of the AIOL may have an internal region that is at least partially defined by the internal fluid chamber, which defines an optical structure having first and second optical components that provide optical power. The external fluid reservoir may include a bellows that is fluidically coupled to the internal fluid chamber. The AIOL provides optical power adjustment in one or more ways. For example, the bellows may have a compliant fold region that deflects when the eye adapts to near vision, thereby transferring fluid between the external fluid reservoir and the internal fluid chamber to change the profile of the internal region and cause a change in optical power. A plurality of protrusions, such as posts or bumps, on the periphery of the internal fluid chamber may (1) provide a predetermined amount of separation between the first and second optical components, and (2) define one or more fluid passages between the internal fluid chamber and the external fluid reservoir. While the bellows may be configured in a variety of ways, in many embodiments, the bellows extends continuously and circumferentially around the optical axis of the AIOL, and one or more folds on opposite sides of the bellows may extend toward each other in a direction similar to the optical axis. The folds of the bellows may extend substantially continuously and circumferentially around the optical axis, such as three hundred and sixty (360) degrees around the optical axis.

[0012] Various aspects of the present disclosure provide an AIOL for placement within a lens capsule of a subject. The AIOL may include a first component having a first optical component and a first bellows region, and a second component having a second optical component and a second bellows region. The second component is coupled to the first component. An internal fluid chamber may be formed between the first and second optical components. An external fluid reservoir may be formed between the first bellows region and the second bellows region, and the external fluid reservoir is in fluid communication with the internal fluid chamber. In operation, fluid is transferred between the internal fluid chamber and the external fluid reservoir in response to a change in the shape of the lens capsule, thereby changing the shape of one or both of the first and second optical components to provide an optical power change to the AIOL.

[0013] Some embodiments of the AIOL also include a fixed lens coupled to the accommodative structure. The fixed lens can provide a base power for the AIOL, and in some embodiments, the accommodative structure may have no base power when in a relaxed state (i.e., when no pressure is applied to the external fluid reservoir). However, in some embodiments, both the fixed lens and the accommodative structure can have the same or different base powers. The fixed lens can be coupled to the rear or front side of the accommodative structure. In operation, the fixed lens can be selected to provide the desired base power of the AIOL, and the accommodative structure can then provide an adjustable power to the AIOL in response to the natural mechanisms that control the focusing of the eye.

[0014] In some embodiments of the AIOL, a fixed lens is coupled to the accommodative structure to be positioned anteriorly relative to the first and second optical components that provide the accommodative optical power. In such embodiments, the fixed lens is spaced anteriorly of the first optical component to allow the first optical component to move forward when fluid is driven from an external fluid reservoir into an internal fluid chamber. In addition, because the fixed lens is located anteriorly of the first and second optical components, the fixed lens can be coupled to the accommodative structure after the accommodative structure is implanted in the native eye capsule. Therefore, a fixed lens can be selected to provide the desired refractive requirements for a particular patient after the accommodative structure is implanted. This feature is useful because the optical properties of the accommodative structure can change after implantation, and the anterior orientation of the fixed lens allows the appropriate fixed lens to be selected after implantation based on the actual implanted optical properties of the accommodative structure.

[0015] Some embodiments of the fixed lens include additional features. For example, the fixed lens may include passages (e.g., holes or cutouts) that allow aqueous fluids to pass through the fixed lens, indexing features for precisely positioning toric or other asymmetric lenses, engagement features and / or skirts. The engagement features are configured to provide a secure attachment of the fixed lens to the accommodative structure while also being removable (e.g., snap-fit ​​or other types of interference fit). In some embodiments, the fixed lens has an optical portion and a skirt, the optical portion providing optical properties to the fixed lens, and the skirt extending backward relative to the optical portion. The skirt separates the fixed lens from the first optical component by the required distance. The skirt can also strengthen the optical performance of the accommodative structure. For example, the skirt limits the periphery of the first optical component to prevent distortion when the fluid moves in / out of the internal fluid chamber. The skirt also defines the radius of the deformable region of the first optical component so that a given amount of fluid causes greater adjustment than when there is no skirt. Additionally, the skirt provides an inner wall that supports the external fluid reservoir, thereby causing more fluid to be pumped from the external fluid reservoir into the internal fluid chamber in response to the eye's natural focusing mechanism rather than the skirt.

[0016] Some embodiments of the present technology relate to a tool kit having an accommodative structure and a first fixed lens without an optical base power. The accommodative structure can be implanted in the native eye capsule, and then the first fixed lens can be coupled to the accommodative structure. The optical properties of the implanted accommodative structure can then be evaluated in situ with the first fixed lens in place to determine the desired optical properties of the fixed lens. If the optical properties of the assembled accommodative structure and the first fixed lens without a base power are suitable, the system can remain implanted without additional changes. However, if a different base power or some other optical property is required (e.g., a toric or other asymmetric optical element), the first fixed lens without a base power can be replaced by a second fixed lens having the desired optical properties based on the optical properties of the implanted accommodative portion attached to the fixed lens. Therefore, the tool kit may further include one or more second fixed lenses with a variety of base powers or other optical properties.

[0017] In many embodiments, the first component is glued to the second component at a joint. Additionally, bumps or other spacers may be located on the inner surface of one or more of the first component or the second component to provide a gap between the first optical component and the second optical component. The first component may be glued to the second component at a joint that extends circumferentially around the first component and the second component.

[0018] The first bellows region may extend continuously circumferentially around the first optical structure, and the second bellows region may extend continuously circumferentially around the second optical structure.

[0019] The first bellows region may include one or more folds extending continuously circumferentially around the optical axis of the first optical component, and the second bellows region may include one or more folds extending continuously circumferentially around the optical axis of the second optical component.

[0020] The first bellows region may include one or more first folds extending inwardly and continuously circumferentially around the first optical component, and the second bellows region may include one or more second folds extending inwardly and continuously circumferentially around the second optical component. Each first fold may extend to a respective one of the second folds.

[0021] The first assembly may include a first annular rigid coupling structure extending circumferentially between the first optical assembly and the first bellows region to inhibit radial movement of the first optical assembly with radial movement of the first bellows region. The second assembly may include a second annular rigid coupling structure extending circumferentially between the second optical assembly and the second bellows region to inhibit radial movement of the second optical assembly with radial movement of the second bellows region. The first annular structure may include a first radial thickness greater than a first thickness of the first bellows region, and the second annular structure may include a second radial thickness greater than a second thickness of the second bellows region.

[0022] The first component may include an anterior component and the second component may include a posterior component. The first component may include a first planar member and the second component may include a second planar member. One or more of the first and second components may include a shell, such as a non-planar shell. One of the first or second components may include a planar member and the other of the first or second components may include a piano-convex member shaped to provide optical power.

[0023] The fluid within the internal fluid chamber shapes the shape of the internal fluid chamber to provide optical power. For example, the shape of the fluid volume in the internal fluid chamber can provide the optical power of the accommodative structure. The change in the optical power of the AIOL may include a change in the optical power provided by the shape of the fluid within the internal fluid chamber. The change in the optical power provided by the shape of the fluid within the internal fluid chamber may include a change in the shape of the internal fluid chamber. The change in the optical power of the AIOL may include a change in the separation distance between the first optical component and the second optical component. For example, the separation distance can be the distance between the centers of the first and second optical components measured along the optical axis.

[0024] The protrusions around the edges of the first and second optical components and radially inward from the bellows region may overlap and may bond to one another.

[0025] The external fluid reservoir may include a bellows having a compliant folded region between an inner bellows region and an outer bellows region. For example, the external fluid reservoir may have a fold defining a folded region, which in turn separates the inner bellows region from the outer bellows region. The compliant folded region may be thinner than the inner bellows region and the outer bellows region. The internal fluid chamber may deflect in response to deflection of the compliant folded region of the external fluid reservoir. The compliant folded region may be thinner than the inner bellows region and the outer bellows region, which are positioned radially inward and radially outward relative to the compliant folded region, respectively.

[0026] The AIOL may also include a plurality of protrusions, such as one or more of bumps and posts, coupled to one or more of the first and second components. The protrusions may separate portions of the first and second components from each other. For example, the plurality of protrusions may be disposed along an outer edge of the interior of the first and second optical components to separate the first and second optical components from each other. The plurality of protrusions may define a plurality of fluid channels between the internal fluid chamber and the external fluid reservoir, wherein each fluid channel is defined between two adjacent protrusions.

[0027] The protrusion may be located between the bellows and the optical component to connect the first component to the second component. The protrusion may be located on one or more rigid coupling structures of one or more of the first component and the second component to (a) provide a gap between the first optical component and the second optical component, and (b) define a plurality of channels between the chamber and the reservoir to fluidically couple the reservoir to the chamber.

[0028] In many embodiments, the external fluid reservoir includes a compliant folded region between the inner bellows region and the outer bellows region. The compliant folded region can be thinner than the inner bellows region and the outer bellows region.

[0029] In many embodiments, the protrusion is coupled to the first or second component, and the protrusion separates the first and second optical components from each other. The protrusion can be disposed between the bellows and the interior region, and the space between the protrusions can define a fluid channel between the interior fluid chamber and the exterior fluid reservoir. For example, each fluid channel is defined between two adjacent columns.

[0030] One or more of the first or second components may comprise a polymeric material, such as a PMMA copolymer. The polymeric material may be water permeable. The polymeric material may be hydrophilic and / or a combination of hydrophilic and hydrophobic materials. For example, when the polymeric material is a hydrophilic and hydrophobic component, the resulting polymeric material is primarily hydrophilic. Water within the subject's lens capsule may be transferred into or out of one or more of the internal fluid chamber or external fluid reservoir through the polymeric material to achieve osmotic equilibrium when the AIOL is placed in the lens capsule. For example, the polymeric material may be impermeable to compounds with a molecular weight greater than 40 kDa. The AIOL according to the present technology may also include a fluid within the internal fluid chamber. The fluid may include one or more of a solution, an oil, a silicone oil, a dextran solution, a high molecular weight dextran solution, or another high molecular weight compound solution.

[0031] In many embodiments, the first and second components are flexible enough to be folded into a delivery configuration with a reduced cross-section. The delivery configuration with a reduced cross-section may include one or more of folds or rolls of the intraocular lens around a delivery axis that is transverse to the optical axis of the accommodative intraocular lens. An AIOL system and / or a kit according to the present technology may include a delivery tube or an aperture, and the delivery configuration with a reduced cross-section may include an intraocular lens advanced into the delivery tube or the aperture.

[0032] In many embodiments, the external fluid reservoir includes a tactile structure for engaging the lens capsule.

[0033] In many embodiments, the refractive index of the fluid within the interior fluid chamber is greater than the refractive index of the aqueous humor, which is about 1.336.

[0034] In many embodiments, in the absence of fluid in the internal fluid chamber, the first or second optical components provide no optical power. In many embodiments, the fluid within the internal fluid chamber provides optical power.

[0035] In many embodiments, the first and second components are bonded to each other.

[0036] In many embodiments, both the first and second components comprise the same polymeric material, and the first and second components are combined with prepolymers of the polymeric material.

[0037] In many embodiments, one or more of the first component or the second component are directly manufactured, such as by three-dimensional (3D) printing.

[0038] In many embodiments, the first component and the second component are manufactured directly together and comprise a single piece.

[0039] In many embodiments, the first component and the second component are molded separately and joined together.

[0040] In many embodiments, the first component and the second component are lathed separately and joined together.

[0041] In many embodiments, the first component and the second component are joined together at a protrusion extending between the first component and the second component.

[0042] In many embodiments, the first assembly includes a first manufactured component and the second assembly includes a second manufactured component.

[0043] Various aspects of the present disclosure provide methods of providing accommodation to an eye of a subject. A varying compressive force from a lens capsule may be received by an external fluid reservoir of an accommodating intraocular lens placed within the lens capsule of the eye. In response to the received varying compressive force, fluid may be pushed between the external fluid reservoir and an internal fluid chamber of the AIOL. The external fluid reservoir may be a bellows comprising folds that extend continuously circumferentially around the optical axis of the intraocular lens. One or more of the size or shape of the internal fluid chamber may change in response to fluid being pushed into or out of the internal fluid chamber to change the optical power of the accommodating intraocular lens.

[0044] In many embodiments, the inner bellows region and the outer bellows region are in fluid communication with each other and with the internal fluid chamber.One or more of the bellows regions may be annular, elliptical, and / or rotationally symmetrical in shape.

[0045] In many embodiments, the external fluid reservoir includes a tactile structure for engaging the lens capsule.

[0046] In many embodiments, changing one or more of the size or shape of the internal fluid chamber includes changing a separation distance between portions of the first and second optical components.

[0047] In many embodiments, changing one or more of a size or a shape of the internal fluid chamber comprises changing a radius of curvature of one or more of the first or second optical components defining the internal fluid chamber.

[0048] In many embodiments, the AIOL includes first and second optical components defining an internal fluid chamber, and one or more of the first or second optical components includes a plano-convex member shaped to provide a minimum optical power to the accommodating intraocular lens. In other embodiments, at least one of the first and second optical components is a lens having optical power, the lens including any suitable lens shape that produces optical power.

[0049] In many embodiments, the internal fluid chamber contains a fluid therein such that the pressure of the fluid shapes the shape of the internal fluid chamber. The resulting fluid shape provides optical power to the accommodating intraocular lens.

[0050] In many embodiments, the addition of a varying compressive force can push fluid from the external fluid reservoir into the internal fluid chamber.

[0051] Embodiments of the present disclosure provide improved AIOLs and methods of making and using AIOLs. Many embodiments of AIOLs according to the present technology include an optical structure comprising a rigid member and a deflectable member (e.g., a deformable member) coupled to a tactile structure. The rigid member and the deflectable member may substantially define an internal fluid chamber of the AIOL. The internal fluid chamber of the AIOL may be filled with a fluid having a refractive index greater than the aqueous humor of the eye, such that the deflectable member defines a convexly curved surface of the fluid volume to provide a fluid lens with adjustable optical power. The deflectable member and the rigid member may be coupled to a tactile structure to deflect the profile of the deflectable member into a convexly curved profile when the eye adapts to near vision.

[0052] In many embodiments, the rigid member includes a lens, such as a plano-convex lens, having an optical power configured to address the patient's distance vision. As the eye accommodates, the deflectable portion provides additional optical power for near vision. In many embodiments, the diameter of the lens of the rigid member corresponds to the diameter of the inner portion of the deflectable member, such that the diameter size of the lens of the rigid member is smaller than the size of the outer portion of the deflectable member to reduce the thickness profile of the AIOL when inserted into the eye.

[0053] In many embodiments, the accommodative IOL comprises a first component and a second component respectively comprising a polymer, and an adhesive comprising a polymer. Alternatively, or in combination, the first component may be fixed to the second component by mechanical coupling (e.g., by an interlocking joint, a thread, a mounting member, or a fastener). In many embodiments, the polymer can absorb water and swell by absorbing water, so that the first component, the second component, and the adhesive swell together (e.g., at the same or substantially similar rate). By swelling together, the stress between the first component, the second component, and the adhesive can be substantially suppressed. Moreover, before the components are bonded together, the absorbent adhesive allows the first and second components to be machined when they are not completely absorbed and become rigid (i.e., a rigid configuration). The rigid configuration may include a polymer that is not completely absorbed, such as a substantially dry polymer. The components can be bonded together in a substantially rigid configuration so as to be operated during the manufacturing process, and then absorb water so that the components bonded by the adhesive include a soft, absorbent configuration for inserting into the eye. The adhesive comprising the polymer can combine the first and second lens components together to provide increased strength by chemical bonds similar to the polymer material itself. For example, a "chemical bond" can be a cross-linked bond identical to a polymer material.

[0054] Another aspect of the present disclosure provides an intraocular lens. The intraocular lens may include an optical structure having an optical power, and includes a deflectable member, a rigid member, and a fluid chamber at least partially defined between the deflectable member and the rigid member. The intraocular lens may include a tactile structure that is coupled to a peripheral region of the rigid member and includes a front element, a rear element, and a fluid reservoir at least partially defined between the front element and the rear element. The fluid reservoir may be in fluid communication with a fluid chamber having one or more channels. In many embodiments, the volume of the fluid chamber may increase in response to a decrease in the volume of the fluid reservoir to change the optical power. The shape of the fluid-filled chamber may change in response to an increase in the volume of the lens fluid chamber to change the optical power.

[0055] In another aspect of the present disclosure, the intraocular lens includes an optical structure, which includes a rear member, an anterior member, and a fluid-filled chamber between the rear member and the anterior member. The intraocular lens may include a tactile structure that interlocks the peripheral area of ​​the rear member and the anterior member to inhibit fluid leakage into and out of the fluid-filled tactile chamber. In many embodiments, the interlocking area may include a fluid seal to inhibit fluid leakage. The tactile structure may have a first side and a second side, the first side having one or more convex members (male members), and the second side having one or more concave members (female members). One or more convex members may pass through the peripheral area of ​​the rear member and the anterior member and be received by one or more concave members to interlock the peripheral area. The peripheral area of ​​the rear member and the anterior member may have one or more pores, and one or more members pass through the one or more pores. The peripheral area of ​​one or more rear members or anterior members may have one or more convex members received by one or more concave members of the tactile structure to interlock the peripheral area. The interlocking of the peripheral regions of the posterior and anterior members may be maintained by the tactile structures as the intraocular lens is deformed to change the optical power of the optical structure and / or folded or rolled into a delivery configuration.

[0056] In yet another aspect of the present disclosure, an AIOL includes an optical structure comprising a posterior member, an anterior member, and a fluid-filled chamber between the posterior member and the anterior member, the fluid-filled chamber providing optical power. The intraocular lens may include a tactile structure coupled to the optical structure. One or more of the shape or volume of the fluid-filled chamber may be configured to change in response to a radial force applied to the tactile structure. Changes in one or more of the shape or volume of the fluid-filled chamber may change the optical power of the fluid-filled chamber while leaving the optical power provided by the posterior member and the anterior member substantially unchanged.

[0057] In another aspect of the present disclosure, a method of providing accommodation to an eye of a patient is provided. The method may include placing an AIOL within a lens capsule of the eye. One or more of a shape or a volume of a fluid-filled chamber of the intraocular lens may be changed to change the optical power of the fluid-filled chamber while leaving the optical power provided by the posterior member and the anterior member substantially unchanged.

[0058] In many embodiments, a deflectable optical member as described herein has the advantage of substantially maintaining the thickness of the optical member while deflecting to suppress optical aberrations when the member is deflected.

[0059] One aspect of the present disclosure provides an intraocular lens for implantation in a lens capsule of an eye of a patient. The intraocular lens may include an optical structure and a tactile structure. The optical structure may have a peripheral portion and may include a planar member, a plano-convex member coupled to the planar member at the peripheral portion, and a fluid optical element defined between the planar member and the plano-convex member. The fluid optical element may include a fluid having a refractive index similar to either or both of the materials comprising the planar member and the plano-convex member. For example, the refractive index of the fluid may be greater than the refractive index of the connate aqueous fluid of the eye. The tactile structure may couple the planar member to the plano-convex member at the peripheral portion of the optical structure. The tactile structure may include a fluid reservoir in fluid communication with the fluid optical element and a peripheral structure for interfacing with the lens capsule. A change in the shape of the lens capsule may cause one or more volume or shape changes of the fluid optical element corresponding to the deformation of the planar member to change the optical power of the fluid optical element. For example, a change in the shape of the lens capsule may cause the tactile structure to apply a mechanical force to the planar member to deform the member and change the optical power of the fluid optical element accordingly. In some cases, such deformation of the planar member may not cause a change in the optical power of the planar member, the plano-convex member, or both (i.e., the change in optical power may be provided solely by one or more shape or volume changes of the fluid optical element, and optionally by a change in the anterior-posterior position of the intraocular lens within the lens capsule).

[0060] A force applied to the tactile fluid reservoir may deform the tactile fluid reservoir to change the optical power of the fluidic optical element. A force applied to the tactile fluid reservoir may transfer fluid from the tactile fluid reservoir into or out of the fluidic optical element to reversibly deform the tactile fluid reservoir.

[0061] In many embodiments, the volume change of the fluid optical element is provided by a fluid contained in a haptic fluid reservoir. In many embodiments, the fluid is transferred into or out of the fluid optical element such that the plano-convex member does not deform. The plano-convex member may include a rigid member and the planar member may include a deflectable member. In these embodiments, the fluid optical element may provide most of the optical power of the intraocular lens. The fluid within the fluid optical element and within the fluid reservoir of the haptic structure may have a refractive index greater than or equal to 1.33.

[0062] The fluid within the fluid optical element and the fluid reservoir of the tactile structure may include an oil, such as silicone oil or a solution such as a high molecular weight dextran. The fluid may have a suitable refractive index. For example, the high molecular weight dextran may be configured to have a suitable refractive index greater than 1.33 and have an osmolality similar to the aqueous humor of the eye. The high molecular weight dextran may also have an average molecular weight of at least 40 kDa, and the average molecular weight may be in the range of about 40 kDa to about 2000 kDa, with an intermediate range having an upper limit and a lower limit defined by any one of 40 kDa, 70 kDa, 100 kDa, 1000 kDa, or 2000 kDa. The high molecular weight dextran may include a molecular weight distribution, and the molecular weight distribution may be narrow or broad. Since the refractive index can be determined based on the weight of the dextran per volume and the osmolality of the number of solute particles per volume, the average molecular weight and amount of the dextran may be used to configure a dextran solution with an appropriate refractive index and osmolality.

[0063] In many embodiments, the haptic structure is configured to orient the intraocular lens at an appropriate position within the lens capsule of the patient's eye. In many embodiments, the haptic structure includes an anterior haptic structure and a posterior haptic structure that are coupled together to define an external fluid reservoir therebetween. In many embodiments, the haptic structure includes an annular structure coupled to a peripheral region of the optical structure. The haptic structure may include a plurality of tabs that are coupled to and distributed over a peripheral portion of the optical structure.

[0064] The peripheral portion may include a plurality of apertures, and the haptic structure may be coupled to the peripheral portion through the plurality of apertures. The plurality of apertures may be oriented substantially parallel to the optical axis of the intraocular lens. Alternatively, or in combination, the plurality of apertures may be oriented transverse to the optical axis of the intraocular lens. The haptic structure may include one or more posts or other structures positioned through the plurality of apertures of the peripheral portion of the optical structure to couple the haptic structure to the peripheral portion. Alternatively, or in combination, the optical structure may include posts for mating with structures such as apertures in the haptic structure.

[0065] The AIOL may be sufficiently flexible to be folded into a reduced cross-sectional delivery configuration. The reduced cross-sectional delivery configuration of the AIOL may be achieved by folding or rolling the AIOL about a delivery axis perpendicular to the optical axis of the AIOL. Alternatively, or in combination, the reduced cross-sectional delivery configuration of the AIOL may be achieved by advancing the intraocular lens through a delivery tube or aperture.

[0066] In many embodiments, the planar member is positioned posterior to the plano-convex member when the AIOL is placed in the lens capsule.

[0067] Another aspect of the present disclosure provides a method for providing accommodation in a patient's eye. First, an AIOL is provided. The AIOL provided may include an optical structure and a tactile structure, and the optical structure may have a peripheral portion. The optical structure may include a first optical element (e.g., a planar member), a second optical element (e.g., a plano-convex member) coupled to the first optical element at the peripheral portion, and a fluid optical element defined between the first optical element and the second optical element. The fluid optical element may include a fluid having a refractive index similar to either or both of the materials of the first and second optical elements. The fluid optical element may have an optical power. The tactile structure may couple the first and second optical elements together at the peripheral portion of the optical structure. The tactile structure may include a fluid reservoir in fluid communication with the fluid optical element and a peripheral structure for connecting to the lens capsule. Second, the AIOL may be folded into a reduced profile configuration. Third, the folded AIOL may be implanted in the lens capsule of the patient's eye. When implanted in the lens capsule, the folded AIOL recovers from the reduced profile configuration to the working configuration. Fourth, one or more of the optical structures or tactile structures may be driven to cause one or more volume or shape changes of the fluid optical element corresponding to the deformation of the planar member, thereby changing the optical power of the fluid optical element.

[0068] One or more optical or tactile structures may be driven to change the optical power of a fluid optical element by deforming the planar member by radially directing a force on the tactile structure. The tactile peripheral structure may be rigidly coupled to a substantially planar member of the optical structure. Fluid may be transferred from a fluid reservoir of the tactile structure into or out of the fluid optical element while the optical power of the fluid optical element is changed. Transfer of fluid from a tactile fluid chamber into or out of the fluid optical element may deflect the planar member while leaving the plano-convex member undeflected. In an alternative embodiment, transfer of fluid from a tactile fluid chamber into or out of the fluid optical element may deflect the planar member and optionally the plano-convex member.

[0069] One or more optical structures and haptic structures may be actuated to change the optical power of the fluid optical element by applying a force on the haptic fluid reservoir to reversibly deform the haptic fluid reservoir.

[0070] In many embodiments, the peripheral portion of the optical structure includes a plurality of pores, and the tactile structure couples the posterior member with the anterior member at the peripheral portion of the optical structure through the plurality of pores. The tactile structure coupled to the plurality of pores of the peripheral portion can keep the substantially planar member and the plano-convex member coupled together when the intraocular lens is folded and during operation or operation of the intraocular lens. The plurality of pores can be oriented substantially parallel to the optical axis of the intraocular lens. The plurality of pores can be oriented transversely to the optical axis of the intraocular lens. The tactile structure can include one or more posts placed through the plurality of pores to couple the tactile structure to the peripheral region. Alternatively or in combination, the peripheral portion of the optical structure can have one or more holes, and one or more posts of the tactile structure can pass through the holes to couple the optical and tactile structures together.

[0071] The AIOL may have a reduced profile configuration by folding or rolling the AIOL about a delivery axis that is perpendicular to the optical axis of the lens. Alternatively, or in combination, the AIOL may be folded into a reduced profile configuration by advancing the intraocular lens through a delivery tube or aperture.

[0072] The folded AIOL can be implanted in the lens capsule by allowing the fluid in the lens fluid chamber to reach osmotic equilibrium with the fluid present in the lens capsule. One or more of the planar or plano-convex members can be water permeable to allow osmotic equilibrium to be reached. In many embodiments, the porous posterior member or anterior member is impermeable to compounds with a molecular weight greater than 40 kDa.

[0073] In many embodiments, one or more of the planar or plano-convex components has substantially no optical power.

[0074] In many embodiments, the planar member is positioned posterior to the plano-convex member when the intraocular lens is placed in the lens capsule.

[0075] In another aspect, an embodiment provides a method for preparing an AIOL by providing a first component comprising a polymer, and a second component comprising the same polymer. The first component is bonded to the second component by an adhesive. The adhesive may comprise a prepolymer of the polymers of the first and second components. For example, the prepolymer may be any portion of the polymer comprising the first and second components or any combination thereof, such as a monomer, a short-chain polymer, and / or a partially polymerized.

[0076] In many embodiments, the prepolymer is cured to bond the first component to the second component, wherein the polymer extends between the first component and the second component.

[0077] In many embodiments, when the first component is combined with the second component and the polymer extends between the first component and the second component, the first component and the second component each comprise a rigid configuration.

[0078] In many embodiments, the first component, the second component, and the cured adhesive absorb water to provide a hygroscopic, soft accommodating intraocular lens.

[0079] In many embodiments, hydrating the first component, the second component, and the adhesive comprises completely hydrating the polymer of each of the first and second components and the adhesive to an amount of water absorption corresponding to the amount of water absorption of the polymer when implanted. In several embodiments, the adhesive is indistinguishable from the base polymer when cured.

[0080] In many embodiments, each of the first component, the second component, and the cured adhesive respectively comprises a first configuration before absorbing water (e.g., a rigid configuration) and a second configuration upon absorbing water (e.g., a soft configuration), and wherein the amount of expansion of each of the first component, the second component, and the cured adhesive from the first configuration to the second configuration is substantially similar to suppress stress at the interface between the adhesive and the first and second components.

[0081] Many embodiments further include providing a polymeric material and forming the polymeric material into a first component and a second component.

[0082] In many embodiments, when the first component and the second component are rigid, the first component and the second component are each turned on a lathe to shape the first component and the second component.

[0083] In many embodiments, the first component and the second component are molded.

[0084] In many embodiments, the prepolymer includes one or more of a monomer, an oligomer, a partially cured monomer, particles, or polymeric nanoparticles.

[0085] In many embodiments, the first component includes a dish-shaped structure and the second component includes a dish-shaped structure, and wherein when joined together, the first component and the second component define a chamber having the dish-shaped structure on opposite sides of the chamber.

[0086] In many embodiments, one of the first component or the second component includes a recess sized and shaped to receive the other of the first or second component, and wherein the adhesive is disposed on the recess.

[0087] In many embodiments, one or more of the first assembly or the second assembly includes an annular structure extending between the first and second dish-shaped structures to separate the first and second dish-shaped structures and define a sidewall of the chamber.

[0088] In another aspect, an AIOL includes a first component, a second component, and an adhesive. The first component includes a polymer material. The second component includes the same polymer material. The cured adhesive includes a polymer between at least a portion of the first component and the second component to bond the first component to the second component and define a cavity.

[0089] In many embodiments, the internal fluid chamber includes an optical element. Many embodiments further include a fluid within the internal fluid chamber having a refractive index greater than the refractive index of the aqueous humor of the eye, about 1.336, and wherein one or more of the first component or the second component is configured to deform to increase the optical power of the accommodative intraocular lens.

[0090] Many embodiments further include one or more haptics to engage the walls of the capsular bag of the eye and increase the curvature of one or more of the first component or the second component at the wall and / or periphery of the zonule attachment of the lens in response to capsular bag contraction to increase the optical power of the accommodating intraocular lens.

[0091] Many embodiments further comprise a fluid comprising one or more of a solution, an oil, a silicone, an oil, a high molecular weight molecule solution, or a high molecular weight dextran solution.

[0092] Many embodiments further include a seam comprising an adhesive extending circumferentially along at least a portion of the first component and the second component.

[0093] In many embodiments, the first component includes a first butterfly structure and the second component includes a second butterfly structure.An annular structure can extend between the first butterfly structure and the second butterfly structure to separate the first butterfly structure from the second butterfly structure and define an internal fluid chamber.

[0094] In many embodiments, the intraocular lens comprises a rigid configuration prior to implantation and a soft configuration upon implantation.

[0095] In many embodiments, the first component includes a first disk-shaped optical structure that includes one or more of a lens, a meniscus, a meniscus lens, or a slab, and wherein the second component includes a second disk-shaped optical structure that includes one or more of a lens, a meniscus, a meniscus lens, or a slab.

[0096] Yet another aspect of the present disclosure provides an AIOL for implantation in a lens capsule of an eye of a patient. The AIOL may include an optical structure and a tactile structure. The optical structure may have a peripheral portion and may include a posterior member, an anterior member coupled to the posterior member at the peripheral portion, and a fluid optical element defined between the posterior member and the anterior member. The fluid optical element may include a fluid having a refractive index similar to either or both of the materials comprising the posterior member and the anterior member. The fluid optical element may have an optical power. The tactile structure may couple the posterior member and the anterior member at the peripheral portion of the optical structure. The tactile structure may include a fluid reservoir in fluid communication with the fluid optical element and a peripheral structure for interfacing with the lens capsule. Changes in the shape of the lens capsule may change the volume or shape of the fluid optical element in response to deformation of one or more of the posterior member or the anterior member to change the optical power of the fluid optical element. One or more of the posterior or anterior members of the optical structure can be water permeable so that when the AIOL is placed therein, water present in the lens capsule of the patient's eye can pass therethrough into or out of the fluid lens chamber to achieve osmotic equilibrium with the fluid present in the lens capsule. The various features of the AIOL can also be configured in many ways according to the many embodiments disclosed herein.

[0097] In another aspect of the present disclosure, an AIOL may include an optical structure having a fluid chamber and a material within the fluid chamber. The material may include a state of incomplete water absorption. A portion of the optical structure may be configured to provide water to the fluid chamber and inhibit leakage of the material from the fluid chamber so that the material can fully absorb water and expand the fluid chamber when placed in the eye.

[0098] In yet another aspect of the present disclosure, a method of implanting an AIOL into a lens capsule of an eye of a patient is provided. The method may include advancing an AIOL comprising an incomplete water absorption configuration through an incision in the eye. Water from the lens capsule may pass through at least a portion of the optical structure to allow the AIOL to fully absorb water. In many embodiments, material within a fluid chamber of the optical structure of the intraocular lens may be inhibited from leaking from at least a portion of the optical structure while water from the lens capsule passes through to allow the material to fully absorb water.

[0099] In several embodiments, the external fluid reservoir and the internal fluid chamber are filled with a hydrophobic oil that inhibits or completely prevents water from migrating into the internal fluid chamber. For example, the hydrophobic oil can be selected from any of the following: hydrocarbons (HYDROBRITE 550), polydimethylsiloxane, polyoctylmethylsiloxane, poly(2-phenylpropyl)methylsiloxane, phenylmethylsiloxane oligomers, phenylmethylsiloxane-di-methylsiloxane copolymers, diphenylsiloxane-dimethylsiloxane copolymers, phenylmethylsiloxane-dimethylsiloxane copolymers, 1,1,3,5,5-pentaphenyl-1,3,5. The fluid is suitable for any AIOL described herein.

[0100] Incorporated by Reference

[0101] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF THE DRAWINGS

[0102] The features of the present technology are particularly set forth in the appended claims. The features and advantages of the present technology will be better understood by reference to the following detailed description of an illustrative embodiment, in which the principles of the invention are used, and the following are the drawings of an illustrative embodiment:

[0103] Figure 1 shows a cross-sectional view of a fluid-filled accommodating lens system including a bellows structure according to an embodiment;

[0104] Figure 2 shows a cross-sectional view of an alternative accommodating lens system according to an embodiment;

[0105] Figure 3 shows a cross-sectional view of an alternative fluid-filled accommodating lens system according to an embodiment;

[0106] Figures 4A-4C An AIOL assembly 400 is shown comprising four main parts according to an embodiment;

[0107] Figure 5 is a complete AIOL assembly 500, an alternative embodiment of AIOL 400;

[0108] Figures 6A-6C shows an AIOL 600 comprising three main parts according to an embodiment; and

[0109] Figure 7A-7B An AIOL 700 is shown comprising three main parts, according to an embodiment.

[0110] Figure 8 An AIOL lens system comprising a plurality of square annular regions is depicted.

[0111] Figures 9A-9C An accommodating intraocular lens system 900 is shown that incorporates additional features to enhance performance.

[0112] Figures 10A-10C An accommodating intraocular lens system 1000 is shown that incorporates additional features to enhance performance.

[0113] Fig.11 An AIOL delivery device 1100 is depicted with the lens system properly oriented into the injector tip for delivery.

[0114] Figures 12A-12C AIOL embodiments including mid-bellows stabilization features are presented.

[0115] Figures 13A-13J Contains two distinct flow features, one defined by external flow-throughs and the other defined by internal flow-throughs.

[0116] Figures 14A-14E An alternative design for a fixed lens assembly is presented.

[0117] Figures 15A-15D An alternative design for a fixed lens assembly is presented.

[0118] Figures 16A-16B A structural element is shown comprising one or more thickened portions on an inner wall, the structural element being shaped to interface with one or more passageways.

[0119] Figures 17A-17G Three external overflows are shown that provide enhanced access for aspiration tools to remove the OVD from the posterior space between the capsule and the posterior surface of the AIOL.

[0120] Figures 18A-18D An accommodating intraocular lens 1800 is shown incorporating features to enhance performance. DETAILED DESCRIPTION

[0121] An accommodative intraocular lens (AIOL) as described herein can be used to provide improved vision and can be combined with one or more of many known surgical procedures and devices (e.g., cataract surgery and intraocular lens inserters). The optical structure of the AIOL is well suited for use with commercially available IOL power calculations based on biometry of the eye and can be used to provide improved vision. In many embodiments, a physician can insert an AIOL as described herein in a manner similar to existing non-accommodative IOLs, thereby facilitating the use of an AIOL as described herein.

[0122] The present disclosure relates to devices, methods, and systems associated with AIOLs. Some embodiments will include a central optical structure that is composed of at least one deformable optical component (e.g., an optical element) spaced along the optical axis, for example by a support structure concentric with the optical axis of the lens. Several embodiments include a first optical component and a second optical component, and at least one of the first and second optical components can be deformable, while the other of the first and second optical components can be deformable or rigid. The volume defined by the first and second optical components and the optional lens support structure can define a fluid chamber that can be filled with an ionic solution (e.g., saline), or a non-ionic solution (e.g., dextran or silicone oil). The first and second optical components can alternatively be defined by one or more tactile structures, and the tactile structures can define an external fluid reservoir filled with fluid and arranged in a plane perpendicular to the optical axis of the first and second optical components. The fluid in the external fluid reservoir of the tactile structure can be in fluid communication with the fluid in the internal fluid chamber defined by the optical structure. Transferring fluid between the haptic structure and the internal fluid chamber of the optical structure may change the accommodation power of the fluid within the internal fluid chamber by deforming one or both of the first and second optical components.The improved AIOL system may additionally include any combination of the features described herein.

[0123] The optical components and some of the supporting structures described herein are generally made of hydrophilic materials that are optically transparent when subjected to water absorption, swell more than 10% when subjected to water absorption, and accommodate strain levels greater than 100% when subjected to water absorption. The materials can be purchased as small discs and rods. For example, the hydrophilic material can include a copolymer of hydroxyethyl methacrylate (HEMA) and methyl methacrylate (MMA), such as CI18, CI21, or CI26 produced by Contamac Ltd., UK. The material may alternatively be comprised of a copolymer of HEMA and EOEMA, such as poly(2-ethyloxyethyl methacrylate), which is available as BENZ IOL 25 or BENZ IOL 25UVX from Benz Research, 6447 Parkland Drive, Sarasota, FL (34243), USA. These materials are also referred to herein as PMMA, and as used herein, PMMA refers to a polymer comprising PMMA or a copolymer comprising PMMA, such as one or more of PMMA polymers (also referred to herein as "poly(methyl methacrylate)"), or a copolymer of HEMA and PMMA, such as p(HEMA-co-MMA). As used herein, p(HEMA-co-MMA) refers to a copolymer of HEMA and PMMA, and may also be referred to as p(HEMA-MMA).

[0124] The copolymer may comprise one or more of a block copolymer (PPPP-HHHH), an alternating copolymer (PHPHPHPH), a statistical or random copolymer (PHPPHPHH), a star copolymer, a brush copolymer, or a graft copolymer, for example, wherein "P" represents "MMA" and "H" represents "HEMA".

[0125] In some embodiments, components of the hydrogel AIOL can be manufactured by 3D printing, including but not limited to any of the following common 3D printing processes: stereolithography (SLA), inkjet material jetting (IMJ), digital light processing (DLP), selective laser sintering (SLS), fused deposition modeling, or fused filament fabrication (FDM / FFF). Methods such as SLA, IMJ, and DLP may be particularly suitable for manufacturing AIOL elements composed of hydrogels (e.g., PMMA) and copolymers (e.g., HEMA). In such embodiments, the starting material may be a monomer or oligomer precursor of a hydrogel polymer, or a combination thereof. One such polymer that can be used to prepare the AIOL described herein may include pHEMA, wherein the polymerization reaction may be photo-initiated by a UV source of appropriate wavelength and duration. In some such embodiments, photo-initiation may be further enhanced by adding a photoinitiator compound mixed with the monomer used for printing. Such photoinitiators may release additional free radicals upon irradiation, thereby increasing the rate of the polymerization reaction. A list of photoinitiators is listed below.

[0126] In some embodiments, the complete AIOL can be manufactured by a 3D printing process, and the unpolymerized material inside the optical structure can be removed after the build is complete. Alternatively, or in combination, the unpolymerized material inside the optical structure can be treated so that the reactive end groups do not react to prevent further polymerization. In other embodiments, the AIOL structure can be manufactured into subassemblies for subsequent assembly, as described elsewhere herein for machined parts.

[0127] As used herein, a positive curvature of an outer surface comprises a convex curvature and a negative curvature of an outer surface comprises a concave curvature.

[0128] As used herein, like reference numerals refer to like structures. In many embodiments as described herein, reference numerals include three or four digits, where the first one or two digits refer to the number of the figure, and the last two digits refer to similar structures in the figures with different digits. For example, reference numerals 105 and 1205 refer to Figure 1 A similar deflectable member as in Figure 12. One of ordinary skill in the art will recognize that text describing structures of one figure can be applied to similar structures of any other figure provided herein.

[0129] In some embodiments, the intraocular lens, lens system, and / or other components of the fluid chamber defining the optical structure are filled with a water-based transparent fluid having a refractive index higher than that of water to increase the optical power of the system. The high refractive index of such fluids may be due to the presence of solutes, such as macromolecules that cannot pass through the chamber-defining components. Examples of suitable macromolecules include dextran, which has an exemplary molecular weight of <40kD, <70kD, <500kD, and <1000kD. Other examples of suitable solutes include sugar molecules. The solute and water may form a dilute solution with an osmotic pressure, for example, which causes water to move into or out of the chamber to achieve an osmotic equilibrium volume. The osmotic equilibrium volume may be sufficient to produce an appropriate optical power in the system to achieve the power required by the patient.

[0130] The soft material of the optic of the AIOL can be formed in one or more of a variety of ways, and may include, for example, machined components, molded components, or a combination thereof.

[0131] An AIOL according to the present technology may have a reduced delivery cross section. The reduced delivery cross section may be facilitated by an optical structure that is capable of transitioning from a delivery configuration to an operational configuration. The optical structure may have a small dimension along the optical axis in the delivery configuration and a larger dimension along the optical axis in the operational configuration. Moreover, the lens support structure may be configured to maintain a distance between the peripheries of the two optical components in the operational configuration and allow fluid to pass between the haptic structure and the fluid volume defined by the optical structure in either configuration.

[0132] The delivery cross section can be achieved by folding or rolling the AIOL around a delivery axis perpendicular to the optical axis. The delivery cross section can be measured as the maximum dimension in the delivery configuration measured in a plane perpendicular to the delivery axis. The delivery cross section achievable for several embodiments of the AIOL disclosed herein can be less than 4.5 mm, and preferably less than 2.5 mm. In alternative embodiments, the delivery cross section can be achieved by forcing the AIOL through a tube or delivery aperture. The cross section of such a tube can be conical so that the AIOL can be compressed as it travels down the tube. The size of the distal end can be designed to interface with an incision in the eye. Delivery can be facilitated by a syringe or piston.

[0133] The intraocular lens system may be composed of at least two PMMA optical components, wherein PMMA refers to a compound comprising one or more of, for example, poly(methyl methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (PHEMA), (hydroxyethyl) methacrylate (HEMA), or methyl methacrylate (MMA). The lens system may include other elements composed of any one or any combination of the following materials: NiTi, polyurethane, hydrophilic PMMA, photoactivated polymer, PMMA precursor, ethylene glycol dimethacrylate (EGDMA), siloxane, siloxane copolymer, etc.

[0134] One or more optical components, such as the substantially planar member or plano-convex member, may comprise a polymeric material. The polymeric material may comprise, for example, materials available from Contamac Ltd., UK or Vista Optics Ltd., UK. For example, the PMMA copolymer can be selected from the list including the following materials: Definitive 50 material, Definitive 65 material, Definitive 74 material, Filcon V3 material, Filcon V4 material, Filcon V5 material, Optimum Classic material, Optimum Comfort material, Optimum Extra material, Optimum Extra 16 material, Optimum Extra 18.25mm material, Optimum Extra 19mm material, Optimum Extra21mm material, Optimum Extreme material, F2 material, F2 Low material, F2 Mid material, F2 High material, Focon III2 material, Focon III3 material, Focon III4 material, Hybrid FS material, Contaflex GM Advance material, Contaflex GM Advance 49% material, Contaflex GM Advance 58% material, Filcon I 2 material, Filcon II 2 material, Contaflex GM349% material, Contaflex GM358% material, Contaflex material, Contaflex 58% material, Contaflex 67% material, Contaflex75% material, Polymacon38% material, Hefilcon 45% material, Methafilcon 55% material, Filcon II material, Filcon IV 2 material, HI56 material, PMMA material, CI26 material, CI26Y material, CI18 material, and other variants available from Contamac Ltd., UK, and Vistaflex GL 59 material, HEMA / GMA material, Advantage+49 material, Advantage+59 material, Filcon I1 material, Filcon 12 material, VSOnVP material, nVP / MMA material, VSO60 material, VSO68 material, VSO75 material, FilconII 1 material, FilconII2 material, VSOpHHEMA material, pHHEMA material, HEMA material, VSO38 material, VSO42 material, VSO50 material, Vistaflex 67 transparent UV material,Polysiloxy-acrylate materials, AddVALUE silicone acrylate materials, AddVALUE 18 materials, AddVALUE 35 materials, poly-fluoro-silicon-acrylate materials, AddVALUE fluorosilicone acrylate materials, AddVALUE 25 materials, AddVALUE 50 materials, AddVALUE 75 materials, AddVALUE 100 materials, Scleral rigid gas permeable materials, hydrophobic intraocular lens materials, VOPhobic Clear Tg16 materials, VOPhobic Yellow Tg16 materials, hydrophilic intraocular lens materials, HEMA-MMA copolymer materials, IOSoft materials, IOSoft clear materials, IOSoft yellow materials, PMMA materials, Vistacryl CQ UV materials, Vistacryl XL blue materials, Vistacryl CQ materials, and other variants available from Vista Optics Ltd. in the United Kingdom. Generally, the polymeric material can be water permeable and / or hydrophilic. Water present in the lens capsule of the patient's eye can be transferred into or out of the fluid optical element through the polymeric material to achieve osmotic equilibrium with the fluid present in the lens capsule when the intraocular lens is placed therein. The polymeric material can be impermeable to silicone oil. The polymeric material can be impermeable to compounds with a molecular weight greater than 40 kDa.

[0135] In some embodiments, an AIOL according to the present technology is inserted into a natural capsule and interfaced with the natural capsule such that the interfaced area forms a seal that forms a toroidal region of the capsule. In operation, fluid transfer between the toroidal region and the interior of the AIOL causes a change in accommodation of the AIOL. In such embodiments, a fluid such as saline may be injected into the toroidal region.

[0136] In some embodiments, an optical component of the lens support structure and the accommodative optical structure is machined or molded into a single structure, and a fixed-power lens is attached to the support structure by bonding. In many other embodiments, the accommodative optical structure and the fluid-based haptic structure of the AIOL are composed of two halves, each half containing an optical component of the accommodative optical structure and a portion of the haptic structure. The two halves are bonded together to form the optical structure and the haptic structure. In other embodiments, a second machining operation can be performed on the bonded structure. Alternative bonding methods may include mechanical connections, such as threads, in which the outer periphery of the lens is threaded and the inner surface of the support structure is threaded. In alternative embodiments, the connection may be a simple interference fit. In some embodiments, attachment includes bonding materials by treating one or two separate bonding surfaces with one or more precursor monomers, one or more short-chain polymers, or one or more partially pre-polymerized base polymers, then assembling the structure, applying a load on the bonding surface, and heating the assembly for a period of time. This process can promote cross-linking between the materials comprising the two components. In some cases, the precursor monomers can be mixed with the polymer of the small particles. In addition, other binders can include urethanes, silicones, epoxies, and acrylics.

[0137] In the devices of the present disclosure, the lens may be composed of a water and ion permeable material. In some embodiments, the AIOL may be allowed to self-fill after implantation, thereby minimizing the delivery cross section.

[0138] In an alternative embodiment, the AIOL is filled after implantation.

[0139] Prior art implementation scheme

[0140] Figure 1 A cross-section of a radially symmetric AIOL 100 is shown, comprising a fixed lens 130 and an accommodative structure 140 . Figure 1 The embodiment of the adjustable structure 140 shown in FIG. 1 includes a first component 140 a and a second component 140 b that together define an internal optical structure 142 and an external fluid reservoir 103 .

[0141] 100 AIOL

[0142] · 101 connector

[0143] · 102 columns

[0144] 103 External fluid reservoir

[0145] 105 fluid chambers

[0146] 107a The first annular rigid region

[0147] 107b Second annular rigid region

[0148] · 108 bellows

[0149] · 109a First Fold

[0150] 109b Second Fold

[0151] 110 First optical component

[0152] · 130 Fixed lens

[0153] 131 interfacing feature

[0154] · 133 Raised Space

[0155] 134 relief

[0156] · 140 regulatory structures

[0157] · 140a First component

[0158] 140b Second component

[0159] 142 Internal optical structure

[0160] 150 Second optical component

[0161] Several embodiments of the AIOL 100 may have a base power associated with the power of the fixed lens 130, but when the accommodative structure 140 is in a relaxed state (i.e., when no pressure is applied to the external fluid reservoir 103), then there is no base power associated with the accommodative structure 140. The first component 140a and the second component 140b may be attached to each other at the seam or joint 101 using a bonding agent such as described elsewhere herein. The first and second components 140a-b may optionally be attached at the junction between the protrusions 102 (also referred to herein as posts).

[0162] The protrusion 102 may be located on an inner surface of one or more of the first component 140a and the second component 140b. The protrusion 102 may, for example, separate the first and second components 140a, 140b as described elsewhere herein. The joint 101 may extend circumferentially around the outer periphery of the first component 140a and the second component 140b.

[0163] The external fluid reservoir 103 may have a bellows 108, and the internal optical structure 142 has an internal fluid chamber 105 in fluid communication with the external fluid reservoir 103. The bellows 108 may be formed by an outer region of the first component 140a and an outer region of the second component 140b. The bellows 108 may include one or more compliant folds 109 (individually identified as 109a and 109b) that extend continuously circumferentially around the optical axis of one or more of the first and second components 140a, 140b. The one or more folds 109a, 109b in the first and second components 140a, 140b may extend, for example, toward each other to define an inner bellows region and an outer bellows region, respectively. Therefore, the external fluid reservoir 103 may have one or more folds 109a-b that define a fold region, and the fold region separates the inner bellows region and the outer bellows region. The bellows 108 may include a plurality of folds or pleats.

[0164] The internal fluid chamber 105 may be defined between the inner surface of the inner region of the first component 140a and the inner surface of the inner region of the second component 140b. More specifically, the first component 140a may have the first optical component 110 in its inner region, and the second component 140b may have the second optical component 150 in its inner region. Figure 1 The fluid chamber 105 shown in FIG. 1 may be at least partially defined by the first and second optical components 110 and 150. The bellows 108 may extend continuously circumferentially around the first and second optical components 110 and 150.

[0165] The protrusions 102 are disposed radially outward from the first and second optical components 110 and 150 (e.g., between the inner and outer regions of the first and second components 140a, 140b). The space between the protrusions 102 can be a fluid channel 149 or conduit between the outer fluid reservoir 103 and the inner fluid chamber 105. The outer fluid reservoir 103 and the inner fluid chamber 105 are thus in fluid communication with each other to provide optical power changes in response to changes in the shape of the lens capsule as previously described herein.

[0166] The first optical component 110 and / or the second optical component 150 may include a planar member. The first optical component 110 and / or the second optical component 150 may be a membrane without optical power in an unbiased state and / or a biased state. The first optical component 110 may include a deflectable planar member configured to deflect in response to a fluid transfer between the internal fluid chamber 105 and the external fluid reservoir 103. For example, when the bellows 108 is compressed and fluid is forced into the internal fluid chamber 105, the first optical component 110 of the first component 140a may deflect along the optical path to apply optical power to the internal optical structure 142. The deflection of the first optical component 110 may include changes in one or more dimensions and shapes of the internal fluid chamber 105, such as changes in the distance separating the inner surfaces of the first and second optical components 110 and 150. The internal optical structure 142 (at Fig. 10B The optical power (shown as area YY in FIG. 1 ) can be, for example, a factor in the change in optical power of AIOL 100. Second optical component 150 can be a planar member having a larger cross-section (i.e., thickness) than first optical component 110, and thus second optical component 150 can deform less than first optical component 110. Any such deformation of second optical component 150 can be accommodated by protrusions 134 in fixed lens 130. For example, protrusions 135 can be defined by grooves in fixed lens 130 so that solid surfaces in the optical field do not contact even during accommodation.

[0167] One or more of the interior regions of the first and second components 140a and 140b may include a shell, such as a non-planar shell (not shown). The first component 140a may include a front component and the second component 140b may include a rear component. Although shown as a planar member in the current embodiment, one or both of the optical components 110 and 150 may include a plano-convex member or another standard optical configuration that provides optical magnification. In any of the foregoing embodiments, at least one of the optical components is configured to deform as the optical fluid is transferred into the optical portion of the fluid chamber 105. In addition, the first component 140a and the second component 140b may include an annular rigid coupling region 107a and 107b, respectively, to inhibit radial movement of the first optical component 110 and the second optical component 150. The coupling region 107a-b combined with the fixation between the first and second components 104a-b at the protrusion 102 can effectively isolate the first optical component 110 and the second optical component 150 to prevent asymmetrical distortion (e.g., deformation) relative to the optical axis of the adjustable structure 140.

[0168] The second component 140b may further include a connection feature 131, which can fix the fixed lens 130 to the second component 140b, as shown. The fixed lens 130 can be configured to snap-fit ​​to the first or second component 140a, 140b. For example, the fixed lens 130 can snap-fit ​​to the first or second component 140a, 140b in situ in the patient's eye or otherwise couple to the first or second component 140a, 140b. The fixed lens 130 can, for example, have an inner surface facing and adjacent to the outer surface of the first or second component 140a, 140b, and the fixed lens 130 is coupled to the outer surface of the first or second component 140a, 140b. The fixed lens 130 can also have a peripheral protrusion 133. The interface feature 131 and the fixed lens 130 may also be configured such that an interface channel exists between the fixed lens 130 and the second component 140b to allow bodily fluid to flow freely into either of the raised spaces 134 and 133. The fixed lens 130 may, for example, comprise a third component of the AIOL 100. The fixed lens 130 may have an optical power.

[0169] One or more of the first and second components 140a, 140b may include a polymeric material as previously described herein. As previously described herein, the first and second components 140a, 140b may be sufficiently flexible to be folded into a reduced cross-sectional delivery configuration for delivery to the eye. As previously described herein, the first and second components 140a, 140b may be coupled to each other. The first and second components 140a, 140b may be manufactured as previously described herein. The third component or fixed lens 130 may be sufficiently flexible to be folded into a reduced cross-sectional delivery configuration for delivery to the eye, and as described above, the fixed lens 130 may be fixedly coupled to the first or second component 140a, 140b in situ.

[0170] AIOL 100 can be filled with a fluid, such as any of the fluids previously described herein. The fluid in internal fluid chamber 105 can provide optical power to accommodative structure 140 .

[0171] The bellows 108 may include a continuous baffle structure disposed around the periphery of the inner fluid chamber 105. As previously described elsewhere herein, the continuous structure of the bellows 108 may be annular, elliptical, and rotationally symmetric in shape.

[0172] The size and geometry of the accommodative lens systems described herein may vary. For example, Figure 2 An alternative AIOL 200 is shown.

[0173] · 200 AIOL

[0174] · 240a First Component

[0175] · 240b Second component

[0176] · 201 connector

[0177] · 202 columns

[0178] · 203 External fluid reservoir

[0179] · 205 Fluid Chamber

[0180] · 207a First annular rigid region

[0181] · 207b Second annular rigid region

[0182] · 208 bellows

[0183] 210 First optical component

[0184] · 230 Fixed lens

[0185] · 231 connection features

[0186] · 233 Raised space, lens attachment features

[0187] · 234 convex space, deformation chamber

[0188] 250 Secondary Optical Components

[0189] AIOL 200 includes structures similar to AIOL 100, and the last two digits of the reference numerals identify similar structures. AIOL 200 may have a second component 240b having a second optical component 250 that is thinner than second optical component 150. Therefore, second optical component 250 can be deformed in a manner that increases the accommodative optical power of AIOL 200 compared to AIOL 100. Additional deformation of the thin second optical component 250 may occur within the deforming protrusion 234 in the second optical component 250, rather than within the fixed lens 130 in AIOL 100. In another embodiment (not shown), AIOL 200 may have the deforming protrusion 234 in the second optical component 150 and the deforming protrusion 134 of the fixed lens 130 of AIOL 100 in the same device. AIOL 200 may also include an external fluid reservoir 203 that includes two folds only in the first component 140a of AIOL 200. For example, the outer region of the first component 240a may define a bellows 208 having two folds 209, while the outer region of the second component 240b does not (eg, a flat portion).

[0190] In other embodiments, the geometry of the fluid chamber or bellows or other fluid reservoir structure may be varied. For example, Figure 3 AIOL 300 is shown, which is similar in structure to AIOL 200, where the last two digits of the reference numerals identify similar structures. AIOL 300 includes an external fluid reservoir 303 that extends continuously and circumferentially around an internal fluid chamber 305 and rigid annular regions 307a-b. External fluid reservoir 303 has a rectilinear cross-sectional shape. Thus, AIOL 300 has a fold-less bellows 308 that drives fluid into or receives fluid from internal fluid chamber 305.

[0191] · 300 AIOL

[0192] · 340a First Component

[0193] 340b Second component

[0194] · 301 connector

[0195] · 302 columns

[0196] · 303 External fluid reservoir

[0197] · 305 Fluid Chamber

[0198] · 307a Annular rigid area-a

[0199] · 307b Annular rigid area-b

[0200] · 308 bellows

[0201] · 310 First optical component

[0202] · 330 Fixed lens

[0203] · 331 connection features

[0204] · 333 Raised space, lens attachment features

[0205] · 334 convex space, deformation chamber

[0206] 350 Second optical components

[0207] The various peripheral fluid-filled bellows 108, 208, 308 of AIOLs 100, 200, and 300, respectively, provide control over the stiffness of the external fluid reservoir. This allows the AIOL to provide the desired accommodation based on the forces exerted on the structure by the eye and the resulting accommodation.

[0208] Figure 4A , 4B, and 4C illustrate an AIOL 400 that is similar to embodiments of AIOLs 100, 200, and 300 above, where the last two digits of the reference numerals identify similar structures.

[0209] 400 AIOL

[0210] · 440a First Component

[0211] · 440b Second assembly element

[0212] 440c outer ring element

[0213] · 401 connector

[0214] · 402 columns

[0215] 403 External fluid reservoir

[0216] 405 Fluid Chamber

[0217] · 407a Annular rigid area

[0218] · 407b Annular rigid area

[0219] · 408 bellows

[0220] 410 First optical component

[0221] · 430 Fixed lens

[0222] · 431 connection features

[0223] · 433 raised space

[0224] · 434 raised space

[0225] · 435 locking mechanism

[0226] 450 Second Optics

[0227] The AIOL 400 may have four major components, including: a first component 440a; a second component 440b; a fixed lens 430 defining a third component; and an outer ring element 440c defining a fourth component (e.g., a thin-walled ring). The outer ring element 440c may be attached to the first component 440a and the second component 440b at a seam or joint 401 to couple the first and second components 440a, 440b to each other at their peripheries. The outer ring element 440c, the first component 440a, and the second component 440b may collectively define an external fluid reservoir 403 in fluid communication with the fluid chamber 405 of the accommodative structure 440. The outer ring element 440c may be made of a material having different material properties than the remaining components of the structure. In some embodiments, the outer ring element 440c may be made of a form of polymer that is used to make the first component 440a and the second component 440b having a reduced elastic modulus. Thus, the outer ring element 440c is easier to manufacture, and it may have a thinner cross-section than otherwise. Alternatively, or in combination, the outer ring element 440c may be spin cast or centripetally cast, thereby allowing a thinner structure than may be obtained by machining.

[0228] AIOL 400 may have a fixed lens 430 including a convex-concave configuration. Fixed lens 430 may be attached to second component 440b by a locking mechanism 435 that interlocks with abutment feature 431. AIOL 400 may have a protrusion 434 created by compensating locking mechanism 435 and the convex surface of fixed lens 430.

[0229] Figure 5 AIOL 500 is shown which is a variation of AIOL 400 and the last two digits of the reference numerals identify similar structures.

[0230] 500 AIOL

[0231] 501 connector

[0232] · 540 regulatory structures

[0233] · 540a First Component

[0234] 540b Second component

[0235] 540c Outer Ring

[0236] 570 slots

[0237] AIOL 500 has a first interface between first component 540a and outer ring 540c, and a second interface between second component 540b (not visible) and outer ring 540c. The first and second interface regions may have slots 570 to increase the flexibility of the peripheral portion of AIOL 500. Slots 570 may be made in the structural assembly including AIOL 500 before or after the assembly is assembled. When slots 570 are added after the structure has been assembled, slots 570 may be constructed by one or more of mechanical cutting, laser cutting, and any other suitable means. Slots 570 may be constructed so that they extend partially down to the seam, so that a portion of the seam remains uncut and the seam between AIOL components remains intact.

[0238] Fig. 6A , 6B and 6C illustrate various aspects of AIOL 600 , which is an additional embodiment of an AIOL similar to the embodiments of AIOLs 100 , 200 , 300 , 400 , and 500 .

[0239] 600 AIOL

[0240] 640a First Component

[0241] 640b Second component

[0242] · 601 connector

[0243] 603 External fluid reservoir

[0244] 603a Internal continuous bellows

[0245] 603b External continuous bellows

[0246] · 607 Annular rigid area

[0247] · 608 bellows

[0248] 610 first optical component or planar member

[0249] · 612 Fluid-accommodating lens

[0250] 620 through hole

[0251] 630 Fixed lens

[0252] · 631 Connecting feature or fixed lens receptor

[0253] · 640 regulatory structures

[0254] 641 Aqueous chamber

[0255] · 649 fluid channels

[0256] 650 Second optical component or optical film

[0257] · 651 right angle edges

[0258] 653 B-side AIOL

[0259] · 654 Fixed Lens Receiver

[0260] · 655 coupling pin

[0261] · 656 Combination Pin Receiver

[0262] 657 Stand off

[0263] AIOL 600 consists of three main structures ( Figure 6B ), the three main structures include (a) fixed lens 630, (b) first component 640a, and (c) second component 640b. The first and second components 640a and 640b are joined together at seam 601 to define Fig. 6A A cross-sectional view of the external fluid reservoir 603 is shown.

[0264] The first component 640a has a fixed lens receiver 631 ( Figure 6C ) and an aqueous humor chamber 641. The fixed lens 630 is attached to a first component 640a at the fixed lens receiver 631, and the fixed lens 630 may have at least one through hole 620 that allows aqueous fluid in the lens capsule to flow into and out of the aqueous humor chamber 641. The first component 640a may be the anterior portion of the AIOL 600, and the lens receiver 631 may be configured to identify and provide the correct fixed lens power for the patient at the time of surgery after the accommodative portion 640 (i.e., the first and second components 640a and 640b) have been placed in the native eye capsule. After the accommodative portion 640 has been implanted in the native eye capsule, the fixed lens 630 may be selected so that the optical power of the fixed lens 630 compensates for any optical power displayed by the accommodative structure 640 in a relaxed capsule. This aspect of AIOL 600, as well as several other AIOLs described herein, is possible because first component 640a is the anterior portion of AIOL 600.

[0265] After implanting the accommodative structure 640, a fixed lens 630 may also be selected to adjust the patient's refractive requirements. For example, the accommodative structure 640 may change the patient's refractive requirements, and thus selecting a fixed lens 630 after implanting the accommodative structure 640 may allow the medical practitioner to meet the patient's refractive requirements using the fixed lens 630.

[0266] Another feature of AIOL 600 is the manner in which first component 640a is attached to second component 640b ( Figure 6C ). The first component 640a includes a coupling pin 655, and the second component 640b includes a coupling pin receiver 656 configured to receive (eg, mate with) the coupling pin 655. The first component 640a further includes a support 657 ( Figure 6B ), the mount forms a fluid chamber 612 between the first optical component 610 and the second optical component 650 when the first and second components 640a and 640b are attached together ( Fig. 6A ). When the optical fluid is in the fluid chamber 612, the optical fluid defines an accommodative lens defined between the first optical component 610 and the second optical component 650. When the first and second components 640a and 640b are assembled, the fluid can flow into and out of the fluid chamber 612 through a separate fluid channel 649 defined by the space between the support 657 and the engaging pin 655.

[0267] Another feature of AIOL 600 is the distance between fixed lens 630 and first optical component 610, which defines aqueous humor chamber 641 ( Fig. 6A ). The fixed lens 630 is spaced apart from the first optical component 610 so that the first optical component 610 can be deflected forwardly (shown in dashed lines) by a sufficient amount to provide the desired accommodation. The distance between the first optical component 610 and the fixed lens 630 in the unbiased planar state (shown in solid lines) can be 1 μm to 4000 μm, or in some applications 4 μm to 800 μm.

[0268] The first and second optical components 610 and 650 may be planar members, such as optical films, and they may be placed by matching with the first and second components 640a and 640b, such as Figure 6C As shown. AIOL 600 may further include a square annular region 651 that provides a barrier to cell migration from the periphery of the patient's capsule to the optical field of view of AIOL 600. Fig. 6A As shown, the square annular region 651 may define a sharp angle in the rearmost region of the lens to inhibit cell migration that may cause postoperative optic opacity.

[0269] Fig. 7A and7B An embodiment of a second component 740b is shown, which can be used Figures 6A-6C More specifically, the AIOL 600 shown in FIG. Fig. 7A and 7B The second component 740b is shown to replace the second component 640b of the AIOL 600.

[0270] 703 External Fluid Reservoir

[0271] 740b Second component

[0272] 750 Second Optical Components

[0273] 756 Receiver

[0274] 757 support

[0275] 760 Thickening feature

[0276] Another feature of AIOL 600 is the distance between fixed lens 630 and first optical component 610, which defines the depth of aqueous chamber 641 (FIG. 6a). Fixed lens 630 is spaced apart from first optical component 610 so that first optical component 610 can be deflected forward (shown in dashed lines) a sufficient amount to provide the desired accommodation. The distance between first optical component 610 and fixed lens 630 in the unbiased flat state (shown in solid lines) can be 0.2 mm-2.0 mm, or in some applications can be 0.4 mm-0.8 mm.

[0277] Fig. 7A and 7B The top view and the cross-sectional side view of the second assembly 740b are shown respectively. The second assembly 740b includes a thickening feature 760, which defines a part of the external fluid reservoir 703b. The thickening feature 760 provides a longer material path to enter the interior of the complete assembly via a needle or a tubular member to inject fluid into the interior of the assembly. The longer path of the base material (bulk material) of the needle passing through the thickening feature 760 provides more surface area to seal the path when the needle is removed. This may eliminate the need for additional sealing measures after removing the needle. As shown, the second assembly 740b also includes an alternative binding pin receiving feature 756, which is composed of a groove relative to the hole realized in the binding pin receiver 656 of the AIOL 600.

[0278] Figure 8 An embodiment of an AIOL 800 is shown that is similar to the embodiments of the AIOL and components shown in FIGS. 6 and 7 . Figure 8, multiple structures are identified by multiple reference numbers, and the last two digits of the reference numbers identify structures similar to those described in the embodiments of AIOL 600 and 700.

[0279] 800 AIOL system

[0280] 801 Seams

[0281] 803 External fluid reservoir

[0282] 810 First optical component

[0283] 812 Fluid chamber, fluid-accommodating lens

[0284] 830 Fixed lens

[0285] 831 Fixed Lens Receiver

[0286] 840 Regulatory structures

[0287] 840a First Component

[0288] 840b Second component

[0289] 850 Second Optical Component

[0290] 851+ annular areas

[0291] 855 Support

[0292] 856 continuous receiver rings

[0293] 860 Thickening feature

[0294] AIOL 800 includes multiple square annular regions 851. For example, AIOL 800 may have four circular, square edge regions 851 incorporated into the posterior (P) and anterior (A) regions of external fluid reservoir 803. Square regions 855 may further inhibit cell migration associated with posterior capsule opacification. In addition, Figure 8 The embodiment of AIOL 800 shown in FIG. 7 incorporates two thickened features 860 into the second component 840b to allow fluid inflow and fluid outflow during the filling process. These thickened features 860 are shown in cross-section and subtend to a circumferential angle similar to the circumferential angle of thickened features 760 ( FIG. 7 ). In another variation of the embodiments of AIOL 600 and 700, the first component 840a includes a seat 855, and the second component 840b includes a continuous receiver ring 856 connected to the seat 855.

[0295] Fig. 9A10A-C and 10A-C respectively show embodiments of AIOL 900 and 1000 similar to AIOL 600, 700, 800, in which additional features are incorporated to enhance performance. Fig. 9A -C and 10A-C, and the last two digits of the reference numerals are the same as those in the above reference numerals. Fig. 6A -A structure similar to the structure described in B.

[0296] 900 AIOL

[0297] 903 External Fluid Reservoir

[0298] · 920 channels

[0299] 930 Fixed lens

[0300] 940 Regulatory structures

[0301] 940a First Component

[0302] 940b Second component

[0303] 955 Coupling Pin

[0304] 956 Coupling Pin Receiver

[0305] 960 Thickening feature

[0306] 966 capsule rotation constraints

[0307] 967 Receiver

[0308] 968 keys

[0309] · 969 Complex surface indexing mark

[0310] 970 Complex surface indexing features

[0311] 1000 AIOL

[0312] 1003 External fluid reservoir

[0313] · 1030 Toric Fixed Lens

[0314] 1040 Regulatory Structure

[0315] 1040a First Component

[0316] 1040b Second Component

[0317] · 1055 support

[0318] 1056 Receiver Ring

[0319] 1060 Thickening feature

[0320] 1066 capsule rotation constraints

[0321] 1067 Receiver

[0322] 1068 keys

[0323] · 1070 Complex surface indexing features

[0324] Embodiments of AIOLs 900 and 1000 include capsule rotation constraint features 966 and 1066, respectively, which enhance performance when AIOLs 900 and 1000 have toric lenses. The toric lens may be located in either the accommodative portion or the fixed portion of the AIOL. Capsular rotation constraint features 966 and 1066 inhibit relative rotation between the optical components themselves and / or relative rotation relative to the capsule in which the optical components are implanted. As shown, the fixed lenses 930 and 1030 are toric lenses. Capsular rotation constraint 966 ( Fig. 9A and 9C ) and 1066( Fig. 10A and 10C ) is located around the outer periphery of the device to fit the lens capsule of the eye and inhibit rotation of the AIOL system within the native lens capsule. Capsular rotation constraints 966 and 1066 may be thickened portions of the first and / or second components 940a / 1040a or 940b / 1040b on the outer periphery of the AIOL 900 and 1000, respectively. Alternative embodiments of the capsular rotation constraint may include any feature that fits the native capsule more securely than other surfaces on the periphery of the AIOL to inhibit rotation of the AIOL relative to the native eye capsule. Alternatively, the AIOL 900 or 1000 may have only a single capsular rotation constraint 966 or 1066 or more than two capsular rotation constraints 966 or 1066.

[0325] In addition to the capsular rotational constraints 966 and 1066, the AIOLs 900 and 1000 may also include features that maintain the rotational orientation of the fixed lens 930 / 1030 relative to the accommodative structure 940 / 1040 of the AIOL 900 / 1000. The capsular rotational constraints 966 / 1066 may define a toric indexing feature of the AIOLs 900 and 1000 that references the rotational orientation of the fixed lens 930 / 1030 relative to the accommodative structure 940 / 1040. The fixed lens 930 of the AIOL 900 may also have a plurality of passages 920 defined by cutouts or holes along the perimeter of the fixed lens 930, and one of the passages 920 defines a receiver 967 in a position to guide the fixed lens 930 to proper orientation relative to the first component 940a. The first component 940a includes a key 968 located at a corresponding radial position to align the toric fixed lens 930. The receiver 967 and the key 968 together define a toric indexing feature 970. The fixed lens 930 may further include a toric indexing mark 969 on or within the fixed lens 930 that identifies which passage 920 defines the receiver 967 to be aligned with the key 968. Alternatively, rather than having a toric indexing mark 969, the key / receiver associated with the proper alignment may have a different shape (e.g., triangular) than other passages 920 in the lens (e.g., curved). Fig. 10B Another alternative embodiment is shown in which the receiver 1067 is a cutout or groove in the inner periphery of the first component 1040a, and the toric fixed lens 1030 includes a key 1068 configured to mate with the receiver 1067.

[0326] The thickened regions of the capsular rotation constraints 966 and 1066 of the AIOLs 900 and 1000 further provide a more rigid leading edge for the capsular rotation constraints 966 and 1066 of the AIOLs 900 and 1000. Fig.11The AIOL delivery device described herein is used when delivering the AIOL 900 and 1000 through a narrow bore constriction or tube of the AIOL delivery device. One of the thickened rotational constraints 966 and 1066 can be positioned as the leading edge of the AIOL system 900 and 1000, while the other can be positioned as the trailing edge when passing them through the narrow bore or tube of the delivery device. By having the thickened rotational constraints 966, 1066 define the leading edge during delivery, the front of the AIOL 900, 1000 can withstand greater pressure because the leading section of the AIOL 900, 1000 is compressed during delivery when the distal-most portion has entered the constriction area of ​​the delivery tool. Specifically, when the leading edge is compressed, the fluid trapped in the AIOL 900 and 1000 can cause the material to rupture. Therefore, increasing the thickness of the material at the leading edge can enable the AIOL 900 and 1000 to withstand the compressive forces during delivery. In some embodiments, AIOLs 900 and 1000 have only a single rotational constraint 966 / 1066.

[0327] Fig.11 Schematically illustrates how one of the thickened rotational constraints 966 of the AIOL system 900 operates in the distal tip of the delivery device 1100 during delivery. Fig.11 The last two digits of these reference numerals are similar to those in the above reference numerals. Figure 6A-10C The structure of the structure.

[0328] 1100 AIOL delivery device

[0329] 900 AIOL

[0330] 966 capsule rotation constraints

[0331] · 1175 Syringe Tip

[0332] 1176 Insert Funnel

[0333] · 1177 Plunger

[0334] 1178 Flexible distal tip

[0335] The AIOL 900 is shown properly oriented relative to the capsular rotational constraint 966 and entering the syringe tip 1175 for delivery. The AIOL 900 complies with the contraction of the delivery tool while being pushed through the insertion funnel 1176 by the flexible distal end 1178 of the plunger 1177. It should be understood that as the fluid in the AIOL 900 is compressed in the insertion funnel 1176, the internal pressure of the fluid in the AIOL 900 increases, and the thickened rotational constraint 966 at the leading edge provides more material to withstand the increase in pressure and avoid rupture of the leading end during delivery.

[0336] Figures 12A-12C An alternative AIOL 1200 is shown that includes at least one intermediate bellows attachment feature 1271 (eg, Figures 12B-12C 12, the last two digits of which are similar to those in the above reference numerals. Figure 6A-10C The structure of the structure.

[0337] 1200 AIOL

[0338] 1201 Seams

[0339] 1203 External fluid reservoir

[0340] 1205 Fluid Chamber

[0341] 1210 First optical component

[0342] · 1212 Fluid-accommodating lens

[0343] 1230 Fixed lens

[0344] · 1240a First Component

[0345] 1240b Second component

[0346] 1250 Second optical component

[0347] 1251 Square Ring Edge

[0348] · 1255 bearing

[0349] 1256 receiver ring

[0350] 1260 Thickening feature

[0351] 1266 capsule rotation constraints

[0352] 1271 Intermediate bellows attachment feature

[0353] 1271a First matching element

[0354] 1271b Second matching element

[0355] 1272 matching regions

[0356] AIOL 1200 is similar to the embodiments of AIOL 1000 described herein. For example, the illustrated embodiment of AIOL 1200 includes first and second components 1240a and 1240b, respectively, joined together at seam 1201 to define an external fluid reservoir 1203. AIOL 1200 further includes a fixed lens 1230, a first optical component 1210, a second optical component 1250, and a fluid chamber 1205 between the first optical component 1210 and the second optical component 1250. At least one of the first and second optical components 1210 and 1250 is deformable (e.g., capable of bending forward and / or backward), and in some embodiments, the first optical component 1210 is more deformable than the second optical component 1250. For example, the first optical component 1210 can be a thin, flexible member, while the second optical component 1250 is at least substantially rigid (e.g., does not bend in a manner that changes optical power). The first optical component 1210 and / or the second optical component 1250, in combination with the optical fluid in the fluid chamber 1205, define a fluid accommodating lens 1212. The AIOL 1200 also includes (a) a thickened feature 1260 that facilitates fluid delivery during the filling process, as described herein with respect to feature 760, and (b) a square annular edge 1251 that provides a barrier to inhibit migration of cells from the periphery of the patient's capsule into the portion of the AIOL 1200 in the optical pathway.

[0357] AIOL 1200 includes intermediate bellows attachment features 1271, each of which includes first and second matching elements 1271a and 1271b that are integrated into first and second components 1240a and 1240b, respectively. The first and second matching elements 1271a and 1271b are connected together at a matching region 1272. The intermediate bellows attachment features 1271 can be circumferentially distributed around the midsection of the external fluid reservoir 1203 at a plurality of spaced-apart locations. For example, at Figures 12A-12C In the embodiment of the AIOL 1200 shown in FIG, the intermediate bellows attachment features 1271 are evenly distributed at eight locations (not all shown) spaced around the midsection of the external fluid reservoir 1203, but the intermediate bellows attachment features 1271 are not limited to a particular number.

[0358] The intermediate bellows attachment feature 1271 provides a more efficient fluid transfer from the external fluid reservoir 1203 to the fluid chamber 1205 of the AIOL 1200. More specifically, without the intermediate bellows attachment feature 1271, when the pressure in the external fluid reservoir 1203 increases during adjustment, the apexes of the peripheries of the first and second components 1204a and 1204b may be separated from each other. The intermediate bellows attachment feature 1271 may limit undesirable or excessive expansion of the middle section of the external fluid reservoir 1203 by inhibiting the separation of the apexes of the peripheries of the first and second components 1204a and 1204b. Conversely, the intermediate bellows attachment feature 1271 may support the middle section of the external fluid reservoir 1203 to inhibit it from collapsing and retaining fluid in the external fluid reservoir 1203. As the pressure in the external fluid reservoir 1203 increases, the intermediate bellows attachment feature 1271 accordingly stabilizes the volume of the middle section of the external fluid reservoir 1203, thereby allowing more fluid to flow from the external fluid reservoir 1203 into the fluid chamber 1205, compared to without the intermediate bellows attachment feature 1271. This provides a more efficient transfer of accommodative fluid from the external fluid reservoir 1203 to the fluid chamber 1205 of the fluid accommodative lens 1212. Fig. 12B A cross section of AIOL 1200 is shown through two of the intermediate bellows attachment features 1271, Fig. 12C A cross section of AIOL 1200 is shown through two spaces between intermediate bellows attachment features 1271 that allow fluid to flow from external fluid reservoir 1203 to fluid chamber 1205 .

[0359] The intermediate bellows attachment feature 1271 is not limited to the above referenced Figures 12A-12C The AIOL 1200 is not used in the described embodiments, but may be incorporated into any suitable embodiments of an AIOL having an external fluid reservoir and fluid chamber as disclosed herein.

[0360] Additional embodiments of AIOL 1300, 1400, 1500, and 1600 are described in FIG. 13A to FIG. 16B , and each of AIOLs 1300, 1400, 1500, and 1600 includes flow features that facilitate material flow from the posterior side of the AIOL to the anterior side of the AIOL. These flow features can reduce or eliminate trapping or stagnation of material between the capsule and the posterior aspect of the AIOL. In particular, these flow features can increase the rate and ease of removal of an Ophthalmic Viscoelastic Device (OVD) used during implantation of the AIOL from the native lens capsule.

[0361] Figures 13A to 13J The AIOL 1300 shown in FIG. 1 includes two different flow features: a first flow feature is defined by an external overflow 1381 , and a second flow feature is defined by an internal overflow 1382 .

[0362] 1300 AIOL

[0363] 1301 Seams

[0364] · 1302 protrusions

[0365] 1303 External Fluid Reservoir

[0366] 1303a The first bellows structure

[0367] 1303b Second bellows structure

[0368] 1310 First optical component

[0369] 1305 Fluid Chamber

[0370] 1330 Fixed lens

[0371] 1331 Fixed Lens Receiver

[0372] · 1340a First Component

[0373] 1340b Second component

[0374] 1349 fluid channels

[0375] · 1351 Square Ring Edge

[0376] · 1355 support

[0377] 1356 Coupling Pin Receiver

[0378] 1360 Thickening feature

[0379] 1371 Intermediate bellows attachment feature

[0380] 1371a First matching element

[0381] 1 371b Second matching element

[0382] 1373 Intermediate bellows channel

[0383] 1381 External overflow, groove

[0384] 1382 Internal overflow, hole

[0385] The external overflow feature 1381 can be a detent, such as a groove, at an area around the periphery of the device. The internal overflow feature 1382 can be an intermediate bellows through hole that passes through the portion of the two intermediate bellows attachment features 1371 between the intermediate bellows channels. As shown, the internal overflow 1382 includes a circular hole, but in an alternative embodiment, the internal overflow 1382 can be a narrow slot. Although only two internal overflows 1382 are shown, the AIOL 1300 can include more than two internal overflows 1382. Generally, there can be as many internal overflows 1382 as there are intermediate bellows attachment features 1371. In some embodiments, the internal overflow 1382 can be added after the AIOL 1300 is manufactured by laser cutting or drilling, or in other embodiments, the internal overflow 1382 can be formed in the component before assembly (e.g., molded or cut into the component before assembly). Although two external overflows 1381 are shown, other embodiments of AIOL 1300 may include fewer or more than two overflows. Additionally, external overflows 1381 provide the rotational constraints described above with respect to embodiments of AIOL 1000.

[0386] 14 and 15 present AIOL implementations 1400 and 1500, respectively, having the following reference features:

[0387] 1400 AIOL

[0388] 1403 External Fluid Reservoir

[0389] · 1420 access

[0390] 1430 Fixed lens

[0391] 1432 Skirt

[0392] 1436 Optical parts

[0393] · 1440a First Component

[0394] 1473 Intermediate bellows channel

[0395] 1500 AIOL

[0396] · 1520 access

[0397] 1530 Fixed lens

[0398] · 1531 matching features

[0399] 1532 Skirt

[0400] 1536 Optical parts

[0401] · 1540a First Component

[0402] Embodiments of AIOL 1400 and 1500 have fixed lens assemblies 1430 and 1530, respectively, which (a) allow fluid to flow through the fixed lens assembly, (b) center the fixed lens assembly 1430 and 1530 in the device, and (c) enhance the structural rigidity of the interior region of the external fluid reservoir 1403. Fig. 14C The fixed lens assembly 1430 shown in the figure includes an optical portion 1436, a skirt 1432 extending from the optical portion 1436, and a passage 1420. The optical portion 1436 has a fixed power as described above, and the passage 1420 is a hole, slot, orifice, etc. that passes through the skirt 1432 and extends into the peripheral area of ​​the optical portion 1436. Fig.15A The fixed lens assembly 1530 shown in FIG. 1 may similarly include an optic 1536, a skirt 1532 extending from the optic 1536, and a passage 1520 passing through the skirt and into the peripheral region of the optic 1536. In these embodiments, as previously described, passages 1420 and 1520 provide for fluid transfer with respect to, for example, through-holes 620 described herein with reference to AIOL 600. Passages 1420 and 1520 also reduce the volume of the fixed lens to allow for delivery via a smaller delivery tool.

[0403] refer to Fig.14D and 14E , the skirt 1432 of the fixed lens assembly 1430 diverges radially outward from the anterior side A to the posterior side P of the AIOL 1400 (i.e., in the posterior direction, the skirt 1432 tilts outward to tilt away from the optical axis of the optical portion 1436). This allows the inner wall of the first component 1440a to retain the fixed lens assembly 1430. The AIOL 1400 may also include an intermediate bellows channel 1473 (e.g., Fig.14D and 14E ), the intermediate bellows passage 1473 allows fluid to flow from the external portion to the external fluid reservoir 1403 ( Fig.14E )’s internal part.

[0404] refer to Fig. 15C and 15D , the skirt 1532 of the fixed lens 1530 converges radially inward from the anterior side A to the posterior side P of the AIOL 1500 (i.e., in the posterior direction, the skirt 1532 is inclined inwardly to be inclined toward the optical axis of the optic). The AIOL 1500 further includes a lip (lip) 1531 around the anterior region of the fixed lens assembly 1530 to maintain the fixed lens assembly 1530 in a desired position.

[0405] During implantation, when the folded fixed lens is delivered into the eye after the accommodative portion has been delivered, the skirts center the fixed lens when unfolded and securely secure the fixed lens within the accommodative portion when fully expanded. More specifically, when the skirts 1432 and 1532 engage the first components 1440a and 1540a, the skirts 1432 or 1532 will automatically position the optical portions 1436 and 1536, respectively, at the desired position relative to the optical axis of the device. In addition, the height / depth of the skirts 1432 and 1532 will also space the optical portions 1436 and 1536, respectively, from the first optical components 1410 and 1510 of the accommodative lens by the desired distance. This will allow the medical practitioner to press the fixed lens assemblies 1430 and 1530 into the appropriate position without the risk of pushing the optical portions 1436 and 1536 too far into the first structural elements 1440a and 1540a.

[0406] Fig.16A and 16B An AIOL 1600 is shown that is similar to an embodiment of AIOL 1400. AIOL 1600 has a first component 1640a that includes at least one thickened portion 1668 on an inner wall that is shaped to interface with one or more passageways 1620 in a fixed lens assembly 1630.

[0407] 1600 AIOL system

[0408] 1601 Seams

[0409] 1603 External Fluid Reservoir

[0410] · 1603a The first bellows structure

[0411] 1603b Second bellows structure

[0412] 1610 First Optical Component

[0413] · 1620 access

[0414] 1630 Fixed lens

[0415] · 1632 Skirt

[0416] 1636 Optical parts

[0417] 1640 Regulatory structures

[0418] 1640a First Component

[0419] 1640b Second component

[0420] 1641 Chamber

[0421] 1650 Second optical component

[0422] 1651+ annular areas

[0423] · 1655 Support

[0424] 1656 Receiver Ring

[0425] 1668 Thickening part

[0426] 1671 Intermediate bellows attachment feature

[0427] 1673 Intermediate bellows channel

[0428] The interface between the thickened portion 1668 and the corresponding passage 1620 can securely fix the fixed lens 1630 in place and provide proper alignment of the fixed lens 1630 when the fixed lens 1630 includes a toric configuration. In such embodiments, the fixed lens 1630 can include any orientation markers described elsewhere herein.

[0429] Figures 17A-17G It has the following characteristics.

[0430] 1700 AIOL

[0431] 1701 Seams

[0432] 1703 External Fluid Reservoir

[0433] 1703a The first bellows structure

[0434] 1703b Second bellows structure

[0435] 1705 Fluid Chamber

[0436] · 1708 bellows

[0437] 1710 First Optical Component

[0438] · 1712 Space

[0439] · 1720 access

[0440] 1730 Fixed lens

[0441] · 1731 Fitting Features

[0442] 1732 Skirt

[0443] 1736 Optical parts

[0444] 1740 Regulatory structures

[0445] 1740a First Component

[0446] 1740b Second component

[0447] 1741 Chamber

[0448] 1749 fluid channels

[0449] 1750 Second optical component

[0450] 1751 Square Ring Edge

[0451] · 1755 Support

[0452] 1756 Receiver Ring

[0453] 1760 Fluid-filled thickening segments

[0454] 1768 Lens with thickened area

[0455] 1771 Intermediate bellows attachment feature

[0456] 1773 Intermediate bellows channel

[0457] 1781 External overflow feature

[0458] Fig.17A and 17B An embodiment of an AIOL 1700 is shown that includes an enhanced overflow feature 1781 to promote material flow from the posterior side of the AIOL 1700 to the anterior side of the AIOL 1700. In particular, the overflow feature 1781 can increase the rate and ease with which an ophthalmic viscoelastic device (OVD) used during implantation of the AIOL can be removed from the native lens capsule. Figures 17A-17E The embodiment of the AIOL 1700 shown in includes three external overflow features 1781. The external overflow features 1781 can be stops, such as grooves, distributed circumferentially along the periphery of the external fluid reservoir 1703. In the illustrated embodiment, the overflow features 1781 are formed in the area of ​​the first and second components 1740a and 1740b. Although three external overflow features 1781 are shown, other embodiments may include fewer or more external overflow features 1781 than shown. In addition, the external overflow features can provide rotational constraints as described herein with respect to the AIOL of embodiment 1000.

[0459] Additionally, embodiments of the AIOL 1700 include alternative designs for securing the lens assembly 1730 . Fig. 17C The fixed lens assembly 1730 shown in the Figure includes an optic 1736, a skirt 1732 extending from the optic 1736, and a passage 1720. The optic 1736 has a fixed power, which may include an asymmetncally powered lens or other lens as described herein, and the passage 1720 is a hole, slot, orifice, etc. that passes through the skirt 1732 and extends into the peripheral region instead of the optic 1736.

[0460] refer to Fig. 17C , the fixed lens assembly 1730 has a mating feature 1731 (e.g., an annular groove) extending around the skirt 1732, and the first component 1740a of the accommodative structure 1740 has a thickened area 1768, such as an annular protrusion (e.g., a ledge) extending radially inward. The fixed lens assembly 1730 can be attached to the accommodative structure 1740 by mating the continuous thickened area 1768 of the first component 1740a with the mating feature 1731 of the fixed lens 1730. In other embodiments (not shown), the thickened area 1768 and the mating feature 1731 can be discontinuous features (e.g., segmented or other grooves or protrusions extending around less than the entire circumference of the fixed lens assembly 1730 and the accommodative structure 1740). Such discontinuous thickened areas 1768 and mating features 1731 may be desirable, for example, when the fixed lens 1730 comprises a toric lens or other asymmetric lens, to maintain a particular radial alignment between the fixed lens assembly 1730 and the accommodative structure 1740. Alternatively, the grooves may be located in the fixed lens 1730 and may be located in protrusions on the accommodative structure 1740.

[0461] AIOL 1700 has a fluid chamber 1705 (defined between a first optical component 1710 and a second optical component 1750) Fig.17D and 17E ) is defined by a fluid-adjustable lens 1712. When the first and second components 1740a and 1740b are assembled, the fluid chamber 1705 is in fluid communication with the external reservoir 1703 via the dispersed fluid channel 1749 between the supports 1756. The first and second optical components 1710 and 1750 can be planar components (e.g., optical films) of the first and second components 1740a and 1740b, respectively, such as Fig.17EFor example, the first and second optical components 1710 and 1750 can be integrally formed as an optical film with the other parts of the first and second components 1740a and 1740b. In alternative embodiments, either or both of the films of the first and second optical components 1710 and 1750 can be a lens (i.e., having optical power).

[0462] The AIOL 1700 may further include a square annular region 1751 that inhibits cell migration from the periphery of the patient's capsule to the optic of the AIOL 1700 (at Fig.17D Such cell migration may lead to postoperative opacification of the optics.

[0463] The outer peripheral portion of the first component 1740a and the second component 1740b defines the external fluid reservoir 1703, and the inner portion of the first and second components 1740a and 1740b defines the adjustable structural element 1740. The first and second components 1740a and 1740b can be combined together at the seam 1701 in a manner as described elsewhere herein. The first and second components 1740a and 1740b can also be combined at other areas (for example, at the support 1755). The support 1755 is separated by a space defining a fluid channel 1749 between the external fluid reservoir 1703 and the internal fluid chamber 1705. The external fluid reservoir 1703 can be a bellows 1708 having an outer bellows region 1703a and an inner bellows region 1703b.

[0464] The external fluid reservoir 1703 has a smaller volume than the external fluid reservoirs of other AIOLs described herein, and in particular the volume of the inner bellows region 1703b is smaller than the outer bellows region 1703a. By reducing the volume of the inner bellows region 1703b, the additional space surrounding the optical zone of the AIOL allows the optical aperture of the fixed lens 1730 to be larger than that of an embodiment with a larger inner bellows region. In addition, the passage 1720 of the fixed lens 1730 (which allows aqueous humor to flow freely into and out of the chamber 1741) is configured to pass only through the outer skirt 1732 and not through the top optical portion 1736. This is expected to reduce unwanted stray light from internal reflections that can pass through the optical system and reach the retina.

[0465] The first component 1740a may also include one or more thickened regions 1760 for use in filling the AIOL with an optical fluid as described above with respect to, for example, AIOL 700. The thickened regions 1760 allow for a longer path for a needle used to fill the accommodative structure with an optical fluid, while a second needle in a different region is used to remove the gas that the fluid is displacing. As shown, the fluid-filled thickened regions 1760 are located near one or more external fluid overflows 1781.

[0466] See also Fig.17E , the external fluid reservoir 1703 of the AIOL 1700 may include (a) a first bellows structure 1703a having a front portion 1704a and a rear portion 1704b, (b) a second bellows structure 1703b radially inward of the first bellows structure 1704a, and (c) an intermediate bellows channel structure 1773 defining a horizontal passage between the first and second bellows structures 1703a and 1703b. During capsule contraction operation, the middle portion of the first bellows structure 1703a is constrained by the intermediate bellows channel 1773, while the front and rear portions 1704a and 1704b of the first bellows structure 1703a move radially inward relative to the intermediate bellows channel 1773. Thus, in response to the same amount of movement of the native bladder, the front and rear portions 1704a and 1704b of the first bellows structure 1703a will bend radially inward to a greater extent than some other external reservoir structures described above (e.g., Figure 1 This results in more fluid flowing from the external fluid reservoir 1703 to the internal fluid chamber 1705, thereby providing more regulation, because the front-to-back collapse of the external fluid reservoir 1703 is less efficient than radial compression of the external fluid reservoir 1703.

[0467] Fig.17F and 17G A channel 1744 is shown extending around the perimeter of the first and second components 1740a and 1740b to allow the space of the thickened portion 1760 to be larger than, for example Fig.13I and 13J The narrower thickened portion 1760 is more flexible than the thickened portion 1360, which enhances the amount of fluid transfer between the external fluid reservoir 1703 and the internal fluid chamber 1705 in response to the same amount of movement of the native bladder.

[0468] Although not shown, in some embodiments, a portion of the outer structure of the adjustable structure 1740, between the two outer overflow features 1781, may include a thickened portion that provides the improved delivery function described above with respect to the thickened feature 1668.

[0469] In some embodiments, the support 1755 may be bonded to the second component 1740b, and in alternative embodiments, the support 1755 may not be bonded to another component. In either case, the interaction of the skirt 1732 with the periphery of the second optical component 1750 will minimize non-uniform deformation in one or both of the first and second optical components 1710 and 1750 originating from their outer peripheries, and thus reduce optical aberrations.

[0470] In some embodiments not shown, the inner surface of the bellows region 1708 of 1740a and / or 1740b may include abutments that limit portions of the bellows from collapsing when compressed and forming a seal.

[0471] Figures 18A-18D An embodiment of an AIOL 1800 is shown in accordance with an embodiment of the present technology. Figures 18A-18D It has the following characteristics.

[0472] 1800 AIOL

[0473] 1801 Seams

[0474] 1803 External Fluid Reservoir

[0475] 1803a The first bellows structure

[0476] 1803b Second bellows structure

[0477] 1805 Fluid Chamber

[0478] · 1808 bellows

[0479] 1810 First Optical Component

[0480] · 1812 Liquid accommodative lens

[0481] · 1820 access

[0482] 1830 Fixed lens

[0483] · 1831 Matching features

[0484] 1832 Skirt

[0485] 1836 Optical parts

[0486] 1840 Regulatory structures

[0487] 1840a First Component

[0488] 1840b Second Component

[0489] 1841 Chamber

[0490] 1850 Second optical component

[0491] 1851 Square Ring Edge

[0492] · 1855 Support

[0493] 1857 Grooves

[0494] · 1858 wall

[0495] 1860 Liquid filled thickening part

[0496] 1868 Lens with thickened area

[0497] 1871 Intermediate bellows attachment feature

[0498] 1873 Intermediate bellows channel

[0499] 1881 External overflow feature

[0500] Fig.18A -D shows an embodiment of an AIOL 1800 that includes different channels for fluid flow from an external fluid reservoir to an internal fluid chamber. Fig.18B , AIOL 1800 has an adjustable structure 1840 having a first component 1840a and a second component 1840b. As described above, the first and second components 1840a and 1840b are assembled to form an external fluid reservoir 1803, an intermediate bellows channel 1873, and an internal fluid chamber 1805. The first component 1840a of the adjustable structure 1840 can have an inner portion having a first optical component 1810, seats 1855, and grooves 1857 between the seats 1855. The seats 1855 protrude radially outward from the grooves 1857. The second component 1840b of the adjustable structure 1840 can have an inner portion having a second optical component 1850 and a wall 1858. See Fig.18C and 18D , which are respectively along Fig.18A In the cross-sectional view taken along the lines AA and BB, the support 1855 contacts the wall 1858 ( Fig.18D ), so that the groove 1857 ( Fig.18B ) defines a channel for fluid to flow from the intermediate bellows channel 1873 to the fluid chamber 1805.

[0501] The interface between the support 1855 and the wall 1858 of the accommodative structure 1840 is different from the interface between the support 1755 and the second optical assembly 1750 described above with reference to the AIOL 1700. More specifically, the support 1855 projects radially outwardly from the mating wall 1858, while the support 1755 is located within the optical zone of the device and projects rearwardly. Therefore, the support 1855 of the AIOL 1800 does not extend into the optical zone of the AIOL, which increases the field of view of the AIOL 1800 compared to the AIOL 1700.

[0502] As with AIOL 1700 described above, AIOL 1800 includes an overflow feature 1881 that enhances the rate and ease with which an ophthalmic viscoelastic device (OVD) used during implantation of the AIOL can be removed from the native lens capsule. Figures 18A-18D The embodiment of the AIOL 1800 shown in includes three external overflow features 1881. The external overflow features 1881 can be stops, such as grooves, distributed circumferentially along the periphery of the external fluid reservoir 1803. In the illustrated embodiment, the overflow features 1881 are formed in the area of ​​the first and second components 1840a and 1840b. Although three external overflow features 1881 are shown, other embodiments may include fewer or more external overflow features than shown. In addition, the external overflow features can provide rotational constraints as described herein with respect to the AIOL of embodiment 1000.

[0503] Additionally, embodiments of AIOL 1800 include a fixed lens assembly 1830 . Fig. 18C The fixed lens assembly 1830 shown in FIG. 1-D includes an optical portion 1836, a skirt 1832 extending from the optical portion 1836, and a passage 1820. The optical portion 1836 has a fixed power, which may include an asymmetric power lens or other lens as described herein, and the passage 1820 is a hole, slot, injection hole, etc. that passes through the skirt 1832 and extends to the peripheral area instead of the optical portion 1836.

[0504] See also Fig.18C, the fixed lens assembly 1830 has a mating feature 1831, such as an annular groove, extending around the skirt 1832, and the first component 1840a of the accommodative structure 1840 has a thickened area 1868, such as an annular protrusion (e.g., a ledge) extending radially inward. The fixed lens assembly 1830 can be attached to the accommodative structure 1840 by mating the continuous thickened area 1868 of the first component 1840a with the mating feature 1831 of the fixed lens 1830. In other embodiments (not shown), the thickened area 1868 and the mating feature 1831 can be discontinuous features (e.g., segmented or other grooves or protrusions that extend around less than the entire circumference of the fixed lens assembly 1830 and the accommodative structure 1840). Such discontinuous thickened areas 1868 and mating features 1831 may be desirable, for example, when the fixed lens 1830 comprises a toric lens or other asymmetric lens, to maintain a particular radial alignment between the fixed lens assembly 1830 and the accommodative structure 1840. Alternatively, the grooves may be located in the fixed lens 1830 and the protrusions on the accommodative structure 1840.

[0505] AIOL 1800 has a fluid chamber 1805 ( Fig. 18C and 18D ) is defined by a fluid-adjustable lens 1812. When the first and second components 1840a and 1840b are assembled, the fluid chamber 1805 is in fluid communication with the external reservoir 1803 via a dispersed fluid channel 1849 between the supports 1855. The first and second optical components 1810 and 1850 can be planar members (e.g., optical films) of the first and second components 1840a and 1840b, respectively. For example, the first and second optical components 1810 and 1850 can be integrally formed as an optical film with other portions of the first and second components 1840a and 1840b. In alternative embodiments, either or both of the films of the first and second optical components 1810 and 1850 can be a lens (i.e., having optical power).

[0506] The AIOL 1800 may further include a square annular region 1851 that inhibits cell migration from the periphery of the patient's capsule to the optic of the AIOL 1800 (at Fig. 18C -D at the most posterior region of the lens). Such cell migration may lead to post-operative opacification of the optic system.

[0507] The outer peripheral portion of the first component 1840a and the second component 1840b defines an external fluid reservoir 1803, and the inner portion of the first and second components 1840a and 1840b defines an adjustable structural element 1840. The first and second components 1840a and 1840b can be combined together at the seam 1801 in a manner as described elsewhere herein. The first and second components 1840a and 1840b can also be combined at other regions (e.g., at the support 1855). The support 1855 is separated by a space defining a fluid channel between the external fluid reservoir 1803 and the internal fluid chamber 1805. The external fluid reservoir 1803 can be a bellows 1808 having an external bellows region 1803a and an internal bellows region 1803b, and the internal bellows region 1803b can be defined by a channel between the supports 1855.

[0508] The external fluid reservoir 1803 has a smaller volume than the external fluid reservoirs of other AIOLs described herein, and in particular, the volume of the internal bellows region 1803b is smaller than the external bellows region 1803a. By reducing the volume of the internal bellows region 1803b, the additional space surrounding the optical zone of the AIOL allows the optical aperture of the fixed lens 1830 to be larger than that of an embodiment with a larger internal bellows region. In addition, the passage 1820 of the fixed lens 1830 (which allows aqueous humor to flow freely into and out of the chamber 1841) is configured to pass only through the external skirt 1832 and not through the top optical portion 1836. It is expected that this will reduce unwanted stray light from internal reflections that can pass through the optical system and reach the retina.

[0509] The first component 1840a may also include one or more thickened regions 1860 for use in filling the AIOL with an optical fluid as described above with respect to, for example, the thickened regions 1860 of AIOL 700. The thickened regions 1860 allow for a longer path for a needle used to fill the accommodative structure with an optical fluid, while a second needle in a different region is used to remove the gas that the fluid is displacing. As shown, the fluid-filled thickened regions 1860 are located near one or more external fluid overflows 1881.

[0510] See also Fig.18D, the external fluid reservoir 1803 of the AIOL 1800 may include (a) a first bellows structure 1803a having a front portion 1804a and a rear portion 1804b, (b) a second bellows structure 1803b radially inward of the first bellows structure 1804a, and (c) an intermediate bellows channel structure 1873 that defines a horizontal passage between the first and second bellows structures 1803a and 1803b. During capsule contraction operation, the intermediate portion of the first bellows structure 1803a is constrained by the intermediate bellows channel 1873 while the front and rear portions 1804a and 1804b of the first bellows structure 1803a move radially inward relative to the intermediate bellows channel 1873. Thus, in response to the same amount of movement of the native bladder, the front and rear portions 1804a and 1804b of the first bellows structure 1803a will bend radially inward to a greater extent than some other external reservoir structures described above (e.g., Figure 1 1803) to a greater extent. This results in more fluid flowing from the external fluid reservoir 1803 to the internal fluid chamber 1805, thereby providing more regulation, because the front-to-back collapse of the external fluid reservoir 1803 is less efficient than radial compression of the external fluid reservoir 1803. Embodiments such as, but not limited to, any of the examples shown herein may be constructed of components where some or all of the portions not in the optical path XX have been dyed or treated to reduce light throughout to limit the ability of stray light entering the outer portions of the optical path to scatter into the optical path YY, such as Fig. 9B shown.

[0511] The fixed lens described in any of the embodiments described herein can be spherical, aspherical, toric, or any other known lens configuration. Alternatively, or in combination, the fixed stereoscopic lens can be plano-convex, convexo-concave, or biconvex. The fixed lens can be configured to have a positive or negative fixed power.

[0512] The fluid lenses described herein can be configured, for example, to have one or more accommodating surfaces, such as two accommodating surfaces.

[0513] In some embodiments, the optical fluid may be composed of high refractive index polyvinyl alcohol.

[0514] In some embodiments, instead of a membrane with no power, the accommodative structure may include one or more deformable lenses that deflect based on fluid pressure within an internal fluid chamber. Each or both of the deformable lenses may have a fixed power that may be positive or negative.

[0515] The multi-part AIOL device described herein can be implanted by preparing the eye and removing the native lens from the capsule in any appropriate manner. The fluid-filled structure can then be placed in the capsule of the eye. The patient's base optical power and / or astigmatism correction can then be assessed, and a fixed lens can be selected to provide the required basic power or astigmatism correction for the fluid-filled structure in the implanted state in the capsule of the eye. The specific fixed lens used to provide the basic power or astigmatism correction after implantation is then inserted into the fluid-filled structure of the previously implanted AIOL. The selected fixed lens can then be coupled to the fluid-filled structure in the eye capsule. This is possible in the AIOL of the present technology because the fixed lens is attached to the front first component of the AIOL. As described above, one or more of the fluid-filled accommodative structure or the fixed lens can each be flexible so that they can be reconfigured (e.g., folded) into a reduced profile delivery configuration for delivery into the lens capsule. In some cases, further corrections may need to be taken to the fixed portion after the surgical time. Such situations may occur anywhere from a few days to several years after surgery. At such a time, the patient may return to the physician and the fixed lens may be replaced with a new fixed lens having a different optical power or other prescription. In such a case, the new prescription may be characterized before or after the original fixed lens is removed. In some cases, the new fixed lens may be manufactured and implanted at the time of the examination, in other cases, the patient may return sometime after the examination to have the fixed lens implanted.

[0516] Several embodiments of the present technology are directed to a kit having an accommodative structure and a first fixed lens without an optical base power. The kit may further include one or more second fixed lenses with a variety of base powers or other optical properties. In practice, the accommodative structure may be implanted in the native eye capsule and the first fixed lens may be coupled to the accommodative structure. The optical properties of the implanted accommodative structure may then be evaluated in situ with the first fixed lens in place to determine the desired optical properties of the fixed lens. If the assembled accommodative structure and the optical properties of the first fixed lens without a base power are appropriate, the system may remain implanted without additional changes. However, if a different base power or some other optical properties are desired (e.g., a toric or other asymmetric optical device), a second fixed lens with the desired optical properties may be used to replace the first fixed lens without a base power, the second fixed lens being based on the optical properties of the implanted accommodative portion to which the fixed lens is attached.

[0517] In some embodiments, the fixed portion of the AIOL can be made of a different material than the accommodative portion. Such materials include hydrophilic or hydrophobic methacrylates or silicones and any other materials traditionally used for non-accommodative IOLs. The fixed lens can be made of a harder material than that used for the accommodative portion.

[0518] Any feature of the intraocular lens system described herein may be combined with any feature of other intraocular lenses described herein, and vice versa.In addition, several specific examples of implementations according to the present technology are set forth in the following examples.

[0519] Example

[0520] 1. An accommodative intraocular lens system, comprising:

[0521] an accommodative structure comprising a first optical component, a second optical component positioned rearward of the first optical component, an internal fluid chamber between the first and second optical components, and an external fluid reservoir fluidly coupled to the internal fluid chamber, wherein the external fluid reservoir surrounds at least a portion of the internal fluid chamber and is configured to interface with a native eye capsule such that fluid flows between the external fluid reservoir and the internal fluid chamber to move the first optical element for providing accommodation; and

[0522] A fixed lens is configured to be removably coupled to the accommodative structure such that the fixed lens is located anterior to the first optical assembly, wherein the fixed lens has a fixed optical power.

[0523] 2. The accommodative intraocular lens system of Example 1, wherein the fixed lens includes an optical portion and a skirt protruding from the optical portion.

[0524] 3. The accommodating intraocular lens system of Example 2, wherein the skirt comprises an annular wall protruding rearwardly from the optical portion.

[0525] 4. The accommodating intraocular lens system of Example 3, wherein the skirt glares rearwardly and radially outwardly from the optic.

[0526] 5. The accommodating intraocular lens system of any of Examples 3-4, wherein the fixed lens further comprises a passage through the skirt.

[0527] 6. The accommodating intraocular lens system of any of Examples 3-5, wherein the fixed lens further comprises a passage extending laterally through the skirt, and wherein the passage does not extend through the optic.

[0528] 7. The accommodating intraocular lens system of any of Examples 3-6, wherein the fixed lens includes a passageway.

[0529] 8. The accommodating intraocular lens system of any of Examples 1-7, wherein the fixed lens has positive optical power.

[0530] 9. The accommodating intraocular lens system of any of Examples 1-7, wherein the fixed lens has a negative optical power.

[0531] 10. The accommodating intraocular lens system of any of Examples 1-7, wherein the optical power of the fixed lens is zero.

[0532] 11. The accommodating intraocular lens system of any of Examples 1-10, wherein the fixed lens comprises an asymmetric lens.

[0533] 12. An accommodative intraocular lens system of any of Examples 1-11, wherein the optical structure has an anterior component and a posterior component, the anterior component includes a first optical component and a first peripheral region surrounding the first optical component, the posterior component includes a second optical component and a second peripheral region surrounding the second optical component, and wherein the first peripheral region is attached to the second peripheral region along a seam so that the first and second peripheral regions define an external fluid reservoir.

[0534] 13. An accommodative intraocular lens system of Example 12, wherein the external fluid reservoir includes a first bellows structure, a second bellows structure radially inward of the first bellows structure, and an intermediate bellows channel structure located between the first and second bellows structures, and wherein the intermediate bellows channel structure includes a transverse portion, and the first bellows structure has a front portion protruding forward from the transverse portion and a rear portion protruding rearward from the transverse portion.

[0535] 14. The accommodating intraocular lens system of example 13, wherein the anterior and posterior portions of the first bellows structure are configured to bend radially inward relative to an outermost segment of the lateral portion during operation.

[0536] 15. An adjustable structure of any of Examples 12-14, wherein at least one of the front portion or the rear portion includes a support located between the internal fluid chamber and the external fluid reservoir, the support defining a channel therebetween for allowing fluid to flow between the internal fluid chamber and the external fluid reservoir.

[0537] 16. The adjustable structure of example 15, wherein at least a portion of the support is coupled to the other of the front portion or the rear portion.

[0538] 17. The accommodating intraocular lens system of any of examples 1-16, further comprising a cell barrier located posterior to the rearmost portion of the external fluid reservoir.

[0539] 18. An accommodative intraocular lens system of any of Examples 1-11, wherein the external fluid reservoir includes a first bellows structure having a front portion and a rear portion, a second bellows structure radially inward of the first bellows structure, and an intermediate bellows channel structure defined by a horizontal passage between the first and second bellows structures, and wherein the middle portion of the first bellows structure is constrained by the intermediate bellows channel structure so that the front portion and the rear portion of the first bellows structure move radially inward relative to the intermediate bellows channel during operation.

[0540] 19. The accommodating intraocular lens system of any of examples 1-18, wherein the external fluid reservoir has a radially inward groove defining an external overflow feature.

[0541] 20. The accommodating intraocular lens system of any of examples 1-19, further comprising at least one thickened portion defining a path for a needle used to fill the accommodating structure with an optical fluid.

[0542] 21. An accommodative intraocular lens system, comprising:

[0543] an accommodative structure having an anterior portion and a posterior portion relative to a reference frame of a native eye, the anterior portion and the posterior portion defining (a) an optical structure having an internal fluid chamber and (b) an external fluid reservoir, wherein the external fluid reservoir is configured to interface with the native eye capsule such that fluid flows between the external fluid reservoir and the internal fluid chamber to change a shape of the optical structure; and

[0544] A fixed lens having a fixed optical power, wherein the fixed lens is configured to couple with and separate from an anterior portion of an accommodative structure when the accommodative structure is implanted in a native eye capsule.

[0545] 22. The accommodating intraocular lens system of example 21, wherein the fixed lens comprises an optical portion and a skirt protruding from the optical portion.

[0546] 23. The accommodating intraocular lens system of Example 22, wherein the skirt comprises an annular wall protruding rearwardly from the optical portion.

[0547] 24. The accommodating intraocular lens system of example 23, wherein the skirt glares rearwardly and radially outwardly from the optic.

[0548] 25. The accommodating intraocular lens system of any of Examples 22-24, wherein the fixed lens further comprises a passage through the skirt.

[0549] 26. The accommodating intraocular lens system of any of Examples 22-24, wherein the fixed lens further comprises a passage extending laterally through the skirt, and wherein the passage does not extend through the optic.

[0550] 27. The accommodating intraocular lens system of any of Examples 22-24, wherein the fixed lens includes a passageway.

[0551] 28. The accommodating intraocular lens system of any of Examples 21-27, wherein the fixed lens has positive optical power.

[0552] 29. The accommodating intraocular lens system of any of Examples 21-27, wherein the fixed lens has a negative optical power.

[0553] 30. The accommodating intraocular lens system of any of Examples 21-27, wherein the optical power of the fixed lens is zero.

[0554] 31. The accommodating intraocular lens system of any of Examples 21-30, wherein the fixed lens comprises an asymmetric lens.

[0555] 32. The accommodative intraocular lens system of any of Examples 21-31, wherein:

[0556] The front portion of the accommodative structure includes a first optical component and a first peripheral region surrounding the first optical component;

[0557] The rear portion of the accommodative structure includes a second optical component and a second peripheral region surrounding the second optical component; and

[0558] The first peripheral region is attached to the second peripheral region along a seam such that the first and second peripheral regions define an external fluid reservoir.

[0559] 33. An accommodative intraocular lens system of Example 32, wherein the external fluid reservoir includes a first bellows structure, a second bellows structure radially inward of the first bellows structure, and an intermediate bellows channel structure located between the first and second bellows structures, and wherein the intermediate bellows channel structure includes a transverse portion, and the first bellows structure has (a) a front portion protruding forward from the transverse portion and (b) a rear portion protruding rearward from the transverse portion.

[0560] 34. The accommodating intraocular lens system of example 33, wherein the anterior and posterior portions of the first bellows structure are configured to bend radially inward relative to an outermost segment of the lateral portion during operation.

[0561] 35. The adjustment structure of Example 32, wherein at least one of the front portion or the rear portion of the adjustable structure includes a support located between the internal fluid chamber and the external fluid reservoir, the support defining a channel therebetween for allowing fluid to flow between the internal fluid chamber and the external fluid reservoir.

[0562] 36. The adjustable structure of Example 35, wherein at least a portion of the support is coupled to the other of the front portion or the rear portion of the adjustable structure.

[0563] 37. The accommodating intraocular lens system of any of Examples 21-36, further comprising a cell barrier located posterior to the rearmost portion of the external fluid reservoir.

[0564] 38. An accommodative intraocular lens system of any of Examples 21-31, wherein the external fluid reservoir includes a first bellows structure having a front portion and a rear portion, a second bellows structure radially inward of the first bellows structure, and an intermediate bellows channel structure defined by a horizontal passage between the first and second bellows structures, and wherein the middle portion of the first bellows structure is constrained by the intermediate bellows channel structure so that the front portion and the rear portion of the first bellows structure move radially inward relative to the intermediate bellows channel during operation.

[0565] 39. The accommodating intraocular lens system of any of Examples 21-38, wherein the external fluid reservoir has a radially inward groove that defines an external overflow feature.

[0566] 40. The accommodating intraocular lens system of any of Examples 21-39, further comprising at least one thickened portion defining a path for a needle used to fill the accommodating structure with an optical fluid.

[0567] 41. An accommodative intraocular lens system, comprising:

[0568] Tool box, including -

[0569] an accommodative structure comprising a first optical component, a second optical component rearward of the first optical component, an internal fluid chamber between the first and second optical components, and an external fluid reservoir fluidly coupled to the internal fluid chamber, wherein the external fluid reservoir surrounds at least a portion of the internal fluid chamber and is configured to interface with the native eye capsule such that fluid flows between the external fluid reservoir and the internal fluid chamber to move the first optical element for providing accommodation; and

[0570] a first fixed lens configured to be removably coupled to the accommodative structure such that the first fixed lens is located anterior to the first optical assembly, wherein the first fixed lens has no optical power; and

[0571] A second fixed lens is configured to be removably coupled to the accommodative structure instead of the first fixed lens such that the second fixed lens is located anterior to the first optical element, wherein the second fixed lens has an optical power.

[0572] 42. The system of example 41, wherein each of the first fixed lens and the second fixed lens comprises an optic portion and a skirt protruding from the optic portion.

[0573] 43. The system of Example 42, wherein the skirt comprises an annular wall protruding rearwardly from the optical portion.

[0574] 44. The system of example 43, wherein the skirt glares rearwardly and radially outwardly from the optical portion.

[0575] 45. The system of any of Examples 42-44, wherein each of the first fixed lens and the second fixed lens further comprises a passage extending laterally through the skirt, and wherein the passage does not extend through the optic.

[0576] 46. ​​The system of any of Examples 41-45, wherein at least one of the first fixed lens or the second fixed lens comprises an asymmetric lens.

[0577] 47. The system of any of Examples 41-46, wherein the optical structure has a front component and a rear component, the front component including a first optical component and a first peripheral region surrounding the first optical component, the rear component including a second optical component and a second peripheral region surrounding the second optical component, and wherein the first peripheral region is attached to the second peripheral region along a seam such that the first and second peripheral regions define an external fluid reservoir.

[0578] 48. The system of Example 47, wherein the external fluid reservoir includes a first bellows structure, a second bellows structure radially inward of the first bellows structure, and an intermediate bellows channel structure located between the first bellows structure and the second bellows structure, and wherein the intermediate bellows channel structure includes a transverse portion, and the first bellows structure has a front portion protruding forward from the transverse portion and a rear portion protruding rearward from the transverse portion.

[0579] 49. The system of Example 48, wherein the front portion and the rear portion of the first bellows structure are configured to bend radially inward relative to the outermost section of the lateral portion during operation.

[0580] 50. The system of Example 47, wherein at least one of the front portion or the rear portion includes a support positioned between the internal fluid chamber and the external fluid reservoir, the support defining a channel therebetween for allowing fluid to flow between the internal fluid chamber and the external fluid reservoir.

[0581] 51. The system of Example 50 wherein at least a portion of the support is coupled to the other of the front portion or the rear portion.

[0582] 52. The accommodating intraocular lens system of any of Examples 41-51, further comprising a cell barrier located posterior to the rearmost portion of the external fluid reservoir.

[0583] 53. The system of any of Examples 41-46, wherein the external fluid reservoir includes a first bellows structure having a front portion and a rear portion, a second bellows structure radially inward of the first bellows structure, and an intermediate bellows channel structure defined by a horizontal passage between the first and second bellows structures, and wherein the intermediate portion of the first bellows structure is constrained by the intermediate bellows channel structure so that the front portion and the rear portion of the first bellows structure move radially inward relative to the intermediate bellows channel during operation.

[0584] 54. The system of any of Examples 41-53, wherein the external fluid reservoir has a radially inward groove that defines an external overflow feature.

[0585] 55. The system of any of Examples 41-54, further comprising at least one thickened portion defining a path for a needle used to fill the adjustable structure with an optical fluid.

[0586] 56. A method of implementing an accommodative intraocular lens system, comprising:

[0587] implanting an accommodative structure into a native eye capsule, wherein the accommodative structure has a first optical component, a second optical component positioned posterior to the first optical component, an internal fluid chamber positioned between the first and second optical components, and an external fluid reservoir fluidically coupled to the internal fluid chamber;

[0588] After the accommodating structure is implanted in the native eye capsule, a fixed lens is coupled to the accommodating structure.

[0589] 57. The method of Example 56, wherein the fixed lens includes a first fixed lens, and the method further includes (a) removing the first fixed lens from the accommodative structure, and (b) attaching a second fixed lens to the accommodative structure, and wherein the second fixed lens has an optical power different from that of the first fixed lens.

[0590] 58. The method of any of Examples 56-57, wherein the fixed lens includes an optical portion and a skirt protruding rearwardly from the optical portion such that when the fixed lens is coupled to the accommodative structure, an aqueous humor chamber is formed between the optical portion of the fixed lens and the first optical component of the accommodative structure.

[0591] 59. The method of any of Examples 56-58, wherein the first optical component is part of an anterior component and the second optical component is part of a posterior component, and the method includes coupling and fluidly sealing the anterior and posterior components together prior to implanting the adjustable structure.

[0592] 60. The method of Example 59, wherein the anterior and posterior components are coupled and fluidly sealed together in a dry state, and further comprising hydrating the coupled and fluidly sealed anterior and posterior components prior to implanting the adjustable structure.

[0593] 61. The method of any of Examples 56-60, wherein the accommodative structure has indexing marks, and the method further comprises rotating the fixed lens based on the indexing marks on the accommodative structure.

[0594] 62. The method of Example 61, wherein the fixed lens has a physical feature, and the process of rotating the fixed lens includes aligning the physical feature of the fixed lens relative to an indexing mark on the accommodative structure.

[0595] 63. The method of example 56, wherein the fixed lens comprises a first fixed lens, and wherein the method further comprises:

[0596] evaluating whether an implanted accommodative structure provides desired accommodation, the implanted accommodative structure having a first fixed lens coupled to the accommodative structure in the eye; and

[0597] When the assessed accommodation differs from the desired accommodation, the first fixed lens is replaced with a second fixed lens having a different base power.

[0598] Although preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided as examples only. Those skilled in the art will make many modifications, variations, and substitutions without departing from the present invention. It should be understood that in implementing the present disclosure, a variety of alternatives to the embodiments of the present disclosure described herein may be used.

Claims

1. An accommodative intraocular lens system, comprising: an accommodative structure having an anterior portion and a posterior portion relative to a reference frame of a native eye, wherein the anterior portion defines a fixed lens receiving feature, wherein the anterior portion and the posterior portion define (a) an optical structure having an internal fluid chamber and (b) an external fluid reservoir, wherein the external fluid reservoir is configured to interface with a native eye capsule so that fluid flows between the external fluid reservoir and the internal fluid chamber to change the shape of the optical structure, and wherein the external fluid reservoir has a radially inward groove that defines an external overflow feature; and A fixed lens having an optical portion and an accommodative structure engagement feature extending from the optical portion, the optical portion having a fixed optical power, wherein the accommodative structure engagement feature is configured to releasably engage a fixed lens receiving feature to allow the fixed lens to be coupled to and separated from the anterior portion of the accommodative structure when the accommodative structure is implanted in a native eye capsule.

2. The accommodative intraocular lens system according to claim 1, wherein: The adjustable structural engagement feature is a skirt that protrudes from the optic portion.

3. The accommodative intraocular lens system according to claim 2, wherein: The skirt includes an annular wall projecting rearwardly from the optical portion.

4. The accommodative intraocular lens system according to claim 3, wherein: The skirt glares rearwardly and radially outwardly from the optical portion.

5. The accommodative intraocular lens system according to claim 3, wherein: The fixed lens also includes a passageway through the skirt.

6. The accommodative intraocular lens system according to claim 3, wherein: The fixed lens also includes a passageway extending laterally through the skirt, and wherein the passageway does not extend through the optic portion.

7. The accommodative intraocular lens system according to claim 1, wherein: The fixed lens includes a passageway.

8. The accommodative intraocular lens system according to claim 1, wherein: The fixed lens has positive optical power.

9. The accommodative intraocular lens system according to claim 1, wherein: The fixed lens has negative optical power.

10. The accommodative intraocular lens system according to claim 1, wherein: The optical power of the fixed lens is zero.

11. The accommodative intraocular lens system according to claim 1, wherein: The fixed lens comprises an asymmetric lens.

12. The accommodating intraocular lens system of claim 1, wherein: The front portion of the adjustable structure includes a first optical component and a first peripheral region surrounding the first optical component; The rear portion of the adjustable structure includes a second optical component and a second peripheral region surrounding the second optical component; as well as The first peripheral region is attached to the second peripheral region along a seam such that the first and second peripheral regions define the external fluid reservoir.

13. An accommodative intraocular lens system according to claim 12, wherein the external fluid reservoir includes a first bellows structure, a second bellows structure radially inward of the first bellows structure, and an intermediate bellows channel structure located between the first and second bellows structures, and wherein the intermediate bellows channel structure includes a lateral portion, and the first bellows structure has (a) a front portion protruding forward from the lateral portion and (b) a rear portion protruding rearward from the lateral portion.

14. The accommodating intraocular lens system of claim 13, wherein the anterior and posterior portions of the first bellows structure are configured to flex radially inwardly relative to an outermost segment of the lateral portion during operation.

15. An accommodative intraocular lens system according to claim 12, wherein at least one of the anterior portion or the posterior portion of the accommodative structure includes a support located between the internal fluid chamber and the external fluid reservoir, and the support defines a channel therebetween for allowing fluid to flow between the internal fluid chamber and the external fluid reservoir.

16. The accommodating intraocular lens system of claim 15, wherein at least a portion of the mount is bonded to the other of the anterior portion or the posterior portion of the accommodating structure.

17. The accommodating intraocular lens system of claim 12, further comprising a cell barrier located posterior to the rearmost portion of the external fluid reservoir.

18. An accommodative intraocular lens system according to claim 1, wherein the external fluid reservoir includes a first bellows structure having a front portion and a rear portion, a second bellows structure radially inward of the first bellows structure, and an intermediate bellows channel structure defined by a horizontal passage between the first and second bellows structures, and wherein the middle portion of the first bellows structure is constrained by the intermediate bellows channel structure so that the front portion and the rear portion of the first bellows structure move radially inward relative to the intermediate bellows channel during operation.

19. The accommodating intraocular lens system of claim 1, further comprising at least one thickened portion defining a path for a needle used to fill the accommodating structure with an optical fluid.

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