Patent Description:
A healthy young human eye can focus an object in far or near distance, as required. The capability of the eye to change back and forth from near vision to far vision is called accommodation. Accommodation occurs when the ciliary muscle contracts to thereby release the resting zonular tension on the equatorial region of the capsular bag. The release of zonular tension allows the inherent elasticity of the lens capsule to alter to a more globular or spherical shape, with increased surface curvatures of both the anterior and posterior lenticular surfaces.

The human lens can be afflicted with one or more disorders that degrade its functioning in the vision system. A common lens disorder is a cataract which is the opacification of the normally clear, natural crystalline lens matrix. The opacification can result from the aging process but can also be caused by heredity or diabetes. In a cataract procedure, the patient's opaque crystalline lens is replaced with a clear lens implant or IOL.

In conventional extracapsular cataract surgery, the crystalline lens matrix is removed leaving intact the thin walls of the anterior and posterior capsules together with zonular ligament connections to the ciliary body and ciliary muscles. The crystalline lens core is removed by phacoemulsification through a curvilinear capsularhexis i.e., the removal of an anterior portion of the capsular sac.

After a healing period of a few days to weeks, the capsular sac effectively shrink-wraps around the IOL due to the capsularhexis, the collapse of the walls of the sac and subsequent fibrosis. Cataract surgery as practiced today causes the irretrievable loss of most of the eye's natural structures that provide accommodation. The crystalline lens matrix is completely lost and the integrity of the capsular sac is reduced by the capsularhexis. The "shrink-wrap" of the capsular sac around the IOL can damage the zonule complex, and thereafter the ciliary muscles may atrophy. Thus, conventional IOL's, even those that profess to be accommodative, may be unable to provide sufficient axial lens spatial displacement along the optical axis or lens shape change to provide an adequate amount of accommodation for near vision.

It is known to implant a combination of lenses to address refraction errors in the existing lens in the case of phakic IOLs or improve the refractive results of standard IOL after cataract surgery in the case of pseudophakic patients. These "piggyback" IOLs can be placed anterior to the previously implanted IOL or natural lens to improve the refractive results of cataract surgery in the case of pseudophakes or to change the refractive status of the eye in the case of phakic eyes, usually to correct high myopia. Generally, these lenses are implanted in the sulcus and are non-accommodating. <CIT> discloses an optical element to be implanted in the vitreous of an eye, wherein the focal length of the optical element is adjusted using electrical focusing signals.

The invention provides an accommodating intraocular lens according to claim <NUM>. For better understanding of the invention, the present disclosure provides also non-claimed examples of an intraocular lens including a shape changing optical element; a force translation element having a first end region coupled to the optical element and a second end region extending towards a ciliary structure, and an attachment portion coupled to the second end region of the force translation element and configured to contact the ciliary structure. The force translation element is configured to functionally transmit movements of the ciliary structure into a force exerted upon the optical element to effect an accommodating and a disaccommodating change of the optical element.

The force translation element can be customized for fit during implantation. The mechanism for customizing the fit can include sliding, twisting, turning, cutting, rolling, expanding, bending, and applying energy to the force translation element. The force translation element can be coated with an expandable material. At least one of the optical element, the force translation element, and the attachment portion can be coated with an agent having biological activity such as heparin, a steroid and rapamicin. The first end region of the force translation element can be coupled to an equator of the optical element. A plurality of force translation elements can be coupled near an equator of the optical element.

The attachment portion can be configured to contact the ciliary structure. The attachment portion can be configured to abut and not penetrate the ciliary structure. The ciliary structure can be the ciliary muscle, the ciliary body, a ciliary process, and a zonule. The attachment portion can be formed of an elastic material. The attachment portion can include one or more rods. The one or more rods can be curved. The attachment portion can include a three dimensional element that fills a space adjacent the ciliary structure. The attachment portion can include a fillable element. The attachment portion can include a glue, hydrogel or fixation material. The attachment portion can elicit a healing response in the ciliary structure to induce soft tissue integration of the attachment portion.

The optical element can have a power in the range of about ±<NUM> diopters to about ±<NUM> diopters. The accommodating change of the optical element can include a change from an ovoid shape to a more spherical shape. The accommodating change of the optical element can include a change in spatial configuration along the optical axis in an anterior direction. The force translation element can be formed of a material generally harder than a material of the optical element. The second lens can be positioned within the capsular bag of the eye. The optical element can be positioned anterior to the second lens. The optical element can be positioned within the capsular bag of the eye. The optical element can be positioned posterior to the iris. The optical element can be positioned anterior to the iris. The second lens can include an implanted intraocular lens.

The lens can further include a haptic coupled to and extending outward from the optical element. The haptic can be positioned within a sulcus. The force translation element can be coupled to the haptic. The force translation element can be coupled to the ciliary body to push on the optical element.

The force translation element can be coupled to the ciliary body to pull on the optical element. The accommodating and disaccommodating change can include a shape change effected over the entire surface of the optical element. The accommodating and disaccommodating change can include a shape change effected over a portion of the optical element. The portion can preferentially bulge upon an accommodating change. The shape change effected over a portion can be due to a difference in modulus of the portion of the optical element compared to the modulus of another portion of the optical element. A center region of the optical element can include a lower modulus material than an outer region of the optical element. The lower modulus material can give way causing a bulge and a change in dioptric effect.

Other features and advantages should be apparent from the following description of various embodiments, which illustrate, by way of example, the principles of the described subject matter.

It should be appreciated that the drawings herein are exemplary only and are not meant to be to scale.

There is a need for improved methods and devices for the treatment of presbyopia in phakic and pseudophakic patients. The intraocular lenses described herein can be switched back and forth repeatedly between accommodation to disaccommodation, just as in a young accommodative natural eye.

The term shape changing optical element refers to an optical element that is made of material that enables the optical element to alter its shape, e.g., become one of more spherical in shape, thicker to focus on a closer object; or become more ovoid in shape, thinner to focus on a more distant and thus alter the optical element's respective optics (alter the dioptric power of the resulting optical element). The shape change can be effected over the entire surface of the optical element, or just over a portion of the optical element, such as by having a preferential change or "bulge" in a portion of the optical element. This can be achieved by varying the modulus of portions of the optical element. For example, the center region may be a lower modulus material than the outer region of the optical element in which case when the ciliary body accommodates and the force will be translated to the center of the optical element preferentially to cause a "bulge" that will provide the desired dioptric effect.

Alternatively, the optical element may be a dual optic that is designed to translate relative to each other to increase or decrease the dioptric power of the system.

The term accommodating shape refers to the shape of the optical element when at least one of the contraction of the ciliary muscle of the mammalian eye, the lower tension of the zonules of the mammalian eye and a decrease in the vitreous pressure in the eye occur to effect a focusing upon a closer object. An accommodating shape is generally more spherical than the disaccommodating shape.

The term disaccommodating shape refers to the shape of the optical element when at least one of the relaxation of the ciliary muscle of the mammalian eye, the higher tension of the zonules of the mammalian eye and an increase in the vitreous pressure in the eye occur to effect a focusing upon a more distant object. A disaccommodating shape is generally more ovoid than the accommodating shape.

The term diopter (D) refers to the reciprocal of the focal length of a lens in meters. For example, a <NUM> D lens brings parallel rays of light to a focus at (<NUM>/<NUM>) meter. After a patient's natural crystalline lens has been surgically removed, surgeons usually follow a formula based on their own personal preference to calculate a desirable diopter power (D) for the selection of an IOL for the patient to correct the patient's preoperational refractive error. For example, when a myopia patient with -<NUM> D undergoes cataract surgery and IOL implantation, the patient can see at a distance well enough even without glasses. Generally, this is because the surgeon has taken the patient's -<NUM> D near-sightedness into account when choosing an IOL for the patient.

The lenses described herein can mechanically or functionally interact with eye tissues typically used by a natural lens during accommodation and disaccommodation such as the ciliary body, ciliary processes, and the zonules, to effect accommodation and disaccommodation of the implanted lens. The forces generated by these tissues are functionally translated to the optical element of the implanted lens causing a power change to allow a phakic or pseudophakic patient to more effectively accommodate.

The intraocular lenses described herein can be implanted in the eye to replace a diseased, natural lens. The intraocular lenses described herein can also be implanted as a supplement of a natural lens (phakic patient) or an intraocular lens previously implanted within a patient's capsular bag (pseudophakic patient). The lenses described herein can be used in combination with intraocular lenses described in <CIT> and <CIT>. As such, the lenses described herein can be used independently or as so-called "piggyback" lenses. Piggyback lenses can be used to correct residual refractive errors in phakic or pseudophakic eyes. The primary IOL used to replace the natural lens is generally thicker and has a power that can be in the range of ±20D. The thicker, larger power lenses generally have less accommodation. In contrast, the supplemental lens need not possess a full range of diopters (D). The supplemental lens can be relatively thin compared to the primary IOL and can undergo more accommodation. Shape change and movement of the thinner lens is generally more easily accomplished relative to a thick primary lens. It should be appreciated, however, that the lenses described herein can be used independently and need not be used in combination as piggyback lenses with the natural lens or an implanted IOL.

<FIG> depicts a cross-sectional view of an eye <NUM> including the cornea <NUM>, iris <NUM>, sulcus <NUM>, ciliary body <NUM>, ciliary processes <NUM>, zonules <NUM> and the capsular bag <NUM> including an IOL <NUM> implanted in the capsular bag <NUM>. A lens <NUM> is shown positioned within the sulcus <NUM> anterior to the IOL <NUM>. It should be appreciated that although the lens <NUM> is shown positioned within the sulcus <NUM> and posterior to the iris <NUM> that it can also be positioned anterior to the iris <NUM> within the anterior chamber <NUM>. The lens <NUM> can also be positioned within the capsular bag <NUM> just in front of the previously implanted IOL <NUM> or natural lens.

The lens <NUM> can include a central optical element <NUM> and at least two force translation elements <NUM> extending outward from the optical element <NUM> (see <FIG>). The optical element <NUM> can be an adjustable lens such that the optical properties can be manipulated after implantation, as will be described in more detail below. The force translation elements <NUM> can functionally couple with at least one of the ciliary structures such as the ciliary body <NUM>, ciliary processes <NUM>, and/or the zonules <NUM> such that movements of these tissues during accommodation and disaccommodation are translated to the optical element <NUM> via the force translation elements <NUM> to cause at least a change in shape or change in position of the optical element <NUM>. The lens <NUM> can further include at least two haptics <NUM> coupled to and extending outward from the optical element <NUM>. The haptics <NUM> can be positioned within the sulcus <NUM> to further aid in the anchoring of the lens in the eye.

<FIG> depicts a cross-sectional, schematic view of the lens <NUM> during accommodation. The ciliary body <NUM> is a generally circular structure. The ciliary muscle is a sphincter shaped like a doughnut. In natural circumstances, when the eye is viewing an object at a far distance, the ciliary muscle within the ciliary body <NUM> relaxes and the inside diameter of the ciliary muscle gets larger. The ciliary processes <NUM> pull on the zonules <NUM>, which in turn pull on the lens capsule <NUM> around its equator. This causes a natural lens to flatten or to become less convex, which is called disaccommodation. During accommodation, the muscles of the ciliary body <NUM> contract and the inside diameter of the ciliary muscle gets smaller. The ciliary processes <NUM> release the tension on the zonules <NUM> and the lens takes on its natural, more convex shape such that the eye can focus at near distance.

Without limiting this disclosure to any particular theory or mode of operation, the eye is believed to act on the implanted intraocular lenses described herein as follows. The force translation elements <NUM> are implanted such that they are in contact with at least one of the ciliary structures (i.e. zonules <NUM>, ciliary processes <NUM> and/or ciliary body <NUM>). The contraction of the ciliary muscle and inward movement of the tissues towards the optical axis O applies a force against the force translation elements <NUM> (see <FIG>). The force translation elements <NUM> transfer the force to the optical element <NUM>, which can take on a more spherical shape suitable for near vision. This contraction of the ciliary muscle and inward movement of the ciliary body <NUM> can also result in a change in the spatial configuration of the lens <NUM> such that it axially displaces along the optical axis O forwardly in an anterior direction (distance D) relative to the natural lens or a previously implanted IOL <NUM>. Both the more spherical shape and the anterior movement away from IOL <NUM> can cause an increase in power needed for accommodation and near vision focus.

As mentioned, the force translation elements <NUM> can be configured to cooperate with at least one of the ciliary body <NUM>, ciliary processes <NUM>, or the zonules <NUM> to change the shape of the optical element <NUM>. It should be appreciated that the vitreous pressure in the eye can also be involved in the accommodating shape of the optical element <NUM>. Further, if the lens <NUM> is implanted anterior to the iris <NUM>, for example within the anterior chamber <NUM>, the structures of the anterior chamber angle can also affect the accommodating shape change of the optical element <NUM>.

<FIG> depict an embodiment of an intraocular lens <NUM> having an optical element <NUM> and two force translation elements <NUM> extending outward from near the equator of optical element <NUM>. It should be appreciated that the force translation elements <NUM> can also extend outward from other regions of the optical element <NUM>. For example, the force translation element <NUM> can be coupled nearer to one or more of the poles of the optical element <NUM>. The force translation elements <NUM> can be coupled to the optical element <NUM> or the force translation elements <NUM> can be coupled to and extend from haptics <NUM>, if present. It should also be appreciated that the lens <NUM> can have more than two force translation elements <NUM> such as three, four, five or more force translation elements <NUM>. In one aspect, the force translation elements <NUM> can extend from the optical element <NUM> on opposing sides of the optical axis O.

When implanted in the eye, an end of the force translation elements <NUM> can be positioned adjacent the ciliary body <NUM> on either side of the eye. The force translation elements <NUM> can be adapted to translate force applied by the adjacent tissues to the optical element <NUM> to cause a shape change or a relative spatial change or both. The force translation elements <NUM> can be generally formed of a harder material than that of the optical element <NUM>. A change in hardness or durometer can be accomplished via a change in material. For example, a higher durometer material can be used for the force translation elements <NUM> than the material used for the optical element <NUM>. For example, the force translation elements <NUM> can be made from silicone and the optical element <NUM> can be made from a softer hydrogel. Alternatively, the materials of the force translation elements <NUM> and the optical element <NUM> can be the same, but the hardness different. Hardness can be determined or quantized using the Shore A or Shore D scale. The
various materials considered herein for forming the components of the lens <NUM> are discussed in more detail below.

As mentioned, the optical element <NUM> can change to a more spherical shape during accommodation upon narrowing of the inside diameter of the ciliary body <NUM> by mechanically and functionally connecting with the movement of one or more of the ciliary tissues. As shown in <FIG>, contraction of the muscles of the ciliary body <NUM> can create a force in the direction of arrows A, which is then applied to the force translation elements <NUM>. The force translation elements <NUM> translate that force to the optical element <NUM> (arrows <NUM>). Depending on the design of the optical element <NUM>, the optical element <NUM> can change shape, for example, along arrows C shown in <FIG> and <NUM> into a more spherical, accommodated shape to view a near object. If a far object is to be viewed, the optical element <NUM> can return to its resting, disaccommodating shape, which is more flat upon relaxation of the ciliary body <NUM> and return to its posterior-most resting configuration decreasing its effective power because the force translation elements <NUM> are no longer being urged inward by the surrounding tissues.

The optical element <NUM> can be designed to include a variety of features that cause an accommodative change in power. The optical element <NUM> can include internal cleavage planes to cause bulging in the center of the optical element <NUM> when the ciliary body <NUM> and its associated tissues are in the accommodative position increasing the power in the center of the optical element <NUM> (as shown in FIG. The optical element <NUM> can also be fluid-filled such that movement of the ciliary body <NUM> and its associated tissues can cause the fluid to move and bulge near the center of the optical element <NUM> increasing its power. The configuration of the optical element <NUM> can vary as is described in <CIT> and <CIT>.

As an example, <FIG> illustrates an optical element <NUM> having an outer lens portion <NUM> and a core lens portion <NUM>. The outer lens portion <NUM> can be structured to include a center section <NUM> that can have a reduced thickness or hardness. The center section <NUM> can surround the optical axis O of the optical element <NUM> and can be located on or near the anterior face <NUM> thereof. When the lens <NUM>, and in particular the optical element <NUM>, is compressed, for example by an inward force at peripheral regions <NUM> and <NUM> applied by the force translation elements <NUM>, the optical element <NUM> can be reshaped by an outward bowing of the anterior face <NUM>. This inward force by the force translation elements <NUM> is due to the compressive force applied to the force translation elements <NUM> by at least one of the ciliary body <NUM>, ciliary processes <NUM>, or zonules <NUM> depending on how the lens <NUM> is implanted.

As shown in <FIG>, the outward bowing or reshaping can be especially pronounced at region <NUM>. This can be due to a reduced thickness of the outer lens portion <NUM> at center section <NUM>. The reduced thickness can be relatively more prone to give way from the internal pressure of the core lens portion <NUM> upon inward force applied at the peripheral regions <NUM>, <NUM>. The core lens portion <NUM> can extend forward, as seen for example in the central region <NUM> in <FIG>. The center section <NUM> can also include a material of reduced hardness or increased elasticity to be more prone to give way from the internal pressure.

The extended central region <NUM> of optical element <NUM> can provide near vision correction power. The remainder of the outer portion <NUM> outside the center section <NUM> can have a greater thickness that can be more resistant to reshaping under such compression at the peripheral regions <NUM>, <NUM>. As such, the annular region <NUM> of optical element <NUM> extending radially outward of center section <NUM> can continue to provide distance vision correction power. The regions <NUM> and <NUM> of optical element <NUM>, under compression, can provide both near and distance vision correction powers, respectively. In other words, the anterior surface <NUM> of optical element <NUM> can be a multifocal surface when the optical element <NUM> is under compression. In contrast, when the optical element <NUM> is in the resting position as shown in <FIG>, the anterior surface <NUM> can be a monofocal surface.

<FIG> illustrates an alternative embodiment of the lens <NUM>, which is substantially the same as that shown in <FIG>, except for a different construction of the outer portion <NUM>. The center section <NUM> can be made of a material that is relatively more susceptible to outward bowing than is the peripheral region surrounding it. The center section <NUM> can be injection molded in combination with the peripheral regions surrounding it to provide a relatively seamless and uninterrupted anterior face <NUM>, at least in the rest position of the lens <NUM>. When the peripheral regions <NUM> and <NUM> are squeezed towards the optical axis O, the core lens portion <NUM> can be placed in compression thus forcing the center section <NUM> in the anterior direction as shown in the extended region <NUM>. The material of the outer portion <NUM> can be generally consistent, though the center section <NUM> can have a different stiffness or elasticity that causes it to bow outward farther than the surrounding region.

The extent to which central region <NUM> extends forwardly, and therefore the magnitude of the near vision correction power obtainable by the optical element <NUM>, can depend on a number of factors, such as the relative thickness, hardness, stiffness, elasticity etc. of center section <NUM>, the overall structure of the outer portion <NUM> and/or the inner portion <NUM>, the material of construction of the outer portion and/or the inner portion, the amount of force that the eye in which lens <NUM> is placed can exert on the lens <NUM> and the like factors. The amount or degree of near power correction obtainable from lens <NUM> can be controlled, or at least partially controlled, by varying one or more of these factors.

The embodiments of the optical element <NUM> described thus far, have a resting configuration when no forces being applied that are lower power or more flat. During accommodation when the ciliary body pushes against the force translation elements <NUM>, the optical element <NUM> can take on a more spherical, higher power configuration. It should be appreciated, however, that the optical element <NUM> can also mimic more closely a natural lens. In this embodiment, the optical element <NUM> is high power or more spherical at a resting configuration when no forces are being applied to it. In this embodiment, the ciliary body relaxes during disaccommodation and applies tension to the force translation elements <NUM> which translate a force on the optical element <NUM> such that the optical element <NUM> flattens for low power and returns to the spherical configuration during accommodation with the ciliary body contracts. In such a configuration, the force translation element <NUM> could incorporate a more robust mechanism of attachment to the tissues.

The lenses described herein have the ability, in cooperation with the eye, to be reshaped to provide for both distance focus and near focus, and to be returned to its first configuration in which only distance focus is provided. The amount of force required to effect a shape change in the optical element <NUM> is generally less than that of moving the optical element <NUM> axially along the optical axis to achieve the desired change in diopter. The change in diopter achieved by a shape change is also generally larger than the change in diopter achieved by an axial displacement. The optical element <NUM> can have a power in the range of about ±1D to about ±4D or about ± <NUM> or about ±6D. In an embodiment, the underlying power of the lens can be within the range of about ±5D. In an embodiment, the underlying power of the lens can be within the range of about ±3D. It should be appreciated that the optical element <NUM> can also have a larger power in the range of about ±20D.

The force translation elements <NUM> contact the eye tissue by way of an attachment portion <NUM> (see <FIG>). The mode of attachment provided by the attachment portion <NUM> can vary. Generally, the attachment portion <NUM> avoids piercing or causing trauma to the ciliary body <NUM>. The attachment portion <NUM> can interfere with the tissues such that movement of the ciliary body <NUM>, ciliary processes <NUM> or zonules <NUM> can be transferred through the force translation elements <NUM> to the optical element <NUM> without causing trauma to the tissues themselves. The attachment portion <NUM> can be formed of a material that is generally softer or more elastic than the force translation elements <NUM>. This provides a more forgiving surface against which the tissues can abut such that piercing of the tissues and inadvertent trauma are avoided. This also allows for the attachment portion <NUM> to provide a better fit in that there is some room for error in the overall length and size of the lens <NUM> and its components. The elasticity of the material can also for a one-size-fits-all approach such that even if the measurement was not exact, the length of the translation elements <NUM> and attachment portions <NUM> would be sufficient to effect shape change of the optical element <NUM> when needed while avoiding constant shape change or tissue damage.

As an example, the attachment portion <NUM> can be a generally rigid, elongate rod or plurality of rods <NUM> (see <FIG>) positioned between and interfering with one or more zonules <NUM> or ciliary processes <NUM>. The rods <NUM> can be straight, curved, or have a bend at a particular angle relative to the longitudinal axis of the force translation element <NUM>. As an example, the plurality of rods <NUM> can be curved such that they form a cup that can interdigitate between the ciliary processes <NUM> and/or zonules <NUM>. The plurality of rods <NUM> can extend to the ciliary body <NUM> with or without making contact with the ciliary body <NUM>.

The attachment portion <NUM> can also have a three-dimensional shape that fills a space surrounding the zonules <NUM> or ciliary processes <NUM> or that fills the space above the ciliary body <NUM>. As an example, the attachment portion <NUM> can have a wedge shape such that the force translation elements <NUM> extends between the ciliary processes <NUM> and the attachment portion <NUM> wedges up against the ciliary body <NUM>. The attachment portion <NUM> can also include a three-dimensional expandable element <NUM> such as a bag, balloon or bulb coupled near an end of the force translation element <NUM>. <FIG> illustrates an attachment portion <NUM> of an embodiment of a force translation element <NUM> having a plurality of rods <NUM>. One or more of the plurality of rods <NUM> can include an expandable element <NUM> near a distal end region. A channel <NUM> can extend through an interior of the force translation element <NUM> into at least a portion of each of the plurality of rods <NUM> such that the channel <NUM> communicates with the expandable elements <NUM>. A fluid (including a gas or liquid or gel) can be injected into a port or other structure positioned along the force translation element <NUM> and into the channel <NUM> such that the expandable element <NUM> expands outward into one or more directions. The position of the port can vary, but is generally located so that it does not interfere with the optical part of the device. In some embodiments, the expandable elements <NUM> can expand three-dimensionally such that they fill the space between the ciliary processes <NUM> or around the ciliary body <NUM> or on top of the ciliary processes <NUM> and covering the ciliary body <NUM>. The expandable elements <NUM> can be filled with a material to provide the desired three-dimensional shape, such as silicone oil, hydrogel, saline or other material.

As shown in <FIG>, the attachment portion <NUM> can include a coating <NUM> made of a material such as glue, hydrogel or other flowable material (see <FIG>). The coating <NUM> can fix the attachment portion <NUM> in place. The coating <NUM> can also act to fill a three-dimensional space surrounding a particular tissue site to help secure the lens <NUM>. The coating <NUM> can be injected through a port and into a channel <NUM> extending through the interior of the force translation element <NUM> into the attachment portion <NUM>. One or more openings <NUM> positioned near a distal end region of the attachment portion <NUM> can allow for the material to flow from the channel <NUM> to an external surface of the attachment portion <NUM> therein coating the external surface.

Soft tissue integration of the attachment portion <NUM> can be achieved by positioning the attachment portion <NUM> in direct contact with one or more of the ciliary tissues such that a minimal level of tissue irritation is achieved to set off a healing response. Upon tissue irritation, a minor inflammatory response ensues that is enough to cause the attachment portion <NUM> to become incorporated into the ciliary processes <NUM> or ciliary body <NUM> without interfering with the physiological role of the tissues. Tissue growth into and/or around the attachment portion <NUM> and integration of the device into the tissue can be achieved without piercing or causing trauma to the tissue, for example affecting its ability to produce aqueous humor.

It should also be appreciated that a combination of attachment portions <NUM> with or without soft tissue integration are considered herein. For example, one or more expandable elements <NUM> can be coupled to an end region of the attachment portion <NUM> that are also filled and coated with a material that provides fixing power such as glue or another flowable material. Further, the expanded shape of the expandable element <NUM> can provide certain characteristics to the attachment portion <NUM>. For example, the expandable element <NUM> when filled can form a wedge shape such that it can be used as described above to wedge up against the ciliary body <NUM> or between the ciliary processes <NUM> when filled upon implantation. The expandable elements <NUM> can also provide a degree of customization to the attachment portion <NUM> such that the fit can be modified during implantation. The expandable element <NUM> can be positioned at a distal end region of the attachment portion <NUM> such that upon filling the expandable element <NUM> provides a customized size that provides the most beneficial fit to the device for a particular patient.

The force translation elements <NUM> and/or the attachment portion <NUM> of the lens can be customized for length, angle and position relative to various structures of the eye. For example, the angle at which the force translation elements <NUM> extend from the optical element <NUM> can play a role in the distance D away from the natural lens or previously implanted IOL that the lens <NUM> is implanted, which in turn can impact the focal power. Further, the length of the force translation elements <NUM> can affect whether or not the force translation elements <NUM> physically contact the ciliary body or neighboring tissues. If the force translation elements <NUM> are too long and make contact with the ciliary body in a resting state it is possible that the tissue structures can be damaged or the optical element <NUM> can remain in a constant state of accommodation. Alternatively, if the force translation elements <NUM> are too short it is possible that not enough shape change would be achieved upon ciliary muscle contraction to effect proper accommodation. It is desirable, therefore, to customize and adjust the length, angle, position or other characteristics of the force translation elements <NUM> and/or the attachment portion <NUM> upon implantation. It should be appreciated that the customization can take place prior to implantation if the appropriate measurements are known in advance of the procedure. Alternatively, customization can take place on-the-fly during implantation or after implantation of the lens <NUM>.

The length of each force translation element <NUM> can be adjusted by a variety of mechanisms including sliding, twisting, turning, cutting, rolling, expanding, etc. For example, the force translation element <NUM> can be unrolled upon implantation in an outward direction from the optical element <NUM> until the optimum length is achieved for proper accommodation to occur upon ciliary muscle contraction. Alternatively, the force translation element <NUM> can be twisted to reduce the overall length it extends outward from the optical element <NUM>. The force translation element <NUM> can also be manually cut to an appropriate length.

The force translation element <NUM> and/or the attachment mechanism <NUM> can be formed of a shape-memory material or other stimuli-responsive material that has the capability of changing shape under an external stimulus. For example, the stimulus can be a temperature change or exertion of an external force (compression or stretching). The shape-memory material can be activated to extend to a pre-set length, shape or angle upon application of energy such as heat. The force translation element <NUM> and/or the attachment mechanism <NUM> can be formed of an elastic or super-elastic material such as Nitinol.

The force translation element <NUM> and/or the attachment mechanism <NUM> can be formed of or coated with a material that expands upon implantation in the eye. The material can expand along a longitudinal axis of the structure or the material can expand in three-dimensionally so as to fill a void adjacent the component. For example, the expanded material can fill a void adjacent the force translation element <NUM> and/or attachment mechanism <NUM> such as the region between the ciliary processes. Expandable materials can include, but is not limited to for example, hydrogel, foam, lyophilized collagen, swelling acrylic, or any material that gels, swells, or otherwise expands upon contact with body fluids. The expandable material can be positioned such that it causes the force translation element <NUM> to move from a retracted state to an expanded state such that it extends between or against an anatomical structure. The expandable material can also coat the attachment mechanisms <NUM> and aid in the attachment mechanism <NUM> taking on a preferred shape. For example, the attachment mechanism <NUM> can be a plurality of rods coated by the expandable material such that upon implantation the rods are forced outward away from one another.

As mentioned above, the force translation element <NUM> can be coupled to a region of the haptic <NUM>. In an embodiment, the haptic <NUM> can be positioned within the sulcus and the force translation element <NUM> can be angled downward to reach the ciliary body. The force translation element <NUM> can be twisted around the haptic <NUM> to achieve a desired length. Alternatively, the force translation element <NUM> can be coupled to the haptic <NUM> in such a way that it can be manually moved along the length of the haptic <NUM> until the desired extension towards the ciliary body is achieved.

The material of the components of the lenses described herein can vary. As mentioned above, the force translation elements <NUM> and haptics <NUM>, if present, are generally formed of a material having a harder durometer than the optical element <NUM> or the attachment mechanism <NUM> such that they can translate forces applied by the surrounding tissues to effect shape change and/or change in spatial configuration of the optical element <NUM>. The force translation elements <NUM>, attachment mechanism <NUM>, haptics <NUM> (if present) and optical element <NUM> can each be the same material, but may have a hardness that differs to achieve the desired functional characteristics when implanted.

Suitable materials for the preparation of the optical element <NUM> disclosed herein vary and include materials that are known in the art. As an example, materials can include, but are not limited to, acrylic polymers, silicone elastomers, hydrogels, composite materials, and combinations thereof. Materials considered herein for forming various components are described in <CIT>and <CIT>. a photosensitive silicone to facilitate post-implantation power adjustment as taught in <CIT>, entitled LENSES CAPABLE OF POST-FABRICATION POWER MODIFICATION.

Suitable materials for the production of the subject force translation elements <NUM> include but are not limited to foldable or compressible materials or hard materials, such as silicone polymers, hydrocarbon and fluorocarbon polymers, hydrogels, soft acrylic polymers, polyesters, polyamides, polyimides, polyurethane, silicone polymers with hydrophilic monomer units, fluorine-containing polysiloxane elastomers and combinations thereof.

A high refractive index is a desirable feature in the production of lenses to impart high optical power with a minimum of optic thickness. By using a material with a high refractive index, visual acuity deficiencies may be corrected using a thinner IOL.

The optical element <NUM> can also be formed from layers of differing materials. The layers may be arranged in a simple sandwich fashion, or concentrically. In addition, the layers may include a series of polymer layers, a mix of polymer and metallic layers, or a mix of polymer and monomer layers. In particular, a Nitinol ribbon core with a surrounding silicone jacket may be used for any portion of the lens <NUM> except for the optics; an acrylic-over-silicone laminate may be employed for the optics. A layered construction may be obtained by pressing/bonding two or more layers together, or deposition or coating processes may be employed.

Where desired, various coatings are suitable for one or more components of the lens <NUM>. A heparin coating may be applied to appropriate locations to prevent inflammatory cell attachment (ICA) and/or posterior capsule opacification (PCO); possible locations for such a coating include the optical element <NUM>. Coatings can also be applied to the lens <NUM> to improve biocompatibility; such coatings include "active" coatings like P-<NUM> peptides or RGD peptides, and "passive" coatings such as rapamicin, steroids, heparin, and other mucopolysaccharides, collagen, fibronectin and laminin. Other coatings, including hirudin, Teflon, Teflon-like coatings, PVDF, fluorinated polymers, and other coatings which are inert may be employed to increase lubricity at locations on the lens system, or Hema or silicone can be used to impart hydrophilic or hydrophobic properties to portions of the lens <NUM>.

One or more of the lens components can also be coated with a therapeutic or other agent that ameliorates a symptom of a disease or disorder including, for example, steroids, small molecule drugs, proteins, nucleic acids, polysaccharides, and biologics or combination thereof. Therapeutic agent, therapeutic compound, therapeutic regimen, or chemotherapeutic include conventional drugs and drug therapies, including vaccines, which are known to those skilled in the art. Therapeutic agents include, but are not limited to, moieties that inhibit cell growth or promote cell death, that can be activated to inhibit cell growth or promote cell death, or that activate another agent to inhibit cell growth or promote cell death. Optionally, the therapeutic agent can exhibit or manifest additional properties, such as, properties that permit its use as an imaging agent, as described elsewhere herein. Exemplary therapeutic agents include, for example, cytokines, growth factors, proteins, peptides or peptidomimetics, bioactive agents, photosensitizing agents, radionuclides, toxins, anti-metabolites, signaling modulators, anti-cancer antibiotics, anti-cancer antibodies, angiogenesis inhibitors, radiation therapy, chemotherapeutic compounds or a combination thereof. The drug may be any agent capable of providing a therapeutic benefit. In an embodiment, the drug is a known drug, or drug combination, effective for treating diseases and disorders of the eye. In non-limiting, exemplary embodiments, the drug is an antiinfective agent (e.g., an antibiotic or antifungal agent), an anesthetic agent, an anti-VEGF agent, an anti-inflammatory agent, a biological agent (such as RNA), an intraocular pressure reducing agent (i.e., a glaucoma drug), or a combination thereof. Non-limiting examples of drugs are provided below.

In an embodiment, the lens <NUM> and/or the mold surfaces are subjected to a surface passivation process to improve biocompatibility. This may be done via conventional techniques such as chemical etching or plasma treatment.

Once formed, the subject force translation elements <NUM> can be permanently attached to optical element <NUM> by numerous methods including but not limited to fastening within a pre-formed optic slot using glue, staking, plasma treatment, friction, or like means or combinations thereof.

Furthermore, appropriate surfaces (such as the outer edges/surfaces of the contacting elements, accommodating elements, etc.) of the lens components can be textured or roughened to improve adhesion to the adjacent tissue surfaces. This can be accomplished by using conventional procedures such as plasma treatment, etching, dipping, vapor deposition, mold surface modification, etc..

In an embodiment, the selected material and lens configuration is able to withstand secondary operations after molding/casting such as polishing, cleaning and sterilization processes involving the use of an autoclave, or ethylene oxide or radiation. After the mold is opened, the lens can undergo deflashing, polishing and cleaning operations, which typically involve a chemical or mechanical process, or a combination thereof. Some suitable mechanical processes can include tumbling, shaking and vibration; a tumbling process may involve the use of a barrel with varying grades of glass beads, fluids such as alcohol or water and polishing compounds such as aluminum oxides. Process rates are material dependent; for example, a tumbling process for silicone can utilize a <NUM>" diameter barrel moving at <NUM>-<NUM> RPM. It is contemplated that several different steps of polishing and cleaning may be employed before the final surface quality is achieved.

A curing process may also be desirable in manufacturing the components of the lens <NUM>. If the lens is produced from silicone entirely at room temperature, the curing time can be as long as several days. If the mold is maintained at about <NUM>. , the curing time can be reduced to about <NUM> hours. If the mold is preheated to <NUM>-<NUM>° C, the curing time can be as short as about <NUM>-<NUM> minutes. The time-temperature combinations vary for other materials.

It should be appreciated that the lenses described herein can be implanted in a phakic or pseudophakic patient. In an exemplary implantation procedure, an IOL implantation is performed anterior to the natural crystalline lens or anterior to a previously-implanted IOL. Although the implantation procedure can vary, one procedure can be performed as follows. One or more clear corneal incisions can be formed. A first incision can be formed for IOL insertion and a second incision can be formed for manipulation and assistance of positioning the IOL. A viscoelastic substance can be inserted into the eye, such as to at least partially fill the anterior chamber and/or an area between the iris and the intra-capsular IOL. The IOL can be inserted into position in the eye and the force-translation elements inserted into a desired position and connected to the ciliary body. One or more IOL can be inserted into the ciliary sulcus and the viscoelastic substance washed out of the eye. A check may then be performed to verify that the corneal incisions are appropriately sealed. Any of a variety of instruments may be used in conjunction with the procedure. Moreover, it should be appreciated that the aforementioned steps may be performed in a different order than described above.

While this specification contains many specifics, these should not be construed as limitations on the scope of the invention as defined by the appended claims, but rather as descriptions of features specific to particular examples provided in the present disclosure.

Claim 1:
An accommodating intraocular lens (<NUM>), comprising:
an optical element (<NUM>) configured to be inserted into a capsular bag;
haptics (<NUM>) coupled to and extending outwards from the optical element (<NUM>), the haptics (<NUM>) capable of anchoring the intraocular lens (<NUM>) within the eye; and
a plurality of force translation elements (<NUM>), each of the plurality of force translation elements having a first end region coupled to the optical element (<NUM>) and a second end region extending towards a ciliary structure,
wherein each of the plurality of force translation elements (<NUM>) comprises an attachment portion coupled to the second end region that is configured to contact and couple with ciliary tissue when the intraocular lens is implanted in the eye, and
wherein, when the intraocular lens is implanted in the eye, the plurality of force translation elements (<NUM>) translate movement of the ciliary tissue that applies a compressive force against the force translations elements (<NUM>) to the optical element (<NUM>) to cause the intraocular lens (<NUM>) to change shape in order to change an optical power of the intraocular lens (<NUM>).