WO2016168458A1

WO2016168458A1 - Methods and apparatuses for implanting an intraocular lens

Info

Publication number: WO2016168458A1
Application number: PCT/US2016/027529
Authority: WO
Inventors: Samir MELKI
Original assignee: Melki Samir
Priority date: 2015-04-14
Filing date: 2016-04-14
Publication date: 2016-10-20

Abstract

The present disclosure relates to systems and methods for fixing an intraocular lens implant within the internal volume of a lens capsule. An intraocular fixation device may have structural characteristics that may be used to secure the intraocular lens implant to the lens capsule of the eye, for example, the anterior capsular surface. For example, a portion of the fixation device may be secured to the intraocular lens implant, and another portion of the fixation device may be secured to the lens capsule. Small openings may be formed on the anterior surface of the lens capsule to accommodate attachment of the fixation device and/or lens implant to the capsule. The intraocular lens implant may be restricted from translation along an anterior-posterior axis of the eye to less than 1.0 mm and rotation about the anterior-posterior axis of the eye to less than 30 degrees.

Description

METHODS AND APPARATUSES FOR IMPLANTING AN INTRAOCULAR LENS

RELATED APPLICATION

This application claims the benefit under 35 U.S.C. § 119(e) to U.S. provisional application serial number 62/147, 136, entitled METHODS AND APPARATUSES FOR

IMPLANTING AN INTRAOCULAR LENS, filed April 14, 2015, the disclosure of which is incorporated by reference herein in its entirety.

BACKGROUND

1. Field

Aspects described herein relate to methods and apparatuses for implanting an intraocular lens.

2. Discussion of Related Art

A cataract is a clouding of the lens inside the eye which leads to a decrease in vision due to the obstruction of light from passing to the retina. A cataract is typically treated through surgery where the opacified lens is removed from its capsular bag and an intraocular lens (IOL) is implanted in its place.

Fig. 1 shows a cross-sectional view of the anatomy of an eye having a cornea 2 on the anterior side A of the eye, enclosing the aqueous humour 4 and pupil opening 6. The iris 8 is the thin, circular structure that controls the size of the pupil opening 6 and, hence, the amount of light that passes in a direction along the anterior-posterior axis A-P through the lens, held within a lens capsule 10, and the vitreous humour 12 before reaching the retina (not shown in the figure). The vitreous humour 12 is the clear gel located on the posterior side P of the lens capsule 10 that fills the space of the eye between the lens capsule 10 and the retina.

An IOL implant typically includes an optical lens and haptics or arms extending from the lens, for holding the lens in place. Upon deployment, the IOL implant typically unfolds within the lens capsule and is allowed to position itself according to the geometrical structure of the haptics.

SUMMARY

The inventor has appreciated that it would be beneficial to fix the position of an intraocular lens implant within the internal volume of a lens capsule more effectively than previously possible. According to various embodiments described herein, upon surgical deployment (e.g., during a cataract surgery, or other surgical procedure), an intraocular lens implant may be secured to the lens capsule of the eye, holding the lens in place, resulting in substantial restriction of the optical lens from translation and rotation.

In some embodiments, an intraocular fixation device may be used to secure the intraocular lens implant to the lens capsule. For example, prior to deployment within the lens capsule, an implant connecting portion of the fixation device may be attached or otherwise secured to a portion of the intraocular lens implant (e.g., haptic, optical lens). Upon positioning of the intraocular lens implant within the internal volume of the lens capsule, a capsule connecting portion of the fixation device may then be secured to the lens capsule. Or, such an intraocular fixation device may be integrated as a part of the intraocular lens implant. Hence, the implant itself may have a capsule connecting portion that may be secured to the lens capsule.

In certain embodiments, the capsule connecting portion may include a plug, clip, hook, protrusion, rivet, or other suitable arrangement that allows for the implant to be coupled to the lens capsule. In some embodiments, small openings are formed in the surface (e.g., anterior capsular surface) of the lens capsule so as to accommodate attachment of the intraocular lens implant to the lens capsule. Such small openings may be produced by any suitable method, such as use of a femtosecond laser system, which enables precise incisions to be formed.

For various embodiments described herein, the intraocular lens implant may be restricted from translation along an anterior-posterior axis of the eye to less than 1.0 mm. Such arrangements may further restrict the intraocular lens implant from rotation about the anterior-posterior axis of the eye to less than 30 degrees.

In an illustrative embodiment, an intraocular fixation device is provided. The device may include an implant connecting portion constructed and arranged to be secured to an intraocular lens implant. The device may also include a capsule connecting portion constructed and arranged to be secured to a lens capsule of an eye. Upon positioning of the intraocular lens implant within an internal volume of the lens capsule, the intraocular lens implant may be restricted from translation along an anterior-posterior axis of the eye to less than 1.0 mm, and the intraocular lens implant may be restricted from rotation about the anterior-posterior axis of the eye to less than 30 degrees.

In another illustrative embodiment, a method of securing an intraocular lens implant to a lens capsule of an eye is provided. The method may include securing an implant connecting portion of the intraocular device to the intraocular lens implant, and positioning the intraocular lens implant within an internal volume of the lens capsule. The method may further include securing a capsule connecting portion of the intraocular device to the lens capsule. Securing the capsule connecting portion to the lens capsule may restrict translation of the intraocular lens implant along an anterior-posterior axis of the eye to less than 1.0 mm, and may further restrict rotation of the intraocular lens implant about the anterior-posterior axis of the eye is restricted to less than 30 degrees.

In yet another illustrative embodiment, an intraocular lens implant is provided. The implant may include an optical lens, and at least one haptic extending from the optical lens. The implant may further include a capsule connecting portion extending from the optical lens or the at least one haptic. The capsule connecting portion may be constructed and arranged to be secured to a lens capsule of an eye such that, upon positioning of the intraocular lens implant within an internal volume of the lens capsule, the intraocular lens implant is restricted from translation along an anterior-posterior axis of the eye to less than 1.0 mm, and the intraocular lens implant is restricted from rotation about the anterior-posterior axis of the eye to less than 30 degrees.

In a further illustrative embodiment, a method of securing an intraocular lens implant to a lens capsule of an eye is provided. The method may include positioning the intraocular lens implant within an internal volume of the lens capsule. The method may further include securing a capsule connecting portion of the intraocular lens implant to the lens capsule, wherein translation of the intraocular lens implant along an anterior-posterior axis of the eye is restricted to less than 1.0 mm, and wherein rotation of the intraocular lens implant about the anterior-posterior axis of the eye is restricted to less than 30 degrees. The capsule connecting portion may extend from an optical lens or at least one haptic of the intraocular lens implant.

Various embodiments of the present disclosure provide certain advantages. Not all embodiments of the present disclosure share the same advantages and those that do may not share them under all circumstances. Various embodiments described may be used in combination and may provide additive benefits.

Further features and advantages of the present invention, as well as the structure of various embodiments of the present disclosure are described in detail below with reference to the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures is represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. Various embodiments of the present disclosure will now be described, by way of example, with reference to the accompanying drawings, in which:

Fig. 1 depicts a cross-sectional view of the anatomy of the eye;

Fig. 2A illustrates a perspective view of an intraocular lens implant to which fixation devices are secured in accordance with some embodiments;

Fig. 2B shows a perspective view of the intraocular lens implant of Fig. 2A located within a lens capsule in accordance with some embodiments;

Fig. 3 depicts a perspective view of a lens capsule including a larger opening and a number of smaller openings in accordance with some embodiments;

Fig. 4A illustrates a perspective view of another intraocular lens implant in accordance with some embodiments;

Fig. 4B shows a perspective view of the intraocular lens implant of Fig. 4A located within a lens capsule in accordance with some embodiments;

Fig. 5A illustrates a perspective view of yet another intraocular lens implant to which fixation devices are secured in accordance with some embodiments;

Fig. 5B shows a perspective view of the intraocular lens implant of Fig. 5A located within a lens capsule in accordance with some embodiments;

Fig. 6A illustrates a perspective view of another intraocular lens implant to which fixation devices are secured in accordance with some embodiments;

Fig. 6B shows a perspective view of the intraocular lens implant of Fig. 6A located within a lens capsule in accordance with some embodiments;

Fig. 7A illustrates a perspective view of an intraocular lens implant to which fixation devices are secured in accordance with some embodiments;

Fig. 7B shows a perspective view of the intraocular lens implant of Fig. 7A located within a lens capsule in accordance with some embodiments;

Fig. 8A illustrates a perspective view of an intraocular lens implant to which fixation devices are secured in accordance with some embodiments;

Fig. 8B shows a perspective view of the intraocular lens implant of Fig. 7A located within a lens capsule in accordance with some embodiments; and

Fig. 9 depicts a perspective view of an intraocular lens implant and a loading cartridge in accordance with some embodiments. DETAILED DESCRIPTION

The present disclosure relates to the ability to fix or otherwise secure an intraocular lens implant in place within the lens capsule of an eye during surgical implantation. By providing a mechanism for suitably holding the intraocular lens implant to the lens capsule, undesirable movement of the lens, which may otherwise lead to unpredictability in vision for the patient, may be substantially reduced or minimized.

For certain embodiments described herein, an intraocular fixation device may be secured to the intraocular lens implant and, when the lens implant is appropriately positioned within the lens capsule upon deployment, the fixation device may further be secured to the lens capsule. Thus, the fixation device effectively holds both the intraocular lens implant and the lens capsule together such that the optical lens is restricted from substantial movement. Alternatively, this fixation device may be provided as an integrated part of the intraocular lens implant where the implant itself is able to be secured directly to the lens capsule, in a desirable manner. By suitably holding the intraocular lens implant in place, predictable and desirable outcomes in vision may be achieved.

On the other hand, for conventional implants, despite employing haptics which aim to generally maintain the overall position of the implant within the capsule, the lens may still be subject to significant movement, such as translation and rotation. That is, the use of haptics alone is insufficient in their ability to restrict movement of the lens within the capsule in a manner that maintains a suitable level of predictability in vision.

By using conventional implants, the position of the lens along the anterior-posterior axis A-P of the eye may vary appreciably, which can lead to undesirable distortion in vision. For instance, translation of the lens along the anterior-posterior axis A-P of the eye of up to 1.0 mm may result in a substantial distortion (e.g., 3.0 diopter variation) in corrective prescription. For toric lenses that are intended to correct for astigmatic conditions, a rotation of up to 15 degrees may also alter the effects of astigmatic correction (e.g., 50% variation).

In accordance with aspects of the present disclosure, the intraocular lens implant may include or otherwise employ an intraocular fixation device and/or other appropriate component(s). The fixation device may include an implant connecting portion (e.g., ring, clip, jaws, adhesive, plug, bayonet, fastener, screw, other structural configuration, etc.) that may be fixed, formed integral with, or otherwise secured to the intraocular lens implant. The fixation device, or lens implant itself, may also include a capsule connecting portion that, upon implantation, extends toward the lens capsule of the eye, for fixation thereto. Upon appropriate fixation of the intraocular lens implant to the lens capsule, the lens is restricted from substantial translation and/or rotation.

In some embodiments, the intraocular lens implant is secured to the anterior capsular surface of the lens capsule. Accordingly, in addition to holding the intraocular lens implant in place, even if the posterior surface of the capsule is punctured, ruptured, torn or otherwise damaged, as a further benefit of aspects of the present disclosure, the lens implant may remain secured to the anterior surface of the capsule and, for example, may avoid falling into the vitreous humour of the eye.

Additionally, the intraocular lens implant may be secured on the inferior side of the anterior capsular surface (inside of the lens capsule). Securing the lens implant on the inferior side of the anterior capsular surface may provide another advantage in that it leaves space for an additional lens implant to be secured on the superior side of the anterior capsular surface (outside of the lens capsule), hence, allowing for additional procedures for vision correction.

Fig. 2A depicts an illustrative embodiment of an intraocular lens implant 50 having an optical lens component 52 and haptics 54, 56 each extending from the longitudinal axis L of the optical lens component 52. Each of the haptics 54, 56 of the intraocular lens implant 50 has a respective intraocular fixation device 100 secured thereto. As shown, each intraocular lens implant 50 includes an implant connecting portion 110 for coupling or otherwise securing the fixation device 100 to the implant 50, and a capsule connecting portion 120 for coupling or otherwise securing the implant 50 to an appropriate lens capsule 10. In some embodiments, for cataract implantation of a toric lens, it may be preferable for the intraocular lens implant 50 to be aligned with the steepest corneal meridian, where the steepest corneal meridian may be determined by methods known in the art.

As provided in this embodiment, the implant connecting portion 110 includes a ringlike or otherwise rounded structure (e.g., circular, ellipsoidal) that is configured to slide from a distal region (further from the optical lens) to a proximal region (closer to the optical lens) along the length of the haptic 54, 56. In some embodiments, as shown here, the proximal region of each of the haptics 54, 56 includes respective grooves 55, 57 that each may provide a recess within which the ring may reside. Hence, while the respective rings of the fixation device 100 may move relatively freely back and forth along the haptics 54, 56, the grooves 55, 57 of the haptics may provide suitable space for the rings to settle, so as to increase the likelihood for the fixation device to be kept in place. That is, the grooves 55, 57 may help to reduce the chances of the fixation device(s) 100 falling away from the respective haptics 54, 56.

Other arrangements are possible. In some embodiments, while not expressly shown in the figures, the proximal region of the haptic may optionally have a thickness that is greater than the thickness along the distal region of the haptic. For example, the thickness at a proximal region of the haptic may be comparable to the inner diameter of the ring-like structure of the implant connecting portion 110 so as to be able to form an interference fit therebetween. Accordingly, securing the fixation device 100 to the implant 50 may involve sliding the ring-like structure from the distal end toward the end of the proximal region of the haptic 54, 56 to the point where the thickness of the haptic is sufficient for the ring-like structure to form a snug tight fit. Alternatively, as shown in Fig. 2A, aside from the grooves 55, 57, there is little variation in the overall thickness of the haptics 54, 56.

It should be understood that that the implant connecting portion of the fixation device may have any suitable construction and, hence, may be secured to the intraocular lens implant according to an appropriate configuration. For example, as discussed further below, the fixation device may be coupled to a suitable region of the implant (e.g., haptic(s), optical lens component, other region) via one or more clips, jaws and/or fastening component.

Alternatively, or in combination, the implant connecting portion may include one or more grooves, slots, ridges, protrusions, screws, fastening components and/or other features having a structure suitable for coupling with a complementary region (e.g., haptic(s), optical lens component) of the implant. Accordingly, an appropriate region of the lens implant may optionally have structure (e.g., grooves, slots, ridges, protrusions, etc.) complementary to that of the implant connecting portion of the fixation device. As an example, the fixation device may be attached or otherwise coupled with the intraocular lens implant by nudging the optical lens or the haptic within an appropriate slot or groove of the fixation device. Or, the fixation device may be screwed or otherwise fastened to the implant at an appropriate location (e.g., haptic, optical lens, junction between the haptic and optical lens, etc.).

In some embodiments, the intraocular lens implant itself may include one or more holes, recesses, openings (not shown in the figures), or other features, at any suitable location of the implant (e.g., haptic(s), optical lens), that may allow for the fixation device to be coupled thereto. For example, the implant connecting portion of the fixation device may include a plug-like feature similar to that described with respect to the capsule connecting portion. That is, the fixation device may include plugs that face in opposing directions. Hence, one of the plugs may be inserted through an opening formed in the intraocular lens implant, and the other of the plugs may be inserted through an opening formed in the surface of the lens capsule. It can be appreciated that for some embodiments, such holes, recesses, openings may extend only partially through the thickness of the implant, and are not required to extend all the way through. In various embodiments, the implant and fixation device may include complementary features (e.g., slots, grooves, protrusions, etc.) that allow for mutual attachment.

The fixation device and the implant may be coupled such that the degree of attachment may be tightened or loosened, as desired. In some embodiments, an adjustable tether and anchor arrangement may be employed between the fixation device and the implant. For example, a tether, or portion thereof (flexible or rigid), may be affixed (e.g., hooked, tied, knotted, joined, adhered, etc.) to the implant, and a corresponding anchor (e.g., stopper) may be affixed to the fixation device; or vice versa, the tether may be affixed to the fixation device and the anchor may be affixed to the implant.

The tether may extend through a hole or opening of the anchor and may be pulled and/or manipulated back and forth so as to adjust the tension of the tether. That is, as the tether is pulled further through or around the anchor, the attachment between the implant and fixation device is increasingly tightened. Conversely, as the tether is released to provide more slack, the attachment between the implant and fixation device is loosened.

It can be appreciated that arrangements provided herein which allow for tightening of an attachment may be used in any aspect or feature of the present disclosure. For example, the manner in which the implant or fixation device is secured to the lens capsule may also employ such arrangements.

For some embodiments, while not shown in the figures, the fixation device may include a handle that allows for the device to be held and/or manipulated before or after being secured to the implant.

Or, as further provided herein, the fixation device may be a part of the intraocular lens implant itself. That is, for some embodiments, the intraocular fixation device is formed to be integral with the intraocular lens implant and is not a separate component that requires separate attachment to the implant. As a result, whether the fixation device is separate or integrally formed with the intraocular lens implant, an appropriate capsule connecting portion extends therefrom (e.g., from the optical lens, haptics or other part of the implant), for attachment to the lens capsule. The capsule connecting portion of the fixation device, or part of the intraocular lens implant itself, may extend from a desired location of the implant (e.g., haptics, optical lens), for securing the implant to the lens capsule. Fig. 2B shows an illustrative embodiment where the intraocular lens implant 50 of Fig. 2A is located within the internal volume of the lens capsule 10, and secured to the inferior surface thereof. In various embodiments, as discussed further below, small openings or holes may be formed at suitable locations of the lens capsule, which may accommodate or otherwise provide for secure connection with the capsule connecting portion 120.

In the embodiment of Figs. 2A-2B, the capsule connecting portion 120 includes a plug-like structure extending from the implant connecting portion 110. The plug-like structure may include a pointed top that is configured to wedge into a corresponding opening of a surface (e.g., anterior, posterior) of the lens capsule, for securing the implant 50 to the lens capsule 10.

It can be appreciated that the capsule connecting portion may employ any suitable configuration that allows it to couple with an appropriate surface of the lens capsule. For example, the capsule connecting portion may be configured to enter one or more openings formed in the surface of the lens capsule, while preventing or otherwise resisting exit therefrom. Alternatively, the capsule connecting portion may include a relatively sharp point that is sufficient to pierce the surface of the lens capsule for penetration thereof.

Or, in some embodiments, similar to the construction of an umbrella, the capsule connecting portion may be placed in a furled position during entry into a respective opening or other location of the lens capsule. After such entry, the capsule connecting portion may be placed in an unfurled or open position, which may prevent or otherwise resist detachment of the capsule connecting portion from the lens capsule. Accordingly, for various embodiments of the present disclosure, the resistance to entry of the capsule connecting portion(s) into the opening(s) made into the lens capsule may be less than the resistance to exit of the same capsule connecting portion(s) from the respective opening(s) of the lens capsule. Hence, for example, when in a furled position, the capsule connecting portion may more readily pass through or across the surface of the lens capsule than when in an unfurled or more open position.

In some embodiments, the capsule connecting portion may include a shaft having one or more hook-like structures extending therefrom. For example, two or more flexible hooks having an arrow-like tip extending from the end of the shaft may be pushed through a suitable opening. While moving through the opening, respective edges of the opening may effectively keep the hooks aligned generally parallel to the shaft, to allow for entry therethrough. Once the hooks are clear of the opening, the hooks are then able to adopt a more relaxed, open position, resulting in a greater level of mechanical resistance upon exit of the hooks back through the opening.

The shaft and hooks of the capsule connecting portion may have any suitable dimensions. In some embodiments, the thickness of the shaft may be between 10 microns and 500 microns, between 10 microns and 300 microns, between 50 microns and 150 microns (e.g., approximately 100 microns), or any other suitable thickness. In various embodiments, the maximum width across a respective hook may be between 10 microns and 500 microns, between 10 microns and 300 microns, between 10 microns and 100 microns (e.g., approximately 50 microns), or any other suitable width. It can be appreciated that the dimensions of the capsule connecting portion may vary depending on the dimensions of the opening with which the capsule connecting portion is to be engaged.

As an example, openings of approximately 200 microns in diameter may be suitable for entry of a capsule connecting portion of a fixation device or implant that includes a shaft having a thickness of approximately 80-100 microns, and hooks extending from the shaft, each having a maximum width across of approximately 50 microns. In such an instance, the shaft and hook arrangement may enter through the opening in a furled position. And, after entry through the opening, the hooks may take on a more open configuration optionally with an increased amount of slack, which may effectively lock or otherwise engage the hooks in place.

As described herein, the lens capsule may be treated or otherwise operated on so as to accommodate fixation of the intraocular lens implant thereto. For example, small holes or openings may be formed in the surface (e.g., anterior capsular surface) of the lens capsule, for suitable attachment at the respective locations of the openings. This is in addition and may be adjacent to the comparatively larger opening for capsulorhexis formed in the surface of the lens capsule which is for insertion of the intraocular lens implant within the internal volume of the lens capsule.

Fig. 3 shows an illustrative embodiment of a lens capsule 10 having a larger opening 20, for deployment of the implant (e.g., capsulorhexis for cataract surgery), and smaller openings 30, for accommodating attachment between the capsule connecting portion of the device, or implant itself, and lens capsule. In general, the smaller openings 30 may be substantially smaller in size than the larger opening 20. For example, the maximum width (e.g., shown as diameter Dl) of the larger opening 20 for accommodating entry of the overall implant may be greater than 2.0 mm, greater than 3.0 mm, greater than 4.0 mm (e.g., approximately between 5.0 mm and 6.0 mm), greater than 5.0 mm, greater than 6.0 mm, greater than 7.0 mm, greater than 8.0 mm, or any other appropriate value that allows the capsule to receive the implant.

The smaller openings formed to accommodate securing of the intraocular lens implant to the lens capsule may have any suitable size. Such openings may be sufficiently sized so as to allow the capsule connecting portion of the fixation device or implant to enter through relatively easily. Though, as noted above, the capsule connection configuration may be such that there is more resistance for the capsule connecting portion to exit from the opening than to enter through it in the first place. That is, it is easier to attach the implant to the lens capsule than to remove the implant therefrom.

In some embodiments, the maximum width (e.g., shown as diameter D2) of openings for accommodating securing of the implant to the lens capsule may be less than 1.0 mm, less than 900 microns, less than 800 microns, less than 700 microns, less than 600 microns, less than 500 microns, less than 400 microns (e.g., approximately between 100 microns and 400 microns), less than 300 microns (e.g., approximately between 100 microns and 300 microns), less than 250 microns, less than 200 microns, less than 150 microns, less than 100 microns, less than 50 microns, or any other suitable value of maximum width. For some embodiments, the maximum width of such openings in the surface of the lens capsule may be greater than 10 microns, greater than 50 microns, greater than 100 microns, greater than 200 microns, greater than 300 microns, greater than 400 microns, greater than 500 microns, or any other suitable value of maximum width. Appropriate combinations of these ranges may be possible. The maximum width for such openings may fall outside of the above noted ranges. It can be appreciated that the openings in the surface of the lens capsule may be appropriately sized so as to minimize or otherwise reduce slack between the implant and the lens capsule to provide a more secure attachment.

The openings along the surface of the lens capsules may have any suitable shape. It can be understood that such openings are not required to be circular. For example, the openings may be formed according to non-circular arcuate shapes (e.g., ellipsoidal, oblong, irregular, etc.). The openings may also be formed according to other shapes, such as triangles, parallelograms, squares, rectangles, pentagons, hexagons, irregular, or any other suitable shape. Accordingly, the capsule connecting portion of the fixation device or implant may be constructed so as to complement the respective shapes of the smaller openings incised on the surface of the lens capsule. In various embodiments, multiple openings for receiving the capsule connecting portion of the device or implant may be formed in the surface of the lens capsule according to any suitable arrangement. For instance, openings may be created adjacent to one another, in a radial, circumferential, grid, random, or other appropriate configuration. Fig. 3 further shows the lens capsule 10 having a number of smaller openings 30 formed in a radial configuration. By creating multiple openings, the medical personnel (e.g., ophthalmologist, surgeon) will have a number of different locations from which to choose, depending on the particular situation or intraoperative aberrometry, for appropriate alignment of the implant within the lens capsule.

During a cataract surgery, as noted above, it may be preferable for the longitudinal axis of a toric intraocular lens implant to be aligned with the steepest corneal meridian.

However, those of skill in the art will appreciate that it may be necessary for multiple corrections in such alignment of the toric lens implant to be made. For example, upon implantation, due to settling of the implant or capsule, or other fluctuations in the overall structural orientation related to the eye, the intraocular lens implant may require re-alignment. Thus, to provide for appropriate alignment of a toric lens implant, it may be preferable for medical personnel to have a suitable level of flexibility in adjusting the location(s) at which the implant is affixed to the lens capsule, such as that provided in the embodiment depicted in Fig. 3.

In some embodiments, the smaller openings for accommodating fixation of the implant to the lens capsule may be sufficiently large so as to allow entry of an appropriate capsule connecting portion therethrough, yet the openings may also be small enough such that they do not prevent or otherwise interfere with deployment and/or operation of the overall intraocular lens implant. For example, when the implant is suitably placed within the internal volume of the lens capsule, other than an appropriate capsule connecting portion of the device or implant, the openings are too small for the haptics, or other part of the implant, to undesirably penetrate through. As noted above, the openings may also be small enough to provide a suitable amount of resistance to exit of the capsule connecting portion once appropriately connected.

Openings formed for the purpose of securing of the intraocular lens implant to the lens capsule may be provided at any suitable location. In some embodiments, the distance between the smaller openings (provided to accommodate securing of the implant to the lens capsule) and the edge of the larger opening (provided for deployment of the implant itself) may be greater than 0.1 mm (e.g., approximately between 0.1 mm and 2.0 mm), greater than 0.2 mm (e.g., approximately between 0.2 mm and 1.0 mm), greater than 0.3 mm, greater than 0.4 mm, greater than 0.5 mm (e.g., approximately between 0.5 mm and 1.0 mm), greater than 0.6 mm, greater than 0.8 mm, greater than 1.0 mm, greater than 1.5 mm, greater than 2.0 mm; or less than 2.0 mm, less than 1.5 mm, less than 1.0 mm, less than 0.8 mm, less than 0.6 mm, less than 0.5 mm, less than 0.4 mm, less than 0.3 mm, less than 0.2 mm, less than 0.1 mm, or any other suitable distance. Appropriate combinations of the above noted ranges may be possible. The distance between such openings may also fall outside of such ranges.

Openings may be formed into the surface of the lens capsule by any suitable manner. For instance, the openings may be formed via an incising tool, such as a sharp mechanical instrument (e.g., needle, scalpel, etc.), laser (e.g., femtosecond laser), or other suitable apparatus.

In some embodiments, a femtosecond laser system may be employed to form suitable openings in the surface of the lens capsule. A femtosecond laser system allows for small, fine incisions to be made at precise locations. In various instances, the openings may be created such that the longitudinal axis of the intraocular lens implant may be substantially aligned along a desired meridian of the lens capsule. Such meridians may be, for example, the steepest meridian, which may generally be aligned with the haptics and/or the

longitudinal axis of the implant such as that shown in Fig. 2B, or the flattest meridian, which may generally be aligned approximately 90 degrees from the longitudinal axis such as that shown in Fig. 4B, further described below. Though, it can be appreciated that the openings may be created such that the longitudinal axis of the intraocular lens implant is aligned along other meridians of the eye.

In various embodiments, the openings themselves may be formed so as to be substantially aligned with a particular meridian of the lens capsule, for example, when capsule connecting portions of a fixation device are located directly opposite one another.

Though, in some cases, more than two capsule connecting portions may be provided, such as in an arrangement where they are relatively evenly spaced around the optical lens. For example, three capsule connecting portions may be provided in a triangular type arrangement around the optical lens, four capsule connecting portions may be provided in a square type arrangement at various corners of the optical lens, five capsule connecting portions may be provided in a pentagon type arrangement around the optical lens, or more capsule connecting portions may be provided according to any suitable pattern.

In accordance with the present disclosure, femtosecond laser systems may be programmed (e.g., via software) so as to create holes or openings at the desired location(s) (e.g., outside of the rhexis or larger opening) on the surface of the lens capsule. In some embodiments, a suitable user interface may be provided for the femtosecond laser system to receive input from a user as to the location, pattern, size or other parameter(s) of the openings. The user interface may also include a display for providing a user with information (e.g., corneal geometry, laser patterns, etc.) helpful for forming an appropriate pattern of openings.

The use of a femtosecond laser, or systems with a similar level of precision, to form openings in the lens capsule may be beneficial in providing the ability to create capsule openings in a predictable and safe manner. This is in contrast to other methods, such as using needles, scissors, forceps or other comparable surgical tools, where the possibility of undesirable tearing of the capsule may be greater, for example, due to the manual nature of the procedure. Upon formation of the opening(s), it may be preferable for the edge of the opening(s) to be substantially smooth, so as to provide for a relatively even distribution of forces applied to the surface of the capsule. That is, for some embodiments, the edge of the opening may be formed so as to exhibit a minimal or otherwise reduced amount of discontinuities that would otherwise promote tearing.

The capsule connecting portion(s) of the device or implant may be configured so as to enter into the respective opening(s) from an inferior (or posterior) position toward a superior (or anterior) position of the opening. Alternatively, the capsule connecting portion(s) may enter into the respective opening(s) from a superior (or anterior) position toward an inferior (or posterior) position of the opening. For example, in various embodiments, the capsule connecting portion may be manipulated from within the internal volume of the lens capsule and pushed (or pulled) through the opening(s) in a direction toward the superior side of the lens capsule, or vice versa.

Figs. 4A-4B show another embodiment of a fixation device 100 secured to an intraocular lens implant 50. Similarly to the embodiment of Figs. 2A-2B, the capsule connecting portion 120 of the fixation device 50 is configured to engage with the lens capsule 10 through movement from the inferior (internal) side of the anterior capsular surface through the respective opening(s) 30 in a direction toward the superior (exterior) side of the capsular surface.

Though, in this embodiment, rather than being substantially or closely aligned with the longitudinal axis of the implant, and coupled thereto via the haptics 54, 56, the fixation device 100 is coupled to the implant via the optical lens component 52. As shown, for this embodiment, the implant connecting portion 110 includes a suitably structured clip having jaws that may clamp down on to and/or form a suitable friction/interference fit with the optical lens 52 of the implant 50, to form a secure attachment between the fixation device 100 and the implant 50. Once the fixation device 100 is secured to the implant 50, the plug of the capsule connecting portion 120 may be pushed (or pulled) through the respective opening 30 of the lens capsule 10 for engagement thereto.

Alternatively, the capsule connecting portion of the device or implant may be able to engage with the respective opening(s) of the lens capsule by moving from the superior (exterior) side of the capsular surface through the opening(s) and toward the inferior

(internal) side of the capsule. Figs. 5A-5B depict another illustrative embodiment where the capsule connecting portion 120 of the fixation device or implant may be manipulated from the superior (exterior) side of the anterior capsular surface so as to move through the respective opening(s) 30 in a direction toward the inferior (interior) side and enter into the internal volume of the lens capsule.

Similar to that shown in Figs. 4A-4B, the implant connecting portion 110 of the fixation device 100 includes a clip having jaws for clamping on to and/or forming a suitable interference fit with the optical lens component 52 and securing the device 100 to the implant 50. Though, for the embodiment of Figs. 5A-5B, the capsule connecting portion 120 has an arm 122 that has a length long enough to extend out from the implant 50 through the larger opening 20 and over the surface of the lens capsule 10. The arm 122 may be suitably flexible and/or able to be manipulated so that the plug may be moved into an appropriate orientation. Hence, as shown in Fig. 5B, the tip of the capsule connecting portion 120 may be able to engage with the respective opening(s) 30 in a direction back toward the implant.

Any suitable method and/or apparatus may be used to secure the capsule connecting portion of the fixation device or implant, to the lens capsule. That is, an instrument such as a cannula, forceps or other appropriate tool(s) may be constructed (e.g., including teeth or other mechanical features) and manipulated so as to engage with the fixation device and/or lens implant, for example, to allow for a user to push or pull the tip of the capsule connecting portion into a corresponding hole or opening. In various embodiments, the instrument may have operative features (e.g., protrusions, teeth, extensions, etc.) that are designed to extend below and/or above the haptic, optical lens and/or fixation device to provide sufficient force for the capsule connecting portion and come into suitable engagement with the lens capsule.

As noted above, the intraocular fixation device may be formed integrally with the intraocular lens implant. Fig. 6A shows an illustrative embodiment where the fixation device 100 is effectively an integral part of the intraocular lens implant 50. Accordingly, the intraocular lens implant 50 has an optical lens component 52 and haptics 54, 56 each extending from the optical lens component 52 along the plane of the optical lens. Extending from opposing sides of the optical lens component approximately 90 degrees from the longitudinal axis L and in a direction substantially perpendicular to the plane of the optical lens are respective capsule coupling portions 120, for coupling or otherwise securing the implant 50 to an appropriate lens capsule 10.

As further shown, the intraocular lens implant 50 may further include handles 53 which allow for the implant to be held or manipulated by a suitable instrument (e.g., forceps, cannula, probes, etc.). For instance, forceps may be used to grasp the handles 53 and push the capsule connecting portion(s) of the implant up through respective openings. The handles 53 may have any appropriate configuration. In some cases, as shown, the handles may have a knob-like configuration, for example, having a width across of approximately 50-150 microns (e.g., about 80-100 microns) and a height of approximately 100-300 microns (e.g., about 150-200 microns). Other arrangements for manipulating the implant may be possible. For instance, the optical lens may have one or more holes or openings which also may allow for a suitable degree of manipulation thereof. Such features (e.g., holes, knobs, handles, etc.) may be positioned at any suitable location in any appropriate orientation of the intraocular lens implant. For example, the knobs may be located closer to the periphery of the optical lens than what is shown in the figures. Or, the knobs may be oriented in an outward direction along the plane of the optical lens. Other locations and configurations may be possible.

It can be appreciated that the implant 50 may include any suitable number of capsule coupling portions 120 provided in any appropriate pattern. For example, the capsule coupling portions 120 may be located closer to or at the haptics 54, 56, and are not required to be located in alignment with or 90 degrees from the longitudinal axis L of the implant. Or, in some embodiments, the implant 50 may include more than two capsule coupling portions 120, for example, three, four, five or more situated at suitable locations of the implant. In some cases, the capsule coupling portions 120 may be relatively evenly spaced around the optical lens component (e.g., three plugs provided in a triangle arrangement, four plugs provided in a square arrangement at various corners of the implant, five plugs provided in a pentagon arrangement, etc.). Fig. 6B shows an illustrative embodiment where the intraocular lens implant 50 of Fig. 6A is located within the internal volume of the lens capsule 10 and is secured to the anterior capsular surface thereof via openings 30.

In some embodiments, the fixation device is provided as a single component such as that shown in Figs. 6A-6B, or may be made up of multiple components that may be connected together to form the overall device. As noted above, when provided as a single component, the capsule connecting portion and implant connecting portion of the fixation device may be integrally formed. Alternatively, the capsule connecting portion and the implant connecting portion may be formed as separate components having complementary coupling regions that provide for mutual attachment. In some embodiments, prior to securing the fixation device to the intraocular lens implant, the capsule connecting portion and the implant connecting portion may first be coupled together. Or, the implant connecting portion of the fixation device may first be secured to the implant and subsequently coupled to the capsule connecting portion.

Figs. 7A-7B depict an illustrative embodiment of a fixation device 100 where the implant connecting portion 110 and capsule connecting portion 120 are formed as separate components. The implant connecting portion 110 includes a clip for engaging with the optical lens component 52 (e.g., via a suitable friction or interference fit). In this

embodiment, the implant connecting portion 110 further includes an opening 112 for receiving a complementary arm extension 122 of the capsule connecting portion 120.

As shown in Fig. 7B, during deployment, the implant 50 may be placed within the internal volume of the lens capsule 10 together with the implant connecting portion 110 of the fixation device 100. When the implant 50 is suitably positioned for attachment to the lens capsule 10, the capsule connecting portion 120 may then be coupled to the corresponding implant connecting portion 110, for example, through an opening 30, securing the implant 50 and lens capsule 10 together. In some embodiments, the implant connecting portion 110 and capsule connecting portion 120 may be engaged via a suitable locking mechanism for ensuring that the implant and capsule and suitably held together.

Figs. 8A-8B show another illustrative embodiment of a fixation device 100 that may be used to secure the implant 50 and the lens capsule 10 together. Similar to other instances described herein, for this embodiment, the implant connecting portion 110 includes a clip for engaging with the optical lens component 52.

Though, as further shown in Fig. 8B, for this embodiment, the fixation device 100 does not enter or otherwise engage with a pre-formed opening in the capsular surface.

Rather, the capsule connecting portion 120 includes an additional clip that engages directly with the lens capsule. Thus, the fixation device 100 may be clipped on to the implant 50. And then, once suitably secured, the fixation device 100 may be further clipped on to the lens capsule 10. Hence, for some embodiments, it is not required for holes or openings to be formed in the surface of the lens capsule for suitable attachment of the intraocular lens implant directly thereto.

For some embodiments, the fixation device may formed so as to extend substantially around the optical lens of the implant, which may provide an even more secure attachment to the implant as well as the capsular surface. For example, the fixation device of Figs. 8A-8B may have an arcuate or rounded configuration extending greater than 10 degrees, greater than 30 degrees, greater than 60 degrees, greater than 90 degrees, greater than 120 degrees, greater than 150 degrees, or other suitable range around the optical lens. In some cases, the fixation device may essentially extend from haptic to haptic on either side of the optical lens. The implant connecting portion of the device may clip on to the optical lens extending inward, for example, approximately 500 microns or less. The capsule connecting portion of the device may clip on to the lens capsule extending inward, for example, approximately 1.0 mm or less.

It can be appreciated that other variations are possible. For example, as provided herein, such a fixation device may be formed integrally with the implant as a single component.

As provided herein, upon suitable positioning of the intraocular lens implant within an internal volume of the lens capsule and coupling therewith (e.g., via the fixation device), the intraocular lens implant may be substantially restricted from translation and rotation, appreciably more so than any such restriction provided by existing intraocular lens implant systems.

In certain embodiments, upon deployment of the intraocular lens implant and coupling with the lens capsule, the intraocular lens implant may be restricted from translation a distance along the anterior-posterior axis of the eye of less than 2.0 mm, less than 1.5 mm, less than 1.0 mm, less than 900 microns, less than 800 microns, less than 700 microns, less than 600 microns, less than 500 microns (e.g., between 50 microns and 500 microns), less than 400 microns (e.g., between 50 microns and 400 microns), less than 300 microns (e.g., between 50 microns and 300 microns, between 100 microns and 300 microns), less than 250 microns, less than 200 microns, less than 150 microns, less than 100 microns, less than 50 microns, or any other suitable distance. In some embodiments, a lower limit of translation of the intraocular lens implant for each of these ranges may be approximately 10-50 microns. Values outside of the above-noted ranges of translation may also be possible.

As noted previously, those of skill in the art will appreciate that translations of the lens along the anterior-posterior axis of the eye of approximately 1.0 mm may result in approximately a 3.0 diopter change from the desired optical power. That is, the use of a conventional intraocular lens implant that is not secured to the lens capsule in the manner described herein may result in marked vision impairment of the patient, such as 3.0 diopters or more due, at least in part, to movement of the lens along the anterior-posterior axis of the eye.

For some embodiments, when the intraocular lens implant is suitably secured to the lens capsule, the intraocular lens implant may be restricted from rotation about the anterior- posterior axis of the eye of less than 30 degrees, less than 25 degrees, less than 20 degrees, less than 15 degrees, less than 14 degrees, less than 13 degrees, less than 12 degrees, less than 11 degrees, less than 10 degrees, less than 9 degrees, less than 8 degrees, less than 7 degrees, less than 6 degrees, less than 5 degrees, less than 4 degrees, less than 3 degrees, less than 2 degrees, less than 1 degree, or any other suitable amount of rotation. In some embodiments, a lower limit of rotation of the intraocular lens implant for each of these ranges may be approximately 1 degree. Values outside of the above-noted ranges of rotation may also be possible.

For toric lenses, it can be appreciated that rotations of the lens about the anterior- posterior axis of the eye of approximately 5 degrees may result in a loss of about 17% in astigmatic correction. Accordingly, the use of a conventional toric intraocular lens implant that is not secured to the lens capsule in the manner described herein may result in astigmatic impairment of the patient of as much as 17% due, at least in part, to rotation of the lens about the anterior-posterior axis of the eye.

Aspects of the present disclosure may apply for any suitable lens implant. For instance, as discussed above, embodiments described herein may be beneficial to restrict undesirable amounts of rotation within the lens capsule for toric lens implants. Or, embodiments described herein may be helpful for suitable alignment of multifocal lens implants. Multifocal lens implants may include concentric rings where de-centering of the lens implant may lead to suboptimal results in vision (e.g., reduced corrective effects, seeing halos, etc.). Such multifocal lens implants, or other types of lenses, may be properly aligned and centered during surgery in a desired location, restricting post operation movement of the lens.

The intraocular lens implant and fixation device may be deployed according to any suitable protocol. In various embodiments, to provide space for placing the intraocular lens implant within the internal volume of the lens capsule, as discussed above, a relatively large opening (e.g., capsulorhexis approximately 4-6 mm in diameter/width) for receiving the implant may be formed on the anterior capsular surface. An appropriate number of smaller openings (e.g., approximately 100-500 microns in diameter/width) may be formed for receiving or otherwise engaging with the capsule connecting portion of the implant or device at appropriate locations around the larger opening. The location of the smaller openings may depend, at least in part, on the particular configuration and positioning of the capsule connecting portion(s) extending from the implant. For example, it may be desirable for the implant to be fixed or otherwise secured to the lens capsule along a particular meridian (e.g., steepest, flattest corneal meridian). These openings may be formed according to any appropriate method, such as via a femtosecond laser, as discussed above.

For embodiments where a separate step occurs for securing the fixation device to the intraocular lens implant, an alignment or loading instrument may be used to ensure that the fixation device is appropriately secured to the implant according to a desired orientation. Particularly for toric intraocular lens implants, proper deployment of the implant within the lens capsule is often dependent on the orientation or axis along which the implant is placed. For example, as noted above, it may be preferable for the longitudinal axis of a toric intraocular lens implant to be aligned along steepest corneal meridian of the eye.

Accordingly, it may be preferable for the toric intraocular lens implant to be held in place as the fixation device is secured thereto.

In some cases, such an alignment or loading instrument may be provided as a loading cartridge within which the implant is placed. As provided above, the fixation device may be optionally secured to the optical lens component of the implant and, for various

embodiments, the implant connecting portion of such fixation devices may include a clip arrangement. It may be preferable for such clips to be attached to the intraocular lens implant such that the longitudinal axis of the lens implant is aligned along a desired corneal meridian (e.g., steepest meridian).

The loading cartridge may include one or more fixation devices provided in a manner so as to be aligned with the desired location of the implant where the lens capsule is to be attached. In some embodiments, the intraocular lens implant may be placed within a space provided by the loading cartridge, which holds a suitable number of fixation devices, for securing thereto. In some embodiments, the loading cartridge includes one or more grooves, positioning members and/or cavities etched therein, for guiding and allowing stable positioning of the implant within the loading cartridge.

Fig. 9 shows an embodiment of such a loading cartridge 200 which is loaded with fixation devices 100, for their attachment to the implant 50. As depicted, in this embodiment, prior to deployment within the lens capsule 10, the intraocular lens implant 50 may be placed within a recess 202. Appropriate positioning columns 204 provided within the recess 202 may serve to position and hold the implant 50 in place. The loading cartridge 200 further includes spring -biased levers 210 having arms 220 for holding the fixation device 100 in a suitable position for attachment to the implant 50. Upon pressing of the levers 210 by a user, for example, from the outside inward toward one another (e.g., squeezing by the thumb and index finger), the fixation devices 100 are firmly secured on opposite sides of the optical lens 52.

Once the fixation device is appropriately secured to the intraocular lens implant, the implant along with the fixation device may then be suitably placed within the internal volume of the lens capsule. In doing so, for some embodiments, the intraocular lens implant, together with the fixation device, may be loaded into a subsequent implant cartridge, which serves as a carrier for delivery of the implant into the internal volume of the lens capsule. Such an implant cartridge may, for example, provide a suitable envelope, delivery bag or other appropriate structure for holding and/or protecting the intraocular lens implant during deployment. In some cases, the implant, along with its haptics, may be appropriately folded or otherwise placed in a contracted state for insertion into the space provided by the implant cartridge. Once suitably loaded into the implant cartridge, the assembly is then ready for insertion into the lens capsule, via the larger opening (capsulorhexis opening).

When the assembly is desirably positioned within the internal volume of the lens capsule, the implant cartridge or envelope may be removed, allowing the haptics to unfold or otherwise relax into a more spread out position that is suitably engaged with the lens capsule. That is, the haptics extending from the optical lens may assist in stabilizing the overall intraocular lens implant with respect to the capsule. Though, as discussed herein, without aspects of the present disclosure, the optical lens part of the implant may be subject to undesirable rotation and/or translation within the lens capsule. Accordingly, the capsule connecting portion of the fixation device, or implant, extends from the implant so as to be secured to the surface of the lens capsule, according to methods of the present disclosure.

In various embodiments, to ease installation of the intraocular lens implant into the lens capsule, a soft, viscoelastic material may be provided within the internal volume of the capsule. This material may be injected into the lens capsule before or after removal of the cataract. Such a material may be biological (e.g., hyaluronic acid, collagenous, protein, etc.) or synthetic (e.g., bio-inspired, polymeric, etc.) in nature, and may provide a suitable level of protection and/or cushioning within the lens capsule during the overall implantation procedure. For instance, the lens capsule may have fragile characteristics such that, during operation (e.g., forming of the opening(s) along the surface of the capsule, implantation of the lens, etc.), the capsule may be prone to rupture or tearing. If the lens capsule tears along the posterior side, fluid from the vitreous humor may undesirably leak into the capsule and interfere with overall positioning of the lens within the bag. In some cases, incorporation of this protective material may reduce the likelihood for the capsule to be punctured or torn during operation.

Upon suitable deployment of the implant, the protective material is typically removed, for example, via aspiration. In some embodiments, the protective material may be removed from the lens capsule after the intraocular lens implant is secured to the lens capsule. That is, the protective material may beneficially provide protection and support while the implant is being secured to the capsule. Or, for other embodiments, at least a portion of the protective material may be removed from the lens capsule prior to deploying the intraocular lens implant. In some cases, the protective material may interfere with the ability for the implant to be suitably secured to the lens capsule, hence, it may be preferable for at least a partial amount of the protective material to be removed.

For some instances, after implantation, the lens capsule secured together with the implant assembly may settle into an equilibrium state. For example, after several days or weeks have passed after deployment of the implant, the capsule may be prone to shrinkage or contraction around the intraocular lens implant and, in some cases, may conform more to the overall shape of the implant.

Upon achieving a suitable degree of contraction, in some instances, the lens capsule has sufficiently conformed to the implant such that the fixation device is no longer necessary to hold the implant in place against the capsular membrane, and may be removed. That is, the intraocular lens implant may be most prone to undesirable movement (e.g., translation, rotation) immediately after implantation before the lens capsule is able to settle around and shrink in a manner that corresponds to the overall shape of the implant. Accordingly, coupling of the implant via a suitable capsule connecting portion may be of primary significance during the time period after implantation and before contraction of the lens capsule.

What is more, after contraction has occurred, it may be preferable to remove at least a part of the capsule connecting portion (of the fixation device) to maintain overall stability of the lens implant. Otherwise, allowing the capsule connecting portion (e.g., protrusions, bumps, edges and/or other features of the fixation device or implant) to remain may give rise to mechanical tilt, movement or other effects that may interfere with the overall performance of the lens implant. In some embodiments, the intraocular lens implant may be appropriately constructed and/or shaped to withstand capsular contraction, which may otherwise result in distortion of the lens.

For some embodiments, various regions of the fixation device or implant, such as the capsule connecting portion, or other region may be resorbable. That is, upon deployment and coupling of the intraocular lens implant to the anterior capsular surface and shrinkage of the capsule to a point where the implant and capsule are suitably secured to one another, the fixation portion of the device or implant may dissolve away without further user

manipulation, with the lens implant and capsule remaining. For example, a portion (e.g., capsule connecting portion) of the fixation device or implant may be made up of a resorbable material, such as a biodegradable polymer (e.g., poly(lactic-co-glycolic acid, polylactic acid, polycaprolactone,, polyester, etc.), biological material (e.g., biodegradable collagen), or other material capable of resorption.

Or, a portion of the fixation device or implant may be removed, for example, during an in-office or post-operation procedure. In some embodiments, an appropriate portion of the fixation device or implant may be manufactured so as to have a thinner, perforated, scored and/or other frangible region that may be easily broken, such as through a follow up procedure. For instance, a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser may be used in a physician office (or operation room if necessary) to release a suitable portion of the fixation device or implant. Once broken off, this portion of the fixation device or implant may be removed from the system altogether.

The intraocular fixation device may include any suitable material or combination of materials. In some embodiments, the fixation device incorporates the same materials as the intraocular lens implant itself. In various embodiments, the fixation device and/or intraocular lens implant may include at least one of silicone, acrylic, acrylate (hydrophobic or hydrophilic), hydrogel, polymethylmethacrylate, surgical-grade metal (e.g., nonferromagnetic titanium) and collamer. In some embodiments, the fixation device and/or intraocular lens implant may include a suitable coating, for example, a biocompatible material, heparin, or other appropriate coating.

Having thus described several aspects of at least one embodiment of the present disclosure, it is to be appreciated various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modification, and improvements are intended to be part of this disclosure, and are intended to be within the spirit and scope of the present disclosure. Accordingly, the foregoing description and drawings are by way of example only.

Claims

1. An intraocular fixation device, comprising:

an implant connecting portion constructed and arranged to be secured to an intraocular lens implant; and

a capsule connecting portion constructed and arranged to be secured to a lens capsule of an eye such that, upon positioning of the intraocular lens implant within an internal volume of the lens capsule, the intraocular lens implant is restricted from translation along an anterior-posterior axis of the eye to less than 1.0 mm, and the intraocular lens implant is restricted from rotation about the anterior-posterior axis of the eye to less than 30 degrees.

2. The device of claim 1, wherein the capsule connecting portion is configured to be coupled to the implant connecting portion.

3. The device of any of claims 1-2, wherein the implant connecting portion and the capsule connecting portion are separate components.

4. The device of any of claims 1-3, wherein the implant connecting portion and the capsule connecting portion have complementary coupling regions for mutual attachment.

5. The device of claim 1, wherein the implant connecting portion and the capsule connecting portion are integrally formed.

6. The device of any of claims 1-5, wherein the implant connecting portion or the capsule connecting portion is made up of a material including at least one of silicone, acrylic, acrylate, hydrogel, polymethylmethacrylate and collamer.

7. The device of any of claims 1-6, wherein the implant connecting portion is constructed and arranged to be secured to a haptic of the intraocular lens implant.

8. The device of any of claims 1-7, wherein the implant connecting portion is constructed and arranged to be secured to an optical lens component of the intraocular lens implant.

9. The device of any of claims 1-8, wherein the implant connecting portion includes at least one of a clip, jaws, groove and a rounded shape.

10. The device of claim 9, wherein the implant connecting portion has a rounded shape adapted to slide along a length of a haptic toward an optical lens of the intraocular lens implant until the device is secured to the intraocular lens implant.

11. The device of claim 9, wherein the implant connecting portion has a clip adapted to be coupled with a haptic or an optical lens of the intraocular lens implant.

12. The device of any of claims 1-11, wherein the capsule connecting portion extends from the implant connecting portion for the device to be secured to the lens capsule.

13. The device of any of claims 1-12, wherein the capsule connecting portion is constructed and arranged for entry into at least one opening in a surface of the lens capsule.

14. The device of claim 13, wherein the at least one opening in the surface of the lens capsule has a maximum width of less than 1.0 mm.

15. The device of any of claims 13-14, wherein a resistance to entry of the capsule connecting portion into the at least one opening of the lens capsule is less than a resistance to exit of the capsule connecting portion from the at least one opening of the lens capsule.

16. The device of any of claims 13-15, wherein the capsule connecting portion is configured to be in a furled position upon entry into the at least one opening and is further configured to be in an open position after entry into the at least one opening.

17. The device of any of claims 1-16, wherein the capsule connecting portion includes at least one of a protrusion, a hook and a plug.

18. An intraocular system, comprising an intraocular lens implant having an optical lens and at least one haptic extending from the optical lens, and the intraocular device of any of claims 1-17 secured to the intraocular lens implant.

19. A method of securing an intraocular lens implant to a lens capsule of an eye, comprising:

securing an implant connecting portion of the intraocular device to the intraocular lens implant;

positioning the intraocular lens implant within an internal volume of the lens capsule; and

securing a capsule connecting portion of the intraocular device to the lens capsule, wherein translation of the intraocular lens implant along an anterior-posterior axis of the eye is restricted to less than 1.0 mm, and wherein rotation of the intraocular lens implant about the anterior-posterior axis of the eye is restricted to less than 30 degrees.

20. The method of claim 19, wherein securing of the implant connecting portion of the intraocular device to the intraocular lens implant occurs prior to positioning of the intraocular lens implant within the lens capsule.

21. The method of any of claims 19-20, wherein securing the implant connecting portion of the intraocular device to the intraocular lens implant includes coupling the implant connecting portion of the intraocular device to a haptic of the intraocular lens implant.

22. The method of claim 21, wherein coupling the implant connecting portion of the intraocular device to the haptic includes sliding the implant connecting portion along a length of the haptic until the device is secured to the intraocular lens implant.

23. The method of claim 21, wherein coupling the implant connecting portion of the intraocular device to the haptic includes clipping the implant connecting portion to the haptic.

24. The method of any of claims 19-23, wherein securing the implant connecting portion of the intraocular device to the intraocular lens implant includes coupling the implant connecting portion of the intraocular device to an optical lens of the intraocular lens implant.

25. The method of claim 24, wherein coupling the implant connecting portion of the intraocular device to the optical lens includes clipping the implant connecting portion to the optical lens.

26. The method of any of claims 19-25, further comprising coupling the implant connecting portion and the capsule connecting portion together.

27. The method of any of claims 19-26, further comprising forming at least one opening in a surface of the lens capsule to accommodate securing of the capsule connecting portion of the intraocular device to the lens capsule.

28. The method of claim 27, wherein forming the at least one opening occurs at the steepest corneal meridian of the eye.

29. The method of claim 27, wherein forming the at least one opening occurs at the flattest corneal meridian of the eye.

30. The method of any of claims 27-29, wherein forming the at least one opening in the surface of the lens capsule includes forming an opening having a maximum width of less than 1.0 mm.

31. The method of any of claims 27-30, wherein forming the at least one opening in the surface of the lens capsule includes forming the opening located between 0.1 mm and 2.0 mm from an edge of a lens opening provided for positioning of the intraocular lens implant within the internal volume of the lens capsule, the lens opening having a maximum width of between 2.0 mm and 8.0 mm.

32. The method of any of claims 27-31, wherein forming the at least one opening in the surface of the lens capsule involves operating a femtosecond laser to form incisions in the surface of the lens capsule.

33. The method of any of claims 27-32, wherein securing the capsule connecting portion of the intraocular device to the lens capsule includes moving the capsule connecting portion of the intraocular device through the at least one opening in the surface of the lens capsule in a superior direction.

34. The method of any of claims 27-33, wherein securing the capsule connecting portion of the intraocular device to the lens capsule includes moving the capsule connecting portion of the intraocular device through the at least one opening in the surface of the lens capsule in an inferior direction.

35. The method of any of claims 27-34, wherein securing the capsule connecting portion of the intraocular device to the lens capsule includes manipulating a haptic of the intraocular lens implant to move the capsule connecting portion of the intraocular device through the at least one opening in the surface of the lens capsule.

36. The method of any of claims 27-35, wherein a resistance to entry of the capsule connecting portion into the at least one opening of the lens capsule is less than a resistance to exit of the capsule connecting portion from the at least one opening of the lens capsule.

37. The method of any of claims 19-36, further comprising removing a viscoelastic material from the intraocular lens implant upon positioning of the intraocular lens implant within the internal volume of the lens capsule.

38. The method of any of claims 19-37, wherein securing the implant connecting portion of the intraocular device to the intraocular lens implant includes coupling the intraocular lens implant to a cartridge loaded with the intraocular device for aligning the implant connecting portion with the intraocular lens implant.

39. The method of claim 38, wherein aligning the implant connecting portion with the intraocular lens implant allows for toric alignment of the intraocular lens implant along the steepest corneal meridian of the eye upon securing the capsule connecting portion of the intraocular device to the lens capsule.

40. The method of any of claims 19-39, further comprising tightening the implant connecting portion or the capsule connecting portion of the intraocular device and the intraocular lens implant relative to one another.

41. An intraocular lens implant, comprising:

an optical lens;

at least one haptic extending from the optical lens; and a capsule connecting portion extending from the optical lens or the at least one haptic and constructed and arranged to be secured to a lens capsule of an eye such that, upon positioning of the intraocular lens implant within an internal volume of the lens capsule, the intraocular lens implant is restricted from translation along an anterior-posterior axis of the eye to less than 1.0 mm, and the intraocular lens implant is restricted from rotation about the anterior-posterior axis of the eye to less than 30 degrees.

42. The implant of claim 41, wherein the capsule connecting portion extends in a superior direction from the optical lens for the implant to be secured to the lens capsule.

43. The implant of any of claims 41-42, wherein the capsule connecting portion extends in a superior direction from the at least one haptic for the implant to be secured to the lens capsule.

44. The implant of any of claims 41-43, wherein the capsule connecting portion is made up of a material including at least one of silicone, acrylic, acrylate, hydrogel,

polymethylmethacrylate and collamer.

45. The implant of any of claims 41-44, wherein the capsule connecting portion is constructed and arranged for entry into at least one opening in a surface of the lens capsule.

46. The implant of claim 45, wherein the at least one opening in the surface of the lens capsule has a maximum width of less than 1.0 mm.

47. The implant of any of claims 45-46, wherein a resistance to entry of the capsule connecting portion into the at least one opening of the lens capsule is less than a resistance to exit of the capsule connecting portion from the at least one opening of the lens capsule.

48. The implant of claim 47, wherein the capsule connecting portion is configured to be in a furled position upon entry into the at least one opening and is further configured to be in an open position after entry into the at least one opening.

49. The implant of any of claims 41-48, wherein the capsule connecting portion includes at least one of a protrusion, a hook and a plug.

50. A method of securing an intraocular lens implant to a lens capsule of an eye, comprising:

securing a capsule connecting portion of the intraocular lens implant to the lens capsule, wherein the capsule connecting portion extends from an optical lens or at least one haptic of the intraocular lens implant, and wherein translation of the intraocular lens implant along an anterior-posterior axis of the eye is restricted to less than 1.0 mm, and wherein rotation of the intraocular lens implant about the anterior-posterior axis of the eye is restricted to less than 15 degrees.

51. The method of claim 50, further comprising forming at least one opening in a surface of the lens capsule to accommodate securing of the capsule connecting portion of the intraocular implant to the lens capsule.

52. The method of claim 51, wherein forming the at least one opening occurs at the steepest corneal meridian of the eye.

53. The method of claim 51, wherein forming the at least one opening occurs at the flattest corneal meridian of the eye.

54. The method of any of claims 51-53, wherein forming the at least one opening in the surface of the lens capsule includes forming an opening having a maximum width of less than 1.0 mm.

55. The method of any of claims 51-54, wherein forming the at least one opening in the surface of the lens capsule includes forming the opening located between 0.1 mm and 2.0 mm from an edge of a lens opening provided for positioning of the intraocular lens implant within the internal volume of the lens capsule, the lens opening having a maximum width of between 2.0 mm and 8.0 mm.

56. The method of any of claims 51-55, wherein forming the at least one opening in the surface of the lens capsule involves operating a femtosecond laser to form incisions in the surface of the lens capsule.

57. The method of any of claims 51-56, wherein securing the capsule connecting portion to the lens capsule includes moving the capsule connecting portion through the at least one opening in the surface of the lens capsule in a superior direction.

58. The method of any of claims 51-57, wherein securing the capsule connecting portion to the lens capsule includes moving the capsule connecting portion through the at least one opening in the surface of the lens capsule in an inferior direction.

59. The method of any of claims 51-58, wherein securing the capsule connecting portion to the lens capsule includes manipulating a haptic of the intraocular lens implant to move the capsule connecting portion through the at least one opening in the surface of the lens capsule.

60. The method of any of claims 51-59, wherein a resistance to entry of the capsule connecting portion into the at least one opening of the lens capsule is less than a resistance to exit of the capsule connecting portion from the at least one opening of the lens capsule.

61. The method of any of claims 50-60, further comprising removing a viscoelastic material from the intraocular lens implant upon positioning of the intraocular lens implant within the internal volume of the lens capsule.

62. The method of any of claims 50-61, further comprising tightening the capsule connecting portion of the intraocular device and the intraocular lens implant relative to one another.