EA042478B1 - ACCOMMODATING INTRAOCULAR LENS - Google Patents

Description

Cross reference to priority documents

This application claims the benefit of priority of jointly pending U.S. Provisional Application No. 61/972183, filed March 28, 2014, and jointly pending U.S. Provisional Application No. 61/977568, filed April 9, 2014, the full disclosures of which are incorporated herein by reference in their entirety.

State of the art

In General, the present discovery relates to the field of ophthalmology, more specifically, to ophthalmic devices, including intraocular lenses (IOLs), such as accommodating intraocular lenses.

A healthy eye of a young person, as necessary, can focus on an object located at a far or near distance. The ability of the eye to change back and forth from short distance vision to long distance vision is called accommodation. Accommodation occurs when the ciliary muscle contracts and thereby weakens the resting tension of the girdle in the equatorial region of the capsular bag. The weakening of the girdle tension allows the lens, under the action of its own elasticity, to change to a more spherical or spherical shape with an increase in the curvature of both the anterior and posterior surfaces of the lens.

The lens of the human eye can be affected by one or more diseases that impair its functioning in the visual system. A common disease of the lens is cataract, which is a clouding of the normally clear matrix of the eye's natural lens. Cloudiness can be the result of the aging process, but it can also be caused by heredity or diabetes. During cataract surgery, the opaque lens of the patient's eye is replaced with a clear lens implant or intraocular lens.

In conventional extracapsular cataract surgery, the lens matrix of the eye is removed, leaving intact the thin walls of the anterior and posterior capsules, as well as the zonular filamentous junctions with the ciliary body and ciliary muscles. The lens nucleus is removed by phacoemulsification through curvilinear capsulorhexis, i.e. remove the anterior portion of the capsular bag.

After a recovery period of several days to weeks, the capsular sac actually wraps tightly around the intraocular lens due to capsulorhexis, collapse of the sac walls, and subsequent fibrosis. The cataract surgery currently practiced results in the irretrievable loss of most of the eye's natural structures that provide accommodation. The matrix of the lens of the eye is completely lost, and the integrity of the capsular bag is reduced due to capsulorhexis. When wrapping the capsular bag around the intraocular lens, the girdle complex can be damaged, and the ciliary muscles can then atrophy. Thus, conventional intraocular lenses, even those claimed to be accommodative, may not provide sufficient axial spatial displacement of the lens along the optical axis or change the shape of the lens to obtain an adequate degree of accommodation for short distance vision.

It is known to implant a combination of lenses to solve the problem of refractive errors of the existing lens in the case of phakic intraocular lenses or the increase in refraction obtained from a standard intraocular lens after cataract surgery in the case of patients with pseudophakic eyes. These overlay intraocular lenses can be placed in front of a previously implanted intraocular lens or natural lens to increase refraction in connection with cataract surgery in cases of pseudophakia or to change the refractive state of the eye in case of phakic eyes, usually to correct severe myopia. Typically, these lenses are implanted in the ciliary sulcus and are non-accommodating.

The essence of the invention

In some embodiments, an accommodating intraocular lens device for treating an eye is disclosed. The lens device includes a stabilizing haptic element configured to be placed in the region of the eye. The lens device includes a lens body having a sealed chamber containing a fixed volume of optical fluid. The lens body includes a shape-changing membrane configured to flex outwardly in a region surrounding the optical axis of the eye; a membrane with a deformable shape, made with the possibility of being subjected to displacement relative to, first of all, changing the shape of the membrane; and a static element. The inner surface of the shape-changing membrane, the inner surface of the deformable membrane, and the inner surface of the static member together form a sealed chamber. In addition, the lens device includes a force-transmitting mechanism having a first end capable of contacting the outer surface of the deformable lens body membrane and a second end capable of engaging with the ciliary structure of the eye. The force-transmitting mechanism is configured to move relative to the lens body when the ciliary structure is moved.

The deformable membrane can be configured to undergo inward displacement towards the optical axis of the eye relative to the deformable membrane during accommodation. Movement inward of the force-transmitting mechanism may cause inward movement along

- 1 042478 at least one or more areas of the membrane with a deformable shape to the optical axis of the eye, causing deformation of the sealed chamber. Moving inside the deformable membrane can cause the optical fluid in the sealed chamber to press against the inner surface of the deformable membrane and cause the deformable membrane to bulge outward. The lens device may also include an internal support located in the sealed chamber. The internal support can mechanically isolate the optical components of the lens from deformation during movement of the force-transmitting mechanism. The internal support may include a plurality of internal supports located at a distance from each other in a sealed chamber. The internal support may include a tapered geometry to avoid contact during movement into the deformable membrane.

A stabilizing haptic element may be attached to the lens body. The haptic stabilizing element can be molded as part of the lens body. The lens device may also include an external support. The internal support may be associated with the perimeter region of the reshaping membrane. The inner support may form a partition in the sealed chamber separating the sealed chamber into a deformable region and a central region. The region to be deformed may be located outside the optical zone. The region to be deformed may be located inside the optical zone. Moving inside the force-transmitting mechanism can cause the membrane to move inside the deformable shape and deform the deformable region. When moving inside the membrane with a deformable shape, the sealed chamber can be compressed. The optical fluid in the sealed chamber may be incompressible and may press against the inner surface of the shape-changing membrane and cause the shape-changing membrane to bulge outward. In addition, the internal support may be associated with the area of the static element. The inner support may include a channel extending through the inner support allowing fluid to be transferred between the deformable region and the central region of the sealed chamber.

In addition, the lens device includes an external support. The outer support may be rigid and may be configured to prevent deformation caused by movement of the force-transmitting mechanisms relative to the lens body. The stabilizing haptic element may be attached to the outer surface of the outer support.

The stabilizing haptic element may be molded as part of the outer support. The first end of the force-transmitting mechanism may extend through a channel in the peripheral wall of the outer support such that the first end is positioned against the deformable membrane. The outer support may include a central circular region and regions on opposite sides. The lens body may include a central portion and opposing deformable portions. The central region may be aligned with the central circular region of the outer support and the deformable portions of the lens body may extend into regions on opposite sides of the outer support. The outer surface of the deformable membrane may be exposed throughout the central circular region. The outer surface of the static element may be exposed throughout the central circular region. The first of the force-transmitting mechanisms may extend through the first opening in the first side wall of the outer support into the first channel. The second of the force transmitting mechanisms may extend through the second opening in the second side wall of the outer support into the second channel. The first channel and the second channel may be on opposite sides of the central circular area. The force transmitting mechanisms may be movable forward and backward in the first and second channels.

The deformable membrane may have a first surface associated with the reshaping membrane and a second surface associated with the static member and a side wall extending between the first surface and the second surface. The side wall of the deformable membrane can be aligned with and attached to the inner surface of the central region of the outer support so that the lens body is stationary with respect to the outer support. The central region may surround the optical axis, and the deformable regions are located outside the central region. The outer surface of the shape-changing membrane near the central portion may be aligned with and attached to the inner surface of the central circular region of the outer support. The deformable sections can be freely movable in the external support. The deformable portions may be configured to undergo inward compressive movement or displacement relative to the central portion during accommodation. The first ends of the force-transmitting mechanisms may be configured to be located opposite the deformable portions. The ciliary structure, when contracted, may press on the second ends, causing the first ends of the force-transmitting mechanisms to press on the deformable regions, and cause a compressive movement inward of the deformable regions towards the central region. The compressive movement inward of the deformable portions towards the central portion may cause the region of the reshaping membrane to buckle outward. Compressive movement inward

- 2 042478 formed areas to the central area can lead to pressure of the optical fluid in the sealed chamber on the inner surface of the shape-changing membrane, causing outward bending of the shape-changing membrane.

The central portion of the lens body may be generally circular and the deformable portions of the lens body may have a shape selected from the group consisting of corrugated, pleated, trapezoidal, cylindrical, elliptical, spherical, and hemispherical. The deformable portions of the lens body can move relative to the central portion of the lens body in response to force applied by the ciliary structure to the force transmitting mechanisms. The deformable portions may move over a distance of about 50 to about 500 microns. Moving the deformable portions over a distance may result in at least a change in the refraction of the lens body by at least 3 diopters. The applied force may be from about 0.1 g-s (0.98 mN) to about 5 g-s (49 mN). The stabilizing haptic element may be configured to maintain alignment of the optics and resist movement of the device after implantation into the eye. The stabilizing haptic element may also include an engaging element to improve fixation of the haptic element in the eye. The engaging element may include a grooved edge and/or an opening. The stabilizing haptic element may be a closed loop, open loop, lamellar, monobloc lamellar, j-loop, c-loop, modified J-loop, composite, one-piece, angular, planar, or curved haptic element. The haptic stabilizing element may be coaxial or co-planar with the force-transmitting mechanisms. The haptic stabilizing element may be located in a different plane than the force transmitting mechanisms. The stabilizing haptic element may be flexible, foldable, or formed from a shape memory material. The stabilizing haptic element can be placed in the ciliary sulcus or capsular sac of the eye.

The lens body may include a deformable portion that may be located outside the optical zone. The deformable region may be a region of the membrane with a deformable shape. The lens body may include a deformable portion that is located within the optical zone. The deformable region may be a region of the membrane with a deformable shape. The shape of the deformable membrane may be circular. The outward curvature of the shape-shifting membrane can be manually adjusted after the device is implanted in the eye. The static element may be a static lens having an optical power. The static lens may be positioned behind the eye and the reshaping membrane may be positioned anterior to the eye. The shape-changing membrane may have a constant thickness. The region of the shape-changing membrane may be a region of reduced thickness prone to deformation under increased internal pressure in a sealed chamber or when pressure from an optical fluid is applied to the inner surface of the shape-changing membrane. The optical fluid may include an incompressible fluid or gel with high transparency and visible transmission.

The optical fluid may be silicone oil or fluorosilicone oil.

The force-transmitting mechanisms may be of length to allow the mechanisms to extend between the deformable lens body shaped membrane and the ciliary structure. The length may be adjusted before the device is inserted into the eye or after the device is inserted into the eye. Adjustment can be mechanical. The force transmitting mechanisms may include two sections connected to each other. The two sections can be connected to each other by a hinge, piston, clamping, threaded or cam mechanism. The two sites may be bonded to each other by a chemical material. The ciliary structure may include at least one of the ciliary muscle, the ciliary body, the ciliary process, and the corbels.

Additional details of devices, systems and methods are provided below in the accompanying drawings and in the description below. Other features and advantages will become apparent from the description and drawings.

Brief description of the drawings

These and other aspects will now be described in detail with reference to the following drawings. Generally speaking, the drawings are not drawn to scale in absolute or comparative terms and are intended to be illustrative. In addition, for the sake of clarity, the relative placement of parts and elements may vary. The drawings show:

fig. 1A is a local sectional perspective view of an eye with a cloudy lens capsule;

fig. 1B is a sectional perspective view of the eye of FIG. 1A in the case of curvilinear capsulorhexis and removal of the lens matrix during implantation of a traditional 3-piece intraocular lens;

fig. 1C - transverse section of the anterior corner of the eye;

fig. 2A is a perspective view of an accommodating intraocular lens (AIOL) according to an embodiment;

fig. 2B is a perspective view of the accommodating intraocular lens of FIG. 2A with space

- 3 042478 nym separation of parts;

fig. 2C is a plan view of the accommodating IOL of FIG. 2A;

fig. 2D is a bottom view of the accommodating intraocular lens of FIG. 2A;

fig. 2E is a cross section along the line E-E of the accommodating intraocular lens of FIG. 2C;

fig. 2F is a cross section along the line F-F of the accommodating IOL of FIG. 2D;

fig. 2G is a side view of the accommodating IOL of FIG. 2A;

fig. 2H is a cross section along the line H-H of the accommodating intraocular lens of FIG. 2G;

fig. 3A is a perspective view of the lens body of the accommodating intraocular lens of FIG. 2A;

fig. 3B is an exploded perspective view of the lens body of FIG. 3A;

fig. 3C is a plan view of a static lens from the lens body of FIG. 3A;

fig. 3D is a cross section along line D-D of the static lens of FIG. 3C;

fig. 3E is a cross-sectional view of a shape-shifting membrane from the lens body of FIG. 3A;

fig. 3F is a detailed sectional view of the shape-shifting membrane from circle F in FIG. 3E;

fig. 4A-4E are various schematic side views of the reshaping membrane;

fig. 5A is a schematic sectional view of a lens body according to an embodiment;

fig. 5B is a schematic plan view of the lens body of FIG. 5A;

fig. 5C is a schematic sectional view of a lens body according to another embodiment;

fig. 5D is a schematic sectional view of the lens body according to the embodiment, and FIG. 5E is a schematic plan view of the lens body of FIG. 5D;

fig. 5F is a schematic sectional view of the lens body according to the embodiment, and FIG. 5G is a plan view of the lens body of FIG. 5F;

fig. 5H is a schematic plan view of a lens body according to another embodiment;

fig. 5I is a schematic sectional view of a lens body according to an embodiment;

fig. 5J is a schematic plan view of the lens body of FIG. 5I;

fig. 6 is a schematic plan view of a force-transmitting force extending between the cilium structure and the lens body;

fig. 7 is a schematic plan view of a force-transmitting force extending between the cilium structure and the lens body;

fig. 8A is a schematic plan view of a force-transmitting force extending between the cilium structure and the lens body;

fig. 8B is a schematic plan view of a force-transmitting force extending between the cilium structure and the lens body;

fig. 9 is a schematic plan view of a force-transmitting force extending between the cilium structure and the lens body;

fig. 10 is a schematic top view of a force-transmitting force extending between the cilium structure and the lens body;

fig. 11 is a schematic plan view of a force-transmitting force extending between the cilium structure and the lens body;

fig. 12 is a schematic plan view of a force-transmitting force extending between the cilium structure and the lens body;

fig. 13 is a schematic side view of a force-transmitting mechanism according to an implementation, a mechanism according to an implementation, a mechanism according to an implementation, a mechanism according to an implementation, a mechanism according to an implementation, a mechanism according to an implementation, a mechanism according to an implementation, a mechanism according to an implementation, a mechanism according to an implementation, continuing between the ciliary structure and the body of the lens. ;

fig. 14A-14B are schematic plan views of a refraction control mechanism according to an embodiment for the devices described herein;

fig. 15 is a schematic plan view of a refraction control mechanism as implemented for the devices described herein;

fig. 16 is a schematic plan view of a refraction control mechanism as implemented for the devices described herein;

fig. 17 is a schematic plan view of a refraction control mechanism as implemented for the devices described herein;

fig. 18 is a view of a deformable membrane 140 having a deformable portion 182 and a central portion 180;

fig. 19 is an illustration of the refractive power (in diopters) achieved in the lens body by moving (in micrometers) a membrane with a deformable shape as a result of applying a force (in gram-force) (millinewtons);

fig. 20 is a fragmentary perspective sectional view of an accommodating intraocular lens device located in the eye;

fig. 21 is a perspective sectional view of the device of FIG. 20, located in the eye, shown without the iris, so that the haptic is visible;

fig. 22 is a sectional side view of the device of FIG. 20 in an unaccommodated state;

fig. 23 is a sectional side view of the device of FIG. 20 in an accommodated state;

fig. 24 is a sectional side view of an accommodating intraocular lens device positioned

- 4 042478 female in the eye shown without the iris, so that the haptic is visible;

fig. 25A is a perspective view of an accommodating intraocular lens according to another embodiment;

fig. 25B and 25C are side views of the lens of FIG. 25A;

fig. 25D and 25E are partial sectional views of the lens of FIG. 25A in a deaccommodated relaxed state and an accommodated activated state, respectively;

fig. 25F is a detailed view from FIG. 25D;

fig. 25G is a detailed view from FIG. 25E;

fig. 26A is a perspective view of an accommodating intraocular lens according to another embodiment;

fig. 26B is a cross section through the lens of FIG. 26A;

fig. 26C is a detailed view from FIG. 26V;

fig. 26D is a perspective view of an accommodating intraocular lens;

fig. 26E is a plan view of the lens of FIG. 26D;

fig. 26F is a sectional side view of the lens of FIG. 26D;

fig. 27A and 27C are local perspective views of an accommodating intraocular lens according to another embodiment in a deaccommodated relaxed state and an accommodated activated state, respectively;

fig. 27B and 27D are partial sectional side views of the lenses of FIG. 27A and 27C in the deaccommodated relaxed state and the accommodated activated state, respectively.

It should be understood that the drawings in this document are by way of example only and are not intended to be drawn to scale.

Detailed description

In general, the present disclosure relates to the field of ophthalmology, more specifically to ophthalmic devices, including intraocular lenses (IOLs), such as accommodating intraocular lenses (AIOLs). The devices described in this document can go from accommodation to disaccommodation repeatedly, just like the accommodative natural eye in youth. The devices described in this document can provide focusing power both at a distance and over ranges of accommodation by mechanically and functionally interacting with ocular tissues commonly used by the natural lens, such as the ciliary body, ciliary processes, and ciliary rims, to perform accommodation and deaccommodation. . The forces generated by these tissues are functionally transferred to the devices described in this document, causing a change in refraction for more efficient accommodation. The devices described in this document are sized and fit before, during, and at any time after implantation. The devices described in this document can be implanted in the eye to replace the affected natural lens. However, it should be understood that the devices can also be implanted in addition to the natural lens (phakic eye patient) or an intraocular lens previously implanted in the patient's capsular bag (pseudophakic eye patient).

Let us turn to Fig. 1A, in which the human eye 10 includes the cornea 12, the iris 16, the ciliary muscle 18, the ciliary bands 20, the lens 21 contained in the capsular bag 22. Accommodation occurs when the ciliary muscle 18 contracts, thereby weakening the zonular tension rest in the equatorial region of the capsular bag 22. The weakening of the zonular tension allows the lens 21 due to its own elasticity to change to a more spherical or spherical shape with an increased curvature of both the anterior lenticular surface 23 and the posterior lenticular surface 24. In addition, the lens of the human eye can be afflicted with one or more diseases that disrupt its functioning in the visual system. A common disease of the lens is cataract, which consists of clouding of the normally clear matrix 26 of the eye's natural lens. Cloudiness can be the result of the aging process, but it can also be due to heredity or diabetes. In FIG. 1A shows a lens capsule containing a capsular bag 22 with an opacified lens nucleus 26.

In cataract surgery, the opaque lens of the patient's eye is replaced with a clear lens implant or intraocular lens 30. As shown in FIG. 1B, in a conventional extracapsular cataract operation, the lens matrix 26 of the eye is removed leaving intact the thin walls of the anterior and posterior capsules, as well as the zonular ligamentous junctions with the ciliary body and ciliary muscles 18. As shown in FIG. 1B, the nucleus of the lens of the eye is removed by phacoemulsification through curvilinear capsulorhexis, i. remove the front section 23 of the capsular bag. In FIG. 1B shows a conventional 3-piece IOL 30 immediately after being implanted into the capsular bag 22. The capsular bag 22, after a recovery period of several days to weeks, can actually wrap tightly around the 3-piece IOL 30 due to capsulorhexis, collapse of the walls of the bag 22 and subsequent fibrosis. . The cataract surgery currently practiced results in the irretrievable loss of most of the natural structures.

- 5 042478 tour of the eyes, which provide accommodation. The matrix 26 of the lens of the eye is completely lost and the integrity of the capsular bag 22 is reduced due to capsulorhexis. Fibrosis of the capsular bag limits the dynamic movement of the lens placed in this bag. Thus, conventional intraocular lenses, even those claimed to be accommodative, may not provide sufficient axial spatial displacement of the lens along the optical axis of the lens or change the shape of the lens to obtain an adequate degree of accommodation for short distance vision.

It is known to implant a combination of lenses to solve the problem of refractive errors of the existing lens in the case of phakic intraocular lenses or the increase in refraction obtained from a standard intraocular lens after cataract surgery in the case of patients with pseudophakic eyes. These overlay intraocular lenses can be placed in front of a previously implanted intraocular lens or natural lens to increase refraction in connection with cataract surgery in cases of pseudophakia or to change the refractive state of the eye in case of phakic eyes, usually to correct severe myopia. Typically, these lenses are implanted in the ciliary sulcus and are non-accommodating. As best shown in FIG. 1C, ciliary groove 16 is the space between the posterior surface of the base of the iris 14 and the anterior surface of the ciliary body.

In addition, accommodative intraocular lenses are useful for non-cataract patients who wish to reduce reliance on spectacles and contact lenses for the correction of myopia, hypermetropia, and presbyopia.

Intraocular lenses used to correct large errors in myopia, hyperopia and astigmatism are called phakic intraocular lenses and are implanted without removing the lens of the eye. In some cases, aphakic intraocular lenses (non-phakic intraocular lenses) are implanted by surgical removal and replacement of the lens even in the absence of cataracts. During this operation, the lens of the eye is removed and replaced with an intraocular lens in a manner very similar to cataract surgery. Similar to cataract surgery, which includes lens replacement, to replace the refractive lens, it is necessary to make a small incision in the eye to insert the lens, use local anesthesia, and this takes about 30 minutes. The accommodating intraocular lenses described in this document can be used for patients when replacing a refractive lens.

This application document describes accommodating intraocular lenses (AIOLs) for which, regardless of the capsular bag, a given change in optical power can be obtained, for example, in the range from 3 to about 5 diopters. The devices described in this document may include one or more force-transmitting mechanisms configured to be located in the eye, designed to use the movements of one or more ciliary structures and convert the movements into acting forces to control the change in the shape of the lens body during accommodation and deaccommodation. . The devices described in this document may also include one or more stabilizing haptic elements, which can be separated from the force-transmitting mechanisms and located, for example, in the ciliary sulcus. The devices described in this document address the known problems that result from the capsular fibrosis described above. It should be understood that the devices described herein may be configured to utilize movements of a single ciliary structure or combinations of ciliary structures including, but not limited to, ciliary muscle, ciliary body, ciliary process, and girdles. For brevity, ciliary structure is used throughout to refer to one or more ciliary structures whose movement can be used by force-transmitting mechanisms to accommodate the lens body, which will be described in more detail herein.

The devices described in this document can be implanted in the eye to replace a diseased natural lens. In some embodiments, the devices described herein can be implanted as aphakic intraocular lenses in refractive lens replacement surgeries. In addition, the intraocular lenses described herein can be implanted in addition to the natural lens (phakic eye patient) or an intraocular lens previously implanted in the capsular sac of the patient's eye (pseudophakic eye patient). The lenses described in this document can be used in combination with the intraocular lenses described in U.S. Patent Publication Nos. 2009/0234449, 2009/0292355, and 2012/0253459, all of which are incorporated herein by reference in their entirety. By themselves, the lenses described in this document can be used independently or as so-called superimposed lenses. Overlay lenses can be used to correct residual refractive errors in phakic or pseudophakic eyes. The primary intraocular lens used to replace the natural lens is usually thicker and typically has a refraction that can be in the range of ±10 to ±25 diopters. Thicker, more refractive lenses usually do not accommodate. In contrast, an additional lens should not have a full diopter range (D). The secondary lens can be relatively thin compared to the main IOL.

- 6 042478 zoi and may be subject to additional accommodation. Reshaping and moving a thinner lens is usually much easier than a thick primary lens. The accommodating intraocular lenses described herein can be used independently and optionally used as overlay lenses in combination with a natural lens or an implanted intraocular lens. The accommodating intraocular lenses described herein may be configured to be positioned in sulcus 16 and/or capsular bag 22.

The devices and systems described in this document may include any of a number of features described in this document, and these elements or features from one implementation of the device and system described in this document may be included as an option or in combination with elements or features from another embodiment of the device and system described herein, as well as various implants and features described in U.S. Patent Publications Nos. . For brevity, detailed descriptions of each of these combinations may be omitted, although the various combinations will be discussed in this document. In addition, the devices and systems described in this document may be located in the eye and need not be implanted exactly as shown in the drawings or as described in this document. Various devices can be implanted, positioned, adjusted, and so on. according to a number of different methods and using a number of different devices and systems. Various devices can be adjusted before, during, and at any time after implantation. While several representative descriptions are provided below of how the various devices may be implanted and positioned, detailed descriptions of each method for each implant or system may be omitted for brevity.

Let us now turn to FIG. 2A-2H, in which an accommodative intraocular lens (AIOL) 100 may include a lens body 105 located in and associated with an external support 110 and having one or more force-transmitting mechanisms 115. One or more stabilizing haptic elements 120 may be incorporated. The outer support 110 may include a central circular region 125 in which the central portion 103 of the lens body 105 may be located, and opposite side regions 130 into which the deformable portions 107 of the lens body 105 extend. The front surface of the lens body 105 can be viewed through an opening in the central circular region 125 of the outer support 110 from the front of the device. Likewise, the rear surface of the lens body 105 can be viewed through an opening in the central circular region 125 of the outer support 110 from the rear of the device. Each of the opposite side regions 130 of the outer support 110 may include a channel 132 extending from an opening 133 or slot in the side wall 134 of the side region 130 into a central circular region 125 (this is best shown in FIG. 2H). It should be understood that although the drawings show two oppositely directed force-transmitting mechanisms, the apparatus described herein may have one, two, three, four, or more force-transmitting mechanisms 115. In some embodiments, one force-transmitting mechanism 115 may continue through the opening 133 of one of the side regions 130 and the second force-transmitting mechanism 115 may extend through the opening 133 of the opposite side region 130. Each of the force-transmitting mechanisms 115 may include an external contact portion 135 configured to contact or engage at least ciliary structure, and an internal contact area 137 configured to contact at least a portion of the body 105 of the lens or position against it. The contact portion 135 of each force-transmitting mechanism 115 may remain outside the outer support 110 so that it may remain in contact with the ciliary structure during accommodation and disaccommodation. The contact portion 137 of each force-transmitting mechanism 115 can move in the channel 132 while continuing through the hole 113. As will be described in more detail below, the force-transmitting mechanisms 115 can freely move back and forth in the channel 132 due to the holes 133 when the ciliary structure is moved to effect a change. accommodative shaped body 105 lenses.

By way of example, and without limiting this disclosure to any particular theory or principle of operation, the ciliary muscle 18 is a circular structure or sphincter. Under natural conditions, when an object is viewed at a great distance with the eye, the ciliary muscle 18 in the ciliary body relaxes and the inner diameter of the ciliary muscle 18 becomes larger. The ciliary processes stretch the bands 20, which, in turn, stretch the lens capsule 22 along its equator. This causes the natural lens to flatten or become less convex, and this is called disaccommodation. During accommodation, the ciliary muscle 18 contracts and the inner diameter of the ciliary muscle 18 becomes smaller. The ciliary processes release the tension on the bands 20 so that the natural lens springs back to its natural more convex shape and the eye can focus at close distances. As will be discussed in more detail below, the devices described in this document are configured to use the communication of movement in/forward of the ciliary muscle 18 (or one or more ciliary structures) with transmitting

- 7 042478 force mechanisms 115. As will be described in more detail in this document, the contact areas 135 of the force-transmitting mechanisms 115 can be implanted so that when the ciliary muscle 18 contracts, they are in rest contact or in a state of readiness to contact at least one of ciliary structures (i.e. with bands, ciliary processes and/or ciliary body). When the ciliary muscle contracts and one or more ciliary structures move in/forward towards the optical axis, a force is applied to the contact areas 135 of the force-transmitting mechanisms 115. The force-transmitting mechanisms 115 transmit force to the lens body 105 while sliding inward through the channels 132 to the central circular region 125. The contact portions 137 of the force-transmitting mechanisms 115 are configured to abut the deformable portions 107 of the lens body 105, which allows the central portion 103 of the lens body 105 to be reshaped to a more spherical or convex shape, thereby increasing the refraction of the lens for appropriate focusing when viewing at small distance.

The outer support 110 may be formed from a biocompatible plastic including, but not limited to, silicone, polydimethylsiloxane (PDMS), polyurethane, polymethyl methacrylate, polyvinylidene fluoride, polyamide, polypropylene, polycarbonate, polyetheretherketone, and the like. or combinations of them. The outer support 110 may be configured to prevent deformation caused by movement of the force transmitting mechanisms 115 through the channels 132. In some embodiments, the outer support 110 may be rigid. In other embodiments, the outer support 110 may be foldable so that the device can be implanted into the eye through a smaller incision than a non-foldable rigid embodiment.

The outer support 110 may be coupled or connected to one or more stabilizing haptic elements 120. In some embodiments, the stabilizing haptic elements 120 may be associated with the outer support 110 via an element 121 surrounding at least a portion of the central circular region 125 of the outer support 110 (this best shown in Fig. 21). In other implementations, the stabilizing haptic elements 120 may be associated directly with the outer support 110 without element 121 (see Fig. 24). The stabilizing haptic elements 120 may be static haptic elements configured to maintain the alignment of the optics of the device and to resist movement of the device after implantation and changes in accommodative shape. Stabilizing haptic elements 120 may be located in and engaged with groove 16 and/or in the capsular bag to maintain device 100 stability during movement of force transmitting mechanisms 115, to prevent and/or limit forward, backward, and rotational movement of the device. Near the ends, the haptic elements 120 may include gripping elements 160, each having a grooved edge 162 and an opening 164, to improve fixation of the haptic element in the eye (see FIG. 2B). Haptic elements 120 may have any of a number of haptic element designs, or any combination of haptic element designs, including, but not limited to, open loop, closed loop, plate, plate loop, monobloc plate, j-loop, c-loop , modified J-shaped loop, composite, solid, angular, planar, curved, etc. Haptic elements 120 may be coaxial or co-planar with force transmitting mechanisms 115. In addition, haptic elements 120 may be located along a different axis than force transmitting mechanisms 115, for example, may be offset from force transmitting mechanisms 115 or may be at angles. relative to force-transmitting mechanisms 115. In some implementations, haptic elements 120 may be angled within 0-20° or other angle relative to force-transmitting mechanisms 115. Haptic elements 120 discussed in this document may include haptic elements developed by Rayner (Rayner Intraocular Lenses Ltd., East Sussex, UK), haptic elements developed by NuLens (NuLens Ltd., Israel), Staar lens designs (Staar Surgical, Monrovia, CA), and others. In some embodiments, haptic elements 120 may be formed from a biocompatible polymer such as silicone, polyurethane, polymethylmethacrylate, polyvinylidene fluoride, polydimethylsiloxane, polyamide, polypropylene, polycarbonate, polyetheretherketone, etc. or a combination of them. Haptic elements 120 may be made of a material that provides folding, or made with the possibility of folding. In some embodiments, haptic elements 120 are formed from a shape memory material.

With regard now to FIG. 2B, 3A-3F, the lens body 105 may include a deformable membrane 140 forming an annular configuration such that it forms a continuous loop or band of material near the periphery of the lens body 105. The deformable membrane 140 may have a first end or surface 141, a second end or surface 142, and a side wall 143 between the first surface 141 and the second surface 142 having an inner surface and an outer surface. The first surface 141 of the deformable membrane 140 may be associated with the deformable membrane 145, for example, on the front side of the accommodating IOL 100. The second surface 142 of the deformable membrane 140 may

- 8 042478 be associated with a static element 150, the shape of which does not change, for example, on the back side of the accommodating IOL 100. The element 150 can be optically transparent and provides a support function without affecting the optics of the accommodating IOL. In addition, element 150 may or may include a static lens. It should be understood that the front membrane may have a front support that defines the diameter of the deformable membrane 145 and is configured to communicate the deformable membrane with the deformable membrane 145. together form a sealed chamber 155 of fixed volume, constant pressure, configured to accommodate a fixed volume of optical fluid. Each member of the deformable membrane 140, the reshaping membrane 145, and the static member 150 may include a central portion and deformable portions such that, when associated with each other, they form a sealed chamber 155 and a central portion 103 and deformable portions 107 of body 105 lenses.

The sealed chamber 155 may be a conventional planar chamber formed by the inwardly facing surfaces of the reshaping membrane 145, the static member 150, and the sidewalls 143 of the deformable membrane 140, and as discussed in more detail below, may take various shapes.

The outer surface of the side wall 143 of the deformable membrane 140 can be aligned with and connected to the inner surface of the central region 125 of the outer support 110 so that the lens body 105 is stationary in the central region 125. It should be understood that the orientation of the lens body 105 in the device 100 and in the eye can be modified so that the shape-shifting membrane 145 can be located in front and the static element 150, such as a static lens, can be located behind the anatomy of the eye. Similarly, the shape-shifting membrane 145 may be positioned posterior and the static member 150 may be positioned anterior to the anatomy of the eye. Furthermore, it should be understood that the shape-shifting membrane 145 and/or the static member 150 may form a sealed chamber 155 in the device 100 in direct communication with the outer support 110 rather than the surfaces 141, 142 of the deformable membrane 140. In addition, the lens may include a front support associated with the shape-changing membrane 145 and defining its diameter.

In FIG. 3C and 3D show an implementation of a static element 150 having a static lens. The static lens can be formed from silicone, urethane, acrylic material, low modulus elastomer, or combinations thereof. The static lens may be a static optic for correcting an emmetropic condition or may have an appropriate refraction for a patient with an aphakic eye (typically ±10 to ±30 diopters). The static lens may have zero refraction and provide rear support for the lens body 105. If the accommodating IOL 100 is used in conjunction with a separate capsular IOL (eg, as an additional overlay lens), the refraction may be in the range of about -5 to about +5 diopters to correct residual refraction or other optical distortions in the optical system of the eye. In some implementations, the static lens may have a flat surface 151 and a curved surface 152. In addition, as described above, the static lens may be positioned within the lens body 105 such that the flat surface 151 is in contact with the fluid of the eye and the curved surface 152 creates an internal the surface facing the sealed chamber 155 of the lens body 105. In other embodiments, the static lens may be positioned outside the lens body 105 such that the flat surface 151 provides an inner surface facing the sealed chamber 155 of the lens body 105 and the curved surface 152 is in contact with the fluid of the eye. The relative refractive indices of the static lens and the fluid surrounding it (whether it be the fluid of the eye or the optical fluid in the sealed chamber 155) will determine the shape of the static lens at any given refraction. A static lens may be plano-convex, convex-flat, biconvex, concave-convex, or any other shape. The static lens may be a spherical lens, an aspherical lens, a diffractive lens, or any combination of both, for example, to reduce or compensate for any aberrations associated with a flexible lens.

The shape-changing membrane 145 may be a flexible optic formed from an optically clear, low modulus elastomer such as silicone. The shape-changing membrane 145 may have a constant thickness so that it is a flat element (see FIG. 4A) or variable thickness (see FIGS. 3E, 3F and also FIGS. 4B-4E) such that the shape-changing membrane 145 has a region of reduced thickness that is relatively more prone to deformation, for example, with increased force applied to the inner surface of the membrane 145 during the deformation of the sealed chamber 155. It should be understood that the structure of the shape-changing membrane 145 can be varied. In some embodiments, reshaping membrane 145 may have a linear gradient thickness (FIG. 4B), a curvilinear gradient thickness (FIG. 4C), or multiple step thicknesses including rounded or square corners (FIG. 4D), or may be made of numerous materials (Fig. 4E), for example, from material

- 9 042478 lov, providing the possibility of bending near the accommodating zone (ie, the region of the membrane 145, undergoing a change in shape), and other materials that provide the possibility of strengthening the optical zone and limiting deformation.

In some embodiments, regions of reduced thickness of reshape membrane 145 may be formed proximate region 170 of reshape membrane 145 around, on, or parallel to optical axis A. Region of reduced thickness 170 may be configured to deform due to increased pressure applied by optical fluid in a sealed chamber. 155 to the inner surface of the shape-changing membrane 145 causing the outer surface (eg, front surface) to bulge outward. Region 172 of reshaping membrane 145 may be thicker than region 170 and may be more resistant to reshaping at such an internal pressure applied by optical fluid in sealed chamber 155. Regions 172 of reshaping membrane 145 may be extended to provide correction long distance vision even in the case where the shape of the region 170 changes with short distance vision. Region 170 of reshaping membrane 145 may be formed from a material that is relatively more susceptible to outward buckling than the material of region 172. Region 170 in combination with regions 172 may be injection molded to provide a relatively seamless and continuous outer surface. Typically, the material of the regions 172 may be consistent, while the region 170 may have a different stiffness or resiliency that allows it to bulge outward a greater distance than the surrounding region. The shape-shifting membrane 145 can be configured to have variable multifocal capabilities to provide the wearer of the accommodating intraocular lenses described herein with improved vision over a wide range of distances, as described, for example, in US Patent Publication No. 2009/0234449, which is incorporated in its entirety in this document by reference.

With regard again to FIG. 2H, the deformable membrane 140 may include a central portion 180 and deformable portions 182. In some embodiments, the deformable portions 182 may be hinged to the central portion 180 such that the deformable portions 182 may compress relative to the central portion 180. portion 180 may be aligned with deformable region 170 of reshaping membrane 145 (and center portion of static member 150) to form a central portion 103 of lens body 105 that is around, on, or parallel to optical axis A. The outer surface of sidewall 143 of center portion 180 may be aligned with the inner surface of the central circular region 125 and attached to it so that the central portion 103 of the lens body 105 is rigidly fixed relative to the central circular region 125 of the outer support 110. In contrast, the deformable portions 107 of the lens body 105 can move freely in the channels 132 of the side regions 130 of the outer support 110, so that just as described in more detail above, the deformable portions 107 of the lens body 105 may undergo compressive movement or displacement inward relative to the central portion 103 during accommodation.

As regards still FIG. 2G, 2H, the deformable portions 182 are configured to come into contact with the contact portion 137 of the force-transmitting mechanisms 115 and move relative to the central portion 180. For example, during accommodation, the force-transmitting mechanisms 115 may be pressed by one or more ciliary structures against the optical axis A The contact portion 135 may be positioned in engagement with one or more ciliary structures, and the contact portion 137 may be positioned opposite the deformable portion 182 of the deformable membrane 140. The contraction may cause movement of the deformable portion 182 of the membrane 140 relative to the central portion 180 of the deformable membrane 140. This movement may be compression, contraction, flattening, indentation, stretching, deformation, rotation, or movement of another kind, which usually occurs towards the optical axis A. This movement of the deformable sections 182 of the membrane 140 with a deformable shape (and therefore the deformable sections 107 of the body 105 of the lens) may cause bending of the shape-changing membrane 145 in the optic zone 101 without applying stress or pressure to the optic zone. Deformable areas 182 may be located inside the optical zone or outside it. The optical zone in this document is usually referred to as the region of the body 105 of the lens, which surrounds the optical axis and is optically transparent to the eye. The optical zone is made so that it has a corrective refraction, although the entire optical zone may not have such a corrective refraction. For example, the central region of the optical zone may have a corrective refraction, and the peripheral region of the optical zone may not have a corrective refraction.

As mentioned above, the sealed chamber 155 of the lens body 105 may be filled with a pure biocompatible optical fluid. The optical fluid may be an incompressible fluid or gel that is clear and transparent in the visible region, for example silicone fluids and gels, functionalized silicone fluids and gels (e.g. halogenated, i.e. fluorine-containing silicones, aromatic,

- 10 042478

those. phenyl-functionalized silicones, etc.), hydrocarbon and functionalized hydrocarbons such as long chain hydrocarbons, halogenated hydrocarbons such as fluorinated and partially fluorinated hydrocarbons, aqueous systems, both fluids and gels whose refractive index (RI) increase with additives in the form of water-soluble or water-swellable polymers, biopolymer swelling additives such as cellulose, and organic or inorganic additives that form nanostructures to increase the refractive index. In some implementations, the optical fluid in the sealed chamber 155 has a refractive index greater than 1.37. In other implementations, the optical fluid in the sealed chamber 155 has a refractive index in the range of 1.37-1.57. In other implementations, the optical fluid in the sealed chamber 155 has a refractive index in the range of 1.37-1.60.

The optical fluid in the sealed chamber 155 can cause the reshaping membrane 145 to flex as the deformable portions 182 of the deformable membrane 140 (and therefore the deformable portions 107 of the lens body 105) move. Movement within the deformable portions 182 may cause the incompressible optical fluid contained in the sealed chamber 155 of the fixed lens body volume to be pressed against the surfaces of the sealed chamber 155, including the inner surface of the shape-changing membrane 145 and the inner surface of the side wall 143 of the shape-changing membrane 140. Because reshaping membrane 145 has an area near region 170 that is configured to bulge outward when a force is applied, the pressure of the optical fluid on the inner wall of reshape membrane 145 causes the outer surface of reshape membrane 145 to bulge outward and reshape as it moves into the deformable portions. 107. The accommodative area of the optical zone becomes more convex, increasing the refraction of the accommodating intraocular lens 100.

It should be understood that this reshaping of the shape-changing membrane 145 occurs without the optical fluid actually flowing from one chamber to another chamber. More specifically, a force applied to the deformable membrane 140 to deform the sealed chamber 155 in the first region may cause the sealed chamber 155 to reactively deform in at least the second region as the optical fluid within the sealed chamber 155 changes shape, along with changing the shape of the sealed chamber 155. The sealed chamber 155 has a fixed volume, is under constant pressure, and is deformable. The optical fluid has a fixed volume, is incompressible, and changes shape depending on the shape of the sealed chamber 155. Inward deformation of one or more portions of the chamber 155 (for example, deformable portions 107) may cause reactive outward deformation of another portion of the chamber 155 (for example, changing region 170). the shape of the membrane 145) due to the presence of an incompressible optical fluid inside the sealed chamber 155. Therefore, the optical fluid does not actually flow between the individual chambers of the accommodating intraocular lens, but rather changes shape along with the change in the shape of the sealed chamber, and therefore the accommodative portion of the optical zone the reshaping membrane 145 bulges outward, increasing the refraction of the accommodating intraocular lens 100.

The deformable membrane 140, the reshape membrane 145, and the static member 150 can together form a lens body 105 having any of a number of shapes. In general, the central portion 103 of the lens body 105 may be circular, and the deformable portions 107 may be any of a number of shapes, including corrugated, pleated, trapezoidal, cylindrical, elliptical, conical, spherical, hemispherical, and the like. (See, for example, Fig. 5B, 5E, 5G). In addition, it should be understood that the deformable portions 107 may have any of a number of shapes in a section along a number of axes (see, for example, Fig. 5A, 5C, 5D and 5F). In addition, the lens body 105 may be a circular elastomeric ring having a central portion 103 and a deformable region in the optical zone, so that, as shown in FIG. 5H, 5I-5J and also in FIG. 25F, the contact portions 137 of the force-transmitting mechanisms 115 are in contact with the deformable-shaped membrane 140 in the optical zone. The deformable portion 107 of the lens body 105 may be located outside or inside the optical zone (see, for example, FIG. 5H), as well as outside or inside the lens body 105. The lens body 105 may have more than two deformable portions 107, including three, four or more deformable portions 107.

The deformable membrane 140 may be formed from an optically clear, low modulus elastomer such as silicone, urethane, or a flexible non-elastic film such as polyethylene. The central portion 180 of the deformable membrane 140 may be made of an elastic material. The deformable portions 182 of the deformable shaped membrane 140 may be formed from elastic or inelastic materials.

With regard again to FIG. 2B and 2H, the devices described herein may include a force-transmitting mechanism 115 configured to extend through an opening 133 in the side wall 134 of the side regions 130 of the outer support 110. As described above, one force-transmitting mechanism 115 may extend through the hole 133 in one of the side areas 130 and the second

- 11 042478 swarm force-transmitting mechanism 115 may extend through opening 113 in opposite side region 130. However, it should be understood that the devices described herein may include less than or more than two force-transmitting mechanisms 115. For example, devices , described in this document, may include one, three, four or more force-transmitting mechanisms 115 spaced evenly around the device. In some embodiments, the force transmitting mechanisms 115 may be made from a rigid polymer such as silicone, polyurethane, polymethyl methacrylate, polyvinylidene fluoride, polydimethylsiloxane, polyamide, polypropylene, polycarbonate, etc. or a combination of them. In some embodiments, the force transmitting mechanisms 115 may be elements reinforced with polymethyl methacrylate.

In some embodiments, each of the force-transmitting mechanisms 115 may include an outer contact portion 135 and an inner contact portion 137, which may take any of a number of shapes (see, for example, FIGS. 2B and 2H). The engagement portion 135 can be configured to abut, contact, engage, operably connect, or intimately tie with one or more ciliary structures, including, but not limited to, the ciliary body, ciliary processes, ciliary muscle, girdles, or a combination of these for control of changing the shape of the optics during accommodation and disaccommodation. The contact portion 135 of each force-transmitting mechanism 115 may remain external to the outer support 110 so that it may remain in contact with the ciliary structure during accommodation and disaccommodation. In some implementations, the contact area 135 may have an outer surface having a curved contour, which may fully correspond to the curvilinear contour of the region of the eye in which the contact area 135 is attached. In some implementations, the contact area 135 may have recesses, grooves, teeth, ridges, or other surface features to improve, for example, contact and interengagement with the ciliary processes or zonular processes. In addition, the outer surface of the contact area 135 may have sharp or beveled edges at the top and/or bottom edges. The contact portions 135 of the force-transmitting mechanisms 115 may include features that enhance bonding to the ciliary structures without damaging them. Typically, the contact areas 135 avoid punctures or damage to the ciliary structures. In some implementations, the contact areas 135 can interact with the ciliary structures in such a way that the movement can be transmitted without causing damage to the tissues themselves.

Contact section 137 may be associated with contact section 135. In some implementations, contact section 137 may be an elongated element associated with and extending from the inner surface of contact section 135 (see Fig. 2B). The contact portion 137 may be shaped to be positioned in the channel 132 such that at least a portion of the force transmitting mechanism 115 can translate in the channel 132. The contact portion 137 may abut at least a region of the lens body 105, such as a deformable section 182 of the membrane 140 with a deformable shape. For example, when the ciliary muscle 18 contracts during accommodation, it contracts towards the optic axis. The ciliary structure may come into contact with the outer surface of the contact portion 135 so that the force transmitting mechanism 115 may move in the channel 132 and the contact portion 137 may press against the deformable portion 107 of the lens body 105 and cause the deformable portion 107 to move relative to the central region 103, thereby , as described above, the change in the accommodative shape of the shape-changing membrane 145 will be controlled.

The position of the force-transmitting mechanisms 115 relative to one or more ciliary structures can be changed. In addition, the force-transmitting mechanisms 115 may have a fixed length or may be adjustable. Adjustments to the force-transmitting mechanisms 115 may be made before, during, and at any time after insertion into the eye. It should be understood that various components and features described for various force-transmitting mechanisms may be included along with one or more of the various components and features described herein in relation to various devices. Any devices and systems described in this document may include any of a number of features and components described in this document. Components or features from one implementation of the device and system described in this document may be included as an option or in combination with components or features from another implementation of the device and system described in this document. For brevity, a detailed description of each of these combinations may be omitted, although various combinations are discussed in this document.

In FIG. 6 shows an implementation of a force transmitting mechanism 115 having a fixed length. The force transmitting mechanism 115 may have an outer contact portion 135 configured to contact one or more ciliary structures, such as the ciliary body. The contact area 135 may be connected to the inner contact area 137 via an elongated member 136. The overall length of the force-transmitting mechanism 115 may be fixed and may be of an appropriate value selected for each patient based on preoperative measurements.

- 12 042478

In FIG. 7 shows an implementation of a force-transmitting mechanism 115 having a length that can be adjusted, for example, before, during, or at any time after implantation. In this embodiment, the force transmitting mechanism 115 has a contact portion 135 and a contact portion 137. The contact portion 135 may have a first elongate member 738 extending from the inner surface of the contact portion 135, and the contact portion 137 may have a second elongate member 739 extending from the outer surface of the contact portion. section 137. The mechanical adjustment interface between the first elongate element 738 and the second elongate element 739 may be a threaded engagement, in which the outer surface of the region of the first and second elongate elements 738, 739 may have threads configured to engage the respective threads on the inner surface of the region of the first and second elongate members 738, 739. For example, the second elongate member 739 may have threads on the outer surface and be capable of being inserted into the chamber 731 of the first elongate member 738 to engage with the corresponding threads. This threaded engagement between the two portions of the force-transmitting mechanism 115 allows quick adjustments to be made to optimal dimensions, for example, prior to insertion of the lens while the patient is on the operating table, during or anytime after the device is implanted in the eye.

The first and second elongated members 738, 739 may engage with each other in accordance with various other mechanical configurations. For example, in FIG. 8A shows another embodiment of the force-transmitting mechanism 115 having a length that can be adjusted. In this embodiment, the force transmitting mechanism 115 has a contact portion 135 and a contact portion 137. The contact portion 135 may have a first elongate member 738 extending from the inner surface of the contact portion 135, and the contact portion 137 may have a second elongate member 739 extending from the outer surface of the contact portion. section 137. The first elongate element 738 and the second elongate element 739 can be aligned with each other until the desired overall length of the force-transmitting mechanism 115 is achieved. Otherwise, the first and second elongate elements 738, 739 can be aligned with each other along a common axis so that one of the elongated elements entered through the opening into the chamber 731 of the opposite elongated element (see Fig. 8B). In both configurations, once the desired length has been reached, the regions of the first and second elongate members 738, 739 can be mechanically secured, such as by crimping in place 861 of the crimp. An adjustment of this kind can be performed, for example, before, during, or at any time after implantation of the device in the eye.

In yet another related embodiment shown in FIG. 9, after reaching the desired distance between the contact areas 135, 137, the first and second elongated members 738, 739 can be attached to each other, for example, using a sliding cam mechanism 963. The first elongate member 738 may be in the form of an asymmetrically shaped rod with an end that is configured to come into contact with a corresponding end of the second elongated member 739, also having an asymmetrical shape. When the end of the first elongate member 738 extends beyond the end of the second elongate member, the two asymmetrically shaped rods engage with each other.

In yet another related embodiment shown in FIG. 10, the first and second elongated members 738, 739 can be engaged with each other to form a piston system. The first elongate member 738 may include a chamber 731, and the end of the second elongate member 739 may extend through the opening into the chamber 731. The chamber 731 may be filled to a predetermined volume with an incompressible material 1090 to control the effective length of the members 738, 739 relative to each other. The chamber 731 can be filled during operation to fine-tune the effective length of the force-transmitting mechanisms 115.

In yet another related embodiment shown in FIG. 11, contact region 135 may be associated with contact region 137 via a flexible hinge mechanism 1192. In some embodiments, contact region 135 is associated with first elongate member 738 and contact region 137 is associated with second elongate member 739. First elongate member 738 is coupled to second elongate member. 739 through the hinge mechanism 1192. It should be understood that the contact region 135 may have more than one elongate element 738 and the contact region 137 may have more than one elongated element 739, each of which are connected to each other, respectively, through the hinge mechanisms 1192. Flexible hinge mechanism ( mechanisms) 1192 can be adjusted before or during surgery. In some implementations, the hinge mechanism 1192 can be fixed in place by heat/radiation/chemical curing. The hinge mechanism 1192 may be rotatable in such a direction that the elongated force-transmitting rods 738, 739 flex outwardly or inwardly. It should be understood that one or more hinge mechanisms 1192 can be folded in one or more axes to provide adjustment not only between optical axis A and the ciliary structures, but also forward and/or rearward adjustment.

In yet another related embodiment shown in FIG. 12, the connection between the first and second

- 13 042478 eye elongated elements 738, 739 may additionally or alternatively include a chemical bond. For example, the first and second elongate members 738, 739 may be bonded and then chemically fixed using a chemical material such as an adhesive or an activating material such as heat/radiation curable polymers or other materials. The material may be applied to the interface between the first and second elongate members 738, 739. In some embodiments, the first elongate member 738 may include a chamber 731 that may be at least partially filled with material 1090 such that the material 1090 surrounds the outer surface of the second elongate member 739 inserted through the opening into chamber 731. Once adjusted to the desired distance, material 1090 can be activated to fix the interface between the first and second elongate members 738, 739. insertion of the device into the eye, and measurement, adjustment and fixation to be performed after implantation of the device 100.

In the related embodiment shown in FIG. 13, the force transmitting mechanism 115 may include a contact portion 137 connected via an elongate member 739 to a contact portion, which may be a membrane 1394 having an interior volume 1396 configured to accommodate material. The material may include a volume-controlled material that can be fixed in situ, such as a heat-sensitive adhesive, shape memory alloys, shape memory polymers, a curable polymer, a heat/radiation activated material, or other material that allows work to make adjustments in volume and space.

It should be understood that there is no need to move the force-transmitting mechanisms 115 relative to the outer support 110 and lens body 105. For example, the force-transmitting mechanisms 115 may be configured to generate an electrical current upon movement of, and contact with, the cilium structure. For example, the force transmitting mechanisms 115 may include a piezoelectric system that generates an electrical charge in response to mechanical stress applied by the ciliary structures. The current generated by the force-transmitting mechanisms 115 can be used to accommodate the lens body 105. For example, the outer surface of contact portion 135 may include a piezoelectric disk that generates voltage and accommodates the lens.

As mentioned in this document, the overall length of the force-transmitting mechanisms 115 can be adjusted and adjusted before, during, and after implantation to individual patients in order to obtain patient-required and optimized contact between the force-transmitting mechanisms 115 and the ciliary structures, as described above, so that, in turn, optimize shape change. It should be understood that the reshaping of the lens body 105 can also be adjusted and adjusted at any time after device 100 is implanted. As shown in FIG. 14A, 14B and similar to the embodiment shown in FIG. 9, in some embodiments, the device 100 may include a cam 1498. The cam 1498 may be positioned between the engagement portion 137 of the force transmitting mechanism 115 and the deformable portion 107 of the lens body 105 to move them apart. The position of the cam 1498 can be changed, for example, by turning a lever or other element such as a twist mechanism. Cam 1498 is shown in the first relaxed position in FIG. 14A and in the maximum active position in FIG. 14V.

In the related embodiment shown in FIG. 15, a rod, thin bar, wedge, or other adjustment member 1502 may be inserted to adjust the relative contact between the contact portion 137 of the force-transmitting mechanism 115 and the deformable portion 107 of the lens body 105. The adjusting element 1502 can be inserted through a corresponding hole in the outer support 110, and the further it is inserted, the more pressure it creates on the deformable portion 107 of the lens body 105 and changes shape to a greater extent. The adjustment element 1502 can be locked in place after the desired refractive adjustment has been achieved. In addition, the adjuster 1502 can be disengaged so that the refraction adjustment can be adjusted by moving the adjuster 1502 away from the outer support 110. Depending on the depth of penetration of the adjuster 1502 into or away from the outer support 110, the position of the adjuster 1502 relative to the outer support 110 can be adjust to varying degrees during operation. Otherwise, the adjusting element 1502 may have a stepped profile so that it can be locked in one, or two, or more predetermined locations. In addition, one or more areas of the adjusting element 1502 may be coated with a heat-sensitive adhesive for fixation during subsequent adjustment.

In the related embodiment shown in FIG. 16 and 17, the pressure applied to the lens body 105 can be controlled separately from the pressure applied by the force-transmitting mechanisms 115 to the deformable portions 107 of the lens body 105. For example, an adjustable member 1602, such as a screw, lever, or rod, may be inserted through the outer support 110 to make contact with an area of the lens body 105, such as a deformable membrane 140 near the central portion 103 of the lens body. Adjuster 1602 can apply additional force

- 14 042478 to the deformable membrane 140 so that the optical fluid in the sealed chamber 155 further acts on the deformable membrane 145. The adjustable element 1602 can be stepwise adjustable to adjust the applied pressure so that refraction adjustment can be made. In addition, it is also possible to obtain a general refractive adjustment solution in an accommodating IOL without accommodation by this mechanism. In FIG. 17 shows a method of using a material that can be expanded or shrink in situ to change the base refraction of the lens body 105. In this implementation, instead of inserting a screw or other mechanical element in relation to the lens body 105, the tension of the shape-changing membrane 145 (or static element 150) can be adjusted. For example, the material may be a heat-sensitive material that can be blistered upon thermal activation. The change in tension and volume of the lens body can occur depending on the formation of swelling, depression or alignment of the material upon activation.

In FIG. 18 shows a deformable membrane 140 having two deformable portions 182 and a central portion 180. The deformable portions 182 may be compressible or retractable, or movable relative to the central portion 180 toward (and also away from) optical axis A. In this embodiment, the deformable the portions 182 are generally rectangular in shape and can shift or move in response to a force applied from the outer surface of the side wall 143 of the deformable membrane 140, i.e. in the direction of arrow A, without moving or displacing the central portion 180. This displacement of the deformable membrane 140 in a closed system can cause the pressure of the optical fluid contained in the sealed chamber to be applied against the inner surface of the reshape membrane and bulge outwardly of the reshape membrane, associated with maintaining the pressure of the reshaping membrane constant in a closed system.

The table below shows the relationship between displacement of the deformable portions 182 (displacement from each side) and outward buckling (and thus diopter change or accommodation) of the shape-changing membrane that occurs. The lens diameter in millimeters refers to the region of the reshaping membrane that is configured to bulge outward in response to the application of optical fluid pressure thereto from the sealed chamber. The optical fluid may be silicone oil having a refractive index in the range of 1.37-1.57. The length of the compressible portion is the length (shown by arrow L) of the deformable portion 182 of the membrane 140, and the height of the compressible portion (shown by arrow H) is the thickness of the side wall 143 of the deformable membrane 140 (see FIG. 18). The offset from each compressible portion (i.e., the deformable portion(s) 182 relative to the central portion 180 of the deformable membrane 140 or, as applied to the lens body 105, from the deformable portion(s) 107 relative to the central portion 103) is equal to the volume V of the sealed chamber 155, divided by the product of the length L of the compressible section, the height H of the compressible section and 2, or V/(LxHx2). The amount of deflection of the lens is:

K \u003d y (for ² + ² ).

The height (h) of the lens can be calculated from the Pythagorean equation: (rh) ² +a ² =r ² .

Therefore, h \u003d r-^ [r ² -a ² )

For example, if the refractive index of the optical fluid is 1.4 and the lens diameter is 3 mm, then by moving each deformable portion 182 by 28 µm, sufficient pressure is applied by the optical fluid to the shape-changing membrane to form a one-dimensional lens, and if If the lens diameter is 3 mm, moving each deformable portion 182 by 84 µm creates a pressure of sufficient magnitude applied by the optical fluid to the shape-changing membrane to form a three-dimensional lens.

- 15 042478

Lens diameter (mm) Index refraction of the optical fluid Compression length (mm) Height of compressible section (mm) Offset from each side (mm) Diopters (dptr) 3 1.4 2 0.6 0.026 1 3.5 1.4 2 0.6 0.048 1 4 1.4 2 0.6 0.082 1 3 1.4 2 0.6 0.052 2 3.5 1.4 2 0.6 0.096 2 4 1.4 2 0.6 0.164 2 3 1.4 2 0.6 0.078 3 3.5 1.4 2 0.6 0.144 3 4 1.4 2 0.6 0.246 3 3.5 1.4 2.5 0.7 0.099 3 4 1.57 1.8 0.5 0.089 3

In FIG. 19 shows the power (in diopters) obtained for the lens body when the reshaping membrane is moved (in micrometers) as a result of the application of force (in units of gram-force (millinewtons). The devices described in this document were evaluated using an optical laboratory test designed to evaluate intraocular lenses (IOLA PLUS, Rotlex, Israel) and a calibrated load cell (and Advanced Force and Torque Indicator (AFTI), Mecmesin, UK), and has been shown to be able to obtain an approximately three-dimensional change when moving 100 µm and applying a force of 1 g-s (9.8 mN).

In FIG. 20 is a partial perspective sectional view of an accommodating intraocular lens 100 positioned in the eye, and FIG. 21 is a perspective sectional view of an accommodating intraocular lens 100 positioned in the eye, shown without the iris so that the haptic 120 is visible.

In FIG. 22 is a sectional side view of an accommodative intraocular lens 100 positioned in the eye and in a non-accommodative state.

In FIG. 23 is a sectional side view of an accommodating intraocular lens 100 positioned in the eye and in an accommodative state. As with the various embodiments described, the accommodative intraocular lens 100 may include a lens body 105 having a sealed chamber 155 formed by the inner surfaces of a deformable membrane 140, a reshaping membrane 145, and a static member 150, and configured to contain an optical fluid. . The lens body 105 may be positioned in and associated with the PO support. The accommodating IOL 100 may include a force-transmitting mechanism 115 and a stabilizing haptic 120. The stabilizing haptic 120 may be positioned behind the iris 14 in the sulcus 16 (see FIG. 24) such that the accommodating IOL 100 is stabilized and fixed due to the interaction of the haptic 120 in groove 16. In addition, the accommodating intraocular lens 100 can be implanted so that the stabilizing haptic 120 is located in the capsular bag. The front surface of the central portion of the shape-shifting membrane 145 may be centered in the central circular region 125 of the support 110 and may be configured to bulge outward upon contraction of the ciliary muscle 18, i. during accommodation. An accommodative IOL 100 is shown implanted in an eye having a capsular sac 22 that is capsulorhexis such that the static member 150 is positioned on the very rear side of the device 105 and typically remains external to the capsulorhexis (see FIG. 20). As described in this document, the static element 150 may be a static lens with refraction for a certain distance.

The devices described herein can be brought into an accommodating (or non-accommodating) form in direct response to movements of the ciliary structure, such as movements of the ciliary body and/or ciliary muscle. This direct ciliary accommodation transfer of the devices described herein may include the transfer of an optical fluid in a sealed chamber. As described above and as shown in FIG. 20-23, the force-transmitting mechanisms 115 may directly contact one or more ciliary structures so that when the force-transmitting mechanisms 115 are actuated, the contact portions 137 may be located in the channels 132 in a first configuration, in which the force-transmitting mechanisms 115 are typically located at a distance from the central axis of the CA device 105 (see Fig. 22), and in the second configuration, the force-transmitting mechanisms 115 could be pressed by the ciliary structure to the central axis of the CA device 105 (see Fig. 23). Shape-changing membrane 145 in general

- 16042478 tea can be flat when the force-transmitting mechanisms 115 are in the first configuration (i.e., are not accommodated), and the shape-changing membrane 145 can be arched outward when the force-transmitting mechanisms 115 are in the second configuration (i.e., are accommodated). This may be due to the contact portions 137 of the force-transmitting mechanisms 115 pressing against the deformable-shaped membrane 140 such that the deformable lens body portion 107 is compressed or moved toward the central portion 103 of the lens body 105. The compression of the deformable portion 107 may cause the optical fluid in the sealed chamber 155 to press against the inner surfaces of the chamber 155 until the front surface of the reshaping membrane 145 assumes a more spherical or convex shape, such that it corresponds to an outward curvature along the optical axis (see Fig. 23).

In FIG. 25A-25G show an interrelated implementation of an accommodating intraocular lens (AIOL) 200 as described herein. It should be understood that the features and components of the devices described in this document may be interrelated and used in combination or in a variant. For the sake of brevity, certain portions of the descriptions regarding components from the various embodiments of the devices described in this document are not repeated, although this should not be taken to mean that these prior descriptions are not applicable to the following implementations.

The accommodating intraocular lens 200 may include a lens body 205, a support 210, force-transmitting mechanisms 215, and one or more stabilizing haptics 220. The support 210 may include an internal and/or external support 210. In some embodiments, support 210 is an external a support 210 having a central circular region, on the central portion of which the lens body 205 is mounted coaxially. The support 210 may include channels or slots 232 through the peripheral sidewall that extend into the central circular region (this is best shown in FIG. 25F). One force-transmitting mechanism 215 may extend through a passage 232 on one side of the support 210, and a second force-transmitting mechanism 215 may extend through a passage 232 on the opposite side of the support 210. Each of the force-transmitting mechanisms 215 may include an outer engagement portion 235 configured contactable with at least a portion of the ciliary structure, and an inner contact portion 237 configured to contact at least a portion of the lens body 205. The contact portion 235 of each force-transmitting mechanism 215 may remain external to the support 210 so that it may remain in contact with the ciliary structure during accommodation and disaccommodation. The contact portion 237 of each force-transmitting mechanism 215 is movable in the channel 232. The force-transmitting mechanisms 215 are free to move back and forth in the channels 232 when the ciliary structure is moved to change the accommodative shape of the lens body 205 as will be described in more detail below.

As in previous embodiments, support 210 may be formed from a rigid polymer, including, but not limited to, silicone, polyurethane, polymethyl methacrylate, polyvinylidene fluoride, polydimethylsiloxane, polyamide, polypropylene, polycarbonate, and the like. or combinations of them. Support 210 may be configured to prevent deformation caused by movement of force transmitting mechanisms 215 through channels 232. As shown in FIG. 25A-25G, support 210 may be an external support located outside of sealed capsule 255, or as shown in FIG. 26A-26F and 27A-27D, the support 210 may be located within the sealed capsule 255, and this will be described in more detail below. In some implementations, one or more stabilizing haptic elements 220 may be attached to the outer support 210. In other implementations, one or more stabilizing haptic elements 220 may be attached to the portion of the lens body 205 and the support 210 located in the sealed chamber of the lens body 205. In other embodiments, one or more stabilizing haptic elements 220 may be molded as part of the lens body 205 or outer support 210. Stabilizing haptic elements 220 may be static haptic elements configured to maintain alignment of the device optics and resist movement of the device after implantation and modification. accommodative form, described in more detail above. In some embodiments, haptic element(s) 220 may be placed in the ciliary sulcus or capsular sac.

The lens body 205 may include a deformable membrane 240, a reshape membrane 245, and a static member 250 that may include a static lens. The deformable membrane 240, the deformable membrane 245, and the static member 250, in combination with the support 210, form a generally planar sealed chamber 255 that is configured to contain an optical fluid. The deformable membrane 240 may be an annular membrane associated with an inner surface similar to the annular support 210. The region of the deformable membrane 245 may be associated with the first surface of the support 210, and the region of the static member 250 may be associated with the second, opposite surface of the support 210. understand that the orientation of the lens body 205 in the accommodating intraocular lens 200 and in the eye can be changed so that the reshaping membrane 245 can be positioned

- 17 042478 lag in front and position the static element 250 behind relative to the structure of the eye. Similarly, the shape-shifting membrane 245 may be positioned posteriorly and the static member 250 may be positioned anterior to the eye structure.

Static element 250, best shown in FIG. 25B and 25C may be a static lens, or may include a static lens formed from silicone, urethane, or low modulus elastomer as described above in other embodiments. Shape-changing membrane 245 may be a flexible optical element made from an optically clear, low modulus elastomer such as silicone. The shape-changing membrane 245 may have a constant thickness such that it is a flat element, or variable thickness such that the shape-changing membrane 245 has a reduced thickness region, i.e. as described in more detail above, relatively more prone to deformation due to increased internal pressure. It should be understood that, as described in this document, the structure of the shape-changing membrane 245 can be changed. The reduced thickness region may be deformable by internal pressure applied by the optical fluid in the sealed chamber 255 causing the outer surface (eg, front surface) to bulge outward.

With regard now to FIG. 25F and 25G, the support 210 may include channels 232 through which the deformably shaped membrane 240 may be accessible to contact portions 237 of the force-transmitting mechanisms 215. For example, during accommodation, the force-transmitting mechanisms 215 may be compressed by one or more ciliary structures. to optic axis A. Inward/forward movement of the ciliary structure can be used by the contact areas 235 causing the force transmitting mechanisms 215 to move inward along the channels 232 to the optic axis A. The contact areas 237 of the force transmitting mechanisms 215 can come into contact with the membrane 240 with a deformable shape and cause movement of the deformable membrane 240 relative to the deformable membrane 245. This movement may be pressure, indentation, stretching, deformation, or another type of movement that is generally directed toward optical axis A. This movement of the deformable membrane 240 may cause bending of the deformable membrane 245. membrane 245 to a more spherical or convex shape in the optical zone 201, thereby increasing the refraction of the lens for focusing vision at a short distance without applying stress to the optical zone or without compressing it, which will be described in more detail below.

As mentioned above, the sealed chamber 255 of the lens body 205 may be filled with an optical fluid, which may be a clear, biocompatible optical fluid. The optical fluid may be an incompressible fluid or gel that is bright and transparent in the visible spectrum, e.g. silicone fluids and gels, functionalized silicone fluids and gels (e.g. halide, i.e. fluorinated silicones, aromatic , i.e. phenyl functionalized silicones, etc.), hydrocarbon and functionalized hydrocarbons such as long chain hydrocarbons, halogenated hydrocarbons such as fluorinated or partially fluorinated hydrocarbons, aqueous systems, both fluids and gels, the refractive index (IR) of which is increased by the addition of water-soluble or water-swellable polymers, biopolymer swelling agents such as cellulose, and organic and inorganic additives that form nanostructures to increase the refractive index. In some implementations, the optical fluid in the sealed chamber 255 has a refractive index greater than 1.37. In other implementations, the optical fluid in the sealed chamber 255 has a refractive index in the range of 1.37-1.57. In other implementations, the optical fluid in the sealed chamber 255 has a refractive index in the range of 1.37-1.60.

The optical fluid in the sealed chamber 255 can cause the shape-changing membrane 245 to flex as the shape-changing membrane 240 moves. Movement inside the deformable membrane 240 may cause the incompressible optical fluid contained in the fixed volume of the sealed chamber 255 to be pressed against the surfaces of the sealed chamber 255, including the inner surface of the reshaping membrane 245. Since the reshaping membrane 245 has an area near the central of an area configured to bulge outward when a force is applied, the pressure of the optical fluid on the inner wall of the shape-changing membrane 245 causes the outer surface of the shape-changing membrane 245 to bulge outward and reshape. FIG. 25D and 25E are sectional views of the device in a relaxed, disaccommodated (non-accommodated) state and an active, accommodated state, respectively. The portion of the optical zone surrounding optical axis A, within and parallel to optical axis A, becomes more convex, increasing the refraction of the accommodative intraocular lens 200. It should be understood that, as described in this document, this reshaping of the reshaping membrane 245 can occur without the actual flow of fluid from one part of the lens body 205 to another. More specifically, compressing one area of the sealed chamber 255, having a fixed volume filled with a corresponding fixed volume of incompressible optical fluid, reactively changes the other

- 18 042478 areas of the sealed chamber 255 formed by the shape-changing membrane 245.

The accommodating IOL 200 may include force transmitting mechanisms 215 configured to extend through channels 232 in the support 210. As described above, the first force transmitting mechanism 215 may extend through a channel 232 on one side and the second force transmitting mechanism 215 may extend through channel 232 on the opposite side. However, it should be understood that the devices described herein may include more than two force-transmitting mechanisms 215. For example, the devices described herein may include three, four, or more force-transmitting mechanisms 215 evenly spaced around devices. In some embodiments, the force transmitting mechanisms 215 may be made of a rigid polymer such as silicone, polyurethane, polymethyl methacrylate, polyvinylidene fluoride, polydimethylsiloxane, polyamide, polypropylene, polycarbonate, etc. or combinations of them. For example, the force transmitting mechanisms 215 may be a first material element reinforced with a second material such as polymethyl methacrylate.

In some implementations, each of the force-transmitting mechanisms 215 may include an outer contact portion 235 and an inner contact portion 237, which may take any of a number of forms described herein. Contact portion 235 may be configured to abut, contact, engage, operably bond, or intimately bond with one or more ciliary structures, including, but not limited to, the ciliary body, ciliary processes, bands, or a combination of these, for control. change in the shape of the optics during accommodation and disaccommodation. The contact portion 235 of each force-transmitting mechanism 215 may remain external to the support 210 so that it may remain in contact with the ciliary structure during accommodation and disaccommodation. In some implementations, the contact area 235 may have an outer surface having a curved contour that may correspond to the curvilinear contour of the region of the eye with which the contact area 235 is closely associated. In some implementations, the contact area 235 may have depressions, notches, teeth, ridges, or other surface features. to improve, for example, contact and closure with the ciliary processes or zonular processes. In addition, the outer surface of the contact area 235 may have sharp or beveled edges on the top and/or bottom edge. Contact area 237 may be associated with contact area 235. In some implementations, contact area 237 may be an elongated element associated with or extending from the inner surface of contact area 235 (see, for example, Fig. 25D and 25E). The contact portion 237 may be shaped to fit within the channel 232 such that at least a portion of the force-transmitting mechanism 215 may move in the channel 232. As described above, the contact portion 237 may abut the deformable membrane 240. For example, when the ciliary muscle 18 contracts during accommodation, it contracts with respect to optical axis A. The ciliary structure can come into contact with the outer surface of the contact area 235, so that the force-transmitting mechanism 215 moves in the channel 232 and, as described above, contact the portion 237 presses the deformable membrane 240 of the lens body 205 and causes the deformable membrane 240 to move relative to the reshape membrane 245, and thereby controls the change in the accommodative shape of the reshape membrane 245. The deformable membrane 240 may be positioned inside or outside the optical areas of the lens body.

In FIG. 26A-26F show an interlocking embodiment of an accommodative intraocular lens (AIOL) 300 having an internal support 312, which will be described in more detail below. It should be understood that the features and components of the devices described in this document may be interrelated and used in combination or in a variant. For the sake of brevity, some of the descriptions regarding components from various implementations of the devices described in this document are not repeated, although this should not be taken to mean that these previous descriptions are not applicable to the following implementations.

The accommodative IOL 300 may include a lens body 305, a support 310, and force-transmitting mechanisms 315. The support 310 may include an internal and/or external support 310. In some implementations, the accommodative IOL 300 has only internal support sufficient to support the lens. without any additional external support. The body 305 of the lens can be located in the Central region of the support 310 and associated with it. The anterior surface of the lens body 305 may be viewable through the anterior opening of the support 310 and the posterior surface of the lens body 305 may be viewable through the rear opening of the support 310. change and that the use of the terms anterior and posterior is not intended to create a limitation.

The support 310 may include channels 332 or slits in the sidewall through which the force-transmitting mechanisms 315 may extend. The force-transmitting mechanisms 315 may freely move back and forth in the channels 332 as the ciliary structures move to effect a change in the accommodative shape of the lens body 305. For example, the first transmitting force

- 19 042478 mechanism 315 may continue along the first channel 332 on one side of the support 310, and the second force-transmitting mechanism 315 may continue along the second channel 332 on the opposite side of the support 310. Each of the force-transmitting mechanisms 315 may include an external contact area 335 configured to contact at least a portion of the ciliary structure, and an inner contact portion 337 configured to move along the channel 332 and come into contact with the lens body 305. The contact portion 335 of each force-transmitting mechanism 315 may remain external to the support 310 so that it may remain in contact with the ciliary structure during accommodation and disaccommodation.

The support 310 may be formed from a material that prevents deformation due to movement of the force transmitting mechanisms 315, as well as preventing unintentional movements of the force transmitting mechanisms 315 (eg, perpendicular to the inward/outward movement direction of the force transmitting mechanism 315). In some implementations, one or more stabilizing haptic elements 320 may be attached to the support 310. In other implementations, one or more stabilizing haptic elements 320 may be attached to the portion of the lens body 305 and the support 310 located in the sealed chamber of the lens body 305. In other embodiments, one or more stabilizing haptic elements 320 may be molded as part of the lens body 305 or outer support 310. Stabilizing haptic elements 320 may be static haptic elements configured to maintain alignment of the device optics and resist movement (e.g., vertical movement). ) an accommodative intraocular lens 300 after implantation and accommodative shape measurement, described in more detail above. In some embodiments, one or more haptic elements 320 may be placed in the ciliary sulcus and/or capsular sac.

The lens body 305 may include a deformable membrane 340, a reshape membrane 345, and a static element 350 (or static lens) coupled to each other to form a generally planar lens body 305 having a sealed chamber 355. The sealed chamber 355 is configured with the possibility of containing an optical fluid, such as fluorosilicone oil, or other optical fluid described in this document. The deformable membrane 340 may be an annular silicone structure (eg, polydimethylsiloxane) whose first surface (eg, front face) is bonded to the perimeter of the deformable membrane 345 or a front support that defines the diameter of the deformable membrane 345. The opposite surface (eg, back surface) of the deformable membrane 340 may be associated with the perimeter of the static member 350. It should be understood that the components of the lens body may be associated with each other as well as with the support 310 in any of a number of configurations. The outer wall of the deformable membrane 340 may have regions configured to engage with the force transmitting mechanisms 315 so that when the force transmitting mechanisms 315 move, the regions also move. As will be described in more detail below, as the deformable membrane 340 is moved, the shape of the sealed chamber 355 is changed to accommodate and disaccommodate. In some embodiments, the deformable membrane 340 may have a first region on the outer wall in engagement with the first force transmitting mechanism 315 and a second region on the outer wall in engagement with the second force transmitting mechanism 315. Each of the first and second regions on The outer wall of the deformable membrane 340 may include a surface element 341 configured to engage a corresponding element 338 on the force transmitting mechanism 315 (this is best shown in FIG. 26C).

The support 310 may be formed from a harder material (or materials) than the deformable membrane 340 to prevent inadvertent movements of the moving parts of the device. Optionally or additionally, the accommodating intraocular lens 300 may include one or more ribs or internal supports 312 located in a sealed chamber 355 of the lens body 305. The internal supports 312 may assist in mechanically isolating the optical components of the lens from optical distortion during movement of the moving parts of the accommodating IOL 300. In some embodiments, one or more internal supports 312 connect the anterior and posterior supports. In some embodiments, the first surface of the inner support 312 may be associated with the perimeter region of the reshaping membrane 345 (this is best shown in FIGS. 26B and 26C) or the front support defining the diameter of the reshaping membrane 345. In some embodiments, the inner support 312 is further associated with static element 350 (or static lens), so that the first surface of the inner support 312 is associated with the perimeter region of the reshaping membrane 345 and the second, opposite surface is associated with the perimeter region of the static element 350 (see Fig. 27A-27D). In any embodiment (i.e., relating to one or both of the front and back surfaces), at least a portion of the inner support 312 is spaced from the deformable membrane 340 such that the internal support 312 separates the sealed chamber 355 into a deformable region 307 And

- 20 042478 the central region 303, which contains the optical fluid. If the inner support 312 is associated only with the shape-changing membrane 345, the channel 342 can continue under the inner support 312, which allows the transfer of fluid between the deformable region 307 and the central region 303 of the sealed chamber 355 (this is best shown in Fig. 26B). If the inner support 312 is associated with both the reshaping membrane 345 and the static member 350, one or more channels 342 may extend through the inner support 312 itself to allow fluid transfer between the deformable region 307 and the central region 303 of the sealed chamber 355 ( this is best shown in Fig. 27B). One or more channels 342 may include a cylindrical opening that extends from the outer wall region into the inner wall region of the inner support 312. It should be understood that the channels 342 may be any of a number of shapes and sizes. Alternatively, a plurality of internal supports 312 may be contained in the sealed chamber 355 spaced apart from each other, creating one or more channels 342 to transfer fluid in the sealed chamber 355 between the deformable region 307 and the central region 303 of the sealed chamber. The accommodative IOL described herein may include one, two, three, four, five, or more internal supports 312 in a sealed chamber 355.

During accommodation, the inward/forward movement of the ciliary structure can be used by the contact portions 335 of the force-transmitting mechanisms 315 to cause the force-transmitting mechanisms 315 to move inward toward optical axis A. When inwardly moved, the force-transmitting mechanisms 315 cause the deformable surface membrane 340 to move or deform relative to the changing surface. the shape of the membrane 345, for example, to the optical axis. Movement inward, flattening, compressing, or deforming the deformable regions 307 of the deformable-shaped membrane 340 toward the optical axis causes the incompressible optical fluid contained in the fixed volume of the sealed chamber 355 to press against the surfaces of the sealed chamber 355, including the inner surface of the reshaping membrane 345. The reshaping membrane 345 may have an area surrounding the optical axis configured to bulge or flex outward when a force is applied to a more spherical or convex shape in the optic zone, thereby increasing the refraction of the lens when focusing for near vision without applying voltage or pressure to the optical zone. The pressure of the optical fluid on the shape-changing membrane 345 changes the shape of the outer surface. It should be understood that this reshaping can occur without fluid flowing from one part of the lens body 305 to another. More specifically, compressing a fixed volume of sealed chamber 355 (and deformable region 307) filled with an incompressible optical fluid causes membrane 345 to change shape. membrane 340 with deformable shape (and deformable region 307) occurs inside the optical zone. Alternatively, deformable region 307 may be located outside the optical zone, so that deformation of the deformable membrane 340 (and deformable region 307) can occur outside the optical zone.

The inner support 312 may have a tapered geometry such that the supports 312 do not come into contact with moving parts of the lens, such as the deformable membrane 340. For example, as shown in FIG. 26C, support 312 may be wider near where support 312 is associated with reshaping membrane 345 and an outer wall that tapers away from reshaping membrane 345 such that support 312 is narrower near where reshaping membrane 340 is. deformed to a greater extent during accommodation. In another example shown in FIG. 27D, support 312 may be wider at both the anterior and posterior ends of the accommodating IOL 300 where support 312 is associated with reshaping membrane 345 and static member 350, respectively, and tapers towards a central region. In this implementation, the support 312 forms a barrel-shaped configuration.

The dimensions of the components of the devices described in this document are subject to change. The devices can be configured to be implantable through an incision that is less than about 4 mm. In some implementations, the overall diameter of the device is approximately 8 mm, although this can be varied. For example, a device having flexible or collapsible haptic stabilizing elements may have a first diameter at the time of implantation that is smaller than the diameter obtained after implantation with subsequent deployment or expansion of the haptic stabilizing elements. In some implementations, the outer support may be made of flexible material(s) to allow the outer support to flex during implantation of the device. In some implementations, the central portion of the optical zone of the lens body may have a diameter that is about 2.5, about 3.0, about 3.5, about 4.0, about 4.5, about 5.0, about 5.5, about 6.0, about 6.5 mm, or larger diameter. In some embodiments, the accommodative diameter, or area of the central optical zone that undergoes reshaping, is greater than 3.0 mm.

As described above, the deformable regions of the lens body can move or contract relative to the central region of the lens body when a force is applied to the reshaping membrane. Force,

- 21 042478 applied to obtain movement of the lens body reshaping membrane, to effect accommodation may be as little as about 0.1 g-s (0.98 mN). In some embodiments, the applied force may be from about 0.1 g-s (0.98 mN) to about 5.0 g-s (49 mN), or from about 0.5 g-s (4.9 mN) to about 1.5 g-s (14.7 mN), or from 1.0 g-s (9.8 mN) to about 1.5 g-s (14.7 mN). Movements of deformable regions of the lens body relative to the central portion of the lens body in response to forces applied to achieve accommodation can be up to about 50 microns. Movements of the deformable regions of the lens body relative to the central region of the lens body (or, for example, the region 107 relative to the central region 103 or the deformable region 182 of the deformable membrane 140 relative to the central region 180 of the deformable membrane 140) in response to applied forces can be from about 50 up to about 500 microns, from about 50 to about 150 microns, or from about 100 to about 150 microns. With these ranges of applied forces and resulting ranges of movement, it is possible to obtain the devices described in this document with an accommodative capacity that is within a dynamic range greater than 3 diopters. In some implementations, the refraction is from 4 to 6 diopters when moving in the range of about 100-150 microns. The devices described in this document can have an accommodative range that is at least 3 diopters when the reshaping membrane is moved by about 100 microns and a force of at least 0.1 g-s (0.98 mN) is applied to the reshaping membrane. . In other embodiments, the devices may have an accommodative range that is at least 3 diopters for a movement of about 50 microns and a force of at least 1.0 g-s (9.8 mN).

Suitable materials or combinations of materials for making the various components of the devices disclosed in this document have been suggested throughout the description. It should be understood that other suitable materials may be considered. U.S. Patent Publication Nos. 2009/0234449, 2009/0292355, and 2012/0253459, each incorporated herein by reference in its entirety, provide additional examples of other materials suitable for forming some of the components of the devices described herein.

Various devices described in this document can be implanted in accordance with surgical methods known in the art. Depending on the features and components of the devices, they can be implanted using different methods or using different instruments. The devices described in this document may be used alone or in combination with another intraocular lens or the patient's natural lens. As described herein, the refraction of the lens body, as well as the relative position of the force-transmitting mechanisms and/or stabilizing haptic elements, can be adjusted and/or fine-tuned before implantation, during implantation, or at any time after implantation. Furthermore, it should be understood that the devices described herein may be inserted through a small incision, such as an incision that is not larger than 3.5 mm. The devices described in this document can be implanted so that the device is located outside the lens capsule, for example in front of the capsule and after the iris. The devices described in this document can be implanted so that the central portion of the lens body is centered relative to the optical axis of the eye. The force-transmitting mechanisms may be positioned relative to one or more ciliary structures, such as the ciliary body or ciliary muscle. The force-transmitting mechanisms can be positioned to abut the ciliary structure (or very close to the ciliary structure without abutment) without exerting pressure on the lens body, including the deformable region of the lens body, when the ciliary structure is at rest, disaccommodated ( unaccommodated) state. However, the force-transmitting mechanisms can be located close enough to the ciliary structure that when the ciliary muscle contracts, the lens body undergoes accommodation, and when the ciliary muscle relaxes, the lens body undergoes disaccommodation and the lens body materials rapidly return to rest. The relative position and length of the force transmitting mechanisms can be adjusted in accordance with the various methods described above using one or more of the different adjustment elements described above. Stabilizing haptic elements can be placed in the ciliary sulcus (or other area) to further stabilize the device in the eye. In addition, it is possible to further adjust and fine-tune the refractive power of the lens body at rest in accordance with the various methods described herein using one or more of the different refractive adjustment elements described herein.

While this specification contains many details, they should not be construed as limiting the scope that is or may be claimed, but rather as representations of features specific to particular embodiments. In addition, certain features that are discussed in this description in the context of separate embodiments may be implemented in combination in one embodiment. Conversely, various features that are considered in the context of one embodiment may also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although the above indications

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Claims (5)

may be described above as operating in certain combinations and even originally claimed as such, in some cases one or more features from the claimed combination may be excluded from the combination, and the claimed combination may be reduced to a subcombination or subcombination variant. Likewise, although the operations are shown in the drawings in a particular order, this should not be understood as a requirement that such operations must be performed in the particular order shown or in sequential order, or that all the operations shown should be performed to obtain the desired results. Only a few examples and implementations are disclosed. Variations, modifications and improvements to the described examples and implementations and other implementations can be made based on the disclosure. In the above description and in the claims, phrases such as at least one or one or more may appear in a conjunctive list of elements or features. In addition, the term and/or may be in a list of two or more elements or features. Unless a phrase, either implicitly or explicitly conflicts with the context in which it is used, such phrase is intended to mean any of the listed elements or features alone, or any of the listed elements or features in combination with any of the other listed elements or features. For example, the phrases at least one of A and B, one or more of A and B, and A and/or B are intended to mean only A, only B, or A and B together. In addition, a similar interpretation is assumed for lists that include three or more items. For example, the phrases at least one of A, B and C, one or more of A, B and C and A, B and/or C are intended to mean A only, B only, C only, A and B together, A and C together, B and C together, or A and B and C together. The use of the term based in the above and in the claims is intended to mean based, at least in part, so that an unlisted feature or element is also possible. CLAIM 1. An accommodating intraocular lens device for treating an eye, wherein the device comprises an optical lens body having a sealed chamber containing a volume of optical fluid, the lens body comprising a shape-changing membrane configured to bend outward in the central region of the lens body, wherein the shape-changing membrane comprises a first thickness in the vicinity of a perimeter region of the lens body and a second thickness in the vicinity of a central region of the lens body; a deformable membrane configured to undergo inward displacement toward the optical axis of the eye relative to the deformable membrane during application of a compressive force to the sealed chamber; a support associated with a shape-changing membrane in the area of the lens body perimeter, wherein the support is configured to mechanically isolate the optical components of the lens body, to prevent deformation during accommodation, and the support has an outer wall that is at a distance from the membrane with a deformable shape and narrows, to exclude contact with the membrane with a deformable shape during movement inside; and a static rear lens element opposed to the reshaping membrane, wherein the reshaping membrane, the deformable membrane, and the static rear lens element together form a sealed lens body chamber containing a volume of optical fluid; a static stabilizing haptic element configured to be positioned within the capsular bag when the accommodating intraocular lens device is implanted in the eye such that the optical axis of the lens body is substantially aligned with the visual axis of the eye; and a force transmitting mechanism protruding outwardly from the deformable lens body shaped membrane and configured to interact with the ciliary structure outside the capsular bag when the accommodating intraocular lens device is implanted in the eye, wherein the force transmitting mechanism is movable relative to the lens body when the ciliary is moved. structures for applying a compressive force to the membrane with a deformable shape to bulge outwardly the central region of the lens body. 2. The apparatus of claim 1, wherein the support forms a partition in the sealed chamber separating the sealed chamber into a deformable region and a central region. 3. The device according to claim 2, wherein the deformable region is located outside the optical zone of the lens housing. 4. The device according to claim 2, in which moving inside the membrane with a deformable shape deforms the deformable region. 5. The device of claim 2, wherein the support is connected to the region of the static rear lens element. -