Adjustable intraocular lens with toric surface

Abstract

Toric accommodating intraocular lenses are disclosed. In one embodiment, a toric accommodating intraocular lens includes an anterior element and a posterior element. The anterior element can include an anterior optical surface. The posterior element can include a posterior optical surface. A fluid-filled optic fluid chamber can be defined between the anterior element and the posterior element. The toric accommodating intraocular lens can be configured to correct corneal astigmatism, spherical aberration, or a combination thereof.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 911,020, filed on October 4, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to the field of intraocular lenses, and more particularly to accommodating intraocular lenses having toric lens surfaces. Background Art

[0004] Cataract is a condition in which the normally clear lens of a patient's eye becomes cloudy. The occurrence of cataracts is due to aging, genetic factors, trauma, inflammation, metabolic disorders or exposure to radiation. Age-related cataracts are the most common type of cataract. When treating cataracts, the surgeon removes the lens matrix from the patient's lens capsule and replaces it with an intraocular lens (IOL). Traditional IOLs provide one or more selected focal lengths that allow the patient to have distance vision. However, after cataract surgery, because the eye can no longer adjust (or change its optical power) to keep a clear image of an object or focus on an object as the distance of the object changes, patients with traditional IOLs usually need glasses or other corrective lenses to carry out certain activities.

[0005] Newer IOLs, such as accommodative IOLs, allow the eye to regain at least some focusing ability. Accommodative IOLs (AIOLs) use the forces available in the eye to change some parts of the optical system in order to refocus the eye on a distant or near target. This can be considered dynamic defocus and low-order aberrations. Examples of AIOLs are discussed in the following U.S. Patent Publications: U.S. Patent Publication No. 2018 / 0256315; U.S. Patent Publication No. 2018 / 0153682; and U.S. Patent Publication No. 2017 / 0049561, as well as in the following issued U.S. Patents: U.S. Patent No. 10,299,913; U.S. Patent No. 10,195,020; and U.S. Patent No. 8,968,396, the contents of which are incorporated herein by reference in their entirety.

[0006] In addition to low-order aberrations, higher-order aberrations can also cause visual disturbances and are often corrected with artificial lenses. These aberrations can include cylindrical astigmatism and spherical aberration. Cylindrical astigmatism typically occurs naturally in the cornea, and most patients with pre-existing cataracts also have some degree of astigmatism. While toric IOLs have been used to correct astigmatism during cataract surgery, these toric IOLs have the same disadvantages as conventional IOLs, namely, they do not provide accommodation.

[0007] Another difficulty faced by all toric lens manufacturers is that these lenses have different optical powers in different meridians, so maintaining cylindrical orientation after lens implantation is critical. This difficulty is even more challenging when astigmatism correction is attempted in conjunction with accommodation or accommodation and spherical aberration correction.

[0008] Therefore, a solution is needed to address the above-mentioned shortcomings and deficiencies of conventional IOLs and toric IOLs. Such a solution should not be overly complex and its manufacture is cost-effective. Summary of the Invention

[0009] Disclosed herein are accommodating intraocular lenses for correcting corneal astigmatism and accommodating intraocular lenses for correcting both corneal astigmatism and spherical aberration. In one embodiment, a toric accommodating intraocular lens is disclosed that includes an optic portion comprising an anterior element and a posterior element. The anterior element may include an anterior optical surface. The posterior element may include a posterior optical surface. A fluid-filled optic fluid cavity may be defined between the anterior element and the posterior element. At least one of the anterior optical surface and the posterior optical surface may be shaped such that a radius of curvature of the at least one of the anterior optical surface and the posterior optical surface is different along different optical surface meridians.

[0010] In some embodiments, the radius of curvature of the posterior optical surface can vary periodically around the posterior optical surface. In some embodiments, the radius of curvature varies periodically (e.g., sinusoidally) around the posterior optical surface.

[0011] The rear element may further include a rear inner surface. The rear inner surface may be the surface of the rear element facing the optic fluid cavity. The rear inner surface may be rotationally symmetric or substantially rotationally symmetric. The rear inner surface may be rotationally symmetric when the radius of curvature of the rear inner surface is the same or substantially the same along all surface meridians.

[0012] The posterior element may also have a posterior element thickness measured from the posterior optical surface to the posterior inner surface. The posterior element thickness may vary periodically around the posterior element such that the posterior element thickness is different along different optical surface meridians. The thickness of the posterior element may vary sinusoidally around the posterior element.

[0013] In some embodiments, the radius of curvature of the anterior optical surface can vary periodically around the anterior optical surface. The radius of curvature of the anterior optical surface can vary periodically around the anterior optical surface when the radius of curvature of the anterior optical surface along one meridian of the optical surface is different from the radius of curvature along another meridian of the optical surface. In certain embodiments, the radius of curvature varies periodically (e.g., sinusoidally) around the anterior optical surface.

[0014] The front element may further include a front inner surface. The front inner surface may be the surface of the front element facing the optical fluid cavity. In some embodiments, at least a portion of the front inner surface and the rear inner surface may serve as the cavity wall of the optical fluid cavity. The front inner surface may be rotationally symmetric or substantially rotationally symmetric. The front inner surface may be rotationally symmetric when the radius of curvature of the front inner surface is the same or substantially the same along all surface meridians.

[0015] The anterior element may also have an anterior element thickness measured from the anterior optical surface to the anterior inner surface. The anterior element thickness may vary periodically around the anterior element such that the anterior element thickness is different along different optical surface meridians. The thickness of the anterior element may vary sinusoidally around the anterior element.

[0016] At least one of the anterior optical surface and the posterior optical surface may include a flat meridian and a steep meridian oriented substantially perpendicular to the flat meridian. The radius of curvature is smallest along the steep meridian and largest along the flat meridian.

[0017] The refractive power of the outer optical surface (either the posterior optical surface or the anterior optical surface) of a toric accommodating intraocular lens can be greatest along the steep meridian of the outer optical surface, and the refractive power of the outer optical surface can be least along the flat meridian of the same outer optical surface. The steep meridian and the flat meridian can be considered the principal meridians of the lens. The flat meridian can also be referred to as the cylindrical axis of the toric lens or simply the "axis."

[0018] For example, the radius of curvature of the posterior optical surface can be smallest along the steep meridian of the posterior optical surface. The radius of curvature of the posterior optical surface can be largest along the flat meridian of the same posterior optical surface. Additionally, the posterior element thickness can be largest (or thickest) along the flat meridian. The posterior element thickness can be smallest (or thinnest) along the steep meridian.

[0019] Furthermore, for example, the radius of curvature of the anterior optical surface can be smallest along the steep meridian of the anterior optical surface. The radius of curvature of the anterior optical surface can be largest along the flat meridian of the same anterior optical surface. Furthermore, the anterior element thickness can be largest (or thickest) along the flat meridian. The anterior element thickness can be smallest (or thinnest) along the steep meridian.

[0020] The optic portion may have a base optical power or a base spherical optical power. The base optical power of the optic portion may be configured to change based on the internal fluid pressure within a fluid-filled optic fluid cavity. The base optical power of the optic portion may be configured to increase or decrease as fluid enters or leaves the optic fluid cavity. The optic portion may be configured to change shape in response to fluid entering or leaving the optic fluid cavity. In some embodiments, a front element of the optic portion may be configured to change shape in response to fluid entering or leaving the optic fluid cavity. In other embodiments, a rear element of the optic portion may be configured to change shape in response to fluid entering or leaving the optic fluid cavity. In further embodiments, both the front and rear elements of the optic portion may be configured to change shape in response to fluid entering or leaving the optic fluid cavity.

[0021] The base optical power of the optic portion can be configured to change in response to a shape change performed by a shape-changing optic portion (e.g., anterior element, posterior element, or a combination thereof). The shape-changing optic portion is configured to change shape in response to physiological muscle movements (e.g., ciliary muscle movements) performed by the patient when the toric accommodating intraocular lens is implanted in the patient's eye.

[0022] In some embodiments, a toric accommodating intraocular lens can include one or more haptics coupled to and extending from the optic portion. Each of the one or more haptics can include a haptic fluid cavity within the haptic. The base optical power of the optic portion can be configured to increase as fluid enters the optic fluid cavity from the one or more haptic fluid cavities. The base optical power of the optic portion can be configured to decrease as fluid exits or is withdrawn from the optic fluid cavity and enters the one or more haptic fluid cavities.

[0023] The optic fluid chamber can be in fluid communication or fluidically connected to one or more haptic fluid chambers. The optic fluid chamber can be in fluid communication with the haptic fluid chambers via a pair of fluid channels. The fluid channels can be conduits or channels that fluidically connect the optic fluid chamber to the haptic fluid chambers. The pair of fluid channels can be spaced apart from each other. For example, the pair of fluid channels can be spaced apart by about 0.1 mm to about 1.0 mm.

[0024] In some embodiments, a pair of fluid channels can be defined and extend through a portion of the optic portion. More specifically, a pair of fluid channels can be defined and extend through the rear element.

[0025] One or more haptics may be coupled to the optic portion at a haptic-optic interface. One or more haptics may be coupled to the optic portion at a reinforced portion along the optic portion. The reinforced portion may be a portion of the haptic-optic interface. A pair of fluid channels may be defined or formed within a portion of the reinforced portion.

[0026] In some embodiments, a toric accommodating intraocular lens may include two haptics coupled to and extending from an optic portion. The first haptic may include a first haptic fluid chamber within the first haptic. The second haptic may include a second haptic fluid chamber within the second haptic. The first haptic may be coupled to the optic portion at a first haptic-optic interface, and the second haptic may be coupled to the optic portion at a second haptic-optic interface.

[0027] In these embodiments, the optics fluid chamber can be in fluid communication with the first haptic fluid chamber and the second haptic fluid chamber. The optics fluid chamber can be in fluid communication with the first haptic fluid chamber via a first pair of fluid channels. The optics fluid chamber can be in fluid communication with the second haptic fluid chamber via a second pair of fluid channels.

[0028] The first pair of fluid channels may be spaced apart from each other. The first pair of fluid channels may be spaced apart by between about 0.1 mm and about 1.0 mm. The second pair of fluid channels may be spaced apart from each other. The second pair of fluid channels may be spaced apart by between about 0.1 mm and about 1.0 mm.

[0029] A first pair of fluid channels and a second pair of fluid channels may be defined and extend through a portion of the optic portion.The first pair of fluid channels and the second pair of fluid channels may be defined and extend through the rear element.

[0030] The optical portion may further include a first reinforcement portion and a second reinforcement portion substantially on opposite sides of the optical portion or substantially diametrically opposite each other. The first pair of fluid channels may be defined or formed within the first reinforcement portion. The second pair of fluid channels may be defined or formed within the second reinforcement portion.

[0031] The first pair of fluid channels may terminate at a first pair of holes defined in the optics portion. The first pair of fluid channels may terminate at a first pair of holes defined in the rear element. The first pair of holes may be spaced between approximately 0.1 mm and approximately 1.0 mm apart. The second pair of fluid channels may terminate at a second pair of holes defined in the optics portion. The second pair of fluid channels may terminate at a second pair of holes in the rear element. The second pair of holes may be spaced between approximately 0.1 mm and approximately 1.0 mm apart.

[0032] In some embodiments, the first pair of fluid channels and the second pair of fluid channels can be positioned substantially on opposite sides of the optic portion.The first pair of fluid channels can be positioned substantially diametrically opposite the second pair of fluid channels.

[0033] In these embodiments, the first pair of holes and the second pair of holes may be positioned substantially on opposite sides of the optic portion.The first pair of holes may be positioned substantially diametrically opposite the second pair of holes.

[0034] As previously described, the base optical power or base spherical power of the optic portion can be configured to change based on the internal fluid pressure within the fluid-filled optic fluid cavity.A toric accommodating intraocular lens can also have cylindrical optical power.

[0035] The cylindrical power of a toric accommodating intraocular lens can be the diopter of the toric accommodating intraocular lens along the steep meridian. Cylinder power is typically expressed as the difference in diopter provided by the steep curvature of the toric lens along the steep meridian (e.g., +1.0D or +3.0D).

[0036] In some embodiments, the toric accommodating intraocular lens can have a cylindrical power between about +0.75D and about +6.00D. For example, the toric accommodating intraocular lens can have a cylindrical power of about +0.75D, +1.50D, +2.25D, +3.00D, +3.75D, +4.50D, +5.25D, or +6.00D. In some embodiments, the toric accommodating intraocular lens can have a cylindrical power of about +0.75D (also referred to as low cylindrical). In other embodiments, the toric accommodating intraocular lens can have a cylindrical power of about +6.0D (referred to as high cylindrical).

[0037] A technical problem faced by applicants is how to introduce cylinder or toricity into an accommodating intraocular lens so that the cylindrical optical power of the accommodating intraocular lens remains essentially unchanged or stable across all base optical power changes (e.g., base optical power changes between about ±1.0 and about ±10.0) throughout the process of accommodation or loss of accommodation of the lens.

[0038] One solution discovered by the applicant is to vary the radius of curvature of an outer optical surface (e.g., the posterior or anterior optical surface) while maintaining the rotational symmetry of the inner surface opposite the outer optical surface (e.g., the posterior or anterior inner surface). Another solution provided by the present invention is to orient the flat meridian of the outer optical surface at an oblique angle relative to the midline that substantially bisects the optic portion. The orientation of the flat meridian will be discussed in more detail in the following sections.

[0039] By designing a toric accommodating intraocular lens in this manner, the cylindrical power of the optic portion can remain substantially constant or stable throughout the process of changing the base power of the optic portion in response to changes in fluid pressure within a fluid-filled optic fluid chamber. For example, the relative refractive power between the steep meridian and the flat meridian can remain substantially constant or stable as the base power of the optic portion changes throughout the process of accommodation and loss of accommodation.

[0040] Toric accommodating intraocular lenses can also have a cylindrical orientation. Cylindrical orientation can refer to the orientation or positioning of the lens meridians. For example, cylindrical orientation can refer to the orientation or positioning of the flat meridian (i.e., the cylindrical axis), the steep meridian, or a combination thereof relative to other components of the lens. Cylindrical orientation can also refer to the orientation or positioning of one meridian relative to another meridian.

[0041] Another technical problem faced by applicants is how to maintain a substantially constant or fixed cylindrical orientation of a toric accommodating intraocular lens across all base power changes throughout the process of lens accommodation or loss of accommodation. Toric intraocular lenses have cylindrical orientations that change or shift significantly when implanted in the eye, which at best is of no benefit (or has no astigmatism correction effect) and at worst can adversely affect the patient's vision (e.g., by inducing astigmatism in another meridian).

[0042] One solution discovered by applicants is to orient the plana meridian of a toric accommodating intraocular lens at an oblique angle to the midline that substantially bisects the optic portion. By designing the toric accommodating intraocular lens in this manner, the cylindrical orientation of the optic portion can remain substantially constant throughout changes in the base optical power of the optic portion in response to changes in internal fluid pressure within the fluid-filled optic's fluid chamber. For example, the orientation or position of the plana meridian of the toric accommodating intraocular lens can remain substantially constant or fixed relative to the eye's corneal astigmatism axis as the base optical power of the optic portion changes throughout accommodation and loss of accommodation.

[0043] In some embodiments, the tilt angle can be a clockwise rotation angle relative to the midline. For example, the tilt angle can be a clockwise rotation angle between approximately 30 degrees and 60 degrees. More specifically, the applanation meridian can be oriented at a clockwise rotation angle between approximately 30 degrees and 60 degrees relative to the midline. In certain embodiments, the tilt angle can be a clockwise rotation angle of approximately 45 degrees. More specifically, the applanation meridian can be oriented at a clockwise rotation angle of approximately 45 degrees relative to the midline.

[0044] In some embodiments, the midline can be a line or axis that substantially bisects the optic portion or divides the optic portion into two halves. In these and other embodiments, the midline can substantially bisect the haptic-optic interface or extend through the middle of the haptic-optic interface. For example, the midline can substantially bisect both the first haptic-optic interface and the second haptic-optic interface. The midline can also extend through or substantially bisect the first reinforcement portion and the second reinforcement portion.

[0045] As previously described, the optic portion can include at least one pair of fluid channels configured to fluidically connect a fluid-filled optic fluid cavity to a haptic fluid cavity. A centerline can extend between the pair of fluid channels or substantially bisect a portion of the optic portion that separates the pair of fluid channels. In some embodiments, the centerline can extend between a pair of apertures or bisect a portion of the optic portion that separates the pair of apertures disposed at the ends of the pair of fluid channels. For example, the optic portion can include a first pair of fluid channels and a second pair of fluid channels, and the centerline can extend between or substantially bisect a portion of the optic portion that separates the first pair of fluid channels and the second pair of fluid channels.

[0046] In some embodiments, the front element can be configured such that the front optical surface is aspherical, or changes shape from a spherical configuration to an aspherical configuration in response to fluid entering the fluid-filled optic fluid cavity. In some embodiments, fluid can enter the fluid-filled optic fluid cavity from one or more haptic fluid cavities of haptics coupled to the optic portion.

[0047] In other embodiments, the rear element can be configured such that the rear optical surface is aspherical or changes its shape from a spherical configuration to an aspherical configuration in response to fluid entering a fluid cavity of a fluid-filled optic. The aspherical configuration can correct for higher-order aberrations, such as spherical aberration.

[0048] Another technical problem faced by the applicant is how to introduce both cylinder / toricity and asphericity into an accommodating intraocular lens. An accommodating intraocular lens that can correct corneal astigmatism and spherical aberration can allow cataract patients with these higher-order aberrations to rely on only a pair of accommodating intraocular lenses to correct these aberrations.

[0049] One solution discovered by the applicants is to separate the external optical surface that is configured to become aspheric from the external optical surface that has a toric lens surface. For example, an accommodating intraocular lens can be configured so that the aspheric optical surface is on the lens element opposite the lens element having the toric optical surface.

[0050] In some embodiments, the posterior element can be shaped such that the radius of curvature of the posterior optical surface is different along different optical surface meridians, and the anterior element can be aspheric.

[0051] In other embodiments, the anterior element can be shaped such that the radius of curvature of the anterior optical surface is different along different optical surface meridians and the posterior element is aspheric.

[0052] Similar to cylindrical power and cylindrical orientation, the asphericity of the outer optical surface can be maintained or maintained stable across some or all base power changes throughout the process of accommodation or loss of accommodation.

[0053] In some embodiments, when fluid enters the fluid-filled optical fluid cavity defined by the front element and the rear element, the external optical surface (the front optical surface or the rear optical surface) can be compressed into an aspheric configuration. The external optical surface can be compressed into an aspheric configuration when the center or central portion of the optical element (the front element or the rear element) is further curved or convex outward than the outer periphery of the optical element held by the adhesive or adhesive layer.

[0054] The adhesive or adhesive layer may bond or otherwise connect the front element to the rear element.The adhesive or adhesive layer may be substantially annular.

[0055] In these and other embodiments, the thickness of the optical element at its center or central portion can be greater than the thickness at its periphery. This thickness differential can also help the exterior optical surface change its shape from a spherical configuration to an aspheric configuration when fluid enters the fluid-filled optical fluid cavity. For example, the thickness of the front element at its center or central portion can be greater than the thickness at the periphery of the front element. This thickness differential can enable the front optical surface to change shape from a spherical configuration to an aspheric configuration when the internal fluid pressure within the optical fluid cavity increases. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Figure 1A A top view of an embodiment of a toric accommodating intraocular lens is shown.

[0057] Figure 1B A cross-sectional view of an embodiment of a toric accommodating intraocular lens is shown.

[0058] Figure 1C An exploded view of an embodiment of a toric accommodating intraocular lens is shown.

[0059] Figure 2A A top view of the posterior element of an embodiment of a toric accommodating intraocular lens is shown.

[0060] Figure 2B Shown along Figure 2A Cross-sectional view of the rear element taken at section AA.

[0061] Figure 2C Shown along Figure 2A A cross-sectional view of the rear element taken at section BB.

[0062] Figure 2D Shown along Figure 2ACross-sectional view of the rear element taken at section CC.

[0063] Figure 3A A top view of the anterior element of an embodiment of a toric accommodating intraocular lens is shown.

[0064] Figure 3B Shown along Figure 3A Cross-sectional view of the front element taken at section AA.

[0065] Figure 3C Shown along Figure 3A A cross-sectional view of the front element taken through section BB.

[0066] Figure 4 The orientation of the flat meridian relative to the midline of a toric accommodating intraocular lens is shown.

[0067] Figure 5 is a graph showing the variation in the specific optical power of a toric accommodating intraocular lens as a function of the internal fluid pressure within the optic fluid chamber of the lens.

[0068] Figure 6 is a graph showing cylindrical stability according to the amount of toric rotation as a function of the cylindrical axis angle relative to the intraocular lens midline. DETAILED DESCRIPTION

[0069] Figure 1A A top view of an embodiment of a toric accommodating intraocular lens (AIOL) 100 for correcting corneal astigmatism, spherical aberration, or a combination thereof is shown. The toric AIOL 100 can include an optic portion 102 and a peripheral portion that, in this embodiment, includes one or more haptics 104, including a first haptic 104A and a second haptic 104B coupled to and extending from the periphery of the optic portion 102. The toric AIOL 100 is configured to be positioned within a natural capsular bag from which the natural lens has been removed.

[0070] When implanted in the natural capsular bag, the optic portion 102 can be adapted to refract light entering the eye onto the retina. One or more haptics 104 can be configured to engage the capsular bag and be adapted to deform in response to ciliary muscle movement associated with capsular bag reshaping (e.g., muscle relaxation, muscle contraction, or a combination thereof). Engagement of the haptics 104 with the capsular bag will be discussed in greater detail in the following sections.

[0071] Figure 1B Shown along Figure 1A A cross-sectional view of an embodiment of a toric AIOL 100 taken at section AA. Figure 1BAs shown, the optic portion 102 can include a front element 106 and a rear element 108. A fluid-filled optic fluid cavity 110 can be defined between the front element 106 and the rear element 108.

[0072] Front element 106 may include a front optical surface 112 and a front inner surface 114 opposite front optical surface 112. Rear element 108 may include a rear optical surface 116 and a rear inner surface 118 opposite rear optical surface 116. Any one of front optical surface 112, rear optical surface 116, or a combination thereof may be considered and referred to as exterior optical surfaces. Front inner surface 114 and rear inner surface 118 may face optics fluid cavity 110. At least a portion of front inner surface 114 and at least a portion of rear inner surface 118 may serve as cavity walls of optics fluid cavity 110.

[0073] Each of the one or more haptics 104 can include a haptic fluid lumen 120 within the haptic 104. For example, the first haptic 104A can include a first haptic fluid lumen 120A within the first haptic 104A, and the second haptic 104B can include a second haptic fluid lumen 120B within the second haptic 104B. The haptic fluid lumen 120 (e.g., any one of the first haptic fluid lumen 120A, the second haptic fluid lumen 120B, or a combination thereof) can be in fluid communication or fluidly connected to the optics fluid lumen 110.

[0074] The optical fluid chamber 110 can be connected to a pair of fluid channels 122 (see Figure 1A ) is in fluid communication with one or more haptic fluid chambers 120. Fluid channels 122 may be conduits or channels that fluidically connect optic fluid chamber 110 to haptic fluid chamber 120. A pair of fluid channels 122 may be spaced apart from each other. For example, a pair of fluid channels 122 may be spaced apart by between about 0.1 mm and about 1.0 mm. In some embodiments, each of a pair of fluid channels 122 has a diameter between about 0.4 mm and about 0.6 mm.

[0075] In some embodiments, a pair of fluid channels 122 can be defined and extend through a portion of the optic portion 102. More specifically, a pair of fluid channels 122 can be defined and extend through the rear element 108.

[0076] Figure 1A 1. One or more haptics 104 are shown as being coupled to the optic portion 102 at a haptic-optic interface 124. For example, one or more haptics 104 may be coupled to the optic portion 102 at a reinforcing portion 126 (see FIG. Figure 1C ) is coupled to the optic portion at a location . The reinforcement portion 126 can be a portion of the haptic-optic interface 124 . A pair of fluid channels 122 can be defined or formed within a portion of the reinforcement portion 126 .

[0077] The optics fluid chamber 110 can be in fluid communication with the first haptic fluid chamber 120A via a first pair of fluid channels 122A. The optics fluid chamber 110 can also be in fluid communication with the second haptic fluid chamber 120B via a second pair of fluid channels 122B.

[0078] The two fluid channels of the first pair of fluid channels 122A may be spaced apart from each other. The two fluid channels of the first pair of fluid channels 122A may be spaced apart from each other by about 0.1 mm to about 1.0 mm. The two fluid channels of the second pair of fluid channels 122B may be spaced apart from each other. The two fluid channels of the second pair of fluid channels 122B may be spaced apart from each other by about 0.1 mm to about 1.0 mm.

[0079] In some embodiments, the first pair of fluid channels 122A and the second pair of fluid channels 122B can be positioned substantially on opposite sides of the optic portion 102. The first pair of fluid channels 122A can be positioned substantially diametrically opposite the second pair of fluid channels 122B.

[0080] The first pair of fluid channels 122A and the second pair of fluid channels 122B can be defined or extend through a portion of the optic portion 102. The first pair of fluid channels 122A and the second pair of fluid channels 122B can be defined or extend through the rear element 108.

[0081] The design with two fluid channels 122 instead of one helps maintain dimensional stability during assembly, which can be important when assembling flexible and thin components. In addition, it has been experimentally observed that the design with two fluid channels 122 provides better optical quality than some single-channel designs throughout the entire adjustment range. The additional stiffness of the two fluid channel design results in less deflection due to pressure changes in the fluid channels.

[0082] like Figure 1C As shown, the optic portion 102 may include a first reinforcement portion 126A and a second reinforcement portion 126B substantially on opposite sides of the optic portion 102 or substantially diametrically opposite each other. The first pair of fluid channels 122A may be defined or formed within the first reinforcement portion 126A. The second pair of fluid channels 122B may be defined or formed within the second reinforcement portion 126B.

[0083] A pair of fluid channels 122 (e.g., either the first pair of fluid channels 122A or the second pair of fluid channels 122B) may have a pair of inner holes 128 disposed at one end of the fluid channels 122 and another pair of outer holes 130 disposed at the other end of the fluid channels 122. The pair of inner holes 128 may be defined or formed on a portion of the rear element 108. Figure 1B and Figure 1CAs shown, the inner hole 128 can be defined or formed on a portion of a raised inner surface 132 of the rear element 108. In some embodiments, the raised inner surface 132 can be inclined or beveled.

[0084] A pair of external apertures 130 can be defined or formed on a portion of a protruding outer surface 134 of the posterior element 108. The protruding outer surface 134 can be a portion of the reinforcement portion 126. The protruding outer surface 134 can also be a portion of the haptic-optic interface 124.

[0085] For example, Figure 1C A pair of internal apertures 128 are shown disposed at one end of the first pair of fluid passages 122A and defined along a raised inner surface 132 of the rear element 108 . Figure 1C Also shown is a pair of outer holes 130 that serve as ends of the second pair of fluid passages 122B and are defined along a protruding outer surface 134 of the rear element 108. The pair of outer holes 130 of the first pair of fluid passages 122A and the pair of inner holes 128 of the second pair of fluid passages 122B are arranged in a manner similar to the embodiment of FIG. Figure 1C is obscured.

[0086] The two holes of the pair of inner holes 128 can be spaced apart from each other by about 0.1 mm to about 1.0 mm. The two holes of the pair of outer holes 130 can be spaced apart from each other by between about 0.1 mm and about 1.0 mm. The pair of inner holes 128 of the first pair of fluid channels 122A can be positioned diametrically opposite the pair of inner holes 128 of the second pair of fluid channels 122B or on opposite sides of the raised inner surface 132 from the pair of inner holes 128 of the second pair of fluid channels 122B.

[0087] Figure 1C It is also shown that each of the haptics 104 (e.g., either the first haptic 104A or the second haptic 104B) can have an optics attachment end 136 and a closed free end 138. A haptic fluid port 140 can be defined at the optics attachment end 136 of the haptics 104. The haptic fluid port 140 can serve as a cavity opening for the haptic fluid cavity 120. When the haptics 104 are coupled to the optics portion 102, fluid within the haptic fluid cavity 120 can flow out of the haptic fluid cavity 120 through the haptic fluid port 140 and into the optics fluid cavity 110 via the pair of fluid channels 122. Similarly, fluid within the optics fluid cavity 110 can flow out of the optics fluid cavity 110 through the pair of fluid channels 122 and into the haptic fluid cavity 120 through the haptic fluid port 140.

[0088] like Figure 1A and Figure 1CAs shown, the haptics 104 can be connected to the optic portion 102 at the stiffening portion 126. For example, the first haptic 104A can be coupled or attached to the optic portion 102 at the first stiffening portion 126A, and the second haptic 104B can be coupled or attached to the optic portion 102 at the second stiffening portion 126B.

[0089] More specifically, the haptic attachment end 136 can be coupled to a protruding outer surface 134 of the posterior element 108. The protruding outer surface 134 can also be referred to as a "platform" or a "haptic attachment platform." The protruding outer surface 134 can extend radially outward from the outer peripheral surface 142 of the optic portion 102. For example, the protruding outer surface 134 can extend radially outward from the outer peripheral surface 142 of the posterior element 108 of the optic portion 102. The protruding outer surface 134 can extend radially outward from the outer peripheral surface 142 by approximately 10 micrometers to 1.0 mm or approximately 10 micrometers to 500 micrometers.

[0090] The haptic attachment end 136 can have a substantially flat surface to adhere or otherwise couple to the substantially flat surface of the protruding outer surface 134. When the haptic attachment end 136 is coupled to the protruding outer surface 134, the haptic fluid port 140 can surround the outer aperture 130 of the fluid channel 122. The haptic 104 can be coupled or adhered to the optic portion 102 using a biocompatible adhesive. In some embodiments, the adhesive can be the same adhesive used to couple or adhere the anterior element 106 to the posterior element 108.

[0091] Each haptic 104 may further include a radially outer portion 144 configured to face and contact the inner surface of the patient's capsular bag when the toric AIOL 100 is implanted in the capsular bag. Each haptic 104 may further include a radially inner portion 146 configured to face the outer peripheral surface 142 of the optic portion 102. The engagement of the capsular bag with the radially outer portions 144 of the haptics 104 will be discussed in more detail in the following sections.

[0092] The optic portion 102 may have a base optical power or a base spherical optical power. The base optical power of the optic portion 102 may be configured to change based on the internal fluid pressure within the fluid-filled optic fluid cavity 110. The base optical power of the optic portion 102 may be configured to increase or decrease as fluid enters or leaves the optic fluid cavity 110.

[0093] The base optical power of the optic portion 102 can be configured to increase as fluid enters the optic fluid cavity 110 from one or more haptic fluid cavities 120. The base optical power of the optic portion 102 can be configured to decrease as fluid flows or is withdrawn from the optic fluid cavity 110 and into one or more haptic fluid cavities 120.

[0094] The optic portion 102 can be partially made of a deformable or flexible material. In some embodiments, the optic portion 102 can be partially made of a deformable or flexible polymer material. For example, the anterior element 106, the posterior element 108, or a combination thereof can be partially made of a deformable or flexible polymer material. One or more haptics 104 (e.g., the first haptic 104A, the second haptic 104B, or a combination thereof) can be partially made of the same deformable or flexible material as the optic portion 102. In other embodiments, one or more haptics 104 can be partially made of a different material than the optic portion 102.

[0095] In some embodiments, the optical portion 102 can be made in part from a cross-linked copolymer comprising a copolymer mixture. The copolymer mixture can include alkyl acrylates or methacrylates, fluoroalkyl (meth)acrylates, and phenyl alkyl acrylates. As contemplated by the present disclosure and understood by those skilled in the art, these types of acrylic cross-linked copolymers can generally be copolymers of multiple acrylates, methacrylates, or combinations thereof, and unless otherwise indicated, the term "acrylate" as used herein can be understood to mean interchangeable acrylates, methacrylates, or combinations thereof. The cross-linked copolymer used to make the optical portion 102 can include or consist in part of an alkyl acrylate in an amount of about 3% to 20% (by weight), a fluoroalkyl acrylate in an amount of about 10% to 35% (by weight), and a phenyl acrylate in an amount of about 50% to 80% (by weight). More specifically, in some embodiments, the cross-linked copolymer can include or consist in part of n-butyl acrylate in an amount of about 3%-20% (by weight) (e.g., about 12%-16%), trifluoroethyl methacrylate in an amount of about 10%-35% (by weight) (e.g., about 17%-21%), and phenylethyl acrylate in an amount of about 50%-80% (by weight) (e.g., about 64%-67%). The final composition of the cross-linked copolymer used to make the optical portion 102 can also include a cross-linker or cross-linking agent, such as ethylene glycol dimethacrylate (EGDMA). For example, the final composition of the cross-linked copolymer can include a cross-linker or cross-linking agent (e.g., EGDMA) in an amount of about 1.0%. The final composition of the cross-linked copolymer used to make the optical portion 102 can also include an initiator or initiator (e.g., Perkadox 16) and a UV absorber.

[0096] One or more haptics 104 may also include or be partially made of a cross-linked copolymer, including a copolymer mixture. The copolymer mixture may include an alkyl acrylate, a fluoroalkyl acrylate, and a phenyl acrylate. For example, the cross-linked copolymer used to make one or more haptics 104 may include or be partially made of an alkyl acrylate in an amount of about 10% to 25% (by weight), a fluoroalkyl acrylate in an amount of about 10% to 35% (by weight), and a phenyl acrylate in an amount of about 50% to 80% (by weight). More specifically, in some embodiments, the cross-linked copolymer may include or be partially made of n-butyl acrylate in an amount of about 10% to 25% (by weight) (e.g., about 19% to about 23%), trifluoroethyl methacrylate in an amount of about 10% to 35% (by weight) (e.g., about 14% to about 18%), and phenylethyl acrylate in an amount of about 50% to 80% (by weight) (e.g., about 58% to about 62%). The final composition of the cross-linked copolymer used to make the one or more haptics 104 may also include a cross-linker or cross-linking agent, such as EGDMA. For example, the one or more haptics 104 may include a cross-linker or cross-linking agent (e.g., EGDMA) in an amount of approximately 1.0%. The one or more haptics 104 may also include a plurality of photoinitiators or photoinitiators.

[0097] In some embodiments, the polymeric or composite material used to make the optic portion 102 can have a refractive index between about 1.48 and about 1.53. In certain embodiments, the polymeric or composite material used to make the optic portion 102 can have a refractive index between about 1.50 and about 1.53 (or about 1.5178).

[0098] The optic portion 102 can be configured to deform, bend, or otherwise change shape in response to fluid entering or exiting the optic fluid cavity 110. The optic portion 102 can be configured to deform, bend, or otherwise change shape due to the material composition (e.g., polymer composition) of the optic portion 102 discussed previously. The one or more haptics 104 can also be configured to deform or otherwise change shape in response to interaction or engagement with the patient's capsular bag when the toric AIOL 100 is implanted in the patient's eye. The one or more haptics 104 can be configured to deform or otherwise change shape due to the material composition (e.g., polymer composition) of the haptics 104 discussed previously.

[0099] In some embodiments, the front element 106 can be configured to deform, bend, or otherwise change shape (e.g., change its curvature) in response to fluid entering or exiting the optics fluid cavity 110. In other embodiments, the rear element 108 can be configured to deform, bend, or otherwise change shape (e.g., change its curvature) in response to fluid entering or exiting the optics fluid cavity 110. In still other embodiments, both the front element 106 and the rear element 108 can be configured to deform, bend, or otherwise change their shape in response to fluid entering or exiting the optics fluid cavity 110.

[0100] In some embodiments, the fluid within the optic fluid cavity 110, the one or more haptic fluid cavities 120, or a combination thereof can be oil. More specifically, in some embodiments, the fluid within the optic fluid cavity 110, the one or more haptic fluid cavities 120, or a combination thereof can be silicone oil or fluid. The fluid can flow between the optic fluid cavity 110 and the one or more haptic fluid cavities 120 in response to deformation, flexure, or shape change by one or more haptics 104, one or more components of the optic portion 102 (e.g., the anterior element 106, the posterior element 108, or a combination thereof), or a combination thereof.

[0101] The fluid within the optic fluid chamber 110, one or more haptic fluid chambers 120, or a combination thereof can be a silicone oil or a fluid comprising or partially consisting of diphenylsiloxane. In other embodiments, the silicone oil or fluid can comprise or partially consist of a ratio of two dimethylsiloxane units to one diphenylsiloxane unit. More specifically, in some embodiments, the silicone oil or fluid can be diphenyltetramethylcyclotrisiloxane. In other embodiments, the silicone oil or fluid can comprise or partially consist of a diphenylsiloxane and dimethylsiloxane copolymer.

[0102] The fluid (e.g., silicone oil) can match the refractive index of the polymeric material or composite material used to make the optical part 102. When the fluid matches the refractive index of the polymeric material or composite material used to make the optical part 102, the entire optical part 102 containing the fluid acts as a single lens. For example, the fluid can be selected so that it has a refractive index between about 1.48 and 1.53 (or between about 1.50 and 1.53, such as about 1.5178). In some embodiments, the fluid (e.g., silicone oil) may have a polydispersity index between about 1.2 and 1.3. In other embodiments, the fluid (e.g., silicone oil) may have a polydispersity index between about 1.3 and 1.5. In other embodiments, the fluid (e.g., silicone oil) may have a polydispersity index of about 1.1 to 1.2. Other exemplary fluids are described in U.S. Patent Publication No. 2018 / 0153682, the entire contents of which are incorporated herein by reference.

[0103] The base optical power of the optic portion 102 can be configured to change in response to shape changes performed by a shape-changing component (e.g., anterior element 106, posterior element 108, or a combination thereof) of the optic portion 102. The optic portion 102 can be configured to change shape in response to physiological muscle movements (e.g., ciliary muscle movements) performed by the patient when the toric AIOL 100 is implanted within the capsular bag of the patient's eye and the toric AIOL 100 deforms or changes shape in response to ciliary muscle-related capsular bag reshaping.

[0104] The toric AIOL 100 can be implanted or introduced into the patient's capsular bag after the natural lens has been removed from the capsular bag. The patient's capsular bag is connected to the zonules, which are connected to the patient's ciliary muscles. The capsular bag is elastic, and ciliary muscle movement can reshape the capsular bag through the zonules. For example, when the ciliary muscles relax, the zonules are stretched. This stretching pulls the capsular bag in a generally radially outward direction due to the radially outward force. This pulling on the capsular bag causes the capsular bag to elongate, thereby creating space within the capsular bag. When the patient's natural lens is present in the capsular bag, the natural lens typically becomes flatter (in the anterior-posterior direction), which reduces the optical power of the lens, thereby allowing distance vision. In this configuration, the patient's natural lens is said to be in an unaccommodated state or experiencing loss of accommodation.

[0105] However, when the ciliary muscle contracts, such as occurs when the eye attempts to focus on a near object, the radially inner portion of the muscle moves radially inward, causing the zonular ligaments to relax. The relaxation of the zonular ligaments allows the elastic capsular bag to contract and exert a radially inward force on the lens within the capsular bag. When the patient's natural lens is present in the capsular bag, the natural lens typically becomes more curved (e.g., the front of the lens becomes more curved), which gives the lens greater optical power, thereby allowing the eye to focus on near objects. In this configuration, the patient's natural lens is said to be in an accommodated state or to have undergone accommodation.

[0106] Therefore, any AIOL implanted in the capsular bag should also have a mechanism that allows the base power of the AIOL to increase when the ciliary muscle contracts and to decrease when the ciliary muscle relaxes.

[0107] In the present case, when the toric AIOL 100 is implanted or otherwise introduced into the patient's natural capsular bag, the radially outer portions 144 of the haptics 104 of the toric AIOL 100 can directly engage or physically contact the portion of the capsular bag that is connected to the zonules or zonule fibers. Thus, the radially outer portions 144 of the haptics 104 can be configured to respond to capsular bag reshaping forces that are radially applied when the zonules relax and stretch due to ciliary muscle movement.

[0108] When the ciliary muscles contract, the peripheral area of ​​the elastic capsular bag reshapes and exerts a radially inward force on the radially outer portions 144 of the haptics 104 (e.g., the elastic capsular bag exerts a radially inward force on the radially outer portions 144 of the first haptic 104A and the radially outer portions 144 of the second haptic 104B). The radially outer portions 144 of the haptics 104 then deform or otherwise change shape, and this deformation or shape change causes the volume of the haptic fluid chamber 120 to decrease. When the volume of the haptic fluid chamber 120 decreases, the fluid within the haptic fluid chamber 120 is displaced or pushed into the optic fluid chamber 110 within the optic portion 102. As previously described, the fluid moves from the haptic fluid chamber 120 to the optic fluid chamber 110 via the fluid channels 122 (e.g., a pair of fluid channels 122) formed within the optic portion 102.

[0109] The optic portion 102 (either the anterior element 106, the posterior element 108, or a combination thereof) can change shape (increase its curvature) in response to fluid entering the optic fluid cavity 110 from the haptic fluid cavity 120. This increases the base optical power or base spherical power of the toric AIOL 100 and allows a patient with the toric AIOL 100 implanted in the patient's eye to focus on near objects. The toric AIOL 100 can also be considered to be in an accommodated state or to have undergone accommodation.

[0110] When the ciliary muscles relax, the peripheral area of ​​the elastic capsular bag stretches radially outward, and the capsular bag elongates, creating more space within the capsular bag. The radially outer portion 144 of the haptics 104 can be configured to respond to the reshaping of the capsular bag by returning to its non-deformed or non-pressurized configuration. This causes the volume of the haptic fluid chamber 120 to increase or return to its non-deformed volume. This increase in the volume of the haptic fluid chamber 120 causes fluid within the optic fluid chamber 110 to be drawn out or flow out of the optic fluid chamber 110 and back into the haptic fluid chamber 120. As previously described, fluid flows from the optic fluid chamber 110 into the haptic fluid chamber 120 through the same fluid channels 122 (e.g., a pair of fluid channels 122) formed within the optic portion 102.

[0111] As previously described, the optic portion 102 (any one of the anterior element 106, the posterior element 108, or a combination thereof) can change shape (reduce its curvature or become flatter) in response to fluid exiting the optic fluid cavity 110 and entering the haptic fluid cavity 120. This reduces the base optical power or base spherical power of the toric AIOL 100 and allows a patient with the toric AIOL 100 implanted in the patient's eye to focus on distant objects or provide distance vision. The toric AIOL 100 can also be considered to be in an unaccommodated state or to have experienced a loss of accommodation.

[0112] like Figure 1B and Figure 1C As shown, the radially inner portion 146 of the haptics 104 can be designed to be thicker or larger (relative to the radially outer portion 144) to provide stiffness or resilience to the haptics 104 in the anterior-posterior direction. Thus, when capsular bag forces are applied to the haptics 104 in the anterior-posterior direction, less deformation and fluid movement occur between the haptic fluid chamber 120 and the optic fluid chamber 110 than when forces are applied in the radial direction. Because less fluid movement occurs, less change in the base optical power of the toric AIOL 100 occurs when forces are applied to the toric AIOL 100 in the anterior-posterior direction. Thus, the design and material properties of the haptics 104 and optic portion 102 can allow the toric AIOL 100 to remain highly sensitive to radial forces applied to the haptics 104 by capsular bag reshaping caused by ciliary muscle movement.

[0113] In some embodiments, the front element 106 can be configured such that the front optical surface 112 changes shape from a spherical configuration to an aspherical configuration in response to fluid entering the optic fluid chamber 110. The aspherical configuration can correct for higher-order aberrations, such as spherical aberration. Fluid can enter the optic fluid chamber 110 from one or more haptic fluid chambers 120 coupled to the optic portion 102 in response to ciliary muscle movement.

[0114] The center or central portion of the front element 106 is larger than the center portion of the front element 106 by the adhesive or adhesive layer 148 (see Figure 1B ) When the outer periphery of the front element 106 retained by the optical element 106 is further bent or bulged outward, the front optical surface 112 can be compressed into an aspheric configuration.

[0115] In other embodiments, the rear element 108 can be configured such that the rear optical surface 116 changes shape from a spherical configuration to an aspherical configuration in response to fluid entering the optic fluid cavity 110 .

[0116] When the center or central portion of the rear element 108 bends or bulges further outward than the outer perimeter of the front element 106 secured by the adhesive or adhesive layer 148, the rear optical surface 116 can be compressed into an aspheric configuration.

[0117] The front element 106 may be attached or otherwise adhered to the rear element 108 by an adhesive layer 148. The adhesive layer 148 may be substantially annular. The adhesive layer 148 may be disposed at a peripheral edge 150 (see FIG. Figure 1C ) at a location between the front element 106 and the rear element 108. For example, the adhesive layer 148 can be disposed on top of the raised inner surface 132 of the rear element 108.

[0118] The adhesive layer 148 or adhesive may include or be made partially of a biocompatible adhesive.The adhesive layer 148 or adhesive may include or be made partially of a biocompatible polymer adhesive.

[0119] The adhesive layer 148 or adhesive may include or be partially made of a crosslinkable polymer precursor formulation. The crosslinkable polymer precursor formulation may include or be partially made of a copolymer mixture, a hydroxyl-functional acrylic monomer, and a photoinitiator (e.g., Darocur 4265 or a 50 / 50 mixture of diphenyl (2,4,6-trimethylbenzoyl) phosphine oxide and 2-hydroxy 2-methylpropiophenone). The copolymer mixture may include an alkyl acrylate (e.g., n-butyl acrylate in an amount of about 41% to about 45% by weight), a fluoroalkyl acrylate (e.g., trifluoroethyl methacrylate in an amount of about 20% to about 24% by weight), and a phenyl alkyl acrylate (phenylethyl acrylate in an amount of about 28% to about 32% by weight). The hydroxyl-functional acrylic monomer may be 2-hydroxyethyl acrylate (HEA) in an amount of about 0.5-5.0 weight percent, preferably about 1.0% to about 2.0 weight percent. A photoinitiator may be used to promote the curing of the hydroxyl-functional prepolymer.

[0120] The first step in preparing the adhesive is to prepare a hydroxyl-functional polymer precursor by photopolymerizing a crosslinkable polymer precursor formulation to produce a cured composition. The second step is to chemically convert the pendant hydroxyl moieties or hydroxyl groups of the precursor polymer into pendant methacrylate functional groups by reaction with methacrylic anhydride or methacryloyl chloride to form a methacrylate-functional crosslinkable polymer, which includes alkyl acrylates or methacrylates (e.g., n-butyl acrylate), fluoroalkyl (meth)acrylates (e.g., trifluoroethyl methacrylate), phenyl-alkyl acrylates (phenethyl acrylate), and 2-(2-methyl-acryloyloxy)ethyl acrylate.

[0121] The methacrylic acid functional crosslinkable polymer can be mixed with a reactive acrylic monomer diluent such as 1-adamantyl methacrylate (ADMA) and the same photoinitiator, such as Darocur 4265. For example, the final composition of the adhesive can include the methacrylic acid functional crosslinkable polymer in an amount of about 50% to about 85% by weight (e.g., about 61% to about 65%), the reactive acrylic monomer diluent in an amount of about 10% to about 40% by weight (32% to about 36%), and the photoinitiator (e.g., Darocur 4265) in an amount of about 2% to about 3% by weight.

[0122] The adhesive or adhesive layer 148 can bond or otherwise connect the anterior element 106 to the posterior element 108. The adhesive can also bond or connect the one or more haptics 104 to the optic portion 102.

[0123] In some embodiments, the anterior optical surface 112 of the anterior element 106 can be manufactured to have an aspheric optical surface prior to implantation of the toric AIOL 100 in the patient's eye. In these embodiments, the anterior optical surface 112 can be aspheric regardless of any fluid pressure changes within the optic fluid cavity 110. In these embodiments, the anterior optical surface 112 can also maintain its asphericity across all base power changes.

[0124] In other embodiments, the posterior optical surface 116 of the posterior element 108 can be manufactured with an aspheric optical surface prior to implantation of the toric AIOL 100 in the patient's eye. In these embodiments, the posterior optical surface 116 can be aspheric regardless of any fluid pressure changes within the optic fluid cavity 110. In these embodiments, the posterior optical surface 116 can maintain its asphericity across all base power changes.

[0125] In some embodiments, the thickness of the front element 106 at its center or central portion may be greater than the thickness at its periphery.In certain embodiments, the rear element 108 may also have a thickness greater than its periphery at its center or central portion.

[0126] like Figure 1B and Figure 1C As shown, the optic portion 102 can have an optical axis 152. The optical axis 152 can extend in the anterior-posterior direction through the center or center point of the optic portion 102. The optical axis 152 can extend through the center or center point of the anterior element 106 and the posterior element 106.

[0127] The thickness of the front element 106 at or near the optical axis 152 can be greater than the thickness at the periphery of the front element 106. In some embodiments, the thickness of the front element 106 can gradually increase from the periphery of the front element 106 toward the optical axis 152.

[0128] In some embodiments, the thickness of the front element 106 at or near the optical axis 152 can be between about 0.200 mm and about 0.300 mm (or about 0.280 mm). In these and other embodiments, the thickness of the front element 106 near the periphery can be between about 0.100 mm and about 0.200 mm (or about 0.135 mm). This thickness difference can help the front optical surface 112 change shape from a spherical configuration to an aspherical configuration as fluid enters the fluid-filled optic fluid cavity 110 from one or more haptic fluid cavities 120.

[0129] Additionally, the anterior interior surface 114 of the anterior element 106 can have less curvature or be flatter than the anterior optical surface 112. This difference in surface curvature between the anterior interior surface 114 and the anterior optical surface 112 can also contribute to the anterior optical surface 112 changing shape from a spherical configuration to an aspherical configuration as fluid enters the fluid-filled optic fluid cavity 110 from the one or more haptic fluid cavities 120.

[0130] In other embodiments, the thickness of the rear element 108 can be greater at or near the optical axis 152 than at a portion of the rear element 108 radially outward from the optical axis 152 but before reaching the raised inner surface 132. The thickness of the rear element 108 can gradually decrease from the optical axis 152 to the portion radially outward from the optical axis 152 but before reaching the raised inner surface 132. The thickness of the rear element 108 can increase again from the beginning of the raised inner surface 132 to the peripheral edge 150.

[0131] In some embodiments, the thickness of the posterior element 108 at or near the optical axis 152 may be between about 0.40 mm and about 0.50 mm (or about 0.43 mm). In these and other embodiments, the thickness of the posterior element 108 radially outward from the optical axis 152 (but before reaching the raised inner surface 132) may be between about 0.30 mm and about 0.40 mm (or about 0.38 mm). The thickness of the posterior element 108 near the peripheral edge 150 may be between about 1.00 mm and 1.20 mm (or about 1.188 mm). This thickness difference may help the posterior optical surface 116 change shape from a spherical configuration to an aspheric configuration when fluid enters the fluid-filled optic fluid cavity 110 from one or more haptic fluid cavities 120.

[0132] Additionally, the posterior interior surface 118 of the posterior element 108 can have less curvature or be flatter than the posterior optical surface 116. This difference in surface curvature between the posterior interior surface 118 and the posterior optical surface 116 can also contribute to the posterior optical surface 116 changing shape from a spherical configuration to an aspherical configuration as fluid enters the fluid-filled optic fluid cavity 110 from the one or more haptic fluid cavities 120.

[0133] One technical problem faced by the applicant is how to introduce both toricity and asphericity into an accommodating intraocular lens. An accommodating intraocular lens that can correct both corneal astigmatism and spherical aberration could allow cataract patients with these higher-order aberrations to rely solely on a pair of accommodating intraocular lenses to correct these aberrations, rather than having to rely on corrective glasses.

[0134] One solution discovered by the applicants is to separate the optical surface configured to become aspheric from the external optical surface having a toric lens surface or a cylindrical surface. For example, the toric AIOL 100 can be configured so that the aspheric optical surface is on the lens element opposite the lens element having a toric optical surface or a cylindrical surface.

[0135] In some embodiments, the posterior element 108 can be shaped to have a toric lens surface or a cylindrical profile, and the anterior element 106 can be configured such that the anterior optical surface 112 is aspherical, or changes shape from a spherical configuration to an aspherical configuration in response to fluid entering the fluid-filled optic fluid cavity 110 from one or more haptic fluid cavities 120.

[0136] In other embodiments, the anterior element 106 can be shaped to have a toric lens surface or a cylindrical profile, and the posterior element 108 can be configured such that the posterior optical surface 116 is aspherical, or changes shape from a spherical configuration to an aspherical configuration in response to fluid entering the fluid-filled optic fluid cavity 110 from one or more haptic fluid cavities 120.

[0137] like Figure 1A As shown, the toric AIOL 100 can be oriented by a midline 154. The midline 154 can be a line or axis that substantially bisects the optic portion 102 or divides the optic portion 102 substantially in half. In some embodiments, the midline 154 can substantially bisect the haptic-optic interface 124 or extend through the middle of the haptic-optic interface 124. For example, the midline 154 can substantially bisect a first haptic-optic interface and a second haptic-optic interface diametrically opposite the first haptic-optic interface. The midline 154 can also extend through or substantially bisect the first stiffening portion 126A and the second stiffening portion 126B.

[0138] As previously described, the optic portion 102 can include at least a pair of fluid channels 122 configured to place a fluid-filled optic fluid lumen 110 in fluid communication with the haptic fluid lumen 120. A centerline 154 can extend between the pair of fluid channels 122 or substantially bisect a portion of the optic portion 102, thereby separating the pair of fluid channels 122.

[0139] In some embodiments, the centerline 154 can extend between a pair of apertures (either the inner aperture 128 or the outer aperture 130) or bisect a portion of the optic portion 102, thereby separating a pair of apertures disposed at the ends of a pair of fluid channels 122. For example, the optic portion 102 can include a first pair of fluid channels 122A and a second pair of fluid channels 122B. The centerline 154 can extend between or substantially bisect the portion separating the first pair of fluid channels 122A and the second pair of fluid channels 122B. The centerline 154 will be discussed in more detail with respect to the orientation or placement of certain meridians of the toric AIOL 100.

[0140] Figure 2A A top view of an embodiment of the posterior element 108 of the toric AIOL 100 is shown. The posterior optical surface 116 can be shaped such that the radius of curvature of the posterior optical surface 116 is different along different optical surface meridians. For example, the radius of curvature along the flat meridian 200 of the posterior optical surface 116 is different from the radius of curvature along the steep meridian 202 of the posterior optical surface 116.

[0141] In some embodiments, the radius of curvature of the posterior optical surface 116 can vary periodically about the posterior optical surface 116. The radius of curvature of the posterior optical surface 116 can vary periodically about the posterior optical surface 116 when the radius of curvature varies continuously in a periodic manner along different optical surface meridians (e.g., as the optical surface meridians rotate about the optical axis 152 or the center point of the posterior optical surface 116). In certain embodiments, the radius of curvature of the posterior optical surface 116 can vary sinusoidally about the posterior optical surface 116.

[0142] like Figure 2A As shown, the posterior optical surface 116 can include a flat meridian 200 and a steep meridian 202 oriented or positioned substantially perpendicular to the flat meridian 200. For example, the flat meridian 200 can be separated from the steep meridian 202 by a rotation angle of approximately 90 degrees.

[0143] Figure 2B A cross-sectional view of the rear element 108 taken along the steep meridian 202 is shown (eg, Figure 2A (shown in section AA). Figure 2C A cross-sectional view of the posterior element 108 taken along a flat meridian 200 is shown (eg, Figure 2A In addition, Figure 2D A cross-sectional view of the rear element 108 taken along the median meridian 204 is shown (eg, Figure 2A ), the median meridian is oriented at a position with an approximately 45 degree rotation angle with respect to the flat meridian 200 and the steep meridian 202.

[0144] The refractive power of the posterior optical surface 116 can be greatest along the steep meridian 202 of the posterior optical surface 116. The refractive power of the posterior optical surface 116 can be least along the flat meridian 200 of the posterior optical surface 116. The steep meridian 202 and the flat meridian 200 can be considered the principal meridians of the lens. The flat meridian 200 can also be referred to as the cylindrical axis of the toric lens or simply the "axis."

[0145] like Figure 2B-2D As shown, the posterior optical surface 116 may include or be defined by a steep meridian radius of curvature (ROC) 206, a flat meridian ROC 208, and an intermediate meridian ROC 210. More specifically, as shown Figure 2B As shown in , the intermediate meridian ROC 210 can be greater than the steep meridian ROC 206. Figure 2B and Figure 2C, the surface profile of the posterior optical surface 116 along the median meridian 204 is shown in dashed lines. In these embodiments, the steep meridian ROC 206 is also smaller than the flat meridian ROC 208.

[0146] like Figure 2C As shown in , the flat meridian ROC 208 can be greater than the mid meridian ROC 210. Additionally, the flat meridian ROC 208 can also be greater than the steep meridian ROC 206.

[0147] like Figures 2A-2D As shown, the radius of curvature of the posterior optical surface 116 can vary sinusoidally around the posterior optical surface 116. For example, the radius of curvature of the posterior optical surface 116 can gradually increase from the steep meridian 202 to the intermediate meridian 204 (when the radius of curvature is viewed along different surface meridians), and then continue to increase until reaching the flat meridian 200. The radius of curvature of the posterior optical surface 116 can then gradually decrease from the flat meridian 200 to the intermediate meridian 204, and then continue to decrease until reaching the steep meridian 202 again after a 180-degree rotation. This periodic variation in the radius of curvature of the posterior optical surface 116 can continue for a full 360 degrees or until returning to the steep meridian 202 again.

[0148] Figure 2B-2D Also shown is that the posterior element thickness 212 can vary along different optical surface meridians. The posterior element thickness 212 can be the thickness or height of the posterior element 108 measured from the posterior inner surface 118 to the posterior optical surface 116.

[0149] The posterior element thickness 212 may vary along different optical surface meridians at or near a radial peripheral portion 214 of the posterior element 108. The radial peripheral portion 214 may be a portion of the posterior element 108 at a peripheral edge of the posterior element 108. In some embodiments, the radial peripheral portion 214 may be a portion of the posterior element 108 between the optical axis 152 and the convex inner surface 132. More specifically, the radial peripheral portion 214 may be a portion of the posterior element 108 that is closer (in terms of radial distance) to the convex inner surface 132 than the optical axis 152.

[0150] In some embodiments, the posterior element thickness 212 can be greatest (or thickest) along the flat meridian 200 at or near the radial peripheral portion 214. In these embodiments, the posterior element thickness 212 can be smallest (or thinnest) along the steep meridian 202 at or near the radial peripheral portion 214. The posterior element thickness 212 can also vary periodically around the posterior element 108 at or near the radial peripheral portion 214 (e.g., as the optical surface meridian rotates about the optical axis 152 or the center point of the posterior optical surface 116). Furthermore, the posterior element thickness 212 can also vary sinusoidally around the posterior element 108 at or near the radial peripheral portion 214.

[0151] In some embodiments, the posterior element thickness 212 at or near the optical axis 152 (or at or near the center point of the posterior optical surface 116) can be the same along different optical surface meridians. For example, the posterior element thickness 212 at or near the optical axis 152 (or at or near the center point of the posterior optical surface 116) can be the same along both the steep meridian 202 and the flat meridian 200.

[0152] In some embodiments, the posterior element thickness 212 can be between about 0.38 mm and about 0.45 mm at or near the radial peripheral portion 214 along the flat meridian 200. In these embodiments, the posterior element thickness 212 along the steep meridian 202 at or near the radial peripheral portion 214 can be between about 0.30 mm and about 0.40 mm.

[0153] The rear element 108 may also include a rear inner surface 118. The rear inner surface 118 may be the surface of the rear element 108 that faces the optics fluid cavity 110. In some embodiments, at least a portion of the rear inner surface 118 may serve as a cavity wall for the optics fluid cavity 110. The rear inner surface 118 may be rotationally symmetric or substantially rotationally symmetric. The rear inner surface 118 may be rotationally symmetric when the radius of curvature of the rear inner surface 118 is the same along all surface meridians. For example, the radius of curvature of the rear inner surface 118 may be between approximately 50.0 mm and 70.0 mm (or approximately 60.0 mm).

[0154] The toric AIOL 100 can also be designed or configured to have a set cylindrical power. Cylinder power can refer to the diopter of the toric AIOL 100 along its steep meridian. Cylinder power is typically expressed as the difference in diopter provided by the steep curvature of the toric lens along its steep meridian (e.g., +1.0D or +3.0D).

[0155] In some embodiments, the toric AIOL 100 having the toric posterior optical surface 116 described previously can have a cylindrical power between approximately +0.75 D and approximately +6.00 D. For example, the toric AIOL 100 having the toric posterior optical surface 116 described previously can have a cylindrical power of approximately +0.75 D, +1.50 D, +2.25 D, +3.00 D, +3.75 D, +4.50 D, +5.25 D, or +6.00 D.

[0156] Table 1 below shows radius of curvature and posterior element thickness values ​​for two versions of a toric AIOL 100 having a toric posterior optical surface 116, each with a different cylindrical power:

[0157] Table 1: Low-cylinder and high-cylinder toric AIOL parameters

[0158]

[0159] As previously mentioned, the base optical power or base spherical power of the optic portion 102 can be configured to change based on the internal fluid pressure within the fluid-filled optic fluid cavity 110. One technical problem faced by applicants is how to introduce cylinder or toricity into an accommodating intraocular lens (AIOL) such that the cylindrical power of the AIOL remains substantially constant or stable across all base power changes throughout the process of lens accommodation or loss of accommodation.

[0160] One solution discovered by the applicant is to vary the radius of curvature of the posterior optical surface 116 while maintaining the rotational symmetry of the posterior inner surface 118 (the surface opposite the posterior optical surface 116). As will be discussed in more detail in the following sections, another solution provided by the present disclosure is to orient the planar meridian 200 of the posterior optical surface 116 at an oblique angle to the midline 154 that substantially bisects the optic portion 102.

[0161] By designing the toric AIOL 100 in this manner, the cylindrical power of the optic portion 102 can be configured to remain substantially constant or stable in response to changes in fluid pressure within the fluid-filled optic fluid cavity throughout changes in the base power of the optic portion 102. For example, the relative refractive power between the steep meridian 202 and the flat meridian 200 can remain substantially constant or stable as the base power of the optic portion 102 changes throughout accommodation and loss of accommodation.

[0162] Figure 2AThe posterior optical surface 116 is also shown to include one or more markings 216 disposed on the posterior optical surface 116. The markings 216 can be visually perceptible to a clinician or physician implanting the toric AIOL 100 in a patient's eye. The one or more markings 216 can be ink markings or dye markings. In other embodiments, the one or more markings 216 can be etchings or surface patterns that appear on the posterior optical surface 116.

[0163] exist Figure 2A In the example embodiment shown, the one or more markings 216 are shown as small dots or spots. In other embodiments, the one or more markings 216 can be in the form of lines, dashed lines, or other shapes other than dots. The one or more markings 216 can help the clinician or physician orient the plana meridian 200 or the cylindrical axis relative to markings previously applied to the patient's eye to indicate the patient's corneal astigmatism. For example, the clinician or physician can align the one or more markings 216 with markings used to indicate the patient's corneal astigmatism to ensure that the toric AIOL 100 is correctly implanted.

[0164] In some embodiments, the anterior optical surface 112 of the toric AIOL 100 can be rotationally symmetric, while the posterior optical surface 116 can be toric or have different radii of curvature along different optical surface meridians. In other embodiments, as previously described, the anterior optical surface 112 of the toric AIOL 100 can be aspheric, while the posterior optical surface 116 can be toric or have different radii of curvature along different optical surface meridians.

[0165] Figure 3A A top view of an embodiment of an anterior element 106 of a toric AIOL 100 is shown. In this embodiment, the anterior element 106 can be shaped such that the radius of curvature of the anterior optical surface 112 is different along different optical surface meridians. For example, the radius of curvature along the flat meridian 300 of the anterior optical surface 112 is different from the radius of curvature along the steep meridian 302 of the anterior optical surface 112.

[0166] In some embodiments, the radius of curvature of the anterior optical surface 112 can vary periodically about the anterior optical surface 112. The radius of curvature of the anterior optical surface 112 can vary periodically about the anterior optical surface 112 when the radius of curvature varies continuously in a periodic manner along different optical surface meridians (e.g., as the optical surface meridians rotate about the optical axis 152 or the center point of the anterior optical surface 112). In certain embodiments, the radius of curvature of the anterior optical surface 112 can vary sinusoidally about the anterior optical surface 112.

[0167] like Figure 3AAs shown, the anterior optical surface 112 can include a flat meridian 300 and a steep meridian 302 oriented or positioned substantially perpendicular to the flat meridian 300. For example, the flat meridian 300 can be separated from the steep meridian 302 by a rotation angle of approximately 90 degrees.

[0168] Figure 3B A cross-sectional view of the front element 106 taken along the steep meridian 302 is shown (eg, Figure 3A (shown in section AA). Figure 3C A cross-sectional view of the same anterior element 106 is shown along the flat meridian 300 (eg, Figure 3A BB).

[0169] The refractive power of the anterior optical surface 112 can be greatest along the steep meridian 302 of the anterior optical surface 112, and the refractive power of the anterior optical surface 112 can be least along the flat meridian 300 of the anterior optical surface 112. The steep meridian 302 and the flat meridian 300 can be considered the principal meridians of the lens. The flat meridian 300 can also be referred to as the cylindrical axis of the toric lens or simply the "axis."

[0170] like Figure 3B-3C As shown, the anterior optical surface 112 can include or be defined by a steep meridian radius of curvature (ROC) 304 and a flat meridian ROC 306. The flat meridian ROC 306 can be larger than the steep meridian ROC 304.

[0171] like Figure 3A-3C As shown, the radius of curvature of the anterior optical surface 112 can vary sinusoidally around the anterior optical surface 112. For example, the radius of curvature of the anterior optical surface 112 can gradually increase from the steep meridian 302 to the intermediate meridian (i.e., a meridian oriented at a rotation angle of approximately 45 degrees from both the planar meridian 300 and the steep meridian 302), and then continue to increase until reaching the planar meridian 300. The radius of curvature of the anterior optical surface 112 can then gradually decrease from the planar meridian 300 to the intermediate meridian, and then continue to decrease until reaching the steep meridian 302 again after rotating 180 degrees. This periodic variation in the radius of curvature of the anterior optical surface 112 can continue for a full 360 degrees or until returning to the steep meridian 302.

[0172] Figure 3B and Figure 3C Also shown is that the anterior element thickness 308 can vary along different optical surface meridians.The anterior element thickness 308 can be the thickness or height of the anterior element 106 measured from the anterior interior surface 114 to the anterior optical surface 112.

[0173] Anterior element thickness 308 at or near radial peripheral portion 310 of anterior element 106 can vary along different optical surface meridians. Radial peripheral portion 310 can be a portion of anterior element 106 at a peripheral edge of anterior element 106. In some embodiments, radial peripheral portion 310 can be a portion of anterior element 106 between optical axis 152 and adhesive layer 148. More specifically, radial peripheral portion 310 can be a portion of anterior element 106 that is closer (in terms of radial distance) to adhesive layer 148 than optical axis 152.

[0174] In some embodiments, the anterior element thickness 308 at or near the radial peripheral portion 310 can be greatest (or thickest) along the flat meridian 300. In these embodiments, the anterior element thickness 308 at or near the radial peripheral portion 310 can be least (or thinnest) along the steep meridian 302. The anterior element thickness 308 at or near the radial peripheral portion 310 can also vary periodically around the anterior element 106 (e.g., as the optical surface meridian rotates about the optical axis 152 or the center point of the anterior optical surface 112). For example, the anterior element thickness 308 can vary sinusoidally around the anterior element 106.

[0175] In certain embodiments, the front element thickness 308 at or near the optical axis 152 (or at or near the center point of the front optical surface 112) can be the same along different optical surface meridians. For example, the front element thickness 308 at or near the optical axis 152 (or at or near the center point of the front optical surface 112) can be the same along both the steep meridian 302 and the flat meridian 300. In one embodiment, the front element thickness 308 at or near the optical axis 152 can be approximately 0.40 mm.

[0176] In some embodiments, the front element thickness 308 at or near the radial peripheral portion 310 along the flat meridian 300 can be between about 0.140 mm and about 0.210 mm. In these embodiments, the front element thickness 308 at or near the radial peripheral portion 310 along the steep meridian 302 can be between about 0.050 mm and about 0.125 mm.

[0177] The front element 106 may also include a front inner surface 114. The front inner surface 114 may be the surface of the front element 106 that faces the optics fluid cavity 110. In some embodiments, at least a portion of the front inner surface 114 may serve as a cavity wall of the optics fluid cavity 110. The front inner surface 114 may be rotationally symmetric or substantially rotationally symmetric. The front inner surface 114 may be rotationally symmetric when the radius of curvature of the front inner surface 114 is the same along all surface meridians. For example, the radius of curvature of the front inner surface 114 may be between approximately 50.0 mm and 70.0 mm (or approximately 60.0 mm).

[0178] The toric AIOL 100 can also be designed or configured to have a set cylindrical power. Cylinder power can refer to the diopter of the toric AIOL 100 along the steep meridian 302. Cylinder power is typically expressed as the difference in diopter provided by the steep curvature of the toric lens along its steep meridian (e.g., +1.0D or +3.0D).

[0179] In some embodiments, the toric AIOL 100 having the toric front optical surface 112 described previously can have a cylindrical power of approximately +0.75 D to approximately +6.00 D. For example, the toric AIOL 100 having the toric front optical surface 112 described previously can have a cylindrical power of approximately +0.75 D, +1.50 D, +2.25 D, +3.00 D, +3.75 D, +4.50 D, +5.25 D, or +6.00 D.

[0180] Table 2 below shows radius of curvature and anterior element thickness values ​​for two versions of a toric AIOL 100 having a toric anterior optical surface 112, each with a different cylindrical power:

[0181] Table 2: Low-cylinder and high-cylinder toric AIOL parameters

[0182]

[0183] As previously mentioned, the base optical power or base spherical power of the optic portion 102 can be configured to change based on the internal fluid pressure within the fluid-filled optic fluid cavity 110. One technical problem faced by applicants is how to introduce cylinder or toricity into an accommodating intraocular lens (AIOL) such that the cylindrical power of the AIOL remains substantially constant or stable across all base power changes throughout the process of lens accommodation or loss of accommodation.

[0184] One solution discovered by the applicant is to vary the radius of curvature of the anterior optical surface 112 while maintaining the rotational symmetry of the anterior inner surface 114 (the surface opposite the anterior optical surface 112). As will be discussed in more detail in the following sections, another solution provided by the present disclosure is to orient the planar meridian 300 of the anterior optical surface 112 at an oblique angle to the midline 154 that substantially bisects the optic portion 102.

[0185] By designing the toric AIOL 100 in this manner, the cylindrical power of the optic portion 102 can be configured to remain substantially constant or stable in response to changes in fluid pressure within the fluid-filled optic fluid cavity throughout changes in the base power of the optic portion 102. For example, the relative refractive power between the steep meridian 302 and the flat meridian 300 can remain substantially constant or stable as the base power of the optic portion 102 changes throughout accommodation and loss of accommodation.

[0186] Figure 3A Also shown is that the anterior optical surface 112 can include one or more markings 312 disposed on the anterior optical surface 112. The markings 312 can be visually perceptible to a clinician or physician implanting the toric AIOL 100 into a patient's eye. The one or more markings 312 can be ink markings or dye markings. In other embodiments, the one or more markings 312 can be etchings or surface patterns that appear on the anterior optical surface 112.

[0187] exist Figure 3A In the example embodiment shown, the one or more markings 312 are shown as small dots or spots. In other embodiments, the one or more markings 312 can be in the form of lines, dashed lines, or other shapes other than dots. The one or more markings 312 can help the clinician or physician orient the plana meridian 300 or the cylindrical axis relative to markings previously applied to the patient's eye to mark the patient's corneal astigmatism. For example, the clinician or physician can align the one or more markings 312 with markings used to indicate the patient's corneal astigmatism to ensure that the toric AIOL 100 is properly implanted.

[0188] In some embodiments, the posterior optical surface 116 of the toric AIOL 100 can be rotationally symmetric, while the anterior optical surface 112 can be toric or have different radii of curvature along different optical surface meridians. In other embodiments, as previously described, the posterior optical surface 116 of the toric AIOL 100 can be aspheric, while the anterior optical surface 112 can be toric or have different radii of curvature along different optical surface meridians.

[0189] Figure 4The cylindrical orientation of the flat meridian relative to the midline 154 of the toric AIOL 100 is shown. Cylinder orientation can refer to the orientation or location of the lens meridian relative to one or more other features of the toric AIOL 100, such as the midline 154. For example, cylinder orientation can refer to the orientation or location of the flat meridian (or "cylindrical axis"), the steep meridian, or a combination thereof relative to the eye. Cylinder orientation can also refer to the orientation or location of one meridian relative to another meridian.

[0190] although Figure 4 It is shown relative to the posterior element 108 and the posterior optical surface 116 (including the flat meridian 200 and the steep meridian 202), but as is contemplated by the present disclosure and understood by those skilled in the art, the flat meridian 300 and the steep meridian 302 of the anterior optical surface 112 may also be oriented at an oblique angle 400 relative to the midline 154.

[0191] One technical problem faced by applicants is how to maintain a substantially constant or fixed cylindrical orientation of a toric AIOL across all base power changes, i.e., throughout the process of accommodation or loss of accommodation. An unstable cylindrical orientation is at best unhelpful (i.e., no astigmatism correction effect) and at worst may adversely affect the patient's vision (e.g., by inducing astigmatism in another meridian).

[0192] One solution discovered by applicants is to orient a planar meridian (e.g., either planar meridian 200 or planar meridian 300) at an oblique angle 400 to midline 154. As previously mentioned, in some embodiments, midline 154 can substantially bisect optic portion 102. For example, midline 154 can be a line or axis that substantially bisects optic portion 102 or divides optic portion 102 into two halves.

[0193] In other embodiments, the midline 154 may substantially bisect the haptic-optic interface 124 or extend through the middle of the haptic-optic interface 124. For example, the midline 154 may substantially bisect the first haptic-optic interface and the second haptic-optic interface (when the toric AIOL 100 has two haptics 104).

[0194] The centerline 154 may also extend through or substantially bisect the reinforcement portion 126. For example, the centerline 154 may extend through or substantially bisect the first reinforcement portion 126A and the second reinforcement portion 126B.

[0195] As previously described, the optic portion can include at least one pair of fluid channels 122 configured to place a fluid-filled optic fluid lumen 110 in fluid communication with the haptic fluid lumen 120. A centerline 154 can extend between the pair of fluid channels 122 or substantially bisect a portion of the optic portion 102, thereby separating the pair of fluid channels 122. In some embodiments, the centerline 154 can extend between a pair of apertures (e.g., inner apertures 128) or bisect a portion of the optic portion 102, thereby separating a pair of apertures (e.g., inner apertures 128) disposed at the ends of the pair of fluid channels 122. For example, the optic portion 102 can include a first pair of fluid channels 122A and a second pair of fluid channels 122B, and the centerline 154 can extend between or substantially bisect a portion of the optic portion 102, thereby separating the first pair of fluid channels 122A and the second pair of fluid channels 122B.

[0196] The applanation meridian (either applanation meridian 200 or applanation meridian 300) can be oriented or otherwise positioned at an oblique angle 400 relative to the midline 154. In some embodiments, the oblique angle 400 can be a clockwise angle. For example, the oblique angle 400 can be a clockwise angle between approximately 30 and 60 degrees. In some embodiments, the oblique angle can be a clockwise angle of approximately 45 degrees. As previously described, the applanation meridian 200 can be oriented substantially perpendicular to the steep meridian 202 or at a 90-degree angle thereto.

[0197] By designing the toric AIOL 100 in this manner, the cylindrical orientation of the optic portion 102 can remain substantially constant throughout changes in the base optical power of the optic portion 102 caused by changes in the internal fluid pressure within the fluid-filled optic fluid cavity 110. For example, once the toric AIOL 100 is implanted in a patient's eye, the orientation or positioning of the flat meridian and the steep meridian of the toric AIOL 100 can remain substantially constant or fixed relative to the axis of corneal astigmatism of the patient's eye (even as the base optical power of the optic portion changes throughout accommodation and loss of accommodation).

[0198] Figure 5 is a graph showing the change in specific optical power of a toric AIOL 100 as a function of internal fluid pressure within the optic fluid cavity 110. Figure 5 As shown, the base optical power of the toric AIOL 100 (or the ability of the toric AIOL 100 to resolve defocus aberrations) is highly responsive to changes in fluid pressure within the fluid-filled optic fluid cavity 110. As the internal fluid pressure within the fluid-filled optic fluid cavity 110 increases, the base optical power of the toric AIOL 100 increases.

[0199] Figure 5 It also illustrates that the cylindrical power of the toric AIOL 100 remains relatively constant and stable despite changes in fluid pressure within the fluid-filled optic fluid cavity 110. Furthermore, the ability of the toric AIOL 100 to correct spherical aberration also remains relatively constant despite changes in fluid pressure within the fluid-filled optic fluid cavity 110.

[0200] Figure 6 is a graph showing cylinder stability as cylinder axis placement varies. For different versions of the toric AIOL 100 with different cylinder axis placement angles, any changes in cylinder orientation (expressed as the degree of "toric rotation" along the y-axis) were recorded. All of these versions of the toric AIOL 100 were subjected to axial loading and unloading using finite element analysis. Figure 6 As shown, all cylinder axis (i.e., flat meridian) placement angles are measured as clockwise rotation angles relative to the midline 154 of the toric AIOL 100. The preferred cylinder axis orientation (i.e., cylinder axis placement angles) is one that maintains cylindrical stability throughout all stages of lens accommodation and loss of accommodation.

[0201] like Figure 6 As can be seen in FIG, a toric AIOL 100 having a cylindrical axis disposition angle of +45 degrees relative to midline exhibits almost 0 degrees of toric rotation (or little change in cylindrical orientation) despite being subjected to axial loading and unloading.

[0202] The present invention discloses a toric accommodative intraocular lens comprising an optic portion including an anterior element having an anterior optical surface, a posterior element having a posterior optical surface, and a fluid-filled optic fluid cavity defined between the anterior element and the posterior element, wherein at least one of the anterior optical surface and the posterior optical surface is shaped such that the radius of curvature of the at least one of the anterior optical surface and the posterior optical surface is different along different optical surface meridians.

[0203] According to the toric accommodating intraocular lens disclosed herein, the posterior optical surface is shaped such that the radius of curvature of the posterior optical surface is different along different optical surface meridians of the posterior optical surface.

[0204] According to the toric accommodating intraocular lens disclosed herein, the radius of curvature of the posterior optical surface varies periodically around the posterior optical surface.

[0205] According to the toric accommodating intraocular lens disclosed herein, the posterior element further comprises a posterior inner surface.

[0206] According to the toric accommodating intraocular lens disclosed herein, the posterior inner surface is rotationally symmetric.

[0207] According to the toric accommodating intraocular lens disclosed herein, the posterior element has a posterior element thickness measured from the posterior optical surface to the posterior inner surface, wherein the posterior element thickness varies periodically around the posterior element.

[0208] According to the toric accommodating intraocular lens disclosed herein, the anterior optical surface is aspheric.

[0209] According to the toric accommodating intraocular lens disclosed herein, the anterior optical surface is shaped such that the radius of curvature of the anterior optical surface is different along different optical surface meridians of the anterior optical surface.

[0210] According to the toric accommodating intraocular lens disclosed herein, the radius of curvature of the anterior optical surface varies periodically around the anterior optical surface.

[0211] According to the toric accommodating intraocular lens disclosed herein, the anterior element further comprises an anterior inner surface.

[0212] According to the toric accommodating intraocular lens disclosed herein, the anterior inner surface is rotationally symmetric.

[0213] According to the toric accommodating intraocular lens disclosed herein, the anterior element has an anterior element thickness measured from the anterior optical surface to the anterior inner surface, wherein the anterior element thickness varies periodically around the anterior element.

[0214] According to the toric accommodating intraocular lens disclosed herein, the posterior optical surface is aspheric.

[0215] According to the toric accommodating intraocular lens disclosed herein, the base optical power of the optic portion is configured to vary based on the pressure within the fluid cavity of the fluid-filled optic.

[0216] According to the toric accommodating intraocular lens disclosed herein, the cylindrical optical power of the optic is configured to remain substantially constant throughout changes in the base optical power of the optic in response to changes in pressure within the fluid cavity of the fluid-filled optic.

[0217] According to the toric accommodating intraocular lens disclosed herein, the cylindrical orientation of the optic is configured to remain substantially constant throughout changes in the base optical power of the optic in response to changes in pressure within the fluid cavity of the fluid-filled optic.

[0218] According to the toric accommodating intraocular lens disclosed herein, at least one of the anterior optical surface and the posterior optical surface includes a flat meridian and a steep meridian oriented substantially perpendicular to the flat meridian, and wherein the radius of curvature is smallest along the steep meridian and the radius of curvature is largest along the flat meridian.

[0219] According to the toric accommodating intraocular lens disclosed herein, the planar meridian is oriented at an oblique angle relative to a midline that substantially bisects the optic portion.

[0220] According to the toric accommodating intraocular lens disclosed herein, the tilt angle is a clockwise rotation angle of between approximately 30 degrees and 60 degrees.

[0221] According to the toric accommodating intraocular lens disclosed herein, the tilt angle is a clockwise rotation angle of about 45 degrees.

[0222] According to the toric accommodating intraocular lens disclosed herein, further comprising a first haptic coupled to the optic portion at a first haptic-optic interface and a second haptic coupled to the optic portion at a second haptic-optic interface diametrically opposed to the first haptic-optic interface, and wherein the midline substantially bisects the first haptic-optic interface and the second haptic-optic interface.

[0223] According to the toric accommodating intraocular lens disclosed herein, the optic portion includes a first pair of fluid channels configured to place the fluid-filled optic fluid chamber in fluid communication with a haptic fluid chamber and a second pair of fluid channels configured to place the fluid-filled optic fluid chamber in fluid communication with another haptic fluid chamber, and wherein the midline extends between the first pair of fluid channels and between the second pair of fluid channels.

[0224] Also disclosed is a toric accommodative intraocular lens comprising an optic portion including an outer optical surface and a fluid-filled optic fluid cavity defined within the optic portion, wherein the refractive power of the outer optical surface is greatest along a steep meridian of the outer optical surface and the refractive power of the outer optical surface is least along a flat meridian of the outer optical surface.

[0225] According to the toric accommodating intraocular lens disclosed herein, the base optical power of the optic portion is configured to vary based on the pressure within the fluid cavity of the fluid-filled optic.

[0226] According to the toric accommodating intraocular lens disclosed herein, the relative refractive power between the flat meridian and the steep meridian is configured to remain substantially constant throughout the process of changing the base optical focal length of the optical member in response to changes in pressure within the fluid cavity of the fluid-filled optical member.

[0227] According to the toric accommodating intraocular lens disclosed herein, the orientation of the flat meridian is configured to remain substantially constant throughout changes in the base optical power of the optic portion in response to changes in pressure within the fluid-filled optic fluid cavity.

[0228] According to the toric accommodating intraocular lens disclosed herein, the other optical surface opposite to the outer optical surface is aspherical.

[0229] According to the toric accommodating intraocular lens disclosed herein, the planar meridian is oriented at an oblique angle relative to a midline that substantially bisects the optic portion.

[0230] According to the toric accommodating intraocular lens disclosed herein, the tilt angle is a clockwise rotation angle of between approximately 30 degrees and 60 degrees.

[0231] According to the toric accommodating intraocular lens disclosed herein, the tilt angle is a clockwise rotation angle of about 45 degrees.

[0232] According to the toric accommodating intraocular lens disclosed herein, further comprising a first haptic coupled to the optic portion at a first haptic-optic interface and a second haptic coupled to the optic portion at a second haptic-optic interface diametrically opposed to the first haptic-optic interface, and wherein the midline substantially bisects the first haptic-optic interface and the second haptic-optic interface.

[0233] According to the toric accommodating intraocular lens disclosed herein, the optic portion includes a first pair of fluid channels configured to place the fluid-filled optic fluid chamber in fluid communication with a haptic fluid chamber and a second pair of fluid channels configured to place the fluid-filled optic fluid chamber in fluid communication with another haptic fluid chamber, and wherein the midline extends between the first pair of fluid channels and between the second pair of fluid channels.

[0234] Also disclosed is a toric accommodating intraocular lens comprising: a shape changing optic portion including an outer optical surface, wherein the refractive power of the outer optical surface is greatest along a steep meridian of the outer optical surface and the refractive power of the outer optical surface is least along a flat meridian of the outer optical surface, and wherein a base optical power of the optic portion is configured to change in response to a shape change by the shape changing optic portion.

[0235] According to the toric accommodating intraocular lens disclosed herein, the shape changing optic is configured to change shape in response to physiological muscle movements performed by the patient when the toric accommodating intraocular lens is implanted in the patient.

[0236] According to the toric accommodating intraocular lens disclosed herein, the relative refractive power between the flat meridian and the steep meridian is configured to remain substantially constant throughout the process of changing the base optical power of the optic portion.

[0237] According to the toric accommodating intraocular lens disclosed herein, the orientation of the flat meridian is configured to remain substantially unchanged throughout a change in the base optical power of the optic portion.

[0238] According to the toric accommodating intraocular lens disclosed herein, the other optical surface opposite to the outer optical surface is aspherical.

[0239] According to the toric accommodating intraocular lens disclosed herein, the planar meridian is oriented at an oblique angle relative to a midline that substantially bisects the optic portion.

[0240] According to the toric accommodating intraocular lens disclosed herein, the tilt angle is a clockwise rotation angle of between approximately 30 degrees and 60 degrees.

[0241] According to the toric accommodating intraocular lens disclosed herein, the tilt angle is a clockwise rotation angle of about 45 degrees.

[0242] According to the toric accommodating intraocular lens disclosed herein, further comprising a first haptic coupled to the optic portion at a first haptic-optic interface and a second haptic coupled to the optic portion at a second haptic-optic interface diametrically opposed to the first haptic-optic interface, and wherein the midline substantially bisects the first haptic-optic interface and the second haptic-optic interface.

[0243] According to the toric accommodating intraocular lens disclosed herein, the radius of curvature of the external optical surface is smallest along the steep meridian, and the radius of curvature of the external optical surface is largest along the flat meridian.

[0244] A number of embodiments have been described. However, it will be understood by those skilled in the art that various changes and modifications may be made to the present disclosure without departing from the spirit and scope of the embodiments. The elements of the systems, devices, apparatuses and methods shown in any embodiment are exemplary for a particular embodiment and may be used in combination or otherwise used on other embodiments within the present disclosure. For example, the steps of any method depicted in the accompanying drawings or described in this disclosure do not require the specific order or sequential order shown or described to achieve the desired results. In addition, other step operations may be provided, or steps or operations may be eliminated or omitted from the described methods or processes to achieve the desired results. In addition, any component or portion of any device or system described in this disclosure or depicted in the accompanying drawings may be removed, eliminated or omitted to achieve the desired results. In addition, for the sake of brevity and clarity, some components or portions of the systems, apparatus or equipment shown or described herein have been omitted.

[0245] Accordingly, other embodiments are within the scope of the following claims, and the specification and / or drawings are to be regarded as illustrative rather than restrictive.

[0246] Each individual variation or embodiment described and illustrated herein has discrete components and features that may be readily separated or combined with the features of any other variation or embodiment. Modifications may be made to adapt a particular situation, material, composition of matter, process, one or more process actions, or one or more steps to one or more of the objectives, spirit, or scope of the present invention.

[0247] The methods recited herein may be performed in any logically possible order of the recited events, as well as in the recited order of events. In addition, additional steps or operations may be provided, or steps or operations may be eliminated to achieve the desired results.

[0248] Furthermore, where a range of values ​​is provided, each intervening value between the upper and lower limits of that range and any other specified or intermediate value within the stated range is included within the invention. Furthermore, any optional features of the described variations of the invention may be set forth and claimed independently or in combination with any one or more of the features described herein. For example, a description of a range from 1 to 5 should be considered to have disclosed subranges such as from 1 to 3, from 1 to 4, from 2 to 5, from 3 to 5, etc., as well as individual numbers within that range, such as 1.5, 2.5, etc., and any full or partial increments therebetween.

[0249] All prior subject matter (e.g., publications, patent applications) mentioned herein are incorporated by reference in their entirety, except to the extent that such subject matter may conflict with the subject matter of the present invention (in which case the content presented herein will control). The cited items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.

[0250] Reference to a singular item includes the possibility that there are multiple identical items. More specifically, as used herein and in the appended claims, the singular forms "a," "an," "said," and "the" include plural referents unless the context clearly dictates otherwise. It should also be noted that the claims can be drafted to exclude any optional elements. Therefore, this statement is intended to serve as a reference basis for the use of exclusive terms such as "solely," "only," etc., or the use of a "negative" limitation in connection with the recitation of claim elements. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs.

[0251] When the phrase "at least one of" modifies multiple items or components (or an enumerated list of items or components), the reference to the phrase "at least one of" means any combination of one or more of those items or components. For example, the phrase "at least one of A, B, and C" means: (i) A; (ii) B; (iii) C; (iv) A, B, and C; (v) A and B; (vi) B and C; or (vii) A and C.

[0252] In understanding the scope of the present disclosure, the terms "comprises" and their derivatives as used herein are intended to be open-ended terms that specify the presence of stated features, elements, parts, assemblies, wholes and / or steps, but do not exclude the presence of other unstated features, elements, parts, assemblies, wholes and / or steps. The foregoing also applies to words with similar meanings, such as the terms "comprises," "having" and their derivatives. In addition, the terms "part," "segment," "portion," "member," "element," or "assembly" when used in the singular may have the dual meaning of a single part or a plurality of parts. As used herein, the following directional terms "forward, backward, above, downward, vertical, horizontal, below, transverse, lateral, and vertical" and any other similar directional terms refer to those positions of a device or piece of equipment or those directions in which a device or piece of equipment is translated or moved.

[0253] Finally, as used herein, terms of degree such as "substantially," "about," and "approximately" refer to a specified value or a specified value and a reasonable amount of deviation therefrom (e.g., up to ±0.1%, ±1%, ±5%, or ±10%, so long as such variations are appropriate) such that the end result is not significantly or substantially changed. For example, "about 1.0 cm" can be interpreted to mean "1.0 cm" or "between 0.9 cm and 1.1 cm." When terms of degree such as "about" or "approximately" are used to refer to a number or value that is part of a range, the term can be used to modify the minimum and maximum number or value.

[0254] The present disclosure is not intended to be limited to the scope of the particular forms set forth, but is intended to cover alternatives, modifications, and equivalents of the variations or embodiments described herein. In addition, the scope of the present disclosure fully encompasses other variations or embodiments that may become apparent to those skilled in the art in light of this disclosure.

Claims

1. A toric accommodative intraocular lens comprising: an optic portion comprising a front element having a front optical surface, a rear element having a rear optical surface, and a fluid-filled optic fluid cavity defined between the front element and the rear element, wherein the posterior optical surface is shaped such that a radius of curvature of the posterior optical surface is different along different optical surface meridians, and wherein the posterior element has a posterior element thickness measured from the posterior optical surface to the posterior interior surface, wherein the posterior element thickness varies periodically around the posterior element.

2. The toric accommodating intraocular lens of claim 1 wherein the radius of curvature of the posterior optical surface varies periodically around the posterior optical surface.

3. The toric accommodating intraocular lens of claim 1 , wherein the posterior element further comprises a rotationally symmetric posterior inner surface.

4. The toric accommodating intraocular lens of claim 1 , wherein the anterior optical surface is aspheric.

5. The toric accommodating intraocular lens of claim 1 wherein the anterior optical surface is shaped such that a radius of curvature of the anterior optical surface is different along different optical surface meridians of the anterior optical surface.

6. The toric accommodating intraocular lens of claim 5, wherein the radius of curvature of the anterior optical surface varies periodically around the anterior optical surface.

7. The toric accommodating intraocular lens of claim 6, wherein the anterior element further comprises a rotationally symmetric anterior inner surface.

8. The toric accommodating intraocular lens of claim 7, wherein the anterior element has an anterior element thickness measured from the anterior optical surface to the anterior inner surface, wherein the anterior element thickness varies periodically around the anterior element.

9. The toric accommodating intraocular lens of claim 5, wherein the posterior optical surface is aspheric.

10. The toric accommodating intraocular lens of claim 1, wherein the base optical power of the optic portion is configured to change based on the pressure within the fluid-filled optic fluid cavity.

11. The toric accommodating intraocular lens of claim 10, wherein the cylindrical optical power of the optic portion is configured to remain constant throughout changes in the base optical power of the optic portion in response to changes in pressure within the fluid-filled optic fluid cavity.

12. The toric accommodating intraocular lens of claim 10, wherein the cylindrical orientation of the optic portion is configured to remain constant throughout changes in the base optical power of the optic portion in response to changes in pressure within the fluid-filled optic fluid cavity.

13. The toric accommodating intraocular lens of claim 1 , wherein at least one of the anterior optical surface and the posterior optical surface comprises a flat meridian and a steep meridian oriented perpendicular to the flat meridian, and wherein the radius of curvature is smallest along the steep meridian and the radius of curvature is largest along the flat meridian.

14. The toric accommodating intraocular lens of claim 13, wherein the planar meridian is oriented at an oblique angle relative to a midline bisecting the optic portion.

15. The toric accommodating intraocular lens of claim 14, wherein the tilt angle is a clockwise rotation angle between 30 degrees and 60 degrees.

16. The toric accommodating intraocular lens of claim 14 further comprising a first haptic coupled to the optic portion at a first haptic-optic interface and a second haptic coupled to the optic portion at a second haptic-optic interface diametrically opposed to the first haptic-optic interface, and wherein the midline bisects the first haptic-optic interface and the second haptic-optic interface.

17. The toric accommodating intraocular lens of claim 14, wherein the optic portion includes a first pair of fluid channels configured to place the fluid-filled optic fluid chamber in fluid communication with a haptic fluid chamber and a second pair of fluid channels configured to place the fluid-filled optic fluid chamber in fluid communication with another haptic fluid chamber, and wherein the midline extends between the first pair of fluid channels and between the second pair of fluid channels.

18. A toric accommodating intraocular lens comprising: an optic portion comprising an exterior optical surface and a fluid-filled optic fluid cavity defined within the optic portion, wherein the refractive power of the external optical surface is greatest along a steep meridian of the external optical surface, and the refractive power of the external optical surface is least along a flat meridian of the external optical surface, and wherein the relative refractive power between the flat meridian and the steep meridian is configured to remain constant throughout a change in the base optical power of the optic portion in response to a change in pressure within a fluid cavity of the fluid-filled optic.

19. The toric accommodating intraocular lens of claim 18, wherein the orientation of the flat meridian is configured to remain constant throughout changes in the base optical power of the optic portion in response to changes in pressure within the fluid-filled optic fluid cavity.

20. The toric accommodating intraocular lens of claim 18, wherein another optical surface opposite the outer optical surface is aspherical.

21. The toric accommodating intraocular lens of claim 18, wherein the planar meridian is oriented at an oblique angle relative to a midline bisecting the optic portion.

22. The toric accommodating intraocular lens of claim 21 further comprising a first haptic coupled to the optic portion at a first haptic-optic interface and a second haptic coupled to the optic portion at a second haptic-optic interface diametrically opposed to the first haptic-optic interface, and wherein the midline bisects the first haptic-optic interface and the second haptic-optic interface.

23. The toric accommodating intraocular lens of claim 21 , wherein the optic portion includes a first pair of fluid channels configured to place the fluid-filled optic fluid chamber in fluid communication with a haptic fluid chamber and a second pair of fluid channels configured to place the fluid-filled optic fluid chamber in fluid communication with another haptic fluid chamber, and wherein the midline extends between the first pair of fluid channels and between the second pair of fluid channels.

24. A toric accommodating intraocular lens comprising: shape-changing optical portion comprising an external optical surface, wherein the refractive power of the external optical surface is greatest along a steep meridian of the external optical surface and the refractive power of the external optical surface is smallest along a flat meridian of the external optical surface, wherein a base optical power of the optic portion is configured to change in response to a shape change by the shape changing optic portion, and Wherein the relative refractive power between the flat meridian and the steep meridian is configured to remain constant throughout a process of changing the base optical power of the optic portion.

25. The toric accommodating intraocular lens of claim 24, wherein the shape changing optic portion is configured to change shape in response to physiological muscle movements performed by a patient when the toric accommodating intraocular lens is implanted in the patient.

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