Accommodative intraocular lens and method of use thereof

Abstract

To provide accommodating intraocular lenses.SOLUTION: The invention relates to accommodating intraocular lenses and methods of use. The accommodating intraocular lenses include peripheral regions that are adapted to be more responsive to certain types of forces than to other types of forces.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] This application claims the benefit of U.S. Provisional Application No. 61 / 557,237, filed November 8, 2011, which is incorporated herein by reference.

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. [Background technology]

[0003] The crystalline lens is a transparent, biconvex structure in the eye that, together with the cornea, helps refract light to focus on the retina. The crystalline lens functions to change the eye's focal length by changing shape, allowing it to focus light on objects at different distances. This adjustment of the crystalline lens is known as accommodation. The crystalline capsule is a smooth, transparent membrane that completely surrounds the crystalline lens. The capsule is elastic and composed of collagen. The crystalline lens is flexible, and its curvature is controlled by the ciliary muscle through the zonules, which connect the crystalline lens to the equatorial region of the capsule. At short focal lengths, the ciliary muscle contracts, the zonules relax, and the crystalline lens thickens, resulting in a rounder shape and therefore higher refractive power. Changing focus to objects at greater distances requires relaxing the ciliary muscles, which increases stress on the zonules and flattens the lens, thus increasing the focal length.

[0004] The lens can be removed and replaced with an artificial lens, commonly called an intraocular lens, for a variety of reasons. Some intraocular lenses are used to replace lenses with cataracts, which are opacities that develop within the eye's lens and block the passage of light. Intraocular lenses can be characterized as non-accommodative or accommodative. Accommodative intraocular lenses are designed to function similarly to the natural lens and are adapted to provide varying power for near and distance vision.

[0005] The natural lens is usually removed by a procedure called extracapsular extraction. The procedure involves making a capsulorhexis, or an annular incision made in front of the capsule, followed by removal of the lens material. A replacement intraocular lens can then be placed into the capsule through the opening made in the annular incision.

[0006] As explained in more detail in U.S. Patent Application Publication No. 2010 / 0139999, filed January 11, 2010, to which this application claims priority, there are variations in capsular bag size from patient to patient, imperfect techniques for measuring capsular size, and post-implant changes that can occur within the eye or in an accommodating intraocular lens. A desirable accommodating intraocular lens is one in which the base state or base power (which may be referred to herein as the "set point") of the lens becomes more predictable after the accommodating intraocular lens is implanted within the eye, yet will still accommodate in response to movement of the ciliary body. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent Application No. 12 / 685,531 [Patent Document 2] US Patent Application Publication No. 2008 / 0306588 [Patent Document 3] U.S. Patent Application No. 13 / 033474 Summary of the Invention

[0008] One aspect of the disclosure is an accommodating intraocular lens comprising an optic portion having an optic fluid chamber, and a haptic fixed to the optic portion and extending peripherally from the optic portion, the haptic having a haptic fluid chamber in fluid communication with the optic fluid chamber through a plurality of fluid paths, the haptic adapted to engage a capsular bag and deforms in response to reshaping of the capsule by movement of the ciliary muscles that move fluid between the haptic fluid chamber and the optic fluid chamber to change the optical parameters of the accommodating intraocular lens.

[0009] In some embodiments, the haptics are secured to the optic at points that extend less than 180 degrees around the periphery of the optic. The haptics can be secured to the optic at points that extend less than 90 degrees around the periphery of the optic. The optic may be secured to the optic at points extending at an angle of about 45 degrees or less around the periphery of the optic.

[0010] In some embodiments, the optic portion includes a buttress portion having a plurality of channels formed therein, and the haptic can include a buttress opening in fluid communication with the haptic fluid chamber, the buttress opening sized and configured to receive the buttress portion therein.

[0011] One aspect of the disclosure is an accommodating intraocular lens comprising an optic portion having an optic fluid chamber, and a peripheral non-optic portion having a peripheral fluid chamber in fluid communication with the optic fluid chamber, the peripheral non-optic portion adapted to engage a capsular bag and deforming in response to capsule reshaping due to movement of the ciliary muscles that move fluid between the peripheral fluid chamber and the optic fluid chamber to change the optical parameters of the accommodating intraocular lens, wherein in a cross-section of the peripheral non-optic portion in a plane extending in the anterior-posterior direction, the radially inner body portion of the peripheral portion has a thickness that is approximately half the width of the peripheral portion.

[0012] In some embodiments, the radially inner body portion has a thickness at least twice that of the peripheral radially outer body portion. The radially inner body portion may have a thickness at least three times that of the peripheral radially outer body portion.

[0013] In some embodiments, the configuration of the fluid chamber in cross section is substantially D-shaped.

[0014] One aspect of the disclosure is an accommodating intraocular lens comprising an optic portion having an optic fluid chamber, and a peripheral non-optic portion having a peripheral fluid chamber in fluid communication with the optic fluid chamber, the peripheral non-optic portion adapted to engage a capsular bag and deforming in response to capsule reshaping due to movement of the ciliary muscles that move fluid between the peripheral fluid chamber and the optic fluid chamber to change the optical parameters of the accommodating intraocular lens, wherein in the region of the peripheral non-optic portion adapted to engage the capsular bag, the peripheral portion has a first cross-section in a plane extending in the anterior-posterior direction, in which the outer surfaces of the haptics have a first structure, and a second cross-section in a plane extending in the anterior-posterior direction, in which the outer surfaces of the haptics have a second structure different from the first structure.

[0015] In some embodiments, the first cross section has an outer surface that has a generally oval configuration.

[0016] In some embodiments, the first cross section has an outer surface with a generally D-shaped configuration.

[0017] In some embodiments, the first cross section has an outer surface that is straighter at the radially inner portion than at the radially outer portion.

[0018] In some embodiments, at a first cross-section, the peripheral bladder has a first bladder structure, and at a second cross-section, the peripheral bladder has a second bladder structure that is substantially the same as the first bladder structure. The first and second bladder structures may have radially inner surfaces that are straighter than radially outer surfaces. The first and second bladder structures may be substantially D-shaped.

[0019] In some embodiments, the peripheral portion has a radially inner body portion that is thicker than the radially outer portion at the first cross-section. The peripheral portion may have a radially inner body portion that is at least twice as thick as the radially outer portion at the first cross-section.

[0020] One aspect of the disclosure is an accommodating intraocular lens comprising an optic portion having an optic fluid chamber, and a peripheral non-optic portion having a peripheral fluid chamber in fluid communication with the optic fluid chamber, the peripheral non-optic portion adapted to fit a capsular bag and deforming in response to capsule reshaping due to movement of the ciliary muscles that move fluid between the peripheral fluid chamber and the optic fluid chamber to change the optical parameters of the accommodating intraocular lens, wherein in a cross section of the peripheral non-optic portion in a plane extending in the anterior-posterior direction, the peripheral fluid chamber is positioned over substantially the entire radially outer portion of the peripheral portion. [Brief explanation of the drawings]

[0021] [Figure 1A] FIG. 1A illustrates an exemplary accommodating intraocular lens. [Figure 1B] FIG. 1B illustrates an exemplary accommodating intraocular lens. [Figure 1C] FIG. 1C is a cross-sectional view of the accommodating intraocular lens of FIGS. 1A and 1B. [Figure 1D] FIG. 1D is a top view of an exemplary posterior element of an accommodating intraocular lens. [Figure 1E] FIG. 1E is an assembled cross-sectional view of an exemplary optic portion of an accommodating intraocular lens. [Figure 1F] FIG. 1F illustrates an exemplary haptic. [Figure 1G] FIG. 1G illustrates an exemplary haptic. [Figure 1H] FIG. 1H illustrates an exemplary connection between the optic and the haptics. [Figure 2A] FIG. 2A illustrates an exemplary haptic. [Figure 2B]FIG. 2B illustrates an exemplary haptic. [Figure 2C] FIG. 2C illustrates an exemplary haptic. [Figure 2D] FIG. 2D is a cross-sectional view of the haptic of FIG. 2A. [Figure 2E] FIG. 2E is a cross-sectional view of the haptic of FIG. 2A. [Figure 2F] FIG. 2F is a cross-sectional view of the haptic of FIG. 2A. [Figure 2G] FIG. 2G shows an opening at a first end of the haptic of FIGS. 2A-2C. [Figure 3] FIG. 3 shows exemplary diameters of accommodating intraocular lenses. [Figure 4] FIG. 4 illustrates an exemplary haptic. [Figure 5A] FIG. 5A illustrates exemplary haptic deformation in response to an exemplary force. [Figure 5B] FIG. 5B illustrates exemplary haptic deformation in response to an exemplary force. [Figure 6] FIG. 6 illustrates exemplary fluid openings in an exemplary haptic. [Figure 7] FIG. 7 illustrates exemplary fluid openings in an exemplary haptic. [Figure 8] FIG. 8 is a cross-sectional view of an exemplary accommodating intraocular lens. [Figure 9] FIG. 9 is a cross-sectional view of an exemplary accommodating intraocular lens with relatively short haptics. DETAILED DESCRIPTION OF THE INVENTION

[0022] The disclosed subject matter generally relates to accommodating intraocular lenses. In some embodiments, the accommodating intraocular lenses described herein are adapted to reside within the natural capsular bag after the natural crystalline lens has been removed. In these embodiments, the peripheral non-optic portion (i.e., the portion not specifically adapted to focus light on the retina) is adapted to respond to the reshaping of the capsular bag through relaxation and contraction of the ciliary muscles. The response is a deformation of the peripheral portion that shifts fluid between the peripheral and optic portions to change the optical parameters (e.g., power) of the intraocular lens.

[0023] The peripheral portions of the accommodating intraocular lenses described herein are adapted so that at least one of the peripheral portions is less sensitive or less responsive to certain types of capsular forces than to other types of capsular forces. As used herein, less sensitive or less responsive generally means that the optical power of the accommodating intraocular lens will change less with a type of force to which the peripheral portion is less sensitive than to other types of forces. Generally, the peripheral portion is less sensitive to anterior-posterior forces than to radial forces. In some cases, anterior-posterior forces may be more sensitive to, for example, the capsular bag and The radial forces are non-ciliary muscle-related capsular forces resulting from size mismatch between the lens and the eye or from the healing response of the capsular bag. Radial forces, as described herein, are capsular forces resulting from capsule remodeling and ciliary muscle contraction and relaxation, resulting in accommodation of the accommodative intraocular lens. Therefore, the accommodative intraocular lens herein is considered to be more sensitive to radial forces than to anterior-posterior forces, and therefore the optical power of the accommodative intraocular lens will change more in response to radial forces than to anterior-posterior forces.

[0024] One advantage of the peripheral portion described herein is that it reshapes the capsule, essentially by "holding" it open, in a predictable manner while still maintaining the radial sensitivity of the peripheral portion to radial forces that make the accommodative lens accommodative. Variations in the baseline state of the accommodative intraocular lens due to one or more anatomical variations in capsule size, inaccurate capsule measurements, or post-implant changes in the capsule are reduced because the peripheral portion is adapted to more predictably reshape the capsule in at least one direction. In some embodiments, the peripheral portion is adapted to more predictably reshape the capsule because it is stiffer in at least one direction. For example, in some embodiments, the peripheral portion is stiffer in the anterior-posterior direction than in the radial direction. In these embodiments, the peripheral portion is adapted to hold the capsule open in the anterior-posterior direction.

[0025] As used herein, "anteroposterior" or its derivatives are not intended to be limited to directions perfectly parallel to the optical axis, but are to be interpreted to mean the general direction commonly referred to as the anterior-posterior direction. For example, and without limitation, the "anteroposterior" direction includes directions or axes 10 degrees from the optical axis of an accommodating intraocular lens. "Radial" forces described herein should not be considered to be in the anterior-posterior direction.

[0026] FIG. 1A is a top view illustrating an accommodating intraocular lens 10, which includes an optic portion 12 and, in this embodiment, a peripheral portion including first and second haptics 14 coupled to the optic portion 12 and extending peripherally from the optic portion 12. The optic portion 12 is adapted to refract light entering the retina of the eye. The haptics 14 are configured to engage the capsular bag and are adapted to deform in response to ciliary muscles associated with reshaping the capsular bag. FIG. 1B is a perspective view of the intraocular lens 10 showing the optic portion 12 and the haptics 14 coupled to the optic portion 12.

[0027] The haptics are in fluid communication with the optic portion. Each haptic has a fluid chamber in fluid communication with an optic fluid chamber in the optic portion. The haptics are formed of a deformable material and are adapted to fit the capsular bag and deform in response to ciliary muscles associated with reshaping the capsular bag. When the haptics deform, the volume of the haptic fluid chamber changes, causing fluid disposed in the haptic fluid chamber and the optic fluid chamber to move from the haptic fluid chamber to the optic fluid chamber or vice versa. When the volume of the haptic fluid chamber decreases, fluid moves into the optic fluid chamber. When the volume of the haptic fluid chamber increases, fluid moves from the optic fluid chamber to the haptic fluid chamber. The flow of fluid into and out of the optic fluid chamber changes the structure of the optic portion and the power of the intraocular lens.

[0028] 1C is a side cross-sectional view through section AA shown in FIG. 1A. Optic portion 12 includes a deformable front element 18 secured to a deformable rear element 20. Each haptic 14 includes a fluid chamber 22 that is in fluid communication with an optic fluid chamber 24 within optic portion 12. Only the connection between the left-hand haptic 14 and optic portion 12 is shown (although hidden) in the cross-sectional view of FIG. 1C. The left-hand haptic Fluid chamber 22 is shown in fluid communication with optic fluid chamber 24 through two apertures 26 formed in rear element 20. Haptic 14 on the right in FIG. 1C is in fluid communication with optic fluid chamber 24 through two additional apertures (not shown) formed in the rear element approximately 180 degrees from the apertures shown.

[0029] FIG. 1D is a top view of the posterior element 20 (the anterior element 18 and haptics 14 are not shown). The posterior element 20 includes a buttress portion 29 having a channel 32 formed therein. The channel 32 provides fluid communication between the optic portion 12 and the haptics 14. The aperture 26 is located at one end of the channel 32. Thus, the optic fluid chamber 24 is in fluid communication with only one haptic through two channels. The buttress portions 29 are configured and dimensioned to be positioned within openings formed in the haptics 14 that define one end of the haptic fluid chamber, as described below. Each of the buttress portions 29 includes two channels formed therein. The first channel in the first buttress is aligned with the first channel in the second buttress. The second channel in the first buttress is aligned with the second channel in the second buttress.

[0030] There are advantages to having two channels within each buttress, as opposed to one channel. Designs with two channels rather than one channel help maintain dimensional stability during assembly, which can be important when assembling flexible, thin components. Furthermore, it has been observed through experimentation that some single-channel designs do not provide sufficient optical quality across the accommodation range. The two-channel buttress design described herein has been found to reduce astigmatism, particularly as the lens is accommodated. In these embodiments, astigmatism is reduced because the stiffness of the buttress is increased by the rib between the two channels. The additional stiffness results in less deflection due to pressure changes within the channels. Less deflection due to pressure changes within the channels results in less astigmatism. In some embodiments, the diameter of the channels is about 0.4 mm to about 0.6 mm. In some embodiments, the diameter of the channels is about 0.5 mm. In some embodiments, the distance between the apertures is about 0.1 mm to about 1.0 mm.

[0031] FIG. 1E is an assembled side view through section AA of optic portion 12, including anterior element 18 and posterior element 20 (haptics not shown for clarity). By including fluid flow passages 32 within posterior element 20, posterior element 20 needs to have sufficient structure through which flow passages 32 can be formed. Buttress portion 29 provides that structure through which flow passages 32 can be formed. At its outermost periphery, posterior element 20 is longer in the anterior-posterior direction than anterior element 18. In alternative embodiments, the flow passages may be formed in anterior element 18 rather than posterior element 20. The anterior element would include buttress portion 29 or other similar structure that provides structure through which flow passages can be formed. In these alternative embodiments, the posterior element could be formed similarly to anterior element 18.

[0032] As shown in FIG. 1E, the posterior element 20 is secured to the anterior element 18 at a peripheral surface 28 that extends around the periphery of the posterior element 20 and is a flat surface. The elements 18, 20 may be secured to one another using known biocompatible adhesives. The anterior element 18 and the posterior element 20 may be formed from a single material, eliminating the need to secure the two elements to one another. In some embodiments, the diameter of the area where the anterior element 18 and the posterior element 20 are secured to one another is about 5.4 mm to about 6 mm.

[0033] In some embodiments, the thickness of the anterior element 18 (measured in the anterior-posterior direction) is greater along the optical axis ("OA" in FIG. 1C) than at the periphery. In some embodiments, the thickness increases from the periphery to the thickest point along the optical axis.

[0034] In some embodiments, the thickness of rear element 20 decreases from along the optical axis toward the edge of the central region "CR" identified in FIG. 1C. The thickness again increases radially outward of the central region CR toward the periphery, as can be seen in FIG. 1C. In some particular embodiments, the central region CR is approximately 3.75 mm in diameter. The apertures are formed in the angled surfaces 30.

[0035] In some embodiments, the thickness of rear element 20 along the optical axis is from about 0.45 mm to about 0.55 mm, and the thickness around the periphery of rear element 20 is from about 1.0 mm to about 1.3 mm.

[0036] In some embodiments, the thickness of rear element 20 along the optical axis is about 0.5 mm, and the thickness around the periphery of rear element 20 is about 1.14 mm.

[0037] In some embodiments, the thickness of the front element 18 along the optical axis is about 0.45 mm to about 0.55 mm, and in some embodiments, about 0.50 mm to about 0.52 mm. In some embodiments, the peripheral thickness of the front element 18 is about 0.15 mm to about 0.4 mm, and in some embodiments, about 0.19 mm to about 0.38 mm.

[0038] In one particular embodiment, the thickness of the front element 18 along the optical axis is about 0.52 mm, the peripheral thickness of the front element 18 is about 0.38 mm, the thickness of the rear element 20 along the optical axis is about 0.5 mm, and the peripheral thickness of the rear element 20 is about 1.14 mm.

[0039] In one particular embodiment, the thickness of the front element 18 along the optical axis is about 0.5 mm, the peripheral thickness of the front element 18 is about 0.3 mm, the thickness of the rear element 20 along the optical axis is about 0.5 mm, and the peripheral thickness of the rear element 20 is about 1.14 mm.

[0040] In one particular embodiment, the thickness of the front element 18 along the optical axis is about 0.51 mm, the peripheral thickness of the front element 18 is about 0.24 mm, the thickness of the rear element 20 along the optical axis is about 0.5 mm, and the peripheral thickness of the rear element 20 is about 1.14 mm.

[0041] In one particular embodiment, the thickness of the front element 18 along the optical axis is about 0.52 mm, the peripheral thickness of the front element 18 is about 0.19 mm, the thickness of the rear element 20 along the optical axis is about 0.5 mm, and the peripheral thickness of the rear element 20 is about 1.14 mm.

[0042] The optic portion is adapted to maintain optical quality during accommodation. This ensures that the optic portion maintains optical quality as the accommodative intraocular lens transitions between the non-accommodative and accommodative configurations. Several factors contribute to the advantageous characteristics of the accommodative intraocular lenses herein. These factors include the peripheral region where the anterior element 18 is secured to the posterior element 20, the shape profiles of the anterior and posterior elements 18 and 20 within the central region CR of the optic portion (see FIG. 1C ), and the thickness profiles of the anterior and posterior elements 18 and 20. These contributing factors ensure that both the anterior and posterior elements flex to maintain the shape necessary to maintain optical quality throughout the range of optical powers.

[0043] FIG. 1F illustrates one haptic 14 of intraocular lens 10. (For clarity, optic portion 12 and a second haptic are not shown.) Haptic 14 includes a radially outer portion 13 adapted to face toward the zonules and a radially inner portion 11 facing toward the periphery of the optic (not shown). Haptic 14 includes a first end region 17 secured to optic portion 12 and a second end region 19 that is closed. Haptic 14 also includes an opening 15 at first end region 17 that provides fluid communication with the haptics. In this embodiment, opening 15 is sized and configured to receive buttress portion 29 of optic portion 12 therein.

[0044] 1G is an enlarged view of opening 15 of haptic 14, which is adapted to receive buttress portion 29 therein. Opening 15 has curved surfaces 33, 35 that are shaped to match the curved surfaces of optic buttress 29. Surface 31 surrounds opening 15 and provides a surface against which a corresponding surface of the optic can be secured.

[0045] 1H is a top, enlarged view of buttress portion 29 (in perspective) of posterior element 20 positioned within opening 15 of haptic 14 (for clarity, the anterior element of the optic is not shown). Channel 32 is shown in perspective. Haptic 14 includes fluid chamber 22 defined by inner surface 21. Fluid travels between the optic fluid chamber and haptic fluid chamber 22 through channel 32 upon deformation of haptic 14.

[0046] FIG. 2A is a top view of one haptic 14 shown in FIGS. 1A-1H. The optic portion and second haptic are not shown. Four sections AD are identified through the haptic. FIG. 2B illustrates a side view of the haptic 14, showing the opening 15 and closed end 19. FIG. 2C is a side view of the haptic 14, showing the radially outer portion 13 and closed end 19.

[0047] FIG. 2D is a cross-sectional view through section AA shown in FIG. 2A. Of the four sections shown in FIG. 2A, section AA is the section closest to closed end 19. Radially inner portion 11 and radially outer portion 13 are identified. Fluid flow passage 22, defined by surface 21, is also shown. In this section, radially inner portion 40 is thicker radially (in the "T" direction) than radially outer portion 42. Inner portion 40 provides stiffness to the haptic in the anterior-posterior direction, allowing the capsule to more predictably reshape in the anterior-posterior direction. Radially inner portion 40 has a maximum thickness dimension 41 along the axis of symmetry of this cross-sectional view. The outer surface of haptic 14 has a generally elliptical configuration with a maximum height dimension in the anterior-posterior direction ("AP") greater than its maximum thickness dimension (measured in the "T" dimension). Fluid chamber 22 has a generally D-shaped configuration, with radially inner wall 43 being less curved (but not completely straight) than radially outer wall 45. The radially outer portion 42 encases the capsular bag with its associated zonules, while the thicker radially inner portion 40 is positioned adjacent the optic.

[0048] FIG. 2E illustrates section BB shown in FIG. 2A. Section BB is approximately the same as section AA, and FIG. 2E provides exemplary dimensions for both sections. The radially inner portion 40 has a maximum thickness of approximately 0.75 mm along the centerline (in the radial "T" direction). The radially outer portion 42 has a thickness of approximately 0.24 mm along the centerline. The bladder 22 has a thickness of approximately 0.88 mm. The haptics 14 have a thickness of approximately 1.87 mm along the centerline. The height of the haptics in the anterior-posterior dimension is approximately 2.97 mm. The height of the bladder is approximately 2.60 mm. In this embodiment, the thickness of the radially inner portion 40 is approximately three times the thickness of the radially outer portion 42. In some embodiments, the thickness of the radially inner portion 40 is approximately twice the thickness of the radially outer portion 42. In some embodiments, the thickness of the radially inner portion 40 is approximately two to three times the thickness of the radially outer portion 42. In some embodiments, the thickness of the radially inner portion 40 is from about 1 to about 2 times the thickness of the radially outer portion 42 .

[0049] The fluid chamber 22 is located within the radially outer portion of the haptic 14. Substantially the entire radially inner region of the haptic 14 in this section is bulk material. The fluid chamber 22 is defined by surfaces 43, 45 (see FIG. 2D), so the position of the fluid chamber 22 is not known. The location and size depend on the thickness of the radially outer portion 42 and the radially inner portion 40 .

[0050] FIG. 2F illustrates section CC shown in FIG. 2A. In section CC, the radially inner portion 40 is slightly thicker than the radially outer portion 42, but the radially inner portion 40 in section CC is not as thick as the radially inner portion 40 in sections AA and BB. In this particular embodiment, the radially inner portion 40 is approximately 0.32 mm in section CC. The radially outer portion 42 has a thickness of approximately 0.24 mm, roughly the same as the radially outer thickness in sections AA and BB. The outer surface of the haptic 14 does not have the same structure as the outer surface in sections AA and BB. In section CC, the radially inner outer surface of the haptic 51 is more linear than in sections AA and BB, giving the outer surface of the haptic in section CC a generally D-shaped shape. In section CC, the fluid chamber 22 is generally D-shaped, as in sections AA and BB. The haptics in section CC have a fluid chamber structure that is substantially the same as the fluid chamber structure in sections AA and BB, but have an outer surface that has a structure different from the structure of the outer surface of the haptics 14 in sections AA and BB.

[0051] The thinner radially inner portion 40 at section CC also creates the access pathway 23 shown in FIG. 1A. This space between the optic portion 12 and the haptics 14 allows the physician to insert one or more irrigation and / or suction devices into the space 23 during surgery to provide suction to remove viscoelastic fluid that may be used to deliver the intraocular lens into the eye. The pathway 23 may be located anywhere along the length of the haptics, and there may be more than one pathway 23. This application incorporates by reference the disclosure of FIGS. 23 and 24 of U.S. Patent Application Publication No. 2009 / 0129999, which includes multiple pathways within the haptics, as well as the textual description thereof.

[0052] Figure 2G shows a view through section DD of Figure 2A. Haptic 14 includes opening 15 therein that is adapted to receive the optic buttress as described herein. The height of opening 15 in this embodiment is about 0.92 mm. The width or thickness of the opening is about 2.12 mm.

[0053] 3 illustrates the relative diameters of the optic portion 12 (not shown) and the peripheral portion, which includes two haptics 14 (only one haptic is shown). In this embodiment, the optic has a diameter of approximately 6.1 cm, while the entire accommodating intraocular lens, including the peripheral portion, has a diameter of approximately 9.95 cm. The dimensions given are not intended to be strictly limiting.

[0054] FIG. 4 is a top view of haptic 14, showing haptic 14 subtending an angle of approximately 175 degrees (i.e., nearly 180 degrees) around the optic. For clarity, the optic portion is not shown; therefore, two haptics each subtend an angle of approximately 180 degrees around the optic. A first region 61 of haptic 14 is shown subtending an exemplary angle of approximately 118 degrees. This is the radially outermost portion of haptic 14, adapted to fit the capsular bag and be most responsive to changes in the shape of the bag. Region 61 may be considered the most responsive portion of haptic 14.

[0055] The angle between sections AA and BB, which are considered the boundaries of the stiffer radially inner portion of the haptic, is approximately 40 degrees. The stiff radially inner portion of haptic 14 is located immediately adjacent the periphery of the optic. It is not intended to be strictly limited to the dimensions and angles given.

[0056] Figures 5A and 5B illustrate a portion of an accommodating intraocular lens 10 positioned within the capsular bag ("CB") after the natural lens has been removed from the CB. In each figure, the anterior direction is up and the posterior direction is down. Figure 5A shows the accommodating intraocular lens in a lower power or non-accommodating configuration compared to the high power or accommodating configuration shown in Figure 5B.

[0057] The elastic capsular bag "CB" is connected to the ciliary zonules "Z," which are connected to the ciliary muscles "CM." As shown in FIG. 5A, when the ciliary muscles relax, the zonules stretch. This stretch pulls the capsular bag in a generally radially outward direction, with a radially outward force "R" due to the general equatorial connection between the capsular bag and the zonules. Stretching of the zonules results in a general elongation and thinning of the capsular bag. If the natural lens were still within the capsular bag, it would become flatter (in the anterior-posterior direction) and more radially elongated, providing less power to the lens. Relaxation of the ciliary muscles, as shown in FIG. 5A, results in distance vision. However, when the ciliary muscles contract, as occurs when the eye attempts to focus on a near object, the radially inner portion of the muscle moves radially inward, relaxing the zonules. This is illustrated in FIG. 5B. Relaxation of the ciliary zonules allows the capsular bag to move towards a generally more curved configuration, with the anterior surface having a greater curvature than in a non-accommodative configuration, resulting in higher power and allowing the eye to focus light on near objects. This is commonly referred to as "accommodation" and the lens is considered to be in an "accommodative" configuration.

[0058] In section AA (same as section BB) of the haptic 14 illustrated in FIGS. 5A and 5B, the radially inner portion 40 includes a thicker bulk material that provides stiffness to the haptic 14 in the anterior-posterior direction. When capsular bag forces are applied to the haptic in the anterior-posterior direction, the stiffness of the inner portion 40 causes it to deform in a more repeatable and predictable manner, making the base state of the lens more predictable. Furthermore, the haptic's stiffer inner portion causes it to deform the capsule in a repeatable manner in the anterior-posterior direction. Furthermore, because the haptic is less flexible along its length, the base state of the accommodative intraocular lens is more predictable because bending of the haptic along its length is one way that fluid can move into the optic (thus changing the power of the lens). An additional benefit realized with a stiffer inner portion is that the haptic is stiffer against other forces, such as torque and tilt, due to the added bulk of the inner portion.

[0059] The radially outer portion 42 is a portion of the haptic that directly engages a portion of the capsular bag connected to the zonules. The outer portion 42 of the haptic is adapted to respond to a capsular reshaping force "R," which is generally applied radially as the zonules relax and stretch. This allows the haptic to deform in response to ciliary muscle related forces (i.e., capsular contraction and relaxation), allowing fluid to flow between the haptic and optic in response to ciliary muscle relaxation and contraction. This is illustrated in FIG. 5B. When the ciliary muscle contracts (FIG. 5B), the peripheral region of the elastic capsular bag reforms and applies a radially inward force "R" to the radially outer portion 42 of the haptic 14. The radially outer portion 42 is adapted to deform in response to this capsular reshaping. The deformation reduces the volume of the fluid chamber 22, thereby forcing fluid from the haptic chamber 22 into the optic chamber 24. This increases the fluid pressure within the optic chamber 24. The increase in fluid pressure causes the flexible anterior element 18 and the flexible posterior element 20 to deform, increasing their curvature and thereby increasing the power of the intraocular lens.

[0060] The haptics are adapted to be stiffer in the anterior-posterior direction than in the radial direction. In this embodiment, the radially outer portion 42 of the haptic 14 is more flexible (i.e., less stiff) in the radial direction than the stiffer inner portion 40 in the anterior-posterior direction. This is due to the relative thicknesses of the outer portion 42 and inner portion 40. The haptics therefore deform less in response to an anterior-posterior force than to a radial force. This also results in less fluid being displaced from the haptic into the optic in response to an anterior-posterior force than into the optic in response to a radial force. The haptics will also deform in a more predictable and repeatable manner due to their stiffer radially inner portion.

[0061] Therefore, the periphery is more sensitive to reshaping of the capsular bag in the radial direction than to reshaping of the capsular bag in the anterior-posterior direction. The haptics are adapted to deform to a greater extent in the radial direction than in the anterior-posterior direction. Thus, the disclosure herein includes a periphery that is less sensitive to capsular forces along a first axis but more sensitive to forces along a second axis. In the example above, the periphery is less sensitive along the anterior-posterior axis and more sensitive in the radial axis.

[0062] An exemplary advantage of the perimeter described above is that it deforms the capsular bag in a predictable manner while still maintaining high sensitivity to radial forces during accommodation. The perimeter described above is stiffer in the anterior-posterior direction than in the radial direction.

[0063] A further example of capsular forces in the anterior-posterior direction is the peripheral capsular force after an accommodative intraocular lens is positioned within the capsular bag and the capsular bag typically undergoes a healing response. The healing response typically causes a haptic contraction force in the anterior-posterior direction, identified as force "A" in FIG. 5A. These and other post-implant, non-accommodation-related capsular bag remodeling forces, for example, are described in U.S. Patent Application Publication No. 2010 / 0129997, filed January 11, 2010, which is incorporated herein by reference. For example, as described in detail in U.S. Patent Application Publication No. 2010 / 0129997, there is some variability in capsular bag size from patient to patient. When the intraocular lens is positioned within the capsular bag, the size difference between the capsule and the intraocular lens may cause a force to be exerted on one or more portions of the intraocular lens in the anterior-posterior direction.

[0064] In the example of capsular healing in the anterior-posterior direction, the deformable haptics may be deformed before any accommodation occurs. This deformation changes the volume of the haptic fluid chamber, allowing fluid to flow between the optic and haptic fluid chambers. This may shift the base power of the lens, possibly undesirably. For example, fluid may be pumped into the optic during capsular healing, increasing the power of the accommodating intraocular lens and creating a permanent myopic shift in the accommodating intraocular lens. Fluid may be pumped from the optic to the haptics, decreasing the power of the accommodating intraocular lens.

[0065] As used herein, "radial" need not be limited to being strictly perpendicular to the anterior-posterior plane, but includes planes that are at 45 degrees from the anterior-posterior plane.

[0066] Exemplary fluids are described in U.S. Patent Application Publication No. 2010 / 0129999, filed January 11, 2010, and U.S. Patent Application Publication No. 2011 / 0129999, filed February 23, 2011, both of which are incorporated herein by reference. For example, the fluid may be a silicone oil that may or may not be index-matched to the polymeric material of the front and rear elements. Using a fluid that is index-matched to the bulk material of the optic section allows the entire optic section to act as a single lens whose outer curvature changes with increasing or decreasing fluid pressure within the optic section.

[0067] In the embodiment of Figures 2A-2G described above, the haptics are a deformable polymer material having a substantially uniform composition in sections AA, BB, and CC. The stiffer radially inner body portion 40 is due to its thickness. In alternative embodiments, the radially inner body portion has a different composition than the outer body portion, and the material of the radially inner body portion is stiffer than the material of the radially outer body portion. In these alternative embodiments, the thickness of the radially inner and outer portions may be the same.

[0068] FIG. 6 illustrates a haptic 50 of the same haptic structure shown in FIG. 2B. A radially outer portion 54 is identified. The haptic has an axis AA that passes through the middle of the height of the haptic. An opening 52 in which the optic buttress is located is posterior to axis A. In this embodiment, the optic is slightly closer to the rearmost portion of the haptic than to the frontmost portion of the haptic.

[0069] FIG. 7 illustrates an alternative haptic 60 (optic not shown), identifying the radially outer portion 64. The haptic 60 includes an axis AA that runs through the middle of the haptic's thickness. The opening 62 is symmetrical about axis A. Additionally, axis AA is the axis of symmetry for the haptic 60. The symmetry of the haptic along axis A improves its ability to mold with relatively low stress components. FIG. 8 illustrates an embodiment of an intraocular lens 70 in which an optic 72 is connected to two haptics 60, similar to the haptics shown in FIG. 7. Additionally, the optic is more anterior than in the embodiment in which the opening is not aligned with the centerline of the haptic. Cross sections AA, BB, and CC of the haptic 60 are the same as those shown in the alternative embodiment illustrated above.

[0070] FIG. 9 illustrates intraocular lens 80, which includes optic 82 and two haptics 84. The optic is identical to the optic portion described herein. Haptic 84 is not as long as haptics 60, 50, or 14, measured in the anterior-posterior direction. In exemplary embodiments, haptic 84 is approximately 2.0 mm to approximately 3.5 mm in length, and in some embodiments, approximately 2.8 mm in length. Intraocular lens 80 may be considered a "small" accommodating intraocular lens for patients with capsular bags below a certain threshold size. The posterior surface of posterior element 86 is positioned slightly posterior to the posteriormost portion 90 of haptics 84.

[0071] The features of intraocular lenses described herein may be applied to non-fluid-actuated accommodative intraocular lenses as well. For example, a non-accommodative intraocular lens may include a periphery having a first, stiffer region with a peripheral region that is less sensitive in a first direction. For example, in an intraocular lens having two lenses adapted to be moved apart from each other to change the power of the lens, the periphery of the lenses may be adapted such that a first type of capsule reshaping does not cause the distance between the lenses to change, and therefore the power of the intraocular lens remains the same.

[0072] Moreover, the accommodating intraocular lenses herein can be adapted to be positioned outside the natural capsular bag. For example, after the natural lens has been removed or while the natural lens is still in the capsular bag, the accommodating intraocular lens can be adapted to be positioned in front of or anterior to the capsular bag, with the periphery of the lens adapted to respond directly to the ciliary muscle rather than relying on capsule reshaping. The present disclosure also includes the following inventions. The first aspect is an optic portion including an optic fluid chamber; a haptic secured to the optic portion and extending peripherally from the optic portion, the haptic including a haptic fluid chamber in fluid communication with the optic fluid chamber through a plurality of fluid paths; An accommodative intraocular lens comprising: The haptic is an accommodating intraocular lens that is adapted to fit into a capsular bag and deforms in response to capsule reshaping by ciliary muscle movement that moves fluid between the haptic fluid chamber and the optic fluid chamber to change the optical parameters of the accommodating intraocular lens. The second aspect is The haptics are affixed to the optic at points extending less than 180 degrees around the periphery of the optic, in a first embodiment of an accommodating intraocular lens. The third aspect is In a second embodiment, the haptics are secured to the optic at points extending less than 90 degrees around the periphery of the optic. The fourth aspect is In a second embodiment of the accommodating intraocular lens, the haptics are secured to the optic at points extending at an angle of about 45 degrees or less around the periphery of the optic. The fifth aspect is The optic portion is an accommodating intraocular lens according to a first embodiment, which includes a buttress portion having a plurality of flow channels formed therein. The sixth aspect is A fifth aspect of an accommodative intraocular lens, wherein the haptic has a buttress opening in fluid communication with the haptic fluid chamber, the buttress opening being sized and configured to receive the buttress portion therein. A seventh aspect is an optic portion including an optic fluid chamber; a peripheral non-optical portion having a peripheral fluid chamber in fluid communication with the optic fluid chamber, the peripheral non-optical portion adapted to engage a capsular bag and deforming in response to capsule reshaping by ciliary muscle movement to move fluid between the peripheral fluid chamber and the optic fluid chamber to change optical parameters of the accommodating intraocular lens; An accommodative intraocular lens comprising: The accommodating intraocular lens is one in which, in a cross section of the peripheral non-optical portion in a plane extending in the anterior-posterior direction, the radially inner body portion of the peripheral portion has a thickness that is approximately half the width of the peripheral portion. The eighth aspect is The accommodating intraocular lens of a seventh aspect, wherein the radially inner body portion has a thickness at least twice that of the peripheral radially outer body portion. A ninth aspect is An accommodating intraocular lens according to an eighth aspect, wherein the radially inner body portion has a thickness at least three times that of the peripheral radially outer body portion. A tenth aspect is A seventh embodiment of an accommodating intraocular lens, wherein the structure of the fluid chamber is substantially D-shaped in cross section. An eleventh aspect is an optic portion including an optic fluid chamber; a peripheral non-optical portion having a peripheral fluid chamber in fluid communication with the optic fluid chamber, the peripheral non-optical portion adapted to engage a capsular bag and deforming in response to capsule reshaping by ciliary muscle movement to move fluid between the peripheral fluid chamber and the optic fluid chamber to change optical parameters of the accommodating intraocular lens; An accommodative intraocular lens comprising: In the region of the peripheral non-optic portion adapted to fit a capsular bag, the peripheral portion is an accommodating intraocular lens having a first cross-section in a plane extending in the anterior-posterior direction in which the outer surfaces of the haptics have a first structure, and a second cross-section in a plane extending in the anterior-posterior direction in which the outer surfaces of the haptics have a second structure different from the first structure. A twelfth aspect is The accommodating intraocular lens of an eleventh embodiment, wherein the first cross section has an outer surface with a generally elliptical configuration. A thirteenth aspect is The accommodating intraocular lens of an eleventh embodiment, wherein the first cross section has an outer surface with a generally D-shaped configuration. A fourteenth aspect is The accommodating intraocular lens of an eleventh aspect, wherein the first cross section has an outer surface whose radially inner portion is straighter than its radially outer portion. A fifteenth aspect is An accommodative intraocular lens in an eleventh aspect, wherein in the first cross section, the peripheral fluid chamber has a first fluid chamber structure, and in the second cross section, the peripheral fluid chamber has a second fluid chamber structure that is approximately the same as the first fluid chamber structure. A sixteenth aspect is In a fifteenth aspect of the present invention, the first fluid chamber structure and the second fluid chamber structure have radially inner surfaces that are straighter than radially outer surfaces. A seventeenth aspect is In a fifteenth aspect of the accommodating intraocular lens, the first fluid chamber structure and the second fluid chamber structure are substantially D-shaped. An eighteenth aspect is The accommodating intraocular lens of an eleventh aspect, wherein the peripheral portion in the first cross section has a radially inner body portion that is thicker than a radially outer portion. A nineteenth aspect is The accommodating intraocular lens of an eighteenth aspect, wherein the peripheral portion in the first cross section has a radially inner body portion that is at least twice as thick as the radially outer portion. The twentieth aspect is an optic portion including an optic fluid chamber; a peripheral non-optical portion having a peripheral fluid chamber in fluid communication with the optic fluid chamber, the peripheral non-optical portion adapted to engage a capsular bag and deforming in response to capsule reshaping by ciliary muscle movement to move fluid between the peripheral fluid chamber and the optic fluid chamber to change optical parameters of the accommodating intraocular lens; An accommodative intraocular lens comprising: In a cross section of the peripheral non-optical portion in a plane extending in the anterior-posterior direction, the peripheral fluid chamber is an accommodating intraocular lens disposed over substantially the entire radially outer portion of the peripheral portion. [Explanation of symbols]

[0073] 10 Accommodative intraocular lenses 11 Radial inner part 12 Optic section 13 Radial outer part 14 Haptic 15 Opening 17 First end area 18 Front element 19 Second end area 20 Rear element 21 Inner 22 Haptic fluid chamber 23 Access Route 24 Optic fluid chamber 26 Opening part 28 Peripheral Surfaces 29 Buttress section 30 Slope 31 sides 32 Flow path 33 Curved Surface 35 curved surface 40 radially inner part 41 Thickness dimension 42 Radial outer part 43 Radial inner wall 45 Radial outer wall 50 Haptic 51 Haptic 52 Opening 54 Radial outer part 60 Haptic 61 1st area 62 Opening 64 Radial outer part 70 Intraocular Lens 72 Optic 80 Intraocular Lens 82 Optic 84 Haptic 86 rear element 90 rear end A. Contractile force CB sac bag CR central area CM Ciliary muscle OA optical axis R radial force Z ciliary corpuscle

Claims

1. In intraocular lenses, The intraocular lens is an optic portion including a front element, a rear element, and an optic fluid chamber defined between the front element and the rear element in a front-to-rear direction; a haptic coupled to the optic portion, the haptic comprising a haptic fluid chamber, the haptic fluid chamber being in fluid communication with the optic fluid chamber through a plurality of fluid channels formed in a reinforced portion of the optic portion extending radially outward from the optic fluid chamber; An intraocular lens, wherein each of the plurality of fluid flow paths terminates in an aperture defined along an angled surface of the posterior element of the optic portion.

2. The intraocular lens of claim 1, further comprising a second haptic connected to the optic portion, the second haptic having a second haptic fluid chamber, the second haptic fluid chamber being fluidly connected to the optic fluid chamber through a further plurality of fluid flow paths arranged diametrically opposite the plurality of fluid flow paths.

3. 10. The intraocular lens of claim 1, wherein at least one of the anterior and posterior elements has a thickness at its center or apex that is greater than the thickness at its periphery.

4. The intraocular lens of claim 1 , wherein the anterior element has an anterior outer surface and a posterior inner surface, the posterior inner surface being flatter than the anterior outer surface.

5. The intraocular lens of claim 1 , wherein the optic portion is centered in the anterior-posterior direction with respect to the centerline of the one haptic.

6. The intraocular lens of claim 1 , wherein the anterior-most portion of the one haptic is positioned further anterior than the anterior-most position on the anterior-most surface of the optic portion.

7. The intraocular lens of claim 1 , wherein the rearmost portion of the one haptic is located further rearward than the rearmost position on the rearmost surface of the optic portion.

8. In intraocular lenses, The intraocular lens is an optic portion including a front element, a rear element, and an optic fluid chamber defined between the front element and the rear element in a front-to-rear direction; a haptic coupled to the optic portion, the haptic comprising a haptic fluid chamber, the haptic fluid chamber being in fluid communication with the optic fluid chamber through a plurality of fluid channels formed in a reinforced portion of the optic portion extending radially outward from the optic fluid chamber; An intraocular lens, wherein the plurality of fluid flow paths include a first fluid flow path terminating in a first aperture portion and a second fluid flow path terminating in a second aperture portion, the first aperture portion and the second aperture portion being defined along an inclined surface of the posterior element.

9. The intraocular lens of claim 8, further comprising a second haptic connected to the optic portion, the second haptic having a second haptic fluid chamber, the second haptic fluid chamber being fluidly connected to the optic fluid chamber through a further plurality of fluid flow paths arranged diametrically opposite the plurality of fluid flow paths.

10. In intraocular lenses, The intraocular lens is an optic portion including a front element, a rear element, and an optic fluid chamber defined between the front element and the rear element in a front-to-rear direction; a haptic coupled to the optic portion, the haptic comprising a haptic fluid chamber, the haptic fluid chamber fluidly communicating with the optic fluid chamber through a first fluid flow path terminating in a first aperture and a second fluid flow path terminating in a second aperture, the distance between the first aperture and the second aperture being between 0.1 mm and 1.0 mm; the first fluid flow path and the second fluid flow path are formed in the optic portion; the first fluid flow path and the second fluid flow path are formed within a reinforcement portion of the optic portion, the reinforcement portion extending radially outward from the optic fluid chamber; The intraocular lens, wherein the first aperture and the second aperture are defined along an inclined surface of the posterior element.

11. The intraocular lens of claim 10, further comprising a second haptic connected to the optic portion, the second haptic having a second haptic fluid chamber, the second haptic fluid chamber being fluidly connected to the optic fluid chamber through a further plurality of fluid flow paths arranged diametrically opposite the first fluid flow path and the second fluid flow path.

Images