SINGLE PIECE INTRA-OCULAR LENSES AND METHODS OF MANUFACTURE THEREOF
20200253721 ยท 2020-08-13
Inventors
- Kevin Cuevas (Littleton, CO, US)
- Shravanthi Reddy (Goleta, CA, US)
- Khalid Mentak (San Ramon, CA, US)
- Kevin S. Harris (Denver, CO, US)
Cpc classification
A61F2250/0051
HUMAN NECESSITIES
A61F2002/1681
HUMAN NECESSITIES
International classification
Abstract
Disclosed herein is an intraocular lens implantable in an eye comprising an optical portion adapted for placement in the lens capsule of the eye and for directing light toward the retina of the eye; an annular ring having an outer diameter and an inner diameter; and at least one elongated fixation member coupled to said optical portion for use in fixing said intraocular lens in the eye; where the outer diameter of the annular ring contacts the elongated fixation member and where the inner diameter of the annular ring contacts the optical portion of the intraocular lens; and where the entire intraocular lens is a single monolithic piece.
Claims
1. An intraocular lens implantable in an eye comprising: an optical portion adapted for placement in the lens capsule of the eye and for directing light toward the retina of the eye; an annular ring having an outer diameter and an inner diameter; and at least one elongated fixation member coupled to said optical portion for use in fixing said intraocular lens in the eye; where the outer diameter of the annular ring contacts the elongated fixation member and where the inner diameter of the annular ring contacts the optical portion of the intraocular lens; and where the entire intraocular lens is a single monolithic piece.
2. The intraocular lens of claim 1 where the intraocular lens comprises at least two elongated fixation members that have an outer diameter of 13.5 millimeters or less.
3. The intraocular lens of claim 1, where the outer diameter of the annular ring is 7 millimeters or less.
4. The intraocular lens of claim 1, where the inner diameter of the annular ring is 6 millimeters or less.
5. The intraocular lens of claim 1, further comprising a membrane that contacts the inner diameter of the annular ring and an outer diameter of the optical portion.
6. The intraocular lens of claim 1, where the entire intraocular lens comprises a single material.
7. The intraocular lens of claim 1, where the intraocular lens comprises an acrylate.
8. The intraocular lens of claim 1, where the intraocular lens comprises a polysiloxane.
9. The intraocular lens of claim 1, where the optical portion comprises a cell barrier for preventing cell migration during or after surgery.
10. The intraocular lens of claim 1, where the optical portion is 5.5 millimeters or less in diameter.
11. A method comprising: molding in one piece an intraocular lens comprising: an optical portion adapted for placement in the lens capsule of the eye and for directing light toward the retina of the eye; an annular ring having an outer diameter and an inner diameter; and at least one elongated fixation member coupled to said optical portion for use in fixing said intraocular lens in the eye; where the outer diameter of the annular ring contacts the elongated fixation member and where the inner diameter of the annular ring contacts the optical portion of the intraocular lens; and where the entire intraocular lens is a single monolithic piece.
12. The method of claim 10, where the molding comprises injection molding.
13. A method comprising: making an incision is made in an edge of a cornea of any eye; making a circular opening in an anterior portion of a lens capsule of the eye; disposing an intraocular lens within the lens capsule through the circular opening in the anterior portion; where the intraocular lens comprises: an optical portion adapted for placement in the lens capsule of the eye and for directing light toward the retina of the eye; an annular ring having an outer diameter and an inner diameter; and at least one elongated fixation member coupled to said optical portion for use in fixing said intraocular lens in the eye; where the outer diameter of the annular ring contacts the elongated fixation member and where the inner diameter of the annular ring contacts the optical portion of the intraocular lens; and where the entire intraocular lens is a single monolithic piece.
14. A retaining cell for holding an intraocular lens comprising: a back wall having an opening for accommodating an aperture of an intraocular lens; such that the opening and the aperture are aligned for directing light toward the retina of the eye; a sidewall that contacts the back wall along its circumference; at least two lips that contact the side wall and protrude radially from a circumference of the side wall towards a center of the opening in the back wall; where a surface of the lip is parallel to a surface of the back wall creating a space therebetween for reversibly accepting an intraocular lens.
15. The retaining cell of claim 14, further comprising an intraocular lens implantable in an eye comprising: an optical portion adapted for placement in the lens capsule of the eye and for directing light toward the retina of the eye; an annular ring having an outer diameter and an inner diameter; and at least one elongated fixation member coupled to said optical portion for use in fixing said intraocular lens in the eye; where the outer diameter of the annular ring contacts the elongated fixation member and where the inner diameter of the annular ring contacts the optical portion of the intraocular lens; and where the entire intraocular lens is a single monolithic piece; where the elongated fixation member is restrained between a lip and the back wall of the retaining cell.
Description
BRIEF DESCRIPTION OF THE FIGURES
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DETAILED DESCRIPTION
[0029] Disclosed herein is a flexible, single piece intra-ocular lens (hereinafter IOL) that may be placed in the lens capsule (43) (see
[0030] With reference now to the
[0031] With reference now to the
[0032] The entire IOL may be constructed of any of the commonly employed materials commonly used for rigid or flexible optics. It is desirable for these materials to be biocompatible. Examples of materials used for rigid optics include polymeric materials such as polycarbonate, polymethylmethacrylate, polyolefin copolymers, polystyrene, polyacrylate, polyetherimides, or a combination thereof.
[0033] Polymeric materials used in resiliently deformable optics may also be used to form the entire IOL, such as polysiloxanes, acrylic polymeric materials, hydrogel-forming polymeric materials, mixtures thereof, and the like.
[0034] In an embodiment, copolymers of polysiloxanes may be used to form the entire IOL. Such copolymers include polycarbonate-polysiloxane copolymers, polymethylmethacrylate-polysiloxane copolymers, polyetherimide-polysiloxane copolymers, polytetrafluoroethylene-polysiloxane copolymers, polyolefin-polysiloxane copolymers.
[0035] The fixation members 115 and 117 in this embodiment are generally C-shaped and are integral with the optic 123 via an annular ring 127. However, this is purely illustrative as the fixation members 115 and 117 may be of other configurations.
[0036] As may be seen in the
[0037] The optic 123 has an anterior face 125, a posterior face 129 and a peripheral edge 127, which is in the form of an annular ring (hereinafter annular ring 127). In this embodiment, the faces 125 and 129 are convex and the peripheral edge 127 is cylindrical, but as indicated above, these shapes are shown only by way of example.
[0038] The annular ring 127 is circular in shape having an outer diameter that contacts the fixation members 115 and 117 and an inner diameter that contacts the optic 123. As seen in the
[0039] The optic 123 is designed to be placed in the lens capsule. The outer diameter of the annular ring 127 is 7 millimeters or less, preferably 6.5 millimeters or less. The annular ring 127 contacts the fixation members 115 and 117 on its outer radial surface. The annular ring 127 also contacts the optic 123 on its inner radial surface. The outer diameter of the optic 123 (which corresponds to the inner diameter of the annular ring 127) may be 6 mm or less, preferably 5.8 mm or less, and more preferably 5.5 mm or less. The optical portion 119 performs the normal function of the optic of an IOL, i.e., to appropriately focus light at or near the retina. The optical portion 119 may be monofocal or multifocal. The optical portion is generally optically transparent.
[0040] The optic 123 has an outer diameter of 6.5 millimeters or less, preferably 6 millimeters or less, preferably 5.8 millimeters or less, preferably 5.5 millimeters or less, and more preferably 5.0 millimeters or less.
[0041] The optional cell barrier portion 121 circumscribing the optical portion 119 is integral with the optical portion 119 and is scribed on at least one surface of the optical portion. The cell barrier portion 121 generally does not focus light on the retina of the eye and includes an irregularly configured structure or surface feature effective to inhibit, and preferably substantially prevent, cell growth or cell migration radially inwardly across the cell barrier portion.
[0042] In an embodiment, the cell barrier portion 121 includes a textured surface. The textures are detailed in U.S. patent application having Ser. No. 14/298,318 to Cuevas et al, the entire contents of which are hereby incorporated by reference.
[0043] In an embodiment, one or more surfaces of the annular ring 127 may include a textured surface to prevent migration of epithelial cells into the optic 123 and into the field of view. The inner surface and the outer surface of the annular ring 127 may be textured with patterns shown in the
[0044]
[0045] In one embodiment, the IOL 111 may have an annular membrane 131 that contacts the annular ring 127 on one circumference and the optical portion 119 of the optic 123 on an opposing circumference. This is depicted in the
[0046] The membrane is generally manufactured from a flexible polymer that is biocompatible. The opposing surfaces of the membrane are parallel to one another.
[0047] The entire IOL is manufactured in a single piece, i.e., it is monolithic and cannot be taken apart without damaging or destroying it. In an embodiment, the entire IOL comprises a single material, while in other embodiments, different portions of the IOL can comprise different materials, where the entire IOL exists in a single monolithic piece.
[0048] In one embodiment, in one method of manufacturing the IOL, a molten plastic is injected into a mold that has the requisite dimensions. The mold has the appropriate texturing in those portions so that texturing can be imparted to the IOL as depicted in the
[0049] In an embodiment, in one method of using the IOL, as is already detailed in the
[0050] The surface texture disposed on the annular ring 127 can comprise a plurality of patterns. In one embodiment, the pattern generally has some features that are of the order of a few nanometers to several hundreds of millimeters in size. Each pattern is defined by a plurality of spaced apart features attached to or projected into the surface of the annular ring 127. The plurality of features on the surface each has at least one neighboring feature that has a substantially different geometry or a substantially different size. The average spacing between adjacent features on the surface texture is between about 1 nanometer to about 1 millimeter in at least a portion of the surface. The surface of the annular ring 127 may be planar, curved, or include portions that are planar combined with other portions that are curved.
[0051] In one embodiment, when the surface texture is viewed in a first direction, the plurality of spaced apart features is represented by a periodic function. In another embodiment, the plurality of spaced apart features forms a pattern. Each pattern is separated from a neighboring pattern by a pathway that has a periodicity to it. The periodicity of this pathway may be sinusoidal.
[0052] In one embodiment, the surface texture can comprise a pattern that comprises a plurality of spaced features. The spaced features are arranged in a plurality of groupings. The groupings of features comprise repeat units that can be repeated laterally and longitudinally across the surface. The spaced features within a grouping are spaced apart at an average distance of about 1 nanometer to about 500 micrometers, preferably at least 1 nanometer to about 10 micrometers. Each spaced feature has a surface that is substantially parallel to a surface on a neighboring feature. Each feature is separated from a neighboring feature and the groupings of features are arranged with respect to one another so as to define a tortuous pathway.
[0053] In yet another embodiment, the surface texture comprises a plurality of spaced features. The features are arranged in a plurality of groupings such that the groupings of features comprise repeat units. The spaced features within a grouping are spaced apart at an average distance of about 1 nanometer to about 500 micrometers, preferably about 1 nanometer to about 10 micrometers. The groupings of features are arranged with respect to one another so as to define a tortuous pathway where a tangent to the tortuous pathway intersects with a spaced feature. The spaced feature is different in geometry (shape or size) from each nearest neighbor and is not in contact with the nearest neighbor.
[0054] In yet another embodiment, the surface texture has a topography that comprises a pattern defined by a plurality of spaced apart features attached to or projected into a base surface of the annular ring 127. The plurality of features comprise at least one feature having a substantially different geometry, wherein neighboring patterns share a common feature, the plurality of spaced apart features having at least one dimension that is about 1 nanometer to about 1,000 micrometers. The neighboring spaced apart features can be spaced apart by a distance of about 5 nanometers to about 500 micrometers, specifically about 10 nanometers to about 100 micrometers, specifically about 1 micrometer to about 50 micrometers, and more specifically about 2 micrometers to about 25 micrometers.
[0055] In yet another embodiment, the surface texture comprises a plurality of spaced features; the features being arranged in a plurality of groupings; the groupings of features comprising repeat units; the spaced features within a grouping being spaced apart at an average distance of about 1 nanometer to about 200 millimeters. The groupings of features are arranged with respect to one another so as to define a tortuous path. In one embodiment, a tangent to the tortuous path intersects with at least one of the features.
[0056] In one embodiment, when viewed in a second direction, the pathway between the features may be non-linear and non-sinusoidal. In other words, the pathway can be non-linear and aperiodic. In another embodiment, the pathway between the features may be linear but of a varying thickness. The plurality of spaced features may be projected outwards from a surface or projected into the surface. In one embodiment, the plurality of spaced features may have the same chemical composition as the surface. In another embodiment, the plurality of spaced features may have a different chemical composition from the surface.
[0057] The tortuous pathway may be represented by a periodic function. The periodic functions may be different for each tortuous pathway. In one embodiment, the patterns can be separated from one another by tortuous pathways that can be represented by two or more periodic functions. The periodic functions may comprise a sinusoidal wave. In an exemplary embodiment, the periodic function may comprise two or more sinusoidal waves.
[0058] In another embodiment, when a plurality of different tortuous pathways are represented by a plurality of periodic functions respectively, the respective periodic functions may be separated by a fixed phase difference. In yet another embodiment, when a plurality of different tortuous pathways are represented by a plurality of periodic functions respectively, the respective periodic functions may be separated by a variable phase difference.
[0059] In another embodiment, the topography of the surface texture 104A, 104B has an average roughness factor (R) of from 2 to 50.
[0060] In one embodiment, each feature of a pattern has at least one neighboring feature that has a different geometry (e.g., size or shape). A feature of a pattern is a single element. Each feature of a pattern has at least 2, 3, 4, 5, or 6 neighboring features that have a different geometry from the feature. In one embodiment, there are at least 2 or more different features that form the pattern. In another embodiment, there are at least 3 or more different features that form the pattern. In yet another embodiment, there are at least 4 or more different features that form the pattern. In yet another embodiment, there are at least 5 or more different features that form the pattern.
[0061] In another embodiment, at least two identical features of the pattern have at least one neighboring feature that has a different geometry (e.g., size or shape). A feature of a pattern is a single element. In one embodiment, two identical features of the pattern have at least 2, 3, 4, 5, or 6 neighboring features that have a different geometry from the identical features. In another embodiment, three identical features of the pattern have at least 2, 3, 4, 5, or 6 neighboring features that have a different geometry from the identical features.
[0062] In another embodiment, each pattern has at least one or more neighboring patterns that have a different size or shape. In other words, a first pattern can have a second neighboring pattern that while comprising the same features as the first pattern can have a different shape from the first pattern. In yet another embodiment, each pattern has at least two or more neighboring patterns that have a different size or shape. In yet another embodiment, each pattern has at least three or more neighboring patterns that have a different size or shape. In yet another embodiment, each pattern has at least four or more neighboring patterns that have a different size or shape.
[0063] The texturing on the surfaces of the annular ring 127 may be represented by nomenclature. One example of the nomenclature adopted here may be represented by +XSKYZ and should deciphered as follows: The +X indicates the height of the texture above the base surface of the clamp while the SK refers to a Sharklet pattern depicted and described in U.S. Pat. No. 7,143,709 B2 to Brennan et al., and patent application having Ser. No. 12/550,870 to Brennan et al.
[0064] In an embodiment, the surface texture disposed on the annular ring 127 as shown in
[0065] In one embodiment, the elements of the pattern are arranged to be parallel with one another in the circumferential direction along the surface of the annular ring 127 such that the spacing of elements relative to one another forms a continuous pattern along the circumference of the inner surface. In another embodiment, the elements of the pattern are arranged to be parallel with one another in the circumferential direction along the surface of the annular ring 127 such that the spacing of each element relative to one another forms a discontinuous pattern along the circumference of the inner surface with gaps in between groupings of elements. Any number of elements may be grouped together in between the gaps, e.g., 3, 5 or 7 elements.
[0066] In one embodiment, the intraocular lens 111 (detailed in the
[0067] With reference now to the
[0068] With reference now to the
[0069] The back wall 202 has an outer diameter of up to 10 millimeters, preferably 7 millimeter to 9.6 millimeters. The back wall 202 has a thickness of up to 0.1 millimeter and contacts the side wall 204. The entire outer circumference of the side wall 204 contacts the entire outer circumference of the back wall 204. In other words, the outer diameter of the side wall is equal to the outer diameter of the back wall. The side wall has an inner diameter of up to 8.5 millimeters, preferably 6.5 millimeters to 8.4 millimeters, and more preferably 7.0 millimeters to 8.0 millimeters.
[0070] The lip 206 protrudes from the inner surface of the side wall and extends from the inner surface of the side wall 204 toward the center of the retaining cell 200 (i.e., it protrudes in the radial direction from the inner surface of the side wall). The lip 206 protrudes towards the center from the side wall 204 for a distance of about 25 to 40% of the outer diameter of the back wall 202. The lip 206 extends towards the center in a parallel arrangement with the back wall 202 to create a space 208 between the back wall and the lip that is used to locate the intraocular lens 111 during its installation and retention in the lens capsule.
[0071] While the lip 206 shown in the
[0072] The retaining cell 200 is manufactured from a flexible material that is biocompatible. Elastomers are suitable examples of materials that may be used in manufacturing the retaining cell. The flexible material does not always have to be elastomeric. Biocompatible elastomers include polysiloxane-containing materials and fluoro-containing polymers. Polydimethylsiloxane and polydimethylsiloxane containing copolymers (listed above) may be used to manufacture the retaining cell 200. Examples of fluoro-containing polymers are polytetrafluoroethylene, polyvinylfluoride, polyvinylidene fluoride, polychlorotrifluoroethylene, perfluoroalkoxy polymer, fluorinated ethylene-propylene, polyethylenetetrafluoroethylene, polyethylenechlorotrifluoroethylene, perfluoropolyether, or the like, or a combination thereof.
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[0075] In other words, the back wall 202 which extends toward a center of the retaining cell 200 acts to guide the fixation member of the intraocular lens 111 so that the intraocular lens can be easily and surely inserted and securely held. Since the back wall 202 is centripetally protruded, an ophthalmologist who performs an operation can not only confirm the back wall 202 of the device which is inserted into an eye and set but also insert and fix the intraocular lens easily and surely. The retaining cell can be retained in the lenticular capsule, when an old intraocular lens is removed and replaced with a new intraocular lens.
[0076] In another method of using the retaining cell 200, the intraocular lens 111 is inserted into the retaining cell 200 whilst outside the lenticular capsule. The retaining cell 200 with the intraocular lens 111 is then inserted into the lenticular capsule 300 through the opening 42.
[0077] It is to be noted that all ranges detailed herein include the endpoints. Numerical values from different ranges are combinable.
[0078] The transition term comprising encompasses the transition terms consisting of and consisting essentially of.
[0079] The term and/or includes both and as well as or. For example, A and/or B is interpreted to be A, B, or A and B.
[0080] While the invention has been described with reference to some embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.