Nanostructured intraocular lens and method for making same

Abstract

Certain embodiments provide an intraocular lens (IOL) comprising a lens body having a monolithic anterior lens element having an anterior nanostructure assembly formed thereon and a monolithic posterior lens element having a posterior nanostructure assembly formed thereon, and one or more haptics coupled to the lens body.

Description

[Technical field]

[0001] The present disclosure relates to nanostructured intraocular lenses and methods for making same. [Background technology]

[0002] The human eye, simply put, functions to provide vision by transmitting light through a clear outer portion called the cornea and focusing an image onto the retina by means of the lens. The quality of the focused image depends on many factors, including the size and shape of the eye and the transparency of the cornea and lens. When age or disease reduces the transparency of the lens, vision is reduced because less light can be transmitted to the retina. Such damage to the eye's lens is medically known as cataracts. The accepted treatment for this condition is to surgically remove the lens and replace its function with an intraocular lens (IOL).

[0003] While existing IOLs and their manufacturing methods and systems may be acceptable, they suffer from several shortcomings. Thus, there is a need for improvements in IOL designs and associated manufacturing techniques for complex optical designs. Summary of the Invention [Means for solving the problem]

[0004] Aspects of the present disclosure provide an intraocular lens (IOL) comprising a lens body having a monolithic anterior lens element having an anterior nanostructure assembly formed thereon, and a monolithic posterior lens element having a posterior nanostructure assembly formed thereon, and one or more haptics coupled to the lens body.

[0005] Aspects of the present disclosure also provide a method of fabricating an intraocular lens (IOL), the method including fabricating a monolithic anterior lens element and a monolithic posterior lens element, bonding the monolithic anterior lens element and the monolithic posterior lens element to form a cavity therebetween, and filling the cavity with an optical fluid, the monolithic anterior lens element having an anterior nanostructure assembly formed thereon, and the monolithic posterior lens element having a posterior nanostructure assembly formed thereon.

[0006] Aspects of the present disclosure further provide a method of constructing an intraocular lens (IOL), the method including calculating a configuration of an anterior nanostructure assembly formed on an anterior lens element of the IOL and a posterior nanostructure assembly formed on a posterior lens element of the IOL based on a lens base poser and a desired value of the refractive index of the IOL, and forming or causing the IOL to be formed based on the calculated configurations of the anterior nanostructure assembly and the posterior nanostructure assembly.

[0007] Having briefly summarized the present disclosure above, so that the above-mentioned features of the present disclosure can be understood in detail, the present disclosure may be more particularly described by reference to embodiments, some of which are illustrated in the accompanying drawings. However, it should be noted that the accompanying drawings only illustrate some aspects of the present disclosure, and that the present disclosure may admit of other equally effective embodiments. [Brief description of the drawings]

[0008] [Figure 1A] FIG. 1A illustrates a top view of an intraocular lens (IOL), according to certain embodiments. [Figure 1B] FIG. 1B shows a side view of a portion of the IOL of FIG. 1A, in accordance with certain embodiments. [Figure 1C] FIG. 1C shows an enlarged view of a portion of the IOL of FIG. 1A, in accordance with certain embodiments. [Diagram 2] FIG. 2 illustrates exemplary operations for fabricating an IOL having nanostructures, according to certain embodiments. [Diagram 3]FIG. 3 illustrates exemplary operations for forming a lens element according to certain embodiments. [Figure 4A-4C] 4A-4C show various aspects of a lens element corresponding to different stages of operation of FIG. 3, according to certain embodiments. [Diagram 5] FIG. 5 illustrates an exemplary system for designing, configuring, and / or forming an IOL, in accordance with certain embodiments. [Figure 6] FIG. 6 illustrates exemplary operations for forming an IOL, according to certain embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] To facilitate understanding, wherever possible, identical reference numerals are used to designate identical elements that are common to each of the figures. It is contemplated that elements and features of one embodiment may be beneficially incorporated in other embodiments without further reference.

[0010] Embodiments described herein provide methods and systems for fabricating an intraocular lens (IOL) having a nanostructured pattern embossed on an outer surface of the IOL. In certain embodiments, the methods and systems include creating anterior and posterior lens elements, each having a nanostructured pattern, bonding the anterior and posterior lens elements to form a cavity therebetween, and filling the cavity with an optical fluid.

[0011] Nanostructured IOLs FIG 1A shows a top view of an intraocular lens (IOL) 100, according to certain embodiments. FIG 1B shows a side view of a portion of the IOL 100. FIG 1C shows an enlarged side view of a portion of the IOL 100. The IOL 100 comprises a lens body 102 and a haptic portion 104 coupled to a peripheral non-optical portion of the lens body 102.

[0012] The lens body 102 comprises an anterior lens element 102A and a posterior lens element 102P. The lens elements 102A and 102P are bonded together to form a cavity 106. The cavity 106 is filled with an optical fluid. The optical fluid may be an incompressible or substantially incompressible fluid that exhibits a different refractive index than the lens elements 102A and 102P. The optical fluid may be an ophthalmic grade refractive index matched silicone oil, such as optical fluids available from Entegris, Inc. of Billerica, Massachusetts. The anterior lens element 102A and the posterior lens element 102P may be fabricated from a clear, flexible, biocompatible polymer, such as a flexible polymer including poly(dimethylsiloxane) (PDMS). The lens body 102 has a diameter φ of about 4.5 mm to about 7.5 mm (e.g., about 6.0 mm).

[0013] The haptic portion 104 is bonded (e.g., glued or welded) to a peripheral portion of the lens body 102 or molded with a portion of the lens body 102, and comprises hollow, radially extending struts (also referred to as "haptics") 104A and 104B that extend outwardly from the lens body 102 to engage the peripheral wall of the eye's capsular bag to maintain the lens body 102 in a desired position on the eye. The haptics 104A and 104B have interior volumes 108A, 108B, respectively, that are in fluid communication with the cavity 106 of the lens body 102. The haptics 104A and 104B may be made of a transparent, flexible, biocompatible material such as modified poly(methyl methacrylate) (PMMA), modified PMMA hydrogel, hydroxyethyl methacrylate (HEMA), PVA hydrogel, other silicone polymer materials, hydrophobic acrylic polymer materials, such as AcrySof® and Clareon® available from Alcon, Inc., Fort Worth, Texas. The haptics 104A and 104B typically have radially outer ends that define arcuate terminal portions. The terminal portions of the haptics 104A and 104B may be separated by a length L of about 6 mm to about 22 mm (e.g., about 13 mm). The haptics 104A and 104B have a particular length such that the terminal portions generate a slight engagement pressure when in contact with the equatorial region of the capsular bag after insertion. FIG. 1A shows one example configuration of haptics 104A and 104B, however, any plate haptics or other types of haptics may be used.

[0014] It should be noted that the shape and curvature of the lens body 102 are shown for illustrative purposes only, and other shapes and curvatures are within the scope of the present disclosure. For example, the lens body 102 shown in FIG. 1B has a biconvex shape. In other examples, the lens body 102 can have a plano-convex, convex-concave, or plano-concave shape. In certain embodiments, as shown in FIG. 1B, the IOL 100 is a monofocal IOL (having a single focus) with no annular echelette formed on the anterior lens element 102A or the posterior lens element 102P. In some other embodiments, the IOL 100 is a multifocal IOL (having multiple foci, e.g., bifocal and trifocal) with annular echelettes on the anterior lens element 102A and / or the posterior lens element 102P (not shown). In some other embodiments, the IOL 100 is an extended depth of focus (EDOF) IOL (having an elongated focus) with annular echelettes on the posterior lens element 102P (not shown).

[0015] In the embodiments described herein, the front lens element 102A has a front nanostructure assembly 110A formed thereon, and the rear lens element 102P has a rear nanostructure assembly 110P formed thereon (not shown). The front nanostructure assembly 110A and the front lens element 102A are formed as a monolithic single piece of the same material, such as a flexible polymer including PDMS. The rear nanostructure assembly 110P and the rear lens element 102P are also formed as a monolithic single piece of material, such as a flexible polymer including PDMS. In certain embodiments, the lens body 102 comprises only one of the front nanostructure assembly 110A or the rear nanostructure assembly 110P. The lens element 102A or 102P that does not have a nanostructure assembly formed thereon may comprise a diffractive structure that adjusts the refractive index and / or reflectivity of the lens.

[0016] As shown in FIG. 1C, the front nanostructure assembly 110A includes protrusions 112. The rear nanostructure assembly 110P includes similar protrusions 112. The shape, size, and density of the protrusions 112 (e.g., spacing between adjacent protrusions 112) are designed to provide the lens body 102 with a desired refractive index. For example, the protrusions 112 may have a height H of about 30 nm to about 200 nm, a width of about 30 nm to about 300 nm, and a spacing between adjacent protrusions 112 of about 30 nm to about 300 nm. The nanostructure assemblies 110A, 110P may further reduce the reflectivity by about 10% to about 90% compared to a lens body without a nanostructure assembly on its front or rear outer surface. In certain embodiments, the nanostructure assemblies 110A, 110P completely cover the front lens element 102A and the rear lens element 102P, respectively, as shown in FIG. 1B. However, in some other embodiments, nanostructure assemblies 110A, 110P only partially cover front lens element 102A and rear lens element 102P, respectively.

[0017] Fabrication of nanostructured IOLs FIG. 2 illustrates an example operation 200 for forming an IOL having nanostructures, according to certain embodiments.

[0018] In step 210, as described below in connection with operation 300, a front lens element (e.g., front lens element 102A) having a nanostructure assembly (e.g., nanostructure assembly 110A (shown in FIG. 1C)) and a rear lens element (e.g., rear lens element 102P) having a nanostructure assembly (e.g., nanostructure assembly 110P) are formed.

[0019] In step 220, the front and rear lens elements are assembled and hermetically sealed to form a cavity (e.g., cavity 106 (shown in FIG. 1B )). The front and rear lens elements may be bonded together by chemical bonding, thermal bonding, UV bonding, or other suitable type of bonding to hermetically seal the cavity therebetween in a peripheral non-optical portion of the lens body (e.g., lens body 102).

[0020] In step 230, the cavity is filled with an optical fluid, such as silicone oil.

[0021] Figure 3 illustrates an example operation 300 (i.e., step 210) for forming each of the lens elements 102A, 102P. Figures 4A, 4B, and 4C illustrate various aspects of the lens elements corresponding to different stages of operation 300. As such, Figures 3, 4A, 4B, and 4C are described together.

[0022] In step 310, a nanostructured pattern (e.g., nanostructured pattern 402) is formed on a substrate (e.g., substrate 404) by standard micro / nano fabrication methods, as shown in the isometric view of FIG. 4A and the cross-sectional view of FIG. 4B. For example, a photolithography process is first performed to spin-coat photoresist on the substrate, and selected areas of the photoresist are exposed to light and developed. The photoresist pattern is then transferred to the substrate by reactive ion etching. The remaining photoresist is then removed by plasma overetching. The nanostructured pattern may span an area of ​​about 7 mm by about 7 mm on the substrate and may comprise an array of trenches (e.g., array of trenches 406) cut into the substrate with a height of about 30 nm to about 200 nm, a width of about 30 nm to about 300 nm, and a spacing between adjacent trenches of about 30 nm to about 300 nm.

[0023] As used herein, the term "substrate" refers to a layer of material that serves as a basis for subsequent processing operations and includes a surface to be cleaned. For example, the substrate may include glass or one or more conductive metals such as nickel, titanium, platinum, molybdenum, rhenium, osmium, chromium, iron, aluminum, copper, tungsten, or combinations thereof. The substrate may also include one or more materials including silicon, including materials related to group IV or group III-V, including compounds such as Si, polysilicon, amorphous silicon, silicon nitride, silicon oxynitride, silicon oxide, Ge, SiGe, GaAs, InP, InAs, GaAs, GaP, InGaAs, InGaAsP, GaSb, InSb, or combinations thereof. Furthermore, the substrate may also include dielectric materials such as silicon dioxide, organosilicates, and carbon-doped silicon oxide. Furthermore, the substrate may include any other materials such as metal nitrides, metal oxides, and metal alloys depending on the application.

[0024] Furthermore, the substrate is not limited to any particular size or shape. The substrate can be a circular wafer having a diameter of 200 mm, a diameter of 300 mm, a diameter of 450 mm, or other diameter. The substrate can also be any polygonal, square, rectangular, curved, or other non-circular workpiece, such as a polygonal glass, plastic substrate.

[0025] In step 320, an elastomeric membrane (e.g., elastomeric membrane 408) is cast on the substrate having the nanostructured pattern formed thereon, as exemplarily shown in FIG. 4C. The elastomeric membrane may be formed of thin PDMS. In the casting process, liquid PDMS may be mixed with a crosslinking agent, poured onto the substrate, and heated at an elevated temperature of about 250° C. to about 350° C. to cure and crosslink the PDMS to form the elastomeric membrane. The elastomeric membrane may have a thickness between about 200 μm to 500 μm. The elastomeric membrane has protrusions (e.g., protrusions 410) that replicate the nanostructured pattern on the substrate. The protrusions may have a height of about 30 nm to about 200 nm, a width of about 30 nm to about 300 nm, and a spacing between adjacent trenches of about 30 nm to about 300 nm. After casting, the elastomeric membrane is removed from the substrate. This elastomeric membrane can be used as a front lens element having a front nanostructure assembly or a rear lens element having a rear nanostructure assembly (exemplary as shown in FIG. 1C).

[0026] A system for designing IOLs 5 illustrates an exemplary system 500 for designing, constructing, and / or forming IOL 100. As illustrated, system 500 includes, but is not limited to, a control module 502, a user interface display 504, an interconnect 506, an output device 508, and at least one I / O device interface 510, which may enable connection of various I / O devices (e.g., a keyboard, a display, a mouse device, a pen input, etc.) to system 500.

[0027] The control module 502 includes a central processing unit (CPU) 512, a memory 514, and storage 516. The CPU 512 may read and execute programming instructions stored in the memory 514. Similarly, the CPU 512 may read and store application data resident in the memory 514. The interconnect 506 transmits programming instructions and application data between the CPU 512, the I / O device interface 510, the user interface display 504, the memory 514, the storage 516, the output devices 508, etc. The CPU 512 may represent a single CPU, multiple CPUs, a single CPU with multiple processing cores, etc. Additionally, in certain embodiments, the memory 514 represents a volatile memory, such as a random access memory. Furthermore, in certain embodiments, the storage 516 may be a non-volatile memory, such as a disk drive, a solid state drive, or a collection of storage devices distributed across multiple storage systems.

[0028] As shown, the storage 516 includes input parameters 518, including the lens base power and the desired value of the refractive index of the lens body. The memory 514 includes a calculation module 520 that calculates control parameters, such as the configuration (e.g., shape, size, and density) of the nanostructure assemblies 110A, 110P. In addition, the memory 514 includes input parameters 522.

[0029] In certain embodiments, the input parameters 522 correspond to the input parameters 518, or at least a subset thereof. In such embodiments, during calculation of the control parameters, the input parameters 522 are retrieved from the storage 516 and executed in the memory 514. In such examples, the calculation module 520 includes executable instructions (e.g., including one or more of the formulas described herein) for calculating the control parameters based on the input parameters 522. In certain other embodiments, the input parameters 522 correspond to parameters received from a user through the user interface display 504. In such embodiments, the calculation module 520 includes executable instructions for calculating the control parameters based on information received from the user interface display 504.

[0030] In certain embodiments, the calculated control parameters are output via output device 508 to a lens manufacturing system configured to receive the control parameters and form a lens in response thereto. In certain other embodiments, system 500 itself represents at least a portion of a lens manufacturing system. In such embodiments, control module 502 then causes hardware components (not shown) of system 500 to form a lens in accordance with the control parameters, per operation 200 described above.

[0031] How the IOL is created 6 illustrates exemplary operations 600 for forming an IOL (e.g., IOL 100). In some embodiments, step 610 of operations 600 is performed by one system (e.g., system 500), while step 620 is performed by a lens manufacturing system. In some other embodiments, both steps 610 and 620 are performed by a lens manufacturing system.

[0032] In step 610, control parameters such as the configuration (e.g., shape, size, and density) of the nanostructure assemblies 110A, 110P are calculated based on the input parameters (e.g., the lens base power and the desired value of the refractive index of the lens body). The calculations performed in step 610 are based on one or more of the embodiments including the formulas described herein.

[0033] In step 620, an IOL (e.g., IOL 100) based on the calculated control parameters, such as the configuration (e.g., shape, size, and density) of nanostructure assemblies 110A, 110P, is formed according to operation 200 above using suitable methods, systems, and equipment typically used in the manufacture of lenses known to those of skill in the art.

[0034] The embodiments described herein provide a method and system for fabricating an IOL with a nanostructured pattern embossed on its outer surface by creating an anterior lens element and a posterior lens element, each having a nanostructured pattern, bonding the anterior lens element and the posterior lens element to form a cavity therebetween, and filling the cavity with an optical fluid. The methods described herein may provide a simplified fabrication process for an IOL with a nanostructured pattern embossed on its outer surface compared to conventional fabrication processes. In addition, the methods described may further eliminate concerns related to the collapse of an inserted IOL formed by fabricating the nanostructures separately and later attaching them to the IOL. Thus, the improved fabrication techniques disclosed herein may produce improved IOLs with nanostructures on their outer surface to reduce customer complaints about glare and halos, as well as reflection problems sometimes associated with the scary eye phenomenon.

[0035] While the forgoing is directed to embodiments of the present disclosure, other and further embodiments of the present disclosure may be devised without departing from the basic scope of the disclosure, which scope is determined by the claims that follow.

Claims

1. a lens body having a monolithic front lens element having a front nanostructure assembly formed thereon and a monolithic rear lens element having a rear nanostructure assembly formed thereon; one or more haptics coupled to the lens body; An intraocular lens (IOL) comprising:

2. The IOL of claim 1 , wherein the monolithic anterior lens element and the monolithic posterior lens element each comprise poly(dimethylsiloxane) (PDMS).

3. an optical fluid filling a cavity formed between the monolithic front lens element and the monolithic rear lens element; The IOL of claim 1 further comprising:

4. The IOL of claim 3 , wherein the optical fluid is a silicone oil.

5. The IOL of claim 3 , wherein the one or more haptics each comprise an interior volume in fluid communication with the cavity.

6. The IOL of claim 1 , wherein each of said anterior nanostructure assembly and said posterior nanostructure assembly comprises a plurality of protrusions having a height of 30 nm to 200 nm, a width of 30 nm to 300 nm, and a spacing between adjacent protrusions of 30 nm to 300 nm.

7. 2. The IOL of claim 1, wherein the anterior nanostructure assembly and the posterior nanostructure assembly are configured to reduce the reflectivity of the lens body by 10% to 90% compared to a lens body not having a nanostructure assembly on the monolithic anterior lens element or the monolithic posterior lens element.

8. Fabricating a monolithic front lens element and a monolithic rear lens element, said monolithic front lens element having a front nanostructure assembly formed thereon; said monolithic rear lens element having a rear nanostructure assembly formed thereon; bonding the monolithic front lens element and the monolithic rear lens element to form a cavity therebetween; filling the cavity with an optical fluid; and A method for making an intraocular lens (IOL), comprising:

9. said fabricating each of said monolithic front lens element and said monolithic rear lens element comprises: Casting an elastomeric film onto a substrate having a nanostructured pattern formed thereon; removing the elastomeric membrane from the substrate; and The method of claim 8 , comprising:

10. The method of claim 9 , wherein the elastomeric membrane comprises poly(dimethylsiloxane) (PDMS).

11. 10. The method of claim 9, wherein the nanostructured pattern formed on the substrate spans an area of ​​7 mm by 7 mm and comprises an array of trenches having a height of 30 nm to 200 nm, a width of 30 nm to 300 nm, and a spacing between adjacent trenches of 30 nm to 300 nm.

12. 9. The method of claim 8, wherein the front nanostructure assembly and the rear nanostructure assembly each comprise a plurality of protrusions having a height between 30 nm and 200 nm, a width between 30 nm and 300 nm, and a spacing between adjacent trenches between 30 nm and 300 nm.

13. The method of claim 8 , wherein the optical fluid is a silicone oil.

14. attaching haptic portions to peripheral non-optical portions of the monolithic anterior lens element and the monolithic posterior lens element; the haptic portion includes one or more hollow haptics having an interior volume in fluid communication with the cavity; The method of claim 8 further comprising:

15. Calculating a configuration of an anterior nanostructure assembly formed on an anterior lens element of an IOL and a posterior nanostructure assembly formed on a posterior lens element of said IOL based on a desired value of a lens base power and a refractive index of said IOL; forming the IOL or causing the IOL to be formed based on the calculated configuration of the anterior nanostructure assembly and the posterior nanostructure assembly; A method of constructing an intraocular lens (IOL), comprising:

16. forming the IOL or causing the IOL to be formed, fabricating the front lens element and the rear lens element; bonding the front lens element and the rear lens element to form a cavity therebetween; filling the cavity with an optical fluid; and 16. The method of claim 15, comprising:

17. said fabricating each of said front lens element and said rear lens element further comprises: Casting an elastomeric film onto a substrate having a nanostructured pattern formed thereon; removing the elastomeric membrane from the substrate; and 17. The method of claim 16, comprising:

18. The method of claim 17 , wherein the elastomeric membrane comprises poly(dimethylsiloxane) (PDMS).

19. 18. The method of claim 17, wherein the nanostructured pattern formed on the substrate spans an area of ​​7 mm by 7 mm and comprises an array of trenches having a height of 30 nm to 200 nm, a width of 30 nm to 300 nm, and a spacing between adjacent trenches of 30 nm to 300 nm.

20. The method of claim 16 , wherein the optical fluid is a silicone oil.

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