Artificial cornea

Abstract

To provide an artificial cornea suitable for surgical implantation.SOLUTION: An embodiment of an artificial cornea includes: an optical element that includes a body having an anterior side and a posterior side and an annular flange extending about the body; and a tissue integration skirt coupled to the optical element, the tissue integration skirt coupled to the optical element. The anterior side of the body includes an anterior optical surface and the posterior side of the body includes a posterior optical surface. The tissue integration skirt is configured to promote tissue ingrowth, and the tissue integration skirt is coupled to the optical element such that at least a portion of a periphery of the annular flange defined between the anterior and posterior sides of the optical element is covered by the tissue integration skirt. Also described are methods for implanting an artificial cornea of the present disclosure, the methods including providing the artificial cornea, removing a section of corneal tissue from the patient's cornea to form a tissue bed of existing tissue to which the artificial cornea can be affixed, implanting the artificial cornea such that the posterior side of the artificial cornea is suspended above the interior of the eye, and mechanically affixing the implanted artificial cornea to the existing corneal tissue of the tissue bed.SELECTED DRAWING: Figure 4

Description

[Technical field]

[0001] The present disclosure relates generally to artificial corneas. The artificial corneas of the present disclosure are suitable for implantation as a corneal substitute. [Background technology]

[0002] The cornea generally refracts and focuses light onto the retina and acts as a protective barrier against the intraocular components of the eye. The cornea is susceptible to a number of diseases, genetic disorders, and trauma that can cause what is otherwise an optically clear window to the retina to become opaque.

[0003] Surgical procedures exist for replacing damaged or diseased corneas with live tissue corneas harvested from donor eyes, however, donor corneas may not be available, the underlying condition of the damaged eye may make the donor cornea more likely to fail or be rejected, and / or the patient's physiology may make the donor cornea more likely to fail or be rejected.

[0004] When transplantation of a donor cornea is not feasible, transplantation of an artificial cornea is a potential alternative treatment. An artificial cornea or keratoprosthesis is an artificial cornea that can be implanted into a patient's eye to replace part or all of a damaged or diseased cornea. The main challenges facing keratoprostheses have been biointegration complications and extrusion of the device from the eye. Other complications include infection, formation of a post-prosthetic membrane, inflammation, glaucoma, lack of mechanical durability, and optical contamination.

[0005] Several approaches have been attempted to solve the problem of device rejection. One approach involves keratoprosthesis designs with a core and skirt type structure. Core and skirt type devices generally have a non-porous optic core for visual restoration and a skirt for biointegration with the ocular tissue surrounding the skirt. Summary of the Invention [Problem to be solved by the invention]

[0006] However, to date, conventional core and skirt type constructions have not demonstrated optimal device fixation and long-term optical patency. Therefore, improved artificial corneas capable of demonstrating long-term optical patency are desirable. [Means for solving the problem]

[0007] According to one example ("Example 1"), an artificial cornea is characterized in that it comprises an optical element including a body having an anterior side and a posterior side and an annular flange extending around the body, and a tissue-integrating skirt coupled to the optical element, wherein the anterior side of the body includes an anterior optical surface and the posterior side includes a posterior optical surface, the tissue-integrating skirt is configured to promote tissue ingrowth, and the tissue-integrating skirt is coupled to the optical element such that at least a portion of a circumference of the annular flange defined between the anterior side and the posterior side of the optical element is covered by the tissue-integrating skirt.

[0008] According to another example ("Example 2"), further to Example 1, the annular flange includes a first flange component and a second flange component rearward of the first flange component, the first flange component defining a first front surface and a peripheral surface, and the second flange component defining a second front surface offset from the first front surface by the peripheral surface.

[0009] According to another example ("Example 3"), further to Example 2, the tissue integration skirt is coupled to each of the first anterior surface, the peripheral surface, and the second anterior surface.

[0010] According to another example ("Example 4"), further to examples 1 or 3, the first front surface and the second front surface of the annular flange are non-parallel.

[0011] According to another example ("Example 5"), in addition to any of Examples 2-4, the annular flange has a non-uniform thickness.

[0012] According to another example ("Example 6"), in addition to any of Examples 2-5, the first flange component and the second flange component each extend radially outwardly around the body.

[0013] According to another example ("Example 7"), in addition to any of Examples 2-5, the second flange component extends radially outwardly further than the first flange component.

[0014] According to another example ("Example 8"), in addition to any of Examples 2-5, the second flange includes at least one aperture configured to allow tissue to grow therethrough.

[0015] According to another example ("Example 9"), in addition to example 8, the at least one aperture is formed by micro-drilling.

[0016] According to another example ("Example 10"), in addition to example 8, the second flange includes a material having a microstructure that forms the at least one aperture.

[0017] According to another example ("Example 11"), in addition to any of Examples 1-10, the posterior optical surface is offset from the posterior surface of the annular flange.

[0018] According to another example ("Example 12"), further to Example 11, an offset between the posterior optical surface and the posterior surface of the annular flange is configured as a barrier to help resist tissue growth across the posterior optical surface.

[0019] According to another example ("Example 13"), in addition to any of Examples 1-12, a rear side of the body is not covered by the tissue-integrating skirt.

[0020] According to another example ("Example 14"), in addition to any of Examples 1-13, the tissue-integrating skirt covers a portion of the anterior side of the optical element.

[0021] According to one example ("Example 15"), an artificial cornea is characterized in that the artificial cornea includes an optical element including a body having an anterior side and a posterior side, the optical element being configured to resist tissue ingrowth, an annular flange extending around the body, and a tissue-integrating skirt configured to allow tissue ingrowth, wherein the anterior side of the body includes an anterior optical surface and the posterior side includes a posterior optical surface, the annular flange includes a first flange component and a second flange component positioned posterior to the first flange component, a peripheral surface of the body is defined between the first flange component and the second flange component, the first flange component defines a posterior flange surface, the second flange component defines an anterior flange surface offset from the posterior flange surface by the peripheral surface, and the tissue-integrating skirt is bonded to the peripheral surface.

[0022] According to another example ("Example 16"), in addition to example 15, the integral skirt is further coupled to the front flange surface, the rear flange surface, or both the front flange surface and the rear flange surface.

[0023] According to another example ("Example 17"), in addition to any of Examples 1-16, the anterior optical surface is convex.

[0024] According to another example ("Example 18"), in addition to any of Examples 1-17, the posterior optical surface is concave.

[0025] According to another example ("Example 19"), in addition to any of Examples 1-18, the optical element includes a fluoropolymer.

[0026] According to another example ("Example 20"), in addition to Example 19, the fluoropolymer is treated to make it hydrophilic.

[0027] According to another example ("Example 21"), in addition to Example 20, the fluoropolymer is hydrophilic.

[0028] According to another example ("Example 22"), in addition to any of Examples 1-21, the optical element includes a copolymer of tetrafluoroethylene (TFE) and perfluoromethylvinylether (PMVE).

[0029] According to another example ("Example 23"), in addition to any of Examples 1 to 22, the artificial cornea is foldable.

[0030] According to another example ("Example 24"), in addition to any of Examples 1 to 23, the artificial cornea is configured to enable in situ measurement of intraocular pressure in the eye by intraocular pressure measurement involving interaction with the artificial cornea.

[0031] According to another example ("Example 25"), further to Example 24, the artificial cornea is configured to enable in situ measurement of intraocular pressure in the eye by measuring the deformation response of a region of the eye where the artificial cornea interfaces with natural corneal tissue when an external force is applied directly to the eye.

[0032] According to another example ("Example 26"), in addition to Example 25, the external force is applied by an object in contact with the interface area to be measured.

[0033] According to another example ("Example 27"), in addition to any of Examples 1 to 26, the refractive index of the artificial cornea is within the range of 1.3 to 1.4.

[0034] According to another example ("Example 28"), in addition to any of Examples 1-27, the optical element is configured to resist tissue ingrowth.

[0035] According to another example ("Example 29"), further to any of Examples 1-28, the anterior optical surface is configured to resist tissue ingrowth while allowing tissue attachment thereto.

[0036] According to another example ("Example 30"), in addition to Example 29, the anterior optical surface includes a microstructure configured to enable tissue attachment to the anterior optical surface while resisting tissue ingrowth.

[0037] According to another example ("Example 31"), in addition to Example 29, the anterior optical surface is at least partially covered by a corneal epithelial growth layer, and the corneal epithelial growth layer is configured to promote and support the formation and maintenance of an organized monolayer of corneal epithelial cells on the anterior optical surface.

[0038] According to another example ("Example 32"), in addition to any of Examples 1-31, the optical element is formed from a material having a microstructure configured to resist tissue ingrowth.

[0039] According to another example ("Example 33"), in addition to any of Examples 1-32, the optical element is coated with a material configured to resist tissue ingrowth.

[0040] According to another example ("Example 34"), in addition to any of Examples 1-33, the tissue integration skirt is formed from a material having a microstructure configured to allow tissue ingrowth.

[0041] According to one example ("Example 35"), a method of forming an artificial cornea includes providing an optical element including a body having an anterior side and a posterior side and an annular flange extending around the body, and further including a posterior optical surface on the posterior side of the body, providing a tissue-integrating skirt configured to promote tissue ingrowth, and bonding the tissue-integrating skirt to the optical element such that a portion of a circumference of the annular flange defined between the anterior and posterior sides of the optical element is covered by the tissue-integrating skirt.

[0042] According to another example ("Example 36"), in addition to Example 35, the posterior optical surface is longitudinally offset from the posterior surface of the annular flange.

[0043] According to another example ("Example 37"), in addition to Example 35 or Example 36, the tissue-integrating skirt is further attached to the optical element such that a portion of the front side of the optical element is covered by the tissue-integrating skirt.

[0044] According to another example ("Example 38"), in addition to any of Examples 35-37, the optical element is configured to resist tissue ingrowth, and a front side of the optical element is configured to allow tissue attachment while resisting tissue ingrowth.

[0045] According to one example ("Example 39"), a method of implanting an artificial cornea includes providing an artificial cornea as described in any one of claims 1 to 34, removing a fragment of corneal tissue from a patient's cornea to form a tissue bed of existing corneal tissue to which the artificial cornea can be attached, implanting the artificial cornea such that a posterior side of the artificial cornea is suspended above the interior of the eye, and mechanically fixing the transplanted artificial cornea to the existing corneal tissue of the tissue bed.

[0046] According to another example ("Example 40"), in addition to Example 39, removing the fragment of corneal tissue includes removing a full-thickness fragment of corneal tissue from the patient's cornea, and implanting the artificial cornea includes implanting the artificial cornea such that a posterior side of the artificial cornea is not supported by existing corneal tissue in the tissue bed.

[0047] While multiple embodiments are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief description of the drawings]

[0048] The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrate embodiments and, together with the description, serve to explain the principles of the disclosure.

[0049] [Figure 1] FIG. 1 is a diagram of an artificial corneal structure according to some embodiments.

[0050] [Diagram 2]FIG. 2 is a rear perspective view of the artificial cornea structure of FIG. 1, according to some embodiments.

[0051] [Diagram 3] FIG. 3 is a top view of the artificial cornea structure of FIG. 1, according to some embodiments.

[0052] [Figure 4] FIG. 4 is a cross-sectional view of the artificial corneal structure of FIG. 1 taken along line 4-4 of FIG. 3, according to some embodiments.

[0053] [Diagram 5] FIG. 5 is a cross-sectional view of the artificial cornea of ​​FIG. 4 with the tissue-integration element removed, according to some embodiments.

[0054] [Figure 6] FIG. 6 is a cross-sectional view of an artificial corneal structure according to some embodiments.

[0055] [Figure 7] FIG. 7 is a diagram of an artificial cornea according to some embodiments.

[0056] [Figure 8] FIG. 8 is a rear perspective view of the artificial cornea structure of FIG. 7 according to some embodiments.

[0057] [Figure 9] FIG. 9 is a top view of the artificial cornea structure of FIG. 7 according to some embodiments.

[0058] [Figure 10] FIG. 10 is a cross-sectional view of an artificial corneal structure taken along line 10-10 of FIG. 9 according to some embodiments.

[0059] [Figure 11] FIG. 11 is a cross-sectional view of the artificial cornea of ​​FIG. 10 with the tissue-integration element removed, according to some embodiments.

[0060] [Figure 12] FIG. 12 is a diagram of an artificial corneal structure according to some embodiments.

[0061] [Figure 13] FIG. 13 is a cross-sectional view of the artificial cornea of ​​FIG.

[0062] [Figure 14] FIG. 14 is a diagram of an artificial corneal structure according to some embodiments.

[0063] [Figure 15] FIG. 15 is a rear perspective view of the artificial cornea structure of FIG. 14 according to some embodiments.

[0064] [Figure 16] FIG. 16 is a top view of the artificial cornea structure of FIG. 14 according to some embodiments.

[0065] [Figure 17] 17A-17C are cross-sectional views of artificial corneal structures taken along lines 17-17 of FIG. 16 according to some embodiments.

[0066] [Figure 18] FIG. 18 is a cross-sectional view of the artificial cornea core of FIGS. 17A-17C with the tissue-integration elements removed, according to some embodiments.

[0067] [Figure 19] FIG. 19 is a cross-sectional view of an artificial corneal structure according to some embodiments.

[0068] [Figure 20] FIG. 20 is a graphical representation showing the relationship between artificial corneal diopter measurements and intraocular pressure, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0069] Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0070] Various aspects of the present disclosure are directed to artificial cornea devices, systems, and methods of manufacture and implantation. More specifically, the present disclosure relates to devices, systems, and methods for manufacturing and using an artificial cornea that includes a core and skirt structure. The artificial cornea 100 is an implantable medical device that functions as a synthetic replacement for a diseased, damaged, or otherwise in need of replacement cornea. In various embodiments, the artificial cornea includes an optic and a tissue-integration element coupled to the optic. In various embodiments, the optic is synthetic and includes a polymeric material. In various embodiments, the tissue-integration element is synthetic and includes a polymeric material. The tissue-integration element is configured to facilitate biological integration of the artificial cornea into the eye, while the optic acts as a functional replacement for the existing cornea.

[0071] In some embodiments, the tissue-integrating element is configured to allow tissue ingrowth and attachment of tissue to the material of the tissue-integrating element. In some embodiments, one or more designated portions or regions of the optical element can be configured to resist tissue ingrowth and attachment. For example, in some embodiments, one or more optical surfaces of the optical element (e.g., the posterior optical surface) can be configured to resist tissue ingrowth and attachment. Additionally or alternatively, in some embodiments, one or more designated portions or regions of the optical element can be configured to allow tissue attachment while being configured to resist tissue ingrowth. That is, in some embodiments, one or more portions or regions of the material of the optical element can be configured to allow tissue attachment. For example, in some embodiments, the optical surface of the optical element (e.g., the anterior optical surface) can be configured to allow tissue attachment while resisting tissue ingrowth.

[0072] Tissue ingrowth may generally be understood to mean cellular intrusion into a material beyond its surface (e.g., the material may include a base material and / or a coating). Tissue ingrowth generally refers to a material's microstructure that includes pores or voids of sufficient size to allow biological cells to grow or otherwise advance through the pores or voids. Thus, tissue ingrowth means that not only can tissue grow across (and reside on) the surface of the material, but also that tissue can substantially invade into the material beyond its surface. On the other hand, as used herein, the term "tissue attachment" may generally be understood to mean cell adhesion or attachment to the surface of a material without cellular intrusion beyond or substantially beyond the surface of the material into the material. The attachment may be due to surface charge, surface roughness, and / or chemical bonds. For example, the material may have a textured surface that is not smooth but includes peaks, valleys, ridges, and / or channels that can support tissue present thereon and therein. In some instances, the microstructure of the material can be non-porous, while in other instances, the microstructure can include pores or voids of insufficient size to accommodate the advancement of cells therethrough. Thus, the surface is configured to support tissue present and growing thereon, but the tissue cannot substantially penetrate beyond the surface of the material (e.g., beyond peaks, valleys, ridges, and / or channels) into the material. By allowing tissue attachment while resisting tissue ingrowth, tissue such as epithelial tissue can proliferate and grow across the surface of the material without substantially penetrating into the material. Avoiding substantial tissue penetration into one or more regions or portions of the optical element helps minimize the possibility of contaminating the optical performance of the optical element, when tissue ingrowth can reduce or otherwise contaminate the optical performance of the material of the optical element. Additionally, minimizing the possibility of tissue substantially penetrating into one or more regions or portions of the optical element allows tissue attached to the surface to be subsequently removed from the surface by a physician, whereas tissue that has substantially penetrated the optical element is difficult to remove (if at all).In some instances, tissue cells growing across the optical surface may become organized in an unorganized manner, causing unsatisfactory distortion of the image when viewed through the optical element. In these instances, the cells may have to be periodically scraped off the surface of the optical element to which they are attached. By limiting the attachment of the cells to the surface and minimizing their penetration into the material beyond the surface, the physician can remove the cells from the optical element, such as by scraping the cells off the surface. In some embodiments, the attachment of tissue to the optical surface helps to convert or transform the mesoplant (e.g., a device that interfaces between the external and internal environments) into an implant, thereby minimizing the risk of infection and device extrusion.

[0073] An artificial cornea 100 according to some embodiments is shown in FIG. 1. As shown, the artificial cornea 100 includes an optical element 200 and a tissue-integrating element 300 (also referred to as a tissue-integrating skirt). The artificial cornea 100 has an anterior side 102 and a posterior side 104 opposite the anterior side 102. When implanted, the anterior side 102 generally faces or is otherwise exposed to the external environment, while the posterior side 104 faces the interior of the natural eye. Thus, when implanted, the artificial cornea 100 may form a barrier between the interior of the eye and the external environment. The artificial cornea 100 may include an anterior surface profile that generally corresponds to a circular, elliptical, or oval shape. One or more of the anterior or posterior optical surfaces (described in more detail below) may be curved or non-curved, such that the edge shape of the artificial cornea may correspond to curved or non-curved anterior and posterior optical surfaces.

[0074] In some instances, the outer peripheral surface 106 of the artificial cornea 100, which generally extends around the periphery of the artificial cornea, can be a regular or irregular shape (e.g., scallops, spokes, star-shaped, etc.) and generally extends around the periphery of the artificial cornea. The artificial cornea 100 includes an anterior optical surface 108 and a posterior optical surface 110. As discussed in more detail below, the anterior and posterior optical surfaces 108 and 110 of the artificial cornea 100 generally correspond to the anterior and posterior optical surfaces of the optic 200 and are therefore shaped accordingly, as will be understood by those skilled in the art. For example, as shown in Figures 1, 2 and 4, the anterior side 102 is generally convex and the posterior side 104 is generally concave.

[0075] Figure 4 shows a cross-sectional view of artificial cornea 100 taken along line 4-4 of Figure 3. As shown, the artificial cornea includes optic 200 and tissue-integration element 300. Tissue-integration element 300 is shown coupled to optic 200 along its peripheral wall or surface 208 and along its anterior surface 220.

[0076] The optical element 200 shown in Figures 1-5 is a disk-shaped member that functions as an optically transparent window to the retina when implanted in a patient's eye. Figure 5 shows the optical element 200 with the tissue integration element removed. The optical element 200 generally includes a body 202, which may be disk-shaped as shown. It is understood, therefore, that the body 202 may include a circular or elliptical shape and may be flat or curved. In various embodiments, the body 202 is formed from a synthetic biocompatible material.

[0077] For example, the body 202 can be formed from a number of suitable materials, including, but not limited to, fluoropolymers selected from copolymers of tetrafluoroethylene (TFE) and perfluoroalkyl vinyl ethers (PAVEs), such as perfluoromethyl vinyl ether (PMVE), perfluoroethyl vinyl ether (PEVE), and perfluoropropyl vinyl ether (PPVE), copolymers of TFE and hexafluoropropylene (FEP), perfluoropolymers preferably containing TFE as a comonomer, perfluoroalkoxy polymers (PFA), perfluoropolyethers, or can include silicone, poly(methyl methacrylate) (PMMA), hydrogels, polyurethanes, or any suitable and appropriate combinations thereof.

[0078] In some examples, the body 202 can be formed from a material including a copolymer of TFE and PMVE, which is uniquely formed to have excellent mechanical properties while being substantially non-crosslinked, i.e., free of crosslinking monomers and curing agents. The copolymer includes 40-80% PMVE units by weight, and complementary 60-20% TFE units by weight. Due to the absence of a crosslinking system, the material is of high purity and, unlike some thermosetting TFE / PMVE elastomers, is ideally suited as an implantable biomaterial. Advantages include excellent biocompatibility, high tensile strength, high transparency, high abrasion resistance, high purity, sufficient elasticity, and ease of processing due to the thermoplastic and non-crosslinked structure of the copolymer. The copolymer is thermoplastic and amorphous. It also has high strength and can be used as a bonding agent that is particularly suitable for bonding porous PTFE to itself or to other porous materials at room temperature or elevated temperatures. It can also be used to bond non-porous materials, including polymers such as non-porous PTFE. US Pat. No. 7,049,380 further illustrates and describes such copolymers of TFE and PMVE, and is incorporated herein by reference in its entirety.

[0079] In some embodiments, the body 202 is configured to minimize, inhibit, or even prevent tissue ingrowth. In some embodiments, the microstructure of the body 202 is configured to minimize, inhibit, or prevent tissue ingrowth. Additionally or alternatively, a coating applied to the body 202 is configured to minimize, inhibit, or prevent tissue ingrowth into the body 202. However, in some instances, tissue attachment to one or more surfaces of the body 202 (e.g., the anterior optical surface 210) is permitted. In some instances, the anterior optical surface 210 may be configured to support tissue attachment while resisting tissue ingrowth (e.g., tissue penetration into the material beyond the surface of the anterior optical surface 210). In some embodiments, one or more surface conditioning processes and / or material coating processes may be utilized to help promote tissue attachment and growth to the anterior optical surface 210 of the optical element 200. For example, the surface may be conditioned (e.g., conditioned so that the surface has a non-smooth surface texture) using one or more known mechanical and / or chemical conditioning processes.

[0080] In some examples, the body 202 can have a refractive index in the range of 1.2 to 1.6, such as in the range of 1.3 to 1.4. In some examples, the body can have a light transmittance in the visible light transmission range (wavelengths of 400 to 700 nm) of greater than 50%, more preferably greater than 80%. Additives such as crosslinkers, bioactive agents (e.g., growth factors, cytokines, heparin, antibiotics or other drugs), hormones, UV absorbers, dyes, other therapeutic agents, etc. can be incorporated into the material forming the body 202 depending on the desired performance of the device.

[0081] In various embodiments, the body 202 is optically transparent in that the optical element 200 acts as a synthetic substitute for a normally functioning cornea. In some instances, one or more portions of the body 202, such as one or more optical portions, are optically transparent. For example, as discussed in more detail below, at least a portion of the body 202 located within a bonding region between the optical element 200 and the tissue integration element 300 is optically transparent.

[0082] In various embodiments, the body 202 of the optical element 200 includes an anterior side 204, a posterior side 206, and a peripheral surface 208 extending between the anterior and posterior sides 204 and 206. In some embodiments, the anterior side 204 generally faces or is otherwise exposed to the external environment, while the posterior side 206 faces the eye (e.g., ocular tissue and the interior of the eye). In various examples, the anterior side 204 is generally convexly curved, while the posterior side 206 is generally concavely curved. The peripheral surface 208 is a surface that extends circumferentially around the body 202 and forms a transition between the anterior and posterior sides 204 and 206. The peripheral surface 208 can be regular or irregular (e.g., scalloped) and can include one or more portions that extend perpendicular or substantially perpendicular to one or more surfaces of the anterior and posterior sides 204 and 206. The peripheral surface 208 can be linear or non-linear and can include multiple surfaces (e.g., sub-surfaces that collectively define the peripheral surface 208). The peripheral surface 208 generally forms or defines at least a portion of a bonding region where the tissue-integrating element 300 is bonded to the body 202. That is, in some embodiments, the tissue-integrating element 300 is bonded to the optical element 200 along a bonding region that is at least partially defined by the peripheral surface 208 (e.g., a portion of the body 202 having a surface extending between the anterior and posterior sides 204 and 206).

[0083] In various examples, the anterior side 204 of the body 202 of the optical element 200 includes an anterior optical surface, such as anterior optical surface 210. In various embodiments, the anterior optical surface 210 contributes to the formation of an image in the range of visual acuity. The anterior optical surface 210 acts as a primary refractive surface in the optical path of light to the retina. In various examples, the anterior optical surface 210 acts as an interface between the body 202 of the optical element 200 of the artificial cornea 100 and the external environment, defining at least a portion of the anterior side 102 of the artificial cornea 100 and defining at least a portion of the anterior side 204 of the body 202 of the optical element 200. The anterior optical surface 210 corresponds to the anterior optical surface 108 of the artificial cornea 100. In various examples, the anterior optical surface 210 is a surface that allows for high light transmission. In various examples, the anterior optical surface 210 is generally curved or non-linear. For example, as shown in FIG. 5, the anterior optical surface 210 is convex.

[0084] In some examples, the optical element 200 includes an anterior protrusion, or a protrusion of the body 202 that extends forward from the body 202. For example, as shown in FIG. 5, the optical element 200 includes an anterior protrusion 212. The anterior protrusion 212 can be all or less than all of the anterior side 204 of the body 202. Thus, as discussed further below and shown in FIG. 5, in various examples, the anterior side 204 of the body 202 can include multiple surfaces that are longitudinally offset from one another. In various examples, the anterior optical surface 210 corresponds to the anterior surface of the anterior protrusion 212. Thus, in examples that include multiple anterior surfaces, the anterior optical surface 210 defines only a portion of the anterior surface 204 of the body 202. However, in some other examples, the anterior optical surface 210 extends across the entire anterior side 204 of the body 202 and defines the anterior side 204 of the body 202.

[0085] In some embodiments, the anterior projection 212 is formed as a protrusion on the anterior side 204 of the body 202. In other instances, the anterior projection 212 is additionally or alternatively formed by forming an annular, circumferentially extending recess in the anterior side 204 of the body 202. That is, in some instances, an annular ring of material is removed from the anterior side 204 of the body 202 to form an annular, circumferentially extending recess around the anterior side 204 of the body 202. In yet other instances, the anterior projection 212 is additionally or alternatively formed by forming an annular flange 218 extending circumferentially around the body 202, where the anterior surface 220 of the annular flange 218 is recessed or otherwise offset posteriorly relative to the anterior optical surface 210. Stated differently, in some instances, the anterior side 204 of the optical element 200 is stepped to include at least a first anterior surface and a second anterior surface offset relative to the first anterior surface. In some examples, the anterior optical surface is offset from the anterior surface 220 of the annular flange 218 by between zero (0) and 200 microns. As shown in FIG. 5 , a first surface or step 224 extends between the anterior optical surface 210 and the annular flange 218's annular front surface 220.

[0086] In various embodiments, the posterior side 206 of the body 202 of the optical element 200 includes a posterior optical surface, such as the posterior optical surface 210. In various examples, the posterior optical surface 210 serves as an interface between the body 202 of the optical element 200 of the artificial cornea 100 and the interior of the eye, and defines at least a portion of the posterior side 104 of the artificial cornea 100 and at least a portion of the posterior side 206 of the body 202 of the optical element 200. The posterior optical surface 214 corresponds to the posterior optical surface 110 of the artificial cornea 100. In various examples, the posterior optical surface 214 is a surface capable of high light transmission. In some embodiments, the posterior optical surface 214 is free of surface defects or imperfections, such as scratches, dents, or gouges. In various examples, the posterior optical surface 210 is generally curved or nonlinear. For example, as shown in FIG. 5, the posterior optical surface 210 is concave.

[0087] In some examples, the optical element 200 includes a posterior protrusion, or protrusion of the body 202 that extends posteriorly from the body 202. For example, as shown in FIG. 5, the optical element 200 includes a posterior protrusion 216. The posterior protrusion 216 can be all or less of the posterior side 206 of the body 202. Thus, as discussed further below and shown in FIG. 5, in various examples, the posterior side 206 of the body 202 can include protrusions that are longitudinally offset from one another. In various examples, the posterior optical surface 210 corresponds to the posterior surface of the posterior protrusion 216. Thus, in examples including multiple posterior surfaces, the posterior optical surface 214 defines only a portion of the posterior side 206 of the body 202. However, in some other examples, the posterior optical surface 210 extends across and defines the entire posterior side 206 of the body 202.

[0088] In some instances, the posterior projection 216 is formed as a protrusion on the posterior side 206 of the body 202. In other instances, the posterior projection 216 is additionally or alternatively formed by forming an annular circumferentially extending recess in the posterior side 206 of the body 202. That is, in some instances, an annular ring of material is removed from the posterior side 206 of the body 202 to form an annular circumferentially extending recess about the posterior side 206 of the body 202. In yet other instances, the posterior projection 216 is additionally or alternatively formed by forming a circumferentially extending annular flange, such as annular flange 218, about the body 202, where the posterior surface of the annular flange is recessed or otherwise offset forwardly relative to the posterior optical surface 214. Stated differently, the posterior side 206 of the optical element 200 is optionally stepped (e.g., discontinuous) to include at least a first posterior surface and a second posterior surface offset relative to the first posterior surface. In some examples, the posterior optical surface 214 is offset from the posterior surface 222 of the annular flange 218 by between zero (0) and one (1) millimeter.

[0089] In various examples, the anterior optical surface 210 is offset from the anterior surface 220 to facilitate placement and orientation and retention of a tissue-integrated skirt on the optical element 200. In some examples, such offset generally corresponds to the thickness of the tissue-integrated skirt, but is not required. In various examples, the posterior optical surface 214 is offset from the posterior surface 222 to facilitate preventing corneal tissue located around the peripheral surface 208 from growing across the posterior side of the optical element and covering the posterior optical surface 214. In some examples, the presence of corneal tissue or other associated ocular tissue on the posterior optical surface 214 may tend to reduce or otherwise contaminate the optical performance of the optical element 200. In various examples, the posterior optical surface 214 may be offset from the posterior surface 222 by an amount that exceeds the expected thickness of adjacent corneal tissue that may be initially inflamed or swollen.

[0090] In some instances, an optical element including offset first and second posterior surfaces operates to further inhibit tissue ingrowth across the posterior side of the optical element. That is, in some instances, a step or surface extending between the first (e.g., optical) posterior surface and the second posterior surface operates to prevent tissue growth or propagation from the second posterior surface to the first posterior surface. For example, such a step operates as a barrier to help prevent tissue growing across the second posterior surface (e.g., growing from the periphery of the optical element) from growing on and across the first posterior surface. As shown in Figures 4 and 5, a surface or step 226 located between the posterior optical surface 214 and the posterior surface 222 of the annular flange 218 operates to prevent or otherwise inhibit tissue from growing from the posterior surface 222 onto the posterior optical surface 214. Such a configuration operates to minimize or otherwise avoid contamination of the posterior optical surface 214 by the presence of biological tissue. In various examples, the posterior optical surface 214 is treated with a coating to prevent tissue growth (including, for example, attachment and / or ingrowth) across it.

[0091] In some instances, the anterior and posterior protrusions 212 and 216 are of a similar size and / or shape. For example, as shown in FIG. 5, the anterior and posterior protrusions 212 and 216 are generally circular. In some instances, the anterior and posterior protrusions 212 and 216 are of different sizes and / or shapes. For example, as shown in FIG. 5, the posterior protrusion 216 protrudes further from the body 202 than the anterior protrusion 212. Similarly, as shown, the posterior protrusion 216 has a larger diameter (or is otherwise more radially expandable) than the anterior protrusion 212.

[0092] In some instances, the anterior projection, a portion of the body, and a portion of the posterior projection form a core portion of the body 202 of the optical element 200. In some instances, the core portion of the body 202 is formed from a different material than the remainder of the body 202 of the optical element 200. In some such instances, the core of the body 202 may be formed from an optically transparent tissue ingrowth inhibiting material as described herein.

[0093] In certain embodiments, the rear side 206 of the body 202 of the optical element 200 does not include the rear protrusion 216, as shown in FIG.

[0094] As noted above, in various embodiments, the optical element 200 includes a circumferential annular flange (or flange portion), such as annular flange 218. In some embodiments, the annular flange 218 can be defined as a portion of the body 202 of the optical element that extends radially outwardly of one or more of the anterior and posterior projections 212 and 216. In various embodiments, the annular flange 218 acts as both a region for coupling the tissue integration element 300 to the body 202 and an element through which one or more fixation elements (e.g., one or more sutures) can be passed to initially secure the artificial cornea 100 to the ocular tissue, as discussed further below. In various examples, the annular flange 218 is defined by an anterior surface 220, a posterior surface 222, and a surface extending between the anterior surface 220 and the posterior surface 222. In various examples, the surface extending between the anterior surface 220 and the posterior surface 222 corresponds to the peripheral surface 208 of the body 202 described above.

[0095] The peripheral surface 208 may include one or more portions that extend perpendicular or substantially perpendicular to one or more of the anterior surface 220 and the posterior surface 222. Additionally or alternatively, the peripheral surface 208 may be parallel or substantially parallel to the central axis of the artificial cornea 100, and may be linear or non-linear, as described above, and may include multiple surfaces (e.g., sub-surfaces) that collectively define the peripheral surface 208. In some embodiments, the central axis of the artificial cornea 100 extends perpendicular to one or more of the anterior and posterior optical surfaces 108 and 110 and intersects with a center point or apex of one or more of the anterior and posterior optical surfaces 108 and 110. Thus, in some instances, the peripheral surface 208 extends perpendicular or substantially perpendicular to the apex of one or more of the anterior and posterior optical surfaces 108 and 110 of the artificial cornea 100.

[0096] The optical element 200 can be formed by a compression molding process or other known processes. For example, in some embodiments, the polymeric material forming the optical element 200 is typically heated and compressed in a preformed mold, such that the heated polymeric material adopts the shape of the preformed mold that closely resembles the desired shape of the optical element 200 as described herein. In some embodiments, after the optical element 200 is formed, the optical element 200 can be subjected to one or more finishing processes. For example, as discussed in more detail below, the optical element 200 or the artificial cornea 100 can be subjected to one or more precision molding processes in which one or more associated optical surfaces are precisely shaped. Examples of other finishing processes include, but are not limited to, post-molding surface smoothing (e.g., removal of surface defects), polishing, wetting, trimming, and / or sterilization (such as chemical, heat, and / or steam sterilization).

[0097] 4, the artificial cornea 100 is shown with a tissue integration element 300 coupled to the annular flange 218. The tissue integration element 300 acts as a mechanical fixation mechanism or element configured to facilitate coupling of the artificial cornea 100 to the surrounding tissue of the eye. In some instances, the tissue integration element 300 is configured to allow tissue to grow into and across the material of the tissue integration element 300, which helps to maintain the position of the artificial cornea 100 within the eye.

[0098] In various examples, the tissue integration element 300 is microporous and configured to promote the ingrowth and attachment of surrounding tissue. In some examples, the tissue integration element 300 includes or is otherwise formed from one or more layers or sheets of porous polymeric material, such as expanded polytetrafluoroethylene (ePTFE). However, these layers or sheets can be formed from other polymers, including, but not limited to, polyurethane, polysulfone, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), acrylic copolymer, hydrogel, silicone, and polytetrafluoroethylene (PTFE). These materials can be in the form of sheets, knits, wovens, or nonwovens, or in porous form. In some examples, the layers or sheets are laminated or otherwise mechanically bonded, such as by heat treatment and / or adhesives and / or high pressure compression and / or other lamination methods known to those skilled in the art.

[0099] In some instances, the layers or sheets of polymeric material forming the tissue-integration element 300 or the tissue-integration element 300 itself are subjected to one or more processes to modify the microstructure (and thus the material properties) of the layered polymeric material. In some instances, such processes include, but are not limited to, material coating processes, surface preconditioning processes, and / or perforation processes. Material coating processes can be utilized to apply one or more drug or antimicrobial coatings, such as metal salts (e.g., silver carbonate) and / or organic compounds (e.g., chlorhexidine diacetate) to the polymeric material. In some embodiments, material coating processes can be utilized to help promote tissue attachment to and growth across the tissue-integration element 300 consistent with the discussion above. Because polymer surfaces are generally hydrophobic in nature, hydrophilic coatings that allow for immediate wetting of the polymer matrix can also be applied via one or more plasma treatment (or chemical modification wetting) processes. For example, the surface of the polymeric material can be modified with a hydrophilic agent, thereby reducing its hydrophobicity and improving its wettability. More specifically, the polymeric material can be pre-treated with a plasma to activate the surface, exposed to a hydrophilic polymer, and treated again with a plasma to crosslink the hydrophilic coating on the surface of the polymeric material.

[0100] In some instances, one or more surface preconditioning processes may additionally or alternatively be utilized to form layers of the tissue-integration element 300 exhibiting a desired microstructure (e.g., wrinkles, folds, or other geometric out-of-plane or undulating structures), as described in U.S. Patent Application Publication No. 2016 / 0167291, Serial No. 14 / 907,668, filed August 21, 2014, the entire contents of which are incorporated herein by reference. Similarly, one or more plasma treatments may be utilized to achieve a desired surface structure (e.g., stucco-like). Such surface preconditioning may promote a more aggressive initial inflammatory phase following surgery and provide an initial stable interface between the artificial cornea 100 and the ocular tissue with which it interfaces. Furthermore, in some instances, one or more perforation processes may additionally or alternatively be utilized to form multiple perforations or pores in the tissue-integration element 300, which may further promote tissue ingrowth.

[0101] In some embodiments, one or more surface coatings containing antioxidant components can be applied to one or more of the optical element 200 and tissue integration element 300 to reduce the body's inflammatory response that occurs naturally during wound healing after surgery. The surface can be modified with anti-proliferative compounds (e.g., mitomycin C, 5-fluoracil) to mitigate surrounding tissue responses in the eye.

[0102] In various examples, the polymeric material of the tissue integration element 300 is subjected to one or more processes to modify the microstructure prior to application to the optical element 200. For example, the polymeric material of the tissue integration element 300 can be subjected to a plasma treatment process to impart a surface structure to the material (e.g., for promoting tissue integration) prior to application of the polymeric material to the optical element 200, as described in U.S. Patent Application Publication No. 2006 / 0047311, Serial No. 11 / 000,414, filed November 29, 2014, the entire contents of which are incorporated herein by reference. In some examples, after treating the polymeric material, the size of the polymeric material is determined and applied to the optical element 200. In some examples, the polymeric material is cut to size, such as by one or more laser cutting or other suitable cutting processes, as will be appreciated by those skilled in the art.

[0103] It should be understood that the tissue-integrating element 300 may be coupled to the optical element 200 without compromising the optical performance of the optical element 200. That is, as discussed in more detail below, the tissue-integrating element 300 is sized and shaped such that, when coupled to the optical element 200, the anterior and posterior optical surfaces 108 and 110 of the optical element 200 remain unobstructed by the tissue-integrating element 300. Thus, the tissue-integrating element 300, when coupled to the optical element 200, can be an annular shaped member that extends circumferentially around one or more of the anterior and posterior optical surfaces 108 and 110.

[0104] 4 , the tissue-integrating element 300 is coupled to the optical element 200 along the peripheral surface 208 and the anterior surface 220, without extending across the anterior and posterior optical surfaces 108 and 110, and without extending across the posterior surface 222. In some embodiments, the peripheral surface 208 thus forms or defines the coupling region of the first tissue-integrating element of the body 202. Similarly, in some embodiments, the anterior surface 220 of the annular flange 218 forms or defines the coupling region of the second tissue-integrating element 300 of the body 202.

[0105] As shown, coupling the tissue-integration element 300 to the optic 200 along the periphery of the annular flange 218 provides tissue integration and device fixation along the peripheral surface of the artificial cornea 100 between the anterior side 204 and the posterior side 206 in a manner distinct from prior devices and designs. Coupling the tissue-integration element 300 to the optic 200 such that the tissue-integration element 300 extends along a portion of the anterior side 204 of the optic 200 provides tissue integration and device fixation partially along the anterior surface of the artificial cornea 100. Similarly, coupling the tissue-integration element 300 to the optic 200 such that the tissue-integration element 300 extends along the peripheral surface 208 provides tissue integration and device fixation along the periphery of the artificial cornea 100 extending between the anterior side 102 and the posterior side 104 of the artificial cornea 100. As the artificial cornea 100 is a mesoplant that connects the internal ocular environment with the external environment, better device fixation and biointegration helps to provide a better seal isolating the internal ocular environment from foreign agents such as bacteria, viruses, fungi or other microorganisms, which helps to increase the likelihood of device retention and reduce the likelihood of device extrusion.

[0106] In some examples, the tissue integrating element 300 can be applied to the optical element 200 according to any known attachment method, including but not limited to adhesive, thermal bonding, pressure, or molding. In some examples, the polymeric material is laser cut using a CO2 laser. Specifically, the cut radius of the inner diameter of the tissue integrating element 300 that is positioned adjacent to the anterior optical surface 210 is sized such that placement of the tissue integrating element 300 on the optical element 200 can be accomplished without a significant gap between the tissue integrating element 300 and the surface 224. In such examples, the tissue integrating element 300 is positioned with a cut hole concentric with the optical element in a lamination fixture. Lenses are used on the top and bottom of the optical element 200 to shape the optical curvatures of the anterior optical surface 210 and the posterior optical surface 214, and molding and lamination are accomplished simultaneously by applying pressure of more than 5 psi to the lenses. Lamination of the tissue-integrating element 300 to the peripheral surface 208 is accomplished in a similar manner by cutting the outer diameter of the tissue-integrating element 300 after the first lamination to the anterior surface 220 of the tissue-integrating element 300, folding the polymeric material of the tissue-integrating element 300 over the peripheral surface 208, and constraining the polymeric material of the tissue-integrating element 300 contacting the peripheral surface 208 radially around the peripheral surface 208. Thereafter, in some instances, the completed laminated assembly is placed in an oven at 175° C. for 20 minutes each for top lamination and side lamination.

[0107] In various examples, the tissue-integration element 300 may additionally or alternatively be subjected to one or more processes to modify the microstructure after it is applied to the optical element 200. For example, after the tissue-integration element 300 is applied to the optical element 200, the polymeric material of the tissue-integration element 300 and / or the optical element 200 may be subjected to one or more wetting processes (e.g., hydrophilic treatments) such that the polymeric material of the tissue-integration element 300 is wettable by ocular fluids. Such a configuration helps provide cosmetology and rapid biointegration. In various examples, being wettable also makes the tissue-integration element 300 substantially transparent, such that the artificial cornea 100 resembles a natural cornea in appearance. In some examples, an additional advantage of a wettable tissue-integration skirt is that it provides easier and faster penetration of ocular fluids and extracellular matrix. Such a configuration generally promotes faster biointegration, which in turn reduces the likelihood of infection and extrusion.

[0108] In some instances, the artificial cornea 100 can be subjected to one or more processes to achieve a desired shape. In some instances, these processes can achieve a desired shape that matches the piercing shape created in the patient's cornea. In some instances, these processes can achieve a desired shape and / or contour of one or more optical surfaces of the artificial cornea 100 (e.g., for proper light refraction). Such processes include the use of glass lenses made to a specific radius of curvature that are directly transferred to the optical element via a secondary molding procedure consistent with the above description. In other instances, the refractive surface is additionally or alternatively achieved by using machined surfaces using stainless steel or other suitable materials. In some instances, such surfaces can also be made to have a specific curvature that offsets the inherent optical distortions specific to the patient's eye.

[0109] As noted above, in some instances, the tissue-integrating element 300 is applied to the optical element 200 such that a portion of the anterior side 204 of the optical element 200 is covered or otherwise obscured by the tissue-integrating element 300. Specifically, in some instances, the tissue-integrating element 300 is applied to at least the anterior surface 220 of the annular flange 218. In some such instances, the thickness of the portion of the tissue-integrating element 300 applied to the anterior surface 220 of the annular flange 218 corresponds to the amount that the anterior projection 212 protrudes beyond the anterior surface 220 of the annular flange 218. That is, in various instances, the tissue-integrating element 300 is applied to the anterior surface 204 of the optical element 200 such that the anterior side 102 of the artificial cornea 100 is smooth. In such instances, the transition between the anterior optical surface 108 of the artificial cornea 100 and the portion of the tissue-integrating element 300 applied to the anterior side of the optical element 200 is smooth (e.g., free of projections, gaps, etc.). The smooth transition between the anterior optical surface 108 and the tissue-integration element 300 provides that the anterior side 102 of the implanted artificial cornea 100 does not cause discomfort or irritation or interfere with other portions of the patient's anatomy (e.g., the patient's eyelid, etc.). Additionally, the incorporation of the tissue-integration element 300 along a portion of the anterior side 102 of the artificial cornea 100 promotes the proliferation of tissue ingrowth along the portion of the anterior side 102 of the artificial cornea. Although the tissue-integration element 300 is shown in FIG. 4 as being applied to the entire peripheral surface 208 of the annular flange 218, it should be understood that in some instances, the tissue-integration element 300 may be applied to less than all of the peripheral surface 208.

[0110] In some embodiments, the peripheral surface 208 can be stepped or otherwise partially recessed to accommodate the polymeric material of the tissue integration element 300. In some embodiments, however, the polymeric material of the tissue integration element 300 is applied to the peripheral surface 208 of the optic such that the tissue integration element 300 extends from the anterior surface 220 to the posterior surface 222 of the annular flange 218. Such a configuration provides for tissue ingrowth around the periphery of the artificial cornea 100.

[0111] In some instances, the portion of the polymeric material of the tissue integration element 300 bonded to the anterior surface 220 of the annular flange 218 and the portion of the polymeric material of the tissue integration element 300 bonded to the peripheral surface 208 of the optical element 200 together form a single monolithic member. In some instances, the tissue integration element 300 may be preformed or preconfigured to reflect the relative orientation of the surface of the optical element to which it is attached or bonded. In other instances, the tissue integration element 300 is malleable in that when it is attached or bonded, it can be manipulated to match the relative orientation of the surface of the optical element to which it is attached or bonded.

[0112] In some embodiments, the tissue-integrating element 300 may include multiple distinct sections that are independently and separately coupled to the optical element 200. For example, a first section or portion of the tissue-integrating element 300 may be applied to the anterior surface 220 of the annular flange 218, while a second distinct section or portion of the tissue-integrating element 300 is applied to the peripheral surface 208 of the optical element 200. In some instances, these distinct sections or portions may be applied adjacent or otherwise in contact with one another in a manner that facilitates comprehensive coverage of the intended portions of the optical element 200. Thus, in some instances, multiple distinct sections of polymeric material may be applied to the optical element 200 to form a generally smooth, continuous tissue-integrating element 300.

[0113] It should be understood that the tissue integration element 300 can include or otherwise be composed of multiple layers of polymeric material. In some instances, these layers can be oriented relative to one another to optimize one or more material properties of the tissue integration element 300, such as wettability, permeability, thickness, conformability, adhesion, transparency, etc. In some such instances, the various layers can be bonded together via one or more bonding, adhesive, or laminating processes as would be understood by one of skill in the art.

[0114] In various instances, the surface condition of the portion of the tissue-integration element 300 covering the anterior surface 220 of the annular flange 218 differs from the surface condition of the portion of the tissue-integration element 300 covering the peripheral surface 208 of the optical element 200. Such configurations operate to promote different degrees and rates of tissue growth. For example, in some instances, the portion of the tissue-integration skirt attached to the anterior surface 220 can be treated to promote rapid epithelialization and attachment thereto, while the portion of the tissue-integration element 300 attached to the peripheral surface 208 can be treated to retard epithelial cell growth and promote stromal ingrowth.

[0115] In various embodiments, the tissue-integration element 300 is applied to the optical element 200 such that the posterior side 206 of the optical element 200 remains uncovered or otherwise exposed. That is, in various examples, the posterior side 206 of the optical element 200 remains free of coverage by the tissue-integration element 300. For example, as shown in FIG. 4 , the tissue-integration element 300 is applied to the optical element 200 such that the posterior side 104 of the artificial cornea 100 (including the posterior optical surface 214 and the posterior surface 222 of the annular flange 218) is exposed or otherwise not covered by a fixation material. Thus, in various examples, the tissue-integration element 300 is applied to the optical element 200 such that the tissue-integration element 300 does not contact the posterior side 206 of the optical element 200, including the posterior optical surface 214 and the posterior surface 222 of the annular flange 218. Stated another way, in various examples, the tissue-integrating element 300 is applied to the optical element 200 such that the posterior side 206 (including the posterior optical surface 214 and the posterior surface 222) remains free of contact with the tissue-integrating element 300, and the posterior side 206 is exposed to the eye (e.g., the interior of the eye and / or the tissue bed of the eye). Placing the tissue-integrating element 300 on the posterior optical surface 214 can impede light transmission and cause optical contamination.

[0116] However, one skilled in the art should understand that in various instances, the tissue integration element 300 may be disposed partially or completely across the posterior surface 222 .

[0117] 7-11 show another example of an artificial cornea 100. The artificial cornea 100 of FIGS. 7-11 includes an optical element 200 and a tissue integration element 300 coupled to the optical element 200. As shown in FIG. 11, the optical element 200 includes a body 202 similar to the body 202 discussed above with respect to FIG. 5 in that the body 202 includes anterior and posterior protrusions 212 and 216 that define anterior and posterior optical surfaces 210 and 214. However, the annular flange 218 of the body 202 shown in FIGS. 7-11 differs from the annular flange of the body shown in FIGS. 1-5. In particular, as shown in FIG. 11, the annular flange 218 is defined by a first flange component 228 (FIG. 11) and a second flange component 230 (FIG. 11), each of which may be further described as, for example, a flange portion, a flange layer, a flange segment, or a flange feature. The first flange component 228 can be defined as a first annular portion of the body 202 of the optical element 200 that extends radially outwardly from one or more of the forward and rearward projections 212 and 216, and the second flange component 230 can be defined as a second annular portion of the body 202 of the optical element 200 that extends radially outwardly from one or more of the forward and rearward projections 212 and 216 and includes the radially outwardly extending portion of the first flange component 228. In various embodiments, the second flange component 230 is located rearwardly of the first flange component 228.

[0118] In various embodiments, the first and second flange components 228 and 230 form a single monolithic body that defines the annular flange 218. Thus, it should be understood that the first and second flange components 228 and 230 can be integral with one another, although separate connected pieces are also contemplated. Similarly, the annular flange 218 can be integral with other portions of the body 202 (e.g., the forward and rearward projections 212 and 216) such that the first and second flange components 228 and 230 are integral with the forward and rearward projections 212 and 216, collectively defining the body 202.

[0119] The first flange component 228 can include a front surface 220 and a peripheral surface 208 (e.g., similar to that discussed above with respect to the optical element of FIGS. 1-5). The second flange component 230 can include a front surface 232, a rear surface 234, and a peripheral or peripheral surface 236 located between or otherwise forming a transition between the front surface 232 and the rear surface 234. In some embodiments, the peripheral edge 236 (also referred to as the peripheral surface 236) of the second flange component 230 and the peripheral edge (or outermost edge) of the optical element 200 are the same. In various embodiments, the first and second flange components 228 and 230 are oriented such that the front surface 220 of the first flange component 228 is located forward of the front surface 232 of the second flange component 230. Conversely, the rear surface 234 of the second flange component 230 is located rearward of the rear surface 222 of the first flange component 228. In some embodiments, a transition 238 is defined between the posterior surface 222 and the posterior surface 234 of the first and second flange components 228 and 230, respectively. The transition 238 can be smooth and continuous, or stepped or discontinuous, as should be understood by one of ordinary skill in the art. As shown in FIG. 11, the peripheral surface 236 of the second flange component 230 extends radially outwardly further than the peripheral surface 208 of the first flange component 228. Additionally, as shown in FIG. 11, the posterior surface 222 of the first flange component 228 is located forward of each of the posterior surface 234 and the posterior optical surface 214 such that the posterior surface 222 defines an annular recess between the posterior surface 234 and the posterior optical surface 214.

[0120] 10, the tissue-integrating element 300 is coupled to the annular flange component 218 such that a first portion of the tissue-integrating element 300 is coupled to the first flange component 228 and a second portion of the tissue-integrating element 300 is coupled to the second flange component 230. In particular, the tissue-integrating element 300 is coupled to the anterior and peripheral surfaces 220 and 208, respectively, of the first flange component 228 and to the anterior surface 232 of the second flange component 230. However, it should be understood that the tissue-integrating element 300 may further be coupled to the peripheral surface 236 of the second flange component 230. As shown in FIG. 11, the tissue-integrating element 300 is not coupled to the posterior surfaces 222 and 234 of the first and second flange components, respectively.

[0121] 7-11 can be advantageous in several ways. For example, according to some examples, the configuration of the body 202 provides an additional surface for supporting the eye's natural corneal tissue following implantation of the artificial cornea 100, which aids in successful biointegration. For example, natural tissue is permitted to grow into and onto the tissue-integration element 300, which is coupled to the anterior surface 220 and peripheral surface 208 of the first flange component 228, and the tissue-integration element 300 is coupled to the anterior surface 232 of the second flange component 230.

[0122] In various embodiments, the first flange component 228 of the annular flange 218 further operates as an element through which one or more fastening elements (e.g., one or more sutures) can be passed to initially secure the artificial cornea 100 to the tissue of the eye, as discussed further below.

[0123] Figures 12 and 13 show another example of an artificial cornea 100. The artificial cornea 100 of Figures 12 and 13 includes an optical element 200 and a tissue integration element 300 coupled to the optical element 200. As shown in Figure 13, the optical element includes a body that differs from the body 202 discussed above with respect to Figures 5, 10, and 11 in the following respects: The body 202 shown in Figures 5, 10, and 11 includes an anterior protrusion 212 that defines an anterior optical surface 210, but the posterior optical surface 214 as shown in Figure 13 is not defined by an anterior protrusion. The annular flange 218 of the body 202 shown in Figures 12 and 13 is defined by a first flange component 228 (Figure 13) and a second flange component 230 (Figure 13), each of which may be further described as, for example, a flange portion, a flange layer, a flange segment, or a flange feature. The first flange component 228 is similar to the first flange component 228 discussed above with respect to Figures 7-11 and may be defined as a first annular portion of the body 202 of the optical element 202 extending radially outward from the anterior projection 212. However, the second flange component 230 shown in Figures 12 and 13 differs from the second flange component 230 of the body shown in Figures 7-11. In particular, as shown in Figures 12 and 13, the second flange 230 includes at least one aperture 256 passing from the anterior surface of the second flange 230 to the posterior surface of the second flange 230. The aperture 256 has a diameter of sufficient size for cells to grow, proliferate or otherwise advance therethrough. The aperture 256 facilitates attachment of the artificial cornea 100 to the surrounding tissue of the eye. In some instances, the aperture 256 is configured to allow tissue growth to spread (ie, proliferate) through the second flange 230, which helps maintain the position of the artificial cornea 100 within the eye.

[0124] In various embodiments, the first and second flange components 228 and 230 form a single monolithic body that defines the annular flange 218. As such, it should be understood that the first and second flange components 228 and 230 can be integral with one another, but are also contemplated as separate connected pieces. Similarly, the annular flange 218 can be integral with other portions of the body 202, but are also contemplated as separate connected pieces. In some embodiments, the second flange 230 comprises the same material as the first flange 228 and / or the body 202. In other embodiments, the second flange 230 comprises a different material than the first flange 228 and the body 202. The aperture 256 can be formed in the second flange by microdrilling techniques, for example, mechanical microdrilling, such as ultrasonic drilling, powder blasting or abrasive waterjet machining (AWJM), thermal microdrilling, such as laser machining, chemical microdrilling, including wet etching, deep reactive ion etching (DRIE) or plasma etching, hybrid microdrilling techniques, such as spark-assisted chemical engraving (SACE), vibration-assisted micromachining, laser-induced plasma micromachining (LIPMM) and water-assisted micromachining. In other embodiments, the second flange 230 comprises a material different from the first flange 228 and the body 202, and the aperture 256 is a feature of the material of the second flange 230. That is, the microstructure of the material of the second flange 230 itself includes pores of sufficient size to form the aperture 256. In certain embodiments, the aperture 256 has a diameter of about 75 pm to about 600 pm. In certain embodiments, the aperture 256 has a diameter of about 200 pm to about 300 pm. In a particular embodiment, the aperture 256 has a diameter of about 300 pm.

[0125] The surfaces of the first and second flange components 228 and 230 of the artificial cornea 100 of Figures 12 and 13 are similar to those described above for the artificial cornea 100 of Figures 7-11.

[0126] 13, the tissue integration element 300 is coupled to the first flange component 228. In particular, the tissue integration element 300 is coupled to each of the anterior and peripheral surfaces of the first flange component 228. It should be understood, however, that the tissue integration element 300 may be further coupled to one or both of the anterior and peripheral surfaces of the second flange component 230.

[0127] In some embodiments, an artificial cornea 100 having an anterior protrusion 212 similar to that shown in FIGS.

[0128] 12 and 13 may be advantageous in that it provides tissue growth across the thickness of the artificial cornea, providing long-term mechanical fixation of the artificial cornea. In some embodiments, tissue may grow into the tissue integration element 300, but having tissue growth across the thickness of the artificial cornea may provide a higher level of fixation and retention.

[0129] 14-18 show another example of an artificial cornea 100. The artificial cornea of ​​FIGS. 14-18 includes an optic 200 and a tissue integration element 300 coupled to the optic 200. As shown in FIG. 18, the optic 200 includes a body 202 including anterior and posterior optical surfaces 210 and 214. However, unlike the other configurations discussed herein, the body 202 does not include a radially extending annular flange to which the tissue integration element is coupled, but instead defines a circumferentially extending recess 240 configured to receive natural corneal tissue therein. The circumferentially extending recess 240 is similarly configured to receive a tissue integration element 300, as shown in FIGS. 17A-17C. With continued reference to Figures 17A-17C and 18, the circumferentially extending recess 240 is defined by a number of surfaces including a first surface 242, a second surface 244 opposite the first surface 242, and a third surface 246 located between and extending across the first surface 242 and the second surface 244.

[0130] In some embodiments, the optical element 200 shown in FIG. 18 can be described as including a body 202 having anterior and posterior optical surfaces 210 and 214 and a plurality of flanges, including anterior flange 248 and posterior flange 250, each extending radially outwardly about its periphery. The anterior and posterior flanges 248 and 250 are offset from one another along a longitudinal axis of the optical element 200 such that a circumferentially extending recess 240 is defined therebetween. In some embodiments, the third surface 246 can be understood to correspond to a peripheral surface of the body 202, while the first surface 242 can be understood to correspond to a posterior surface of the anterior flange 248, while the second surface 244 can be understood to correspond to a front surface of the posterior flange 250. In some embodiments, the anterior surface 252 of the anterior flange 248 and the anterior optical surface 210 collectively define the anterior side of the optical element 200 shown in FIGS. 14-18. Similarly, in some embodiments, the rear surface 254 of the rear flange 250 and the rear optical surface 214 collectively define the rear side of the optical element 200 shown in Figures 14-18.

[0131] As shown in FIG. 17A , tissue-integrating element 300 is coupled to first, second and third surfaces 242, 244 and 246, respectively, so that when implanted into a patient's eye, cornea or other associated ocular tissue can grow into tissue-integrating element 300 along first, second and third surfaces 242, 244 and 246, respectively.

[0132] As shown in FIG. 17B , the tissue integration element 300 is coupled to the second and third surfaces 244 and 246 such that, when implanted into a patient's eye, the cornea or other associated ocular tissue can grow into the tissue integration element 300 along the second and third surfaces 244 and 246, respectively, while in such a configuration, the first surface 242, which is resistant to tissue ingrowth, acts as an alignment edge to align the artificial cornea within the patient's eye.

[0133] As shown in FIG. 17C , the tissue integration element 300 is bonded only to the third surface 246, such that when implanted into a patient's eye, the cornea or other associated ocular tissue can grow into the tissue integration element 300 along the third surface, while the first and second surfaces 242 and 244, which are resistant to tissue ingrowth in such a configuration, act as alignment edges to align the artificial cornea within the patient's eye.

[0134] In various examples, the artificial corneas illustrated and described herein are implanted in conjunction with a through-the-corneal transplant surgical procedure in which a full-thickness fragment of tissue is removed from the diseased or damaged cornea using a surgical cutting instrument such as a trephine or laser. In various examples, a circular full-thickness plug of the diseased or damaged cornea is removed, leaving a tissue bed of corneal tissue to which the artificial cornea 100 can be attached. In such a configuration, some or all of the posterior side 104 of the artificial cornea 100 is suspended above the interior of the eye. That is, some or all of the posterior side 104 of the artificial cornea 100 is not supported by the existing corneal tissue of the eye. With a full-thickness corneal ablation, the cornea is generally removed from the epithelium down to the endothelium.

[0135] The artificial cornea 100 illustrated and described herein is also configured to be implanted in combination with partial thickness surgical procedures, such as Descemet's membrane stripping and automated endothelial keratoplasty (DSAEK), in which less than the full thickness of tissue is removed from a diseased or damaged cornea, leaving a residual bed of healthy corneal tissue. In these embodiments, the diseased portion of the anterior cornea is resected and the artificial cornea 100 is placed over the residual bed of healthy corneal tissue.

[0136] In various examples, the artificial corneas discussed herein are configured to be temporarily folded and deformed to help facilitate implantation. That is, unlike many conventional designs, the artificial cornea (including, for example, the body 202 of the optical element 200) is configured to be malleable and non-rigid. For example, during an implantation procedure, a physician may need to fold or deform the artificial cornea to achieve a proper orientation and / or to properly seat the artificial cornea in the natural tissue bed. In some cases, a separate restraining member may be utilized to temporarily maintain the deformation of the artificial cornea before and during the implantation procedure. In various examples, the artificial cornea 100 is sufficiently elastic to assume an undeformed geometry when released into or onto the tissue bed and / or when secured to the tissue bed. Configuring the artificial cornea to be malleable and non-rigid also allows the intraocular pressure of the eye to be monitored according to conventional methods while the artificial cornea is implanted.

[0137] For example, since the artificial cornea is malleable (e.g., has a measure of malleability comparable to the natural cornea), the intraocular pressure of the eye in which the artificial cornea is implanted can be determined through known tonometry methods, including, but not limited to, applanation tonometry, Goldmann tonometry, dynamic contour tonometry, electronic indentation tonometry, rebound tonometry, airway tonometry, indentation or impression tonometry, and non-contact tonometry. When used in combination with the artificial corneas discussed herein, these methods include measuring the deformation response along the interface between the artificial cornea and the natural corneal tissue when acted upon by a force external to the eye. For example, measurements can be made at one or more locations along the circumference of the optical element where the optical element and the natural corneal tissue (e.g., the limbus) engage or interface. This may include purely natural corneal tissue, or may include the area where the natural corneal tissue overlaps the artificial cornea. The external force delivered by the tonometry device can include air pressure and / or an external force applied by an object contacting the measurement area of ​​the eye. It should be understood that there are other methods for measuring intraocular pressure through interaction with other areas of the eye (e.g., the sclera) and are distinct from tonometry, which includes measuring intraocular pressure along the interface between the artificial cornea and the natural corneal tissue. It should be understood that tonometry is not possible with conventional rigid artificial cornea designs because the rigid conventional artificial cornea designs are not sufficiently deformable themselves, nor are the natural ocular tissues and interfaces along such conventional rigid artificial cornea designs sufficiently deformable.

[0138] FIG. 19 shows an embodiment of an artificial cornea 100. The artificial cornea 100 of FIG. 19 is similar to that of FIG. 13, but with two important differences. First, as shown, the second flange component 230 of FIG. 19 does not include an aperture 256. Second, the embodiment shown in FIG. 19 further includes a corneal epithelial cell growth layer 258. The corneal epithelial cell growth layer 258 is configured to promote and support the formation and maintenance of an organized monolayer of corneal epithelial cells across the anterior side 204 of the optical element 200. The corneal epithelial cell growth layer 258 is deposited on the anterior side 204 of the optical element 200 such that the anterior side 102 of the artificial cornea 100 is smooth. In such an example, the transition between the corneal epithelial cell growth layer 258 and the portion of the tissue integration element 300 applied to the anterior side of the optical element 200 is smooth (e.g., free of protrusions, gaps, etc.). The smooth transition between the epithelial cell growth layer 258 and the tissue integration element 300 provides that the anterior side 102 of the implanted artificial cornea 100 does not cause discomfort or irritation or interfere with other parts of the patient's anatomy (e.g., the patient's eyelids). Additionally, the tissue integration element 300 promotes the proliferation of tissue ingrowth along a portion of the anterior side 102 of the artificial cornea, while the epithelial cell growth layer 258 promotes the formation of an organized monolayer of corneal epithelial cells on the anterior side 204 of the optic 200. Although the tissue integration element 300 is shown in FIG. 19 as being applied to the entire peripheral surface 208 of the annular flange 218, it should be understood that in some instances the tissue integration element 300 may be applied to less than all of the peripheral surface 208. 19 as being applied over the entire anterior side 204 of the optical element 200 that is not covered by the tissue-integration element 300, in some examples, the epithelial cell growth layer 258 may be applied to less than all of the anterior side 204 of the optical element 200 that is not covered by the tissue-integration element 300. Although described with respect to the examples above, the epithelial cell growth layer 258 may be incorporated into any of the examples of the artificial cornea disclosed and described herein.

[0139] In some embodiments, the epithelial cell growth layer 258 comprises one or more plasma coatings (positively or negatively charged), glycoproteins, collagens and gelatins and / or proteoglycans. Useful glycoproteins include, for example, fibronectin, laminin and vitronectin. Useful collagen types include, for example, type I, type II, type III, type IV and type V. Useful proteoglycans include, for example, versican, perlecan, neurocan, aggrecan and brevican. In certain embodiments, the epithelial cell growth layer comprises a mixture of molecules forming a matrix. The composition of the epithelial cell growth layer 258 is selected to encourage an organized monolayer of corneal epithelial cells to grow and proliferate across the anterior side 204 of the optical element 200.

[0140] Turning now to FIG. 20, there is shown a graphical representation of the empirical relationship between intraocular pressure and diopter determined according to the tonometry method discussed above when the artificial cornea discussed herein is implanted. Healthy intraocular pressure in the eye is in the range of 10-20 mmHg. As shown, when implanted, the artificial cornea is associated with a diopter of approximately 48.2 diopters at 10.1 mmHg and approximately 49 diopters at 20.3 mmHg. The slope of the line in FIG. 20 corresponds to the accommodation or elasticity of the measured area and is expressed in units of diopters per mmHg. The graph shown in FIG. 20 shows the accommodation of the interface area between the artificial cornea and the natural corneal tissue, which is approximately 0.064 diopters per mmHg. The compliance of the interface region is based, at least in part, on the compliance of the natural corneal tissue and artificial corneal material located at and around the measured interface region. Thus, it should be appreciated that the artificial corneas discussed herein are sufficiently compliant to facilitate accurate ocular pressure measurements at the interface region that cannot be achieved with conventional rigid artificial corneal designs.

[0141] In some embodiments, the compliant or elastic artificial cornea can have a compliance or elasticity greater than zero and up to about 0.075 diopters per millimeter of mercury. It is understood that the stiffness of the artificial cornea increases as the slope of diopters / mmHg decreases, and the stiffness of the artificial cornea decreases as the slope of diopters / mmHg increases. Thus, although not shown in FIG. 20, as the slope approaches zero (0) diopters per millimeter of mercury (mmHg), the corresponding artificial cornea approaches minimum or zero elasticity. This is an elasticity that is consistent with many conventional artificial cornea designs. As a result, artificial corneas associated with slopes approaching zero (0) diopters per millimeter of mercury (mmHg) within the range of at least 10-20 millimeters (mmHg) reduce the accuracy of measurements of intraocular pressure via interaction with the rigid artificial cornea, because the artificial cornea or the natural corneal tissue adjacent to the rigid artificial cornea cannot deform sufficiently under test conditions to accurately measure intraocular pressure.

[0142] Conversely, slopes increasing beyond 0.075 diopters per millimeter of mercury (mmHg) within at least the range of 10-20 mmHg are increasingly susceptible to perceptible vision changes over the course of expected normal daily fluctuations in intraocular pressure in a healthy patient. For example, an artificial cornea with an accommodation or elasticity of 0.075 diopters per millimeter of mercury (mmHg) would be expected to experience a vision difference of approximately 0.375 diopters if the patient's intraocular pressure was expected to vary between 10-15 mmHg over the course of a day. By comparison, an artificial cornea having an accommodation or elasticity of 0.05 diopters per millimeter of mercury (mmHg) would be expected to experience a visual acuity difference of approximately 0.25 diopters under the same conditions, while an artificial cornea having an accommodation or elasticity of 0.095 diopters per millimeter of mercury (mmHg) would be expected to experience a visual acuity difference of approximately 0.475 diopters under the same conditions.

[0143] It is desirable to provide an artificial cornea that is sufficiently compliant while minimizing the likelihood of perceptible vision changes under expected intraocular pressure variations. Thus, it should be appreciated that the compliance or elasticity of the artificial cornea should be selected based on the patient's expected intraocular pressure variations.

[0144] In some instances, the surgical implantation method requires undersizing the bone drilling fenestrated hole made in the host cornea relative to the diameter of the artificial cornea. In some instances, this is to account for the amount of growth that the excised host cornea will undergo when it experiences trauma (e.g., incision). In some instances, such undersizing also serves to account for recession due to partial corneal melting after surgery. Additionally, such undersizing allows the wound to be air-tight and liquid-tight after suturing, helping to avoid the risk of infection due to the introduction of pathogens.

[0145] In various examples, after the artificial cornea is properly positioned and oriented within the tissue bed of the existing corneal tissue, the artificial cornea is mechanically coupled to the existing corneal tissue. In various examples, one or more sutures are utilized to mechanically secure the artificial cornea to the existing corneal tissue. In some other examples, an ophthalmic adhesive may additionally or alternatively be utilized to mechanically couple the artificial cornea to the existing corneal tissue. In the case of suturing, the particular surgical suturing technique (e.g., interrupted, uninterrupted, combined, single, double, etc.) may vary based on a number of surgical indications, as will be understood by those skilled in the art. In various examples involving the fixation of the artificial cornea to the existing corneal tissue with one or more sutures, the sutures generally extend within the annular flange 218 of the optical element 200 of the artificial cornea 100. In some examples, the one or more sutures extend through only a portion of the annular flange 218. For example, one or more sutures may enter the anterior side 102 of the artificial cornea 100, exit the artificial cornea 100 through the peripheral surface 208 and any tissue-integrating skirt material covering the peripheral surface 208, and then enter existing corneal tissue. In some instances, the one or more sutures may additionally or alternatively extend completely through the annular flange 218 (including one or more of the first flange component and the second flange components 228 and 230). For example, the one or more sutures may enter the anterior side 102 of the artificial cornea 100, exit the posterior surface 222 of the annular flange 218, and then enter existing corneal tissue. In one such instance, the sutures exiting the posterior surface 222 of the annular flange 218 may enter existing corneal tissue on which the posterior surface 222 of the annular flange 218 rests.

[0146] Those skilled in the art should appreciate that one or more sutures may additionally or alternatively enter the annular flange through the peripheral surface 208 of the annular flange and any tissue-integrating skirt material covering the peripheral surface 208, and then exit through the peripheral surface 208 of the annular flange and any tissue-integrating skirt material covering the peripheral surface 208. Additionally or alternatively, in some instances, one or more sutures may enter the annular flange through the peripheral surface 208 of the annular flange and any tissue-integrating skirt material covering the peripheral surface 208, and then exit the posterior surface 222 of the annular flange 218. Those skilled in the art should also appreciate that the mechanical fixation or attachment (e.g., sutures) of the artificial cornea 100 to existing corneal tissue may be temporary or permanent. For example, in some instances, sutures provide mechanical fixation of the device after the implantation procedure, while subsequent tissue ingrowth into the tissue integration element 300 serves as a permanent mechanism for attachment.

[0147] In various embodiments, securing the artificial cornea 100 to existing corneal tissue serves to maintain the relative position between the artificial cornea 100 and the existing corneal tissue while the corneal tissue grows into the tissue integration element 300, as will be appreciated by those skilled in the art. Similarly, securing the artificial cornea 100 to existing corneal tissue serves to maintain contact between the existing corneal tissue and the artificial cornea 100 while the corneal tissue grows into the tissue integration element 300, as will be appreciated by those skilled in the art. Such an arrangement also seals the interior of the eye from the external environment and possible bacterial intrusion.

[0148] In various examples, the sutures can comprise any suitable biocompatible material, including nylon, polypropylene, silk, polyester, and fluoropolymers such as ePTFE and other copolymers discussed herein.

[0149] Although the above embodiments include configurations in which the skirt covers only a portion of the anterior surface, in some instances, the skirt can cover the entire anterior side, including the anterior optical surface. Such a configuration helps promote epithelial tissue growth and integration over the entire anterior surface of the artificial cornea that is exposed to the external environment, which helps further biointegration. Furthermore, such a configuration helps to increase optical wettability and minimize contamination. However, in certain cases, epithelial tissue growth over the entire anterior surface of the artificial cornea may be undesirable. For example, in certain instances, diseased tissue lacks the appropriate morphology to become a well-defined refractive surface. Thus, in such cases, the regenerated epithelial tissue should be avoided, as it may be unclear and lead to optical contamination.

[0150] The scope of the present invention of this application has been described above both generally and with reference to specific examples. It will be apparent to those skilled in the art that various modifications and variations can be made in the examples without departing from the scope of the present disclosure. Similarly, various components discussed in the examples discussed herein can be combined. Therefore, the examples are intended to cover modifications and variations within the scope of the present invention.

Claims

[Claim 1] an optical element including a body having opposing surfaces and a flange extending around a periphery of the body; a tissue-integrating skirt bonded to the periphery of the optical element; An artificial cornea comprising: The tissue-integrating skirt is configured to promote tissue ingrowth.

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