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  Corneal onlays and methods of producing sameUSPTO Application #: 20060241751Title: Corneal onlays and methods of producing same Abstract: Corneal onlays and corneal onlay production methods are described. The present corneal onlays include a lens body. An example of a corneal onlay includes a lens body that includes a corneal epithelium-contactable anterior surface and a Bowman's membrane-contactable posterior surface. The lens body has an optical power from about −10 diopters to about +10 diopters, an optic zone diameter from about 5 mm to about 11 mm, a base curve from about 5 mm to about 12 mm, a center thickness from about 10 micrometers to about 300 micrometers, and an edge thickness from about 0 micrometers to about 120 micrometers. Methods include forming the present corneal onlays from polymeric materials. (end of abstract) Agent: Frank J. Uxa - Irvine, CA, US Inventors: J. Christopher Marmo, Arthur Back USPTO Applicaton #: 20060241751 - Class: 623005110 (USPTO) Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Eye Prosthesis (e.g., Lens Or Corneal Implant, Or Artificial Eye, Etc.), Corneal Implant The Patent Description & Claims data below is from USPTO Patent Application 20060241751. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional application of U.S. application Ser. No. 10/661,400, filed Sep. 12, 2003, which claims the benefit of U.S. Provisional Application No. 60/464,590, filed Apr. 21, 2003, and U.S. Provisional Application No. 60/464,004, filed Apr. 18, 2003, and U.S. Provisional Application No. 60/410,837, filed Sep. 13, 2002, the disclosures of all of which are hereby incorporated by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to devices and methods of improving a patient's vision. [0004] In particular, the invention relates to improving vision of a patient by placing a corrective ocular device between an epithelium of the patient's eye and the stroma of the cornea of the patient's eye. The corrective ocular device may be a lens, including a corneal onlay. The corrective ocular device may have a preformed epithelial cell layer secured over the device when placed on an eye of a patient. The preformed epithelial cell layer may be synthesized in vitro or the preformed epithelial cell layer may include at least a portion of the patient's corneal epithelium. [0005] 2. Description of Related Art [0006] The cornea of the human eye provides between approximately 60 and 70 percent of the focusing power of the eye. As understood in the art, lenses may be placed in proximity of the cornea to augment the focusing capabilities of the eye. Examples of vision correction lenses include corneal inlays, which are implanted within the cornea, corneal onlays, which are placed over the cornea after the epithelium has been removed, and contact lenses, which are placed over the corneal epithelium. Corneal onlays differ from contact lenses in that corneal onlays are covered by an epithelial cell layer compared to contact lenses that are placed over the corneal epithelium. [0007] Because corneal onlays are placed on a deepithelialized cornea, it is necessary for the epithelium to be replaced over the onlay to prevent damage and infection to the eye. Epithelial cells develop from the corneal limbus and migrate over the eye. Unfortunately, many materials from which existing corneal onlays are manufactured from do not effectively promote epithelial cell growth and migration over the onlay. [0008] Some attempts have been made to create corneal onlays that attempt to improve the migration of epithelial cells over the onlay. For example, U.S. Pat. No. 5,171,318 discloses the use of fibronectin disposed over the surface of an onlay to facilitate cell migration over the onlay and attachment to the onlay. U.S. Pat. No. 5,713,957 discloses non-biodegradable non-hydrogel corneal onlays having large pores in the periphery of the onlay, which are intended to facilitate securement of the onlay to the eye by permitting cells to grow through the pores. U.S. Pat. No. 5,836,313 discloses a composite hydrogel corneal onlay that comprises a layer of corneal tissue or collagen to improve cell migration over the corneal onlay. U.S. Pat. No. 5,994,133 discloses corneal onlays fabricated from various polymers that permit epithelial cells to migrate over the onlay. U.S. Patent Publication No. US 2001/0047203 A1 discloses corneal onlays with surface indentations that supports attachment and migration of the epithelial cells over the onlay. PCT Publication No. WO 02/06883 discloses a corneal onlay derived from donor corneal tissue. In addition, WO 02/06883 appears to disclose the use of an epithelial cell layer placed over the onlay; the epithelial cell layer may be obtained from donor tissue, such as fetal or embryonic tissue, or autologous tissue biopsies of corneal epithelial cells. The corneal onlays which require epithelial cells to migrate over the onlay surface fail to provide satisfactory coverage of the onlay with the epithelium. For example, when epithelial cells are required to migrate over corneal onlays, the epithelial cells may not differentiate fully. Moreover, as the epithelial cells migrate, there may be a tendency for the epithelium to grow under the corneal onlay placed over the eye and cause the onlay to be dislodged or encapsulated. In addition, the recovery time for the epithelial cells to grow and migrate over the onlay is prohibitive and contributes to the undesirability of these approaches. [0009] While WO 02/06883 discloses the use of cultured epithelial cells to create a layer of epithelium that may be used to cover a corneal onlay, it does not disclose using cultured stem cells to create a layer of epithelium. Indeed, culturing stem cells to create a corneal epithelium has only recently been explored (e.g., see Han et al., "A fibrin-based bioengineered ocular surface with human corneal epithelial stem cells", Cornea, 21(5): 505-510 (2002); and U.S. Patent Publication No. US 2002/0039788 A1). These references disclose culturing corneal epithelial stem cells to repair damaged ocular surfaces. Although complications did not appear to be too significant for correcting damaged ocular surfaces, it was noted that it may be problematic to use cultured stem cells with corrective lenses. SUMMARY OF THE INVENTION [0010] The present invention is directed to a corneal appliance or ocular device that is structured to improve a patient's vision, and methods of improving or correcting a patient's vision. The corneal appliance has a lens or a lenticule, and a layer of epithelial cells disposed over the lens. [0011] In one aspect, the epithelial cells may be derived from autologous stem cells, or in other words, from stem cells obtained from the patient receiving the corneal appliance. [0012] In another aspect, the epithelial cells may include at least a portion of the patient's corneal epithelium that has been separated from Bowman's membrane and/or the stroma of the patient's cornea. [0013] A corneal appliance has been invented that addresses the problems associated with current corneal onlays, and the use of epithelial cells in conjunction with onlays. In addition, methods of correcting a patient's vision have been invented that include inserting a corrective ocular device beneath the corneal epithelium of the patient. [0014] A corneal appliance that is structured to be placed over a deepithelialized eye includes a lens and a layer of epithelial cells fixedly positioned over the lens. The epithelial cells of the appliance may be derived from stem cells, which are grown in culture, or may be epithelial cells of the patient receiving the corneal appliance. The stem cells used may include corneal limbal stem cells, or may be exclusively corneal limbal stem cells. [0015] A corneal appliance, as disclosed herein, may be manufactured by a process comprising steps of culturing stem cells until at least a fraction of the stem cells have differentiated into corneal epithelial cells; and applying a plurality of cells obtained from the culture over an anterior surface of a lens to form a layer of epithelial cells that are fixedly secured over the lens before the lens is placed on an eye. [0016] In addition, a corneal appliance may be obtained by a process of inserting a lens underneath an epithelium of an eye substantially without exposing or uncovering the underlying corneal surface and allowing the epithelium to be fixedly secured over the lens. [0017] The lens of the corneal appliance may include collagen, including recombinant collagen. The lens may be a synthetic stroma having a desired optical power, or the lens may be made from a hydrogel or non-hydrogel material suitable for vision correction lenses. The lens may be structured to facilitate attachment of the cells to the lens, for example, by creating indentations in the lens. Alternatively, or in addition, the appliance may include a cellular attachment element disposed between the lens and the epithelial cells. [0018] The cells of the appliance may be derived from cultured stem cells that are grown in vivo or ex vivo. For example, the cells may be cultured in a culture dish, and then transferred to the lens. The cells may be transferred in a suspension, or as a layer of cells. The cells may be cultured on a surface of the lens. For example, the cells may be cultured on a lens positioned in a lens mold adapted to provide conditions suitable for culturing cells. Or, the cells may be cultured on the lens when the lens is placed over an eye. The cells that are applied to the lens may be stem cells, a mixture of stem cells and differentiated epithelial cells, or differentiated epithelial cells without stem cells. [0019] The epithelial cells of the corneal appliance may also be part of a layer of corneal epithelium of the patient receiving the appliance. For example, a layer or flap of epithelium of the patient may be created by separating the epithelium from the cornea of the patient. The layer may be completely removed from the cornea, or may be partially removed to create a flap that remains attached to the remaining epithelium of the patient. The layer or flap of epithelial cells may then be placed over the lens body of the corneal appliance. In one embodiment, the layer of epithelial cells is encouraged to attach to the lens body by providing a suspension of stem cells over the lens body. In addition, the epithelial cells may be a part of the epithelium that is separated from Bowman's membrane, but that is not part of an epithelial flap. For example, the epithelial cells may be a portion of an epithelial pocket, such as, a portion of a preformed layer of epithelium that is located in proximity to where the layer of the epithelium begins to separate from the Bowman's membrane or stroma of the eye. [0020] Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. In addition, any feature or combination of features may be specifically excluded from any embodiment of the present invention. [0021] Additional advantages and aspects of the present invention are apparent in the following detailed description. Continue reading... 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