CORNEAL IMPLANTS AND METHODS OF MANUFACTURING

Abstract

Corneal implants that have an implant body comprising manufactured corneal tissue. Methods of manufacturing corneal implant that include manufacturing a volume of corneal tissue. Corneal implants that have an implant body made from cornea tissue removed from a living subject.

Claims

1-8. (canceled)

9. A method of manufacturing a corneal device, comprising providing a volume of corneal tissue; cutting the volume into a meniscus shaped lens with a 1-3 mm diameter.

10. The method of claim 9, wherein the cutting step comprises cutting the volume into a meniscus shaped lens with a laser.

11. The method of claim 9, wherein providing a volume of corneal tissue comprises manufacturing a volume of corneal tissue.

12. The method of claim 11, wherein manufacturing the volume of corneal tissue comprising manufacturing the volume from human keratocytes.

13. The method of claim 11, wherein manufacturing the volume from human keratocytes comprising manufacturing the volume on a template.

14. The method of claim 11, wherein manufacturing the volume from human keratocytes comprises manufacturing the volume of corneal tissue to have aligned collagen fibrils.

15. A corneal device, comprising: a meniscus-shaped body with a 1-3 mm diameter, the body comprising corneal tissue.

16. The corneal device of claim 15, wherein the body comprises manufactured corneal tissue.

17. The corneal device of claim 16, wherein the manufactured corneal tissue is made from human keratocytes.

18. The corneal device of claim 16, wherein the manufactured corneal tissue has aligned collagen fibrils.

19. The corneal device of claim 15, wherein the body has a central thickness of 50 microns or less.

Description

DETAILED DESCRIPTION

[0015] The disclosure is related to corneal implants and their methods of manufacture. Corneal implants, as the term is used herein, includes corneal inlays and corneal onlays. Corneal inlays are currently made from plastic-based materials such as hydrogels, which are less biocompatible than corneal tissue. A corneal reaction, such as keratocyte activity around the inlay, can result in local haziness.

[0016] An alternative material from which to construct inlays is artificial cornea, whether from a donor cornea or from fabricated corneal tissue such as in Gouveia. An inlay made of artificial cornea could be constructed using a femtosecond laser, similar to those employed to make corneal cuts for LASIK, which could cut the volume of the lens with sufficient accuracy. Alternatively, the inlay could be constructed by placing it on a lathe and cutting it down to the required size and configuration in the same manner as a contact lens is manufactured. This could also be done in a very cold environment in which the tissue is frozen for ease of cutting.

[0017] Such an inlay could then be placed under a kerototomy flap in such a way as to correct a patient's vision by amending the optical pathway of the eye by altering the surface of the cornea, examples of which are provided in U.S. Pat. No. 8,057,541, issued Nov. 15, 2011; U.S. Pub. No 2008/0262610, published Oct. 23, 2008; U.S. Pub. No 2009/0198325; and U.S. Pub. No. 2011/0218623.

[0018] The artificial cornea tissue can be used to construct inlays that can be used to correct vision in, for example, hyperopes, presbyopes, myopes and pseudophakic patients.

[0019] One of the advantages of implanting corneal implants made from the fabricated corneal tissue is that it solves a problem of corneal rejection of material introduced into it due to the biological nature of the inlay material. Corneal transplants have shown that the cornea is immune privileged, and as such a particular type of corneal tissue is not required for a particular individual. This is unlike, for instance, a blood transfusion where the right type of blood is required based on the individual's blood type. Small pieces of artificial cornea implanted within a cornea should therefore be well tolerated.

[0020] One aspect of the disclosure is a corneal implant, such as a corneal inlay, that has been manufactured from fabricated bio-prosthetic human corneal tissue. Another aspect of the disclosure is a method of constructing a corneal implant, such as a corneal inlay, from fabricated human corneal tissue.

[0021] The size and configurations of the corneal implants herein can be selected, or chosen, take into account epithelial remodeling of the cornea after implantations, which is described in U.S. Pat. No. 8,900,296, and which is incorporated herein by reference.

[0022] This disclosure also includes corneal implants, such as the inlays herein, which are constructed from transplanted human corneal tissue. In some aspect the corneal implants are constructed from corneal tissue that has been removed from living corneal tissue (i.e., removed while the subject is still alive). For example, the corneal implants can be constructed from living corneal tissue that has been removed from a subject's cornea during a refractive lenticule extraction (ReLEx) procedure, which includes femtosecond lenticule extraction (FLEx) and small incision lenticular extraction (SMILE) procedures. Cornea Lenticule Viability and Structural Integrity after Refractive Lenticule Extraction (ReLEx) and Cryopreservation (Mohamed-Noriega, Molecular Vision 2011; 17:3437-3449), which is incorporated herein by reference, describes exemplary techniques and procedures for obtaining and/or processing living corneal tissue from ReLEx procedures. Any of the methods and steps in Mohamed-Noriega can be used herein as part of the overall method of constructing the corneal implant. For example, a corneal lenticule removed from living corneal tissue during a SMILE procedure can be used to construct a corneal implant, such as a corneal inlay with a 1-4 mm diameter (such as 103 mm) for treating presbyopia.

[0023] In some embodiments the corneal implants are constructed from corneal tissue removed from recently deceased (e.g., within 24, or 48 hours after death) subjects. For example, any suitable volume of corneal tissue from a recently deceased individual can be removed and used to construct any of the corneal implants herein.