Corneal lenslet implantation with a cross-linked cornea

Patent metadata

Field	Value
Publication number	US-9937033-B1
Application number	US-201615230445-A
Country	US
Kind code	B1
Filing date	Aug 7, 2016
Priority date	May 12, 2014
Publication date	Apr 10, 2018
Grant date	Apr 10, 2018

Abstract

A method of corneal lenslet implantation with a cross-linked cornea is disclosed herein. In one or more embodiments, the method includes the steps of: (i) forming a two-dimensional cut into a cornea of an eye; (ii) creating a three-dimensional pocket in the cornea of the eye in tissue around the two-dimensional cut to gain access to tissue surrounding the three-dimensional pocket; (iii) applying a photosensitizer inside the three-dimensional pocket so the photosensitizer permeates at least a portion of the tissue surrounding the three-dimensional pocket to facilitate cross-linking of the tissue surrounding the three-dimensional pocket; (iv) irradiating the cornea to activate cross-linkers in the portion of the tissue surrounding the three-dimensional pocket, and thereby stiffen the cornea, prevent corneal ectasia of the cornea, and kill cells in the portion of the tissue surrounding the three-dimensional pocket; and (v) inserting a lens implant into the three-dimensional pocket through a small corneal incision.

First claim

The invention claimed is:

1. A method of corneal lenslet implantation with a cross-linked cornea, said method comprising:
forming a two-dimensional cut into a cornea of an eye;
creating a three-dimensional pocket in the cornea of the eye in tissue around the two-dimensional cut so as to gain access to tissue surrounding the three-dimensional pocket;
after the three-dimensional pocket in the cornea has been formed, applying a photosensitizer inside the three-dimensional pocket so that the photosensitizer permeates at least a portion of the tissue surrounding the three-dimensional pocket, the photosensitizer facilitating cross-linking of the tissue surrounding the three-dimensional pocket;
irradiating the cornea so as to activate cross-linkers in the portion of the tissue surrounding the three-dimensional pocket, and thereby stiffen the cornea, prevent corneal ectasia of the cornea, and kill cells in the portion of the tissue surrounding the three-dimensional pocket; and
after the portion of the tissue surrounding the three-dimensional pocket has been stiffened and is devoid of cellular elements by the activation of the cross-linkers, inserting a lens implant into the three-dimensional pocket through a small corneal incision.

2. The method according to claim 1 , wherein the step of forming a two-dimensional cut into a cornea of an eye comprises forming the two-dimensional cut using a femtosecond laser; and
wherein the step of creating a three-dimensional pocket in the cornea of the eye further comprises opening the two-dimensional cut with a spatula so as to create the three-dimensional pocket.

3. The method according to claim 1 , wherein the step of forming a two-dimensional cut into a cornea of an eye further comprises removing a portion of the cornea having scar tissue so that the lens implant is capable of occupying the space previously occupied by the scar tissue.

4. The method according to claim 1 , wherein the step of creating a three-dimensional pocket in the cornea of the eye further comprises forming a circular-shaped pocket, an oval-shaped pocket, or a square-shaped pocket in the cornea of the eye using a femtosecond laser, and removing the tissue inside the circular-shaped pocket, the oval-shaped pocket, or the square-shaped pocket from the eye.

5. The method according to claim 1 , wherein the portion of the tissue surrounding the three-dimensional pocket comprises stromal tissue of the cornea.

6. The method according to claim 1 , wherein the step of applying the photosensitizer inside the three-dimensional pocket comprises injecting the photosensitizer inside the three-dimensional pocket using a needle, the photosensitizer comprising riboflavin; and
wherein the step of irradiating the cornea so as to activate cross-linkers in the portion of the tissue surrounding the three-dimensional pocket comprises irradiating the cornea with ultraviolet light, another wavelength of light, microwaves, or combinations thereof.

7. The method according to claim 1 , wherein the lens implant is coated with a biocompatible material selected from the group consisting of collagen, elastin, polyethylene glycol, biotin, streptavidin, and combinations thereof, and wherein the lens implant and the coating are cross-linked with the photosensitizer prior to being implanted into the three-dimensional pocket in the cornea of the eye.

8. The method according to claim 1 , wherein the lens implant is a lens formed from a biocompatible transparent material selected from the group consisting of silicone, methacrylate, hydrogel, hydroxyethylmethacrylate (HEMA), an organic material, a synthetic material, and combinations thereof; and wherein the lens implant is cross-linked prior to the implantation of the lens implant in the cornea of the eye.

9. The method according to claim 1 , wherein the lens implant is formed from a donor cornea that is cross-linked prior to implantation in the eye so as to strengthen the donor cornea, kill donor keratocytes in the donor cornea, and make the donor cornea less antigenic to the eye of a recipient patient.

10. The method according to claim 1 , further comprising the step of:
prior to the implantation of the lens implant, constructing the lens implant in vitro by three-dimensionally printing the lens implant to a desired shape so as to correct a refractive error of the eye.

11. The method according to claim 10 , wherein the three-dimensionally printed lens implant is coated with a biocompatible material selected from the group consisting of collagen, elastin, polyethylene glycol, biotin, streptavidin, and combinations thereof, and wherein the three-dimensionally printed lens implant and the coating are cross-linked with a photosensitizer prior to being implanted into the three-dimensional cross-linked pocket in the cornea of the eye to eliminate an immune response to the implant.

12. The method according to claim 1 , wherein the lens implant is implanted subsequent to the implantation of an intraocular lens so as to correct a remaining portion of the refractive error of the eye, thereby obviating the need for replacing the intraocular lens.

13. The method according to claim 1 , wherein the lens implant is ablated with an excimer laser to a desired shape prior to implantation in the three-dimensional pocket.

14. The method according to claim 1 , wherein the lens implant is cut with a femtosecond laser in a three-dimensional manner to a desired shape prior to implantation in the three-dimensional pocket to compensate for the refractive error of the eye.

15. The method according to claim 1 , further comprising the step of:
prior to the implantation of the lens implant, injecting a predetermined amount of hyaluronic acid or a viscous biocompatible material into the three-dimensional pocket so as to simplify the insertion of the lens implant in the three-dimensional pocket.

16. The method according to claim 1 , wherein the lens implant comprises a plurality of circumferentially spaced-apart indicia holes proximate to a periphery of the lens implant; and wherein the method further comprises the step of:
after the implantation of the lens implant, rotating the lens implant using a hook inserted through one of the indicia holes in the lens implant so as to match the axis of an astigmatic error of the eye which is simultaneously measured during the surgical procedure with a wavefront diagnostic system.

17. The method according to claim 16 , wherein each of the indicia holes in the lens implant has a hole diameter between approximately 0.01 millimeters and approximately 2 millimeters.

18. The method according to claim 1 , wherein the step of inserting a lens implant into the three-dimensional pocket comprises inserting the lens implant overlying the central visual axis of the eye, the lens implant providing 1 to 3 times magnification so as to obviate the need for magnifying reading glasses for a patient whose macula is affected by a disease process requiring monocular magnifying vision correction for reading.

19. The method according to claim 1 , further comprising the step of:
injecting a medication into the cornea of the eye so as to prevent inflammatory processes after the corneal surgery or to prevent future cell growth in the lens implant or in tissue adjacent to the acellular corneal tissue of the eye, the medication selected from the group consisting of a steroid, a nonsteriodal anti-inflammatory drug (NSAID), an immune-suppressant, an anti-proliferative agent, an antimetabolite agent, an antibiotic, and combinations thereof.

Assignees

• Peyman Gholam A

Inventors

• Peyman Gholam A

Classifications

• A61F2/142

  Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue · CPC title

• A61F2009/00872

  Cornea · CPC title

• A61F2/1451 Primary

  Inlays or onlays · CPC title

• A61F9/00814

  Laser features or special beam parameters therefor · CPC title

• A61F2/1602

  Corrective lenses for use in addition to the natural lenses of the eyes or for pseudo-phakic eyes · CPC title