KERATOPROSTHESIS DEVICES AND KITS AND SURGICAL METHODS OF THEIR USE

Abstract

The invention provides keratoprosthesis devices and kits and surgical methods of their use.

Claims

1. A keratoprosthesis comprising: (a) a central optical core having an anterior surface and a posterior surface; and (b) a peripheral skirt around said central optical core, comprising at least one biocompatible polymer and having a width capable of being placed under the conjunctiva and above sclera of the eye; wherein said central optical core comprises an anterior rim extending radially from the anterior surface and a posterior rim extending radially from and below the posterior surface; wherein said anterior rim comprises at least two suturing holes and at least two access ports; and wherein said posterior rim comprises at least two extended flanges.

2. A keratoprosthesis according to claim 1, wherein said anterior rim comprises at least three suturing holes.

3. A keratoprosthesis according to claim 1, wherein said suturing holes are located at predetermined distance from each other on the anterior rim.

4. A keratoprosthesis according to claim 1, wherein said anterior rim comprises at least three access ports.

5. A keratoprosthesis according to claim 1, wherein said access ports are located at predetermined distances from each other on the anterior rim.

6. A keratoprosthesis according to claim 1, wherein said anterior rim further comprises at least one biocompatible polymer.

7. A keratoprosthesis according to claim 1, wherein said posterior rim comprises at least three extended flanges.

8. A keratoprosthesis according to claim 1, wherein said extended flanges are located at equivalent distances from each other on the posterior rim.

9. A keratoprosthesis according to claim 1, wherein said central optical lens has a radius/diameter of at least 3 mm.

10. A keratoprosthesis according to claim 1, wherein said anterior rim has a width of at least 1 mm.

11. A keratoprosthesis according to claim 1, wherein said posterior rim has a width of at least 1 mm.

12. (canceled)

13. (canceled)

14. (canceled)

15. A keratoprosthesis according to claim 1, wherein said peripheral skirt has a width of at least 3 mm.

16. (canceled)

17. (canceled)

18. (canceled)

19. (canceled)

20. (canceled)

21. (canceled)

22. (canceled)

23. (canceled)

24. (canceled)

25. (canceled)

26. (canceled)

27. (canceled)

28. (canceled)

29. A kit comprising: a keratoprosthesis comprising: (a) a central optical core comprising a central optical lens having an anterior surface and a posterior surface; and (b) a peripheral skirt around said central optical core, comprising at least one biocompatible polymer and having a width capable of being placed under the conjunctiva and above sclera of the eye; wherein said central optical core comprises an anterior rim extending from the anterior surface and a posterior rim extending from the posterior surface; wherein said anterior rim comprises at least two suturing holes and at least two access ports; and wherein said posterior rim comprises at least two extended flanges; and a marking tool comprising a polymeric surface in the shape of said central optical core, having bumps protruding below the polymeric surface, located at the positions of said at least two suturing holes, at least two access ports of the central optical core and the trephination edge.

30. (canceled)

31. (canceled)

32. (canceled)

33. A surgical procedure for implanting a keratoprosthesis in a subject in need there of comprising the steps of: (1) Providing a kit according to any one of claims 27 to 30; (2) performing a 360 degree peritomy in the eye of said subject; (3) performing epithelial debridement; (3) marking the center of the cornea with a surgical marker; (4) marking the suturing and access ports on the eye of the subject using the marking tool of the kit using the mark of the center of the cornea for reference; (5) pre-placing of corneal anchoring suture threads in the marked suturing holes; (6) intra-cameral injection of epinephrine and (OVD) ophthalmic viscosurgical device; (7) trephination and removal of central diseased cornea; (8) approximation of keratoprosthesis of the invention by tying of sutures made in the eye with the suturing holes in the keratoprosthesis of the invention; (9) OVD exchange with balanced salt solution; (10) tying closure of conjunctiva over the peripheral skirt and rim with sutures.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0062] The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying drawings in which:

[0063] FIG. 1 shows the central optical core of a keratoprosthesis of the invention from a bottom view (the open posterior part of the device).

[0064] FIG. 2 shows the central optical core of a keratoprosthesis of the invention from a bottom view (the open posterior part of the device).

[0065] FIG. 3 shows the central optical core of a keratoprosthesis of the invention from a top view (the anterior part of the device).

[0066] FIG. 4 shows a keratoprosthesis of the invention.

[0067] FIG. 5A-5B shows a cross section of the central optical core of a keratoprosthesis of the invention (5A) and a detail thereof (5B).

[0068] FIG. 6 shows the results of the clinical evaluation of an implanted keratoprosthesis of the invention in a NZW rabbit during 26 weeks from implantation.

[0069] FIG. 7A-7D show tissue processing and histology of the NSW rabbit implanted with a keratoprosthesis of the invention. Eyes implanted were embedded in SPURR blocks. Each block was bisected sagittally through the center of the eye and stained with hematoxylin and eosin (H&E) and Masson's Trichrome (MT).

[0070] FIG. 8A-8J shows a cornea implantation surgical procedure of the invention using a keratoprosthesis and kit of the invention.

[0071] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

[0072] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.

[0073] FIG. 1 shows a bottom view (a view from the posterior open part of the device of the invention) the optical central core of a keratoprosthesis of the invention (100), showing the optical lens (101), the anterior rim (102) extending around from said optical lens (from its anterior surface). The anterior rim is showing the suturing holes (103) and the access ports (104). Further the posterior rim is shown (105) extending below and around the optical lens (from its posterior surface) and the flanges (106) extending from said posterior rim. The figure also shows the marking of the access ports (107).

[0074] FIG. 2 shows a bottom side view (a view from the posterior open part of the device of the invention) the optical central core of a keratoprosthesis of the invention (200), showing the optical lens (201), the anterior rim (202) extending around from said optical lens (from its anterior surface). The anterior rim is showing the suturing holes (203) and the access ports (204). Further the posterior rim is shown (205) extending below and around the optical lens (from its posterior surface) and the flanges (206) extending from said posterior rim. The figure also shows the marking of the access ports (207).

[0075] FIG. 3 shows a top view (a view from the anterior side of the device of the invention) the optical central core of a keratoprosthesis of the invention (300), showing the optical lens (301), the anterior rim (302) extending around from said optical lens (from its anterior surface). The anterior rim is showing the suturing holes (303) and the access ports (304). Further the posterior rim is shown (305) extending below and around the optical lens (from its posterior surface) and the flanges (306) extending from said posterior rim. The figure also shows the marking of the access ports (307).

[0076] FIG. 4 shows a keratoprosthesis of the invention (400), showing the peripheral skirt (401) around said central optical core (placed on the distal zone of the anterior rim). The figure also shows the optical lens (402), from which the posterior rim (403) extends around and below its posterior surface. Said posterior rim shows the flanges (405). The figure also shows the proximal zone of the anterior rim extending around and from the optical lens (406) and the distal zone (404).

[0077] FIG. 5A shows a cross section of the central optical core of a keratoprosthesis of the invention (500) showing the anterior surface of the optical lens (501) and the posterior surface of the optical lens (502). The figure shows in cross section the width of the anterior rim (503) extending from the anterior surface of the optical lens, the width of the posterior rim (504) extending below the posterior surface of the optical lens and the flanges (505). The space formed between the anterior rim and the posterior rim is able to accommodate the edges of the trephined cornea and thus holding the device on the eye of the subject firmly in position, the suturing reinforces the stability of the device in the eye.

[0078] FIG. 5B shows a detail of the cross section of the central optical core of a keratoprosthesis of the invention of FIG. 5A, showing the posterior rim width (506) and the flange (507).

EXAMPLE 1

In Vivo Examination in NZW Rabbits of a Keratoprosthesis of the Invention

[0079] Keratoprosthesis of the invention were implanted in 8 rabbits unilaterally and followed up for 6 months. Upon completion, progressive integration with no inflammatory rejections were recorded.

[0080] Methods: Eight male NZW rabbits were subjected to a unilateral intraocular implantation of the keratoprosthesis of the invention, while the contralateral eye serves as an untreated control, all under Good Laboratory Practice guidelines. Eight animals were clinically observed for a duration of 6-months to assess safety, during which the eyes are repeatedly monitored by slit-lamp bio-microscopy. At termination, eyes will be enucleated and evaluated histologically.

[0081] Results: Clinical evidence shows progressive integration and cessation of inflammatory response. Eyes are all intact with no evident breach of integrity or leak of aqueous humor. Animals exhibit use of implanted eyes routinely. Some animals exhibit iatrogenic (surgically induced) Cataract. FIG. 6 shows the results of the clinical evaluation of an implanted keratoprosthesis of the invention in a NZW rabbit during 26 weeks from implantation in terms of inflammatory response of the conjunctiva, anterior chamber (AC) reaction, conjunctiva and iris congestion. Histological data and slides prove seamless and durable tissue integration of the deice with the ocular wall (FIGS. 7A-7D). Clinical and histopathological findings of low and gradually decreasing inflammatory reaction coupled with progressive integration of the peripheral skirt prove short and medium-term safety.

[0082] The surgical procedure using a kit and keratoprosthesis of the invention are shown in FIGS. 8A-8J. In FIG. 8A a peritomy of 360 degrees is made, elevating both conjunctiva and tenon; FIG. 8B shows the removal of epithelial cells layer. FIG. 8C shows the marking of the native cornea's center and suturing holes with the dedicated marker tool. FIG. 8D shows the creation of two ports to the anterior chamber for infusion and tools after which the eye is filled with viscoelastic material; FIG. 8E shows the anchoring sutures—three limbal sutures are pre-placed for optic anchoring at 120 degrees apart as marked by the marker; FIG. 8F shows the trephination of the central cornea is carried out; FIG. 8G shows the tightening the anchoring sutures thereby displacing the keratoprosthesis so that it will be approximated to the native corneal remnant, facilitating its insertion; FIG. 811 shows how the optical zone is inserted into the trephined space using the snapper tool; FIG. 81 shows the bio-integrating peripheral skirt is laid on the bare sclera and the conjunctiva and tenon are put back and sutured to their position; FIG. 8J shows that the viscoelastic is replaced with BSS (balanced saline solution) in the implanted eye.

[0083] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.