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1. WO2020115605 - CORNEAL IMPLANT WITH PERIPHERAL SKIRT

Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

[ EN ]

CORNEAL IMPLANT WITH PERIPHERAL SKIRT

FIELD OF THE INVENTION

The present invention relates generally to corneal implants, such as for treating an over-hydrated, edematous cornea, and particularly to a comeal implant with a peripheral skirt that improves adhesion of the implant to the comeal tissue.

BACKGROUND OF THE INVENTION

US Patents 8109997 and 8500803 to Daphna describe bonding a hydrophobic pseudo-endothelial implant to a posterior portion of the cornea adjacent the aqueous humor with a binding agent. The implant serves as a water barrier enabling dehydration of the cornea, and may be used in the treatment of an edematous cornea.

The adhesion of an implant to comeal tissue without sutures or mechanical fasteners poses a challenge. The adhesive materials must be compatible with the ocular environment and yet must provide good adhesion for a long time without degradation in the ocular quality of the eye.

SUMMARY OF THE INVENTION

The present invention relates to a comeal implant with a peripheral skirt that improves adhesion of the implant to the corneal tissue, as is described more in detail hereinbelow.

In one aspect of the invention, the corneal implant has a central portion of about 4 mm in diameter (“about” is ±10%) and the peripheral skirt is outwards of the central portion. The central portion is transparent and may or may not have optical properties, such as positive or negative magnification, astigmatism correction, refraction adjustment and others. The peripheral skirt may be transparent but can instead be opaque. In one aspect of the invention, the peripheral skirt includes a mesh that enables cell growth in and through the mesh to enhance adhesion of the implant to the cornea. The peripheral skirt may be thinner or thicker than the central portion.

There is provided in accordance with an embodiment of the present invention a comeal implant including a central portion and a peripheral skirt extending outwards from the central portion, wherein at least a portion of the peripheral skirt includes a mesh.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:

Figs. 1 and 2 are simplified planar-view and edgewise-view illustrations, respectively, of a comeal implant, constructed and operative in accordance with a non limiting embodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to Figs. 1 and 2, which illustrate a comeal implant 10, constructed and operative in accordance with an embodiment of the present invention. The implant 10 may be a pseudo-endothelial implant, which can be used instead of an implant from a donor in a DSEK (Descemet Stripping Endothelial Keratoplasty) or DMEK (Descemet Membrane Endothelial Keratoplasty) surgery. Implant 10 serves as a water barrier enabling the dehydration of the cornea.

Implant 10 may be constmcted of a clear, transparent, biologically compatible material, such as but not limited to, polymethylmethacrylate (PMMA), silicone, silicone mbber, collagen, hyaluronic acid (including the sodium, potassium and other salts thereof), hydrogel, such as acrylic or methacrylic hydrogels, e.g., hydroxyethyl methacrylate or methacrylic acid copolymer/partially hydrolyzed poly(2-hydroxyethyl methacrylate) (known as Poly HEM A), polysulfones, thermolabile materials and other relatively hard or relatively soft and flexible biologically inert optical materials, or any combination of such materials, such as a gel encapsulated in a polymer. Implant 10 may thus be rigid, semi-rigid or foldable, for example.

Some or all of implant 10 may be hydrophilic or hydrophobic.

In one aspect of the invention, comeal implant 10 has a central portion 12 of about 4 mm in diameter (“about” is ±10%) and a peripheral skirt 14 extending outwards from the central portion 12. The central portion 12 may be transparent and may or may not have optical properties, such as positive or negative magnification, astigmatism correction, refraction adjustment and others.

The peripheral skirt 14 may be made of the same material as central portion 12. Alternatively, peripheral skirt 14 may be made of a different material than central portion 12 and bonded or otherwise attached to central portion 12. The peripheral skirt 14 may be transparent but can instead be opaque.

In one aspect of the invention, at least a portion of the peripheral skirt 14 includes a mesh 16 that enables cell growth in and through the mesh to enhance adhesion of the implant to the cornea. The mesh 16 may have openings of equal or different sizes

Non-limiting dimensions of the implant are as follows, using the nomenclature shown in Fig. 2:

Outer diameter of implant 10 (OD): 4.2-7.0 mm

Maximum thickness of central portion 12 (CPT): 25-75 pm

Peripheral width of peripheral skirt 14 (PS): 0.1- 1.5 mm

Minimum thickness of peripheral skirt 14 (PST): 0-25 pm

Extra thickness of central portion 12 more than skirt 14 (CPE): 0-75 pm

Radius of curvature (RC) of implant from radius origin O: 6-10 mm

Accordingly, peripheral skirt 14 may have a different thickness than the central portion 12 or may be the same thickness.

As another alternative, peripheral skirt 14 may be formed with one or more radial slits 33, which may extend the entire width of peripheral skirt 14 or just a portion of the width.

As another alternative, peripheral skirt 14 may include one or more radially extending portions 40 or 42 (shown in broken lines), which may be curved or straight with pointed on non-pointed ends.

The increased adhesion of peripheral skirt 14 may create a bond between the implant and the comeal tissue without the need for application of an external adhesive substance.