Endothelial ocular implant
Inventors
Daphna, Ofer • Dubson, Dmitry • Ferera, Nahum
Assignees
Publication Number
US-11737919-B2
Publication Date
2023-08-29
Expiration Date
2041-06-17
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Abstract
An ocular implant is constructed of a clear, transparent, biologically compatible material and includes a hydrophilic outer surface configured for continuous attachment to a posterior surface of a cornea. The ocular implant has a first radius of curvature at initial attachment to the posterior surface of the cornea and a second radius of curvature at post-initial attachment to the posterior surface of the cornea. The first radius of curvature is different than the second radius of curvature. The ocular implant remains attached to the posterior surface of the cornea at both the first and second radii of curvature.
Core Innovation
The invention provides an endothelial ocular implant constructed of a clear, transparent, biologically compatible material with a hydrophilic outer surface configured for continuous attachment to the posterior surface of the cornea. The implant has a first radius of curvature at initial attachment and a second radius of curvature after treatment, with these radii being different, yet the implant remains attached to the cornea at both radii of curvature. This implant serves as a physical water barrier to maintain corneal dehydration and clarity during and after treatment of corneal edema.
The implant is made preferably of a copolymer of hydroxyethyl methacrylate and methyl methacrylate, such as Ci26, which has hydrophilic and hydrophobic components enabling it to be flexible, foldable for insertion, and adaptable to the varying curvature of the posterior corneal surface during edema treatment and healing. The material is annealed to remove internal stresses and enhance toughness and flexibility, allowing it to retain mechanical, physical and optical properties after changing curvature and unfolding inside the eye.
The implant includes an optional peripheral edge that is thinner than the central portion, forming a stepped barrier that allows cell growth to adhere to the peripheral edge but blocks cells from growing over the central portion. This cell growth aids bio-active attachment and anchoring of the implant to the corneal tissue without the need for sutures or binding agents, although such adjuncts may be used temporarily. The implant is configured to accommodate changes in corneal thickness and curvature from the edematous to post-treatment normal state, sustaining effective attachment throughout the treatment process.
The background problem addressed by the invention is corneal edema caused by endothelial dysfunction leading to corneal overhydration and loss of transparency, which significantly impairs vision and may cause pain and scarring. Existing methods rely on donor tissue implantation or surgical procedures which can have limitations. The present ocular implant provides a synthetic, biologically compatible alternative to maintain corneal dehydration by physically blocking fluid ingress, thus preserving transparency while allowing for corneal healing.
Claims Coverage
The patent contains one independent device claim and one independent method claim, each defining core inventive features related to the ocular implant and its use in treating edema.
Ocular implant with variable radius of curvature and hydrophilic surface
An ocular implant constructed of a transparent, biologically compatible material comprising a hydrophilic outer surface for continuous attachment to the posterior corneal surface, having a first radius of curvature at initial attachment and a different second radius of curvature after post-initial attachment, with the implant remaining attached at both radii of curvature.
Method of treating edema using the ocular implant
A method involving providing the described ocular implant and instructing it to be attached to the posterior surface of the cornea to treat edema.
The claims cover an ocular implant designed to adapt to different curvatures of the posterior corneal surface while maintaining hydrophilic continuous attachment, and methods of treating corneal edema using the implant.
Stated Advantages
The implant maintains corneal dehydration and clarity by serving as a water barrier to the passive movement of aqueous humor into the cornea.
Its hydrophilic external surface enables adherence to the cornea without sutures or additional binding agents, simplifying implantation.
The implant can change its radius of curvature to follow the contour of the healing cornea, retaining shape and optical properties throughout.
The peripheral edge with stepped barrier promotes cell growth to enhance bio-active anchoring, improving long-term adherence.
The material used (e.g., Ci26) is foldable and injectable through small incisions, allowing minimally invasive implantation.
The implant is biologically inert, transparent, durable to scratches, and stable under ultraviolet radiation for long-term implantation.
Documented Applications
Treatment of corneal edema caused by endothelial dysfunction or damage.
Use as a pseudo-endothelial implant alternative to donor tissue in surgeries such as Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet Membrane Endothelial Keratoplasty (DMEK).
Maintaining corneal dehydration and clarity during corneal healing after swelling due to surgery, trauma, or disease.
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