Keratoprosthesis and uses thereof
Inventors
Assignees
Publication Number
US-10667902-B2
Publication Date
2020-06-02
Expiration Date
2036-06-08
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Abstract
The present invention provides a keratoprosthesis assembly comprising a central optical core; and a peripheral skirt comprising at least one porous biocompatible layer and methods of using it in keratoprosthesis procedures.
Core Innovation
The invention provides a keratoprosthesis assembly comprising a central optical core and a peripheral skirt with at least one porous biocompatible layer having a pore size of at least about 2 μm. The central optical core functions as an artificial cornea's optical part, covering the anterior chamber of the eye and can be made of acrylic, silicate, or other clear, durable polymers, optionally with an external layer repelling optical depositions. The peripheral skirt surrounds the optical core and is designed for placement beneath the conjunctiva of the eye, facilitating biointegration with surrounding tissues.
The keratoprosthesis aims to improve the optical quality of artificial grafts, enhance biointegration, and increase resistance to trauma. The porous biocompatible layer of the skirt is fibrous, possibly formed of nanofibers produced through electrospinning or other spinning techniques. This porous structure allows cell tissue growth and assimilation, enabling better integration with conjunctiva and potentially avoiding deleterious reactions. The optical core includes structural features such as extended portions and grooves for anchoring firmly into the trephined corneal space, ensuring stable positioning and water-tightness.
Claims Coverage
The patent includes one independent claim detailing the keratoprosthesis assembly, with inventive features relating to both the central optical core and the peripheral skirt, their dimensions, materials, and their method of attachment.
Central optical core with extended anchoring portion
The keratoprosthesis comprises a transparent central optical core having a diameter of at least 3 mm and including an extended portion extending axially below the surface formed by the core and skirt. This extended portion is sized and configured for anchoring the core into a trephined space of the central cornea.
Annular peripheral skirt with porous biocompatible layer
The peripheral skirt substantially surrounds the central optical core's perimeter and comprises at least one porous biocompatible layer with a pore size of at least 2 μm. The skirt has an anterior surface contacting the conjunctiva and a posterior surface contacting the sclera. It has a width of at least 3 mm and a thickness from about 100 to 2000 microns, sized for placement beneath the conjunctiva and above the sclera.
Porous biocompatible layer formed by electrospinning and comprising nanofibers
The porous biocompatible layer is formed by an electrospinning process and comprises nanofibers. It can be a polymeric layer, nonwoven fabric, or fibers from materials such as poly(DTE carbonate), PCL, PLA, PLLA, and others.
Peripheral skirt functionalization with biomolecules or antibiotics
The peripheral skirt can further comprise biomolecules or antibiotic agents covalently attached to the porous biocompatible layer, including proteins, collagen, fibronectin, TGF-beta 2, heparin, growth factors, antibodies, and chemotherapeutic agents.
Mechanical or chemical attachment of optical core to peripheral skirt
The central optical core and peripheral skirt are attached to each other either mechanically, for example by sutures or connecting layers, or chemically, by gluing, fusing, or applying heat or pressure to join them securely.
The independent claim covers a keratoprosthesis with a central optical core designed for anchoring into a trephined cornea, surrounded by an annular peripheral skirt comprising a porous biocompatible layer with specific dimensions and materials. The claim includes features related to the formation of the porous layer by electrospinning, incorporation of biomolecules, and methods for attaching the core and skirt to ensure stability and biointegration.
Stated Advantages
Improved optical quality of the artificial graft.
Better bio-integration with surrounding eye tissues due to the porous biocompatible skirt.
Improved resistance to trauma.
Stable positioning and immediate water-tightness provided by the central optical core's extended grooved portion.
Simplification of the surgical procedure to a single staged, approximately 30-minute process that is significantly simpler than existing solutions.
Documented Applications
Use in keratoprosthesis procedures for replacing diseased corneas of subjects in need thereof.
Placement of the peripheral skirt under the conjunctiva and above the sclera during implantation to enhance biointegration.
Surgical implantation involving trephination of the central cornea followed by insertion of the keratoprosthesis central optical core and application of the peripheral skirt beneath the conjunctiva.
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