Keratoprosthesis and uses thereof
Inventors
Assignees
Publication Number
US-11213382-B2
Publication Date
2022-01-04
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, the latter including at least one porous biocompatible layer with a pore size of at least about 2 μm. The central optical core functions as the optical part of the keratoprosthesis, covering the anterior chamber of the eye, and can be made of acrylic, silicate, or other clear, durable polymers. This core may have an extended portion that enables anchoring into a trephined cornea, including grooves for snap-fitting and holes for core-to-skirt attachment and tissue integration.
The peripheral skirt substantially surrounds the central optical core and is designed for biointegration by being made from a porous biocompatible layer, such as an electrospun fibrous polymeric material, facilitating cell growth and tissue assimilation. The skirt can be positioned beneath the conjunctiva over the sclera and may carry biomolecules or antibiotics covalently attached to promote healing and prevent infection.
The invention addresses significant limitations of prior keratoprosthesis devices, such as poor biointegration, postoperative complications including glaucoma, and restricted access for subsequent ocular surgeries. It provides a simplified, single-stage implantation procedure involving removal of the diseased cornea, insertion of the optical core into the trephined space, and placement of the biointegrating skirt beneath the conjunctiva, allowing better optical quality, improved tissue integration, and enhanced mechanical stability while reducing complexity and risk.
Claims Coverage
The patent includes one independent claim detailing a procedure for implanting a keratoprosthesis, with several main inventive features concerning the keratoprosthesis structure and implantation steps.
Keratoprosthesis assembly architecture
The keratoprosthesis comprises a transparent central optical core and an annular peripheral skirt substantially surrounding the core's perimeter, with the skirt having an anterior conjunctiva-contacting surface and a posterior sclera-contacting surface configured for proper eye placement.
Extended portion for anchoring
An extended portion extends axially below the surface formed by the central optical core and the annular peripheral skirt and is sized and configured to anchor the central optical core securely in a trephined space of the central cornea.
Porous biocompatible peripheral skirt
The annular peripheral skirt includes at least one porous biocompatible layer having pore size of at least 2 μm, a width of at least 3 mm, and thickness ranging from about 100 microns to about 2000 microns, configured to be placed under the conjunctiva and above the sclera.
Implantation procedure steps
The procedure comprises performing a 360 degree peritomy, elevating and dissecting both tenon capsule and conjunctiva from sclera, trephination of the central cornea, placing the optical core into the trephined space, placing the peripheral skirt under the dissected tenon and conjunctiva, and replacing the tenon capsule and conjunctiva onto the peripheral skirt.
Porous layer material variations
The at least one porous biocompatible layer can be a polymeric layer, a nonwoven fabric, or comprise nanofibers, and it can be formed via an electrospinning process.
Peripheral skirt functionalization
The peripheral skirt can further comprise a biomolecule or an antibiotic agent.
The inventive features cover a keratoprosthesis assembly with a transparent optical core and a porous, biocompatible peripheral skirt designed for enhanced biointegration and mechanical stability, coupled with a detailed, single-stage implantation procedure that improves placement and tissue integration.
Stated Advantages
Improved optical quality of the artificial graft.
Better bio-integration with ocular tissue due to the porous biocompatible skirt.
Improved resistance to trauma compared to existing keratoprosthesis solutions.
Simplified, single-stage 30-minute implantation procedure that is less complex than current solutions.
Enhanced mechanical stability and water-tightness provided by the grooved extended portion of the optical core.
Facilitates thorough clinical exams and ocular access post-implantation.
Documented Applications
Use of the keratoprosthesis assembly in keratoprosthesis procedures replacing a diseased cornea.
Implantation following trephination of the central cornea in patients with corneal blindness or disease.
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