Keratoprosthesis devices and kits and surgical methods of their use
Inventors
Litvin, Gilad • Aley-Raz, Almog
Assignees
Publication Number
US-12364591-B2
Publication Date
2025-07-22
Expiration Date
2040-04-26
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Abstract
The invention provides surgical procedures for implanting a keratoprosthesis in an eye of a subject in need using a kit comprising keratoprosthesis comprising a central optical core, a peripheral skirt around said central optical core, comprising at least one biocompatible polymer; and a marking tool comprising a polymeric surface in the shape of said central optical core.
Core Innovation
The invention provides a keratoprosthesis assembly comprising a central optical core with a central optical lens having an anterior and posterior surface, and a peripheral skirt around the central optical core made of at least one biocompatible polymer. The central optical core includes an anterior rim extending radially from the anterior surface and a posterior rim extending radially from and below the posterior surface. The anterior rim includes at least two suturing holes and at least two access ports, while the posterior rim comprises at least two extended flanges. The peripheral skirt is configured to be placed beneath the conjunctiva and above the sclera of the eye, allowing biointegration and secure placement of the keratoprosthesis.
The invention addresses the problem of corneal blindness where traditional treatments such as keratoplasty are limited by donor tissue availability, high risk of graft rejection, and unsuitability for cases with corneal vascularization or repeated graft failures. Existing keratoprosthesis devices have complications including glaucoma, elevated intraocular pressure, poor biointegration, and limited postoperative surgical access, which impair long-term outcomes and increase risks and costs. This invention aims to provide an improved artificial cornea device and surgical kit that enhance secure fixation, biointegration, and facilitate surgical implantation and postoperative procedures.
The kit includes the keratoprosthesis and a marking tool shaped as the central optical core with bumps corresponding to suturing holes, access ports, and trephination edge to enable precise marking during surgery. The surgical procedure involves steps of peritomy, epithelial debridement, marking with the tool, pre-placing sutures, intra-cameral injection of anesthetic/viscoelastic agents, trephination and removal of diseased cornea, suturing the keratoprosthesis, and closure of conjunctiva over the skirt. These features provide improved surgical accuracy, stability, and integration of the keratoprosthesis device in the recipient eye.
Claims Coverage
The claims cover a surgical procedure for implanting a keratoprosthesis using a kit, detailing the keratoprosthesis structure and specific procedural steps with defined features of the device and method.
Surgical procedure using a keratoprosthesis kit with defined optical core and peripheral skirt
Using a kit comprising a keratoprosthesis having a central optical core with anterior and posterior surfaces, a peripheral skirt with at least one biocompatible polymer capable of placement under conjunctiva and above sclera, an anterior rim with at least two suturing holes and two access ports, and a posterior rim with at least two extended flanges, along with a marking tool shaped as the central optical core with bumps at suturing holes, access ports, and trephination edge.
Performing a 360 degree peritomy and epithelial debridement
Performing a 360 degree peritomy in the eye and removing the epithelial layer as part of the surgical preparation.
Marking corneal center and locations of suturing holes and access ports using the marking tool
Marking the center of the cornea with a surgical marker and using the marking tool of the kit to mark suturing holes and access ports on the eye based on the corneal center.
Pre-placing corneal anchoring sutures at marked locations
Pre-placing corneal anchoring suture threads in the marked suturing holes prior to keratoprosthesis implantation.
Injection of epinephrine and ophthalmic viscosurgical device (OVD) intra-camerally
Injecting epinephrine and OVD into the anterior chamber of the eye to maintain chamber stability during the surgery.
Trephination and removal of diseased central cornea
Performing trephination and removal of the central diseased cornea to prepare for keratoprosthesis placement.
Approximation and suturing of the keratoprosthesis to the eye
Approximating the keratoprosthesis to the ocular surface by tying sutures through suturing holes to secure the device.
Exchange of OVD with balanced salt solution
Exchanging the ophthalmic viscosurgical device with balanced salt solution to refill the anterior chamber.
Closing the conjunctiva over the peripheral skirt and rim with sutures
Tying closure of the conjunctiva over the keratoprosthesis peripheral skirt and rim with sutures to seal the surgical site.
Configuration features of the keratoprosthesis components
Additional features wherein the anterior rim has at least three suturing holes, and suturing holes and access ports are spaced at predetermined distances. The anterior rim may include biocompatible polymer. The posterior rim may have at least three extended flanges located at equivalent distances. The central optical lens has a diameter of at least 3 mm. The rims and peripheral skirt have specified minimum widths.
The claim coverage defines a comprehensive surgical procedure employing a keratoprosthesis kit with a centrally structured optical core and peripheral skirt, detailing device structural features and precise surgical steps to ensure accurate implantation and stable integration of the keratoprosthesis.
Stated Advantages
Enhanced surgical accuracy by use of marking tool indicating exact suturing holes, access ports, and trephination edge.
Improved biointegration with ocular tissue due to peripheral skirt comprising porous biocompatible polymers and surface nanofibers.
Secure fixation of keratoprosthesis by means of anterior suturing holes, posterior extended flanges, and peripheral skirt placement under conjunctiva.
Facilitation of postoperative access to the anterior chamber through access ports on the anterior rim.
Reduced postoperative complications compared to known keratoprosthesis devices by structural and material innovations.
Simplified and safer surgical procedure due to pre-marking, suture placement, and viscoelastic device use.
Documented Applications
Treatment of corneal blindness and diseases unsuitable for keratoplasty using the implantable keratoprosthesis device.
Use in surgical replacement of diseased cornea by implanting the keratoprosthesis device in the anterior segment of the eye.
Application in subjects requiring artificial cornea implantation where donor tissue is unavailable or rejection risk is high.
Enabling surgical procedures requiring access to internal parts of the eye post-implantation through access ports.
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