Corneal implant

Inventors

GROSSO, EDOARDOLepore, Emiliano

Assignees

RECORNEA S.R.L.

Publication Number

US-11957568-B2

Publication Date

2024-04-16

Expiration Date

2039-05-31

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Abstract

A corneal implant designed for correcting irregularities of the corneal curvature of a subject, the implant having a dome-shaped structural body configured to impose a regular curvature to the corneal portions designed to be in contact with the implant. The structural body includes an outer peripheral ring and an inner reticular structure. The inner reticular structure includes at least one first and one second series of beams intersecting each other. The beams of the first series have a respective first end connected to the outer peripheral ring. The total area of void portions within the meshes of the reticular structure is between 50 and 99.9% of the surface area of the reticular structure. The inner reticular structure includes an innermost peripheral ring and the beams of the second series include annular beams arranged concentrically to each other. The reticular structure includes a third series of beams, having a respective first end connected to the outer peripheral ring and a respective second end connected to an annular beam defining a circumference or perimeter greater than the circumference or perimeter defined by the innermost peripheral ring.

Core Innovation

The invention relates to a corneal implant designed to correct irregularities in the curvature of a subject's cornea by imposing a substantially regular curvature onto the corneal portions in contact with the implant. The implant has a dome-shaped structural body comprising an outer peripheral ring and an inner reticular structure formed by at least two intersecting series of beams, which create a mesh with void portions spanning between 50% and 99.9% of the reticular structure’s surface area. The beams of the first series are connected at one end to the outer peripheral ring, and the inner reticular structure includes an innermost peripheral ring and annular beams arranged concentrically.

The problem solved by the invention arises from the limitations of existing treatments for corneal curvature irregularities, such as contact lenses, intra corneal ring segments (ICRS), ablative laser treatments, and incisional refractive surgeries. These treatments either have risks like infection, intolerance, corneal thinning, ectasia, or poor predictability, or lack the ability to impose a defined regular curvature on the cornea effectively. Existing corneal implants offer limited ability to shape the cornea due to reduced radial size or central openings and do not adequately regularize both anterior and posterior corneal surfaces. The present invention addresses this by providing a structurally rigid, dome-shaped corneal implant with a large area of voids to minimally interfere with physiological functions and light transmission while imposing a predefined regular curvature.

The implant’s rigid dome shape and continuous outer peripheral ring provide stability and three-dimensional conformation, allowing surgical implantation by sliding into the corneal stroma atraumatically. The presence of an innermost peripheral ring further increases structural stability. The reticular structure formed by intersecting radial and annular beams imparts both strength and flexibility, enhancing effectiveness in correcting corneal irregularities. The implant’s high rigidity, superior to the corneal tissue, enables it to maintain its curvature post-implantation, thereby restoring optimal optical conditions and reducing aberrations that compromise visual acuity and contrast sensitivity.

Claims Coverage

The patent includes one independent claim with several inventive features focusing on the structural design of the corneal implant.

Dome-shaped structural body with dual peripheral rings

The corneal implant has a dome-shaped structural body comprising an outermost peripheral ring and an innermost peripheral ring, with an inner reticular structure located between these rings.

Intersecting series of beams defining a mesh with controlled void area

The inner reticular structure comprises at least one first series and one second series of beams intersecting to form a mesh with void portions between 50% and 99.9% of the surface area.

Radial longitudinal beams connected between peripheral rings

Beams of the first series are longitudinal beams extending radially with one end connected to the outermost peripheral ring and the other to the innermost peripheral ring.

Concentric annular beams

Beams of the second series comprise annular beams arranged concentrically to each other within the reticular structure.

Third series of beams connecting outer peripheral ring to annular beams

The inner reticular structure includes a third series of beams extending radially, with one end connected to the outermost peripheral ring and the other end connected to an annular beam defining a larger circumference than that of the innermost peripheral ring.

Innermost peripheral ring diameter specification

The innermost peripheral ring has a diameter ranging from 0.5 mm to 7.0 mm.

Coaxial arrangement of peripheral rings

The outermost peripheral ring and the innermost peripheral ring are arranged coaxially.

The independent claim defines a corneal implant characterized by a dome-shaped body with concentric peripheral rings bridged by intersecting radial and annular beams forming a mesh with high void percentage, providing structural rigidity and regular curvature-imposing capability.

Stated Advantages

The implant imposes a predefined regular curvature to the cornea, unlike intra corneal ring segments and ablative treatments that have limited predictability and irreversibility.

The large void area in the reticular structure allows minimal interference with oxygen and molecule passage through the cornea, maintaining physiological functions.

The implant reduces incoming light by only 5-10% and minimizes diffractive phenomena, substantially improving correction of low- and high-order optical aberrations.

Its placement near the nodal point makes the implant substantially imperceptible to the patient.

The implant can be grafted atraumatically into the corneal stroma or fixed under the epithelium, is easily removable with minimal damage, and enables faster visual recovery and improved patient quality of life.

The implant maintains its dome-shaped configuration under surgical and daily stresses due to its superior rigidity compared to corneal tissue.

Documented Applications

Correction of irregular corneal curvature in patients with non-inflammatory corneal ectasia such as keratoconus and marginal pellucid degeneration.

Treatment of ectasia following corneal refractive surgical procedures.

Correction of irregular or elevated astigmatism in subjects undergoing perforating keratoplasty or deep anterior lamellar keratoplasty.

Implantation in healthy subjects to vary corneal curvature for correcting refractive errors.

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