Corneal implant

Inventors

GROSSO, EDOARDOLepore, Emiliano

Assignees

RECORNEA S.R.L.

Publication Number

US-11510775-B2

Publication Date

2022-11-29

Expiration Date

2039-05-31

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Abstract

Corneal implant (1) designed for correcting irregularities of the corneal curvature of a subject, the implant (1) having a generally dome-shaped structural body (2) configured to impose a regular curvature to the corneal portions designed to be in contact with the implant, wherein the structural body comprises an outer peripheral ring (10) and an inner reticular structure (20), wherein the inner reticular structure (20) comprises at least one first and one second series of beams (21, 22) intersecting each other, the beams (21) of the first series having a respective first end (31) connected to the outer peripheral ring (10), wherein the total area of void portions (24) within the meshes of the reticular structure (20) is between 50 and 99.9% of the surface area of the reticular structure (20).

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 on the corneal portions in contact with the implant. The implant comprises a generally dome-shaped structural body that includes an outer peripheral ring and an inner reticular structure with at least one first and one second series of intersecting beams. These beams form meshes that contain void portions, where the total area of the void portions is between 50% and 99.9% of the surface area of the reticular structure.

The problem being solved arises from limitations of existing corneal treatments and implants. Current solutions such as contact lenses, intracorneal ring segments (ICRS), ablative laser treatments, and incisional surgeries have disadvantages including risk of infection, limited ability to impose a precise regular curvature, poor predictability, tissue removal, and risk of inducing corneal ectasia. Existing corneal implants have limited radial cross-section size, reducing their ability to precisely reshape the cornea.

The invention offers an improved corneal implant with a dome-shaped body featuring a continuous outer peripheral ring and an inner reticular structure capable of imposing a predetermined regular curvature on the cornea. The implant has a large proportion of void area within the reticular meshes to allow light and oxygen passage with minimal interference. Embodiments include configurations with or without an innermost peripheral ring that enhances structural stability, and intersecting series of beams arranged radially and concentrically. The implant has structural rigidity superior to that of corneal tissue, enabling it to maintain its shape and correct corneal irregularities effectively.

Claims Coverage

The patent discloses two independent claims which define the structure and mechanical properties of the corneal implant, focusing on key inventive features of the reticular structure and peripheral rings.

Dome-shaped structural body with peripheral rings and reticular structure

The implant comprises a dome-shaped structural body sized and configured to impose a regular curvature to corneal portions. It includes an outermost peripheral ring, an innermost peripheral ring, and an inner reticular structure arranged between these rings.

Intersecting series of beams forming reticular meshes with high void area

The inner reticular structure comprises at least one first and one second series of intersecting beams defining meshes with void portions. The beams of the first and second series have first ends connected to the outermost peripheral ring, and at least some beams have second ends connected to the innermost peripheral ring. The total area of the voids is between 50% and 99.9% of the reticular structure surface area.

Specific dimensional and mechanical rigidity parameters

The innermost peripheral ring diameter ranges from 0.5 mm to 7.0 mm. The corneal implant has rigidity characterized by Young's modulus ranging from 10 MPa to 300 GPa. The outermost and innermost peripheral rings are coaxial, and the beam arrangement defines substantially equal sectors configured as arcs of circular or elliptical annuli.

The independent claims cover a corneal implant featuring a dome-shaped structural body with concentric outermost and innermost peripheral rings, an intersecting beam reticular structure with a large void area to reduce interference with physiological functions, and mechanical rigidity parameters enabling the implant to impose a regular curvature on the cornea.

Stated Advantages

The implant's mechanical rigidity allows it to impose and maintain a predefined regular curvature on the cornea, enabling correction of optical aberrations without tissue ablation.

The large area of void portions minimizes interference with oxygen and molecule passage through the cornea and reduces light attenuation and diffraction, preserving visual quality.

The continuous outer peripheral ring enables atraumatic implantation by allowing the implant to slide within corneal layers and improves conformational stability.

The implant is implantable inside the corneal stroma or fixable below the epithelium, allowing easy grafting and removability with minimal tissue damage, reducing postoperative pain and speeding visual recovery.

Positioning near the nodal point of the eye makes the implant not substantially perceived by the patient.

Documented Applications

Treatment of irregular corneal curvature pathologies such as keratoconus, marginal pellucid degeneration, and ectasia following corneal refractive surgery.

Correction of irregular or elevated astigmatism after perforating keratoplasty or deep anterior lamellar keratoplasty.

Implantation in subjects intolerant to contact lenses where optical aberrations cannot be corrected with lenses.

Use in healthy subjects to variably modify corneal curvature and correct refractive errors.

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