WO-2026093792-A1 - CORNEO-CAPSULAR PROTECTION SYSTEM (CCPS)

Abstract

The invention relates to a corneo-capsular protection system (CCPS), which is an ophthalmological device designed to simultaneously protect the corneal endothelium and the posterior capsule during intraocular surgery (phacoemulsification), the system comprising a corneal protection dome (CPD) and a capsular protection floor (CPF). The dome is a foldable, transparent lens that protects the endothelium against mechanical and thermal damage while optionally providing a magnifying effect to improve surgical visibility. The floor is a foldable lens designed to protect the posterior capsule from perforations and trauma. It has a central condensation facilitating its safe removal, and can also provide protection to the macula against prolonged exposure to light. The two components are designed for easy insertion and removal through micro-incisions, thereby reducing the risk of postoperative complications, and have a complete, potentiated protective effect if used in combination.

Inventors

• LOUAYA, Shamil

Dates

Publication Date

20260507

Application Date

20241103

Claims (1)

1. Demands: 1. Corneal-capsular protection system (CCPS) (figure 1) for intraocular surgery, comprising a foldable, transparent corneal protection dome designed to protect the corneal endothelium from mechanical and thermal damage while improving visibility, and a foldable capsular protection floor designed to protect the posterior capsule from perforation and trauma, positioned in the ciliary sulcus or on the anterior surface of the iris. Method of using the CCPS, including among the surgical steps the insertion of the dome under the corneal endothelium to protect the endothelium during surgery and positioning of the floor in the ciliary sulcus to protect the posterior capsule, all during cataract surgery or other anterior segment procedures. 3. Corneal protection dome (Figure 3) according to claim 1, characterized by a thickness of 0.3 mm, a diameter of 7 mm, and a suitable radius of curvature of 8 mm, allowing protection of the endothelium while providing a neutral optical effect or magnification up to 2x, ensuring better visibility. This radius of curvature prevents central contact with the cornea. Corneal protection dome according to claim 1, characterized by a peripheral edge allowing for limiting direct contact between the dome and the central corneal endothelium. This peripheral edge is designed to trap the viscoelastic substance as an interpositional interface between the outer surface of the dome and the endothelium, thus reducing the risk of endothelial damage while providing effective protection during intraocular surgery. 5 The dome can be without a handle or with 2, 3 or 4 handles to stabilize it. 6 Capsular protection floor (figure 7) according to claim 1, characterized by a thickness of 0.3 mm, a diameter of 7 mm, designed for insertion through a microincision of 1.6 to 2.8 mm. 7 SPCC system according to claim 1, wherein the floor is provided with a central condensation facilitating its removal without touching the posterior capsule. 8 Corneal dome according to claim 1, wherein the lens has a depression at 12H allowing easy injection of the viscoelastic substance for easy and safe removal of the lens after surgery. 9 Capsular floor according to claim 4, characterized by a customizable concave lens, which can be transparent and/or colored and/or opaque, and/or also providing macular protection against exposure to microscope light. 10 Corneal dome according to claim 3, offering a shape memory effect, allowing the dome to return to its initial configuration after insertion. 11. SPCC system according to claim 1, made of soft biocompatible materials, similar to those used for intraocular implants, ensuring optimal tolerance of ocular tissues. 12. Capsular floor according to claim 4, designed to absorb mechanical and thermal shocks, providing complete protection against ultrasound and surgical instruments. 13. SPCC system according to claim 1, wherein the dome and floor are designed to be inserted and removed through small incisions, thereby reducing operating time and the risks of surgical complications. 12. Corneal dome according to claim 3, designed to offer or not a magnifying effect of up to two times, improving the visibility of intraocular structures during complex interventions (magnifying effect optional as appropriate). 13. SPCC system (figure 4) according to claim 1, wherein the dome and floor provide complete thermal and mechanical insulation, preventing crystalline fragments and ultrasonic waves from causing damage to intraocular structures (corneal endothelium and posterior capsule of the lens). 14. SPCC system according to claim 1, adapted for use in traumatic surgeries of the anterior segment or interventions on the iris or iridocorneal angle. 15. Method of using the SPCC according to claim 2, wherein the device is used to simultaneously protect the corneal endothelium and the posterior capsule during the handling of luxated lenses in the anterior chamber or lens fragments in the anterior chamber, in order to avoid capsular perforations. 16. SPCC system according to claim 1, designed to reduce thermal risks thanks to the optimal thickness of 0.3 mm of the dome, and to reduce mechanical risks thanks to the thickness of 0.3 mm of the floor, acting as a barrier against instruments and ultrasound. 17. The combined use of these two lenses provides a complete protective shield, offering greater safety than using each lens separately.

Description

The comeocapsular protection system (CCPS) Description Technical field: The invention is in the field of ophthalmic surgery, and more specifically in devices used to protect sensitive intraocular structures during surgical procedures of the anterior segment of the eye; it is mainly intended for cataract surgery, ocular trauma surgery, iris surgery, and iridocorneal angle surgery. The industrial sector concerned includes medical technologies, in particular those related to the manufacture of ophthalmic devices, such as intraocular implants, eye protection devices, and ophthalmic surgical instruments. Intervention is designed for healthcare professionals specializing in ophthalmology, as well as companies developing solutions to improve the safety and effectiveness of eye surgeries. It can also be used in the research and development of new surgical techniques aimed at minimizing postoperative complications. Technical problem: The operative steps during phacoemulsification cataract surgery include a main corneal microincision at 11 o'clock, measuring 1.6 to 2.75 millimeters (mm), and another lateral service microincision at 1 o'clock. A viscoelastic substance (oval viscoelastic device - OVD) is then injected into the anterior chamber to keep the anterior chamber open and protect the corneal endothelium. The anterior capsule is stained with a vital dye to clearly distinguish it. A circular opening (capsulorhexis) is then created in the anterior capsule of the lens. The opacified lens is then fragmented using ultrasound and aspirated with the handpiece of the phacoemulsification device. After filling the remaining capsular bag with OVD, an intraocular lens is implanted. The anterior chamber and capsular bag are then gently irrigated, and finally, the edges are closed with hydrosuture. corneal incisions. The major problem during anterior segment surgery, and particularly cataract surgery, is that corneal or posterior capsule complications are often difficult to avoid; these complications result from: On the one hand, traumatic mechanical damage during the operation, surgical instruments and fragments generated by the procedure can come into contact with the endothelial cells of the cornea, causing local lesions and loss of endothelial cells, and on the other hand, it can damage the posterior capsule and cause a rupture with vitreous release and all the resulting complications. On the other hand, the impact of ultrasound will cause a loss of corneal endothelial cells, resulting in corneal edema with reduced transparency and increased corneal thickness, and finally endothelial decompensation; these ultrasounds can easily cause rupture of the posterior capsule in case of accidental contact, collapse of the anterior chamber, or surge effect. These complications are common in all forms of cataracts (soft, hard, Morganian, etc.). Prior art (prior technique): Work in the anterior segment of the eye involves the entire confined space between the posterior capsule of the lens and the corneal endothelium, so to work there with maximum safety it is necessary to protect these two fragile tissues and isolate them from the contents of this space. Unfortunately, there is currently no system capable of fully and simultaneously protecting these two fragile structures while being simple to install in the anterior segment and easy to remove. Current techniques, such as the use of viscoelastic substances and personal protective equipment, have several important limitations. Viscoelastic substances used for protection have several significant limitations. Due to their non-solid nature, they cannot form a stable and durable insulating barrier. Their capacity to absorb thermal shock is limited, making them ineffective at dissipating the thermal energy generated during surgical procedures. Furthermore, they fail to adequately protect against the severe mechanical stresses caused by surgical instruments, leading to the inevitable loss of corneal endothelial cells. Despite improvements in the composition of these viscoelastic substances, the goal of stable and durable protection during surgery is never achieved. • Insufficient protection: Current devices generally only protect one structure at a time: either the corneal endothelium (with a few patents available for isolated corneal endothelium protection, but with many limitations), or the posterior capsule (with one patent available for posterior capsule protection, but difficult to apply in practice and not foldable). This partial protection exposes the other, unprotected structure to the risk of injury. This is particularly problematic during complex surgeries such as phacoemulsification (or other manual cataract surgery techniques), where both the corneal endothelium and the posterior capsule are subjected to continuous mechanical and ultrasonic stresses during the procedure. • Lack of visibility: Current devices do not provide optimal visibility for surgeons. The lenses are thin an