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.

Description

[0001] The comeocapsular protection system (CCPS)

[0002] Description

[0003] Technical field:

[0004] 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.

[0005] 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.

[0006] 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.

[0007] Technical problem:

[0008] The operative times during phacoemulsification cataract surgery include a main corneal microincision at 11H of size 1.6 to 2.75 millimeters (mm) and another micro-incision laterally at 1H, then an injection into the anterior chamber of a viscoelastic substance (ophthalmic viscoelastic device OVD) to keep the anterior chamber open and to protect the corneal endothelium, the anterior capsule is stained with a vital dye to clearly distinguish it, then a circular opening (capsulorhexis) is created at the level of the anterior capsule of the lens, then the opacified lens is fragmented by ultrasound and aspirated using the handpiece of the phacoemulsification device and after filling the remaining capsular bag with OVD, an intraocular implant is implanted then a gentle wash of the anterior chamber and the bag is made and finally a hydrosuture is performed to close the edges of the corneal incisions.

[0009] 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:

[0010] On the one hand, traumatic mechanical damage during the operation can occur. Surgical instruments and fragments generated by the procedure can come into contact with the endothelial cells of the cornea, causing local damage and endothelial cell loss. On the other hand, they can damage the posterior capsule and cause a rupture with vitreous leakage and all the resulting complications. Furthermore, the impact of ultrasound can lead to corneal endothelial cell loss, resulting in corneal edema with reduced transparency and increased corneal thickness. Finally, in cases of endothelial decompensation, these ultrasounds can easily cause rupture of the posterior capsule in the event of accidental contact, anterior chamber collapse, or a surge effect.

[0011] These complications are common in all forms of cataracts (soft, hard, Morganian, etc.).

[0012] Prior art (prior technique):

[0013] 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.

[0014] 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.

[0015] Current techniques, such as the use of viscoelastic substances and personal protective equipment, have several important limitations.

[0016] 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.

[0017] • 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.

[0018] • Lack of visibility: Current devices do not provide optimal visibility for surgeons. The lenses are thin and do not offer additional magnification.

[0019] Macular protection: No current optical system protects the macula from direct microscope light during cataract surgery. Complications related to existing materials: Rigid or semi-rigid lenses used to protect ocular structures can cause complications during handling, including an increased risk of perforation or trauma. Furthermore, these devices may not be suitable for procedures requiring smaller incisions.

[0020] A technique based on using a capsular disc cut from the anterior capsule during femtosecond laser surgery and applying it directly to the corneal endothelial surface as a protective membrane during the procedure has been shown to reduce the rate of postoperative corneal endothelial loss. However, this approach has several significant limitations: an intraoperative capsulorhexis of less than 6 mm covers only the central region of the corneal endothelium, leaving peripheral areas exposed; the flexible capsular disc wrinkles easily, making its uniform application to the inner surface of the cornea difficult and increasing the complexity of the procedure; and the manual cutting of the anterior capsule is highly dependent on the surgeon's dexterity, making this method of corneal protection using the capsular disc very challenging.

[0021] The patents registered under the following numbers: (WO 1999018900A1 published April 22, 1999) (CN No. 111728767a, published October 2, 2020) (CN112932784A published June 11, 2021) (US 2024 / 0108502 A1 published April 4, 2024), propose lenses for the protection of the corneal endothelium only without protection for the posterior capsule.Each lens partially protects corneal endothelial cells from damage induced by ultrasonic energy because all these lenses, from the various published patents, have a thickness of less than 300 micrometers. This thickness is desirable to constitute a total barrier preventing the propagation of ultrasonic energy from the handpiece during phacoemulsification and also to cushion as much as possible the traumatic shocks from the instruments and fragments of the lens. The other major drawback of this invention lies in the complexity of the lens removal procedures, which represent a considerable challenge in terms of surgical handling.

[0022] Furthermore, regarding posterior capsule protection, two patents have been published for the protection of the posterior capsule during phacoemulsification:

[0023] Patent RU2511447Cl, published on April 10, 2014, describes a protective device for the posterior capsule of the lens used during phacoemulsification cataract surgery. This device consists of an oval-shaped working plate with a concentric cavity on one face, allowing for the capture of lens nucleus fragments during the operation.The plate is connected to a handle via a connecting element placed at an angle. This device has several limitations, such as the complexity of insertion and removal, making it difficult to introduce and remove the protective plate into the capsular space, particularly due to the nature of the plate and the angle of the handle. This can make the operation more complex with a high risk of damage to the posterior capsule, and improper handling of the device during its insertion or removal can lead to damage or perforation of the posterior capsule. Furthermore, the complexity of removing this device prolongs the operating time, thus increasing the risk of surgical complications, especially if additional adjustments are required.Patent CN109044615 A, published on December 21, 2018, concerns a medical device used in ophthalmic surgery, specifically for semi-luxation lens procedures. The device, called a capsule injector, is designed for use during surgery to stabilize the lens capsule during eye operations. It consists of three connected parts: a head, a body, and a tail. The head, shaped like a curved and perforated tube, allows for uniform diffusion of fluid around the lens capsule, thus stabilizing the capsular membrane and facilitating the aspiration of debris during the operation. However, this device has the following limitations: complexity of use. The process of inserting the device through the corneal incision and stabilizing the capsule can be complex.Improper handling can lead to damage or instability of the capsule during the operation, thus increasing the risk of surgical complications, given that the arc design and multiple perforations of the tube may not be ideal for all patients or all eye anatomies, which limits the adaptability of the device in various surgical situations and also, being made of metal, the device may not offer the flexibility required for some procedures where greater flexibility is needed, thus increasing the risk of damage to surrounding structures.

[0024] Detailed description of the invention

[0025] The invention relates to a comeo-capsular protection system (CCPS) (Figure 1), which is a state-of-the-art ophthalmological device designed to protect sensitive structures of the eye during anterior segment surgeries, such as cataract surgery. Its primary objective is to simultaneously protect the corneal endothelium and the posterior capsule during the procedure by isolating a confined and protected working space capable of containing a dislodged lens, lens fragments, or any other intraocular foreign body, thereby reducing the risk of surgical complications related to these structures.

[0026] The SPCC consists of two main components, firstly by a corneal protection dome (CPD) (figures: 3, 4, 5 and 6) which corresponds to a special foldable convex lens, placed under the corneal endothelium to protect against damage caused by instruments and ultrasound, this lens has a magnifying effect on the image and secondly by a capsular protection floor (CPF) (figures: 7 and 8) which corresponds to a foldable concave lens which protects the posterior capsule from mechanical trauma during surgery, this lens can also have a macular protective effect.

[0027] 1. Corneal Protection Dome (CPD) (figures 3, 4, 5 and 6):

[0028] • Material and design: o The dome is made of biocompatible materials similar to those used in the manufacture of intraocular lenses (IOLs). These materials ensure dimensional stability and sufficient strength to withstand surgical conditions. With a thickness of 0.3 mm, a diameter of 7 mm, and a radius of curvature of 8 mm, direct contact between the majority of the lens and the endothelium is never maintained. This contact is limited to the edge of the lens and thus only to the peripheral region of the corneal endothelium, which is characterized by the highest density of endothelial cells. o The dome is always separated from the endothelium by a layer of viscoelastic material (OVD) that provides protection and cushioning.o Furthermore, its design and composition make it both flexible and resistant and easy to be inserted and removed through a corneal microincision during surgery.

[0029] • The different variants of the corneal protection dome: o Isolated 7 mm dome (figure: 5):

[0030] Designed for direct endothelial protection without central contact, without additional loops, but with a 12 o'clock depression for viscoelastic injection. 7 mm dome with two extension loops (Figure 6):

[0031] Equipped with two extension loops, each 1 to 2 mm long and 1.5 mm wide, positioned at 5 and 7 o'clock.

[0032] The loops allow for easy and secure removal, and the 12 o'clock depression ensures the injection of viscoelastic material for safe extraction. 7 mm dome with four extension loops (Figures 3 and 4):

[0033] Variant with four handles, each 1 to 2 mm long and 1.5 mm wide, placed at 5 o'clock, 7 o'clock, 1 o'clock and 11 o'clock.

[0034] The configuration offers increased stability, and the 12H depression facilitates the injection of viscoelastic material for safe extraction.

[0035] • A peripheral rim, which will adhere to the mid-peripheral region of the corneal endothelium, has several advantages such as minimizing the risk of endothelial damage: The viscoelastic interface, located between the endothelium and the dome, acts as a protective barrier to absorb mechanical forces and reduce thermal effects during phacoemulsification or other intraocular interventions and also ensures effective protection during surgery for patients with a weakened endothelium (for example, those with Fuchs dystrophy or who have undergone previous surgical interventions) thus this design not only improves the safety of surgical procedures, but it also helps to preserve endothelial integrity, which is crucial to avoid postoperative complications such as corneal edema.

[0036] • Protective effect: The dome provides continuous protection for the corneal endothelium, reducing the risk of thermal damage such as that caused by the ultrasound of the phacoemulsifier, or mechanical damage from surgical instruments used during the procedure. This effect is guaranteed exclusively by its carefully designed thickness of 0.3 mm, its precisely adapted diameter of 7 mm, and its exact radius of curvature of 8 mm. • Ease of insertion: Being foldable and possessing shape memory, it quickly returns to its initial configuration once inserted into the eye, thus ensuring very rapid and risk-free deployment and providing optimal protection during the operation.

[0037] • Improved surgical visibility: The SPCC corneal dome is designed to provide total transparency during surgery.

[0038] • Magnification effect: In addition to the magnification provided by the operating microscope, the optical properties of the dome can provide magnification and depth of field in the anterior chamber, significantly improving the visibility of ocular structures and allowing the surgeon to perform precise movements with a better view of the surgical site. This feature is essential for complex procedures, such as phacoemulsification, which require extremely precise maneuvers, but this dome can also function without additional magnification.

[0039] • Ease of extraction: The dome has a depression located at 12 o'clock (figure 9) which will facilitate the injection of viscoelastic substances to move the dome away from the corneal endothelium without risk of tissue damage and the edge of the dome or the loops allow easy grasping of the lens at the end of the operation to remove it safely without risk of damaging the intraocular structures.

[0040] • After insertion of the intraocular lens (IOL), the flexibility of the dome allows for its quick and efficient removal. It can be grasped using 20-gauge or 23-gauge distally operated forceps or any other suitable non-traumatic, foam-tipped forceps, thus facilitating its safe extraction. Capsular Protection (CPP) release (Figures 7 and 8):

[0041] • Unique design and specific features: o The floor is a foldable concave lens, 7 mm in diameter, 0.3 mm thick, and with a variable radius of curvature from 6 mm to 10 mm. This lens is designed to be inserted, via the injector, through the same microincision (1.6 mm to 2.8 mm) as the dome. o This lens is positioned in the ciliary sulcus or on the anterior surface of the iris, ensuring protection against perforation or accidental damage to the posterior capsule. o The central part of this floor features a 2 mm diameter central condensation, 2 mm in diameter and 0.4 mm thick, which allows the surgeon to easily grasp the lens and lift it into the anterior chamber for removal with 20 or 23-gauge forceps after phacoemulsification of the lens nucleus, without risk of touching or damaging the posterior capsule.

[0042] • Customization:

[0043] Transparency and coloration: The floor can be transparent, colored, or opaque, depending on specific surgical requirements. Macular protection: In addition to protecting the posterior capsule, it can also protect the macula during exposure to the light of the operating microscope.

[0044] Advantages of the complete invention (dome and floor) compared to the prior art:

[0045] 1. Simultaneous and complete protection:

[0046] Unlike current devices, which focus on protecting only one structure (either the corneal endothelium or the posterior capsule), the SPCC offers simultaneous and combined protection for both structures, which is unavailable. Combined use is safer than individual use. This significantly reduces the risk of postoperative complications, such as corneal endothelial injury and posterior capsule rupture, which can occur during surgery.

[0047] It is not an assembly of two special lenses but a complete system in which the presence of both components allows for optimal safety and secure work, creating a total protective shield.

[0048] 2. Improved surgical visibility:

[0049] The SPCC corneal dome is designed to provide complete transparency during surgery. In addition to protecting the endothelium, the dome can be neutral or offer a magnifying effect (up to 2x) (in specific DPC designs) that enhances the visibility of ocular structures, allowing the surgeon to perform precise movements with improved visualization of the surgical site. This feature is essential for complex procedures, such as phacoemulsification, which require extremely precise maneuvers.

[0050] 3. Ease of use and reduced operating time:

[0051] The two components of the SPCC are designed for easy insertion and removal through minimally sized incisions, typically less than 2.8 mm. This feature not only reduces the impact on ocular structures but also the operating time, thus minimizing surgical risks and improving patient safety.

[0052] • The dome and the floor are equipped with specific gripping points, facilitating their extraction at the end of the intervention without requiring complex or risky manipulations; for the dome there are three peripheral gripping zones and for the floor there is a central gripping zone.

[0053] 4. Reduction of thermal and mechanical risks:

[0054] The risk of thermal damage from the use of ultrasound during surgery is significantly reduced thanks to the protective dome, with its optimal thickness of 300 micrometers, which acts as an insulating barrier against the heat generated by the ultrasound. The floor, meanwhile, protects the posterior capsule from surgical instruments and lens fragments that could enter the posterior chamber.

[0055] 5. Biocompatible Materials and Safety: The materials used in the SPCC dome and floor are fully biocompatible, similar to those used in the manufacture of intraocular lenses (IOLs), and are well tolerated by ocular tissues, thus reducing the risk of adverse reactions. Their flexibility allows for easy adaptation to the anatomical characteristics of each patient's eye.

[0056] 6. Versatility:

[0057] The SPCC is designed for use in various intraocular surgical procedures. In addition to cataract surgery, it can be used in more complex operations, such as ocular trauma or anterior segment interventions in patients with anatomical peculiarities. The floor also provides protection for the macula, making it particularly useful in cases involving prolonged or intense exposure to microscope light.

[0058] The steps of surgery using the SPCC are:

[0059] Topical anesthesia; locoregional disinfection; blepharostat placement; corneal incision at 1 o'clock and main corneal incision of < 2.8 mm at 11 o'clock; viscoelastic substance (OVD) injection; capsulorhexis; hydrodissection and mobilization of the lens nucleus; injection of the protective corneal dome; positioning of the dome under the corneal endothelium by OVD injection; hydrodissection of the nucleus and anterior dislocation of the nucleus; injection of OVD under the cornea and under the nucleus in front of the posterior capsule; injection of the protective capsular floor under the nucleus, in the sulcus, and in front of the posterior capsule, thus the SPCC is fully in place (Figure 2); phacoemulsification of the nucleus using the Chop technique; extraction of the protective capsular floor by easily grasping it through the central condensation without risk of touching any intraocular structures; irrigation of the masses and injection of OVD;Implantation in the capsular bag; Extraction of the corneal protective dome by easily grasping it with 20 or 23 gauge forceps at the edge or by grasping one of the superior loops, without risk of touching any intraocular structure; Irrigation of the masses and injection of the OVD; Implantation in the capsular bag; Irrigation of the OVD; Hydrosuture of the corneal incisions; Postoperative care.

[0060] Conclusion :

[0061] The corneocapsular protection system is a device that provides total protection during intraocular surgery of the anterior segment of the eye, representing a significant advancement in the safety of intraocular surgical procedures. By protecting sensitive structures such as the corneal endothelium and the posterior capsule, and also improving visibility through its magnifying effect, it helps reduce postoperative complications and improve clinical outcomes.

[0062] Drawings

[0063] Figure 1: Sagittal section showing the complete SPCC device. Figure 2: Sagittal section showing the arrangement of the lens relative to the SPCC.

[0064] Figure 3: Sagittal section showing the comeal protective dome

[0065] Figure 4: Top view showing the 4-loop comeal protective dome

[0066] Figure 5: Top view showing the comeal protective dome without loops

[0067] Figure 6: Top view showing the comeal protection dome with 2 loops

[0068] Figure 7: Sagittal section showing the capsular protective floor

[0069] Figure 8: Top view showing the capsular protective floor

[0070] Figure 9: Sagittal section showing the comeal protective dome with the 12H depression

Claims

AMENDED CLAIMS received by the International Bureau on July 21, 2025 (21.07.2025) Claim 1: Corneal capsular protection system (CCPS) for intraocular surgery, comprising a corneal protection dome (CPD) and a capsular protection floor (CPP), together forming a complete intraocular protection plug. Claim 2: System according to claim 1, wherein the corneal protection dome (CPD) is made of a convex, foldable, transparent lens, made of biocompatible material, having a thickness of 0.3 mm, a diameter of 7 mm, a radius of curvature of 8 mm, comprising one or more peripheral loops, a depression at 12 o'clock for injection of viscoelastic, and capable of generating an optical magnifying effect up to four times or remaining optically neutral. Claim 3: System according to any one of the preceding claims, wherein the capsular protection floor (CPF) consists of a concave, foldable lens made of biocompatible material, having a thickness of 0.3 mm, a diameter of 7 mm, a variable radius of curvature from 6 mm to 10 mm, having a central thickened condensation of 2 mm in diameter facilitating grasping, and being able to be transparent, colored or opaque, suitable for providing macular protection against operative light glare. Claim 4: System according to claim 1, wherein the DPC and the PPC are designed to be inserted and extracted through corneal microincisions of 1.6 to 2.8 mm. Claim 5: System according to any one of the preceding claims, wherein the DPC is separated from the corneal endothelium by a layer of viscoelastic substance, forming a thermal and mechanical protective interface. Claim 6: System according to any one of the preceding claims, wherein the PPC is positioned in the ciliary sulcus to protect the posterior capsule. Claim 7: System according to any one of the preceding claims, wherein the combination of DPC and PPC creates an isolated and secure intraocular space for the manipulation of lens fragments, preventing damage to endothelial and capsular structures. Claim 8: System according to any one of the preceding claims, wherein the DPC and the PPC include gripping areas allowing their atraumatic removal after surgical intervention.

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