Anti-aphakia system (foldable artificial capsular bag with specialized injector and intraoperative stabilization support)

Abstract

The present invention provides an innovative system for correcting aphakia in the absence of a natural capsular bag. It comprises a foldable artificial capsular bag made of biocompatible material, traversed by polypropylene 6-0 threads extended by thin pliable needles, allowing stable and precise scleral fixation. A specialized injector equipped with a cartridge having a single longitudinal opening facilitates insertion by positioning the threads without overlapping. This cartridge closes firmly after folding, ensuring stability during injection, while being compatible with standardized injectors. An ergonomic intraoperative stabilization headband, positioned on the forehead of the patient, holds the injector in place by virtue of inverted supports, improving surgical precision and reducing unnecessary manipulations. This system simplifies surgery, reduces complications and optimizes the visual results.

Description

[0001] Anti-aphakia system (Foldable artificial capsular bag with specialized injector and intraoperative stabilization support)

[0002] Anti-aphakia System (Foldable artificial capsular bag with specialized injector and peroperative stabilization support)

[0003] The present invention relates to the field of medical devices used in ophthalmic surgery. It specifically concerns a complete system for correcting aphakia in cases of absence or deterioration of the natural capsular bag. This system comprises three main components: a foldable artificial capsular bag, a specialized injector, and an ergonomic device in the form of an intraoperative stabilization headband. The objective is to simplify the surgical procedure while improving postoperative visual outcomes, offering a solution tailored to surgeons and compatible with existing tools.

[0004] -Technical problem

[0005] Aphakia, characterized by the absence of the natural lens, presents a major challenge in ophthalmology when there is no natural capsular support. Current techniques have several limitations. They often require advanced expertise and specialized equipment, thus increasing surgical complexity. The risk of instability or dislocation of intraocular lenses (IOLs) after implantation is also high. Furthermore, poor ergonomics and multiple manipulations increase the risk of intraoperative and postoperative complications. These constraints also lead to high costs, particularly related to the use of custom-made lenses and prolonged surgical time.

[0006] -Prior art

[0007] Current approaches to correcting aphakia include several techniques:

[0008] Scleral fixation with suture: This method uses sutures to anchor the intraocular lens to the scleral structures. While this approach ensures stable fixation, it is technically demanding and associated with risks such as scleral erosion and infection.

[0009] Sutureless scleral fixation: This category includes fixation with biological glue, the Yamane technique (using flanges), or with 6-0 polypropylene sutures according to Canabrava. These techniques, while promising, require high precision and can be associated with complications such as dislocations or misalignments. Custom implantation: This method relies on the creation of personalized implants, tailored to the patient. Although effective, it is time-consuming, expensive, and highly dependent on the surgeon's expertise.

[0010] Several patents have also attempted to address these limitations:

[0011] US 8,900,300 B1 describes a prosthetic capsular bag stabilizing the position of the intraocular lens, but it does not incorporate a simplified insertion mechanism or an ergonomic device.

[0012] JP 7411705 B2 offers a rigid capsule with advanced optical measurement capabilities, but its rigidity makes implantation complex, especially in small incisions.

[0013] US 2021 / 0315687A1 features a capsular bag with trans-scleral fixation without suture, but the lack of stabilization during surgery limits its effectiveness.

[0014] WO2021016678 and WO2023143555 focus on the biocompatibility and stability of rigid capsular bags, but do not meet the needs of rapid and ergonomic implantation.

[0015] None of the existing solutions integrate a collapsible capsule bag combined with a specialized injector and an ergonomic support, meeting the requirements of simplicity, safety and efficiency.

[0016] -Detailed description of the invention

[0017] Foldable artificial capsule

[0018] The capsule is made of biocompatible material, such as hydrophobic or hydrophilic acrylic, offering both strength and flexibility. It is traversed by two 6-0 polypropylene threads extended by fine, bendable needles, allowing for precise and stable scleral fixation. Its bendable design facilitates insertion via an injection cartridge, even through small incisions. It is compatible with a wide range of intraocular lenses, making it universally applicable.

[0019] The capsular bag has specific characteristics, including a diameter of 10 to 13 mm, a height of 0.5 to 1 mm, and a thickness of 50 to 300 µm. It features two central openings (anterior and posterior) for optimal lens handling and four strategically positioned perforations to ensure stable and long-lasting fixation.

[0020] Specialized injector

[0021] The injection cartridge features a unique longitudinal opening that allows for precise positioning of the polypropylene threads without risk of overlap. Once the capsule is in place, the cartridge seals securely after folding, ensuring optimal stability during injection. Each of the cartridge wings contains two longitudinal cylinders (0.1 mm diameter) to stabilize the flexible needles. This cartridge is compatible with standard injectors used in ophthalmic surgery, thus reducing the need for specialized equipment.

[0022] Ergonomic intraoperative stabilization device

[0023] A flexible plastic headband, either sterilizable or single-use, is designed to be positioned on the patient's forehead, above the surgical field. It is equipped with two inverted supports, 0.8 mm in diameter, which stabilize the injector depending on the eye being operated on. This device frees the surgeon's hands, thus improving precision and reducing the risk of intraoperative contamination.

[0024] -Advantages of the invention

[0025] This invention brings major improvements such as aphakia management by an almost natural system, simplification of operations allowing adoption by a greater number of surgeons, increased ergonomics with a stabilizing headband facilitating surgical manipulations and finally a reduction in costs through the use of standardized lenses and simplified surgical steps (all intraocular implants can be used)

[0026] -The stages of surgery:

[0027] Stabilizing the injector: Mount the specialized cartridge containing the foldable capsular bag onto the support corresponding to the side of the operated eye, fixed to the ergonomic headband.

[0028] Thread passage: Introduce the 6-0 polypropylene threads through the sclerotomies created at the 8 o'clock, 4 o'clock, 10 o'clock and 2 o'clock positions using bendable needles guided by 30 gauge needles.

[0029] Insertion of the capsular bag: Carefully insert the tip of the specialized cartridge through a corneal incision, then gently inject the pliable capsular bag into the posterior chamber of the eye.

[0030] Securing the wires:

[0031] Cut off the first two ends of the 6-0 wires and create solid flanges by electrocautery.

[0032] Hypotonicize the globe to manipulate the last two sutures; pinch the base of the sutures at the sclerotomies to create a depression, then cut each suture 1 cm from the base before forming solid flanges using electrocautery. Intraocular lens (IOL) implantation: Insert the intraocular lens into the stabilized capsular bag and perform hydrosuture to close the corneal incision.

[0033] -Conclusion

[0034] The present invention proposes an innovative solution for the correction of aphakia. The system, composed of a foldable capsule bag, a specialized injector, and an ergonomic headband, improves surgical precision, reduces potential complications, and simplifies the surgeon's experience, while optimizing visual results for the patient.

[0035] Drawing :

[0036] Figure 1: Top view of the special cartridge with a full longitudinal opening

[0037] Figure 2: Superior view of the artificial capsular bag

[0038] Figure 3: Arrangement of suture threads through the artificial capsular bag

[0039] Figure 4: Injector support

[0040] Figure 5: Arrangement of the artificial capsular bag on the special cartridge

Claims

AMENDED CLAIMS received by the International Bureau on July 21, 2025 (21.07.2025) 1. System for the correction of aphakia (see figures 1 to 5), characterized in that it comprises: o An artificial capsular bag (figure 2), made of biocompatible material, suitable for folding for intraocular insertion, said bag being traversed by two 6-0 polypropylene wires, each extended by a foldable needle, allowing transscleral fixation (figure 3); o A specialized injection cartridge (figure 1), having a longitudinal opening for positioning said wires without overlapping, said cartridge being resealable to ensure mechanical stability after folding; o An intraoperative stabilization device (figure 4), consisting of a flexible headband, provided with two inverted supports designed to maintain the injector in position during the surgical procedure.

2. System according to claim 1, wherein the capsular bag (figure 2) has a diameter between 10 mm and 13 mm, a height of 0.5 mm to 1 mm and a thickness of 50 to 300 µm.

3. System according to claim 1, wherein the capsular bag (figure 2) has two central orifices for the insertion of intraocular lenses, compatible with monofocal, toric or multifocal lenses.

4. System according to claim 1, wherein the capsular bag has four circular perforations for attachment to scleral structures (figure 3).

5. System according to claim 1, wherein each wing of the cartridge (figure 1) comprises two longitudinal cylinders of 0.1 mm for stabilizing the bendable needles.

6. System according to any one of the preceding claims, wherein the cartridge allows the introduction of the capsular bag through a standard surgical incision of 2.2 mm or adjustable between 1.4 mm and 2.8 mm.

7. System according to claim 1, wherein the inverted supports of the headband (figure 4) are adjustable according to the operated eye (left or right).

8. System according to claim 1, wherein the stabilizing band is made of flexible, sterilizable or single-use plastic.

9. System according to claim 1, wherein the capsular bag (figure 5) is compatible with standardized ophthalmic injectors.

10. System according to claim 1, wherein the longitudinal closure of the cartridge (figure 1) ensures stability during and after injection.

11. System according to claim 1, wherein the headband (figure 4) is designed to free the surgeon's hands during the procedure.

12. System according to claim 1, wherein the 6-0 polypropylene threads are extended by bendable needles passing through the sclerotomies (figure 3).

13. System according to claim 1, wherein the cartridge (figure 1) is equipped with a folding mechanism facilitating the insertion of the bag into the posterior chamber via a corneal incision.

14. System according to claim 1, wherein the inverted supports of the band (figured) are oriented to optimize the stabilization of the injector.

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