Adaptable intraocular lens for implantation under various capsular bag conditions

Abstract

Intraocular lens (10) for implantation in patients undergoing cataract surgery, adaptable to various conditions of the capsular bag (17d), comprising a central optical portion (11) and two lateral haptics (12a, 12b), said lateral haptics (12a, 12b) being integral with said central optical portion (11) and having a polygonal shape with five sides and rounded vertices, the first end of the first side and the final end of the fifth side of each of said haptics (12a, 12b) being integral with said central optical portion (11).

Description

[0001] ADAPTABLE INTRAOCULAR LENS FOR IMPLANTATION UNDER

[0002] VARIOUS CAPSULAR BAG CONDITIONS

[0003] DESCRIPTION

[0004] The present invention pertains to the technical field of ophthalmic devices for vision correction, in particular intraocular lenses (lOLs) used in cataract surgery. The objective is to develop an intraocular lens which, thanks to a specific geometry and dedicated technical features, can be used in all clinical situations, thereby simplifying surgical procedures and improving patient outcomes.

[0005] In current surgical practice, during cataract surgery, the opacified natural crystalline lens is removed and replaced with an artificial intraocular lens. This lens is inserted inside the intact capsular bag, a thin transparent membrane that serves as support for both the natural crystalline lens and the artificial lens. The capsular bag has a diameter of approximately 9 mm and a thickness of about 2 micrometers.

[0006] Existing intraocular lenses have various types of haptics, such as C-loop haptics or loop-shaped haptics — curved structures that help maintain the lens centered within the capsular bag — and "cookie-type" haptics, which have a shape resembling a cookie and offer a different type of support.

[0007] In cases where the capsular bag is damaged, either during surgery or due to trauma, implanting the lens becomes complicated. Current techniques often require additional procedures, special instruments, and may increase the risk of complications. For instance, the "Carlevale" lens requires the creation of scleral flaps and the use of expensive forceps for fixation. The use of such lenses presents several technical complications. After the lens is inserted into the eye, forceps must be used to grasp a small tab on the lens itself, which must be extracted through a scleral flap — i.e., a small opening created in the sclera, the outer wall of the eye, with a thickness of approximately 0.7 millimeters.

[0008] Creating scleral flaps involves various issues, such as the invasive procedure requiring cutting and lifting part of the sclera, the risk of intraocular fluid leakage with consequent ocular collapse and potential postoperative complications, the critical sizing of the flap which — if too narrow — prevents the tab from passing through, or — if too wide — may lead to lens dislocation or excessive fluid leakage, and the risk of damage when pulling the tab through the flap, with potential breakage of the tab itself or damage to the lens.

[0009] Additionally, the use of the special forceps required for this procedure adds further complications, such as the high cost of the forceps, limited availability (since not all surgical facilities are equipped with such tools), and operational complexity, as the procedure requires the simultaneous use of two forceps, demanding high coordination and surgical experience.

[0010] The technical problem arises from the fact that, in current surgical practices, the placement of an intraocular lens becomes complex in the presence of a damaged or absent capsular bag, requiring additional surgical techniques, expensive instruments, and increasing the risk of postoperative complications. Existing systems are limited by the need to use different types of lenses depending on the condition of the capsular bag, complicating both material management and surgical procedures. Thus, the unresolved problem remains: to provide a device — specifically, an intraocular lens — that is versatile, easy to implant, and capable of reducing complications associated with existing techniques.

[0011] To address this problem, the present invention provides an intraocular lens (10) for implantation in patients undergoing cataract surgery, adaptable to different conditions of the capsular bag (17d), comprising a central optical portion (11 ) and two lateral haptics (12a, 12b). Said lateral haptics (12a, 12b) are integral with the central optical portion (11 ) and have a polygonal shape comprising five sides with rounded vertices, where the first end of the first side and the final end of the fifth side of each of said haptics (12a, 12b) are connected to said central optical portion (11 ).

[0012] The invention will now be described with reference to the attached Figures 1 to 8.

[0013] Figure 1 shows a top view of the invention with all of its components. The figure illustrates the intraocular lens (10) with the central optical portion (11 ) in the version with lateral sutures (13a, 13b) integrated into the lateral haptics (12a, 12b).

[0014] Figure 2 shows a cross-sectional view of the eye, illustrating the positioning of the intraocular lens (10) in the presence of an intact capsular bag (17d): the intraocular lens (10) is inserted into the capsular bag through a superior opening, with a diameter of approximately 5-6 mm.

[0015] Figure 3 shows a cross-sectional view of the eye, illustrating the positioning of the intraocular lens (10) in the presence of a ruptured capsular bag (17d): when the bag is tom, typically in the posterior portion, the intraocular lens (10) is placed on the remaining capsule. The two lateral haptics (12a, 12b) are positioned in the ciliary sulcus, between the iris and the ciliary body (where the capsular bag is anchored via fibrils), without requiring sutures.

[0016] Figure 4 shows a cross-sectional view of the eye illustrating the positioning of the intraocular lens (10) in the absence of the capsular bag: in this case, the intraocular lens (10) is sutured to the sclera, with the two lateral haptics (12a, 12b) positioned in the ciliary sulcus. In the illustration, the eyeball (17c), the corneal limbus (17a), and the pupil (17b) are visible. The lateral haptics (12a, 12b) rest precisely on the capsular remnant, ensuring stable fixation of the intraocular lens (10) by means of the lateral sutures (13a, 13b) anchored to the sclera, thereby ensuring the proper positioning of the IOL within the eye.

[0017] Figure 5 shows a front view of the eye illustrating one possible positioning of the intraocular lens (10) with a ruptured capsular bag; Figure 6 shows a front view of the eye illustrating another possible positioning of the intraocular lens (10). This view displays the imaginary reference axis (18) passing through the notches (15a, 15b), used by the surgeon to maintain the correct orientation of the lens inside the eye.

[0018] Figure 7 shows a front view of one embodiment in which the fillet radii between the sides of the polygonal haptic are enlarged.

[0019] Figure 8 shows a front view of another embodiment in which the lateral haptics have a lower height profile and feature two through holes on the central side of the pentagon, corresponding to the notches (15a, 15b).

[0020] The axis (18) is an imaginary reference axis that connects the notches on the two lateral haptics of the intraocular lens. This axis defines the orientation of the lens inside the eye, serving as a guide for the surgeon during implantation. Depending on the design of the lens and the clinical requirements, the reference axis (18) can be aligned horizontally or vertically with respect to the anatomy of the eye, allowing the surgeon to place the lens precisely and symmetrically — especially in the case of toric lenses or when a specific orientation is necessary for vision correction.

[0021] As shown in the drawings, the present invention proposes an intraocular lens (10) designed for implantation in patients undergoing cataract surgery, adaptable to various conditions of the capsular bag (17d), whether intact, ruptured, or absent. The lens comprises a central optical portion (11 ) made of biocompatible acrylic material and two lateral haptics (12a, 12b) shaped as polygons with five sides and rounded corners.

[0022] As is clear from the drawings, the term “polygonal with five sides” refers to the fact that each lateral haptic has five sides, while the sixth edge lies along the connection to the lens body.

[0023] Each lateral haptic (12a, 12b) has a central side provided, on its outer face, with a notch (15a, 15b) intended for attaching the scleral fixation sutures along a determined axis (18), and on its inner face, with a triangular reinforcement (16a, 16b) oriented toward the inside of the lens. As evident from the drawings, the haptics (12a, 12b) and the triangular reinforcements (16a, 16b) preferably have a planar configuration.

[0024] This triangular reinforcement (16a, 16b) is designed to prevent deformation of the side when traction is applied to the lateral sutures (13a, 13b), thereby maintaining the correct position of the intraocular lens (10) within the eye. Furthermore, it facilitates movement of the haptic toward the center of the eye, as it can be hooked with a hook instrument to aid in implantation into the capsular bag or the sulcus. Current lenses on the market do not provide a mechanism for hooking the haptic and moving it toward the center of the eye, which makes lens positioning more complicated.

[0025] To allow engagement with a hook instrument, the triangular reinforcements are not solid but include a central through hole.

[0026] Thanks to the notch (15a, 15b), the surgeon has a precise reference point for connecting the lateral sutures (13a, 13b), thus maintaining the correct position of the lens within the eye and allowing it to be implanted along the axis (18), as shown in Figure 6.

[0027] The triangular reinforcement (16a, 16b) is preferably manufactured in one piece with the lateral haptics (12a, 12b), forming a single body with the central optical portion (11 ). The lateral sutures (13a, 13b) for scleral fixation are preferably, though not necessarily, integrated into the notches (15a, 15b) of the lateral haptics (12a, 12b) and have a length between 15 mm and 100 mm, facilitating easy handling during the surgical procedure. These lateral sutures (13a, 13b) are made of prolene with a diameter ranging between 8-0 and 10- 0. Prolene is a biocompatible material commonly used in ophthalmic surgery, and the filaments can be fixed to the lateral haptics (12a, 12b) by gluing or by integration during the manufacturing process.

[0028] The length of the lateral sutures (13a, 13b) can be adjusted based on surgical needs and may be trimmed or not integrated into the lateral haptics (12a, 12b) to allow the lens to be adapted for specific surgical requirements, including use as a standard IOL.

[0029] The total width of the intraocular lens (10), including the size of the lateral haptics (12a, 12b), ranges from 11 mm to 13 mm, adapting to different ocular sizes. The central optical portion (11 ) has a diameter between 6.0 mm and 6.5 mm and a thickness of less than 1.5 mm. The intraocular lens (10) is entirely made of biocompatible materials to ensure compatibility with ocular tissues.

[0030] The lateral haptics (12a, 12b) are provided with visual markers (14a, 14b) to guide the surgeon in proper orientation during implantation.

[0031] The two markers (14a, 14b) are not symmetrical; if the lens were flipped around its main plane (orthogonal to the optical axis), their position would be mirrored compared to that shown in Figure 1 — i.e. , from top right and bottom left to bottom right and top left.

[0032] The intraocular lens (10) can be used in combination with existing implantation techniques to improve stability and positioning. The technical problem addressed lies in the fact that, during the traction of the sutures for scleral fixation, the side of the haptic to which the forces are applied tends to deform. This deformation can alter the position of the lens, making it asymmetrical and compromising correct visual function.

[0033] The proposed solution consists in integrating the triangular reinforcement (16a, 16b) on the central side of the lateral haptics (12a, 12b), preventing deformation during the traction of the lateral sutures (13a, 13b) and ensuring that the lens maintains its correct position within the eye, thereby improving the stability and effectiveness of the implant.

[0034] The intraocular lens (10) features closed lateral haptics: unlike open haptics found in some existing lenses, closed haptics offer greater stability and facilitate positioning inside the eye without the risk of unintended rotation. This design differs from the commonly used “C-loop” or “cookie-type” haptics, offering uniform support and better adaptability to different ocular dimensions. The lateral sutures (13a, 13b), anchored to the lateral haptics (12a, 12b), eliminate the need for forceps to fix the intraocular lens (10). These lateral sutures (13a, 13b) can be easily manipulated and extracted through small scleral incisions using fine needles, removing the need for expensive instruments and simplifying the surgical procedure.

[0035] The intraocular lens (10) proposed by this invention eliminates the need for creating scleral flaps, thus reducing the risks associated with such procedures, including intraocular fluid leakage and postoperative complications. Moreover, the absence of external protruding elements simplifies the implantation process and improves patient comfort.

[0036] The Yamane technique involves the use of needles to fix the lens to the sclera without sutures, but it has some limitations, such as short haptics that make manipulation difficult and increase the risk that the haptic may slip back into the eye during the procedure; the need for larger incisions to insert the lens, which increases the risk of complications; and the overall complexity of the procedure, requiring significant skill and experience from the surgeon.

[0037] The intraocular lens (10) proposed here overcomes these limitations through its closed lateral haptic design (12a, 12b) and integrated lateral sutures (13a, 13b), which facilitate positioning and fixation of the lens without the need for wide incisions or special instruments. The total width of the intraocular lens (10), ranging between 11 mm and 13 mm, ensures that it can effectively adapt to the human ocular cavity, providing proper stability once implanted and avoiding undesirable movements for optimal optical function (see Fig. 1 , Plate 1 ). To the best of the inventor’s knowledge, suture-based scleral fixation systems for intraocular lenses are known in the prior art, such as those described in patents US5275623 and WO2018191816. However, such systems have significant limitations, requiring complex surgical procedures, expensive specialized instruments, and increasing the risk of complications such as tissue erosion or lens dislocation.

[0038] Advantageously, the proposed system is based on an intraocular lens (10) with lateral haptics (12a, 12b) and lateral sutures (13a, 13b), which allow for simple scleral fixation without the need for scleral flaps or special instruments, and is adaptable to all capsular bag conditions.

[0039] Existing systems are limited by the need to use different types of lenses depending on the condition of the capsular bag, complicating material management and surgical procedures. Therefore, the problem remains unresolved of providing a device that overcomes the limitations of known devices — specifically, one that is versatile, easy to implant, and capable of reducing complications associated with existing techniques.

[0040] The invention described herein aims to provide an intraocular lens (10) usable in the presence of an intact capsular bag, ensuring stable positioning inside the bag; allowing the use of the same lens in the case of a ruptured capsular bag, resting on the remaining capsule without the need for additional fixations; and enabling scleral fixation of the lens in the complete absence of the capsular bag, without requiring the creation of scleral flaps or the use of expensive instruments. This approach reduces surgical time and postoperative complications, simplifying the procedures and improving the patient experience. This problem is effectively solved by the intraocular lens (10), which includes a central optical portion (11 ) made of biocompatible acrylic material, with a diameter between 6.0 mm and 6.5 mm. This central portion is supported by two lateral haptics (12a, 12b), also connected to the central optical portion, with an overall width ranging from 11 mm to 13 mm, to accommodate various eye sizes. The haptics are fixed with lateral sutures (13a, 13b) made of prolene, with a length between 15 mm and 100 mm. This range of lengths has been experimentally determined to provide the surgeon with optimal handling of the device, avoiding issues caused by sutures that are too long or too short, as is common with devices currently on the market.

[0041] Conveniently, the device may be manufactured without integrating the lateral sutures (13a, 13b), allowing the lens to be adapted to specific surgical needs and making it suitable for use as a standard IOL. Furthermore, the closed polygonal shape of the lateral haptics (12a, 12b) prevents undesirable rotations of the lens once implanted, ensuring proper optical alignment. Preferably, the device is made entirely of biocompatible materials, ensuring compatibility with ocular tissues and reducing the risk of adverse reactions.

[0042] When the capsular bag is intact, the intraocular lens (10) is implanted inside the bag. The lateral haptics (12a, 12b) exert elastic force to keep the lens centered and stable, avoiding undesirable rotations. If the capsular bag is damaged, the lens can be placed on the capsular remnant, with the larger lateral haptics (12a, 12b) providing stable support without the need for additional fixations. In the complete absence of the capsular bag, the lens can be fixed to the sclera using the lateral sutures (13a, 13b). The procedure involves inserting needles through the sclera, passing the lateral sutures (13a, 13b) through the needles, and securing them externally via cauterization or insertion into scleral tunnels. The lateral sutures (13a, 13b) may be cut to adapt the lens to specific needs or to use it as a standard IOL.

[0043] The proposed intraocular lens (10) differs from currently available lenses, such as the “Carlevale” lens, which requires more complex surgical procedures and the use of expensive instruments. The use of the lateral sutures (13a, 13b) avoids the need for special forceps and simplifies the surgical procedure, reducing the risk of complications and improving the patient experience. Moreover, the absence of external knots reduces the risk of tissue irritation.

[0044] The intraocular lens (10) offers a unique and versatile solution for cataract treatment in patients with various capsular bag conditions. The shape of the intraocular lens (10) and the integration of the lateral sutures (13a, 13b) enable effective implantation in all clinical situations, simplifying surgical procedures, reducing the risk of complications, and improving patient outcomes. This versatility also reduces the need to have various lens types available, simplifying material management and reducing associated costs.

[0045] In the embodiment shown in Figure 8, the central side of the polygon features two through holes at the position of the notches (15a, 15b). These through holes connect the outer face of the central side to its inner face and form two oblique tunnels (17a, 17b), configured to allow passage of the scleral fixation sutures.

[0046] The tunnels (17a, 17b) are formed within the thickness of the haptic body and are inclined relative to the main plane of the lens, defined as the plane orthogonal to the optical axis of the central optical portion. Each tunnel connects two opposite surfaces of the haptic, starting from a lateral notch and ending on a different surface of the same haptic, at an angle that defines an oblique path.

[0047] Each suture inserted through the tunnels has one end equipped with a head larger than the hole diameter, such that it locks into place within the tunnel once passed through.

[0048] The tunnels are not symmetrical to each other; they are inclined differently with respect to the reference axis (18) passing through the central points of the central side of each of said lateral haptics (12a, 12b), in order to achieve three main advantages:

[0049] - to prevent rotation of the lens along the optical axis once implanted;

[0050] - to stabilize the lens through active mechanical constraints in different directions;

[0051] - to define a unique implantation orientation, as the correct positioning is determined by the functional alignment between the oblique tunnels and the sutures.

Claims

CLAIMS1. Intraocular lens (10) for implantation in patients undergoing cataract surgery, adaptable to various conditions of the capsular bag (17d), comprising a central optical portion (11 ) and two lateral haptics (12a, 12b), said lateral haptics (12a, 12b) being integral with said central optical portion (11 ) and having a polygonal shape comprising five sides with rounded vertices, the first end of the first side and the final end of the fifth side of each of said haptics (12a, 12b) being integral with said central optical portion (11 ).

2. Intraocular lens (10) according to claim 1 , characterized in that the central side of each of said lateral haptics (12a, 12b) comprises, on its outer surface, a notch (15a, 15b), and on its inner surface a triangular reinforcement (16a, 16b) oriented toward the inside of the lens.

3. Intraocular lens (10) according to claim 2, characterized in that said haptics (12a, 12b) and said triangular reinforcements (16a, 16b) have a planar configuration.

4. Intraocular lens (10) according to claim 3, characterized in that said triangular reinforcements are provided with a central through hole to allow engagement with a hook instrument.

5. Intraocular lens (10) according to claim 3 or 4, characterized in that said haptics (12a, 12b), said triangular reinforcements (16a, 16b), and saidoptical portion (11 ) are manufactured as a single piece.

6. Intraocular lens (10) according to any of the preceding claims, further comprising lateral sutures (13a, 13b) integrated into the lateral haptics (12a, 12b).

7. Intraocular lens (10) according to claim 6, characterized in that said lateral sutures (13a, 13b) are secured to said notches (15a, 15b) of the lateral haptics (12a, 12b) and have a length between 15 mm and 100 mm.

8. Intraocular lens (10) according to claim 6 or 7, characterized in that said lateral sutures (13a, 13b) are made of prolene with a diameter ranging from 8-0 to 10-0.

9. Intraocular lens (10) according to any of the preceding claims, having a total width, including the size of the lateral haptics (12a, 12b), between 11 mm and 13 mm, a diameter of the central optical portion (11 ) between 6.0 mm and 6.5 mm, and a thickness less than 1 .5 mm.

10. Intraocular lens (10) according to any of the preceding claims, characterized in that the lateral haptics (12a, 12b) include visual markers (14a, 14b) to indicate to the surgeon the correct orientation during implantation.11 . Intraocular lens (10) according to any of the preceding claims, characterized in that the central side of said five-sided polygonal shape has two through holes corresponding to said notches (15a, 15b), said through holes connecting the outer surface of said central side to the inner surface of said central side.

12. Intraocular lens (10) according to claim 11 , characterized in that said through holes are inclined differently from one another with respect to the reference axis (18) passing through the central points of the central side of each of said lateral haptics (12a, 12b).

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