Pupil expander device

Abstract

The present invention relates to the field of medical devices used in ophthalmic surgery and, more specifically, to systems designed to achieve and maintain pupil expansion during surgical procedures such as cataract removal. The invention concerns a pupil expander device configured to be positioned in the anterior chamber of the eye, which allows for stable pupil dilation while ensuring ease of use, reduced risk of tissue trauma, and compatibility with standard surgical instruments. The device comprises a sinusoidal octagonal structure (1) with eight rounded tips (3) alternately positioned above and below the iris to ensure stability and anchoring. The structure features eight contact points evenly distributed along the pupillary margin, providing uniform force distribution and minimizing the risk of intraocular damage. The device is made of hydrophilic or hydrophobic polymers or polypropylene, depending on the clinical requirements. In one embodiment, the structure is configured as an open ring, with overlapping or interlocking ends (hook and small ring), allowing elastic compression for easier insertion and safe removal.

Description

[0001] PUPIL EXPANDER DEVICE

[0002] DESCRIPTION

[0003] The present invention pertains to the field of medical devices used in ophthalmic surgery, specifically systems designed to achieve and maintain pupil expansion during surgical procedures such as cataract removal.

[0004] In particular, the subject of this invention is a pupil expander device configured to be positioned in the anterior chamber of the eye (6), enabling stable pupil dilation while ensuring ease of use, reduced risk of tissue trauma, and compatibility with standard surgical instruments available on the market. This invention aims to develop a device that overcomes the limitations and disadvantages of currently available devices, offering a safe, cost-effective, and user-friendly solution for surgeons.

[0005] The technical problem arises from the fact that known pupil expander devices, although effective in terms of dilation, present several drawbacks. These include the need for specialized auxiliary instruments, such as complex forceps or injectors, for application and removal; the use of rigid materials, like polymethylmethacrylate (PMMA), which can cause trauma to intraocular tissues during insertion or positioning; and geometric configurations that do not always ensure optimal stability of the device once positioned in the anterior chamber of the eye. Additionally, currently available devices often have high production costs and relative complexity of use, limiting their dissemination and applicability in various clinical settings.

[0006] To the best of the inventor's knowledge, existing pupil expander devices, while representing advanced solutions, have significant technical limitations. Relevant patent documents include: US2023200794, CN203988624, and US10130350. Although these systems offer some advantages, they share common disadvantages, such as the use of rigid materials or configurations that do not ensure optimal stabilityduring surgery, increasing the risk of unwanted movements and tissue trauma. Therefore, the problem of providing a pupil expander device that overcomes these limitations and offers a truly safe, stable, and economically advantageous solution remains unresolved.

[0007] The objective of the pupil expander device subject of the present invention is achieved through an instrument comprising the features described in the main claim. The attached figures illustrate:

[0008] Figure 1 : A front view of a preferred embodiment of the device;

[0009] Figure 2: A front view and corresponding sectional view;

[0010] Figure 3: A view of the device's positioning relative to the iris and pupil;

[0011] Figures 4 and 5: Views of two additional embodiments of the device.

[0012] The pupil expander device (1) comprises:

[0013] - a sinusoidal octagonal structure (1) configured to be positioned in the anterior chamber of the eye (6) with eight contact points (2) distributed along the pupillary margin (4) to stabilize the device during application and ensure uniform force distribution;

[0014] - eight rounded tips (3) corresponding to the sides of the sinusoidal octagonal (1) structure, configured to be alternately positioned partially under the iris (5), between the iris and the lens, and partially above the iris, to ensure stability and anchoring.

[0015] The term "sinusoidal octagonal structure" refers to a planar configuration with a substantially annular shape, characterized by both an external and internal undulating profile. Specifically, both the outer and inner edges have an alternating sequence of rounded indentations and protrusions, defining a closed sinusoidal pattern. The number of undulations is identical between the inner and outer profiles, totalling eight,resulting in an overall symmetrical structure relative to the component's central axis. It is evident that the tips (3) are, in fact, rounded connections.

[0016] Preferably, the curvature radii of the segments composing the sinusoidal octagonal structure range between 0.5 mm and 2 mm, sufficient to ensure both the necessary elasticity for insertion and positioning, and the geometric stability to maintain pupil dilation.

[0017] This geometric configuration ensures optimal stability due to the symmetrical arrangement of the eight tips (3), designed to anchor stably under and above the iris (5). The eight tips are arranged alternately: some are configured to be positioned partially under the iris between the iris and the lens, while others remain above the iris. This configuration ensures a balance of applied forces and prevents lateral movements during application, enhancing the precision and safety of the procedure. The device features eight contact points (2) evenly distributed along the pupillary margin (4). These contact points ensure uniform force distribution along the pupillary margin (4) thanks to a curved and flexible design, allowing progressive adaptation during insertion, reducing the risk of tissue trauma. The device is also characterized by optimized dimensions: the internal diameter ranges between 5 mm and 7 mm, ensuring sufficient dilation for surgical access to the lens, while the thickness and width range between 0.20 mm and 0.80 mm, balancing flexibility and robustness. The term "internal diameter" refers to the distance between two opposite sides of the sinusoidal octagonal structure, measured at their centers along the device's plane. As shown in Figure 3, the internal diameter represents the effectively free and central area through which the surgeon accesses the pupil and lens during the procedure. "Thickness" refers to the device's thickness measured perpendicularly to its plane (as seen in the sectional view of Figure 2). "Width" refers to the lateral dimension of thestructure's profile, i.e. , the width of the segment forming each side of the octagon, within the structure's plane.

[0018] Regarding materials, the device can be made from various options depending on specific clinical needs. In a preferred embodiment, the device is made from a hydrophilic polymer, designed to facilitate intraoperative handling and reduce tissue trauma due to its greater flexibility.

[0019] "Hydrophilic polymer" refers to a plastic material with an affinity for water, tending to swell or become softer when immersed in an aqueous environment (such as the eye's aqueous humor), enhancing flexibility and biocompatibility during insertion. Preferably, the hydrophilic polymer used for the device is selected from a group including Poly(HEMA) (hydroxyethyl methacrylate); Poly(vinylpyrrolidone) (PVP); modified hydrophilic polyurethanes; cross-linked hydrophilic acrylate formulations suitable for ophthalmic use.

[0020] Alternatively, it can be made from a hydrophobic polymer, providing greater rigidity, making it particularly suitable for clinical applications requiring robustness. Another option involves using polypropylene, a material already employed in ophthalmic devices like the Malyugin Ring, offering resistance and durability over time.

[0021] In an alternative embodiment, the sinusoidal octagonal structure can be shaped as an open ring. In other words, the structure is formed by a shaped filamentary element to obtain the described octagonal structure, equipped with a first end (1.1) and a second end (1.2). This open-ring configuration is particularly advantageous when the device is made from more rigid materials, such as polypropylene, as it allows temporary elastic compression of the structure during insertion into the anterior chamber of the eye.

[0022] Specifically, the presence of the two open ends (1.1, 1.2) allows for slight radialdeformation of the element (1), reducing its effective diameter and thus facilitating introduction through the surgical incision. Once positioned inside the eye, the device naturally tends to regain its original configuration due to the material's elastic properties, restoring the substantially annular shape necessary for the pupil's dilating action.

[0023] In an improved version of this configuration, the ends (1.1, 1.2) can be shaped with a tapered and elongated profile, allowing partial overlapping within the anterior chamber. This overlapping does not increase the device's overall thickness and enables the structure, once inserted, to self-configure stably into a closed-ring arrangement, ensuring effective and continuous action.

[0024] This configuration not only simplifies insertion but also offers advantages during removal: one of the two ends can be easily grasped using a retrieval thread or a dedicated surgical instrument, allowing controlled extraction of the device while minimizing the risk of damage to ocular tissues. The combination of functional overlapping, material elasticity, and reduced end section represents a technical improvement capable of combining clinical efficacy and constructive simplicity.

[0025] The device is configured to be compatible with standard surgical instruments. The eight rounded tips (3) are sized and oriented to allow manual positioning using common surgical tools, such as hooks or spatulas, thanks to a curvature that facilitates grip and manipulation. Additionally, the device is configured to be inserted using a standard injector compatible with artificial lenses. During insertion, the device is temporarily compressed to allow passage through the injector and regains its sinusoidal shape once positioned in the anterior chamber.

[0026] As known in the art, the standard injector is a mechanical device used in ophthalmic surgery to introduce foldable devices into the anterior chamber of the eye through amicro-incision.

[0027] The expander according to the invention can be temporarily compressed (thanks to its sinusoidal geometry and elastic material), allowing it to be loaded into the injector. Features enabling its use include:

[0028] - Flexible and compressible geometry of the sinusoidal structure;

[0029] - Dimensions compatible with the internal channels of standard IOL injectors (compressed diameter < 2 mm);

[0030] - Elastic memory of the material, allowing the device to regain its original shape once expelled into the anterior chamber.

[0031] In a further embodiment, still with an open-ring sinusoidal octagonal structure (1) equipped with two ends, the device can be configured with one end (1.4) featuring a hook and the other end (1.3) featuring a small ring.

[0032] This configuration allows the pupil expander device — preferably made of polypropylene — to be initially closed into a smaller diameter ring, thereby facilitating insertion into the anterior chamber of the eye. Once positioned, the device can be gradually expanded as it is released, until the desired dilation is achieved.

[0033] This solution also improves the removal phase: it is in fact possible to open the ring by disengaging the hook (1.4) from the small ring (1.3), transforming the device into an open ring that can be easily extracted from the eye using a thread or another dedicated surgical tool, minimizing the risk of tissue damage.

[0034] The sinusoidal octagonal configuration prevents lateral shifts, ensuring intrinsic stability of the device and reducing the risk of accidental dislocation during surgery. This feature, combined with the uniform distribution of forces and compatibility with standard instruments, simplifies application, reduces operative time, and improves overall patient safety.The invention described herein will now be illustrated according to a preferred embodiment, which refers to the attached drawings. Additional features and advantages of the invention will become evident upon reading the following detailed description, provided by way of example and not limitation, with the aid of the drawings shown in the annexed tables. A skilled person in the art will better understand the invention from the detailed description of the drawings, as follows: Table 1, Figure 1: Top view of the pupil expander device, showing the sinusoidal octagonal structure and the eight rounded tips corresponding to the sides of the sinusoidal octagonal structure.

[0035] Table 1, Figure 2: Cross-sectional view of the sinusoidal octagonal structure.

[0036] Table 2, Figure 2: View of the pupil expander device positioned in the anterior chamber of the eye (6) with eight contact points (2) distributed along the pupillary margin (4) and with the eight tips (3) positioned partially under the iris (5) (between the iris and the lens) and partially above the iris, ensuring stability and anchoring. This illustrates the symmetrical arrangement and curved design intended to ensure stability and safety.

[0037] These technical features allow the device to achieve significant advantages over prior art devices. The device is easy to use, does not require complex auxiliary instruments, ensures uniform force distribution along the pupillary margin (4) due to the curved design of the eight contact points (2), and is safe for intraocular tissues thanks to the possibility of using flexible or rigid materials depending on needs. Furthermore, the device is economical to produce and compatible with existing surgical equipment, making it an ideal solution to improve pupil dilation procedures in ophthalmic surgery.

[0038] The invention has been previously described with reference to a preferredembodiment, wherein the pupil expander device combines a sinusoidal octagonal structure (1) with specifically selected materials to ensure safety and stability during surgical procedures. However, it is clear that the invention is susceptible to numerous variants that fall within its scope, such as modifications in dimensions, materials, or application methods, provided that the fundamental features ensuring stable and safe pupil dilation are maintained. These characteristics, together with the overall structure of the device, allow for significant economic and manufacturing benefits, as the device can be easily mass-produced using standard industrial processes while maintaining a robust and reliable configuration. Such variants offer flexibility in adapting the device to specific clinical needs, making it a versatile and cost-effective solution for a wide range of ophthalmic surgical applications

Claims

CLAIMS1. Pupil expander configured to be positioned in the anterior chamber of the eye (6) during an ophthalmic surgical procedure, comprising a sinusoidal octagonal structure having a planar configuration with a substantially annular pattern, featuring an alternating sequence of eight indentations and eight rounded protrusions (3) that define a closed sinusoidal profile, said structure being configured to be positioned in the anterior chamber of the eye (6), such that at said eight indentations are located eight respective contact points (2) distributed along the pupillary margin (4), while said eight protrusions (3) are configured to be positioned alternately under or above the iris.

2. Pupil expander according to claim 1, characterized in that the curvature radii of the segments composing the sinusoidal octagonal structure are in the range between 0.5 mm and 2 mm.

3. Pupil expander according to claim 1 or 2, characterized in that it has an internal diameter ranging between 5 mm and 7 mm, and thickness and width ranging between 0.20 mm and 0.80 mm.

4. Pupil expander according to one of the preceding claims, characterized in that it is made of a hydrophilic polymer selected from a group comprising: Poly(HEMA) (hydroxyethyl methacrylate); Poly(vinylpyrrolidone) (PVP); modified hydrophilic polyurethanes; cross-linked hydrophilic acrylate formulations suitable for ophthalmic use.

5. Pupil expander according to one of claims 1 to 4, characterized in that it is made of a hydrophobic polymer.

6. Pupil expander according to one of claims 1 to 4, characterized in that it is made of polypropylene.

7. Pupil expander according to one of the preceding claims, characterized in that said structure (1 ) is obtained from a shaped filamentary element configured as an open structure, comprising a first end (1.1) and a second end (1.2).

8. Pupil expander according to claim 7, characterized in that said first end (1.1) and second end (1.2) are shaped with a profile configured to allow partial overlapping without increasing the overall thickness of the device.

9. Pupil expander according to claim 7, characterized in that one of the ends of said structure comprises a hook (1.3), and the other end comprises a small ring (1.4).

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