Spacer device for insertion inside an eye to create a three-dimensional volume for controlling intraocular fluids.

Abstract

Spacer device 800 for implantation into an eye, comprising a flexible body configured to conform to an anatomical tissue surface of the eye, the body comprising an inner surface 825 and an outer surface 845, wherein the spacer device is configured to reversibly transition between a compressed configuration suitable for feeding through an application element 400 and an expanded configuration defining a convex, internal three-dimensional volume 370 for receiving fluid from an anterior chamber of the eye, wherein the spacer device comprises engagement elements 810, 830, each positioned along and extending along a longitudinal axis of the inner surface 825, and wherein the engagement elements are configured to: (i) engage with an application element 400 to stabilize the spacer device during implantation into the eye, and (ii) engage with the tissue surface after insertion, and wherein a central slot 865 arranged between the engagement elements 810, 830 forms a primary drainage path for the fluid circulation.

Description

TECHNICAL AREA

[0001] The present invention relates generally to the field of a spacer device for ophthalmic procedures and in particular to a spacer device that is used inside an eye to create a three-dimensional volume for the control of intraocular fluids. BACKGROUND

[0002] Glaucoma comprises a group of eye diseases characterized by progressive damage to the optic nerve. Elevated intraocular pressure (IOP) is a primary risk factor, and if left untreated, glaucoma can lead to irreversible vision loss and blindness. Treatments to lower IOP include topical medications, laser treatments, and surgical procedures; however, these approaches do not produce sufficient results in some patients, potentially requiring further surgical intervention.

[0003] Glaucoma drainage devices (shunts) are used when drug therapies and / or laser treatments are insufficient. These devices are typically made of biocompatible materials such as silicone or polypropylene and provide an alternative drainage pathway for aqueous humor to lower intraocular pressure and reduce further damage to the optic nerve. Shunts are particularly important in refractory glaucoma.

[0004] Commonly used implants include the Ahmed glaucoma valve, the Baerveldt glaucoma implant, and the Molteno implant. While these implants vary in size, configuration, and material, they all aim to facilitate the outflow of aqueous humor to lower intraocular pressure. Some implants, for example, consist of a silicone tube connected to a plate that is positioned under the conjunctiva or on the scleral surface, with the tube being inserted into the anterior chamber.

[0005] A significant postoperative challenge is scarring (fibrosis) around the implant, which can obstruct aqueous humor outflow and impair long-term shunt function. To reduce the fibrotic response, antifibrotic agents such as mitomycin C (MMC) and 5-fluorouracil (5-FU) are sometimes used intraoperatively or perioperatively to maintain implant patency.

[0006] Despite their usefulness, antifibrotic agents are associated with potential side effects, including corneal toxicity and collateral damage to ocular tissue, leading to a continuous review of their risk-benefit profile in glaucoma surgery.

[0007] Conventional tube shunt designs typically provide drainage regulated by intraocular pressure and a fixed hydrodynamic resistance. Fixed-resistance outflow can be suboptimal in various postoperative phases. Shortly after implantation, insufficient resistance can lead to hypotony (e.g., intraocular pressure < 6 mmHg), which is associated with complications such as hypotony maculopathy and choroidal detachment. Conversely, over time, progressive fibrosis around the implant and distal outflow pathways can increase the effective resistance, causing intraocular pressure to rise to non-physiological levels and compromising long-term pressure control. These limitations highlight the need for improved approaches to regulating aqueous humor outflow and mitigating both early hypotony and late fibrotic failure.

[0008] In light of the above, there remains a need for alternative implants and procedures for eye surgery to treat eye diseases such as glaucoma. PRESENTATION OF THE INVENTION

[0009] This presentation serves to introduce a selection of concepts in simplified form, which are explained in more detail below. This presentation is not intended to identify any essential or fundamental aspects of the claimed subject matter.

[0010] As described herein and generally, the present disclosure relates to a spacer device for implantation into an eye, comprising a flexible body configured to conform to anatomical tissue surfaces of the eye, wherein the spacer device is configured to reversibly switch between a compressed configuration suitable for delivery by an application element and an expanded configuration defining a convex, internal three-dimensional volume for receiving fluid from an anterior chamber of the eye, and wherein the spacer device comprises one or more engagement elements configured to engage with the delivery element to stabilize the spacer device during implantation into the eye.

[0011] As described herein and generally, the present disclosure also relates to a spacer device for insertion into an eye, comprising: a support structure; at least one deformable element arranged relative to the support structure to define a three-dimensional volume, wherein the support structure and the at least one deformable element are movable between a compressed configuration dimensioned to pass through a lumen of an application element and an expanded configuration, wherein in the expanded configuration the at least one deformable element extends away from the support structure to form a curved shape defining and containing the three-dimensional volume, and wherein the three-dimensional volume is configured to accommodate a fluid when the device is inserted into the eye.

[0012] As described herein and generally, the present disclosure also relates to a method for inserting a spacer device into an eye, comprising: providing the spacer device described herein; inserting an insertion element into the eye, wherein the insertion element receives the spacer device; and inserting the spacer device into the eye, wherein the spacer device expands out of the insertion element itself upon insertion.

[0013] As described herein and generally, the present disclosure also relates to an insertion device comprising a) a body with a proximal and a distal end, b) a spacer device for implantation into an eye, comprising a flexible body configured to conform to anatomical tissue surfaces of the eye, and c) an insertion element comprising a proximal section and a distal section, wherein the proximal section is connected to the distal end of the body, the distal section having a distal penetrating tip, the insertion element defining an inner lumen extending from the distal section to the proximal section, and the insertion element containing the spacer device within the lumen, the spacer device being configured to reversibly switch between a compressed configuration,which is suitable for insertion through the insertion element, and an expanded configuration that defines a convex, internal three-dimensional volume for receiving fluid from an anterior chamber of the eye, wherein the application device is configured to cause an axial displacement movement of the spacer device through the application element in the compressed configuration, and wherein the application device is configured to push the spacer device out of the distal tip, thereby transitioning the spacer device into the expanded configuration.

[0014] As described herein and generally, the present disclosure also relates to a method comprising: a) providing a delivery device comprising: i) a body with a proximal and a distal end, ii) a spacer device for implantation into an eye, comprising a flexible body configured to conform to anatomical tissue surfaces of the eye, the spacer device being configured to reversibly switch between a compressed configuration suitable for delivery by a delivery element and an expanded configuration defining a convex, internal three-dimensional volume for receiving fluid from an anterior chamber of the eye, and iii) a delivery element comprising a proximal section and a distal section, the proximal section being connected to the distal end of the body.wherein the distal section has a distal penetrating tip, wherein the delivery element defines an inner lumen extending from the distal section to the proximal section, and wherein the delivery element contains the spacer device within the lumen; b) inserting the delivery element into a subconjunctival, subtenonal, or suprachoroidal space of the eye; c) causing an axial displacement movement of the spacer device by the delivery element, wherein the spacer device is in the compressed configuration; and d) unfolding the spacer device from the distal tip, wherein the spacer device transitions into the expanded configuration.

[0015] As described herein and generally, the present disclosure also relates to the use of a spacer device comprising a flexible body configured to reversibly transition between a compressed configuration and an expanded configuration defining a convex internal volume for receiving aqueous humor, for implantation into an eye for the purpose of directing aqueous humor outflow and promoting bubble formation.

[0016] As described herein and generally, the present disclosure also relates to a delivery device comprising a body with a proximal and a distal end, a spacer device for implantation into the eye comprising a flexible body configured to conform to the anatomical tissue surfaces of an eye, a delivery means comprising a proximal section connected to the distal end of the body and comprising a distal penetrating tip, wherein the delivery means defining an internal cavity extending from a distal end to a proximal end thereof, and wherein the delivery means containing the spacer device in the expanded configuration within the lumen, and wherein the penetrating tip has a tapered, crescent-shaped or scoop-like structure that gradually narrows its outer profile.

[0017] All features of the exemplary embodiments described in this disclosure, which are not mutually exclusive, can be combined with one another. Elements of one embodiment can be used in the other embodiments without further mention. Further aspects and features of the present invention will become apparent to the person skilled in the art after reviewing the following description of specific embodiments in conjunction with the accompanying figures. BRIEF DESCRIPTION OF THE FIGURES

[0018] For a better understanding of the various embodiments described herein and for a clearer illustration of how these different embodiments can be implemented, reference is made to the accompanying figures, which show at least one exemplary embodiment and are now described. The figures are not intended to limit the scope of the teachings described herein. In the figures: Fig. Figure 1 is a cross-sectional diagram of the general anatomy of a human eye. Fig. Figure 2 is another cross-sectional diagram of the human eye and certain anatomical structures of the eye. Fig. Figure 3 is a non-restrictive perspective side view of a first embodiment of a spacer device for insertion into an eye in an expanded configuration according to non-restrictive embodiments of the present disclosure. Fig. Figure 4 is a non-restrictive perspective side view of a distal end of an application element, which includes the spacer device. Fig. 3 in a compressed configuration, according to non-restrictive embodiments of the present disclosure. Fig. Figure 5 is a non-restrictive top view of a distal end of an application element, wherein the spacer device is made of Fig. 3 of which is used and is in an expanded configuration, according to non-restrictive embodiments of the present disclosure. Fig. Figure 6A is a non-restrictive perspective side view of a second embodiment of a spacer device for insertion into an eye in a compressed configuration according to non-restrictive embodiments of the present disclosure. Fig. 6B is a non-restrictive perspective top view of the spacer device made of Fig. 6A according to non-restrictive embodiments of the present disclosure. Fig. 7A is a non-restrictive perspective side view of the spacer device made of Fig. 6A in an expanded configuration according to non-restrictive embodiments of the present disclosure. Fig. 7B is a non-restrictive perspective top view of the spacer device made of Fig. 7A according to non-restrictive embodiments of the present disclosure. Fig. Figure 8 shows a third embodiment of a spacer device for insertion into an eye in an expanded configuration according to non-restrictive embodiments of the present disclosure. Fig. 9A is a non-restrictive perspective view of a variant of the spacer device made of Fig. 8 according to non-restrictive embodiments of the present disclosure. Fig. 9B is a non-restrictive perspective side view of the spacer device made of Fig. 9A according to non-restrictive embodiments of the present disclosure. Fig. 9C is a non-restrictive top view of the spacer device made of Fig. 9A according to non-restrictive embodiments of the present disclosure. Fig. 9D is a non-restrictive perspective bottom view of a variant of the spacer device made of Fig. 8 according to non-restrictive embodiments of the present disclosure. Fig. 9E is a non-restrictive elevated perspective view of the spacer device made of Fig. 9D according to non-restrictive embodiments of the present disclosure. Fig. 9F to 9H are non-restrictive representations of the implantation procedure for a variant of the spacer device made of Fig. 8A according to non-restrictive embodiments of the present disclosure. Fig. 9F shows the insertion of a first interventional element into the sclera of the eye. Fig. Figure 9G shows the swiveling with the application element to bring the spacer device into an S-shape. Fig. 9H shows the insertion of the second intervention element into the sclera. Fig. Figure 9I is a non-restrictive perspective side view of the spacer device made of Fig. 9F to 9H after implantation into the ocular sclera according to non-restrictive embodiments of the present disclosure. Fig. 9J is a non-restrictive representation of the pivoting movement, which describes the unfolding of the spacer device according to the one in Fig. The implantation procedure shown in 9F to 9H, according to non-restrictive embodiments of the present disclosure, has the effect. Fig. 9K is an elevated view of a variant of a single-wire spacer device of the device made from Fig. 7A, which forms a dome shape, according to non-restrictive embodiments of the present disclosure. Fig. 9L is a side view of the spacer device made of Fig. 9K. Fig. 9M to 9P are elevated views of the variants of the spacer device made of Fig. 8A. Fig. Figure 10A is a non-restrictive top view of a fourth embodiment of a spacer device for insertion into an eye in an expanded configuration, as well as variants thereof according to non-restrictive embodiments of the present disclosure. Fig. 10B is a non-restrictive underside view of the spacer device and variants thereof. Fig. 10A according to non-restrictive embodiments of the present disclosure. Fig. 10C is a non-restrictive top view of additional variants of the spacer device and variants of Fig. 10A according to non-restrictive embodiments of the present disclosure. Fig. 10D is a non-restrictive top view of additional variants of the spacer device and variants of Fig. 10C according to non-restrictive embodiments of the present disclosure. Fig. 10E is a non-restrictive perspective bottom view of specific embodiments from Fig. 10D according to non-restrictive embodiments of the present disclosure. [0046.1] Fig. Figure 10F is an elevated underside view of another variant of the spacer device according to non-restrictive embodiments of the present disclosure. [0046.2] Fig. 10G is a side view of the spacer device made of Fig. 10F. [0046.3] Fig. 10H is a cross-sectional view of the spacer device made of Fig. 10G. [0046.4 Fig. 10I is a variant of the spacer device made of Fig. 10F. Fig. 11A, Fig. 11B and Fig. Figure 11D are non-restrictive perspective views of an application device or components thereof for supplying a spacer device described herein to an eye according to non-restrictive embodiments of the present disclosure. Fig. 11C is a view of an application element according to the state of the art. Fig. 12A to 12C are non-restrictive top views of the application device. Fig. 11A with a spacer device described herein according to non-restrictive embodiments of the present disclosure. Fig. 13A and Fig. Figure 13B shows non-restrictive top views of an insertion stem connected to the spacer device. Fig. 10F is engaged, according to non-restrictive embodiments of the present disclosure. Fig. 13C is a non-restrictive top view of the feed stem and the spacer device made of Fig. 13B according to non-restrictive embodiments of the present disclosure. Fig. 13D is a non-restrictive side view of the feed stem and spacer device made of Fig. 13B according to non-restrictive embodiments of the present disclosure. Fig. Figure 14 is a cross-sectional diagram of the spacer device of the present disclosure in conjunction with a shunt placed in an eye according to non-limiting embodiments of the present disclosure. Fig. Figures 15A to 15D are non-restrictive representations of a spacer device implanted in an eye according to non-restrictive embodiments of the present disclosure. Fig. 16A and Fig. Figure 16B are non-restrictive cross-sectional diagrams of an application element that accommodates the spacer device, wherein the application element, according to non-restrictive embodiments of the present disclosure, comprises a bend proximal to the distal end. Fig. Figure 17 is a non-restrictive flowchart of a method for introducing the spacer device of the present disclosure into an eye according to non-restrictive embodiments of the present disclosure.

[0019] The figures show exemplary embodiments. It is expressly understood that the description and figures serve only to illustrate certain embodiments and to aid understanding. They are not intended to define the limits of the invention. DETAILED DESCRIPTION

[0020] The present invention is explained in more detail below. This description is not intended to be a detailed catalog of all the different ways of implementing the invention or of all the features that can be added to the present invention. For example, features shown in relation to one embodiment can be incorporated into other embodiments, and features shown in relation to a particular embodiment can be removed from that embodiment. Furthermore, numerous variations and additions to the various embodiments proposed herein will be obvious to the person skilled in the art, taking into account the present disclosure, and these variations and additions do not deviate from the present invention.Therefore, the following description is intended to illustrate some embodiments of the technology and not to exhaustively specify all permutations, combinations, and variations thereof.

[0021] In this detailed description and the following claims, specific directional terms are used according to their standard anatomical meaning to describe parts of an eye, implant, or surgical instrument with respect to their orientation or relative positions. For example, "proximal" refers to the part of an instrument or component positioned closest to the torso, while "distal" refers to the part furthest from the torso. Similarly, directional terms such as "anterior" refer to the direction toward the front of the body, while "posterior" refers to the direction toward the back of the body. "Superior" refers to a position above another object or structure, while "inferior" refers to a position below it.

[0022] In this description, the terms "implant" and "device" may be used synonymously and refer to the same component or device. These standardized definitions are intended to ensure clarity and consistency in the description of the components of the invention and to guarantee precise spatial orientation and anatomical reference within the context of the invention.

[0023] The inventors have developed a spacer device for use in the eye, for example, for implantation in the subconjunctival, subtenonal, or suprachoroidal space.

[0024] When the spacer device is used in the eye, it has one or more technical advantages that improve its functionality and effectiveness in ocular applications, such as in the formation of blisters.

[0025] For example, the spacer device can incorporate a shape-memory structure, enabling a simple, one-step implantation process. The open, three-dimensional volume defined and contained within the spacer device also allows for greater fluid capacity and more efficient handling compared to flat or single-channel drainage devices.

[0026] For example, the spacer device may have an open structure that allows it to be folded or compressed for insertion through small incisions, minimizing trauma to the ocular tissue. Once inserted, the spacer device can gently expand to assume a predefined internal volume, reducing the risk of excessive pressure on surrounding ocular structures. This feature is particularly valuable in delicate eye surgeries where minimizing the physical presence of surgical instruments is critical for preserving ocular integrity.

[0027] Furthermore, or alternatively, the open structure allows for the unimpeded movement of ocular fluids, thus preventing blockages or disruptions to the natural flow within the eye. This is crucial for maintaining intraocular pressure and avoiding complications such as edema or local tissue compression. Unlike rigid implants, which can obstruct fluid pathways, the design of this device allows for better integration into the eye's natural physiology, thereby reducing the risk of fluid-related complications. Additionally, the device's structure minimizes friction and shear forces on surrounding tissue, improving biocompatibility and reducing irritation or inflammation.

[0028] For example, the spacer device may incorporate tissue interface structures that include one or more penetrating elements to secure the spacer within the eye. These penetrating elements may be designed to engage gently yet securely with the ocular tissue, providing stable fixation without sutures or adhesives. Alternatively, suture points may be used. This stability can be advantageous for maintaining precise positioning within the eye, which is particularly important for applications such as glaucoma stents or intraocular scaffolds, where displacement of the device could compromise function. The anchoring points also provide a means of fine-tuning by the user (e.g., an ophthalmic surgeon), who can easily reposition the spacer device as needed to optimize its alignment within the eye's anatomical features.

[0029] For example, the spacer device can have an overall curved shape and configuration, allowing it to naturally conform to the spherical shape of the eye, maximizing its stability and minimizing the potential for irritation. The curved design provides a degree of flexibility that adapts to the eye's round anatomy, helping the device maintain contact over a larger surface area without causing pressure points. This flexibility is particularly beneficial in long-term applications where the device needs to remain in place for extended periods without slipping or causing discomfort.

[0030] For example, the spacer device can incorporate one or more collapse-resistant reinforcement features configured to maintain the convex, internal three-dimensional volume in the expanded configuration while allowing elastic compression for delivery, with the reinforcement features being integral to or attached to the flexible body. For instance, the one or more collapse-resistant reinforcement features can include elongated or contoured stiffening structures that provide collapse-resistant support under tissue loading without relying on the thickness of the volume material. Advantageously, in the expanded state, the one or more collapse-resistant reinforcement features allow the device to exhibit a controlled bladder architecture with a low apex height (e.g.,approximately 600-1000 µm) and maintains a stable distance, thereby reducing focal pressure points on the eye tissue.

[0031] For example, the spacer device can have a continuous surface that defines the three-dimensional volume. In other words, the spacer device can eliminate perforations through the spacer surface. Such a feature can advantageously reduce potential niches for fibrovascular ingrowth and scarring while maintaining an open internal volume and directed flow paths; in contrast, perforations in plate-like structures can serve as sites for tissue ingrowth, impairing long-term outflow.

[0032] For example, the open internal volume and optional recess and flow-conducting geometries can further reduce the likelihood of flow obstructions, fibrosis-related encapsulations and interactions with the anterior cornea, thereby improving the uniformity of outflow and long-term control of intraocular pressure.

[0033] Together, these features offer an unexpectedly effective balance between availability, atraumatic implantation, and reliable maintenance of a functional bladder space with a reduced profile, thus solving the technical problem of achieving minimally invasive implantation while maintaining long-term drainage performance and device stability. Eye structure

[0034] According to Fig. Figure 1 depicts the general anatomy of an eye 20, for example, a human eye. It includes the anterior chamber 1, which is bordered anteriorly by the cornea 2 and posteriorly by the iris 4. Below the iris 4 is the lens 5, which is responsible for focusing light onto the retina. The anterior chamber 1 is filled with aqueous humor 3, a fluid that plays an important role in maintaining intraocular pressure. The aqueous humor 3 drains from the anterior chamber through a trabecular meshwork in the sclera 8, which is not shown in detail in the figure. From there, the fluid enters a space 6 beneath the conjunctiva 7, where it further drains into the venous system and ultimately contributes to the regulation of intraocular pressure.

[0035] Fig. Figure 1 shows a cross-section of the eye with more detailed anatomical information. The conjunctiva 12 is shown in relation to Tenon's capsule 13, a fascial layer of connective tissue that envelops the eyeball and extraocular muscles. Tenon's capsule attaches anteriorly at the limbal fusion 9, where the conjunctiva 12 and Tenon's capsule 13 merge with the sclera 8. This point of attachment is critical for maintaining structural integrity. As shown, Tenon's capsule 13 extends posteriorly until it fuses with the dura mater surrounding the optic nerve. The subconjunctival space 14 lies between the conjunctiva 12 and the sclera 8, and the space between Tenon's capsule 13 and the sclera 9 is called the intra-Tenon's space 10. These anatomical features are important for various eye surgeries, including procedures to treat glaucoma.

[0036] In glaucoma, increased pressure in the anterior chamber, caused by a buildup of aqueous humor, can damage the optic nerve and vascular structures in the posterior chamber of the eye. Treatments for glaucoma and other conditions that lead to elevated intraocular pressure focus on lowering this pressure to prevent further damage. This is usually achieved by promoting the outflow of aqueous humor from the anterior chamber, either naturally or through surgery. spacers

[0037] This document describes a spacer device configured for implantation in an eye. The spacer device has a size, volume, diameter, length, cross-section, and / or shape configured for positioning within an eye, such as a human or animal eye. For example, it may be implanted in the subconjunctival, subtenonal, or suprachoroidal space.

[0038] In some embodiments, the spacer device, when correctly positioned in the eye, can act as a spacer for the ocular tissue. In other words, the spacer device can function as a structure that forms a curved shape and defines a three-dimensional volume (i.e., a cavity) between adjacent layers of ocular tissue or within a single layer of ocular tissue. This creates a dedicated space for drainage, collection, or other fluid management functions.

[0039] The term "tissue layer," as used here, encompasses both a single tissue layer and a collection of layers, such as adjacent stacked layers (a multiple layer) or separate layers. However, the standard interpretation usually refers to a single tissue layer. Furthermore, the term "tissue layer" often refers to a tissue wall characterized by a certain thickness and two sides (outer and inner, or proximal and distal).

[0040] In some embodiments, the spacer device can be in fluid communication with one or more eye sites. For example, the spacer device can be configured to hold a fluid, such as an intraocular fluid and / or an injected fluid.

[0041] In some embodiments, the spacer device can be configured for implantation below the conjunctiva or below Tenon's capsule. The conjunctiva is a thin, transparent membrane that covers the white part of the eye (sclera) and the inner eyelids. This implantation typically allows easy access for drainage. Tenon's capsule is a layer of connective tissue between the conjunctiva and the sclera. When the ocular tissue spacer is placed below Tenon's capsule, it is positioned deeper than below the conjunctiva, thereby reducing direct exposure and potentially stabilizing the ocular tissue spacer more securely.

[0042] In some embodiments, the spacer device can be in fluid communication with the anterior chamber of the eye, such that the spacer device is configured to collect aqueous humor draining from the anterior chamber, thereby lowering intraocular pressure. Such fluid communication with the anterior chamber can be established via an ocular implant, for example, a shunt, positioned between the anterior chamber and the spacer device. The ocular implant (e.g., a shunt) can form a drainage channel, and the spacer device can thus collect aqueous humor draining from the anterior chamber of the eye, which then flows through the ocular implant, thereby reducing intraocular pressure.

[0043] When the spacer device for reducing intraocular pressure is in fluid contact with the anterior chamber of the eye, it can be useful in treating glaucoma. This is intended to include primary and secondary open-angle glaucoma. However, it is conceivable that this spacer device could be used to treat other types of glaucoma, as well as other eye conditions that require relief of intraocular pressure through drainage of aqueous humor, such as pigment dispersion syndrome, neovascular glaucoma, uveitic glaucoma, chronic angle-closure glaucoma, and pseudoexfoliation syndrome.

[0044] Additionally or alternatively, the spacer device can be used to introduce a fluid into the eye, for example, by injection. The fluid can be, for example, a medication, a therapeutic agent, saline solution, viscoelastic fluids, and the like. The saline solution can be used for rinsing. The viscoelastic fluids can include, for example, hyaluronic acid, chondroitin sulfate, cellulose, derivatives, mixtures thereof, or solutions thereof. In one variant, the viscoelastic fluid includes sodium hyaluronate. In another variant, the viscoelastic composition can additionally contain a medication. For example, the viscoelastic composition can contain a medication suitable for treating glaucoma, lowering or reducing intraocular pressure (IOP), reducing inflammation, and / or preventing infection.Medications such as antimetabolites, steroids, heparin, other anticoagulants, and fibrinolytic compounds can also be administered in combination with the viscoelastic composition. Examples of glaucoma medications include prostaglandins, beta-blockers, miotics, alpha-adrenergic receptor agonists, or carbonic anhydrase inhibitors. Anti-inflammatory drugs such as corticosteroids or other steroids can be used. For example, steroids such as prednisolone, prednisone, cortisone, cortisol, triamcinolone, or shorter-acting steroids can be used. Examples of antimetabolites include 5-fluorouracil (5-FU) or mitomycin C (MMC). In another variation, the spacer device is used to deliver the medication alone, without the viscoelastic composition. A saline solution can also be used as the liquid.

[0045] In some embodiments, the spacer device may be coated with a biomaterial on at least part of an inner surface, at least part of an outer surface, or both, to increase the surface area and / or reduce irritation. Alternatively or additionally, the spacer device may be coated on at least part of an inner surface, at least part of an outer surface, or both, with a compound suitable for treating ocular hypertension, glaucoma or pre-glaucoma, infections, scarring, or post-operative inflammation, and / or with a compound suitable for reducing friction and thus facilitating insertion into the eye.

[0046] In some embodiments, the spacer device can be used in conjunction with antimetabolites and / or in combination with other anti-scar, anti-VEGF, or anti-fibrosis agents. When used with antimetabolites such as 5-fluorouracil (5-FU) or mitomycin C (MMC), the interior or surrounding surfaces of the device could serve as a vehicle to localize and deliver these antimetabolites. The three-dimensional structure of the device and its position between or within the ocular tissue would allow for a sustained, controlled release of the antimetabolites to the target area.

[0047] Alternatively, the spacer device can also be implanted without the simultaneous use of antimetabolites. In these cases, the design and materials of the implant can be optimized to minimize inflammatory reactions and fibrotic scarring on their own, without the need for additional pharmacological agents.

[0048] The versatile architecture of the spacer device offers multiple surfaces and spaces that could accommodate these complementary therapies, thereby enabling localized delivery to the surrounding ocular tissue.

[0049] Whether used alone or as part of a combination therapy, integrating the spacer device into glaucoma or retinal treatments expands potential therapeutic options. Its ability to incorporate drug delivery functions alongside its structural spacer and stabilization capabilities enhances the overall clinical utility of the device.

[0050] In some embodiments, the spacer device is solid or semi-solid and is intended to be bioabsorbable.

[0051] In some embodiments, the spacer device is fixed or semi-fixed and intended for permanent use.

[0052] In some embodiments, the spacer device can be inserted into and positioned in the eye using an application device configured for ab interno procedures. Alternatively, the spacer device can be inserted and positioned using an application device configured for ab externo procedures. For example, the spacer device can be inserted into and positioned in the eye using an application device with an application element.

[0053] In some embodiments, the spacer device can be configured to reversibly transition from a compressed configuration (with a smaller profile) to an expanded configuration (with a larger profile). For example, the spacer device can be configured so that the transition from the compressed configuration to the expanded, deployed configuration is instantaneous or gradual, or so that the degree of expansion is controllable. The transition can occur in several discrete steps (i.e., extending one dimension after the device has entered an expanded state), in one step, or continuously, with at least one of its volume, shape, size, diameter, length, etc., changing until the desired expansion endpoint is reached to achieve the desired size.For example, a minimal expanded or high-profile state is initially achieved, with the option to further expand or extend the high-profile state to meet space requirements.

[0054] Advantageously, the compact configuration facilitates delivery to the implantation site. Furthermore, the compact configuration allows the spacer device to be received and / or transported through the lumen of an application element of an application device configured for positioning and delivering the spacer device into the eye.

[0055] In some embodiments, the spacer device comprises a flexible body configured to conform to the anatomical tissue surfaces of the eye. The spacer device may be configured to reversibly transition between a compressed configuration, suitable for delivery by an application element, and an expanded configuration, defining a convex, internal three-dimensional volume for receiving fluid from the anterior chamber of the eye. The spacer device may include one or more engagement elements configured to engage with the application element to stabilize the spacer device during implantation in the eye.

[0056] For example, the flexible body can be configured so that it can be compressed or folded along its longitudinal axis to facilitate insertion by the application element.

[0057] In some embodiments, the spacer device comprises a support structure and at least one deformable element arranged relative to the support structure to define a receiving space. For example, the support structure may be configured to define a boundary in a first plane. For example, in some embodiments, the support structure and the at least one deformable element may be separate structures, or in other embodiments, they may form a single continuous structure. The support structure and the at least one deformable element are movable between a compressed configuration, dimensioned to pass through a lumen, and an expanded configuration. In the expanded configuration, the at least one deformable element extends away from the first plane to form a three-dimensional volume (e.g., a 360° cavity).to define a cavity with an apex spaced from the first plane. The support structure and / or the at least one deformable element consist of a shape-memory material prestressed to the expanded configuration. For example, the three-dimensional volume is configured to accommodate and contain a fluid when the spacer device is deployed within the ocular tissue.

[0058] In some embodiments, the at least one deformable element deforms elastically during compression leading to the compressed configuration and folds downwards toward the plane defined by the support structure. When the device is compressed, the at least one deformable element flattens and aligns itself substantially parallel to the plane defined by the support structure, while the support structure compresses inward to fit within the lumen of the application element. The medical-grade material of both the support structure and the at least one deformable element allows for significant elastic deformation without plastic deformation or loss of shape memory.During compression, the support structure deforms into an elongated shape, giving the entire device a compressed profile that fits into the lumen of the application element, which may have a relatively small inner diameter. The inherent spring force of the materials maintains sufficient outward preload during compression to ensure reliable self-expansion during use, while remaining below the materials' elastic limit to prevent fatigue or permanent deformation from multiple compression-expansion cycles.

[0059] In some embodiments, the spacer device can be self-expanding or adjustable to expand, depending on the required distance in the eye tissue.

[0060] In some embodiments, the spacer device incorporates tissue interface features connected to the support structure. These tissue interface features may include specific tissue engagement elements to anchor the device in the desired location within the eye after insertion. For example, the spacer device may be stabilized in position by using tissue engagement elements such as hooks, miniature pins, or suture points extending from the tissue interface features of the support structure. Alternatively, the tissue engagement elements may include small protrusions, barbs, or other surface irregularities that readily engage or become entangled in the surrounding ocular tissue. This helps prevent unwanted migration or displacement of the device once it has been placed in the target position.Alternatively, the fabric interface elements could include eyelets or other attachment points to sew the device in place. This offers a more secure fastening method than relying solely on friction between the fabric grip elements and the fabric.

[0061] Integrating these tissue-intervention elements as part of the overall tissue interface features of the support structure ensures that the spacer device remains stably positioned and in place even during normal eye movements or fluid dynamics. This improves the reliable performance and therapeutic efficacy of the device.

[0062] In some embodiments, the spacer device can further be configured to include a port for receiving or fluidically connecting an ocular implant (e.g., a shunt). This port can be in fluid communication with the three-dimensional volume.

[0063] In some embodiments, the spacer device can be used with a reduced width and increased height profile to be positioned in the suprachoroidal space with a curved ab interno delivery cannula. This could serve both to lower intraocular pressure and to provide a depot for drug delivery. In the suprachoroidal space, the sclera thickness is approximately 0.5 mm, so a delivery element with a length of at least 0.5 mm to 1.2 mm could, for example, administer antihypertensive drugs, anti-inflammatory agents (such as steroids), or gene therapies for retinal dystrophies, wet age-related macular degeneration (AMD), or diabetic maculopathy.

[0064] By reconfiguring the device to a taller, more elongated form, it can be effectively inserted and held in the suprachoroidal space using a minimally invasive ab interno approach. This positioning allows the device to create a pathway for aqueous humor drainage to lower intraocular pressure while providing a protected microenvironment that serves as a depot for drug delivery.

[0065] The increased height of the device in this configuration, compared to its wider base in previous implantations, accommodates the relatively thin scleral tissue in the suprachoroidal space. Needle lengths in the range of 0.5 to 1.2 mm would be sufficient to penetrate the sclera and position therapeutic agents near the target structures of the eye.

[0066] The use of the spacer device in this suprachoroidal drug delivery application leverages its versatile design and ability to adapt its dimensional profile to access different ocular tissue levels. This expands the device's potential clinical benefits beyond its purely mechanical spacer function.

[0067] In non-restrictive applications, the device can be used in combination with a trabeculectomy procedure. Trabeculectomy is a surgical procedure to treat glaucoma by lowering intraocular pressure (IOP). It involves creating a small flap in the sclera (the white outer layer of the eyeball) and making an opening underneath it so that excess aqueous humor (fluid) from inside the eye can drain into a space under the conjunctiva (the clear tissue that covers the white part of the eye). This drainage reduces pressure on the optic nerve and helps prevent further vision loss. Trabeculectomy is often recommended when medication or laser treatments are unable to adequately control IOP.Alternatively, the device can be used in conjunction with an ab externo or ab interno implant to drain fluid from the anterior chamber to the outside, under the conjunctiva or Tenon's membrane.

[0068] When used with a trabeculectomy, the spacer device can be positioned to fill the surgically created fistula, thus maintaining the patency of the drainage pathway. Its self-expanding three-dimensional structure fills the space and prevents occlusion, while aqueous humor flow continues through the internal volume of the implant or around its circumference.

[0069] In a separate application, the spacer device could be implanted in conjunction with a drainage implant that drains fluid from the anterior chamber into the subconjunctival or subtenonal space. The tissue-grasping elements of the implant could help stabilize the position of the drainage implant, while its cavity could integrate into the drainage pathway to facilitate the drainage of aqueous humor.

[0070] Whether used in trabeculectomy or drainage implantation, the versatile design of the spacer device can be adapted to the specific surgical technique. Its ability to switch between compressed and expanded configurations and adjust its dimensional profile allows it to be effectively combined with other glaucoma procedures to improve their performance and durability.

[0071] The unique geometry of the device described here enables it to function effectively in controlled environments where precise containment, fluid distribution, or structural support is required. First implementation

[0072] Fig. Figure 3 shows a first, non-restrictive implementation of a spacer device arranged and configured according to certain features, aspects and advantages of the present disclosure.

[0073] In some embodiments, the spacer device 300 can be configured to reversibly transition from a first, compressed configuration (with a lower profile) to a second, expanded configuration (with a larger profile). For example, the spacer device 300 can have self-expanding properties and be reversibly movable from the compressed configuration to the expanded configuration and vice versa.

[0074] In some embodiments, the spacer device 300 is configured to reversibly switch between the compressed configuration, which is dimensioned to fit into at least part of the application element 400, and the expanded configuration.

[0075] In some embodiments, the spacer device 300 includes a support structure 320. For example, the support structure 320 may consist of a single wire structure that can expand into the expanded configuration as an unfolded loop frame.

[0076] In some embodiments, the support structure 320 can be a wire with a round cross-section and a sufficient diameter to reduce the likelihood of tearing or damage to the eye structures during insertion and placement of the spacer device 300 in the eye. The diameter of this round wire can be between approximately 0.02 mm and approximately 0.7 mm, but can also be any other size that prevents excessive stress on the eye. Alternatively, the profile of the support structure 320 can be oval with a greater width or height, or it can be a strap.

[0077] In some embodiments, the inserted loop has a circumference that defines a circular, oval, or other atraumatic cross-sectional interior. The interior can be any size suitable for guiding and implanting the spacer device 300 into the eye without damaging ocular structures or causing significant discomfort to the patient.

[0078] For example, the loop used can have a circumference that defines a circular cross-sectional interior area.

[0079] In some embodiments, the support structure 320 is in a compressed configuration when the spacer device 300 is in a compressed configuration. For example, in the compressed configuration, the support structure 320 forms a collapsed loop with a reduced interior area. For example, the collapsed loop may have an elliptical shape that is elongated compared to that of the unfolded loop section. When used, the support structure 320 in the compressed configuration may be of a size that allows it to fit within the lumen of an application element 400, as shown in Fig. 4 shown. Depending on the material used to manufacture the support structure 320, the support structure 320 in the compressed configuration can have such a degree of stiffness that it can be directly inserted and pushed through the application element 400.

[0080] In some embodiments, the support structure 320 is configured to transition between the compressed configuration, which is dimensioned to fit into at least part of the application element 400, and the expanded configuration.

[0081] In some embodiments, the support structure 320 is made of a medical-grade material suitable for use in the eye. For example, the support structure 320 may comprise a material that allows it to transition from the compressed configuration to the expanded configuration with a degree of elasticity. For example, the support structure 320 may be made of nitinol (nickel-titanium alloy), magnesium alloys, polyamide, polyimide, silicone, or any suitable shape-memory polymer such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polylactic acid (PLA), polycaprolactone (PCL), polyurethanes, polyhydroxybutyrate (PHB), chitosan, silk fibroin, polydioxanone (PDO), or any combination thereof.

[0082] In some embodiments, the spacer device 300 further comprises at least one deformable element 350. For example, the at least one deformable element 350 can be arranged relative to the support structure 320 to define a three-dimensional volume.

[0083] In some embodiments, when the spacer device expands upon insertion, the at least one deformable element 350 expands from its compressed configuration and extends from the support structure 320 to form the three-dimensional volume—for example, by projecting in an arc or curve relative to the plane formed by the support structure 320. This expansion can form a dome-shaped structure that arches over the plane, thereby creating a defined three-dimensional volume (e.g., a cavity) between the apex of the dome and the plane of the support structure 320.The at least one deformable element 350 can curve upwards from its connections to the frame 320, extending in a direction that is substantially perpendicular to the base plane at its connection points, and then curve inwards towards a central axis of the device 300 that is perpendicular to the plane formed by the support structure 320. Due to its inherent spring force, the at least one deformable element 350 maintains its curved configuration, thus forming and maintaining the three-dimensional cavity structure suitable for receiving and containing fluid, while the device 300 can be compressed for delivery by the delivery element 400. This three-dimensional volume is configured to receive and contain a fluid, facilitating a therapeutic or structural purpose within the eye.The at least one deformable element is strategically positioned to maintain the dome shape and provide structural integrity to the three-dimensional volume when the device is fully deployed.

[0084] Alternatively, the at least one deformable element 350 connects to a circumference of an upper annular element (not shown) that is in an opposite and remote relationship to the support structure 320 when the spacer device 300 is in the expanded configuration. For example, the upper annular element may have a circumference defining a substantially circular or oval cross-section corresponding to the cross-sectional shape of the open area of ​​the support structure 320.

[0085] Alternatively, at least one deformable element 350 is connected to the circumference of an upper plate 360, as in Fig. Figure 5 shows that the spacer device 300 is in an opposite and distant relationship to the support structure 320 when it is in the expanded configuration. For example, the upper plate 360 ​​can have a substantially circular or oval cross-section that corresponds to the cross-sectional shape of the open area of ​​the support structure 320.

[0086] In some embodiments, when the spacer device 300 is in the compressed configuration, the at least one deformable element 350 is compressed, allowing the spacer device 300 to be accommodated within the application element 400. In other words, the at least one deformable element 350 can essentially form a compact structure with the support structure 320 so that the spacer device 300 can be accommodated within a lumen of the application element 400. During compression for feeding, the at least one deformable element 350 deforms elastically and folds downwards towards the base plane defined by the support structure 320.When the device 300 is compressed, the at least one deformable element 350 flattens and aligns itself substantially parallel to the base plane, while the support structure 320 compresses inward to fit into the lumen of the application element 400. The medical-grade material of both the frame 320 and the deformable elements 350 allows for significant elastic deformation without plastic deformation or loss of shape memory. Upon compression, the frame 320 deforms into an elongated shape, giving the entire device 300 a compressed profile that fits into an application element 400 with a relatively small inner diameter.The inherent spring force of the materials maintains sufficient outward preload during compression to ensure reliable self-expansion during use, while remaining below the elastic limit of the materials to prevent, for example, fatigue or permanent deformation from multiple compression-expansion cycles.

[0087] In some embodiments, the spacer device 300 is designed such that the support structure 320 defines a circumferential boundary and a base plane, wherein the at least one deformable element 350 extends outwards and away from this plane to create the three-dimensional volume, as in Fig. Figure 3 shows that, for example, the at least one deformable element 350 can expand from its compressed state and project in an arc-like or dome-like shape relative to the plane formed by the support structure 320. This expansion forms a dome-shaped structure that arches over the plane, creating a defined cavity between the apex of the dome and the plane of the frame. This cavity is configured to receive and contain a fluid, facilitating a therapeutic or structural purpose within the eye. The at least one deformable element 350 is strategically positioned to maintain the dome shape and provide structural integrity to the cavity when the device is fully deployed.

[0088] Such a transition can be achieved with a self-expansion characteristic of the spacer device 300.

[0089] In some embodiments, the at least one deformable element 350 consists of a medical-grade material suitable for use in the eye. For example, the at least one deformable element 350 may comprise a material that allows it to transition from the compressed configuration to the expanded configuration with a degree of elasticity. For example, the at least one deformable element 350 may be formed from any suitable material, including, but not limited to, metals, polymers, elastomers, hydrogels, smart materials, or composites thereof. Suitable metals include, for example, shape memory alloys such as Nitinol (nickel-titanium alloy), copper-aluminum-nickel alloys, and iron-based shape memory alloys.Suitable polymers include polyamide, polyimide, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polylactic acid (PLA), polycaprolactone (PCL), polyurethanes, polyhydroxybutyrate (PHB), chitosan, polydioxanone (PDO), silk fibroin, acrylic polymers, and thermoplastic or thermosetting materials. Polyurethanes include, for example, thermoplastic polyurethane (TPU), medical-grade polyether urethane, and silicone-polyurethane copolymers. Acrylic polymers include, for example, hydrophobic acrylic, hydrophilic acrylic, and cross-linked copolymers of methacrylate and acrylate derivatives. Elastomeric materials, such as silicone-based elastomers, can also be used. Examples of silicone-based elastomers include polydimethylsiloxane (PDMS), cross-linked medical-grade silicone, and room-temperature vulcanizing (RTV) silicone.Hydrogels can be used, including but not limited to poly(2-hydroxyethyl methacrylate) (PHEMA), polyacrylamide-based hydrogels, polyvinyl alcohol (PVA) hydrogels, collagen hydrogel copolymers, and polyethylene glycol (PEG)-based hydrogels. Intelligent or stimulus-responsive polymers can also be used, including thermoreactive and shape-memory polymers. Examples of thermoreactive polymers include poly(N-isopropylacrylamide) (PNIPAM), poly(N-vinylcaprolactam) (PVCL), and polyethylene glycol-based block copolymers. Biodegradable polymers with shape-retention properties can also be used. Examples of such biodegradable polymers include poly(lactic acid-co-glycolic acid) (PLGA), polycaprolactone (PCL), polydioxanone (PDO), and poly(L-lactic acid) (PLLA).Other suitable materials may include magnesium alloys, Collamer (hydroxyethyl methacrylate with porcine collagen), PolyHEMA collagen copolymers, acrylic urethane hybrids, or any biocompatible composites or combinations thereof.

[0090] In some embodiments, a distance 325 exists between each adjacent deformable element 350, each of the respective distances 325 extending along an edge of the respective expandable element 350, as in Fig. Figure 5 shows that such a distance 325 can contribute to the flexibility properties of the spacer device 300 and thus enable the reversible transition from the expanded to the compressed configuration. Second embodiment

[0091] Fig. 6A to 7B and Fig. 9K and Fig. Figure 9L illustrates a second non-restrictive embodiment of a spacer device arranged and configured according to certain features, aspects and advantages of the present disclosure.

[0092] In some embodiments, the spacer device 700 can be configured to reversibly transition from a first, compressed configuration (with a lower profile) to a second, expanded configuration (with a larger profile). For example, the spacer device 700 can have self-expanding properties and be reversibly movable from the compressed configuration to the expanded configuration and vice versa.

[0093] In some embodiments, the spacer device 700 is configured to reversibly switch between the compressed configuration, which is dimensioned to fit into at least part of the application element 400, and the expanded configuration.

[0094] In some embodiments, the spacer device 700 includes a support structure 720. For example, the support structure 720 may consist of a single wire structure that can expand into the expanded configuration as an inserted loop to form the dome shape, as in Fig. 9K and Fig. 9L shown. For example, the single wire structure can form concentric, circular rings arranged in a concentric configuration, with the single wire structure forming a continuous ring whose diameter increases from a central area to the peripheral boundary.

[0095] In some embodiments, the support structure 720 can be a wire with a round cross-section and a sufficient diameter to reduce the likelihood of tearing or damage to eye structures during insertion and placement of the spacer device 700 in the eye. The diameter of this round wire can be between approximately 0.02 mm and approximately 0.7 mm, but can also be any other size that prevents excessive stress on the eye. Alternatively, the profile of the support structure 720 can be oval with a greater width or height, or it can be a band.

[0096] In some embodiments, the inserted loop has a circumference that defines a circular, oval, or other atraumatic cross-sectional interior. The interior can be any size suitable for guiding and implanting the spacer device 700 into the eye without damaging ocular structures or causing significant discomfort to the patient.

[0097] For example, the loop used can have a circumference that defines a circular cross-sectional interior area.

[0098] In some embodiments, when the spacer device 700 is in its compressed configuration, the support structure 720 forms a collapsed loop with a reduced inner surface area. For example, the collapsed loop frame 720 may have an elliptical shape that is elongated compared to that of the unfolded loop. In use, the collapsed loop may have a size and shape that allows it to be accommodated (stored) within the application element 400 of a suitable spacer device, similar to the spacer device 300. Depending on the material used to manufacture the support structure 720, the support structure 720 in its compressed configuration may have a degree of rigidity that allows it to be directly inserted and pushed through the application element 400.

[0099] In some embodiments, the support structure 720 is configured to transition between the compressed configuration, which is dimensioned to fit into at least part of the application element 400, and the expanded configuration.

[0100] In some embodiments, the support structure 720 is made of a medical-grade material suitable for use in the eye. For example, the support structure 720 may comprise a material that allows it to transition from the compressed configuration to the expanded configuration with some elasticity. For example, the support structure 720 may be made of nitinol (nickel-titanium alloy), magnesium alloys, polyamide, polyimide, silicone, or any suitable shape-memory polymer such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polylactic acid (PLA), polycaprolactone (PCL), polyurethanes, polyhydroxybutyrate (PHB), chitosan, silk fibroin, polydioxanone (PDO), or any combination thereof.

[0101] In some embodiments, the spacer device 700 further comprises at least one deformable element 750, as shown in Fig. 6B shown. For example, the at least one deformable element 750 can be arranged relative to the support structure 720 to define a three-dimensional volume in the expanded configuration.

[0102] In some embodiments, the at least one deformable element 750 extends on one side of a plane formed by the support structure 720.

[0103] In some embodiments, the at least one deformable element 750 can comprise concentric, circular rings arranged in a spaced-apart configuration. For example, the at least one deformable element 750 can form an open, grid-like surface that defines the contour of the spacer device 700. In the expanded configuration, the spacer device 700 forms a three-dimensional volume defined by the at least one deformable element 750 and the support structure 720.

[0104] In some embodiments, the concentric circular rings are arranged in a concentric configuration, with each element 750 forming a continuous ring whose diameter increases from a central region to the peripheral boundary defined by the support structure 720. The concentric circular rings extend away from the support structure 720 to form an apex region spaced from the plane formed by the support structure 720. This arc-like extension of the at least one deformable element 750 forms a closed cavity or volume capable of receiving and containing a fluid. The inherent spring force and shape memory of the at least one deformable element 750 enable self-expansion from a compressed configuration into this three-dimensional expanded configuration when the limiting forces are removed from the lumen of the application element 400 during unfolding.

[0105] In some embodiments, each of the at least one deformable element 750 can be connected to the support structure 720. Such a connection can be made, for example, via an indirect connection through one or more support elements 780, as shown in Fig. Figures 6A to 7B illustrate this. For example, the one or more support elements 780 can be one or more arcuate support rods extending radially from a first outer edge of the support structure 720 to a second outer edge of the support structure 720, with the first and second edges opposite each other. The one or more support elements 780 can extend radially from the first to the second outer edge of the support structure 720 and pass through a central region of the support structure 720. As shown in Fig. As shown in Figures 6A to 7B, the spacer device 700 can comprise a single support element 780.

[0106] In some embodiments, the spacer device 700 can be separated from the one described in Fig. 7A and Fig. 7B shown expanded configuration, which forms a dome shape, into which in Fig. 6A and Fig. 6B shows a compressed configuration which forms a planar disk shape by compressing the concentric deformable elements 750 and the one or more support elements 780 along an axis perpendicular to the plane of the support structure 720.

[0107] In some embodiments, when the spacer device 700 is in the compressed configuration, the at least one deformable element 750 is compressed, allowing the spacer device 700 to be accommodated within the application element 400. In other words, the at least one deformable element 750 can essentially form a compact structure with the support structure 720 so that the spacer device 700 can be accommodated within a lumen of the application element 400. To facilitate feeding through a small lumen, the spacer device is in a compressed configuration. In the compressed state, the at least one deformable element 750 is arranged concentrically, aligned essentially parallel to the support structure 720, and decreases in diameter towards the central region.The support structure 720 also deforms into a narrower profile. This compression reduces the overall height and width of the device 700, allowing it to fit within the lumen of a feeding instrument shaft 400. For example, the elastic properties of the at least one deformable element 750 and the base structure 720 enable this compression without plastic deformation, ensuring that the device can reliably expand back to its desired three-dimensional volume after insertion and the release of the restrictive forces.

[0108] In some embodiments, when the spacer device 700 transitions into the expanded configuration, the at least one deformable element 750 extends away from a plane formed by the support structure 720, as shown in Fig. 7A and Fig. Figure 7B shows such a transition can be achieved with a self-expansion characteristic of the spacer device 700.

[0109] In some embodiments, the spacer device 700 is able to form a dome structure in the expanded configuration, as shown in Fig. 7A and Fig. 8B shown.

[0110] Such a transition can be achieved with a self-expansion characteristic of the spacer device 700.

[0111] In some embodiments, the at least one deformable element 750 and / or the support elements 780 are made of a medical-grade material suitable for use in the eye. For example, the at least one deformable element 750 and / or the support elements 780 may comprise a material that allows them to transition from the compressed configuration to the expanded configuration with some elasticity. For example, the at least one deformable element 750 and / or the support elements 780 may be made of any suitable material, including, but not limited to, metals, polymers, elastomers, hydrogels, smart materials, or composites thereof. Suitable metals include, for example, shape memory alloys such as Nitinol (nickel-titanium alloy), copper-aluminum-nickel alloys, and iron-based shape memory alloys.Suitable polymers include polyamide, polyimide, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polylactic acid (PLA), polycaprolactone (PCL), polyurethanes, polyhydroxybutyrate (PHB), chitosan, polydioxanone (PDO), silk fibroin, acrylic polymers, and thermoplastic or thermosetting materials. Polyurethanes include, for example, thermoplastic polyurethane (TPU), medical-grade polyether urethane, and silicone-polyurethane copolymers. Acrylic polymers include, for example, hydrophobic acrylic, hydrophilic acrylic, and cross-linked copolymers of methacrylate and acrylate derivatives. Elastomeric materials, such as silicone-based elastomers, can also be used. Examples of silicone-based elastomers include polydimethylsiloxane (PDMS), cross-linked medical-grade silicone, and room-temperature vulcanizing (RTV) silicone.Hydrogels can be used, including but not limited to poly(2-hydroxyethyl methacrylate) (PHEMA), polyacrylamide-based hydrogels, polyvinyl alcohol (PVA) hydrogels, collagen hydrogel copolymers, and polyethylene glycol (PEG)-based hydrogels. Intelligent or stimulus-responsive polymers can also be used, including thermoreactive and shape-memory polymers. Examples of thermoreactive polymers include poly(N-isopropylacrylamide) (PNIPAM), poly(N-vinylcaprolactam) (PVCL), and polyethylene glycol-based block copolymers. Biodegradable polymers with shape-retention properties can also be used. Examples of such biodegradable polymers include poly(lactic acid-co-glycolic acid) (PLGA), polycaprolactone (PCL), polydioxanone (PDO), and poly(L-lactic acid) (PLLA).Other suitable materials may include magnesium alloys, Collamer (hydroxyethyl methacrylate with porcine collagen), PolyHEMA collagen copolymers, acrylic urethane hybrids, or any biocompatible composites or combinations thereof.

[0112] In some embodiments, there is a distance 725 between each adjacent deformable element 750, each of the respective distances 725 extending along an edge of the respective expandable element 750, as shown in Fig. 7A and Fig. 7B shown. Such a distance 825 can contribute to the flexibility properties of the spacer device 700 and thus enable the reversible transition from the expanded to the compressed configuration. Third embodiment

[0113] Fig. Figures 8A to 9P illustrate a third, non-restrictive embodiment of a spacer device arranged and configured according to certain features, aspects and advantages of the present disclosure.

[0114] In some embodiments, the spacer device 900 can be configured to reversibly transition from a first, compressed configuration (with a lower profile) to a second, expanded configuration (with a larger profile). For example, the spacer device 900 can have self-expanding properties and be reversibly movable from the compressed configuration to the expanded configuration and vice versa.

[0115] In some embodiments, the spacer device 900 is configured to reversibly switch between the compressed configuration, which is dimensioned to fit into at least part of the application element 400, and the expanded configuration.

[0116] In some embodiments, the spacer device 900 includes a support structure 920. For example, the support structure 920 can consist of a single wire structure that can expand into the expanded configuration. Depending on the material used to manufacture the support structure 920, the support structure 920 can have such a degree of stiffness in the compressed configuration that it can be directly inserted and pushed through the application element 400.

[0117] In some embodiments, the support structure 920 consists of a medical-grade material suitable for use in the eye. For example, the support structure 920 may comprise a material that allows it to transition from the compressed configuration to the expanded configuration with a degree of elasticity. For example, the support structure 920 may be made of nitinol (nickel-titanium alloy), magnesium alloys, polyamide, polyimide, silicone, or any suitable shape-memory polymer such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polylactic acid (PLA), polycaprolactone (PCL), polyurethanes, polyhydroxybutyrate (PHB), chitosan, silk fibroin, polydioxanone (PDO), or any combination thereof. Preferably, the support structure 920 consists of nitinol.

[0118] In some embodiments, the support structure 920 is configured to switch between the compressed configuration, which is dimensioned to fit into at least part of the application element 400, and the expanded configuration.

[0119] In some embodiments, the support structure 920 comprises at least one deformable element 950. For example, the at least one deformable element 950 can be arranged relative to the support structure 920 to define a three-dimensional volume in the expanded configuration.

[0120] In some embodiments, the at least one deformable element 950 extends from the support structure 920. For example, the support structure 920 and the at least one deformable element 950 can consist of a single wire. In the expanded configuration, the spacer device 900 can form a curved shape. For example, the single wire can expand to form a crown region spaced apart from the plane formed by the support structure 920. This expansion of the single wire forms the curved shape (e.g., a dome shape) that defines and encloses a cavity or volume 370 that can receive and contain a fluid.The inherent spring force and shape memory of the at least one deformable element 950 enable self-expansion from a compressed configuration into this three-dimensional expanded configuration when the limiting forces are removed during unfolding from the lumen of the application element 400.

[0121] In some embodiments, the at least one deformable element 950 comprises at least one section that can be overmolded with a biocompatible material 955 to increase the surface area and / or reduce irritation. The biocompatible material may, for example, comprise a biocompatible plastic or silicone.

[0122] In some embodiments, the spacer device 900 is brought into the desired expanded configuration during the manufacturing process and then bent straight into a wire that fits into the insertion element 400 in order to be inserted into the eye.

[0123] In some embodiments, the at least one deformable element 950 (or the single wire) in the expanded configuration forms a winding, wave-like pattern - alternating between curved sections a 1...x and relatively straight sections b 1...x . For example, a coiled structure that forms a continuous, looped path and defines the internal volume 370 of the device.

[0124] Fig. Figure 8A shows a spacer device 900 with a single straight section b 1...x . Fig. Figures 9A to 9C show a spacer device 900 with three straight sections b 1...x . Fig. Figures 9D to 9E show a variant of the spacer device 900, which has five straight sections b 1...x includes. The reader will understand that another variant, for example, more or less straight sections b. 1...x may include.

[0125] Each even section b 1...x It bends gently at regular intervals, forming a continuous, wave-like structure aligned along the central axis of the device 900. The at least one deformable element 950 forms arcs that rise and fall, shaping the internal volume and maximizing the use of available space without requiring a rigid enclosure. This configuration allows the device to enclose or support materials within the internal volume while maintaining an open structure that minimizes weight and material consumption. The wave-like bends and curves of the at least one deformable element 950 allow the transition to an expanded configuration with outward extension while maintaining structural integrity.

[0126] In some embodiments, the spacer device 900 can form a shape with a single arc, as in Fig. 8A, Fig. 8B, Fig. 9I and Fig. 9M shown.

[0127] Alternatively, the spacer device 900 can form a shape with multiple arcs, as shown in Fig. 9A to 9E, Fig. 9N to 90 shown. In one variant, the spacer device can have 900 adjacent sections forming a multi-arc shape, for example, two individual arc-shaped bodies arranged side by side to form multiple arcs, as in Fig. 9P shown in a non-restrictive representation.

[0128] In some embodiments, when introducing the spacer device 900 into the eye, the user (e.g., a surgeon) can position the insertion element 400 relatively perpendicular to the eye and insert a first end of the wire of the spacer device 900 into the surrounding ocular tissue, anchoring the first end in the eye (e.g., with spot sutures or by pressing an intervention element into the ocular tissue), as shown in Fig. 9F shown. The user then guides the remainder of the stretched wire of the spacer device 900 through the entry point, as shown in Fig. 9G shows that the wire of the spacer device 900 can fall downwards and expand into the pre-formed expanded configuration shape, e.g. the curved shape 990, which is shown in Fig. 9A to 9C are shown as a virtual form.

[0129] In some embodiments, after unfolding from the application element 400, the spacer device 900 transitions into its expanded configuration, thus defining and enclosing the three-dimensional volume and creating a dedicated space for drainage, collection, or other fluid management functions. At this stage, the user (e.g., the surgeon) can secure the second end of the wire of the spacer device 900 in the surrounding ocular tissue to provide additional anchorage (e.g., with spot sutures or by pressing an intervention element into the ocular tissue), as shown in Fig. 9H is shown. This helps to secure the device 900 in place and prevents migration or displacement over time.

[0130] In some embodiments, the wire of the spacer device 900 has a cross-sectional size and forms a three-dimensional shape with a size that can vary, as long as the wire of the spacer device 900 has a diameter small enough to allow minimally invasive insertion, yet still provides sufficient structural integrity to maintain the desired pre-formed expanded configuration. For example, the coiled wire pattern can provide structural integrity to maintain the curved shape and internal volume while simultaneously allowing the device 900 to conform to the patient's unique ocular anatomy.

[0131] In some embodiments, the spacer device 900 is fed in by laterally pivoting the application element receiving the spacer device, as in Fig. 9J is shown with arrow 666.

[0132] Compared to other fluid management approaches, this device offers several advantages. Its shape-memory wire construction allows for a straightforward, single-step implantation process. The open, three-dimensional cavity also enables greater fluid capacity and more efficient management compared to flat or single-channel drainage devices. The arrangement described here is particularly suitable for applications where a lightweight yet structurally stable framework is advantageous, such as in biomedical, filtration, or fluid transport systems. Fourth implementation

[0133] Fig. Figures 10A to 10I illustrate a fourth, non-limiting implementation of a spacer device, arranged and configured according to certain features, aspects, and advantages of the present disclosure. These figures show several variants of this spacer device implementation.

[0134] In some embodiments, the spacer device 800 can be configured to reversibly transition from a first, compressed configuration (with a lower profile) to a second, expanded configuration (with a larger profile). For example, the spacer device 800 can have self-expanding properties and be reversibly movable from the compressed configuration to the expanded configuration and vice versa.

[0135] In some embodiments, the spacer device 800 is configured to reversibly switch between the compressed configuration, which is dimensioned to fit into at least part of the application element 400, and the expanded configuration.

[0136] In some embodiments, the spacer device 800 comprises a flexible, generally contoured body shaped to conform to anatomical tissue surfaces, such as the sclera or the subtenon space. In this context, the term "flexible" generally refers to the body's ability to deform, bend, or compress to fit into a delivery cannula and to expand back to its original shape upon exiting the delivery cannula.

[0137] In some embodiments, the forward-facing portion of the spacer body includes a recess 870 (a depressed or corrugated geometry) designed to prevent direct contact with the cornea. This anterior recess 870 can serve a dual purpose: it can prevent irritation or abrasion of the corneal tissue and also maintain a clear zone for optical coherence and implant alignment. The anterior recess 870 also facilitates the formation of an anterior vesicle space in which fluid can accumulate while maintaining distance from the cornea.

[0138] In the posterior region of the spacer or along the side walls, one or more enlarged posterior recesses or raised walls 820 may be provided. These recesses or raised walls 820 can promote posterior and / or lateral fluid migration, allowing the bladder to expand in a substantially posterior direction, away from the visual axis and sensitive anterior structures. This configuration can also ensure that the spacer device 800 supports both the formation of an anterior bladder for initial pressure reduction and the expansion of a posterior bladder for long-term drainage and tissue adaptation.

[0139] The cutouts or raised walls 820 in the spacer device 800 can also play an additional role in the mechanical flexibility and availability of the device. In particular, the cutouts or raised walls 820 can allow the spacer to be compressed, folded, or rolled longitudinally so that it can be inserted through the tapered section of the dispensing element during dispensing. Once inserted, the spacer device 800 expands or unfolds into its expanded, functional configuration, in which its inherent curvature and structural design restore the intended spacing and flow-guiding geometry, as shown in Fig. Shown 15A to 15D.

[0140] In some embodiments, the spacer device is positioned such that its curved anterior surface 870 faces the limbus, and its posterior limbs or extensions 880 direct the fluid posteriorly over and around an associated glaucoma canal, implant, or shunt. This anatomical orientation advantageously ensures that the spacer device elevates the overlying conjunctiva to create and maintain the bladder space while preserving the patency of the underlying drainage implant or sclerostomy. The posterior limbs or extensions 880 can act as flow channels or struts to maintain the space while directing fluid expansion in the desired direction, as shown in Fig. Shown 15A to 15D.

[0141] At least two size variants of the spacer device are conceivable to accommodate anatomical differences between species and patients. A smaller version, designed for an eyeball diameter of approximately 16 mm, is intended for preclinical testing in rabbit models. A larger variant, designed for eyeballs with a diameter of approximately 25 mm, is configured for use in human or porcine eyes. While both variants may retain one or more of the features described here (interventional elements, central slits, posterior cutouts, and compressibility for delivery), they may differ in curvature, length, and cutout dimensions to optimize performance in their respective ocular environments.

[0142] The spacer's reusable fluid drainage capability, combined with its anatomical curvature and compatibility with administration methods, makes it particularly suitable for minimally invasive eye surgeries where controlled bubble formation and implant release are advantageous. The integration of flow-guiding structures and recess geometries ensures not only effective reduction of intraocular pressure but also compatibility with a wide range of implant geometries and ocular anatomies.

[0143] In some embodiments, the spacer device 800 comprises one or more centrally positioned elongated engagement elements 810, 830 extending along a longitudinal axis of the device. Fig. Figure 10E shows a pair of engagement elements 810 and 830. These engagement elements 810 and 830 are configured to engage with a suitable delivery mechanism, such as a delivery rod 550 (described elsewhere in this text), and / or with an ocular tissue surface during the implantation procedure. For example, the engagement elements 810 and 830 may define shallow grooves, channels, or slots designed to receive prongs or fingers of the delivery rod 550, thereby ensuring secure retention and controlled release of the device as it is advanced by the application element. The engagement elements may be integrally formed or shaped as part of the spacer device 800 and help to maintain the device's orientation during insertion.

[0144] Fig. 10F and Fig. Figure 10H schematically shows the dimensions of the device, including the apex height Y, the first diameter X, the second diameter Z, the body thickness THK, and a gap dimension G. The apex height Y represents the maximum convex elevation of the inner three-dimensional volume from a base reference plane. The body can have a curvature of its outer surface 845 of approximately 10 to 14 degrees, while the surface Cp of the intervention elements 810, 830 in contact with the ocular tissue can have a profile corresponding to the curvature of the eye (e.g., a curvature of 25 degrees) in order to lie flush against the tissue, e.g., the sclera or Tenon's capsule. In non-restrictive embodiments, Y, X, and Z are selected to achieve the desired bubble architecture. The body thickness THK is optimized to achieve a balance between adaptability and collapse resistance.The gap dimension G defines the opening height of the bubble chamber, which can range from approximately 0.45 mm to 0.90 mm to accommodate different eye anatomies while maintaining a controlled bubble height. Overall, the device can form a curvature Φ when viewed from an elevated top view of approximately 6 degrees to approximately 10 degrees. The coordination of these dimensions helps to create a flat bubble with sufficient volume for consistent drainage.

[0145] As shown, the device has a central slot 865 positioned between the engagement elements 810 and 830 on the inner surface 825. These engagement elements are configured to: (i) engage with an application element to stabilize the device during implantation, and (ii) engage with the tissue surface after implantation. The central slot 865 provides a primary drainage pathway for fluid circulation.

[0146] Fig. Figure 10I shows a variant of the spacer device 800 in which the body has one or more discrete openings 895 for optional suture fixation to the underlying ocular tissue. This feature provides surgeons with an additional means of securing the implant, which can be particularly useful in cases where improved long-term stability or precise positioning is required. To prevent tearing of the flexible body material, these openings can be surrounded by local reinforcing elements (e.g., collars, ribs, or thickened ridges) that serve to distribute suture stress without compromising the bubble architecture. These suture points are strategically positioned in peripheral areas, away from the central slit 865 and the optional anterior recess 870, to maintain critical flow paths and preserve distance to the cornea.As an alternative or supplement to sutures, other tissue-grasping elements such as microhooks or anchors can be integrated for atraumatic stabilization.

[0147] In some embodiments, the spacer device 800 is made of a medical-grade material suitable for use in the eye. For example, the spacer device 800 may comprise a material that allows it to transition with some elasticity from the compressed configuration to the expanded configuration. The spacer device 800 may be made of any suitable material, including but not limited to metals, polymers, elastomers, hydrogels, smart materials, or composites thereof. Suitable metals include, for example, shape memory alloys such as Nitinol (nickel-titanium alloy), copper-aluminum-nickel alloys, and iron-based shape memory alloys.Suitable polymers include polyamide, polyimide, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polylactic acid (PLA), polycaprolactone (PCL), polyurethanes, polyhydroxybutyrate (PHB), chitosan, polydioxanone (PDO), silk fibroin, acrylic polymers, and thermoplastic or thermosetting materials. Polyurethanes include, for example, thermoplastic polyurethane (TPU), medical-grade polyether urethane, and silicone-polyurethane copolymers. Acrylic polymers include, for example, hydrophobic acrylic, hydrophilic acrylic, and cross-linked copolymers of methacrylate and acrylate derivatives. Elastomeric materials, such as silicone-based elastomers, can also be used. Examples of silicone-based elastomers include polydimethylsiloxane (PDMS), cross-linked medical-grade silicone, and room-temperature vulcanizing (RTV) silicone.Hydrogels can be used, including but not limited to poly(2-hydroxyethyl methacrylate) (PHEMA), polyacrylamide-based hydrogels, polyvinyl alcohol (PVA) hydrogels, collagen hydrogel copolymers, and polyethylene glycol (PEG)-based hydrogels. Intelligent or stimulus-responsive polymers can also be used, including thermoreactive and shape-memory polymers. Examples of thermoreactive polymers include poly(N-isopropylacrylamide) (PNIPAM), poly(N-vinylcaprolactam) (PVCL), and polyethylene glycol-based block copolymers. Biodegradable polymers with shape-retention properties can also be used. Examples of such biodegradable polymers include poly(lactic acid-co-glycolic acid) (PLGA), polycaprolactone (PCL), polydioxanone (PDO), and poly(L-lactic acid) (PLLA).Other suitable materials may include magnesium alloys, Collamer (hydroxyethyl methacrylate with porcine collagen), PolyHEMA collagen copolymers, acrylic urethane hybrids, or any biocompatible composites or combinations thereof. Three-dimensional volume

[0148] In some embodiments, the spacer device described here defines an internal three-dimensional volume 370, which is of a suitable size for receiving and managing liquids. For example, for forming a bubble to manage intraocular pressure. For example, in the case of the spacer device 800, the three-dimensional volume 370 is defined within the walls of the surface 825.

[0149] In some embodiments, the spacer device described here can have a height Y at the vertex, a first diameter X, and a second diameter Z (as in Fig. 3 shown) exhibiting which are suitable to form the inner three-dimensional volume 370 with the desired dimensions.

[0150] In some embodiments, the height Y at the apex can be between about 0.5 mm and about 2.5 mm, including all ranges or values ​​in between. For example, the height Y at the apex can be about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, or about 2.5 mm. Preferably, the height Y at the tip can be between about 1.2 mm and about 1.6 mm, including all ranges or values ​​therein. Even more preferably, the height Y at the tip can be between about 1.3 mm and about 1.5 mm, including all ranges or values ​​therein.

[0151] In some embodiments, the spacer device described herein can have a structural thickness of approximately 0.4 mm to approximately 1.0 mm, including all ranges or values ​​therein. For example, the structural thickness can be approximately 0.4 mm, approximately 0.5 mm, approximately 0.6 mm, approximately 0.7 mm, approximately 0.8 mm, approximately 0.9 mm, or approximately 1.0 mm. Preferably, the structural thickness can be between approximately 0.6 mm and approximately 0.8 mm, including all ranges or values ​​therein.

[0152] In some embodiments, the first diameter X and the second diameter Z can be selected independently of each other from a size in the range of about 2.5 mm to about 4.0 mm, including all ranges or values ​​therein. For example, the first diameter X and the second diameter Z can be independently about 2.5 mm, about 3.0 mm, about 3.5 mm, or about 4.0 mm. Preferably, the first diameter X and the second diameter Z are of the same size. Even more preferably, the first diameter X and the second diameter Z are about 3.5 mm in size.

[0153] In some embodiments, the three-dimensional volume 370 can have a height at the apex of about 600 µm to about 900 µm, including all regions or values ​​therein. For example, a height of about 600 µm, about 700 µm, about 800 µm, or about 900 µm. Preferably, the height of the cavity is about 750 µm.

[0154] In some embodiments, the aforementioned dimensions may be more suitable for adult patients with an intraocular pressure (IOP) of approximately 8 mmHg. For example, the dimensions may differ for adult patients with a different IOP or for pediatric patients, in some cases where a device with a greater width and a smaller height may be desirable and even yield better results.

[0155] In some embodiments, the three-dimensional volume 370 is configured to receive a fluid. For example, the spacer device described here can be in fluid communication with the anterior chamber of the eye 20 via a channel created through a layer of ocular tissue, for example by canaloplasty (a procedure to open Schlemm's canal), by minimally invasive suction trabeculotomy (MIST) (a technique in which a special instrument is used to create a small opening in the trabecular meshwork, the eye's natural drainage pathway, to improve fluid outflow), or via an ocular implant 100, such as a shunt, located between the anterior chamber and the ocular tissue spacer.The channel, MIST orifice, or ocular implant 100 can form a drainage channel, and the spacer device described herein can thus function as a structure that defines and contains a three-dimensional volume configured to collect aqueous humor effluxing from the anterior chamber of the eye and drain it through the channel, MIST orifice, or ocular implant, thereby reducing intraocular pressure.

[0156] Fig. Figure 14 illustrates the non-restrictive case in which the spacer device described here is in fluid communication with the anterior chamber via the eye implant 100. Fastening features

[0157] In some embodiments, the spacer device described here further comprises one or more fastening features for attaching the spacer device to an eye surface.

[0158] For example, the one or more fastening devices may include fastening elements 310, 710, 910 for attaching or securing the spacer device to eye tissue. In another example, the one or more fastening devices may include openings 915 for fastening through a suture point, as in Fig. 8A shown.

[0159] In some embodiments, one or more fastening elements 310, 710 are arranged around the circumference of the support structure 320, 720. Each of the fastening elements 310, 710 extends away from the surface of the support structure 320, 720.

[0160] In some embodiments, one or more fastening elements 910 are arranged at one end of the support structure 920. The one or more fastening elements 910 extend in a direction that is substantially perpendicular to a plane formed by the support structure 920.

[0161] In some embodiments, the one or more fastening elements 310, 710, 910 are configured to be anchored to an ocular tissue structure. For example, when the spacer device described here is correctly positioned in the eye, the one or more fastening elements 310, 710, 910 engage with ocular tissue structures to prevent movement of the spacer device relative to the eye and thus enable its proper function.

[0162] In some embodiments, the spacer device described here can be configured to be positioned beneath the conjunctiva or Tenon's capsule of the eye. The one or more engagement elements then penetrate ocular tissue to prevent movement of the spacer device relative to the eye.

[0163] In some embodiments, one or more fastening elements (such as 310, 710 and 910) may be hooks or anchors configured to engage with ocular tissue structures, such as the sclera. Application device

[0164] The spacer device described here can be inserted into and positioned in the eye using any suitable medical delivery device with appropriate features. For example, the medical delivery device may include an application element configured to receive the spacer device. For example, the medical delivery device may include a penetrating tip on the application element configured to pierce a layer of ocular tissue to deliver the spacer device.

[0165] A non-restrictive embodiment of a medical application device is now described with reference to Fig. 4 and Fig. Described in sections 11A to 12C.

[0166] In some embodiments, the device 200 includes a gripping body 210. For example, the body extends along a longitudinal axis Ω.

[0167] While the in Fig. From the specific embodiment shown in Figure 11A, which is formed with a one-piece body, the reader will understand that in some variants the device 200 may be formed from more than one segment, for example from a proximal and a distal segment which can be connected to each other by a suitable coupling connection, such as the device described in US 2025 / 0312194, the entire contents of which are hereby incorporated by reference.

[0168] In some embodiments, the body 210 can be configured with a first and a second housing segment 240, 260. For example, the first and second housing segments 240, 260 can be configured to be connected to one another by a suitable connecting means. The coupling device can, for example, comprise a plurality of screws with which the first and second housing segments 240, 260 are screwed together, thereby forming the body 210. In other embodiments, the first housing segment 260 can comprise a plurality of peripherally spaced projections. Correspondingly, the second segment 260 can have a plurality of peripherally spaced notches that receive the corresponding projections to join the first and second housing segments 240, 260 together, thus forming the body 210.

[0169] In some embodiments, the body 210 may have at least one segment of its surface that is raised, recessed, grooved, or textured to improve grip or user comfort. The user may be a medical professional, such as an ophthalmologist, optometrist, eye surgeon, or similar.

[0170] In some embodiments, the body 210 can be autoclaved or sterilized by other means. For example, the body 210 can be made of any suitable material, such as, but not limited to, polyethylene (PE), including low-density PE, high-density PE or ultra-high molecular weight PE; polypropylene (PP), polytetrafluoroethylene, thermoplastic polyurethane, polycarbonate, polyphthalic acid, acrylic, acrylonitrile butadiene styrene (ABS), silicone and the like.

[0171] In some embodiments, the body 210 can be configured to have a shape that facilitates handling of the device 200. For example, during use, the user can grip the device 200 by bending one or more fingers (e.g., the middle finger) on a first side of the body 210 and by bending and counter-moving the thumb on a second side of the body 210, with the first side facing the second side.

[0172] In some embodiments, the body 210 may have suitable dimensions that facilitate the handling of the device 200. For example, the body 210 may have a length of approximately 50 mm to approximately 150 mm, including any values ​​or ranges therein. For example, a length of approximately 55 mm, approximately 60 mm, approximately 65 mm, approximately 70 mm, approximately 75 mm, approximately 80 mm, approximately 85 mm, approximately 90 mm, approximately 95 mm, approximately 100 mm, approximately 110 mm, approximately 120 mm, approximately 130 mm, approximately 140 mm, or approximately 150 mm. For example, a length of approximately 74 mm. For example, the body 210 may have a height of approximately 10 mm to approximately 30 mm, including any values ​​or ranges therein. For example, a height of approximately 10 mm, approximately 15 mm, approximately 20 mm, approximately 25 mm, approximately 30 mm. For example, a height of approximately 15 mm. For example, body 210 can have a depth of approximately 8 mm to approximately 20 mm, including all values ​​or areas within it.For example, a depth of approximately 8 mm, approximately 10 mm, approximately 12 mm, approximately 14 mm, approximately 16 mm, approximately 18 mm, or approximately 20 mm. For example, a depth of approximately 12.5 mm.

[0173] In some embodiments, the device 200 is a disposable device that can be discarded after use.

[0174] The device 200 described here comprises components that can be adapted for specific ophthalmic procedures. In some embodiments, the device 200 may include other components that can benefit from the features and advantages described here and that can be adapted for similar ophthalmic procedures. Delivery section

[0175] In some embodiments, the device 200 described here is equipped with an application element which may be particularly useful for piercing a layer of eye tissue.

[0176] In a non-restrictive practical implementation, the device 200 comprises an application element 400. The application element 400 may have a proximal section 450 connected to a distal end of the device body 210, and may have a distal section 455.

[0177] The application element 400 defines an internal cavity or lumen 420 extending from a distal end to a proximal end thereof.

[0178] In some embodiments, the application element 400 comprises a penetrating tip 70 at its distal end.

[0179] In some embodiments, the penetrating tip 70 has a tapered, contoured cross-section 75, as in Fig. Figure 11D shows a design that significantly reduces the cross-sectional area of ​​the distal end of the application element compared to conventional prior art designs. In contrast, prior art needle tips, such as those shown in Figure 11D, use a significantly reduced cross-sectional area of ​​the distal end of the application element compared to conventional prior art designs. Fig. Figure 11C shows a typically blunt or beveled cylindrical structure with an outer diameter (OD) of approximately 1.7 mm to facilitate implant insertion. This standard geometry necessitates the creation of a relatively large entry wound in the ocular tissue (e.g., conjunctiva), potentially increasing tissue trauma and compromising healing outcomes. In contrast, the penetrating tip 70 features a flat needle tip in which the cross-sectional geometry at the distal end is reduced by more than approximately 50% compared to the conventional prior art cylindrical design. This is achieved through a tapered, crescent-shaped or scoop-like structure 75 that gradually narrows the lumen and outer profile while still allowing implant delivery through the inner lumen.The result is a minimized insertion profile, reducing the size of the entry point into the ocular tissue required for implantation. This improves patient comfort and accelerates tissue regeneration. This design also facilitates smoother tissue displacement and reduces insertion force, offering significant advantages in surgical handling and clinical outcomes for implant delivery.

[0180] When used, the penetrating tip 70 can be positioned so that the open cavity faces the surface of the eye, as shown in Fig. 16B shown.

[0181] In some embodiments, the insertion element 400 can form an optional bend 420 proximal to the distal section 455. This bend can be between about 10 and about 45 degrees. In a preferred embodiment, the bend is about 15 degrees. The eye has a curvature, and the bend 420 can conform to this curvature, as shown in Fig. 16B shown.

[0182] As in the Fig. As shown, the bend 420 can be a smooth, pre-formed angular deviation of the application element 400 from its primary longitudinal axis. In certain embodiments, the bend 420 is located at a position proximal to the penetrating tip 70 by a distance sufficient to maintain the conical, contoured cross-section at the distal end while simultaneously realigning the shaft segment immediately proximal to it. The bend 420 can be configured with a defined bend angle within the range described above and a controlled bend radius to prevent kinking and lumen collapse, thereby maintaining the patency of the lumen 420 for the passage of the implant.The bend 420 is aligned such that, as the device 200 approaches the upper quadrant of the eye, the distal section 455 is aligned tangentially to the curvature of the ocular surface and directs the penetrating tip 70 with an optimized approach vector to the intended tissue plane (e.g. conjunctiva and underlying sclera).

[0183] The bend 420 can facilitate the insertion of the application element 400 into the eye by accommodating the anatomical limitations associated with topographic access, including the curvature of the eyeball, the presence of the upper eyelid and eyebrow, and the spatial relationship of the periocular structures. By offsetting the distal section 455 relative to the proximal section 450, the user (e.g., the surgeon) can maintain a comfortable hand position and instrument distance while achieving a trajectory that reduces the risk of inadvertent corneal contact, minimizes impact on the eyelid margin, and improves visibility of the entry point.The controlled angular alignment provided by the 420 bend reduces the insertion force and improves controllability during the initial piercing and advancement, contributing to safer tissue intervention and less trauma.

[0184] From a mechanical point of view, the bend 420 can be designed with a curvature sufficient to maintain the column strength and torsional responsiveness of the insertion element 400. In certain embodiments, the bend 420 is designed to distribute bending stresses over a finite bending radius, thereby reducing local stress concentrations and mitigating the risk of work hardening or cracking in metallic shafts or buckling in polymer shafts. The geometry of the bend 420 can be selected to maintain the coaxial orientation of the lumen 420 and minimize internal flow disturbances, thus enabling smooth passage of the implant. Suitable materials for the insertion element 400 can be (e.g.,(e.g., mandrel forming, heat fixing or thermoforming) so that the desired bending angle and radius are achieved without compromising the integrity of the lumen.

[0185] Compared to embodiments without the bend 420, the one in the Fig. 16A and Fig. The configuration shown in Figure 16B, with superior access, offers improved ergonomics, increased safety margins, and a more predictable instrument trajectory. Devices without the bend may require steeper access angles relative to the ocular surface, which increases insertion force, enlarges the entry wound, and raises the risk of slippage or off-axis puncture. In contrast, the curved configuration allows for a shallower approach, improved tactile feedback, and better alignment with the ocular surface curvature, thereby reducing tissue trauma, improving wound apposition, and potentially accelerating healing.

[0186] In certain embodiments, the bend 420 can be indexed relative to the body 210 so that the rotational alignment is controlled; for example, a wedge connection on the proximal section 450 can ensure that the angular offset is consistently aligned with the upper quadrant during use. The combination of the bend 420 with the conical, contoured cross-section of the penetrating tip 70 offers a technical advantage, as the reduced distal profile facilitates tissue entry, while the bend optimizes the approach angle and instrument distance, together enabling precise, tissue-sparing insertion of the device through the lumen 420.

[0187] In some embodiments, the insertion element 400 may be of a suitable size, which can be selected from one of the needle sizes listed in Table 1: Table 1 Nadelstärke Außendurchmesser(Zoll) Außendurchmesser (mm) Innendurchmesser(Zoll) Innendurchmesser (mm) 7 0,180 4,572 0,150 3,810 8 0,165 4,191 0,135 3,429 9 0,148 3,759 0,118 2,997 10 0,134 3,404 0,106 2, 692 11 0,120 3,048 0,094 2,388 12 0,109 2,769 0,085 2,159 13 0,095 2,413 0,071 1,803 14 0,083 2,108 0,063 1,600 15 0,072 1, 829 0,054 1,372 16 0,065 1,651 0, 047 1,194 17 0,058 1,473 0, 042 1,067 18 0,050 1,270 0,033 0,838 19 0,042 1, 067 0, 027 0, 686 20 0,03575 0,9081 0, 02375 0, 603 21 0,03225 0,8192 0,02025 0,514 22 0,02825 0,7176 0,01625 0,413 22s 0,02825 0,7176 0,006 0,152 23 0,02525 0, 6414 0,01325 0,337 24 0,02225 0,5652 0,01225 0,311 25 0,02025 0,5144 0,01025 0,260 26 0,01825 0,4636 0,01025 0,260 26s 0,01865 0,4737 0,005 0,127 27 0,01625 0,4128 0,00825 0,210 28 0,01425 0,3620 0,00725 0, 184 29 0,01325 0,3366 0,00725 0,184 30 0,01225 0,3112 0,00625 0,159 31 0,01025 0,2604 0,00525 0,133

[0188] In some embodiments, the penetrating tip 70 may have any diameter suitable for piercing the eye in order to cause an incision of a suitable size sufficient to pass through the spacer device described herein.

[0189] In some embodiments, the application element 400 may have at least a portion of a surface which may be transparent, thereby enabling preoperative visualization of the spacer device contained in the lumen 420.

[0190] In some embodiments, the application element 400 accommodates the spacer device within its lumen.

[0191] In some embodiments, the lumen portion of the proximal section 450 accommodates the spacer device. For example, the lumen portion of the proximal section 450 can accommodate the spacer device in the expanded configuration, as shown in Fig. 12A shown.

[0192] In some embodiments, the application element 400 may have a generally rectangular or oval cross-section (e.g., elongated with curved shorter sides) at the proximal section 450 and a generally tapered cross-section at the distal section 455, as shown in Fig. 11B shown. In such embodiments, the spacer device transitions from the expanded configuration to the compressed configuration as it moves from the proximal section 450 through the distal, tapered section 455, as shown in Fig. 12B shown.

[0193] In some embodiments, the overall geometry of the application element 400 is streamlined to promote controlled tissue penetration. For example, in the embodiment where there is a transition from the wider proximal body to the narrower distal tip, a flat, aerodynamic configuration is created. The body surface can have smooth contours and a continuous curvature, thereby minimizing sharp corners and promoting atraumatic interaction with the surrounding tissue.

[0194] In some embodiments, the lumen 420 of the application element 400 corresponds to the outer shape and is configured to securely hold the spacer device in its delivery state. The application element 400 may include one or more internal structural features, such as guide rails, ridges, or retaining elements, to position the implant within the lumen and prevent premature deployment.

[0195] The application element 400 can comprise biocompatible plastic, polymer or metal, such as stainless steel or a shape memory alloy, and can be manufactured using machining, laser cutting or electropolishing techniques to achieve the precision and sharpness required for ophthalmic procedures.

[0196] When used, the application element 400 can perform a dual function: piercing a layer of ocular tissue, such as the sclera or conjunctiva, and receiving and delivering the spacer device described herein. Once the target location within the eye has been reached, the medical application device can be activated to reversibly convert the spacer device from its compressed to its expanded configuration and vice versa.

[0197] A specific feed for the spacer device is described with reference to Fig. Described in sections 12A to 12C.

[0198] The application element 400 can accommodate the spacer device described here in an expanded configuration within the lumen 420, as shown in Fig. Figure 12A shows that when the feed mechanism, including the feed rod 550, is actuated, the spacer device 800 is displaced by the tapered section of the application element with a coaxial forward movement of the feed mechanism, which in Fig. Figure 12B is shown with arrow 120. At this point, the spacer device is pressed against the inner walls of the tapered section of the application element 400, thereby compressing or folding the spacer device 800 into the compressed configuration along its longitudinal axis. With continued actuation of the feed mechanism, the spacer device moves coaxially through the lumen 430 out of the distal tip 70, thereby expanding the spacer device back into the expanded configuration, as shown in Figure 12B. Fig. 12C shown.

[0199] In some embodiments, this reversible transition to the expanded configuration occurs passively due to the material from which the spacer device is made, as explained elsewhere in this text. Actuator assembly

[0200] In a non-restrictive practical implementation, the device 200 further comprises an actuating device configured to effect an axial displacement movement of the spacer device. For example, the actuating device may comprise any suitable component or combination of components capable of providing the functionality described herein. While the following text describes certain embodiments of an actuating device with reference to the figures, the reader will nevertheless understand that variations may be used to achieve a similar result.

[0201] Fig. Figure 11A shows a non-restrictive practical implementation of the actuating assembly, which includes a suitable component or combination of components that can provide the functionality described herein. For example, the actuating assembly includes a control point that can be actuated by the user to effect an axial displacement movement of the spacer device.

[0202] In some embodiments, the control point can be a manually operated, CO2-actuated, or screw-driven actuator. In some embodiments, the control point can have the form of a manually operated actuator 90. For example, the actuator 90 can advantageously be arranged on a proximal section of the body 210 to facilitate access with a finger, preferably the index finger.

[0203] In some embodiments, the actuator 90 can be a slider, a trigger, a wheel or any other shape that can be easily operated, preferably with only one finger, for example the index finger.

[0204] In some embodiments, the actuator 90 may have teeth or another shape capable of generating friction, for example along an edge thereof, to improve the user's ability to safely touch, actuate (e.g., press), and release the actuator 90, even in wet conditions or when wearing gloves. To further enhance safety when using the device 200, the actuator 90 may also include a locking mechanism or a device to prevent unintentional activation or release of the actuator.

[0205] In some embodiments, the control point can actuate and control a dispensing mechanism to drive the spacer device through the lumen of the dispensing element and eject the spacer device from the distal tip. In some embodiments, the feed mechanism can comprise a feed rod 550, at least a portion of which extends within the lumen 430. The feed rod 550 is functionally coupled to the control point (e.g., the actuator 90) and serves to push the spacer device described herein through the lumen 420 and out of the distal tip 70. The feed rod 550 can be functionally coupled to the control point (e.g., the actuator 90) via one or more internal elements connected to the application device (not shown), such as those described in PCT / CA2023 / 051644, which is hereby incorporated in its entirety by reference.

[0206] For example, the feed rod 550 can simply push out the spacer device when the application element 400 reaches the desired implantation site in the eye 20. Alternatively, the feed rod 550 can engage with the spacer device in a detachable manner, so that when the spacer device reaches the desired position, the user releases the spacer device by actuating a suitable actuator.

[0207] As in Fig. As shown in Figure 13A, the distal end of the rod 550 can have an engagement element 560 designed to engage with the spacer device. As previously explained, the spacer device 800 can comprise one or more engagement elements 810, 830 configured to interact with at least the engagement element 560 in a manner that allows a connection with the spacer device to stabilize the spacer device during insertion into an anatomical target site of a patient's eye. For example, the engagement element 560 can comprise a flexible arm, a spring-loaded clamp, or a shaped projection with a geometry tailored to the interface with the body of the spacer device. The Fig. The orientation shown in Figure 13A illustrates the approach of the rod 550 to the spacer device 800 (variant g) in preparation for the engagement.

[0208] In Fig. Figure 13B shows the retaining element 560 fully engaged with the spacer device 800. The coupling is designed to withstand the forces occurring during insertion and navigation through the tissue while simultaneously ensuring precise alignment of the spacer device with respect to the distal end of the rod 550. Engagement can be achieved by mechanical interference, frictional fit, or elastic deformation of one or more components. In some embodiments, the interface can also provide tactile or acoustic feedback to confirm the correct seating of the components.

[0209] Fig. Figure 13C shows an elevated view of the system from below, illustrating in more detail the internal configuration of the spacer device 800 and the spatial relationship between the engagement structures. The spacer device comprises engagement elements 810 and 830, which are positioned on an inner surface 825 facing an outer surface 845, as shown in Fig. Shown 10A to 10D.

[0210] In some embodiments, the engagement elements 810 and 830 are configured to receive and engage at least portions of the engagement element 560 of the rod 550. These engagement elements 810 and 830 may have ribs, detent lugs, or surface structures that improve engagement through increased surface contact or mechanical locking. In this configuration, the engagement element 560 can be inserted into the central slot of the spacer device 800, so that it is flanked by the engagement elements 810 and 830. The geometry of the slots and the engagement element 560 is designed to create a releasable push-fit or snap-fit ​​closure, enabling reliable and repeatable fastening.

[0211] As shown, the spacer device 800 includes at least one central slot 865 positioned between the engagement elements 810 and 830. This slot 865 can form a primary channel or fluid outflow pathway through the body of the spacer device 800. When in use, aqueous humor draining from the anterior chamber via an ostomy or implant (e.g., a glaucoma shunt) can pass through this central slot 865 into the surrounding subconjunctival or episcleral space, thereby promoting bubble formation and fluid distribution away from the limbus.

[0212] In alternative configurations, the body of the Spacer Device 800 can have raised lateral sidewalls along its curved anterior-posterior profile. These raised edges form lateral fluid drainage channels, allowing aqueous humor to drain not only through the central slot but also through the sides of the Spacer Device 800. These lateral channels help direct fluid flow posteriorly and laterally, promoting more even distribution and expansion of the subconjunctival blister while reducing anterior pressure and mechanical stress near the corneal limbus.

[0213] The design can also allow for controlled release of the spacer device upon application of an axial force, rotation, or actuation of a release mechanism (not shown). The ability to retain and then selectively release the spacer device is advantageous in clinical situations where repositioning or removal may be necessary.

[0214] Fig. Figure 13D shows a side view of the assembled components and further illustrates how the feed rod 550 and the engagement element 560 interact with the spacer device 800. In this view, the curvature of the spacer device 800 and the engagement element 560 is clearly visible, indicating a conformal interface that can follow the natural contours of the eye's anatomy. This ergonomic curvature can improve maneuverability and allow the device to rest against anatomical landmarks to aid precise positioning. The engagement element 560 is shown in a recessed section of the spacer body, which can serve both to guide the feed rod 550 during insertion and to protect the interface from lateral forces.

[0215] In alternative embodiments, the engagement element 560 can have features such as detents, elastic arms, or magnetic components to facilitate engagement. Likewise, the spacer device can have engagement receptacles or guide rails shaped to receive and align the rod and its retaining element with minimal play.

[0216] Depending on the desired flexibility, reusability or disposable nature of the device, biocompatible plastics, shape memory alloys or elastomeric polymers can be used as materials. Practical implementation

[0217] This document describes a spacer device configured for implantation in an eye, for example, a human or animal eye. The spacer device may have a predetermined size, volume, diameter, length, cross-sectional shape, and / or geometry tailored for subconjunctival, subtenonic, or suprachoroidal implantation to provide spacing, support, or modulation of tissue or fluid dynamics.

[0218] The spacer device can be inserted into and positioned in the eye using a special application device. In one embodiment, the application device comprises an elongated application element or cannula that defines an internal lumen configured to receive the spacer device. The distal end of the application element may include a sharpened or beveled cutting or penetrating tip designed to penetrate the ocular surface or a selected tissue layer. The application element may further include a longitudinally movable delivery rod or piston configured to expel the spacer device from the distal end.

[0219] Advantageously, the implantation procedure can be performed minimally invasively under local anesthesia, eliminating the need for general anesthesia or an operating room. In particular, the procedure can utilize an ab externo approach (i.e., penetrating the eye from the outside), minimizing trauma and reducing the complexity of the procedure. The small profile of the insertion element and the self-expanding properties of the spacer further contribute to the efficiency and safety of the procedure.

[0220] A practical, non-restrictive implementation of such a procedure is now being developed with reference to the [document / section / etc.] in [reference / reference]. Fig. 17 methods are described in 1100.

[0221] In step 1110, the procedure involves positioning the distal end of the delivery element at a first target point on the ocular surface, for example, the superior temporal quadrant of the conjunctiva. Positioning can be performed visually or optionally aided by imaging or anatomical landmarks.

[0222] In step 1120, the procedure further includes advancing the application element along its longitudinal axis until the distal tip contacts the target tissue surface, e.g., the conjunctiva or Tenon's capsule. Further advancing of the application element causes the distal tip to incise into the tissue (step 1120). The application element is inserted to a predetermined depth, positioning the distal tip at or near the desired implantation site. The implantation site may be, for example, subconjunctival, subtenonal, or suprachoroidal. The spacer device remains within the lumen of the application element during this insertion.

[0223] In step 1130, the procedure involves inserting the spacer device at the implantation site by actuating a control point. The control point can be, for example, a manually operated, CO2-actuated, or screw-driven actuator. The control point can actuate and control a feeding mechanism to drive the spacer device through the lumen of the application element and eject the spacer device from the distal tip.

[0224] In a specific embodiment, the spacer device can reversibly transition from an expanded configuration to a compressed configuration during its movement through the lumen. For example, the spacer device can be stored in the expanded configuration within a lumen of the application element and then transition to the compressed configuration when the feeding mechanism drives the spacer device into a distal, tapered section of the application element—with the inner walls of the application element causing the spacer device to fold, for example, along its longitudinal axis.

[0225] During movement through the lumen of the application element, the spacer device is generally in a compressed configuration. Once the spacer device exits the distal tip of the application element, it expands into its expanded configuration. In some embodiments, this expansion can be driven by elastic memory, hydration, or other material properties. Depending on the design, the spacer device can then function as a mechanical spacer, support element, or drug-release structure.

[0226] The spacer device can be used in conjunction with a channel in the eye that allows fluid to drain from the inner chamber of the eye to lower intraocular pressure. In one embodiment, the spacer device is implanted adjacent to or within fluid communication via a surgical ostomy, for example, during glaucoma filtration surgery. The channel can be created, for example, using a channel-generating device such as those described in U.S. patent applications numbered 19 / 087,331 and / or 19 / 048,877, which are hereby incorporated in their entirety by reference.

[0227] For example, the spacer device can be used in conjunction with an implanted glaucoma shunt in the eye, which allows fluid to drain from the inner chamber to lower intraocular pressure. The glaucoma shunt can be, for example, any suitable shunt such as those described in U.S. patent application number 19 / 072,936 and / or PCT patent application number PCT / CA2023 / 051644, which are hereby incorporated in their entirety by reference. The spacer device is implanted adjacent to or in fluid-filled connection with a distal opening of the glaucoma shunt to collect fluid flowing from the shunt into its cavity, for example, during the implantation of a subconjunctival glaucoma implant.Alternatively, the spacer device can be positioned so that at least part of its body is located above the distal opening of the glaucoma shunt in order to collect fluid flowing from the shunt into its cavity.

[0228] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as they are generally understood by a person skilled in the field of the present invention. Unless otherwise specified or required by the context, the following terms have the definitions given below.

[0229] Further examples of embodiments will become clear to the reader in light of the lessons taught in this description and are therefore not described further here.

[0230] All references cited throughout this description are hereby incorporated by reference in their entirety for all purposes.

[0231] It should be noted that, for the convenience of the reader, titles or subtitles may be used in this disclosure, but these are not intended to limit the scope of the invention in any way. Furthermore, certain theories may be proposed and disclosed here; however, these, whether correct or incorrect, should in no way limit the scope of the invention, as long as the invention is practiced in accordance with this disclosure without regard to any particular theory or scheme of action.

[0232] As used here, the term “independently selected” in relation to a group of specific elements refers to the fact that, if more than one element is selected from the group of elements, the decision to select a particular element is not influenced by the decision to select any of the preceding or following elements.

[0233] References throughout the description to "some embodiments," etc., mean that a particular element (e.g., feature, structure, and / or property) described in connection with the invention is included in at least one embodiment described herein and may or may not be present in other embodiments. Furthermore, it should be understood that the described inventive features can be combined in any suitable way in the various embodiments.

[0234] Those skilled in the art will understand that, in this description, the term "a" used before a term encompasses embodiments that include one or more of the terms to which the term refers. They will also understand that the term "comprising," used in this description synonymously with "including," "containing," or "characterized by," is inclusive or open and does not exclude additional, unspecified elements or process steps.

[0235] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as generally understood by a person skilled in the art in the field to which this invention relates. In case of discrepancies, this document, including its definitions, shall prevail.

[0236] As used in the present disclosure, where the terms "by", "about", or "approximately" precede a quantitative value, they also include the specific quantitative value itself, unless expressly stated otherwise. As used herein, the terms "by", "about", or "approximately" refer to a deviation of ±10% from the nominal value, unless otherwise stated or derived.

[0237] Unless otherwise specified, the expression "at least" or "at least one of" in this document includes each of the objects listed after the expression and the various combinations of two or more of the listed objects, unless the context and usage indicate otherwise. The expression "and / or" in conjunction with three or more listed objects should be understood to have the same meaning, unless the context indicates otherwise.

[0238] The use of the terms “comprise”, “includes”, “include”, “have”, “has”, “with”, “contain”, “contains” or “containing”, including their grammatical equivalents, should generally be understood as open and non-restrictive, i.e., additional, unlisted elements or steps are not excluded unless expressly stated otherwise or it is clear from the context.

[0239] Unless otherwise specified, the order of the steps or the order in which certain measures are carried out is irrelevant as long as the present invention remains functional. Furthermore, two or more steps or measures can be carried out simultaneously.

[0240] Unless otherwise stated, the use of all examples or illustrative phrases in this description, such as "like" or "including," serves only to better illustrate the present invention and does not constitute a limitation of the scope of the invention. No phrase in the description should be interpreted as indicating that an unclaimed element is essential for carrying out the present invention.

[0241] Although the various embodiments and descriptions may specify certain anatomical locations, species, or surgical procedures, it should be noted that these embodiments are also applicable to other locations, species, and surgical procedures.

[0242] Although various embodiments of the disclosure have been described and illustrated, it will be obvious to the person skilled in the art, considering the present description, that numerous modifications and variations are possible. The scope of the invention is defined more precisely in the appended claims. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] US 2025 / 0312194

[0167] PCT / CA2023051644 [0205, 0227] US 19 / 072,936

[0227]

Claims

[1] Spacer device 800 for implantation into an eye, comprising a flexible body configured to conform to an anatomical tissue surface of the eye, the body comprising an inner surface 825 and an outer surface 845, wherein the spacer device is configured to reversibly transition between a compressed configuration suitable for feeding through an application element 400 and an expanded configuration defining a convex, internal three-dimensional volume 370 for receiving fluid from an anterior chamber of the eye, wherein the spacer device comprises engagement elements 810, 830, each positioned along and extending along a longitudinal axis of the inner surface 825, and wherein the engagement elements are configured to: (i) engage with an application element 400 to stabilize the spacer device during implantation into the eye, and (ii) engage with the tissue surface after insertion, and wherein a central slot 865 arranged between the engagement elements 810, 830 forms a primary drainage path for the fluid circulation. [2] Spacer device according to claim 1, wherein the flexible body comprises a shape-memory, biocompatible material. [3] Spacer device according to claim 1 or 2, wherein the flexible body is configured to be compressed or folded along its longitudinal axis to facilitate insertion by the application element 400. [4] Spacer device according to one of claims 1 to 3, wherein the central slot 865 is configured to engage with a corresponding feed rod 550 of the application element 400. [5] Spacer device according to any one of claims 1 to 4, wherein the body has a wave-shaped circumference to facilitate the flow of fluid along lateral or posterior directions. [6] Spacer device according to any one of claims 1 to 5, wherein a forward-facing section of the body has a recess 870 configured to avoid contact with the cornea and to promote the formation of an anterior blister. [7] Spacer device according to any one of claims 1 to 6, wherein a rear section of the body has one or more cutouts or raised side walls 820 configured to allow fluid migration and rear bubble expansion. [8] Spacer device according to any one of claims 1 to 7, wherein the inner three-dimensional volume 370 defined by the expanded configuration has a height of about 600 µm to about 900 µm at its apex. [9] Spacer device according to any one of claims 1 to 8, wherein the device has a thickness of about 0.4 mm to about 1.0 mm. [10] Spacer device according to any one of claims 1 to 9, wherein the device has a first diameter and a second diameter, each independently of the other being in the range of about 2.5 mm to about 4.0 mm. [11] Spacer device according to any one of claims 1 to 10, wherein the engagement elements 810, 830 are integrally formed with the body and extend perpendicularly from an inner surface 825 of the device. [12] Spacer device according to any one of claims 1 to 10, wherein the one or more engagement elements 810, 830 are configured to anchor the device to ocular tissue structures, including the sclera or Tenon's capsule. [13] Spacer device according to any one of claims 1 to 12, wherein the spacer device is configured for implantation in the subconjunctival, subtenonal or suprachoroidal space. [14] Spacer device according to any one of claims 1 to 13, wherein the body is oriented in situ with a curved surface towards the limbus and one or more legs 880 extend posteriorly to direct the aqueous humor flow. [15] Spacer device according to any one of claims 1 to 14, wherein the compressed configuration allows passage through the application element 400, wherein the application element 400 has a lumen 420 with an inner diameter of less than 1 mm. [16] Spacer device according to any one of claims 1 to 15, wherein the body comprises one or more discrete openings 895 for attaching sutures to the underlying surface of the eye, wherein the openings 895 are positioned in peripheral areas, away from the central slot 865. [17] Spacer device according to any one of claims 1 to 16, wherein the openings 895 are surrounded by local reinforcement elements designed to distribute the seam loads. [18] Application device 200, comprising a) a body 210 with a proximal and a distal end, b) a spacer device 800 for implantation into an eye, comprising a flexible body configured to adapt to anatomical tissue surfaces of the eye, and c) an application element 400 with a proximal section 450 and a distal section 455, wherein the proximal section 450 is connected to the distal end of the body 210, wherein the distal section 455 has a distal penetrating tip 70, wherein the application element 400 defines an inner lumen 420 extending from the distal section 455 to the proximal section 450, and wherein the application element 400 contains the spacer device 800 within the lumen 420, wherein the spacer device 800 is configured to reversibly transition between a compressed configuration suitable for feeding through the application element 400 and an expanded configuration defining a convex, internal three-dimensional volume 370 for receiving fluid from an anterior chamber of the eye, wherein the application device 200 is configured to cause an axial displacement movement of the spacer device 800 through the application element 400 in the compressed configuration, and wherein the application device 200 is configured to push the spacer device 800 out of the distal tip 70, thereby transitioning the spacer device 800 into the expanded configuration. [19] Application device according to claim 18, wherein the penetrating tip 70 has a tapered, crescent-shaped or scoop-like structure 75 which gradually narrows its outer profile. [20] Application device according to claim 18 or 19, wherein the application element 400 has a substantially rectangular or oval cross-section at the proximal section 450 and a tapered cross-section at the distal section 455. [21] Application device according to claims 18 to 20, which further comprises a control point which can be actuated by the user to effect an axial displacement movement of the spacer device 800. [22] Application device according to claim 21, wherein the control point has the form of a manually operated actuator 90, preferably a slider, a trigger or a wheel. [23] Application device according to claim 21 or 22, wherein the control point actuates and controls an application mechanism to drive the spacer device 800 through the lumen 420 of the application element 400 and to eject the spacer device 800 from the distal tip 70. [24] Application device according to claim 23, wherein the application mechanism comprises a feed rod 550 which is functionally coupled to the control point and serves to push the spacer device 800 through the lumen 420 and out of the distal tip 70. [25] Application device according to one of claims 18 to 24, wherein the application element 400 forms a bend 420 of about 10 to about 45 degrees proximal to the distal section 455.

Images