US-20260124072-A1 - MEDICAL DEVICE FOR DEPLOYMENT WITHIN AN EYE FOR MANAGEMENT OF INTRAOCULAR FLUIDS

Abstract

The disclosure relates to ophthalmic implants, specifically a flexible, self-expanding spacer device deployable in subconjunctival, sub-Tenon's, or suprachoroidal spaces to manage intraocular fluids. The device addresses limitations of fixed-resistance drainage and fibrosis-related failure in glaucoma surgery by maintaining a controlled three-dimensional reservoir (bleb space) for aqueous humor outflow while minimizing tissue trauma. In one aspect, a shape-memory body transitions from a compressed, delivery-compatible state to an expanded configuration defining a convex internal volume, optionally with collapse-resistant reinforcements and tissue-engaging elements for atraumatic stabilization. Preferred embodiments include anterior relief geometry to avoid corneal contact and posterior flow-directing features to promote posterior bleb formation and uniform pressure control. A delivery member with a reduced-profile, tapered piercing tip and optional bent shaft enables minimally invasive ab externo implantation and controlled, coaxial deployment. Advantages include streamlined single-step delivery, stable long-term bleb architecture, reduced hypotony and fibrotic encapsulation, and compatibility with trabeculectomy and shunt-based outflow.

Inventors

• Nir Shoham-Hazon
• Houfar Sekhavat
• Kenneth Dale Johannaber

Assignees

• HEXIRIS INC.

Dates

Publication Date

20260507

Application Date

20251118

Priority Date

20241119

Claims (17)

1. 1 . A spacer device for implantation in an eye, comprising a flexible body configured to conform to an anatomical tissue surfaces of the eye, wherein the body includes an internal surface and an external surface, wherein the spacer device is configured to reversibly transition between a compressed configuration suitable for delivery through a delivery member and an expanded configuration defining a convex, internal three-dimensional volume for receiving fluid from an anterior chamber of the eye, wherein the spacer device includes at least a pair of engaging elements centrally positioned on the internal surface and extending along a longitudinal axis of the spacer device, the engaging elements projecting perpendicularly from the internal surface and defining a central slot therebetween, and wherein the engaging elements are configured to (i) interface with the delivery member to stabilize the spacer device during implantation in the eye, (ii) engage with the tissue surface, and (iii) define, together with the central slot, an outflow path along the eye tissue surface engaged by the engaging elements to allow fluid to circulate therethrough.
2. 2 . The spacer device of claim 1 , wherein the flexible body comprises a shape-memory biocompatible material.
3. 3 . The spacer device of claim 1 , wherein the flexible body is configured to be compressed or folded along its longitudinal axis to facilitate insertion through the delivery member.
4. 4 . The spacer device of claim 1 , wherein the engaging elements are further configured to engage with a corresponding delivery rod within the delivery member through at least a portion of the central slot.
5. 5 . (canceled)
6. 6 . The spacer device of claim 1 , wherein the body has an undulating perimeter to facilitate fluid flow along lateral or posterior directions.
7. 7 . The spacer device of claim 1 , wherein an anterior-facing portion of the body includes a relief cut-out configured to avoid contact with the cornea and to support anterior bleb formation.
8. 8 . The spacer device of claim 1 , wherein a posterior portion of the body includes one or more cut-outs or elevated sidewalls configured to enable fluid migration and posterior bleb expansion.
9. 9 . The spacer device of claim 1 , wherein the internal three-dimensional volume defined by the expanded configuration has a height at its apex of from about 600 μm to about 900 μm.
10. 10 . The spacer device of claim 1 , wherein the device has a thickness of from about 0.4 mm to about 1.0 mm.
11. 11 . The spacer device of claim 1 , wherein the device has a first diameter and a second diameter each independently ranging from about 2.5 mm to about 4.0 mm.
12. 12 . The spacer device of claim 1 , wherein the engaging elements are integrally molded with the body and contribute to maintaining orientation of the spacer device during deployment.
13. 13 . The spacer device of claim 1 , wherein the engaging elements are configured to anchor the device to the eye tissue surface, and wherein the eye tissue surface is the sclera or Tenon's capsule.
14. 14 . The spacer device of claim 1 , wherein the spacer device is configured for subconjunctival, sub-Tenon's or suprachoroidal space implantation.
15. 15 . The spacer device of claim 1 , wherein the body is oriented in situ with a curved surface facing the limbus and one or more legs extending posteriorly to direct aqueous humor flow.
16. 16 . The spacer device of claim 1 , wherein the compressed configuration allows passage through the delivery member wherein the delivery member has a lumen having an internal diameter of less than 1 mm.
17. 17 - 19 . (canceled)

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a continuation patent application based on International patent application number PCT/CA2025/051476 filed on Nov. 6, 2025, which claims the benefit of U.S. provisional patent application Ser. No. 63/716,920 filed on Nov. 6, 2024, British patent application serial number 2416974.0 filed on Nov. 19, 2024, and U.S. provisional patent application Ser. No. 63/828,578 filed on Jun. 23, 2025. The contents of each of the above-referenced documents are incorporated herein by reference in their entirety. TECHNICAL FIELD This application generally relates to the field of a spacer device for ophthalmic procedures and, more specifically, to a spacer device for deployment within an eye to create a three-dimensional volume for the management of intraocular fluids. COPYRIGHT A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. BACKGROUND Glaucoma comprises a group of eye disorders characterized by progressive damage to the optic nerve. Elevated intraocular pressure (IOP) is a primary risk factor, and if unmanaged, glaucoma can lead to irreversible vision loss and blindness. Treatments to lower IOP include topical medications, laser procedures, and incisional surgeries; however, a subset of patients does not achieve adequate control with these approaches and may require more advanced surgical interventions. Glaucoma drainage devices (tube shunts) are used when medical therapy and/or laser procedures are insufficient. Typically fabricated from biocompatible materials such as silicone or polypropylene, these devices provide an alternate outflow pathway for aqueous humor to lower IOP and mitigate further optic nerve damage. Tube shunts are particularly important in refractory glaucoma. Commonly used devices include, for example, the Ahmed Glaucoma Valve, the Baerveldt Glaucoma Implant, and the Molteno Implant. While differing in size, configuration, and materials, these devices share the objective of facilitating aqueous humor drainage to reduce IOP. By way of example, some devices employ a silicone tube coupled to a plate positioned beneath the conjunctiva or on the scleral surface, with the tube inserted into the anterior chamber. A significant postoperative challenge is peri-implant scarring (fibrosis), which can impede aqueous outflow and diminish long-term shunt performance. To reduce fibrotic response, anti-fibrotic agents such as mitomycin-C (MMC) and 5-fluorouracil (5-FU) are sometimes used intraoperatively or perioperatively to help maintain device patency. Despite their utility, anti-fibrotic agents have been associated with potential adverse effects, including corneal toxicity and collateral damage to ocular tissues, leading to ongoing scrutiny of their risk-benefit profiles in glaucoma surgery. Known tube shunt designs typically provide drainage governed by IOP and a fixed hydrodynamic resistance. Fixed-resistance outflow can be suboptimal across postoperative phases. Shortly after implantation, insufficient resistance may precipitate hypotony (e.g., IOP<6 mmHg), which is associated with complications such as hypotony maculopathy and choroidal detachment. Conversely, over time, progressive fibrosis around the device and distal outflow pathways can increase effective resistance, elevating IOP to non-physiologic levels and compromising long-term pressure control. These limitations highlight a need for improved approaches to regulate aqueous outflow and mitigate both early hypotony and late fibrotic failure. In view of the above, there remains a need for alternate devices and procedures for ocular surgeries for treatment of ophthalmic conditions, such as glaucoma. SUMMARY This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key aspects or essential aspects of the claimed subject matter. As embodied and broadly described herein, the present disclosure relates to a spacer device for implantation in an eye, comprising a flexible body configured to conform to anatomical tissue surfaces of the eye, wherein the spacer device is configured to reversibly transition between a compressed configuration suitable for delivery through a delivery member 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 includes one or more engaging elements configured to interface with the delivery member to stabilize the spacer device during implantation in the eye. As embodied and broadly described herein, the present disclosu