Medical device for deployment within an eye for management of intraocular fluids
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.
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 . The spacer device of claim 1 , wherein the flexible body comprises a shape-memory biocompatible material.
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 . 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 . The spacer device of claim 1 , wherein the body has an undulating perimeter to facilitate fluid flow along lateral or posterior directions.
6 . 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.
7 . 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.
8 . 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.
9 . The spacer device of claim 1 , wherein the device has a thickness of from about 0.4 mm to about 1.0 mm.
10 . 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.
11 . 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.
12 . 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.
13 . The spacer device of claim 1 , wherein the spacer device is configured for subconjunctival, sub-Tenon's or suprachoroidal space implantation.
14 . 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.
15 . 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.