Expandable Ocular Device for Glaucoma Drainage
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Solution Overview
Problem
Current treatments for glaucoma, including drug therapies and surgical implants, are inadequate in effectively reducing intraocular pressure and often come with adverse side effects and poor patient compliance, lacking long-lasting and complication-free solutions.
Innovation Solution
An expandable ocular device with a proximal end, distal end, and internal lumen is inserted ab interno to affect aqueous humor outflow, featuring an expandable portion with interconnected struts that can change cross-sectional shape for insertion and expansion within the eye, facilitating drainage through structures like Schlemm's canal to reduce intraocular pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a drainage device is implanted using traditional surgical procedure with scleral flap, then aqueous humor drainage is achieved, but the procedure becomes traumatic with large implant size causing infections, scarring, and need for re-operation
Solution Approach 1:
The ocular device is nested within a delivery catheter system that guides it through a small corneal incision. The device is delivered in a compressed state within the catheter and then expanded in situ, eliminating the need for large scleral flaps and reducing surgical trauma while maintaining drainage effectiveness
Solution Approach 2:
The ocular device transitions from a compressed delivery state to an expanded functional state after implantation. This dynamic transformation allows the device to be delivered through a small incision and then expand to its full drainage-capable size, reducing both surgical trauma and implant visibility
2Reliability
If drug treatment is used to lower intraocular pressure, then pressure control is attempted, but patient compliance is poor leading to treatment failure and symptom progression
Solution Approach 1:
The ocular device provides self-service by mechanically facilitating aqueous humor drainage without requiring patient action or compliance. The device's expandable structure passively maintains drainage pathways, eliminating the need for daily medication administration and ensuring consistent pressure control regardless of patient behavior
3Reliability
If existing surgical treatments are used, then intraocular pressure reduction is achieved, but the treatments are not long-lasting and require repeated interventions
Solution Approach 1:
The expandable ocular device provides excessive drainage capability by creating multiple controlled openings in Schlemm's canal and surrounding tissues. This over-engineered approach ensures long-lasting pressure reduction by establishing redundant drainage pathways that maintain effectiveness over time without requiring re-intervention
4Reliability
If an expandable device is used to improve drainage, then aqueous humor outflow is enhanced, but device complexity increases with expandable struts and delivery mechanism
Solution Approach 1:
The complex expandable device with interconnected struts is nested within a delivery catheter that simplifies its delivery. The catheter system manages the complexity by providing a guided delivery path and controlled expansion mechanism, allowing the complex device structure to be delivered through a simple percutaneous approach without increasing procedural complexity
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device effectively reduces elevated intraocular pressure by expanding and maintaining tissue structures to improve aqueous humor outflow, potentially offering a less invasive and more durable solution compared to existing treatments.
Implementation Method 1
an expandable portion having a plurality of interconnected struts forming multiple openings in the device communicating with the flow pathway. The expandable portion has a first cross-sectional shape suitable for insertion into the eye that is generally cylindrical and a second cross-sectional shape that is larger than the first cross-sectional shape
Data Source
AI summary
Disclosed herein are systems, devices and methods for treating an ocular disorder in an eye. The ocular device includes a proximal end, a distal end, and an internal lumen forming a flow pathway extending from the proximal end to the distal end; at least one inflow region that communicates with the flow pathway; and an expandable portion having a plurality of interconnected struts forming multiple openings in the device communicating with the flow pathway. The expandable portion has a first cross-sectional shape suitable for insertion into the eye that is generally cylindrical and a second cross-sectional shape that is larger than the first cross-sectional shape. The system also includes a delivery device for inserting the ocular device into an eye including a sheath configured to surround at least a portion of the ocular device; an applier configured to insert into the internal lumen of the ocular device; and an actuator.