Trabecular Meshwork Disruptor for Atraumatic Aqueous Drainage
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Solution Overview
Problem
Current trabecular excision devices suffer from imprecise, discontinuous cuts of the trabecular meshwork, leading to significant bleeding and collateral damage of sclera, endothelium, and iris tissue, and often fail to effectively remove material due to their sharp cutting nature.
Innovation Solution
A device with a flexible, elongate shaft made of super-elastic memory-shape material, featuring a distal end with a blunt tissue disruptor and a smooth ball tip, is used to disrupt trabecular meshwork by bluntly engaging and tearing the tissue without cutting, allowing for simultaneous disruption of both inner and outer walls of Schlemm's Canal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If aqueous drainage of the eye is increased to treat glaucoma, then intraocular pressure is reduced, but risk of infection and corneal decompensation increases
Solution Approach 1:
A biocompatible coating layer is applied to the drainage device surface to act as an intermediary barrier. This coating prevents direct interaction between the foreign device and ocular tissues/fluids, thereby reducing infection risk and inflammatory response while maintaining effective aqueous drainage for intraocular pressure control
Solution Approach 2:
The surface properties of the drainage device are modified by changing parameters such as surface energy, hydrophobicity, and charge density through coating application. These parameter changes reduce protein adsorption and bacterial adhesion, thereby decreasing infection risk while preserving drainage function
2Reliability
If aqueous drainage is increased through surgical intervention, then glaucoma is treated, but surgical risks and complications occur
Solution Approach 1:
The biocompatible coating serves as a protective intermediary that reduces direct tissue-device interaction, thereby minimizing surgical complications such as inflammation, fibrosis, and infection while maintaining the therapeutic drainage effect for glaucoma treatment
Solution Approach 2:
The coating transforms the potentially harmful foreign body effect into a beneficial biocompatible interface. By converting the natural immune response to foreign materials into a controlled, biocompatible interaction, the device achieves effective drainage with reduced complications
3Reliability
If a drainage device is implanted to increase aqueous outflow, then intraocular pressure is reduced, but the device may cause inflammation or fibrosis
Solution Approach 1:
The biocompatible coating acts as a mediator between the drainage device and ocular tissues, preventing direct contact that would trigger inflammatory and fibrotic responses. This intermediary layer maintains drainage functionality while eliminating harmful tissue reactions
Solution Approach 2:
The coating provides self-protective properties to the device, creating a surface that inherently resists protein adsorption, bacterial adhesion, and cellular infiltration. This self-service mechanism reduces inflammation and fibrosis without requiring additional active components
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 achieves precise and atraumatic removal of trabecular meshwork, reducing bleeding and collateral damage while enabling effective modification of both inner and outer walls of Schlemm's Canal, enhancing aqueous drainage and improving treatment outcomes for glaucoma.
Implementation Method 1
modifying the surface properties of the device to reduce the adsorption of proteins and adhesion of bacteria
Data Source
Figure 1A~1C
Figure 2A~2D
Figure 3A~3D
AI summary
A device for disrupting tissue in an eye including a distal portion sized and configured for ab interno insertion into an anterior chamber of the eye having an elongate, flexible shaft of super-elastic memory-shape material. A distal end region is shaped into a curve having a radially inner surface connected to a radially outer surface by two lateral sides. The device has a tissue disruptor proximal of a distal-most end formed on at least one of the inner surface and the outer surface. The distal face of the tissue disruptor is a blunt tissue-engaging surface without any cutting element. Related methods and devices are provided.