Flexible Trabecular Meshwork Disruptor for Continuous Canal Access
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Solution Overview
Problem
Current trabecular excision devices for glaucoma treatment cause imprecise, discontinuous cuts, significant bleeding, and collateral damage due to sharp cutting elements, and are limited by rigid shafts that require complex motions to follow the curved shape of Schlemm's canal.
Innovation Solution
A non-cutting device with a flexible, superelastic shaft and a blunt tissue engager that tears and disinserts trabecular meshwork by applying shear and tension, guided by a curved guide member to follow the canal's contour, reducing the need for sharp cutting and minimizing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of substance
If sharp cutting elements are used to excise trabecular meshwork, then material removal is achieved, but tissue damage, bleeding, and imprecise cuts occur
Solution Approach 1:
The invention extracts the harmful cutting function from the device and replaces it with a non-cutting extraction mechanism. The blunt probe engages the trabecular meshwork and pulls it out through Schlemm's canal, removing the problematic substance without the harmful cutting action that causes tissue damage and bleeding.
Solution Approach 2:
Instead of using a sharp blade to cut and remove tissue, the invention inverts the approach by using a blunt probe to engage and pull the tissue out. This reverse methodology achieves material removal through extraction rather than excision, eliminating the harmful effects of cutting while maintaining the therapeutic goal.
2Device complexity
If rigid shafts with fixed cutting elements are used, then device simplicity is maintained, but complex motions are required to follow the curved shape of Schlemm's canal
Solution Approach 1:
The invention transitions from a static rigid shaft to a dynamic flexible shaft that can adapt its shape during operation. The flexible shaft naturally conforms to the curved anatomy of Schlemm's canal, eliminating the need for complex manual manipulation while maintaining device structural simplicity.
Solution Approach 2:
The invention employs a flexible shaft constructed from elastic materials that can bend and flex to follow the curved contour of Schlemm's canal. This flexible construction allows the device to adapt to anatomical variations without requiring complex mechanical articulation or multiple moving parts.
3Productivity
If single stab-like partial cuts are made in the trabecular meshwork, then the procedure is simple, but discontinuous and imprecise cuts result
Solution Approach 1:
The invention replaces discontinuous stab-like cuts with a continuous extraction action. The blunt probe engages the trabecular meshwork and pulls it out in one continuous motion through Schlemm's canal, achieving both procedural efficiency and precise, complete removal of the targeted tissue.
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, continuous trabeculorhexis with reduced bleeding and collateral damage, stabilizing the shaft through a spring-loaded mechanism that naturally follows the canal's shape, enhancing aqueous drainage.
Implementation Method 1
The shaft may be made of a superelastic material and the tissue engager may tear a strip of the TM along a continuous segment of Schlemm's canal
Implementation Method 2
The shaft may be flexible and may be deformed during use to provide a spring load on the tissue engager
Implementation Method 3
The shaft may be resilient relative to forces exerted in an advancing direction so that the shaft develops a spring load in the advancing direction. The shaft may also be resilient in a direction perpendicular to the advancing direction
Data Source
Figure 1A~1D
Figure 2A~2B
Figure 3A~3C
AI summary
Devices and methods to disrupt tissue in an eye to treat glaucoma and other conditions. A distal portion sized and configured for ab interno insertion comprises an elongate flexible shaft, a distal guide member, and a tissue disruptor coupled to the shaft proximally of the guide member. The tissue disruptor comprises a protrusion and a blunt tissue-engaging surface without any cutting element. The distal guide member is configured to be inserted through the trabecular meshwork into a portion of Schlemm's Canal. As the distal guide member advances along Schlemm's Canal, the tissue-engaging surface of the protrusion bluntly tears trabecular meshwork tissue to remove a portion of an inner wall of Schlemm's Canal.