Non-migrating Stent Anchoring Hooks Prevent Migration
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Solution Overview
Problem
Current stent devices for managing post-surgical anastomosis strictures and vascular ostium high-grade stenosis often migrate or occlude, requiring frequent external drain exchanges and multiple procedures, which are painful and inconvenient for patients, and do not effectively prevent migration or occlusion.
Innovation Solution
Non-migrating stent devices with a central conduit section, anchoring sections, and transitional sections that can expand from a first configuration with a constant outer diameter to a second configuration with a larger diameter, featuring anchoring hooks and living hinges to secure the device in place, preventing migration and occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional stent devices are used to manage post-surgical anastomosis strictures, then the stricture can be supported, but the stent devices migrate or occlude requiring frequent exchanges
Solution Approach 1:
The stent device is divided into distinct functional sections: anchoring sections with hooks at the ends, transitional sections with living hinges connecting the anchoring sections to the central conduit section. This segmentation allows each part to perform its specific function - anchoring for stability, transitional for flexibility, and conduit for flow maintenance.
Solution Approach 2:
The anchoring hooks are pre-configured in a compressed state within the delivery catheter, ready to deploy upon reaching the target site. The living hinges are pre-formed to enable the transitional sections to flex and adapt when the stent is deployed, ensuring proper anchoring before the stent begins to expand.
2Reliability
If external drains are used for biliary enteric and ileal conduit strictures, then drainage can be maintained, but frequent prophylactic exchanges are required every 4-8 weeks
Solution Approach 1:
The stent device is designed to be self-anchoring through its hooks that engage with the tissue at the stricture site, eliminating the need for external fixation or frequent medical intervention for exchange. The device maintains its position and function autonomously once deployed.
Solution Approach 2:
The stent transitions from a compressed delivery state to an expanded functional state, with the anchoring hooks deploying to engage tissue and the living hinges allowing the structure to adapt to anatomical movements, ensuring long-term stability without requiring exchange.
3Reliability
If stent devices are placed to treat strictures, then the stricture can be supported, but the devices often migrate or occlude
Solution Approach 1:
The anchoring hooks are designed with asymmetric geometry that allows them to engage with the tissue in one direction while preventing migration in the opposite direction. The hooks are configured to catch on the tissue wall, creating a mechanical interlock that resists displacement.
Solution Approach 2:
The stent device changes its physical parameters from a compressed cylindrical configuration during delivery to an expanded configuration with deployed hooks after placement. This parameter change enables the device to transition from a deliverable state to a stable, anchored state that resists migration.
4Reliability
If multiple dilatations are performed over several months for segmental stricturoplasty, then the stricture can be treated, but the procedure requires multiple visits and prolonged hospital stays
Solution Approach 1:
The stent device is pre-formed with the final expanded configuration's dimensions, allowing it to be delivered compressed and then expanded in situ to the desired size. This eliminates the need for multiple incremental dilatation procedures, as the stent provides immediate, sustained expansion.
Solution Approach 2:
The stent device provides continuous support and expansion force throughout its retention period, maintaining the stricture in an open state without requiring repeated procedural interventions. The anchoring hooks ensure continuous stability while the mesh structure provides sustained radial support.
Data Source
AI summary
Non-migrating stent devices and methods for using the devices are provided for treatment of visceral anastomosis strictures or vascular ostium high grade stenosis. For example, placement of a non-migrating stent may be appropriate following a surgical procedure such as hollow visceral anastomosis.