Modular Stent System with Secondary Elements for Venous Patency
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Solution Overview
Problem
Current stent designs for venous systems face challenges due to the variability and flexibility of veins, leading to issues like slippage, reduced luminal diameter, and turbulence, particularly in the pelvic region where mobility and external compression complicate stent placement and adjustment.
Innovation Solution
A stent system comprising a primary stent with deployable secondary stent elements that apply chronic outward radial force to modify the aspect ratio of the lumen, enhancing patency and resistance to external compressions, while being adaptable to individual anatomy through adjustable positioning and properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple overlapping stents are used to accommodate vessel mobility and flexure, then adaptability to venous system variability is improved, but device complexity and procedure time increase
Solution Approach 1:
The stent is divided into multiple modular segments that can be independently deployed and positioned. Each segment can accommodate local anatomical variations while maintaining overall structural integrity, allowing the stent to adapt to venous system variability without requiring a complex array of overlapping stents.
Solution Approach 2:
The stent incorporates dynamic elements such as flexible connectors and adjustable segments that allow movement and adaptation after deployment. This enables the stent to accommodate vessel mobility and flexure while maintaining a simpler overall structure compared to fixed multi-stent configurations.
2Reliability
If multiple stents with sealing collars are deployed to join adjacent stents, then connectivity and sealing are improved, but luminal diameter is reduced and turbulence is created
Solution Approach 1:
The sealing and connection functions are merged into a single integrated mechanism at the stent segment interfaces. This eliminates the need for separate sealing collars that protrude into the lumen, maintaining full luminal diameter while ensuring both connectivity and sealing through a streamlined design.
3Ease of manufacture
If a single stent design is used for all venous stenting cases, then device simplicity is maintained, but adaptability to individual anatomy and pelvic variability is reduced
Solution Approach 1:
The stent design incorporates universal modular segments that can be configured in different patterns to accommodate various anatomical requirements. The same basic segment design serves multiple functions and can be adapted to different venous locations and patient anatomies through selective deployment patterns rather than requiring entirely different stent designs.
4Reliability
If stents are placed to counteract extrinsic venous compression, then vessel patency is restored, but predictability of placement and ability to adjust outcome are reduced
Solution Approach 1:
The stent system incorporates markers and imaging capabilities that provide real-time feedback during deployment, allowing the operator to verify correct positioning and orientation before final deployment. This enhances predictability of placement and allows for adjustment if the initial positioning is suboptimal for counteracting the specific compression forces present.
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 system improves stent placement predictability, reduces complications, and maintains vessel patency by allowing for personalized adjustment and reinforcement within the venous system, addressing the limitations of existing stent designs.
Implementation Method 1
the at least one secondary stent element is configured to apply a chronic outward radial force to the interior surface of the primary stent so as to effect modification of or to resist change to an aspect ratio of the lumen
Data Source
AI summary
A stent system is provided comprising a primary stent for location in a lumen of a target vessel, such as a vein or artery that may be fully or partially occluded. The primary stent contacts a vessel wall and at least one secondary stent element is deployed wholly within the primary stent and configured to engage with the interior surface of the primary stent. The secondary stent element is configured to apply a chronic outward radial force to the interior surface of the primary stent so as to effect modification of or to resist change to an aspect ratio of the lumen of the target vessel at the location where the secondary stent element is deployed. In this way the secondary stent element cooperates with the primary stent to restore patency to the target vessel. Various configurations of the stent system are provided as well as deployment devices and methods of treating fully or partially occluded vessels.