Orientable Implantable Devices With Non-Circular Delivery Geometry
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Solution Overview
Problem
Current medical devices struggle to reliably deploy stents and other vascular devices in desired orientations within tortuous intracranial and other vasculatures, leading to improper placement and increased procedural risks, particularly in treating aneurysms and fistulas.
Innovation Solution
The use of non-circular transverse cross-sectional configurations for catheters and wires to inhibit rotation and facilitate precise orientation of stents and other devices, allowing for accurate positioning of differentially porous and fenestrated stents relative to branch vessels and aneurysms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional circular catheters and wires are used for stent delivery, then the devices can be easily manufactured and inserted, but the stents cannot be reliably positioned in the desired rotational orientation within tortuous vasculature
Solution Approach 1:
The catheter and delivery wire are designed with non-circular transverse cross-sections that have asymmetric geometries. These asymmetric shapes create corresponding asymmetric engagement features that prevent relative rotation between the catheter and wire, thereby ensuring the stent is deployed in a controlled and reproducible rotational orientation. The asymmetry in the cross-sectional configuration directly resolves the orientation precision problem while maintaining manufacturing feasibility.
Solution Approach 2:
The patent employs curved or rounded geometric features in the non-circular cross-sectional designs of the catheter and wire. These curved geometries provide smooth engagement surfaces that facilitate controlled interaction between the delivery components, enabling precise rotational positioning of the stent while maintaining flexibility for navigation through tortuous vasculature. The curvature helps in achieving reliable orientation without requiring complex mechanical structures.
2Reliability
If differentially porous stents with variable porosity are deployed, then blood flow can be selectively modified to treat aneurysms and fistulas, but improper orientation leads to increased procedural risks
Solution Approach 1:
The asymmetric non-circular cross-sections of the catheter and wire are designed in advance to inherently control the rotational orientation of the stent during delivery. This preliminary geometric configuration ensures that when the stent is deployed, it automatically assumes the correct orientation relative to the vasculature, eliminating the need for complex intra-procedural rotation maneuvers and thereby improving procedural safety.
Solution Approach 2:
The patent incorporates radiopaque markers or other visualization features on the asymmetric catheter and wire that align with specific features on the stent. This feedback mechanism allows real-time verification of stent orientation during the procedure through imaging, enabling immediate detection and correction of positioning errors, thereby enhancing procedural reliability.
3Adaptability or versatility
If fenestrated stents are used to maintain blood flow to branch vessels, then adequate perfusion is achieved, but incorrect orientation can obstruct branch vessel origins
Solution Approach 1:
The asymmetric non-circular cross-sectional configuration of the delivery catheter and wire creates a mechanical coupling that maintains the relative rotational orientation between the stent and the delivery system. This asymmetry ensures that fenestrations positioned at specific locations on the stent remain aligned with branch vessel origins during deployment, achieving precise fenestration positioning without requiring complex post-delivery adjustment mechanisms.
Solution Approach 2:
The stent is designed with non-uniform porosity distribution, where specific regions have different pore densities or configurations tailored to local vascular requirements. The asymmetric delivery system ensures that these locally optimized porosity patterns are deployed in the correct orientation, allowing adequate blood flow to branch vessels while maintaining manufacturing and positioning precision.
4Adaptability or versatility
If custom-designed stents are created for specific vascular anatomies, then treatment effectiveness is maximized, but deployment reliability in tortuous vasculature remains unproven
Solution Approach 1:
The asymmetric non-circular cross-sections of the delivery catheter and wire provide a mechanical framework that maintains controlled rotational orientation even when navigating through tortuous and complex vascular anatomy. This asymmetric design ensures that custom stents retain their intended orientation during deployment, making the delivery system adaptable to various vascular configurations while maintaining reliable and reproducible stent positioning.
Data Source
AI summary
An intravascular system having a first catheter having a first non-circular transverse cross-sectional configuration and a first delivery device configured for insertion into the lumen of the catheter. The first delivery device includes an implantable medical device and an elongated member supporting the first medical device such that the first elongated member and the first medical device are movable through the lumen of the first catheter. The first elongated member has a second non-circular transverse cross-sectional configuration corresponding to the first non-circular transverse cross-sectional configuration to thereby inhibit rotation of the first elongated member within the catheter and control orientation of the first medical device relative to the catheter.