Orientable Intravascular Stent Delivery via Asymmetric Catheter
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Solution Overview
Problem
Current medical devices lack the ability to reliably and accurately deploy stents with differential porosity in tortuous intracranial and other vasculatures, leading to ineffective treatment of aneurysms and fistulas due to unpredictable orientation and obstruction of branch vessels.
Innovation Solution
The development of non-circular transverse cross-sectional configurations in catheters and wires that inhibit rotation while allowing axial movement, enabling precise orientation and placement of stents with varying porosity to accurately position fenestrations and regions of decreased porosity relative to branch vessels and aneurysms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional circular catheters and wires are used for stent delivery, then the device can be easily manufactured and operated, but the stent orientation becomes unpredictable and cannot be reliably controlled in tortuous vasculature
Solution Approach 1:
The patent applies asymmetry by changing the catheter lumen and wire cross-section from circular to non-circular (e.g., triangular, rectangular, or other polygonal shapes). This asymmetric geometry prevents rotation of the wire within the catheter and the stent within the wire, enabling predictable orientation control. The asymmetric shape creates a unique fit that maintains rotational position throughout delivery through tortuous vasculature, directly resolving the orientation control reliability issue.
Solution Approach 2:
The patent transitions from a two-dimensional rotational degree of freedom (circular cross-section allowing free rotation) to a constrained dimensional state (non-circular cross-section eliminating rotation). By adding geometric constraints in the cross-sectional dimension, the system eliminates unwanted rotational movement while preserving axial delivery capability, enabling precise orientation control without significantly increasing overall device complexity.
2Manufacturing precision
If non-circular transverse cross-sectional configurations are used in catheters and wires, then stent orientation can be precisely controlled, but the device structure becomes more complex
Solution Approach 1:
The asymmetric non-circular cross-sectional geometry (triangular, rectangular, or other polygonal shapes) provides inherent rotational constraints that enable precise stent placement. The asymmetric shape creates a unique geometric fit between catheter lumen, wire, and stent, ensuring predictable orientation without requiring complex active control mechanisms. This geometric constraint approach achieves high manufacturing precision while keeping the device structure relatively simple.
Solution Approach 2:
The patent changes the geometric parameter of the cross-sectional shape from circular to non-circular. This parameter change fundamentally alters the rotational behavior of the wire-cathent-stent system, enabling precise orientation control. By modifying this single geometric parameter, the system achieves high placement precision without introducing complex mechanical or electronic control systems.
3Reliability
If stents with differential porosity are deployed in tortuous vasculature without orientation control, then the device can treat aneurysms and fistulas, but branch vessels may be obstructed and treatment efficacy is reduced
Solution Approach 1:
The asymmetric non-circular cross-sectional geometry provides passive rotational constraint throughout the delivery system. This ensures that when the stent is deployed at the target site in tortuous vasculature, its asymmetric porosity pattern (with different mesh densities for different functions) is oriented correctly relative to branch vessels. The asymmetric shape maintains orientation without requiring complex active control during deployment, preserving ease of operation while improving reliability.
Solution Approach 2:
The orientation control is established preliminarily through the geometric design of the non-circular cross-section before the stent reaches the target site. The asymmetric shape pre-positions the stent in the correct rotational orientation during navigation through tortuous vasculature, so that upon deployment, the differential porosity regions are already correctly aligned with respect to branch vessels and aneurysms, eliminating the need for complex orientation adjustments at the deployment site.
Data Source
AI summary
An orientable intravascular device having a “twelve o'clock” marker on a proximal and distal end for treating an aneurysm, including a packaging catheter with an identical fixed non-circular shaped inner lumen, a pusher wire having an occlusion device releasably disposed on the distal end of said pusher wire, pre-loaded at a fixed circumferential orientation, with corresponding markers on the outside of said packaging catheter, a hub having an inner lumen that is shaped to marry with the outer lumen of the packaging catheter to deliver a delivery wire and occlusion stent in a predicted orientation, and maintaining such orientation as the wire and stent are advanced through said delivery catheter, and while said delivery catheter is withdrawn. Methods of using same are disclosed.