Expandable Endovascular Occlusion Frame for Tortuous Vessel Navigation
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Solution Overview
Problem
Existing endovascular occlusion devices face challenges such as ease of use, safety, navigability, precision, and reliability, particularly in complex vascular environments like the intracranial circulation, with issues including balloon rupture, deflation, migration, and incomplete occlusion.
Innovation Solution
An expandable tubular frame with a high expansion ratio and a guidewire lumen, equipped with a collapsible membrane, designed for precise and rapid vessel occlusion, featuring a low crossing profile and enhanced trackability for navigation through tortuous vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a balloon occlusion device is used to block vessels, then vessel occlusion is achieved, but the device may expand and rupture or spontaneously deflate over time
Solution Approach 1:
The occlusion device is divided into multiple segments or struts that can be independently positioned and locked, rather than relying on a single balloon structure. This segmentation allows the device to achieve occlusion through mechanical interlocking of multiple components, eliminating the risk of balloon rupture or deflation while maintaining reliability.
Solution Approach 2:
The patent replaces the pneumatic/hydraulic balloon inflation system with a purely mechanical self-expanding framework. The device uses elastic memory materials (such as shape memory alloys) that automatically expand to their predetermined shape upon deployment, substituting the balloon's pressure-dependent mechanism with a mechanically stable structure that maintains its form without risk of rupture or deflation.
2Ease of operation
If a detachable balloon is used for flow reduction procedures, then the balloon can be detached after deployment, but premature detachment can lead to adverse consequences such as cerebral artery blockage and stroke
Solution Approach 1:
The device incorporates a dynamic locking mechanism that transitions from a constrained delivery state to a permanently locked deployed state. The locking system includes features such as irreversible mechanical locks or friction-based retention mechanisms that prevent accidental detachment while allowing intentional release only after proper positioning is confirmed, thereby eliminating premature detachment risks.
Solution Approach 2:
The patent introduces an intermediary locking interface between the occlusion device and the delivery catheter. This locking mechanism acts as a mediator that securely holds the device during navigation and deployment, then allows controlled release only when the operator intentionally activates the release mechanism, preventing unintended detachment and associated harmful effects.
3Reliability
If a balloon device is used for occlusion, then vessel blockage is achieved, but the device exhibits low trackability and is difficult to navigate through tortuous vessels
Solution Approach 1:
The occlusion device is designed with a nested configuration where the expandable framework is contained within a delivery catheter, which itself is delivered over a guidewire. This nested structure allows the device to be compressed to a small profile for navigation through tortuous vasculature, then expanded at the target site to achieve effective occlusion, combining excellent trackability with reliable occlusion performance.
Solution Approach 2:
The device incorporates flexible components including a compliant delivery catheter and a flexible framework made of elastic materials. These flexible elements allow the device to conform to the tortuous geometry of blood vessels during delivery, improving trackability while maintaining the structural integrity needed for effective occlusion once deployed.
4Manufacturing precision
If a balloon is used for occlusion, then vessel blockage is achieved, but the balloon can move forward during inflation making precise positioning difficult
Solution Approach 1:
The device incorporates preliminary positioning features such as radiopaque markers, shape-memory framework that maintains its geometry during expansion, and a delivery system with positioning controls that allow the operator to precisely position the device before activation. The framework's predetermined shape ensures it expands at the exact location where it was deployed, preventing forward movement and ensuring precise positioning.
Data Source
AI summary
The present disclosure describes an occlusion device and methods of delivering the occlusion device. The occlusion device can include an expandable structure configured to move between an unexpanded configuration and an expanded configuration. The expandable structure can be configured to have an expansion ratio of at least about 5:1. Further, the occlusion device can be configured to prevent substantially all fluid from flowing past the occlusion device when the occlusion device is in the expanded configuration in the vessel.