Aneurysm Occlusive Member With Embolic Neck Sealing
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Solution Overview
Problem
Current treatments for intracranial aneurysms, such as platinum coil placement and flow diverters, face challenges with long-term recanalization and the need for antiplatelet therapy, which can be risky, especially after aneurysm rupture, highlighting the need for innovative solutions to promptly and effectively treat and prevent re-rupture.
Innovation Solution
A method involving an expandable occlusive member positioned within the aneurysm cavity, where an embolic element is delivered to transform the occlusive member from a first expanded state to a second state, forming a stable seal at the aneurysm neck, using a system comprising an elongated shaft and an embolic kit with biopolymer and chemical crosslinking agents to create a scaffold for tissue remodeling and blood flow diversion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If platinum coil is disposed within aneurysm interior volume, then aneurysm occlusion is achieved, but long-term recanalization occurs especially for wide-necked and large-volume aneurysms
Solution Approach 1:
The invention uses a composite structure combining a flow diverter stent with a biodegradable polymer coating. The stent provides mechanical support and flow diversion, while the polymer layer enhances initial occlusion and promotes thrombus formation. This composite approach addresses the limitation of plain coils by adding a material that actively promotes occlusion and maintains it over time, preventing recanalization in wide-necked and large-volume aneurysms.
Solution Approach 2:
The invention changes the physical and chemical parameters of the occlusive material by using a biodegradable polymer with specific degradation characteristics. The polymer has controlled porosity, degradation rate, and mechanical properties that evolve over time. Initially, it provides dense occlusion, then gradually degrades to allow tissue ingrowth, maintaining long-term patency while preventing premature recanalization.
2Reliability
If flow diverter is deployed in intracranial blood vessel, then blood flow is diverted from aneurysm, but weeks to months are required for aneurysmal thrombus formation and endothelial coverage
Solution Approach 1:
The biodegradable polymer coating is applied to the stent before deployment, creating a pre-formed occlusive layer that immediately promotes thrombus formation upon contact with blood. This preliminary preparation eliminates the waiting period required for natural thrombus formation, achieving rapid aneurysm occlusion within days rather than weeks or months while the stent simultaneously diverts blood flow.
Solution Approach 2:
The polymer coating creates a hydrophilic surface that alters blood flow dynamics at the aneurysm entrance. The material's porosity and surface properties promote platelet adhesion and coagulation cascade activation, creating a hydraulic barrier that rapidly stops blood entry into the aneurysm sac, accelerating closure time.
3Reliability
If flow diverter is used to treat aneurysm, then antiplatelet therapy is required to prevent thrombus in main channel, but antiplatelet therapy is contraindicated after initial aneurysm rupture due to high re-rupture risk
Solution Approach 1:
The invention extracts the antiplatelet therapy requirement by using a biodegradable polymer that is inherently thrombogenic rather than thromboresistant. The polymer material naturally promotes clot formation on its surface, eliminating the need for systemic antiplatelet medications. This allows treatment of ruptured aneurysms without exposing patients to the bleeding risks associated with antiplatelet therapy, while still preventing pathological thrombus in the main vessel channel.
Solution Approach 2:
The invention converts the potentially harmful thrombogenic property into a beneficial feature. Instead of using materials that resist clotting (which require antiplatelet therapy), the device uses a polymer that actively promotes controlled thrombus formation at the aneurysm site. This controlled clotting occludes the aneurysm safely without requiring antiplatelet medications, turning a harmful effect into a therapeutic mechanism.
4Reliability
If occlusive member is expanded to first expanded state, then aneurysm cavity is occluded, but recanalization may occur without complete seal at aneurysm neck
Solution Approach 1:
The occlusive member is designed with dynamic properties that allow it to change shape and density over time. The biodegradable polymer coating gradually degrades and remodels, allowing the device to adapt to the aneurysm geometry and achieve progressive sealing. The structure transitions from an initial expanded state to a remodeled state with improved neck seal, preventing recanalization through continuous adaptation rather than static positioning.
Solution Approach 2:
The invention utilizes parameter changes in the polymer material during degradation. As the polymer breaks down, its porosity, mechanical strength, and surface properties change, allowing it to progressively seal the aneurysm neck more effectively. The material transforms from a delivery-state configuration to a deployed-state configuration with optimized sealing characteristics, ensuring complete occlusion and preventing recanalization.
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
This approach provides immediate and effective occlusion of the aneurysm, reducing the risk of rupture and re-rupture by forming a complete seal and promoting endothelial growth, while minimizing long-term recanalization and avoiding the complications associated with antiplatelet therapy.
Implementation Method 1
embolic kit with biopolymer and chemical crosslinking agents to create a scaffold for tissue remodeling
Implementation Method 2
flow diverter is often a mesh tube that causes blood to preferentially flow along a main channel of the blood vessel while blood within the aneurysm stagnates
Implementation Method 3
the presence of the coil should induce formation of a thrombus
Data Source
AI summary
Systems and methods for treating an aneurysm in accordance with embodiments of the present technology include intravascularly delivering an occlusive member to an aneurysm cavity via an elongated shaft and transforming a shape of the occlusive member within the cavity. The method may include introduction of an embolic element to a space between the occlusive member and an inner surface of the aneurysm wall. In some embodiments, the elongated shaft is detachably coupled to a distal portion of the occlusive member.