3D-Printed Shape Memory Polymer Aneurysm Occlusion
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Solution Overview
Problem
Current endovascular coil embolization therapies for intracranial aneurysms face challenges such as low packing density, incomplete occlusion, and unsatisfactory long-term occlusion, particularly in wide-necked and large aneurysms, with existing SMP devices failing to address these issues effectively.
Innovation Solution
Development of patient-specific 3D-printed shape memory polymer (SMP) devices with a thermal deployment mechanism, tailored to fit individual aneurysm geometries, which occupy the aneurysm volume and enhance occlusion by transitioning to their permanent shape upon reaching the glass transition temperature during deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If Guglielmi detachable coils (GDCs) are used for endovascular embolization therapy, then the procedure becomes minimally invasive, but packing density remains low (26%-33% of aneurysm volume) and complete occlusion rates are insufficient (60%-70%)
Solution Approach 1:
The patent employs shape memory polymers that undergo parameter changes in response to thermal stimuli. The SMP material transitions from a temporary compressed shape suitable for catheter delivery to a permanent expanded shape that fills the aneurysm sac, thereby achieving high packing density while maintaining minimally invasive delivery
Solution Approach 2:
The SMP-based embolic device is designed to be dynamic rather than static. It transitions from a compressed delivery state to an expanded functional state after deployment, allowing the device to adapt its volume and shape to maximize packing density within the aneurysm sac while being delivered through a minimally invasive catheter
2Reliability
If traditional surgical clip ligation is used to treat intracranial aneurysms, then complete occlusion can be achieved, but procedural mortality is higher
Solution Approach 1:
The patent replaces the mechanical clip ligation system with a shape memory polymer-based embolic system activated by thermal energy. This substitution maintains the reliability of complete occlusion while avoiding the high procedural mortality associated with open surgical clipping, as the SMP device can be delivered endovascularly and activated remotely through thermal triggering
3Quantity of substance
If SMP devices are deployed to occlude aneurysms, then packing density improves, but the devices must be heated above glass transition temperature requiring thermal triggering mechanism
Solution Approach 1:
The patent introduces an intermediary thermal triggering mechanism that mediates between the delivered SMP device and its shape transformation. This intermediary system (heating element or thermal environment) enables the SMP to transition from compressed to expanded state, achieving high packing density while managing the complexity of thermal activation through a dedicated but manageable subsystem
4Reliability
If SMP material is used to fill aneurysm volume, then complete occlusion is achieved, but the porous structure requires time for blood clotting to occur
Solution Approach 1:
The patent utilizes porous SMP material to fill the aneurysm sac. The porous structure provides a scaffold that promotes blood clotting while maintaining complete occlusion. The porosity allows blood to penetrate and coagulate within the matrix, achieving reliable occlusion while minimizing the time required for clot formation compared to solid embolic materials
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 SMP devices achieve improved packing density and complete occlusion rates, reducing the risk of aneurysm rupture and stroke by fully filling the aneurysm volume and promoting blood clotting within a porous structure.
Implementation Method 1
SMP devices have been developed for the purposes of clot removal, aneurysm occlusion, and vascular stenting. In particular, SMPs have been designed to achieve aneurysm occlusion using four different approaches with a thermal triggering mechanism for device deployment
Implementation Method 2
which occupy the aneurysm volume and enhance occlusion by transitioning to their permanent shape upon reaching the glass transition temperature during deployment
Implementation Method 3
with a thermal deployment mechanism, tailored to fit individual aneurysm geometries, which occupy the aneurysm volume and enhance occlusion by transitioning to their permanent shape upon reaching the glass transition temperature during deployment
Data Source
AI summary
A novel shape memory polymer (SMP)-based device for surgical treatment of an intracorporeal defect (e.g., a void or anomaly) such as an intracranial aneurysm or fistula. In at least one non-limiting embodiment, the SMP device is a 3D-printed SMP material sized to specifically fit and thus occlude an intracranial aneurysm (ICA). The SMP device may be delivered to the intracorporeal defect via a catheter having a heating mechanism wherein the SMP device is raised above its glass transition temperature as it is deployed, causing the SMP device to return to its permanent shape after it is deployed into the intracorporeal defect. SMP device delivery systems that include the SMP devices, as well as methods of making and using the devices and systems, are also disclosed.