Self-Expanding Fabric Aneurysm Occluder
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Solution Overview
Problem
Current medical devices for treating vascular aneurysms, particularly in the neuro-vasculature, face challenges such as limited accessibility, trauma to the vascular wall, and inadequate filling of small aneurysms, especially berry aneurysms, due to their size and shape, which can lead to rupture and complications like stroke or death.
Innovation Solution
A medical device with a self-expanding fabric layer that can be deployed at an angle to the vascular wall, allowing it to conform to the shape of the aneurysm without obstructing blood flow, using braided strands of materials like stainless steel or shape memory alloys, and featuring end features that secure the strands and facilitate delivery through tortuous vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional medical devices are used to treat wide-necked aneurysms, then coils can be prevented from falling out using a stent, but the device complexity increases and may not adequately fill small aneurysms
Solution Approach 1:
The patent combines the functions of a stent and embolic material into a single integrated device. The self-expanding fabric structure incorporates both the support function (formerly requiring a separate stent) and the embolic function (filling the aneurysm) in one unified device, eliminating the need for separate components while maintaining coil retention and providing adequate filling for small aneurysms.
Solution Approach 2:
The self-expanding fabric device performs multiple functions simultaneously: it provides structural support to prevent coil displacement, fills the aneurysm sac to promote thrombosis, and maintains vessel patency. This multi-functional design eliminates the need for separate stent and embolic material applications, reducing procedural complexity.
2Reliability
If metallic coils are used to fill small aneurysms, then the aneurysm can be occluded, but the coils may embolize or protrude into the native vessel
Solution Approach 1:
The self-expanding fabric acts as an intermediary structure between the embolic material and the aneurysm sac. It provides a matrix that contains the embolic material, preventing its displacement into the native vessel while still allowing effective occlusion of the aneurysm. The fabric structure serves as a containment barrier that eliminates the harmful embolization effect.
3Reliability
If liquid embolics are used to fill aneurysms, then the aneurysm can be occluded, but the solidification process may release chemicals into the blood stream and inadequately fill or seal the aneurysm
Solution Approach 1:
The patent employs absorbable, biocompatible materials for the self-expanding fabric that degrade harmlessly in the body over time. These materials do not release harmful chemicals like liquid embolics, and their temporary presence is sufficient to maintain aneurysm occlusion during the healing process. The fabric serves as a temporary scaffold that is eventually replaced by natural tissue.
4Reliability
If surgical treatment is used to repair aneurysms, then the aneurysm can be treated, but the procedure is complex and poses additional risks to the patient
Solution Approach 1:
The patent replaces complex surgical mechanical procedures with a minimally invasive endovascular approach. Instead of open surgery requiring large incisions and direct surgical manipulation, the self-expanding fabric device is delivered through a catheter and deployed internally, eliminating the need for complex surgical exposure and reducing procedural risks.
5Reliability
If endovascular stent-grafts are used to reinforce vessel walls, then the aneurysm can be treated, but adequate landing zones may not be available in certain locations
Solution Approach 1:
The self-expanding fabric device is designed as a segmented or modular structure that can be adapted to different aneurysm sizes and locations. The device can be configured in various shapes and dimensions to match specific aneurysm geometries, allowing placement in locations where traditional stent-grafts with fixed landing zone requirements cannot be deployed.
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 device effectively occludes aneurysms by conforming to their shape, minimizing trauma and obstruction, and can be delivered through smaller catheters, reducing the risk of rupture and improving treatment outcomes for complex aneurysm locations like the carotid artery.
Implementation Method 1
The body portion is formed from a self-expanding fabric layer that has been heat set to a predefined shape corresponding to the shape of an aneurysm
Implementation Method 2
The body portion is formed from a self-expanding fabric layer that has been heat set to a predefined shape corresponding to the shape of an aneurysm
Data Source
AI summary
Medical devices are provided that include at least one layer that defines a proximal end, a distal end, and an expanded volume portion between the proximal and distal ends. The expanded volume portion defines a longitudinal axis extending between the proximal and distal ends. A first end feature including a reversible connection for attachment to a pusher member may be attached to the proximal end. The first end feature may define a first axis between its opposing ends. Similarly, a second end feature defining a second axis between its opposing ends may be located at the distal end. In the contracted state (e.g., when constrained within a delivery catheter), the first axis and the second axis may be aligned with the longitudinal axis, and in the expanded state (e.g., when deployed), the first axis and/or the second axis may be angled with respect to the longitudinal axis.