Expandable Aneurysm Implant for Endothelialization and Flow Disruption
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Solution Overview
Problem
Existing treatments for vascular defects such as aneurysms, including the use of platinum coils, stents, and flow diverters, often result in recanalization, prolonged procedure times, stenosis, and are unsuitable for aneurysms at bifurcations, requiring prolonged use of blood thinners and have high recanalization rates.
Innovation Solution
An expandable medical device with an electropositive woven or braided implant that promotes endothelialization by recruiting endothelial cells, occupying the aneurysm volume and disrupting blood flow, formed from materials like Nitinol, MP35N, and stainless steel, which can be delivered in a collapsed configuration and expanded at the treatment site to fit complex vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If platinum coils are used to treat aneurysm, then the aneurysm sac can be packed, but recanalization occurs in about 30% of cases requiring prolonged procedure times and increased radiation exposure
Solution Approach 1:
The device is divided into multiple segments including a delivery catheter, expandable frame with radial support members, and separately deliverable coil components. This segmentation allows for more controlled deployment and reduces the need for repeated procedures, thereby reducing overall procedure time and radiation exposure while maintaining treatment effectiveness.
Solution Approach 2:
The expandable frame is deployed first to provide structural support and define the aneurysm space before coil packing. This preliminary action creates a stable framework that prevents recanalization, reducing the need for prolonged procedures and follow-up interventions.
2Reliability
If both coil and stent are used for aneurysm treatment, then the neck of aneurysm can be treated, but the procedure becomes more complex with longer procedure time and requires indefinite blood thinner use
Solution Approach 1:
The device combines the functions of a stent (radial support members providing structural support and neck coverage) and a coil packable system (flexible coils for sac filling) into a single integrated expandable frame structure. This merging eliminates the need for separate stent and coil procedures, reducing procedural complexity and eliminating the need for indefinite blood thinner use while effectively treating both the neck and sac of the aneurysm.
Solution Approach 2:
The expandable frame serves multiple functions: it provides radial support like a stent, defines the aneurysm space, and serves as a scaffold for coil packing. This multi-functionality replaces the need for separate stent and coil procedures, simplifying the overall treatment approach.
3Reliability
If flow diverter is used to prevent blood flow into aneurysm, then blood flow diversion can be achieved, but stenosis of blood vessel occurs and recanalization rate increases
Solution Approach 1:
The radial support members are selectively positioned to provide flow diversion specifically at the aneurysm neck region while maintaining patent lumen in the parent vessel. The expandable frame creates localized flow disruption only where needed (at the aneurysm entrance) rather than causing generalized vessel stenosis, and the open architecture allows continued blood flow through the parent vessel.
Solution Approach 2:
The expandable frame has an open, mesh-like structure with spaces between radial support members that allows blood to pass through while still disrupting flow into the aneurysm. This porous configuration provides flow diversion effectiveness while preventing complete vessel occlusion and reducing recanalization risk.
4Reliability
If expandable implant is deployed to occupy aneurysm volume, then blood flow disruption is achieved, but the device must be deliverable in collapsed configuration through complex vasculature
Solution Approach 1:
The device transitions from a collapsed, flexible configuration during delivery through complex vasculature to an expanded, rigid configuration after deployment in the aneurysm. The radial support members are collapsible during delivery but expand to provide stable structural support and flow disruption after deployment, combining ease of delivery with effective treatment.
Solution Approach 2:
The expandable frame with radial support members is nested within the delivery catheter in a collapsed state, allowing it to pass through complex vasculature. After reaching the target site, the frame expands outward from the catheter into the aneurysm space, transforming from a compact deliverable form to an expanded therapeutic form.
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
Reduces recanalization risk by promoting endothelialization, preventing blood flow into the aneurysm, and facilitating healing without the need for prolonged blood thinner use, suitable for aneurysms at bifurcations and tortuous vasculature.
Implementation Method 1
An expandable medical device with an electropositive woven or braided implant that promotes endothelialization by recruiting endothelial cells
Implementation Method 2
occupying the aneurysm volume and disrupting blood flow
Data Source
AI summary
Devices and methods for treating vascular defects, such as, for example, balloon-type aneurysms, are described herein. In one embodiment, an apparatus includes an insertion portion and an expandable implant. The expandable implant is configured to be deployed in an aneurysm and is coupled to the insertion portion. The expandable implant has a first portion and a second portion coupled to the first portion. The expandable implant is movable between a first configuration in which the first portion and the second portion are substantially linearly aligned and a second configuration in which the second portion at least partially overlaps the first portion.