Vascular prosthesis for leak prevention during endovascular aneurysm repair
Inventors
Maitland, Duncan J. • Landsman, Todd L. • Horn, John • Nash, Landon • Yeh, Chung
Assignees
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Publication Number
US-12251500-B2
Publication Date
2025-03-18
Expiration Date
Abstract
An embodiment includes a process for treating an abdominal aortic aneurysm (AAA) endoleak with a shape memory polymer (SMP) foam device. First, a bifurcated stent graft is placed within the aneurysm while a micro guidewire is positioned within the aneurysm for future catheter access. Second, after placing the iliac graft extension, a catheter is introduced over wire to deliver embolic foams. Third, embolic foams expand and conform to the aneurysm wall. Fourth, embolic foams create a stable thrombus to prevent endoleak formation by isolating peripheral vessels from the aneurysm volume.
Core Innovation
The invention relates to open-cell polyurethane thermoset shape memory polymer (SMP) foams used to prevent endoleak in endovascular aneurysm repair. The disclosed approach places thermally actuated, expandable SMP foam(s) in a conduit positioned for abdominal aortic aneurysm (AAA) treatment. The foam expands to conform to the aneurysm wall region and forms a stable thrombus for peripheral vessel isolation.
A delivery concept is described in which a first, a second, and a third open-cell polyurethane thermoset SMP foam are arranged serially within a conduit during EVAR. The first, second, and third SMP foams are not fixedly coupled to each other, and each foam is coupled to a corresponding metal structure that is localized to a proximal third using planes orthogonal to the foam long axis.
The disclosure addresses limitations of prior embolics by emphasizing reduced delivery friction and improved volumetric filling, including expansion on the order of up to approximately 70×. It also emphasizes fluoroscopic visibility using radiopaque formulations and/or radiopaque fiber, coil, or marker bands, and uses biodurable non-degradable SMP to avoid oxidative degradation and recanalization. The document further describes tuning of glass transition temperature, foam hydrophobicity and moisture plasticization kinetics, and plasma surface functionalization to delay expansion.
Claims Coverage
The provided independent claim covers three inventive features in a serial conduit system with open-cell polyurethane thermoset SMP foams.
Serially arranged three open-cell polyurethane thermoset SMP foams in a conduit
A conduit simultaneously disposes a first, a second, and a third open-cell polyurethane thermoset shape memory polymer foam, with the second foam between the first and third foams, and the foams are not fixedly coupled to each other.
Proximal-localized metal structures defined by orthogonal planes
A first metal structure, a second metal structure, and a third metal structure are coupled to the respective foams; each structure intersects a corresponding plane orthogonal to the foam long axis at a proximal third and does not extend to the middle or distal thirds.
Unexpanded foam diameter constrained for each SMP foam
The first, second, and third SMP foams each have an unexpanded diameter between 0 and 5 mm measured orthogonal to their respective long axes.
The inventive concept is a conduit carrying three distinct serial open-cell polyurethane thermoset SMP foams that are not fixedly coupled, each coupled to a metal structure localized to a proximal third by plane and axis geometry, with unexpanded foam diameters constrained to 0–5 mm.
Stated Advantages
Reduced delivery friction.
Improved volumetric filling, including expansion on the order of up to approximately 70×.
Improved fluoroscopic visibility.
Avoidance of oxidative degradation and recanalization via biodurable non-degradable SMP.
Documented Applications
Prevention of endoleak in endovascular aneurysm repair for abdominal aortic aneurysm, including peripheral vessel isolation through stable thrombus formation.
Use of serially deployable SMP foam configurations within conduit systems in AAA endoleak prevention contexts.
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