Vascular prosthesis for leak prevention during endovascular aneurysm repair
Inventors
Maitland, Duncan J. • Landsman, Todd L. • Horn, John • Nash, Landon • Yeh, Chung
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10485903-B2
Publication Date
2019-11-26
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 an EVAR leak-prevention approach that uses polyurethane shape memory polymer (SMP) foam devices delivered via a conduit. The SMP foams thermally actuate in situ to expand and conform to aneurysm/perigraft spaces to promote rapid flow stasis and stable thrombus formation to prevent endoleaks.
A system is described in which open-cell, polyurethane, thermoset SMP foams are deployed from the conduit in serial fashion so that they are not fixedly secured to one another immediately after collective deployment. The foams include backbones and can incorporate radiopaque or visualization components such as tungsten-doped foams or radiopaque fibers, coil, or marker bands, with attention to radiopacity and visualization during imaging.
The invention further describes SMP foam morphologies and formulations designed to manage deployment behavior and degradation concerns, including biodurable, non-degradable, and biodegradable variants. In particular embodiments, iodine is included in SMP formulations and may be covalently bonded in triiodobenzene monomers, and the disclosed approaches are evaluated in flow-loop and animal/perigraft models with imaging modalities including CT, angiography, and fluoroscopy.
Claims Coverage
The partial content provides three independent claims, each covering a conduit-deliverable SMP foam system with defined foam structure and deployment arrangement, and in some embodiments radiopacity and iodine-containing formulations.
Three non-fixedly coupled, serially deployable SMP foams in a conduit
A conduit that simultaneously disposes a first, second, and third open-cell polyurethane thermoset SMP foam, where the foams are not fixedly coupled to each other; the foams are configured to deploy from the conduit such that they are not fixedly secured to one another immediately after collective deployment and are configured to deploy in serial fashion, with the first deploying before the second and the second before the third.
Partially reticulated open-cell SMP foam with defined void path and anisotropic cells
A conduit that has disposed an open-cell polyurethane thermoset SMP foam in which the foam includes first and second cells directly contacting each other, with a ring of struts and a partially reticulated membrane that is partially reticulated but not fully reticulated; the partially reticulated membrane includes a void forming a path allowing fluid to flow between the first and second cells, and the cells are anisotropic in shape with unequal major and minor axes.
Three non-fixedly coupled, serially deployable SMP foams with corresponding metal structures arranged by planes
A conduit that simultaneously disposes a first, second, and third open-cell polyurethane thermoset SMP foams and first, second, and third metal structures, where each SMP foam is spatially intersected by planes that define proximal and distal halves relative to its corresponding metal structure; the SMP foams are not fixedly coupled to each other and are configured to deploy in serial fashion from the conduit so that the first deploys before the second and the second before the third, and each metal structure includes at least one of platinum, tantalum, iridium, or tungsten.
Across the independent claims, the core coverage centers on conduit-deliverable open-cell polyurethane thermoset SMP foams deployable in serial fashion without being fixedly secured to one another immediately after collective deployment, with additional claim features directed to a partially reticulated membrane and void structure, anisotropic foam cells, corresponding metal structures arranged by planes, and specified refractory metals.
Stated Advantages
Promotes rapid flow stasis and stable thrombus formation to prevent endoleaks.
Improves delivery and volumetric filling relative to conventional embolics, including reduced delivery friction and improved volumetric filling.
Provides radiopacity and visualization options for imaging.
Documented Applications
EVAR leak-prevention in abdominal aortic aneurysm (AAA), including preventing endoleaks and associated perigraft flow.
Imaging evaluation using CT, angiography, and fluoroscopy in flow-loop and porcine aneurysm model contexts.
Radiopacity and visualization for the SMP foam devices during imaging.
Interested in licensing this patent?