Shape memory polymer vessel occlusion device
Inventors
Maitland, Duncan J. • Landsman, Todd L. • Rodriguez, Jennifer N. • Boyle, Anthony J. • Glowczwski, Alan C. • Wierzbicki, Mark A.
Assignees
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Publication Number
US-11369385-B2
Publication Date
2022-06-28
Expiration Date
Abstract
An embodiment includes a system comprising: an outer conduit; a shape memory polymer (SMP) foam; a metal backbone including: (a)(i) a first portion that extends from the SMP foam proximal end to the SMP foam distal end and which is generally covered by the SMP foam, and (a)(ii) a distal portion that extends distally from the SMP foam distal end and which is not covered by the SMP foam; wherein: (b)(i) SMP foam and the metal backbone are both included within the outer conduit adjacent to the outer conduit distal end; (b)(ii) the metal backbone distal portion transitions from a secondary shape that is uncoiled to a primary shape that is coiled; and (b)(iii) the metal backbone distal portion is in the metal backbone distal portion secondary shape and is located between the SMP foam distal end and the distal end of the outer conduit.
Core Innovation
The disclosed invention describes a minimally invasive endovascular vascular occlusion system that includes an outer conduit with proximal and distal ends, a shape memory polymer (SMP) foam positioned within the outer conduit near the distal end, and a metal backbone/anchor system configured to stabilize occlusion. The SMP foam transitions from a secondary shape to a primary shape when heated above its transition temperature, thereby expanding within a vessel lumen.
The metal backbone includes a first portion that is generally covered by the SMP foam and a second portion that extends distally from the SMP foam distal end and is not covered by the SMP foam. The metal backbone second portion transitions from a secondary shape that is uncoiled to a primary shape that is coiled, and the coiled form is located between the SMP foam distal end and the distal end of the outer conduit.
The metal backbone includes an outer metal portion having a channel and an inner metal portion included within the channel, and the first portion includes the inner metal portion but does not include the outer metal portion. The disclosure addresses reliable, minimally invasive vascular occlusion, anchoring, and reduced failure due to migration or insufficient stabilization, with flow stagnation, endothelial injury, tissue factor binding sites, porous morphology, recirculation zones, platelet aggregation/activation, clot formation timing, complete occlusion under in vitro perfusion, and occlusion time measurements in a pig model.
Claims Coverage
The partial content identifies one independent claim and several dependent claim refinements. The independent claim includes four inventive features: thermally driven SMP foam transition, a covered first backbone portion and uncovered second portion, an uncoiled-to-coiled distal backbone transition, and an inner metal portion within a channel with an outer metal portion only in the second portion.
Outer conduit with distal SMP-foam expansion
An outer conduit having proximal and distal ends; a shape memory polymer (SMP) foam having proximal and distal ends and that transitions from a secondary shape to a primary shape when the SMP foam is heated above its transition temperature.
Two-portion metal backbone with covered first portion and uncovered second portion
A metal backbone including a first portion extending from the SMP foam proximal end to the SMP foam distal end and generally covered by the SMP foam, and a second portion extending distally from the SMP foam distal end and not covered by the SMP foam; wherein the SMP foam and the metal backbone are both included within the outer conduit adjacent to the outer conduit distal end; and wherein the metal backbone second portion is located between the SMP foam distal end and the distal end of the outer conduit.
Coiled primary shape anchor from uncoiled secondary shape
The metal backbone second portion is configured to transition from a secondary shape that is uncoiled to a primary shape that is coiled.
Inner metal portion within channel and outer metal portion only on the second portion
The metal backbone second portion includes an outer metal portion including a channel and an inner metal portion included within the channel, and the metal backbone first portion also includes the inner metal portion but does not include the outer metal portion.
The independent claim set centers on a deployable system in which an SMP foam thermally expands from secondary to primary shape within an outer conduit while a distal, uncovered metal backbone portion transitions from an uncoiled secondary shape to a coiled primary shape. The claim further limits the backbone structure to an inner metal portion within a channel, where the outer metal portion is present in the second portion and absent in the first portion.
Stated Advantages
Reliable, minimally invasive vascular occlusion.
Improving anchoring and reducing failure due to migration or insufficient stabilization.
Flow stagnation, endothelial injury, tissue factor binding sites, porous morphology, recirculation zones, platelet aggregation/activation, and clot formation timing.
Complete occlusion under in vitro perfusion and occlusion time measurements in a pig model.
Documented Applications
Minimally invasive endovascular vascular occlusion.
Vessel lumen occlusion.
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