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-10786261-B2
Publication Date
2020-09-29
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 provides a system with an outer conduit having proximal and distal ends and a shape memory polymer (SMP) foam having proximal and distal ends. The SMP foam transitions from a secondary shape to a primary shape when the SMP foam is heated above its transition temperature. The system also includes a metal backbone that includes a first portion extending from the SMP foam proximal end to the SMP foam distal end and that is 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.
The SMP foam and the metal backbone are both included within the outer conduit adjacent to the outer conduit distal end. The metal backbone second portion is configured to transition from a secondary shape that is uncoiled to a primary shape that is coiled, and the metal backbone second portion in the secondary shape is located between the SMP foam distal end and the distal end of the outer conduit. The SMP foam includes a proximal portion including the proximal end of the SMP foam and a distal portion including the distal end of the SMP foam.
One of the proximal or distal portions of the SMP foam fixedly adheres to the metal backbone first portion, while the other of the proximal or distal portions slideably couples to the metal backbone first portion. The partial description further characterizes minimally invasive vascular occlusion using polyurethane SMP foam that self-expands in response to body temperature/moisture to fill a vessel lumen and promote thrombosis, with optional radiopaque markers and visualization by ultrasound/fluoroscopic techniques.
Claims Coverage
The partial set contains one independent claim directed to a system architecture combining an outer conduit, SMP foam shape transition, and a metal backbone with an uncoiled-to-coiled transition, including placement within the distal end region and coupling between SMP foam portions and the metal backbone first portion.
Outer conduit carrying distal SMP foam with transition on heating
An outer conduit having proximal and distal ends, together with an SMP foam having proximal and distal ends that transitions from a secondary shape to a primary shape when the SMP foam is heated above its transition temperature.
Metal backbone first and second portions with uncoiled-to-coiled transition
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, where the metal backbone second portion transitions from an uncoiled secondary shape to a coiled primary shape.
Distal placement of SMP foam and metal backbone adjacent to the outer conduit distal end
Both the SMP foam and the metal backbone are included within the outer conduit adjacent to the outer conduit distal end, with the metal backbone second portion in its secondary shape located between the SMP foam distal end and the distal end of the outer conduit.
Fixed and slideable coupling between SMP foam portions and the metal backbone first portion
The SMP foam includes a proximal portion and a distal portion, where one of the proximal or distal portions fixedly adheres to the metal backbone first portion and the other of the proximal or distal portions slideably couples to the metal backbone first portion.
Across the independent claim, the main inventive concept is the combined use of an SMP foam that transitions from secondary to primary shape when heated above its transition temperature, and a metal backbone second portion that transitions from an uncoiled secondary shape to a coiled primary shape, with both components positioned in the distal end region of an outer conduit and with the SMP foam portions having fixed and slideable coupling to the metal backbone first portion.
Stated Advantages
Provides rapid thrombosis through self-expansion that fills a vessel lumen.
Allows visualization using ultrasound and/or fluoroscopy.
Documented Applications
Minimally invasive vascular occlusion using a polyurethane SMP foam system that self-expands in response to body temperature/moisture to fill a vessel lumen and promote thrombosis.
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