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-11944317-B2
Publication Date
2024-04-02
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 invention relates to a minimally invasive vascular occlusion system that includes an outer conduit having proximal and distal ends, a polyurethane shape memory polymer foam, and a metal backbone. The SMP foam has proximal and distal ends and transitions from an SMP foam secondary shape to an SMP foam primary shape when heated above its transition temperature. The metal backbone includes a first portion 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, and the metal backbone second portion is positioned between the SMP foam distal end and the distal end of the outer conduit. The metal backbone second portion transitions from a secondary shape to a primary shape and includes an outer metal portion including a channel and an inner metal portion included within the channel. The SMP foam is slidingly coupled to the metal backbone.
Upon the SMP foam transitioning to the primary shape, the SMP foam and the metal backbone deploy to fill a vessel lumen and stabilize the implant via coil/anchor structures formed by the metal backbone second portion. The metal backbone second portion primary shape has a circular base between the SMP foam and a distal tip of the metal backbone, and the system supports tuning of SMP foam expansion kinetics. Radiopaque markers and visualization through ultrasound/fluoroscopy are also described in the performance and safety discussion.
Claims Coverage
The partial set provides two independent claims. Each independent claim centers on an outer conduit containing both an SMP foam and a metal backbone that undergo coordinated secondary-shape to primary-shape transitions when the SMP foam is heated above its transition temperature, with sliding coupling between the SMP foam and the metal backbone.
Secondary-to-primary SMP foam transition within an outer conduit
An outer conduit having proximal and distal ends, and an SMP foam having proximal and distal ends configured to transition from an SMP foam secondary shape to an SMP foam primary shape when the SMP foam is heated above its transition temperature.
Coordinated metal backbone transition positioned between SMP distal end and conduit distal end
A metal backbone including a first portion 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 metal backbone second portion is in the metal backbone second portion secondary shape and located between the SMP foam distal end and the distal end of the outer conduit, and is configured to transition from the metal backbone second portion secondary shape to a metal backbone second portion primary shape.
Outer metal portion with channel and inner metal portion within channel
The metal backbone second portion includes an outer metal portion including a channel and an inner metal portion included within the channel.
Circular-base metal backbone primary shape and sliding coupling of SMP foam to metal backbone
The metal backbone second portion primary shape has a circular base between the SMP foam and a distal tip of the metal backbone, and at least a portion of the SMP foam is slidingly coupled to the metal backbone.
Secondary-to-primary SMP foam transition within an outer conduit (independent claim 14)
An outer conduit having proximal and distal ends, and an SMP foam having proximal and distal ends configured to transition from an SMP foam secondary shape to an SMP foam primary shape when the SMP foam is heated above its transition temperature.
Coordinated metal backbone transition positioned between SMP distal end and conduit distal end (independent claim 14)
A metal backbone including a first portion 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 metal backbone second portion is in the metal backbone second portion secondary shape and located between the SMP foam distal end and the distal end of the outer conduit, and is configured to transition from the metal backbone second portion secondary shape to a metal backbone second portion primary shape.
Outer metal portion with channel and circular-base metal backbone primary shape (independent claim 14)
The metal backbone second portion includes an outer metal portion including a channel, and the metal backbone second portion primary shape has a circular base between the SMP foam and a distal tip of the metal backbone.
Sliding coupling of SMP foam to metal backbone (independent claim 14)
At least a portion of the SMP foam is slidingly coupled to the metal backbone.
Across both independent claims, the central inventive structure is a coordinated SMP foam and metal backbone deployment inside an outer conduit, where the SMP foam transitions from secondary to primary shape upon heating above its transition temperature while the metal backbone second portion transitions between corresponding shapes, including an outer metal portion with a channel, an inner metal portion within the channel, a circular-base primary shape, and sliding coupling of the SMP foam to the metal backbone.
Stated Advantages
Reduced radial force relative to vessel rupture thresholds, supporting safety.
Reduced device stiffness compared to commercial plugs.
Visualization during deployment using ultrasound/fluoroscopy, including echogenicity and radiopaque markers.
Documented Applications
Vessel occlusion, described in the context of minimally invasive vascular occlusion and chronic venous insufficiency (CVI).
Deployment in pig hind limb vessels, including in vitro blood perfusion testing and in vivo occlusion timing.
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