Vascular occlusion devices and methods
Inventors
Lubock, Paul • Quick, Richard • Rosenbluth, Robert • Cox, Brian J.
Assignees
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Publication Number
US-10660648-B2
Publication Date
2020-05-26
Expiration Date
Abstract
A vascular occlusion device includes a braided filament mesh structure defining a longitudinal axis. The mesh structure has a relaxed configuration in which it has an axial array of radially-extending occlusion regions, each of which has a proximal side and a distal side meeting at a peripheral edge, the sides of each occlusion region forming a first angle relative to the longitudinal axis. Each occlusion region is axially separated from the adjacent occlusion region by a reduced-diameter connecting region. The mesh structure is radially compressible to a compressed state in which it is deployed intravascularly to a target site through a catheter. Upon deployment, the device radially expands to a constrained configuration in which the peripheral edges of the occlusion regions engage the vascular wall, and the sides of the occlusion regions form a second angle relative to the longitudinal axis that is smaller than the first angle.
Core Innovation
The invention relates to an expandable braided-filament vascular occlusion device for embolizing a blood vessel having an endoluminal wall defining a vascular lumen. The device is advanced to a target site in a compressed state and then deployed by radially expanding from the compressed state to an expanded state while defining a longitudinal axis. In the expanded state, the device includes a plurality of radially extending regions that include apices contacting the endoluminal wall of the blood vessel.
A central structural feature is that each apex has a thickness along the longitudinal axis of the occlusion device, and the combined thicknesses of the apices are less than about 50% of a total length of the mesh structure along the longitudinal axis. The device geometry is described as forming a constrained occlusion configuration when deployed intravascularly, including a short focal occlusion zone, where disc/edge engagement with the vessel wall corresponds to a smaller second angle relative to the longitudinal axis.
The described device structure includes a longitudinally defined array of radially-extending disc-like occlusion regions separated by reduced-diameter connecting cores, with a relaxed-state angle that changes upon deployment in the vessel to form the constrained configuration. Additional described characteristics include optional non-structural thrombogenic fibers, radiopaque composite/tube filaments and fill ratios, and low-force detachment systems such as tether release and optional energy-assisted release.
Claims Coverage
The document provides three independent method claims that cover embolizing a blood vessel using a mesh-based endoluminal occlusion device advanced in a compressed state, radially expanded at a target site, detached from a pusher/catheter system, and maintained in the expanded state until embolization occludes blood flow. The key inventive features are the radially extending regions with apices contacting the vessel wall and the proportional apex-thickness limitation relative to the total mesh length, together with the compressed-to-expanded deployment and maintenance requirements.
Compressed-to-expanded radially expanding mesh occlusion deployment with vessel-wall contacting apices
Deploying the occlusion device at the target site in the blood vessel includes radially expanding the occlusion device from the compressed state to an expanded state, wherein the occlusion device includes a mesh structure defining a longitudinal axis, and in the expanded state includes a plurality of radially extending regions with individual ones of the radially extending regions including an apex that contacts the endoluminal wall of the blood vessel.
Proportional combined apex thickness limitation
In the expanded state, each of the apices has a thickness along the longitudinal axis of the occlusion device, and the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis.
Detachment from a pusher and maintaining expanded occlusion until embolization
Detaching the occlusion device from the pusher and maintaining the occlusion device in the expanded state at the target site in the blood vessel at least until the vascular lumen at the vascular site is embolized to occlude blood flow through the vascular lumen.
Catheter delivery in compressed state with expanded-state occlusion maintenance
Advancing an occlusion device through a catheter, in a compressed state, to a target site in the vascular lumen of the blood vessel, deploying the occlusion device at the target site by radially expanding from the compressed state to an expanded state, and maintaining the occlusion device in the expanded state at the target site at least until the vascular lumen at the vascular site is embolized to occlude blood flow through the vascular lumen.
Across the independent method claims, the inventive coverage centers on deploying a mesh structure with radially extending regions whose apices contact the endoluminal wall, enforcing a combined apex-thickness proportion less than about 50% of the mesh length along the longitudinal axis, and keeping the occlusion device in the expanded state until embolization occludes blood flow. The independent claims further specify compressed-state delivery to the target site and require detachment from a pusher in one independent claim or catheter-based delivery in another, followed by expanded-state maintenance.
Stated Advantages
Provides extensive parameter ranges and performance rationale for deliverability through microcatheters.
Supports focality via a short focal occlusion zone (occlusion length and contact region fraction).
Provides engagement stability, including constrained configuration and optional engagement features.
Documented Applications
Embolizing a blood vessel having an endoluminal wall defining a vascular lumen by advancing and deploying the occlusion device in the vascular lumen to a target site until blood flow through the vascular lumen is occluded.
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