Vascular occlusion devices and methods

Inventors

Lubock, PaulQuick, RichardRosenbluth, RobertCox, Brian J.

Assignees

Okami Medical Inc

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Publication Number

US-10376267-B2

Patent

Publication Date

2019-08-13

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 embolizing a blood vessel by delivering an expandable self-expanding braided-filament occlusion device intravascularly using a catheter and deploying it within a target vascular site. The occlusion device has a longitudinal axis and comprises a braided filament mesh extending between a proximal device end and a distal device end, with filaments terminating at a proximal hub and a distal hub.

In a relaxed configuration, the device includes a plurality of radially-extending occlusion regions that have a proximal side and a distal side meeting at a peripheral edge. Upon deployment from a radially-compressed configuration, the device expands radially within the vascular lumen so that the peripheral edge of each radially-extending occlusion region engages the endoluminal wall at the target vascular site.

The occlusion device defines an occlusion zone in the vascular lumen between the peripheral edge of a most distal one of the occlusion regions and the peripheral edge of a most proximal one of the occlusion regions. The peripheral edges of the occlusion regions contact less than about 25% of the endoluminal wall surface area defined by the occlusion zone, while still maintaining engagement with the endoluminal wall.

The invention further includes maintaining engagement of the peripheral edge with the endoluminal wall at the deployed position at least until the vascular lumen at the target vascular site is embolized to occlude blood flow through the vascular lumen. Dependent claim language and disclosed structure emphasize deployment geometry and braided-mesh mechanics, including first and second angles relative to the longitudinal axis in relaxed and deployed configurations, and force behavior in which outward force at the peripheral edges increases with blood-flow pressure and resists downstream movement of the occlusion device.

Claims Coverage

The partial content includes two independent methods. Each independent claim is grounded in delivering a catheter-deployed braided filament occlusion device, deploying to engage the endoluminal wall, and maintaining engagement until embolization to occlude blood flow, with specific geometric and coverage constraints tied to contact area and occlusion-zone definition.

Catheter-delivered braided-filament occlusion device deployment for embolizing

Providing a catheter dimensioned to be introduced intravascularly to a target vascular site, providing an occlusion device comprising a braided filament mesh with proximal and distal hubs, advancing the catheter to position its distal open end in or near the target vascular site, advancing the occlusion device in a radially-compressed configuration through the catheter lumen until the occlusion device emerges from the open distal end into the vascular lumen for deployment, allowing the occlusion device to expand radially to a deployed configuration at the target vascular site, and maintaining the peripheral edge of each radially-extending occlusion region in engagement with the endoluminal wall at least until the vascular lumen is embolized to occlude blood flow.

Peripheral-edge contact area less than about 25% of the occlusion-zone endoluminal wall surface area

Defining an occlusion zone in the vascular lumen between the peripheral edge of a most distal occlusion region and the peripheral edge of a most proximal occlusion region, wherein the peripheral edges of the occlusion regions contact less than about 25% of the endoluminal wall surface area defined by the occlusion zone.

Relaxed-to-deployed occlusion-region angle reduction with thickness-limited peripheral edges

In the relaxed configuration, each radially-extending occlusion region defines a first angle relative to the longitudinal axis; in the deployed configuration, each occlusion region defines a second angle relative to the longitudinal axis less than the first angle; each peripheral edge has a thickness along the longitudinal axis; and the combined thicknesses of the peripheral edges is less than about 25% of a total length of the braided filament mesh along the longitudinal axis.

Maintaining engagement until embolization of the vascular lumen

Maintaining the peripheral edge of at least one of the radially-extending occlusion regions in engagement with the endoluminal wall at the target vascular site at least until the vascular lumen at the target vascular site is embolized to occlude blood flow through the vascular lumen.

Across the two independent claims, the core coverage is directed to deploying a braided-filament occlusion device via an intravascular catheter so that peripheral edges engage the endoluminal wall, defining an occlusion zone with limited peripheral-edge contact area and a thickness constraint, and maintaining engagement until blood-flow occlusion.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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