Vascular occlusion devices and methods
Inventors
Lubock, Paul • Quick, Richard • Rosenbluth, Robert • Cox, Brian J.
Assignees
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Publication Number
US-11304701-B2
Publication Date
2022-04-19
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 document describes an implantable device for embolizing a blood vessel that includes a mesh structure configured to radially expand from a compressed delivery state to an expanded deployed state when positioned at a target site in the vascular lumen. In the delivery state, the mesh structure has a generally cylindrical shape. In the expanded state, the mesh structure includes a plurality of radially extending regions that are porous and configured to disrupt blood flow through the implantable device and the vascular lumen.
The radially extending regions include individual apices configured to contact the endoluminal wall of the blood vessel, where each apex has a thickness along a longitudinal axis and an edge radius between 0.10 mm and 0.40 mm. The combined thicknesses of the apices are less than about 50% of a total length of the mesh structure along the longitudinal axis. These geometric constraints define how the apices contribute to vessel contact while maintaining a bounded structural thickness relative to the mesh length.
The document further describes angular geometry relationships between relaxed or deployed configurations and a longitudinal axis. In a relaxed or unconstrained state, individual ones of the radially extending regions define a first angle relative to the longitudinal axis, and in a deployed or partially expanded state the individual radially extending regions define a second angle that is between about 20°-60° less than the first angle. The mesh structure is constrained by the blood vessel in the deployed state such that it is partially expanded, and is further configured to radially expand to a relaxed state when unconstrained, with apices in the partially-expanded state.
Claims Coverage
The provided independent claims (clm-00001, clm-00012, clm-00013, clm-00017) cover implantable endoluminal/within-blood-vessel embolization devices with radially expandable porous mesh regions, vessel-contacting apices, and geometric constraints on apex dimensions and thickness relative to mesh length. Across the independents, the angular relationship between relaxed and deployed/partially-expanded states and the partially-expanded-to-fully-expanded behavior are also central inventive aspects, with additional structural constraints specified in some independents.
Radially expandable mesh from compressed delivery state to expanded deployed state
A mesh structure configured to radially expand from a compressed delivery state to an expanded deployed state when the implantable device is positioned at a target site in the vascular lumen of the blood vessel, wherein in the delivery state the mesh structure has a generally cylindrical shape.
Porous radially extending regions to disrupt blood flow
In the expanded state the mesh structure includes a plurality of radially extending regions, wherein the radially extending regions are porous and configured to disrupt blood flow through the implantable device and the vascular lumen.
Apex contacting endoluminal wall with constrained edge radius
Individual ones of the radially extending regions include an apex configured to contact the endoluminal wall of the blood vessel, wherein each of the apices has an edge radius that is between 0.10 mm and 0.40 mm.
Limited combined apex thickness relative to mesh length
Each of the apices has a thickness along a longitudinal axis of an occlusion device, and wherein the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis.
Partially expanded deployed state constrained by the blood vessel with further expansion to relaxed
A mesh structure configured to radially expand from a compressed delivery state to an expanded deployed state when positioned at a target site in the vascular lumen, wherein the mesh structure is constrained by the blood vessel in the deployed state such that the mesh structure is partially expanded in the deployed state, and wherein the mesh structure is further configured to radially expand to a relaxed state when the mesh structure is unconstrained by the blood vessel.
Angular reduction of radially extending regions from relaxed to deployed state
In the relaxed state, individual ones of the radially extending regions define a first angle relative to a longitudinal axis, and wherein in the deployed state individual ones of the radially extending regions define a second angle that is between about 20°-60° less than the first angle.
Expanded/partially-expanded state porous regions impeding blood flow with apex vessel wall contact
In the deployed and relaxed states, the mesh structure includes a plurality of radially extending regions, wherein in the relaxed state the radially extending regions are porous and configured to disrupt blood flow through the implantable device and the vascular lumen, and individual ones of the radially extending regions include an apex configured to contact the endoluminal wall of the blood vessel.
Apex thickness limiting in embolization device to less than about 50%
Each of the apices has a thickness along a longitudinal axis of an occlusion device, and wherein the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis.
Radially expandable mesh within the blood vessel from compressed state to expanded state
A mesh structure configured to radially expand from a compressed state to an expanded state within the blood vessel, wherein in the compressed state the mesh structure has a generally cylindrical shape.
Porous radially extending regions configured to impede blood flow
In the expanded state the mesh structure includes a plurality of radially extending regions, wherein the radially extending regions are porous and configured to impede blood flow through a vascular lumen.
Apex thickness less than about 1 mm with constrained edge radius
Individual ones of the radially extending regions include an apex configured to contact a wall of the blood vessel, wherein each of the apices has a thickness along a longitudinal axis of the device of less than about 1 mm, and each of the apices has an edge radius that is between 0.10 mm and 0.40 mm.
Apex thickness combined limit to less than about 50% of mesh length
The combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis.
Compressed to partially-expanded state with further expansion to fully-expanded when unconstrained
A mesh structure configured to radially expand from a compressed state to a partially-expanded state within the blood vessel, wherein the mesh structure is further configured to radially expand to a fully-expanded state when the mesh structure is unconstrained by the blood vessel.
Angular relationship between first angle in fully-expanded state and second angle in partially-expanded state
In the fully-expanded state, individual ones of the radially extending regions define a first angle relative to a longitudinal axis, in the partially-expanded state individual ones of the radially extending regions define a second angle relative to the longitudinal axis, and the second angle is between about 20°-60° less than the first angle.
Porous radially extending regions in partially-expanded state to impede blood flow
In the partially-expanded state the radially extending regions are porous and configured to impede blood flow through a vascular lumen.
Apex configured to contact vessel wall with substantially symmetric circular cross-section
Individual ones of the radially extending regions include an apex configured to contact a wall of the blood vessel, wherein each of the radially extending regions are substantially symmetric about a plane extending through the apex and perpendicular to the longitudinal axis and have a circular cross-sectional shape along the plane.
Combined apex thickness limit relative to mesh length
Each of the apices has a thickness along the longitudinal axis of the 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.
Taken together, the independent claims consistently require a mesh structure radially expandable from a compressed generally cylindrical delivery state to an expanded/deployed state within a blood vessel, where porous radially extending regions disrupt or impede blood flow. They further require vessel-wall-contacting apices with constrained edge radius (0.10 mm to 0.40 mm) and a limitation that the combined apex thicknesses are less than about 50% of the mesh length. Key claim differences focus on constrained partially-expanded deployment with further expansion to relaxed/fully-expanded states and an angular change where the deployed/partially-expanded angle is between about 20°-60° less than a relaxed/fully-expanded reference angle, with additional constraints including apex thickness less than about 1 mm and substantially symmetric circular cross-sectional geometry.
Stated Advantages
Documented Applications
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