Patent Description:
The present technology is directed generally to devices, systems, and methods for the treatment of vascular defects.

Aneurysms are blood-filled dilations of a blood vessel generally caused by disease or weakening of the blood vessel wall. The wall of the aneurysm may progressively thin, which increases the risk of rupture causing hemorrhagic stroke or even sudden death. There are about <NUM>,<NUM> to <NUM>,<NUM> cases of aneurysmal rupture per year in the United States, accounting for about <NUM>% of all strokes. The prognosis after aneurysmal rupture is poor; the <NUM>-day mortality rate is approximately <NUM>% and a positive functional outcome is achieved in only <NUM>-<NUM>% of survivors. Traditional approaches to preventing aneurysmal rupture often include packing the aneurysm with metal coils to reduce the inflow of blood to the aneurysm and prevent further enlargement and rupture. Such coils are often referred to as "embolic coils" or "microcoils," and can be categorized into the following three groups based on their structural properties: framing coils, filling coils, and finishing coils. Framing coils are inserted first into the aneurysm and form the base structure into which the later-delivered filling coils are packed. As such, framing coils are stiffer than filling and finishing coils to provide structural stability and generally have a complex or three-dimensional shape for approximating the periphery of the aneurysm. Filling coils, in contrast, are softer than framing coils, and multiple filling coils are packed within the framework of the framing coil(s) to achieve a high packing density. Finishing coils are delivered last to fill any remaining gaps left between filling coils.

Embolic coils, however, have several drawbacks. First, embolic coils generally only achieve a <NUM>-<NUM>% packing density (i.e., ratio of the volume of the coils inserted into the aneurysm sac and the volume of the aneurysm sac). As a result, blood continues to flow into the aneurysm (also known as recanalization) in about <NUM>% of coil cases, which can cause further swelling of the aneurysm over time. In addition, because the coils must be very small to fit within a microcatheter for delivery through the tiny cranial vessels, numerous coils are often required to adequately fill the aneurysm. These numerous coils must be delivered one-by-one, thereby increasing procedure time and complexity. Yet another drawback is that embolic coils cannot accommodate the wide range of aneurysm shapes and sizes. Embolic coils, for example, are difficult to stabilize within wide-necked aneurysms, which can result in migration of one or more coils across the neck such that a portion of the migrated coil(s) protrudes into the parent blood vessel. The protruding portion of the migrated coil(s) can be a nidus for thromboembolism, which can be fatal if left unaddressed. To address this shortcoming, many existing treatments include positioning an intracranial stent across the neck of the aneurysm to prevent all or part of a coil from migrating across the neck. However, intracranial stents can also be a nidus for thromboembolism, and further increase procedure time and cost. Thus, there is a need for improved devices, systems, and methods for treating aneurysms. Document <CIT> relates to devices for treating vascular defects such as aneurysms.

The present technology is directed generally to devices, systems, and methods for the treatment of vascular defects, and in particular, to vascular occlusion devices for treating hemorrhagic stroke. The present technology includes an expandable occlusion device comprising a mesh structure having a low-profile state for intravascular delivery to an aneurysm and an expanded state in which the mesh is configured to be positioned within the interior cavity of the aneurysm. As used herein, "mesh" or "mesh structure" may refer to a stent, a braid, a lattice, a weave, a laser-cut sheet, and/or any other suitable porous structures. The occlusion device includes a mesh structure having two or more mesh portions that have different shapes and/or configurations. The mesh portions complement one another when positioned together within the aneurysm to stabilize and/or anchor the mesh within the aneurysm, fill space within the aneurysm, and/or seal the neck of the aneurysm to prevent or reduce blood flow therethrough.

According to an aspect, the first and second elongated meshes are self-expanding. According to an aspect, the first and second bands together bound a generally spherical shape, and wherein the first and second bands conform to an interior geometry of the aneurysm when the device is positioned within the aneurysm. According to an aspect, the device is configured to be positioned in the aneurysm in an expanded state such that the first or second overlap region is positioned at the neck of the aneurysm, thereby substantially covering the neck and reducing blood flow through the neck from a parent vessel.

According to an aspect, the first axis is generally perpendicular to the second axis. Each of the first and second bands have a generally constant width along their respective circumferential lengths. According to an aspect, the occlusion device comprises a third elongated mesh having a low-profile state for intravascular delivery to the aneurysm and an expanded state in which the third elongated mesh is curved about a third axis different than the first axis and the second axis to form a third band.

According to an aspect, at least one of the first elongated mesh and the second elongated mesh is a braid. According to an aspect, at least one of the first elongated mesh and the second elongated mesh is a flattened tubular braid. The device includes a flexible joint between a distal end of the first elongated mesh and a proximal end of the second elongated mesh.

According to an aspect, the first elongated mesh and the second elongated mesh are formed of a single, continuous elongated mesh, and wherein the joint is a narrowed region of the mesh configured to direct a proximal portion of the second elongated mesh away from the first band when the device is in an expanded state. According to an aspect, the first elongated mesh and second elongated mesh are discrete, separate meshes, and wherein the joint is a coupler.

According to an aspect, the first and second elongated meshes have at least two layers such that the first and second overlap regions of the device include at least four mesh layers. According to an aspect, a proximal end of the first elongated mesh is configured to be detachably coupled to an elongated delivery member.

According to an aspect, a distal end of the second elongated mesh is coupled to an atraumatic lead-in member that extends distally from the second elongated mesh. According to an aspect, the device includes a plurality of openings between the first and second elongated meshes.

According to an aspect, the first and second bands together bound a predetermined, three-dimensional shape, the first elongated mesh has first longitudinal side edges, the second elongated mesh is bound by second longitudinal side edges, and when the device is in the expanded state, the first and the second side edges are spaced apart from one another along at least a portion of their circumferential lengths such that the device includes openings at its outer surface.

According to an aspect, the first and second bands together bound a predetermined, three-dimensional shape, the first elongated mesh has first longitudinal side edges, the second elongated mesh is bound by second longitudinal side edges, and when the device is in the expanded state, the first and the second side edges contact one another along at least a portion of their circumferential lengths and/or overlap one another along at least a portion of their circumferential lengths such that the first and second bands define a continuous outer surface of the three-dimensional shape.

According to an aspect, in the expanded state, the first band is an open band such that when the first band is viewed in cross section, it does not form a closed shape. According to an aspect, in the expanded state, the second band is an open band such that when the second band is viewed in cross section, it does not form a closed shape. According to an aspect, in the expanded state, the first band is a closed band such that when the first band is viewed in cross section, it forms a closed shape.

According to an aspect, in the expanded state, the second band is a closed band such that when the second band is viewed in cross section, it forms a closed shape. According to an aspect, the first and second bands together bound a predetermined, three-dimensional shape.

According to an aspect, an occlusive device is described for treating an aneurysm, wherein a neck of the aneurysm opens to a blood vessel, the device comprising: a first elongated mesh strip having a low-profile state for intravascular delivery to the aneurysm and an expanded state in which the first elongated mesh strip is curved about a first axis to form a first band encircling at least a portion of a first opening; a second elongated mesh strip having a low-profile state for intravascular delivery to the aneurysm and an expanded state in which the second elongated mesh strip is curved about a second axis to form a second band encircling at least a portion of a second opening; and a third elongated mesh strip having a low-profile state for intravascular delivery to the aneurysm and an expanded state in which the third elongated mesh strip is curved about a third axis to form a third band encircling at least a portion of a third opening, wherein, when the device is in an expanded, unconstrained state, the first, second, and third openings are aligned with first, second, and third planes, respectively, and the first second and third planes are perpendicular to one another.

According to an aspect, the first, second, and third elongated mesh strips are self-expanding. According to an aspect, the first, second, and third bands together bound a generally spherical shape, and wherein the first, second, and third bands conform to an interior geometry of the aneurysm when the device is positioned within the aneurysm.

According to an aspect, the device includes: first and second overlap regions in which the first band intersects the second band; third and fourth overlap regions in which the first band intersects the third band; and fifth and sixth overlap regions in which the second band intersects the third band.

According to an aspect, the device is configured to be positioned in the aneurysm in an expanded state such that at least one of the first-sixth overlap regions are positioned at the neck of the aneurysm, thereby substantially covering the neck and reducing blood flow from a parent vessel through the neck. According to an aspect, at least one of the first, second, and third elongated mesh strips is a braid.

According to an aspect, at least one of the first, second, and third elongated mesh strips is a flattened tubular braid. According to an aspect, wherein a distal end of the first elongated mesh strip is coupled to a proximal end of the second elongated mesh strip at a first joint, and a distal end of the second elongated mesh strip is coupled to a proximal end of the third elongated mesh strip at a second joint.

According to an aspect, the third elongated mesh is configured to be released from a delivery catheter before the second elongated mesh, and the second elongated mesh is configured to be released from a delivery catheter before the first elongated mesh. According to an aspect, wherein a proximal end of the first elongated mesh strip is configured to be detachably coupled to an elongated delivery member.

According to an aspect, a distal end of the third elongated mesh strip is coupled to an atraumatic lead-in member that extends distally from the third elongated mesh. According to an aspect, when the device is in an expanded, unconstrained state, the third band is radially inward of the second band, and the second band is radially inward of the first band.

According to an aspect, wherein the first, second, and third elongated mesh strips are formed of a single, continuous elongated mesh. According to an aspect, wherein the first, second, and third elongated mesh strips are discrete, separate meshes.

According to an aspect, the first, second, and third bands together bound a predetermined, three-dimensional shape, the first elongated mesh has first longitudinal side edges, the second elongated mesh is bound by second longitudinal side edges, the third elongated mesh is bound by third longitudinal side edges, and when the device is in the expanded state, the first, second, and third side edges are spaced apart from one another along at least a portion of their circumferential lengths such that the device includes openings at its outer surface.

According to an aspect, wherein: the first, second, and third bands together bound a predetermined, three-dimensional shape, the first elongated mesh has first longitudinal side edges, the second elongated mesh is bound by second longitudinal side edges, and when the device is in the expanded state, the first and the second side edges contact one another along at least a portion of their circumferential lengths and/or overlap one another along at least a portion of their circumferential lengths such that the first, second, and third bands define a continuous outer surface of the three-dimensional shape.

According to an aspect, in the expanded state, the first band is an open band such that when the first band is viewed in cross section, it does not form a closed shape. According to an aspect, in the expanded state, the second band is an open band such that when the second band is viewed in cross section, it does not form a closed shape.

According to an aspect, in the expanded state, the third band is an open band such that when the third band is viewed in cross section, it does not form a closed shape. According to an aspect, in the expanded state, the first band is a closed band such that when the first band is viewed in cross section, it forms a closed shape.

According to an aspect, in the expanded state, the second band is a closed band such that when the second band is viewed in cross section, it forms a closed shape. According to an aspect, in the expanded state, the third band is a closed band such that when the third band is viewed in cross section, it forms a closed shape.

According to an aspect, wherein the first, second, and third bands together bound a predetermined, three-dimensional shape.

According to an aspect (not forming part of the claimed invention), a method for treating an aneurysm with an occlusive device including a first elongated mesh and a second elongated mesh is described, wherein a neck of the aneurysm opens to a blood vessel, the method comprising: pushing the first elongated mesh distally from a delivery catheter into an interior region of the aneurysm, wherein pushing the first elongated mesh distally includes curving the first elongated mesh back on itself to form a first band that expands against and conforms to an inner surface of the aneurysm wall; pushing a second elongated mesh distally from the delivery catheter into the interior region of the aneurysm, wherein pushing the second elongated mesh distally includes curving the second elongated mesh back on itself to form a second band that expands against and conforms to the inner surface of the aneurysm wall, wherein the first and second bands intersect at first and second overlap regions when the device is in an expanded state; and positioning the device within the aneurysm such that the first or second overlap region is positioned at the neck of the aneurysm, thereby substantially covering the neck and reducing blood flow from a parent vessel through the neck.

According to an aspect, the first elongated mesh is pushed distally from the delivery catheter before the second elongated mesh is pushed distally from the delivery catheter. According to an aspect, curving the first elongated mesh back on itself to form a first band includes curving the first elongated mesh around a first axis; and curving the second elongated mesh back on itself to form a second band includes curving the second elongated mesh around a second axis different than the first axis.

According to an aspect, the first axis is perpendicular to the second axis. According to an aspect, the first and second elongated meshes are formed of a single, continuous elongated mesh. According to an aspect, the first and second elongated meshes are discrete, separate meshes.

According to an aspect, the method can further comprise pushing a third elongated mesh distally from the delivery catheter into the interior region of the aneurysm, wherein pushing the third elongated mesh distally includes curving the third elongated mesh back on itself to form a third band that expands against and conforms to the inner surface of the aneurysm wall.

According to an aspect, the third band is an open band. According to an aspect the third band is a closed band. According to an aspect, the first band intersects the third band at third and fourth overlap regions of the device, and the second band intersects the third band at fifth and sixth overlap regions of the device.

According to an aspect, the method can further comprise positioning the device within the aneurysm such that one or more of the first-sixth overlap regions are positioned at the neck of the aneurysm. According to an aspect, curving the first elongated mesh back on itself to form a first band includes curving the first elongated mesh around a first axis; curving the second elongated mesh back on itself to form a second band includes curving the second elongated mesh around a second axis different than the first axis; and curving the third elongated mesh back on itself to form a third band includes curving the third elongated mesh around a third axis different than the first and second axes.

According to an aspect, the first, second, and third axes are perpendicular to one another. According to an aspect, the first band is an open band. According to an aspect, the first band is a closed band. According to an aspect, wherein the second band is an open band. According to an aspect, the second band is a closed band. Example <NUM>.

According to an aspect, a method for treating an aneurysm comprising positioning any one of the occlusive devices described herein within an aneurysm is disclosed.

According to an aspect, a method for treating an aneurysm comprising positioning two or more of the occlusive devices described herein within an aneurysm, in succession is disclosed.

The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. However, the subject technology may be practiced without these specific details.

<FIG> shows an occlusion device <NUM> in accordance with some embodiments of the present technology shown in an expanded, relaxed configuration outside of an aneurysm. <FIG> is a different view of the occlusion device <NUM> of <FIG> coupled to a delivery member <NUM>. As shown in <FIG> and <FIG>, the occlusion device <NUM> comprises a mesh structure <NUM> having a low-profile state (not shown) for intravascular delivery to an aneurysm (e.g., a cerebral aneurysm) and an expanded state in which the mesh structure <NUM> is configured to be positioned within the interior cavity of the aneurysm. In the expanded state, the mesh structure <NUM> includes a plurality of interconnected, nested bands <NUM>, <NUM>, <NUM> that together define a predetermined three-dimensional shape, such as the spherical shape shown in <FIG>. Depending on the geometry of the aneurysm to be treated, the predetermined shape delimited by the bands <NUM>, <NUM>, <NUM> can be selected from a variety of spherical or non-spherical shapes, including cylinders, hemispheres, noodles, polyhedrons (e.g., cuboids, tetrahedrons (e.g. pyramids), octahedrons, prisms, etc.), prolate spheroids, oblate spheroids, plates (e.g., discs, polygonal plates), bowls, non-spherical surfaces of revolution (e.g., toruses, cones, cylinders, or other shapes rotated about a center point or a coplanar axis), and combinations thereof. In <FIG>, the mesh structure <NUM> includes three bands (referred to as first, second, and third bands <NUM>, <NUM>, <NUM>). In some embodiments, the mesh structure <NUM> can have more or fewer than three bands (e.g., two bands, four bands, five bands, six bands, etc.).

<FIG> is a top view of the occlusion device <NUM> after being unfurled from the deployed, relaxed configuration shown in <FIG> and held in an unfurled, elongated configuration to provide a better view of the entire length of the occlusion device <NUM>. Referring to <FIG> together, in some embodiments the mesh structure <NUM> can be formed of a single, continuous mesh ribbon <NUM> such that each of the bands <NUM>, <NUM>, <NUM> is formed of a different portion of the ribbon <NUM>. In some embodiments, the bands <NUM>, <NUM>, <NUM> are formed of separate meshes and are joined end-to-end by one or more coupling elements. As best shown in <FIG>, the mesh ribbon <NUM> has a proximal end portion 102a, a distal end portion 102b, a longitudinal axis L extending between the proximal and distal end portions 102a, 102b, and side edges 110a and 110b extending longitudinally between the proximal and distal end portions 102a, 102b. In some embodiments, such as that shown in <FIG>, the occlusion device <NUM> includes a proximal connector <NUM> and a distal connector <NUM> coupled to the proximal and distal end portions 102a, 102b, respectively, of the mesh ribbon <NUM>. The proximal connector <NUM> may be configured to detachably couple the occlusion device <NUM> to a delivery system, and the distal connector <NUM> may be configured to couple a lead-in member to the mesh structure <NUM>, as described in greater detail below with respect to <FIG>.

The mesh ribbon <NUM> can be formed of a tubular mesh that has been flattened along its longitudinal axis such that opposing portions of the sidewall are pressed against one another and/or into close proximity with one another. In some embodiments, the mesh ribbon <NUM> is formed of a flattened tubular braid. The braid may be formed of a plurality of wires, at least some of which (e.g., <NUM>% of the wires, <NUM>% of the wires, <NUM>% of the wires, <NUM>% of the wires, etc.) are made of one or more shape memory and/or superelastic materials (e.g., Nitinol). In some embodiments, at least some of the plurality of wires may be drawn-filled tubes ("DFT") having a have a radiopaque core (e.g., platinum) surrounded by a shape memory alloy and/or superelastic alloy (e.g., Nitinol). In these and other embodiments, at least a portion of the wires can be made of other suitable materials.

In some embodiments, the mesh ribbon <NUM> includes a plurality of band portions <NUM>, <NUM>, <NUM> positioned along its longitudinal axis L, and one or more bend portions <NUM> individually positioned between adjacent band portions <NUM>, <NUM>, <NUM> along the longitudinal axis L. The first, second, and third band portions <NUM>, <NUM>, <NUM> may be configured to form the first, second, and third bands <NUM>, <NUM>, <NUM>, respectively, when the mesh structure <NUM> is in the expanded state. For example, as shown in <FIG>, the mesh ribbon <NUM> may include a first band portion <NUM>, a second band portion <NUM> distal of the first band portion <NUM> along the longitudinal axis L, and a third band portion <NUM> distal of the second band portion <NUM> along the longitudinal axis L. When the mesh structure <NUM> is in an expanded state, the first band portion <NUM> curves around a first axis (coming out of the page) to form the first band <NUM>, the second band portion <NUM> curves around the second axis A2 to form the second band <NUM>, and the third band portion <NUM> may curve around a third axis A3 to form the third band <NUM>.

The occlusion device <NUM> is configured to be positioned in a compressed or low-profile state within a delivery catheter (e.g., a microcatheter) so that the distal end 102b of the mesh structure <NUM> is closest to the distal opening of the catheter and thus will be released from the delivery catheter first. Accordingly, the third band <NUM> deploys first from the delivery catheter, followed by the second band <NUM> and the first band <NUM>. As a result, the second band <NUM> expands within an interior region defined by the already-expanded third band <NUM>, and the first band <NUM> expands within an interior region defined by the already-expanded second band <NUM>. Thus, when the mesh structure <NUM> is in an expanded configuration positioned within the aneurysm, the second band <NUM> is positioned radially inward of the third band <NUM>, and the first band <NUM> is positioned radially inward of the second band <NUM>. Even if one of the bands <NUM>, <NUM>, <NUM> is positioned radially inwardly of another of the bands <NUM>, <NUM>, <NUM> in the expanded configuration, when the mesh structure <NUM> is expanded within an aneurysm, any radially inward band may still contact and conform to the inner surface of the aneurysm along its non-overlapping regions, especially if the diameter of the mesh structure <NUM> in the expanded, relaxed state is greater than that of the aneurysm. In some embodiments, when the mesh structure <NUM> is in an expanded state, an outer surface of the second band <NUM> contacts an inner surface of the third band <NUM> at the corresponding overlapping regions, and an outer surface of the first band <NUM> contacts an inner surface of the second band <NUM> at the corresponding overlapping regions.

Because the bands <NUM>, <NUM>, <NUM> are oriented along different planes, the bands <NUM>, <NUM>, <NUM> overlap one another along their respective circumferences, thereby forming a plurality of overlapping regions in which the porosity of the mesh structure <NUM> is less than it is at the non-overlapping regions of the mesh structure <NUM>. For example, as shown in <FIG>, the mesh structure <NUM> may include six overlapping regions (e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>). Depending on the number of the bands and width of the bands, the mesh structure <NUM> may include more or fewer overlapping regions (e.g., two overlapping regions, eight overlapping regions, etc.). The occlusion device <NUM> may be configured to be positioned within the aneurysm so that at least one of the overlapping regions is positioned over all or a portion of the neck of the aneurysm, thereby preventing egress of the device <NUM> into the parent vessel, and also disrupting the flow of blood into the aneurysm. Even if a single overlapping region covers only a portion of the aneurysm neck, the portions of the bands adj acent that overlapping region collectively provide complete or near complete neck coverage.

In some embodiments, for example as shown in <FIG>, when the device <NUM> is in the expanded state, the side edges 110a, 110b of each of the bands are spaced apart from the side edges of the other bands along at least a portion of their circumferential lengths such that the device includes openings <NUM> at its outer surface. In some embodiments, when the device <NUM> is in the expanded state, the device <NUM> may be configured such that the side edges 110a, 110b contact one another along at least a portion of their circumferential lengths and/or overlap one another along at least a portion of their circumferential lengths such that the bands together define a continuous outer surface of the three-dimensional shape formed by the bands (such as a sphere).

Each of the bands <NUM>, <NUM>, <NUM> may be a closed band (e.g., circumscribes a closed shape) (shown schematically in <FIG>) or an open band (e.g., circumscribes an open shape) (shown schematically in <FIG>). For example, as shown in <FIG>, in some embodiments the third band portion <NUM> may curve <NUM> degrees around the third axis A3 (coming out of the page in <FIG>) such that the proximal end 146a of the third band portion <NUM> comes back around and meets the distal end 146b of the third band portion <NUM>, thereby closing the loop and forming a closed band. As illustrated by <FIG>, in some embodiments the third band portion <NUM> may wrap around the third axis A3 more than <NUM> degrees such that it overlaps itself (i.e., the proximal end 146a extends circumferentially beyond the distal end 146b) along at least a portion of the circumference of the band <NUM>, thereby forming a closed band. As illustrated by <FIG>, in some embodiments the third band portion <NUM> may curve around the third axis A3 less than <NUM> degrees (e.g., <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees, <NUM> degrees, etc.) such that the proximal end 146a of the third band portion <NUM> does not meet the distal end 146b, thereby forming an open band. The foregoing description of the "closed" and "open" configurations of the third band <NUM>/third band portion <NUM> also applies to the "closed" and "open" configurations of the first band <NUM>/first band portion <NUM> and the second band <NUM>/second band portion <NUM>. In some embodiments, all of the bands <NUM>, <NUM>, <NUM> may be closed bands, and in some embodiments all of the bands <NUM>, <NUM>, <NUM> may be open bands. In some embodiments, at least one of the bands <NUM>, <NUM>, <NUM> is an open band and at least one of the bands <NUM>, <NUM>, <NUM> is a closed band. In some embodiments, it may be beneficial to include at least one open band as such a configuration decreases the overall length of the mesh ribbon <NUM> (thus making the occlusion device <NUM> easier to deliver through a catheter to the aneurysm) and/or frees up some of the length of the mesh ribbon <NUM> that can instead be used for additional bands or turns of the mesh.

The bands <NUM>, <NUM>, <NUM>/band portions <NUM>, <NUM>, <NUM> can have the same or different widths w (i.e., distance between the side edges 110a, 110b) as the other bands/band portions. As shown in <FIG>, each of the bands <NUM>, <NUM>, <NUM> may have tapered proximal and distal ends and a generally constant width therebetween. In some embodiments, the bands/band portions do not have any tapered regions and maintain a generally constant width along their entire respective lengths. In some embodiments not falling under the wording of the independent claim, one or more of the bands/band portions have a width w that varies along its respective length.

As shown in <FIG>, adjacent bands/band portions may be coupled to one another via the bend portions. In those embodiments where the bands <NUM>, <NUM>, <NUM> are formed of a single mesh ribbon, the bend portions can be narrowed regions of the mesh ribbon <NUM> that have been heat set to form a predetermined bend when the mesh structure <NUM> is in the expanded state. For example, in some embodiments the first band <NUM>/first band portion <NUM> may be coupled to the second band <NUM>/second band portion <NUM> by a proximal narrowed region <NUM>, and the second band <NUM>/second band portion <NUM> may be coupled to the third band <NUM>/third band portion <NUM> by a distal narrowed region <NUM>. At least when the mesh structure <NUM> is in the expanded, relaxed state, each of the narrowed regions <NUM>, <NUM> can have a width that is less than a width w of each of the band/band portions. In those embodiments where the bands/band portions are formed of separate, discrete mesh ribbons, the bend portions can comprise separate coupling elements that link the ends of adjacent bands/band portions (such as the articulation joints shown in <FIG> and <FIG>).

Referring to <FIG>, when the mesh structure <NUM> is in an expanded state, each of the bands <NUM>, <NUM>, <NUM> may be centered about a different axis. For example, the narrowed regions <NUM> and <NUM> are heat set to form a predetermined bend in the mesh ribbon <NUM> in the expanded configuration that positions the bands <NUM>, <NUM>, <NUM> at a predetermined angle relative to one another. In some embodiments, such as that shown in <FIG>, the individual axes of the bands <NUM>, <NUM>, <NUM> may be perpendicular to one another.

In some embodiments the occlusion device <NUM> may optionally include a soft, curved lead-in member <NUM> coupled to the distal end portion 102b of the mesh structure <NUM> via the distal connector <NUM>. The lead-in member <NUM> may have a curved shape in a deployed configuration. For example, the lead-in member <NUM> initially extends distally with respect to the mesh structure <NUM> (e.g., from the distal connector <NUM>) then curves proximally. Because the lead-in member <NUM> is the first portion of the occlusion device <NUM> that exits the delivery catheter and contacts the aneurysm wall, the soft material and/or curved shape of the lead-in member <NUM> reduces or eliminates stress on the aneurysm wall when delivering the occlusion device <NUM> to the aneurysm sac. In some embodiments the lead-in member <NUM> can be generally straight and/or have other atraumatic yet sufficiently resilient configurations. In some embodiments, the lead-in member <NUM> is a curled mesh (e.g., a braid) that is coupled to the distal connector <NUM>. The curled mesh can be integral with the mesh that forms the mesh structure <NUM>, or the curled mesh can be a separate mesh. In some embodiments, the lead-in member <NUM> is a separate, coiled tube (e.g., a radiopaque coil) that is coupled to the distal connector <NUM>. In some embodiments, the lead-in member <NUM> can be formed integrally or monolithically with the occlusion device <NUM>. In yet other embodiments, the occlusion device <NUM> does not include a lead-in member <NUM> and the distal portion of the occlusion device <NUM> is comprised solely of the distal connector <NUM> and/or distal end portion 102b of the mesh structure <NUM>.

In some embodiments, the stiffness of the mesh structure <NUM> and/or occlusion device <NUM> is generally constant along its longitudinal axis L. In some embodiments, the stiffness of the mesh structure <NUM> and/or occlusion device <NUM> varies along its longitudinal axis L. For example, the stiffness of one or more portions of the mesh ribbon <NUM> and/or mesh structure <NUM> can be different than other portions of the mesh ribbon <NUM> and/or mesh structure <NUM> by varying one or more parameters such as the materials, porosity, thickness, braid count (if applicable), and braid pitch (if applicable) in the individual portions. For example, for the mesh ribbon <NUM> shown in <FIG>, it may be desirable for the more distal first band portion <NUM> comprising the outermost portion of the mesh structure <NUM> to have a first stiffness for framing the aneurysm, and the more proximal first and second band portions <NUM>, <NUM> comprising the inner mesh structures to have a second stiffness less than the first stiffness so that the first and second bands <NUM>, <NUM> are more flexible than the larger third band <NUM> for packing the aneurysm. Moreover, it may be desirable for the third band portion <NUM> to be relatively stiffer than the more proximal first and second band portions <NUM>, <NUM> since, once the occlusion device <NUM> is positioned within the aneurysm, the stiffness will enhance the anchoring and structural integrity of the first band <NUM>.

To enhance visibility of the occlusion device <NUM> and/or mesh structure <NUM> during delivery to the aneurysm and/or subsequent to implantation within the aneurysm, the occlusion device <NUM> may optionally include a flexible member (not shown), such as a radiopaque element (e.g., a platinum coil), that extends along and/or within at least a portion of the length of the mesh structure <NUM>. The proximal and distal ends of the flexible member are coupled to the proximal and distal end portions 102a, 102b, respectively, of the mesh structure <NUM> and/or the proximal and distal connectors <NUM>, <NUM>, respectively (e.g., directly or via a suture). In other embodiments, only one end of the flexible member is connected to one of the proximal connector <NUM> or the distal connector <NUM>.

In use, the occlusion device <NUM> is intravascularly delivered to a location within a blood vessel lumen L adjacent a target aneurysm A in a low-profile configuration (not shown) within a delivery catheter <NUM>. The distal portion of the delivery catheter <NUM> is then advanced through the neck N of the aneurysm A to an interior region of the aneurysm A. As shown in <FIG>, the occlusion device <NUM> is then deployed by pushing the occlusion device <NUM> distally through the distal opening of the delivery catheter <NUM> towards the inner wall of the aneurysm A. The third band portion <NUM> exits the delivery catheter <NUM> first and, as it's deployed, the third band portion <NUM> curves around the curved inner surface of the aneurysm A until forming the third band <NUM>. The distal narrowed region <NUM> deploys next and assumes a first predetermined bend that directs the following second band portion <NUM> to curve around the aneurysm wall about an axis that is perpendicular to the central axis of the third band <NUM>, thereby forming the second band <NUM>. The proximal narrowed region <NUM> deploys next and assumes a second predetermined bend that directs the following first band portion <NUM> to curve around the aneurysm wall about an axis that is perpendicular to a central axis of the third band <NUM> and a central axis of the second band <NUM>, thereby forming the first band <NUM>. As shown in <FIG>, at least one of the overlapping regions is positioned over all or a portion of the neck N, thereby preventing egress of the device <NUM> into the parent vessel, and also disrupting the flow of blood into the aneurysm A. Unlike conventional devices, the occlusion device <NUM> is configured to treat a range of aneurysm geometries without additional anchoring devices. For example, <FIG> show the occlusion device <NUM> anchored within and conformed to a tall aneurysm geometry (aspect ratio ≤ <NUM>:<NUM>), and <FIG> show the occlusion device <NUM> anchored within and conformed to a wide aneurysm geometry (aspect ratio ≥ <NUM>:<NUM>).

<FIG> show several embodiments of occlusion devices configured in accordance with the present technology. For example, <FIG> illustrates an occlusion device <NUM> (or "device <NUM>", not falling under the wording of the independent claim) comprising a mesh structure <NUM> having an expanded, relaxed state in which it includes a globular (e.g., cylindrical, spherical, ball-shaped, barrel-shaped, etc.) first portion <NUM> and a helical second portion <NUM>. In some embodiments, such as that shown in <FIG>, the first and second portions <NUM>, <NUM> can be separate meshes coupled via a coupling element <NUM>. In some embodiments, the first and second portions <NUM>, <NUM> can be formed from a single, continuous mesh such that the first and second portions <NUM>, <NUM> are integrally connected with one another. In some embodiments, one or both of the first and second portions <NUM>, <NUM> are formed of a braided material.

The globular first portion <NUM> can have a proximal connector <NUM> at its proximal end and a distal connector <NUM> at its distal end. The proximal connector <NUM> is configured to detachably couple the occlusion device <NUM> to a delivery device (such as delivery member <NUM>). As such, the helical second portion <NUM> is configured to be delivered first to the aneurysm, followed by the first portion <NUM>. The distal connector <NUM> may include a loop <NUM> extending therefrom and configured to engage and/or interlock with a loop <NUM> extending from a proximal connector <NUM> at a proximal end of the second portion <NUM>. The interlocking loops <NUM>, <NUM> allow the second portion <NUM> to bend and rotate (to some extent) relative to the first portion <NUM> (and vice versa), thus enabling the device <NUM> to adapt to the shape and size of the aneurysm.

The helical second portion <NUM> can be formed of a mesh ribbon <NUM> wrapped about an axis a plurality of times to form a plurality of mesh turns <NUM> (only two labeled for ease of illustration) in the expanded configuration. The mesh turns <NUM> may overlap one another along their edges. The mesh ribbon <NUM> can be formed of a tubular mesh (e.g., a braided tube) that has been flattened along its longitudinal axis such that opposing portions of the sidewall are pressed against one another and/or into close proximity with one another. In some embodiments, the mesh ribbon <NUM> is formed of a flattened tubular braid. The braid may be formed of a plurality of wires, at least some of which (e.g., <NUM>% of the wires, <NUM>% of the wires, <NUM>% of the wires, <NUM>% of the wires, etc.) are made of one or more shape memory and/or superelastic materials (e.g., Nitinol). In some embodiments, at least some of the plurality of wires may be drawn-filled tubes ("DFT") having a have a radiopaque core (e.g., platinum) surrounded by a shape memory alloy and/or superelastic alloy (e.g., Nitinol). In these and other embodiments, at least a portion of the wires can be made of other suitable materials.

<FIG> are fluoroscopic images the occlusion device <NUM> being deployed within a wide aneurysm in accordance with some embodiments of the present technology, and <FIG> are fluoroscopic images showing the occlusion device <NUM> being deployed within a tall aneurysm in accordance with some embodiments of the present technology. As shown, the helical second portion <NUM> may be deployed first within the aneurysm, followed by the first portion <NUM>. The globular first portion <NUM> can press outwardly against the aneurysm wall and help anchor the first portion <NUM> within the aneurysm. The globular first portion <NUM> can also fill any gaps at the neck of the aneurysm left by the second portion <NUM>.

<FIG> illustrates an occlusion device <NUM> (or "device <NUM>") comprising a mesh structure <NUM> having an expanded, relaxed state in which it includes a globular (e.g., cylindrical, spherical, ball-shaped, barrel-shaped, etc.) first portion <NUM> and a second portion <NUM>. In some embodiments, such as that shown in <FIG>, the first and second portions <NUM>, <NUM> can be separate meshes coupled via a coupling element <NUM>. In some embodiments, the first and second portions <NUM>, <NUM> can be formed from a single, continuous mesh such that the first and second portions <NUM>, <NUM> are integrally connected with one another. In some embodiments, one or both of the first and second portions <NUM>, <NUM> are formed of a braided material.

The globular first portion <NUM> can have a proximal connector <NUM> at its proximal end and a distal connector <NUM> at its distal end. The proximal connector <NUM> is configured to detachably couple the occlusion device <NUM> to a delivery device (such as delivery member <NUM>). The distal connector <NUM> may include a loop <NUM> extending therefrom and configured to engage and/or interlock with a loop <NUM> extending from a proximal connector <NUM> at a proximal end of the second portion <NUM>. The interlocking loops <NUM>, <NUM> allow the second portion <NUM> to bend and rotate (to some extent) relative to the first portion <NUM> (and vice versa), thus enabling the device <NUM> to adapt to the aneurysm cavity.

The second portion <NUM> can include a plurality of rectangular regions <NUM> separated by flexible, narrowed bend regions <NUM>. The second portion <NUM> may be formed of a mesh ribbon <NUM>. The mesh ribbon <NUM> can be formed of a tubular mesh (e.g., a braided tube) that has been flattened along its longitudinal axis such that opposing portions of the sidewall are pressed against one another and/or into close proximity with one another. In some embodiments, the mesh ribbon <NUM> is formed of a flattened tubular braid. The braid may be formed of a plurality of wires, at least some of which (e.g., <NUM>% of the wires, <NUM>% of the wires, <NUM>% of the wires, <NUM>% of the wires, etc.) are made of one or more shape memory and/or superelastic materials (e.g., Nitinol). In some embodiments, at least some of the plurality of wires may be drawn-filled tubes ("DFT") having a have a radiopaque core (e.g., platinum) surrounded by a shape memory alloy and/or superelastic alloy (e.g., Nitinol). In these and other embodiments, at least a portion of the wires can be made of other suitable materials.

<FIG> are fluoroscopic images showing the occlusion device <NUM> being deployed within a tall aneurysm in accordance with some embodiments of the present technology, and <FIG> are fluoroscopic images showing the occlusion device <NUM> being deployed within a wide aneurysm in accordance with some embodiments of the present technology. As shown, the second portion <NUM> may be deployed first within the aneurysm, followed by the first portion <NUM>. The globular first portion <NUM> can press outwardly against the aneurysm wall and help anchor the first portion <NUM> within the aneurysm. The globular first portion <NUM> can also fill any gaps at the neck of the aneurysm left by the second portion <NUM>.

Claim 1:
An occlusive device for treating an aneurysm, wherein a neck of the aneurysm opens to a blood vessel, the device comprising:
a first elongated mesh having a low-profile state for intravascular delivery to the aneurysm and an expanded state in which the first elongated mesh is curved about a first axis to form a first band (<NUM>, <NUM>); and
a second elongated mesh having a low-profile state for intravascular delivery to the aneurysm and an expanded state in which the second elongated mesh is curved about a second axis different than the first axis to form a second band (<NUM>, <NUM>), wherein the second band is positioned radially inward of the first band such that the device includes first and second overlap regions in which the first band (<NUM>, <NUM>) overlaps the second band (<NUM>, <NUM>), and wherein the first and second overlap regions are spaced apart from one another along a circumference of the first band (<NUM>, <NUM>), wherein the device includes a flexible joint between a distal end of the first elongated mesh and a proximal end of the second elongated mesh, wherein the first and second band (<NUM>, <NUM>, <NUM>, <NUM>) each comprise a proximal end portion and a distal end portion
characterised in that
the first and second band each comprise a generally constant width between the proximal end portion and the distal end portion in the expanded state.