Vascular plug with proximal clotting medium

Abstract

A vascular plug for use in treating blood vessels that includes a self-expanding anchoring member and a clotting medium composed of a circular array of polymers. The vascular plug is configured to be delivered in a collapsed state by a pusher (delivery) wire through a microcatheter to a pre-determined site. Upon delivery, the microcatheter is slowly pulled back, allowing the anchoring member to expand to its delivered state and freeing the clotting medium. The plug is then detached leaving the clotting medium positioned in the vessel and held in place distally by the anchoring member within the vessel.

Description

[0001]

[0002] VASCULAR PLUG WITH PROXIMAL CLOTTING MEDIUM

[0003] BACKGROUND OF INVENTION

[0004] This application claims priority to provisional application 63 / 750,815, filed January 29, 2025, the entire contents of which are incorporated herein by reference.

[0005] Field of the Invention

[0006] This invention relates to medical devices, and more particularly, to occlusion devices used in vasculature.

[0007] Background

[0008] The technique of embolization using platinum coils coated with synthetic fibers as a way to treat malformations of the brain was first discussed in 1968. The intent of the procedure was to bring about complete occlusion, healing the malformation.

[0009] In 1988, the surgical results of human trials to assess thrombogenicity of various coil designs with and without synthetic fibers was published. What the study found was the vast majority of clot formation was primarily around the synthetic fibers. The bare platinum coils produced little clots and the adjacent vessel walls remained “histologically uncompromised”. Unfortunately, the platinum coils with synthetic fibers were too large for delivery through the neurovascular microcatheters being developed at the time in addition to being non-retrievable once partially deployed. Soon they were replaced by Target Therapeutic’s Guglielmi Detachable Coil (GDC) which was a 100% retrievable bare platinum coil in various shapes and lengths as disclosed in US Pat. No. US 5,122,136 to Guglielmi et al.

[0010] As the use of bare platinum coils became the gold standard for the treatment of neurovascular brain malformations, the recanalization data specific to brain aneurysm treatment was compiled. The data showed bare platinum coils had a recanalization rate of around 20-25%. Over the years, new bare platinum coil designs were developed and showed similar results.

[0011] In the meantime, platinum coils with synthetic fibers did find a use in the peripheral vasculature where large inner diameter (ID) catheters were being used. However, the coils were found to be less stable in high flow, larger peripheral vessels where they carried higher risks of migration, inefficiency or recanalization. Soon vascular plugs were introduced as a more controlled, stable and efficient alternative to coils.A vascular plug introduced into the peripheral vasculature space was the Amplatzer Vascular Plug (A VP), Pat. No. US 8,398,670 to Amplatz et al. (hereinafter the ‘670 patent). The ‘670 patent describes a collapsible implantable medical device made up of metal strands and expandible to a larger diameter configuration.

[0012] This Amplatzer device does not incorporate any synthetic filaments in the design for thrombus formation; it is intended to bring about mechanical occlusion using the mesh body. The device is designed to track through catheters with inner diameters ranging from 0.038” to 0.98” making them peripheral use only devices. Over time, these devices have been shown to dislodge and migrate if not sized correctly.

[0013] In the neurovascular space, one of the earliest vascular plug designs for aneurysm treatment was disclosed in US Pat. No. 6,391,037 to Greenhalgh (hereinafter the ‘037 patent). This device goes back to the early roots of embolization to combine metal with synthetic filaments. In one of the embodiments, Greenhalgh describes a bag having a dual braided structure with a convex shape and a proximal opening to receive a clotting medium, such as a bare platinum coils, on which blood clots can be induced to form by mechanical or electrolytic means. The bag (outer braid) comprises a tube or a sleeve made of multifilament yarns while the inner braid is constructed of supplemental filamentary members made of a shape-memory metal such as nitinol wire ranging from 0.005”-0.009” in diameter. In use, the supplemental filamentary members push outwardly against the bag to expand and support it so that it can be filled with bare platinum coils though a proximal opening that is held open through an external force. Once filled, the external force is removed and the openings assume their constricted state, closing off the bag.

[0014] While Greenhalgh combines both fibers and radiopaque metal, he does not disclose using the fiber (bag) itself as the effective clotting medium. Instead, he relies on a clotting medium (bare platinum coils) to be delivered into the bag to induce clotting through mechanical packing or electrothrombosis within the aneurysm sac. As such, the bag is designed to allow for the passage of blood into the bag unimpeded to make contact with the coils for clotting. Also, when discussing delivery, the ‘037 patent contemplates an assembly of bag and the catheter ready to be used to treat the aneurysm. In Figures 5 and 6, the bag is shown being delivered over the clotting medium (wire) without a locking attachment. It is simply forced into the aneurysm where it expands due to the biasing of yarns to assume its shape without any means for retrievability. It is then filled with wire (clotting medium). Lastly, in its deployed state, the bag tapers at its proximal end as theconstriction closes inward to keep coils from exiting the bag. This leaves a gap between the wall of the aneurysm and the bag. Over time the water hammer effect can cause the gap to widen on either side which can lead to recanalization as there is no clotting medium across the aneurysm neck / parent artery interface to promote thrombus formation.

[0015] More recent approaches to the treatment of brain aneurysms have concentrated on treating the neck of the aneurysm at the parent level as opposed to the volume of the aneurysm using coils. One of the early designs was disclosed in US Pat. No. 8,236,042 to Berez et al (hereinafter the ‘042 patent). In the ‘042 patent, a low radial force braided flow diverting stent (FDS) with increased metal coverage (low porosity) is delivered through a catheter and released across the parent artery to cover the aneurysm neck. The purpose of the flow diverter is to promote flow along the parent vessel and decrease flow into the aneurysm while maintaining sufficient porosity to maintain branch vessel and perforator patency. Ultimately, the stagnant flow should result in aneurysm remodeling that ultimately promotes endothelialization across the aneurysm neck and arterial reconstruction.

[0016] While this design does promote endothelization across the neck, FDS procedures are susceptible to a variety of thromboembolic complications as well as other adverse events. Therefore, post-procedure dual antiplatelet therapy (DAPT) is prescribed for all FDS procedures. Some examples of frequent patient reported adverse events using the FDS include death, thrombosis / thrombus, cerebral infarction, aneurysm, occlusion and neurological deficit / dysfunction. Examples of the frequent FDS device related reports include positioning / separation problems, break, difficult to open or close, migration and detachment of the device or component.

[0017] In an attempt to move away from the need for post-procedure DAPT and to develop a safer option for treating brain aneurysms, vascular plugs specific for use in the neurovascular space have been developed. Rebranded as intrasaccular flow di sruptors / di verters (IFD), these devices can trace their roots back to the Amplatzer Vascular Plug (A VP) currently used in the peripheral vascular space. Flow disruptors are a category of intrasaccular aneurysm devices that combine the properties of flow diversion and coiling to permanently occlude aneurysms and limit the need for dual antiplatelet therapy. Unlike the AVP, these vascular plugs are designed to track through microcatheters with inner diameters ranging between 0.017” and 0.033” thus allowing for treatment in small, tortuous vessels.One such device is the Woven EndoBridge (WEB) as described in US Pat. No. 12,082,821 to Marchand et al. The WEB device is a self-expanding high-density mesh ball made of nitinol that is delivered into the aneurysm. Upon delivery, the device radially expands to assume a larger volume to engage with some or all of the aneurysm wall to anchor it in place and occlude the neck of the aneurysm which causes disruption of the blood flow into the aneurysm as well as promotes clotting.

[0018] However, this design fails to bring about total occlusion greater than what is seen with bare platinum coils. At the 1-year follow-up in 3 European studies, there was complete occlusion in 52.9% of the cases, neck remnants in 26.1%, and aneurysm remnant in 20.9%. In addition, 6.9% of the patients required retreatment. At the five-year follow-up, there was complete occlusion or neck remnant in 77.9% of the patients. Retreatment was performed in 11.6% aneurysms, mostly during the first two years post-treatment.

[0019] Another commercially available intrasaccular flow disruptor is Cerus Endovascular’s Contour Neurovascular System™ as described in US Pat. No. 10,130,372 to Griffin (hereinafter the ‘372 patent). The Contour System is a dual-layered, radiopaque mesh device made of nitinol DFT ® (drawn-filled tube) wire with a platinum radiopaque marker that is heat set into its desired shape. The Contour forms a bowl -shaped hemisphere and conforms to the aneurysm neck when deployed. Although the currently marketed Contour device is purely metal as described above, the ‘372 patent does mention polymer variations such as filling the polymer strands with a radiopaque material, coating the radiopaque metal with a polymer, and combining the radiopaque metal with a polymer into a braid. The problem with these mentioned variations is the heat set temperature required to shape set shape memory alloys such as nitinol is between 500-550°C (930-1020°F) which far exceeds the melting point of polymers.

[0020] Griessenauer et al. published a multi-center study of 10 European Centers of Contour embolization in 279 aneurysms. At 1-year follow-up, the complete occlusion rate was 63.2%, neck remnants were 28.3% and thromboembolic events were about 6.8%. Retreatment was performed in 2.5% of the aneurysm.

[0021] Other convex intrasaccular braided concepts in development include US. Pat. No.

[0022] 10,751,065 to Soto Del Valle et al. and US application Ser. No. 18 / 219,809 (Publication No.

[0023] 2023 / 0346382) to Arthur et al. (LuSeed Vascular) (hereinafter the ‘809 patent application). Both of these designs disclose dual braid concepts (inner and outer braids) in convex, basket -like shapesas disclosed in the ‘037 patent. Tn one embodiment, the ‘809 application describes the outer body as being made of mesh and including a polymer layer. However, there is no description of how the polymer layer structure is formed (braid, sheet, etc.) or of the material used in the construction. Based on public presentations by LuSeed Vascular, both layers are indeed metal and the focus of the design is on flow disrupt! on / di ver si on. In fact, LuSeed claims to have 70% acute blood blockage potential compared to the WEB’s 37% and Contour’s 50%. It is expected that both of these designs will have similar percentages of neck-remnants as well as thromboembolic events as the WEB and Contour as they also continue to concentrate on flow disruption with devices composed purely of metal.

[0024] Clearly there is a need for a low-profde vascular plug that addresses the problems with the devices discussed above. Such a design could be delivered into both the neurovascular e.g., for treating brain aneurysms, and peripheral vascular to treat vessel malformations in small, tortuous vessels using low profde microcatheters.

[0025] SUMMARYOF THE INVENTION

[0026] This present invention overcomes the problems and deficiencies of the prior art. The present invention provides a vascular plug that overcomes the above discussed limitations in prior art structural designs by providing a clotting medium to promote early thrombus formation at a proximal region of the expanded vascular plug / flow disruptor. It advantageously combines the mechanical occlusive properties of a vascular plug (metal mesh braid) with the thrombogenic properties of synthetic fiber to bring about rapid clot formation at a proximal region of the plug.

[0027] The vascular device (vascular plug) of the present invention includes an anchoring member expandable within the vessel and a proximal clotting medium / component / region positioned proximal of or at a proximal region of the anchoring member to effect thrombogenic occlusion.

[0028] In one aspect of the present invention, a vascular occlusion device (vascular plug) for treating vessels is provided comprising an anchoring member having a first collapsed condition for insertion and a second expanded condition for placement within the vessel, the anchoring member expandable to contact a wall of the vessel and a clotting medium positioned at least at a proximal region of the anchoring member.

[0029] In some embodiments, the clotting member is different in configuration than the anchoring member, the clotting medium having a plurality of polymer filaments that extend radiallyoutwardly with respect to the anchoring member and extend distally to surround at least a proximal region of the anchoring member.

[0030] In some embodiments, the device includes a locking member for joining the anchoring member and clotting medium.

[0031] In some embodiments, the device includes a distal marker adjacent a distally extending neck of the anchoring member. In some embodiments, the clotting medium has a proximal neck having a lumen, and a proximal end of the anchoring member is positioned within the lumen. In some embodiments, the proximal end of the anchoring member narrows into a proximally extending neck which is positioned within the lumen of the proximal neck of the anchoring member. In some embodiments, the device includes a proximal marker adjacent a proximally extending neck of the anchoring member adjacent a joining region of the anchoring member and clotting medium.

[0032] In some embodiments, the plurality of filaments of the clotting medium form a circular array about a longitudinal axis of the anchoring member.

[0033] In some embodiments, the clotting medium is used for treating an aneurysm and is configured so that at least some of the plurality of filaments extend laterally to cover a neck of the aneurysm.

[0034] In some embodiments, the clotting medium comprises a plurality of polymer filaments that extend in a circular array and are positioned within the anchoring member; in other embodiments, some of the polymer filaments are positioned inside the anchoring member and outside the anchoring member.

[0035] In some embodiments, the anchoring member has a vessel wall contact region and a proximal region proximal of the wall contact region, wherein the clotting medium extends distally and terminates adjacent or proximal of the wall contact region of the anchoring member; in other embodiments the clotting medium terminates distal of the wall contact region of the anchoring member.

[0036] In some embodiments, the device includes a second clotting medium having a plurality of polymer filaments and extending distally of the anchoring member.

[0037] In some embodiments, the clotting medium comprises a plurality of multifilament yarns. In some embodiments, the anchoring member includes a braid configured for mechanical occlusion and the clotting member is configured for thrombogenic occlusion.In accordance with another aspect of the present invention, a method for promoting occlusion in a vessel is provided comprising a) inserting into a vessel an occlusion device having an anchoring member and a clotting medium at a proximal portion of the anchoring member; b) releasing the anchoring member within the vessel such that it expands from a collapsed condition to an expanded condition into contact with a wall of the vessel; and c) subsequently releasing the clotting medium within the vessel, the clotting medium having a plurality of filaments wherein at least some of the filaments extend across the vessel; d) wherein the clotting medium provides thrombogenic occlusion at a proximal (upstream) region of the vessel and the anchoring member provides subsequent mechanical occlusion. The clotting medium proximal end can be positioned upstream of the anchoring member distal end.

[0038] In some embodiments, the occlusion device is placed in an aneurysm and the filaments when released extend across the neck of the aneurysm.

[0039] In some embodiments, the vascular plug is used for treating an aneurysm and forms three distinct regions within the aneurysm based on where the walls of the anchoring member make direct contact with the walls of the aneurysm, the regions comprising a stagnation region, an anchoring region distal of the stagnation region and a dome region distal of the anchoring region, wherein the clotting medium is positioned at least at the stagnation region. In some embodiments, at least some of the filaments extend to adjacent the anchoring region. In some embodiments, at least some of the filaments extend to the dome region.

[0040] In accordance with another aspect of the present invention, a vascular device is provided comprising a vascular plug having a) an anchoring member having an inverted bell shape braided body having a proximal neck, and that is expandable from a collapsed (delivery) state to an expanded state for anchoring to the wall of a vessel, e.g., an aneurysm wall, b) a clotting medium in the form of a circular array of multifilament yams and / or monofilaments yarns that has at least a proximal neck configured for the insertion of (receipt of) the anchoring member’s proximal neck, and c) a radiopaque locking member configured for the insertion and bonding of the combined proximal necks as well as a portion of a pusher (delivery) wire.

[0041] In some embodiments, the anchoring member of the vascular plug has only a proximal neck for insertion into the clotting medium’s neck and is convex (basket) shaped. In other embodiments, the anchoring member includes a distal neck.In some embodiments, the anchoring member of the vascular plug is convex (basket) shaped with a proximal neck for insertion into the clotting medium’s proximal neck and can have a distal end that slightly inverts into the convex (basket) shape.

[0042] In some embodiments, the anchoring member has multiple (changing) outer diameters. In some embodiments, the anchoring member has multiple diameters that increase proximally to distally.

[0043] In other embodiments, the anchoring member has walls that taper increasingly from a first diameter to a second diameter.

[0044] In some embodiments, the clotting medium comprises multifilament yarns and monofilament yarns that have been separated by heat treatment or mechanical processing arranged in an array around a central neck. In some embodiments, the clotting medium is composed only of multifilament yarns that have been separated and arranged in an array around a central neck.

[0045] In some embodiments, the clotting medium is composed of multifilament yarns and / or monofilament yarns that are melted together to form a neck that will act as a locking member.

[0046] In some embodiments, the clotting medium is comprised only of multifilament yams that have been textured to modify the texture / physical appearance of the fibers and in such embodiments, they can be arranged in a circular array around a central neck.

[0047] In some embodiments, the clotting medium is composed of multifilament yarns and / or monofilament yarns in a loose, braided tubular configuration and has a proximal neck.

[0048] In some embodiments, the clotting medium is composed of multifilament yarns and monofilament yarns in a braided tubular configuration with a neck that is heat set in a pattern similar to the anchoring member. In other embodiments, the clotting medium is composed of only multifilament yarns in a braided tubular configuration with a proximal neck that is heat set in a pattern similar to the anchoring member.

[0049] In some embodiments, the clotting medium has both a proximal and distal neck.

[0050] In some embodiments, the clotting medium is inverted over itself to form a dual layer of filaments. That is, by this inversion, there is an inner layer and an outer layer overlapping the inner layer. This inversion can be created for example by distal regions inverted, proximal regions inverted or combinations thereof.

[0051] In some embodiments, a dual layer of filaments is created by placing one clotting medium on top of another. Stated another way, a (first) clotting medium can be fully or partially positionedwithin another (a second) clotting medium to provide an inner clotting medium and an outer clotting medium surrounding in whole or in part the inner clotting medium. The first and second clotting mediums can be the same configuration or a different configuration and none, some or all of the filaments of the first clotting medium can be the same length and / or the same configuration as the filaments of the second clotting medium.

[0052] In some embodiments, the circular array of filaments of the clotting medium, when placed in an aneurysm, sits free in or near the neck of the aneurysm. In some embodiments, when placed in an aneurysm, the distal portion of the circular array of filaments is pinned to the walls of the aneurysm by the anchoring member. In some embodiments, when placed in an aneurysm, the distal ends of the circular array of filaments are in the dome of the aneurysm, distal of the anchoring member. In some embodiments, the circular array of filaments is inside the anchoring member.

[0053] In some embodiments, the locking member which joins the anchoring member and clotting medium is radiopaque and configured with a central lumen for insertion of a portion of pusher (delivery) wire for bonding.

[0054] In some embodiments, the locking member is formed by melting the neck of the circular array of filaments to form a tube with an inner and outer diameter.

[0055] Also disclosed herein are the regions formed within the aneurysm when the vascular plug is deployed inside the aneurysm. They include the stagnation region, anchoring region and dome region. Positioning of the clotting medium with respect to these regions in accordance with various designs of the clotting member are discussed below. Such regions are also formed when the vascular plug is deployed in other vasculature, however, the dome region can be considered the distal region where an anatomical “dome” is not present.

[0056] Additionally disclosed herein are methods for manufacture and / or methods for delivery and / or deployment of the vascular device and its various components.

[0057] BRIEF DESCRIPTION OF THE DRAWINGS

[0058] So that those having ordinary skill in the art to which the subject invention appertains will more readily understand how to make and use the system and apparatus (device) disclosed herein, preferred embodiments thereof will be described in detail hereinbelow with reference to the drawings, which are not necessarily drawn to scale, wherein:

[0059] FIGS. 1A-1C are illustrations of the prior art whereinFIG. 1 A is a side view of a flow disrupting device of the prior art deployed in an aneurysm;

[0060] FIG. IB is an enlarged view of the neck of the aneurysm showing residual blood flow into the aneurysm between the wall of the device and the aneurysm wall;

[0061] FIG. 1C is an enlarged view of the neck of the aneurysm showing the progression of clot formation across the neck of the aneurysm;

[0062] FIG. 2 is a side view of a vascular plug (occlusion device) in accordance with an embodiment of the present invention;

[0063] FIGS. 3 A and 3B are side views of an anchoring member of the vascular plug in accordance with an alternate embodiment of the present invention;

[0064] FIG. 4A is a side view of an alternate embodiment of the clotting medium of the present invention;

[0065] FIG. 4B is a side view of another alternate embodiment of the clotting medium of the present invention;

[0066] FIG. 4C is a side view of another alternate embodiment of the clotting medium of the present invention;

[0067] FIG. 5A is a cross-sectional view of an embodiment of the vascular plug (occlusion device) having the anchoring member of FIG. 3 A and the clotting medium of FIG. 4B;

[0068] FIG. 5B is an enlarged cross sectional side view of a vascular plug locking member of the device of FIG. 5 A;

[0069] FIG. 6A is a partial cross-sectional view of the vascular plug of FIG. 5A deployed inside an aneurysm and illustrating the location of various regions formed within the aneurysm upon device deployment;

[0070] FIG. 6B is a partial cross-sectional view of the vascular plug of FIG. 6A deployed inside an aneurysm and illustrating clot formation;

[0071] FIG. 6C is a partial cross-sectional view similar to FIG. 5A except showing an alternate embodiment of the vascular plug wherein the multifdament yams extend into the dome region, and further showing clot formation;

[0072] FIGS. 7A-7D are cross-sectional views showing delivery and deployment of a vascular plug (occlusion device) of the present invention in an aneurysm, the vascular plug having theclotting medium of FIG. 4B and a basket shaped anchoring member in accordance with an alternate embodiment, wherein

[0073] FIG. 7A shows the vascular plug fully contained within the lumen of the microcatheter as it is advanced into the aneurysm by the delivery wire;

[0074] FIG. 7B shows the vascular plug partially advanced from the microcatheter wherein the anchoring member of the vascular plug is exposed and the clotting medium remains contained within the microcatheter;

[0075] FIG. 7C shows the vascular plug fully exposed from the microcatheter but still connected to the delivery wire of the delivery system; and

[0076] FIG. 7D shows the device detached from the delivery wire and left in the aneurysm, with the anchoring member expanded into contact with the wall of the aneurysm and the clotting member extending radially across the neck of the aneurysm;

[0077] FIG. 8 is a side view of the vascular plug in accordance with an embodiment of the present invention having the anchoring member of FIG.3A and the clotting medium of FIG. 4B positioned inside the anchoring member;

[0078] FIG. 9 is a side view of the vascular plug in accordance with an alternate embodiment of the present invention having a somewhat cylindrical shaped anchoring member and the clotting medium of FIG. 4B; and

[0079] FIG. 10 is a side view of the vascular plug in accordance with an alternate embodiment of the present invention having the anchoring member of FIG. 9, the clotting medium of FIG. 4B and an additional distal clotting medium;

[0080] FIG. 11 is a side view of the vascular plug in accordance with an alternate embodiment of the present invention having the anchoring member of FIG. 9; and

[0081] FIG. 12 is a side view showing the vascular plug of Figure 9 placed in a vessel.

[0082] DETAILED DESCRIPTION

[0083] The present invention provides a vascular occlusion device with enhanced blood clotting features that positions a uniform clotting surface across the entire neck of an aneurysm, such as a brain aneurysm, or across the entire internal diameter of a blood vessel. The occlusion device, which can be interchangeably referred to as a vascular plug or flow disruptor, includes an anchoring member and a clotting medium. It can further include a locking member. Variousembodiments of the vascular plug are disclosed herein which include various embodiments of the anchoring member, the clotting medium and the locking member.

[0084] The vascular plug (occlusion device) has an anchoring member in the form of a metallic self-expanding tubular braid that has been formed into a preset shape which serves to anchor the vascular plug to the wall of a vessel, such as an aneurysm wall, as it applies a radial force to the wall. The vascular plug also includes a clotting medium / member / component configured to effect thrombogenic occlusion which is in the form of an array of polymer filaments, arranged in a circular independent array or interweaved array, and positioned at a proximal region of the anchoring member, extending radially, and extending distally alongside / extemal the anchoring member. A radiopaque locking member joins the anchoring member and clotting member together at a proximal end of the vascular plug as well as provides an orifice for the attachment of the device to a pusher (delivery) wire or other delivery member.

[0085] The vascular plug is designed to be collapsed for delivery through a microcatheter into a vessel. Once positioned in this collapsed position / condition, the vascular plug is deployed by slowly pulling the microcatheter back to start to expose a distal end of the vascular plug. As the distal end of the vascular plug deploys, the anchoring member starts to self-expand distally to proximally at some point causing the proximally positioned clotting medium to expand (depending on the clotting medium design). At full expansion of the anchoring member to its expanded position / condition, the clotting medium is secured in position in the vessel, (at the neck of the aneurysm when the vascular plug is utilized to treat aneurysms) creating a clotting surface preferably across the entire vessel (or when used to treat aneurysms across the entire neck of the aneurysm and, in some versions, further within the aneurysm sac dependent on the embodiment). That is, depending on the embodiment, when used to treat aneurysms, the clotting medium when positioned can sit free in or near the neck of the aneurysm or can extend distally such that the distal portion of the clotting medium is pinned to the walls of the aneurysm by the anchoring member or can extend distally such that the distal ends are in the dome of the aneurysm distal of the anchoring member. In any of these cases, the clotting medium is at least at a proximal portion of the vascular plug. This is also the case (free, pinned, distal extension) when used to treat other vasculature.

[0086] The expanded occlusion device of the present invention has several advantages. One advantage is the introduction of a clotting medium adjacent to and / or proximal to the anchoring member’s proximal end at the aneurysm neck / parent artery level. This feature allows for a moreuniform and rapid clot formation across the entire neck / parent artery to reduce healing time. Another advantage is the stagnation zone created between the clotting medium and the proximal side / end of the anchoring member. As clot forms in this zone, it locks the occlusion device to the aneurysm wall by way of the thrombus formation reducing the likelihood of aneurysm recanalization or device compaction due to blood flow getting in between the device and the aneurysm wall. These advantages are also present when the occlusion device is used in other vasculature.

[0087] The occlusion device of the present invention provides a vascular treatment device that can be used to treat aneurysms as well as can be used throughout the body to treat other vascular or luminal defects as an alternative to coils. These features are described in greater detail below.

[0088] A detailed discussion follows for the use of the occlusion device in treatment of an aneurysm by way of example, it being understood, as explained below, that the occlusion device can be used in other vasculature for occlusion.

[0089] Initially, the problem facing flow disruptor healing in aneurysms will be illustrated to better understand the challenge to treating aneurysms, followed by a description of the structural elements of the vascular plugs of the present invention and variations thereof that overcome these challenges.

[0090] FIG. 1A shows an intrasaccular flow disruptor 10 of the prior art in its deployed (expanded) state inside aneurysm 12. Flow disruptor 10 includes walls 14 and 16 and neck 18 at a proximal end. FIG. 1A also shows the blood flow 20 (arrows A) inside artery 22 into artery side branches 24 and 26. With exact sizing and positioning, the flow disruptor 10 will disrupt blood flow 20 away from the aneurysm neck 13 to side branches 24 and 26. This would be the ideal scenario: all blood is diverted away from the aneurysm neck thus allowing it to progressively heal over time, but in practice, this scenario is an “ideal” objective and not fully achievable. Kallmes et. al in Evaluation of the Angiographic Grading Scale in Aneurysms Treated with the WEB Device in 80 Rabbits: Correlation with Histologic Evaluation found that although imaging such as Digital Subtraction Angiography (DSA) suggested a complete occlusion in 8 (10%) of the cases, followup histology identified them as incomplete. Thus, even when the aneurysm appeared fully occluded and deployment was successful, undetected residual flow into the aneurysm neck persisted and, over time, lead to recanalization. It should be noted that the same healing problemoccurs with bare metal coils in contact with vessel walls as well. Metal to wall contact does not promote rapid clot formation at the contact point so over time 20% - 25% cases will recanalize.

[0091] FIG. IB is a close-up view of the neck region of Figure 1A and shows the enlarged image of neck 13 of aneurysm 12 with residual blood flow 20 entering aneurysm 12 at neck 13 between aneurysm wall 28 and intrasaccular flow disruptor wall 14. This residual flow can occur due to a few factors, including: a wide aneurysm neck, improper device sizing, deviation from the aneurysm axis during placement, the use of dual antiplatelet therapy which can inhibit clotting within the device, and sometimes due to the aneurysm's unique anatomy. Eventually the intrasaccular flow disruptor 10 will start to clot (see clot 30) at its center where the porosity is at its lowest and progress outward (arrows B) as shown in FIG. 1C. At the same time, blood flow 20 entering at neck 13 will potentially continue to widen the gap between the aneurysm wall 28 and intrasaccular flow disruptor wall 14 due to the water hammer effect. At follow-up, the gap between the flow disruptor 10 and the aneurysm wall 28 may now be visible and, if so, the aneurysm will be down-graded from complete occlusion to residual aneurysm which may require retreatment within 2 and 2.5 years.

[0092] The problem facing consistent, complete occlusion of aneurysms using current intrasaccular flow disruptor designs is the use solely of bare metal in their construction. This only produces a mechanical occlusion, not a thrombogenic reaction from the blood. They also occlude from the center of the device to the edges where the metal may or may not make complete contact with the aneurysm wall. As early bare metal coil studies found, bare metal produces little clot and adjacent aneurysm walls remain “histologically uncompromised” making them vulnerable to recanalization / regrowth where the device hits the vessel wall. The present invention addresses this problem by uniquely providing a synthetic clotting medium at the neck aneurysm / artery interface that targets tissue growth across the entire aneurysm neck, including the edges of the aneurysm neck.

[0093] As used herein, the term “proximal” refers to the part / region of the device closer to the user and the term “distal” refers to the part / region of the device further from the user. For example, when used in a cerebral aneurysm, the distal region would be closer to the dome and the proximal region would be closer to the neck or parent vessel.

[0094] When delivered into a vessel by the delivery member disclosed herein, the proximal end of the device is attached to the delivery member.Referring now to the drawings and particular embodiments of the present invention wherein like reference numerals identify similar structural features of the apparatus / devices disclosed herein, Figures 2-11 illustrate embodiments of the vascular plug (occlusion device) of the present invention. Note Figure 2 shows an embodiment of the entire occlusion device with FIGS. 3A and 3B showing the anchoring member itself (without the proximal clotting medium / member / component) and FIGS. 4A-4C showing the clotting medium / member / component itself for clarity. FIGS. 5A and 5B show cross-sections of the occlusion device having the anchoring member of FIG. 3 A and the clotting medium of FIG. 4B, however, it should be understood that the alternate embodiments of the clotting medium of FIGS. 2, 4A and 4C (as well as other clotting mediums disclosed herein) can be provided with the anchoring member of FIG. 3A. It should further be appreciated that the clotting medium of FIGS. 2, 4A, 4B and 4C (as well as other clotting mediums disclosed herein) can be provided with the alternate anchoring members of FIGS. 7A, 9, 10 and 11 (as well as other anchoring members disclosed herein).

[0095] Turning now to the embodiment of the implantable vascular plug (occlusion device) illustrated in FIG. 2 (and FIGS. 3A and 3B), the vascular plug is designated generally by reference numeral 32. The vascular plug 32 has a proximal region / section 32b and a distal region / section 32a. Vascular plug 32 includes an anchor (anchoring) member 34 composed of strands / filaments 36, a clotting medium 38 composed of an array of fdaments 40, a locking member 42 with a through lumen 46 and a distal marker 48. Adhesive 44 aids in attachment of the components as described below.

[0096] The anchoring member 34 can be of various shapes and forms. One embodiment is shown in FIGS. 3A and 3B, with the anchoring member 34 illustrated in its expanded configuration. It is preferably formed from a single layer self-expanding braid (mesh tube) 35 that can be made of strands / filaments 36. The strands / filaments can be a mix of nitinol interwoven with a radiopaque wire material such as platinum for visibility or of Nitinol DFT ® (drawn-filled tube) wire which is manufactured by Fort Wayne Metals Corp. (Fort Wayne, Ind., U.S.A.). The DFT filaments have a nitinol -titanium outer wall and a platinum core for radiopacity making it capable of being both shape-set and radiopaque. The braid 35 can be constructed of between about 32 and about 180 filaments, although a different number / range is also contemplated, depending on the desired final structural properties such as density, picks per inch (PPI), porosity, compliance, etc. Different braid patterns (such as 1x1, 1x2, or 2x2, etc.) and braid angles may also produce varied results. Thebraid diameter can range from about 2 mm up to about 25 mm or greater than about 25 mm for devices used in the treatment of high flow, large vessel occlusion. In general, since anchoring member 34 serves as an anchoring device for the occlusion device 32 with some flow diversion characteristics by default, the porosity of the device could but need not be the same as currently marketed devices as it could be higher (less metal coverage) than currently marketed flow disruptors making it more trackable and easier to deploy.

[0097] The tubular braid 35 is heat set into an inverted bell shape (see FIG. 3 A) to form anchoring member 34 with distal end 50, proximal end 52, walls 54 and 56 extending between the distal end 50 and proximal end 52 and dome 58. This is one possible shape, however, other shapes such as tubular / cylindrical single lobe or multiple lobes, globular, apple, cup, basket, etc. are also contemplated. Also, the braid 35 may be inverted over itself to create a dual layer mesh and heat set to any desired shape (i.e., bell, cup basket, etc.). The distal end 50 can be substantially planar.

[0098] Extending from distal end 50 of anchoring member 34 is distal neck 60 with proximal end 64 extending distally from distal end 50 of anchoring member 34 and terminating at distal end 62. Through lumen 66 extends through the distal neck 60. Proximal neck 68 extends from the opposite side of braid 35, i.e., it extends from proximal end 52 of anchoring member 34. Proximal neck 68 of anchoring member 34 has a distal end 70 extending proximally from proximal end 52 terminating at proximal end 72. Through lumen 74 extends through the proximal neck 68. The distal and proximal necks 60, 68 as shown are elongated and generally aligned with the longitudinal axis of the anchoring member 32. As shown, the anchoring member 34 can taper (or step) at a proximalmost end into the neck 68 or can be formed by a convergence and upward bend as in the distal neck 60. (The taper and convergence can best be seen in the cross-sectional view of FIG. 5A). For handling during manufacturing, the necks 60 and 68 can be about 1 cm or longer. For the final versions, distal and proximal necks 60 and 68 can be trimmed to from about 0.25 mm to about 1 mm in length, although other lengths are envisioned based on the embodiment, clinical application, etc.

[0099] Anchoring member 34 serves to anchor the vascular plug 32 to the aneurysm by making contact with the aneurysm walls at a position distal of the aneurysm neck, and in some embodiments, depending on the size of the anchoring member and / or size of the aneurysm, apply a radial force to the inner wall of the aneurysm. In the illustrated embodiment of FIGS. 3 A and 3B, has diameters, DI, D2, and D3, and height H of the anchoring member 34 areidentifi ed / 1 abeled. The diameters DI, D2, D3 increase proximal to distal so D1<D2<D3, although in alternate embodiments, D2 can be equal to D3 or DI can be equal to D3, or DI can be equal to D2, for example. The diameter can taper distal of diameter D3 as it extends toward the distal end as shown in FIG. 3B. Stated another way, the transverse cross-sectional dimension of the anchoring member 34 varies where it increases / widens from a proximal region to a distal region, and can then narrow (lessen) at diameter D4 toward the distalmost end. The anchoring portion of anchoring member 34 occurs between D2 and D3 where walls 54 and 56 progressively increase from D2 to D3 and provide a larger diameter (larger transverse dimension) for aneurysm wall contact. A preferable range for diameters is between about 2 mm and about 25 mm although devices for giant aneurysms or large, high flow vessels may require diameters larger than 25 mm. So, for example, DI could be about 2 mm, D2 could be about 4 mm and D3 could be about 6 mm. In this example, the use of tapering walls allows for anchoring the implant to aneurysms with maximum diameters less than about 6 mm but greater than about 4 mm. Height H can range from about 2 mm up to about 20 mm or greater, although other heights are also contemplated.

[0100] Note the diameter change in alternate embodiments need not be progressive as discussed above. For instance, if the anchoring member 34 has a tubular / cylindrical single lobe body shape (see e.g., FIG. 9), the device’s body diameter may be near constant and have flat or almost flat distal and proximal ends (pre-deployed shape).

[0101] Note that FIGS. 2, 3A and 3B show anchoring member 32 in its expanded position / condition. For delivery, the anchoring member 32 would be in a reduced diameter (reduced transverse dimension) collapsed position / condition within a delivery member, and expandable to its expanded position / condition when released from the delivery member. Delivery of the device is discussed below in conjunction with FIGS. 7A-7D.

[0102] The clotting medium 38 (also referred to herein as the clotting component or clotting member, as well as can be considered a clotting region) of vascular plug 32, as shown in FIG. 2, includes a plurality of fdaments 40 arranged in a circular array. The fdaments 40 can be considered as extending around a longitudinal axis LA of the occlusion device 32. As such, they are external an outer wall of the anchoring member 34 and extend radially and distally, encircling (surrounding in part or entirely) at least a proximal region of the anchoring member 34. In the embodiment of FIG. 2, the filaments 40 are only at a proximal region 32b of the anchoring member 32, extending radially with respect to the anchoring member 32 and distally around the proximal region 32bthereof. In other words, the filaments 40 overlap the outer wall of the anchoring member 34, and some of the filaments 40 can be sufficiently close to be in contact with the outer wall of the anchoring member 32 as they extend distally and other of the filaments can be radially spaced outwardly and out of contact with the outer wall of the anchoring member 34; in other embodiments, all the filaments can be radially spaced from and out of contact with the outer wall of the anchoring member 34 as they extend distally. A number of filaments (labeled as filaments 40a) as shown can extend transversely (horizontally) so as to extend across a majority of, or the entirety of, the aneurysm neck. The clotting medium 38 is formed from a tubular braid made of multifilament yarns and, optionally, some monofilament yarns for rigidity. This construction is discussed below.

[0103] As mentioned above, at full expansion of the vascular plug, the clotting medium 38 is secured in position at the neck of the aneurysm creating a clotting surface preferably across the entire neck of the aneurysm and, in some embodiments, further within the aneurysm sac. Thus, the clotting medium 38, when positioned, can sit free in or near the neck of the aneurysm or can extend sufficiently distally with respect to the anchoring member 34 such that a portion, e.g., a distal portion, of the filaments 40 of the clotting medium 38 is pinned to the walls of the aneurysm by the anchoring member 34 or can extend even further distally with respect to the anchoring member 34 such that the distal ends of the filaments are in the dome of the aneurysm adjacent to a distal end of the anchoring member or in further embodiments extend distal of the anchoring member 34. These variations of the distal extent of the filaments of the clotting medium are fully applicable to the other clotting mediums discussed herein, e.g., clotting mediums 75, 79 and 81, as the filaments of these clotting mediums (and alternative clotting mediums disclosed herein) can extend different distal distances with respect to the anchoring member.

[0104] FIGS. 4A-4C show different embodiments of the clotting medium of the vascular plug, each having an array of filaments, preferably arranged in a circular array. The arrangement and / or formation of the filaments in these embodiments differ from each other and from clotting medium 38 of FIG. 2.

[0105] With reference to Figure 4A, the clotting medium 75, configured to be external the anchoring member 34, is formed from filaments 73. Clotting medium 75 is formed from a tubular braid made of multifilament yarns 76 and, optionally, some monofilament yarns 78 (shown in bold) for rigidity. The multifilament yarns 76 are generally made of a synthetic, semi-synthetic,natural or thermoplastic polymer that may be permanent (non-absorbable) or absorbable. The preferred polymers are polyester (e.g., PET) or nylon however other polymer materials may include, for example, Dacron, ePTFE, PTFE, polyethylene, polypropylene, polydioxanone (PDO), PGA, PLA, polyphosphazenes, poly anhydrides, polyacetals, poly (ortho esters), polyphosphoesters, polycaprolactones, polyurethanes, polylactides, polycarbonates, and polyamides, or combinations thereof. The yams 76 are preferably made of a 30 denier / 34 filament textured nylon or polyester but they can range, for example, from about 5 denier up to about 50 denier with the number of filaments ranging from about 16 up to about 80. The yams can be nontextured or textured. Texturing can be used to modify the texture / physical appearance of the fibers. Texturing techniques can include bulking (where the thermoplastic fibers are twisted heat set and untwisted), crimping and coiling, amongst others. The monofilament yarns 78 are preferably made of the same materials as the multifilament yarns 76 (although alternatively they can be made of different materials), with the preferred material being polyester (PET) or nylon. The diameters of the monofilament yarns 78 can range from about 0.001” to about 0.035” with the preferred to be about 0.001”. Other diameters are also contemplated as are mixing of yams of different materials. The clotting mediums of the alternate embodiments disclosed herein can also be formed in the foregoing fashion and of the forgoing materials.

[0106] The multifilament yarns 76 of FIG. 4A illustrates clotting medium 75 with circular array of filaments 73 which by way of example features 16 multifilament 30 denier / 34 filament yarns of textured PET 76 braided with 16 PET monofilament yams 78 (darker yams) each with a length L. Note, in some embodiments, clotting medium 75 may be composed solely of multifilament yarns 76 or solely of monofilament yarns 78 or in some numerical combination of the two. In other words, the combination does not need to be an even 50 / 50 split between the yarn types. The monofilament yarns 78 will typically be added for structural stability, if needed. This structure shows the remnants of the base tubular braid pattern 88 (lattices). The clotting mediums of the alternate embodiments disclosed herein can also be formed in this fashion. The clotting medium 75 has a proximal neck 80 (extending proximally from the array of filaments) and is cut to the desired length and has a distal side (end) 84, a proximal side (end) 86 and a through lumen 82. The lumen 82 is sized and configured to receive the proximal neck 68 of the anchoring member 34 as described below.Yarn length L can range from about 2 mm to 20 mm or longer. In some embodiments, length L may be greater than compressed height H (in catheter) of the anchoring member 34 in which case they may be free floating above the anchoring member 34 in the dome of the aneurysm or equal to or less than the radius of DI . In some instances, the yarns can be free to float below the anchoring member in the aneurysm neck. The clotting mediums of the alternate embodiments disclosed herein can also be formed in this fashion / dimension.

[0107] FIG. 4B shows an alternate embodiment of the clotting medium in which the clotting medium 79 with circular array of filaments 77a is formed with a 16-end braid using 30 denier / 34 filament multifilament yarns of textured nylon. Textured multifilament yarns 77b are typically used in the construction of fibered coils to improve clot formation and stability, which makes vessel occlusion faster and more reliable. The use of a polymer such as nylon, that can be melted at a relatively low temperature, also allows for the formation of a small diameter, smooth neck 80 with a relatively thin wall. The clotting medium 79, like clotting medium 75, has a proximal neck 80 (extending proximally from the array of filaments), is cut to the desired length and has a distal side (end) 84, a proximal side (end) 86, and a through lumen 82 to receive the proximal neck of the anchoring member.

[0108] The clotting mediums 75, 79 of FIGS. 4A and 4B are first formed as a braid over a mandrel having a diameter that can range between about 0.008” to about 0.030” depending on the clotting medium size needed. Typically, the clotting medium 75, 79 is intended to have a linear run of yarns that come together at proximal neck 80 as seen in FIGS. 4A and 4B. To achieve this, a braider is configured to run a tightly woven (solid) braid over a wire to produce the neck 80 portion and then a relatively straight section (non-braided) run to produce the circular array of filaments 73, 77a. The pattern is then repeated along the length of the wire producing multiple units. Note, even though the linear section is intended to be strictly straight, there may be some remnants of the base tubular braid pattern (lattices) as the neck portion will not immediately go from braid to linear.

[0109] Once braided, a section of the braid containing the neck 80 and circular array of filaments 73, 77a will be cut to the desired length and heat set, if desired, to mold the filaments outward from the distal end 84 of the neck 80. In addition to setting the array shape, the heating process will help to loosen and separate the multifilament yarns into separate, individual filaments, freeing them from one another (no longer yarn bundles). The separation of the multifilament yams postbraiding helps to maximize the surface area of the final array as well as to allow the individual filaments to move more easily and tangle in blood flow for optimum clotting. So, for example, for an 8-end braid made solely of 10 denier / 16 filament multifilament yarn, the clotting medium 38 would have a circular array of filaments made up of 128 individual filaments arranged around and below the proximal side of the vascular plug 32. A different number of yams and individual filaments are also contemplated.

[0110] Likewise, a 16-end braid made of 30 denier / 34 filament yarns, once separated, would have an array of 544 individual filaments. Although heat treating is mentioned as the method for separating the multifilament yams, this is only an example and other methods can be employed. If desired, the neck 80 outer diameter may be further reduced with heat shrink tubing to achieve smaller diameters as shown in FIG. 4B.

[0111] An alternate embodiment of the clotting medium is shown in FIG. 4C in which the clotting medium 81 with circular array of filaments 87 is formed from both multifilament yarns 89a and monofilament yarns 89b forming braid pattern 83. The clotting medium 81, like clotting medium 75, has a proximal neck 80 (extending from the array of filaments) which is cut to the desired length and has a distal side (end) 84, a proximal side (end) 86, and a through lumen 82 to receive the proximal neck of the anchoring member. Clotting medium 81 is cup / basket shaped and formed to mate with the shape and diameter of the expanded anchoring member 34. For this embodiment, the mandrel diameter may run from about 2 mm to about 20 mm or more for the cup. The neck 80 would then be formed in an additional step to reduce its OD down to between about 0.014” and about 0.028”. The braids for the cups / baskets will have a preferred porosity between about 0.010” to about 0.020” with a ppi in the approximate 50 to 100 range. A mold or other manufacturing aid can be used to form the neck and basket / cup shape or other form. It should be noted that the appearance of the cup / basket in FIG. 4C shows an even weave, however, with handling, the braid could have a different appearance due to unraveling leaving a very loose, uneven weave.

[0112] For each of the aforedescribed embodiments of the clotting medium (and the additional embodiments described below), the length of neck 80 can be greater than about 1 cm or more for handling during manufacturing for any of the embodiments. For the final device, the neck 80 can be trimmed to between about 0.25 mm to about 1 mm, although other lengths are possible, if needed. The neck 80 in some embodiments could serve as the locking member 42 if desired.Note, in some embodiments, when the anchoring member expands, it could also further expand the softer material filaments of the clotting medium in which it is positioned. In such embodiments, the filaments do not need to be self expandable. In other embodiments, the filaments can be shape set and self expanding when released. In still other embodiments, the filaments are shape set to a first position and are further expanded by expansion of the anchoring member.

[0113] FIG. 5A shows a cross-sectional view of a preferred construction of the vascular plug 32 showing the anchoring member 34 of FIG. 3A and the clotting medium 79 of FIG. 4B. (The other anchoring members and clotting mediums can be constructed in a similar fashion). Note FIG. 4B shows clotting medium 79 somewhat compressed while FIG. 5A shows clotting medium 79 fully radially expanded. The distal neck 60 which extends from the distal end 50 of the anchoring member 34 is covered with a distal marker band 48. Distal marker 48 is made of a radiopaque material such as platinum, gold, platinum / iridium alloy and / or combination thereof. The distal marker band 48 can generally have approximately the same length as distal neck 60, although in alternate embodiments, the length can differ. The distal marker length can range between about 0.25 mm and about 1 mm with a wall thickness of about 0.001”. Other dimensions are also contemplated. After the distal marker 48 is placed over distal neck 60, neck 60 is cut to a length approximately flush with distal marker band 48. Joining the distal marker 48 to neck 60 is adhesive 44. Adhesive 44 can be an epoxy material such as manufactured by Epoxy Technology, Inc. located in Billerica, MA. The epoxy can be thermally cured or hardened with the application of heat or UV (ultra-violet) light or a thermally cured, two-part epoxy. The trimming of distal neck 60 can occur prior or after application of the adhesive 44. The parts may alternatively be joined using laser or spot-welding techniques. In alternate embodiments, the distal marker band 48 may be omitted and the distal neck 60 can be bonded closed with a meltable polymer such as nylon or PET, for example, or by other attachment techniques, as the distal neck 60 may, in some embodiments, be composed to be radiopaque by providing radiopaque filaments in the anchoring member 34 construction.

[0114] On the opposite (proximal) side of the vascular plug 32, an appropriately sized mandrel is inserted into through lumen 74 (shown as finished neck 46 of vascular plug 32) of proximal neck 68 of anchoring member 34. The proximal neck 68, with the mandrel inside, is inserted into through lumen 82 of proximal neck 80 of clotting medium 79 until the proximal end 52 of anchoring member 34 is set to the desired distance dl from the distal face 90 of clotting filamentarray 77a. The distance dl may range for example from zero or close to zero (close to flush with the distal face 90), as shown in FIG. 5B, to about 2 mm or less. As the anchoring member 34 serves as an anchor for the vascular plug 32 as opposed to solely a flow diverter, a larger distance dl (greater than zero) can place the anchoring member 34 deeper inside the aneurysm sac upon deployment (more distal from the aneurysm neck). Note the above description is just one method to assemble the anchoring member 34 to the clotting medium 79. For example, alternatively, the anchoring member 34 can be inserted through the proximal opening in lumen 82 of neck 80 of clotting medium 79 and advanced distally until the correct position is achieved between the parts. This method may require the distal end of the anchoring member 34 to be assembled later in the manufacturing process.

[0115] After insertion of the proximal neck 68 of the anchoring member into the neck 80 of the clotting medium 79, locking member 42 is then slid over the combined neck 68 and neck 80 and adjusted a distance d2 from the proximal face 92 of clotting filament array 77a. The locking member 42 can be in the form of a tubular band, such as a radiopaque marker band for example. The distance d2 for example can be flush, close to flush, or up to a distance of approximately 0.25 mm to approximately 1 mm from the proximal face 92 of the clotting array 77a. Locking member 42 can be in the form of a marker band and is preferably made of a radiopaque material such as platinum, gold, platinum / iridium alloy and / or combination thereof. It will generally have approximately the same length or a shorter length than neck 68 and 80, which it covers. Specifically, it can range between about 0.25 mm and about 1 mm with a wall thickness of about 0.001”.

[0116] loining the locking member 42 to proximal neck 68 and neck 80 is adhesive 44. Adhesive 44 is an epoxy material as manufactured by Epoxy Technology, Inc. located in Billerica, MA. The epoxy can be thermal cured or hardened with the application of heat or UV (ultra-violet) light or a thermally cured, two-part epoxy. The parts may also be joined using laser spot-welding techniques or a melted polymer such as PET or nylon. Further, the locking member 42 can in some embodiments be left off and the neck 68 and 80 can be bonded together with a nylon or PET, for example, as the proximal neck 68 may be radiopaque due to the use of radiopaque filaments in the anchoring member 34 construction. Alternatively, the neck 80 of clotting medium 79 can act as the locking member if formed from a meltable polymer. Once locking member 42 is bonded, the mandrel is removed and the necks 68 and 80 are cut to length at the epoxy joint. However,alternatively, the necks can be cut to length prior to bonding as well. For clarity, the completed through lumen formed with the combined components that make up vascular plug 32 will be referred to as through lumen 46. Through lumen 46 is configured for attachment to a detachment / delivery mechanism / system. For example, detachment mechanisms include, without limitation, electrolytic, mechanical, e.g., interlocking, fluid pressure, hydraulic, and the like.

[0117] FIG. 6A shows the vascular plug 32 of Figure 5A in a partial cross-sectional view deployed inside an aneurysm 12. The vascular plug 32 in this embodiment uses only multifilament yarns 77b in clotting medium 79. Upon deployment, vascular plug 32 will form three distinct regions within aneurysm 12 based on where walls 54 and 56 of anchoring member 34 make direct contact with walls 28 and 29 of the aneurysm 12. The regions are: stagnation region 94, anchoring region 96 distal of stagnation region 94, and dome region 98 distal of anchoring region 96.

[0118] The stagnation region 94 is formed in the neck region 100 of aneurysm 12 between the distal side 102 (denoted by dotted line) of locking member 42 and dotted line 104, where walls 54 and 56 of anchoring member 34 first make direct contact with walls 28 and 29 of aneurysm 12. In this region, blood flow will enter aneurysm 12 where it will interact with multifilament yams 77b of circular array of filaments 77a, which are not pinned to aneurysm walls 28 and 29, to slow blood flow and bring about stagnation and clot 30 formation at neck 18 of aneurysm 12.

[0119] The anchoring region 96 is formed where walls 54 and 56 of anchoring member 34 make direct contact with walls 14 and 16 of aneurysm 12. In FIG. 6A, this is between dotted lines 104 and 106. This region is where vascular plug 32 is pinned to aneurysm walls 28 and 29, locking vascular plug 32 in place. Vascular plug 32 will typically make contact with the aneurysm walls between diameters D2 and D3 (not shown in FIG. 6A; shown in FIG. 3B) of anchoring member 34. By default, the anchoring member 34 will also aid in stagnation as the braid design will act as a flow disruptor, slowing the flow at its proximal end 52.

[0120] The distalmost region is the dome region 98. This is typically above (distal of) line 106, in dome 108 of aneurysm 12. In this region, blood flow should be minimal due to the flow diversion characteristics of anchoring member 34 leading to clot formation in the dome 108.

[0121] FIG. 6B shows clot formation effected by the vascular plug 32 (shown in partial cross-sectional view) deployed inside an aneurysm 12. The multifilament yarns 77b sit below anchoring member 34, free to move in the blood flow 20. A heavy formation of clot 30 has formed in the stagnation region 94. Over time, the clot 30 formation progresses distally into the center of theanchoring member 34 and eventually clotting in dome 108 of aneurysm 12. However, clot formation may occur earlier or at the same rate in the anchoring and dome regions depending on the vascular plug design.

[0122] FIG. 6C shows an alternate embodiment of the vascular plug in a partial cross-sectional view deployed inside an aneurysm 12. In this embodiment, multifilament yams 77c extend from the proximal region distally into the dome 108 of aneurysm 12 as designated by region 77d, terminating at ends 77e. Thus, as shown, multifilament yarns 77c extend distally along the anchoring member 34 as they extend distally past the distal end 50 of the anchoring member, and in the illustrated embodiment, distally beyond the marker 48. The multifilament yarns 76 are pinned between walls 54 and 56 of anchoring member 34 and aneurysm walls 28 and 29. Clot 30 has formed at neck 18 of aneurysm 12 and inside anchoring member 34. With the addition of yarns 77c in dome 108 (at 77d), clot 30 formation will accelerate distally.

[0123] It should be understood that yarns 77c can be of other lengths (i.e., cut to any length) and in some embodiments, they end in the anchoring region 96. That is, the multifilament yams 77b, 77c can be configured to extend to lengths that could end in the stagnation region 94, the anchoring region 96 or the dome region 98 and can terminate at various lengths within such regions. For example, multifilament yams 77c of FIG. 6C could terminate in the dome region 98 proximal of the distal marker 48 rather than distal thereof as in the illustrated embodiment.

[0124] It is also envisioned that the yams used in the clotting mediums disclosed herein can be a combination of multifilament yams 76 and monofilament yarns 78 as described above. While yarns are described herein as a preferred clot-promoting medium, it is also envisioned that highly thrombogenic material may be used in place of the yams and positioned proximal and / or distal to the anchoring member to facilitate, enhance, or accelerate healing in a similar manner as the clotting mediums disclosed herein. That is, other thrombogenic material can be utilized to achieve the effect of the vascular plug of the present invention wherein thrombogenic occlusion is achieved at a proximal region, e.g., adjacent the neck of the aneurysm, and mechanical occlusion can be achieved distally of the proximally positioned thrombogenic occlusion medium.

[0125] Note that the anchoring member in FIGS. 6A-6C is shown expanded in the aneurysm to a specific size / configuration. However, it should be understood that the anchoring member could expand to a different size / configuration if placed in a different sized / configured aneurysm.FIGS. 7A through 7D show delivery and / or deployment of a vascular plug of the present invention. The vascular plug 32’ is different from vascular plug 32 in that the anchoring member 34 is in the shape of a basket rather than the aforedescribed inverted bell shape. The clotting medium illustrated is the clotting medium 38 of FIG. 2 with filaments 40 (designated as 38’ and 40’) since it is used with a different anchoring member). Note the delivery system described in reference to FIGS. 7A-7D can be utilized with other embodiments of the vascular plug to deliver such vascular plugs. That is, although FIGS. 7A and 7D show an alternate embodiment of the anchoring member in the form of a basket, it should be appreciated that vascular plugs with other shaped anchoring members, such as the shape of FIG. 2, and / or other configured clotting mediums such as those of FIGS. 4A-4C, would be delivered in a similar manner and thus for brevity delivery of these alternative vascular plugs is not discussed in further detail since the discussion of FIGS.

[0126] 7A-7D is fully applicable to the other embodiments of the vascular plug, and their alternatives, disclosed herein.

[0127] Turning initially to FIG. 7A, vascular plug 32’ is attached to pusher (delivery) wire 110 which is shown being advanced through microcatheter 112 into aneurysm 12. The pusher wire 110 in this embodiment features a bi-polar electrolytic detachment mechanism wherein application of energy will effect detachment of the vascular plug 32’ from the delivery wire 110. The pusher wire 110 in the illustrated embodiment is constructed of a laser cut hypo tube 114 that can be made out of nitinol or stainless steel. The pusher wire 110 outer diameter can range from about 0.012” to about 0.021” with an inner diameter of about 0.0065” or greater. The length can range from about 170 cm to about 200 cm. Other embodiments may use a coil to hypo tube design instead of a laser cut tube, which can in some embodiments be more suitable for electrolytic detachment systems.

[0128] Inside pusher wire 110 is detachment (delivery) wire 116. Detachment wire 116 can be made of nitinol, stainless steel or any implantable material, either metal or plastic. The detachment wire 116 is coated in an insulating material (not shown) and can have a diameter ranging from about 0.001” to about 0.0025”. In other embodiments, the detachment wire 116 can be noninsulated and an insulating liner may be slid over it. In embodiments utilizing mechanical detachment instead of electrolytic detachment, insulation is optionally not provided. The detachment wire 116 runs the entire length of the pusher wire 110 with a short tip of it exiting the pusher wire 110 distal tip. In manufacture, an epoxy joint 118 is formed at the pusher wire 110and detachment wire 116 junction where it exits pusher wire 110 to bond them together. This is at the proximal side of the detachment zone 120. A small portion of the insulating material is then removed (during manufacture) from the exposed portion of the detachment wire 116 for the detachment zone 120. The tip of the detachment wire 116 is then inserted into vascular plug 32’ lumen 46 (not shown) of locking member 42’ (same as locking member 42) and epoxy joint 122 is formed, bonding vascular plug 32’ to pusher wire 110 and completing the detachment zone 120. Alternate embodiments allow for other bonding materials or methods in place of epoxy.

[0129] During clinical use, after insertion of the microcatheter distal end into the aneurysm with the vascular plug 32’ in the collapsed state / condition, microcatheter 112 is pulled back, anchoring member 34’ will start to be exposed followed by filaments 40’ of clotting medium 38’ as shown in FIG. 7B. FIG. 7C shows complete expansion and anchoring of vascular plug 32’ to aneurysm walls 28 and 29. If needed, vascular plug 32’ can be repositioned and redeployed using the microcatheter 112 and pusher wire 110 since it remains attached to the detachment (delivery) wire 116. At this point, vascular plug 32’ is ready for detachment. A detachment controller (not shown) is then attached to the proximal end of the detachment wire 116 and a current is applied to dissolve the detachment zone 120. FIG. 7D shows vascular plug 32’ in its deployed state (condition) inside aneurysm 12, fully released from the delivery system, expanded to contact the walls 28, 29 of the aneurysm 12 and the fdaments 40’ extending distally around, e.g., partially or fully encircling or surrounding, at least the proximal region of the anchoring member 34’. Thus, the detached vascular plug 32’ leaves the clotting medium 38’ at the neck / parent interface and held in place distally by the anchoring member 34’ within the aneurysm sac.

[0130] The vascular device can be inserted into other vasculature in a similar manner. For example, FIG. 12 illustrates the vascular plug of FIG. 9 deployed (placed) in a vessel V, in contact with vessel walls VI, V2. (Its expansion shown limited in FIG. 12 by the size of the vessel wall so it does not expand to the size of Figure 9, and in preferred embodiments, expands to provide a radial force on the walls of the vessel).

[0131] In some embodiments of the basket design of FIG. 7A, the distal braid portion (distal opening) of the anchoring member may have some of its wall inverted into itself so that the individual braid fdaments do not contact the aneurysm wall. Alternatively, the fdaments may be joined together to prevent wall injury.An alternate embodiment of the vascular plug is illustrated in FIG. 8 and designated generally by reference numeral 124. In this embodiment, the clotting medium 130 has a circular array of filaments 132 placed inside anchoring member 125. Anchoring member 125 is composed of a braid 127 with a low porosity section 126 and a high porosity section 128. The low porosity section 126 is generally located at a proximal region near or in contact with the neck of the aneurysm to act as a flow disruptor. The high porosity section 128 is more distal of the low porosity section 126 and allows the circular array of filaments 132 to interact with the wall of the aneurysm to aid in attaching the vascular plug 124 to the aneurysm for stability. By placing the clotting medium 130 inside the anchoring member 125, the possibility of clot forming on the circular array of filaments 132 and breaking loose into an artery in some clinical applications is minimized by the low porosity section 126. Vascular plug 124 (as well as the other alternate embodiments of the vascular plugs disclosed herein) can have distal and proximal necks and proximal and distal marker bands in the same manner as the vascular plug of FIG 5A. The proximal and distal radiopaque marker bands adjacent the proximal and distal necks of the anchoring member 125 are designated by reference numerals 129b, 129a, respectively.

[0132] Note FIG. 8 shows the clotting medium 130 placed within the anchoring member having a shape of the anchoring member 34 of FIG. 2; however, it should be appreciated that the clotting medium 130, can be placed within the other anchoring member configurations, e.g., the anchoring members of FIG. 7C or FIG. 9. Further, it should be appreciated that other forms of clotting mediums, e.g., the clotting mediums 77 and 79 of FIGS. 4A and 4B, can be placed inside any of the anchoring member configurations disclosed herein.

[0133] Note, in alternate embodiments, the clotting medium can be placed both inside and outside the anchoring member, i.e., some of the filaments of the clotting member can be positioned within the anchoring member and other filaments positioned outside the anchoring member, or some of the filaments can extend both inside and outside the clotting medium.

[0134] As shown, the filaments in the illustrated embodiments preferably encircle / surround the proximalmost region of the anchoring member as they extend from the neck, which extends proximally from the anchoring member. In this manner, in preferred embodiments, a proximalmost region of the filaments is at least at the proximalmost end of the anchoring member. Note this is applicable to preferred embodiments as alternate embodiments are also contemplated.It should be appreciated that clotting medium 130 is shown in a circular array (an array around the anchoring member), however, it should be appreciated that other filament arrays are also contemplated for clotting mediums placed internal the anchoring member and for clotting mediums placed outside the anchoring member.

[0135] In general, the clotting medium is configured, whether placed inside or outside of the anchoring member to interact with the aneurysm walls. The clotting medium may also sit at the distal end of the anchoring member and be secured by the distal marker.

[0136] The alternate embodiments of the anchoring members disclosed herein could have regions of high porosity and low porosity as in anchoring member 125, and such different porosities can be in various regions of the anchoring member.

[0137] FIG. 9 shows an alternate embodiment of the vascular plug, designated generally by reference numeral 140. In this embodiment, the clotting medium 146 has a circular array of filaments 148 placed outside anchoring member 142. Anchoring member 142 is composed of a braid. Anchoring member 142 has a somewhat cylindrical shape. Clotting medium 146 could alternatively be placed inside anchoring member 142. The distal radiopaque marker band adjacent the proximal distal neck of the anchoring member 142 is designated by reference numeral 149a while the proximal neck is designated 149b. In this embodiment, the proximal neck 149b is formed by the array of filaments 148, however, in alternate embodiments, a proximal marker band can be utilized. In either case, the proximal neck provides a narrowed portion extending proximally from the cylindrical shape (or from the inverted bell shape in other embodiments) so it can be considered an external neck protruding proximally therefrom. The vascular plug 140 in all other respects is the same as vascular plug 32 of FIG. 5 A.

[0138] Figure 11 shows an alternate embodiment of the vascular plug, designated generally by reference numeral 170. In this embodiment, the clotting medium 176 has a circular array of filaments 178 placed outside anchoring member 172. Anchoring member 172 is composed of a braid. Anchoring member 172 differs from the somewhat cylindrical shape anchoring member 142 of FIG. 9 in that it has a recessed distal end 173 and a recessed proximal end 175. Clotting medium 176 could alternatively be placed inside anchoring member 172. The distal radiopaque marker band adjacent the proximal distal neck of the anchoring member 172 is designated by reference numeral 179a while the proximal neck is designated by reference numeral 179b. In this embodiment, the proximal neck 179b is formed by the array of fdaments 178, however, in alternateembodiments, a proximal marker band can be utilized. The vascular plug 170 is all other respects is the same as vascular plug 32 of FIG. 5 A.

[0139] Additionally, although the embodiments of the vascular plug shown have the clotting medium only on the proximal side of the vascular plug, it is envisioned that in alternate embodiments a clotting medium can also be attached to the distal side of the vascular plug so a clotting medium is positioned on both sides. This is illustrated in FIG. 10 wherein the vascular plug 150 has a clotting medium 154 with a circular array of filaments 155 placed outside anchoring member 152 at a proximal region and a clotting medium 156 with a circular array of filaments 158 placed distal of anchoring member 152. Anchoring member 152 is composed of a braid which in some embodiments can have a low porosity section 160 at a proximal region and a high porosity section 162 distal of the low porosity section 160. The distal radiopaque marker bands adjacent the distal neck of the anchoring member 152 is designated by reference numeral 159a while the proximal neck is designated by reference numeral 159b.

[0140] Note this version with two clotting mediums 154, 156 can be used with the other shaped / configured anchoring members disclosed herein. Further, alternate embodiments of the clotting mediums can be placed on the proximal and distal sides of the anchoring member and the same or different clotting mediums can be provided on the proximal and distal sides of the anchoring member.

[0141] In alternate embodiments, the vascular plug can may include two or more clotting arrays arranged one on top of another, i.e. one inside the other.

[0142] It should be appreciated that anchoring member configurations other than those disclosed herein can be used with the various clotting mediums so long as they achieve the functions described herein.

[0143] The vascular plugs of the present invention, as can be appreciated from the description above, focus on where prior art coils, plugs and flow disruptors fail - the proximal end. The vascular plugs of the present invention therefore provide a clotting medium at the proximal end as the plug creates a focal point(s) for clot at the base of the plug. By providing dense embolic fibers, (e.g., dense nylon embolic fibers) at the proximal region, immediate proximal thrombogenic occlusion occurs as it encourages formation of proximal thrombus. The vascular plugs also provide other advantageous features including one of more of i) a fiber neck band to enhance thrombogenic occlusion; ii) structure to encourage centralized thrombus formation; iii) a densemesh (e.g., high density braid) design at the anchoring region (distal of the proximal region) to provide solid anchoring and immediate mechanical occlusion; iv) fiber bundles (e.g., nylon fiber bundles) at the base to ensure no fiber detachments; v) Al braid design suited for deep selective embolization; vi) drawn filled tubing wires to provide radiopacity for improved visibility and control; vii) structure that reduces likelihood of recanalization; viii) structure that prevents migration by preventing blood from getting between the device and the aneurysm wall; ix) deployable through standard microcatheters ranging from 0.021 inches 0.033 inches; and x) retrievable and repositionable, even after expansion. In short, the vascular plugs of the present invention advantageously embolize like a plug, track like a coil and promote thrombogenic and mechanical occlusion.

[0144] The applications of the vascular plug of the present invention discussed above are not limited to the treatment of brain aneurysms, but include any number of vascular maladies such as treating AVMs / AVFs, occluding aneurysms outside of the brain, occlusion of parent vessels, preoperative devascularization, endoleak management, flow diversion, varicocele / gonadal vein embolization, and to cover punctures in vessel walls. This list is not meant to limit the use of the device; it is an example of situations in which the plug may be used and thus should not be considered limiting the use. Also, the device is not limited to use in the neurovascular. The vascular plug may be used throughout the body, including the peripheral vasculature (vessels located in outer parts of the body, outside the heart and brain, such as in the arms, hands, legs and feet), as an alternative to coils, embolics and other vascular plugs. It can be used for peripheral vascular interventions such as occluding side branches before stent graft placement in aneurysm repair, in venous occlusion for conditions like varicose veins, to prevent reflux or for closing collateral vessels for treating congenital heart disease or other cardiac procedures. In short, the vascular occlusion device is used in endovascular therapy for occlusion of blood vessels - designed to block or reduce blood flow in targeted vessels without requiring open surgery. It is deployed via a catheter and preferably under imaging guidance.

[0145] Embodiments of the vascular plug of the present invention provide a single device reducing the need for additional embolics, result in reduction in SKUs leading to less inventory and complexity, reduce procedure time improving lab throughput and reduce fluoroscopy time benefits staff and patients.As can be appreciated from the above, embodiments of the vascular occlusion device of the present invention effect immediate occlusion without future recanalization, are expandable for use in multiple vessel sizes and are configured for microcatheter delivery regardless of device size.

[0146] Although the apparatus and methods of the subject invention have been described with respect to preferred embodiments, which constitute non-limiting examples, those skilled in the art will readily appreciate that changes and modifications may be made thereto without departing from the spirit and scope of the present invention as defined by the appended claims.

[0147] It will be understood by those skilled in the art that the above particular embodiments are shown and described by way of illustration only. The principles and the features of the present disclosure may be employed in various and numerous embodiments thereof without departing from the scope and spirit of the disclosure as claimed. The above-described embodiments do not restrict the scope of the disclosure.

[0148] Additionally, persons skilled in the art will understand that the elements and features shown or described in connection with one embodiment may be combined with those of another embodiment without departing from the scope of the present invention.

[0149] Where a range of values is provided, it is understood that each intervening value, between the upper and lower limit of that range is encompassed within the invention.

[0150] Throughout the present disclosure, terms such as “approximately,” “about,” “generally,” “substantially,” and the like should be understood to allow for variations in any numerical range or concept with which they are associated. For example, it is intended that the use of terms such as “approximately,” “about” and “generally” should be understood to encompass variations on the order of 25%, or to allow for manufacturing tolerances and / or deviations in design.

[0151] Although terms such as “first,” “second,” “third,” etc., may be used herein to describe various operations, elements, components, regions, and / or sections, these operations, elements, components, regions, and / or sections should not be limited by the use of these terms in that these terms are used to distinguish one operation, element, component, region, or section from another. Thus, unless expressly stated otherwise, a first operation, element, component, region, or section could be termed a second operation, element, component, region, or section without departing from the scope of the present disclosure.

[0152] Also, the phrases “at least one of A, B, and C” and “A and / or B and / or C” should each be interpreted to include only A, only B, only C, or any combination of A, B, and C.

Claims

WHAT TS CLAIMED TS;1. A vascular occlusion device for treating a vessel comprising:a) an anchoring member having a first collapsed condition for insertion and a second expanded condition for placement within the vessel, the vascular plug expandable to contact a wall of the vessel; andb) a clotting medium positioned at least at a proximal region of the anchoring member.

2. The vascular occlusion device of claim 1, wherein the clotting medium is different in configuration than the anchoring member, the clotting medium having a plurality of polymer filaments that extend radially outwardly with respect to the anchoring member and extend distally to surround at least the proximal region of the anchoring member.

3. The vascular occlusion device of claim 2, further comprising a locking member for joining the anchoring member and clotting medium.

4. The vascular occlusion device of claim 3, wherein the locking member comprises a marker band.

5. The vascular occlusion device of claim 2, further comprising a distal marker adjacent a distally extending neck of the anchoring member.

6. The vascular occlusion device of claim 2, wherein the clotting medium has a proximal neck having a lumen, and a proximal end of the anchoring member is positioned within the lumen of the proximal neck of the clotting medium.

7. The vascular occlusion device of claim 6, wherein the proximal end of the anchoring member narrows into a proximally extending neck which is positioned within the lumen.

8. The vascular occlusion device of claim 1, wherein the clotting medium comprises a plurality of filaments forming a circular array about a longitudinal axis of the anchoring member and are outside the anchoring member.

9. The vascular occlusion device of claim 2, wherein the clotting medium is configured so that at least some of the plurality of filaments extend laterally to cover a neck of an aneurysm in which it is placed.

10. The vascular occlusion device of claim 1, wherein the clotting medium comprises a plurality of polymer filaments that extend in a circular array and are positioned within the anchoring member.

11. The vascular occlusion device of claim 1, wherein the clotting medium comprises a plurality of polymer filaments that extend in a circular array and some of the filaments are positioned inside the anchoring member and some of the filaments are positioned outside the anchoring member.

12. The vascular occlusion device of claim 2, wherein the anchoring member has a vessel wall contact region and a proximal region proximal of the wall contact region, wherein the clotting medium extends distally and terminates proximal of the wall contact region of the anchoring member.

13. The vascular occlusion device of claim 2, wherein the anchoring member has a vessel wall contact region, a distal region distal of the wall contact region and a proximal region proximal of the wall contact region, wherein the clotting medium extends distally and terminates distal of the wall contact region of the anchoring member.

14. The vascular occlusion device of claim 2, wherein the anchoring member has a first porosity region and second porosity region having a higher porosity than the first porosity region.

15. The vascular occlusion device of claim 2, further comprising a proximal marker adjacent a proximally extending neck of the anchoring member adjacent a joining region of the anchoring member and clotting medium.

16. The vascular occlusion device of claim 2, further comprising a second clotting medium having a plurality of polymer filaments extending distally of the anchoring member.

17. The vascular occlusion device of claim 2, wherein the clotting medium comprises a plurality of multifilament yarns.

18. The vascular occlusion device of claim 2, wherein the anchoring member includes a braid configured for mechanical occlusion and the clotting medium is configured for thrombogenic occlusion.

19. A method for promoting thrombogenic occlusion in a vessel comprising:a) inserting into the vessel an occlusion device having an anchoring member and a clotting medium at a proximal portion of the anchoring member;b) releasing the anchoring member within the vessel such that it expands from a collapsed condition to an expanded condition into contact with a wall of the vessel; and c) subsequently releasing the clotting medium within the vessel, the clotting medium having a plurality of filaments wherein at least some of the filaments extend across the vessel;d) wherein the clotting medium provides thrombogenic occlusion at a proximal region of the vessel and the anchoring member provides subsequent mechanical occlusion.

20. The method of claim 19, wherein the occlusive device is placed within an aneurysm and has three distinct regions within the aneurysm based on where walls of the anchoring member make direct contact with walls of the aneurysm, the regions comprising a stagnation region, an anchoring region distal of the stagnation region and a dome region distal of the anchoring region, and the clotting medium is positioned at least at the stagnation region.

21. The method of claim 20, wherein at least some of the filaments extend to adjacent the anchoring region.

22. The method of claim 20, wherein at least some of the filaments extend to the dome region.

23. The method of claim 20, wherein the filaments when released extend across a neck of the aneurysm.

Images