Intracapsular flow diverter

Abstract

To provide an intrasaccular flow diverter.SOLUTION: An intrasaccular flow diverter includes: an interior fill braid physically inverted over itself forming a proximal inverted end and an opposite free end; and a dome braid disposed distally to and secured to the interior fill braid. Subject to application of an external mechanical force, the dome braid is transitionable between an expanded state and a compressed state. The dome braid has a proximal end with an opening defined therein, through which the interior fill braid is passable starting at the free end, so that a radially outward force can be exerted on the dome braid. A delivery wire is releasably detachable from the proximal inverted end of the interior fill braid. The dome braid has a stiffer profile than the interior fill braid to keep the dome braid in position within an aneurysm as the interior fill braid is advanced therein.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] The present invention relates to the endovascular treatment of intracranial aneurysms using an intrasaccular flow diverter, and in particular to an improved intrasaccular flow diverter consisting of two parts: a dome braid and an inner filler braid. [Background technology]

[0002] Abnormal dilation or expansion of a blood vessel wall is known as an aneurysm. Typically located in the heart (aorta) or brain (cerebral), such blood vessel abnormalities can result in thinning, weakening, and ballooning of the vessel wall, making it more susceptible to rupture and therefore potentially causing death.

[0003] Aneurysms are generally treated by excluding the weakened portion of the blood vessel from the arterial circulation. There are several forms of conventional treatment procedures to treat cerebral aneurysms, including invasive surgical procedures in which a clip is secured around the neck of the aneurysm to prevent blood from entering the aneurysm. Minimally invasive, non-surgical procedures involve filling or packing the aneurysm with a vascular occlusion device (e.g., a small flexible wire coil) or an embolic material to induce thrombosis and ultimately remove the clot from the bloodstream within the vasculature. Conventional coils impose several disadvantages. One issue is that multiple coils (e.g., typically 5-10 coils) are required to pack the aneurysm, requiring additional time for implantation. Another recognized issue is the tendency of conventional coils to migrate within the aneurysm and potentially cause recanalization.

[0004] Instead of traditional coils, intrasaccular flow diverter or blockade devices (ISFDs) may be implanted to divert or block blood flow away from the aneurysm. One such device, the Woven EndoBridge (WEB device) aneurysm embolization system from MicroVention, Inc., is a braid shaped into a sphere. During implantation, the WEB device is introduced into the groin and delivered intravascularly to the intracranial aneurysm sac where it deploys to fill the aneurysm. The mesh provides tension to keep the device in place, promoting thrombosis by blocking blood flow to the aneurysm. A geometric mismatch between a non-spherical aneurysm (e.g., elliptical, bilobed) and the braided sphere shape of the flow diverter device may undesirably result in inadequate occlusion of the aneurysm.

[0005] It is therefore desirable to develop an improved intrasaccular flow diversion device (eg, an intrasaccular flow diverter) for the treatment of intracranial aneurysms that addresses the aforementioned problems associated with conventional treatment devices. Summary of the Invention [Means for solving the problem]

[0006] One aspect of the present invention relates to an improved intrasaccular flow diversion device (eg, an intrasaccular flow diverter) for intracranial aneurysm treatment that fills, stabilizes, and occludes the aneurysm using a single device.

[0007] Another aspect of the invention relates to an intrasaccular flow diverter including an internal filling braid that is physically inverted on itself to form a proximal inverted end and an opposing free end, and a dome braid that is disposed distally of and secured to the internal filling braid. Upon application of an external mechanical force, the dome braid is transitionable between an expanded state and a compressed state in which the overall diameter is reduced. The dome braid has a proximal end with an opening defined therein through which the free end of the internal filling braid can freely pass within the dome braid. A delivery wire is releasably removable from the proximal inverted end of the internal filling braid. The intrasaccular flow diverter is configured such that the dome braid has a stiffer profile than the internal filling braid such that the dome braid is maintained in place within the aneurysm as the internal filling braid advances therethrough.

[0008] Yet another aspect of the invention relates to a method of treating an aneurysm with the intrasaccular flow diverter described in the preceding paragraph. A microcatheter is navigated through a blood vessel to a target site proximate the aneurysm. Using a delivery wire, the intrasaccular flow diverter is advanced through the lumen of the microcatheter while the dome braid and the internal filling braid are each in a compressed state. Upon exiting the distal end of the microcatheter, the dome braid automatically deploys to an expanded state in which it expands in diameter to fill the aneurysm, with only a distal portion of the internal filling braid, including the free end, positioned inside the deployed dome braid. Using the delivery wire, the intrasaccular flow diverter is configured to further advance through the lumen of the microcatheter until the everted proximal end of the internal filling braid is positioned proximate to the deployed dome braid but remains outside the dome. At that point, the delivery wire is released from the everted proximal end of the internal filling braid, automatically transitioning the internal filling braid to an expanded state that exerts a radially outward force against the deployed dome braid to substantially conform to the shape of the aneurysm.

[0009] A further aspect of the invention relates to a method for treating an aneurysm using an intrasaccular flow diverter, the intrasaccular flow diverter including an internal filling braid and a dome braid disposed distal to the internal filling braid. The dome braid is first deployed within the aneurysm to be treated. The deployed dome braid returns to a preformed shape of a dome, sphere, or hemisphere. The deployed dome braid is then apposed to conform to the shape of the aneurysm to be treated, and an outward radial force is applied inwardly on the deployed dome braid with the internally introduced internal filling braid. [Brief description of the drawings]

[0010] These and other features of the present invention will become more readily apparent from the following detailed description and drawings which illustrate the invention and in which like reference numerals refer to like elements throughout the several views. [Figure 1A] FIG. 2 is an axial cross-sectional view of an intrasaccular flow diverter of the present invention being manipulated through the lumen of a microcatheter to a target site within a blood vessel aligned with an aneurysm to be treated (A). [Figure 1B] FIG. 1B is an enlarged view of section I(B) of the intrasac flow diverter of the present invention of FIG. 1A. [Figure 2A] FIG. 2 is an axial cross-sectional view of an intrasaccular flow diverter of the present invention, in which the dome braid is deployed within an aneurysm to be treated, with a portion of the free end of the inner filling braid emerging therein. [Figure 2B] FIG. 2B is an enlarged view of section II of the intrasaccular flow diverter of FIG. 2A, showing the inverted proximal end of the inner filling braid secured to the distal end of the pusher or delivery wire. [Figure 3A] FIG. 1 is an axial cross-sectional view of an intrasaccular flow diverter device of the present invention with a deployed inner filling braid positioned in front of a deployed dome braid, the intrasaccular flow diverter device being apposed to the aneurysm being treated after being released from a pusher or delivery wire. [Figure 3B] FIG. 3B is an enlarged view of section III(B) of the intrasaccular flow diverter of FIG. 3A showing the inverted proximal end of the internal filling braid that does not include a delivery or pusher wire. [Figure 4A] 2B is a series of enlarged partial views of the intrasaccular flow diverter showing the connection point or interface between the dome braid and the inner filling braid of FIG. 2A at three different stages as the inner filling braid advances distally through the microcatheter in the lumen of the deployed stationary dome braid. FIG. 2C is an enlarged partial view of the inner filling braid of the intrasaccular flow diverter of FIG. 2A where the free end of the inner filling braid is beginning to emerge within the deployed dome braid. [Figure 4B] 2B is a series of enlarged partial views of an intrasaccular flow diverter showing the connection point or interface between the dome braid and the inner filling braid of FIG. 2A at three different stages as the inner filling braid advances distally through the microcatheter in the lumen of the deployed, stationary dome braid. FIG. 2C is an enlarged partial view of the inner filling braid extending further inward and partially deployed within the dome braid. [Figure 4C] 3A-3C are a series of enlarged partial views of the intrasaccular flow diverter showing the connection or interface between the dome braid and the inner filling braid of FIG. 2A at three different stages as the inner filling braid advances distally through the microcatheter in the lumen of the deployed, stationary dome braid; and FIG. 3A-3C are enlarged partial views of the inner filling braid of the intrasaccular flow diverter of FIG. 3A where the inner filling braid has further extended and is fully deployed within the deployed dome braid. [Diagram 5] FIG. 2B is an enlarged partial view of the intrasaccular flow diverter of FIG. 2A, illustrating a specific embodiment in which fixation between the neck of the deployed dome braid and the internal filling braid at the connection point or interface is achieved using a crimped marker band. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The terms "distal" or "proximal" are used in the following description with reference to a location or direction relative to the treating or interventional physician. "Distal" or "distally" is a location or direction away from the physician or interventional physician. "Proximal" or "proximal" or "proximal" is a location or direction closer to the physician or interventional physician. The terms "obstruction," "clot," or "blockage" are used interchangeably.

[0012] FIG. 1A shows an intrasaccular flow diverter 100 of the present invention being manipulated through a blood vessel (BV) via the lumen of a microcatheter 115 to a target site aligned with an aneurysm (A) to be treated. FIG. 1B shows an enlarged view of section I (B) of the intrasaccular flow diverter 100 of FIG. 1A. Referring to the enlarged view of FIG. 1B, the intrasaccular flow diverter 100 is made up of two parts, namely, a dome braid 105 disposed distal to an internal filling braid 110 that is "folded" inwardly, as described in more detail below. Both the dome braid and the internal filling braid 105, 110 are in a compressed state in FIG. 1A and FIG. 1B. The open proximal end of the dome braid 105 is permanently, fixedly, or non-releasably attached to the open distal end of the internal filling braid 110 at a connection point or interface 113. Various configurations for connecting, attaching, or securing the dome braid 105 to the internal filling braid 110 at the connection point or interface 113 are contemplated and are within the intended scope of the present invention. In Figures 1A, 1B, 2A, 2B, 3A, 3B, 4A-4C, the connection point or interface 113 between the dome braid 105 and the internal filling braid 110 is laser welded. Other conventional non-mechanical forms of attachment are possible, including but not limited to adhesives. Alternatively, a mechanical device such as a band or ring 500 crimped around the two braids 105, 110 as shown in Figure 5 can be used to physically secure the two components together. The band or ring is preferably (i) made of a radiopaque material, (ii) includes one or more radiopaque features, or (iii) has a radiopaque material coating layer on at least a portion thereof to aid in visibility during steering the intrasaccular flow diverter through the vasculature to the target site using conventional imaging techniques.

[0013] Referring to each component separately, the dome braid 105 is a self-expanding braid, mesh, cage, or framework having a plurality of openings defined therein. The dome braid is made of a biocompatible material, the pattern, braid angle, and number of wires comprising the braid can be selected as desired. Upon application of a physical mechanical force from the outside (e.g., during insertion and advancement within the lumen of the microcatheter 115), the dome braid 105 is collapsible to a compressed or contracted state having a cylindrical tube configuration with a sufficiently reduced overall diameter so that it can be received within the lumen of the microcatheter 115. When no external physical mechanical force is present or applied (e.g., before the dome braid is introduced into the lumen of the microcatheter, after the dome braid exits the distal end of the microcatheter), the dome braid 105 is in an expanded or uncompressed state having a "dome-shaped", spherical, or hemispherical shape with an expanded or maximum overall diameter.

[0014] The inner filling braid 110 is similarly configured as a self-expanding braid, mesh, cage, or framework having a plurality of openings defined therein. During insertion of the intrasaccular flow diverter 100 into the lumen of the microcatheter, the inner filling braid 110 is in a contracted or compressed state in which it assumes a substantially linear configuration, thus reducing its overall diameter so that it can be received into the lumen of the microcatheter 115. In the absence or application of external physical mechanical forces (e.g., before the inner filling braid is introduced into the lumen of the microcatheter, after the inner filling braid exits the distal end of the microcatheter), the inner filling braid 105 is in a non-compressed or expanded state having a complex helical, spiral, or ribbon-like preformed configuration that fills within the deployed dome braid 105 and pushes radially outward.

[0015] The dome braid 105 is designed to have a higher shell stiffness than the internal filling braid 110. This higher shell stiffness of the dome braid can be achieved by modifying one of the following characteristics: (i) increasing the thickness (diameter) of the individual wires forming the braid, mesh, cage, or framework; (ii) decreasing the braid angle; and (iii) increasing the number of wires forming the braid. In contrast, the internal filling braid 110, which has a lower shell stiffness, is soft or flexible enough that the internal filling braid can be physically inverted (i.e., its outer surface can be folded inward like a sock or sleeve). Hereinafter, an internal filling braid in an inverted "outside-in" state is referred to as inverted, retracted, pulled, turned over, or folded over on itself. That is, the distal end of the internal filling braid 110 remains permanently fixed, connected, or attached to the open proximal end (neck) of the dome braid 105 at a connection point or interface 113, and the opposite free end 111 of the internal filling braid 110 is "turned inward" or "pulled inward" distally through an axial passage defined in the internal filling braid forming an everted proximal end 112. The everted proximal end 112 of the internal filling braid 110 is then releasably / removably fixed, attached, connected, or affixed to a pusher or delivery wire 120. The intrasaccular flow diverter 100 can be advanced distally through the lumen of the microcatheter 115 using the pusher or delivery wire 120. Preferably, the inner filling braid 110 is everted, retracted, pulled, flipped, or folded back on itself in a distal direction to the extent that the free inverted end of the inner filling braid extends into the dome braid 105 beyond the connection point or interface 113. As a result of the high shell stiffness, the deployed dome braid 105 maintains its shape while the inverted inner filling braid 110 is advanced distally into the cavity formed by the deployed dome braid 105.

[0016] During manufacturing of the intrasaccular flow diverter (in an uncompressed or expanded state, not subjected to any external physical mechanical force), the dome braid 105 is preformed to have a dome-shaped, spherical, or hemispherical shape, while the inner filling braid 110 has a complex helical, spiral, or any other preformed shape sufficient to exert a radially outward physical force against the inner wall of the deployed dome braid in apposition to the aneurysm.

[0017] As shown in FIG. 1A, during treatment of an aneurysm using the intrasaccular flow diverter 100 of the present invention, a microcatheter 115 is first introduced into the body, preferably via the groin, and introduced through a blood vessel (BV) to a target site (e.g., substantially aligned with the target aneurysm (A) to be treated). While the dome braid 105 and the inner filling braid 110 are both in a compressed or contracted state with reduced overall diameter (as shown in FIGS. 1A and 1B), the intrasaccular flow diverter 100 of the present invention is advanced distally through the lumen of the microcatheter 115 using a pusher or delivery wire 120. In this compressed or contracted state, the dome braid 105 is folded while the inner filling braid 110 maintains a substantially straight or linear configuration, such that each component has a reduced overall diameter so that it can be received in the lumen of the microcatheter.

[0018] When the intrasaccular flow diverter 100 is advanced distally through the microcatheter 115 using the pusher or delivery wire 120, the internal filling braid 105 begins to emerge from the distal end of the microcatheter 115. The dome braid 105 is fully deployed when the connection point 113 is proximate to the distal end of the microcatheter 115. As shown in FIG. 2A, the braided dome 105 is no longer physically constrained by the inner wall of the microcatheter 115 and automatically returns to a preformed spherical or hemispherical ("dome") shape (i.e., returns to a non-compressed state) and expands or expands in overall diameter to fill the aneurysm being treated. Also shown in FIG. 2A, a portion of the free end 111 of the internal filling braid 110 extends distally beyond the connection point or interface 113 into the cavity of the deployed dome braid 105. At this stage of treatment, only a relatively small portion of the inverted filling braid 110 extends into the cavity of the deployed dome braid 105, so that the exposed portion of the inner filling braid remains approximately linear or straight despite being unconstrained by the microcatheter 115.

[0019] As previously mentioned, because the dome braid 105 has a higher shell stiffness than the inner filling braid 110, the deployed dome braid 105 remains stationary within the aneurysm being treated as the inner filling braid 110 is pushed or advanced further distally through the neck and into the cavity of the dome braid 105 using the pusher or delivery wire 120. Continued distal advancement of the intrasaccular flow diverter automatically causes more of the inner filling braid 110, no longer constrained by the microcatheter, to return automatically to the preformed complex helical or spiral shape, as shown in FIG.

[0020] In FIG. 3A, the internal filling braid 110 is advanced further distally through the neck into the cavity of the expanded dome braid 105 by the interventionist using a pusher or delivery wire 120. The advancement of the internal filling braid 110 is stopped when the everted proximal end 112 of the internal filling braid 110 is proximate to the outside of the proximal opening (neck) of the deployed dome braid 105. At that point, the pusher or delivery wire 120 is released or detached from the proximal everted end 112 of the internal filling braid 110, whereupon the pusher or delivery wire 120 is withdrawn proximally from the body and through the microcatheter 115. FIG. 3B is an enlarged cross section III(B) of FIG. 3A of the everted proximal end 112 of the internal filling braid 110 released from the pusher or delivery wire 120. Within the deployed dome braid 105, the detached internal filling braid 110 automatically deploys back to a non-inverted (preformed) state (e.g., a complex helical, spiral, or any other desired shape) as shown in FIG. 3A to exert a radially outward force on the inner wall of the deployed dome braid apposing the aneurysm. Even when the internal filling braid 110 is fully deployed and free of the pusher or delivery wire 120, the inverted proximal end 112 of the internal filling braid 110 remains outside the deployed dome braid body 105. Release or detachment of the pusher or delivery wire 120 from the proximal inverted end 112 of the internal filling braid 110 can be accomplished in any number of conventional ways. For example, release can occur automatically when a simple pusher or delivery wire exits the distal end of the microcatheter. Alternative electrical, mechanical, or hydraulic detachment processes or mechanisms are contemplated to achieve deployment.

[0021] The inverted internal filling braid of the intrasac flow diverter of the present invention is described above as being sufficiently flexible or pliable to allow the internal filling braid to be physically turned "outside-in" (i.e., its outer surface folded inward like a sock or sleeve) when the distal end of the non-inverted internal filling braid is first connected, secured or attached to the proximal opening (neck) of the dome braid 105 at the connection point or interface 113 before being inverted, retracted, folded or pulled back on itself. However, if the internal filling braid is first inverted, retracted, folded or pulled back before being connected to the proximal opening (neck) of the dome braid 105, the internal filling braid can be inverted, retracted, folded or pulled back on itself by either inverting "outside to inside", i.e., by pulling the free end 111 distally inward through an axial passage defined in the internal filling braid that forms the inverted proximal end 112, or by inverting "inside to outside", i.e., by pulling the free end 111 distally outward on the outside of the internal filling braid that forms the inverted proximal end 112. Regardless of the process that produces the inverted internal filling braid (whether the internal braid is inverted "outside to inside" or "inside to outside"), the resulting structure is the same. That is, the inverted inner filling braid is non-releasably secured to the neck of the dome braid at connection point 113 and has a free end 111 disposed inside the cavity of the dome braid 105, and an inverted proximal end 112. Thus, to encompass either of the processes, the term "inverted" is generally defined as pulling upon itself and encompasses both "pull inward / outside in" or "pull outward / inside out."

[0022] The intrasaccular flow diverter of the present invention provides numerous advantages, some of which are summarized herein. Meanwhile, the expanded dome braid 105 holds the deployed inner filling braid 110 inside, limiting migration or movement of the inner filling braid, while the deployed inner filling braid 110 apposes the aneurysm, resulting in the shape of the deployed dome braid substantially conforming to the shape of the aneurysm. Thus, the intrasaccular flow diverter of the present invention may be widely used to treat aneurysms of a wide range of shapes and sizes to improve the adequacy of occlusion. Also, the neck of the deployed dome braid seals the aneurysm. The multi-component structure of the intrasaccular flow diverter of the present invention simultaneously fills the aneurysm with the deployed dome braid and occludes the aneurysm with the deployed inner filling braid, exerting a radial outward force from the inside. Furthermore, the intrasaccular flow diverter of the present invention uses a single device to fill and occlude aneurysms that previously required packing of multiple (e.g., 5-10) coils, which required more time to treat and risk of migration.

[0023] Although the basic novel features of the present invention as applied to the preferred embodiment thereof have been shown, described, and pointed out, those skilled in the art will appreciate that various omissions, substitutions, and changes in the form and details of the illustrated systems / devices, and in their operation, may be made without departing from the spirit and scope of the present invention. For example, all combinations of elements and / or steps that perform substantially the same functions in substantially the same manner to achieve the same results are expressly intended to be encompassed within the scope of the present invention. Also, the substitution of elements from one embodiment described above for another embodiment is fully intended and anticipated. It should also be understood that the drawings are not necessarily drawn to scale, and are merely conceptual. It is therefore intended to be limited only by the scope of the appended claims.

[0024] All issued patents, pending patent applications, publications, articles, books, or other references cited herein are each hereby incorporated by reference in their entirety.

[0025] [Embodiment] (1) An intracapsular flow diverter comprising: an internal fill braid that is physically inverted upon itself to form a proximal inverted end and an opposing free end; a dome braid disposed distally of and secured to the inner filling braid, the dome braid being transitionable between an expanded state and a compressed state having a reduced overall diameter upon application of an external mechanical force, the dome braid having a proximal end with an opening defined therein, the free end of the inner filling braid being able to pass freely through the dome braid through the opening; a delivery wire releasably detachable from the proximal inverted end of the inner filling braid; An intrasaccular flow diverter, wherein the dome braid has a stiffer profile than the inner fill braid. (2) An intrasaccular flow diverter as described in embodiment 1, wherein (i) the internal filling braid has a complex helical or spiral preformed shape in the expanded state and a substantially linear configuration in the compressed state, and (ii) the dome braid has a dome-shaped, spherical, or hemispherical preformed shape in the expanded state and a cylindrical tube configuration in the compressed state. (3) An intrasaccular flow diverter as described in embodiment 1, wherein the dome braid and the inner filling braid are secured together adjacent to the opening by a band marker. (4) An intrasaccular flow diverter as described in embodiment 1, wherein the profile of the dome braid which is stiffer than the internal filling braid can be achieved by at least one of the following characteristics: (i) increasing the thickness of the individual wires forming the dome braid, (ii) decreasing the braid angle between the wires forming the dome braid, and (iii) increasing the number of wires forming the dome braid. (5) A method of treating an aneurysm using an intrasaccular flow diverter, the intrasaccular flow diverter comprising: an internal filling braid physically invertable thereon forming a proximal inverted end and an opposite free end; a dome braid disposed distal to the internal filling braid, the dome braid being transitionable from an expanded state to a compressed state having a reduced overall diameter upon application of an external mechanical force, the dome braid having a proximal end having an opening defined therein, the free end of the internal filling braid being freely passable through the dome braid through the opening; and a delivery wire releasably detachable from the proximal inverted end of the internal filling braid, the dome braid having a stiffer profile than the internal filling braid, the method comprising: navigating a microcatheter through a blood vessel to a target site proximate the aneurysm; advancing the intrasaccular flow diverter through a lumen of the microcatheter using the delivery wire while the dome braid and the inner filler braid are each in the compressed state; automatically deploying the dome braid upon exiting the distal end of the microcatheter to the expanded state in which the dome braid expands in diameter to fill the aneurysm, wherein only a distal portion of the inner filling braid, including the free end, is disposed within the deployed dome braid; while the deployed dome braid is maintained to fill the aneurysm, further advancing the intrasaccular flow diverter through the lumen of the microcatheter using the delivery wire until the proximal inverted end of the inner filling braid is disposed adjacent to but remains outside of the deployed dome braid; releasing the delivery wire from the proximal inverted end of the inner filling braid and automatically transitioning the inner filling braid to the expanded state in which the inner filling braid exerts a radially outward force inward against the deployed dome braid to substantially conform to the shape of the aneurysm; A method comprising:

[0026] (6) The method of claim 5, wherein (i) the inner filling braid has a complex helical or spiral preformed shape in the expanded state and a substantially linear configuration in the compressed state; and (ii) the dome braid has a dome-shaped, spherical, or hemispherical preformed shape in the expanded state and a cylindrical tube configuration in the compressed state. (7) The method of claim 5, wherein the dome braid and the inner filling braid are secured together adjacent the opening by a band marker. (8) The method of claim 5, wherein the profile of the dome braid that is stiffer than the inner fill braid is achieved by at least one of the following characteristics: (i) increasing the thickness of the individual wires that form the dome braid, (ii) decreasing the braid angle between the wires that form the dome braid, and (iii) increasing the number of wires that form the dome braid. (9) A method of treating an aneurysm using an intrasaccular flow diverter, the intrasaccular flow diverter including an internal filling braid and a dome braid disposed distal to the internal filling braid, the method comprising: deploying the dome braid within the aneurysm to be treated, the dome braid returning to a dome-like, spherical, or hemispherical preformed shape; juxtaposing the shape of the deployed dome braid to conform to the shape of the aneurysm to be treated by applying an outward radial force internally on the deployed dome braid using the internally introduced internal filling braid; A method comprising: (10) The method of embodiment 9, wherein the internal filling braid is physically invertible upon itself to form a proximal inverted end and an opposite free end, the dome braid is capable of transitioning from an expanded state to a compressed state having a reduced overall diameter upon application of an external mechanical force, the dome braid having a proximal end with an opening defined therein, and the free end of the internal filling braid is capable of passing freely within the dome braid through the opening.

[0027] (11) The method of embodiment 10, wherein the intrasaccular flow diverter further comprises a delivery wire releasably detachable from the proximal inverted end of the internal filling braid. (12) The method of claim 9, wherein the dome braid has a stiffer profile than the inner filling braid. (13) The method of claim 10, wherein (i) the inner filling braid has a complex helical or spiral preformed shape in the expanded state and a substantially linear configuration in the compressed state; and (ii) the dome braid has a dome-shaped, spherical, or hemispherical preformed shape in the expanded state and a cylindrical tube configuration in the compressed state. (14) The method of claim 10, wherein the dome braid and the inner filling braid are secured together adjacent the opening by a band marker. (15) The method of claim 12, wherein the profile of the dome braid that is stiffer than the inner filling braid is achieved by at least one of the following characteristics: (i) increasing the thickness of the individual wires that form the dome braid, (ii) decreasing the braid angle between the wires that form the dome braid, and (iii) increasing the number of wires that form the dome braid.

Claims

1. 1. An intracapsular flow diverter comprising: an internal fill braid that is physically inverted upon itself to form a proximal inverted end and an opposing free end; a dome braid having a proximal end secured to the inner filling braid at a connection with the open distal end of the inner filling braid, the dome braid being in a compressed state in which an overall diameter is reduced when subjected to an external mechanical force and being capable of transitioning from the compressed state to an expanded state when the external mechanical force is no longer applied, the proximal end having an opening defined therein, the free end of the inner filling braid being capable of passing through the opening and being positioned within the dome braid; a delivery wire releasable from the proximal inverted end of the inner filling braid; An intrasaccular flow diverter, wherein the stiffness of the dome braid is greater than the stiffness of the internal filling braid, and when the proximal inverted end of the internal filling braid is pushed by the delivery wire while the dome braid is in the expanded state and deployed within the aneurysm, the shape of the dome braid is maintained while the inverted portion of the internal filling braid is advanced distally into the dome braid.

2. 2. The intrasac flow diverter of claim 1, wherein: (i) the internal filling braid is transitionable from a compressed state of the internal filling braid to an expanded state, and in the expanded state of the internal filling braid, the portion of the inverted internal filling braid located within the dome braid has a helical or spiral preformed shape, and in the compressed state of the internal filling braid, the internal filling braid has a substantially linear configuration; and (ii) in the expanded state of the dome braid, the dome braid has a dome-shaped, spherical, or hemispherical preformed shape, and in the compressed state of the dome braid, the dome braid has a cylindrical tube configuration.

3. The intrasaccular flow diverter of claim 1 , wherein the dome braid and the inner filler braid are secured together adjacent the opening by a band marker.

4. 2. The intrasac flow diverter of claim 1, wherein the stiffness of the dome braid that is greater than the stiffness of the internal filling braid is achieved by at least one of the following characteristics: (i) a thickness of the individual wires forming the dome braid that is greater than a thickness of the individual wires forming the internal filling braid, (ii) a braid angle between the wires forming the dome braid that is less than a braid angle between the wires forming the internal filling braid, and (iii) a number of wires forming the dome braid that is greater than the number of wires forming the internal filling braid.

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