Vascular Occlusion Devices and Delivery Assemblies

Abstract

A vaso-occlusive device is provided for creating an embolism or vaso-occlusion in a patient's blood vessel. The vascular occlusion treatment system (100) includes a delivery assembly (104) and a vascular occlusion device (102) removably connected to the delivery assembly (104) by a delivery assembly junction (200). The vascular occlusion device (102) includes a braided portion (106) made of one or more composite wires, a coiled portion connected to the braided portion (106), and intra-device junctions (300-1, 300-2) connecting the braided portion (106) to the coiled portion. Each composite wire includes a core made of a core metallic material and an outer layer made of an outer metallic material different from the core metallic material. One of the core and the outer layer has higher radiolucency and lower stiffness than the other of the core and the outer layer, respectively.

Description

[Technical field]

[0001] This application claims the benefit under 35 U.S.C. §119 to U.S. Provisional Application No. 62 / 269,867, filed December 18, 2015, and U.S. Provisional Application No. 62 / 341,789, filed May 26, 2016, both of which are incorporated by reference in their entireties.

[0002] The technical field of the disclosed invention relates generally to vaso-occlusive devices for creating an embolism or vaso-occlusion in a blood vessel of a human patient. In particular, the disclosed invention relates to at least partially meshed or woven vaso-occlusive devices, junctions within such devices, and junctions connecting such devices to a delivery system. [Background technology]

[0003] Vascular occlusion devices or implants are used for a variety of reasons, including the treatment of endovascular aneurysms. A commonly used vaso-occlusion device comprises a soft, helically wound coil formed by wrapping a platinum (or platinum alloy) wire strand around a "primary" mandrel. This coil is then wound around a larger "secondary" mandrel and heat treated to a secondary shape. For example, U.S. Patent No. 4,994,069 to Ritchart et al., which is incorporated by reference herein as if set forth in its entirety, describes a vaso-occlusion device that assumes a linear, helical primary shape when extended for placement through the lumen of a delivery catheter and a collapsed, bent secondary shape when released from the delivery catheter and positioned within the vasculature.

[0004] To deliver a vaso-occlusive device to a desired site within the vasculature, e.g., an aneurysmal sac, it is well known to first position a low-profile delivery catheter or "microcatheter" at the site using a steerable guidewire. Typically, the distal end of the microcatheter, selected either by the attending physician or by the manufacturer, is provided with a preformed bend, e.g., 45°, 26°, "J", "S", or other bent shape, depending on the patient's anatomy, so that when the guidewire is withdrawn, the distal end remains in the desired position for releasing one or more vaso-occlusive devices within the aneurysm. A delivery or "pusher" assembly or "wire" is then passed through the microcatheter until the vaso-occlusive device connected to the distal end of the delivery assembly extends out the distal end opening of the microcatheter into the aneurysm. Once inside the aneurysm, a portion of the vaso-occlusive device is deformed or bent to more efficiently and completely pack it. The vaso-occlusive device is then released or "unfastened" from the distal end of the delivery assembly, and the delivery assembly is withdrawn back through the catheter. Depending on the particular needs of the patient, one or more vaso-occlusive devices may be pushed through the catheter and released at the same site.

[0005] One well-known method of releasing a vaso-occlusive device from a delivery assembly is the use of an electrically severable junction. The junction is a small exposed section or detachment zone located along the distal end portion of the delivery assembly. The detachment zone is usually made of stainless steel and is located just proximal to the vaso-occlusive device. The electrically severable junction is sensitive to electrolysis and separates when the delivery assembly becomes electrically charged in the presence of an ionic solution such as blood or other bodily fluids. Thus, when the detachment zone exits the distal end of the catheter and is exposed to the patient's vascular blood pool, current passed through the conductive pusher via the electrical contacts forms an electrolyte detachment circuit with the return electrode, causing the detachment zone to separate by electrolysis. Other detachment mechanisms for releasing a vaso-occlusive device from a delivery assembly include mechanical, thermal, and hydraulic mechanisms.

[0006] To better surround and fill the aneurysm, vaso-occlusive coils can be shaped into complex three-dimensional secondary shapes to alter the stiffness / flexibility of the vaso-occlusive coils. However, vaso-occlusive coils continue to have performance limitations, including braking performance, shape retention, and anchoring ability.

[0007] The proximal end of some vaso-occlusive devices is connected to the distal end of the delivery assembly with an adhesive, known as the "primary junction" or "delivery assembly junction" of the vaso-occlusive device treatment system. Another primary junction design is disclosed in U.S. Patent No. 8,202,292 to Kellett, which is incorporated by reference in its entirety as if fully set forth herein. The primary junction includes a flat adapter that connects the delivery wire to the vaso-occlusive coil. The delivery wire has a hook or "J" shaped distal end configured to receive the adapter in an opening at the proximal end, connecting the delivery wire to the adapter. The vaso-occlusive coil has windings that define openings configured to receive fingers at the distal end of the adapter, connecting the vaso-occlusive coil to the adapter. The adapter, in turn, facilitates connection of the delivery wire to the vaso-occlusive coil. Another primary junction design is disclosed in U.S. Patent Application Serial No. 14 / 457,970 to Chen et al., which is incorporated by reference in its entirety as if fully set forth herein.

[0008] Although primary junctions with adhesively connected flat adapters have worked well, the connection between the delivery assembly and the vaso-occlusive device can be improved, and therefore a need remains for other systems and methods for connecting a vaso-occlusive device to a delivery assembly at a primary junction. Summary of the Invention

[0009] In one embodiment, an implantable vaso-occlusive device includes a braid formed from one or more drawn filled tubes. Each of the drawn filled tubes includes a core made of a core metal material and an outer layer made of an outer metal material different from the core metal material. The core metal material and the outer metal material each have a distinct radiopacity and a distinct stiffness. One of the core metal material and the outer metal material is more radiopaque and less stiff than the other of the core metal material and the outer metal material, respectively. Each of the one or more drawn filled tubes has a "yield strength to ultimate strength" ratio of less than 80%.

[0010] In one or more embodiments, the core metallic material comprises platinum and the outer metallic material comprises nitinol. In other embodiments, the core metallic material comprises nitinol and the outer metallic material comprises platinum. The braid may comprise first and second composite metallic tubes twisted together. Each of the one or more composite metallic tubes has a "yield strength to ultimate strength" ratio of less than 70%, 60, or 50%.

[0011] In another embodiment, an implantable vaso-occlusive device comprises a braid of 16-48 composite metal tubes, each having a core comprising platinum and an outer layer comprising nitinol, each of the plurality of composite metal tubes having a platinum content of 35% to 60% by volume and an outer diameter of 0.0010 inch to 0.0015 inch.

[0012] In one or more embodiments, the braid is made of 24-32 composite metal tubes, each having 40% to 50% platinum by volume and an outside diameter of 0.00115" to 0.00125". Nitinol has an austenite finish temperature of 30° C. to 45° C. The composite metal tube may include an oxide coating.

[0013] In another embodiment, a vascular occlusion treatment system includes a delivery assembly and a vascular occlusion device removably connected to the delivery assembly by a delivery assembly junction, the vascular occlusion device including a braided portion, a coiled portion, and an intra-device junction connecting the braided portion to the coiled portion.

[0014] In one or more embodiments, the bladed portion comprises a proximal end and a central portion, the diameter of the proximal end being smaller than the diameter of the central portion. The bladed portion comprises a distal end and a central portion, the diameter of the distal end being smaller than the diameter of the central portion. The coiled portion comprises a proximal end and a central portion, the diameter of the proximal end being smaller than the diameter of the central portion. The coiled portion comprises a distal end and a central portion, the diameter of the distal end being smaller than the diameter of the central portion.

[0015] In one or more embodiments, the delivery assembly has a distal end that forms a hook. The bladed portion may include an elongate member that forms a loop at its proximal end. The hook passes through the elongate member to connect the delivery assembly to the vaso-occlusive device. The vaso-occlusive device may have a reduced diameter proximal end to prevent proximal movement of the hook.

[0016] In various embodiments, the delivery assembly junction comprises a link having a proximal end and a distal end, the distal end of the link comprising a plurality of fingers configured to interface between adjacent elongate members of the blade-like portion, and a plurality of fingers configured to interface between adjacent open windings of the coil-like portion.

[0017] In one or more embodiments, the delivery assembly comprises a blade-like member, at least a portion of which is radially disposed within the vaso-occlusive device.

[0018] In one or more embodiments, the delivery assembly junction comprises a tubular body disposed around at least a portion of the vaso-occlusive device, the tubular body comprising a metal band and / or a laminated polymer tube.

[0019] In one or more embodiments, the vaso-occlusive device includes a stretch resistance member. The stretch resistance member may be an elongated member and / or a braided tube. The intra-device junction may include a loop formed at a proximal end of the stretch resistance member. The loop surrounds the elongated member of the braided portion and secures the stretch resistance member to the device. The loop surrounds the reduced diameter of the vaso-occlusive device and secures the stretch resistance member to the device. The intra-device junction may include a wire having a hook formed at an end thereof that can pass through the loop.

[0020] In one or more embodiments, the intra-device junction comprises an enlarged body formed at a proximal end of the stretchable resistance member, the enlarged body being disposed adjacent the reduced diameter portion of the vaso-occlusive device and securing the stretchable resistance member to the body. The intra-device junction comprises a hook formed at a proximal end of the stretchable resistance member. A central portion of the stretchable resistance member can be configured to facilitate articulation of the vaso-occlusive device. The stretchable resistance member can comprise an elongate member, which also forms at least a portion of the vaso-occlusive device.

[0021] In one or more embodiments, the intra-device junction comprises a tubular body disposed around at least a portion of the vaso-occlusive device, the tubular body may be a metal band and / or a laminated polymer tube.

[0022] In one or more embodiments, the intra-device junction comprises a tubular body disposed within a lumen defined by a portion of the vaso-occlusive device. The tubular body may comprise a braided tube, a coil, and / or a solid body. The intra-device junction may comprise a pin extending radially through the braided and coiled portions, thereby connecting the braided and coiled portions. The coiled portion may comprise a flat winding disposed at an end thereof. A major axis of the flat winding is generally parallel to a longitudinal axis of the vaso-occlusive device.

[0023] In one or more embodiments, the bladed portion comprises a bladed distal end and the coiled portion comprises a coiled proximal end. The bladed distal end may be disposed inwardly of the coiled proximal end. The coiled proximal end may be disposed inwardly of the bladed distal end.

[0024] In one or more embodiments, the bladed portion comprises a bladed proximal end and the coiled portion comprises a coiled distal end. The bladed proximal end may be disposed within the coiled distal end. The coiled distal end may be disposed within the bladed proximal end. The coiled portion may be configured to facilitate articulation of the vaso-occlusive device.

[0025] According to another aspect, an embodiment of the present invention includes a vascular occlusion treatment system having a delivery assembly and a vascular occlusion device removably connected to the delivery assembly by a severable junction, the vascular occlusion device comprising a blade having an inner axial lumen, a proximal end portion connected to the severable junction, and a proximal end portion connected to a distal end portion of the proximal end coil by a first intra-device junction, the blade being a plurality of elongated blade-like members, two or more of which extend proximally from the blade through the axial lumen of the proximal coil and are each secured to the proximal end portion of the proximal coil to form a coil stretch prevention member.

[0026] In one embodiment, each proximal coil anti-stretch member has a proximal end attached to a distal portion of a severable junction connected to a proximal end portion of the proximal coil, the severable junction being configured such that the distal portion of the severable junction remains connected to the proximal end portion of the proximal coil when the severable junction is detached. In one non-limiting example, the proximal ends of the proximal coil anti-stretch members each include a hook that engages an opening formed in the distal portion of the severable junction. Similarly, the vaso-occlusive member includes a distal coil having a proximal end portion attached to a distal end portion of a braid by a second intra-device junction, the distal coil having an inner axial lumen, and two or more blade-like members, either the same or different, extending distally from the braid through the axial lumen of the distal coil and each secured to a distal end portion of the distal coil, thereby forming a distal coil anti-stretch. In such an embodiment, the vaso-occlusive device further comprises a distal end joint connected to a distal end portion of the distal coil and formed by at least partially connecting together the distal ends of the distal coil anti-stretch members.

[0027] In accordance with a further embodiment of the present invention, a vascular occlusion treatment system includes a delivery assembly and a vascular occlusion device removably connected to the delivery assembly by a severable junction, the vascular occlusion device comprising an inner axial lumen and a blade having a distal end portion connected to a proximal end portion of a proximal end coil by an intra-device junction, the blade comprising a plurality of elongated blade-like members, two or more of which extend distally from the blade through the axial lumen of the distal coil and are each secured to the distal end portion of the distal coil to form a coil stretch prevention member.

[0028] In one embodiment, the system also includes a distal joint connected to a distal end portion of the distal coil and formed by at least partially connecting the distal ends of the distal coil anti-stretch members to one another.

[0029] According to a further aspect of the invention, an implantable vaso-occlusive device is provided comprising one or more elongated blade-like members, each of which comprises a core, an intermediate layer at least partially surrounding the core, and an outer layer at least partially surrounding the intermediate layer, each of which is made of a metallic material, each of which is radiopaque and rigid, and one of the core, intermediate layer, and outer layer being more opaque and / or less rigid than the other. According to one non-limiting example, the core metallic material may comprise platinum, the intermediate layer metallic material may comprise nitinol, and the outer layer metallic material may comprise titanium. In another non-limiting example, the core may comprise a radiopaque metallic material, the intermediate layer may comprise a superelastic metallic material, and the outer layer may comprise an oxidation-resistant metallic material. In a further non-limiting example, the core may be more radiopaque than the intermediate layer and the outer layer, the intermediate layer may be less rigid than each of the core and the outer layer, and the outer layer may be more oxidation-resistant than each of the core and the intermediate layer.

[0030] In yet another embodiment, a vaso-occlusive treatment system includes a delivery assembly; and a vaso-occlusive device removably connected to the delivery assembly at a delivery assembly junction. The vaso-occlusive device includes a braided section made of one or more composite wires, a coiled section connected to the braided section, and an intra-device junction connecting the braided section to the coiled section. Each composite wire includes a core made of a core metallic material and an outer layer made of an outer metallic material different from the core metallic material. Each of the core and the outer layer is more radiopaque and less stiff than the other of the core and the outer layer.

[0031] In one or more embodiments, the core metallic material comprises platinum and the outer metallic material comprises nitinol, hi other embodiments, the core metallic material comprises nitinol and the outer metallic material comprises platinum.

[0032] In one or more embodiments, each of the one or more composite wires may have a yield strength to ultimate strength ratio of less than 80%.

[0033] In one or more embodiments, the braided portion comprises a braid of a plurality of composite wires, each of the composite wires having a core comprising platinum and an outer layer comprising nitinol, each of the plurality of composite wires having a platinum content of between 35 and 60% by volume, and each of the plurality of composite wires having an outer diameter of between 0.0010 inches and 0.0015 inches.

[0034] In one or more embodiments, the plurality of composite wires comprises between 24 and 32 composite wires, each wire having a platinum content of between 40 and 50% by volume and an outer diameter of between 0.00115 inches and 0.00125 inches.

[0035] In one or more embodiments, the delivery assembly has a distal end, the distal end forming a hook. The delivery assembly junction comprises a link having a proximal end and a distal end, the distal end of the link comprising a plurality of fingers. The delivery assembly junction comprises a blade-like member, at least a portion of the blade-like member disposed radially inside the vaso-occlusive device. The delivery assembly junction may comprise a tubular body disposed around at least a portion of the vaso-occlusive device.

[0036] In one or more embodiments, the intra-device junction comprises a tubular member disposed about at least a portion of the vaso-occlusive device. The intra-device junction may comprise a tubular body disposed within a lumen defined by the portion of the vaso-occlusive device. The tubular body may comprise a braided tube.

[0037] In one or more embodiments, the intra-device junction comprises a pin that extends radially through the blade and coil portions, thereby connecting the blade and coil portions.

[0038] In one or more embodiments, the coiled portion includes a flat winding at an end thereof, the long axis of the flat winding being generally parallel to the longitudinal axis of the vaso-occlusive device.

[0039] In one or more embodiments, the width of the blade portion is substantially constant.

[0040] In one or more embodiments, the core and outer metallic materials are each radiopaque and rigid.

[0041] In one or more embodiments, the ratio of yield strength to ultimate strength of each of the one or more composite wires is less than 80%.

[0042] In one or more embodiments, one of the core and outer layer provides radiopacity to the composite wire, and the other of the core and outer layer provides superelasticity and / or shape memory (i.e., the ability of the braid to return to its original width) to the composite wire.

[0043] In one or more embodiments, the core may be made from discontinuous segments of wire and / or powder, such that the core may be less stiff than an equivalent core made from a continuous wire.

[0044] In one or more embodiments, the width of the blade-like portion is between 0.5 mm and 2.5 mm. The width to thickness ratio of the blade-like portion is in the range of 1:1 to 40:1. The blade angle of the blade-like portion may be in the range of 10° to 90°.

[0045] Other and further aspects and features of embodiments of the present invention will become apparent from the following detailed description when considered in conjunction with the accompanying drawings. [Brief description of the drawings]

[0046] The drawings illustrate the design and utility of various embodiments of the present invention. In the drawings, like elements are commonly designated by reference numerals. The drawings are not necessarily to scale. For a better understanding of how the above-mentioned and other advantages and objects may be obtained, more particular descriptions of the embodiments are described and shown in the accompanying drawings. These drawings depict only exemplary embodiments of the present invention for purposes of facilitating discussion and the following detailed description, and therefore should not be considered as limiting the scope of the invention. [Figure 1] FIG. 1 illustrates an exemplary vaso-occlusive treatment system including a vaso-occlusive device and delivery assembly constructed in accordance with one embodiment. [Diagram 2] FIG. 2 is a photograph of the vascular occlusion treatment system shown in FIG. [Diagram 3] FIG. 3 is an image of the vaso-occlusive device shown in FIG. 1 deployed within the vasculature of an animal. [Figure 4] FIG. 4 is an image of the vaso-occlusive device shown in FIG. 1 deployed within the vasculature of an animal. [Diagram 5] FIG. 5 is a photograph showing a vaso-occlusive device constructed in accordance with an embodiment of the present invention in an unconstrained state. [Figure 6] FIG. 6 is a photograph showing a vaso-occlusive device constructed in accordance with an embodiment of the present invention in an unconstrained state. [Figure 7] FIG. 7 is a perspective view of an elongate member from which a vaso-occlusive device, or portions thereof, may be formed in accordance with embodiments of the present invention. [Figure 8] FIG. 8 is a longitudinal cross-sectional view of a vaso-occlusive treatment system including a vaso-occlusive device constructed in accordance with various embodiments of the present invention. [Figure 9] FIG. 9 is a longitudinal cross-sectional view of a vaso-occlusive treatment system including a vaso-occlusive device constructed in accordance with various embodiments of the present invention. [Figure 10] FIG. 10 is a longitudinal cross-sectional view of a vaso-occlusive treatment system including a vaso-occlusive device constructed in accordance with various embodiments of the present invention. [Figure 11]FIG. 11 is a longitudinal cross-sectional view of a vaso-occlusive treatment system including a vaso-occlusive device constructed in accordance with various embodiments of the present invention. [Figure 12] FIG. 12 is a longitudinal cross-sectional view of a primary junction constructed in accordance with various embodiments of the present invention. [Figure 13] FIG. 13 is a longitudinal cross-sectional view of a primary junction constructed in accordance with various embodiments of the present invention. [Figure 14] FIG. 14 is a longitudinal cross-sectional view of a primary junction constructed in accordance with various embodiments of the present invention. [Figure 15] FIG. 15 is a longitudinal cross-sectional view of a primary junction constructed in accordance with various embodiments of the present invention. [Figure 16] FIG. 16 is a longitudinal cross-sectional view of a primary junction constructed in accordance with various embodiments of the present invention. [Figure 17] FIG. 17 is a longitudinal cross-sectional view of a primary junction constructed in accordance with various embodiments of the present invention. [Figure 18] FIG. 18 is a longitudinal cross-sectional view of a primary junction constructed in accordance with various embodiments of the present invention. [Figure 19] FIG. 19 is a longitudinal cross-sectional view of a primary junction constructed in accordance with various embodiments of the present invention. [Figure 20] FIG. 20 is a longitudinal cross-sectional view of a primary junction constructed in accordance with various embodiments of the present invention. [Figure 21] FIG. 21 is a longitudinal cross-sectional view of a primary junction constructed in accordance with various embodiments of the present invention. [Figure 22] FIG. 22 is a longitudinal cross-sectional view of a primary junction constructed in accordance with various embodiments of the present invention. [Figure 23] FIG. 23 is a photograph of a primary junction used in a vaso-occlusive device delivery system constructed in accordance with various embodiments of the present invention. [Figure 24] FIG. 24 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Diagram 25] FIG. 25 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Figure 26] FIG. 26 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Figure 27] FIG. 27 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Figure 28] FIG. 28 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Figure 29] FIG. 29 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Diagram 30] FIG. 30 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Diagram 31] FIG. 31 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Diagram 32] FIG. 32 is a photograph of a primary junction used in a vaso-occlusive device delivery system constructed in accordance with various embodiments of the present invention. [Diagram 33] FIG. 33 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Diagram 34] FIG. 34 is a photograph of three intra-device junctions according to one embodiment, similar to the intra-device junction shown in FIG. [Diagram 35] FIG. 35 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Diagram 36] FIG. 36 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Figure 37]FIG. 37 is a photograph of a primary junction used in a vaso-occlusive device delivery system constructed in accordance with various embodiments of the present invention. [Figure 38] FIG. 38 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Figure 39] FIG. 39 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Diagram 40] FIG. 40 is a photograph of a braided vaso-occlusive device constructed in accordance with one embodiment. [Diagram 41] FIG. 41 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Diagram 42] FIG. 42 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Diagram 43] FIG. 43 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Diagram 44] FIG. 44 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Diagram 45] FIG. 45 is a longitudinal cross-sectional view of an alternative in-device junction constructed in accordance with various embodiments of the present invention. [Figure 46] FIG. 46 is a longitudinal cross-sectional view of components of a vascular occlusion treatment system in an exemplary manufacturing process according to an embodiment of the present invention. [Figure 47] FIG. 47 is a longitudinal cross-sectional view of components of a vascular occlusion treatment system in an exemplary manufacturing process according to an embodiment of the present invention. [Figure 48] FIG. 48 is a longitudinal cross-sectional view of components of a vascular occlusion treatment system in an exemplary manufacturing process according to an embodiment of the present invention. [Figure 49] FIG. 49 is a longitudinal cross-sectional view of components of a vascular occlusion treatment system in an exemplary manufacturing process according to an embodiment of the present invention. [Figure 50] FIG. 50 is a longitudinal cross-sectional view of an exemplary vaso-occlusive treatment system including a vaso-occlusive device and delivery assembly constructed in accordance with an embodiment of the present invention. [Figure 51] FIG. 51 is a longitudinal cross-sectional view of a portion of a vascular occlusion treatment system, including a main junction and an intra-device junction, constructed in accordance with various embodiments of the present invention. [Figure 52] FIG. 52 is a longitudinal cross-sectional view of a portion of a vascular occlusion treatment system, including a main junction and an intra-device junction, constructed in accordance with various embodiments of the present invention. [Diagram 53] FIG. 53 is a longitudinal cross-sectional view of a portion of a vascular occlusion treatment system, including a main junction and an intra-device junction, constructed in accordance with various embodiments of the present invention. [Figure 54] FIG. 54 is a longitudinal cross-sectional view of a portion of a vascular occlusion treatment system, including a main junction and an intra-device junction, constructed in accordance with various embodiments of the present invention. [Figure 55] FIG. 55 is a longitudinal cross-sectional view of a portion of a vascular occlusion treatment system, including a main junction and an intra-device junction, constructed in accordance with various embodiments of the present invention. [Figure 56] FIG. 56 is a longitudinal cross-sectional view of a portion of a vascular occlusion treatment system, including a main junction and an intra-device junction, constructed in accordance with various embodiments of the present invention. [Figure 57] FIG. 57 is a longitudinal cross-sectional view of a further vascular occlusion treatment system constructed in accordance with an embodiment of the present invention. [Figure 58] FIG. 58 is a longitudinal cross-sectional view of a further vascular occlusion treatment system constructed in accordance with an embodiment of the present invention. [Figure 59] FIG. 59 is a cross-sectional view of an elongate member from which a vasoocclusive device or portion thereof may be formed, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] Exemplary embodiments and applications of the present invention are described herein. However, the present invention is not limited to these exemplary embodiments and applications or the manner in which the exemplary embodiments and applications operate or are described herein. Additionally, the figures are simplified or partial views, and the dimensions of the elements in the figures may be exaggerated or not to scale. Additionally, elements of similar structure or features are similarly numbered throughout the figures. Additionally, an embodiment illustrated in the figures need not have all of the aspects or advantages shown herein. An aspect or advantage described in connection with a particular embodiment is not necessarily limited to that embodiment and may be practiced in other embodiments, even if not so described.

[0048] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or anywhere in this specification.

[0049] As used herein, the terms "on," "attached to," "connected to," "coupled to," "secured to," or similar terms refer to one element (e.g., a material, layer, substrate, etc.) being "on," "attached to," "connected to," "coupled to," or "secured to" another element, whether the one element is directly on, attached to, connected to, coupled to, or secured to the other element, or whether there are one or more intervening elements between the one element and the other element. When directions (e.g., above, below, top, bottom, side, above, below, lower, upper, upper side, lower, horizontal, vertical, "x," "y," "z," etc.) are described, the directions are relative and are provided merely by way of example and for purposes of explanation and discussion, and not by way of limitation. When a list of elements is labeled (e.g., elements a, b, c), such labels are intended to include any one of the elements in the list, combinations of fewer than all of the elements in the list, and / or combinations of all of the elements in the list.

[0050] As used herein, "substantially" means to function fully for its intended purpose. The term "substantially" therefore contemplates slight, insignificant variations from an absolute or perfect state, dimension, measurement, result, or other such thing that one of ordinary skill in the art would expect, but which do not appreciably affect overall performance. The term "plurality" means one or more.

[0051] All numerical values ​​are assumed herein to be modified by the term "about," whether or not expressly stated. The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (thus having the same function or result). In many cases, the term "about" includes numbers that are rounded to the nearest significant figure. The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0052] As used in this specification and the claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the claims, the term "or" is used with the understanding that it includes "and / or" unless the content clearly dictates otherwise.

[0053] As used herein, a plurality of "elongated members" used to form a blade includes only a single elongated member used to form the blade, i.e., the single elongated member returns back onto itself at the end of the blade. As used herein, the terms "tube," "cylindrical," "diameter," "radius," and "perimeter" apply to objects having non-circular cross sections, as well as objects having circular cross sections.

[0054] 1 and 2 show a vascular occlusion treatment system 100 including an implantable vaso-occlusion device 102 connected to a delivery assembly 104. The vaso-occlusion device 102 includes a central bladed section 106 axially disposed between proximal and distal sections 108, 110. A primary junction 200 connects the distal end of the delivery assembly 104 to the proximal end of the proximal section 108. The "primary junction" is also known as the "delivery assembly junction." A proximal inter-device junction 300-1 connects the proximal end of the central section 106 to the distal end of the proximal section 108. A distal inter-device junction 300-2 connects the distal end of the central section 106 to the proximal end of the distal section 110.

[0055] The central portion 106 is a braid of dissimilar metal drawn filled tubing (DFT) elongated members (e.g., "wires"), such as those available from Fort Wayne Metals, Inc., Fort Wayne, Indiana. DFT is a type of composite wire. For example, the central portion 106 can be braided with 24 DFT wires, each having a cross-sectional diameter of 0.00125 inches. The braid can be flat or round. In another embodiment, the central portion 106 is braided with 24 to 34 DFT wires, each having a cross-sectional diameter of 0.00115 to 0.00125 inches. The proximal and distal portions 108, 110 are coils of one or more of the same DFT wires. In an alternative embodiment, the proximal and distal portions 108, 110 can be coils of one or more substantially pure NiTi wires instead of DFT wires.

[0056] The DFT wire comprises a substantially pure platinum ("Pt") core at least partially surrounded by a substantially pure nitinol ("NiTi") outer layer. As used herein, "substantially pure" Pt includes, but is not limited to, 99.95% commercial purity manufactured according to ASTM B561. The Pt core is about 40-50% by volume of the DFT wire (the "Pt core content"). In some embodiments, the DFT wire is formed by inserting a core portion (a solid elongated member) into an outer member (a tubular elongated member) to form a composite elongated member (e.g., a composite wire). The composite elongated member is repeatedly mechanically drawn and thermally annealed to increase its axial length and reduce its cross-sectional diameter. For example, the drawing and annealing process may successively reduce the diameter of the composite elongate member from 1 inch to 0.5 inch, 0.5 inch to 0.25 inch, 0.25 inch to 0.025 inch, and 0.025 inch to 0.0025 inch.

[0057] Although the materials (e.g., Pt and NiTi) forming the various portions (e.g., core and outer layer) of the DFT wire may have different stiffnesses (e.g., bending stiffness), the relative stiffness (e.g., bending stiffness) of the resulting portions of the DFT may not necessarily reflect the composite of the materials from which the DFT is made. For example, the bending modulus (i.e., stiffness) of Pt is greater than that of NiTi in various embodiments, but the bending modulus of Pt combined with the diameter of the Pt wire will be softer (i.e., less stiff) than the corresponding NiTi outer layer.

[0058] The central portion 106 of the vaso-occlusive device 102 can be braided onto a mandrel. The mandrel can be flat or round depending on the final shape desired. After braiding, the central portion 106 can be heat treated (e.g., at 500° C.-550° C. for 1-10 minutes). After this heat treatment, the braid forms the straight "primary shape" of the central portion 106. After the heat treatment, the braid is then wrapped around a second mandrel (e.g., a three-dimensional mandrel) and heat treated for a second time to form a three-dimensional "secondary shape." As shown in Figures 5 and 6, a NiTi outer layer improves retention of the secondary shape.

[0059] Vascular implants (e.g., stents) have been formed with NiTi-DFT-Pt wires with Pt core content up to about 30%, but NiTi-DFT-Pt wires with Pt core content of about 40% to 50% have not been used to form stents. This is because stents typically require wires with higher yield to ultimate strength ratios (e.g., >80% of ultimate strength (UTS)) to maintain vascular patency. On the other hand, the instant vaso-occlusive device 102 comprises DFT wires with lower yield to UTS ratios, which improves device properties including lower bending moment and improved damping performance. In various embodiments, the DFT wires forming the vaso-occlusive device 102 have yield to UTS ratios of <50% UTS, <60% UTS, <70% UTS, and 80% UTS. Yield is the maximum amount of force that can be exerted on a material before it begins to elastically deform. UTS is the minimum amount of force that can be exerted on a material before it fails. Braiding at least a portion of the vaso-occlusive device with wires that have a ratio of UTS to yield strength of less than 80% is essential to simultaneously achieve the properties of improved radiopacity, shape retention, and damping performance.

[0060] It has not previously been known to form vascular implants, including vaso-occlusive devices, with NiTi-DFT-Pt wires with a Pt core content of about 40% to 50%. Braiding the central section 106 with DFT wires with a Pt core content of about 40% to 50% provides the central section 106 with (1) radiopacity throughout its length, (2) improved shape retention, and (3) improved damping performance along the entire length of the braid. The Pt core provides radiopacity for a significantly larger percentage of the vaso-occlusive device 102 as shown in Figures 3 and 4. Figures 3 and 4 are x-rays showing the radiopacity of various vaso-occlusive devices 102 implanted in patients. The x-ray shown in Figure 3 has the following characteristics: posterior 1°, 1° right anterior oblique, 69 kVp, and 1.36 mA. The x-ray shown in Figure 4 has the following characteristics: posterior 1°, 1° right anterior oblique, 100 kVp, and 3.73 mA. The superelastic attributes of the NiTi outer layer contribute to improved shape retention. The flexibility of Pt contributes to improved damping performance, i.e., the ability of the vaso-occlusive device 102 to bend and fold to conform to the shape of a body lumen. These characteristics of the central portion 106 make the vaso-occlusive device 102 suitable for intrasaccular embolization of vascular defects such as aneurysms, i.e., a nearly consistent visualization grayscale throughout the device 102 and an optimal flexibility profile.

[0061] Braiding at least a portion of the vascular embolic device 102 with 16 to 48 DFT wires, each having a cross-sectional diameter of 0.0010 to 0.0015 inches, and a Pt content of 35% to 60% is absolutely essential to simultaneously achieve improved radiopacity, shape retention, and damping performance. Unexpectedly, the effect of increasing Pt content on reducing flexibility is reduced as the Pt content increases. Thus, braids braided with DFT wires having a platinum content of 35% to 60% are surprisingly suitable for vascular occlusion applications, such as intra-aneurysmal applications requiring flexible devices. Such braids are particularly suitable when braided with 16 to 48 DFT wires, each having a cross-sectional diameter of 0.0010 to 0.0015 inches. In a preferred embodiment, at least a portion of vaso-occlusive device 102 is braided from 24-32 DFT wires, each having a cross-sectional diameter of 0.00115 inches to 0.00125 inches, and a Pt content of 40% to 50%.

[0062] Typically, it is finished with an austenitic NiTi finish, or "A f The temperature is about 25°C, which is the temperature at which the transformation of the martensite phase to the austenite phase is complete. f By changing the temperature to 30°C to 45°C, a more flexible vascular occlusion device is obtained. f Setting the temperature achieves a desired balance between device flexibility and conformance, improving the device's suitability for treating aneurysms. f The temperature setting can be achieved by adjusting the Ni content in NiTi from the usual 50% to 50.4%-50.8%. f can be adjusted by heat treatment of NiTi. In a preferred embodiment, A f The temperature is between 38°C and 40°C.

[0063] The DFT may include an oxide coating of controlled thickness that enhances thrombus formation (e.g., clots) and increases vascular occlusion within the aneurysm. Preferably, the oxide coating has an average thickness of 50 nm to 500 nm. This is in contrast to conventional DFT braided implants (e.g., stents) in which the oxide coating is substantially removed (e.g., by electropolishing, etc.) to form a "bright" stent. Conventional DFT braided stents limit the thickness of the oxide coating to less than 50 nm.

[0064] Referring again to FIG. 1, the proximal and distal sections 108, 110 are intact coils to minimize tissue damage during insertion and deployment of the vaso-occlusive device 102. The central section 106 also has a predetermined break point 112 that is created by twisting the segments of the central section 106 together or by necking down a point within the blades of the central section 106 during formation of the secondary shape. In some embodiments, the break point 112 may be bent 90 degrees to better secure the device to the body cavity. The delivery assembly 104 also includes an electrolytically decomposable segment 114 at its distal end. In other embodiments, alternative detachment mechanisms for releasing the vaso-occlusive device 102 from the delivery assembly 104 include mechanical, thermal, and hydraulic mechanisms.

[0065] In another embodiment, instead of DFT wires, the central portion 106 is braided with elongate members 116 formed of smaller DFT wires 118 twisted together, as shown in FIG. 7. Each DFT wire 118 is made of NiTi-DFT-40Pt. Braiding elongate members 116 (made of smaller DFT wires) instead of larger DFT wires results in a softer central portion 106 with approximately the same Pt ​​core content. Thus, the central portion 106 (i.e., the braid of twisted elongate members 116) according to this embodiment provides similar radiopacity as the softer braid. The braid according to this embodiment also provides a larger surface area to promote thrombus formation, thereby enhancing occlusion of the aneurysm.

[0066] FIG. 8 illustrates a vascular occlusion treatment system 100 according to one embodiment. The vascular occlusion treatment system 100 includes a vascular occlusion device 102 connected to a delivery assembly 104 at a main junction 200. The delivery assembly 104 includes an electrolytically decomposed segment 114 at its distal end. The vascular occlusion device 102 includes a central braided portion 106 connected to a distal portion 110 at an intra-device junction 300. The central portion 106 is braided with DFT (i.e., composite) wire as described above and has a substantially constant width (i.e., cross-sectional dimension). As described above, the distal coiled portion 110 is a coil wound with one or more DFT wires. In other embodiments, the central and distal portions 106, 110 can be formed of other elongated members. The distal portion 110 also includes an intact distal tip 120, which is made of a small amount of adhesive. A stretchable resistance member 122 extends from the primary junction 200, through the intra-device junction 300, to the intact distal tip 120 to reduce elongation of the vaso-occlusive device 102 as it is withdrawn proximally during its delivery. The stretchable resistance member 122 is made of a polymer (e.g., polypropylene) or a metal (e.g., NiTi).

[0067] The primary junction 200 includes a hook 202 formed on the distal end of the delivery assembly 104. The hook 202 may be formed from the distal end of the core wire of the delivery assembly 104, as described in U.S. Patent Application Serial No. 14 / 457,970, which is incorporated by reference. The stretchable resistance member 122 defines a proximal loop 124 on its proximal end. The hook 202 passes through the proximal loop 124 to mechanically connect the delivery assembly 104 to the central portion 106 of the vaso-occlusive device 102. The primary junction 200 also includes a necked-down proximal end 126 of the central portion 106 of the vaso-occlusive device 102. The necked-down proximal end 126 has a reduced profile connected to the hook 202. The proximal end 126 of the vaso-occlusive device 102 surrounds the hook 202 and the proximal loop 124 of the stretchable resistance member 122. The main junction 200 also includes an adhesive drop 204 that penetrates the braided proximal end 126 of the central portion 106 of the vascular occlusion device 102 and connects together (1) the hook 202 of the delivery assembly 104; (2) the proximal loop 124 of the elastic resistance member 122; and (3) the proximal end 126 of the central portion 106 of the vascular occlusion device 102, thereby forming the main junction 200.

[0068] The intra-device junction 300 comprises the necked-down distal end 128 of the central portion 106 of the vaso-occlusive device 102 and the open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102. The distal end 128 of the central portion 106 is necked down to fit inside the open proximal end 130 of the distal portion 110. The intra-device junction 300 also comprises an adhesive drop 302 that penetrates the coiled open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102 and connects it to the distal end 128 of the central portion 106 of the vaso-occlusive device 102 to form the intra-device junction 300. The adhesive drop 302 also connects the portion of the stretchable resistance member 122 that passes through the intra-device junction 300.

[0069] FIG. 9 illustrates another embodiment of a vascular occlusion treatment system 100. The vascular occlusion treatment system 100 includes a vascular occlusion device 102 connected to a delivery assembly 104 at a main junction 200. The delivery assembly 104 includes an electrolytically detachable segment 114 at its distal end. The vascular occlusion device 102 includes a central braided portion 106 connected to proximal and distal coiled portions 108, 110 at proximal and distal inter-device junctions 300-1 and 300-2, respectively. The central portion 106 is braided with DFT (i.e., composite) wire as described above and has a substantially constant width (i.e., cross-sectional dimension). The proximal and distal portions 108, 110 are coils wound with one or more DFT wires as described above. In alternative embodiments, the central, proximal and distal sections 106, 108, 110 may be made of other elongate members. The distal section 110 also includes an intact distal tip 120, which may be formed with a small amount of adhesive. A stretch resistance member 122 extends from the primary junction 200, through the intra-device junction 300, to the intact distal tip 120.

[0070] The primary junction 200 includes a link / adapter 206 connected to both the distal end of the delivery assembly 104 and the open proximal end 132 of the proximal portion 108, thereby connecting the delivery assembly 104 and the proximal portion 108. The link 206 may be formed from a sheet, as described in U.S. Patent No. 8,202,292, which is incorporated by reference in its entirety. The link 206 is generally flat and includes a number of fingers 208 formed on its proximal end. The link 206 also includes proximal and distal openings 210, 212. The proximal portion 108 of the vaso-occlusive device 102 is a coil with an open pitch proximal winding 134 at its open proximal end 132. At least some of these proximal windings 134 mate with fingers 208 of link 206 to connect link 206 to the proximal portion 108 of vaso-occlusive device 102 .

[0071] The primary junction 200 also includes a hook 202 formed from the distal end of the core wire of the delivery assembly 104, as described above. The hook 202 passes through a proximal opening 210 in the link 206, connecting the delivery assembly 104 to the link 206 (and the proximal portion 108 attached thereto). The stretchable resistance member 122 forms a proximal loop 124 at its proximal end. The proximal loop 124 passes through a distal opening 212 in the link 206, mechanically connecting the link 206 (and the delivery assembly 104 attached thereto) to the proximal portion 108 of the vaso-occlusive device 102. The primary junction 200 also includes an adhesive drop 204 that penetrates through the open pitch proximal winding 134 to the open proximal end 132 of the vascular occlusion device 102 and connects together: (1) the hook 202 of the delivery assembly 104; (2) the link 206; (3) the proximal loop 124 of the elastic resistance member 122; and (4) the proximal end 132 of the proximal portion 108 of the vascular occlusion device 102, thereby forming the primary junction 200.

[0072] The proximal and distal intra-device junctions 300-1, 300-2 are mirror images of each other. The proximal intra-device junction 300-1 comprises the open distal end 136 of the proximal portion 108 of the vaso-occlusive device 102 and the necked-down proximal end 126 of the middle portion 106 of the vaso-occlusive device 102. The proximal end 126 of the middle portion 106 is necked down to fit within the open distal end 136 of the proximal portion 108. The proximal intra-device junction 300-1 also comprises an adhesive drop 302 that penetrates the coiled open distal end 136 of the proximal portion 108 of the vaso-occlusive device 102. Adhesive 302 connects the proximal end 126 of the central portion 106 of the vaso-occlusive device 102 to the open distal end 136 of the proximal portion 108 of the vaso-occlusive device 102, thereby forming a proximal inter-device junction 300-1. Adhesive drop 302 also connects the portion of the elastic resistive member 122 that passes through proximal inter-device junction 300-1.

[0073] The distal inter-device junction 300-2 comprises the necked-down distal end 128 of the central portion 106 of the vaso-occlusive device 102 and the open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102. The distal end 128 of the central portion 106 is necked down to fit within the open proximal end 130 of the distal portion 110. The distal inter-device junction 300-2 also comprises an adhesive drop 302 that penetrates the coiled open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102. The adhesive 302 connects the distal end 128 of the central portion 106 of the vaso-occlusive device 102 and the open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102 to one another, thereby forming the distal inter-device junction 300-2. Additionally, adhesive drop 302 also connects to the portion of elastic resistive member 122 that passes through intra-device junction 300-2.

[0074] FIG 10 illustrates a further embodiment of a vascular occlusion treatment system 100. The vascular occlusion treatment system 100 illustrated in FIG 10 is almost the same as the vascular occlusion treatment system 100 illustrated in FIG 8. One difference is that the primary junction 200 further includes an inner braid 214 disposed radially between the hook 202 at the distal end of the delivery assembly 104 and the necked-down proximal end 126 of the central portion 106 of the vascular occlusion device 102. The inner braid 214 also surrounds the proximal loop 124 of the elastic resistance member 122. The inner braid 214 can be woven from DFT, Pt and / or NiTi wire as described above. The primary junction 200 also comprises an adhesive drop 204 that penetrates the proximal end 126 of the braid at the central portion 106 of the vaso-occlusive device 102, connecting (1) the hook 202 of the delivery assembly 104; (2) the proximal portion of the inner braid 214; (3) the proximal loop 124 of the elastic resistance member 122; and (4) the proximal end 126 of the central portion 106 of the vaso-occlusive device 102 to form the primary junction 200. The inner braid 214 enhances extrudability, reduces twisting of the central portion 106 (particularly at the primary junction 200), and protects and strengthens the primary junction 200. In particular, the inner braid 214 prevents twisting by bringing the effective stiffness of the distal end of the delivery assembly 104 and the proximal end of the vaso-occlusive device 102 closer together, minimizing the stiffness differential that would cause twisting.

[0075] FIG. 11 illustrates a vascular occlusion treatment system 100 according to a further embodiment. The vascular occlusion treatment system 100 illustrated in FIG. 11 is similar to the vascular occlusion treatment system 100 illustrated in FIG. 10. One difference is that the inner braid 214 extends from the main junction 200, through the intra-device junction 300, to the distal tip 120 of the distal portion 110 of the vascular occlusion device 102. The inner braid 214 spans the entire vascular occlusion device and acts as a stretch resistance member, thereby eliminating the need for a separate stretch resistance member. A third difference is that the hook 202 at the distal end of the delivery assembly 104 can be mechanically connected to the proximal end of the inner braid 214. The inner braid 214 can be woven from DFT, Pt and / or NiTi wire, as described above. The primary junction 200 also includes an adhesive drop 204 that penetrates the proximal end 126 of the braid at the central portion 106 of the vaso-occlusive device 102, connecting (1) the hook 202 of the delivery assembly 104; (2) the proximal portion of the inner braid 214; and (3) the proximal end 126 of the central portion of the vaso-occlusive device 102 to each other to form the primary junction 200. In this embodiment, the inner braid 214 further enhances extrudability, reduces twisting of the entire vaso-occlusive device 102, and protects both the primary junction 200 and the intra-device junction 300, preventing stretching of the vaso-occlusive device 102 when it is pulled proximally during delivery.

[0076] 8-11 include various combinations of vascular occlusion devices 102, main junctions 200, and intra-device junctions 300, but this disclosure is not limited by the exemplary vascular occlusion treatment systems 100. Thus, the vascular occlusion devices 102, main junctions 200, and intra-device junctions 300 disclosed herein can each be assembled in any suitable manner to form different vascular occlusion treatment systems 100. It will be apparent that the components of the disclosed vascular occlusion treatment systems 100 need not be present in all vascular occlusion treatment systems 100.

[0077] 12-23 show various embodiments of a primary junction 200. The primary junction 200 shown in FIGS. 12 and 14-23 does not include a stretch resistance member, but can be modified to include one or more stretch resistance members. Additionally, the primary junction 200 can be modified to function as an intra-device junction 300.

[0078] The primary junction 200 depicted in FIG. 12 is similar to that depicted in FIG. 8 , except that the primary junction 200 depicted in FIG. 12 includes a pair of marker bands 216 surrounding the necked-down proximal end 126 of the central portion 106 of the vaso-occlusive treatment system 102. The marker bands 216 strengthen the connection between the hooks 202 (and delivery assembly 104) and the proximal end 126 of the central portion 106 of the vaso-occlusive device 102, thereby increasing the strength of the primary junction 200. The marker bands 216 also maintain a small diameter at the necked-down proximal end 126. The more proximal marker bands 216 also mechanically interface (e.g., interlock) with the hooks 202, strengthening the connection between the hooks 202 and the proximal end 126 and increasing the strength of the primary junction 200.

[0079] The primary junction 200 depicted in FIG. 13 is the same as that depicted in FIG. 9, except that the vaso-occlusive device 102, partially depicted in FIG. 13, does not include a proximal portion 108. Thus, the primary junction 200 depicted in FIG. 13 includes a link / adapter 206 and the necked-down proximal end 126 of the central portion 106 of the vaso-occlusive device 102. The blades of the necked-down proximal end 126 are open enough to allow the fingers 208 of the link to pass radially through the blades. Additionally, a portion of the necked-down proximal end 126 adjacent the link 206 can be welded or soldered to the link 206 to strengthen the connection between the link 206 (and the delivery assembly 104 connected thereto) and the central portion 106 of the vaso-occlusive device 102.

[0080] The vascular occlusion measurement system 100, partially depicted in Figure 14, is the same as that depicted in Figure 9, except that the proximal inter-device junction 300-1 of the vascular occlusion treatment system 100, partially depicted in Figure 14, is axially longer than the proximal inter-device junction 300-1 of the vascular occlusion treatment system 100 depicted in Figure 9. The proximal inter-device junction 300-1 depicted in Figure 14 includes an open distal end 136 of the proximal portion 108 of the vascular occlusion device 102, a necked-down proximal end 126 of the central portion 106 of the vascular occlusion device 102, and an adhesive drop 302. The necked-down proximal end 126 of the central portion 106 includes an extended length of blade disposed inside the distal end 136 of the proximal portion 108, thereby lengthening the proximal inter-device junction 300-1. The region of the proximal end 108 of the vaso-occlusive device 102 between the main junction 200 and the proximal intra-device junction 300-1 (i.e., the coil) forms an articulation portion 138 configured to facilitate bending of the vaso-occlusive device 102.

[0081] The primary junction 200 in Figure 15 is similar to that in Figure 8, except that the necked-down proximal end 126 of the central portion 106 of the vaso-occlusive device 102 in Figure 15 has a reduced diameter where the sides of the blades abut, thereby mechanically interfacing with the hook 202. This modification of the necked-down proximal end 126 strengthens the bond between the hook 202 and the proximal end 126. The hook 202 and the proximal end 126 also cannot be bonded by laser welding, soldering, or by applying a drop of adhesive.

[0082] The primary junction 200 depicted in Figure 16 is the same as that depicted in Figure 15, except that the primary junction 200 depicted in Figure 16 includes a laminate layer 218 that surrounds the necked-down proximal end 126 of the central portion 106 of the vaso-occlusive device 102. This laminate layer 218 strengthens the connection between the hooks 202 (and delivery assembly 104) and the proximal end 126 of the central portion 106 of the vaso-occlusive device 102. The laminate layer 218 also maintains the reduced diameter of the necked-down proximal end 126.

[0083] The primary junction 200 shown in Figure 17 is similar to that shown in Figure 8 except that the blades in the necked-down proximal end 126 of the central portion 106 of the vaso-occlusive device 102 shown in Figure 17 are partially open, defining an opening 40. A hook 202 formed on the distal end of the delivery assembly 104 passes through the opening 140, thereby connecting the hook 202 and the proximal end 126.

[0084] The primary junction 200 of FIG. 18 is the same as that of FIG. 8, except that the braiding of the necked-down proximal end 126 of the central section 106 of the vaso-occlusive device 102 of FIG. 18 forms a proximal loop 142. The proximal loop 142 may be formed of one or more elongate members from which the central section 106 is braided. A hook 202 formed on the distal end of the delivery assembly 104 passes through the proximal loop 142, connecting the hook 202 to the proximal end 126. The primary junction 200 also includes an adhesive drop 302 that connects the hook 202 of the delivery assembly 104 to the proximal loop 142 formed on the proximal end 126 of the central section 106 of the vaso-occlusive device 102.

[0085] The primary junction 200 depicted in Figure 19 is the same as that of Figure 10, except that the inner braid 214 is shorter and does not extend over the hooks 202. The inner braid 214 is radially disposed between the distal end of the delivery assembly 104 and the necked-down proximal end 126 of the central portion 106 of the vaso-occlusive device 102. The inner braid 214 is mechanically interfered with (e.g., interlocked with) the hooks 202. The inner braid 214 may be woven from DFT, Pt, and / or NiTi wire as described above. The primary junction 200 also includes an adhesive drop 204 that penetrates the braided proximal end 126 of the central portion 106 of the vaso-occlusive device 102 to connect (1) the hook 202 of the delivery assembly 104; (2) the proximal portion of the inner braid 214; and (3) the proximal end 126 of the central portion 106 of the vaso-occlusive device 102, thereby forming the primary junction 200. The inner braid 214 strengthens the connection between the hook 202 and the proximal end 126. The inner braid 214 also enhances extrudability, reduces twisting of the central portion 106 (particularly at the primary junction 200), and protects and strengthens the primary junction 200.

[0086] The primary junction 200 depicted in FIG. 20 is similar to that depicted in FIG. 10, except that the primary junction 200 depicted in FIG. 20 does not include a stretch resistant member. Thus, the adhesive drop 204 of the primary junction 200 connects (1) the hook 202 of the delivery assembly 104; (2) the proximal portion of the inner braid 214; and (3) the proximal end 126 of the central portion 106 of the vaso-occlusive device 102, thereby forming the primary junction 200. The inner braid 214 strengthens the connection between the hook 202 and the proximal end 126. The inner braid 214 also enhances extrudability, reduces twisting of the central portion 106 (especially at the primary junction 200), and protects and strengthens the primary junction 200.

[0087] The primary junction 200 depicted in Figure 21 is similar to that depicted in Figure 8, except that the primary junction 200 depicted in Figure 21 does not include a stretch resistant member. The hooks 202 mechanically interface (e.g., interlock) with the necked-down proximal end 126 of the central portion 106 of the vaso-occlusive device 102, thereby providing strength to the primary junction 200. Thus, the adhesive drops 204 of the primary junction 200 connect (1) the hooks 202 of the delivery assembly 104; and (2) the proximal end 126 of the central portion 106 of the vaso-occlusive device 102, thereby forming the primary junction 200.

[0088] The primary junction 200 shown in Figure 22 is the same as that shown in Figure 12, except that the primary junction 200 shown in Figure 22 includes one marker band instead of two marker bands 216. The marker band 216 surrounds the necked-down proximal end 126 of the central portion 106 of the vaso-occlusive device 102. The marker band 216 strengthens the connection between the hook 202 (and delivery assembly 104) and the proximal end 126 of the central portion 106 of the vaso-occlusive device 102, thereby increasing the strength of the primary junction 200. The marker band 216 also maintains the reduced diameter of the necked-down proximal end 126.

[0089] Figure 23 illustrates a primary junction 200 connecting a delivery assembly 104 and a central portion 106 of a vaso-occlusive device 102 according to one embodiment. The primary junction 200 illustrated in Figure 23 may be similar or the same as that illustrated in Figures 8, 10-13, and 15-22, as adhesive drops 204 obscure the details of the primary junction 200.

[0090] 24-51 illustrate various embodiments of intra-device junctions 300. While the particular intra-device junctions 300 depicted in FIGS. 24-51 may or may not include a stretch resistance member, these junctions can be modified to include or not include one or more stretch resistance members. Additionally, intra-device junctions 300 can be modified to function as primary junctions 200. Additionally, although the intra-device junctions 300 depicted in FIGS. 24-51 connect the central portion 106 to the distal portion 110, they can also be modified to connect the central portion 106 to the proximal portion 108.

[0091] The intra-device junction 300 shown in FIG. 24 is similar to that shown in FIG. 8. One difference is that the stretchable resistance member 122 terminates just proximal to the intra-device junction 300 in a loop 304 instead of extending all the way to the main junction 200. The loop 304 encircles the portion of the braid forming the distal end 128 of the central portion 106 of the vaso-occlusive device 102, thereby anchoring the proximal end of the stretchable resistance member 122. The stretchable resistance member 122 extends from proximal to the intra-device junction 300 to the intact distal tip 120, reducing the elongation of the distal portion 110 of the vaso-occlusive device 102 when it is pulled proximally during delivery. The stretchable resistance member 122 connects the central and distal portions 106, 110 of the vaso-occlusive device 102. The intra-device junction 300 also includes an adhesive drop 302 that connects (1) the distal end 128 of the central portion 106 of the vascular occlusion device 102; (2) the elastic resistive member 122; (3) the loop 304; and (4) the open proximal end 130 of the distal portion 110 of the vascular occlusion device 102 to one another, thereby forming the intra-device junction 300 and connecting the central and distal portions 106, 110 of the vascular occlusion device 102.

[0092] The intra-device junction 300 in FIG. 25 is similar to that in FIG. 8, with one difference being that the intra-device junction 300 in FIG. 25 includes a DFT blade 306, which acts as a stretch resistance member. Thus, the intra-device junction 300 in FIG. 25 does not include a stretch resistance member as in FIG. 8. The DFT blade 306 extends from the intra-device junction 300 to the intact distal tip 120, reducing the elongation of the distal portion 110 when it is pulled proximally during delivery. Although the DFT blade 306 shown in FIG. 25 terminates at the intra-device junction 300, in other embodiments, the DFT blade 306 may extend proximally all the way to the end of the main junction 200. The DFT blade 306 connects the central and distal portions 106, 110 of the vaso-occlusive device 102. The intra-device junction 300 also includes proximal and distal adhesive drops 302-1, 302-2. The proximal adhesive drop 302-1 penetrates the necked-down distal end 128 of the braided central portion 106 and connects the proximal end of the DFT braid 306 to the necked-down distal end 128 of the central portion 106. The distal adhesive drop 302-2 penetrates the open pitch windings 308 at the proximal end 130 of the coiled distal portion 110 and connects the central portion of the DFT braid 306 to the proximal end 130 of the distal portion 110. The portion of the DFT braid 306 between the proximal and distal adhesive drops 302-1, 302-2 forms an articulation portion 310 configured to facilitate bending of the vaso-occlusive device 102.

[0093] The intra-device junction 300 of FIG. 26 is similar to that of FIG. 8, except that the distal end 128 of the central portion 106 is necked down less than that of FIG. 8. Instead of having the distal end 128 necked down to fit inside the open proximal end 130 of the distal portion 110, the distal end 128 of the central portion 106 is necked down so that its diameter is approximately the same as the diameter of the proximal end 130 of the distal portion 110. The intra-device junction 300 of FIG. 25 also includes a tube 312 (e.g., PET tubing) that melts onto (and into) the central and distal portions 106, 110 of the vaso-occlusive device 102. The tube 312 passes through the open pitch windings 308 at the proximal end 130 of the coiled distal portion and the braid at the distal end 128 of the central portion 106 to more securely connect the central and distal portions 106, 110.

[0094] The intra-device junction 300 shown in Figure 27 is similar to that shown in Figure 8. One difference is that the intra-device junction 300 does not include a stretchable resistive member. The adhesive drop 302 penetrates the open pitch winding 308 at the proximal end 130 of the coiled distal portion 110 and the braid at the distal end 128 of the central portion 106. The adhesive drop 302 connects the distal end 128 of the central portion 106 of the vaso-occlusive device 102 and the open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102 together, thereby forming the intra-device junction 300 and connecting the central and distal portions 106, 110 of the vaso-occlusive device 102.

[0095] The intra-device junction 300 of FIG. 28 is similar to that of FIG. 8, with one difference being that the distal end 128 of the central portion 106 is necked down less than that of FIG. 8. Instead of necking down the distal end 128 to fit inside the open proximal end 130 of the distal end portion 110, the distal end 128 of the central portion 106 is necked down such that its diameter is slightly larger than the diameter of the proximal end 130 of the distal portion 110. Also, instead of the distal end 128 of the central portion 106 being located at the proximal end 130 of the distal portion 110, the proximal end 130 of the distal portion 110 is located at the distal end 128 of the central portion 106. Additionally, the intra-device junction 300 does not include a stretch resistance member. The adhesive drop 302 penetrates the braid at the distal end 128 of the central portion 106 and the open pitch windings 308 at the proximal end 130 of the coiled distal portion 110. The adhesive drop 302 connects the distal end 128 of the central portion 106 of the vaso-occlusive device 102 and the open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102, thereby forming an intra-device junction 300 connecting the central and distal portions 106, 110 of the vaso-occlusive device 102.

[0096] The intra-device junction 300 shown in FIG. 29 is similar to that shown in FIG. 28, except that in addition to the necked-down distal end 128 of the central portion 106, the proximal end 130 of the distal portion 110 is also necked down. The distal end 128 of the central portion 106 and the proximal end 130 of the distal portion 110 are necked down such that the diameter of the distal end 128 of the central portion 106 is slightly larger than the diameter of the proximal end 130 of the distal portion 110. This allows the proximal end 130 of the distal portion 110 to be positioned at the distal end 128 of the central portion 106. Thus, when the vaso-occlusion device 102 is pushed distally during delivery, the distal end 128 of the central portion 106 pushes against the proximal end 130 of the distal portion 110, transmitting the force distally. Additionally, the intra-device junction 300 does not include a stretchable resistance member. The adhesive drop 302 penetrates the braid at the distal end 128 of the central portion 106 and the open pitch windings 308 at the proximal end 130 of the coiled distal portion 110. The adhesive drop 302 connects the distal end 128 of the central portion 106 of the vaso-occlusive device 102 and the open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102 together, thereby forming an intra-device junction 300 and connecting the central and distal portions 106, 110 of the vaso-occlusive device 102.

[0097] The intra-device junction 300 depicted in Figure 30 is similar to that depicted in Figure 28. One difference is that instead of connecting the distal end 128 of the central portion 106 and the proximal end 130 of the distal portion 110 with an adhesive drop, the central and distal portions 106, 110 are welded together (e.g., laser welded). As shown in Figure 30, a weld 314 connects the distal end 128 of the central portion 106 and the proximal end 130 of the distal portion 110. This connection 314 strengthens the intra-device junction 300.

[0098] The intra-device junction 300 shown in Figure 31 is the same as that shown in Figure 9, except that the intra-device junction 300 does not include a stretchable resistive member. An adhesive drop 302 passes through the open pitch winding 308 at the proximal end 130 of the coiled distal portion 110 and the braid at the distal end 128 of the central portion 106. The adhesive drop 302 connects the distal end 128 of the central portion 106 of the vaso-occlusive device 102 and the open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102 together, thereby forming the intra-device junction 300 and connecting the central and distal portions 106, 110 of the vaso-occlusive device 102.

[0099] The intra-device junction 300 depicted in Figure 33 is similar to that depicted in Figure 8, with one difference being that the stretchable resistance member 122 terminates just proximal to the intra-device junction 300 at the flare 316, instead of extending the entirety of the main junction 200. The stretchable resistance member 122 extends from proximal to the intra-device junction 300 to the intact distal tip 120, reducing the stretching of the distal portion 110 of the vaso-occlusive device 102 as it is pulled proximally during delivery. The stretchable resistance member 122 connects the central and distal portions 106, 110 of the vaso-occlusive device 102. The intra-device junction 300 also includes an adhesive drop 302 that connects: (1) the necked-down distal end 128 of the central portion 106 of the vaso-occlusion device 102; (2) the elastic resistance member 122 that passes through the distal portion 128; and (3) the enlarged portion 316.

[0100] Figure 34 illustrates three intra-device junctions 300 connecting the central and distal portions 106, 110, respectively, of a vaso-occlusive device 102, according to one embodiment. The intra-device junctions 300 illustrated in Figure 34 are similar or the same as those illustrated in Figure 33. An enlarged portion 316 formed at the proximal end of the stretchable resistance member 122 can be seen in each of the three intra-device junctions 300.

[0101] The intra-device junction 300 depicted in FIG. 35 is similar to that of FIG. 24. One difference is that the adhesive drop 302 penetrates only the necked-down distal end 128 of the central portion 106 of the vaso-occlusive device 102, rather than the entire intra-device junction 300. The stretchable resistance member 122 terminates just proximal to the intra-device junction 300 in a loop 304 that surrounds the portion of the braid that forms the distal end 128 of the central portion 106 of the vaso-occlusive device 102, thereby anchoring the proximal end of the stretchable resistance member 122. The stretchable resistance member 122 extends from the proximal side of the intra-device junction 300 to the intact distal tip 120, reducing the elongation of the distal portion 110 of the vaso-occlusive device 102 when it is pulled proximally during delivery. The stretchable resistance member 122 connects the central and distal portions 106, 110 of the vaso-occlusive device 102. The adhesive drop 302 connects (1) the distal end 128 of the central portion 106 of the vaso-occlusive device 102; (2) the elastic resistance member 122; and (3) the loop 304 to each other.

[0102] The intra-device junction 300 shown in FIG. 36 is almost the same as that shown in FIG. 24. One difference is that the adhesive drop 302 penetrates only the necked-down distal end 128 of the central portion 106 of the vaso-occlusive device 102, rather than the entire intra-device junction 300. A loop 304 (at the proximal end of the stretchable resistance member 122) surrounds the bladed portion that forms the distal end 128 of the central portion 106 of the vaso-occlusive device 102, thereby securing the proximal end of the stretchable resistance member 122. The stretchable resistance member 122 extends from the proximal side of the intra-device junction 300 to the intact distal tip 120, reducing the elongation of the distal portion 110 of the vaso-occlusive device 102 when it is pulled proximally during delivery. The stretchable resistance member 122 connects the central and distal portions 106, 110 of the vaso-occlusive device 102. Adhesive drop 302 connects (1) distal end 128 of central portion 106 of vaso-occlusive device 102 ; and (2) elastic resistance member 122 .

[0103] The intra-device junction 300 depicted in FIG. 38 is similar to that depicted in FIG. 8. One difference is that the intra-device junction 300 does not include a stretch resistive member. Another difference is that the intra-device junction 300 includes a "U" shaped locking pin 318. The locking pin 318 passes radially through both (1) the proximal end 130 of the distal portion 110 of the vaso-occlusive device 102 and (2) the necked-down distal end 128 of the central portion 106 of the vaso-occlusive device 102, thereby connecting the central and distal portions 106, 110. The locking pin 318 passes through both sides of the central and distal portions 106, 110 to strengthen this connection. The intra-device junction 300 also includes an adhesive drop 302 that connects (1) the distal end 128 of the central portion 106 of the vascular occlusion device 102; (2) the proximal end 130 of the distal portion 110 of the vascular occlusion device 102; and (3) the locking pin 318; thereby forming the intra-device junction 300 and connecting the central and distal portions 106, 110 of the vascular occlusion device 102.

[0104] The intra-device junction 300 of FIG. 39 is similar to that of FIG. 29, except that instead of adhesive drops, the intra-device junction 300 of FIG. 39 includes a marker band 320 surrounding the necked-down distal end 128 of the central portion 106 and the necked-down proximal end 130 of the distal portion 110. Portions of the marker band 320 are laser welded to melt (1) the portion of the marker band 320; (2) a portion of the distal end 128 of the central portion 106; and (3) a portion of the proximal end 130 of the distal portion 110. When the portions cool and solidify, they are connected to one another. Additionally, the distal end 128 of the central portion 106 and the proximal end 130 of the distal portion 110 are necked down such that the diameter of the distal end 128 of the central portion 106 is slightly larger than the diameter of the proximal end 130 of the distal portion 110. This positions the proximal end 130 of the distal portion 110 against the distal end 128 of the central portion 106, and when it is pushed distally during delivery, the distal end 128 of the central portion 106 pushes against the proximal end 130 of the distal portion 110, transmitting force distally.

[0105] FIG. 40 shows a marker band 302 disposed around a braided vaso-occlusive device 102 and illustrates that the marker band 302 can be connected to the braided vaso-occlusive device 102 using laser welding, similar to the laser welding connection shown in FIG. 39. FIG. 40 shows a weld spot 322 on the marker band 320 formed with a 15 ms burst of a fiber laser at 33% power. The braided vaso-occlusive device 102 was formed from 16 NiTi filaments with a braid of 24 picks per inch. The outer diameter of the braided vaso-occlusive device 102 is 0.0008 inches. The marker band 320 is made of metal with an inner diameter of 0.0085 inches, an outer diameter of 0.0105 inches, and a length of 0.025 inches.

[0106] The intra-device junction 300 depicted in FIG. 41 is similar to that depicted in FIG. 11. One difference is that the inner blades 324 of the intra-device junction 300 do not extend the length of the vaso-occlusion device 102 as do the inner blades 214 depicted in FIG. 11. Another difference is that the distal end 128 of the central portion 106 is necked down less than that depicted in FIG. 11. Instead of the distal end 128 necking down to fit inside the open proximal end 130 of the distal portion 110, the distal end 128 of the central portion 106 is necked down so that its diameter is approximately the same as the diameter of the proximal end 130 of the distal portion 110. The inner blades 324 underlie both the distal end 128 of the central portion 106 and the proximal end 130 of the distal portion 110. The intra-device junction 300 also includes an adhesive drop 302 that permeates the braided distal end 128 of the central portion 106 of the vaso-occlusive device 102 and the open pitch windings 308 at the proximal end 130 of the coiled distal portion 110. The adhesive drop 302 connects (1) the distal end 128 of the central portion 106; (2) the proximal end 130 of the coiled distal portion 110; and (3) the inner braid 324 to form the intra-device junction 300. The inner braid 324 enhances extrudability, reduces twisting of the central portion 106 (particularly in the inner device 300), and protects and strengthens the intra-device junction 300.

[0107] The intra-device junction 300 shown in Figure 42 is nearly identical to that shown in Figure 41, except that the inner braid 324 shown in Figure 41 has been replaced with an inner coil 326 shown in Figure 42. The amount of neck-down at the distal end 128 of the central portion 106 and the adhesive drop 302 are nearly identical in the intra-device junction 300 shown in Figures 41 and 42. The inner coil 326 enhances extrudability, reduces twisting of the central portion 106 (particularly in the inner device 300), and protects and strengthens the intra-device junction 300.

[0108] The intra-device junction 300 depicted in Figure 43 is similar to that depicted in Figure 11, except that the inner braids 324 of the intra-device junction 300 do not extend the length of the vaso-occlusive device 102 as in the inner device depicted in Figure 11. The inner braids 324 enhance extrusion and reduce twisting of the central portion 106 (particularly in the inner device 300), protecting and strengthening the intra-device junction 300.

[0109] The intra-device junction 300 of FIG. 44 is similar to that of FIG. 25, except that the DFT blade 306 of FIG. 25 is replaced with a wire 328 and stretchable resistive member 122. Another difference is that the intra-device junction 300 includes proximal and distal adhesive drops 302-1, 302-2. The wire 328 has a proximal hook 330 and a distal hook 332. The proximal hook 330 is connected to the necked-down distal end 128 of the central section 106 by the proximal adhesive drop 302-1. The distal hook 332 passes through a loop 304 formed at the proximal end of the stretchable resistive member 122, thereby connecting the wire 328 to the distal section 110 of the vaso-occlusive device 102. Distal adhesive drop 302-2 penetrates open pitch winding 308 at proximal end 130 of coiled distal section 110, connecting (1) distal end of wire 328 (including distal hook 332); (2) proximal end of stretchable resistive member 122; and (3) proximal end 130 of distal section 110. Proximal adhesive drop 302-1 penetrates necked-down distal end 128 of braided central section 106, connecting proximal end of wire 328 (including proximal hook 330) to necked-down distal end 128 of central section 106. The portion of wire 328 between proximal and distal adhesive drops 302-1, 302-2 forms articulation portion 310 configured to facilitate bending of vaso-occlusive device 102.

[0110] The in-device junction 300 shown in FIG. 45 is similar to that shown in FIG. 41, with one difference being that the inner blade 324 shown in FIG. 41 is replaced with a solid support 334 (e.g., a Pt rod) shown in FIG. 45. Another difference is that the adhesive drop 302 shown in FIG. 41 is replaced with a crimped marker band 320 in FIG. 45. Assembly of the in-device junction 300 shown in FIG. 45 can begin by half-inserting the solid support 334 into the open proximal end 130 of the coiled distal portion 110. The distal end 128 of the bladed central portion 106 can be placed over the half-exposed portion of the solid support 334. The marker band 320 can then be placed over the portion of the central and distal portions 106, 110 that is over the solid support 334. Finally, the marker band 320 is crimped to mechanically bond the marker band 320 to portions of the central and distal sections 106, 110 and the solid support 334 to form the intra-device junction 300. The solid support 334 and marker band 320 enhance extrudability, reduce twisting of the central section 106 (particularly in the inner device 300), and protect and strengthen the intra-device junction 300.

[0111] 46-49 show a method of forming an intra-device junction 300 according to two embodiments. FIG. 46 shows a mandrel 336 inserted into the open proximal end 130 of the coiled distal portion 110. The windings 308 at the proximal end 130 of the distal portion 110 are then crimped against the mandrel 336 from a circular cross-section to an elliptical cross-section while maintaining the same outer coil diameter as shown in FIG. 47. The necked-down distal end 128 of the central portion 106 is then inserted into the crimped proximal end 130 of the distal portion 110. The elliptical cross-section of the windings 308 allows for a larger contact area between the central and distal portions 106, 110. Finally, the overlapping central and distal portions 106, 110 are connected with the adhesive drop 302 as shown in FIG.

[0112] In an alternative embodiment, the distal end 128 of the central portion 106 is necked down to a diameter slightly larger than the diameter of the crimped proximal end 130 of the distal portion 110. After crimping, the crimped proximal end 130 of the distal portion 110 is inserted into the necked-down distal end 128 of the central portion 106. The elliptical cross-section of the windings 308 allows for a larger contact area between the central and distal portions 106, 110. The overlapping central and distal portions 106, 110 are then connected with a laser weld 314, as shown in FIG.

[0113] Figures 32 and 37 show intra-device junctions 300 connecting central and distal portions 106, 110 of a vaso-occlusive device 102 according to various embodiments. The intra-device junctions 300 shown in Figures 32 and 37 are similar or the same as those shown in Figures 8-11, 24-31, 33, 35, 36, 38, and 41-49, as adhesive drops 302 obscure the details of each of the intra-device junctions 300.

[0114] The vascular occlusion treatment system 100 shown in Figure 50 is similar to that shown in Figure 9, except that the proximal and distal intra-device junctions 300-1, 300-2 include proximal and distal inner coils 326-1, 326-2, respectively. The structure and function of the proximal and distal inner coils 326-1, 326-2 are the same as the inner coils shown in Figure 42 and described above. However, the vaso-occlusion device 102 shown in Figure 50 includes a stretchable resistance member 122 that spans the length of the vaso-occlusion device 102, and the proximal and distal inner coils 326-1, 326-2 perform the additional function of centering the stretchable resistance member 122 to provide a smooth transition. The proximal and distal inner coils 326-1, 326-2 also enhance extrudability and reduce twisting of the central portion 106 (especially at the proximal and distal intra-device junctions 300-1, 300-2), protecting and strengthening the proximal and distal intra-device junctions 300-1, 300-2.

[0115] The vascular occlusion treatment system 100 depicted in part in FIG. 51 is similar to that depicted in FIG. 50. One difference is that the proximal intra-device junction 300-1 depicted in FIG. 51 does not include a proximal inner coil 326-1. Instead, the distal end 136 of the coiled proximal section 108 necks down to meet inside the open proximal end 126 of the central section 106. Additionally, the stretchable resistance member 122 does not extend distally beyond the proximal intra-device junction 300-1. The stretchable resistance member 122 includes a proximal loop 124 that passes through a proximal opening 210 in the link 206 to connect the stretchable resistance member 122 to the link 206, similar to the system 100 depicted in FIG. 50. Unlike the system 100 depicted in FIG. 50, the distal end of the stretch resistance member 122 forms two distal hooks 338 located just distal to the distal end 136 of the coiled proximal section 108. The distal hooks 338 are prevented from moving proximally by mechanically interfacing with the necked-down distal end 136 of the coiled proximal section 108, thereby anchoring the distal end of the stretch resistance member 122. The stretch resistance member 122 is made of DFT or NiTi wire, facilitating the formation of distal hooks 338 that are strong enough to anchor the distal end of the stretch resistance member 122.

[0116] The proximal intra-device junction 300-1 also includes a marker band 320 crimped onto the proximal end 126 of the central portion 106, the distal end 136 of the coiled proximal portion 108, and the elastic resistance member 122, thereby forming the proximal intra-device junction 300-1 and connecting the central and distal portions 106, 110 of the vascular occlusion device 102.

[0117] The vascular occlusion treatment system 100 partially shown in FIG. 52 is almost identical to that shown in FIG. 51. One difference is that the primary junction 200 shown in FIG. 52 does not include a link. Instead, the primary junction 200 includes a hook 202 formed at the distal end of the delivery assembly 104 that passes through a loop 124 formed at the proximal end of the stretchable resistance member 122, thereby mechanically connecting the delivery assembly 104 and the stretchable resistance member 122. FIG. 52 illustrates the system 100 shown in FIG. 8 rotated approximately 90 degrees in orientation, perpendicular to the plane of the hook 202 that appears in the line of FIG. 52.

[0118] Although not shown in Figures 51 and 52, the distal end of the vascular occlusion device 102 comprises a coiled distal portion and has a distal intra-device junction having a fixed distal elastic resistance member similar to the elastic resistance member 122 shown in Figures 51 and 52.

[0119] The vascular occlusion treatment system 100 partially shown in FIG. 53 is similar to that shown in FIG. 50 except that the proximal intra-device junction 300-1 shown in FIG. 53 does not include a proximal inner coil 326-1. Another difference is that the stretchable resistance member 122 does not extend distally through the proximal intra-device junction 300-1. Instead, as in the system 100 shown in FIG. 50, the stretchable resistance member 122 includes a proximal loop 124 that passes through a proximal opening 210 in the link 206 to connect the stretchable resistance member 122 to the link 206. Unlike the system 100 shown in FIG. 50, the distal end of the stretchable resistance member 122 forms two distal hooks 338 located just distal to the distal end 136 of the necked-down proximal end 126 of the central portion 106. The distal hook 338 is prevented from moving proximally by mechanical interference from the necked-down proximal end 126 of the central section 106, thereby anchoring the distal end of the stretchable resistance member 122. The stretchable resistance member 122 is made from DFT or NiTi wire, facilitating the formation of a distal hook 338 that is strong enough to anchor the distal end of the stretchable resistance member 122.

[0120] The proximal intra-device junction 300-1 also includes an adhesive drop 302 connecting (1) the distal end 136 of the coiled proximal portion 108; (2) the proximal end 126 of the central portion 106 of the vaso-occlusion device 102; (3) the distal portion of the elastic resistance member 122; and (4) the hook 338, thereby forming the proximal intra-device junction 300-1 and connecting the central and distal portions 106, 110 of the vaso-occlusion device 102.

[0121] The vascular occlusion treatment system 100 depicted in part in Figure 54 is substantially identical to that depicted in Figure 53. One difference is that the primary junction 200 depicted in Figure 54 does not include a link. Instead, the primary junction 200 includes a hook 202 formed at the distal end of the delivery assembly 104 that passes through a loop 124 formed at the proximal end of the elastic resistance member 122, thereby mechanically connecting the delivery assembly 104 and the elastic resistance member 122. Figure 54 shows the system 100 rotated approximately 90 degrees from the orientation of the system 100 depicted in Figure 8, with the view perpendicular to the plane of the hook 202, which is shown as a line in Figure 54.

[0122] Although not shown in Figures 53 and 54, the distal end of the vaso-occlusive device 102 may include a coiled distal portion having a distal intra-device junction with a distal elastic resistance member similarly secured to elastic resistance member 122 shown in Figures 53 and 54.

[0123] The vascular occlusion treatment system 100 depicted in part in FIG. 55 is similar to that depicted in part in FIG. 54, except that the proximal intra-device junction 300-1 also includes a weld 314 (e.g., formed by a laser) that further secures the necked-down proximal end 126 of the central portion 106 of the vascular occlusion device 102. Additionally, the stretchable resistance member 122 does not extend distally past the proximal intra-device junction 300-1. The stretchable resistance member 122 includes a proximal loop 124 that passes through a hook 202 formed at the distal end of the delivery assembly 104 to connect the stretchable resistance member 122 to the delivery assembly 104, as in the system 100 depicted in FIG. 54. 54, the distal end of the stretchable resistance member 122 forms a distal loop 342 (instead of a hook) that is disposed around the necked-down, welded proximal end 126 of the central section 106 of the vaso-occlusive device 102. The distal loop 342 is prevented from moving proximally from the necked-down, welded proximal end 126 of the central section 106 by mechanical interference, thereby anchoring the distal end of the stretchable resistance member 122. The stretchable resistance member 122 is made of DFT or NiTi wire, facilitating the formation of a distal loop 324 that has sufficient strength to anchor the distal end of the stretchable resistance member 122.

[0124] Proximal intra-device junction 300-1 also includes adhesive drops 302 interconnecting (1) distal end 136 of coiled proximal portion 108; (2) proximal end 126 of central portion 106 of vaso-occlusive device 102; (3) distal portion of stretchable resistance member 122; and (4) distal loop 342, thereby forming proximal intra-device junction 300-1 and connecting central and distal portions 106, 110 of vaso-occlusive device 102. Although not shown in FIG. 55, the distal end of vaso-occlusive device 102 may include a coiled distal portion with a distal intra-device junction having a distal stretchable resistance member similarly secured to stretchable resistance member 122 as shown in FIG.

[0125] The vascular occlusion treatment system 100 partially shown in FIG. 56 is substantially identical to that shown in FIG. 54. One difference is that the stretchable resistance member 122 shown in FIG. 56 is made of an elongated member 116, the other end of which is braided with another braid wire to form the central portion 106 of the vasoocclusion device 102. The other braid wire is trimmed at or near the proximal intra-device junction 300-1, leaving the elongated member 116 to act as the stretchable resistance member 122. The stretchable resistance member 122 includes a proximal loop 124 that passes through a hook 202 formed at the distal end of the delivery assembly 104 to connect the stretchable resistance member 122 to the delivery assembly 104 as in the system 100 shown in FIG. 54. In the system 100 shown in FIG. 56, the proximal loop 124 is welded to the hook 202 to further secure these two components of the main junction 200.

[0126] Proximal inter-device junction 300-1 also includes adhesive drops 302 connecting (1) distal end 136 of coiled proximal portion 108; (2) proximal end 126 of central portion 106 of vaso-occlusive device 102; and (3) distal portion / elongate member 116 of stretchable resistance member 122, thereby forming proximal inter-device junction 300-1 and connecting central and distal portions 106, 110 of vaso-occlusive device 102. Although not shown in FIG. 56, the distal end of vaso-occlusive device 102 may include a coiled distal portion with a distal inter-device junction having a distal stretchable resistance member similarly secured to stretchable resistance member 122 as shown in FIG.

[0127] Although not shown in Figures 51-56, the distal end of each vaso-occlusion device 102 may include a coiled distal portion having a distal intra-device junction with a fixed distal elastic resistance member similar to elastic resistance member 122 shown in Figures 51-56.

[0128] The adhesive drops 204, 302 described herein can be formed by placing a polymer (e.g., PET) tube over the adhesive drops 204, 302 and the portion of the vascular occlusion treatment system 100 on the mandrel before the adhesive is set. The tube is then heat shrunk to form the adhesive drops 204, 302. Although adhesive drops 204, 302 are used in various embodiments herein, other materials and techniques may be used to connect the components. For example, laser welding and soldering may be used to connect the components of the vascular occlusion treatment system 100 described herein.

[0129] 57 and 58 show a vascular occlusion treatment system 100 constructed in accordance with yet another embodiment. The system 100 includes a vascular occlusion device 102 (see FIG. 58) having a central portion 106 configured to connect to proximal and distal portions 108, 110 by proximal and distal intra-device junctions 300-1, 300-2, respectively. The central portion 106 is braided with DFT (i.e., composite) wire as described above and has a substantially uniform width (i.e., cross-sectional dimension). The proximal and distal intra-device junctions 300-1, 300-2 are mirror images of each other. The proximal intra-device junction 300-1 includes the open distal end 136 of the proximal portion 108 of the vascular occlusion device 102 and the necked-down proximal end 126 of the central portion of the vascular occlusion device 102. The proximal end 126 of the central portion 106 is necked down to fit inside the open distal end 136 of the proximal portion 108. The proximal inter-device junction 300-1 also includes an adhesive drop 302 that penetrates the coiled open distal end 136 of the proximal portion 108 of the vaso-occlusive device 102. The adhesive 302 connects the proximal end 126 of the central portion 106 of the vaso-occlusive device 102 and the open distal end 136 of the proximal portion 108 of the vaso-occlusive device 102 to one another, thereby forming the proximal inter-device junction 300-1. The adhesive drop 302 also connects the portion of the stretchable resistance member 122 that extends into the proximal inter-device junction 300-1.

[0130] The stretchable resistance member 122 of the proximal portion 108 of the vaso-occlusive device 102 comprises at least two members 122-1 and 122-2, each made of one or more wires extending from the proximal end 126 of the vaso-occlusive device 102. As a non-limiting example, a braided DFT wire at the proximal end 126 of the vaso-occlusive device 102 is trimmed to form the stretchable resistance member 122 (i.e., members 122-1, 122-2). The at least two members 122-1, 122-2 comprise proximal ends 122-1a, 122-2a and distal ends 122-1b, 122-2b, respectively. A hook 123 is formed on each of the proximal ends 122-1a and 122-2a of the stretchable resistance members 122-1 and 122-2. The hooks 123 are configured to connect to the link / adapter 206 of the main junction 200, as shown in Figure 58. The distal ends 122-1b, 122-2b of the stretchable resistance members 122-1, 122-2, respectively, are connected to the proximal in-device junction 300-1.

[0131] The distal intra-device junction 300-2 comprises the necked-down distal end 128 of the central portion 106 of the vaso-occlusive device 102 and the open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102. The distal end 128 of the central portion 106 is necked down to fit within the open proximal end 130 of the distal portion 110. The distal intra-device junction 300-2 also comprises an adhesive drop 302 that penetrates the coiled open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102. The adhesive 302 connects the distal end 128 of the central portion 106 of the vaso-occlusive device 102 and the open proximal end 130 of the distal portion 110 of the vaso-occlusive device 102 together, thereby forming the intra-device junction 300-2. Additionally, adhesive drop 302 also connects the portion of stretchable resistance member 122 that extends into distal in-device junction 300-2.

[0132] The stretchable resistance member 122 of the distal portion 110 of the vaso-occlusive device 102 comprises at least two members 122-3 and 122-4. Each member is made of one or more wires extending from the distal end 128 of the braided vaso-occlusive device 102. For example, the braided DFT wire at the distal end 128 of the vaso-occlusive device 102 can be trimmed to form the stretchable resistance members 122 (i.e., members 122-3 and 122-4). The two members 122-3 and 122-4 each comprise a proximal end 122-3a, 122-4a and a distal end 122-3b, 122-4b, respectively. The proximal end 122-3a and 122-4a of each of the stretchable resistance members 122-3 and 122-4 are connected to a distal intra-device junction 300-2. Distal ends 122-3b and 122-4b of respective stretchable resistance members 122-3 and 122-4 are connected together to form distal joint 125. Joint 125 is formed by twisting distal ends 122-3b and 122-4b of respective stretchable resistance members 122-3 and 122-4 together. Joint 125 may be formed by adhesives, bonding, welding, or other suitable connection techniques. Joint 125 is configured to connect to intact distal tip 120, as shown in FIG. 58.

[0133] 58, the vaso-occlusive treatment system 100 includes a vaso-occlusive device 102 connected to a delivery assembly 104 by a main junction 200. The delivery assembly 104 includes an electrolytically detachable segment 114 at its distal end. The central portion 106 of the vaso-occlusive device 102 is braided with DFT wire, as described above. The proximal and distal portions 108, 110 are coils wound with one or more DFT wires, as described above.

[0134] The vascular occlusion treatment system 100 shown in Figures 57 and 58 is similar to the system shown in Figure 9 and partially shown in Figure 56. One difference from Figure 9 is that the system shown in Figures 57-58 includes at least two sets of stretchable resistance members 122, each set consisting of one or more wires at the proximal end 126 and distal end 128 of the braided vaso-occlusion device 102. A first set of stretchable resistance members 122, including members 122-1, 122-2, extends from the proximal end 126 of the vaso-occlusion device 102 and the proximal inter-device junction 300-1 into the link / adapter 206 of the main junction 200. A second set of stretchable resistance members 122, including members 122-3 and 122-4, extends from the distal end 128 of the vaso-occlusion device 102 and the inter-device junction 300-2 to the intact distal tip 120. One difference from FIG. 56 is that the first set of elastic resistance members shown in FIGS. 57 and 58 comprises two members 122-1 and 122-2 each having a distal end hook 123.

[0135] 58, the primary junction 200 includes a link / adapter 206 connected to both the distal end of the delivery assembly 104 and the open proximal end 132 of the proximal portion 108, thereby connecting the delivery assembly 104 and the proximal portion 108. The link 206 also includes a distal opening 212. The hooks 123 at the proximal ends 122-1a, 122-2a of each of the stretch resistance members 122-1 and 122-2 pass through the distal openings 212 of the link 206 to connect the delivery assembly 104 and the link 206 (and the proximal portion 108 connected thereto).

[0136] The distal portion 110 of the system 100 of FIG. 58 includes an atraumatic distal tip 120 that is formed with a suitable amount of adhesive. Extending from the distal intra-device junction 300-2, stretch resistance members 122-3 and 122-4 extend distally into the atraumatic distal tip 120. Distal ends 122-3b and 122-4b of the respective stretch resistance members 122-3 and 122-4 are connected together to form a distal joint 125. The joint 125 is connected and / or disposed within the atraumatic distal tip 120.

[0137] FIG. 59 illustrates a cross-section of an elongate member from which the vascular occlusion treatment system 100, vascular occlusion device 102, or portions thereof, may be formed. The elongate member 115 (e.g., a wire) comprises a core 117 made of a radiopaque material, an intermediate layer 119 made of a superelastic material, and an outer layer 121 made of a material configured to provide oxidation protection. In the embodiment of FIG. 59, the wire 115 comprises a substantially pure platinum (Pt) core 117 at least partially surrounded by a substantially pure nitinol (NiTi) intermediate layer 119; the intermediate layer 119 is at least partially surrounded by a thin outer layer 121 of substantially pure titanium (Ti). As used in this application, a "thin" outer layer may be in the range of, but is not limited to, about 0.001 to 20 micrometers. The Ti outer layer 121 is configured to avoid or minimize affecting the flexibility and / or strength of the wire 115 and the element (e.g., braid) formed from the wire 115. It will be appreciated that the thin outer layer 121 may be made of any suitable density or other biocompatible material to provide oxidation protection to the wire 115 .

[0138] Variations in thickness of the intermediate layer 119 and / or outer layers, and / or variations in diameter of the core 117 can be anticipated to optimize desired characteristics of the wire 115 (e.g., flexibility, stiffness, radiopacity, etc.). The wire 115 can be manufactured by co-extrusion techniques, or other suitable manufacturing techniques. For example, the Ti outer layer 121 can be applied by plating, coating, physical vapor deposition (PVD) to a DFT wire as described above (NiTi-DFT-40 / 0Pt).

[0139] Braids woven from wire 115 are suitable for vascular occlusion applications. During the heat setting process of a braid formed from wire 115, the Ti outer layer 121 oxidizes to form a Ni-free barrier layer against the underlying intermediate NiTi layer 119. The use of wire 115 to form the braid is configured to eliminate the steps of removing surface oxides by etching / EP and passivation processes and / or eliminates the issue of Ni leaching during use. Additionally, braids formed from wire 115 can be heat set in an air environment.

[0140] As used herein, "stiffness" in reference to a blade or portion thereof includes, but is not limited to, bending stiffness.

[0141] Various embodiments of the disclosed invention are described with reference to the drawings. The drawings are not drawn to scale, and elements of similar structure or function are numbered the same throughout the drawings. Additionally, the drawings are merely to facilitate the description of the embodiments, and are not intended as an exclusive description of the disclosed invention, or as a limitation on the scope of the disclosed invention, which is defined only by the claims and their equivalents. Moreover, each embodiment need not have all aspects or advantages of each feature described herein. Aspects or advantages described in connection with a particular embodiment of the disclosed invention are not necessarily limited to that embodiment, and may be practiced in other embodiments, even if not so described.

Claims

1. In the vascular occlusion treatment system, A delivery assembly. a vaso-occlusive device removably coupled to the delivery assembly by a severable junction, the vaso-occlusive device comprising: a distal coil having an inner axial lumen and a distal coil stretch prevention member disposed within the distal coil; a blade having a distal end portion coupled to a proximal end portion of the distal coil by an in-device junction; an enlarged body formed at a proximal end of the distal coil extension prevention member; the enlarged body is disposed adjacent the reduced diameter portion of the blade and secures the distal coil stretch prevention member thereto; The blade has a central portion having a first diameter greater than a second diameter of the reduced diameter portion.

2. 2. The vascular occlusion treatment system according to claim 1, wherein the distal coil extension prevention member connects the distal coil to the blade.

3. 10. The vascular occlusion treatment system of claim 1, wherein the vascular occlusion device further comprises an adhesive bonding together the reduced diameter portion of the braid, the portion of the distal coil stretch prevention member, and the enlarged body.

4. 2. The vascular occlusion treatment system according to claim 1, wherein the vascular occlusion device further comprises: Internal axial lumen, a proximal coil extension prevention member; a proximal end portion attached to the cleavable junction; A vascular occlusion treatment system comprising a proximal coil having a

5. 5. The vascular occlusion treatment system of claim 4, wherein the proximal coil extension prevention member has a proximal end attached to a distal portion of the severable junction that is coupled to a proximal end portion of the proximal coil, and the severable junction is configured such that when the severable junction is cut, the distal portion of the severable junction remains coupled to the proximal end portion of the proximal coil.

6. In the vascular occlusion treatment system, A delivery assembly. a vaso-occlusive device removably connected to the delivery assembly by a severable junction, the vaso-occlusive device comprising: a distal coil having an inner axial lumen and a distal coil stretch prevention member disposed within the distal coil; a blade having a distal end portion coupled to a proximal end portion of the distal coil by an in-device junction; a loop formed at a proximal end of the distal coil stretch prevention member; Equipped with 11. A vascular occlusion treatment system, comprising: said blade having a central portion having a first diameter; said blade having a reduced diameter portion having a second diameter, said first diameter being greater than said second diameter.

7. 7. The vascular occlusion treatment system of claim 6, wherein the loop encircles an elongated member of the braid from which the braid is formed and secures the distal coil stretch prevention member thereto.

8. 7. The vascular occlusion treatment system of claim 6, wherein the loop encircles a reduced diameter portion of the braid and secures the stretch prevention member thereto.

9. 7. The vascular occlusion treatment system according to claim 6, wherein the distal coil extension prevention member connects the distal coil to the blade.

10. 7. The vascular occlusion treatment system of claim 6, wherein the vascular occlusion device further comprises an adhesive bonding the reduced diameter portion of the braid and a portion of the distal coil extension prevention member.

11. 7. The vascular occlusion treatment system of claim 6, wherein the vascular occlusion device further comprises a proximal coil having an inner axial lumen, a proximal coil stretch prevention member, and a proximal end portion coupled to a severable junction.

12. 12. The vascular occlusion treatment system of claim 11, wherein the proximal coil extension prevention member has a proximal end attached to a distal portion of the severable junction that is coupled to the proximal end portion of the proximal coil, and the severable junction is configured such that when the severable junction is cut, the distal portion of the severable junction remains coupled to the proximal end portion of the proximal coil.

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