Vascular occlusion devices and delivery assemblies

Abstract

The vascular occlusion treatment system includes a delivery assembly and a vaso-occlusive device removably coupled to the delivery assembly by a delivery assembly interface. The vaso-occlusive device includes a braided portion formed from one or more wires, the braided portion including a packed end bundle. The vaso-occlusive device also includes a coil portion coupled to the braided portion. The vaso-occlusive device further includes an intra-device interface coupling the braided portion to the coil portion, the intra-device interface including a stretch-resistant member extending from the packed end bundle to the delivery assembly interface.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 309,300, filed February 11, 2022, the entire disclosure of which is expressly incorporated herein by reference.

[0002] The field of the disclosure relates generally to vaso-occlusive devices for establishing an embolism or vaso-occlusion in a blood vessel of a human patient. More specifically, the disclosure relates to at least partially braided or woven vaso-occlusive devices, joints within such devices, and joints for connecting such devices to a therapeutic system. [Background technology]

[0003] Vascular occlusion devices or implants are utilized for a variety of purposes, including the treatment of intravascular aneurysms. Commonly used vaso-occlusion devices include a helically wound soft coil formed by wrapping a platinum (or platinum alloy) wire strand around a "primary" mandrel. The coil is then wrapped around a larger "secondary" mandrel and heat treated to impart a secondary shape. For example, U.S. Pat. No. 4,994,069 issued to Ritchart et al. describes a vaso-occlusion device that assumes a straight, helical primary shape when stretched for placement through the lumen of a delivery catheter and a collapsed, coiled secondary shape when released from the delivery catheter and placed in the vasculature. Other examples of vaso-occlusion devices include at least partially braided or woven devices, such as those described in U.S. Pat. No. 10,321,915 issued to Murphy et al. and U.S. Pat. No. 10,893,870 issued to Wang et al., which are fully incorporated herein by reference as if set forth in their entirety.

[0004] To deliver a vaso-occlusive device to a desired site in the vasculature, e.g., into an aneurysmal sac, it is well known to first position a small profile delivery catheter or "microcatheter" at the site using a steerable guidewire. Typically, the distal end of the microcatheter is given a preselected shape of bend, e.g., 45°, 90°, "J", "S", or other bend shape, by the attending physician or manufacturer depending on the patient's particular anatomy, so that it will remain in the desired position to release one or more vaso-occlusive devices into the aneurysm after the guidewire is withdrawn. A delivery assembly or "pusher" assembly or "wire" is then threaded through the microcatheter, and the vaso-occlusive device pushed by the distal end of the delivery assembly is extended from the distal end opening of the microcatheter into the aneurysm. Once inside the aneurysm, a portion of the vaso-occlusive device deforms or bends to allow for more efficient and complete filling. The vaso-occlusive device coupled to the distal end of the delivery assembly is released or "detached" from the distal end of the delivery assembly after it has been extended into the aneurysm. The delivery assembly is then pulled back through the catheter. Depending on the particular needs of the patient, one or more additional vaso-occlusive devices may be pushed through the catheter and released at the same site.

[0005] One well-known method of releasing the vaso-occlusive device from the end of the delivery assembly is to use an electrolytically severable joint, which is a small exposed or severable area located along the distal end of the delivery assembly. This severable area is typically made of stainless steel and is located just proximal to the vaso-occlusive device. The electrolytically severable joint is susceptible to electrolysis and breaks down when the delivery assembly becomes charged in the presence of ionic solutions such as blood and other bodily fluids. Thus, when the severable area exits the catheter distal end and is exposed to the blood pool in the patient's blood vessel, a current applied through the electrical contacts to the conductive pusher completes an electrolytic severing circuit with the return electrode, causing the severable area to disintegrate electrolytically. Other detachment mechanisms for detaching the vaso-occlusive device from the delivery assembly include mechanical, thermal, and hydraulic mechanisms.

[0006] To better shape and fill aneurysms, complex three-dimensional secondary shapes can be imparted to vascular occlusion devices, and their stiffness / flexibility can be altered, but vascular occlusion devices still have performance limitations, such as fracture performance, shape retention, and flexibility.

[0007] The proximal end of some vaso-occlusive devices are coupled to the distal end of the delivery assembly using what is known as the "main interface," "delivery assembly interface," or simply the "delivery interface" of the vaso-occlusive treatment system. Another main interface design is disclosed in U.S. Pat. No. 8,202,292 issued to Kellett, which is incorporated herein by reference in its entirety as if set forth in its entirety. The main interface comprises a flat adapter that couples a delivery wire to the vaso-occlusive device. The delivery wire has a hook or "J" shaped distal end configured to be received in an opening in the proximal end of the adapter and couple the delivery wire to the adapter. The vaso-occlusive device has windings that define an opening configured to receive fingers at the distal end of the adapter to couple the vaso-occlusive device to the adapter. In this manner, the adapter facilitates coupling of the delivery wire to the vaso-occlusive device. Another main interface design is disclosed in U.S. Pat. No. 9,480,479 issued to Chen et al., which is incorporated herein by reference in its entirety as if set forth in its entirety.

[0008] Some vaso-occlusive devices include one or more braided sections and one or more coiled sections. In such vaso-occlusive devices, the braided and coiled sections are joined by one or more "internal device joints." Some vaso-occlusive devices also include a stretch-resistant member configured to hold the coiled section in compression to control structural properties (such as flexibility and stiffness) of the coiled section that would otherwise change when the coiled section is stretched. The stretch-resistant member may form both the internal device joints and the delivery joints. In some vaso-occlusive devices, the stretch-resistant member is formed from one or more braided wires that pass through a first end of the coiled section and are anchored at their second ends. In such vaso-occlusive devices, the diameter of the stretch-resistant member depends on the diameter of the braided wires that form the braided section. Thus, the structural properties of the internal device joints and the delivery joints are unnecessarily dependent on the properties of the braided wires. As a result, vaso-occlusive devices having braided sections with fine braided wires (eg, 0.0008 inch or 0.0009 inch diameter) have lower tensile strength at the intra-device and delivery junctions.

[0009] Thus, a need remains for a vaso-occlusive treatment system having a vaso-occlusive device in which the size of the braid is decoupled from the strength of the intra-device and delivery junctions, and a method for making the same. Summary of the Invention

[0010] According to one aspect of the present disclosure, a vascular occlusion treatment system includes a delivery assembly and a vaso-occlusive device removably coupled to the delivery assembly by a delivery assembly interface. The vaso-occlusive device includes a braided portion formed from one or more wires, the braided portion including a packed end bundle. The vaso-occlusive device also includes a coil portion coupled to the braided portion. The vaso-occlusive device further includes an intra-device interface coupling the braided portion to the coil portion, the intra-device interface including a stretch-resistant member spanning from the packed end bundle to the delivery assembly interface.

[0011] According to various aspects of the present disclosure, the restrained end includes an adhesive disposed at an end of the braided portion or a weld disposed at an end of the braided portion, and may define an end surface that is orthogonal or oblique to a longitudinal axis of the restrained end.

[0012] According to various aspects of the disclosure, the elongation resistant member includes a first and a second end. The first end of the elongation resistant member may terminate within the delivery wire junction and the second end of the elongation resistant member may terminate within the braided portion or within the coiled portion. The first and second ends may be flattened. The first and second ends may each terminate within the braided portion. The first and second ends may cross each other within the braided portion.

[0013] According to various aspects of the disclosure, the elongation resistant member includes a bend. The first and second ends terminate within the delivery wire junction, and the bend may be disposed adjacent to the restrained end. The bend may be disposed distal to the restrained end. The first and second ends terminate adjacent to the restrained end, and the bend may be disposed within the delivery wire junction. The delivery assembly junction includes a link defining an opening, and the bend may be disposed within the opening. Each of the first and second ends may terminate within the braided portion.

[0014] According to various aspects of the present disclosure, the vascular occlusion treatment system also includes a second stretch-resistant member including third and fourth ends, the first and third ends terminating within the delivery wire junction and the second and fourth ends terminating adjacent the restraining end.

[0015] According to various aspects of the disclosure, the elongation resistant member is a loop including a first and a second bend. The first bend can be disposed within the delivery wire junction and the second bend can be disposed adjacent to the restraining end. The first bend can be disposed distal to the restraining end. The delivery assembly junction can include a link defining an opening and the second bend can be disposed within the opening.

[0016] According to various aspects of the present disclosure, the restrained end is a proximal restrained end, the coil portion is a proximal coil portion, the intra-device joint is a proximal intra-device joint, the stretch resistant member is a proximal stretch resistant member, and the braided portion further includes a distal restrained end. The system also includes a distal coil portion coupled to the distal restrained end and a distal intra-device joint coupling the braided portion to the distal coil portion. The distal intra-device joint includes a distal stretch resistant member extending from the distal restrained end to a distal end of the distal coil portion.

[0017] According to various aspects of the present disclosure, the distal restraining end includes an adhesive disposed at the distal end of the braided portion or a weld disposed at the distal end of the braided portion, and may define a distal end surface that is orthogonal or oblique to a longitudinal axis of the distal restraining end.

[0018] According to various aspects of the disclosure, the distal elongation resistant member includes first and second distal elongation resistant member ends. The first distal elongation resistant member end of the distal elongation resistant member may terminate within the distal end of the distal coil portion and the second distal elongation resistant member end of the distal elongation resistant member may terminate within the braided portion or within the distal coil portion. The first and second distal elongation resistant member ends may be flattened. The first and second distal elongation resistant member ends may each terminate within the braided portion. The first and second distal elongation resistant member ends may cross each other within the braided portion.

[0019] According to various aspects of the disclosure, the distal elongation resistant member includes a distal elongation resistant member bend. The first and second distal elongation resistant member ends may terminate within a distal end of the distal coiled portion, and the distal elongation resistant member bend may be disposed adjacent to the distal restrained end. The distal elongation resistant member bend may be disposed proximal to the distal restrained end. The first and second distal elongation resistant member ends may terminate adjacent to the distal restrained end, and the distal elongation resistant member bend may be disposed within the distal end of the distal coiled portion. Each of the first and second distal elongation resistant member ends may terminate within the braided portion.

[0020] According to various aspects of the present disclosure, the vascular occlusion treatment system also includes a second distal stretch-resistant member including third and fourth distal stretch-resistant member ends, the first and third distal stretch-resistant member ends may terminate within the distal end of the distal coil portion, and the second and fourth distal stretch-resistant member ends may terminate adjacent to the distal restraining end.

[0021] According to various aspects of the present disclosure, the distal stretch-resistant member is a loop including first and second distal stretch-resistant member bends. The first distal stretch-resistant member bend can be disposed within a distal end of the distal coil portion and the second distal stretch-resistant member bend can be disposed adjacent the distal restrained end. The first distal stretch-resistant member bend can be disposed proximal to the distal restrained end.

[0022] According to various aspects of the present disclosure, the delivery assembly has a distal end, the distal end forming a hook, the delivery assembly joint includes a link having a proximal end and a distal end, the distal end of the link may include a plurality of fingers.

[0023] According to another aspect of the disclosure, a method of manufacturing the vascular occlusion treatment system includes forming a vascular occlusion device, the method including placing a tube around a proximal end of a braided section formed from one or more wires, applying heat to the tube to shrink the tube around the proximal end of the braided section to form a shrunken proximal end, applying adhesive to the shrunken proximal end to form a constrained end, removing the tube from around the constrained end, threading a stretch-resistant member through the braided section adjacent and distal to the constrained end, inserting at least a portion of the stretch-resistant member and the constrained end into the coil section, and applying adhesive to the constrained end and the bend in the stretch-resistant member to form an intra-device joint. The method also includes bonding a distal end of a delivery assembly to the proximal end of the coil section and the proximal end of the stretch-resistant member. The method further includes applying an adhesive to the distal end of the delivery assembly, the proximal end of the coil portion, and the proximal end of the stretch-resistant member to form a delivery joint.

[0024] According to yet another aspect of the present disclosure, a method of manufacturing a vascular occlusion treatment system includes forming a restrained end. The step of forming the restrained end includes placing a tube around a proximal end of a braided section formed from one or more wires, applying heat to the tube to shrink the tube around the proximal end of the braided section to form a shrunken proximal end, applying adhesive to the shrunken proximal end to form a restrained end, and removing the tube from around the restrained end. The method also includes forming a delivery joint. The step of forming the delivery joint includes bonding a distal end of a link to a proximal end of a coil section, bonding a distal end of a delivery assembly to the proximal end of the link, threading an elongation-resistant member through an opening defined by the link to form a bend in the elongation-resistant member in the opening, and applying adhesive to the link, the proximal end of the coil section, the distal end of the delivery assembly, and the bend in the elongation-resistant member to form a delivery joint. The method further includes inserting at least a portion of the restrained end into the coil section. The method further includes bonding an end of the stretch-resistant member to a braided portion adjacent and distal to the restrained end, and applying an adhesive to the restrained end and the end of the stretch-resistant member to form an intra-device bond.

[0025] According to various aspects of the present disclosure, the coil portion is a proximal coil portion and the method also includes coupling a distal coil portion to a distal end of the braided portion. Other and further aspects and features of the present disclosure will become apparent from the following detailed description considered in conjunction with the accompanying drawings. [Brief description of the drawings]

[0026] This patent or application contains at least one color drawing. Copies of this patent or patent application publication with color drawing(s) will be provided by the U.S. Patent and Trademark Office upon request and payment of the necessary fee.

[0027] The drawings illustrate the design and utility of various aspects of the present disclosure, with similar elements being referred to by common reference numerals. The drawings are not necessarily drawn to scale. To better understand how the above and other advantages and objects can be obtained, a more particular description of the present disclosure, as illustrated in the accompanying drawings, is presented. These drawings depict only exemplary aspects of the present disclosure, for the purpose of illustrating and facilitating the following detailed description, and therefore should not be considered as limiting its scope. [Figure 1] FIG. 1 is a schematic diagram of an exemplary vascular occlusion treatment system including a vascular occlusion device and a delivery assembly according to various embodiments of the present disclosure. [Diagram 2] 2A and 2B are detailed schematic diagrams illustrating steps for manufacturing an exemplary vaso-occlusive device according to various aspects of the present disclosure. [Diagram 3] FIG. 3 is a schematic diagram of an exemplary vascular occlusion treatment system including a respective vascular occlusion device and delivery assembly according to various embodiments of the present disclosure. [Figure 4] FIG. 4 is a schematic diagram of an exemplary vascular occlusion treatment system including a respective vascular occlusion device and delivery assembly according to various embodiments of the present disclosure. [Diagram 5] FIG. 5 is a schematic diagram of an exemplary vascular occlusion treatment system including a respective vascular occlusion device and delivery assembly according to various embodiments of the present disclosure. [Figure 6] FIG. 6 is a schematic diagram of an exemplary vascular occlusion treatment system including a respective vascular occlusion device and delivery assembly according to various embodiments of the present disclosure. [Figure 7] FIG. 7 is a schematic diagram of an exemplary vascular occlusion treatment system including a respective vascular occlusion device and delivery assembly according to various embodiments of the present disclosure. [Figure 8] FIG. 8 is a detailed schematic diagram of an exemplary intra-device joint of a vaso-occlusive device according to various embodiments of the present disclosure. [Figure 9] FIG. 9 is a detailed schematic diagram of an exemplary intra-device joint of a vaso-occlusive device according to various embodiments of the present disclosure. [Figure 10] FIG. 10 is a detailed schematic diagram of an exemplary intra-device joint of a vaso-occlusive device according to various embodiments of the present disclosure. [Figure 11] 11A-11I are a series of schematic diagrams illustrating an exemplary method for manufacturing a vascular occlusion treatment system including a vascular occlusion device and a delivery assembly according to various embodiments of the present disclosure. [Figure 12] 12A-12I are a series of schematic diagrams illustrating an exemplary method for manufacturing a vascular occlusion treatment system including a vascular occlusion device and a delivery assembly according to various embodiments of the present disclosure. [Figure 13] 13A-13D are schematic diagrams illustrating the proximal restraining end of respective vaso-occlusive devices according to various embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] This specification describes exemplary aspects and applications of the present disclosure. However, the present disclosure is not limited to these exemplary aspects and applications, nor are the exemplary aspects and applications limited to those of the operations or aspects described herein. Furthermore, the figures may show simplified or partial views, and the dimensions of the elements in the figures may be exaggerated or out of proportion. Furthermore, elements having similar structures or functions are represented by similar reference numerals throughout the drawings. Furthermore, the illustrated embodiment does not necessarily have all the features or advantages shown. Features or advantages described in connection with a particular embodiment are not necessarily limited to that embodiment, and may be implemented in other embodiments, even if not so shown.

[0029] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

[0030] When terms such as "on," "attached," "connected," "bonded," "secured to," and the like are used herein, it means that one element (e.g., a material, layer, substrate, etc.) is on, attached, connected, bonded, or secured to another element, and may be "on," "attached," "connected," "bonded," or "secured to" the other element, regardless of whether there are one or more intervening elements between the one element and the other element. Directions (e.g., above, below, top, bottom, side, upper, lower, under, over, above, horizontal, vertical, "x," "y," "z," etc.), when provided, are relative and are provided only for ease of illustration and description, not limitation. When referring to a list of elements (e.g., elements a, b, c), such reference is intended to include any one of the listed elements alone, any combination of less than all of the listed elements, and / or all combinations of the listed elements.

[0031] As used herein, "substantially" means sufficient to serve the intended purpose. Thus, the term "substantially" allows for minor and inconsequential variations from absolute or perfect conditions, dimensions, measurements, results, etc., that do not significantly affect overall performance, as would be expected by one of ordinary skill in the art. "Ones" means plural.

[0032] All numerical values, whether expressly stated or not, are intended to be modified herein by the term "about." The term "about" generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" includes numerical values ​​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, 5).

[0033] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0034] As used herein, the multiple "elongate members" used to form the braid may include only a single elongate member used to form the braid, i.e., a single elongate member may be folded back on itself at the end of the braid. As used herein, the terms "tube," "tubular," "diameter," "radius," and "circumference" encompass objects having circular cross sections as well as objects having non-circular cross sections. As used herein, the terms "rigidity" or "flexibility" in relation to a wire, coil, braid, or portion thereof includes, but is not limited to, bending stiffness. As used herein, the term "constrained" refers to, but is not limited to, (1) the braid is held in a compressed, elongate configuration by a force applied by a delivery catheter or the like, and (2) the dope is held in a compressed, short configuration by a force applied by a stretch-resistant member or the like. As used herein, the term "unconstrained" includes, but is not limited to, the absence of an external force acting on an object, including, but not limited to, a braid or coil. Although "unconstrained" is used synonymously with "deployed" in this specification with respect to the braid, the anatomy of some patients may apply forces to a deployed vaso-occlusive device that includes a braid.

[0035] 1 shows a vasoconstriction treatment system 100 including a vasoocclusion device 110 having a braided portion 120 and proximal and distal coil portions 130, 140. The proximal end of the vasoocclusion device 110 is removably coupled to a delivery assembly 150 for delivery to a patient. Details regarding the delivery wire assembly and delivery of the vasoocclusion treatment system are described in U.S. Patent Nos. 8,202,292, 9,480,479, 10,321,915, and 10,893,870, which are previously incorporated by reference herein.

[0036] The braided portion 120 can be braided from any type of elongated member (e.g., "alloy wires," "wires"), so long as the materials used to make such elongated members are biocompatible. For example, the braided portion 120 can be braided from 24 wires, each having a cross-sectional diameter of 0.001 inches. The braiding can be flat or circular. According to other aspects of the present disclosure, the braided portion 120 can be braided from 16 to 32 wires, each having a cross-sectional diameter of 0.00075 inches to 0.0015 inches. The proximal and distal portions 130, 140 are coils wound from one or more of the same or different alloy wires. According to other aspects of the present disclosure, the portion 120 can be braided from 32 or more wires, each having a cross-sectional diameter of 0.0.00075 inches to 0.0.00125 inches.

[0037] According to some aspects of the present disclosure, the alloy wire or wires can be drawn filled tube (DFT) available from Fort Wayne Metals, Inc., Fort Wayne, Indiana. DFT wires include 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 comprises approximately 40%-50% of the DFT wire by volume ("Pt core content"). According to other aspects of the present disclosure, DFT wires are formed by inserting a core member (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 stretched and annealed by heating to increase its axial length and decrease its cross-sectional diameter. For example, the draw anneal process may successively reduce the diameter of the composite elongated 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.

[0038] The materials (e.g., Pt and NiTi) forming the various portions (e.g., core, outer layer, etc.) of the DFT wire may have different stiffnesses (i.e., bending stiffness), but the relative stiffnesses (i.e., bending stiffness) of the resulting DFT portions may not necessarily reflect the stiffness of the materials from which they are made. For example, the bending modulus (i.e., stiffness) of Pt is greater than NiTi, but the combination of the bending modulus of Pt and the diameter of the Pt wire results in a platinum wire that is softer (i.e., less stiff) than the corresponding NiTi outer layer.

[0039] The braided portion 120 of the vaso-occlusive device 110 may be braided onto a flat or circular mandrel depending on the final shape desired. After braiding, the braided portion 120 may be heat set (e.g., at 500°C-550°C for 1-10 minutes). The heat set braid forms the linear "primary shape" of the braided portion 120. The heat set braid is then wrapped around a second mandrel (e.g., a three-dimensional mandrel) and heat set a second time to impart a three-dimensional "secondary shape". The NiTi outer layer improves retention of the secondary shape.

[0040] Vascular implants (i.e., stents) have been formed from NiTi-DFT-Pt wires with Pt core content up to about 30%, but NiTi-DFT-Pt wires with Pt core content of about 40%-50% have not been used to form stents. Stents typically require wires with a high ratio of yield strength to ultimate strength (80% of ultimate tensile strength (UTS)) to maintain vascular patency. Vascular occlusion device 110, on the other hand, includes DFT wires with a low yield strength to UTS ratio, which improves device properties such as lower bending moment and improved fracture performance. According to various aspects of the present disclosure, DFT wires forming (part of) vasoocclusion device 110 have yield strengths relative to UTS of <50% UTS, <60% UTS, <70% UTS, and <80% UTS. Yield strength is the maximum amount of force that can be applied before a material begins to plastically deform. UTS is the minimum amount of force that must be applied to cause the material to break. Braiding at least a portion of the vascular occlusion device with wires having a yield strength to UTS ratio of less than 80% is crucial to simultaneously achieve the properties of improved radiopacity, shape retention, and fracture performance.

[0041] According to another aspect of the present disclosure, a vascular implant, including a vaso-occlusive device, is formed from NiTi-DFT-Pt wire with a Pt core content of about 40%-50%. By braiding the braided portion 120 from DFT wire with a Pt core content of about 40%-50% ("NiTi-DFT-40 / 50Pt"), the braided portion 120 (1) has radiopacity throughout its entire length, (2) has improved shape retention, and (3) has improved break performance throughout the entire length of the braid. The Pt core provides radiopacity for the majority of the vaso-occlusive device 110, providing radiopacity for the various vaso-occlusive devices implanted in the patient. The superelastic properties of the NiTi outer layer provide improved shape retention. The softness of platinum contributes to improved break performance, i.e., the ability of the vaso-occlusive device 110 to bend and fold to conform to the shape of the body lumen. These properties of the braided portion 120 result in a vaso-occlusive device 110 that is suitable for intraluminal embolization of vascular defects such as aneurysms, i.e., providing a substantially consistent visualization grayscale and optimal flexibility profile throughout the vaso-occlusive device 110.

[0042] At least a portion of the vaso-occlusive device 110 may be braided with 16 to 32 DFT wires having a cross-sectional diameter of 0.00075 to 0.0015 inches and a Pt content of 35% to 60% to simultaneously improve radiopacity, shape retention, and break performance characteristics. As the Pt content increases, the effect of increasing Pt content on reducing flexibility decreases. Thus, braids made with DFT wires having a Pt content of 35% to 60% are surprisingly suitable for vaso-occlusive applications requiring flexible devices, such as intima pouch applications. Such braids are particularly suitable when braided with 24 to 32 DFT wires, each having a cross-sectional diameter of 0.00075 to 0.00125 inches. According to various embodiments of the present disclosure, at least a portion of the vaso-occlusive device 110 is braided from 24-32 DFT wires, each having a cross-sectional diameter of 0.00075 inches to 0.00125 inches and a Pt content of 40% to 50%.

[0043] Typically, the austenite finish temperature, or "Af" temperature, of NiTi is around 25°C, which is the temperature at which the martensite phase completes the transformation to the austenite phase. Modifying the DFT NiTi so that the Af temperature is between 30°C and 45°C softens the vascular occlusion device. Setting the Af temperature in this range achieves a desirable balance between device softness and compatibility, improving the device's compatibility for aneurysm treatment. Setting the Af of NiTi is possible by adjusting the composition of Ni in NiTi from the usual 50% to 50.4%-50.8%. Additionally, Af can be adjusted by heat treatment of NiTi. According to various aspects of the present disclosure, the Af temperature is between 38°C and 40°C.

[0044] The DFT can also include an oxide coating of controlled thickness that promotes thrombus formation (e.g., clotting) to increase vascular occlusion within the aneurysm. Preferably, the average oxide coating thickness is between 50 nm and 500 nm. This is in contrast to previous DFT braided implants (e.g., stents) in which the oxide coating is substantially removed (e.g., by electropolishing) to produce a "bright" stent. Previous DFT braided stents limited the oxide coating thickness to 50 nm or less.

[0045] In other embodiments, instead of DFT wires, the braided portion 120 may be braided from elongated members formed by twisting together smaller DFT wires. Each DFT wire may be made of Niti-DFT-40Pt. Braiding elongated members (made from smaller DFT wires) rather than larger DFT wires results in a softer braided portion 120 with approximately the same Pt ​​core content. Thus, the braided portion 120 according to this aspect of the disclosure (i.e., the braiding of twisted elongated members) provides similar radiopacity with a softer braid. Such braids also provide a large surface area that promotes thrombus formation, thereby promoting occlusion of the aneurysm.

[0046] The proximal and distal coil portions 130, 140 are atraumatic coils to minimize tissue damage during insertion and deployment of the vaso-occlusive device 110. The proximal and distal coil portions 130, 140 may be coils wound with one or more types of wire, such as Nitinol wire, DFT, or other alloy wire.

[0047] The vascular occlusion treatment system 100 includes a vascular occlusion device 110 coupled to a delivery assembly 150 by a delivery joint 160. The delivery assembly 150 includes an electrolytically degradable segment 152 at its distal end. The vascular occlusion device 110 includes a braided portion 120 coupled to proximal and distal coiled portions 130, 140 by proximal and distal intra-device joints 170, 180, respectively. The braided portion 120 is braided with alloy wire or other wires (e.g., DFT) as described above and has a substantially constant width (i.e., cross-sectional dimension). The proximal and distal coiled portions 130, 140 are each coils wound with one or more alloy wires (such as DFT wires), as described above. According to various aspects of the present disclosure, the braided portion and the proximal and distal coiled portions 120, 130, 140 can be formed from any elongated member. The proximal coil portion 130 also has a proximal elongation-resistant member 132 that extends distally from the delivery joint 160, through the proximal coil portion 130 to the proximal intra-device joint 170, to reduce stretching of the proximal coil portion 130 as it is pulled back proximally during delivery.

[0048] The proximal stretch-resistant member 132 is made from two braided wires, as shown in Figures 2A and 2B. Figure 2A shows the first step in the manufacture of the braided section 120. During manufacture, a tie-down wire 210 is used to compress the waisted portion of the braided section 120 to form a bundle 220. Figure 2B shows the second step in the manufacture of the braided section 120, in which all but two of the braided wires are trimmed off. The remaining two untrimmed braided wires are used to construct the proximal stretch-resistant member 132.

[0049] The delivery joint 160 includes a link / adapter 162 coupled to both the distal end of the delivery assembly 150 and the open proximal end of the proximal coil portion 130, thereby coupling the delivery assembly 150 and the proximal coil portion 130. The link 162 may be formed from a sheet, as described in U.S. Pat. No. 8,202,292, previously incorporated by reference herein. The link 162 is generally flat and includes a number of fingers 163 formed on its proximal end. The link also includes proximal and distal openings 164, 165. The proximal coil portion 130 of the vaso-occlusive device 110 is a coil having open-pitched proximal windings 134 at its open proximal end. At least a portion of these proximal windings 134 engage the fingers 163 of the link 162, connecting the link 162 to the proximal coil portion 130 of the vaso-occlusive device 110.

[0050] Delivery junction 160 also includes a hook 154 formed at the distal end of the core wire of delivery assembly 150, as described above. Hook 154 passes through a proximal opening 164 in link 162, coupling delivery assembly 150 and link 162 (and the proximal coil portion 130 coupled thereto). The proximal end of proximal stretch-resistant member 132 terminates near link 162 adjacent a distal opening 165 in link 162, mechanically coupling link 162 (and the delivery assembly 150 coupled thereto) to the proximal coil portion 130 of vaso-occlusive device 110. The delivery joint 160 also has an adhesive drop 166 that penetrates through the open pitch proximal winding 134 to the proximal end of the vasoocclusive device 110 to join (1) the hook 154 of the delivery assembly 150, (2) the link 162, (3) the proximal end of the proximal elongation resistant member 132, and (4) the open proximal end of the proximal coil portion 130 of the vasoocclusive device 110, thereby forming the delivery joint 160.

[0051] The proximal intra-device joint 170 includes the distal end of the proximal coil section 130 of the vaso-occlusive device 110 and the necked-down proximal end of the braided section 120 of the vaso-occlusive device 110. The proximal end of the braided section 120 is necked down to fit inside the open distal end of the proximal coil section 130. The proximal intra-device joint 170 also has an adhesive drop 176 that penetrates the coiled open end of the proximal coil section 130 of the vaso-occlusive device 110. The adhesive 176 joins (1) the open distal end of the proximal coil section 130 of the vaso-occlusive device 110, (2) the distal end of the proximal elongation resistant member 132, and (3) the proximal end of the braided section 120 of the vaso-occlusive device 110, thereby forming the proximal intra-device joint 170.

[0052] Distal intra-device joint 180 is a mirror image of proximal intra-device joint 170. Distal intra-device joint 180 includes a narrowed distal end of braided portion 120 of vaso-occlusive device 110 and an open proximal end of distal coiled portion 140 of vaso-occlusive device 110. The distal end of braided portion 120 narrows to fit inside the open proximal end of distal coiled portion 140. Distal intra-device joint 180 also includes an adhesive drop 186 that penetrates the coiled open proximal end of distal coiled portion 140 of vaso-occlusive device 110. Adhesive 186 joins (1) the distal end of braided portion 120 of vasoocclusive device 110, (2) the proximal end of distal elongation resistant member 142, and (3) the open proximal end of distal coil portion 140 of vasoocclusive device 110, thereby forming distal intra-device joint 180.

[0053] The distal coil portion 140 also has an atraumatic distal tip 144, which may be formed with a small amount of adhesive. The distal end of the distal stretch-resistant member 142 extends from the distal intra-device joint 180 through the distal coil portion 140 to the atraumatic distal tip 144, where the distal end of the distal stretch-resistant member 142 terminates.

[0054] FIG. 3 illustrates a vascular occlusion treatment system 300 according to various aspects of the disclosure. The vascular occlusion treatment system 300 is similar to the vascular occlusion treatment system 100 shown in FIG. 1. The primary difference between the vascular occlusion treatment systems 100 and 300 is that the proximal and distal stretch-resistant members 332, 342 of the vascular occlusion treatment system 300 are external stretch-resistant members rather than extensions of the braided wire from the braided portion 320. The external stretch-resistant members can be selected based on physical properties (e.g., diameter, strength, flexibility, etc.) independent of the braided wire of the braided portion 320. Thus, the external stretch-resistant members can be selected to tailor the physical properties of the various portions of the vascular occlusion treatment system 300 (e.g., the delivery junction 360, the proximal coil portion 330, the proximal intra-device junction 370, the distal intra-device junction 380, and the distal coil portion 340) independent of the braided wire of the braided portion 320.

[0055] The vascular occlusion treatment system 300 includes a vascular occlusion device 310 coupled to a delivery assembly 350 by a delivery joint 360. The delivery assembly 350 includes an electrolytically degradable segment 352 at its distal end. The vascular occlusion device 310 includes a braided portion 320 coupled to proximal and distal coiled portions 330, 340 by proximal and distal intra-device joints 370, 380, respectively. The braided portion 320 is braided with DFT (i.e., composite) wire or other alloy wire and has a substantially constant width (i.e., cross-sectional dimension), as described above. The proximal and distal coiled portions 330, 340 are each coils wound with one or more DFT wires or other alloy wires, as described above. According to various aspects of the present disclosure, the braided portion and the proximal and distal coiled portions 320, 330, 340 can be formed from any elongated member. The proximal coil portion 330 also has a proximal stretch resistance member 332 that extends distally from the delivery joint 360, through the proximal coil portion 330 to the proximal intra-device joint 370, to reduce stretching of the proximal coil portion 330 of the vaso-occlusion device 310 as it is pulled back proximally during delivery.

[0056] Proximal stretch-resistant member 332 is an external stretch-resistant member that may be made from DFT (i.e., composite) wire or other elongate member. Proximal stretch-resistant member 332 has first and second ends 333, 335 and a bend 336 between first and second ends 333, 335.

[0057] The delivery joint 360 includes a link / adapter 362 coupled to both the distal end of the delivery assembly 350 and the open proximal end of the proximal coil portion 330, thereby coupling the delivery assembly 350 and the proximal coil portion 330. The link 362 may be formed from a sheet, as described in U.S. Pat. No. 8,202,292, previously incorporated by reference herein. The link 362 is generally flat and includes a plurality of fingers 363 formed on its proximal end. The link also includes proximal and distal openings 364, 365. The proximal coil portion 330 of the vaso-occlusive device 310 is a coil having open-pitched proximal windings 334 at its open proximal end. At least a portion of these proximal windings 334 engage the fingers 363 of the link 362, connecting the link 362 to the proximal coil portion 330 of the vaso-occlusive device 310.

[0058] The delivery junction 360 also includes a hook 354 formed at the distal end of the core wire of the delivery assembly 350, as described above. The hook 354 passes through a proximal opening 364 in the link 362, coupling the delivery assembly 350 and the link 362 (and the proximal coil portion 330 coupled thereto). The first and second ends 333, 335 of the proximal stretch resistant member 332 terminate near the link 362 adjacent the distal opening 365 of the link 362, mechanically coupling the link 362 (and the delivery assembly 350 coupled thereto) to the proximal coil portion 330 of the vaso-occlusive device 310. The delivery joint 360 also has an adhesive drop 366 that penetrates through the open pitch proximal winding 334 to the proximal end of the vasoocclusive device 310 to join (1) the hook 354 of the delivery assembly 350, (2) the link 362, (3) the first and second ends 333, 335 of the proximal elongation resistant member 332, and (4) the open proximal end of the proximal coil portion 330 of the vasoocclusive device 310, thereby forming the delivery joint 360.

[0059] The proximal intra-device joint 370 includes the distal end of the proximal coil section 330 of the vaso-occlusive device 310 and the waisted proximal end of the braided section 320 of the vaso-occlusive device 310. The proximal end of the braided section 320 narrows to form a proximal restrained end 372 that fits inside the open distal end of the proximal coil section 330. The bend 336 of the proximal stretch-resistant member 332 loops around the proximal restrained end 372 and passes through an opening in the proximal end of the braided section 320, thereby mechanically securing the proximal stretch-resistant member 332 to the braided section 320 of the vaso-occlusive device 310. The proximal intra-device joint 370 also has an adhesive drop 376 that penetrates the coiled open distal end of the proximal coil section 330 of the vaso-occlusive device 310. Adhesive 376 bonds (1) the open distal end of proximal coil portion 330 of vasoocclusive device 310, (2) the bend 336 of proximal elongation resistant member 332 around proximal restrained end 372, and (3) the proximal restrained end 372 of braided portion 320, thereby forming proximal intra-device joint 370.

[0060] Similar to the proximal stretch-resistant member 332, the distal stretch-resistant member 342 is an external stretch-resistant member that may be made from DFT (i.e., composite) wire or other elongated member. The distal stretch-resistant member 342 has first and second ends 343, 345 and a bend 346 between the first and second ends 343, 345.

[0061] Distal intra-device joint 380 is a mirror image of proximal intra-device joint 370. Distal intra-device joint 380 includes a narrowed distal end of braided portion 320 of vaso-occlusive device 310 and an open proximal end of distal coiled portion 340 of vaso-occlusive device 310. The distal end of braided portion 320 narrows to form a distal restrained end 382 that fits inside the open proximal end of distal coiled portion 340. A bend 346 of distal stretch-resistant member 342 loops around distal restrained end 382 and passes through an opening in the distal end of braided portion 320, thereby mechanically securing distal stretch-resistant member 342 to braided portion 320 of vaso-occlusive device 310. Distal intra-device joint 380 also includes an adhesive drop 386 that penetrates the coiled open proximal end of distal coiled portion 340 of vaso-occlusive device 310. Adhesive 376 bonds (1) distal restrained end 382 of braided portion 320, (2) bend 346 of distal elongation resistant member 342 around distal restrained end 382, ​​and (3) the open proximal end of distal coiled portion 340 of vaso-occlusive device 310, thereby forming distal intra-device joint 380.

[0062] The distal coil portion 340 also has an atraumatic distal tip 344 that may be formed with a small amount of adhesive. The first and second ends 343, 345 of the distal stretch-resistant member 342 extend from the distal intra-device joint 380 through the distal coil portion 340 to the atraumatic distal tip 344, where the first and second ends 343, 345 of the distal stretch-resistant member 342 terminate.

[0063] FIGURE 4 illustrates a vascular occlusion treatment system 400 according to various aspects of the present disclosure. Vascular occlusion treatment system 400 is similar to vascular occlusion treatment system 300 shown in FIGURE 3, and like elements are similarly numbered. The primary difference between vascular occlusion treatment systems 300, 400 is that second end portion 445 of distal elongation-resistant member 442 of vascular occlusion treatment system 400 terminates in the middle of distal coil portion 440, rather than extending distally to an atraumatic distal tip 444 at the distal end of distal coil portion 440.

[0064] FIG 5 illustrates a vascular occlusive treatment system 500 according to various aspects of the disclosure. Vascular occlusive treatment system 500 is similar to vascular occlusive treatment system 300 shown in FIG 3, and like elements are similarly numbered. Similar to delivery joint 360 of FIG 3, delivery joint 560 includes a hook 554 formed at the distal end of the core wire of delivery assembly 550, as described above. Hook 554 passes through a proximal opening 564 in link 562, coupling delivery assembly 550 and link 562 (and the proximal coil portion 530 coupled thereto). One difference between vascular occlusion treatment systems 300, 500 is that the proximal stretch-resistant member 532 is threaded through a proximal opening 565 in the link 562 such that the bend 536 of the proximal stretch-resistant member 532 is disposed within the proximal opening 565, mechanically coupling the link 562 (and the delivery assembly 550 coupled thereto) to the proximal coil portion 530 of the vasoocclusion device 510. The delivery joint 560 also has an adhesive drop 566 that penetrates through the open pitch proximal winding 534 and into the proximal end of the vasoocclusion device 510 to couple (1) the hook 554 of the delivery assembly 550, (2) the link 562, (3) the bend 536 of the proximal stretch-resistant member 532, and (4) the open proximal end of the proximal coil portion 530 of the vasoocclusion device 510, thereby forming the delivery joint 560.

[0065] Proximal intra-device junction 570 includes the distal end of proximal coil section 530 of vaso-occlusive device 510 and the narrowed proximal end of braided section 520 of vaso-occlusive device 510. The proximal end of braided section 520 narrows to form a proximal restrained end 572 that fits inside the open distal end of proximal coil section 530. Another difference between vaso-occlusive treatment systems 300, 500 is that first and second ends 533, 535 of proximal elongation-resistant member 532 of vaso-occlusive treatment system 500 each terminate adjacent (e.g., locked to) the proximal end of braided section 520 distal to proximal restrained end 572, instead of forming a bend 336 as in vaso-occlusive treatment system 300. Proximal intra-device joint 570 also has an adhesive drop 576 that penetrates the coiled open distal end of proximal coiled portion 530 of vaso-occlusive device 510. Adhesive 576 bonds (1) the open distal end of proximal coiled portion 530 of vaso-occlusive device 510, (2) first and second ends 533, 535 of proximal stretch-resistant member 532 around proximal restrained end 572 of braided portion 520, and (3) proximal restrained end 572, thereby forming proximal intra-device joint 570.

[0066] Similar to the proximal stretch-resistant member 532, the distal stretch-resistant member 542 is an external stretch-resistant member that may be made from DFT (i.e., composite) wire or other elongated member. The distal stretch-resistant member 542 has first and second ends 543, 545 and a bend 546 between the first and second ends 543, 545.

[0067] Distal intra-device joint 580 is a mirror image of proximal intra-device joint 570. Distal intra-device joint 580 includes a narrowed distal end of braided portion 520 of vaso-occlusive device 510 and an open proximal end of distal coiled portion 540 of vaso-occlusive device 510. The distal end of braided portion 520 narrows to form a distal restrained end 582 that fits inside the open proximal end of distal coiled portion 540. First and second ends 543, 545 of distal stretch-resistant member 542 of vaso-occlusive treatment system 500 each terminate adjacent (e.g., locked to) the distal end of braided portion 520 proximal to distal restrained end 582, thereby mechanically securing distal stretch-resistant member 542 to braided portion 520 of vaso-occlusive device 510. Distal intra-device joint 580 also includes an adhesive drop 586 that permeates the coiled open proximal end of distal coiled portion 540 of vaso-occlusive device 510. Adhesive 586 bonds (1) distal restrained end 582 of braided portion 520, (2) first and second ends 543, 545 of distal stretch-resistant member 542 around distal restrained end 582, and (3) the open proximal end of distal coiled portion 540 of vaso-occlusive device 510, thereby forming distal intra-device joint 580.

[0068] Distal coil section 540 also has an atraumatic distal tip 544, which may be formed with a small amount of adhesive. Distal stretch-resistant member 542 extends from distal intra-device joint 580 through distal coil section 540 to atraumatic distal tip 544, with a bend 546 of distal stretch-resistant member 542 disposed within atraumatic distal tip 544 at the distal end of distal coil section 540.

[0069] Figure 6 illustrates a vascular occlusive treatment system 600 according to various aspects of the present disclosure. Vascular occlusive treatment system 600 is similar to vascular occlusive treatment system 500 shown in Figure 5, and like elements are similarly numbered. The primary difference between vascular occlusive treatment systems 500, 600 is that second end 645 of distal elongation resistant member 642 of vascular occlusion treatment system 600 terminates in the middle of distal coil portion 640, rather than extending proximally to braided portion 620.

[0070] 7 illustrates a vascular occlusive treatment system 700 according to various aspects of the disclosure. The vascular occlusive treatment system 700 is similar to the vascular occlusive treatment system 300 illustrated in FIG. 3, and like elements are labeled with like reference numbers. The primary difference between the vascular occlusive treatment systems 300, 700 is that the first and second ends 743, 745 of the distal stretch-resistant member 742 of the vascular occlusive treatment system 700 each terminate adjacent (e.g., locked to) the distal end of the braided portion 720 proximal to the distal restrained end 782. Additionally, the bend 746 of the distal stretch-resistant member 742 is disposed within the atraumatic distal tip 744 at the distal end of the distal coiled portion 740.

[0071] FIG. 8 illustrates a portion of a vascular occlusion treatment system 800 according to various aspects of the disclosure. FIG. 8 focuses on a proximal intra-device joint 870 and various components included therein (e.g., proximal coil portion 830, proximal stretch-resistant member 832, braided portion 820, proximal restrained end 872, and adhesive 876). The proximal intra-device joint 870 is similar to the proximal intra-device joints 570, 670 shown in FIGS. 5 and 6. For example, the first and second ends 833, 835 of the proximal stretch-resistant member 832 of the vascular occlusion treatment system 800 each terminate adjacent (e.g., locked to) a proximal end of the braided portion 820 distal to the proximal restrained end 872. Each of the first and second ends 833 , 835 terminates adjacent (eg, locked to) the proximal end of the braided portion 820 by being folded back after being threaded through the braided portion 820 .

[0072] FIG. 9 illustrates a portion of a vascular occlusion treatment system 900 according to various aspects of the disclosure. FIG. 9 focuses on a proximal intra-device joint 970 and various components included therein (e.g., a proximal coil portion 930, a proximal elongation-resistant member 932, a braided portion 920, a proximal restrained end 972, and an adhesive 976). The proximal intra-device joint 970 is similar to the proximal intra-device joint 870 of FIG. 8. The primary difference between the proximal intra-device joints 870, 970 is that the first and second ends 933, 935, respectively, of the proximal elongation-resistant member 932 of the vascular occlusion treatment system 900 are flattened against the braided portion 920 that forms the proximal restrained end 972, connecting the proximal elongation-resistant member 932 to the braided portion 920.

[0073] 10 is a diagram illustrating a portion of a vascular occlusion treatment system 1000 according to various aspects of the present disclosure. FIG. 10 focuses on a proximal intra-device joint 1070 and the various components contained therein (e.g., proximal coiled portion 1030, proximal elongation resistant member 1032, braided portion 1020, proximal restrained end 1072, and adhesive 1076). The proximal intra-device joint 1070 is similar to the proximal intra-device joint 870 of FIG. 8. The primary difference between the proximal intra-device joints 870, 1070 is that the first and second ends 1033, 1035 of the proximal elongation resistant member 1032 in the vascular occlusion treatment system 1000 are each threaded through the braided portion 1020 and then terminated (e.g., locked) adjacent to the proximal end of the braided portion 1020 by crossing the other ends to couple the proximal elongation resistant member 1032 to the braided portion 1020.

[0074] 11A-11I show schematic diagrams of a method of manufacturing a vascular occlusion treatment system including a vascular occlusion device, such as the vascular occlusion treatment system 300 and vascular occlusion device 310 shown in FIG. 3. FIG. 11A shows step 1110 of cutting the braided portion 320 to a predetermined length after secondary wrapping. FIG. 11B shows step 1120 of placing a heat shrink polymer tube 11 around the proximal end of the braided portion 320 and applying heat to the heat shrink polymer tube 11 to compress the proximal end of the braided portion 320. An example of such a heat shrink polymer tube 11 includes PTFE heat shrink tubing. FIG. 11C shows step 1130 of applying adhesive to the proximal end of the compressed braided portion 320. For example, adhesive can be applied from the proximal end of the compressed braided portion 320 into the heat shrink polymer tube 11 along a desired length "L". FIG 11D illustrates a step 1140 in which a contracted polymer tube (not shown) is removed from around the compressed proximal end of the braided section 320 to form a proximal braided restrained end 372. FIG 11E illustrates a step 1150 in which an external stretch-resistant member 332 is threaded through the proximal end of the braided section 320 distal to the restrained end 372 to form a bend 336 through the proximal end of the braided section 320 distal to the restrained end 372. FIG 11F illustrates a step 1160 in which the first end 333 and the second end 335 of the external stretch-resistant member 332, along with at least a portion of the proximal end of the proximal braided restrained end 372, are threaded proximally into the proximal coiled section 330. FIG 11G illustrates a step 1170 in which adhesive 376 is applied to the distal end of the proximal coil section 330, the proximal braided restraining end 372, the bend 336 of the external stretch resistant member 332, and the proximal end of the braided section 320 to form the proximal intra-device joint 370. FIG 11H illustrates a step 1180 in which the first and second ends 333, 335 of the external stretch resistant member 332 are bonded to a link 362 connected to the delivery wire assembly 350, and the proximal end 334 of the proximal coil section 330 is threaded into the fingers 363 of the link 362. Adhesive 366 is then applied to the distal end of the delivery assembly 350, the link 363, the proximal end of the proximal coil section 330, and the first and second ends 333, 335 of the external stretch resistant member 332 to complete the assembly of the delivery joint 360.FIG. 11I shows step 1190, in which steps 11B through 11G are repeated at the distal end of braided portion 320 and adhesive is applied to the distal end of distal coil portion 340 to secure first and second ends 343, 345 of distal external stretch resistant member 342, completing the assembly of vascular occlusion treatment system 300 and vascular occlusion device 310.

[0075] 12A-12I show a schematic of a method of manufacturing a vascular occlusion treatment system including a vascular occlusion device, such as the vascular occlusion treatment system 500 and vascular occlusion device 510 shown in FIG. 5. FIG. 12A shows step 1210 of cutting the braided portion 520 to a predetermined length after secondary wrapping. FIG. 12B shows step 1220 in which a heat shrink polymer tube 11 is placed around the proximal end of the braided portion 520 and heat is applied to the heat shrink polymer tube 11 to compress the proximal end of the braided portion 520. An example of the heat shrink polymer tube 11 is a PTFE heat shrink tube. FIG. 12C shows step 1230 of applying adhesive to the proximal end of the compressed braided portion 520. For example, adhesive can be applied from the proximal end of the compressed braided portion 520 into the heat shrink polymer tube 11 along a desired length "L". FIG 12D illustrates a step 1240 in which the external stretch-resistant member 532 is threaded through a proximal opening 565 of a link 562 coupled to the delivery wire assembly 550 and the proximal end of the proximal coil section 530 is threaded through the fingers 563 of the link 562. FIG 12E illustrates a step 1250 in which a contracted polymer tube (not shown) is removed from around the compressed proximal end of the braided section 520 to form a proximal braided restrained end 572. FIG 12F illustrates a step 1260 in which the proximal end of the proximal braided restrained end 572 is inserted into the distal end of the proximal coil section 530 with the first and second ends 533, 535 of the external stretch-resistant member 532 held between the exterior / outer surface 572' of the proximal braided restrained end 572 and the interior / inner surface 530' of the distal end of the proximal coil section 530. 12G illustrates a step 1270 in which the first and second ends 533, 535 of the external stretch-resistant member 532 are terminated (e.g., locked) adjacent to the proximal end of the braided portion 520 and trimmed. Each of the first and second ends 533, 535 are terminated (e.g., locked) adjacent to the proximal end of the braided portion 520 by being folded back after threading through the braided portion 520. FIG. 12H illustrates a step 1280 in which adhesive 576 is applied to the distal end of the proximal coil portion 530, the proximal braid restraining end 572, the first and second ends 533, 535 of the external stretch-resistant member 532, and the proximal end of the braided portion 520 to form a proximal intra-device joint 570.FIG. 12I shows step 1290 of repeating steps 12B-12G at the distal end of braided portion 520 to form distal intra-device joint 580 and applying adhesive to the distal end of distal coil portion 540 to secure bend 546 of distal external stretch resistant member 542 to complete assembly of vascular occlusion treatment system 500 and vascular occlusion device 510.

[0076] 13A-13D show proximal braid restrained ends according to various embodiments of the present disclosure. FIG. 13A shows a proximal braid restrained end 1372 formed from a compressed proximal end of a braided portion 1320 and an adhesive 13, such as the proximal braid restrained ends described herein. FIG. 13B shows a proximal braid restrained end 1372 held in place by a heat shrink tube 11 surrounding the compressed proximal end of the braided portion 1320 without the addition of an adhesive / glue. The proximal end of the proximal restrained end 1372 has a surface 1302 that is approximately perpendicular to the longitudinal axis 1301 of the braided portion 1320. FIG. 13C also shows a proximal braid restrained end 1372 having a proximal end surface 1303 that is oblique or angled relative to the longitudinal axis 1301 of the braided portion 1320. Such angled surface 1303 facilitates insertion of proximal restrained end 1372 into the coiled portion. FIG. 13D shows proximal restrained end 1372 formed from the compressed and welded proximal end of braided portion 1320.

[0077] The external stretch-resistant member can have any shape and form. For example, the external stretch-resistant member can be a wire or a tube with various cross-sectional shapes. The external stretch-resistant member can be made from any type of biocompatible material. The external stretch-resistant member can be the same material as the braided wire or a different material. For example, it can be DFT with the composition as described above. The external stretch-resistant member can be made from a metal or alloy, such as platinum (Pt), tungsten (W), gold (Au), platinum group metals, and alloys thereof. For example, the external stretch-resistant member can be made from Pt-8%wtW (Pt-8W) or Au-34%wtPt (AuPt34). Delivery joints made with the external stretch-resistant members described herein can improve the tensile strength of the joint. According to various embodiments of the present disclosure, an external stretch-resistant member made of 0.0011 inch diameter AuPt34 incorporated into a delivery junction as described herein provided a tensile strength of 0.350 lbs ± 0.025 lbs at the delivery junction. Incorporating an external stretch-resistant member as described herein into vascular occlusion devices and vascular occlusion treatment systems can also simplify assembly (especially at intra-device junctions) and allow for control of the tensile strength of the delivery junction independent of braided wire properties or braided wire diameter.

[0078] Various aspects of the present disclosure will now be described with reference to the drawings. Please note that the figures are not drawn to scale, and that elements with similar structures or functions are represented by similar reference numerals throughout the drawings. Please also note that the drawings are for ease of explanation only, and are not intended as an exhaustive description of the present disclosure, or as limiting the scope of the present disclosure, which is defined solely by the appended claims and their equivalents. Furthermore, each illustrated aspect does not necessarily have all the features or advantages of the aspects described herein. Features or advantages described in connection with a particular aspect of the present disclosure are not necessarily limited to that aspect, and may be implemented in other aspects, even if not so shown.

Claims

1. In a vascular occlusion treatment system (500), Delivery assembly (550), A vascular occlusion device (510) is removably connected to the delivery assembly (550) by a delivery assembly joint (560), wherein the vascular occlusion device (500) is A braided portion (520) formed of one or more wires, the braided portion (520) having a restraining end (572), The coil portion (530) is connected to the braided portion (520), The device comprises an internal joint (570) that connects the braided portion (520) and the coil portion (530), and the internal joint (570) having an extension resistance member (532) that extends from the restraining end (572) to the delivery assembly joint (560), The extension resistance member (532) further comprises a bendable portion (536), The delivery assembly joint (560) comprises a link (562) defining an opening (565), and the bent portion (536) is positioned within the opening (565). The system is characterized in that the stretch-resistant member (532) includes first and second ends (533, 535), and each of the first and second ends (533, 535) is locked to the proximal end of the braided portion (520), and is a vascular occlusion treatment system.

2. The vascular occlusion treatment system (500) according to claim 1, further comprising a second stretch-resisting member (542), wherein the second stretch-resisting member (542) has third and fourth ends (543, 545).

3. The restraining end (572) is a proximal restraining end (572), The coil portion (530) is the proximal coil portion (530), The aforementioned in-device junction (570) is a proximal in-device junction (570), The extension resistance member (532) is the proximal extension resistance member (532), The braided portion (520) further comprises a distal restraining end (582), The aforementioned system (500) further, The distal coil portion (540) connected to the distal restraining end (582), A vascular occlusion treatment system (500) according to claim 1 or 2, comprising a distal internal device joint (580) connecting the braided portion (520) to the distal coil portion (540), wherein the distal internal device joint (580) comprises a distal stretch resistance member (542) extending from the distal restraint end (582) to the distal end of the distal coil portion (540).

4. The vascular occlusion treatment system (500) according to claim 3, wherein the distal restraining end (582) includes an adhesive (586) disposed at the distal end of the braided portion (520).

5. The vascular occlusion treatment system (500) according to claim 3, wherein the distal restraining end (582) includes a welded portion located at the distal end of the braided portion (520).

6. The vascular occlusion treatment system (500) according to claim 3, wherein the distal restraint end (582) defines a distal end face perpendicular to the longitudinal axis of the distal restraint end.

7. The vascular occlusion treatment system (500) according to claim 3, wherein the distal restraint end (582) defines a distal end face oblique to the longitudinal axis of the distal restraint end.

8. The vascular occlusion treatment system (500) according to claim 3, wherein the distal stretch-resistant member (542) includes first and second distal stretch-resistant member ends (543, 545).

9. The vascular occlusion treatment system (500) according to claim 8, wherein the first and second distal extension resistance member ends (543, 545) of the distal extension resistance member (542) are terminated within the braided portion (520).

10. The vascular occlusion treatment system (500) according to claim 1, wherein the proximal end of the braided portion (520) is located within the distal end of the coil portion (530).

Images