Vascular occlusion device and delivery assembly

Abstract

A vascular occlusion treatment system includes a delivery assembly and a vascular occlusion device detachably coupled to the delivery assembly through a delivery assembly junction. The vascular occlusion device includes a braided portion formed of one or more threads, the braided portion including a packaged end bundle. The vascular occlusion device also includes a coiled portion coupled to the braided portion. The vascular occlusion device also includes an in-device junction coupling the braided portion to the coiled portion, the in-device junction including a tensile member spanning from the package end bundle to the delivery assembly junction.

Description

[0001] Field

[0002] The field of the present disclosure generally relates to vaso - occlusive devices for creating emboli or vascular occlusions in the blood vessels of a human patient. More specifically, the present disclosure relates to at least partially braided or woven vaso - occlusive devices, junctions within such devices, and junctions for coupling such devices to a treatment system.

[0003] Background

[0004] Vaso - occlusive devices or implants are used for a variety of reasons, including the treatment of endovascular aneurysms. Commonly used vaso - occlusive devices include soft, helically wound coils formed by winding platinum (or platinum alloy) wire strands around a “primary” mandrel. The coil is then wound around a larger “secondary” mandrel and heat - treated to impart the secondary shape. For example, U.S. Patent No. 4,994,069 to Ritchart et al. describes a vaso - occlusive device that assumes a linear, helical primary shape when stretched to be placed through the lumen of a delivery catheter and a folded, convoluted secondary shape when released from the delivery catheter and deposited in the vasculature. All references cited herein are incorporated by reference in their entirety as if set forth in full. Other examples of vaso - occlusive devices include at least partially braided or woven devices, such as those described in U.S. Patent No. 10,321,915 to Murphy et al. and U.S. Patent No. 10,893,870 to Wang et al.

[0005] In order to deliver a vascular occlusive device to a desired location within the vasculature (e.g., within an aneurysm sac), it is well known that a small-profile delivery catheter or "micro-catheter" is first positioned at that location using a steerable guide wire. Typically, the distal end of the micro-catheter is provided by the attending physician or manufacturer with a selected preformed bend (e.g., 45°, 90°, "J-shaped", "S-shaped") or other curved shape, depending on the patient's specific anatomy, such that once the guide wire is withdrawn, the distal end of the micro-catheter will remain in the desired position to release one or more vascular occlusive devices into the aneurysm. Then, a delivery or "pusher" assembly or "wire" (the distal end of which is coupled to the vascular occlusive device) is passed through the micro-catheter until the vascular occlusive device pushed by the distal end of the delivery assembly extends out of the distal end opening of the micro-catheter and into the aneurysm. Once within the aneurysm, a portion of the vascular occlusive device deforms or bends to allow for more effective and complete filling. The vascular occlusive device coupled to the distal end of the delivery assembly is released or "detached" from the distal end of the delivery assembly after extending into the aneurysm. Then, the delivery assembly is withdrawn through the catheter. One or more additional vascular occlusive devices may be pushed through the catheter and released at the same location, depending on the particular needs of the patient.

[0006] One well-known way to release a vascular occlusive device from the end of a delivery assembly is by using an electrolysable junction, which is a small exposed section or separation zone located along the distal end portion of the delivery assembly. The separation zone is typically made of stainless steel and is located just proximal to the vascular occlusive device. When the delivery assembly is charged in the presence of an ionic solution such as blood or other body fluids, the electrolysable junction is prone to electrolysis and decomposition. Thus, once the separation zone exits the distal end of the catheter and is exposed in the patient's vessel blood pool, the current applied to the conductive pusher through the electrical contacts completes an electrolysis separation circuit with a return electrode, and the separation zone decomposes due to electrolysis. Other separation mechanisms for releasing a vascular occlusive device from a delivery assembly include mechanical, thermal, and hydraulic mechanisms.

[0007] In order to better frame and fill an aneurysm, a complex three-dimensional secondary shape may be imparted to the vascular occlusive device, and the stiffness / flexibility of the vascular occlusive device may be modified. However, the vascular occlusive device continues to have performance limitations, including fracture performance, shape retention, and flexibility.

[0008] The proximal end of some vascular occlusion devices is coupled to the distal end of a delivery assembly by a component referred to as the “primary junction” or “delivery assembly junction” or simply “delivery junction” of a vascular occlusion treatment system. Another primary junction design is disclosed in U.S. Patent No. 8,202,292 to Kellett, which is incorporated herein by reference in its entirety as if fully set forth herein. The primary junction includes a flat adapter that couples a delivery wire to the vascular occlusion device. The delivery wire has a hook or “J”-shaped distal end that is configured to be received in a hole in the proximal end of the adapter to couple the delivery wire to the adapter. The vascular occlusion device has a winding that defines an opening that is configured to receive fingers in the distal end of the adapter to couple the vascular occlusion device to the adapter. Thus, the adapter facilitates coupling of the delivery wire to the vascular occlusion device. Other primary junction designs are disclosed in U.S. Patent No. 9,480,479 to Chen et al., which is incorporated herein by reference in its entirety as if fully set forth herein.

[0009] Some vascular occlusion devices include one or more braided portions and one or more coiled portions. Generally, the coiled portions are attached to the distal and proximal ends of the braided portion to facilitate manipulation of the vascular occlusion device and to allow the coiled portions to assume their secondary shape and provide a non-invasive end to the vascular occlusion device. Referring Figure 1 , a proximal end of an example of one such vascular occlusion device 10 is shown. The vascular occlusion device 10 includes a braided portion 12 having a proximal end 14. A coil 16 having a proximal end 18 and a distal end 20 is attached to the braided portion 12. More specifically, the distal end 20 of the coil 16 is attached to the proximal end 14 of the braided portion 12. The braided portion 12 is coupled to the coil 16 by an intra-device junction 24.

[0010] Some vascular occlusion devices also include a tensile member that is configured to hold the coiled portion compacted or compressed to control the structural properties (e.g., flexibility and stiffness) of the coiled portion, which can change when the coiled portion is stretched. The tensile member can form part of both the intra-device junction and the delivery junction. In some vascular occlusion devices (e.g., Figure 1 and Figure 2 the device 12 shown), the tensile member is formed by one or more braided wires. Figure 2 The braided portion 12 of the vascular occlusion device 10 is shown, and two tensile members 18a, 18b formed by the braided wires of the braided portion 12 are shown. As Figure 2As shown, the proximal end 14 of the braided portion 12 to be coupled to the coil 16 is trimmed to leave only the anti-tensile wires 18a, 18b. The anti-tensile wires 18a, 18b pass through and through the coil 16 from the distal end 20 of the coil 16, and are fixed to the proximal end 18 of the coil 16 at the proximal ends 22a, 22b. The in-device junction 24 can also couple the distal end 20 of the coil to the distal ends 26a, 26b of the anti-tensile members 18a, 18b.

[0011] In a vascular occlusion device (such as Figure 1 and Figure 2 the vascular occlusion device 10 shown), the diameters of the anti-tensile members 18a, 18b depend on the diameter of the braided wires forming the braided portion 12. Thus, the structural characteristics of the in-device junction and the delivery junction unnecessarily depend on the characteristics of the braided wires. Accordingly, a vascular occlusion device having a braided portion with thin braided wires (e.g., 0.0008 inches or 0.0009 inches in diameter) will have in-device junctions and delivery junctions with lower tensile strength than other structures of the elements of the vascular occlusion device.

[0012] In addition, the assembly of the components of the vascular occlusion device (including the braided portion, the coiled portion, and the anti-tensile members) is complex, requiring many assembly steps and a great deal of handling of the relatively fragile braided portion. For example, when the braided wires are trimmed at the ends to leave only the braided wires forming the anti-tensile members, and when passing the anti-tensile members through the coil and fixing the anti-tensile members to the coil, the braided portion must be handled. This results in a high percentage of scrap and low yields, as well as high manufacturing costs.

[0013] Accordingly, there is still a need for a vascular occlusion treatment system having a vascular occlusion device in which the strength of the anti-tensile members is independent of the structural characteristics of the braided portion, and a manufacturing method that overcomes the disadvantages of prior manufacturing processes.

[0014] Overview

[0015] Disclosed herein are a vascular occlusion device having a reticulated portion (i.e., a braided or woven portion) and an innovative anti-tensile member independent of the reticulated portion, and a vascular occlusion treatment system utilizing such a vascular occlusion device. According to one disclosed embodiment, the vascular occlusion device includes a reticulated portion formed of one or more wires configured in a reticulated structure. As used herein, the terms "reticulum" and "reticulated structure" mean a structure formed by an interwoven network of wires and / or wire filaments, including braided structures, woven structures, and the like.

[0016] In some aspects, when constrained within a delivery catheter, the mesh portion can have a primary shape (also referred to as a "delivery configuration" or a "constrained configuration"), and when released from the delivery catheter to occlude a vascular defect (e.g., an aneurysm), the mesh portion can have a secondary shape that is different from the primary shape (also referred to as a "deployed configuration" or a "relaxed configuration"). For example, the primary shape can be a substantially linear shape, and the secondary shape can be a folded three-dimensional shape. The mesh portion has a proximal end and a distal end. As used herein, the terms "proximal" and "distal" are relative to the position of the respective element where the device is oriented for insertion into the vasculature, where "proximal" refers to toward the insertion site into the vasculature (e.g., the femoral artery in a patient's leg), and "distal" refers to away from the insertion site.

[0017] The vascular occlusion device also includes a proximal coil having a proximal end and a distal end, wherein the distal end is coupled to the proximal end of the mesh portion. The proximal coil is configured to facilitate advancing and maneuvering the vascular occlusion device to the insertion site (e.g., via a delivery catheter) to allow the braided portion to assume its secondary shape to fill the vascular defect and provide a relatively soft and atraumatic tip.

[0018] A first anti-tensile member is coupled to the proximal coil to limit stretching of the proximal coil (i.e., limit the ability of the coil to extend, and / or maintain the coil in a compacted or compressed state), which preserves the structural properties (e.g., flexibility and stiffness) of the coil. When stretched, the structural properties of the proximal coil can change. The first anti-tensile member is independent of the mesh portion. As used herein, the term "independent" means that the element is not made of or does not include another element. In this case, the anti-tensile member is not made of or does not include the mesh portion. For example, the anti-tensile member is not formed by any of the wires forming the mesh portion. The anti-tensile member can be a wire, rod, or other structure having a tensile strength that prevents the first anti-tensile member from being overstretched (e.g., opening the pitch of the coil windings or permanently straining the proximal coil). The first anti-tensile member extends through the proximal coil and has a proximal end coupled to the proximal end of the proximal coil and a distal end coupled to the distal end of the proximal coil.

[0019] The vascular occlusion device also has a proximal junction that physically attaches the proximal end of the mesh portion, the distal end of the first anti-tensile member, and the distal end of the proximal coil together. In other words, the proximal junction attaches the proximal end of the mesh portion to both the distal end of the first anti-tensile member and the distal end of the proximal coil, and attaches the proximal end of the anti-tensile member to the proximal end of the proximal coil.

[0020] In another aspect of the vascular occlusion device, the proximal junction may consist of an adhesive. When assembling the vascular occlusion device, the proximal end of the mesh portion, the distal end of the first anti-tensile member, and the distal end of the proximal coil are positioned together, and the adhesive is applied to the junction to attach them all together. In yet another aspect, the proximal junction may consist of a single, integral bead of adhesive having a tapered portion. The tapered portion of the adhesive bead tapers outward as it extends distally.

[0021] Alternatively or additionally, the proximal junction may include hooking, threading, braiding, gluing, welding, soldering, sintering, and / or crimping together the proximal end of the mesh portion, the distal end of the first anti-tensile member, and the distal end of the proximal coil.

[0022] In another aspect, the first anti-tensile member may include a single first line having a first end, a second end, and a bend therebetween. The bend forms the proximal end of the first anti-tensile member, and the first end and the second end of the first line form the distal end of the first anti-tensile member. Thus, the bend is coupled to the proximal end of the proximal coil, and the first end and the second end of the first line are coupled to the distal end of the proximal coil.

[0023] In yet another aspect, a coupling link may be provided on the proximal end of the proximal coil for coupling the vascular occlusion coil to a delivery assembly such as a delivery wire. The coupling link is also configured to be coupled to the proximal end of the first anti-tensile member. For example, in one embodiment, the coupling link may have a first hole positioned within the proximal coil. The first line forming the first anti-tensile member passes through the first hole such that the bend in the first line is disposed within the first hole, thereby coupling the proximal end of the anti-tensile member to the proximal end of the proximal coil.

[0024] In yet another aspect, the first end and the second end of the first line each have a ball formed thereon to enhance the bond between the first end and the second end of the first line and the proximal junction. The balls may be formed by micro-welding the first end and the second end of the first line or other suitable methods.

[0025] In yet another aspect of the vascular occluding device, the first end and the second end of the first line may each have a radially outward bend to enhance the bond between the first end and the second end of the first line and the proximal junction. It can be seen that if the end portions of the first line extend parallel or nearly parallel to the longitudinal axis of the proximal coil, the axial force can more easily pull the end portions out of the proximal junction (e.g., the adhesive bead) compared to the case where the end portions are radially outwardly bent. In another aspect, the first end and the second end have a bend of at least 20 degrees radially outward from the longitudinal axis of the proximal coil. Alternatively, the first end and the second end of the first line can be bent radially inward to obtain a similar benefit of enhancing the bond between the first end and the second end of the first line and the proximal junction. In yet another aspect, the first end and / or the second end of the first line can each have a hook formed thereon to enhance the bond between the first end and the second end of the first line and the proximal junction in a manner substantially the same as the radially bent portion. In another aspect, the first end and the second end have a bend of at least 75 degrees radially inward from the longitudinal axis of the proximal coil.

[0026] In yet another aspect, the proximal end of the mesh portion can be tapered (necked) downward and inserted into the distal end of the proximal coil. For example, the mesh portion generally has a diameter larger than that of the proximal coil, such that the diameter of the mesh portion must be reduced to fit into the proximal coil. This feature allows the proximal end of the mesh portion and the distal end of the proximal coil to overlap, which can make it easier to effectively attach them together using the proximal junction.

[0027] In yet another feature of the vascular occluding device, the proximal coil can have one or more expanded windings between adjacent windings such that the proximal junction extends into the expanded windings of the proximal coil. For example, an adhesive or other connecting means can extend through the expanded windings to form part of the junction between the proximal end of the mesh portion, the distal end of the first anti-tensile member, and the distal end of the proximal coil.

[0028] In other embodiments disclosed herein, the vascular occlusion device may further include a distal coil coupled to the distal end of the mesh portion. The distal coil provides the same benefits and functions as the proximal coil, except at the distal end of the vascular occlusion device. The distal coil has a proximal end and a distal end, wherein the proximal end of the distal coil is coupled to the distal end of the mesh portion. Also independent of the mesh portion, the second tensile member is the same or similar to the first tensile member and provides the same functions and benefits relative to the distal coil as the first tensile member provides for the proximal coil. The second tensile member extends through the distal coil and has a proximal end coupled to the proximal end of the distal coil and a distal end coupled to the distal end of the distal coil. The distal junction physically attaches the distal end of the mesh portion, the proximal end of the second tensile member, and the proximal end of the distal coil together. As described herein, the distal junction may have all aspects and features of the proximal junction, such as being composed of an adhesive, a single integral adhesive bead having a tapered portion, including connecting the distal end of the mesh portion, the proximal end of the tensile member, and the proximal end of the distal coil together by one or more of hooking, threading, braiding, gluing, welding, soldering, sintering, and crimping.

[0029] In yet another aspect, the vascular occlusion device may further have an atraumatic tip disposed at the distal end of the distal coil, to which the distal end of the tensile member is coupled. For example, the atraumatic tip may include an adhesive ball or other shaped bead of adhesive, and the distal end of the second tensile member is encapsulated in the adhesive, thereby coupling the distal end of the tensile member to the distal end of the distal coil.

[0030] The second tensile member may include a second wire, the same or similar to the first tensile member, having a first end and a second end and a bend therebetween. The bend forms the distal end of the second tensile member, and the first and second ends of the second resistant member form the proximal end of the second tensile member.

[0031] In a further aspect, the first and second ends of the second wire may have additional aspects and features of the first and second ends of the first wire, such as formed balls, radial bends, hooks, etc. Additionally, the distal end of the mesh portion may taper downward and be inserted into the proximal end of the distal coil, the same or similar to the proximal end of the mesh portion.

[0032] In another aspect, the distal coil may further have one or more unwind windings between adjacent windings, and the distal junction extends through the adjacent windings into the unwind windings of the distal coil, the same or similar to the same feature of the proximal coil.

[0033] Another disclosed embodiment relates to a vascular occlusion treatment system utilizing any of the vascular occlusion devices disclosed herein. In one disclosed embodiment, the vascular occlusion treatment system includes a delivery assembly detachably coupled to the vascular occlusion device. The delivery assembly includes a delivery catheter and a delivery or pusher device (e.g., a delivery wire). The delivery device has a linkage at its distal end that is coupled to the proximal end of the vascular occlusion device, such as a coupling link disposed at the proximal end of the proximal coil. The linkage also includes a separation joint for separating the vascular occlusion device from the delivery device. For example, the separation joint can be an electrolytically separable (i.e., degradable) joint that decomposes by electrolysis when charged in the presence of an ionic solution (e.g., blood or other body fluid).

[0034] A method of using the vascular occlusion treatment system includes advancing the delivery catheter through the patient's vasculature to a target implantation site (e.g., the location of an aneurysm to be filled by the vascular occlusion device). Then, the delivery device with the vascular occlusion device attached to its distal end is advanced through the delivery catheter to the target implantation site with the vascular occlusion device in a constrained delivery configuration. The delivery device is used to push the vascular occlusion device out through the distal end opening of the delivery catheter. The vascular occlusion device is inserted into a vascular defect (e.g., an aneurysm) at the target implantation site. When the vascular occlusion device exits the delivery catheter and is inserted into the vascular defect, the vascular occlusion device deforms and bends into its deployed configuration to fill the vascular defect. After the entire vascular occlusion device is delivered, the separation joint is used to separate the delivery device from the vascular occlusion device. Then the delivery device can be withdrawn through the delivery catheter. If needed to fill the vascular defect, one or more additional vascular occlusion devices can be delivered by the delivery device through the inserted delivery catheter and inserted and released into the vascular defect in the same manner. Then, the delivery device and the delivery catheter can be withdrawn from the patient.

[0035] Yet another disclosed embodiment relates to a method of manufacturing the vascular occlusion device disclosed herein. In one embodiment, the method of manufacturing the vascular occlusion device includes providing a mesh portion. When constrained within the delivery catheter, the mesh portion can have a primary shape, and when released from the delivery catheter to occlude a vascular defect such as an aneurysm, the mesh portion can have a secondary shape different from the primary shape. A first anti-tensile member (independent of the mesh portion) and a proximal coil are also provided. These components of the vascular occlusion device can be provided as an assembly kit. Next, the proximal end of the mesh portion is compressed to taper the proximal end downward to have a smaller diameter. This step can also be performed before providing the mesh portion such that the mesh portion with a downward-tapered proximal end is part of the assembly kit.

[0036] Insert the tapered proximal end of the mesh portion into the distal end of the proximal coil and insert the first anti-tensile member through the proximal coil to position the proximal end of the first anti-tensile member adjacent to the proximal end of the proximal coil and the distal end of the first anti-tensile member adjacent to the distal end of the proximal coil. Then form a proximal junction to physically attach together the proximal end of the mesh portion, the distal end of the first anti-tensile member (e.g., the first and second ends of the first wire), and the distal end of the proximal coil. In one aspect, the proximal junction may include an adhesive that is applied to encapsulate the proximal end of the mesh portion, the distal end of the first anti-tensile member, and the distal end of the proximal coil. In another aspect, the proximal coil may have one or more unwind windings between adjacent windings and the proximal junction (e.g., the adhesive) extends into the unwind windings of the proximal coil.

[0037] In other embodiments, the proximal junction may be formed by connecting the proximal end of the mesh portion, the distal end of the first anti-tensile member, and the distal end of the proximal coil together by any one or more of hooking, threading, braiding, gluing, welding, soldering, sintering, and crimping.

[0038] The proximal end of the first anti-tensile member is coupled to the proximal end of the proximal coil. The proximal end of the first anti-tensile member may be coupled to the proximal end of the proximal coil prior to forming the proximal junction such that the proximal coil to which the proximal end of the first anti-tensile member is coupled is part of an assembly kit. For example, in an embodiment where the first anti-tensile wire includes a first wire having a first end and a second end and a bend between the first end and the second end, where the bend forms the proximal end of the first anti-tensile member, the proximal end of the first anti-tensile member will typically be coupled to the proximal end of the proximal coil prior to forming the proximal junction. For example, in one aspect, the vascular occlusion device may include a coupling link disposed on the proximal end of the proximal coil. The coupling link is configured to be coupled to the distal end of a delivery device for coupling the vascular occlusion device to a delivery assembly. As described herein, the coupling link may have a first hole positioned within the proximal coil. In such a case, the manufacturing method may include passing the first anti-tensile member (e.g., the first wire) through the first hole such that the bend in the first wire is disposed within the first hole, thereby coupling the proximal end of the anti-tensile member to the proximal end of the proximal coil. The steps in this process may be performed before or after forming the proximal junction.

[0039] In another aspect of the method of manufacturing a vascular occluding device, as part of the process of attaching the proximal end of the mesh portion, the distal end of the first anti-tensile member, and the distal end of the proximal coil together, the method may further include pre-bonding the distal end of the first anti-tensile member to the distal end of the proximal coil. In one embodiment, an adhesive may be used to bond the distal end of the first anti-tensile member to the distal end of the proximal coil, such as gluing the first and second ends of a first wire to the distal end of the proximal coil. This pre-bonding process can make the step of forming the proximal joint easier and faster, which can reduce the handling and scrap rate of the mesh portion.

[0040] The manufacturing method may further include forming balls, bends, or hooks on the first and second ends of the first wire. This step in the process can be performed at any suitable step in the method, including but not limited to before starting to assemble the components, such that the kit includes the first wire having balls, bends, or hooks. Alternatively, the balls, bends, or hooks located on the first and second ends of the first wire can be formed after the first wire is inserted through the proximal coil but before forming the proximal joint.

[0041] In another aspect, the manufacturing method may further include attaching a distal coil and a second anti-tensile member to the vascular occluding device. The distal coil and the second anti-tensile member can be attached to the device in any of the same processes used to attach the proximal coil and the first anti-tensile member. For example, the distal end of the mesh portion is compressed to taper downward towards the proximal end to have a smaller diameter. This step can also be performed before providing the mesh portion, such that the mesh portion having a tapered distal end (and a tapered proximal end) is part of the assembly kit.

[0042] The tapered distal end of the mesh portion is inserted into the proximal end of the distal coil, and the second anti-tensile member is inserted through the distal coil to position the proximal end of the second anti-tensile member adjacent to the proximal end of the distal coil. Then a distal joint is formed to physically attach the distal end of the mesh portion, the proximal end of the second anti-tensile member (e.g., the first and second ends of a second wire), and the proximal end of the distal coil together. In one aspect, the distal joint may include an adhesive that is applied to encapsulate the distal end of the mesh portion, the proximal end of the anti-tensile member, and the proximal end of the distal coil. In another aspect, the distal coil may have one or more deployed windings between adjacent windings, and the distal joint (e.g., the adhesive) extends into the deployed windings of the distal coil.

[0043] In other embodiments, the distal junction can be formed by joining together the distal end of the mesh portion, the proximal end of the second tensile member, and the proximal end of the distal coil by any one or more of hooking, threading, braiding, gluing, welding, soldering, sintering, and crimping. The method can also include pre-bonding the proximal end of the second tensile member to the proximal end of the distal coil, similar to the step of pre-bonding the distal end of the first tensile member to the distal end of the proximal coil. This pre-bonding process makes the step of forming the distal junction easier and faster, which also reduces the handling and scrap rate of the mesh portion.

[0044] The distal end of the second tensile member is coupled to the distal end of the distal coil. The distal end of the second tensile member can be coupled to the distal end of the distal coil prior to forming the distal junction such that the distal coil to which the distal end of the second tensile member is coupled is part of an assembly kit. In one aspect, the distal end of the second tensile member can be coupled to the distal end of the second tensile member using an adhesive (such as an adhesive ball or adhesive bead) that encapsulates the distal end of the second tensile member and the distal end of the distal coil, thereby coupling the distal end of the second resistant member to the distal end of the distal coil. The adhesive can be shaped and positioned to form a non-traumatic tip on the distal end of the distal coil, which also constitutes the farthest distal end of the vascular occluding device.

[0045] In the case where the second tensile member includes a second wire having a first end, a second end, and a bend between the first end and the second end, the bend forms the distal end of the second tensile member, and the distal end of the second tensile member is coupled to the distal end of the distal coil, for example, by using an adhesive ball. The first end and the second end of the second resistant member form the proximal end of the second tensile member, which is physically attached to the distal end of the mesh portion and the proximal end of the distal coil through the distal junction. Brief Description of the Drawings

[0047] The drawings illustrate the design and utility of various aspects of the present disclosure, where like elements are denoted by common reference numerals. These drawings are not necessarily to scale. To better understand how the above and other advantages and objects are obtained, a more specific description of the present disclosure illustrated in the drawings will be given. These drawings depict only exemplary aspects of the present disclosure for purposes of illustration and facilitating the following detailed description and should not be considered as limiting its scope.

[0048] Figure 1 is a side view of a proximal portion of a prior art vascular occluding device having a braided portion and a tensile member coupled to a coil.

[0049] Figure 2 isFigure 1 Side view of the braided portion of the vascular occluding device, showing the tensile resistant member formed by the wires of the braided portion.

[0050] Figure 3 Is a perspective view of a vascular occluding device assembly according to one embodiment disclosed herein.

[0051] Figure 4 Is during assembly according to one embodiment disclosed herein Figure 3 Enlarged side cross-sectional view of the proximal portion of the vascular occluding device.

[0052] Figure 5 Is after assembly according to one embodiment disclosed herein Figure 4 Enlarged side cross-sectional view of the proximal portion of the vascular occluding device.

[0053] Figure 6 Is an enlarged side cross-sectional view of the proximal portion of a vascular occluding device according to another embodiment disclosed herein.

[0054] Figure 7 Is an enlarged side cross-sectional view of the proximal portion of a vascular occluding device according to another embodiment disclosed herein.

[0055] Figure 8 Is an enlarged side cross-sectional view of the proximal portion of a vascular occluding device according to another embodiment disclosed herein.

[0056] Figure 9 Is an enlarged side cross-sectional view of the proximal portion of a vascular occluding device according to another embodiment disclosed herein.

[0057] Figure 10 Is an enlarged side cross-sectional view of the proximal portion of a vascular occluding device according to another embodiment disclosed herein.

[0058] Figure 11 Is an enlarged side cross-sectional view of the proximal portion of a vascular occluding device according to another embodiment disclosed herein.

[0059] Figure 12 Is a partially cut-away perspective view of the distal portion of the proximal coil subassembly of a vascular occluding device according to another embodiment disclosed herein, showing an alternative proximal junction.

[0060] Figure 13 Is a partially cut-away perspective view of the distal portion of the proximal coil subassembly of a vascular occluding device according to another embodiment disclosed herein, showing an alternative proximal junction.

[0061] Detailed description of the present disclosure

[0062] This specification describes exemplary embodiments, aspects, and applications of the present disclosure. However, the present disclosure is not limited to these exemplary embodiments, aspects, and applications or the manner in which the exemplary embodiments, aspects, and applications are operated or described herein. Additionally, the drawings may show simplified or partial views, and the dimensions of the elements in the drawings may be exaggerated or otherwise out of proportion. Further, throughout the drawings, elements of similar structure or function are denoted by the same reference numerals. Additionally, the aspects shown need not have all of the features or advantages shown. Features or advantages described in connection with a particular aspect are not necessarily limited to that aspect and may be practiced in any other aspect, even if not so shown.

[0063] For the terms defined below, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0064] In the case of a reference to a list of elements (e.g., elements a, b, c), such reference is intended to include any one of the listed elements by itself, any combination of less than all of the listed elements, and / or a combination of all of the listed elements.

[0065] As used herein, "substantially" means sufficient for the intended purpose. Thus, the term "substantially" allows for minor, insignificant variations from an absolute or perfect state, dimension, measurement, result, etc., as would be expected by a person of ordinary skill in the art, but which do not appreciably affect overall performance. The term "a" means more than one.

[0066] Whether or not explicitly stated, all numerical values herein are assumed to be modified by the term "about". The term "about" generally refers to a range of numerical values that a person of ordinary skill in the art would consider equivalent to the stated value (i.e., having the same function or result). In many instances, the term "about" may include numerical values that are rounded to the nearest significant digit. A numerical range stated 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).

[0067] As used in this specification and the appended claims, unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" include plural referents. As used in this specification and the appended claims, the term "or" generally is used in its sense including "and / or", unless the context clearly dictates otherwise.

[0068] Reference Figure 3 , shows a component 102 for a vascular occlusion device 100 according to an embodiment of the disclosure. The component 102 includes a mesh portion 104, a proximal coil subassembly 106, and a distal coil subassembly 108. The mesh portion 104 has a proximal end 110 and a distal end 112.

[0069] As Figure 3 depicted, the mesh portion 104 is shown in its secondary shape, which is the deployed, relaxed (unconstrained) configuration of the mesh portion 104. The mesh portion 104 may include a mesh formed by one or more wires interwoven into a braided structure or a woven structure, etc. The wires forming the mesh portion 104 may be made of any suitable biocompatible material, including but not limited to platinum, nitinol, alloys of any of the foregoing materials, etc. For example, the mesh portion 104 may be braided from 24 wires, each having a cross-sectional diameter of 0.001 inches. The braid may be a flat braid or a round braid. According to other aspects of the present disclosure, the mesh portion 104 may be braided from 16 to 32 wires, each having a cross-sectional diameter of 0.00075 inches to 0.0015 inches. According to other aspects of the present disclosure, the mesh portion 104 may be braided from more than 32 wires, each having a cross-sectional diameter of 0.00075 inches to 0.00125 inches.

[0070] In another aspect, the wires forming the mesh portion 104 may be drawn filled tubing (DFT) available from Fort Wayne Metals of Fort Wayne, Indiana. The DFT wire includes a substantially pure platinum ("Pt") core at least partially surrounded by a substantially pure nitinol ("NiTi") outer layer. As used in this application, "substantially pure" Pt includes but is not limited to 99.95% commercial purity produced according to ASTM B561. The Pt core is approximately 40%-50% by volume of the DFT wire ("Pt core content"). According to other aspects of the present disclosure, the DFT wire is formed by inserting a core component (solid elongated member) into an outer component (tubular elongated member) to form a composite elongated member (e.g., composite wire). The composite wire is repeatedly mechanically drawn and annealed by heating to increase its axial length and decrease its cross-sectional diameter. For example, the drawing and annealing process may continuously reduce the diameter of the composite elongated member from 1 inch to 0.5 inches, from 0.5 inches to 0.25 inches, from 0.25 inches to 0.025 inches, and from 0.025 inches to 0.0025 inches.

[0071] Although the materials (e.g., Pt and NiTi) of the individual parts (e.g., core and outer layer) forming the DFT wire may have different stiffnesses (i.e., bending stiffnesses), the relative stiffness (i.e., bending stiffness) of the resulting parts of the DFT may not necessarily reflect the stiffness of the materials from which they are made. For example, even though the bending modulus (i.e., stiffness) of Pt is greater than the bending modulus of NiTi, the combination of the bending modulus of Pt and the diameter of the Pt wire results in the platinum wire being softer (i.e., less stiff) than the corresponding NiTi outer layer.

[0072] The mesh portion 104 of the vascular occlusion device 100 can be interwoven (e.g., braided or woven) on a mandrel, which can be flat or round, depending on the desired final shape. Figure 3 The mesh portion 104 depicted has a flat ribbon cross-section, i.e., a flat rectangular cross-section. According to some aspects, the mesh portion 104 can be formed from 25 wires, each having a cross-sectional diameter of 0.001 inches (0.0254 mm) or less than 0.001 inches (0.0254 mm). According to other aspects, the braided portion can be formed from 16 to 32 wires, each having a cross-sectional diameter of 0.0075 inches (0.191 mm) to 0.0015 inches (0.0381 mm).

[0073] After interweaving, the mesh portion 104 can be heat-set (e.g., at 500 °C to 550 °C for 1 minute to 10 minutes). The heat-set mesh portion 104 forms the linear “primary shape” of the mesh portion 104. The linear primary shape is a delivery configuration or a constrained configuration, such as when the mesh portion 104 is constrained within the delivery catheter 186 (see Figure 5 ). Then, the heat-set mesh portion 104 can be wound and / or coiled around a second mandrel (e.g., a three-dimensional mandrel), and heat-set a second time to impart a three-dimensional “secondary shape”, as Figure 3 depicted. The NiTi outer layer improves the retention of the secondary shape.

[0074] Although vascular implants (i.e., stents) have been formed from NiTi-DFT-Pt wires with a Pt core content of up to about 30%, NiTi-DFT-Pt wires with a Pt core content of about 40% to 50% have not been used to form stents. This is because stents typically require wires with a high yield strength to ultimate strength ratio (i.e., >80% of the ultimate tensile strength (“UTS”)) to maintain vascular patency. On the other hand, the vascular occlusion device 100 includes DFT wires with a lower yield strength to UTS ratio, which improves device characteristics, including lower bending moments and improved fracture properties. According to various aspects of the present disclosure, the DFT wires forming (part of) the vascular occlusion device 100 have a yield strength to UTS ratio of <50% UTS, <60% UTS, <70% UTS, and <80% UTS. Yield strength is the maximum force that can be applied to a material before it begins to plastically deform. UTS is the minimum force that must be applied to a material before it fails. Braiding at least a portion of the vascular occlusion device with wires having a yield strength to UTS ratio less than 80% UTS is crucial for simultaneously achieving the characteristics of improved radiopacity, shape retention, and fracture properties.

[0075] In other aspects of the present disclosure, a vascular implant including a vascular occlusion device is formed from NiTi-DFT-Pt wire having a Pt core content of from about 40% to 50%. Forming the mesh portion 104 from DFT wire with a Pt core content of from about 40% to 50% (“NiTi-DFT-40 / 50Pt”) provides a mesh portion 104 having the following characteristics: (1) radiopacity throughout its entire length, (2) improved shape retention, and (3) improved fracture properties along the entire length of the braid. The Pt core provides radiopacity for most of the vascular occlusion device 110, thereby providing radiopacity for the various vascular occlusion devices implanted in a patient. The superelastic properties of the NiTi outer layer help to improve shape retention. The softness of Pt helps to improve the fracture properties, i.e., the ability of the vascular occlusion device 100 to bend and fold to conform to the shape of the body cavity. These characteristics of the mesh portion 104 result in the vascular occlusion device 100 being more suitable for intracapsular embolization of vascular defects (such as aneurysms), i.e., a substantially uniform visualization gray scale and an optimal softness profile throughout the entire vascular occlusion device 110.

[0076] At least a portion of the mesh portion 104 is braided with from 16 to 32 DFT wires, each wire having a cross-sectional diameter of from 0.00075 inches to 0.0015 inches and having a Pt content of from 35% to 60%, while providing the characteristics of improved radiopacity, shape retention, and fracture properties. As the Pt content increases, the effect of increasing the Pt content on reducing flexibility decreases. Thus, a braid woven from DFT wire having a Pt content of from 35% to 60% is surprisingly suitable for vascular occlusion applications, such as intracapsular applications that require a flexible device. Such a braid is particularly suitable when it is woven from 24 to 32 DFT wires (each wire having a cross-sectional diameter of from 0.00075 inches to 0.00125 inches). In various aspects of the present disclosure, at least a portion of the vascular occlusion device 110 is braided from 24 to 32 DFT wires, each wire having a cross-sectional diameter of from 0.00075 inches to 0.00125 inches and having a Pt content of from 40% to 50%.

[0077] Typically, the austenite finish temperature or “Af” temperature of NiTi is about 25°C, which is the temperature at which the martensitic phase completes its transformation to the austenitic phase. Modifying NiTi in the DFT such that its Af temperature is between 30°C and 45°C results in a softer vascular occlusive device. Setting the Af temperature within this range achieves a desired balance between device flexibility and conformability, which improves the device's suitability for aneurysm treatment. The Af of NiTi can be set by adjusting the Ni composition in NiTi from the normal 50% to 50.4% - 50.8%. Additionally, the 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.

[0078] The DFT may also include an oxide coating having a controlled thickness that will enhance thrombus formation (e.g., blood clotting) to increase vascular occlusion within the aneurysm. Preferably, the oxide coating has an average thickness between 50 nm and 500 nm. This is in contrast to prior DFT braided implants (e.g., stents) from which the oxide coating (e.g., via electropolishing) is substantially removed to produce a “bright” stent. In prior DFT braided stents, the oxide coating thickness was limited to less than 50 nm.

[0079] In other embodiments, instead of DFT wires, the reticular portion 104 may be braided from elongated members formed by smaller DFT wires twisted together. Each DFT wire may be made of Niti - DFT - 40Pt. Braiding the elongated members (made of smaller DFT wires) instead of larger DFT wires results in a softer reticular portion 104 at approximately the same Pt core content. Thus, the reticular portion 104 according to this aspect of the present disclosure (i.e., the twisted elongated member braid) provides radiopacity similar to that of a softer braid. Such a braid also provides a higher surface area to promote thrombus formation, thereby enhancing aneurysm occlusion.

[0080] The proximal end 110 of the reticular portion 104 tapers downward to a smaller diameter than the intermediate section of the reticular portion 104. The downward - tapering proximal end 110 of the reticular portion 104 is inserted into the distal end 118 of the proximal coil 114.

[0081] The proximal coil subassembly 106 includes a proximal coil 114 having a proximal end 116 and a distal end 118. The proximal coil 114 generally has a lower bending stiffness than the mesh portion 104 such that the proximal coil 114 can facilitate the advancement and manipulation of the vascular occluding device 100 through a delivery catheter that traverses the tortuous path of the patient's vascular system to an insertion site to facilitate the mesh portion 104 assuming its secondary shape after deployment to fill a vascular defect and provide a relatively soft, atraumatic tip that minimizes tissue damage when the vascular occluding device 100 is deployed. In one aspect, the proximal coil 114 can be a coil wound from any type and size of wire described for the wire forming the mesh portion 104 or even the same type and size of wire used for the mesh portion 104. In other aspects, the proximal coil 114 can be a coil wound from a wire of a different type, size, and / or material than the wire used for the mesh portion 104. The proximal coil 114 has an open pitch proximal winding at the proximal end 116 of the proximal coil 114.

[0082] The proximal coil subassembly 106 also includes a coupling link 120 and one or more proximal tensile members 126 (also referred to as the "first tensile member 126" or "tensile member 126"). The coupling link 120 is disposed at the distal end 116 of the proximal coil 114. The coupling link 120 has a first coupler 122 for coupling the proximal end 128 of the tensile member 126 to the proximal end 116 of the proximal coil 114. The coupling link 120 has a plurality of fingers 140 at the distal end of the coupling link 120 that interlace with the open pitch proximal winding at the proximal end 116 of the proximal coil 114. In the illustrated embodiment, for example Figure 4 and Figure 5 in the embodiment of, the first coupler 122 is a hole through the coupling link 120. The coupling link 120 is also used to couple a delivery coupler 184 to the proximal end of the delivery device 182 of the delivery assembly 180 (see, for example Figure 5 ). The coupling link 120 also has a second coupler 123 for coupling the delivery coupler 184 to the proximal end of the delivery device 182 of the delivery assembly 180. The second coupler 123 can also be a hole through the coupling link 120.

[0083] Figure 4 and Figure 5 show an enlarged view of one disclosed embodiment of the proximal coil subassembly 106a. Figure 4 Shows the proximal end of the vascular occluding device 100 before the mesh portion 104, the proximal tensile member 126, and the proximal coil 114 are joined together, and Figure 5Shows the proximal end of the vascular occlusion device 100 after the mesh portion 104, the anti-tensile member 126, and the proximal coil 114 are joined together. The proximal anti-tensile member 126 has a proximal end 128 and a distal end 130. The proximal anti-tensile member 126 is independent of the mesh portion 104. In other words, the proximal anti-tensile member 126 is not made of or does not include the mesh portion 104, and is not formed by any wire forming the mesh portion 104. The proximal anti-tensile member 126 can be a wire, rod, or other structure having a tensile strength that prevents the first anti-tensile member from being overstretched (e.g., opening the pitch of the windings of the proximal coil 114 or permanently straining the proximal coil 114).

[0084] In Figure 4 and Figure 5 embodiments, the anti-tensile member 126 includes a wire 132 having a first end 134, a second end 136, and a bend 138 between the first end 134 and the second end 136. The first end 134 and the second end 136 form the distal end 130 of the anti-tensile member 126, and the bend 138 forms the proximal end 128 of the anti-tensile member 126. The anti-tensile member 126 extends through the proximal coil 126, and the bend 138 passes through the first coupler 122.

[0085] As Figure 4 shown, the distal end 130 of the anti-tensile member 126 includes the first end 134 and the second end 136 of the wire 132. As Figure 5 shown, the first end 134 and the second end 136 are formed as a corresponding first ball 135 and a second ball 137 (the first ball 135 and the second ball 137 now form the distal end 130 of the anti-tensile member 126).

[0086] To assemble the vascular occlusion device 100a, the tapered proximal end 110 of the mesh portion 104 is inserted into the distal end 118 of the proximal coil 114. The proximal anti-tensile member 126 is inserted through the proximal coil 114 and through the first coupler 112 to couple the proximal end 128 of the anti-tensile member 126 to the proximal end 116 of the proximal coil 114 via the coupling link 120. The first ball 135 and the second ball 137 (the distal end 130 of the anti-tensile member 126) are positioned adjacent to the distal end 118 of the proximal coil 114 and the tapered proximal end 110 of the mesh portion 104. Then a proximal joint 142 is formed to physically attach the proximal end 110 of the mesh portion 104, the first ball 135 and the second ball 137 (the distal end 130 of the proximal anti-tensile member 126), and the distal end 118 of the proximal coil 114 together. As Figure 5As shown, the proximal junction 142 includes an adhesive that is applied to encapsulate the proximal end 110 of the mesh portion 104, the first ball 135 and the second ball 137 of the proximal anti-tensile member 126, and the distal end 118 of the proximal coil 114.

[0087] As Figure 5 shown, the vascular occlusion device 100 is attached to the delivery assembly 180 (e.g., a delivery catheter assembly) by attaching the proximal coil subassembly 106a to the delivery assembly 180. The delivery assembly 180 includes a delivery catheter 186, a delivery device 182 (e.g., a pusher device) extending through the lumen of the delivery catheter 186, and a delivery coupler 184 at the distal end of the delivery device 182. The proximal coil subassembly 106 can be attached to the delivery device 182 by engaging the second coupler 123 of the delivery device 182 with the linkage 120. The delivery coupler 184 includes a separation device 185 for releasing the vascular occlusion device 100 from the delivery device 182. In one embodiment, the separation device 185 is an electrolytically separable junction that decomposes via electrolysis when charged in the presence of an ionic solution such as blood or other body fluid. Details of suitable delivery assemblies and delivery of vascular occlusion treatment systems are described in U.S. Patent Nos. 8,202,292, 9,480,479, 10,321,915, and 10,893,870.

[0088] Now turning to Figures 6 - 9 , several other embodiments of the vascular occlusion device 100 with an alternative embodiment of the proximal coil subassembly 106 are shown. Figures 6 - 9 The embodiments of have a multi-step bonding process and / or a differently formed distal end of the anti-tensile member 126 to provide better anchoring when encapsulated in the adhesive of the proximal junction 142. Figure 6 The vascular occlusion device 100b having the proximal coil subassembly 106b shown in Figure 5 is substantially the same as the vascular occlusion device 100a shown in, except that the vascular occlusion device 100b has straight first and second ends 134 and 136 with no balls formed thereon, and the proximal junction 142 includes a pre-gluing process (also referred to as pre-bonding). The first end 134 and the second end 136 of the distal end 130 of the anti-tensile member 126 terminate proximal to the distal end 118 of the proximal coil 114. For example, the first end 134 and the second end 135 can be trimmed to an appropriate length.

[0089] The proximal coil subassembly 106b is assembled by pre-bonding the first end portion 134 and the second end portion 136 (i.e., the distal end portion 130 of the anti-tensile member 125) to the distal end portion 118 of the proximal coil 114 and / or inserting them into the proximal end portion 110 of the mesh portion 104 inserted into the proximal coil 114. An adhesive 144 can be used to bond the first end portion 134 and the second end portion 136, the distal end portion 118 of the proximal coil 114 and / or the proximal end portion 110 of the mesh portion 104 together. After allowing the adhesive 144 to cure, a proximal joint 142 is formed to physically attach the first end portion 134 and the second end portion 136 (i.e., the distal end portion 130 of the anti-tensile member 126) together to the distal end portion 118 of the proximal coil 114 and / or the proximal end portion 110 of the mesh portion 104 inserted into the proximal coil 114, which is the same as or similar to the proximal joint 142 formed in the vascular occlusion device 100a. This pre-bonding process strengthens the proximal joint 142 and also makes the step of forming the proximal joint 142 easier and faster, which can reduce the handling and scrap rate of the mesh portion.

[0090] Reference Figure 7 , the vascular occlusion device 100c having a proximal coil subassembly 106c is substantially the same as Figure 5 the vascular occlusion device 100a shown, except that the vascular occlusion device 100c has straight first and second end portions 134 and 136 with no balls formed thereon, and the proximal joint 142 includes a longer bonding process, thereby allowing the adhesive to wick further proximally along the proximal end portion 110 of the mesh portion 104. The first end portion 134 and the second end portion 136 can also be slightly radially outwardly curved, for example, curved 10 degrees - 30 degrees from the longitudinal axis of the proximal coil, or curved more than 20 degrees from the longitudinal axis of the proximal coil 114. The first end portion 134 and the second end portion 136 of the distal end portion 130 of the anti-tensile member 126 extend beyond the distal end portion 118 of the proximal coil 114, such as extending beyond the distal end portion 118 by about 1.0 mm to 5.0 mm. For example, after applying the desired radially outward angle, the first end portion 134 and the second end portion 136 can be trimmed to an appropriate length.

[0091] Thus, as described herein, the vascular occlusion device 100c is assembled similarly to the vascular occlusion device 100a. When forming the proximal junction 142 to physically attach the first end 134 and the second end 136 (i.e., the distal end 130 of the anti-tensile member 126) together to the distal end 118 of the proximal coil 114 and the proximal end 110 of the mesh portion 104 inserted into the proximal coil 114, an adhesive is applied and allowed to wick proximally along the proximal end 110 of the mesh portion 104 for a longer time before curing. This longer process extends the bonding area between the proximal coil 114, the first end 134 and the second end 136 of the anti-tensile member 126, and the proximal end of the mesh portion 104. This results in a stronger bond, although it may also reduce the flexibility of the distal end 118 of the proximal coil 114.

[0092] Now turning to Figure 8 , another embodiment of a vascular occlusion coil 100d having a proximal coil subassembly 106d is shown. The vascular occlusion coil 100d having the proximal coil subassembly 106d is substantially the same as the Figure 5 vascular occlusion device 100a shown, except that the vascular occlusion device 100d has an anti-tensile member 126 that has sharp bends at the first end 134 and the second end 136. As Figure 8 shown, the first end 134 and the second end 136 of the anti-tensile member 126 have bends of approximately 80 degrees radially outward. The bends in the first end 134 and the second end 136 increase the bonding strength between the anti-tensile member 126 and the proximal junction 142. Similar to or the same as other embodiments described herein, after applying the desired radially outward angle, the first end 134 and the second end 136 can be trimmed to an appropriate length. Alternatively, the bend can be at least 20 degrees, or greater than 45 degrees, or greater than 30 degrees. The vascular occlusion device 100d is assembled using the same process as the vascular occlusion device 100a.

[0093] Referring to Figure 9 , the vascular occlusion device 100e having the proximal coil subassembly 106e is the same as the Figure 8The vascular occlusion device 100d shown is substantially the same, except that the vascular occlusion device 100e has a first end 134 and a second end 136, and the first end 134 and the second end 136 each have circumferential rings 146 and 148 respectively wound around the proximal end 110 of the downwardly tapered mesh portion 104. The rings 146, 148 may include any suitable number of windings, such as 1, 1.5, 2, 2.5, 3 or more windings. Similar to or the same as other embodiments described herein, after applying the desired radially outward angle, the first end 134 and the second end 136 can be trimmed to an appropriate length. The vascular occlusion device 100e can also utilize a pre-bonding process as described for the Figure 6 vascular occlusion device 100b shown. Thus, the vascular occlusion device 110d is assembled using the same process as for assembling the vascular occlusion device 100b.

[0094] Figure 10 Another embodiment of the vascular occlusion device 100f with a proximal coil subassembly 106f is shown in. The vascular occlusion device 100f is substantially the same as the Figure 6 vascular occlusion device 100b shown, except that the vascular occlusion device 100f has a proximal coil 114 that has one or more spread windings 115 between adjacent windings, and the proximal junction 142 extends into the spread windings of the proximal coil 114. Figure 10The embodiment shown in [Fig. 0] has a proximal coil 114 that has two deployed windings 115 toward the distal end 118 of the proximal coil 114. An adhesive or other linking means forming the proximal junction 142 extends through the deployed windings 115 and forms part of the junction between the proximal end 110 of the mesh portion 104, the first end 134 and the second end 136 of the proximal anti-tensile member 126, and the distal end 118 of the proximal coil 114. Similar or identical to other embodiments described herein, after applying the desired radially outward angle, the first end 134 and the second end 136 can be trimmed to the appropriate length. During the assembly of the vascular occlusion device 100f, the (one or more) deployed windings 115 can be used to provide a visual check of the correct insertion length of the proximal end 110 of the mesh portion 104 into the proximal coil 114. For example, the proximal end 110 of the mesh portion 104 can have the correct insertion length such that the proximal end 110 is aligned with the most proximal deployed winding 115, which can be visually confirmed by observing the most proximal deployed winding 115 and inserting the tapered mesh portion 104 downward until the proximal end is visible through the most proximal deployed winding 115. The assembly of the vascular occlusion device 100f is substantially the same as that of the vascular occlusion device 100 and can include a pre-bonding process as described for the vascular occlusion device 100b. Additionally, the proximal junction 142 includes an adhesive inserted into the deployed windings 115 such that the proximal junction 142 further includes deployed winding junctions 142a and 142b that further bond the proximal end 110 of the mesh portion 104, the first end 134 and the second end 136 of the proximal anti-tensile member 126, and the distal end 118 of the proximal coil 114.

[0095] Any of the vascular occlusion devices 100 disclosed herein (including vascular occlusion devices 100a - 100g and 100h) can utilize the deployed winding concept of the vascular occlusion device 100f to increase the tensile strength of the vascular occlusion device 100.

[0096] Now turning to Figure 11 , another embodiment of a vascular occlusion coil 100h having a proximal coil subassembly 106h is shown. The vascular occlusion coil 100h having the proximal coil subassembly 106h is substantially the same as the Figure 8 vascular occlusion device 100d shown, except that the first end 134 and the second end 136 are bent to form hooks 150 and 152, respectively. The hooks 150 and 152 increase the bonding strength between the anti-tensile member 126 and the proximal junction 142. In an alternative embodiment, the anti-tensile member 126 can include a single wire attached to and extending from the proximal end 116 of the proximal coil 114 such that the distal end 130 of the anti-tensile member 126 includes only a single hook 150 (e.g., seeFigure 12 )。The same process used to assemble the vascular occlusion device 100d is used to assemble the vascular occlusion device 100h.

[0097] In any of the embodiments disclosed herein, the proximal junction 142 of the proximal coil subassembly 106 may use a coupling device different from simply gluing with an adhesive. For example, FIGS. 15 and 16 show the distal portions of additional embodiments of the vascular occlusion device 100, which have a proximal junction 142 formed by connecting the proximal end 110 of the mesh portion 104, the distal end 130 of the proximal anti-tensile member 126, and the distal end 118 of the proximal coil 114 together by any one or more of hooking, threading, braiding, gluing, welding, soldering, sintering, and crimping.

[0098] Figure 12 is a partially cutaway perspective view of the distal portion of the proximal coil subassembly 106g of the vascular occlusion device 100, showing an alternative embodiment for the proximal junction 142. Figure 12 The proximal portion of the coil subassembly 106g not shown in may be the same as or similar to the proximal portion of any one of the coil subassemblies 106a - 106f. The proximal coil subassembly 106g is similar to the proximal coil subassembly 106 described above, except that the proximal anti-tensile member 126 does not have a bend 138 as shown in the other illustrated embodiments, such that the wire 126 does not fold back from the proximal end at the coupling link 120. Additionally, the proximal junction 142 is not formed only by gluing. The distal end 130 of the proximal anti-tensile member 126 is formed as a hook 150 to increase the bonding strength between the anti-tensile member 126 and the proximal junction 142. The proximal junction 142 is formed by connecting the proximal end 110 of the mesh portion 104, the distal end 130 (including the hook 150) of the proximal anti-tensile member 126, and the distal end 118 of the proximal coil 114 together by any one or more of welding, soldering, sintering, and / or gluing.

[0099] Figure 13 is a partially cutaway perspective view of the distal portion of the proximal coil subassembly 106g of the vascular occlusion device 100, showing an additional alternative embodiment for the proximal junction 142. Figure 13The proximal portion of the coil subassembly 106g, not shown, may be the same as or similar to the proximal portion of any of the coil subassemblies 106a - 106f. The proximal coil subassembly 106h is similar to the proximal coil subassembly 106 described above, except that the proximal anti - tensile member 126 does not have the bend 138 as shown in the other illustrated embodiments, such that the wire 126 does not fold back from the proximal end at the coupling link 120. Additionally, the proximal joint 142 is not formed only by gluing, but by other means. The distal end 130 of the proximal anti - tensile member 126 is formed as a hook 150 to increase the bonding strength between the anti - tensile member 126 and the proximal joint 142. The proximal joint 142 is formed by any one or more of the following: hooking, threading, weaving, and / or crimping the distal end 130 of the proximal anti - tensile member to the proximal end of the mesh portion 104, and welding, brazing, sintering, and / or gluing together the proximal end 110 of the mesh portion 104, the distal end 130 of the proximal anti - tensile member 126, and the distal end 118 of the proximal coil 114. As Figure 13 can be seen, the distal end 130 of the proximal anti - tensile member 126 is hooked, threaded, woven, or crimped through the proximal end of the mesh portion 104. Then, the proximal joint 142 is formed by connecting the proximal end 110 of the mesh portion 104 and the distal end 130 of the proximal anti - tensile member 126 together by any one or more of welding, brazing, sintering, and / or gluing.

[0100] Referring again to Figure 3, each vascular occlusion device 100 disclosed herein also has a distal coil subassembly 108 attached to the distal end 112 of the mesh portion 104. The distal coil subassembly 108 includes a distal coil 160 having a proximal end 162 and a distal end 164. Similar or identical to the proximal coil subassembly 106, the distal coil subassembly 108 has a distal anti-tensile member 166 (also referred to as the "second anti-tensile member 166" or simply the "anti-tensile member 166"). The distal anti-tensile member 166 is also independent of the mesh portion 104, i.e., the distal anti-tensile member 166 is not made of the mesh portion 104 or does not include the mesh portion 104 or is not formed by any wire forming the mesh portion 104. The distal anti-tensile member 166 can be a wire, rod, or other structure having a tensile strength that prevents the distal anti-tensile member 166 from being overstretched (e.g., opening the pitch of the windings of the distal coil 160 or permanently straining the distal coil 160). The distal anti-tensile member 166 has a proximal end 168 and a distal end 170. The distal anti-tensile member 166 extends through the distal coil 160. The proximal end 168 of the distal anti-tensile member 166 is attached to the proximal end 162 of the distal coil 160, and the distal end 170 of the distal anti-tensile member 166 is attached to the distal end 164 of the distal coil 160. Similar or identical to the proximal end 110 of the mesh portion 104, the distal end 112 of the mesh portion 104 tapers downward to insert into the proximal end 162 of the distal coil 160.

[0101] The distal junction 172 physically attaches the proximal end 162 of the distal coil 160, the proximal end 168 of the distal anti-tensile member 166, and the distal end 172 of the mesh portion 104 together. Similar or identical to the proximal junction 142, the distal junction 172 includes an adhesive that is applied to encapsulate the proximal end 162 of the distal coil 160, the proximal end 168 of the distal anti-tensile member 166, and the distal end 172 of the mesh portion 104. For example, the distal junction can consist of a single integral adhesive bead having a tapered portion. In other embodiments, the distal junction 172 can be formed by connecting the proximal end 162 of the distal coil 160, the proximal end 168 of the distal anti-tensile member 166, and the distal end 172 of the mesh portion 104 together by any one or more of hooking, threading, braiding, gluing, welding, soldering, sintering, and crimping, similar to the junctions shown in the above Figures 12 - 13 as described.

[0102] The distal end 170 of the distal tensile member 166 and the distal end 164 of the distal coil 160 can be attached together using a distal end joint 174. The distal end joint is formed by an adhesive, such as an adhesive ball or bead that encapsulates the distal end 170 of the distal second tensile member 166 and the distal end 164 of the distal coil 160. The adhesive forming the distal end joint 174 is shaped and positioned to form a non-invasive end on the distal end 164 of the distal coil 160. For example, the non-invasive end can be in the shape of a ball or a spherical cap. The non-invasive end constitutes the farthest distal end of the vascular occlusion device 100.

[0103] Similar to the proximal tensile member 126, the distal tensile member 166 can include a second wire having a first end, a second end, and a bend therebetween. In this case, the bend forms the distal end 170 of the distal tensile member 166 and is attached to the distal end 164 of the distal coil 160 by a distal end joint 174 (such as an adhesive ball).

[0104] The vascular occlusion device 100 disclosed herein provides many technical advantages over previously disclosed devices. For example, the independent tensile members 126, 166 allow the strength of the tensile members to be independent of the characteristics of the mesh portion 104. This can result in a vascular occlusion device having a much higher tensile strength than a similar-sized device having tensile members formed from the wires of the mesh portion. Additionally, the vascular occlusion device design utilizing the independent tensile members 126, 166 significantly reduces the number of process steps required to manufacture the vascular occlusion device. For example, compared to a device having an integral tensile member, the independent tensile member design disclosed herein can reduce the manufacturing process steps by more than 50%, thereby reducing the typical number of steps from approximately 89 steps to approximately 43 steps. The simplified manufacturing greatly reduces the handling of the delicate mesh portion, thereby reducing the scrap rate and lowering the total manufacturing cost. In fact, the improved manufacturability can reduce the total unit production cost by approximately 30%.

[0105] Aspects of the present disclosure are described below with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale and that, in all the drawings, elements of similar structure or function are represented by like reference numerals. It should also be noted that the drawings are only intended to facilitate the description and are not intended as an exhaustive description of the present disclosure or as a limitation on the scope of the present disclosure, the scope of which is defined only by the appended claims and their equivalents. Additionally, the various aspects shown do 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 can be practiced with any other aspect, even if not so shown.

Claims

1. A vascular occlusion device, comprising: a mesh portion formed by one or more wires configured as a mesh, the mesh portion having a proximal end and a distal end; a proximal coil having a proximal end and a distal end, the distal end of the proximal coil being coupled to the proximal end of the mesh portion; a first tensile member independent of the mesh portion, the first tensile member extending through the proximal coil and having a proximal end coupled to the proximal end of the proximal coil and a distal end coupled to the distal end of the proximal coil; a proximal junction physically attaching the proximal end of the mesh portion, the distal end of the first tensile member, and the distal end of the proximal coil together.

2. The vascular occlusion device according to claim 1, wherein, The proximal junction consists of an adhesive.

3. The vascular occlusion device according to claim 2, wherein The proximal junction consists of a single integral adhesive bead having a tapered portion.

4. The vascular occlusion device according to claim 1, wherein, The proximal junction includes connecting the proximal end of the mesh portion, the distal end of the first tensile member, and the distal end of the proximal coil together by one or more of hooking, threading, weaving, gluing, welding, brazing, sintering, and crimping.

5. The vascular occlusion device according to claim 1, wherein: the first tensile member includes a single first wire having a first end and a second end and a bend therebetween, and the bend forms the proximal end of the first tensile member, and the first end and the second end of the first wire form the distal end of the first tensile member.

6. The vascular occlusion device according to claim 5, further comprising: a coupling link disposed on the proximal end of the proximal coil, the coupling link being configured to be coupled to the proximal end of the first tensile member.

7. The vascular occlusion device according to claim 6, wherein: the coupling link has a first hole positioned within the proximal coil; and the first wire forming the first tensile member passes through the first hole such that the bend is disposed within the first hole, thereby coupling the proximal end of the tensile member to the proximal end of the proximal coil.

8. The vascular occlusion device according to claim 5, wherein The first end and the second end of the first wire each have a ball formed thereon to enhance the bond between the first end and the second end of the first wire and the proximal junction.

9. The vascular occlusion device according to claim 8, wherein, The balls are formed by micro-welding the first end and the second end of the first wire.

10. The vascular occlusion device according to claim 5, wherein, The first end and the second end of the first wire each have a bend at least 20 degrees radially outward from the longitudinal axis of the proximal coil to enhance the bond between the first end and the second end of the first wire and the proximal junction.

11. The vascular occlusion device according to claim 5, wherein, Each of the first end and the second end of the first line has a bend that is at least 75 degrees radially inward from the longitudinal axis of the proximal coil to strengthen the connection between the first end and the second end of the first line and the proximal junction.

12. The vascular occlusion device according to claim 5, wherein, Each of the first end and the second end of the first line has a hook formed on the first end and the second end to strengthen the connection between the first end and the second end of the first line and the proximal junction.

13. The vascular occlusion device according to any one of claims 1-12, wherein, The proximal end of the mesh portion tapers downward and is inserted into the distal end of the proximal coil.

14. The vascular occlusion device according to any one of claims 1-13, wherein, The proximal coil has unwind windings between adjacent windings, and the proximal junction extends into the unwind windings of the proximal coil.

15. The vascular occlusion device according to any one of claims 1-14, wherein, The proximal coil has a plurality of unwind windings between corresponding adjacent windings, and the proximal junction extends into the plurality of unwind windings of the proximal coil.

16. The vascular occlusion device according to any one of claims 1-15, further comprising: A distal coil having a proximal end and a distal end, the proximal end of the distal coil being coupled to the distal end of the mesh portion; A second anti-tensile member independent of the mesh portion, the second anti-tensile member extending through the distal coil and having a proximal end coupled to the proximal end of the distal coil and a distal end coupled to the distal end of the distal coil; A distal junction that physically attaches the distal end of the mesh portion, the proximal end of the anti-tensile member, and the proximal end of the distal coil together.

17. The vascular occlusion device according to claim 16, wherein, The distal junction is composed of an adhesive.

18. The vascular occlusion device according to claim 17, wherein, The distal junction is composed of a single integral adhesive bead having a tapered portion.

19. The vascular occlusion device according to claim 1, wherein, The distal junction includes connecting the distal end of the mesh portion, the proximal end of the anti-tensile member, and the proximal end of the distal coil together by one or more of hooking, threading, braiding, gluing, welding, soldering, sintering, and crimping.

20. The vascular occlusion device according to claim 16, wherein: The second anti-tensile member includes a second line having a first end and a second end and a bend between the first end and the second end, and the bend forms the distal end of the second anti-tensile member, and the first end and the second end of the second resistant member form the proximal end of the second anti-tensile member.

21. The vascular occlusion device according to claim 20, further comprising: A non-invasive tip disposed on the distal end of the distal coil, the non-invasive tip being coupled to the distal end of the anti-tensile member.

22. The vascular occlusion device according to claim 21, wherein, The non-invasive tip includes an adhesive ball (or spherical cap); and The distal end of the second anti-tensile member is encapsulated in the adhesive ball, thereby coupling the distal end of the anti-tensile member to the distal end of the distal coil.

23. The vascular occlusion device according to claim 22, wherein, The first end and the second end of the second wire each have a ball formed on the first end and the second end to strengthen the bond between the first end and the second end of the second wire and the distal engagement portion.

24. The vascular occlusion device according to claim 23, wherein, The balls are formed by micro-welding the first end and the second end of the second wire.

25. The vascular occlusion device according to claim 21, wherein, The first end and the second end of the second wire each have a bend that is at least 20 degrees radially outward from the longitudinal axis of the distal coil to strengthen the bond between the first end and the second end of the second wire and the adhesive engagement portion.

26. The vascular occlusion device according to claim 21, wherein, The first end and the second end of the second wire each have a bend that is at least 75 degrees radially inward from the longitudinal axis of the distal coil to strengthen the bond between the first end and the second end of the second wire and the adhesive engagement portion.

27. The vascular occlusion device according to claim 16, wherein, The first end and the second end of the second wire each have a hook formed on the first end and the second end to strengthen the bond between the first end and the second end of the second wire and the distal engagement portion.

28. The vascular occlusion device according to any one of claims 16-27, wherein, The distal end of the mesh portion tapers downward and is inserted into the proximal end of the distal coil.

29. The vascular occlusion device according to any one of claims 16-28, wherein, The distal coil has unwind windings between adjacent windings, and the distal engagement portion extends into the unwind windings of the distal coil.

30. The vascular occlusion device according to any one of claims 16-29, wherein, The distal coil has a plurality of unwind windings between corresponding adjacent windings, and the distal engagement portion extends into the plurality of unwind windings of the distal coil.

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