Vascular occlusion devices

Abstract

This invention relates to a device and method for occluding vascular defects such as aneurysms. [Solution] The vascular occlusion device includes an elongated vascular occlusion structure 16 configured to be implanted within an aneurysm sac A. The vascular occlusion structure 16 has a delivery configuration when confined within a delivery catheter 12 and a deployment configuration when released from the delivery catheter 12 into an aneurysm sac A. At least a portion of the vascular occlusion device is made of a gold-platinum (AuPt) alloy.

Description

Technical Field

[0001]

[0001] This disclosure generally relates to medical devices and intravascular medical procedures, and more specifically to devices and methods for occluding vascular defects such as aneurysms.

Background Art

[0002]

[0002] Vascular occlusion devices or implants are used for various reasons, such as the treatment of intravascular aneurysms. An aneurysm is an expansion of a blood vessel or other vessel, which can pose a risk to a patient's health due to rupture, clotting, or dissection. For example, the rupture of an aneurysm in a patient's brain can cause a stroke, leading to brain damage and death. Cerebral aneurysms can be detected in patients, for example, by seizures or bleeding, and can be treated by applying a vascular occlusion device.

[0003]

[0003] Generally used vascular occlusion devices comprise a flexible coil wound helically, formed by winding platinum (or platinum alloy) wire strands around a "primary" mandrel. This coil is then wound around a larger "secondary" mandrel and heat-treated to give it a secondary shape. For example, U.S. Patent No. 4,994,069 issued to Ritchart et al., which is hereby incorporated by reference in its entirety, describes a vascular occlusion device that takes on a linear helical primary shape when extended for placement through the lumen of a delivery catheter and a curved helical secondary shape when released from the delivery catheter and positioned in the vascular system. A complex three-dimensional secondary shape can be imparted to the vascular occlusion device to better conform to and fill an aneurysm, and the rigidity / flexibility of the vascular occlusion device can be varied.

[0004]

[0004] To deliver a vascular occlusion device to a desired site in the vascular system, for example, into the aneurysm sac, it is commonly known that a guidewire is first used to position a small-profile delivery catheter or “microcatheter” at that site. Typically, the distal end of the microcatheter is provided with a pre-formed bend, e.g., 45°, 26°, “J” type, “S” type, or other bend shape, selected by the attending physician or manufacturer according to the patient’s specific anatomical structure, so that when the guidewire is withdrawn, it remains in the desired position for releasing one or more vascular occlusion devices into the aneurysm sac. Next, the delivery or “pusher” assembly or “wire” is passed through the microcatheter, extending the vascular occlusion device, coupled to the distal end of the delivery assembly, into the aneurysm sac through the distal end opening of the microcatheter. Once inside the aneurysm sac, a portion of the vascular occlusion device deforms or bends to achieve more efficient and complete filling. The vascular occlusion device is then released or “separated” from the distal end of the delivery assembly, and the delivery assembly is withdrawn through the microcatheter. Depending on the patient's specific needs, one or more additional vascular occlusion devices can be inserted via a microcatheter and released into the same aneurysm sac.

[0005]

[0005] Importantly, fluoroscopy is typically used to visualize the occlusion device during delivery to the aneurysm, while magnetic resonance imaging (MRI) is typically used to visualize the treated site to confirm that the aneurysm sac is properly occluded after the procedure (e.g., several weeks after the initial treatment of the aneurysm). Therefore, it is important that the occlusion device is constructed in a way that achieves radiopaqueness during the treatment of the aneurysm while minimizing artifacts that obscure visualizations on post-treatment MRI (i.e., being MRI-compatible). It is also of paramount importance that such occlusion devices be "soft" (i.e., laterally flexible or adaptable) and therefore non-traumatic to prevent rupture of the delicate tissue of the aneurysm.

[0006]

[0006] Furthermore, it is important that such vascular occlusion devices be chronically retained within the aneurysm. However, aneurysms with a large opening, commonly known as "wide-neck aneurysms," present challenges in the placement and retention of vascular occlusion devices within the aneurysm sac, and small, relatively thin vascular occlusion coils, in particular, lack substantial secondary morphological strength to maintain their position within the aneurysm sac, no matter how skillfully they are placed. For this reason, stents or balloons must be placed in vessels adjacent to the neck of the aneurysm to ensure the vascular occlusion coil is securely retained within the aneurysm sac, thereby complicating the procedure. To address this problem, vascular occlusion devices consisting of at least partially braided (or woven) structures have been developed. Such braided vascular occlusion devices provide a wide area and effective backbone throughout the neck of the aneurysm, and can therefore be effectively retained within wide-neck aneurysms without the need to deploy auxiliary aneurysm retention devices such as balloons or stents.

[0007]

[0007] However, whether coiled or braided occlusive devices are used, conventional delivery systems for occlusive devices have limitations in that the occlusive devices are relatively short and have limited expandability, otherwise it would be difficult (if not impossible) to push them into / out of the microcatheter. Unfortunately, small (short) occlusive devices are less desirable because the delivery of such small occlusive devices to an aneurysm sac requires a longer and more complex procedure. For example, a 7 mm diameter neuroaneurysm sac is typically filled with 5 to 7 individual spring coils, which is a longer and more complex procedure than reducing the number of devices.

[0008]

[0008] Theoretically, the length of the occlusive device can be increased to reduce the number of occlusive devices required to treat the aneurysm. However, increasing the length of the occlusive device inevitably increases the friction between such a occlusive device and the lumen of the delivery catheter. Therefore, to ensure that the occlusive device is reliably delivered into the aneurysm, it is necessary to increase the column strength of such occlusive devices (e.g., by selecting a material with a high Young's modulus or by increasing the diameter of the wire on which the occlusive device is formed), and / or increase the diameter of the delivery catheter. However, as mentioned above, it is important that the diameter of the delivery catheter be as small as possible so that the aneurysm can be accessed from a very small vascular system, and that the occlusive device is soft enough so as not to damage the delicate aneurysmal tissue.

[0009]

[0009] While relatively long vascular occlusion devices have the column strength required to be delivered through a relatively small diameter delivery catheter, there are very few materials that meet other counter requirements, including softness, radiopaqueness, and MRI compatibility requirements.

[0010]

[0010] For example, known materials with relatively high Young's modulus and relatively high radiopaqueness, such as platinum-tungsten (PtW) alloys on which vascular occlusion coils are typically manufactured, can provide the column strength required for relatively long vascular occlusion devices. However, the diameter of the wire on which such vascular occlusion devices are manufactured must be reduced to meet the flexibility requirements while ensuring that the vascular occlusion device fits within a small-diameter delivery catheter. As a result, the radiopaqueness of the vascular occlusion device decreases, reducing the column strength, which may necessitate shortening the vascular occlusion device and / or requiring a larger diameter delivery catheter.

[0011]

[0011] As another example, known materials having relatively low Young's modulus and low radiopaqueness, such as nitinol, can be used to provide the necessary softness for a vascular occlusion device, but such a vascular occlusion device would lack the desirable radiopaqueness and column strength necessary to increase the length of the vascular occlusion device. Furthermore, the heating process to set the nitinol into a predetermined shape can result in surface oxides, which may crack and release toxic nickel. Therefore, such oxides must be removed from the vascular occlusion device using a costly and time-consuming process.

[0012]

[0012] As yet another example, if an optimal diameter is selected for the wire on which such a vascular occlusion device is manufactured using a known material having a relatively intermediate Young's modulus and low radiopaqueness, such a vascular occlusion device can be provided with the column strength required for a relatively long and flexible vascular occlusion device, but such a vascular occlusion device would not exhibit the required radiopaqueness.

[0013]

[0013] Therefore, there is an ongoing need to provide a vascular occlusion device that satisfies the aforementioned requirements. [Overview of the Initiative]

[0014]

[0014] According to one aspect of the present invention, the vascular occlusion device comprises an elongated vascular occlusion structure (for example, at least 5 cm in length) configured to be implanted in an aneurysm sac. The vascular occlusion structure has a delivery configuration when confined within a delivery catheter and a deployment configuration when released from the delivery catheter into the aneurysm sac. At least a portion of the vascular occlusion structure is made of a gold-platinum (AuPt) alloy, for example, containing 25% to 40% by weight of platinum and having a Young's modulus of 25 × 10⁻¹⁶ 6 It is less than pounds per square inch (psi). The vascular occlusion structure may be further composed of iridium and / or tungsten.

[0015]

[0015] In one embodiment, the vascular occlusion structure includes a mesh portion (e.g., a braided portion) made of an AuPt alloy. The bending stiffness of the mesh portion may be less than 150 mN / mm. The entire vascular occlusion structure may include the mesh portion, or broadly, the vascular occlusion structure may further include two helically wound coil portions located at both ends of the mesh portion. The coil portions may be made of an AuPt alloy. The mesh portion may include at least one wire (e.g., 8 to 96 wires), each having a minimum cross-sectional dimension of, for example, 0.0008 to 0.004 inches. Each wire may have, for example, a circular or square cross-section. Each wire may have, for example, a single strand or a twisted strand. If the mesh is a braided portion, this braided portion may have an unconstrained braiding angle of 20° to 130°, preferably 20° to 60°. The mesh portion may have an expanded shape with a circular or flat cross-section (for example, having a width of 0.5 mm to 5.0 mm, preferably 1.0 mm to 2.0 mm).

[0016]

[0016] The vascular occlusion device may be incorporated into a vascular occlusion assembly which further includes a pusher member to which the vascular occlusion device is removably (e.g., electrolytically) coupled. The vascular occlusion assembly may be incorporated into a vascular occlusion treatment system which includes a delivery catheter in which the vascular occlusion assembly is placed.

[0017]

[0017] Other and further aspects and features of the disclosed embodiments of the invention will become apparent from the following detailed description with reference to the accompanying drawings. [Brief explanation of the drawing]

[0018]

[0018] The drawings illustrate the design and usefulness of preferred embodiments of the present invention, in which the same elements are given common reference numerals. Note that the drawings are not drawn to a fixed ratio, and elements of the same structure or function are represented by the same reference numerals throughout the drawings. Note that these drawings are intended solely to facilitate the description of the embodiments. They are not intended as an exhaustive description of the present invention or as a limitation of the scope of the present invention as defined only by the appended claims and their equivalents. Furthermore, illustrated embodiments of the disclosed invention do not have to have all the aspects or advantages shown. Aspects or advantages described in relation to a particular embodiment of the disclosed invention are not necessarily limited to that embodiment and may be implemented in any other embodiment even if not shown as such. To better understand how the above and other advantages and advantages of the present invention are obtained, a more specific description of the present invention, as briefly described above, is made by referring to the particular embodiment shown in the appended drawings. Understanding that these drawings depict only typical embodiments of the present invention and should not be considered as limiting its scope, the present invention is described more specifically and in detail by using the following appended drawings. [Figure 1]

[0019] Figure 1 is a side view of a vascular occlusion treatment system constructed according to one embodiment of the present invention, and in particular shows vascular occlusion within a delivery catheter in the delivery configuration. [Figure 2]

[0020] Figure 2 is a side view of the vascular occlusion treatment system shown in Figure 1, and in particular shows the vascular occlusion device in an expanded configuration deployed from the delivery catheter. [Figure 3]

[0021] Figure 3 is a plan view of the vascular occlusion structure of the vascular occlusion treatment system shown in Figure 1, deployed within the aneurysm sac. [Figure 4]

[0022] Figure 4 is a plan view of the mesh portion of the vascular occlusion structure of the vascular occlusion treatment system shown in Figure 1. [Figure 5]

[0023] Figure 5A is a cross-sectional view of one embodiment of the wire used in the mesh portion of FIG. 4.

[0024] Figure 5B is a cross-sectional view of another embodiment of the wire used in the mesh portion of FIG. 4.

[0025] Figure 5C is a cross-sectional view of yet another embodiment of the wire used in the mesh portion of FIG. 4. [Figure 6]

[0026] Figure 6A is a cross-sectional view of one embodiment of the mesh portion of the vascular occlusion treatment system of FIG. 1.

[0027] Figure 6B is a cross-sectional view of another embodiment of the mesh portion of the vascular occlusion treatment system of FIG. 1. [Figure 7A]

[0028] Figure 7A is a fluoroscopic image of a prototype of a vascular occlusion structure constructed in accordance with the present invention. [Figure 7B]

[0029] Figure 7B is a fluoroscopic image of a prototype of another vascular occlusion structure constructed in accordance with the present invention. [Figure 8]

[0030] Figure 8A is an MRI image of a prototype of an aneurysm filled with a conventional Pt / 8W vascular occlusion coil.

[0031] Figure 8B is an MRI image of a prototype of an aneurysm filled with an Au / Pt vascular occlusion coil constructed in accordance with one embodiment of the present invention. [Figure 9]

[0032] Figure 9 is a side view of a vascular occlusion treatment system constructed in accordance with another embodiment of the present invention, and particularly shows a vascular occlusion device within a delivery catheter in a delivery configuration. [Figure 10]

[0033] Figure 10 is a side view of the vascular occlusion treatment system of FIG. 9, and particularly shows a vascular occlusion device in an expanded configuration deployed from the delivery catheter.

Mode for Carrying Out the Invention

[0019]

[0034] An embodiment of a vascular occlusion treatment system 10 constructed according to the present invention will be described with reference to Figures 1 and 2. The vascular occlusion treatment system 10 comprises a delivery catheter 12 and a vascular occlusion assembly 14 slidably disposed within the delivery catheter 12. The vascular occlusion assembly 14 comprises a vascular occlusion structure 16 and a pusher member 18 to which the vascular occlusion structure 16 is detachably connected at a joint 20.

[0020]

[0035] The delivery catheter 12 has a tubular structure and can take the form of, for example, a microcatheter. The delivery catheter 12 comprises an elongated sheath body 22 having a proximal portion 24 and a distal portion 26, and a lumen 28 (shown by a dashed line) extending through the sheath body 22 between the proximal portion 24 and the distal portion 26. The proximal portion 24 of the sheath body 22 remains outside the patient and accessible to the operator when the vascular occlusion treatment system 10 is in use, while the distal portion 26 of the sheath body 22 is of a size and size that can reach distant locations in the vascular system and is configured to deliver the vascular occlusion structure 16 to the aneurysm. The delivery catheter 12 may have at least one port 30 that fluidizes the lumen 28 of the delivery catheter 12 and is used to introduce fluid into the sheath body 22. The vascular occlusion assembly 14 is positioned within the lumen 28 of the delivery catheter 12, as can be clearly seen in Figure 1.

[0021]

[0036] The delivery catheter 12 may include one or more regions along its length having different configurations and / or properties. For example, the distal portion 26 of the sheath body 22 may have a smaller outer diameter than the proximal portion 24 of the sheath body 22 in order to reduce the profile of the distal portion 26 and facilitate navigation in the winding vascular system. Furthermore, the distal portion 26 may be more flexible than the proximal portion 24. Generally, the proximal portion 24 may be formed from a more rigid material than the distal portion 26 of the sheath body 22, so that the proximal portion 24 has sufficient pushability to advance through the patient's vascular system, while the distal portion 26 may be formed from a more flexible material so that the distal portion 26 maintains flexibility to more easily track along the guidewire and access remote locations in winding regions of the vascular system. The sheath body 22 may be composed of a suitable polymer material such as polyethylene or stainless steel, a metal and / or alloy, or other suitable biocompatible material or a combination thereof. In some embodiments, the proximal portion 24 may include a reinforcing layer, such as a braided or coiled layer, to enhance the indentation of the sheath body 22. The sheath body 22 may include a transition region between the proximal portion 24 and the distal portion 26.

[0022]

[0037] Generally, the vascular occlusion structure 16 can be inserted into the patient (e.g., minimally invasively) by inserting the vascular occlusion treatment system 10 into the patient's vascular system to reach the aneurysm site. Therefore, the delivery catheter 12 is made as small as possible and has a very narrow inner diameter (i.e., lumen 28) (e.g., 0.015 inches to 0.025 inches, preferably 0.015 inches to 0.018 inches). The vascular occlusion treatment system 10 can be used in an "over-the-wire" configuration in which the delivery catheter 12 is introduced into the patient via a previously introduced guidewire, and the delivery catheter 12 extends along the entire length of the guidewire (not shown). Alternatively, the vascular occlusion treatment system 10 can be used in a "rapid exchange" configuration in which the guidewire extends only through the distal portion of the vascular occlusion treatment system 10 from a guidewire port (not shown). In other alternative embodiments, the vascular occlusion treatment system 10 may be introduced into the patient after the guidewire has been withdrawn, leaving the distal portion of the sheath or access catheter at the target site, and the vascular occlusion treatment system 10 may be navigated through the patient's vascular system within the sheath or access catheter.

[0023]

[0038] At the aneurysm site, the vascular occlusion structure 16 can be pushed distally through the aneurysm neck N into the aneurysm sac A via a pusher member 18 from a delivery catheter 12 located in the parent vessel V, as shown in Figure 3. After being pushed out from the delivery catheter 12, the vascular occlusion structure 16 can self-expand into a pre-configured form, as described below. Once the vascular occlusion structure 16 is inserted into the aneurysm sac A, it can be detached from the pusher member 18. A sufficient number of vascular occlusion devices 16 can be delivered to fill and occlude the aneurysm sac A. The vascular occlusion structure 16 can also be removed or withdrawn by pulling it proximal to the pusher member 18, folded, and returned to the delivery catheter 12.

[0024]

[0039] The pusher member 18 may be a coil, wire, tendon, etc., having sufficient column strength to push the vascular occlusion structure 16 into the aneurysm sac. The joint 20 to which the pusher member 18 is coupled to the vascular occlusion structure 16 may take the form of an electrolytic segment for electrolytically detaching the vascular occlusion structure 16 from the pusher member 18, but other alternative detachment mechanisms may include mechanical, thermal, and hydraulic mechanisms for detaching the vascular occlusion structure 16 from the pusher member 18.

[0025]

[0040] The pusher member 18 has a proximal portion 32 extending proximal to the proximal portion 24 of the delivery catheter 12, and a distal portion 34 to which the vascular occlusion device 14 is attached. The pusher member 18 may be made of a conventional guidewire, torqueable cable tube, or hypotube. In any case, there are many materials available to make the pusher member 18 achieve the desired properties commonly associated with medical devices. Some examples may include metals, metal alloys, polymers, metal-polymer composites, or any other suitable material. For example, the pusher member 18 may include nickel-titanium alloy, stainless steel, or a nickel-titanium alloy and stainless steel composite. In some cases, the pusher member 18 may be made of the same material along its length, or in some embodiments, it may include parts or sections made of different materials. In some embodiments, the material used to construct the pusher member 18 is selected to give different parts of the pusher member 18 different flexibility and rigidity properties. For example, the proximal and distal portions 34 of the pusher member 18 may be formed from different materials, such as materials with different elastic moduli, resulting in differences in flexibility. For instance, the proximal portion 32 could be made of stainless steel and the distal portion 34 of a nickel-titanium alloy. However, any suitable material or combination of materials can be used for the pusher member 18 as needed.

[0026]

[0041] The vascular occlusion structure 16 is sized for implantation in the aneurysm sac A and can take on any shape or form in cross-section. For example, in the illustrated embodiment, the vascular occlusion structure 16 takes the form of an elastic tubular member having a proximal end 36 and a distal end 38. In this case, the distal end 38 of the vascular occlusion structure 16 is typically free or loose (allowing for maximum expansion), while the proximal end 36 of the vascular occlusion structure 16 is coupled / attached to a pusher member 18. Thus, the distal end 38 of the vascular occlusion structure 16 is free to float. In another example, the vascular occlusion structure 16 can take the form of a flat member with both proximal and distal ends fixed (allowing for minimal expansion). The vascular occlusion structure 16 has a compact delivery configuration when radially constrained within the delivery catheter 12 and is biased to expand radially outward into a deployable configuration when released from the delivery catheter 12 into the aneurysm sac. The cross-sectional dimensions of the vascular occlusion structure 16 in the extended deployment configuration may be, for example, greater than 1.5 times, preferably greater than 2 times, and most preferably greater than 3 times, the cross-sectional dimensions of the vascular occlusion structure 16 in its compact delivery configuration. The extended deployment configuration of the vascular occlusion structure 16 can be pre-configured and may be bent, curved, three-dimensional (e.g., ball-shaped, loop-shaped, etc.) and may include secondary or tertiary structures.

[0027]

[0042] Importantly, the inventors preferably use platinum and 25 × 10⁻¹⁶ by weight. 6It was discovered that a platinum (AuPt) alloy with a Young's modulus of less than pounds per square inch (psi) allows for a suitable vascular occlusion structure 16 to achieve the required softness (e.g., bending stiffness of less than 150 mN / mm), desired length (e.g., above 5 cm), compatibility with small-diameter delivery catheters (e.g., inner diameter of 0.017 inches), sufficient radiopaqueness, sufficient MRI compatibility, and ease of manufacture (e.g., no need for surface oxide removal). Therefore, at least a portion of the vascular occlusion structure 16 is composed of an AuPt alloy. In addition to the AuPt alloy, the vascular occlusion structure 16 may be further composed of iridium and / or tungsten to improve its mechanical properties.

[0028]

[0043] In the embodiments shown in Figures 1 and 2, the entire vascular occlusion structure 14 includes a porous mesh portion 40 made of AuPt alloy, but as will be further detailed below, only a portion of the vascular occlusion structure 16 may include the mesh portion 40. In the illustrated embodiments, the mesh portion 40 is formed by braiding or weaving together wires 42 (e.g., having 8 to 96 wires, typically 16 to 32 wires), but in alternative embodiments, the mesh portion 40 can be formed as a monolithic structure by etching or cutting a pattern from, for example, a tube or sheet of stent material, or by cutting or etching a sheet of material according to a desired pattern and then winding the sheet or otherwise forming it into a desired substantially tubular, branched, or other shape.

[0029]

[0044] The mesh portion 40 may have a desired length (e.g., over 5 cm, 5 cm to 45 cm, 5 cm to 30 cm, etc.). The braid can be braided around a mandrel using a braiding machine (e.g., a mandrel having a circular, elliptical, flat, or other shape depending on the desired final cross-sectional shape of the vascular occlusion structure 16). Alternatively, the wire 42 may be braided into a flat braid, then shaped and heat-set around the mandrel to form a flat braid of a predetermined shape. After braiding, the mesh portion 40 can be heat-set (e.g., at 450°C to 650°C for 1 to 60 minutes). The heat-set braid forms the linear "primary shape" of the mesh portion 40. Next, this heat-set braid can be wrapped around a second mandrel (e.g., a three-dimensional mandrel) and heat-set a second time to give it a three-dimensional "secondary shape" or "tertiary shape".

[0030]

[0045] Each wire 42 may be a monofilament strand, as shown in Figures 5A and 5B, but in an alternative embodiment, each wire 42 may be a multifilament strand, as shown in Figure 5C. Each wire 42 may have any suitable cross-section with any suitable dimensions. For example, if the cross-section of each wire 42 is circular (as shown in Figure 5A), the diameter may be 0.0008 to 0.0040 inches, and if the cross-section of each wire 42 is rectangular (as shown in Figure 5B), the thickness may be greater than 0.0008 inches and the width may be less than 0.005 inches. In another embodiment, each wire 42 may be in the form of a twisted wire (as shown in Figure 5C) to increase the flexibility of the resulting vascular occlusion structure 16.

[0031]

[0046] All wires 42 constituting the mesh portion 40 may be the same size and composition, but it should be understood that the wires 42 may have different sizes and compositions, as long as at least some of the wires 42 constituting the vascular occlusion structure 16 are made of AuPt alloy. Preferably, the unconstrained braiding angle 44 of the mesh portion 40 (i.e., the angle between two intersecting wires 42) is 20° to 130°, more preferably 20° to 60°. Generally, the braiding angle 44 can be the angle between two intersecting wires viewed in the longitudinal direction. Selecting a braiding angle 44 prevents the mesh portion 40 from collapsing, thereby improving the pushability of the vascular occlusion structure 16 within the delivery catheter 12, otherwise the mesh portion 40 would bundle together within the delivery catheter 12 when pushed, causing the vascular occlusion structure 16 to become lodged within the delivery catheter 12. Ultimately, the number of wires 42 within the mesh portion 40, the braiding angle 44, and / or the expanded configuration of the mesh portion 40 relative to its folded configuration can be selected to best fit the inner diameter of the delivery catheter 12 used.

[0032]

[0047] In one embodiment shown in Figure 6A, the mesh portion 40 has an expanded shape that may have a flat shape (e.g., ribbon) with a width of, for example, 0.5 mm to 5.0 mm, while in an alternative embodiment shown in Figure 6B, the mesh portion 40 may have an expanded shape that is cylindrical (i.e., has a circular cross-section) with a diameter of, for example, 0.5 mm to 5.0 mm. Thus, the mesh portion 40 can be a flat blade or a round blade. Through prototyping and testing, the precise composition of the AuPt alloy, the size and number of wires 42 used to construct the mesh portion 40 of the vascular occlusion structure 16, the braiding angle, and the shape and size of the expanded vascular occlusion structure 16 can be optimized to obtain superior performance according to the requirements of the target application.

[0033]

[0048] For example, one prototype of a relatively soft, long, but radiopaque vascular occlusion device was constructed by braiding 24 wires into a flat braid 1.25 mm wide and 25 cm long at a 32° braiding angle, with each wire composed of AuPt34 with a Young's modulus of 19 Msi and a wire diameter of 0.001 inches. The vascular occlusion material could be delivered with a frictional force of less than 0.06 pounds via an Excelsior SL-10™ microcatheter (outer diameter 0.026 inches and inner diameter 0.0165 inches) and demonstrated good shape retention, good bending stiffness (44.45 mN / mm), and good radiopaqueness at an X-ray energy of 82 kVp, as shown in Figure 7A.

[0034]

[0049] As another example, a different prototype of a relatively soft, long, but radiopaque vascular occlusion device was constructed by braiding 24 wires into a flat braid 1.25 mm wide and 25 cm long at a 32° braiding angle, with each wire composed of AuPt29 with a Young's modulus of 17 Msi and a wire diameter of 0.00115 inches. The vascular occlusion material was deliverable via an Excelsior SL-10™ microcatheter (0.026 inch outer diameter and 0.0165 inch inner diameter) with a frictional force of less than 0.06 pounds and demonstrated good shape retention, good bending stiffness (67.33 mN / mm), and good radiopaqueness at an X-ray energy of 82 kVp. Note that although this vascular occlusion device is not as soft as the previously described vascular occlusion device (67.33 mN / mm vs. 44.45 mN / mm), it exhibits superior radiopaqueness, as shown in Figure 7B.

[0035]

[0050] As another example, the MR compatibility characteristics of a prototype spirally wound coil-shaped vascular occlusion device made of AuPt29 were compared with those of a conventional spirally wound coil made of Pt / 8W. A 6mm aneurysm was filled with the AuPt29 vascular occlusion coil at a packing density of 35%, and the area was imaged using 3T MRI (see Figure 8B). On the other hand, the same 6mm aneurysm was filled with the conventional Pt / 8W vascular occlusion coil at a packing density of 35%, and the area was imaged using 3T MRI (see Figure 8A). As can be seen, the MRI images of the conventional Pt / 8W vascular occlusion coil have artifacts such as interface artifacts, but the MRI images of the novel AuPt29 vascular occlusion coil are advantageously free of such interface artifacts.

[0036]

[0051] As briefly described above, only a portion of the vascular occlusion structure 16 may include the mesh portion 40. For example, another embodiment of a vascular occlusion treatment system 10' constructed according to the present invention will be described with reference to Figures 9 and 10. The vascular occlusion treatment system 10' is similar to the vascular occlusion treatment system 10, except that the vascular occlusion structure 16' comprises a central mesh portion 40' and two helically wound coil portions 39a, 39b positioned at both ends of the central mesh portion 40'. The central mesh portion 40' can be constructed in the same manner as the mesh portion 40 described with reference to Figures 1 and 2. Preferably, the coil portions 39a, 39b are made of an AuPt alloy. It should be noted that the coil portions 39a, 39b provide the vascular occlusion structure 16' with additional non-traumatic properties.

[0037]

[0052] Although the vascular occlusion structures 16 and 16' shown in Figures 1-2 and 9-10 are described as having a single layer of braiding, it should be understood that the vascular occlusion structure may have multiple layers of braiding (i.e., a blade-over-blade structure), or it may have a single layer of braiding (e.g., an outer braid) and a coil layer (e.g., an inner coil) (i.e., a blade-over-coil structure). In any case, all layers of the vascular occlusion structure are preferably made of AuPt alloy.

[0038]

[0053] While specific embodiments of the invention disclosed herein have been shown and described, they are not intended to limit the invention, and it will be apparent to those skilled in the art that various changes and modifications (e.g., dimensions of various parts) can be made without departing from the scope of the disclosed invention, which should be defined solely by the appended claims and its equivalents. Therefore, this specification and the drawings should be taken as illustrative, not restrictive. The various embodiments of the disclosed invention shown and described herein are intended to cover alternatives, modifications, and equivalents of the disclosed invention that may fall within the scope of the appended claims.

Claims

1. A vascular occlusion device, A vascular occlusion device comprising an elongated vascular occlusion structure configured to be implanted into an aneurysm sac, wherein the vascular occlusion structure becomes a delivery configuration when confined within a delivery catheter and becomes an unfolded configuration when released from the delivery catheter into the aneurysm sac, and at least a portion of the vascular occlusion structure is made of a gold-platinum (AuPt) alloy.

2. The vascular occlusion device according to claim 1, wherein the AuPt alloy contains 25% to 40% by weight of platinum.

3. The AuPt alloy is 25 × 10 ６ Pounds per square inch (psi) (17225 x 10 ４ A vascular occlusion device according to claim 1 or 2, having a Young's modulus less than kPa.

4. The vascular occlusion device according to any one of claims 1 to 3, wherein the vascular occlusion structure includes a mesh portion made of the AuPt alloy.

5. The vascular occlusion device according to claim 4, wherein the mesh portion is a braided portion.

6. The vascular occlusion device according to claim 4, wherein the entire vascular occlusion structure includes the mesh portion.

7. The vascular occlusion device according to claim 4, wherein the vascular occlusion structure further includes two spirally wound coil portions positioned at both ends of the mesh portion.

8. The vascular occlusion device according to claim 7, wherein each of the two helically wound coil portions is made of an AuPt alloy.

9. The vascular occlusion device according to any one of claims 4 to 8, wherein the mesh portion includes at least one wire having a minimum cross-sectional dimension in the range of 0.0008 to 0.004 inches (0.02032 to 0.1016 mm).

10. The vascular occlusion device according to any one of claims 4 to 9, wherein the mesh portion includes at least one twisted strand.

11. The vascular occlusion device according to any one of claims 4 to 10, wherein the mesh portion has 8 to 96 wires.

12. The vascular occlusion device according to claim 11, wherein the mesh portion has 16 to 32 wires.

13. The vascular occlusion device according to any one of claims 4 to 12, wherein the mesh portion has an unrestrained braiding angle of 20° to 60°.

14. The vascular occlusion device according to any one of claims 4 to 13, wherein the mesh portion has an expanded shape having a circular cross-section.

15. The vascular occlusion device according to any one of claims 1 to 13, wherein the mesh portion has an expanded shape with a rectangular cross-section.

16. The vascular occlusion device according to claim 15, wherein the cross-section of the rectangular part has a width of 1.0 mm to 2.0 mm.

17. The vascular occlusion device according to claim 15 or 16, wherein the mesh portion has a bending rigidity of less than 150 mN / mm.

18. The vascular occlusion device according to any one of claims 1 to 17, wherein the vascular occlusion structure is further composed of iridium and tungsten, or both.

19. A vascular occlusive device delivery system, A vascular occlusion device according to any one of claims 1 to 18, A vascular occlusive device delivery system characterized by comprising a pusher member assembly having a distal end portion to which the vascular occlusive device is detachably coupled.

20. The vascular occlusion device delivery system according to claim 19, further comprising a delivery catheter on which the pusher member assembly is arranged.

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