Vascular occlusion device, method for manufacturing the same, and method for using the same

Abstract

The vaso-occlusive device includes a wire having a primary configuration in a constrained state. The wire forms a secondary configuration in a relaxed, unconstrained state. The secondary configuration includes a pyramidal shaped portion including a plurality of distal coils. Each distal coil is wound from the wire, the windings having a tapered circumference from the interior to the exterior of the pyramidal shaped portion, and transition segments of wire between each distal coil connecting each distal coil. The plurality of distal coils are arranged in a pyramidal shape such that each coil is on a different side of the pyramidal shape. The vaso-occlusive device may also include a body portion proximal to and extending proximally from the pyramidal shaped portion formed from the wire.

Description

Technical Field

[0001] The present disclosure generally relates to medical devices and endovascular medical procedures, and more particularly, to devices for occluding vascular disorders such as aneurysms, and methods for manufacturing and using such devices.

Background Art

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

[0003] Generally used vascular occlusion devices include soft, helically wound coils 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 impart 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 as if fully set forth herein) describes a vascular occlusion device that assumes a linear, helical primary shape when stretched for placement through the lumen of a delivery catheter and a folded, complex secondary shape when released from the delivery catheter and placed in the vascular system. A complex three-dimensional secondary shape can be imparted to the vascular occlusion device to more appropriately frame and fill an aneurysm, and the rigidity / flexibility of the vascular occlusion device can be changed.

[0004] To deliver a vascular occlusion device to a desired site within the vascular system, such as the aneurysm sac, it is known that a small-profile delivery catheter or "microcatheter" is first positioned at that site using a guidewire. Generally, the distal end of the microcatheter is provided with a selected pre-formed bend, such as 45°, 26°, "J"-shaped, "S"-shaped, or other bends, depending on the patient's specific anatomical structure, by the attending physician or manufacturer, 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. Subsequently, the delivery assembly or "pusher" assembly or "wire" is passed through the microcatheter until the vascular occlusion device, coupled to the distal end of the delivery assembly, extends from the distal end opening of the microcatheter into the aneurysm sac. Once inside the aneurysm sac, a portion of the vascular occlusion device may be deformed or bent to allow for 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 pushed through a microcatheter and released into the same aneurysm sac.

[0005] Fluoroscopy is typically used to visualize the occlusion device during delivery into the aneurysm, while magnetic resonance imaging (MRI) is typically used to visualize the treated site after the procedure (e.g., several weeks after initial treatment of the aneurysm) to confirm that the aneurysm sac is properly occluded. For this reason, it is important that the occlusion device is constructed to allow for its radiopaqueness during aneurysm treatment while minimizing artifacts that interfere with visualization during post-procedure MRI (i.e., being MRI-compatible). Furthermore, it is preferable that such occlusion devices be "soft" (i.e., laterally flexible or adaptable) and thus non-traumatic to prevent rupture of the delicate tissue of the aneurysm.

[0006] Furthermore, it is crucial that such vascular occlusion devices remain within the aneurysm for extended periods. However, aneurysms with large openings, commonly known as "platycervical aneurysms," are difficult to position and retain vascular occlusion devices within the aneurysm sac, and small, relatively thin vascular occlusion coils, in particular, lack sufficient mechanical strength to maintain their position within such aneurysm sacs, no matter how skillfully they are placed. For example, small aneurysms (e.g., those with a diameter of less than approximately 7 mm, or even smaller, less than approximately 5 mm) often feature a wide neck and a short dome. More specifically, small aneurysms often have a relatively wide neck compared to the size of the aneurysm (i.e., the ratio of neck width to aneurysm diameter is often larger in small aneurysms compared to such a ratio in larger aneurysms). Due to the relatively wide neck, small aneurysms (generally platycervical aneurysms) are at high risk of coil dislodgement into the parent vessel both during placement and retention. Figure 1 shows a portion of the vascular occlusion coil dislodgement outside the aneurysm after implantation. Several placement techniques have been developed to mitigate coil dislodgement during placement. One such placement technique is called "indwelling technique," which uses a balloon or stent placed in a vessel adjacent to the neck region of the aneurysm to prevent the occluding coil from exiting the aneurysm sac. Figure 2 shows the indwelling technique using a balloon-actuated catheter. The balloon-actuated catheter is used to deploy a balloon adjacent to the neck region of the aneurysm. The balloon prevents the coil from dislodging from the aneurysm as it is implanted in the aneurysm. However, as shown in Figure 2, this technique carries the risk that the balloon will push the tip of the catheter into the dome of the aneurysm, causing it to rupture. Figure 3 shows the indwelling technique using a stent. The stent is placed and expanded around the neck of the aneurysm to prevent the coil from exiting the aneurysm sac. Similar to balloon-actuated catheters, the stent technique also carries the risk of pushing the tip of the catheter into the dome of the aneurysm, causing it to rupture. Figure 4 shows another placement technique for implanting a vascular occluding device called "ReCross." In this technique, a delivery catheter extends through the opening of the stent.A stent can prevent the coil from protruding outside the aneurysm sac. However, because the positioning of the delivery catheter through the stent opening is inherently unpredictable, there is a risk that the catheter tip may be pushed into the dome during the operation to guide and position the delivery catheter, thereby rupturing the aneurysm.

[0007] To address these detachment and implantation problems, vascular occlusion coils have been developed that offer higher neck coverage and morphological stability to effectively "frame" aneurysms. However, the three-dimensional shape of current vascular occlusion devices is either unsuitable for framing aneurysms or prone to detachment during deployment into the aneurysm. Small aneurysms are best treated with as few coils as possible, and current vascular occlusion devices cannot balance morphological stability and flexibility on their own. In fact, the shape and configuration of current vascular occlusion devices result in a direct correlation between morphological stability and flexibility. That is, the more flexible the device (i.e., the lower its resistance to deformation by external forces), the less stable the device, and vice versa (i.e., the less flexible the device, the more stable the shape of the vascular occlusion device). Therefore, softer coils are less likely to rupture an aneurysm, but because they cannot maintain their shape, detachment from the aneurysm is more likely to occur during deployment and / or retention. Conversely, the stiffer the coil, the better it can maintain its shape and frame the aneurysm, but it also places high stress on the aneurysm wall, increasing the risk of rupture of the aneurysm, especially small aneurysms that are at high risk of rupture. Furthermore, particularly with the complex external shapes employed in current designs, the initial distal loops (e.g., the first and second loops) are more likely to detach from the aneurysm by being pushed out by the subsequent loops during deployment.

[0008] Therefore, there is a need for a vascular occlusion device that can mitigate the problem of detachment during placement and retention, provide effective framing of the aneurysm, and have a sufficiently soft and flexible structure that does not rupture the aneurysm, especially small bladder aneurysms. [Overview of the project]

[0009] According to one aspect of the medical devices and endovascular medical procedures of this disclosure, the vascular occlusion device includes an elongated vascular occlusion device (e.g., 0.5 to 100 cm in length) configured to be implanted in an aneurysm sac. The vascular occlusion devices disclosed herein are not limited to being configured and used to treat small broad-necked aneurysms, but are particularly well suited to such configurations and uses. The vascular occlusion device typically has a delivery configuration (having a primary shape) when constrained within a delivery catheter and a deployment configuration (having a secondary shape different from the primary shape) when released from the delivery catheter into the aneurysm sac.

[0010] The vascular occlusion device includes a wire having a primary configuration in a constrained state. For example, the primary configuration can be the shape of the wire when constrained within the delivery catheter, such as a helical coil shape or a linear shape. The wire is also configured to form a secondary configuration in a relaxed, unconstrained state, such as when the wire is released from the delivery catheter without any external force acting on it.

[0011] The secondary configuration of the wire provides a balanced solution between morphological stability and flexibility, ensuring that the vascular occlusion device has a stable shape that prevents detachment during deployment and retention, while also providing effective framing of the aneurysm, and sufficient flexibility to avoid aneurysm rupture. The pyramidal shape has an inherent ability to effectively dissipate forces applied to its apex, thereby reducing the risk of excessive force acting on the aneurysm wall that could rupture the aneurysm. Specifically, the secondary configuration includes a pyramidal section with multiple distal coils wound from the wire. Each distal coil includes a winding that forms a closed loop of more than 360°, and the winding has an outer circumference that tapers from the inside outward from the inside of the pyramidal section. For example, in the case of a spiral coil winding, the diameter of the coil increases outward so that the inner portion of the coil loop has a smaller diameter than the outer portion of the coil loop. Each distal coil also includes transition segments of wire between each distal coil, connecting each distal coil to one or more adjacent distal coils.

[0012] Multiple distal coils are arranged in a pyramidal shape such that each coil is located on a different side of the pyramidal shape and is parallel to the side. For clarity, there are no distal coils on the base of the pyramidal shape. For example, the pyramidal shape is a tetrahedron with a base and three sides connected to its vertices, where each edge of the base and each vertex forms a triangle, and each triangle defines one of the three sides. The base portion of the pyramidal shape can form the main body portion, which is described below.

[0013] Furthermore, the secondary structure also includes a main body portion located proximal to the pyramidal portion. The main body portion is formed from wire and includes a coil that extends proximal to the pyramidal portion. For example, the main body portion can extend proximal to the base of the pyramidal shape.

[0014] In another embodiment, a pyramidal shape is a polyhedron formed from a polygonal base with n edges and n faces connected to the vertices, such as a tetrahedron (triangular base and three sides, also called a triangular pyramid), a pentahedron (square base and four sides, also called a square pyramid or rectangular pyramid), or a hexahedron (pentagonal base and five sides, also called a pentagonal pyramid).

[0015] In yet another embodiment, each distal coil may include at least 1+2 / 3 loops or turns (600° windings), or 1+2 / 3 loops to 2+2 / 3 loops (960° windings). In yet another feature, the distal coils overlap at the transition from one distal coil to an adjacent distal coil. In other words, the transition segment overlaps the coil as it extends from one distal coil to a subsequent adjacent coil.

[0016] In another embodiment, the primary configuration includes an elongated helical coil. The helical coil has an outer diameter (OD) configured to fit within the lumen of a suitable delivery catheter for deployment. Typically, the elongated helical coil has zero pitch between each loop of the coil, providing the most compact coil. Alternatively, the elongated helical coil may have a non-zero pitch or a varying pitch.

[0017] In another embodiment of the vascular occlusion device, the wire may be formed from a shape memory material, and the secondary configuration may be set by winding the wire around a mandrel and heat-treating the wire wound around the mandrel.

[0018] In another embodiment, each distal coil may have a coil diameter (the diameter of the innermost loop of each distal coil) of 10 to 90 percent of the diameter of the aneurysm for which the device is designed to treat, or alternatively, a coil diameter (the diameter of the innermost loop of each distal coil) of 55 to 85 percent of the diameter of the aneurysm for which the device is designed to treat.

[0019] In another embodiment of the vascular occlusion device, the primary shape has a longitudinal length of 1 to 70 cm.

[0020] Methods for manufacturing any of the vascular occlusive devices described herein, as well as mandrels used for manufacturing vascular occlusive devices, are also disclosed. In one method for manufacturing a vascular occlusive device using a mandrel, a mandrel for forming a vascular occlusive device is provided. This mandrel comprises a central spherical element. From this central spherical element, a number of distal coil posts extend. The distal coil posts are arranged at angular intervals around the spherical element. Each distal coil post has a cross-sectional diameter that tapers outward as the distal coil post extends away from the spherical element. Each distal coil post also has a longitudinal axis, and the longitudinal axis is oriented such that each plane perpendicular to the respective longitudinal axis has an intersection line that forms a pyramidal shape with a vertex distal to the distal coil post.

[0021] Furthermore, the mandrel also has a body post extending from the spherical element. Typically, the body post extends proximal to the spherical element.

[0022] The wire having the primary structure is then wound around a mandrel. The wire can be formed from a shape memory material. The primary structure may be the configuration of the wire in a constrained state, such as within a sheath or delivery catheter, and can have any suitable shape, such as a helical coil.

[0023] The wire is wound in a first direction around a first distal coil post of a plurality of distal coil posts, and then wound inward toward the intersection of the first distal coil post and the spherical element, forming a first loop (600°) of at least 360° or at least 1+2 / 3 around the first distal coil post. In this specification, the winding "direction" is the relative direction when viewed inward along the winding axis toward the mounting position of the winding post to the central spherical element or other central structure. After the wire is wound around the first distal coil post, the wire traverses along the spherical element in a first transition segment to the next distal coil post immediately adjacent to the first distal coil post of the plurality of posts. Subsequently, the wire is wound around the next distal coil post in a second direction opposite to the first direction, starting from the intersection of the next distal coil post and the spherical element, forming a next loop of at least 1+2 / 3 around the next distal coil post, and then traversed along the spherical element in the next transition segment to the next distal coil post immediately adjacent to the preceding distal coil post. The process of winding the wire around each distal coil post in alternating winding directions from the preceding distal coil post to the subsequent distal coil post is then repeated for each distal coil post. After winding the wire around the last distal coil post, the wire transitions along the spherical element to the main post. The wire is then wound around the main post for at least one loop.

[0024] In another embodiment of the method for manufacturing a vascular occlusion device, a wire wound around a mandrel is heat-treated to set the secondary configuration of the vascular occlusion device. In yet another embodiment, the secondary configuration is a relaxed, unrestrained configuration of the wire.

[0025] In yet another embodiment of the method for manufacturing a vascular occlusion device, the secondary configuration includes a pyramidal portion and a body portion located proximal to the pyramidal portion. The pyramidal portion includes a plurality of distal coils wound from wire around each distal coil post. Each distal coil includes a winding that forms a closed loop greater than 360°, or a closed loop of at least 1+2 / 3 loops, and the winding has an outer circumference tapered from the inside outward from the pyramidal portion. Between each distal coil, there are also transition segments of wire connecting each distal coil. The plurality of distal coils are arranged in a pyramidal shape such that each coil is located on a different side of the pyramidal shape. The body portion includes a coil located proximal to the pyramidal portion, formed from wire wound around the body post, and extending proximal to the pyramidal portion.

[0026] In another aspect of this method, the pyramidal shape is a polyhedron formed from a polygonal base with n edges and n faces connected to the vertices, such as a tetrahedron (triangular base and three sides, also called a triangular pyramid), a pentahedron (square / quadrilateral base and four sides, also called a square pyramid), or a hexahedron (pentagonal base and five sides, also called a pentagonal pyramid).

[0027] In yet another embodiment, each distal coil may contain at least 1+2 / 3 loops or turns, or 1+2 / 3 loops to 2 loops. In yet another embodiment, each transition segment crosses over at least a portion of a loop, from which the transition segment transitions so that the distal coils overlap in the transition from one distal coil to an adjacent distal coil. In other words, the transition segment overlaps the coil as it extends from one distal coil to a subsequent adjacent coil.

[0028] In another aspect, the primary configuration includes an elongate helical coil. The helical coil has an outer diameter (OD) configured to fit within the lumen of a suitable delivery catheter for deploying the catheter. Typically, the elongate helical coil has a pitch of zero between each loop of the coil, providing the most compact coil. Alternatively, the elongate helical coil can have a non-zero pitch or a varying pitch.

[0029] In yet another aspect of the method, each post can have a cross-sectional diameter that outwardly expands at an angle of about 5 to 15 degrees or about 1 to 30 degrees as the post extends away from the spherical element.

[0030] In a further aspect of the devices disclosed herein, the vascular occlusion device disclosed herein can be part of a vascular occlusion system that includes a vascular occlusion assembly and a delivery assembly. For example, the vascular occlusion assembly can include any of the vascular occlusion devices described herein and a pusher member detachably coupled to the proximal end of the vascular occlusion device. The pusher member is configured such that a clinician can advance the vascular occlusion device through the patient's vasculature along a delivery catheter to a target site, such as an aneurysm to be treated with the vascular occlusion device, and deploy the vascular occlusion device by extruding the vascular occlusion device from the distal end of the delivery catheter.

[0031] In yet another aspect, the vascular occlusion assembly can also include a separation device that detachably couples the pusher member to the vascular occlusion device. For example, the separation device can include electrolytic separation, mechanical connectors, thermally actuated separation, dissolution separation, and the like. The delivery assembly can include a delivery catheter through which the vascular occlusion device can be introduced in its compact delivery configuration. The delivery assembly can also include a guide wire for guiding the delivery catheter to a target implantation site within the patient's vasculature, such as an aneurysm. Thereafter, the guide wire is removed and the vascular occlusion device is advanced through the delivery catheter to the target implantation site. [[ID=I4]]

[0032] In yet another aspect of this disclosure, the devices disclosed herein are not limited to vascular occlusion devices, but may be any medical device having the same or similar structure as the vascular occlusion devices disclosed herein. For example, the medical device may be any suitable thrombectomy device, stent retriever, embolic filter, stent delivery system, other implantable device, guidewire, intravascular device, or other medical device.

[0033] Methods for deploying either the vascular occlusion devices or other medical devices disclosed herein into anatomical cavities such as aneurysms are also disclosed. In one method, the vascular occlusion device is deployed using a delivery catheter. The delivery catheter is first inserted into the patient's vascular system and advanced within the vascular system, with its distal end positioned at the target insertion site. In this example, the target insertion site is an aneurysm. It should be understood that the target insertion site may be any suitable anatomical site or cavity within the vascular system where the vascular occlusion device is deployed. If a guidewire is used, the guidewire is first inserted into the patient's vascular system and advanced through the vascular system to the site of the aneurysm. The delivery catheter is then advanced along the guidewire to the aneurysm, after which the guidewire is removed.

[0034] Subsequently, the vascular occlusion device is inserted into the delivery catheter in its compact delivery configuration and advanced along the delivery catheter until the distal end of the vascular occlusion device is positioned at the target insertion site. The vascular occlusion device is then pushed distally from the delivery catheter, for example, by using a pusher member detachably attached to the proximal end of the vascular occlusion device. First, the portion of the vascular occlusion device with its compact delivery configuration (e.g., a spiral coil) including the distal coil is advanced from the delivery catheter into the aneurysm sac. Once this portion, including the distal coil, exits the delivery catheter and enters the aneurysm, it takes on a secondary configuration including the distal coil. As the vascular occlusion device continues to advance outside the delivery catheter, the main body also advances into the aneurysm sac. Once the entire vascular occlusion device is inserted into the aneurysm sac, it can be detached from the pusher member, for example, by activating or activating a separation device. The vascular occlusion device in the secondary configuration has a stable shape with inwardly facing loops. Due to its outwardly tapered diameter, each loop or turn of the distal coil faces inward. In other words, the surface of the loop is oriented inward toward the pyramidal geometric interior of the pyramidal portion. The inwardly oriented loop tends to avoid dislodgement from the aneurysm during deployment and retention, and the pyramidal configuration of the distal coil also provides shape stability that effectively frames the aneurysm, while also exhibiting a soft and flexible structure that avoids excessive force acting on the wall that could rupture the aneurysm.

[0035] In some cases, a single occlusive device may be sufficient to fill and occlude an aneurysm. If multiple occlusive devices are needed, this process can be repeated to deliver enough devices to fill and occlude the aneurysm.

[0036] Thus, there is a need for a vascular occlusion device that can mitigate the problem of detachment during placement and retention, provide effective framing of the aneurysm, and at the same time have a sufficiently soft and flexible structure that does not rupture the aneurysm, especially small bladder aneurysms.

[0037] Other and further embodiments and features of the disclosed invention will become apparent from the following detailed description with reference to the accompanying drawings. [Brief explanation of the drawing]

[0038] The drawings illustrate the design and usefulness of various embodiments of the devices and methods disclosed herein, with similar elements denoted by common reference numerals. Note that the drawings are not drawn to scale, and elements of similar structure or function are indicated by the same reference numerals throughout the drawings. Also note that the drawings are intended solely to facilitate the explanation of various embodiments of the disclosed technology. They are not intended to be an exhaustive description of the technology or a limitation of its scope, and the scope of the technology is defined solely by the appended claims and their equivalents. Furthermore, exemplary embodiments of the disclosed technology do not necessarily have all embodiments or advantages disclosed or described herein. Embodiments or advantages described in relation to a particular embodiment of the disclosed technology are not necessarily limited to that embodiment and may be implemented in any other embodiment, even if not so illustrated. To better understand how the above and other advantages and objectives of the technology are obtained, a more specific description of the technology, as briefly described above, will be provided by referring to the specific examples illustrated in the appended drawings. With understanding that these drawings and corresponding descriptions only illustrate exemplary embodiments of the disclosed technology and should not be considered to limit its scope, the technology will be described and presented in more specific and detailed terms through the use of the accompanying drawings.

[0039] [Figure 1] Figure 1 is a side cross-sectional view of the delivery catheter deploying the vascular occlusion device, showing the vascular occlusion device in a detached state. [Figure 2] Figure 2 is a cross-sectional side view of a delivery catheter used to deploy a vascular occlusion device and a balloon-actuated catheter used in implantation techniques. [Figure 3] Figure 3 shows a cross-sectional side view of a delivery catheter used to deploy a vascular occlusion device and a stent used in the implantation technique. [Figure 4] Figure 4 shows a cross-sectional side view of a delivery catheter used to deploy a vascular occlusion device and a stent used in the ReCross technique. [Figure 5] Figure 5 is a side perspective view of a vascular occlusion device in a relaxed deployment configuration. [Figure 6] Figure 6 is a simplified top perspective view of the intersecting plane of the three distal coils in Figure 5 that form the pyramidal portion of the pyramidal occlusion device. [Figure 7] Figure 7 is a simplified top perspective view of the intersecting plane of the four distal coils that form the pyramidal portion of a pyramidal occlusion device. [Figure 8] Figure 8 is a side view of the distal coil post for forming the distal coil, illustrating the taper angle for the coil loop. [Figure 9] Figure 9 is a side perspective view of an example of an alternative pyramidal portion of the vascular occlusion device of Figure 5, in which the distal coil has various diameters and various numbers of turns. [Figure 10] Figure 10 is a side perspective view of an exemplary mandrel for manufacturing the vascular occlusion device shown in Figure 5. [Figure 11] Figure 11 is a side perspective view of an exemplary mandrel for manufacturing a vascular occlusion device having four distal coils forming a pyramidal portion of a square-shaped structure. [Figure 12] Figure 12A is a top perspective view of the mandrel from Figure 10 with wire wound around it to manufacture the vascular occlusion device shown in Figure 5. Figure 12B is a side perspective view of the mandrel from Figure 12A with wire wound around it to manufacture the vascular occlusion device shown in Figure 5. [Figure 13] Figure 13 is a flowchart showing a method for manufacturing the vascular occlusion device described herein using the mandrel described herein. [Figure 14]Figure 14A is a cross-sectional side view of a vascular occlusion system including the vascular occlusion device of Figure 5 in a delivery configuration constrained within a delivery catheter. Figure 14B is a cross-sectional side view of the vascular occlusion system of Figure 14A, with the vascular occlusion device deployed from the delivery catheter in its expanded deployment configuration. [Figure 15] Figure 15 is a cross-sectional side view showing a guidewire being advanced into a portion of the patient's vascular system to the location of the aneurysm. [Figure 16] Figure 16 is a cross-sectional side view showing the guidewire and the patient's vascular system as the delivery catheter is advanced along the guidewire, as shown in Figure 15. [Figure 17] Figure 17 is a cross-sectional side view showing the vascular occlusion system from Figures 14A and 14B advancing within the delivery catheter from Figure 16 in order to deploy the vascular occlusion device into the aneurysm. [Figure 18] Figure 18 is a cross-sectional side view showing the vascular occlusion system of Figures 14A and 14B, with the vascular occlusion device deployed into the aneurysm from the delivery catheter shown in Figure 16. [Figure 19] Figure 19 is a flowchart illustrating an exemplary method for deploying the vascular occlusion device disclosed herein into an aneurysm using the vascular occlusion systems of Figures 14A and 14B. [Modes for carrying out the invention]

[0040] Referring to Figure 5, an example of the vascular occlusion device 100 disclosed herein is shown. Figure 5 shows the vascular occlusion device 100 in a relaxed, unrestrained secondary configuration. In other words, Figure 5 shows the vascular occlusion device 100 when no external force is acting on it. The secondary configuration of the vascular occlusion device 100 has a distal pyramidal portion 104 and a proximal body portion 106, with the distal pyramidal portion 104 being distal to the proximal body portion 106. In this specification, the terms “distal” and “proximal” are relative to the vascular occlusion device 100 as it is intended to be deployed, with “distal” referring to the end of the device 100 that is first inserted and “proximal” referring to the end of the device 100 that is last inserted.

[0041] The vascular occlusion device 100 includes a wire 102 having a primary configuration of a constrained configuration. For example, the constrained configuration may be an elongated helical coil when the wire 102 is constrained within the delivery catheter (see Figure 14A). Typically, the primary configuration has a longitudinal length of 1 cm to 70 cm. The wire 102 can be made from any suitable material, but is typically formed from platinum group metals including platinum, rhodium, palladium, and rhenium, and radiopaque shape memory materials such as tungsten, gold, silver, tantalum, and their alloys.

[0042] The pyramidal portion 104 of the secondary configuration of the vascular occlusion device 100 is formed by the distal portion of the primary configuration of the vascular occlusion device 100 (see Figure 14A). The pyramidal portion 104 includes a plurality of distal coils 108 wound from a wire 102. In the example shown in Figure 5, the pyramidal portion 104 includes three distal coils 108a, 108b, and 108c arranged to form a pyramidal shape with three sides, also called a triangular pyramid, as the base (the distal coils 108 do not include the distal coils at the base of the pyramidal shape) is triangular and each coil 108 is located on each side of the triangular pyramid. The planes on which each distal coil 108 is located are not parallel to each other but intersect each other. As shown in Figure 6, simplifying the intersecting planes of the distal coils 108 forms a tetrahedron, more specifically, a triangular pyramid. The vascular occlusion device 100 in Figure 5 is an example and is not limited to distal coils 108 forming a triangular pyramidal shape. Other suitable pyramidal shapes may also exist, for example, n distal coils 108 forming a pyramid having a polygonal base with n sides and n sides connected to the vertices. For example, the vascular occlusion device 100 may have distal coils 108 on each side of such pyramidal shapes, such as a square pyramid with a square base and four sides, a square pyramid with a square base and four sides, or a pentagonal pyramid with a pentagonal base and five sides. As shown in Figure 7, the pyramidal portion 104 may have four distal coils 108 on each side arranged to form a square pyramid with a square base and four sides.

[0043] Returning to Figure 5, each distal coil 108 includes a winding that forms a closed loop of more than 360°, i.e., at least a complete closed loop. In the illustrated vascular occlusion device 100, each distal coil 108 includes a winding of 1+2 / 3 loops (also called "turns"), which corresponds to a 600° winding. Alternatively, each distal coil 108 may have at least 1+2 / 3 turns, or turns between 1+2 / 3 turns (600°) and 2 turns (720°).

[0044] Each distal coil 108 winding also has a tapered width that widens outward from a reference point inside the pyramidal portion. In the case of a helical coil as shown in the example in Figure 5, the width of each distal coil 108 is the diameter of the coil. If the distal coil 108 is wound in various shapes such as a square, pentagon, or other polygon or curved shape, the width may be an average width, such as the average of the maximum and minimum widths drawn through the geometric center of the shape. Returning to the example in Figure 5, the diameter of each distal coil 108 is tapered such that the diameter of the outer portion of the coil 108 is greater than the diameter of the inner portion of the coil 108. This can be better illustrated by referring to the cross-section of the cylindrical post on which the distal coil 108 is wound, as shown in Figure 8. The post has a diameter that widens outward from the inner portion to the outer portion of the post, as shown in Figure 8. The taper angle 114 of the post defines the taper angle of the distal coil 108 in the secondary configuration of the vascular occlusion device 100. Due to the outwardly tapered diameter, each loop or turn of the distal coil 108 is oriented inward. In other words, the surface of the loop is oriented inward toward the pyramidal geometric interior of the pyramidal portion 104.

[0045] Each distal coil 108 has a diameter of 10 to 90 percent of the diameter of the aneurysm for which the vascular occlusion device 100 is designed to treat (defined as the diameter of the innermost loop of each distal coil 108). Alternatively, the diameter of each distal coil 108 may be 55 to 85 percent of the diameter of the aneurysm for which the vascular occlusion device 100 is designed to treat.

[0046] In an alternative design of the vascular occlusion device 100, the distal coils 108 may have different diameters and / or different numbers of turns of the wire 102, as shown in Figure 9. As shown in Figure 9, the first distal coil 108a has a larger diameter and more turns of wire 102 (3 turns, i.e., 1080°) than the second distal coil 108b, which has 1+2 / 3 turns (600°). Similarly, the third distal coil 108c also has a larger diameter than the second distal coil 108b (with the same diameter as the first distal coil 108a but with 1+2 / 3 turns (600°)).

[0047] Furthermore, the pyramidal section 104 includes each transition segment 110 of the wire 102, which lies between adjacent distal coils 108 and connects them to one another. Each transition segment 110 extends from the end of one distal coil 108 to the beginning of the subsequent distal coil 108. That is, transition segment 110a extends from the end of distal coil 108a to the beginning of distal coil 108b, and transition segment 110b extends from the end of distal coil 108 to the beginning of distal coil 108c. There is also a transition segment 112 from the end of the winding of the last distal coil 108c to the beginning of the main body section 106.

[0048] The main body portion 106 includes a winding of wire 102 extending proximal from the pyramidal shape 104. The main body portion 106 can extend from the hypothetical base of the pyramidal shape portion 104. In the example shown in Figure 5, the main body portion 106 is a helical coil extending proximal from the pyramidal shape portion 104. The main body portion 106 can have a constant diameter, or alternatively, it can have a diameter that tapers outward or inward as it extends proximal from the pyramidal shape portion 104. The main body portion 106 comprises at least one complete loop of wire 102. The main body portion 106 does not have a maximum number of turns and can include any appropriate number of turns, such as 1 to 20 turns. The main body portion 106 shown in Figure 5 has about two complete turns of wire 102. The main body portion 106 shown in Figure 9 has about four complete turns of wire 102.

[0049] Referring to Figure 10, an exemplary mandrel 200 for manufacturing the vascular occlusion device 100 using method 300 (described later) is shown. The mandrel 200 is used to wind the wire 102 to form the secondary components of the vascular occlusion device 100. The mandrel 200 is configured to form the vascular occlusion device 100, which includes a pyramidal portion 104 having a triangular pyramidal shape.

[0050] The mandrel 200 has a central spherical element 202. Multiple distal coil posts 204 extend outward from this central spherical element 202. The distal coil posts 204 are configured to form the distal coil 108 of the vascular occlusion device 100. The distal coil posts 204 are arranged at angular intervals around the spherical element 202. In the illustrated mandrel 200, the distal coil posts 204 are arranged at equal intervals such that the respective longitudinal axes of each distal coil are at equal angular intervals around the spherical element 202. That is, in the case of three distal coil posts 204, the distal coil posts 204 are arranged at 120° intervals.

[0051] Each distal coil post 204 has a cross-sectional diameter that widens outward as it extends away from the spherical element 202, as shown in Figure 8, which shows one side view of the distal coil post 204. The taper angle 114 of the distal coil post 204 is the same as the taper of the distal coil 108 described herein. The longitudinal axis of each distal coil post 204 is also inclined distally, so that the planes perpendicular to each longitudinal axis are non-parallel and non-perpendicular, and these planes have lines of intersection that form a pyramidal shape with its apex distal to the distal coil post 204.

[0052] The mandrel 200 also has a main post 206 extending from the spherical element 202. The main post 206 is configured to form the main body portion 106 of the vascular occlusion device 100. In the example shown in Figure 10, the main post 206 extends proximal to the spherical element 202 and perpendicular to the pyramidal base. The main post 206 may be a cylinder with a constant diameter, or alternatively, the main post 206 may be tapered outward or inward as it extends from the spherical element 202.

[0053] With the help of this specification, those skilled in the art will understand how to modify the mandrel 200 to be configured to manufacture a vascular occlusion device 100 including a pyramidal portion 104 having other pyramidal shapes disclosed herein. For example, Figure 11 shows a mandrel 210 configured to manufacture a vascular occlusion device 100 including a pyramidal portion 104 having a square pyramidal shape. This mandrel 210 is the same as or substantially the same as the mandrel 200, except that the mandrel 210 has four distal coil posts 204 arranged at equal angular intervals around a central spherical member 202.

[0054] Referring to the drawings in Figures 12A and 12B and the flowchart in Figure 13, an exemplary method 300 for manufacturing a vascular occlusion device 100 using a mandrel 200 is shown. A wire 102 having a primary structure is wound around the mandrel 300. As described herein, the wire 102 may be formed of a shape memory material, and the primary structure may be the structure of the wire 102 in a constrained state, such as within a sheath or delivery catheter. The primary structure may have any suitable shape, such as a helical coil.

[0055] In step 302, first, the wire 102 is wound around the first distal coil post 108a in a first direction, starting from the post of the first distal coil post 108a and moving toward the intersection of the first distal coil post 204a and the spherical element 202. Subsequent winding begins from the intersection of the post 204a and the spherical element 202 and winds toward the spherical element 202. In this specification, the winding "direction" is the direction when viewed inward along the winding axis toward the mounting position of the winding post toward the central spherical element or other central structure. Thus, the "first direction" shown in the examples of Figures 12A and 12B is clockwise. The wire 102 is wound around the first distal coil post 204a as described herein to form a winding of the desired degree of winding for the first distal coil 108a.

[0056] After winding the wire 102 around the first distal coil post 204a, in step 304, the wire 102 is traversed along the spherical element 202 to the second distal coil post 108b immediately adjacent to the first distal coil post 108a in order to form the first transition segment 110a. In step 306, the wire 102 is wound around the second distal coil post 204b from the intersection of the second distal coil post 204b and the spherical element 202 in a second direction opposite to the first direction (counterclockwise, as shown in the examples in Figures 12A and 12B). Then, the wire 102 is wound around the second distal coil post 204b as described herein to form a winding of the desired degree of winding for the second distal coil 108a.

[0057] After winding wire 102 around the second distal coil post 204b, in step 308, wire 102 is traversed along the spherical element 202 to the third distal coil post 204c immediately adjacent to the second distal coil post 204b in order to form the second transition segment 110a. In step 310, wire 102 is wound around the third distal coil post 204c from the intersection of the third distal coil post 204c and the spherical element 202 in a third direction opposite to the second direction (clockwise, as shown in the examples in Figures 12A and 12B). Then, wire 102 is wound around the third distal coil post 204c as described herein to form a winding of the desired degree of winding for the third distal coil 108c.

[0058] Looking at post 204, which is wound axially along the axis of rotation, each of the other three posts 204 can represent 1 / 3 of a turn as the coil is wound. Therefore, a 1+2 / 3 loop or turn (i.e., 600°) winding means that as the wire 102 is wound around post 204, each of the other posts 204, 206 that it passes through represents 1 / 3 of a loop or turn of winding. Thus, a 1+2 / 3 loop winding totals 1+2 / 3 loops by passing through the three other posts 204, 206 once, and then passing through two of the other three posts 204, 206 again. A winding of approximately 2+2 / 3 (960°) passes through each of the other posts 204, 206 twice, and then passes through the next two posts again (for the third time). For winding a complete loop (360°) or multiple complete loops (360° × integer) + another 2 / 3 loop, position the ends of the coil 108 so that they wind in opposite directions at the next adjacent post 108. Those skilled in the art will immediately understand how to determine the exact amount of loops for mandrels with more than three posts 108, such as four posts 108, five posts 108, etc.

[0059] For mandrels 200 having more than three distal coil posts 204, step 312 traverses the wire 102 along the spherical element 202 to the next distal coil post 204 immediately adjacent to the preceding distal coil post 204 for the next transition segment 110. In step 314, the wire is wound around the next distal coil post 204 to form the next distal coil 108, and steps 312-314 are repeated for each additional distal coil post 204. After winding the wire around the last distal coil post 204, step 316 migrates the wire 102 along the spherical element 202 to the body post 206. In step 318, the wire 102 is wound around the body post 206 as described herein to form a winding of the desired degree of winding for the body portion 106.

[0060] In step 320, the wire 102 is heat-treated to set the secondary configuration of the vascular occlusion device 100 so that it is wound around the mandrel 200. Then the wire 102 is removed from the mandrel 200. The wire 102 will have a secondary configuration that has a secondary shape as if it were wound around the mandrel in a relaxed, unrestrained state.

[0061] Thus, this specification discloses a vascular occlusion device 100 and a method for manufacturing the same 300, which mitigates the problem of detachment during placement and retention, provides effective framing of the aneurysm, and has a structure that is soft and flexible enough not to rupture the aneurysm, particularly small and / or bladder aneurysms. The pyramidal shape of the distal coil 108 of the vascular occlusion device 100 has an inherent ability to effectively dissipate the force applied to its apex, thereby reducing the risk of applying excessive force to the aneurysm wall that could rupture the aneurysm, including small and / or bladder aneurysms. Furthermore, the distal coil is tapered inward, and the distal coil has a fully closed loop and cross-overlapping segments, which fold more tightly than an open loop when placed in the aneurysm, thus reducing the risk of detachment during placement and retention. At the same time, the inherent ability of the pyramidal shape to dissipate the force applied to its apex does not impair the stability of the shape. Furthermore, as shown in Figure 5, the pyramidal vascular occlusion device 100 is more compact than a cubic vascular occlusion device having eight coils forming the eight faces of a cube. That is, the volume of the pyramidal vascular occlusion device 100 is smaller than that of the cube. Moreover, the distal coil 108 of the vascular occlusion device 100 has a smaller diameter than the coil of a cubic vascular occlusion device having the same or nearly the same overall height as the vascular occlusion device 100. This is because the diameter of each distal coil 108 is smaller than the overall height of the vascular occlusion device 100 (for example, the overall height of the vascular occlusion device 100 is 3.2 mm, while the diameter of the distal coil is 2.4 mm). On the other hand, the diameter of the coil of the cubic vascular occlusion device extends to the overall height of the vascular occlusion device (the height is the length of any one of the sides of the cubic vascular occlusion device).

[0062] Referring to Figures 14A and 14B, the vascular occlusion device 100 is also a component of a vascular occlusion system 400 that can be used to deploy the vascular occlusion device 100 into a body cavity such as an aneurysm 440 (see Figures 15-18). The vascular occlusion system 400 comprises a delivery assembly 402 and a vascular occlusion assembly 404. As shown in Figures 15 and 16, the delivery assembly 402 may include a delivery catheter 406 and an optional guidewire 408. The vascular occlusion assembly 404 comprises the vascular occlusion device 100 and a pusher member 410 that is detachably coupled to the vascular occlusion device 100 via a separation device or joint 412. Figure 14A shows the vascular occlusion assembly 404 after the vascular occlusion device 100 has been slidably positioned within the delivery catheter 406 so that it is in its compact delivery configuration.

[0063] The delivery catheter 406 is typically an elongated flexible tube, which may be, for example, a microcatheter. The delivery catheter 406 comprises an elongated sheath body 414 having a proximal portion 416, a distal portion 418, and a lumen 420 extending from the proximal portion 416 to the distal portion 418. The proximal portion 416 of the delivery catheter 406 is typically left outside the patient's body when the vascular occlusion system 400 is used and accessible to the clinician, while the distal portion 418 is sized and dimensional to reach a remote location in the patient's vascular system and is configured to deliver the vascular occlusion device 100 to a body cavity such as an aneurysm. The delivery catheter 406 may also have one or more ports 422 that communicate with the lumen 420 for introducing fluid into the sheath body 414 or for removing fluid from the sheath body. The sheath body 414 can be made of suitable polymer materials, metals and / or alloys, such as polyethylene, stainless steel, or other suitable biocompatible materials or combinations thereof. In some cases, the proximal portion 416 may include a reinforcing layer, such as a braided layer or a coiled layer, to enhance the ease of inserting the sheath body 414. The sheath body 414 may include a transition region between the proximal portion 416 and the distal portion 418.

[0064] The vascular occlusion device 100 may be any of the vascular occlusion devices 100 disclosed herein, having any one or more of the features and embodiments described herein.

[0065] The vascular occlusion assembly 404 also includes a pusher member 410. The pusher member 410 is configured to be slidably received within the lumen 420 of the delivery catheter 406. The pusher member 410 has a proximal portion 450, which typically extends proximal to the proximal portion 416 of the delivery catheter 406, and a distal portion 452 that is detachably coupled to the proximal end of the vascular occlusion device 100 via a separation device 412. The pusher member 410 may be a coil, wire, tendon, conventional guidewire, torque-transmitting cable tube, hypotube, etc., having sufficient columnar strength to allow the vascular occlusion device 100 to be pushed into the aneurysm sac 440 through the distal end 418 of the delivery catheter 406 (see Figures 17 and 18).

[0066] The separation device 412 provides a detachable connection between the pusher member 410 and the vascular occlusion device 100. The separation device 412 may include electrolytic separation, mechanical connectors, thermally operated separation, dissolution separation, or other mechanical, thermal, and fluid pressure mechanisms. For example, the separation device 412 may be an electrolytically decomposable segment for electrolytically separating the vascular occlusion device 100 from the pusher member 410.

[0067] As shown in Figures 15 and 16, the optional guidewire 408 of the delivery assembly 402 has a proximal end 444 and a distal end 446. As shown in Figure 16, after the guidewire 408 is positioned within the patient's vascular system 442 with its distal end 446 positioned at the target insertion site, the delivery catheter 406 is advanced over the guidewire 408 with the guidewire 408 positioned within the lumen 420 of the delivery catheter 406. In a “rapid exchange” configuration of the delivery catheter 406 and guidewire 408, the guidewire 408 extends only through the distal portion of the delivery catheter 406, such as the rapid exchange lumen. The guidewire 408 is typically used by first advancing the guidewire 408 through the patient's vascular system to the target insertion site (e.g., the neck 448 of an aneurysm filled by the vascular occlusion device 100, see Figures 15–18), and then advancing the delivery catheter 406 over the guidewire 408 to the target insertion site.

[0068] Next, with reference to Figures 15–19, an exemplary method 500 for deploying a vascular occlusion device 100 into an anatomical body cavity using a vascular occlusion system 200 will be described. This method 500 will be described, as an example, in relation to deploying the vascular occlusion device 100 into an aneurysm sac 440. However, method 500 is not limited to deploying the vascular occlusion device 100 into an aneurysm sac 440, and the vascular occlusion device 100, or any other medical device disclosed herein, can be used to deploy into any suitable anatomical body cavity accessible via the patient's vascular system. As shown in the flowchart of Figure 19 and in Figure 16, step 502 involves inserting a guidewire 408 into the patient's vascular system 442 and advancing it to the target insertion site, i.e., the aneurysm sac 440. As described herein, the use of the guidewire 408 is optional and not required in method 500 for deploying the vascular occlusion device 100 using a vascular occlusion system 200.

[0069] In step 504, the delivery catheter 406 of the delivery assembly 402 is advanced along the guidewire 408 until the open distal end 418 is adjacent to or inside the aneurysm neck 448 of the aneurysm 440, as shown in Figure 17. In step 506, the guidewire 408 is withdrawn from the delivery catheter 406, leaving the delivery catheter 406 in place. In step 508, the vascular occlusion assembly 404 is inserted into the delivery catheter 406 of the delivery assembly 402 and advanced within the delivery catheter 406, so that the distal end of the vascular occlusion device 100 is positioned adjacent to the distal portion 418 of the delivery catheter 406, as shown in Figure 18. In this position, the proximal portion 450 of the pusher member 410 is located proximal to and outside the proximal portion 416 of the delivery catheter 406. Before inserting the vascular occlusion device 100 into the delivery catheter 406, the vascular occlusion device 100 can be pre-introduced into the sheath so that it becomes its constrained delivery configuration (primary configuration). Then, by bringing the distal end of the sheath into contact with the proximal end 416 of the delivery catheter 406 and pushing the vascular occlusion device 406 out of the sheath into the delivery catheter 406, the vascular occlusion device 100 is inserted into the delivery catheter 406, thereby ensuring that the vascular occlusion device 100 remains in its delivery configuration within the delivery catheter 206.

[0070] In step 510, the proximal portion 450 of the pusher member 412 is pushed, thereby pushing the vascular occlusion device 100 distally away from the delivery catheter 406 through the lumen 420 of the delivery catheter 406. In step 512, as the vascular occlusion device 100 is pushed out from the open distal end 418 of the delivery catheter 406, the pyramidal portion 104 is advanced into the aneurysm sac 440 through the aneurysm neck 448, expanding the distal portion of the vascular occlusion device 100 from the delivery configuration (primary configuration) to the secondary configuration (deployed configuration), and forming the distal coil 108 of the pyramidal portion 104 within the aneurysm sac 240. Also in step 512, the proximal portion of the vascular occlusion device 100 from the delivery catheter 406 is further advanced via the pusher member 412, expanding it into its secondary configuration (deployed configuration) which forms the base portion 106 within the aneurysm sac 440. Once the entire vascular occlusion device 100 has been inserted into the aneurysm sac 440, step 514 detaches the vascular occlusion device 100 from the pusher member 410 by activating, activating, or otherwise manipulating the separation device 412. Step 516 removes the pusher member 410 from the patient's vascular system 442 by pulling it out via the delivery catheter 406. If a single vascular occlusion device 100 is sufficient to fill and occlude the aneurysm sac 440, method 500 proceeds to step 520 to remove the delivery catheter 406 from the patient's vascular system 442. If multiple vascular occlusion devices 100 are to be implanted, the process of steps 508-516 is repeated to deliver a sufficient number of vascular occlusion devices 100 to fill and occlude the aneurysm sac 440. Once a sufficient number of vascular occlusion devices 100 have been implanted in the aneurysm sac 440, step 520 removes the delivery catheter 406.

[0071] While specific embodiments of the disclosed invention have been shown and described herein, it will be understood by those skilled in the art that they are not intended to limit the invention. Furthermore, 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 as defined solely by the following claims and their equivalents. Therefore, the specification and drawings should be considered 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 appended claims.

Claims

1. A vascular occlusion device, A single wire having a primary configuration in a constrained state, The single wire forms a secondary configuration in a relaxed, unrestrained state, and the secondary configuration is A pyramidal portion comprising a plurality of distal coils wound from a single wire and transition segments between each distal coil, wherein each distal coil includes a winding forming 1 + 2 / 3 turns to 2 turns (winding of 600° to 720°), in each distal coil the diameter of the outer portion of the distal coil is greater than the diameter of the inner portion of the distal coil, and a straight line extending longitudinally along the outer edges of the outer and inner portions forms an angle of 5 to 15 degrees with respect to a common central axis of the outer and inner portions, the transition segments connect one distal coil to an adjacent distal coil, the plurality of distal coils are arranged in a pyramidal shape with each coil located on a different side of the pyramidal shape, each distal coil is in contact with the portion of the winding exceeding one turn (360°), and each transition segment from one distal coil to an adjacent distal coil has a portion that overlaps with the winding of the one distal coil, A vascular occlusion device characterized by comprising a main body portion located proximal to the pyramidal portion, the main body portion being formed from a single wire and including a coil extending proximal to the pyramidal portion.

2. In the vascular occlusion device according to claim 1, A vascular occlusion device characterized in that the pyramidal shape is a tetrahedron that forms a triangular pyramidal shape having three sides.

3. In the vascular occlusion device according to claim 1, A vascular occlusion device characterized in that the pyramidal shape is a pentahedron that forms a square pyramidal shape having four sides.

4. In the vascular occlusion device according to claim 1, A vascular occlusion device characterized in that the pyramidal shape is a polyhedron formed from a base of a polygon having n sides and n sides connected to the vertices.

5. In a vascular occlusion device according to any one of claims 1 to 4, A vascular occlusion device characterized in that the primary configuration includes an elongated spiral coil.

6. In the vascular occlusion device according to claim 5, A vascular occlusion device characterized in that the wire is formed from a shape memory material, and the secondary configuration is set by winding the wire around a mandrel and heat-treating the wire wound around the mandrel.

7. In the vascular occlusion device according to claim 6, The vascular occlusion device is configured to treat an aneurysm having a diameter to be treated, and each of the distal coils has an average outer diameter of 10 to 90% of the diameter of the aneurysm for which the vascular occlusion device is designed to treat.

8. In a vascular occlusion device according to any one of claims 1 to 4, The vascular occlusion device is configured to treat an aneurysm having a diameter of a target to be treated, and each of the distal coils has an average outer diameter of 55-85% of the diameter of the aneurysm for which the vascular occlusion device is designed to treat.

9. A method for manufacturing a vascular occlusion device, A step of providing a mandrel, wherein the mandrel is The central spherical element, A plurality of distal coil posts extending from the central spherical element, wherein each post is arranged at an angular interval around the spherical element, the cross-sectional diameter of each post increases as it extends away from the spherical element, the outer edge of each post forms an angle of 5 to 15 degrees with respect to the longitudinal axis of each post, and the longitudinal axis is oriented such that each of the pyramidal faces lies on a plane perpendicular to one of the longitudinal axes, A step including a main post extending from the aforementioned spherical element, A step of providing a single wire having a primary configuration, The steps include: winding the single wire around a first distal coil post among the plurality of distal coil posts in a first direction from the first distal coil post toward the intersection of the first distal coil post and the spherical element to form a first loop of 1 + 2 / 3 to 2 loops (windings of 600° to 720°) around the first distal coil post; then moving the single wire from at least a portion of the first loop to a first transition segment formed along the spherical element to a second distal coil post immediately adjacent to the first distal coil post among the plurality of distal coil posts; The steps include: winding the single wire around the next distal coil post in a second direction opposite to the first winding direction, starting from the intersection of the next distal coil post and the spherical element, to form a next loop of 1 + 2 / 3 to 2 loops (windings of 600° to 720°) around the next distal coil post; then moving the single wire from at least a portion of the next loop to a next transition segment formed along the spherical element to the next distal coil post immediately adjacent to the previous distal coil post among the plurality of distal coil posts; The process involves repeatedly winding the single wire around each distal coil post, alternating the winding direction from the preceding distal coil post, and then moving it to each distal coil post. A method characterized by comprising the steps of winding the single wire around the last distal coil post, moving the single wire along the spherical element to the main post, and winding the single wire in at least one loop around the main post.

10. In the method according to claim 9, A method further comprising the step of setting the secondary configuration of the vascular occlusion device by heat-treating the wire wound around the mandrel.

11. In the method according to claim 10, A method characterized in that the secondary configuration is a loose, unrestrained configuration of wires.

12. In the method according to claim 11, A method characterized in that the primary configuration is a configuration of wires in a constrained state.

13. In the method according to claim 9, The method involves manufacturing a vascular occlusion device having a secondary component, wherein the secondary component is A pyramidal portion comprising a plurality of distal coils wound from a single wire and transition segments between each distal coil, wherein each distal coil includes a winding forming 1 + 2 / 3 turns to 2 turns (winding of 600° to 720°), in each distal coil the diameter of the outer portion of the distal coil is greater than the diameter of the inner portion of the distal coil, and a straight line extending longitudinally along the outer edges of the outer and inner portions forms an angle of 5 to 15 degrees with respect to a common central axis of the outer and inner portions, the transition segments connect one distal coil to an adjacent distal coil, the plurality of distal coils are arranged in a pyramidal shape with each coil located on a different side of the pyramidal shape, each distal coil is in contact with the portion of the winding exceeding one turn (360°), and each transition segment from one distal coil to an adjacent distal coil has a portion that overlaps with the winding of the one distal coil, A method characterized by comprising a main body portion located proximal to the pyramidal portion, the main body portion being formed from the single wire and including a coil extending proximal to the pyramidal portion.

14. In the method according to claim 13, The method is characterized in that the pyramidal shape is one of a tetrahedron that forms a triangular pyramid with three sides, and a pentahedron that forms a square pyramid with four sides.

15. In the method according to any one of claims 9 to 14, The method is characterized in that the primary configuration includes an elongated spiral coil, and the single wire is formed from a shape memory material.

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