Vascular occlusion device and methods of making and using 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 relates generally to medical devices and intravascular medical procedures, and more particularly to devices for occluding vascular defects such as aneurysms, and methods for making and using such devices. [Background technology]

[0002] Vascular occlusion devices or implants are used for a variety of reasons, including the treatment of intravascular aneurysms. Aneurysms are dilations of vasculature, such as blood vessels, that can rupture, clot, or dissociate, posing a risk to a patient's health. For example, an aneurysm in a patient's brain may rupture, causing a stroke, leading to brain damage and death. Cerebral aneurysms may be detected in a patient, for example, after a stroke or hemorrhage, and treated by application of a vascular occlusion device.

[0003] A commonly used vaso-occlusive device comprises a soft, helically wound coil formed by winding a platinum (or platinum alloy) wire strand around a "primary" mandrel. This coil is then wound around a larger "secondary" mandrel and heat treated to impart a secondary shape. For example, U.S. Pat. No. 4,994,069 issued to Ritchart et al. (which is incorporated in its entirety by reference as if fully set forth herein) describes a vaso-occlusive 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 vasculature. Complex three-dimensional secondary shapes can be imparted to the vaso-occlusive device to better frame and fill the aneurysm, and the stiffness / flexibility of the vaso-occlusive device can be altered.

[0004] To deliver a vaso-occlusive device to a desired site within the vasculature, e.g., into an aneurysmal sac, it is known to first position a small profile delivery catheter or "microcatheter" at the site using a guidewire. Typically, the distal end of the microcatheter is provided with a selected preformed bend, e.g., 45°, 26°, "J" shaped, "S" shaped or other bend shape, by the attending physician or manufacturer depending on the patient's particular anatomy, so that when the guidewire is withdrawn, it will remain in a desired position to release one or more vaso-occlusive devices into the aneurysmal sac. A delivery or "pusher" assembly or "wire" is then threaded through the microcatheter until the vaso-occlusive device coupled to the distal end of the delivery assembly extends from the distal end opening of the microcatheter into the aneurysmal sac. Once inside the aneurysmal sac, a portion of the vaso-occlusive device can be deformed or bent to allow for more efficient and complete filling. The vaso-occlusive device is then released or "detached" from the distal end of the delivery assembly, and the delivery assembly is pulled back through the microcatheter. Depending on the particular needs of the patient, one or more additional vaso-occlusive devices can be pushed through the microcatheter and released into the same aneurysm sac.

[0005] Fluoroscopy is typically used to visualize the vaso-occlusion device during delivery into the aneurysm, while magnetic resonance imaging (MRI) is typically used to visualize the treatment site post-procedure (e.g., several weeks after initial treatment of the aneurysm) to ensure that the aneurysm sac has been adequately occluded. For this reason, it is important that the vaso-occlusion device be constructed to allow for its radiopacity during treatment of the aneurysm while minimizing visualization-impeding artifacts that arise during post-procedure MRI (i.e., MRI-compatible). It is also preferable that such vaso-occlusion devices be "soft" (i.e., laterally flexible or malleable) and thereby atraumatic, to prevent rupture of the delicate tissue of the aneurysm.

[0006] It is also important that such vaso-occlusion devices are retained within the aneurysm for an extended period of time. However, aneurysms with large mouths, commonly known as "wide-necked aneurysms," present difficulties in placing and retaining vaso-occlusion devices within the aneurysm sac, particularly small and relatively thin vaso-occlusion coils that, no matter how skillfully placed, lack sufficient mechanical strength to maintain their position within such an aneurysm sac. For example, small aneurysms (e.g., aneurysms having a diameter of less than about 7 mm, or even smaller, less than about 5 mm) often have wide neck and short dome characteristics. More specifically, small aneurysms often have relatively wide necks compared to the size of the aneurysm (i.e., the ratio of neck width to aneurysm diameter is often greater for small aneurysms compared to such ratios for larger aneurysms). Due to the relatively wide necks, small aneurysms (generally wide-necked aneurysms) are at high risk of coil dislodging within the parent vessel both during placement and retention. Figure 1 illustrates how a portion of a vaso-occlusion coil dislodges out of the aneurysm after implantation. Several placement techniques have been developed to mitigate coil dislodging during placement. One such deployment technique, called the "deployment technique," utilizes a balloon or stent placed in the blood vessel adjacent the neck region of the aneurysm to prevent the vaso-occlusive coil from exiting the aneurysm sac. Figure 2 illustrates a deployment technique using a balloon-actuated catheter. A balloon-actuated catheter is used to deploy a balloon adjacent the neck region of the aneurysm. The balloon prevents the coil from detaching from the aneurysm as it is implanted into the aneurysm. However, as shown in Figure 2, this technique carries the risk that the balloon may push the tip of the catheter into the dome of the aneurysm, causing the aneurysm to rupture. Figure 3 illustrates a deployment technique using a stent. A stent is placed around the neck of the aneurysm and expanded to prevent the coil from exiting the aneurysm sac. Like the balloon-actuated catheter, the stent technique also carries the risk of pushing the tip of the catheter into the dome of the aneurysm, causing the aneurysm to rupture. Figure 4 illustrates another deployment technique for implanting a vaso-occlusive device, called the "recross." In this technique, a delivery catheter extends through an opening in the stent.The stent can prevent the coils from expelling out of the aneurysm sac, but because the positioning of the delivery catheter through the opening in the stent is inherently unpredictable, there is a risk that the maneuver of guiding and positioning the delivery catheter could force the catheter tip into the dome, thereby rupturing the aneurysm.

[0007] To address these dislodgement and embedment issues, vaso-occlusion coils have been developed that provide higher neck coverage and shape stability to effectively “frame” the aneurysm. However, the three-dimensional shape of current vaso-occlusion devices is not suitable for framing the aneurysm or is prone to dislodgement during deployment within the aneurysm. Small aneurysms are best treated with as few coils as possible, and current vaso-occlusion devices are unable to balance shape stability and softness on their own. In fact, the shape and configuration of current vaso-occlusion devices result in a directly proportional relationship between shape stability and softness. That is, the softer the device is (i.e., the less resistant it is to deformation due to external forces), the less stable the device is, and vice versa (i.e., the less soft the device is, the more stable the shape of the vaso-occlusion device is). Thus, softer coils are less likely to rupture the aneurysm, but are unable to retain their shape, making them more susceptible to dislodgement from the aneurysm during deployment and / or retention. Conversely, the stiffer the coil, the better it can hold its shape and frame the aneurysm, but the higher the stress it places on the aneurysm wall and the higher the risk of rupturing the aneurysm, especially small aneurysms that are at higher risk of rupture. Furthermore, especially with the outer complex 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 subsequent loops during deployment.

[0008] Thus, there is a need for a vaso-occlusive device that can mitigate the problem of dislodgement during placement and retention, and provide effective framing of the aneurysm, while at the same time having a structure that is soft and flexible enough not to rupture aneurysms, especially small wide-necked aneurysms. Summary of the Invention

[0009] In accordance with one aspect of the medical devices and endovascular medical procedures of the present disclosure, the vaso-occlusive device comprises an elongated vaso-occlusive device (e.g., 0.5-100 cm in length) configured for implantation into an aneurysm sac. The vaso-occlusive devices disclosed herein are particularly well suited for, but are not limited to, being configured and used to treat small, wide-necked aneurysms. The vaso-occlusive device typically has a delivery configuration (having a primary shape) when constrained within a delivery catheter, and a deployed configuration (having a secondary shape different from the primary shape) when released from the delivery catheter into the aneurysm sac.

[0010] The vaso-occlusive 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 a delivery catheter, such as a helical coil shape or a linear shape. The wire is also configured to be formed into a secondary configuration in a relaxed, unconstrained state, such as when the wire is released from the delivery catheter without an external force acting on the wire.

[0011] The secondary configuration of wires provides a balanced solution between shape stability and softness, allowing the vaso-occlusive device to have a stable shape that prevents dislodging during deployment and retention and provides effective framing of the aneurysm, while also being soft / flexible enough to avoid rupturing the aneurysm. The pyramidal shape has an inherent ability to effectively dissipate forces applied to its apex, thereby reducing the risk of excessive forces acting on the aneurysm wall that could rupture the aneurysm. That is, the secondary configuration includes a pyramidal shaped portion having multiple distal coils wound from the wire. Each distal coil includes a winding that forms a closed loop of more than 360°, the winding having a circumference that tapers from the inside of the pyramidal shaped portion to the outside. For example, in the case of a helical coil shaped winding, the diameter of the coil increases outward such 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 a transition segment of wire between each distal coil that connects each distal coil to one or more adjacent distal coils.

[0012] The 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 is no distal coil at the base of the pyramidal shape. For example, the pyramidal shape is a tetrahedron having a base and three sides that connect to an apex, where each side of the base and the apex form a triangle, and each triangle defines one of the three sides. The base portion of the pyramidal shape can be formed by a body portion, as described below.

[0013] The secondary configuration also has a body portion proximal to the pyramidal shaped portion. The body portion includes a coil formed from wire and extending proximally from the pyramidal shaped portion. For example, the body portion can extend proximally from a location at the base of the pyramidal shape.

[0014] In another embodiment, the pyramidal shape is a polyhedral shape formed from a polygonal base having n sides and n sides that connect to a vertex, such as a tetrahedral shape (triangular base and three sides, also called a triangular pyramid), a pentahedral shape (quadrilateral base and four sides, also called a square or rectangular pyramid), or a hexahedral shape (pentagonal base and five sides, also called a pentagonal pyramid).

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

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

[0017] In another aspect of the vaso-occlusive 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 mandrel-wrapped wire.

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

[0019] In another embodiment of the vaso-occlusive device, the primary shape has a longitudinal length of between 1 and 70 cm.

[0020] Also disclosed are methods of making any of the vaso-occlusive devices described herein, and mandrels used to make the vaso-occlusive devices. In one method of making a vaso-occlusive device using a mandrel, a mandrel for forming the vaso-occlusive device is provided. The mandrel includes a central spherical element having a plurality of distal coil posts extending therefrom. The distal coil posts are angularly spaced about the spherical element. Each distal coil post has a cross-sectional diameter that tapers outwardly as the distal coil post extends away from the spherical element. Each distal coil post also has a longitudinal axis oriented such that a respective plane perpendicular to the respective longitudinal axis has an intersection line that forms a pyramidal shape with an apex distal to the distal coil post.

[0021] The mandrel also has a body post extending from the spherical element, typically extending proximally from the spherical element.

[0022] The wire having a primary configuration is then wound around a mandrel. The wire can be formed from a shape memory material. The primary configuration can 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 wrapped in a first direction around a first distal coil post of the plurality of distal coil posts and wrapped inwardly toward the intersection of the first distal coil post with the spherical element to form a first loop (600°) of at least 360° or at least 1+2 / 3 around the first distal coil post. As used herein, a "direction" of wrapping refers to a relative direction when viewed inwardly along the winding axis toward the attachment location of the wrapping post to the central spherical element or other central structure. After the wire is wrapped around the first distal coil post, the wire is traversed 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. The wire is then wrapped around the next distal coil post from the intersection of the next distal coil post with the spherical element in a second direction opposite to the first direction to form at least 1+2 / 3 of the next loop around the next distal coil post, and then traverses 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 wrapping the wire around each distal coil post in alternating winding directions from the preceding distal coil post and transitioning to the subsequent distal coil post is then repeated for each distal coil post. After wrapping the wire around the last distal coil post, the wire transitions along the spherical element to the body post. The wire is then wrapped around the body post for at least one loop.

[0024] In another aspect of the method of manufacturing a vaso-occlusive device, the wire wrapped around a mandrel is heat treated to set a secondary configuration of the vaso-occlusive device, hi yet another aspect, the secondary configuration is a relaxed, unconstrained configuration of the wire.

[0025] In yet another aspect of the method of making a vaso-occlusive device, the secondary configuration includes a pyramidal shaped portion and a body portion proximal to the pyramidal shaped portion. The pyramidal shaped portion includes a plurality of distal coils wound from wire on respective distal coil posts. Each distal coil includes a winding that forms a closed loop of more than 360°, or at least 1+2 / 3 loops, with the winding having a circumference that tapers from the interior to the exterior of the pyramidal shaped portion. There is also a transition segment of wire between each distal coil that connects 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 body portion includes a coil proximal to the pyramidal shaped portion that is formed from wire wound on the body post and extends proximally from the pyramidal shaped portion.

[0026] In another aspect of the method, the pyramidal shape is a polyhedral shape formed from a polygonal base having n sides and n sides that connect to a vertex, such as a tetrahedral shape (triangular base and three sides, also called a triangular pyramid), a pentahedral shape (square / rectangular base and four sides, also called a square pyramid), or a hexahedral shape (pentagonal base and five sides, also called a pentagonal pyramid).

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

[0028] In another aspect, the primary configuration includes an elongated helical coil having an outer diameter (OD) configured to fit within the lumen of a suitable delivery catheter for deploying the catheter. Typically, the elongated helical coil has zero pitch between each loop of the coil, providing the most compact coil. Alternatively, the elongated 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 flares outward as the post extends away from the spherical element at an angle of about 5-15 degrees or at an angle of about 1-30 degrees.

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

[0031] In yet another aspect, the vaso-occlusive assembly can also include a detachment device that releasably couples the pusher member to the vaso-occlusive device. For example, the detachment device can include an electrolytic detachment, a mechanical connector, a thermally actuated detachment, a dissolution detachment, etc. The delivery assembly can include a delivery catheter through which the vaso-occlusive device can be introduced in its compact delivery configuration. The delivery assembly can also include a guidewire for guiding the delivery catheter to a target implantation site within the patient's vasculature, such as an aneurysm. The guidewire is then removed and the vaso-occlusive device is advanced through the delivery catheter to the target implantation site.

[0032] In yet another aspect of the present disclosure, the devices disclosed herein are not limited to being vaso-occlusive devices, but may be any medical device having the same or similar structure as the vaso-occlusive devices disclosed herein, for example, the medical device may be any suitable thrombus removal device, stent retriever, embolic filter, stent delivery system, other implantable device, guidewire, intravascular device or other medical device.

[0033] Also disclosed are methods of deploying any of the vascular occlusion devices disclosed herein or other medical devices within an anatomical body cavity, such as an aneurysm. In one method, the vascular occlusion device is deployed using a delivery catheter. The delivery catheter is first inserted into the patient's vasculature and advanced within the vasculature until a distal end of the delivery catheter is positioned at a 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 body cavity within the vasculature where the vascular occlusion device is to be deployed. If a guidewire is utilized, the guidewire is first inserted into the patient's vasculature and advanced through the vasculature to the site of the aneurysm. A delivery catheter is then advanced along the guidewire to the aneurysm, after which the guidewire is removed.

[0034] The vaso-occlusive device is then inserted into the delivery catheter in its compact delivery configuration and advanced along the delivery catheter until the distal end of the vaso-occlusive device is located at the target insertion site. The vaso-occlusive device is then pushed distally out of the delivery catheter, such as by using a pusher member detachably attached to the proximal end of the vaso-occlusive device. First, a portion of the vaso-occlusive device in the compact delivery configuration (e.g., a helical coil) including the distal coil of the vaso-occlusive device is advanced from the delivery catheter into the aneurysm sac. When the portion including the distal coil exits the delivery catheter and enters the aneurysm, the portion assumes a secondary configuration including the distal coil. As the vaso-occlusive device continues to advance out of the delivery catheter, a body portion also advances into the aneurysm sac. Once the entire vaso-occlusive device is inserted into the aneurysm sac, the vaso-occlusive device can be detached from the pusher member, such as by activating or actuating a detachment device. The vaso-occlusive device in the secondary configuration has a stable shape with inwardly facing loops. Due to the outwardly tapered diameter, each loop or turn of the distal coil faces inward. In other words, the surfaces of the loops face inwardly toward the geometric interior of the pyramidal shape of the pyramidal shaped portion. The inward facing loops tend to avoid detaching from the aneurysm during deployment and retention, and the pyramidal configuration of the distal coil also provides shape stability to effectively frame the aneurysm while also presenting a soft, flexible structure to avoid exerting excessive forces on the wall that could rupture the aneurysm.

[0035] In some cases, a single vaso-occlusive device may be sufficient to fill and occlude the aneurysm, and if multiple vaso-occlusive devices are required, the process can be repeated to deliver a sufficient number of vaso-occlusive devices to fill and occlude the aneurysm.

[0036] Thus, there is a need for a vaso-occlusion device that can mitigate the problem of dislodgement during placement and retention, provide effective framing of the aneurysm, and at the same time has a structure that is soft and flexible enough not to rupture aneurysms, especially small wide-necked aneurysms.

[0037] Other and further aspects and features of embodiments of the disclosed invention will become apparent from the following detailed description considered in conjunction with the accompanying drawings. [Brief description of the drawings]

[0038] The drawings illustrate the design and utility of various aspects of the devices and methods disclosed herein, with similar elements being commonly numbered. It should be noted that the drawings are not drawn to scale, and elements of similar structure or function are indicated by similar numbers throughout the drawings. It should also be noted that the drawings are intended only to facilitate the description of various aspects of the disclosed technology. They are not intended as an exhaustive description of the technology or as a limitation on the scope of the technology, which is defined only by the appended claims and their equivalents. Furthermore, an exemplary embodiment of the disclosed technology need not have all aspects or advantages disclosed or described herein. An aspect or advantage described in connection with a particular embodiment of the disclosed technology is 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 objects of the technology are obtained, a more particular description of the technology, briefly described above, will be made by reference to specific examples thereof illustrated in the accompanying drawings. The present technology will be explained and described with additional specificity and detail through the use of the accompanying drawings, with the understanding that the drawings and corresponding description illustrate only illustrative embodiments of the disclosed technology and therefore should not be considered as limiting its scope.

[0039] [Figure 1] FIG. 1 is a side cross-sectional view of a delivery catheter for deploying a vaso-occlusive device, showing the vaso-occlusive device in a detached state. [Diagram 2] FIG. 2 is a cross-sectional side view of a delivery catheter for deploying a vaso-occlusive device and a balloon-actuated catheter for use in the deployment technique. [Diagram 3] FIG. 3 is a cross-sectional side view of a delivery catheter that deploys the vaso-occlusive device and stent used in the deployment technique. [Figure 4] FIG. 4 is a cross-sectional side view of a delivery catheter for deploying a vaso-occlusive device and a stent for use in the Recross technique. [Diagram 5] FIG. 5 is a side perspective view of a vaso-occlusive device in a relaxed, deployed configuration. [Figure 6] FIG. 6 is a simplified top perspective view of the intersecting planes of the three distal coils of FIG. 5 that form the pyramidal shaped portion of the triangular pyramidal shaped vaso-occlusive device. [Figure 7] FIG. 7 is a simplified top perspective view of the intersecting planes of four distal coils that form the pyramidal shaped portion of a pyramidal shaped vaso-occlusive device. [Figure 8] FIG. 8 is a side view of a distal coil post for forming a distal coil, illustrating the taper angle for the loops of the coil. [Figure 9] FIG. 9 is a side perspective view of one example of an alternative pyramidal shaped portion of the vaso-occlusive device of FIG. 5 in which the distal coil has a varying diameter and a varying number of turns. [Figure 10] FIG. 10 is a side perspective view of an exemplary mandrel for manufacturing the vaso-occlusive device of FIG. [Figure 11] FIG. 11 is a side perspective view of an exemplary mandrel for manufacturing a vaso-occlusive device having four distal coils forming a pyramidal shaped portion of a pyramidal shape. [Figure 12] Figure 12A is a top perspective view of the mandrel of Figure 10 around which wire is wrapped to produce the vaso-occlusive device of Figure 5. Figure 12B is a side perspective view of the mandrel of Figure 12A around which wire is wrapped to produce the vaso-occlusive device of Figure 5. [Figure 13] FIG. 13 is a flow chart illustrating a method of manufacturing a vaso-occlusive device described herein using a 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 constrained delivery configuration within a delivery catheter, and 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 deployed configuration. [Figure 15] FIG. 15 is a cross-sectional side view showing a guidewire being advanced into a portion of a patient's vasculature to the location of an aneurysm. [Figure 16] FIG. 16 is a cross-sectional side view of the guidewire of FIG. 15 and a patient's vasculature with a delivery catheter advanced over the guidewire. [Figure 17] FIG. 17 is a cross-sectional side view showing the vaso-occlusive system of FIGS. 14A and 14B being advanced within the delivery catheter of FIG. 16 to deploy a vaso-occlusive device within an aneurysm. [Figure 18] 18 is a cross-sectional side view of the vaso-occlusive system of FIGS. 14A and 14B with the vaso-occlusive device deployed within the aneurysm from the delivery catheter shown in FIG. [Figure 19] FIG. 19 is a flow chart of an exemplary method for deploying the vaso-occlusive devices disclosed herein within an aneurysm using the vaso-occlusive system of FIGS. 14A and 14B. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] Referring to Figure 5, an example of a vaso-occlusive device 100 disclosed herein is shown. Figure 5 shows the vaso-occlusive device 100 in a secondary configuration in a relaxed, unconstrained state. In other words, Figure 5 shows the vaso-occlusive device 100 when no external forces are acting on the vaso-occlusive device 100. The secondary configuration of the vaso-occlusive 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. As used herein, the terms "distal" and "proximal" refer to the vaso-occlusive device 100 as it is intended to be deployed, with the term "distal" referring to being located toward the end of the device 100 that is inserted first and the term "proximal" referring to being located toward the end of the device 100 that is inserted last.

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

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

[0043] 5, each distal coil 108 includes windings that form a closed loop of more than 360°, i.e., at least a complete closed loop. In the illustrated vaso-occlusive device 100, each distal coil 108 includes 1+2 / 3 loops (also referred to as "turns") of windings, which corresponds to 600° of windings. Alternatively, each distal coil 108 can have at least 1+2 / 3 turns, or between 1+2 / 3 turns (600°) and 2 turns (720°).

[0044] The windings of each distal coil 108 also have a width that tapers outward from a reference point inside the pyramidal shaped portion. For the helical coil shown in the example of FIG. 5, the width of each distal coil 108 is the diameter of the coil. If the distal coil 108 is wound into a variety of shapes, such as a square, pentagon or other polygon or curved shape, the width may be an average width, such as an average of the maximum and minimum widths drawn through the geometric center of the shape. Returning to the example of FIG. 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 explained with reference to a cross-section of a cylindrical post around which the distal coil 108 is wound, as shown in FIG. 8. The post has a diameter that flares outward from the inner portion of the post to the outer portion of the post, as shown in FIG. 8. The angle 114 of the taper of the post defines the angle of taper of the distal coil 108 in the secondary configuration of the vaso-occlusive device 100. Due to the outwardly tapered diameter, each loop or turn of the distal coil 108 faces inwardly, in other words, the surfaces of the loops face inwardly toward the geometric interior of the pyramidal shape of the pyramidal shaped portion 104.

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

[0046] In an alternative design of the vaso-occlusive device 100, the distal coils 108 can 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 the wire 102 (3 turns, i.e., 1080°) than the second distal coil 108b, which has 1+2 / 3 turns (600°). The third distal coil 108c also has a larger diameter (same diameter as the first distal coil 108a, but 1+2 / 3 turns (600°)) than the second distal coil 108b.

[0047] The pyramidal shaped portion 104 also includes transition segments 110 for each of the wires 102 that are between and connect adjacent distal coils 108. 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, transition segment 110b extends from the end of distal coil 108 to the beginning of distal coil 108c, and so on. There is also a transition segment 112 from the end of the turns of the last distal coil 108c to the beginning of the body portion 106.

[0048] The body portion 106 includes a winding of the wire 102 extending proximally from the pyramidal shape 104. The body portion 106 can extend from an imaginary base of the pyramidal shape of the pyramidal shaped portion 104. In the example shown in FIG. 5, the body portion 106 is a helical coil extending proximally from the pyramidal shaped portion 104. The body portion 106 can have a constant diameter, or alternatively, the body portion 106 can have a diameter that tapers outwardly or inwardly as it extends proximally from the pyramidal shaped portion 104. The body portion 106 comprises at least one complete loop of the wire 102. The body portion 106 does not have a maximum number of windings and can include any suitable number of turns, such as 1-20 turns. The body portion 106 shown in FIG. 5 has about 2 complete turns of the wire 102. The body portion 106 shown in FIG. 9 has about 4 complete turns of the wire 102.

[0049] 10, an exemplary mandrel 200 is shown for manufacturing vaso-occlusive device 100 using method 300 (described below). Mandrel 200 is used to wind wire 102 to form a secondary configuration of vaso-occlusive device 100. Mandrel 200 is configured to form vaso-occlusive device 100 that includes pyramidal shaped portion 104 having a triangular pyramidal shape.

[0050] The mandrel 200 has a central spherical element 202 from which extend a plurality of distal coil posts 204. The distal coil posts 204 are configured to form the distal coils 108 of the vaso-occlusive device 100. The distal coil posts 204 are angularly spaced about the spherical element 202. In the illustrated mandrel 200, the distal coil posts 204 are equally spaced such that the respective longitudinal axes of each distal coil are angularly equally spaced about the spherical element 202. That is, in the case of three distal coil posts 204, the distal coil posts 204 are spaced 120° apart.

[0051] Each distal coil post 204 has a cross-sectional diameter that flares outward as the distal coil post 204 extends away from the spherical element 202, as shown in Figure 8, which shows a side view of one of the distal coil posts 204. The angle 114 of the taper 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 tilted distally such that respective planes perpendicular to their respective longitudinal axes are non-parallel and non-perpendicular, with the planes having intersections that form a pyramidal shape with an apex distal to the distal coil post 204.

[0052] The mandrel 200 also has a body post 206 extending from the spherical element 202. The body post 206 is configured to form the body portion 106 of the vaso-occlusive device 100. In the example shown in Figure 10, the body post 206 extends proximally from the spherical element 202 and perpendicular to the base of the pyramidal shape. The body post 206 may be a cylinder having a constant diameter, or alternatively, the body post 206 may taper outwardly or inwardly as it extends from the spherical element 202.

[0053] With the aid of this disclosure, one of ordinary skill in the art will understand how to modify the mandrel 200 to be configured to manufacture a vaso-occlusive device 100 including a pyramidal shaped portion 104 having other pyramidal shapes as disclosed herein. For example, FIG. 11 illustrates a mandrel 210 configured to manufacture a vaso-occlusive device 100 including a pyramidal shaped portion 104 having a pyramidal shape. The mandrel 210 is the same as or substantially similar to the mandrel 200, except that the mandrel 210 has four distal coil posts 204 equiangularly spaced about a central spherical member 202.

[0054] 12A and 12B and the flow chart of FIG. 13, an exemplary method 300 of manufacturing a vaso-occlusive device 100 using a mandrel 200 is shown. A wire 102 having a primary configuration is wound around the mandrel 300. As described herein, the wire 102 may be formed of a shape memory material, and the primary configuration may be the configuration of the wire 102 in a constrained state, such as within a sheath or delivery catheter. The primary configuration may have any suitable shape, such as a helical coil.

[0055] In step 302, the wire 102 is first wrapped around the first distal coil post 108a in a first direction from the post of the first distal coil post 108a toward the intersection of the first distal coil post 204a with the spherical element 202. Subsequent wraps begin at the intersection of the post 204 with the spherical element 202 and wrap away from the spherical element 202. As used herein, a "direction" of wrapping is a direction looking inward along the wrapping axis toward the attachment of the wrapping post to the central spherical element or other central structure. Thus, the "first direction" shown in the examples of FIGS. 12A and 12B is a clockwise direction. The wire 102 is wrapped around the first distal coil post 204a as described herein to form a winding of the desired number of turns for the first distal coil 108a.

[0056] After wrapping 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 to form the first transition segment 110a. In step 306, the wire 102 is wrapped around the second distal coil post 204b from the intersection of the second distal coil post 204b with the spherical element 202 in a second direction opposite the first direction (counterclockwise as shown in the example of Figures 12A and 12B). The wire 102 is then wrapped around the second distal coil post 204b as described herein to form the desired degree of winding for the second distal coil 108a.

[0057] After wrapping the wire 102 around the second distal coil post 204b, in step 308, the 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 to form the second transition segment 110a. In step 310, the wire 102 is wrapped around the third distal coil post 204c from the intersection of the third distal coil post 204c with the spherical element 202 in a third direction opposite the second direction (clockwise as shown in the example of Figures 12A and 12B). The wire 102 is then wrapped around the third distal coil post 204c as described herein to form the desired degree of winding for the third distal coil 108c.

[0058] Looking at the post 204 as it 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. Thus, a winding of 1+2 / 3 loops or turns (i.e., 600°) means that as the wire 102 is wound around the post 204, each of the other posts 204, 206 it passes through represents a winding of 1 / 3 loops or turns. Thus, a winding of 1+2 / 3 loops passes through three other posts 204, 206 once, then passes again through two of the three other posts 204, 206, totaling 1+2 / 3 loops. A winding of approximately 2+2 / 3 (960°) passes through each of the other posts 204, 206 twice, then passes again (a third time) through the next two posts. The ends of the coil 108 are positioned so that a full loop (360°) or multiple full loops (360° x an integer) plus another 2 / 3 loop winding will wrap in the opposite direction around the next adjacent post 108. One skilled in the art will readily understand how to determine the exact amount of loops for mandrels having 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, in step 312, the wire 102 is traversed along the spherical element 202 to the next distal coil post 204 immediately adjacent the preceding distal coil post 204 for the next transition segment 110. In step 314, the wire is wrapped 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 wrapping the wire around the last distal coil post 204, in step 316, the wire 102 is transitioned along the spherical element 202 to the body post 206. In step 318, the wire 102 is wrapped around the body post 206 as described herein to form the desired number of turns of winding for the body portion 106.

[0060] In step 320, wire 102 is heat treated to set the secondary configuration of vaso-occlusive device 100 as if wound on mandrel 200. Wire 102 is then removed from mandrel 200. Wire 102 will assume the secondary configuration having the secondary shape as if wound on the mandrel in a relaxed, unconstrained state.

[0061] Thus, disclosed herein is a vascular occlusion device 100 and method 300 for its manufacture that mitigates disengagement problems during deployment and retention, provides effective framing of the aneurysm, while at the same time having a structure that is soft and flexible enough not to rupture aneurysms, particularly small and / or wide-necked aneurysms. The pyramidal shape of the distal coil 108 of the vascular occlusion device 100 has an inherent ability to effectively dissipate forces applied to its apex, thereby reducing the risk of applying excessive forces to the aneurysm wall that may rupture aneurysms, including small and / or wide-necked aneurysms. Furthermore, the distal coil is tapered inwardly, and the distal coil includes a complete closed loop and cross-over segments that fold more tightly than an open loop when deployed within the aneurysm, thereby reducing the risk of disengagement during deployment and retention. At the same time, the inherent ability of the pyramidal shape to dissipate forces applied to its apex does not compromise shape stability. Furthermore, as shown in FIG. 5, the pyramidal shaped vaso-occlusive device 100 is more compact than a cube shaped vaso-occlusive device having eight coils forming the eight faces of the cube. That is, the volume of the pyramidal shaped vaso-occlusive device 100 is smaller than a cube. Furthermore, the distal coils 108 of the vaso-occlusive device 100 have a smaller diameter than a coil of a cube shaped vaso-occlusive device having the same or approximately the same overall height as the vaso-occlusive device 100. This is because the diameter of each of the distal coils 108 is smaller than the overall height of the vaso-occlusive device 100 (e.g., the overall height of the vaso-occlusive 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 cube shaped vaso-occlusive device spans the entire height of the entire vaso-occlusive device (the height is the length of any one of the sides of the cube shaped vaso-occlusive device).

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

[0063] The delivery catheter 406 is typically an elongated flexible tube and may be, for example, a microcatheter or the like. 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 typically remains outside the patient's body and is accessible to a clinician when the vascular occlusion system 400 is in use, while the distal portion 418 is sized and dimensioned to reach a remote location in the patient's vasculature 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 in fluid communication with the lumen 420 for introducing fluid into the sheath body 414 or removing fluid from the sheath body. The sheath body 414 can be constructed from a suitable polymeric material, metal and / or alloy, such as polyethylene, stainless steel, or other suitable biocompatible materials or combinations thereof. In some cases, the proximal portion 416 can include a reinforcing layer, such as a braided or coiled layer, to enhance the pushability of the sheath body 414. The sheath body 414 can include a transition region between the proximal portion 416 and the distal portion 418.

[0064] The vaso-occlusive device 100 can be any of the vaso-occlusive devices 100 disclosed herein having any one or more of the features and embodiments described herein.

[0065] The vaso-occlusive 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 proximally beyond the proximal portion 416 of the delivery catheter 406, and a distal portion 452 that is detachably coupled to the proximal end of the vaso-occlusive device 100 via a detachment device 412. The pusher member 410 may be a coil, wire, tendon, conventional guidewire, torque-transmitting cable tube, hypotube, or the like, having sufficient column strength to enable the vaso-occlusive device 100 to be pushed through the distal end 418 of the delivery catheter 406 and into the aneurysmal sac 440 (see FIGS. 17 and 18).

[0066] The detachment device 412 provides a severable connection between the pusher member 410 and the vaso-occlusive device 100. The detachment device 412 may include electrolytic detachment, mechanical connectors, thermally actuated detachment, dissolution detachment, or other mechanical, thermal, and hydraulic mechanisms. For example, the detachment device 412 may be an electrolytically degradable segment for electrolytically detaching the vaso-occlusive 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 vasculature 442 with the distal end 446 located 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 a 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 vasculature to the target insertion site (e.g., the neck 448 of the aneurysm to be 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] 15-19, an exemplary method 500 of deploying vascular occlusion device 100 in an anatomical body cavity using vascular occlusion system 200 will now be described. Method 500 will be described in the context of deploying vascular occlusion device 100 in an aneurysmal sac 440, by way of example. However, method 500 is not limited to deploying vascular occlusion device 100 in an aneurysmal sac 440, but may be used to deploy vascular occlusion device 100, or other medical devices disclosed herein, in any suitable anatomical body cavity accessible via a patient's vasculature. As shown in the flow chart of FIG. 19 and in FIG. 16, in step 502, guidewire 408 is inserted into patient's vasculature 442 and advanced to a target insertion site, i.e., aneurysmal sac 440. As described herein, the use of guidewire 408 is optional and not required in method 500 of deploying vascular occlusion device 100 using vascular occlusion system 200.

[0069] In step 504, the delivery catheter 406 of the delivery assembly 402 is advanced over the guidewire 408 to a position where the open distal end 418 is adjacent to or within the aneurysm neck 448 of the aneurysm 440, as shown in FIG. 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 vaso-occlusive assembly 404 is inserted into and advanced through the delivery catheter 406 of the delivery assembly 402 until the distal end of the vaso-occlusive device 100 is positioned adjacent the distal portion 418 of the delivery catheter 406, as shown in FIG. 18. In this position, the proximal portion 450 of the pusher member 410 remains proximal and outside the proximal portion 416 of the delivery catheter 406. Prior to insertion of vaso-occlusive device 100 into delivery catheter 406, vaso-occlusive device 100 may be pre-introduced into a sheath so that vaso-occlusive device 100 is in its constrained delivery configuration (primary configuration). Vascular occlusive device 100 is then inserted into delivery catheter 406 by abutting the distal end of the sheath with the proximal end 416 of delivery catheter 406 and pushing vaso-occlusive device 406 out of the sheath and into delivery catheter 406, such that vaso-occlusive device 100 remains in its delivery configuration within delivery catheter 206.

[0070] In step 510, the vaso-occlusive device 100 is pushed distally out of the delivery catheter 406 through the lumen 420 of the delivery catheter 406 by pushing the proximal portion 450 of the pusher member 412. In step 512, as the vaso-occlusive device 100 is pushed out of the open distal end 418 of the delivery catheter 406, the pyramidal shaped portion 104 is advanced through the aneurysmal neck 448 and into the aneurysmal sac 440, expanding the distal portion of the vaso-occlusive device 100 in the delivery configuration (primary configuration) to a secondary configuration (deployed configuration) and forming the distal coil 108 of the pyramidal shaped portion 104 within the aneurysmal sac 440. Also in step 512, continued advancement of the vaso-occlusive device 100 out of the delivery catheter 406 via the pusher member 412 expands the proximal portion of the vaso-occlusive device 100 in the delivery configuration (primary configuration) to its secondary configuration (deployed configuration) forming the base portion 106 within the aneurysmal sac 440. Once the entire vaso-occlusive device 100 is inserted within the aneurysmal sac 440, in step 514, the detachment device 412 is actuated, activated or otherwise manipulated to separate the vaso-occlusive device 100 from the pusher member 410. In step 516, the pusher member 410 is removed from the patient's vasculature 442 by withdrawing it out through the delivery catheter 406. If a single vaso-occlusive device 100 is sufficient to fill and occlude the aneurysmal sac 440, the method 500 proceeds to step 520, where the delivery catheter 406 is removed from the patient's vasculature 442. Alternatively, if multiple vaso-occlusive devices 100 are to be implanted, the process of steps 508-516 is repeated to deliver a sufficient number of vaso-occlusive devices 100 to fill and occlude the aneurysmal sac 440. Once a sufficient number of vaso-occlusive devices 100 have been implanted within the aneurysmal sac 440, in step 520, the delivery catheter 406 is removed.

[0071] While specific embodiments of the disclosed invention have been shown and described herein, those skilled in the art will understand that they are not intended to limit the invention. It will also 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 is defined solely by the following claims and equivalents thereof. Accordingly, the specification and drawings should be regarded in an illustrative, rather than a restrictive, sense. The various embodiments of the disclosed invention shown and described herein are intended to cover alternatives, modifications and equivalents of the disclosed invention, which may fall within the scope of the appended claims.

Claims

1. 1. A vascular occlusion device comprising: a wire having a primary configuration in a constrained state; The wire forms a secondary configuration in a relaxed, unconstrained state, the secondary configuration comprising: a pyramidal shaped portion including a plurality of distal coils wound from wire, each distal coil including windings forming a closed loop of more than 360 degrees, the windings having an outer periphery tapered from the interior to the exterior of the pyramidal shaped portion at an angle of 5 to 15 degrees, and transition segments of wire between each distal coil connecting each distal coil to an adjacent distal coil, the plurality of distal coils arranged in a pyramidal shape with each coil located on a different side of the pyramidal shape, each distal coil including 1 2 / 3 to 2 turns, and the distal coils overlap at the transition from one distal coil to an adjacent distal coil; a main body portion proximal to the pyramidal portion, the main body portion being formed from wire and including a coil extending proximally from the pyramidal portion.

2. 10. The vaso-occlusive device of claim 1, A vaso-occlusive device, characterized in that the pyramidal shape is a tetrahedron forming a triangular pyramid shape having three sides.

3. 10. The vaso-occlusive device of claim 1, A vaso-occlusive device, characterized in that the pyramidal shape is a pentahedron forming a quadrangular pyramid shape having four sides.

4. 10. The vaso-occlusive device of claim 1, A vaso-occlusive device, wherein the pyramidal shape is a polyhedron formed from a polygonal base having n sides and n side faces connected to the vertex.

5. The vascular occlusion device according to any one of claims 1 to 4, A vaso-occlusive device wherein the primary configuration comprises an elongated helical coil.

6. 6. The vascular occlusion device according to claim 5, A vaso-occlusive device, wherein 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. 7. The vaso-occlusive 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 that is 10 to 90% of the diameter of the aneurysm that the vascular occlusion device is designed to treat.

8. The 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 to be treated, and each of the distal coils has an average outer diameter that is 55 to 85% of the diameter of the aneurysm that the vascular occlusion device is designed to treat.

9. 1. A method of manufacturing a vaso-occlusive device, comprising: Providing a mandrel, said mandrel comprising: a central spherical element; a plurality of distal coil posts extending from the central spherical element, each post angularly spaced about the spherical element, each post having a cross-sectional diameter that tapers outward at an angle of 5-15 degrees as it extends away from the spherical element, each post having a longitudinal axis oriented such that respective planes perpendicular to their longitudinal axes have intersections that form a pyramidal shape with an apex distal to the post; a step including a body post extending from the spherical element; providing a wire having a primary configuration; winding a wire around a first distal coil post of the plurality of distal coil posts in a first direction from the first distal coil post toward an intersection of the first distal coil post and the spherical element to form a first loop of 1 2 / 3 to 2 loops around the first distal coil post, and then transferring the 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 of the plurality of distal coil posts; winding the wire around a next distal coil post from an intersection of the next distal coil post and the spherical element in a second direction opposite to the first winding direction to form a next loop of 1 2 / 3 to 2 loops around the next distal coil post, and then transferring the wire from at least a portion of the next loop to a next transition segment formed along the spherical element to a next distal coil post immediately adjacent to the previous one of the plurality of distal coil posts; repeating winding the wire around each distal coil post, alternating the winding direction from the preceding distal coil post, and moving to each distal coil post; and after wrapping the wire around the last distal coil post, transitioning the wire along the spherical element to the body post and wrapping the wire around the body post in at least one loop.

10. 10. The method of claim 9, The method further comprising the step of setting a secondary configuration of the vaso-occlusive device by heat treating the wire wound on the mandrel.

11. 11. The method of claim 10, The method, wherein the secondary configuration is a relaxed, unconstrained configuration of the wire.

12. 12. The method of claim 11, The method, wherein the primary configuration is a configuration of wires in a constrained state.

13. 10. The method of claim 9, The method involves producing a vaso-occlusive device having a secondary structure, the secondary structure comprising: a pyramidal shaped portion including a plurality of distal coils wound from wire, each distal coil including a winding of wire forming a closed loop including 1 2 / 3 to 2 turns, the winding having an outer periphery tapered from the interior to the exterior of the pyramidal shaped portion at an angle of 5 to 15 degrees, and transition segments of wire between each distal coil connecting the distal coils, the plurality of distal coils being arranged in a pyramidal shape with each coil located on a different side of the pyramidal shape; a body portion proximal to the pyramidal shaped portion, the body portion being formed from wire and including a coil extending proximally from the pyramidal shaped portion.

14. 14. The method of claim 13, The pyramidal shape is one of a tetrahedron shape forming a three-sided triangular pyramid and a pentahedron shape forming a four-sided square pyramid.

15. The method according to any one of claims 9 to 14, The method, wherein the primary configuration comprises an elongated helical coil, and the wire is formed from a shape memory material.

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