Patent Description:
A wide variety of intracorporeal medical devices have been developed for medical use, for example, surgical and/or intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.), and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and/or using medical devices.

<CIT> relates to an embolic coil delivery system including a catheter. An embolic coil assembly is disposed within the catheter and includes a first embolic coil and a second embolic coil. The first embolic coil has an engaging member at its proximal end and the second embolic coil has an engaging member at its distal end and an engaging member at its proximal end. A pusher wire has an engaging member at its distal end. The embolic coil assembly further may include a control wire, where a coil is engaged with a pusher wire by engaging members in combination with the control wire. Each engaging member includes a ramped face with a slot and a longitudinally-extending passageway for receiving the control wire. The control wire extends through lumens in the pusher wire and in the coil, respectively. The engaging members cannot disengage until the control wire is pulled out of an opening of the passageway. At least one embolic coil differs from at least another embolic coil in at least one coil parameter and the coil parameter can be selected from length, inner diameter, outer diameter, stiffness, secondary shape, and degree of fiber coverage.

<CIT> relates to a device for delivering embolic coils to a selected site within the vasculature of the human body via use of a catheter. A pusher sheath within the catheter lumen pushes embolic coils mounted on a guidewire through the end of the catheter lumen. The catheter may have a constricted distal tip or other means of controlling the release of the embolic coils. The guidewire may engage the embolic coils from their interior to allow precise placement of the coils.

<CIT> relates to a medical implant deployment system including a delivery catheter, a delivery system, and an embolic coil. The delivery system includes an elongate release member positioned within the lumen of the catheter.

<CIT> discloses a vascular dilator including first, second, and third markers, respectively, adjacent the proximal end portion thereof. The markers can be in the form of color-coded bands, grooves, or ridges, to provide the surgeon or other medical professional a visual or tactile indicator of the positions of first and second inflatable members, relative to the open distal end portion of an introducer sheath. In other words, the positions and the number of the markers are selected so as to indicate the positions of the inflatable members in a blood vessel, and more specifically relative to the distal end portion of the introducer sheath.

Further embodiments are provided by the dependent claims.

In a further aspect, a method of embolizing an artery not forming part of the claimed invention may comprise: advancing a vascular occlusion system to a treatment site within the artery, the vascular occlusion system including a plurality of occlusive medical devices releasably connected to a distal end of an elongate shaft and a release wire slidably disposed within a lumen of the elongate shaft and at least a portion of each of the plurality of occlusive medical devices; withdrawing the release wire proximally to release one of the plurality of occlusive medical devices from the elongate shaft at the treatment site; positioning a distal end of one of the plurality of occlusive medical devices still connected to the elongate shaft adjacent the released occlusive medical device; and withdrawing the release wire further proximally to release the positioned occlusive medical device from the elongate shaft.

While aspects of the disclosure are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described.

The following description should be read with reference to the drawings, which are not necessarily to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate but not limit the claimed invention. Those skilled in the art will recognize that the various elements described and/or shown may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate example embodiments of the claimed invention.

The term "extent" may be understood to mean a greatest measurement of a stated or identified dimension. For example, "outer extent" may be understood to mean a maximum outer dimension, "radial extent" may be understood to mean a maximum radial dimension, "longitudinal extent" may be understood to mean a maximum longitudinal dimension, etc. Each instance of an "extent" may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be apparent to the skilled person from the context of the individual usage. Generally, an "extent" may be considered a greatest possible dimension measured according to the intended usage. In some instances, an "extent" may generally be measured orthogonally within a plane and/or cross-section, but may be, as will be apparent from the particular context, measured differently - such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc..

Diseases and/or medical conditions that impact and/or are affected by the cardiovascular system are prevalent throughout the world. For example, some forms of arterial venous malformations (AVMs) may "feed" off of normal blood flow through the vascular system. Without being bound by theory, it is believed that it may be possible to treat, at least partially, arterial venous malformations and/or other diseases or conditions by starving them of normal, oxygen and/or nutrient-rich blood flow, thereby limiting their ability to grow and/or spread. Other examples of diseases or conditions that may benefit from vascular occlusion include, but are not limited to, bleeds, aneurysms, venous insufficiency, shutting off blood flow prior to organ resection, or preventing embolic bead reflux into branch vessels in the liver. Disclosed herein are medical devices that may be used within a portion of the cardiovascular system in order to treat and/or repair some arterial venous malformations and/or other diseases or conditions. The devices disclosed herein may also provide a number of additional desirable features and benefits as described in more detail below.

<FIG> and <FIG> illustrate aspects of an example vascular occlusion system <NUM>. The vascular occlusion system <NUM> includes an elongate shaft <NUM> having a lumen <NUM> extending from a proximal end <NUM> of the elongate shaft <NUM> to a distal end <NUM> of the elongate shaft <NUM>. In some embodiments, the elongate shaft <NUM> may be a catheter, a hypotube, or other similar tubular structure. Some suitable but non-limiting materials for the elongate shaft <NUM>, for example metallic materials, polymer materials, composite materials, etc., are described below.

The vascular occlusion system <NUM> includes a microcatheter <NUM> sized and configured to navigate a vasculature and/or to deliver a plurality of occlusive medical devices <NUM> to a treatment site within the vasculature, for example an artery or a vein. The elongate shaft <NUM> and the plurality of occlusive medical devices <NUM> are slidably disposed within a lumen <NUM> of the microcatheter <NUM>. In some embodiments, the microcatheter <NUM> may facilitate percutaneous delivery of the plurality of occlusive medical devices <NUM> to the vasculature and/or the treatment site. Some suitable but non-limiting materials for the microcatheter <NUM>, for example metallic materials, polymer materials, composite materials, etc., are described below.

The vascular occlusion system <NUM> includes the plurality of occlusive medical devices <NUM> releasably connected to the elongate shaft <NUM>. In some embodiments, the plurality of occlusive medical devices <NUM> may include a first occlusive medical device <NUM>, a second occlusive medical device <NUM>, and/or a third occlusive medical device <NUM>. Fewer and/or additional occlusive medical devices may be used and/or added as desired. For simplicity, the plurality of occlusive medical devices <NUM> is illustrated herein as a plurality of shape memory embolic coils, such as those used to treat aneurysms for example, but other suitable occlusive medical devices transported, delivered, used, released etc. in a similar manner are also contemplated, including but not limited to stents, embolic filters, replacement heart valves, occlusion devices, and/or other medical implants, etc. In some embodiments, at least one of the plurality of occlusive medical devices <NUM> is a coiled member configured to assume a first shape when connected to the elongate shaft <NUM> and a second shape when disconnected from the elongate shaft <NUM>. At least one of (e.g., one, two, each, etc.) of the plurality of occlusive medical devices <NUM> may be configured to shift between an elongated delivery configuration (for example, when connected to the elongate shaft <NUM>) as seen in <FIG> and <FIG>, and a deployed configuration (for example, when disconnected from the elongate shaft <NUM>) as seen in <FIG> and <FIG>. In some embodiments, each of the plurality of occlusive medical devices <NUM> may be configured to assume a different shape after being released from the elongate shaft <NUM>. Turning back to <FIG> and <FIG>, the plurality of occlusive medical devices <NUM> may be disposed proximate the distal end <NUM> of the elongate shaft <NUM> when connected to the elongate shaft <NUM>. In some embodiments, the plurality of occlusive medical devices <NUM> may be releasably connected to the elongate shaft <NUM> in series.

The first occlusive medical device <NUM> may have a proximal end disposed adjacent the distal end <NUM> of the elongate shaft <NUM>, and the second occlusive medical device <NUM> may have a proximal end disposed adjacent a distal end of the first occlusive medical device <NUM>. The third occlusive medical device <NUM> may have a proximal end disposed adjacent a distal end of the second occlusive medical device <NUM>. In at least some embodiments, in the elongated delivery configuration, at least one of the plurality of occlusive medical devices <NUM> may have a different overall length than a different one of the plurality of occlusive medical devices <NUM>. For example, in the elongated delivery configuration, the third occlusive medical device <NUM> may be longer than the first occlusive medical device <NUM> and/or the second occlusive medical device <NUM>. In some embodiments, in the elongated delivery configuration, each of the plurality of occlusive medical devices <NUM> may have a different overall length. In some embodiments, in the elongated delivery configuration, each of the plurality of occlusive medical devices <NUM> may have a similar overall length.

At least one of the plurality of occlusive medical devices <NUM> may have a different stiffness than a different one of the plurality of occlusive medical devices <NUM>. More specifically, a distalmost one of the plurality of occlusive medical devices <NUM> (e.g., the third occlusive medical device <NUM>) has a stiffness greater than any other of the plurality of occlusive medical devices <NUM> (e.g., the first occlusive medical device <NUM> and/or the second occlusive medical device <NUM>), to facilitate anchoring against and/or apposition to a wall at the treatment site (e.g., a wall of a vessel lumen), for example. In some embodiments, a proximalmost one of the plurality of occlusive medical devices <NUM> (e.g., the first occlusive medical device <NUM>) may have a stiffness less than any other of the plurality of occlusive medical devices <NUM> (e.g., the second occlusive medical device <NUM> and/or the third occlusive medical device <NUM>), to facilitate packing against the second occlusive medical device <NUM> and/or the third occlusive medical device <NUM>, for example. Differences in stiffness may facilitate positioning, placement, fixation, retention, and/or occlusion of the plurality of occlusive medical devices <NUM> within the vasculature and/or the treatment site. In some embodiments, a distal tip of the distalmost one of the plurality of occlusive medical devices <NUM> (e.g., the third occlusive medical device <NUM>) may have an atraumatic tip, feature, or distal end. Some suitable but non-limiting materials for the plurality of occlusive medical devices <NUM>, for example metallic materials, polymer materials, composite materials, shape memory materials, etc., are described below.

In some embodiments, one or more (e.g., one, two, each, etc.) of the plurality of occlusive medical devices <NUM> may include a plurality of fibers and/or a fabric or woven material disposed within and/or attached to individual coils of the plurality of occlusive medical devices <NUM>. The plurality of fibers and/or the fabric or woven material disposed within, attached to, and or embedded within individual coils of the plurality of occlusive medical devices <NUM> may be configured to enhance coagulation and/or occlusion of the vasculature (e.g., the artery, vein, etc.) and/or the treatment site.

The vascular occlusion system <NUM> may further comprise one or more attachment mechanisms releasably connecting, attaching, and/or securing the plurality of occlusive medical devices <NUM> to the distal end <NUM> of the elongate shaft <NUM>. In some embodiments, the vascular occlusion system <NUM> may comprise a first attachment mechanism <NUM> disposed between the distal end <NUM> of the elongate shaft <NUM> and the proximal end of the first occlusive medical device <NUM>, wherein the first attachment mechanism comprises a first part <NUM> and a second part <NUM>. In some embodiments, the vascular occlusion system <NUM> may comprise a second attachment mechanism <NUM> disposed between the distal end of the first occlusive medical device <NUM> and the proximal end of the second occlusive medical device <NUM>, wherein the second attachment mechanism comprises a third part <NUM> and a fourth part <NUM>. In some embodiments, the vascular occlusion system <NUM> may comprise a third attachment mechanism <NUM> disposed between the distal end of the second occlusive medical device <NUM> and the proximal end of the third occlusive medical device <NUM>, wherein the third attachment mechanism comprises a fifth part <NUM> and a sixth part <NUM>. Additional details related to the first, second, and third attachment mechanisms will be described below with respect to <FIG>.

Continuing with <FIG> and <FIG>, the vascular occlusion system <NUM> includes a release wire <NUM> slidably disposed within the lumen <NUM> of the elongate shaft <NUM> and at least a portion of each of the plurality of occlusive medical devices <NUM>. The release wire <NUM> is configured to releasably secure and/or attach the plurality of occlusive medical devices <NUM> to the distal end <NUM> of the elongate shaft <NUM> when the release wire <NUM> is disposed within at least a portion of each of the plurality of occlusive medical devices <NUM>. The release wire <NUM> extends completely through at least one of the plurality of occlusive medical devices <NUM>. In some embodiments, the release wire <NUM> may be alternately and/or interchangeably referred to as a pull wire, an actuation wire, and/or a locking wire. The release wire <NUM> may generally be a solid wire or shaft, but may also be tubular in some embodiments. Some suitable but non-limiting materials for the release wire <NUM>, for example metallic materials, polymer materials, composite materials, etc., are described below.

The vascular occlusion system <NUM> may include a securement member <NUM> fixedly attached to and/or extending proximally from the proximal end <NUM> of the elongate shaft <NUM>, and fixedly attached to a proximal portion and/or a proximal end of the release wire <NUM>. The securement member <NUM> may include a proximal portion <NUM>, a distal portion <NUM>, and a wall extending from a proximal end of the securement member <NUM> to a distal end of the securement member <NUM>. In at least some embodiments, the proximal portion <NUM> of the securement member <NUM> may be integrally formed with the distal portion <NUM> of the securement member <NUM> as a single unitary structure. Some suitable but non-limiting materials for the securement member <NUM>, for example metallic materials, polymer materials, composite materials, etc., are described below.

In some embodiments, the proximal portion <NUM> of the securement member <NUM> may be configured to disengage from the distal portion <NUM> of the securement member <NUM>. The proximal portion <NUM> of the securement member <NUM> may be fixedly attached to the proximal portion and/or the proximal end of the release wire <NUM>. The distal portion <NUM> of the securement member <NUM> may be fixedly attached to the proximal end <NUM> of the elongate shaft <NUM>. In at least some embodiments, an outer surface of the distal portion <NUM> of the securement member <NUM> may be fixedly attached to an inner surface of the elongate shaft <NUM> (e.g., a surface defining the lumen <NUM>). Alternatively, in some embodiments, an inner surface of the distal portion <NUM> of the securement member <NUM> may be fixedly attached to an outer surface of the elongate shaft <NUM>. In some embodiments, the proximal portion <NUM> of the securement member <NUM> may be releasably secured to and/or configured to disengage from the distal portion <NUM> of the securement member <NUM> at a joint <NUM> (e.g., a perforation, a frangible link, etc.) formed in the wall of the securement member <NUM>.

In at least some embodiments, the joint <NUM> may include a series of apertures extending through the wall of the securement member <NUM>. In some embodiments, the joint <NUM> may extend circumferentially about an entire circumference of the wall of the securement member <NUM>. In some embodiments, the joint <NUM> may extend partially and/or intermittently about the entire circumference of the wall of the securement member <NUM>. While an exemplary series of apertures may be round holes, the skilled person will recognize that other suitable shapes (e.g., square, rectangular, ovoid, irregular, etc.) may also be used. For example, in some embodiments, the joint <NUM> may include a series of rectangular notches having a major dimension oriented circumferentially, the series of rectangular notches extending through the wall of the securement member <NUM>. Additionally, while the joint <NUM> is illustrated as being generally oriented and/or positioned within a plane perpendicular to a longitudinal axis of the securement member <NUM>, the elongate shaft <NUM>, the release wire <NUM>, and/or the vascular occlusion system <NUM>, other orientations and/or positioning may be used. For example, in some embodiments, the joint <NUM> and/or the series of apertures may be oriented and/or positioned within or along a plane at an oblique angle to the longitudinal axis of the securement member <NUM>, the elongate shaft <NUM>, the release wire <NUM>, and/or the vascular occlusion system <NUM>. Other, for example non-planar, configurations are also possible. The proximal portion <NUM> of the securement member <NUM> is disposed proximal of the joint <NUM> and the distal portion <NUM> of the securement member <NUM> is disposed distal of the joint <NUM>. As mentioned above, the proximal portion <NUM> of the securement member <NUM> may be releasably secured to and/or configured to disengage from the distal portion <NUM> of the securement member <NUM> at the joint <NUM> formed in the wall of the securement member <NUM>.

In at least some embodiments, the frangible link may include a thinned and/or weakened feature, or series of features, formed in the wall of the securement member <NUM> that is more susceptible to fracture and/or separation than the remainder of the wall. In some embodiments, the frangible link may extend circumferentially about an entire circumference of the wall of the securement member <NUM>. In some embodiments, the frangible link may extend partially and/or intermittently about the entire circumference of the wall of the securement member <NUM>. The proximal portion <NUM> of the securement member <NUM> is disposed proximal of the frangible link and the distal portion <NUM> of the securement member <NUM> is disposed distal of the frangible link. As mentioned above, the proximal portion <NUM> of the securement member <NUM> may be releasably secured to and/or configured to disengage from the distal portion <NUM> of the securement member <NUM> at the frangible link formed in the wall of the securement member <NUM>.

In some embodiments, the joint <NUM> of the securement member <NUM> may include both the perforation and the frangible link. For example, the perforation may be formed within the frangible link. In some embodiments, a portion of the circumference of the securement member <NUM> may include the perforation while a different portion of the circumference of the securement member <NUM> may include the frangible link. Other combinations and/or configuration are also contemplated.

In at least some embodiments, the securement member <NUM> may prevent axial translation of the release wire <NUM> relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> prior to disengagement of the proximal portion <NUM> of the securement member <NUM> from the distal portion <NUM> of the securement member <NUM>. Disengaging the proximal portion <NUM> of the securement member <NUM> from the distal portion <NUM> of the securement member <NUM> may permit the release wire <NUM> to axially translate relative to the distal portion <NUM> of the securement member <NUM>, the elongate shaft <NUM>, and/or the plurality of occlusive medical devices <NUM>. In other words, the wall of the distal portion <NUM> of the securement member <NUM> may define a lumen, wherein the release wire <NUM> is slidably disposed within the lumen of the distal portion <NUM> of the securement member <NUM>. Upon disengagement of the proximal portion <NUM> of the securement member <NUM> from the distal portion <NUM> of the securement member <NUM>, as seen in <FIG> and <FIG> for example, axial translation of the proximal portion <NUM> relative to the distal portion <NUM> of the securement member <NUM>, the elongate shaft <NUM>, and/or the plurality of occlusive medical devices <NUM> may translate the release wire <NUM> relative to the elongate shaft <NUM> and/or the distal portion <NUM> of the securement member <NUM> to release at least one of the plurality of occlusive medical devices <NUM> from the distal end <NUM> of the elongate shaft <NUM>, as will be explained in more detail herein.

In some embodiments, and as illustrated in <FIG>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, and/or the third attachment mechanism <NUM> may be constructed in a substantially similar manner. Some suitable but non-limiting materials for the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, and/or the third attachment mechanism <NUM>, for example metallic materials, polymer materials, composite materials, etc., are described below.

The first attachment mechanism <NUM> may comprise the first part <NUM> having a first longitudinal lumen <NUM> configured to slidably receive the release wire <NUM> therein, and the second part <NUM> having a second longitudinal lumen <NUM> configured to slidably receive the release wire <NUM> therein. The first part <NUM> of the first attachment mechanism <NUM> may be fixedly attached to the distal end <NUM> of the elongate shaft <NUM> and the second part <NUM> of the first attachment mechanism <NUM> may be fixedly attached to the proximal end of the first occlusive medical device <NUM>. The first part <NUM> of the first attachment mechanism <NUM> and the second part <NUM> of the first attachment mechanism <NUM> may be configured to interlock with each other such that relative axial translation between the first part <NUM> of the first attachment mechanism <NUM> and the second part <NUM> of the first attachment mechanism <NUM> is prevented when a face of the first part <NUM> of the first attachment mechanism <NUM> abuts and/or engages a face of the second part <NUM> of the first attachment mechanism <NUM> and the first longitudinal lumen <NUM> of the first part <NUM> of the first attachment mechanism <NUM> is aligned coaxially with the second longitudinal lumen <NUM> of the second part <NUM> of the first attachment mechanism <NUM>. Additionally, in some embodiments, the first part <NUM> of the first attachment mechanism <NUM> and the second part <NUM> of the first attachment mechanism <NUM> may be configured to interlock with each other such that relative lateral translation between the first part <NUM> of the first attachment mechanism <NUM> and the second part <NUM> of the first attachment mechanism <NUM> is prevented when a face of the first part <NUM> of the first attachment mechanism <NUM> abuts and/or engages a face of the second part <NUM> of the first attachment mechanism <NUM>, the first longitudinal lumen <NUM> of the first part <NUM> of the first attachment mechanism <NUM> is aligned coaxially with the second longitudinal lumen <NUM> of the second part <NUM> of the first attachment mechanism <NUM>, and the release wire <NUM> is slidably engaged with the first longitudinal lumen <NUM> of the first part <NUM> of the first attachment mechanism <NUM> and the second longitudinal lumen <NUM> of the second part <NUM> of the first attachment mechanism <NUM>.

The second attachment mechanism <NUM> may comprise the third part <NUM> having a third longitudinal lumen <NUM> configured to slidably receive the release wire <NUM> therein, and the fourth part <NUM> having a fourth longitudinal lumen <NUM> configured to slidably receive the release wire <NUM> therein. The third part <NUM> of the second attachment mechanism <NUM> may be fixedly attached to the distal end of the first occlusive medical device <NUM> and the fourth part <NUM> of the second attachment mechanism <NUM> may be fixedly attached to the proximal end of the second occlusive medical device <NUM>. The third part <NUM> of the second attachment mechanism <NUM> and the fourth part <NUM> of the second attachment mechanism <NUM> may be configured to interlock with each other such that relative axial translation between the third part <NUM> of the second attachment mechanism <NUM> and the fourth part <NUM> of the second attachment mechanism <NUM> is prevented when a face of the third part <NUM> of the second attachment mechanism <NUM> abuts and/or engages a face of the fourth part <NUM> of the second attachment mechanism <NUM> and the third longitudinal lumen <NUM> of the third part <NUM> of the second attachment mechanism <NUM> is aligned coaxially with the fourth longitudinal lumen <NUM> of the fourth part <NUM> of the second attachment mechanism <NUM>. Additionally, in some embodiments, the third part <NUM> of the second attachment mechanism <NUM> and the fourth part <NUM> of the second attachment mechanism <NUM> may be configured to interlock with each other such that relative lateral translation between the third part <NUM> of the second attachment mechanism <NUM> and the fourth part <NUM> of the second attachment mechanism <NUM> is prevented when a face of the third part <NUM> of the second attachment mechanism <NUM> abuts and/or engages a face of the fourth part <NUM> of the second attachment mechanism <NUM>, the third longitudinal lumen <NUM> of the third part <NUM> of the second attachment mechanism <NUM> is aligned coaxially with the fourth longitudinal lumen <NUM> of the fourth part <NUM> of the second attachment mechanism <NUM>, and the release wire <NUM> is slidably engaged with the third longitudinal lumen <NUM> of the third part <NUM> of the second attachment mechanism <NUM> and the fourth longitudinal lumen <NUM> of the fourth part <NUM> of the second attachment mechanism <NUM>.

The third attachment mechanism <NUM> may comprise the fifth part <NUM> having a fifth longitudinal lumen <NUM> configured to slidably receive the release wire <NUM> therein, and the sixth part <NUM> having a sixth longitudinal lumen <NUM> configured to slidably receive the release wire <NUM> therein. The fifth part <NUM> of the third attachment mechanism <NUM> may be fixedly attached to the distal end of the second occlusive medical device <NUM> and the sixth part <NUM> of the third attachment mechanism <NUM> may be fixedly attached to the proximal end of the third occlusive medical device <NUM>. The fifth part <NUM> of the third attachment mechanism <NUM> and the sixth part <NUM> of the third attachment mechanism <NUM> may be configured to interlock with each other such that relative axial translation between the fifth part <NUM> of the third attachment mechanism <NUM> and the sixth part <NUM> of the third attachment mechanism <NUM> is prevented when a face of the fifth part <NUM> of the third attachment mechanism <NUM> abuts and/or engages a face of the sixth part <NUM> of the third attachment mechanism <NUM> and the fifth longitudinal lumen <NUM> of the fifth part <NUM> of the third attachment mechanism <NUM> is aligned coaxially with the sixth longitudinal lumen <NUM> of the sixth part <NUM> of the third attachment mechanism <NUM>. Additionally, in some embodiments, the fifth part <NUM> of the third attachment mechanism <NUM> and the sixth part <NUM> of the third attachment mechanism <NUM> may be configured to interlock with each other such that relative lateral translation between the fifth part <NUM> of the third attachment mechanism <NUM> and the sixth part <NUM> of the third attachment mechanism <NUM> is prevented when a face of the fifth part <NUM> of the third attachment mechanism <NUM> abuts and/or engages a face of the sixth part <NUM> of the third attachment mechanism <NUM>, the fifth longitudinal lumen <NUM> of the fifth part <NUM> of the third attachment mechanism <NUM> is aligned coaxially with the sixth longitudinal lumen <NUM> of the sixth part <NUM> of the third attachment mechanism <NUM>, and the release wire <NUM> is slidably engaged with the fifth longitudinal lumen <NUM> of the fifth part <NUM> of the third attachment mechanism <NUM> and the sixth longitudinal lumen <NUM> of the sixth part <NUM> of the third attachment mechanism <NUM>.

<FIG> and <FIG> generally illustrate at least one of the plurality of occlusive medical devices <NUM> being released from the distal end <NUM> of the elongate shaft <NUM>, such as at a treatment site, for example. In use, the microcatheter <NUM> of the vascular occlusion system <NUM> may be inserted into a patient's anatomy and/or vasculature and a distal end guided and/or advanced to a location adjacent a treatment site. The plurality of occlusive medical devices <NUM> disposed at the distal end <NUM> of the elongate shaft <NUM> may be inserted into a proximal end of the lumen <NUM> disposed within the microcatheter <NUM> and advanced through the microcatheter <NUM> to the treatment site. In some embodiments, the plurality of occlusive medical devices <NUM> may be disposed within the lumen <NUM> of the microcatheter <NUM> proximate to the distal end <NUM> of the elongate shaft <NUM>. In some embodiments, the plurality of occlusive medical devices <NUM> may be disposed within the lumen <NUM> of the microcatheter <NUM> proximate to the distal end <NUM> of the elongate shaft <NUM> prior to use and/or prior to inserting the microcatheter <NUM> into the patient's anatomy and/or vasculature.

Deployment and/or release of at least one of the plurality of occlusive medical devices <NUM> may be performed selectively depending upon the type of occlusive medical devices and/or the desired treatment process or method. It has been found that the exact amount of occlusive medical device (e.g., embolic coil, etc.) needed to properly occlude a vasculature (e.g., an artery, vein, etc.) or treatment site may not be known until the treatment procedure is underway, due to variations in the size of the vasculature, plaque build-up within the vasculature, distention of the vasculature, etc. If an insufficient amount of occlusive medical device is provided to the treatment site initially, additional occlusive medical device(s) may need to be prepared and inserted into the patient's vasculature via additional vascular occlusion system(s), thus extending the treatment procedure and any attendant risks to the patient. In order to reduce the treatment procedure duration and to provide more flexibility in deploying and/or releasing the required amount of occlusive medical device(s), the vascular occlusion system <NUM> has been developed which includes a plurality of occlusive medical devices <NUM> releasably connected to the distal end <NUM> of the elongate shaft <NUM>. Using the vascular occlusion system <NUM> described herein, an operator may selectively deploy one or more of the plurality of occlusive medical devices <NUM> based upon the individual procedure requirements, while requiring only a single vascular occlusion system, thus reducing the treatment procedure duration and the overall cost of the treatment procedure (due to fewer vascular occlusion systems, along with the attendant packaging, preparation requirements, etc., being used).

When ready to deploy at least one of the plurality of occlusive medical devices <NUM> at the treatment site, the elongate shaft <NUM> may be advanced and/or translated distally relative to the microcatheter <NUM> until at least one of the plurality of occlusive medical devices <NUM> is exposed and/or disposed distal of the microcatheter <NUM>. The elongate shaft <NUM> may have sufficient length that the proximal end <NUM> of the elongate shaft <NUM> and/or the securement member <NUM> remains proximal of (e.g., extends proximally from) the microcatheter <NUM> when the plurality of occlusive medical devices <NUM> is disposed distal of the microcatheter <NUM>. In use, the elongate shaft <NUM> and the microcatheter <NUM> may have sufficient length to reach from the treatment site to a position outside of the patient where the vascular occlusion system <NUM> may be manipulated by an operator (e.g., clinician, physician, user, etc.). The operator of the vascular occlusion system <NUM> may then place a first hand on the distal portion <NUM> of the securement member <NUM> and a second hand on the proximal portion <NUM> of the securement member <NUM>. The proximal portion <NUM> of the securement member <NUM> may be configured to disengage from the distal portion <NUM> of the securement member <NUM> at a location proximal of a proximal end of the microcatheter <NUM> when the plurality of occlusive medical devices <NUM> is disposed distal of the microcatheter <NUM>. In at least some embodiments, the proximal portion <NUM> of the securement member <NUM> may be disengaged from the distal portion <NUM> of the securement member <NUM> by bending, twisting, and/or pulling the proximal portion <NUM> of the securement member <NUM> relative to the distal portion <NUM> of the securement member <NUM>. In some embodiments, disengaging the proximal portion <NUM> of the securement member <NUM> from the distal portion <NUM> of the securement member <NUM> may include moving the proximal portion <NUM> of the securement member <NUM> relative to the distal portion <NUM> of the securement member <NUM> to separate the proximal portion <NUM> of the securement member <NUM> from the distal portion <NUM> of the securement member <NUM>. In some embodiments, disengaging the proximal portion <NUM> of the securement member <NUM> from the distal portion <NUM> of the securement member <NUM> may include using an external device (e.g., a torque device, an external handle, etc.) to move the proximal portion <NUM> of the securement member <NUM> relative to the distal portion <NUM> of the securement member <NUM>.

When the proximal portion <NUM> of the securement member <NUM> is disengaged and/or separated from the distal portion <NUM> of the securement member <NUM>, as seen in <FIG>, the release wire <NUM> is translated in a proximal direction relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> to release the sixth part <NUM> of the third attachment mechanism <NUM> and/or the third occlusive medical device <NUM> from the fifth part <NUM> of the third attachment mechanism <NUM> and/or the elongate shaft <NUM> (e.g., to release the third occlusive medical device <NUM> from the distal end <NUM> of the elongate shaft <NUM>). When the release wire <NUM> is translated and/or withdrawn proximally relative to the elongate shaft <NUM> and/or the third occlusive medical device <NUM>, the third occlusive medical device <NUM> is released from the distal end <NUM> of the elongate shaft <NUM> and shifts from the first shape and/or the elongated delivery configuration to the second shape and/or the deployed configuration.

The release wire <NUM> includes one or more indicators <NUM> disposed proximate the proximal end of the release wire <NUM> configured to show how much of the release wire <NUM> has been withdrawn and/or configured to communicate to a user of the vascular occlusion system <NUM> how much or how many of the plurality of occlusive medical devices <NUM> has been released, as seen in <FIG> and <FIG> for example. The one or more indicators <NUM> may include lines, detents, colors, notches, or other suitable indicators. The one or more indicators <NUM>, if visible, may be seen between the proximal portion <NUM> of the securement member <NUM> and the distal portion <NUM> of the securement member <NUM> after the proximal portion <NUM> of the securement member <NUM> has been disengaged from the distal portion <NUM> of the securement member <NUM> at the joint <NUM>, as described above.

After releasing one of the plurality of occlusive medical devices <NUM> (e.g., the third occlusive medical device <NUM>) at the treatment site, the vascular occlusion system <NUM> and/or the elongate shaft <NUM> may be advanced distally, if necessary, to position the distal end of one of the plurality of occlusive medical devices <NUM> (e.g., the second occlusive medical device <NUM> and/or the first occlusive medical device <NUM>) still connected to the distal end <NUM> of the elongate shaft <NUM> adjacent the released occlusive medical device (e.g., the third occlusive medical device <NUM>). The release wire <NUM> may then be further translated proximally relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> to release the positioned occlusive medical device (e.g., the second occlusive medical device <NUM> and/or the first occlusive medical device <NUM>) from the distal end <NUM> of the elongate shaft <NUM>, as seen in <FIG> for example. When the release wire <NUM> is translated and/or withdrawn proximally relative to the elongate shaft <NUM> and/or the second occlusive medical device <NUM>, the second occlusive medical device <NUM> is released from the distal end <NUM> of the elongate shaft <NUM> and shifts from the first shape and/or the elongated delivery configuration to the second shape and/or the deployed configuration.

After releasing two of the plurality of occlusive medical devices <NUM> (e.g., the second occlusive medical device <NUM> and the third occlusive medical device <NUM>) at the treatment site, the vascular occlusion system <NUM> and/or the elongate shaft <NUM> may be advanced distally, if necessary, to position the distal end of one of the plurality of occlusive medical devices <NUM> (e.g., the first occlusive medical device <NUM>) still connected to the distal end <NUM> of the elongate shaft <NUM> adjacent the released occlusive medical device(s) (e.g., the third occlusive medical device <NUM> and/or the second occlusive medical device <NUM>). The release wire <NUM> may then be further translated proximally relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> to release the positioned occlusive medical device (e.g., the first occlusive medical device <NUM>) from the distal end <NUM> of the elongate shaft <NUM>. When the release wire <NUM> is translated and/or withdrawn proximally relative to the elongate shaft <NUM> and/or the first occlusive medical device <NUM>, the first occlusive medical device <NUM> is released from the distal end <NUM> of the elongate shaft <NUM> and shifts from the first shape and/or the elongated delivery configuration to the second shape and/or the deployed configuration.

<FIG> and <FIG> illustrate an alternative attachment and/or release mechanism for use with the plurality of occlusive medical devices <NUM> described herein. While illustrated with respect to the first occlusive medical device <NUM> and the distal end <NUM> of the elongate shaft <NUM>, the illustrated alternative attachment and/or release mechanism may be used with any and/or each of the plurality of occlusive medical devices <NUM>. In embodiments using the alternative attachment and/or release mechanism, the vascular occlusion system <NUM> may further comprise a second release wire <NUM> slidably disposed within the lumen <NUM> of the elongate shaft <NUM> and at least a portion of each of the plurality of occlusive medical devices <NUM>. The second release wire <NUM> may include a ball tip <NUM> fixedly attached to and/or disposed at a distal end of the second release wire <NUM>, wherein the ball tip <NUM> has an outer diameter greater than an outer diameter of the second release wire <NUM>. The release wire <NUM> extends distally of the ball tip <NUM> of the second release wire <NUM> when the release wire <NUM> and the second release wire <NUM> are slidably disposed within at least a portion of each of the plurality of occlusive medical devices <NUM>.

The vascular occlusion system <NUM> may further comprise a securing member <NUM> fixedly attached to a proximal end of each of the plurality of occlusive medical devices <NUM> (e.g., the first occlusive medical device <NUM>, the second occlusive medical device <NUM>, and/or the third occlusive medical device <NUM>). The release wire <NUM> and the second release wire <NUM> may be configured to releasably connect, attach, and/or secure the plurality of occlusive medical devices <NUM> to the distal end <NUM> of the elongate shaft <NUM> when the release wire <NUM> and the second release wire <NUM> are disposed within at least a portion of each of the plurality of occlusive medical devices <NUM> and/or when both the release wire <NUM> and the second release wire <NUM> extend through the securing member <NUM> simultaneously. When both the release wire <NUM> and the second release wire <NUM> extend through the securing member <NUM> simultaneously, as shown in <FIG> for example, the second release wire <NUM> is prevented from being withdrawn through the securing member <NUM> due to interference between the ball tip <NUM> and the securing member <NUM>.

Proximal withdrawal of the release wire <NUM> and then the second release wire <NUM> through the securing member <NUM> and/or relative to the elongate shaft <NUM> releases one of the plurality of occlusive medical devices <NUM> (e.g., the first occlusive medical device <NUM>, the second occlusive medical device <NUM>, and/or the third occlusive medical device <NUM>) from the distal end <NUM> of the elongate shaft <NUM>. For example, by withdrawing the release wire <NUM> through the securing member <NUM>, the second release wire <NUM> is permitted to deflect radially inward as it contacts and/or passes through the securing member <NUM> instead of interfering with the securing member <NUM> when the ball tip <NUM> contacts the securing member <NUM>, wherein the ball tip <NUM> is prevented from deflecting by the release wire <NUM>. Thus, proximal withdrawal of the release wire <NUM> and then the second release wire <NUM> through the securing member <NUM> and/or relative to the elongate shaft <NUM> releases one of the plurality of occlusive medical devices <NUM> (e.g., the first occlusive medical device <NUM>, as shown in <FIG> for example) from the distal end <NUM> of the elongate shaft <NUM>. As mentioned above, the same process may apply to each of the plurality of occlusive medical devices <NUM>.

In some embodiments, the release wire <NUM> and the second release wire <NUM> may extend completely through at least one of the plurality of occlusive medical devices <NUM>. In some embodiments, the release wire <NUM> and the second release wire <NUM> may extend completely through the first occlusive medical device <NUM> and the second occlusive medical device <NUM>, and into at least a portion of the third occlusive medical device <NUM>. In some embodiments, proximal withdrawal of the release wire <NUM> and then the second release wire <NUM> relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> sequentially releases each of the plurality of occlusive medical devices <NUM> from a distalmost occlusive medical device (e.g., the third occlusive medical device <NUM>) to a proximalmost occlusive medical device (e.g., the first occlusive medical device <NUM>). In some embodiments, the second release wire <NUM> may be alternately and/or interchangeably referred to as a pull wire, an actuation wire, and/or a locking wire. The second release wire <NUM> may generally be a solid wire or shaft, but may also be tubular in some embodiments. Some suitable but non-limiting materials for and the second release wire <NUM>, for example metallic materials, polymer materials, composite materials, etc., are described below.

The vascular occlusion system <NUM> may be used in a method of embolizing a vasculature (e.g., an artery, a vein, etc.), aspects of which are illustrated in <FIG>. The method may comprise advancing the vascular occlusion system <NUM> to the treatment within the vasculature (e.g., an artery, a vein, etc.). As discussed above, the vascular occlusion system <NUM> may include the plurality of occlusive medical devices <NUM> releasably connected to the distal end <NUM> of the elongate shaft <NUM>, and a release wire <NUM> slidably disposed within the lumen <NUM> of the elongate shaft <NUM> and at least a portion of each of the plurality of occlusive medical devices <NUM>.

The method may further comprise withdrawing the release wire <NUM> proximally relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> to release one of the plurality of occlusive medical devices <NUM> from the distal end <NUM> of the elongate shaft <NUM> at the treatment site. For example, withdrawing the release wire <NUM> proximally relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> may release the third occlusive medical device <NUM> from the distal end <NUM> of the elongate shaft <NUM> at the treatment site by releasing the sixth part <NUM> of the third attachment mechanism <NUM> from the fifth part <NUM> of the third attachment mechanism <NUM>. In at least some embodiments, the third occlusive medical device <NUM> (e.g., the one of the plurality of occlusive medical devices <NUM>) may be configured to shift from the first shape and/or the elongated delivery configuration to the second shape and/or the deployed configuration within and/or against a wall of the vasculature (e.g., the artery, the vein, etc.) and/or the treatment site. In some embodiments, the third occlusive medical device <NUM> (e.g., the one of the plurality of occlusive medical devices <NUM>) may be configured to assume a substantially helical configuration and/or shape within and/or against the wall of the vasculature (e.g., the artery, the vein, etc.) and/or the treatment site. Other configurations and/or shapes are also contemplated. The third occlusive medical device <NUM> (e.g., the one of the plurality of occlusive medical devices <NUM>) has a stiffness greater than any other of the plurality of occlusive medical devices <NUM> to form a solid "base" or "anchor" within the vasculature (e.g., the artery, the vein, etc.) and/or the treatment site, thereby preventing migration of the deployed plurality of occlusive medical devices <NUM>.

The method may further comprise positioning the distal end of one of the plurality of occlusive medical devices <NUM> (e.g., the second occlusive medical device <NUM>, the first occlusive medical device <NUM>, etc.) still connected to the distal end <NUM> of the elongate shaft <NUM> adjacent the released occlusive medical device (e.g., the third occlusive medical device <NUM>, the one of the plurality of occlusive medical devices <NUM>, etc.). For example, the method may comprise positioning the distal end of the second occlusive medical device <NUM> and/or the fifth part <NUM> of the third attachment mechanism <NUM> adjacent the third occlusive medical device <NUM>, which was previously deployed within the vasculature (e.g., the artery, the vein, etc.) and/or the treatment site.

The method may further comprise withdrawing the release wire <NUM> proximally relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> to release the positioned occlusive medical device (e.g., the second occlusive medical device <NUM>) from the distal end <NUM> of the elongate shaft <NUM> at the treatment site. For example, withdrawing the release wire <NUM> proximally relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> may release the second occlusive medical device <NUM> from the distal end <NUM> of the elongate shaft <NUM> at the treatment site by releasing the fourth part <NUM> of the second attachment mechanism <NUM> from the third part <NUM> of the second attachment mechanism <NUM>. In at least some embodiments, the second occlusive medical device <NUM> (e.g., the positioned occlusive medical device) may be configured to shift from the first shape and/or the elongated delivery configuration to the second shape and/or the deployed configuration within the vasculature (e.g., the artery, the vein, etc.) and/or the treatment site. In some embodiments, the second occlusive medical device <NUM> (e.g., the positioned occlusive medical device) may be configured to assume a configuration and/or a second shape within the vasculature (e.g., the artery, the vein, etc.) and/or the treatment site that is different from the third occlusive medical device <NUM>. In some embodiments, the second occlusive medical device <NUM> (e.g., the positioned occlusive medical device) may assume a substantially randomized and/or irregular second shape. Other configurations and/or shapes are also contemplated. The second occlusive medical device <NUM> (e.g., the positioned occlusive medical device) has a stiffness less than the third occlusive medical device <NUM> (e.g., the one of the plurality of occlusive medical devices <NUM>), thereby permitting easier "packing" of the second occlusive medical device <NUM> against, within, and/or around the third occlusive medical device <NUM> to fill and/or occlude the vasculature (e.g., the artery, the vein, etc.) and/or the treatment site.

After releasing two of the plurality of occlusive medical devices <NUM> (e.g., the second occlusive medical device <NUM> and the third occlusive medical device <NUM>) at the treatment site, the method may further comprise positioning the distal end of one of the plurality of occlusive medical devices <NUM> (e.g., the first occlusive medical device <NUM>) still connected to the distal end <NUM> of the elongate shaft <NUM> adjacent the released occlusive medical device (e.g., the second occlusive medical device <NUM> and/or the third occlusive medical device <NUM>, the one of the plurality of occlusive medical devices <NUM>, etc.). For example, the method may comprise positioning the distal end of the first occlusive medical device <NUM> and/or the third part <NUM> of the second attachment mechanism <NUM> adjacent the third occlusive medical device <NUM> and/or the second occlusive medical device <NUM>, which was previously deployed within the vasculature (e.g., the artery, the vein, etc.) and/or the treatment site.

The method may further comprise withdrawing the release wire <NUM> proximally relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> to release the positioned occlusive medical device (e.g., the first occlusive medical device <NUM>) from the distal end <NUM> of the elongate shaft <NUM> at the treatment site. For example, withdrawing the release wire <NUM> proximally relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> may release the first occlusive medical device <NUM> from the distal end <NUM> of the elongate shaft <NUM> at the treatment site by releasing the second part <NUM> of the first attachment mechanism <NUM> from the first part <NUM> of the first attachment mechanism <NUM>. In at least some embodiments, the first occlusive medical device <NUM> (e.g., the positioned occlusive medical device) may be configured to shift from the first shape and/or the elongated delivery configuration to the second shape and/or the deployed configuration within the vasculature (e.g., the artery, the vein, etc.) and/or the treatment site. In some embodiments, the first occlusive medical device <NUM> (e.g., the positioned occlusive medical device) may be configured to assume a configuration and/or a second shape within the vasculature (e.g., the artery, the vein, etc.) and/or the treatment site that is different from the third occlusive medical device <NUM> and/or the second occlusive medical device <NUM>. In some embodiments, the first occlusive medical device <NUM> (e.g., the positioned occlusive medical device) may assume a substantially randomized and/or irregular second shape. Other configurations and/or shapes are also contemplated. The first occlusive medical device <NUM> (e.g., the positioned occlusive medical device) has a stiffness less than the third occlusive medical device <NUM> and possibly also the second occlusive medical device <NUM> (e.g., the one of the plurality of occlusive medical devices <NUM>), thereby permitting easier "packing" of the first occlusive medical device <NUM> against, within, and/or around the third occlusive medical device <NUM> and/or the second occlusive medical device <NUM> to fill and/or occlude the vasculature (e.g., the artery, the vein, etc.) and/or the treatment site.

In some embodiments, proximal withdrawal of the release wire <NUM> relative to the elongate shaft <NUM> and/or the plurality of occlusive medical devices <NUM> sequentially releases each of the plurality of occlusive medical devices <NUM> from a distalmost occlusive medical device (e.g., the third occlusive medical device <NUM>) to a proximalmost occlusive medical device (e.g., the first occlusive medical device <NUM>).

The materials that can be used for the various components of the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc. (and/or other systems disclosed herein) and the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other elements, members, components, or devices disclosed herein, such as, but not limited to, the first occlusive medical device <NUM>, the second occlusive medical device <NUM>, the third occlusive medical device <NUM>, the first part <NUM>, the second part <NUM>, the third part <NUM>, the fourth part <NUM>, the fifth part <NUM>, the sixth part <NUM>, etc. and/or elements or components thereof.

In some embodiments, the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc., and/or components thereof (such as, but not limited to, the first occlusive medical device <NUM>, the second occlusive medical device <NUM>, the third occlusive medical device <NUM>, the first part <NUM>, the second part <NUM>, the third part <NUM>, the fourth part <NUM>, the fifth part <NUM>, the sixth part <NUM>, etc.), may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 444V, <NUM>, and 314LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; and the like; or any other suitable material.

of Kanagawa, Japan. Other suitable materials may include ULTANUIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota).

In at least some embodiments, portions or all of the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc., and/or components thereof, may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids a user in determining the location of the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc. to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc. For example, the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc., and/or components or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc., or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N® and the like), nitinol, and the like, and others.

In some embodiments, the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc., and/or portions thereof, may be made from or include a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-<NUM>-isobutylene-<NUM>-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, polyurethane silicone copolymers (for example, ElastEon® from Aortech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about <NUM> percent LCP.

In some embodiments, the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc. and/or other elements disclosed herein may include a fabric material disposed over or within the structure. The fabric material may be composed of a biocompatible material, such a polymeric material or biomaterial, adapted to promote tissue ingrowth. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), a polyolefinic material such as a polyethylene, a polypropylene, polyester, polyurethane, and/or blends or combinations thereof.

In some embodiments, the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc. may include and/or be formed from a textile material. Some examples of suitable textile materials may include synthetic yarns that may be flat, shaped, twisted, textured, pre-shrunk or un-shrunk. Synthetic biocompatible yarns suitable for use in the present invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyesters, polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxylene derivatives, natural silk, and polytetrafluoroethylenes. Moreover, at least one of the synthetic yarns may be a metallic yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those yarns made from or containing stainless steel, platinum, gold, titanium, tantalum or a Ni-Co-Cr-based alloy. The yarns may further include carbon, glass or ceramic fibers. Desirably, the yarns are made from thermoplastic materials including, but not limited to, polyesters, polypropylenes, polyethylenes, polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like. The yarns may be of the multifilament, monofilament, or spun-types. The type and denier of the yarn chosen may be selected in a manner which forms a biocompatible and implantable prosthesis and, more particularly, a vascular structure having desirable properties.

In some embodiments, the vascular occlusion system <NUM>, the elongate shaft <NUM>, the release wire <NUM>, the second release wire <NUM>, the securing member <NUM>, the plurality of occlusive medical devices <NUM>, the securement member <NUM>, the first attachment mechanism <NUM>, the second attachment mechanism <NUM>, the third attachment mechanism <NUM>, the microcatheter <NUM>, etc. may include and/or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include anti-thrombogenic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone)); anti-proliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antineoplastic/antiproliferative/anti-mitotic agents (such as paclitaxel, <NUM>-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors); anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine); anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containing compound, heparin, anti-thrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin); cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vascoactive mechanisms.

Claim 1:
A vascular occlusion system (<NUM>), comprising:
a microcatheter (<NUM>) configured to navigate a vasculature;
an elongate shaft (<NUM>) slidably disposed within a lumen (<NUM>) of the microcatheter (<NUM>), the elongate shaft (<NUM>) having a lumen (<NUM>) extending from a proximal end (<NUM>) of the elongate shaft (<NUM>) to a distal end (<NUM>) of the elongate shaft (<NUM>);
a plurality of occlusive medical devices (<NUM>) releasably connected to the elongate shaft (<NUM>),
wherein at least one of the plurality of occlusive medical devices (<NUM>) has a different stiffness than a different one of the plurality of occlusive medical devices (<NUM>),
wherein a distalmost one of the plurality of the occlusive medical devices (<NUM>) has a stiffness greater than any other of the plurality of occlusive medical devices; and
a release wire (<NUM>) slidably disposed within the elongate shaft (<NUM>) and at least a portion of each of the plurality of occlusive medical devices (<NUM>);
wherein the release wire (<NUM>) secures each of the plurality of occlusive medical devices (<NUM>) to the distal end (<NUM>) of the elongate shaft (<NUM>) when the release wire (<NUM>) is disposed within at least a portion of each of the plurality of occlusive medical devices (<NUM>),
wherein the release wire (<NUM>) includes one or more indicators (<NUM>) disposed proximate the proximal end of the release wire (<NUM>) configured to show how much of the release wire (<NUM>) has been withdrawn and/or configured to communicate to a user of the vascular occlusion system (<NUM>) how much or how many of the plurality of occlusive medical devices (<NUM>) has been released.