Neurovascular Flow Diverters and Delivery Systems

Abstract

Disclosed herein are neurovascular flow diverters and delivery systems and methods of using them. The system may include an introducer sheath, a catheter, a deployable flow diverter that may be housed in the introducer sheath or catheter, a core wire, and one or more deployment mechanisms coupled to the core wire and engaging the flow diverter. The deployment mechanisms may include one or more pushers, one or more frictional bumps, one or more deployment coils, a claw mechanism, a self-expanding element, a support coil, a tip coil, and / or an atraumatic tip. One or more of the deployment mechanisms may be radiopaque.

Description

[Technical field]

[0001]

[0001] Cross-reference of related application data This application claims the benefit of U.S. Provisional Application No. 63 / 313,205, filed February 23, 2022, 35 USC §119(e), which is incorporated herein by reference in its entirety for all purposes. [Background technology]

[0002]

[0002] An aneurysm is a bulge in a blood vessel caused by a weakness in the vessel wall that causes it to expand and fill with blood. Aneurysms frequently occur where blood vessels branch. As blood passes through the weakened vessel, blood pressure causes a small area to bulge outward like a balloon. Aneurysms can form in any blood vessel in the body, but are most common in arteries that carry blood away from the heart, such as the aorta, or in the brain.

[0003] Aneurysms that form inside the brain are called intracranial or cerebral aneurysms. Cerebral aneurysms typically only cause noticeable symptoms if they burst, rupture, or leak. The rupture or rupture of a cerebral aneurysm causes a severe, life-threatening condition known as a subarachnoid hemorrhage. Symptoms of such hemorrhage include sudden, severe headache, stiff neck, nausea and vomiting, and pain when looking at light. Subarachnoid hemorrhage is life-threatening and a very serious medical emergency.

[0004]

[0004] Due to the significant risks posed by such hemorrhage, prevention, early detection, and safe and effective treatment of cerebral aneurysms are desirable. However, the complex nature of the neurovascular system, including the small diameter and tortuous anatomical structure of many blood vessels, makes such treatment difficult. In light of the risks posed by subarachnoid hemorrhage and the challenges in treating cerebral aneurysms, improved treatment systems and methods are desirable. Summary of the Invention

[0005]

[0005] The present invention relates to systems, devices, and methods for delivering flow diverters to blood vessels, particularly neurovascular vessels. The system may include an introducer sheath, a catheter, a deployable flow diverter that may be housed in the introducer sheath or catheter, a core wire, and one or several deployment mechanisms coupled to the core wire and engaging the flow diverter. The core wire may be tapered. The deployment mechanisms may include a pusher, one or several friction bumps, one or several deployment coils, a claw mechanism, a self-expanding element, a support coil, a tip coil, and / or an atraumatic tip. These deployment mechanisms may be arranged in different combinations to facilitate deployment of the flow diverter.

[0006] In some embodiments, the deployment mechanism can include a pusher and at least one frictional bump. Both the pusher and the at least one frictional bump can be disposed on a tapered distal portion of the core wire, with the at least one frictional bump disposed distal to the pusher. The pusher can be a pusher coil and can have a distal end that abuts and engages with a proximal end of the flow diverter. The pusher can fully deploy the flow diverter regardless of whether the remainder of the deployment mechanism is engaged with the flow diverter.

[0007] In some embodiments, the at least one frictional bump may be a plurality of frictional bumps extending along a portion of the core wire that extends distally beyond the pusher. Some or all of the plurality of frictional bumps may include a radiopaque element, which may be a radiopaque wire coil.

[0008]

[0008] When the flow diverter is housed within the introducer sheath or catheter, each of the frictional bumps can engage the flow diverter. However, when the flow diverter is deployed from the catheter, the flow diverter expands and disengages from the frictional bumps. Multiple extended frictional bumps increase the length over which the frictional bumps contact the flow diverter, increasing control of the flow diverter's movement. Specifically, multiple frictional bumps extending distally from the pusher can increase the amount of flow diverter that can be deployed while maintaining control of the flow diverter, since the frictional bumps only engage the flow diverter when a portion of the flow diverter is between the frictional bump and the catheter inner wall.

[0009] In some embodiments, the deployment mechanism includes a single frictional bump. This single frictional bump may be distal to the pusher and may cover and extend beyond the distal end of the core wire. In some embodiments, the single frictional bump abuts the pusher. By having a single frictional bump directly contacting the pusher, friction maintains engagement with the flow diverter until the flow diverter is fully deployed. This increases flexibility of treatment by allowing retraction of the flow diverter at any state of partial deployment, as long as a portion of the flow diverter remains within the catheter. Additionally, embodiments having a single frictional bump may reduce the length of the deployment mechanism, terminating at a proximal portion of the flow diverter. This reduced length allows for the use of such embodiments in treating smaller and more distal vasculature.

[0010]

[0010] The deployment mechanism may further include a support coil extending along and around all or a portion of the distal portion of the core wire. In some embodiments, the support coil may begin proximal to the pusher, below the pusher, or distal to the pusher. The support coil may extend from its beginning location to the pusher, to a position below the pusher, or to a position distal to the pusher. The support coil strengthens the core wire, and in particular, the tapered distal portion of the core wire. In particular, the support coil strengthens the core wire so that it does not buckle when subjected to compressive loads, such as when the core wire is used to deploy a flow diverter.

[0011]

[0011] In some embodiments, the deployment mechanism can include a proximal delivery coil, a distal delivery coil, and a friction bump located intermediate the proximal and distal delivery coils. Each of the proximal and distal delivery coils can extend along and around a portion of the core wire, specifically around a portion of the distal portion of the core wire. Each of the proximal and distal delivery coils can reinforce the distal portion of the core wire to prevent buckling under compressive loads, and each of the proximal and distal delivery coils engages with the flow diverter to deploy the flow diverter.

[0012]

[0012] Similar to the friction bumps, the proximal and distal delivery coils engage the flow diverter when a portion of the flow diverter is compressed between a respective one of the proximal and / or distal delivery coils and the catheter inner wall. In some embodiments, the proximal delivery coil can engage a portion of the flow diverter that includes the proximal end of the flow diverter, and the distal delivery coil can engage a portion of the flow diverter that includes the distal end of the flow diverter. By engaging a portion of the flow diverter that includes both the proximal and distal ends of the flow diverter, this embodiment retains control over the deployment of the flow diverter for as long as a portion of the flow diverter remains within the catheter, in other words, until just before the last portion of the flow diverter is fully deployed from the catheter. This increases the flexibility of the treatment by allowing the flow diverter to be retracted at any state of partial deployment until the last portion of the flow diverter is fully deployed from the catheter.

[0013] In some embodiments, the deployment mechanism can include a pusher and a pawl mechanism. Each of the pusher and the pawl mechanism can be coupled to the core wire, with the pawl mechanism coupled to the core wire at a location distal to the pusher. In some embodiments, the pawl mechanism can be coupled to a distal end of the core wire.

[0014]

[0014] The claw mechanism may include an elongated body and a gripping element. The elongated body and / or the gripping element may be rigid. The gripping body may extend radially from the elongated body and may include one or several engagement mechanisms capable of engaging the flow diverter. These engagement mechanisms may be sized and shaped to be inserted into gaps in the flow diverter, and in particular to be inserted into gaps between the strands of the flow diverter.

[0015] The claw mechanism can replace, for example, one or several friction bumps and offers the advantage of engaging the flow diverter without exerting a radial force on the flow diverter. The claw mechanism facilitates deployment of the flow diverter because the claw mechanism does not exert a radial force on the flow diverter and compresses the flow diverter against the inner wall of the catheter, a force that may push the flow diverter into the catheter making it more difficult to deploy the flow diverter from the catheter.

[0016]

[0016] In some embodiments, the deployment mechanism can include an expansion element, which can be either a self-expanding element or a controlled expansion element. The expansion element can be positioned within the catheter and within the inner diameter of the flow passage of the flow diverter, thereby compressing the flow diverter via the expansion element and the inner catheter wall. The expansion element can engage the flow diverter as the expansion element presses the flow diverter against the inner catheter wall. Thus, the expansion element can facilitate deployment of the flow diverter from the catheter and / or retraction of the flow diverter back into the catheter.

[0017]

[0017] When deployed, the expansion elements can expand and aid in the expansion of the deployed flow diverter. For example, the expansion elements can generate a greater force urging the expansion elements into an expanded configuration than the force generated by the flow diverter. Thus, when positioned inside the flow path of the flow diverter, these radial forces can urge the flow diverter toward a greater and / or more complete expansion against the vessel wall.

[0018] In some embodiments, an expansion element, which may be in some of the flow paths of the flow diverter, can expand upon exiting the catheter. This expansion of the flow diverter can be done by either self-expansion or controlled expansion. The expansion of the flow diverter can bias the flow diverter toward greater and / or full expansion against the vessel wall at the location of the expansion element. The expansion element can then be moved through the flow diverter, for example, by advancing the expansion element distally through the flow diverter and / or by retracting the expansion element proximally through the flow diverter. The combination of expansion of the expansion element and movement of the expansion element through the deployed flow diverter can cause the flow diverter to be fully expanded and / or further expanded. This improved expansion of the flow diverter improves contact between the flow diverter and the vessel wall along the length of the flow diverter, preventing the "fishmouth" phenomenon, endoleaks, and minimizing foreshortening of the flow diverter. The improved expansion of the flow diverter further results in easier and more reliable deployment. Specifically, the improved expansion of the flow diverter eliminates the need for any post-treatment of the flow diverter, such as post-treatment involving the use of balloon angioplasty. The easier and more reliable deployment resulting from the improved expansion by the expansion element reduces procedure time and improves patient safety.

[0019]

[0019] In addition to this, each of the expansion element and optional frictional bumps improves control of the flow diverter during deployment of the flow diverter. This can include the advantage of one or several frictional bumps located proximally of the expansion element. Such proximal location of one or several frictional bumps can improve control of the flow diverter during deployment, and in particular can increase flexibility of treatment by allowing retraction of the flow diverter at more stages of its deployment.

[0020] Each of these embodiments of the deployment mechanism may be utilized in deploying a flow diverter to treat an aneurysm in a neurovasculature. Such deployment may include advancing a catheter proximal to a treatment location in the neurovasculature, advancing a corewire through the catheter, and deploying a flow diverter from the catheter into the neurovasculature to treat the aneurysm. The flow diverter may be deployed by advancing the deployment mechanism with advancement of the corewire, the deployment mechanism engaging the flow diverter.

[0021]

[0021] The deployment of the flow diverter can be monitored by imaging. In some embodiments, this can include imaging of the catheter marker bands, the flow diverter, e.g., the flow diverter braid when deployed, and / or one or more deployment mechanisms, such as one or more deployment mechanisms that are radiopaque and / or include radiopaque elements. Through this imaging, the positioning of the flow diverter can be monitored relative to the distal end of the catheter. In some embodiments, the position of the flow diverter and / or the distal end of the catheter can be monitored relative to the proximal most of the deployment mechanism, which allows for retraction of the flow diverter.

[0022] When the flow diverter is to be repositioned, and when the proximal-most of the deployment mechanism that allows for retraction of the flow diverter is fully or partially within the lumen of the catheter and engaged with the flow diverter, the flow diverter can be fully or partially retracted into the catheter and repositioned. In some embodiments, the deployment mechanism that allows for retraction of the flow diverter can include, for example, a frictional bump, such as the proximal-most of one of the frictional bumps, a deployment coil, such as a proximal deployment coil, an extension element, or a claw mechanism.

[0023]

[0023] In some embodiments, the deployment mechanism can improve control of the deployment of the flow diverter, which can beneficially improve the positioning of the flow diverter and the effectiveness of the flow diverter. This improved positioning can be particularly important when multiple flow diverters are being deployed. This improved control over the deployment of the flow diverter can help ensure that the multiple flow diverters are in a desired position relative to one another, e.g., overlapping one another sufficiently to achieve a desired therapeutic effect.

[0024] In embodiments in which the deployment mechanism includes an expansion element, the further benefit of improved expansion of the flow diverter can be achieved. This can beneficially improve the contact between the flow diverter and the vessel wall, thereby enhancing the integrity of the flow diverter performance. Such improved expansion can be even more important when deploying multiple flow diverters, as the use of an expansion element can facilitate complete expansion of the flow diverter, resulting in more consistent and uniform expansion between the multiple layers of the flow diverter. Such improved expansion consistency can improve the effectiveness of the flow diverter in preventing blood flow to one or several aneurysms.

[0025]

[0025] The flow diverter can be initially housed within a lumen of the introducer sheath. The core wire can extend into this lumen of the introducer sheath and can engage the flow diverter. The introducer sheath can be inserted into a lumen of the catheter and the core wire can be advanced to push both the core wire and the flow diverter into the catheter. The catheter can be advanced to a position at, near, or beyond the treatment location and the flow diverter can be deployed. In some embodiments, the catheter can be advanced to a position distal to the treatment location and the flow diverter can be deployed. Deploying the flow diverter can include distally advancing the core wire to push the flow diverter distally out of the catheter.

[0026]

[0026] Deployment of the flow diverter can be monitored by imaging to ensure proper placement of the flow diverter. If desired, the flow diverter can be fully or partially retrieved within the catheter, and the catheter can be repositioned as needed.

[0027]

[0027] One or several flow diverters can be delivered to the treatment location. These flow diverters can be delivered in a fully or partially overlapping manner. Delivery of multiple flow diverters to the treatment location can, for example, improve flow redirection or extend the length of the treatment portion of the blood vessel.

[0028]

[0028] One aspect of the present disclosure relates to a system for delivering a flow diverter into a neurovasculature to treat an aneurysm. The system includes an elongated tubular member having a proximal end and a distal end. The tubular member can include an inner wall defining a lumen. The system can include a flow diverter, which can be or include a self-expanding member having a proximal end and a distal end. The flow diverter can define a flow passage that can extend through the flow diverter such that the flow diverter is tubular. The flow diverter can be contained within a lumen of the tubular member in a constrained configuration. The system can include a deployment wire extending within the lumen of the tubular member and within the flow passage of the flow diverter. The deployment wire can have a proximal end, a distal end, and a tapered distal portion. The deployment wire can include at least one deployment mechanism coupled to the flow diverter such that movement of the deployment wire relative to the tubular member moves the flow diverter relative to the tubular member into the neurovasculature. The at least one deployment mechanism can include a pusher extending along and around a distal portion of the deployment wire, at least one frictional bump disposed along a portion of the deployment wire that extends distally beyond the pusher, and a support coil extending along and around the distal portion of the deployment wire. The pusher can have a distal end capable of engaging a proximal end of the flow diverter, and the at least one frictional bump is inside the flow path of the flow diverter and can engage a portion of the flow diverter.

[0029] In some embodiments, the at least one friction bump can be a plurality of friction bumps, and the plurality of friction bumps can be equally spaced apart. In some embodiments, the at least one friction bump can include a radiopaque element. In some embodiments, the radiopaque element can be a coil of wire.

[0030] In some embodiments, the at least one frictional bump can include a first frictional bump, a second frictional bump, and a third frictional bump. In some embodiments, the first frictional bump can be closer to the pusher than the second frictional bump and the third frictional bump. In some embodiments, the third frictional bump is closer to the distal end of the deployment wire than the first frictional bump and the second frictional bump. In some embodiments, the support coil extends at least partially through the pusher and distally beyond the third frictional bump, terminating to form an atraumatic tip.

[0031] In some embodiments, the pusher may be a pusher coil. In some embodiments, the pusher coil is soldered to the deployment wire. In some embodiments, the pusher coil includes a radiopaque element.

[0032] In some embodiments, the at least one frictional bump includes a single frictional bump. In some embodiments, the single frictional bump covers and extends distally beyond the distal end of the deployment wire. In some embodiments, the single frictional bump abuts the pusher.

[0033]

[0033] One aspect relates to a system for delivering a flow diverter into a neurovasculature to treat an aneurysm. The system can include an elongated tubular member having a proximal end and a distal end. In some embodiments, the tubular member can include an inner wall defining a lumen. The system can include a flow diverter, which can be a self-expanding member having a proximal end and a distal end. In some embodiments, the flow diverter can define a flow passage that can extend through the flow diverter. In some embodiments, the flow diverter is contained within the lumen of the tubular member in a constrained configuration. The system can include a deployment wire extending within the lumen of the tubular member and into the flow passage of the flow diverter. In some embodiments, the deployment wire can have a proximal end, a distal end, and a tapered distal portion. In some embodiments, the deployment wire can include at least one deployment mechanism coupled to the flow diverter such that movement of the deployment wire relative to the tubular member moves the flow diverter relative to the tubular member into the neurovasculature. In some embodiments, the at least one deployment mechanism can include a proximal delivery coil, a distal delivery coil extending at a distal end of the deployment wire, and at least one frictional bump located between the proximal delivery coil and the distal delivery coil. The proximal delivery coil can extend around a distal portion of the deployment wire and can engage a proximal portion of the flow diverter in the flow path. The distal delivery coil can extend around a distal portion of the deployment wire and can engage a distal portion of the flow diverter in the flow path. The at least one frictional bump can be disposed inside the flow path of the flow diverter and can engage an intermediate portion of the flow diverter.

[0034] In some embodiments, at least one of the friction bumps can include a radiopaque element. In some embodiments, each of the proximal and distal delivery coils includes a wire winding.

[0035] In some embodiments, each of the proximal and distal delivery coils is coupled to the deployment wire via at least one spacer. In some embodiments, the distal end of the proximal delivery coil is coupled to the deployment wire via a first spacer, the proximal end of the distal delivery coil is coupled to the deployment wire via a second spacer, and the distal end of the distal delivery coil is coupled to the deployment wire via a third spacer. In some embodiments, the height of each of the first spacer, the second spacer, and the third spacer is such that the proximal and distal delivery coils have the same diameter. In some embodiments, the height of each of the first spacer, the second spacer, and the third spacer counteracts the taper of the distal portion of the deployment wire.

[0036] In some embodiments, the at least one deployment mechanism further includes a pusher coil extending along and around a portion of the deployment wire, the pusher coil being proximal to the proximal delivery coil. In some embodiments, the at least one deployment mechanism further includes a support coil extending along and around a distal portion of the deployment wire. In some embodiments, at least one of the proximal delivery coil and the distal delivery coil is radiopaque.

[0037]

[0037] One aspect relates to a system for delivering a flow diverter into a neurovasculature to treat an aneurysm. The system includes an elongated tubular member having a proximal end and a distal end. The tubular member can include an inner wall defining a lumen. The system can include a flow diverter including a self-expanding member having a proximal end and a distal end. The flow diverter can define a flow path extending therethrough. In some embodiments, the flow diverter can be contained within the lumen of the tubular member in a constrained configuration. The system can include a core wire extending within the lumen of the tubular member and within the flow path of the flow diverter. The core wire can have a proximal end, a distal end, and a tapered distal portion. The system can include a pusher extending around a portion of the distal portion of the core wire, the pusher can have a distal end that engages the proximal end of the flow diverter. In some embodiments, the core wire protrudes distally beyond the pusher. The system can include a claw mechanism coupled to a distal end of the core wire. The claw mechanism can include a gripping element that engages the flow diverter. In some embodiments, the pusher and claw mechanism engage a portion of the flow diverter within the flow path such that movement of the core wire relative to the elongate tubular member moves the flow diverter relative to the tubular member to a deployed configuration within the neurovasculature.

[0038] In some embodiments, the claw mechanism includes an elongate body having a proximal end and a distal end. In some embodiments, the proximal end of the elongate body can be coupled to the distal end of the core wire. In some embodiments, the gripping element is at the distal end of the elongate body of the claw mechanism. In some embodiments, the elongate body of the claw mechanism is rigid.

[0039] In some embodiments, the proximal end of the elongate body of the claw mechanism is coupled to the distal end of the core wire at a junction. In some embodiments, the junction is flexible. In some embodiments, the system includes a support coil that extends along and around at least a portion of the distal portion of the deployment wire. In some embodiments, the support coil extends across the junction and over a portion of the elongate body of the claw mechanism.

[0040]

[0040] In some embodiments, the system includes a flexible tip coil extending distally from a distal end of the elongate body of the claw mechanism. In some embodiments, the tip coil terminates distally in an atraumatic tip. In some embodiments, the system includes a frictional bump. In some embodiments, the frictional bump is radiopaque. In some embodiments, the frictional bump is disposed at the junction. In some embodiments, at least a portion of the claw mechanism is radiopaque. In some embodiments, the gripping element extends radially from the elongate body of the claw mechanism. In some embodiments, the pusher may be a pusher coil.

[0041]

[0041] One aspect relates to a system for delivering a flow diverter into a neurovasculature to treat an aneurysm. The system includes an elongated tubular member having a proximal end and a distal end, the tubular member including an inner wall defining a lumen. The system can include a core wire extending at least partially through the lumen of the tubular member, the core wire having a proximal end, a distal end, and a tapered distal portion. In some embodiments, the distal portion of the core wire can extend from an intermediate portion of the core wire to the distal end of the core wire. The system can include a self-expanding element, the self-expanding element can include a first end coupled to the distal end of the core wire and extending distally to a second end. The system can include a first frictional bump disposed on one of the first end and the second end of the self-expanding element and a support coil extending along and around at least the distal end of the core wire. The system can include a flow diverter, which can be an expandable member. The expandable member of the flow diverter can define a flow path that can extend through the flow diverter. In some embodiments, the flow diverter can be circumferentially disposed within the lumen of the tubular member between a wall of the tubular member and the self-expanding element. In some embodiments, the self-expanding element is disposed within the flow path, and the flow diverter can be moved relative to the tubular member into the neurovasculature while the self-expanding element is deployed from the tubular member to expand the flow diverter.

[0042] In some embodiments, the self-expanding element can be a stent. In some embodiments, the stent can be laser cut. In some embodiments, the flow diverter can be a braided expandable member. In some embodiments, the flow diverter can be self-expanding.

[0043] In some embodiments, the first frictional bump can be a radiopaque element. In some embodiments, the radiopaque element can be a coil of wire.

[0044] In some embodiments, the system includes a second frictional bump located at one of the first end and the second end of the self-expanding element. In some embodiments, the system can include a flexible tip coil extending distally from the second end of the self-expanding element. In some embodiments, the tip coil terminates distally in an atraumatic tip. In some embodiments, the tubular member can be an introducer sheath. In some embodiments, the tubular member can be a catheter.

[0045]

[0045] One aspect relates to a method for delivering a flow diverter into a neurovasculature to treat an aneurysm. The method includes advancing a microcatheter proximal to a treatment location in the neurovasculature, advancing a corewire through the microcatheter, and deploying a flow diverter from the microcatheter into the neurovasculature to treat the aneurysm by advancing a pusher and at least one friction bump with advancement of the corewire. The corewire can have a proximal end, a distal end, and a tapered distal portion. In some embodiments, the distal end of the corewire can extend into a flow passage of the flow diverter. In some embodiments, the flow diverter can be housed in a constrained configuration within the microcatheter. In some embodiments, the corewire can be coupled to the flow diverter via at least one deployment mechanism. In some embodiments, the at least one deployment mechanism can include a pusher extending along and around a distal portion of the corewire. In some embodiments, the pusher can have a distal end that can engage a proximal end of the flow diverter. The at least one deployment mechanism can include at least one frictional bump along a portion of the core wire that extends distally beyond the pusher, hi some embodiments, the at least one frictional bump is inside the flow passage of the flow diverter and engages a portion of the flow diverter.

[0046] In some embodiments, the at least one frictional bump comprises a plurality of frictional bumps distributed along a portion of the core wire, the plurality of frictional bumps being equally spaced apart. In some embodiments, at least one of the plurality of frictional bumps can comprise a radiopaque element. In some embodiments, each of the plurality of frictional bumps can facilitate retraction of the flow diverter into the microcatheter when the flow diverter is partially deployed from the microcatheter and can facilitate deployment of the flow diverter from the microcatheter. In some embodiments, the plurality of frictional bumps can comprise a first frictional bump, a second frictional bump, and a third frictional bump. In some embodiments, the first frictional bump is closer to the pusher than the second frictional bump and the third frictional bump, and the third frictional bump is closer to a distal end of the core wire than the first frictional bump and the second frictional bump.

[0047] In some embodiments, the at least one deployment mechanism can include a support coil. In some embodiments, the support coil can extend along and around a distal portion of the core wire. In some embodiments, the support coil extends at least partially through the pusher and distally past the third frictional bump. In some embodiments, the support coil that extends distally past the third frictional bump terminates to form an atraumatic tip.

[0048]

[0048] In some embodiments, the at least one frictional bump can be a single frictional bump. In some embodiments, the single frictional bump covers the distal end of the core wire and abuts the pusher. In some embodiments, the pusher coil and the single frictional bump together form a shortened delivery system and / or a shortened deployment mechanism. The shortened delivery system can terminate at a proximal portion of the flow diverter. In some embodiments, the termination of the shortened delivery system at a proximal portion of the flow diverter can facilitate deployment and allow treatment of smaller vessels. In some embodiments, the single frictional bump remains engaged with the flow diverter until the flow diverter exits the microcatheter. In other words, the single frictional bump engages with the flow diverter as long as a portion of the flow diverter remains within the microcatheter. In some embodiments, the flow diverter can be retracted through the single frictional bump as long as a portion of the flow diverter remains within the catheter, in other words, just before the last portion of the flow diverter is fully deployed from the microcatheter.

[0049] In some embodiments, the method includes retracting the flow diverter into the microcatheter, adjusting the positioning of the microcatheter relative to the treatment location, and advancing a core wire through the microcatheter to fully deploy the flow diverter from the microcatheter. In some embodiments, at least one of the pusher and the at least one frictional bump is radiopaque. In some embodiments, the method further includes imaging at least one of the pusher and the at least one frictional bump to determine the location of the flow diverter within the neurovasculature and the location of the pusher and / or the at least one frictional bump relative to the microcatheter. In some embodiments, at least one of the pushers and at least one of the frictional bumps that are imaged may be radiopaque. In some embodiments, the flow diverter is retracted into the microcatheter when at least one of the at least one frictional bump has not exited the microcatheter. In some embodiments, the positioning of the microcatheter is adjusted relative to the treatment location based on the imaging.

[0050] In some embodiments, the method includes loading a flow diverter into the microcatheter. In some embodiments, loading the flow diverter into the microcatheter includes inserting an introducer sheath including the flow diverter through the access device and into the microcatheter, and advancing a corewire through the introducer sheath to advance the flow diverter from the introducer sheath into the microcatheter.

[0051]

[0051] One aspect relates to a method for delivering a flow diverter into a neurovasculature to treat an aneurysm. The method includes advancing a microcatheter to a treatment location in the neurovasculature, near the treatment location, or beyond the treatment location, e.g., distally, advancing a corewire through the microcatheter, and advancing proximal and distal delivery coils over the coil wire to deploy a flow diverter from the microcatheter into the neurovasculature to treat the aneurysm. In some embodiments, the corewire can have a proximal end, a distal end, and a tapered distal portion. The corewire can be coupled to the flow diverter via at least one deployment mechanism, the at least one deployment mechanism can include a proximal delivery coil, a distal delivery coil extending to a distal end of the corewire, and at least one frictional bump located between the proximal delivery coil and the distal delivery coil. The flow diverter can be housed in a constrained configuration within the microcatheter. The proximal delivery coil can extend around a distal portion of the deployment wire and can engage a proximal portion of the flow diverter in the flow passage. The distal delivery coil can extend around a distal portion of the deployment wire and can engage a distal portion of the flow diverter in the flow passage. The at least one friction bump can be disposed inside the flow passage of the flow diverter and can engage an intermediate portion of the flow diverter.

[0052] In some embodiments, the method further includes retracting the core wire to at least partially retract the flow diverter into the microcatheter and advancing the core wire through the microcatheter to fully deploy the flow diverter from the microcatheter. In some embodiments, the flow diverter can be retracted, also referred to herein as retrieved, and deployed at the same or a different location. In some embodiments, the method further includes adjusting the positioning of the microcatheter relative to the treatment location. In some embodiments, at least one of the proximal delivery coil, the distal delivery coil, and the at least one frictional bump is radiopaque. In some embodiments, the method further includes imaging at least one of the proximal delivery coil, the distal delivery coil, and the at least one frictional bump to determine the location of the flow diverter within the neurovasculature and the location of at least one of the proximal delivery coil, the distal delivery coil, and the at least one frictional bump relative to the microcatheter. In some embodiments, at least one of the imaged proximal delivery coil, the distal delivery coil, and the at least one frictional bump can be radiopaque. In some embodiments, the flow diverter retracts into the microcatheter when at least one of the proximal delivery coil, the distal delivery coil, and the at least one friction bump does not exit the microcatheter. In some embodiments, the positioning of the microcatheter is adjusted relative to the treatment location based on the imaging.

[0053] In some embodiments, the method includes loading a flow diverter into the microcatheter. In some embodiments, loading the flow diverter into the microcatheter includes inserting an introducer sheath including the flow diverter into the microcatheter through a rotating hemostatic valve and advancing a corewire through the introducer sheath to advance the flow diverter from the introducer sheath into the microcatheter.

[0054]

[0054] One aspect relates to a method for delivering a flow diverter into a neurovasculature to treat an aneurysm. The method includes advancing a microcatheter to a location at, near, or beyond (including distal to) a treatment location in the neurovasculature, advancing a corewire through the microcatheter, and deploying a flow diverter from the microcatheter into the neurovasculature to treat the aneurysm by advancing a pusher and claw mechanism through the corewire. In some embodiments, the corewire can have a proximal end, a distal end, and a tapered distal portion. In some embodiments, the distal end of the corewire extends into a flow passage of the flow diverter. The flow diverter can be housed in a constrained configuration within the microcatheter. The corewire can be coupled to the flow diverter via at least one deployment mechanism. In some embodiments, the at least one deployment mechanism can include a pusher extending around a portion of a distal portion of the corewire. In some embodiments, the pusher can have a distal end that engages a proximal end of the flow diverter. In some embodiments, the core wire protrudes distally beyond the pusher. The at least one deployment mechanism can include a claw mechanism coupled to a distal end of the core wire. In some embodiments, the claw mechanism can include a gripping element that engages the flow diverter. In some embodiments, the pusher and claw mechanism engage the flow diverter such that movement of the core wire relative to the microcatheter moves the flow diverter relative to the microcatheter.

[0055] In some embodiments, the claw mechanism can have an elongate body having a proximal end and a distal end. In some embodiments, the proximal end of the elongate body of the claw mechanism can be coupled to the distal end of the core wire. In some embodiments, the elongate body of the claw mechanism can be rigid. In some embodiments, the gripping element is at the distal end of the elongate body of the claw mechanism. In some embodiments, the proximal end of the elongate body of the claw mechanism is coupled to the distal end of the core wire at a junction. In some embodiments, the at least one deployment mechanism further includes a support coil that extends along and around at least a portion of the distal portion of the core wire, across the junction and over a portion of the elongate body. In some embodiments, the at least one deployment mechanism further includes a flexible tip coil that extends distally from the distal end of the elongate body of the claw mechanism. In some embodiments, the tip coil terminates distally in an atraumatic tip.

[0056]

[0056] In some embodiments, the method includes retracting the core wire to at least partially retract the flow diverter into the microcatheter, adjusting the positioning of the microcatheter relative to the treatment location, and advancing the core wire through the microcatheter to fully deploy the flow diverter from the microcatheter. In some embodiments, at least a portion of the claw mechanism is radiopaque. In some embodiments, the method further includes imaging the radiopaque portion of the claw mechanism to determine a location of the flow diverter within the neurovasculature and a location of the claw mechanism relative to the microcatheter. In some embodiments, the flow diverter retracts into the microcatheter when the claw mechanism has not exited the microcatheter. In some embodiments, the positioning of the microcatheter is adjusted relative to the treatment location based on the imaging.

[0057] In some embodiments, the method includes loading a flow diverter into the microcatheter. In some embodiments, loading the flow diverter into the microcatheter includes inserting an introducer sheath including the flow diverter through the access device and into the microcatheter, and advancing a corewire through the introducer sheath to advance the flow diverter from the introducer sheath into the microcatheter.

[0058]

[0058] One aspect relates to a method for delivering a flow diverter into a neurovasculature to treat an aneurysm, the method including advancing a microcatheter to a location within the neurovasculature at, near, or beyond (including distal to) a treatment location, advancing a self-expanding element coupled to a distal end of a corewire through the microcatheter to unsheath the flow diverter from the microcatheter, deploying the self-expanding element from the microcatheter into the neurovasculature to treat the aneurysm by advancing the self-expanding element over the corewire, and pushing the self-expanding element through the delivered flow diverter to expand the flow diverter. In some embodiments, the flow diverter is contained within the microcatheter in a constrained configuration. In some embodiments, the self-expanding element is expanded when pushed through the delivered flow diverter to expand the flow diverter.

[0059] In some embodiments, pushing the self-expanding element through the flow diverter to expand the flow diverter includes pushing the expanded self-expanding element distally through the flow diverter. In some embodiments, the method includes retracting the self-expanding element proximally through the flow diverter and into the microcatheter. In some embodiments, the self-expanding element can be a stent. In some embodiments, the flow diverter can be a tubular braided member.

[0060] In some embodiments, the self-expanding element includes a first end coupled to the distal end of the core wire and extending distally to a second end, In some embodiments, the self-expanding element can include a first frictional bump located at the first end of the self-expanding element and a second frictional bump located at the second end of the self-expanding element.

[0061] In some embodiments, the microcatheter includes an inner wall defining a lumen. In some embodiments, the flow diverter defines a diverter lumen. In some embodiments, the self-expanding element is at least partially in the diverter lumen. In some embodiments, the flow diverter is circumferentially disposed within the lumen of the microcatheter between the microcatheter inner wall and the self-expanding element.

[0062] In some embodiments, the method includes retracting a self-expanding element coupled to a distal end of the core wire to at least partially retract the flow diverter into the microcatheter prior to deploying the self-expanding element from the microcatheter, and adjusting a positioning of the microcatheter relative to the treatment location prior to deploying the self-expanding element from the microcatheter. In some embodiments, at least the self-expanding element is radiopaque. In some embodiments, the method further includes imaging the radiopaque self-expanding element to determine a location of the flow diverter within the neurovasculature and a location of the self-expanding element relative to the microcatheter. In some embodiments, the flow diverter retracts into the microcatheter when the self-expanding element has not exited the microcatheter. In some embodiments, the positioning of the microcatheter is adjusted relative to the treatment location based on the imaging.

[0063] In some embodiments, the method includes loading a flow diverter into the microcatheter. In some embodiments, loading the flow diverter into the microcatheter includes inserting an introducer sheath including the flow diverter into the microcatheter through a rotating hemostatic valve and advancing a corewire through the introducer sheath to advance the flow diverter from the introducer sheath into the microcatheter.

[0064] In some embodiments, the self-expanding element intermittently contacts the inner wall of the flow diverter, thereby expanding the flow diverter. In some embodiments, the self-expanding element intimately contacts the inner wall of the flow diverter, thereby expanding the flow diverter.

[0065]

[0065] Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating various embodiments, are intended for purposes of illustration only and are not intended to necessarily limit the scope of the present disclosure. [Brief description of the drawings]

[0066] [Figure 1] FIG. 1 illustrates an embodiment of a system for deploying a flow diverter. [Diagram 2] FIG. 1 is a diagram of an introducer sheath and delivery of a flow diverter through the introducer sheath to a catheter. [Diagram 3] FIG. 13 is a diagram of the flow diverter in a constrained delivery state. [Figure 4] FIG. 2 is a diagram of the flow diverter in an expanded deployed state. [Diagram 5] FIG. 1 is a close-up view of the braid of the flow diverter. [Figure 6] FIG. 1 is a diagram of a first flow diverter delivery system. [Figure 7] FIG. 2 is a diagram of a first delivery system in a partially deployed configuration. [Figure 8] FIG. 2 is a diagram of a second delivery system. [Figure 9] FIG. 2 is a diagram of a second delivery system in a partially deployed configuration. [Figure 10] FIG. 2 is a diagram of a second delivery system in a deployed configuration. [Figure 11] FIG. 11 is a diagram of a third delivery system. [Figure 12] FIG. 13 illustrates one embodiment of the deployment of a third delivery system. [Figure 13] FIG. 4 is a diagram of a fourth delivery system. [Figure 14] FIG. 1 illustrates one embodiment of a pawl mechanism. [Figure 15] FIG. 11 is a diagram of a fourth delivery system in a first partially deployed configuration. [Figure 16] FIG. 11 is a diagram of a fourth delivery system in a second, partially deployed configuration. [Figure 17] FIG. 5 is a diagram of a fifth delivery system. [Figure 18] FIG. 5 is a diagram of a deployment mechanism for the delivery system. [Figure 19] FIG. 5 is a diagram of a fifth delivery system in a partially deployed configuration. [Figure 20] FIG. 1 illustrates an embodiment of an active delivery system. [Figure 21] FIG. 1 illustrates one embodiment of a deployment mechanism for an active delivery system. [Figure 22] FIG. 1 illustrates one embodiment of an active delivery system in a partially deployed configuration. [Diagram 23] FIG. 1 is a diagram of the treatment area. [Figure 24] FIG. 2 is a diagram of a catheter in a first position relative to a treatment site. [Diagram 25] FIG. 2 is a diagram of a partially deployed flow diverter with the catheter in a first position relative to the treatment site. [Figure 26] FIG. 2 is a diagram of the catheter in a second position relative to the treatment site. [Figure 27] FIG. 2 is a diagram of a partially deployed flow diverter with the catheter in a second position relative to the treatment site. [Figure 28]FIG. 13 is a further partially deployed view of the flow diverter with the catheter in a second position relative to the treatment site. [Figure 29] FIG. 13 is a diagram of the flow diverter fully deployed. [Diagram 30] FIG. 1 illustrates the deployment of additional flow diverters above one or several previously deployed flow diverters. [Diagram 31] FIG. 13 illustrates the deployment of an additional flow diverter that overlaps one or several previously deployed flow diverters. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0067]

[0097] The present invention relates to a flow diverter, a flow diverter delivery system, and a method of delivering a flow diverter. A flow diverter is a device that can be placed in a vasculature to divert flow away from a portion of the vasculature covered by the flow diverter. As used herein, a flow diverter can be any device that can be placed in a patient's blood vessel and divert a portion of blood flow through that vessel. In some embodiments, the flow diverter can be an endovascular prosthesis used to treat intracranial aneurysms. The flow diverter can include, for example, a stent, such as a laser cut stent, a braided member, or the like. In some embodiments, the flow diverter can include a braided member including a plurality of braided wires, which can be, for example, cobalt chrome, nitinol, or the like.

[0068]

[0098] The flow diverter can be used to treat intracranial aneurysms, including, for example, saccular aneurysms, particularly unruptured saccular aneurysms, or fusiform or circumferential aneurysms. The flow diverter can be positioned within the blood vessel to extend across and cover the aneurysm. The flow diverter can divert blood flow away from the aneurysm, thereby reducing blood flow within the aneurysm. The reduced blood flow can cause the aneurysm to close and heal over time.

[0069]

[0099] Although simple in principle, the reality of precisely placing a flow diverter in the often small and tortuous cerebral vasculature can be very complicated. Thus, a device with high flexibility that allows for navigation of this vasculature is desirable. Furthermore, such a device must be capable of precisely placing the flow diverter within the vessel. Precise positioning of the flow diverter can include adjusting the position of the flow diverter, and in some embodiments, positioning multiple flow diverters in a fully or partially overlapping manner. The use of multiple partially or fully overlapping flow diverters can be particularly beneficial in addressing multiple closely packed or larger aneurysms. In some embodiments, multiple flow diverters can be positioned in a fully or partially overlapping manner to further reduce blood flow to the aneurysm.

[0070]

[0100] The embodiments disclosed herein provide several beneficial improvements. These include, for example, a reduction in the size of the system. This reduction in the size of the system allows for access and treatment of smaller vessels. This increases the range of treatable aneurysms and therefore improves patient outcomes. Additionally, the embodiments disclosed herein improve the flexibility of the system, thereby also increasing the range of treatable aneurysms.

[0071]

[0101] 1, a diagram of one embodiment of a system 100 for placing a flow diverter is shown. The system 100 can include a catheter system 102. The catheter system 102 can be configured to provide access to a patient's vasculature, and in particular to the patient's neurovasculature. In some embodiments, the catheter system 102 can be configured to be inserted into the patient's vasculature at an access point and navigate through the patient's vasculature to a location where the flow diverter is delivered.

[0072]

[0102] The catheter system 102 can include a proximal end 130 and a distal end 132. The catheter system 102 can include an elongated catheter 104 that defines a lumen extending through all or a portion of the catheter 104. Thus, in some embodiments, the catheter system 102 can include an elongated tubular member that defines a lumen, specifically, an elongated tubular member that includes an inner wall that defines a lumen. The catheter 104 can include a variety of sizes, materials, and / or manufactures. In some embodiments, the catheter 104 can be flexible and can include a biocompatible material. The catheter 104 can include, for example, an elongated tubular member, the diameter of which can be, for example, 0.005 inches, 0.01 inches, 0.017 inches, 0.02 inches, 0.021 inches, 0.027 inches, 0.03 inches, or any other or intermediate diameter.

[0073]

[0103] The catheter 104 can include a catheter hub 106 that can be coupled to an access device. The access device 108 can be a valve, such as, for example, a rotating hemostatic valve (RHV) 109. The access device 108 can be a hemostatic valve that can be configured to provide selectable and / or controllable access to a lumen of the catheter 104. In some embodiments, the access device 108 can be configured to minimize blood loss while the catheter 104 is in use. The access device 108 can be sized for use in connection with the catheter 104.

[0074]

[0104] The system 100 for placing a flow diverter can include a deployment wire 110 having a proximal end 111 and a distal end 113. The deployment wire 110 can be configured to facilitate and / or control advancement of the flow diverter into and / or through the catheter system 102, specifically into and / or through a lumen of the catheter 104. In some embodiments, the proximal end 111 of the deployment wire 110 is configured to be controlled to control advancement of the flow diverter into and / or through the catheter system 102, and the distal end 113 can be configured to be coupled to and / or interact with the flow diverter to advance the flow diverter into and / or through the catheter system 102.

[0075]

[0105] The deployment wire 110 can include a core wire 112. The core wire 112 can include an elongated wire that can be flexible to allow for navigation through the vasculature. In some embodiments, the core wire 112 can include a unitary reinforced delivery wire. The core wire 112 can include a variety of shapes and sizes and can be made from a variety of materials. The core wire 112 can include a biocompatible wire, which can be, for example, a Nitinol wire.

[0076]

[0106] Core wire 112 can include a proximal portion 114 and a distal portion 116. Compared to distal portion 116, proximal portion 114 is relatively closer to proximal end 111 of deployment wire 110. Similarly, compared to proximal portion 114, distal portion 116 is relatively closer to distal end 113 of deployment wire 110.

[0077]

[0107] During a procedure, the distal end of the distal portion 116 may be inserted into the patient first. The core wire 112 may comprise a variety of shapes and sizes. In some embodiments, the core wire 112 may have a constant diameter along its length, and in some embodiments, the core wire 112 may have a non-constant diameter along its length. In some embodiments, the core wire 112 comprises a tapered core wire 112, which comprises a section of reduced diameter. In some embodiments, the tapered section may taper to a point, and in some embodiments, the tapered section may taper to a flattened delivery tip. The tapered section may be, for example, all or a portion of the distal portion 116 of the core wire 112. In some embodiments, the portion of the core wire 112 that is reduced in diameter may be, for example, up to the distal 5% of the core wire 112, up to the distal 10% of the core wire 112, up to the distal 15% of the core wire 112, up to the distal 20% of the core wire 112, up to the distal 25% of the core wire 112, up to the distal 30% of the core wire 112, up to the distal 40% of the core wire 112, up to the distal 50% of the core wire 112, or any other portion or intermediate portion.

[0078]

[0108] In some embodiments, for example, the length of the core wire 112 can be the same length as or longer than the catheter system 102. The maximum outer diameter of the core wire 112 can be, for example, up to 0.1 inches, 0.05 inches, 0.04 inches, 0.03 inches, 0.02 inches, 0.015 inches, 0.01 inches, 0.005 inches, or any other value or intermediate value.

[0079]

[0109] The deployment wire 110 may include one or several deployment mechanisms 118. The deployment mechanism 118 may be disposed on the distal portion 116 of the core wire 112. The deployment mechanism 118 may include one or several mechanisms configured to interact with the flow diverter to allow the core wire 112 to control and / or manipulate the core wire 112. In some embodiments, the deployment mechanism may be configured to allow the core wire 112 to interact with the flow diverter to push the flow diverter into the lumen of the catheter 104 and / or move the flow diverter into and / or through the lumen of the catheter. In some embodiments, the deployment mechanism 118 may be configured to couple the flow diverter to the core wire 112 such that the flow diverter may be deployed from the catheter 104 into the patient. Details of the deployment mechanism 118 are described in more detail below.

[0080]

[0110] The flow diverter deployment system 100 may include an introducer sheath 120. The introducer sheath 120 may include an elongated tubular member having a proximal end 122 and a distal end 124. In some embodiments, each of the proximal end 122 and the distal end 124 of the introducer sheath 120 may be open. The introducer sheath 120 may include an inner wall defining a lumen extending therethrough.

[0081]

[0111] The introducer sheath can be configured to hold the flow diverter before the flow diverter is inserted into the catheter system 102, specifically into the proximal end 130 of the catheter system 102. In some embodiments, the introducer sheath 120 can be configured to hold the flow diverter within the lumen of the introducer sheath. In some embodiments, as shown in FIG. 2A, the introducer sheath 120 holds the flow diverter within the lumen of the introducer sheath 120, and the deployment wire 110 is at least partially inserted into the lumen of the introducer sheath coupling the deployment mechanism 118 of the deployment wire 110 and the flow diverter. As shown in FIG. 2B, the introducer sheath 120, specifically the distal end 124 of the introducer sheath 120, can be inserted through the access device 108 into the catheter 104, specifically into the catheter hub 106 of the catheter 104. In some embodiments, this may include inserting a flow diverter-containing introducer sheath and deployment wire 110 combination into the catheter system 102 , and specifically into the catheter 104 .

[0082]

[0112] In some embodiments, the introducer sheath 120 can be advanced through the access device 108 and into the catheter 104 in the direction indicated by arrow 202. The core wire 112 can be inserted into the catheter system 102, and specifically into the proximal end 130 of the catheter system 102. In some embodiments, the core wire 112 can be inserted into the introducer sheath 120, which can be inserted into the catheter system 102.

[0083]

[0113] The corewire 112 may be advanced through the introducer sheath 120 in the direction indicated by arrow 202 to advance the flow diverter from the introducer sheath 120 into the catheter 104. After the flow diverter has been advanced into the catheter 104, the introducer sheath 120 may be retracted from the catheter 104 and from the access device 108 in the direction indicated by arrow 204.

[0084]

[0114] 3 and 4, a perspective view of one embodiment of a flow diverter 300 is shown. The flow diverter 300 can be, for example, a stent, a braided member, or the like. In some embodiments, the flow diverter can include an elongated braided member including a plurality of braided wires, which may be, for example, cobalt chrome, nitinol, or the like. The flow diverter 300 can include, in some embodiments, a tubular member defined by an outer wall 302 having a first end 304, also referred to as a proximal end 304, and a second end 306, also referred to herein as a distal end 306. As seen in FIG. 4, the elongated tubular member of the flow diverter 300 can have a central axis 400 and can extend from the proximal end 402 to the distal end 404. A flow path 406, also referred to herein as a diverter lumen 406, may be defined by an inner wall 403 of the flow diverter 300 and may extend through the flow diverter 300 along a central axis 400. In some embodiments, the proximal end 402 and the distal end 404 may each include an opening to the flow path 406 such that fluid, specifically blood, may flow through the flow path 406, entering the proximal end 402 and exiting the distal end 404.

[0085]

[0115] The flow diverter 300 can be in a compressed state, also referred to herein as a constrained state, delivery configuration, or constrained configuration as shown in FIG. 3, or in an expanded state, also referred to herein as an unconstrained state and / or unconstrained configuration as shown in FIG. 4. In the constrained configuration, the flow diverter 300 can have a compressed outer diameter 308, in other words, the flow diverter 300 in the constrained configuration cannot be fully expanded and / or is constrained such that it cannot be fully expanded. In some embodiments, the flow diverter 300 can be held in a constrained state when the flow diverter is contained and / or constrained within the introducer sheath 120 and / or catheter 104. In some embodiments, the flow diverter can be sized to have a compressed outer diameter 308 that fits within the introducer sheath 120 and / or catheter.

[0086]

[0116] In an unconstrained state, the flow diverter 300 can have an expanded outer diameter 408. The expanded diameter 408 can be greater than the compressed outer diameter 308. In some embodiments, the flow diverter 300 can be self-expanding such that once the flow diverter 300 exits the catheter 104 and enters the patient's blood vessel, the flow diverter 300 automatically expands to match the inner diameter of the blood vessel. In some embodiments, the flow diverter 300 can be made in a variety of sizes for use with different sized blood vessels. In some embodiments, the expanded diameter 408 of the flow diverter 300 can be up to 20 mm, up to 12 mm, up to 10 mm, up to 8 mm, up to 7 mm, up to 6 mm, up to 5 mm, up to 4 mm, 0.5 mm to 10 mm, 1 mm to 8 mm, 1.25 mm to 6.5 mm, or any other or intermediate diameter or range of diameters.

[0087]

[0117] The flow diverter may be deployed within a patient's blood vessel using the system 100 of Figure 1. Deployment may include the use of a deployment mechanism 119 on a deployment wire 110. An embodiment of the deployment mechanism 118 is illustrated in Figures 5-21 below.

[0088]

[0118] The flow diverter 300, in some embodiments, can include a braided member. One embodiment of a flow diverter braid is depicted at 450 in detail in FIG. 5. As seen in FIG. 5, the braided member can be made from a plurality of wires 452, also referred to herein as strands 452. These wires 452 can include a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, for example, the diameter of the wires 452 can be about 0.0002 inches to about 0.01 inches, about 0.0005 inches to about 0.005 inches, about 0.0007 inches to about 0.002 inches, about 0.0008 inches, about 0.001 inches, about 0.0012 inches, or any other or intermediate diameter.

[0089]

[0119] In some embodiments, the wire 452 can comprise various types and / or materials. In some embodiments, the wire 452 can comprise a stretch-filled tube (DFT). In some embodiments, the DFT can comprise an inner core and an outer tube. Each of the inner core and the outer tube can comprise one material. In some embodiments, one or both of the inner core and the outer tube can be radiopaque. In some embodiments, for example, the outer tube can provide strength to the braided member of the flow diverter 300 and the inner core can be radiopaque.

[0090]

[0120] In some embodiments, for example, the inner core can include platinum and / or a platinum alloy, which can include, for example, platinum and tungsten. In some embodiments, the platinum alloy can include, for example, about 28% platinum. In some embodiments, the outer tube can include an alloy, such as, for example, stainless steel, nitinol, a cobalt chromium alloy, such as 35N LT alloy, etc.

[0091]

[0121] In some embodiments, the wire can be cold worked, specifically having a minimum cold work of at least 30%, at least 60%, about 60.8%, or any other or intermediate amount of cold work. In some embodiments, the tensile strength minimum of wire 452 can be at least about 50,000 PSI, at least about 100,000 PSI, at least 200,000 PSI, about 235,000 PSI, about 250,000 PSI, or any other or intermediate tensile strength minimum.

[0092]

[0122] The braid of the flow diverter 300 can include any desired number of strands. In some embodiments, the braid of the flow diverter 300 can include about 10 to about 200 strands, about 20 to about 150 strands, about 40 to about 100 strands, about 64 strands, or any other or intermediate number of strands. As seen in FIG. 5, the wires 452 can include wire 452-A, which extends in a first direction and is braided with wire 452-B, which extends in a second direction. The wires 452 can be braided in any desired manner, including, for example, one wire over one stitch and under one stitch braid, one wire over two stitches and under two stitches braid as shown in FIG. 5, or any other braid.

[0093]

[0123] 6, there is shown a schematic diagram of a first delivery system 500. The system 500 can include a flow diverter 300 that can be held in a constrained configuration within a lumen 502 defined by an inner wall 504 of the catheter 104 or introducer sheath 120.

[0094]

[0124] Lumen 502 can include a variety of shapes and sizes. In some embodiments, lumen 502 can include a cylindrical lumen, and in particular can have a circular cross-section. The size of lumen 502 can be defined by an inner diameter, in some embodiments. In some embodiments, the inner diameter of lumen 502 can be, for example, up to: 0.2 inches, 0.1 inches; 0.05 inches, 0.04 inches, 0.03 inches, 0.025 inches, 0.021 inches, 0.02 inches, 0.017 inches, 0.015 inches, 0.01 inches, 0.005 inches, or any other value or intermediate value.

[0095]

[0125] The deployment wire 110 can extend at least partially within both the flow diverter 300 and within a lumen 502 of the catheter 104 or introducer sheath 120. The deployment wire 110 can include a core wire 112, which can extend within the lumen 502 of the catheter 104 and / or introducer sheath 120, and a deployment mechanism 118, which is shown generally within the lumen 502 of the catheter 104 and / or introducer sheath 120.

[0096]

[0126] In the embodiment shown in FIG. 6, the deployment mechanism 118 includes a pusher 505, such as a pusher coil 506 that wraps around a portion of the core wire 112, and one or more frictional bumps 508. The one or more frictional bumps may include, for example, a first frictional bump 508-A, a second frictional bump 508-B, and a third frictional bump 508-C. In some embodiments, the one or more frictional bumps 508 may include multiple frictional bumps 508 that may be distributed along a portion of the deployment wire 110, and specifically, may be distributed along a portion of the core wire 112. In some embodiments, the frictional bumps 508 may be disposed inside the flow passage 406 of the flow diverter 300 and may engage the flow diverter 300, as shown in FIG.

[0097]

[0127] In some embodiments, the one or more friction bumps 508 can include a single friction bump. This single friction bump can extend, for example, from the pusher 505 to the location of the third friction bump 508-C in FIG. 6. Thus, instead of having multiple friction bumps 508 over this length of the core wire 112, a single friction bump 508, also referred to herein as a friction pad, can extend over all or a portion of this length of the core wire 112. In some embodiments, this single friction pad can extend beyond the proximal portion of the flow diverter 300 to a distal portion of the flow diverter 300.

[0098]

[0128] In some embodiments, a single long friction pad can provide better engagement with the flow diverter 300. However, embodiments having multiple spaced apart friction bumps can improve flexibility of the core wire 112. In some embodiments, the single long friction pad can include the same material as the friction bumps 508, and in some embodiments, the single long friction pad can include a material configured to improve flexibility.

[0099]

[0129] The deployment mechanism 118 further includes a support coil 510, also referred to herein as a support coil 510, wrapped around a portion of the core wire 112, and in particular wrapped around a distal portion of the core wire 112, which may be tapered. As seen in FIG. 6, the support coil 510 may extend at least partially through the pusher coil 506 and may extend along the core wire 112 between the frictional bumps 508, distally beyond the final frictional bump 508, or as shown in FIG. 3, beyond the third frictional bump 508-C. Specifically, as seen in FIG. 6, the support coil 510 may begin at a location between the proximal end 514 and the distal end 516 of the pusher 505 and / or pusher coil 506, and may extend distally to a location distally beyond the final frictional bump 508. In such an embodiment, the support coil 510 may be between at least a portion of the pusher 505 and / or pusher coil 506 and the core wire 112. The deployment mechanism 118 may also include an atraumatic tip 512 at the distal-most end of the deployment wire 110 .

[0100]

[0130] In some embodiments, the portions of the support coils 510 that extend distally beyond the final friction bump 508 can support the flow diverter 300. In particular, the portions of the support coils 510 that extend distally beyond the final friction bump 508 can extend through at least a portion of the length of the flow diverter 300 and, in some embodiments, can strengthen those portions of the flow diverter 300. In particular, in some embodiments, the portions of the support coils 510 that extend distally beyond the final friction bump 508 can prevent the flow diverter from collapsing and / or buckling.

[0101]

[0131] The deployment wire 110, including the deployment mechanism 118, can be configured for navigating a patient's vasculature, and in particular for navigating a patient's neurovasculature. Thus, in some embodiments, the deployment mechanism 118 can be configured to promote and / or maintain flexibility of the core wire 112, and in particular the distal portion 116 of the core wire 112.

[0102]

[0132] The pusher coil 506 can be configured to apply a force to the flow diverter 300 as the deployment wire 110 advances distally into and / or through the catheter 104 and / or introducer sheath 120. The pusher coil 506 can include a coil formed by wire windings. The wire forming the wire windings can include a variety of materials and sizes. In some embodiments, the wire forming the pusher coil 506 can include a biocompatible wire, such as a Nitinol wire. The diameter of the wire forming the pusher coil 506 can include, for example, 0-0.01 inches, 0-0.005 inches, 0-0.002 inches, about 0.002 inches, or any other or intermediate diameter.

[0103]

[0133] The pusher coil 506 can have an outer diameter sized to fit into the lumen 502 of the catheter 104 and / or introducer sheath 120. In some embodiments, the pusher coil 506 can have a diameter smaller than the diameter of the lumen 502 of the catheter 104 and / or smaller than the inner diameter of the lumen of the introducer sheath 120. The outer diameter of the pusher coil can be sized relative to the diameter of the lumen 502 of the catheter 104 and / or introducer sheath 120 such that the flow diverter 300 does not fit between the pusher coil 506 and the inner wall 504 of the catheter 104 and / or introducer sheath 120. In some embodiments where the lumen 502 of the catheter 104 and / or introducer sheath 120 has an inner diameter of 0.017 inches, the pusher coil 506 can have an outer diameter of 0.015 inches, for example. In some embodiments in which the lumen 502 of the catheter 104 and / or introducer sheath 120 has an inner diameter of 0.021 inches, the pusher coil 506 can have an outer diameter of, for example, 0.019 inches.

[0104]

[0134] The pusher coil 506 can have a proximal end 514 and a distal end 516. In some embodiments, one or both of the proximal end 514 and the distal end 516 of the pusher coil 506 can be configured to secure the pusher coil 506 to the deployment wire 110. In some embodiments, one or both of the proximal end 514 and the distal end 516 of the pusher coil 506 can include solder that secures the pusher coil 506 to the deployment wire 110, in other words, the pusher coil 506 can be soldered to the deployment wire 110. In some embodiments, the distal end 516 of the pusher coil 506 can be further configured to provide a support surface against which the pusher coil 506 can apply a force to the flow diverter 300. In some embodiments, a bearing surface can be formed in the solder of the distal end 516. In some embodiments, the distal end 516 of the pusher coil 506 can include a bumper portion configured to engage the flow diverter 300. The bumper portion may be convex to better engage with the flow diverter 300. In some embodiments, the bumper portion may include a flattened tube.

[0105]

[0135] The deployment mechanism 118 can include one or more frictional bumps 508. In some embodiments, the frictional bumps are configured to press a portion of the flow diverter 300 against the inner wall 504 of the catheter 104 and / or introducer sheath 120 when the portion of the flow diverter 300 is within the catheter 104 and / or introducer sheath 120. In some embodiments, the frictional bumps 508 can include a material that engages, and in particular deformably engages, with the flow diverter 300 such that the frictional force between the flow diverter 300 and the frictional bump 508 is greater than the frictional force between the flow diverter 300 and the inner wall 504 of the catheter 104 and / or introducer sheath 120. Due to the relatively large frictional forces between the friction bumps 508 and the flow diverter 300, each friction bump 508 facilitates control of the flow diverter 300, and in particular, the position of the flow diverter 300 relative to the catheter 104 and / or introducer sheath 120. In some embodiments, the interaction between the friction bumps 508 and the flow diverter 300 can enable the deployment wire 110 to deploy the flow diverter 300 from the catheter 104 and / or to retract and / or partially retract a partially deployed flow diverter 300 back into the catheter 104.

[0106]

[0136] The friction bumps 508 can include a deformable material, such as, for example, an elastomer. In some embodiments, the friction bumps 508 can include a polymer that can accommodate a radiopaque element, such as, for example, a platinum coil and / or platinum wire. In some embodiments, the friction bumps 508 can include a tungsten-loaded polymer or a tungsten-loaded elastomer. In some embodiments, the friction bumps can include a UV adhesive that can be doped with a radiopaque material, such as, for example, tantalum powder. In some embodiments, some or all of the friction bumps 508 can be radiopaque and / or can include a radiopaque element. In some embodiments, the radiopaque element can include one or several radiopaque particles embedded in the friction bumps 508, and in some embodiments, as shown in FIG. 6, the friction bumps can include a radiopaque coil 509 that can include a piece of wire, such as, for example, a coil of platinum wire.

[0107]

[0137] In some embodiments where the deployment wire 110 includes multiple frictional bumps 508, the frictional bumps 508 can be equally or unequally spaced apart. In some embodiments, the frictional bumps 508 can be spaced apart by between 1 mm and 20 mm, between 1 mm and 15 mm, between 2 mm and 10 mm, between 3 mm and 8 mm, about 5 mm, or any other value or intermediate value.

[0108]

[0138] In some embodiments, the deployment mechanism 118 can include a support coil 510. The support coil 510 can prevent the core wire 112 from buckling as the core wire 112 advances the flow diverter 300 distally within the catheter 104 and / or introducer sheath 120. For example, to increase the flexibility of the core wire 112, the core wire 112 can be tapered at its distal portion 116. This taper can increase the flexibility of the core wire 112, but at the same time, it reduces the strength of the core wire 112. This reduction in strength of the core wire 112 can result in buckling of the core wire 112 as the core wire 112 is used to distally advance the flow diverter 300 within the catheter 103 and / or introducer sheath 120. The support coil 510 can extend along a portion of the core wire 112 to prevent the core wire 112 from buckling. Thus, the combination of the tapered core wire 112 and the support coil 510 allows the deployment wire 110 to be flexible to navigate tortuous vasculature while also having sufficient strength to deploy the flow diverter 300.

[0109]

[0139] 6, the support coil 510 can extend over a portion of the core wire 112, specifically over all or a portion of the distal portion 116 of the core wire 112. As further seen in FIG. 6, the support coil 510 can extend over the core wire 112 between the friction bumps 508, distally beyond the last friction bump 508, and more specifically, distally beyond the third friction bump 508-C.

[0110]

[0140] The diameter of the wire forming the support coil can include, for example, 0-0.01 inches, 0-0.005 inches, 0-0.002 inches, about 0.002 inches, or any other or intermediate diameter. In some embodiments, the wire forming the support coil 510 can have the same diameter as the wire forming the pusher coil 506, and in some embodiments, the wire forming the support coil 510 can have a different diameter than the wire forming the pusher coil 506. In some embodiments, the outer diameter of the support coil 510 can be, for example, up to 0.04 inches, up to 0.03 inches, up to 0.02 inches, up to 0.015 inches, up to 0.01 inches, up to 0.005 inches, up to 0.001 inches, or any other value or intermediate value.

[0111]

[0141] The deployment wire 110 can extend distally past the frictional bump 508, and in some embodiments, distally past the third frictional bump 508-C. The deployment wire 110 can terminate in an atraumatic tip 512, which can be disposed at a distal end of the deployment wire 110. In some embodiments, the portion of the deployment wire 110 that extends distally past the frictional bump 508 can include a portion of the support coil 510. The atraumatic tip 512 can be configured to avoid damaging tissue that may be impinged upon during the procedure, particularly while deploying the flow diverter 300 within the patient's vasculature. The atraumatic tip 512 can be attached to the distal end of the core wire 112 and / or the distal end of the support coil 510. The atraumatic tip can have a diameter that matches the outer diameter of the support coil 510. In some embodiments, the atraumatic tip 512 can be spaced from the last friction bump 508 by between 1 mm and 20 mm, between 1 mm and 15 mm, between 2 mm and 10 mm, between 3 mm and 8 mm, about 5 mm, or any other value or intermediate value.

[0112]

[0142] In some embodiments, the delivery system, and as shown in FIG. 6, the first delivery system 500, can include a retraction sleeve 520. The retraction sleeve 520 can be coupled to the deployment wire 110 and can extend over a proximal portion 522 of the flow diverter 300. In some embodiments, the retraction sleeve 520 can extend over the proximal portion 522 of the flow diverter 300 when the flow diverter 300 is housed within the introducer sheath 120 and / or catheter 104. In some embodiments, the retraction sleeve 520 can extend some or all of the length of the deployment mechanism 118 and thus can extend over some or all of the proximal portion 522 of the flow diverter 300 that engages the deployment mechanism 118.

[0113]

[0143] In some embodiments, the retraction sleeve 520 can be positioned intermediate the proximal portion 522 of the flow diverter 300 and the introducer sheath 120 and / or catheter 104, thereby reducing friction between the proximal portion 522 of the flow diverter 300 and the introducer sheath 120 and / or catheter 104. In some embodiments, the retraction sleeve 520 can not only reduce friction between the proximal portion 522 of the flow diverter 300 and the introducer sheath 120 and / or catheter 104, but can also protect the proximal portion 522 of the flow diverter 300 from damage that may result from movement of the flow diverter 300 relative to the introducer sheath 120 and / or catheter 104, such as may occur during deployment and / or retraction of the flow diverter 300.

[0114]

[0144] The retraction sleeve 520 can comprise a flexible polymer that can be coupled to the deployment wire 110. In some embodiments, the retraction sleeve 520 can be coupled to the deployment wire 110 at a location distal to all or a portion of the deployment mechanism 118, as shown in FIG. 6. In some embodiments, the retraction sleeve 520 can comprise a heat shrink polymer tube that can be disposed over a proximal portion 522 of the flow diverter 300 and over a portion of the deployment wire 110 distal to the flow diverter 300. The retraction sleeve 520 can be heat shrunk around the flow diverter 300 to fit snugly around the flow diverter 300.

[0115]

[0145] The retraction sleeve 520 may further include one or more slits extending proximally from the distal end of the retraction sleeve 520. The one or more slits separate the portion of the retraction sleeve 520 that extends over the proximal portion 522 of the flow diverter 300 into multiple segments. For example, in one embodiment of the retraction sleeve 520 including two slits, the retraction sleeve 520 may be split into two portions, which may be two equal halves. The one or more slits may allow the retraction sleeve 520 to open and separate from the flow diverter 300 when the flow diverter 300 is deployed. Thus, as seen in FIG. 7, the retraction sleeve 520 protrudes distally beyond the catheter 104. As can be seen, the retraction sleeve 520 that extends distally beyond the catheter 104 is split and separated from the flow diverter 300, allowing the flow diverter 300 to expand and allowing the retraction sleeve 520 to be retracted into the catheter 104 upon full deployment of the flow diverter 300.

[0116]

[0146] 7, a schematic diagram of the first delivery system 500 in a partially deployed configuration is shown. As seen in FIG. 7, the catheter 104 including the deployment wire 110 and the flow diverter 300 is within a blood vessel 600. As further seen in FIG. 7, the deployment wire 110 has been advanced distally relative to the catheter 104, as indicated by arrow 602, thereby partially deploying the flow diverter 300. The combination of the friction bump 508 and the pusher coil 506 engages the flow diverter 300 and advances it distally into and out of the catheter 104 as the deployment wire 110 advances distally. As the deployment wire 110 advances distally, the flow diverter 300 begins to deploy and expand from the catheter 104. This distal advancement continues until the flow diverter 300 is fully deployed. Alternatively, if the flow diverter 300 is not fully deployed from the catheter 104, and consequently at least one of the frictional bumps 508 is still within the catheter 104 and engaged with the flow diverter 300, the flow diverter 300 may be retracted and / or partially retracted into the catheter 104. In some embodiments, successful deployment of the flow diverter 300 may be achieved by advancing the deployment wire 110 only in a distal direction, and in some embodiments, successful deployment of the flow diverter 300 may be achieved by alternately advancing the flow diverter 300 distally and retracting it proximally until the desired positioning and / or deployment is achieved.

[0117]

[0147] 8, there is shown a schematic diagram of a second delivery system 700. The system 700 can include a flow diverter 300 that can be restrained within a lumen 502 defined by an inner wall 504 of the catheter 104 or introducer sheath 120.

[0118]

[0148] The deployment wire 110 can extend at least partially within both the flow diverter 300 and within a lumen 502 of the catheter 104 or introducer sheath 120. The deployment wire 110 can include a core wire 112, which can extend within the lumen 502 of the catheter 104 and / or introducer sheath 120, and a deployment mechanism 118, which is shown generally within the lumen 502 of the catheter 104 and / or introducer sheath 120.

[0119]

[0149] The deployment mechanism 118 includes at least one frictional bump 508 and a delivery coil 702. The frictional bump 508 and delivery coil 702 can engage with the flow diverter 300 when the flow diverter is within the catheter 300 and / or the introducer sheath 120, and can be engaged to the flow diverter as shown in FIG. 8. Each of the frictional bump 508 and delivery coil 702 can be coupled to the delivery wire 100, and in particular, can be coupled to the core wire 112. In some embodiments, the frictional bump 508 and / or the one or more delivery coils 702 can be radiopaque and / or include radiopaque elements.

[0120]

[0150] The delivery coils 702 can include a proximal delivery coil 702-A and a distal delivery coil 702-B. Each of the delivery coils 702 can include a proximal end and a distal end, with the proximal end of the delivery coil 702 being relatively closer to the proximal end of the core wire 112 than the distal end of the delivery coil 702.

[0121]

[0151] The delivery coils 702 can each include a wire winding. The diameter of the wire forming the delivery coils 702 can include, for example, 0-0.01 inches, 0-0.005 inches, 0-0.002 inches, about 0.002 inches, or any other or intermediate diameter. In some embodiments, as shown in FIG. 8, the distal delivery coil 702-B extends to the distal end 704 of the deployment wire 110, and at least one friction bump 508 can be disposed between the proximal delivery coil 702-A and the distal delivery coil 702-B.

[0122]

[0152] The delivery coil 702 can be configured to push a portion of the flow diverter 300, specifically the portion of the flow diverter 300 in contact with the delivery coil, into the inner wall 504 of the catheter 104 and / or introducer sheath 120 when that portion of the flow diverter 300 is within the catheter 104 and / or introducer sheath 120. In some embodiments, the delivery coil 702 can engage the flow diverter 300 such that the frictional force between the flow diverter 300 and the delivery coil 702 is greater than the frictional force between the flow diverter 300 and the inner wall 504 of the catheter 104 and / or introducer sheath 120. The relatively greater frictional force between the delivery coil 702 and the flow diverter 300 allows each delivery coil 702 to facilitate control of the flow diverter 300, specifically the position of the flow diverter 300 relative to the catheter 104 and / or introducer sheath 120. In some embodiments, interaction between the delivery coil 702 and the flow diverter 300 can enable the deployment wire 110 to deploy the flow diverter 300 from the catheter 104 and / or to retract and / or partially retract a partially deployed flow diverter 300 back into the catheter 104.

[0123]

[0153] The delivery coil 702 can have an outer diameter sized to fit within the lumen 502 of the catheter 104 and / or introducer sheath 120. In some embodiments, the delivery coil 702 can have a diameter smaller than the diameter of the lumen 502 of the catheter 104 and / or smaller than the inner diameter of the lumen of the introducer sheath 120. The outer diameter of the delivery coil 702 can be sized relative to the diameter of the lumen 502 of the catheter 104 and / or introducer sheath 120 and can also be sized relative to the dimensions of the flow diverter 300 such that the delivery coil 702 presses the flow diverter 300 into the inner wall 504 of the catheter 104 and / or introducer sheath 120 with such a force that the flow diverter 300 moves with the deployment wire 110 as the deployment wire 110 moves relative to the catheter 104 and / or introducer sheath 120.

[0124]

[0154] The delivery coil 702 may be attached directly to the core wire 112 or, in some embodiments, may be coupled to the core wire 112 via one or several spacers 706. In some embodiments, the proximal delivery coil 702-A and the distal delivery coil 702-B are each coupled to the deployment wire 110, and specifically the core wire 112, via at least one spacer 706.

[0125]

[0155] The one or more spacers 706 can increase the diameter of the delivery coil 702 and can provide a constant diameter of the delivery coil 702 against the taper of the core wire 112. The spacers 706 can include a metal, a polymer, an elastomer, or any desired material.

[0126]

[0156] The spacers 706 may include a first spacer 706-A that couples a distal end of the proximal delivery coil 702-A to the core wire 112, a second spacer 706-B that couples a proximal end of the distal delivery coil 702-B to the core wire 112, and a third spacer 706-C that couples a distal end of the distal delivery coil 702-B to the core wire 112. In some embodiments, as shown in FIG. 8, the proximal end of the proximal delivery coil 702-A couples directly to the core wire 112.

[0127]

[0157] The spacers 706 counteract the taper of the core wire 112 such that each of the delivery coils 702 has a constant diameter, and the proximal delivery coil 702-A and the distal delivery coil 702-B have the same diameter. Thus, in some embodiments, the height of each of the first spacer 706-A, the second spacer 706-B, and the third spacer 706-C is configured such that the proximal delivery coil 702-A and the distal delivery coil 702-B have the same diameter, and the proximal delivery coil 702-A and the distal delivery coil 702-B have a constant diameter. In some embodiments, the height of each of the spacers 706, specifically the first spacer 706-A, the second spacer 706-B, and the third spacer 706-C, counteracts the taper of the distal portion 116 of the core wire 112.

[0128]

[0158] 8, in some embodiments, the second delivery system 700 can include a pusher 505 and / or a support coil 510. In some embodiments, the pusher 505 can be a pusher coil 506. In some embodiments, the pusher 505 can extend along and around a portion of the deployment wire 110. In some embodiments, the pusher 505 can be disposed proximal to the proximal delivery coil 702. In some embodiments, the support coil 510 can extend along and around a distal portion 116 of the deployment wire 110, specifically around the distal portion 116 of the core wire 112.

[0129]

[0159] 9, a schematic diagram of a second delivery system 700 in a partially deployed configuration is shown. As seen in FIG 9, the catheter 104, including the deployment wire 110 and flow diverter 300, is within a blood vessel 600. As further seen in FIG 9, the deployment wire 110 has been advanced distally relative to the catheter 104, as indicated by arrow 602, thereby partially deploying the flow diverter 300. The combination of friction bump 508 and delivery coil 702 engages the flow diverter 300 to advance it distally in and out of the catheter 104 as the deployment wire 110 advances distally.

[0130]

[0160] As the deployment wire 110 is advanced distally, the flow diverter 300 begins to deploy and expand from the catheter 104. This distal advancement continues until the flow diverter 300 is fully deployed. Alternatively, if the flow diverter 300 is not fully deployed from the catheter 104, and consequently at least a portion of the proximal delivery coil 702-A is still within the catheter 104 and engaged with the flow diverter 300, the flow diverter 300 may be retracted and / or partially retracted into the catheter 104. In some embodiments, successful deployment of the flow diverter 300 may be achieved by advancing the deployment wire 110 only distally, and in some embodiments, successful deployment of the flow diverter 300 may be achieved by alternately advancing the flow diverter 300 distally and retracting the flow diverter 300 proximally until the desired positioning and / or deployment is achieved.

[0131]

[0161] 10, there is shown a schematic diagram of the second delivery system 700 in a deployed configuration. As seen in FIG. 10, the flow diverter 300 has expanded out of the catheter 104 and against the blood vessel 600. Because the flow diverter 300 is expanded, the deployment wire 110 can be retracted into the catheter 104 without retracting the flow diverter 300.

[0132]

[0162] 11 , there is shown a schematic diagram of a third delivery system 1000. The system 1000 can include a flow diverter 300 that can be held in a constrained configuration within the lumen 502 of the catheter 104 via a tube 1002 and compression coil 1010 combination.

[0133]

[0163] The tube 1002 may include any elongated tubular member having an inner wall 1006 defining a lumen 1008 and may be slidably received within the catheter 104. In some embodiments, the tube 1002 may include a flexible tube configured to navigate the neurovasculature, and in some embodiments, the tube 1002 may include a slotted and / or spiral cut hypotube. In some embodiments, the slots and / or spiral cuts in the hypotube may be configured to increase the flexibility of the hypotube.

[0134]

[0164] In some embodiments, the tube 1002 can include a proximal end (not shown) and a distal end 1004. The tube 1002 can include an inner tube wall 1006 that can define a tube lumen 1008. As seen in FIG. 11 , the core wire 112 can extend distally through the tube lumen 1008 and beyond the tube 1002. As further seen in FIG. 11 , a portion of the flow diverter 300 can be received within the lumen 1008 of the tube 1002, and specifically, a portion of the flow diverter 300 including the first end 304 can be received at the distal end 1004 of the lumen 1008 of the tube 1002.

[0135]

[0165] The compression coil 1010 may include a member coupled to the deployment wire 110 and configured to receive a portion of the flow diverter 300, specifically a portion of the flow diverter 300 including the second end 306. In some embodiments, the compression coil 1004 may compress this portion of the flow diverter 300 to maintain the portion of the flow diverter 300 in a compressed state.

[0136]

[0166] The compression coil 1010 may include a proximal end 1012 and a distal end 1014. The proximal end 1012 may open to an internal volume 1016. As seen in FIG. 11 , the internal volume 1016 may face proximally such that a distal portion of the flow diverter 300, including the second end 306, may be received within the internal volume 1016. In some embodiments, the portion of the flow diverter received within the internal volume 1016 of the compression coil 1010 may be held in a restrained state.

[0137]

[0167] The compression coil 1010 may include a wire wound into a coil, which may be a conical coil having a point at the distal end 1014 of the flow diverter 300 and a base at the proximal end 1012 of the flow diverter 300. The compression coil 1010 may have a diameter smaller than the diameter of the catheter 104 and may be slidably received within the lumen 502 of the catheter 104.

[0138]

[0168] In some embodiments, the compression coil 1010 can engage the flow diverter 300 sufficiently that the compression coil 1010 can pull the flow diverter 300 out of the tube 1002. In other words, the frictional force between the compression coil 1010 and the flow diverter 300 can be greater than the frictional force between the flow diverter 300 and the tube 1002. However, in some embodiments, the frictional force between the blood vessel 600 and the flow diverter 300 can be greater than the frictional force between the compression coil 1010 and the flow diverter 300. Thus, advancement of the core wire 112 and the compression coil 1010 coupled thereto can pull the flow diverter 300 out of the tube 1002. When the flow diverter 300 is pulled from the tube 1002, it can expand and engage the blood vessel 600. Once the flow diverter 300 has sufficiently engaged the blood vessel 600, the flow diverter 300 can be released from the compression coil 1010 by further distally advancing the core wire 112 and the compression coil 1010 coupled thereto. If any portion of the flow diverter 300 is still within the tube 1002, proximal retraction of the tube 1002 or the tube 1002 and catheter 104 can result in full deployment of the flow diverter 300. Once the flow diverter is fully deployed, the compression coil 1010 can be retracted proximally through the flow diverter 300 and back into the catheter 104.

[0139]

[0169] In some embodiments, as shown in FIG. 11 , the core wire 112 can be coupled to a distal end 1014 of the compression coil 1010. In some embodiments, the core wire 112 can extend distally beyond the compression coil 1010. In some embodiments, a tip coil 1018, which can be a flexible tip coil 1018, can extend distally from the compression coil 1010, specifically from the distal end 1014 of the compression coil 1010. The tip coil 1018 can extend along and around all or a portion of the core wire 112 that extends distally beyond the compression coil 1010. The tip coil 1018 and / or the core wire 112 can terminate at an atraumatic tip 512. The atraumatic tip 512 can be at the most distal point of the core wire 112 and / or the tip coil 1018 in some embodiments. In some embodiments, the flexible tip coil 1018 and / or the flexible tip coil 1018 and atraumatic tip 512 can facilitate navigating the system 1200 and / or the core wire 112 through the vasculature, particularly through tortuous vasculature.

[0140]

[0170] 11 , the third delivery system 1000 can include at least one frictional bump 508. The at least one frictional bump 508 can be coupled to the core wire 112 and can be spaced proximally from the compression coil 1010 to engage a portion of the flow diverter 300 adjacent the first end 304 when the flow diverter second end 306 is received by the compression coil 1010.

[0141]

[0171] 11, the third delivery system 1000 can include a pusher 505, which can be, for example, a pusher coil 506. The pusher 505 can be coupled to the core wire 112, specifically, a distance from the proximal end 1012 of the compression coil 1010 such that the flow diverter 300 is constrained by the tube 1002 and held between the compression coil 1010 and the pusher 505 until the first end 304 of the flow diverter 300 deploys from the tube 1002. At that point, the flow diverter 300 can expand, allowing the pusher 505 to push the flow diverter 300 while allowing the compression coil 1010 to be further advanced to separate the compression coil 1010 from the flow diverter 300.

[0142]

[0172] In some embodiments, one or more of the friction bump 508, the tube 1002, the pusher 505, and the compression coil 1010 are radiopaque and / or include a radiopaque element. The radiopaque element may include a radiopaque wire, specifically a radiopaque wire coil. In some embodiments, the wire forming the wire core may be platinum or any other radiopaque material.

[0143]

[0173] 12, a depiction of one embodiment of the deployment of the third delivery system 1000 is shown. As seen in this figure, the catheter 104 has been advanced proximate to a treatment area within the blood vessel 600. The catheter 104 advanced proximate to a treatment area within the blood vessel 600 can be at, near, or beyond the treatment area within the blood vessel 600. In some embodiments, this can include positioning the catheter 104 distal to the treatment area within the blood vessel 600.

[0144]

[0174] The tube 1002 and core wire 112 are advanced such that the distal end 1004 of the tube 1002 is at the end of the catheter 104 or distal beyond the end of the catheter 104. In some embodiments, the tube 1002 and core wire 112 can be advanced to a desired location relative to the treatment site, which in some embodiments can be distal to the treatment site or an intermediate location to the treatment site.

[0145]

[0175] Once in the desired position, the flow diverter 300 can be deployed by advancing the core wire 112 relative to the tube 1002. This can be accomplished by advancing the core wire 112 while maintaining the position of the tube 1002, retracting the tube 1002 while maintaining the position of the core wire 112, or advancing the core wire 112 while retracting the tube 1002.

[0146]

[0176] In some embodiments, the core wire 112 and the compression coil 1010 coupled thereto advance distally, thereby pulling and / or deploying the flow diverter 300 from the tube 1002. As the flow diverter 300 deploys, its deployed portion expands and begins to engage the vessel 600. When both ends of the flow diverter 300 are contained within either the compression coil 1010 or the tube 1002, during deployment, a middle portion of the flow diverter 300 deploys first and then expands. The expanded portion can engage the vessel wall, and this engagement can help deploy the remaining portion of the flow diverter 300. Specifically, as the flow diverter 300 is deployed from the tube 1002, engagement between the deployed portion of the flow diverter 300 and the wall of the vessel 600 can facilitate completion of the deployment of the flow diverter 300 from the compression coil 1010.

[0147]

[0177] Additionally, control of deployment of the flow diverter 300 is improved because each end of the flow diverter 300 is still contained within one of the compression coils 1010 and tubes 1002. Specifically, the system 1000 maintains control of both ends 402, 404 of the flow diverter 300. With this improved control, the system 1000 facilitates repositioning of a partially deployed flow diverter.

[0148]

[0178] As engagement between the flow diverter 300 and the vessel 600 increases, the flow diverter 300 begins to pull out of the compression coil 1010. If any portion of the flow diverter remains within the tube 1002, the core wire 112 can be advanced further distally to deploy the remaining portion of the flow diverter 300 and / or the tube 1002 can be retracted proximally. Due to the engagement between the deployed portion of the flow diverter 300 and the vessel 600, the remaining portion of the flow diverter 300 can be pulled out of the tube 1002 and deployed. Once the flow diverter 300 is deployed and expanded, the compression coil 1010 can be retracted proximally through the flow diverter 300 and back into the catheter 104.

[0149]

[0179] 13, there is shown a schematic diagram of a fourth delivery system 1200. The system 1200 can include a flow diverter 300 that can be restrained within the lumen 502 of the catheter 104 and / or introducer sheath 120.

[0150]

[0180] The deployment wire 110 can extend at least partially within both the flow diverter 300 and within a lumen 502 of the catheter 104 or introducer sheath 120. The deployment wire 110 can include a core wire 112, which can extend within the lumen 502 of the catheter 104 and / or introducer sheath 120, and a deployment mechanism 118, which is shown generally within the lumen 502 of the catheter 104 and / or introducer sheath 120.

[0151]

[0181] The deployment mechanism 118 includes at least one pusher 505 and a claw mechanism 1202, also referred to herein as a gripping mechanism 1202. The claw mechanism 1202 and pusher 505, shown in FIG. 13, engage the flow diverter such that movement of the corewire 112 relative to the catheter 104 and / or introducer sheath 120 similarly moves the flow diverter 300 relative to the catheter 104 and / or introducer sheath 120.

[0152]

[0182] The pusher 505 can be, for example, a pusher coil 506. The pusher 505 can extend around and / or along the distal portion 116 of the core wire 112. In some embodiments, the pusher 505 can include a distal end 516, which can engage with the first end 304 of the flow diverter 300, as shown in FIG. 13. The pusher 505 can be coupled to the core wire 112. Specifically, the pusher 505 can be coupled to the core wire 112 proximal to the distal end 113 of the core wire 112 such that the core wire 112 extends distally beyond the pusher 505.

[0153]

[0183] The claw mechanism 1202 can be configured to engage with the flow diverter 300. Through this engagement between the claw mechanism 1202 and the flow diverter 300, the claw mechanism can transfer force and / or motion from the core wire 112 to the flow diverter 300 such that the flow diverter 300 can be deployed by advancing the core wire 112 distally.

[0154]

[0184] The pawl mechanism 1202 can include a variety of shapes and sizes and can be made from a variety of materials, such as, for example, tungsten, titanium, stainless steel, cobalt chrome, etc. In some embodiments, all or a portion of the pawl mechanism can be rigid, flexible, and / or radiopaque. In some embodiments, the pawl mechanism 1202 can be sized to be received within the lumen 502 of the catheter 104 and / or introducer sheath 120 and engage with a flow diverter 300 also contained within the lumen 502.

[0155]

[0185] The pawl mechanism 1202 can comprise an elongated body 1204. The elongated body 1204 can include a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the elongated body 1204 can be made from, for example, tungsten, titanium, stainless steel, cobalt chrome, etc. In some embodiments, all or a portion of the elongated body 1204 can be rigid, flexible, and / or radiopaque.

[0156]

[0186] The elongated body 1204 of the pawl mechanism 1202 can include a proximal end 1206 and a distal end 1208. In some embodiments, as shown in view 1302 of FIG. 14 , the proximal end 1206 of the elongated body 1204 can be coupled to the distal end 113 of the core wire 112 at a junction 1210. In some embodiments, the coupling of the elongated body 1204 to the core wire 112 can be a flexible coupling, and in some embodiments, the junction 1210 is flexible. In some embodiments, the flexibility of the coupling of the elongated body 1204 to the core wire 112 can be a result of the flexibility of the core wire, particularly the flexibility of the tapered distal portion 116 of the core wire 112.

[0157]

[0187] The claw mechanism 1202 can include one or more claws 1212, also referred to herein as one or more gripping portions 1212 or one or more gripping elements 1212. In some embodiments, the gripping elements 1212 can comprise the same material as the elongated body 1204. In some embodiments, the gripping elements 1212 can be rigid, and in some embodiments, the gripping elements 1212 can be flexible.

[0158]

[0188] In some embodiments, each of the one or more gripping portions 1212 can extend radially from the elongated body 1204. Some or all of the one or more gripping elements 1212 can be configured to engage with the flow diverter 300. An exemplary gripping portion 1212 shape is shown in view 1304 of FIG. 14. View 1304 is taken along view plane AA and is perpendicular to view 1302 of FIG.

[0159]

[0189] In some embodiments, one or more of the gripping elements 1212 may each engage with the flow diverter 300 via one or more of the engagement features 1306. In some embodiments, each of the engagement features 1306 may include protrusions and / or points. Some or all of the engagement features of the gripping portion 1212 may engage with a portion of the flow diverter 300. Specifically, in some embodiments, some or all of the engagement features 1306 may be sized and / or shaped to engage with structures on the flow diverter 300, specifically to fit into openings in the flow diverter. Through this engagement, as the core wire 112 advances, the engagement features 1306 that engage with structures on the flow diverter 300 exert a force on the flow diverter 300 to advance the flow diverter 300. In some embodiments in which the flow diverter 300 includes a braided member, the engagement features 1306 are configured to fit and / or partially fit between the braided and / or woven fibers and / or strands that form the braided flow diverter 300.

[0160]

[0190] As seen in view 1304 of FIG. 14, gripper 1212 can include a variety of shapes and sizes and can have a desired number of engagement members 1306. For example, gripper 1212-A can include a rectangular or cylindrical member that forms a T-shape with elongated body 1204. In such an embodiment, gripper 1212-A can include two engagement members 1306. Grip 1212-B can include a triangle that can have three engagement members 1306, gripper 1212-C can include a square and / or rectangle with four engagement members 1306, gripper 1212-D can include a pentagon with five engagement members 1306, or in some embodiments, gripper 1212 can include a hexagon with six engagement members 1306, a heptagon with seven engagement members 1306, or an octagon with eight engagement members 1306. In some embodiments, grippers 1212 may be star-shaped, such as, for example, gripper 1212-E having four engagement members 1306, gripper 1212-F having five engagement members 1306, and gripper 1212-G having six engagement members 1306. In some embodiments, grippers 1212 may be sprocket-shaped, such as, for example, gripper 1212-H and gripper 1212-I.

[0161]

[0191] The gripping element 1212 and gripping mechanism 1202 provide an important advantage in that the gripping element 1212 engages the flow diverter 300 by engaging a structure of the flow diverter 300, as opposed to frictional forces between the flow diverter 300 and the element, e.g., compressing the flow diverter 300 into the inner wall 504 of the lumen 502 of the catheter 104 and / or introducer sheath 120. In such engagement between the gripping element 1212 and a structure of the flow diverter 300, one or some of the engagement members 1306 of the gripping portion 1212 extend into the braid of the flow diverter 300, and one or some of the fibers forming the braid of the flow diverter cover a portion of the distal end 1208 of the gripping mechanism 1202, specifically, cover the portion of the distal end 1208 of the gripping mechanism formed by the engagement members 1306 of the gripping portion 1212.

[0162]

[0192] This non-frictional engagement between the gripping element 1212 and the flow diverter 300 facilitates deployment of the flow diverter 300. Specifically, because the gripping element 1212 does not compress the flow diverter 300 against the inner wall 504 of the lumen 502, frictional forces between the flow diverter 300 and the inner wall 504 of the lumen 502 are minimized. This minimization of frictional forces between the inner wall 504 of the lumen 502 and the flow diverter 300 also reduces the force applied to the core wire 112 to move the flow diverter 300 within the lumen 502 of the catheter 104 and / or introducer sheath 120, facilitating deployment of the flow diverter 300 from the catheter 104 and / or movement of the flow diverter 300 relative to the introducer sheath 120.

[0163]

[0193] 14 , the gripper 1212 can be located at the distal end 1208 of the elongate body 1204. Alternatively, in some embodiments, the gripper 1212 can be located at an intermediate location along the elongate body 1204, which can be between the proximal end 1206 and the distal end 1208 of the elongate body 1204.

[0164]

[0194] The system 1200 can further include a support coil 510. The support coil 510 can extend along and / or around at least a portion of the distal portion 116 of the core wire 112. As previously described, this distal portion 116 can be tapered to increase the flexibility of the distal portion 116 of the core wire 112. The support coil 510 can prevent the core wire 112, and in particular, the tapered distal portion 116 of the core wire, from buckling under compressive loads, such as when the core wire 112 is advanced distally to deploy the flow diverter 300.

[0165]

[0195] The support coil 510, in some embodiments, can extend from a location proximal to the pusher 505, and can extend distally beyond the pusher 505. In some embodiments, the support coil 510 can extend around and / or along at least a portion of the distal portion 116 of the core wire 112, including along and / or around the distal end 113 of the core wire 112. In some embodiments, the support coil 510 can extend across the junction 1210, along and / or around at least a portion of the elongated body 1204. In some embodiments, the support coil 510 can extend along and / or around the elongated body 1204 to the prongs 1212.

[0166]

[0196] In some embodiments, the system 1200 can include a friction bump 508 coupled to the core wire 112. The friction bump 508 can be radiopaque or can include a radiopaque element such as a wire coil in some embodiments. The friction bump 508 can be included in place of or in addition to the pusher 505 in some embodiments. When the friction bump 508 is included in addition to the pusher 505, the friction bump 508 can be coupled to the core wire 112 at a location distal to the pusher 505. In embodiments where the friction bump 508 replaces the pusher 505, the friction bump 508 can be positioned such that both the friction bump 508 and the pawl mechanism 1202 can simultaneously engage the flow diverter 300. In some embodiments, the friction bump 508 can be positioned at the junction 1210.

[0167]

[0197] In some embodiments, as seen in FIGS. 15 and 16 , the system 1200 can include a tip coil 1018, which can be a flexible tip coil 1018. The tip coil 1018 can extend distally from the claw mechanism 1202, specifically from the distal end 1208 of the claw mechanism 1202. The tip coil 1018 can terminate at an atraumatic tip 512. The atraumatic tip 512 can be at the distal-most point of the tip coil 1018, in some embodiments. In some embodiments, the flexible tip coil 1018 and / or the flexible tip coil 1018 and the atraumatic tip 512 can facilitate navigating the system 1200 and / or the core wire 112 through the vasculature, particularly through tortuous vasculature.

[0168]

[0198] In some embodiments, the flexible tip coil 1018 can support the flow diverter 300. In particular, the flexible tip coil 1018 can extend through at least a portion of the length of the flow diverter 300 and in some embodiments can strengthen those portions of the flow diverter 300. In particular, in some embodiments, the flexible tip coil 1018 can prevent the flow diverter from collapsing and / or buckling.

[0169]

[0199] As seen in FIG. 15 , the flow diverter 300 is partially deployed from the catheter 104. The flow diverter 300 is partially deployed from the catheter 104 by moving the core wire 112, and therefore the flow diverter 300, distally relative to the catheter 104. In some embodiments, this relative movement can be achieved, for example, by holding the position of the catheter 104 and advancing the core wire 112, and therefore the flow diverter 300, distally. In some embodiments, this relative movement can be achieved, for example, by holding the position of the core wire 112 and retracting the catheter 104 proximally. In some embodiments, the relative movement can be achieved by a combination of movement of both the core wire 112 and the catheter 104 to achieve relative distal advancement of the core wire 112 and the flow diverter 300 relative to the catheter 104.

[0170]

[0200] 16 , this relative distal advancement of the core wire 112 and flow diverter 300 relative to the catheter 104 can eventually result in the claw mechanism 1202 exiting the catheter 104. Once the claw mechanism 1202, and the portion of the flow diverter 300 with which it is engaged, exits the catheter 104, the flow diverter 300 expands and disengages from the claw mechanism 1202. Further advancement of the core wire 112 relative to the catheter 104 can result in full deployment of the flow diverter 300, at which point the catheter 104 and / or core wire 112 can be retracted from the blood vessel 600.

[0171]

[0201] 17, there is shown a schematic diagram of a fifth delivery system 1600. This system 1600 is a shortened delivery system that terminates at the proximal end 402 of the flow diverter 300. This shortened delivery system offers an advantage over other delivery embodiments as it reduces the distance that the delivery system 1600 extends into the neurovasculature, thereby increasing the ability to treat smaller and more distal vasculature.

[0172]

[0202] In some embodiments, for example, the flow diverter 300 shortens significantly as it is deployed. This shortening of the flow diverter 300 allows the core wire 112 to advance significantly beyond the length of the deployed flow diverter 300. This allows the core wire 112, specifically the distal end 113 of the core wire 112, to extend beyond the flow diverter 300 into the vessel. Pushing the core wire 112 distally beyond the flow diverter 300 into the vessel 600 can pose significant problems. These problems may arise especially in the neurovasculature where the vessels tend to be smaller and more tortuous. In such circumstances, the portion of the core wire 112 that extends distally beyond the flow diverter 300 can damage or even puncture the wall of the vessel 600. This risk can be mitigated, for example, by including a distal coil 1018. The embodiment of Figures 16-18 mitigates these risks with a shortened delivery system that in some embodiments does not extend beyond the deployed flow diverter 300.

[0173]

[0203] Specifically, a flow diverter 300 in a constrained configuration within the catheter 104 is often multiple times longer than the same flow diverter 300 in an unconstrained, expanded configuration. Foreshortening of the flow diverter 300 due to deployment of the flow diverter 300 can easily cause the distally extending portion of the deployment wire 110 to extend distally beyond the distal end 404 of the flow diverter 300. This can be particularly problematic in small, tortuous blood vessels, as the portion that extends distally beyond the flow diverter 300 can damage the blood vessel 600 and, in extreme circumstances, can penetrate the wall of the blood vessel 600.

[0174]

[0204] 18, the frictional bump 508 abuts the pusher 505 and covers the distal end 113 of the core wire 112, and, as seen in FIGURE 17, the frictional bump 508 remains entirely within the proximal end 402 of the flow diverter 300. Thus, during deployment, neither the frictional bump 508 nor the deployment wire 110 extend distally beyond the distal end 404 of the deployed flow diverter 300.

[0175]

[0205] The system 1600 may include a flow diverter 300 that may be held in a restrained configuration within a lumen 502 of the catheter 104 and / or introducer sheath 120. A deployment wire 110 may extend at least partially through both the flow diverter 300 and the lumen 502 of the catheter 104 or introducer sheath 120. The deployment wire 110 may include a core wire 112 that may extend within the lumen 502 of the catheter 104 and / or introducer sheath 120, and a deployment mechanism 118 that is shown generally within the lumen 502 of the catheter 104 and / or introducer sheath 120. As can be seen in FIG. 17, these deployment mechanisms are coupled to the flow diverter such that movement of the deployment wire 110 and / or core wire 112 relative to the catheter 104 and / or introducer sheath 120 similarly moves the flow diverter 300 relative to the catheter 104 and / or introducer sheath 120.

[0176]

[0206] The deployment mechanism 118 includes a pusher 505 and a frictional bump 508. The frictional bump 508 and pusher 505, shown in FIG. 17, engage the flow diverter 300 such that movement of the corewire 112 relative to the catheter 104 and / or introducer sheath 120 similarly moves the flow diverter 300 relative to the catheter 104 and / or introducer sheath 120.

[0177]

[0207] The pusher 505 can be, for example, a pusher coil 506. The pusher 505 can extend around and / or along the distal portion 116 of the core wire 112. In some embodiments, the pusher 505 can include a distal end 516 that can engage with the first end 304 of the flow diverter 300, as shown in FIG. 17 . The pusher 505 can be coupled to the core wire 112. Specifically, the pusher 505 can be coupled to the core wire 112 proximal to the distal end 113 of the core wire 112 such that the core wire 112 extends distally beyond the pusher 505.

[0178]

[0208] The friction bump 508 can be coupled to the deployment wire 110, and specifically, can be coupled to the core wire 112. The friction bump 508 can be radiopaque or can include a radiopaque element such as a wire coil, in some embodiments. The friction bump 508 can include a single friction bump 508, which can be a cylindrical friction bump 508. In some embodiments, as shown in FIG. 18, the friction bump 508 can cover the distal end 113 of the deployment wire 110, and specifically, can cover the distal end 113 of the core wire 112. In some embodiments, the friction bump 508 abuts the pusher 505, and specifically, in some embodiments, the proximal end of the friction bump 508 abuts the distal end 516 of the pusher 505.

[0179]

[0209] One embodiment of the deployment of a flow diverter with the system 1600 is shown in FIG. 19. As seen in this figure, the deployment wire 110 and flow diverter 300 are advanced distally in the direction indicated by arrow 1800 until the flow diverter 300 exits the catheter 104. Once the flow diverter 300 exits the catheter 104, the flow diverter 300 may begin to expand and begin to engage the interior of the blood vessel 600. In some embodiments, the distal advancement of the deployment wire 110 and flow diverter 300 may continue until the flow diverter 300 is fully deployed. Alternatively, if the flow diverter 300 is not fully deployed from the catheter 104, the flow diverter 300 may be retracted and / or partially retracted into the catheter 104. Due to the location of the frictional bump 508 at the distal end 113 of the core wire 112, the frictional bump 508 remains engaged with the flow diverter 300 until the flow diverter 300 has left the catheter 104 and is fully deployed. Thus, the flow diverter 300 remains retractable for as long as the last portion of the flow diverter 300 remains within the catheter 105, in other words, until just before the flow diverter 300 is fully deployed. Thus, the use of frictional bumps 508 as shown in system 1600 can provide a high degree of flexibility and control of the deployment of the flow diverter 300.

[0180]

[0210] 20, a schematic diagram of one embodiment of a dynamic delivery system 1900 is shown. The system 1900 may include a flow diverter 300 that may be held in a constrained state within a lumen 502 of the catheter 104 and / or introducer sheath 120. In some embodiments, the flow diverter 300 may include an expandable braided member that may define a flow path 406. In some embodiments, the flow diverter 300 may include a self-expanding braided member.

[0181]

[0211] The flow diverter 300 may be disposed in the lumen 502 of the catheter 104 and / or introducer sheath 120. In some embodiments, the flow diverter 300 may be disposed circumferentially within the lumen 502 of the catheter 104 and / or introducer sheath 120 between an inner wall 504 that defines the lumen 502 of the catheter 104 and / or introducer sheath 120 and an expanding element, which may be a self-expanding element, as described at greater length below.

[0182]

[0212] The deployment wire 110 can extend at least partially into both the flow diverter 300 and into a lumen 502 of the catheter 104 or introducer sheath 120. The deployment wire 110 can include a core wire 112, which can extend into the lumen 502 of the catheter 104 and / or introducer sheath 120, and deployment mechanisms 118, which are shown generally within the lumen 502 of the catheter 104 and / or introducer sheath 120. As seen in FIG. 20 , these deployment mechanisms 118 are coupled to the flow diverter such that movement of the deployment wire 110 and / or core wire 112 relative to the catheter 104 and / or introducer sheath 120 similarly moves the flow diverter 300 relative to the catheter 104 and / or introducer sheath 120.

[0183]

[0213] The deployment mechanism 118 includes one or more frictional bumps 508, a support coil 510, an expansion element 1901, a tip coil 1018, and an atraumatic tip 512. The tip coil can be a flexible tip coil 1018. In some embodiments, the flexible tip coil 1018 and / or the flexible tip coil 1018 and the atraumatic tip 512 can facilitate navigating the system 1200 and / or the core wire 112 through the vasculature, particularly through tortuous vasculature.

[0184]

[0214] In some embodiments, some or all of these deployment mechanisms 118 engage the flow diverter or engage with the flow diverter 300 as shown in FIG. 20. The deployment mechanisms 118 engage and / or can engage with the flow diverter 300 such that movement of the core wire 112 results in corresponding movement of the flow diverter 300.

[0185]

[0215] The expansion element 1901 can include a self-expanding element 1902 or a controlled expansion element. In some embodiments, the self-expanding element 1902 can expand upon exiting the catheter 104. In some embodiments, the controlled expansion element can expand when controlled to expand. The controlled expansion element can include, for example, a stent, a braid, a balloon, and the like. In some embodiments where the expansion element 1902 includes a braided member, the thickness of the strands of the braid can be varied to achieve a desired effect. For example, the strands can be thicker to increase expansion force or the strands can be thinner to increase flexibility. In some embodiments, the strands can include various materials, including, for example, DFT, which can be radiopaque, for example. In some embodiments, the strands can include a polymer, such as a high tensile strength polymer. In some embodiments, the polymer used in the strands can advantageously increase friction between the expansion element 1902 and the flow diverter 300, thereby increasing the ability of the expansion element 1902 to retract the flow diverter 300. In embodiments where the strands include a polymer, the polymer can be treated and / or doped to be radiopaque.

[0186]

[0216] In some embodiments, the materials of the flow diverter 300 and / or the expansion element 1902 can be selected to minimize the compressed diameter of the flow diverter 300 around the expansion element 1902. In some embodiments, when high tensile strength materials are selected and used, such as, for example, materials having a tensile strength of 100 kpsi or more, 150 kpsi or more, 200 kpsi or more, 250 kpsi or more, the outer diameter of the fully compressed expansion element 1902 can be, for example, about 0.005 inches to 0.035 inches, about 0.01 inches to 0.015 inches, about 0.013 inches, or any other or intermediate outer diameter. In such an embodiment, when the flow diverter 300 is axially disposed around and over the dilating element 1902, the combination of the dilating element 1902 and the flow diverter 300, both in a compressed state, can have, for example, an outer diameter of about 0.01 inch to 0.04 inch, about 0.015 inch to 0.035 inch, about 0.017 inch, or any other or intermediate outer diameter. As used herein, "approximately" indicates a value that is within a range of + / - 5% of the associated value, + / - 10% of the associated value, and / or + / - 20% of the associated value. Thus, the combination of the flow diverter 300 and the dilating element 1902 can fit into a catheter 104 having, for example, an inner diameter of about 0.01 inch to 0.04 inch, about 0.015 inch to 0.035 inch, about 0.017 inch, or any other or intermediate inner diameter.

[0187]

[0217] In some embodiments, the controlled expansion element can include one or several features configured to allow for control of the expansion of the controlled expansion element. These features can include one or several wires, catheters, rods, and the like. In some embodiments, the controlled expansion element can be expanded by compressing the controlled expansion element axially such that the proximal end of the controlled expansion element approaches the distal end of the controlled expansion element. Although the following description focuses on the use of a self-expanding element 1902, it will be understood that the self-expanding element 1902 can be replaced with a controlled expansion element.

[0188]

[0218] 21, the self-expanding element 1902 includes a proximal end 1904, also referred to herein as a first end 1904, and a distal end 1906, also referred to herein as a second end 1906. The proximal end 1904 of the self-expanding element 1902 can be coupled to the distal end 113 of the deployment wire 110, more specifically, to the distal end 113 of the core wire 112. The self-expanding element 1902 can extend distally from the proximal end 1904 to the distal end 1906 of the self-expanding element 1902, as shown in FIG.

[0189]

[0219] The self-expanding element 1902 can include a stent or braided member. In some embodiments, the self-expanding element includes a laser cut stent. The self-expanding element 1902 can include a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the self-expanding element 1902 can be made from a Nitinol stretch-filled tube, which can include, for example, Nitinol, a cobalt chrome exterior and a platinum interior, such as a mixture of Nitinol and cobalt chrome. In some embodiments, the self-expanding element 1902 can include a plurality of braided strands, at least a portion of which can be radiopaque.

[0190]

[0220] The self-expanding member 1902 can be configured to engage the flow diverter 300 when the flow diverter is contained within the catheter 104 and / or the introducer sheath 120, such that movement of the deployment wire 110, and particularly the core wire 112, results in corresponding movement of the flow diverter 300. When the self-expanding element 1902 is deployed from the catheter 104, the self-expanding element 1902 expands to a fully expanded state, or to a maximum expanded state permitted by the vessel in which the self-expanding element 1902 is contained. In some embodiments, the self-expanding element 1902 can be advanced distally and / or retracted proximally through the flow diverter 300.

[0191]

[0221] In some embodiments, the expansion element 1902, such as a controlled expansion element or a self-expanding element 1902, can generate a radial force that can expand the flow diverter 300 more than would otherwise occur. For example, even if the flow diverter 300 is self-expanding, the expansion element 1901, such as a controlled expansion element or a self-expanding element 1902, can generate a radial expansion force that is greater than that generated by the flow diverter 300. By moving the expansion element 1901 through the flow diverter 300, these greater radial expansion forces generated by the expansion element 1901 can be applied to the flow diverter 300, causing the flow diverter 300 to expand further. This increased expansion can increase and / or improve contact between the flow diverter 300 and the blood vessel 600. In some embodiments, the use of the expansion element 1901, such as a controlled expansion element, or as a self-expanding element.

[0192]

[0222] In some embodiments, the expansion element 1902 can have a diameter larger than the diameter of the unconstrained flow diverter 300 when unconstrained, and in some embodiments, the expansion element 1902 can have a diameter smaller than the diameter of the unconstrained flow diverter 300 when unconstrained. Thus, in some embodiments, when unconstrained, the expansion element 1902 can have a diameter larger or smaller than the diameter of the blood vessel 600. In some embodiments, when deploying the flow diverter 300, kinks, twists, compression, or bends may occur in the flow diverter 300 that may prevent the flow diverter 300 from expanding. In some embodiments, the expansion element 1902 can straighten, correct, and / or eliminate these kinks, twists, compression, or bends in the flow diverter 300 by expanding to a diameter smaller than the diameter of the blood vessel 600. In such embodiments, expansion by the expansion element 1902, which is smaller than the diameter of the blood vessel 600, can straighten, straighten, and / or eliminate these kinks, kinks, compression, or bends in the flow diverter 300, such that the flow diverter 300 can self-expand to engage the walls of the blood vessel 600. Thus, in some embodiments, the expansion element 1902 begins to expand, and then the expansion is continued and completed by the flow diverter 300.

[0193]

[0223] In some embodiments, the expansion of the expandable element 1902 can result in shortening of the expandable element 1902. This shortening can move the distal end 113 of the core wire 112 proximally, which in turn can move the atraumatic tip 512 proximally. This proximal movement of the distal end 113 of the core wire 112 and / or the atraumatic tip 512 can reduce the distal extension of these portions of the core wire 112 into the blood vessel, thereby reducing the risk of damage to the blood vessel.

[0194]

[0224] The one or more frictional bumps 508 can be coupled to the deployment wire 110, and specifically, can be coupled to the core wire 112. In some embodiments, the one or more frictional bumps 508 can be directly coupled to the deployment wire 110, and specifically, the core wire 112, and in some embodiments, the one or more frictional bumps 508 can be indirectly coupled to the deployment wire 110, and specifically, the core wire 112, for example, via a self-expanding element.

[0195]

[0225] In some embodiments, one or more frictional bumps 508 can be disposed on one or both ends of the self-expanding element. Thus, in some embodiments, at least one of the frictional bumps 508 is disposed on one of the proximal end 1904 and the distal end 1906. In some embodiments, at least one of the frictional bumps 508 is disposed on one of the proximal end 1904 and the distal end 1906, and another frictional bump is disposed on the other of the proximal end 1904 and the distal end 1906. As seen in FIG. 21 , the frictional bumps 508 include a first frictional bump 508-A disposed adjacent to and / or on the proximal end 1904 of the self-expanding element 1902 and a second frictional bump 508-B disposed adjacent to and / or on the distal end 1906 of the self-expanding element 1902. In some embodiments, the frictional bumps 508 can extend across and / or over a portion of the self-expanding element 1902. In some embodiments, one or more of the friction bumps 508 may be radiopaque and / or may include a radiopaque element such as a wire coil 509.

[0196]

[0226] The system can include a support coil 510. The support coil 510 can extend around and / or along at least a portion of the distal portion 116 of the core wire 112, including along and / or around the distal end 113 of the core wire 112. The support coil 510, in some embodiments, can extend from a location proximal to the self-expanding element 1902 to the self-expanding element 1902 and / or from a location proximal to the first frictional bump 508-A to the first frictional bump 508-A. In some embodiments, the support coil 510 can extend at least partially into the first frictional bump 508-A.

[0197]

[0227] The system 1900 can include a tip coil 1018, which in some embodiments can be a flexible tip coil 1018. The tip coil 1018 can extend distally from the self-expanding element 1902, specifically, can extend distally from the distal end 1906 of the self-expanding element 1902. The tip coil 1018 can extend distally beyond the self-expanding element 1902 and can terminate at an atraumatic tip 512. The atraumatic tip 512 can be at the distal-most point of the tip coil 1018 in some embodiments. In some embodiments, the flexible tip coil 1018 and / or the flexible tip coil 1018 and atraumatic tip 512 can facilitate navigating the system 1200 and / or the core wire 112 through the vasculature, particularly through tortuous vasculature.

[0198]

[0228] One embodiment of a deployment of a flow diverter with the system 1900 is shown in FIG. 22. In FIG. 22, the self-expanding member 1902 is shown in a deployed configuration. In some embodiments, the self-expanding member 1902 can include a variety of shapes and sizes. In the embodiment shown in FIG. 22, the self-expanding member 1902 includes a proximal end 1904 and a distal end 1906. The self-expanding member 1902 further includes a proximal portion 2110 and a distal portion 2114. In some embodiments, intermediate between the proximal portion 2110 and the distal portion 2114 can be an intermediate portion 2112 that connects the proximal portion 2110 and the distal portion 2114. In some embodiments, the proximal portion 2110 can extend distally from the proximal end 1904 to the intermediate portion 2112, and the distal portion 2114 can extend proximally from the distal end 1906 to the intermediate portion 2112, as shown in FIG. 22.

[0199]

[0229] In some embodiments, the proximal portion 2110 can have a diameter in the expanded configuration that gradually increases as the distance from the proximal end 1904 increases. In some embodiments, the intermediate portion 2112 can have a constant diameter. In some embodiments, the distal portion 2114 can have a diameter that gradually decreases as the distance from the proximal end 1904 increases. In some embodiments, each of the different portions 2110, 2112, 2114 of the self-expanding member 1902 can be configured to engage the flow diverter 300 to expand and / or further expand the flow diverter 300.

[0200]

[0230] In some embodiments, during deployment of the flow diverter 300, the self-expanding members 1902 can intermittently contact the flow diverter 300, specifically the inner wall 303 of the flow diverter 300, causing the flow diverter 300 to expand. For example, in some embodiments, some portions of the flow diverter 300 may not fully expand while other portions of the flow diverter 300 may fully expand. For example, in embodiments where the flow diverter 300 extends around a corner of a vessel, the bent portions of the flow diverter 300 may not fully deploy. In such embodiments, the self-expanding members 1902 can intermittently contact the flow diverter 300, specifically, the non-fully deployed portions of the flow diverter 300. Through this intermittent contact, the non-fully deployed portions of the flow diverter 300 can be deployed by the self-expanding members 1902. In some embodiments, this intermittent contact can occur along one or more of the proximal portion 2110, the intermediate portion 2112, and / or the distal portion 2114 of the self-expanding member 1902. In the embodiment of FIG. 22, contact occurs between the flow diverter 300 and the self-expanding member 1902 along the proximal portion 2110 and the intermediate portion 2112.

[0201]

[0231] In some embodiments, during deployment of the flow diverter 300, the self-expanding members 1902 can intimately contact the flow diverter 300, specifically the inner wall 303 of the flow diverter 300, causing the flow diverter to expand. In some embodiments, this intimate contact can cause the flow diverter 300 to fully deploy and / or more fully deploy. In some embodiments, this intimate contact can occur along all or a portion of the flow diverter 300. In some embodiments, the intimate contact between the flow diverter 300 and the self-expanding members 1902 can occur along one or more of the proximal portion 2110, the intermediate portion 2112, and / or the distal portion 2114 of the self-expanding members 1902.

[0202]

[0232] 22, the catheter 104 has been inserted into the vasculature and advanced to a location proximate to the treatment site 2100, which may be at, near, or beyond the treatment site 2100. In some embodiments, the position of the catheter may be determined by imaging, such as fluoroscopy.

[0203]

[0233] As seen in this figure, the deployment wire 110 and flow diverter 300 advance distally in the direction indicated by arrow 2102 until the flow diverter 300 exits the catheter 104. Once the flow diverter 300 exits the catheter 104, the flow diverter 300 may begin to expand and begin to engage the interior of the blood vessel 600. In some embodiments, the distal advancement of the deployment wire 110 and flow diverter 300 may continue until the flow diverter 300 is fully deployed. Alternatively, if the flow diverter 300 is not fully deployed from the catheter 104, the flow diverter 300 may be retracted and / or partially retracted within the catheter 104. In some embodiments, the flow diverter 300 may be retracted and / or partially retracted within the catheter 104 until the frictional bumps 508 and / or the proximal most side of the self-expanding elements 1902 exit the catheter 104. In some embodiments, the position of the flow diverter 300, the catheter 104, the frictional bumps 508 and / or the self-expanding elements 1902 may be determined by imaging, specifically, by imaging portions of the radiopaque elements and / or the catheter 104, the frictional bumps 508 and / or the self-expanding elements 1902. In some embodiments, based on the results of this imaging, it may be determined whether the flow diverter 300 may be retracted and / or partially retracted into the catheter 104.

[0204]

[0234] As the self-expanding element 1902 exits the catheter 104, the self-expanding element 1902 expands and exerts a radially outward force on the flow diverter 300, further expanding the flow diverter 300. Alternatively, if a controlled expansion element is used, the controlled expansion element can expand upon exiting the catheter 104.

[0205]

[0235] The self-expanding element 1902 can continue to advance distally relative to the catheter 104 until the flow diverter 300 is fully deployed. Once the flow diverter 300 is fully deployed, the self-expanding element 1902 can advance distally through the flow diverter 300 to fully and / or maximally expand the flow diverter 300, at which point the self-expanding element 1902 can retract proximally through the flow diverter 300 and then back into the catheter 104. In some embodiments, the distal advancement and proximal retraction of the expanding element 1902 through the flow diverter 300 can be repeated multiple times before retracting the expanding element 1902 into the catheter 104. In some embodiments, the repeated movement of the expanding element 1902 through the deployed flow diverter 300 can facilitate achieving full deployment of the flow diverter 300, particularly if all or a portion of the flow diverter 300 is not fully deployed. This movement of the self-expanding element 1902 through the flow diverter 300, first distally and then proximally, can increase the expansion of the flow diverter 300 and improve the connection between the flow diverter and the blood vessel 600.

[0206]

[0236] Once the self-expanding element 1902 is retracted within the catheter 104, the catheter can be retracted and / or one or several additional flow diverters can be delivered to the treatment site.

[0207]

[0237] 22-30, pictorial depictions of embodiments for delivering a flow diverter 300 are shown, particularly embodiments for delivering a flow diverter 300 into a blood vessel 600 to treat an aneurysm. In some embodiments, the blood vessel may be a neurovascular vessel, in other words, a blood vessel in or around the patient's brain. In some embodiments, delivery of the flow diverter 300 into the blood vessel 600 may include partial deployment of the flow diverter 300 from the catheter 104, and / or full or partial retraction of the flow diverter 300 into the catheter 104. As used herein, full retraction occurs when the flow diverter 300 is retracted until it is fully housed in the catheter 104, and partial retraction occurs when a portion of the flow diverter 300 remains outside of the catheter 104 following retraction of the flow diverter 300.

[0208]

[0238] In some embodiments, the flow diverter 300 may be fully or partially deployed after being retracted into the catheter 104. In some embodiments, the flow diverter 300 may be partially deployed and retracted once, and in some embodiments, the flow diverter 300 may be partially deployed and retracted into the catheter 104 repeatedly.

[0209]

[0239] The flow diverter 300 may be fully or partially retracted for a number of reasons. In some embodiments, the flow diverter 300 may be fully or partially retracted into the catheter 104 to facilitate repositioning of the flow diverter 300 relative to a treatment location, for example. In some embodiments, the flow diverter 300 may be retracted into the catheter 104 and removed from the blood vessel. In some embodiments, the flow diverter 300 may be replaced with another flow diverter 300 of a different size, for example, a flow diverter having a larger or smaller diameter. In some embodiments, the flow diverter 300 may be retracted and redeployed to improve expansion of the flow diverter 300. In some embodiments, for example, retracting and redeploying the flow diverter 300 may result in a more complete opening of the flow diverter 300 and / or improved contact between all or a portion of the flow diverter 300 and the blood vessel in which the flow diverter is deployed.

[0210]

[0240] In some embodiments, the flow diverter 300 can be retracted and / or redeployed to affect the portion of the blood vessel covered by the deployed flow diverter 300. In some embodiments, the coverage of the flow diverter 300 of the blood vessel at the treatment location can be affected, for example, by controlling the position and / or movement of both the catheter 104 and the core wire 112 during deployment. For example, after engaging a distal portion of the flow diverter 300 with the blood vessel, thereby coupling the flow diverter 300 to the blood vessel, the length of the deployed flow diverter can be affected by retracting the catheter 104 while deploying the flow diverter 300. In particular, the relative speed of retraction of the catheter 104 relative to the deployment of the flow diverter 300 can affect the length of the flow diverter 300. For example, the length of the deployed flow diverter can be shortened by retracting the catheter 104 relatively slowly relative to the deployment of the flow diverter 300. Alternatively, the flow diverter 300 can be stretched as it is deployed by retracting the catheter 104 relatively quickly relative to the deployment of the flow diverter 300, thereby increasing the length of the deployed flow diverter 300.

[0211]

[0241] In some embodiments, by controlling the length of the deployed flow diverter 300, the surgeon can affect the diameter of the deployed flow diverter 300. Specifically, as the length of the deployed flow diverter increases, the deployed unconstrained diameter of the flow diverter decreases. Thus, in some embodiments in which the flow diverter 300 is deployed in a vessel having a larger diameter, the surgeon can decrease the length of the deployed flow diverter to achieve a desired deployed diameter of the flow diverter 300.

[0212]

[0242] The process begins in Figure 23 where a treatment location 2100 is identified. As seen in Figure 23, this treatment location is within a blood vessel and includes an aneurysm 2202 or other structure that is covered or partially covered by the flow diverter 300. In some embodiments, the treatment location 2100 can be adjacent to one or several structures that should not be covered by the flow diverter 300, such as, for example, one or several branches 2204 of the blood vessel 600.

[0213]

[0243] After the treatment location 2100 is identified, the catheter 104, which may be a microcatheter 104, may be inserted into the patient's vasculature via the access point, and the catheter 104 may be advanced within the patient's vasculature until the catheter 104, and in particular, the distal end 132 of the catheter 104, is proximate to the treatment site 2100, or in other words, at, near, or beyond the treatment location, as shown in FIG. 24. In some embodiments, the insertion of the catheter 104 into the patient's vasculature and the position of the catheter 104, and in particular, the position of the distal tip 132 of the catheter 104 within the patient's vasculature, may be monitored by imaging.

[0214]

[0244] The flow diverter 300 may be loaded into the lumen 502 of the catheter 104. In some embodiments, this may be performed before the catheter 104 is inserted into the patient's vasculature, and in some embodiments, this may be performed after the catheter 104 is inserted into the patient's vasculature. In some embodiments, the flow diverter 300 may be loaded into the lumen 502 of the catheter 104 after the catheter 104 has been advanced to a position proximate the treatment location 2100. In some embodiments, loading of the flow diverter 300 into the catheter 104 may be performed as described above with respect to FIG. 2.

[0215]

[0245] As shown in FIG. 25, the core wire 112 can be advanced distally within the catheter 104, thereby beginning to deploy the flow diverter 300 from the catheter 104. This can include advancing the core wire 112 through the catheter 104 to partially deploy the flow diverter 300 from the catheter 104. The core wire 112 can be coupled to the flow diverter 300 via one or several deployment mechanisms 118. In some embodiments, distal advancement of the core wire 112 relative to the catheter 104 can similarly advance the flow diverter 300 distally relative to the catheter 104. In some embodiments, as shown in FIG. 25, the flow diverter 300 expands and / or begins to expand as the flow diverter 300 exits the catheter 104.

[0216]

[0246] The deployment of the flow diverter 300 can be monitored. In some embodiments, this monitoring can be determining whether the flow diverter 300 is properly positioned, determining whether the flow diverter 300 is expanded and / or has expanded to a desired diameter, determining whether the flow diverter 300 provides a desired length of coverage of the treatment site 2100, determining whether the flow diverter 300 has a desired size or diameter, etc. In some embodiments, this can include monitoring the position of the flow diverter 300 itself via imaging, where the flow diverter 300 is at least partially radiopaque and / or can include one or several radiopaque elements. In some embodiments, this can include monitoring the position of the catheter 104 and / or the core wire 112 and / or one or several delivery mechanisms 118. This monitoring can include monitoring the position of the flow diverter 300 within the blood vessel 600 and / or monitoring the relative positions of one or several of the components and / or features described above with respect to one another.

[0217]

[0247] In some embodiments, the position of the flow diverter 300 within the blood vessel 600 and / or the relative positions of one or more of the components and / or features may be determined by imaging and monitoring the position of one or more of the friction bumps 508, the pusher 505, the deployment coil 702, the tube 1002, the compression coil 1010, the claw mechanism 1202, the self-expanding element 1902, the tip coil 1018, the support coil 510, and / or the atraumatic tip 512. In some embodiments, the position of the core wire 112 and / or one or more of the delivery mechanisms 118 may be monitored relative to the position of the catheter 104 to determine whether the flow diverter 300 can be retracted into the catheter 104 to reposition the catheter 104 and / or the flow diverter 300 relative to the treatment site 2100.

[0218]

[0248] 25, the catheter 104 is advanced too far into the blood vessel 600 and the flow diverter 300, if deployed in its current location, obstructs and / or partially obstructs one or several structures that should not be covered by the flow diverter 300, specifically, obstructs and / or partially obstructs the bifurcation 2204 of the blood vessel 600. If the flow diverter 300 is determined to be improperly positioned, the flow diverter 300 may be retracted and / or partially retracted into the catheter 104 via proximal retraction of the core wire 112 based on the position of the core wire 112 and / or one or several delivery mechanisms 118 relative to the position of the catheter 104. In some embodiments, the positioning of the catheter 104 relative to the treatment location 2100 may be adjusted based at least in part on the imaging.

[0219]

[0249] Further, if it is determined that the flow diverter 300 is the wrong size or a different size flow diverter 300 is desired, the expansion of the flow diverter 300 can be improved, the length of the flow diverter 300 within the treatment site 2100 can be improved, etc., the flow diverter 300 can be fully or partially retracted into the catheter 104 based on the position of the flow diverter 300 relative to the core wire 112 and / or one or more delivery mechanisms 118.

[0220]

[0250] As shown in FIG. 26, the catheter 104 can be repositioned relative to the treatment area 2100 and then the core wire 112 can be advanced distally within the catheter 104, thereby beginning to deploy and / or further deploy the flow diverter 300 from the catheter 104. In some embodiments, as shown in FIG. 26, the catheter 104 can be positioned distal, and in some embodiments just distal, to the treatment site 2100. In some embodiments, distal advancement of the core wire 112 relative to the catheter 104 can similarly advance the flow diverter 300 distally relative to the catheter 104. In some embodiments, the flow diverter 300 can be deployed by advancing the core wire 112 relative to the catheter 104. In some embodiments, this advancement of the core wire 112 relative to the catheter 104 may include retracting the catheter 104 within the blood vessel 600 while maintaining the position of the core wire 112 relative to the blood vessel 600, advancing the core wire 112 relative to the blood vessel 600 while maintaining the position of the catheter 104 relative to the blood vessel 600, or advancing the core wire 112 relative to the blood vessel 600 while simultaneously retracting the catheter 104 relative to the blood vessel 600.

[0221]

[0251] In some embodiments, as shown in Figure 27, the flow diverter 300 expands and / or begins to expand as the flow diverter 300 exits the catheter 104. The flow diverter 300 can continue to deploy as shown in Figure 28 with further distal advancement of the core wire 112, and thus the flow diverter, and the flow diverter 300 can be fully deployed as shown in Figure 29.

[0222]

[0252] After the flow diverter 300 is fully deployed, the core wire 112 can be retracted distally into the catheter 104, and the catheter can be retracted from the treatment location 2100 and from the patient's vasculature. In some embodiments, one or several additional flow diverters 300 can be deployed at the treatment location 2100. This can include placing an additional flow diverter 300-B over one or several previously deployed flow diverters 300-A, as shown in FIG. 30. Alternatively, one or several additional flow diverters 300 can be placed in a partially overlapping manner to increase the length of the blood vessel 600 being treated. In such an embodiment, the distal end of the additional flow diverter 300-B can be placed overlapping the proximal end or previously placed flow diverter 300, as shown in FIG. 31.

[0223]

[0253] In the foregoing specification, the invention has been described with reference to specific embodiments thereof, but those skilled in the art will recognize that the invention is not limited thereto. The various features and aspects of the invention described above can be used individually or together. Moreover, the invention can be utilized in any number of environments and applications beyond those described herein without departing from the broader spirit and scope of the specification. Thus, the specification and drawings should be regarded as illustrative rather than restrictive. It will be recognized that the terms "comprising," "including," and "having" as used herein are specifically intended to be interpreted as open-ended terms of technology.

Claims

1. 1. A system for intravascular delivery of a flow diverter to treat an aneurysm, the system comprising: an elongated tubular member having a proximal end and a distal end, said tubular member comprising an inner wall defining a lumen; a flow diverter comprising a self-expanding member having a proximal end and a distal end, the flow diverter defining a flow path extending therethrough, the flow diverter being received within the lumen of the tubular member in a constrained configuration; a deployment wire extending within the lumen of the tubular member and within the flow passage of the flow diverter, the deployment wire having a proximal end, a distal end, and a tapered distal portion, the deployment wire comprising at least one deployment mechanism coupled to the flow diverter such that movement of the deployment wire relative to the tubular member moves the flow diverter relative to the tubular member and into the neurovasculature, the at least one deployment mechanism comprising: a pusher extending along and around the distal portion of the deployment wire, the pusher having a distal end configured to engage the proximal end of the flow diverter; at least one frictional bump disposed along the distal portion of the deployment wire that extends distally beyond the pusher, the at least one frictional bump being inside the flow channel of the flow diverter and engaging a portion of the flow diverter; a support coil extending along and around the distal portion of the deployment wire; a deployment wire; A system comprising:

2. The system of claim 1 , wherein the at least one friction bump comprises a plurality of friction bumps, the plurality of friction bumps being equally spaced apart.

3. The system of claim 1 , wherein the at least one friction bump comprises a radiopaque element.

4. The system of claim 3 , wherein the radiopaque element comprises a coil of wire.

5. 2. The system of claim 1, wherein the at least one friction bump includes a first friction bump, a second friction bump, and a third friction bump, the first friction bump being closer to the pusher than the second and third friction bumps, and the third friction bump being closer to the distal end of the deployment wire than the first and second friction bumps.

6. 6. The system of claim 5, wherein the support coil extends at least partially through the pusher and distally beyond the third frictional bump, the support coil extending distally beyond the third frictional bump and terminating to form an atraumatic tip.

7. The system of claim 1 , wherein the pusher comprises a pusher coil.

8. The system of claim 7 , wherein the pusher coil is soldered to the deployment wire.

9. The system of claim 8 , wherein the pusher coil includes a radiopaque element.

10. The system of claim 1 , wherein the at least one frictional bump comprises a single frictional bump, the single frictional bump covering and extending beyond the distal end of the deployment wire.

11. The system of claim 10 , wherein the single friction bump abuts the pusher.

Images