Patent ID: 12213676

DETAILED DESCRIPTION

The present relates to flow diverters, flow diverter delivery systems, and methods of delivering a flow diverter. A flow diverter is a device that can be placed within vasculature to divert flow away from portions of the vasculature covered by the flow diverter. As used herein, a flow diverter can be any device that is positionable within a patient's blood vessel and can divert a portion of the blood flow through that blood vessel. In some embodiments, a flow diverter can be an endovascular prosthesis used in treating intracranial aneurysms. A flow diverter can include, for example, a stent such as a laser cut stent, a braided member, or the like. In some embodiments, a flow diverter can comprise a braided member comprising a plurality of braided wires, which wires can be, for example, cobalt-chrome, Nitinol, or the like.

A flow diverter can be used to treat an intracranial aneurysm including, for example, saccular aneurysm and particularly an unerupted saccular aneurysm, or a fusiform shape or circumferential aneurysm. A flow diverter can be placed in a blood vessel to extend across and cover an aneurysm. The flow diverter can divert blood flow away from the aneurysm, thereby reducing blood flow in the aneurysm. Having reduced blood flow, over time, the aneurysm can close and heal.

While simple in principle, the reality of accurately placing a flow diverter in frequently small and tortuous vasculature of the brain can be very complicated. Accordingly, devices are desired that have high flexibility to enable the navigation of this vasculature. Further, such devices should be able to accurately position a flow diverter within a blood vessel. Accurately positioning of a flow diverter can include adjusting the position of the flow diverter, and in some embodiments can include, positioning multiple flow diverters to wholly or partially overlap. The use of multiple partial or wholly overlapping flow diverters can be of particular benefit in dealing with multiple closely spaced aneurysms or with a larger aneurysm. In some embodiments, multiple flow diverters can be positioned to wholly or partially overlap to further reduce blood flow to an aneurysm.

Neurovascular vessels have a wide range of lengths and diameters. Further, the diameter of a neurovascular vessel varies along its length, with the diameter normally decreasing at progressively distal locations of that neurovascular vessel. Hospitals must have varying lengths of flow diverters in supply to accommodate the different sizes neurovascular vessel, of side branches, and/or bifurcations. In addition, hospitals must stock flow diverters in various diameter sizes, resulting in a large number of SKUs to manage. Such a large and varied supply and stock system including the full range of sizes to optimally match flow diverter to a desired location becomes economically burdensome to maintain. Further, the need to have numerous different diameters and lengths of flow diverters complicates surgery, as the best fitting flow diverter must be placed in each location. To ensure a best fit, a surgeon must have flow diverters of the correct length and diameter in the operating room, which can lead to waste. Further, as flow diverters are provided a fixed lengths, a surgeon may be forced to use a flow diverter of a sub-optimal length. Various aspects of the present disclosure provide improved flexibility in flow diverter length selections, and specifically enable customization of flow diverter length. This customization decreases the number of SKUs that a hospital must keep in stock, decreases waste, and improves the likelihood of use of a properly-sized flow diverter.

Various embodiments of the present disclosure provide customizable flow diverter. Conventional designs provide a flow diverter packaged in an introducer sheath on a delivery system where a delivery wire extends past the implant, thereby fixing the length of the flow diverter. Embodiments disclosed herein do not have the deployment wire extending beyond the length of the flow diverter. Embodiments of the present disclosure provide a customizable system that allow users to tailor the length of the implant to match the specifications of the treatment site. Because the deployment wire does not extend distally beyond the distal end of the flow diverter, and terminates proximal to the distal end of the flow diverter, embodiments presented herein provide a delivery system where users can trim the flow diverter to a desired length without compromising the delivery system. Specifically, in some embodiments, users can trim the flow diverter at locations between where the deployment wire terminates and the distal end of the flow diverter. In some embodiments, the deployment wire terminates in a proximal portion of the flow diverter to thereby provide the user with the ability to trim the flow diverter in relatively distal portions of the flow diverter.

Furthermore, the presently disclosed customizable flow diverter delivery system advantageously includes deployment mechanisms which enable customization. For example, in conventional designs, deployment mechanisms are coupled to and/or are configured to be used with the aforementioned deployment wire which extends distally beyond the distal end of the flow diverter. Such mechanisms would prevent customization at the distal end of the flow diverter as there would not be any disposable material up to and including the distal end of the flow diverter. The presently disclosed customizable flow diverter delivery system overcomes these obstacles by providing a proximally located deployment wire and deployment mechanisms, leaving flexibility for adjusting the length of the distal end of the flow diverter.

Embodiments disclosed herein provide several beneficial improvements. These include, for example, a decrease in the size of the system. This decrease in size of the system enables the accessing and treating of smaller blood vessels. This increases range of treatable aneurysms, and thus improves patient outcomes. Further, embodiments disclosed herein improve flexibility of the system, thereby also increasing the range of treatable aneurysms.

However, and despite the benefit of being able to customize the flow diverter, having a deployment wire that terminates inside of the flow diverter has drawbacks. Namely, the lack of the deployment wire extending beyond the distal end of the flow diverter during deployment of the flow diverter diminishes the ability of the deployment wire to effectively function as a guidewire to assist in the navigation of the vasculature. However, it has been found that the benefit of customizing the flow diverter outweighs the diminished control.

With reference now toFIG.1a depiction of one embodiment of a system100for placement of a flow diverter is shown. The system100can include a catheter system102. The catheter system102can be configured to provide access to the patient's vasculature, and specifically to the patient's neurovasculature. In some embodiments, the catheter system102can be configured for insertion into the patient's vasculature at an access point, and for navigating through the patient's vasculature to a location at which the flow diverter is to be delivered.

The catheter system102can comprise a proximal end130and a distal end132. The catheter system102can comprise an elongate catheter104defining a lumen extending through all or portions of the catheter104. Accordingly, in some embodiments, the catheter system102can comprise an elongate tubular member defining a lumen, and specifically the elongate tubular member comprising an interior wall defining a lumen. The catheter104can comprises a variety of sizes, materials, and/or manufactures. In some embodiments, the catheter104can be flexible and can comprise a biocompatible material. The catheter104can comprise, for example, an elongate tubular member can have a diameter of, 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.

The catheter104, which can include a catheter hub106, can be coupled to an access device. The access device108can be a valve such as, for example, a rotating hemostasis valve (RHV)109. The access device108can be a hemostasis valve that can be configured to provide selectable and/or controllable access to the lumen of the catheter104. In some embodiments, the access device108can be configured to minimize blood loss while the catheter104is being used. The access device108can be sized for use in connection with the catheter104.

The system100for placement of the flow diverter can include a deployment wire110comprising a proximal end111and a distal end113. The deployment wire110can be configured to facilitate and/or control the advance of the flow diverter into and/or through the catheter system102, and specifically into and/or through the lumen of the catheter104. In some embodiments, the proximal end111of the deployment wire110is configured to be controlled to control the advance of the flow diverter into and/or through the catheter system102, and the distal end113can be configured to be coupled to and/or to interact with the flow diverter to cause the flow diverter to advance into and/or through the catheter system102.

The deployment wire110can comprise a core wire112. The core wire112can comprise an elongate wire that can be flexible to enable navigation vasculature. In some embodiments, the core wire112can comprise a unibody reinforced delivery wire. The core wire112can comprise a variety of shapes and sizes and can be made from a variety of materials. The core wire112can comprise a biocompatible wire that can be, for example, a Nitinol wire.

The core wire112can, comprise a proximal portion114and a distal portion116. Compared to the distal portion116, the proximal portion114is relatively closer to the proximal end111of the deployment wire110. Likewise, compared to the proximal portion114, the distal portion is relatively closer to the distal end113of the deployment wire110.

During a procedure, a distal end of the distal portion116can be first inserted into the patient. The core wire112can comprise a variety of shapes and sizes. In some embodiments, the core wire112can have a constant diameter along its length, and in some embodiments, the core wire112can have a non-constant diameter along its length. In some embodiments, the core wire112comprises a tapered core wire112, which tapered core wire112comprises a portion having a decreased diameter. In some embodiments, the tapered portion can taper to a point, and in some embodiments, the tapered portion can taper to a flattened delivery tip. The tapered portion can be, all or portions of, for example, the distal portion116of the core wire112. In some embodiments, the portion of the core wire112having a decreased diameter can be, for example, up to a distal 5% of the core wire112, up to a distal 10% of the core wire112, up to a distal 15% of the core wire112, up to a distal 20% of the core wire112, up to a distal 25% of the core wire112, up to a distal 30% of the core wire112, up to a distal 40% of the core wire112, up to a distal 50% of the core wire112, or any other or intermediate portion.

In some embodiments, for example, the core wire112can have a length that is as long as, or longer than the catheter system102. The core wire112can have a maximum outer diameter of, for example, up: 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 or intermediate value.

The deployment wire110can include one or several deployment features118. The deployment features118can be located on the distal portion116of the core wire112. The deployment features118can comprise one or several features configured to interact with the flow diverter to enable the core wire112to control and/or manipulate the core wire112. In some embodiments, the deployment features can be configured to enable the core wire112to interact with the flow diverter to push the flow diverter into and/or move the flow diverter in and/or through the lumen of the catheter104. In some embodiments, the deployment features118can be configured to couple the flow diverter to the core wire112such that the flow diverter can be deployed from the catheter104into the patient. Details of the deployment features118will be discussed at greater length below.

The flow diverter placement system100can include an introducer sheath120. The introducer sheath120can comprise an elongate tubular member having a proximal end122and a distal end124. In some embodiments, each of the proximal end122and the distal end124of the introducer sheath120can be open. The introducer sheath120can comprising an interior wall defining a lumen extending through the introducer sheath120.

The introducer sheath can be configured to hold the flow diverter before the flow diverter is inserted into the catheter system102, and specifically into the proximal end130of the catheter system102. In some embodiments, the introducer sheath120can be configured to hold the flow diverter in the lumen of the introducer sheath. In some embodiments, and as shown inFIG.2(A), the introducer sheath120is holding the flow diverter in the lumen of the introducer sheath120, and the deployment wire110is at least partially inserted into the lumen of the introducer sheath coupling the deployment features118of the deployment wire110with the flow diverter. As shown inFIG.2(B), the introducer sheath120, and specifically the distal end124of the introducer sheath120can be inserted into and through the access device108and into the catheter104and specifically into the catheter hub106of the catheter104. In some embodiments, this can include inserting the combination of the introducer sheath containing the flow diverter and the deployment wire110into the catheter system102and specifically into the catheter104.

In some embodiments, the introducer sheath120can be advanced through the access device108and into the catheter104in the direction indicated by arrow202. The core wire112can inserted into the catheter system102, and specifically into the proximal end130of the catheter system102. In some embodiments, the core wire112can be inserted into the introducer sheath120, which introducer sheath can be inserted into the catheter system102.

The core wire112can be advanced in the direction indicated by arrow202through the introducer sheath120to advance the flow diverter from the introducer sheath120into the catheter104. After the flow diverter is advanced into the catheter104, the introducer sheath120can be retracted from the catheter104and from the access device108in the directed indicated by arrow204.

With reference now toFIGS.3and4, perspective view of an embodiment of a flow diverter300is shown. The flow diverter300can be, for example, a stent, a braided member, or the like. In some embodiments, a flow diverter can comprise an elongate braided member comprising a plurality of braided wires, which wires can be, for example, cobalt-chrome, Nitinol, or the like. The flow diverter300can, in some embodiments, comprise a tubular member defined by an external wall302having a first end304, also referred to as a proximal end304, and a second end306, also referred to herein as a distal end306. The flow diverter300can include a proximal portion310and a distal portion312. In some embodiments, the proximal portion310can comprise a proximal half of the flow diverter300and the distal portion312can comprise a distal half of the flow diverter300. In some embodiments, the proximal portion310can comprise, approximately, the most proximal third of the flow diverter300and the distal portion312can comprise the approximately two thirds of the flow diverter300distal to the proximal portion310of the flow diverter300. In some embodiments, the proximal portion310can comprise, approximately, the most proximal quarter of the flow diverter300and the distal portion312can comprise the approximately three quarters of the flow diverter300distal to the proximal portion310of the flow diverter300.

As seen inFIG.4, the elongate tubular member of the flow diverter300can have a central axis400and can extend from a proximal end402to a distal end404. A flow channel406, also referred to herein as a diverter lumen406, can be defined by an inner wall403of the flow diverter300and can extend along the central axis400and through the flow diverter300. In some embodiments, each of the proximal end402and the distal end404can comprise an opening into the flow channel406such that fluid, and specifically blood can flow through the flow channel406, flowing into the proximal end402and out the distal end404.

The flow diverter300can be in a compressed state, also referred to herein as a constrained state, a delivery configuration, or as a constrained configuration as shown inFIG.3, or can be in an expanded state, also referred to herein as an unconstrained stated and/or unconstrained configuration as shown inFIG.4. In the constrained configuration, the flow diverter300can have a compressed outer diameter308, in other words, cannot the flow diverter300in the constrained configuration is not fully expanded and/or is constrained so as not to be able to fully expand. In some embodiments, the flow diverter300can be held in the constrained state when the flow diverter is contained and/or constrained within the introducer sheath120and/or in the catheter104. In some embodiments, the flow diverter can be sized to have a compressed outer diameter308that fits in the introducer sheath120and/or in the catheter.

In the unconstrained state, the flow diverter300can have an expanded outer diameter408. The expanded diameter408can be larger than the compressed outer diameter308. In some embodiments, the flow diverter300can be self-expanding such that when the flow diverter300exits the catheter104into a patient's blood vessel, the flow diverter300automatically expands to match the inner diameter of that blood vessel. In some embodiments, the flow diverter300can be made in a variety of sizes for use in blood vessels of different sizes. In some embodiments, the flow diverter300can have an expanded diameter408of 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, between 0.5 mm and 10 mm, between 1 mm and 8 mm, between 1.25 mm and 6.5 mm, above 4.25 mm, or any other or intermediate diameter or range of diameters.

In some embodiments, the flow diverter300can have an undeployed length and a deployed length. In some embodiments, when the flow diverter300is deployed, the length of the flow diverter300can change due to the foreshortening of the flow diverter300, which foreshortening can be related to the expansion of the flow diverter300. Thus, the flow diverter300will experience relatively more foreshortening as the amount of expansion of the flow diverter300increases. In some embodiments, the flow diverter300can have a fully expanded length of less than approximately one-half of its constrained length, of between approximately one-third and one fourth of its constrained length, or any other or intermediate fully expanded length. Thus, in some embodiments, the flow diverter and have a foreshortening ratio of greater than approximately 2, of between approximately 3 and approximately 4, or any other or intermediate foreshortening ratio.

In some embodiments, the flow diverter300can have a constrained length of greater than approximately 10 mm, greater than approximately 15 mm, greater approximately 20 mm, greater than approximately 25 mm, greater than approximately 30 mm, greater than approximately 35 mm, of between approximately 10 mm and approximately 400 mm, of between approximately 25 mm and approximately 240 mm, or any other or intermediate length. In some embodiments, the flow diverter can have a deployed length of, for example, between approximately 5 mm and approximately 60 mm.

The flow diverter can be deployed into a patient's blood vessel through use of the system100ofFIG.1. The deployment can involve use of deployment features118of the deployment wire110.

The flow diverter300can, in some embodiments, comprise a braided member. One embodiment of the braid of the flow diverter is depicted in450, shown in detail inFIG.5. As seen inFIG.5, the braided member can be made from a plurality of wires452, also referred to herein as strands452. These wires452can comprise a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, for example, the wires452can have a diameter of between approximately 0.0002 inches and approximately 0.01 inches, between approximately 0.0005 inches and approximately 0.005 inches, between approximately 0.0007 inches and approximately 0.002 inches, of approximately 0.0008 inches, of approximately 0.001 inches, of approximately 0.0012 inches, or any other or intermediate diameter.

In some embodiments, the wires452can comprise a variety of types and/or materials. In some embodiments, the wires452can comprise drawn filled tube (DFT). In some embodiments, the DFT can include an inner core and an outer tube. Each of the inner core and the outer tube can comprise a material, which can be a same material, or which can be different materials. 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 diverter300and the inner core can be radiopaque.

In some embodiments, for example, the inner core can comprise platinum and/or a platinum alloy that can include, for example, platinum and tungsten. In some embodiment, the platinum alloy can comprise, for example, approximately 28% platinum. In some embodiments, the outer tube can comprise an alloy such as, for example, stainless teel, nitinol, cobalt chromium alloy such as 35N LT alloy, or the like.

In some embodiments, the wires can be cold worked, and specifically can have a minimum cold work of at least 30%, of at least 60%, of approximately 60.8%, or any other or intermediate amount of cold work. In some embodiments, the wires452can have a tensile strength minimum of at least approximately 50,000 PSI, of at least approximately 100,000 PSI, of at least 200,000 PSI, of approximately 235,000 PSI, of approximately 250,000 PSI, or any other or intermediate tensile strength minimum.

The braid of the flow diverter300can include any desired number of strands. In some embodiments, the braid of the flow diverter300can include between approximately 10 strands and approximately 200 strands, between approximately 20 strands and approximately 150 strands, between approximately 40 strands and approximately 100 strands, approximately 64 strands, or any other or intermediate number of strands. As seen inFIG.5, the wires452can include wires452-A extending in a first direction and braided with wires452-B extending in a second direction. The wires452can be braided in any desired way including, for example, a 1 wire over 1 under 1 braid, a 1 wire over 2 under 2 braid as shown inFIG.5, or any other braid.

With reference now toFIG.6, a schematic illustration of a delivery system500is shown. The delivery system500can include a flow diverter300that can be held in a constrained configuration within a lumen502defined by an interior wall504of a catheter104or of an introducer sheath120.

The lumen502can comprise a variety of shapes and sizes. In some embodiments, the lumen502can comprise a cylindrical lumen, and specifically can have a circular cross section. The size of the lumen502can, in some embodiments, be defined by an internal diameter. In some embodiments, the lumen502can have an internal diameter of, 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 or intermediate value.

The deployment wire110can extend at least partially into both the flow diverter300and the lumen502of the catheter104or of the introducer sheath120. The deployment wire110, can include the core wire112which can extend into the lumen502of the catheter104and/or of the introducer sheath120, and the deployment features118, which are shown wholly within the lumen502of the catheter104and/or of the introducer sheath120.

In the embodiment shown inFIG.6, the deployment features118include a pusher505such as a pusher coil506wrapping around a portion of the core wire112, one or several friction bumps508. These one or several friction bumps can include, for example, a first friction bump508-A, a second friction bump508-B, and third friction bump508-C. In some embodiments, these one or several friction bumps508can comprises a plurality of friction bumps508can be distributed along a portion of the deployment wire110, and specifically can be distributed along a portion of the core wire112. In some embodiments, and as shown inFIG.6, the friction bumps508can be positioned inside of the flow channel406of the flow diverter300and can engage with the flow diverter300.

In some embodiments the number of friction bumps508in the deployment features118can vary based on the lengths of the flow diverter300being deployed by the deployment features118, including the friction bumps508. For example, as the length of the flow diverter300being deployed increases, the number of friction bumps508used in deploying the flow diverter300can increase. Thus, in an embodiment with a relatively shorter flow diverter300, a relatively smaller number of friction bumps508can be used. Similarly, in an embodiment with a relatively longer flow diverter300, a relatively larger number of friction bumps508can be included in the deployment features118. In some embodiments, this variation of the number of friction bumps508with respect to the length of the flow diverter300can affect the length of the core wire112with respect to flow diverter300, thereby leading to the termination of the core wire112within the flow channel406of the flow diverter300.

In some embodiments, and by terminating in the flow channel406of the flow diverter300, a portion of the flow diverter300distal to the termination of the deployment wire110can be trimmed without damaging the deployment wire110and/or the deployment features118of the deployment wire. In some embodiments, the deployment wire110can be sized and positioned relative to the flow diverter300such that the deployment wire110terminates in the proximal portion310of the flow diverter300. In such an embodiment, the termination of the deployment wire110in the proximal portion310of the flow diverter300allows trimming of the distal portion312of the flow diverter300without damaging the deployment wire110and specifically without damaging the deployment features118of the deployment wire110.

In some embodiments, the one or several friction bumps508can comprise a single friction bump. This single friction bump can, for example, extend from the pusher505to the position of the third friction bump508-C ofFIG.6. Thus, instead of having multiple friction bumps508across this length of the core wire112, and single friction bump508, also referred to herein as a friction pad can extend across all or portions of this length of the core wire112. In some embodiments, this single friction pad can extend beyond a proximal portion of the flow diverter300and into a distal portion of the flow diverter300.

In some embodiments, a single, long friction pad can provide for better engagement with the flow diverter300. However, embodiments with multiple, spaced-apart friction bumps can provide for improved flexibility of the core wire112. In some embodiments, the single, long friction pad can comprise the same material as the friction bumps508, and in some embodiments, the single, long friction pad can comprise a material configured to improve flexibility.

The deployment features118further include a support coil510, also referred to herein as a supporting coil510, wrapping around a portion of the core wire112, and particularly winding around the distal portions of the core wire112, which distal portions can be tapered. As seen inFIG.3, the supporting coil510can extend at least partially through the pusher coil506, and can extend along the core wire112between friction bumps508and distally beyond a final friction bump508, or as shown inFIG.3, beyond the third friction bump508-C. Specifically, and as seen inFIG.6, the support coil510can begin at a location between the proximal end514and the distal end516of the pusher505and/or of the pusher coil506, and can distally extend to a location distally beyond the final friction bump508. In such an embodiment, the support coil510can be intermediate between at least a portion of the pusher505and/or the pusher coil506and the core wire112. The deployment features118can also include an atraumatic tip512at a distal most end of the deployment wire110.

In some embodiments, for example, the deployment wire110and/or the core wire112can terminate within the flow diverter300when the flow diverter300is contained within the catheter104and/or the introducer sheath120. For example, in the embodiment depicted inFIG.6, the atraumatic tip512is located within the flow diverter300that is contained within the catheter104and/or the introducer sheath120, and thus the deployment wire110and/or the core wire112terminates within the flow diverter300that is contained within the catheter104and/or the introducer sheath120. In some embodiments, this can include the deployment wire110and/or the core wire112terminating at a location between the proximal end304and the distal end306of the flow diverter300, and specifically can include the deployment wire110and/or core wire112terminating in the proximal portion310of the flow diverter300.

In some embodiments, the deployment wire110and/or the core wire112can terminate within the flow diverter300when the flow diverter300is constrained, deployed, and/or partially deployed, for example, when the flow diverter300has a deployed diameter of at least approximately 2 mm, at least approximately 3 mm, at least approximately 4 mm, at least approximately 4.25 mm, at least approximately 5 mm, at least approximately 6 mm, or any other or intermediate deployed diameter. In some embodiments, the deployment wire110and/or the core wire112can terminate within the flow diverter300when the flow diverter300is constrained, deployed, and/or partially deployed when the flow diverter300has a constrained length of at least approximately 10 mm, of at least approximately 15 mm, of at least approximately 20 mm, of at least approximately 25 mm, of at least approximately 30 mm, of at least approximately 35 mm, or any other or intermediate length. In some embodiments, the deployment wire110and/or the core wire112can terminate within the flow diverter300when the flow diverter300is constrained, deployed, and/or partially deployed when the flow diverter300has at least one of a constrained length greater than approximately 25 mm of a deployed diameter of greater than approximately 4.25 mm.

In some embodiments, in which the deployment wire110and/or the core wire112does not extend distally beyond the distal end306of the flow diverter300, the deployment wire110and/or core wire112can be sized and/or positioned with respect to the flow diverter300in the constrained configuration such that the deployment wire110and/or the core wire112terminate in the proximal portion310including the proximal half of the flow diverter300, terminate in the proximal portion310including the most proximal third of the flow diverter300, terminate in the proximal portion310including the most proximal quarter of the flow diverter300, or terminate in any other or intermediate portion of the flow diverter300. In some embodiments, this termination location for the deployment wire110and/or the core wire112can be determined based on the foreshortening ratio of the flow diverter300.

In some embodiments, and as seen inFIG.6, the deployment wire110and/or the core wire112has a length and/or position relative to the length of the flow diverter300such that the deployment wire110and/or the core wire112, and specifically the distal end of the deployment wire110and/or the core wire112terminates within the flow diverter300when the flow diverter300is contained within the catheter104and/or the introducer sheath120.

In some embodiments, the portion of the support coil510extending distally beyond the final friction bump508can support the flow diverter300. Specifically, the portion of the support coil510extending distally beyond the final friction bump508can extend through at least a portion of the length of the flow diverter300and can, in some embodiments, strengthen those portions of the flow diverter300. Specifically, and in some embodiments, the portion of the support coil510extending distally beyond the final friction bump508can prevent the flow diverter from collapsing and/or buckling.

The deployment wire110, including the deployment features118can be configured for navigating a patient's vasculature, and specifically for navigating a patient's neurovasculature. Thus, in some embodiments, the deployment features118can be configured to facilitate and/or maintain flexibility of the core wire112, and specifically of the distal portion116of the core wire112.

The pusher coil506can be configured to apply a force to the flow diverter300when the deployment wire110is distally advanced into and/or through the catheter104and/or the introducer sheath120. The pusher coil506can comprise a coil formed by wire winding. The wire forming the wire winding can comprise a variety of materials and sizes. In some embodiments, the wire forming the pusher coil506can comprise a biocompatible wire such as a Nitinol wire. The wire forming the pusher coil506can comprise a diameter of, for example, between 0 and 0.01 inches, between 0 and 0.005 inches, between 0 and 0.002 inches, approximately 0.002 inches, or any other or intermediate diameter.

The pusher coil506can have an outer diameter that is sized to fit in the lumen502of the catheter104and/or of the introducer sheath120. In some embodiments, the pusher coil506can have a diameter that is less than the diameter of the lumen502of the catheter104and/or less than the inner diameter of the lumen of the introducer sheath120. The outer diameter of the pusher coil can be sized with respect to the diameter of the lumen502of the catheter104and/or of the introducer sheath120such that flow diverter300does not fit between pusher coil506and the interior wall504of the catheter104and/or of the introducer sheath120. In some embodiments in which the lumen502of the catheter104and/or of the introducer sheath120has an internal diameter of 0.017 inches, the pusher coil506can have an outer diameter of, for example, 0.015 inches. In some embodiments in which the lumen502of the catheter104and/or of the introducer sheath120has an internal diameter of 0.021 inches, the pusher coil506can have an outer diameter of, for example, 0.019 inches.

The pusher coil506can have a proximal end514and a distal end516. In some embodiments, one or both of the proximal end514and the distal end516of the pusher coil506can be configured to affix the pusher coil506to the deployment wire110. In some embodiments, one or both of the proximal end514and the distal end516of the pusher coil506can comprise solder affixing the pusher coil506to the deployment wire110, or in other words, the pusher coil506can be soldered to the deployment wire110. In some embodiments, the distal end516of the pusher coil506can be further configured to provide a bearing surface with which the pusher coil506can apply a force to the flow diverter300. In some embodiments, the bearing surface can be formed in the solder of the distal end516. In some embodiments, the distal end516of the pusher coil506can comprise a bumper portion configured to engage with the flow diverter300. The bumper portion can be convex to better engage with the flow diverter300. In some embodiments, the bumper portion can comprise a flattened tube.

The deployment features118can comprise one or several friction bumps508. In some embodiments, a friction bump is configured to press a portion of the flow diverter300into the interior wall504of the catheter104and/or the introducer sheath120when that portion of the flow diverter300in within the catheter104and/or the introducer sheath120. In some embodiments, the friction bump508can comprise a material that engages, and specifically that deformably engages, with the flow diverter300such that a friction force between the flow diverter300and the friction bump508is greater than a friction force between the flow diverter300and the interior wall504of the catheter104and/or introducer sheath120. Due to the comparatively greater friction force between the friction bump508and the flow diverter300, each friction bump508facilitates control of the flow diverter300, and specifically facilitates control of the position of the flow diverter300with respect to the catheter104and/or introducer sheath120. In some embodiments, the interaction between a friction bump508and the flow diverter300can enable the deployment wire110to deploy the flow diverter300from the catheter104and/or retract and/or partially retract a partially deployed flow diverter300back into the catheter104.

The friction bump508can comprise, for example, a deformable material such as an elastomer. In some embodiments, the friction bumps508can comprise a polymer that can encase a radiopaque element such as, for example, a platinum coil and/or platinum wire. In some embodiments, the friction bumps508can comprise a tungsten loader polymer or a tungsten loaded elastomer. In some embodiments, the friction bumps can comprise a UV glue, which can be, for example, doped with a radiopaque material such as, for example, tantalum powder. In some embodiments some or all of the friction bumps508can be radiopaque and/or include a radiopaque element. In some embodiments, the radiopaque element can comprise one or several radiopaque particles embedded in the friction bump508, and in some embodiments, and as shown inFIG.6, the friction bump can comprise a radiopaque coil509, which can comprise, for example, a piece of wire such as a coil of platinum wire.

In some embodiments in which the deployment wire110comprises a plurality of friction bumps508, the friction bumps508can be equally or unequally spaced. In some embodiments, the friction bumps508can be spaced apart so as to be separated by between 1 mm and 20 mm, by between 1 mm and 15 mm, by between 2 mm and 10 mm, by between 3 mm and 8 mm, by approximately 5 mm, or by any other or intermediate value.

In some embodiments, the deployment features118can include support coil510. Support coil510can prevent the core wire112from buckling when the core wire112is distally advancing the flow diverter300in the catheter104and/or in the introducer sheath120. For example, to increase the flexibility of the core wire112, the core wire112can taper at its distal portion116. This taper can increase the flexibility of the core wire112, but also decreases the strength of the core wire112. This decrease in strength of the core wire112can result in the core wire112buckling when the core wire112is used to distally advance the flow diverter300in the catheter103and/or in the introducer sheath120. The supporting coil510can extend along portions of the core wire112to prevent the core wire112from buckling. Thus, through the combination of the tapered core wire112and the support coil510, the deployment wire110can be flexible to navigate tortuous vasculature while also having sufficient strength to deploy the flow diverter300.

As seen inFIG.6, the support coil510can extend over portions of the core wire112, and specifically over all or portions of the distal portion116of the core wire112. As further seen inFIG.6, the support coil510can extend over the core wire112between the friction bumps508, and distally beyond the last friction bump508, or more specifically, distally beyond the third friction bump508-C.

The wire forming the support coil can comprise a diameter of, for example, between 0 and 0.01 inches, between 0 and 0.005 inches, between 0 and 0.002 inches, approximately 0.002 inches, or any other or intermediate diameter. In some embodiments, the wire forming the support coil510can have the same diameter as the wire forming the pusher coil506, and in some embodiments, the wire forming the support coil510can have a different diameter than the wire forming the pusher coil506. In some embodiments, the supporting coil510can have an outer diameter of, 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 or intermediate value.

The deployment wire110can extend distally beyond the friction bumps508, and in some embodiments, distally beyond the third friction bump508-C. The deployment wire110can terminate with an atraumatic tip512that can be located at the distal end of the deployment wire110. In some embodiments, the portion of the deployment wire110extending distally beyond the friction bump508can include a portion of the support coil510. The atraumatic tip512can be configured to not damage tissue it may be bumped into during the performing of a procedure, and specifically during the deploying of a flow diverter300in a patient's vasculature. The atraumatic tip512can be attached to the distal end of the core wire112and/or to the distal end of the support coil510. The atraumatic tip can have a diameter matching the outer diameter of the supporting coil510. In some embodiments, the atraumatic tip512can be spaced apart from the last friction bump508by between 1 mm and 20 mm, by between 1 mm and 15 mm, by between 2 mm and 10 mm, by between 3 mm and 8 mm, by approximately 5 mm, or by any other or intermediate value.

In some embodiments, the delivery system, and as shown inFIG.6, the delivery system500can include a retraction sleeve520. The retraction sleeve520can be coupled to the deployment wire110and can extend over a proximal portion522of the flow diverter300. In some embodiments, the retraction sleeve520can extend over the proximal portion522of the flow diverter300when the flow diverter300is contained within the introducer sheath120and/or the catheter104. In some embodiments, the retraction sleeve520can extend some or all of the length of the deployment features118, and thus can extend over some or all of the proximal portion522of the flow diverter300engaging with the deployment features118.

In some embodiments the retraction sleeve520can be positioned intermediate between the proximal portion522of the flow diverter300and the introducer sheath120and/or the catheter104and can thereby reduce friction between the proximal portion522of the flow diverter300and the introducer sheath120and/or the catheter104. In some embodiments, the retraction sleeve520can not only decrease friction between the proximal portion522of the flow diverter300and the introducer sheath120and/or the catheter104, but can also protect the proximal portion522of the flow diverter from damage that may arise from movement of the flow diverter300with respect to the introducer sheath120and/or the catheter104such as can occur during the deployment and/or retraction of the flow diverter300.

The retraction sleeve520can comprise a flexible polymer that can be coupled to the deployment wire110. In some embodiments, the retraction sleeve520can be coupled to the deployment wire110at a position distal of all or portions of the deployment features118, as shown inFIG.6. In some embodiments, the retraction sleeve520can comprise a heat-shrink polymer tube that can be positioned over the proximal portion522of the flow diverter300and over a portion of the deployment wire110distal of the flow diverter300. The retraction sleeve520can then be heat-shrunk around the flow diverter300to snugly fit around the flow diverter300.

The retraction sleeve520can further include one or more slits extending proximally from a distal end of the retraction sleeve520. The one or more slits separate the portion of the retraction sleeve520extending over the proximal portion522of the flow diverter300into a plurality of segments. For example, in an embodiment of the retraction sleeve520containing two slits, the retraction sleeve520can be divided into two pieces, which can be two equal halves. The one or more slits can allow the retraction sleeve520to open and separate from the flow diverter300as the flow diverter300is deployed. Thus, as seen inFIG.7, as the retraction sleeve520protrudes distally beyond the catheter104. As seen the retraction sleeve520extending distally beyond the catheter104has split and separated from the flow diverter300, allowing the flow diverter300to expand, and allowing the retraction of the retraction sleeve520into the catheter104upon full deployment of the flow diverter300.

With reference now toFIG.7, a schematic depiction of the delivery system500in a partially deployed configuration is shown. As seen inFIG.7, the catheter104containing the deployment wire110and the flow diverter300is in a blood vessel600. As further seen inFIG.7, the deployment wire110has been distally advanced, as indicated by arrow602, with respect to the catheter104, thereby partially deploying the flow diverter300. The combination of the friction bumps508and the pusher coil506engage with the flow diverter300to cause the flow diverter300to distally advance in and out of the catheter104when the deployment wire110is distally advanced. As the deployment wire110is distally advanced, the flow diverter300deploys from the catheter104and begins to expand. This distal advance continues until the flow diverter300is fully deployed. Alternatively, if the flow diverter300has not been fully deployed from the catheter104, and in the event that at least one of the friction bumps508is still within the catheter104and engaging with the flow diverter300, the flow diverter300can be retracted and/or partially retracted into the catheter104. In some embodiments, a successful deployment of a flow diverter300can be achieved by only distally advancing the deployment wire110, and in some embodiments, a successful deployment of the flow diverter300can be achieved by alternatingly distally advancing and proximally retracting the flow diverter300until a desired positioning and/or deployment is achieved.

With reference now toFIG.8, a schematic depiction of one embodiment of a dynamic delivery system800is shown. The system800can include a flow diverter300that can be held in a constrained state within the lumen502of the catheter104and/or of an introducer sheath120. In some embodiments, the flow diverter300can comprise an expandable, braided member that can define a flow channel406. In some embodiments, the flow diverter300can comprise a self-expanding braided member.

The flow diverter300can be positioned in a lumen502of the catheter104and/or of the introducer sheath120. In some embodiments, the flow diverter300can be positioned in a lumen502of the catheter104and/or of the introducer sheath120circumferentially between the interior wall504defining the lumen502of the catheter104and/or of the introducer sheath120and the expanding element, which can be a self-expanding element, discussed at greater length below.

The deployment wire110can extend at least partially into both the flow diverter300and the lumen502of the catheter104or of the introducer sheath120. The deployment wire110, can include the core wire112which can extend into the lumen502of the catheter104and/or of the introducer sheath120, and the deployment features118, which are shown wholly within the lumen502of the catheter104and/or of the introducer sheath120. The deployment features118are coupled to the flow diverter such that movement of the deployment wire110and/or of the core wire112with respect to the catheter104and/or the introducer sheath120likewise moves the flow diverter300relative to the catheter104and/or the introducer sheath120.

In some embodiments, and as depicted inFIG.8, the deployment wire110and the core wire112terminate within the flow channel of the flow diverter300, in other words, do not extend distally beyond the distal end of the flow diverter300. In some embodiments, the deployment wire110and/or the core wire112are sized and/or configured such that neither the deployment wire110nor the core wire112extends distally beyond the distal end306of the flow diverter300when the flow diverter300is in the constrained configuration, or in the unconstrained configuration after being deployed from the catheter104. Thus, the atraumatic tip512at the distal end of the deployment wire110is located within the flow diverter300and not distally beyond the distal end306of the flow diverter300.

The deployment features118include one or more friction bumps508, the supporting coil510, a pusher514, an expanding element802, a tip coil810, and an atraumatic tip512. The tip coil can be a flexible tip coil810. In some embodiments, the flexible tip coil810and/or the flexible tip coil810and the atraumatic tip512can facilitate in navigating the system800and/or the core wire112through the vasculature, and specifically through tortuous vasculature.

In some embodiments, some or all of these deployment features118engage with, or as shown inFIG.8, are engaged with the flow diverter300. The deployment features118are engage and/or can be engaged with the flow diverter300such that movement of the core wire112results in corresponding movement of the flow diverter300.

The expanding element802can comprise a self-expanding element802or a controlled expanding element. In some embodiments, the self-expanding element802can expand upon exiting the catheter104. In some embodiments, the controlled expanding element can expand when controlled to expand. The controlled expanding element can comprise, for example, a stent, a braid, a balloon, or the like. In some embodiments in which the expanding element802comprises a braided member, the thickness of the stands of the braid can be varied to achieve a desired effect. For example, the strands can be thicker to provide increased expansion force, or the stands can be thinner to provide increased flexibility. In some embodiments, the strands can comprise a variety of material including, for example, DFT, which can be, for example, radiopaque. In some embodiments, the strands can comprise a polymer such as a high tensile strength polymer. In some embodiments, a polymer used in the strands can advantageously increase friction between the expanding element802and the flow diverter300, thereby increasing the ability of the expanding element802to retract the flow diverter300. In embodiments in which the stands comprise a polymer, that polymer can be treated and/or doped to be radiopaque.

In some embodiments, the materials of the flow diverter300and/or the expanding element802can be selected to minimize a compressed diameter of the flow diverter300around the expanding element802. In some embodiments, for example, the selection and use of a high tensile strength material, such as a material having a tensile strength at or above 100 kpsi, 150 kpsi, 200 kpsi, 250 kpsi, or the like, the fully compressed expanding element802can have an outer diameter, for example, between approximately 0.005 inches and 0.035 inches, between approximately 0.01 inches and 0.015 inches, of approximately 0.013 inches, or any other or intermediate outer diameter. In such an embodiment, when the flow diverter300is axially positioned around and over the expanding element802, the combination of the expanding element802and the flow diverter300, both in a compressed state can have an outer diameter of between, for example, approximately 0.01 inches 0.04 inches, between approximately 0.015 inches and 0.035 inches, an outer diameter of approximately 0.017 inches, or any other or intermediate outer diameter. As used herein, “approximately” indicates values falling within: +/−5% of the associated value, +/−10% of the associated value, and/or +/−20% of the associated value. Thus, the combination of the flow diverter300and the expanding element802can fit in a catheter104having an inner diameter between, for example, approximately 0.01 inches and 0.04 inches, between approximately 0.015 inches and 0.035 inches, of approximately 0.017 inches, or any other or intermediate inner diameter.

In some embodiments, the controlled expanding element can include one or several features configured to enable control of the expansion of the controlled expanding element. These features can include one or several wires, catheters, rods, or the like. In some embodiments, the controlled expanding element can be expanded by bring axially compressing the controlled expanding element such that a proximal end of the controlled expanding element is brought closer to a distal end of the controlled expanding element. While the following discussion focuses on use of the self-expanding element802, it will be appreciated that the self-expanding element802can be replaced with the controlled expanding element.

As shown inFIG.8, the self-expanding element802comprises a proximal end804, also referred to herein as a first end804, and a distal end806, also referred to herein as a second end806. The proximal end804of the self-expanding element802can be coupled to the distal end113of the deployment wire110, and more specifically to the distal end113of the core wire112. The self-expanding element802can, as shown inFIG.8, distally extend from the proximal end804to the distal end806of the self-expanding element802.

The self-expanding element802can comprise a stent or a braided member. In some embodiments, the self-expanding element comprises a laser cut stent. The self-expanding element802can comprise a variety of shapes and sizes and can be made from a variety of materials. In some embodiments, the self-expanding element802can be made from Nitinol, a drawn filled tube which can comprise, for example, Nitinol, a cobalt chromium exterior and a platinum interior, a mixture of, for example, Nitinol and cobalt chromium, or the like. In some embodiments, the self-expanding element802can comprise a plurality of braided strands, at least some of which can be radiopaque.

The self-expanding element802can be configured to engage with the flow diverter300when the flow diverter is contained within the catheter104and/or in the introducer sheath120such that movement of the deployment wire110, and specifically of the core wire112, results in corresponding movement of the flow diverter300. When the self-expanding element802has deployed from the catheter104, the self-expanding element802expands to a fully expanded state, or to a maximum expanded state allowed by the blood vessel in which the self-expanding element802is contained. In some embodiments, the self-expanding element802can be distally advanced and/or proximally retracted through the flow diverter300.

In some embodiments, the expanding element802, such as the controlled expanding element or the self-expanding element802can generate radial forces which can expand the flow diverter300to a greater degree than would otherwise occur. For example, even if the flow diverter300is self-expanding, the expanding element802such as the controlled expanding element or the self-expanding element802may generate greater radial, expansive forces than generated by the flow diverter300. By moving the expanding element802through the flow diverter300, these greater radial, expansive forces generated by the expanding element802can be applied to the flow diverter300and can further expand the flow diverter300. This increased expansion can increase and/or improve the contact between the flow diverter300and the blood vessel600. In some embodiments, the use of an expanding element802such as the controlled expanding element or as the self-expanding element.

In some embodiments, the expanding element802, when unconstrained, can have a diameter greater than a diameter of the unconstrained flow diverter300, and in some embodiments, the expanding element802, when unconstrained, can have a diameter less than a diameter of the unconstrained flow diverter300. Thus, in some embodiments, and when unconstrained, the expanding element802can have a diameter greater than, or less than the diameter of the blood vessel600. In some embodiments, when deploying a flow diverter300, kinks, twists, compression, or bends can occur in the flow diverter300, which can prevent the expansion of the flow diverter300. In some embodiments, the expanding element802can straighten, remedy, and/or eliminate these kinks, twists, compression, or bends in the flow diverter300by expanding to a diameter less than the diameter of the blood vessel600. In such an embodiment, an expansion by the expanding element802of less than the diameter of the blood vessel600can straighten, remedy, and/or eliminate these kinks, twists, compression, or bends in the flow diverter300, which can result in the flow diverter300self-expanding to engage with the wall of the blood vessel600. In such an embodiment, while the expanding element802may not force the flow diverter300to expand to engage with the wall of the blood vessel, the expanding element802can force the flow diverter300to expand sufficiently to eliminate, straighten, and/or remedy these kinks, twists, compression, or bends in the flow diverter300such that the flow diverter300can self-expand to engage with the wall of the blood vessel600. Thus, in some embodiments, the expanding element802initiates expansion, which is then continued and completed by the flow diverter300.

Alternatively, in some embodiments, the diameter of the expanding element802can be such that the movement of the expanding element802through the deployed flow diverter300forces the deployed flow diverter300to expand to engage with the wall of the blood vessel600. In such an embodiment, the expanding element802can expand to a diameter that is equal to and/or greater than the diameter of the blood vessel600.

In some embodiments, the expansion of the expanding element802can result in the shortening of the expanding element802. This shortening can move the distal end113of the core wire112proximally. This can specifically move the atraumatic tip512proximally. This proximal movement of the distal end113of the core wire112and/or of the atraumatic tip512can decrease the distal extension of those portions of the core wire112into the blood vessel, thereby decreasing the risk of damage to the blood vessel.

The one or more friction bump508can be coupled to the deployment wire110, and specifically can be coupled to the core wire112and/or to the support coil510. In some embodiments, the one or more friction bumps508can be directly coupled to the deployment wire110and specifically to the core wire112, and in some embodiments, the one or more friction bumps508can be indirectly coupled to the deployment wire110and specifically to the core wire112via, for example, the self-expanding element. In some embodiments, the friction bumps508can be coupled directly to the support coil510. In some embodiments, the friction bump508can be soldered to the supporting coil510, which solder can infiltrate the supporting coil510can further couple the friction bump508to the core wire112.

In some embodiments, one or more friction bumps508can be located at one or both of the ends of the self-expanding element. Thus, in some embodiments, at least one of the friction bumps508is located at one of the proximal end804and the distal end806. In some embodiments, at least one of the friction bumps508is located at one of the proximal end804and the distal end806, and another of the friction bumps is located at the other of the proximal end804and the distal end806. As seen inFIG.8, the friction bumps508include a first friction bump508-A located at, adjacent to, and/or on the proximal end804of the self-expanding element802, and a second friction bump508-B located at, adjacent to, and/or on the distal end806of the self-expanding element802. In some embodiments, the friction bump508can extend across and/or over a portion of the self-expanding element802. In some embodiments, one or more of the friction bumps508can be radiopaque, and/or can include a radiopaque element such as a wire coil509. In some embodiments, the expanding element802, and/or one or both of the friction bumps508can facilitate in retracting a partially deployed flow diverter300wholly or partially into the catheter104. In some embodiments, the first friction bump508-A, due to its relatively most proximal position, can best facilitate retraction of the flow diverter300wholly or partially into the catheter104as compared to the relatively more distally located expanding element802and the second friction bump508-B.

In some embodiments, the first friction bump508-A can be coupled to the proximal end804of the expanding element802and/or to the distal end of the core wire112. In some embodiments, the first friction bump508-A can be coupled to supporting coil510. Specifically, in some embodiments, the first friction bump508-A can directly couple to the supporting coil510. In some embodiments, the first friction bump508-A can be soldered to the supporting coil510, which solder can infiltrate the supporting coil510and can further couple the first friction bump508-A to the core wire112and specifically to the distal end of the core wire112. In some embodiments, this solder can form all or portions of the first friction bump508-A.

In some embodiments, the second friction bump508-B can be coupled to the distal end806of the expanding element802and/or to the tip coil810. In some embodiments, the second friction bump508-B can be soldered to the distal end806of the expanding element802and/or to the tip coil810. In some embodiments, this solder can form all or portions of the second friction bump508-B.

The system can include a support coil510. The support coil510can extend around and/or along at least part of the distal portion116of the core wire112, including, along and/or around the distal end113of the core wire112. The support coil510can, in some embodiments, extend from a location proximal of the self-expanding element802to the self-expanding element802, and/or from a location proximal to the first friction bump508-A to the first friction bump508-A. In some embodiments, the support coil510can extend at least partially into the first friction bump508-A.

In some embodiments, the core wire112terminates at and/or in the first friction bump508-B. Thus, in some embodiments, the distal end806of the expanding element802does not directly couple to a distal end of the core wire112, but rather is indirectly coupled to the distal end of the core wire112via the proximal end804of the expanding element802. Thus, in some embodiments, the core wire112does not extend through the expanding element802. In some embodiments, this coupling of only the proximal end804of the expanding element802to the core wire112allows the expanding element802to shorten in connection with the radial expansion of the expanding element802. In some embodiments, the absence of the core wire112extending through the expanding element802increases the flexibility of the expanding element802.

In some embodiments in which the core wire112terminates at the proximal end804of the expanding element802, a coupling wire820can connect to the distal end806of the expanding element802, to the tip coil810, and/or to the atraumatic tip512. In some embodiments, the coupling wire820can be configured to prevent loss of distal portions of the deployment wire110in the event that, for example, the expanding element802, the tip coil810, and/or the atraumatic tip512break. In such an embodiment, the coupling wire820enables retraction of the distal portions of the deployment wire110from the patient.

In some embodiments, the coupling wire820can connect to the distal end of the core wire112, and in some embodiments, the coupling wire820can extend parallel and/or through the core wire112, and can, in some embodiments, be used as a pull wire to control expansion and/or to facilitate expansion of the expanding element802.

In some embodiments, the coupling wire820can be taught when the expanding element802is contained within the catheter104and/or in the introducer sheath120, and the coupling wire820can be slack when the expanding element802is deployed from the catheter104and/or is in the expanded configuration.

The system800can, in some embodiments, include a tip coil810, which can be a flexible tip coil810. The tip coil810can distally extend from the self-expanding element802, and specifically can distally extend from the distal end806of the self-expanding element802. The tip coil810can extend distally beyond the self-expanding element802and can terminate in an atraumatic tip512. The atraumatic tip512can, in some embodiments, be at the distal most point of the tip coil810. In some embodiments, the flexible tip coil810and/or the flexible tip coil810and the atraumatic tip512can facilitate in navigating the system800and/or the core wire112through the vasculature, and specifically through tortuous vasculature.

An embodiment of the deployment of the flow diverter with the system800is shown inFIG.8. The catheter104has been inserted into the vascular system and has been advanced to a location proximate to a treatment site812, which location can be at, near, or beyond the treatment site812. In some embodiments, the position of the catheter can be determined via imaging, such as via fluoroscopy.

As seen in that figure, the deployment wire110and the flow diverter300are distally advanced in the direction indicated by arrow814until the flow diverter300exits the catheter104. As the flow diverter300exits the catheter104, the flow diverter300can begin to expand and can begin to engage the interior of the blood vessel600. In some embodiments, the distal advance of the deployment wire110and the flow diverter300can continue until the flow diverter300is fully deployed. Alternatively, if the flow diverter300has not been fully deployed from the catheter104, the flow diverter300can be retracted and/or partially retracted into the catheter104. In some embodiments, the flow diverter300can be retracted and/or partially retracted into the catheter104until the proximal most of the friction bumps508and/or the self-expanding element802exits the catheter104. In some embodiments, the position of the flow diverter300, of the catheter104, of the friction bumps508and/or the self-expanding element802can be determined via imaging, and specifically via imaging of radiopaque elements and/or portions of the catheter104, of the friction bumps508, and/or the self-expanding element802. In some embodiments, and based on the results of this imaging, it can be determined if the flow diverter300can be retracted and/or partially retracted into the catheter104.

When the self-expanding element802exits the catheter104, the self-expanding element802expands and applies radially outward forces to the flow diverter300causing the flow diverter300to further expand. Alternatively, in the event that a controlled expanding element is being used, open exiting the catheter104, the controlled expanding element can be expanded.

The self-expanding element802can continue to be distally advanced relative to the catheter104until the flow diverter300is fully deployed. When the flow diverter300is fully deployed, the self-expanding element802can be distally advanced through the flow diverter300to fully and/or maximally expand the flow diverter300, at which point the self-expanding element802can be proximally retracted through the flow diverter300and then back into the catheter104. In some embodiments, the distal advance and the proximal retraction of the expanding element802through the flow diverter300can be repeated multiple times before retracting the expanding element802into the catheter104. In some embodiments, the repeated movement of the expanding element802through the deployed flow diverter300can facilitate in achieving full deployment of the flow diverter300, specifically in the event that all or portions of the flow diverter300have not fully deployed. This movement of the self-expanding element802, first distally and then proximally through the flow diverter300can increase the expansion of the flow diverter300and improve the connection between the flow diverter and the blood vessel600.

Once the self-expanding element802has been retracted into the catheter104, the catheter can be retracted and/or one or several additional flow diverters can be delivered to the treatment site.

As shown inFIG.8, a graphical depiction of an embodiment of delivering a flow diverter300, and specifically for delivery a flow diverter300into a blood vessel600to treat an aneurysm is shown. In some embodiments, the blood vessel can be a neurovascular blood vessel, or in other words, can be a blood vessel in or around the patient's brain. In some embodiments, the delivery of the flow diverter300into the blood vessel600can include the partial deployment of the flow diverter300from a catheter104, and/or the full or partial retraction of the flow diverter300into the catheter104. As used herein, a full retraction occurs when the flow diverter300is retracted until it is completely contained with the catheter104, and a partial retraction occurs when a portion of the flow diverter300remains exterior to the catheter104after retraction of the flow diverter300.

In some embodiments, the flow diverter can be fully or partially deployed subsequent to the retraction of the flow diverter300into the catheter104. In some embodiments, the flow diverter300can be partially deployed and retracted once, and in some embodiments, the flow diverter300can be repeatedly partially deployed and retracted into the catheter104.

In some embodiments, the flow diverter300can be retracted into the catheter104and removed from the blood vessel. In some embodiments, the flow diverter300can be replaced with another flow diverter300of a different size, such as, for example, a flow diverter having a larger or a smaller diameter. In some embodiments, the flow diverter300can be retracted and redeployed to improve expansion of the flow diverter300. In some embodiments, for example, a retracting and redeploying the flow diverter300can result in a more complete opening of the flow diverter300, and/or improved contact between all or portions of the flow diverter300and the blood vessel in which it is deployed.

In some embodiments, the flow diverter300can be retracted and/or redeployed to affect the portion of the blood vessel covered by the deployed flow diverter300. In some embodiments, for example, and by controlling a position and/or movement of both the catheter104and the core wire112during deployment, the coverage of the flow diverter300of the blood vessel in the treatment location can be affected. For example, and after a distal portion of the flow diverter300has engaged with the blood vessel, thereby coupling the flow diverter300to the blood vessel, the length of the deployed flow diverter can be affected by retracting the catheter104while deploying the flow diverter300. Specifically, the relative speed of the retraction of the catheter104with respect to the deployment of the flow diverter300can affect the length of the flow diverter300. For example, by retracting the catheter104relatively slowly with respect to the deployment of the flow diverter300, the length of the deployed flow diverter can be decreased. Alternatively, by retracting the catheter104relatively quickly with respect to the deployment of the flow diverter300, the flow diverter300can be stretched while being deployed and the length of the deployed flow diverter300can be increased.

In some embodiments, and by controlling the length of the deployed flow diverter300, the surgeon can affect the diameter of the deployed flow diverter300. 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 a flow diverter300is deployed into a blood vessel having a larger diameter, the surgeon may decrease the length of the deployed flow diverter to achieve the desired deployed diameter of the flow diverter300.

With reference now toFIG.9, a schematic depiction of a customizable delivery system900is shown. As seen inFIG.9, the deployment wire110and the flow diverter300are positioned at least partially within the introducer sheath120. As seen inFIG.9, in some embodiments, no portion of the deployment wire110extends distally beyond the distal end307of the flow diverter300. As further seen inFIG.9, in some embodiments, no portion of the deployment wire110extends distally beyond the distal end124of the introducer sheath120before the flow diverter300is customized.

As further seen inFIG.9, the deployment wire110including the tapered core wire112is coupled deployment features118, which, as shown inFIG.9, include the pusher505and the friction bump508as described in detail above. AlthoughFIGS.9through16depict embodiments with the friction bump508and/or the pusher505, these embodiments could include the deployment features118depicted inFIG.8, specifically, for example, the expanding element802and the friction bumps508-A,508-B.

The combination of the friction bump508and the pusher505engage with the flow diverter300to cause the flow diverter300to distally advance in and out of the catheter104when the deployment wire110is distally advanced. As the deployment wire110is distally advanced, the flow diverter300deploys from the catheter104and begins to expand. This distal advance continues until the flow diverter300is fully deployed. Alternatively, if the flow diverter300has not been fully deployed from the catheter104, and in the event that the friction bump508is still within the catheter104and engaging with the flow diverter300, the flow diverter300can be retracted and/or partially retracted into the catheter104. In some embodiments, a successful deployment of a flow diverter300can be achieved by only distally advancing the deployment wire110, and in some embodiments, a successful deployment of the flow diverter300can be achieved by alternatingly distally advancing and proximally retracting the flow diverter300until a desired positioning and/or deployment is achieved. According to system900as shown inFIG.9, the flow diverter300extends a first length902beyond the distal end124of the introducer sheath120.

The system900as shown inFIG.9further includes a customizing member901that can allow the customizing of the flow diverter300. The customizing member901can, in some embodiments, allow customizing of the flow diverter300before insertion of the flow diverter300into the catheter104.

The customizing member901can comprise an elongate tubular member having a proximal end and a distal end. In some embodiments, the elongate tubular member of the customizing member901comprises an interior wall defining a lumen. In some embodiments, the customizing member901can include one or several cuttable portions that allow cutting, and thereby customizing of the flow diverter300.

The customizing member901can include a proximal portion930and a distal portion932. In some embodiments, the proximal portion930can comprise a proximal half of the customizing member901and the distal portion932can comprise a distal half of the customizing member901. In some embodiments, the proximal portion930can comprise, approximately, the most proximal third of the customizing member901and the distal portion932can comprise the approximately two thirds of the customizing member901distal to the proximal portion930of the customizing member901. In some embodiments, the proximal portion930can comprise, approximately, the most proximal quarter of the customizing member901and the distal portion932can comprise the approximately three quarters of the customizing member901distal to the proximal portion930of the customizing member901.

In some embodiments, the customizing member901can include one or several components. The customizing member901can include the introducer sheath120. In some embodiments, the introducer sheath120can be cuttable to customize the flow diverter300. In some embodiments, the customizing member901can include the introducer sheath120coupled and/or coupleable to another feature which is cuttable for customization of the flow diverter300. In some embodiments, for example, the customizing member901can include a tubular member such as the introducer sheath120and a cuttable support which extends along and around the distal end124of the elongate tubular member (e.g., the introducer sheath120). In some embodiments, the cutable support can be a tubing904which extends along and around the distal end124of the elongate tubular member (e.g., the introducer sheath120). The tubing904may be a polymeric tubing attached to the distal end306of the flow diverter300. The tubing904preferably comprises a polymer tubing including heat shrinkable PTFE, Pebax, Polyolefin, FEP. In at least some embodiments, the tubing904is transparent, partially transparent, or opaque. For example, in at least some approaches, the flow diverter300is visible or partially visible within the tubing904.

In some embodiments, and as depicted inFIGS.9through17, the deployment features118and/or the deployment wire110do not distally extend into the tubing904, but rather terminate in the introducer sheath120. In some embodiments, the deployment features and/or the deployment wire110terminate in a proximal portion930of the customizing member901. Thus, in some embodiments, the deployment features terminate in the proximal portion310of the flow diverter300which proximal portion of the flow diverter300is contained in the introducer sheath120and not in the tubing904.

The tubing904extends a second length906beyond the distal end124of the introducer sheath120. As seen inFIG.9, the distal end306of the flow diverter300can be contained within the tubing904. The tubing904is preferably cuttable and configured to enable customization of the length of the flow diverter300via cutting of the tubing904and the therein contained flow diverter300. In at least some embodiments, the tubing is semi-rigid and peelable.

In at least some approaches, the first length902and the second length906are equal such that the flow diverter300and the tubing904distally extend the same length beyond the distal end124of the introducer sheath120. In other approaches, the second length906(e.g., the length the tubing904extends beyond the distal end124of the introducer sheath120) may be more or less than the first length902(e.g., the length the flow diverter300extends beyond the distal end124of the introducer sheath120). In at least some embodiments, the deployment wire110terminates before the distal end306of the flow diverter300such that the distal end of the deployment wire110does not extend into the tubing904. The deployment wire110does not extend distally beyond the distal end306of the flow diverter300.

In some embodiments, the flow diverter300is cuttable within the tubing904to a desired length. Specifically, in some embodiments, the combination of the dimensions and composition of the individual strands in the flow diverter300and the weave of the braid can make the flow diverter300cuttable. In some embodiments, this can include, for example, a weave of the braid that does not unravel when the flow diverter300is cut. The heat shrink tubing restrains the braid and maintains the braid in a constrained configuration. In various approaches, the braid has been heat treated to maintain its shape and tubular configuration.

Via cutting of the flow diverter300, the desired length of the flow diverter300may be customizable such that a physician tailors the length of the flow diverter300to match the specifications of the treatment site. For example, the physician may trim the flow diverter300within the tubing904to a desired length without compromising the delivery system900. The tubing904aids the flow diverter300trimming-on-demand process.

In at least some embodiments, the tubing904comprises graduation markings908equally spaced along a portion of the tubing904, and specifically along a distal portion910of the tubing904. In various embodiments, the flow diverter300may include graduation markings908equally spaced along a portion of the flow diverter300in a manner such that the graduation markings908are visible through the tubing904. The graduation markings908may be used as a ruler for guiding the cutting of the flow diverter300and/or the tubing904to the desired length.

The tubing904comprises a proximal end912and a distal end914opposite the proximal end912, a first longitudinal portion916have a first proximal pull tab918, and a second longitudinal portion920having a second proximal pull tab922. In some embodiments, the first longitudinal portion916is coupled to the second longitudinal portion920via a coupling portion, which coupling portion is relatively thinner than each of the first longitudinal portion916and the second longitudinal portion920. Each of the first longitudinal portion916and the second longitudinal portion920extend from the proximal end912of the tubing904. In various embodiments, the tubing904is peelably removable from the distal portion of the introducer sheath120by separating the first longitudinal portion916from the second longitudinal portion920, using the first proximal pull tab918and the second proximal pull tab922, in a manner which would be understood by one having ordinary skill in the art. Specifically, in some embodiments, the peeling of the tubing904from the introducer sheath can include the separating of the first longitudinal portion916from the second longitudinal portion920along the coupling portion.

As shown inFIG.10, the system900may be used to customize the length of the flow diverter300to a desired length1000. In at least some embodiments, a discarded section1002may be removed (e.g., cut) from the tubing904having the flow diverter300located within the tubing904. The graduation markings908may be used to measure the desired length1000and/or the discarded section1002to determine where a cut1004should be made. Referring now toFIG.11, the discarded section1002has been removed and the desired length1000remains.

As shown inFIG.12, the tubing904first longitudinal portion916having a first proximal pull tab918and second longitudinal portion920having a second proximal pull tab922can be peelably removed from the distal portion of the introducer sheath120by separating the first longitudinal portion916from the second longitudinal portion920, using the first proximal pull tab918and the second proximal pull tab922, in a manner which would be understood by one having ordinary skill in the art. For example, the first longitudinal portion916is pulled by the pull tab918in a first direction1200generally perpendicular to a longitudinal axis1202of the introducer sheath120. Similarly, the second longitudinal portion920is pulled by the pull tab922in a second direction1204generally perpendicular to a longitudinal axis1202of the introducer sheath120and opposite from the first direction1200.

In at least some embodiments, the desired length1000of the flow diverter300is retracted into the introducer sheath120such that the flow diverter300is substantially within the introducer sheath120, prior to or during the peelable removal of the tubing904. In some embodiments, the introducer sheath120has a length such that the entire flow diverter300can be retracted from the tubing904into the introducer sheath120whether the flow diverter300is trimmed or untrimmed. In some such embodiments, the introducer sheath120has a length greater than or equal to the length of the untrimmed flow diverter300. Thus, in some embodiments the combined length of the introducer sheath120with the attached tubing is longer than the untrimmed flow diverter. The flow diverter300can be retracted into the introducer sheath120via actuation of the deployment wire110and movement relative to the introducer sheath120, in a manner described in detail above. For example, retracting the flow diverter300into the introducer sheath120is performed by distally retracting the deployment wire110.

Pealably removing the tubing904includes separating the tubing904from the distal portion of the introducer sheath120. The tubing904may be separated from the distal portion of the introducer sheath120by peeling the tubing904from the distal portion of the introducer sheath120as described above where peeling the tubing904includes separating the first longitudinal portion916from the second longitudinal portion920, however, separating the tubing904from the distal portion of the introducer sheath120may be performed in other ways, such as, for example, only one pull tab is used to separate the tubing904. In some approaches, the tubing904is separated from the distal portion of the introducer sheath120after the flow diverter300is retracted into the introducer sheath.

Referring now toFIG.13, after the tubing904is peelably removed from the distal portion of the introducer sheath120and the desired length1000of the flow diverter300is retracted into the introducer sheath120, the remaining system1300may be loaded into the catheter system102, and specifically into the catheter104of the catheter system102via actuation of the deployment wire110as shown inFIG.14. The flow diverter300can then be delivered to a neurovascular vessel (e.g., blood vessel600). This can include moving a distal end132of the catheter system102proximate to a treatment location, for example, advancing the catheter system102proximal to a treatment location within a neurovascular blood vessel, advancing a core wire through the microcatheter, and deploying the flow diverter from the microcatheter and into the neurovascular blood vessel600to treat an aneurysm by advancing the pusher and the at least on friction bump via advancement of the core wire.

In some embodiments, the catheter system102can be positioned distal, and in some embodiments, just distal of the treatment location. In some embodiments, the distal advance of the deployment wire110with respect to the catheter system102can likewise cause the flow diverter300to distally advance with respect to the catheter system102. In some embodiments, the flow diverter300can be deployed by advancing the deployment wire110with respect to the catheter system102. In some embodiments, this advancing of the deployment wire110with respect to the catheter system102can include retracting the catheter system102in the blood vessel600while maintaining the position of the deployment wire110with respect to the blood vessel600, advancing the deployment wire110with respect to the blood vessel600while maintaining the position of the catheter system102with respect to the blood vessel600, or simultaneously retracting the catheter system102with respect to the blood vessel600while advancing the deployment wire110with respect to the blood vessel600.

In some embodiments, the flow diverter300expands and/or begins to expand as the flow diverter300exits the catheter system102. The flow diverter300can continue to be deployed via the further distal advance of the deployment wire110and thus of the flow diverter, and the flow diverter300can be fully deployed.

After the flow diverter300has been fully deployed, the deployment wire110can be distally retracted into the catheter system102, and the catheter can be retracted from the treatment location, and from the patient's vasculature. In some embodiments, one or several additional flow diverters300can be deployed to the treatment location. This can include placing an additional flow diverter on top of one or several previously deployed flow diverter300. Alternatively, one or several additional flow diverters300can be placed to be partially overlapping to increase the length of treated blood vessel600. In such an embodiment, a distal end of an additional flow diverter can be overlappingly placed over the proximal end or a previously placed flow diverter300.

In some embodiments, at least one of the pusher and the at least one friction bump is radiopaque. Delivery of the catheter system102may include imaging the at least one of the pusher and the at least one friction bump to determine a position of the flow diverter in the neurovascular blood vessel and a position of the pusher and/or the at least one friction bump with respect to the microcatheter.

In some embodiments, the flow diverter is retracted into the microcatheter when at least one of the at least one friction bump has not exited the microcatheter. In at least some aspects, the positioning of the microcatheter is adjusted with respect to the treatment location based on the imaging.

In various aspects, the flow diverter is loaded into the catheter system102. In some embodiments, loading the flow diverter into the microcatheter includes inserting an introducer sheath containing the flow diverter through an access device into the microcatheter, and advancing the deployment wire through the introducer sheath to advance the flow diverter from the introducer sheath into the microcatheter.

As shown inFIG.15, a second customizable flow diverter delivery system1500includes a template1502. The template1502comprises a top1504, a bottom1506, a front1508, a back1510, a first side1512, and a second side1514. The template1502includes graduation markings1516similar to graduation markings908shown at least inFIG.9. The graduation markings1516are configured to aid in cutting the flow diverter300to a desired length in a similar manner as described above. The graduation markings1516preferably correlate to a deployed length of the flow diverter300.

In some embodiments, the tubing904may comprise graduation markings such as those shown at least inFIG.9. The second customizable flow diverter delivery system1500depicts an alternative and/or supplemental approach to guiding a physician to cut the flow diverter300within the peelably removable tubing904to a desired length. In at least some approaches, graduation markings may be provided on both the tubing904and a template1502supplied with a flow diverter delivery system.

In various embodiments, the template1502includes a cutting aperture, slit, or notch1518extending through the bottom1506of the template1502. The cutting aperture, slit, or notch1518is proximate to one of the first side1512and the second side1514. The graduation markings1516may be positioned between the cutting aperture, slit, or notch1518and the other of the first side1512and the second side1514. For example, the graduation markings1516are positioned between the cutting aperture, slit, or notch1518and the first side1512. In another example, the graduation markings1516are positioned between the cutting aperture, slit, or notch1518and the second side1514, as shown inFIG.15.

In some embodiments, the template1502includes a first set of graduation markings along the bottom1506of the front1508of the template1502and a second set of graduation markings along the bottom1506of the back1510of the template1502. In one embodiment, one of the front1508of the template1502and the back1510of the template1502is configured for right-handed users and the other of the front1508of the template1502and the back1510of the template1502is configured for left-handed users.

In various embodiments, the template1502comprises a formula configured to aid in cutting the flow diverter300to the desired length, not shown. The formula may be printed along the top1504of the template1502. For example, the formula may be printed along the top portion of the template1502. In other examples, the formula may be centered on either the front1508and/or the back1510of the template1502. The formula may be printed anywhere along the template1502on either side. In a preferred embodiment, the formula and the graduation markings1516are printed on each of the front1508and the back1510of the template1502.

In at least one embodiment, the formula includes:

LT=LI-LD⁢RR=0.2⁢7⁢D+1.2

where:LT=Trimmed LengthLD=Deployed LengthLI=Insheath LengthR=RatioD=Implant Diameter

In one example, an implant diameter (D) is 4 mm, the desired deployed length (LD) is 25 mm, and the Insheath length (LI) is 80 mm.

To calculate:

R=0.2⁢7⁢(4)+1.2=2.28LT=80-25⁢(2.28)=23⁢mm

Therefore, in order to achieve a deployed length of 25 mm, an operator needs to trim off 23 mm.

As shown inFIG.16, the second customizable flow diverter delivery system1500includes a protective sleeve1600extending along and around a proximal end304of the flow diverter300, wherein the protective sleeve1600is configured to reduce friction and/or reduce damage to the flow diverter300when the flow diverter300is moved relative to the elongate tubular member (e.g., introducer sheath120). In various approaches, the protective sleeve1600extends beyond the proximal end304of the flow diverter300and/or the pusher505, as shown inFIG.16.

The protective sleeve1600may be a heat shrink plastic. In some embodiments, the protective sleeve1600can comprise a flexible polymer that is coupled to the deployment wire110. In some embodiments, the protective sleeve1600can be coupled to the deployment wire110at a position distal of all or portions of the deployment features (e.g., such as friction bump508, support coil510, etc.). In some embodiments, the protective sleeve1600can comprise a heat-shrink polymer tube that can be positioned over the proximal end304of the flow diverter300and over a portion of the deployment wire110distal of the flow diverter300. The protective sleeve1600can then be heat-shrunk around the flow diverter300to snugly fit around the flow diverter300. The protective sleeve1600is coupled to the pusher505and/or the core wire112.

The protective sleeve1600may further include one or move slits (not shown) extending proximally from a distal end of the protective sleeve1600. The one or more slits separate the portion of the protective sleeve1600extending over the proximal end304of the flow diverter300into a plurality of segments. For example, in an embodiment of the protective sleeve1600containing two slits, the protective sleeve1600can be divided into two pieces, which can be two equal halves. The one or more slits can allow the protective sleeve1600to open and separate from the flow diverter300as the flow diverter300is deployed. The protective sleeve1600may extend distally beyond the catheter104and split such that the protective sleeve1600separates from the flow diverter300, allowing the flow diverter300to expand, and allowing the retraction of the protective sleeve1600into the catheter104upon full deployment of the flow diverter300.

As shown inFIG.17, the second customizable flow diverter delivery system1500includes the customizing member901an expanding element1700wherein the expanding element1700is configured to reduce friction and/or reduce damage to the flow diverter300when the flow diverter300is moved relative to the elongate tubular member (e.g., introducer sheath120). The expanding element1700may be a self-expanding element or a controlled expanding element. In some embodiments, a self-expanding element can expand upon exiting the catheter104. In some embodiments, the controlled expanding element can expand when controlled to expand. The expanding element1700can comprise, for example, a stent, a braid, a balloon, or the like. In some embodiments in which the expanding element1700comprises a braided member, the thickness of the stands of the braid can be varied to achieve a desired effect. For example, the strands can be thicker to provide increased expansion force, or the stands can be thinner to provide increased flexibility. In some embodiments, the strands can comprise a variety of material including, for example, DFT, which can be, for example, radiopaque. In some embodiments, the strands can comprise a polymer such as a high tensile strength polymer. In some embodiments, a polymer used in the strands can advantageously increase friction between the expanding element1700and the flow diverter300, thereby increasing the ability of the expanding element1700to retract the flow diverter300. In embodiments in which the stands comprise a polymer, that polymer can be treated and/or doped to be radiopaque.

Referring now toFIG.18, a customizable flow diverter delivery system1800may be implemented without tubing. In such an embodiment, the customizing member901does not include distally attached cuttable tubing as shown in previous embodiments. In this alternative embodiment, the flow diverter300may extend a length1802beyond the distal end124of the introducer sheath120. As further seen, in such an embodiment, the deployment wire110terminates within the introducer sheath120such that the deployment wire110does not distally extend beyond the distal end124of the introducer sheath120. A physician may use a template (not shown) to measure and cut1804the flow diverter300to the desired length1806and the flow diverter300may be retracted into the introducer sheath120as described in detail above. In such an embodiment, and as discussed above with respect toFIGS.9through17. The introducer sheath120can have a length sufficient to receive the entirety of the flow diverter300, whether trimmed or untrimmed.

Referring now toFIG.19, a customizable flow delivery system1900includes a customizing member901including a cuttable introducer sheath1902. The cuttable introducer sheath1902includes an outer introducer sheath layer1904and an inner cuttable tubing1906surrounding the flow diverter300. In some approaches, the outer introducer sheath layer1904is rigid and the inner cuttable tubing1906is semi-rigid (e.g., similar to the tubing904described in detail above). In some embodiments, the outer introducer sheath layer1904has a length sufficient to receive the entirety of the flow diverter300, whether trimmed or untrimmed.

In various approaches, the introducer sheath1902(e.g., the outer introducer sheath layer1904) may be tapered distally. In other approaches, the introducer sheath1902is not tapered and includes a constant diameter throughout the length of the introducer sheath1902.

In one alternative embodiment, not shown, the introducer sheath1902is a unitary, cuttable feature. For example, the introducer sheath1902only comprises a relatively thin and rigid material in contrast to the embodiment including the outer introducer sheath layer1904and the inner cuttable tubing1906and as shown inFIG.19. In some embodiments, the unitary, cuttable introducer sheath1902is semi-rigid to allow cutting of the introducer sheath1902, but is sufficiently rigid to engage with the catheter hub106to allow transfer of the flow diverter300from the introducer sheath1902to the catheter104.

The outer introducer sheath layer1904defines an outer sheath layer lumen1908and the inner cuttable tubing1906defines an inner tubing lumen1910. A flow diverter (such as flow diverter300described in detail above) is contained within the inner tubing lumen1910in a constrained position, as shown inFIG.19.

In various embodiments, the system1900includes a deployment wire (such as deployment wire110described in detail above) extending into the inner tubing lumen1910and into the flow channel of the flow diverter300. As the deployment wire110is distally advanced, the flow diverter300deploys from the catheter104and begins to expand. This distal advance continues until the flow diverter300is fully deployed.

As shown inFIG.20, the inner cuttable tubing1906and the flow diverter300may be cut2002to a desired length2004according to any of the aspects described in detail above. As seen inFIGS.20through26, the deployment wire110and/or the deployment features118terminate proximally of the distal end of the flow diverter300, and specifically terminate proximally of the location at which the flow diverter300may be cut2002such that the cutting of the flow diverter300does not cut the deployment wire110and/or the deployment features118.

In some embodiments, the flow diverter300can be cut2002to the desired length2004. For example, the inner cuttable tubing1906may include graduation markings and/or be provided with a template having graduation markings for enabling a physician to determine and measure the desired length2004. The remaining portion2006may be discarded after performing the cut2002(e.g., after cutting the inner cuttable tubing1906and the flow diverter300) as depicted inFIG.21.

In some embodiments, as shown inFIG.22, after cutting the inner cuttable tubing1906and the flow diverter300, the outer introducer sheath layer1904may be advanced distally2200position the inner tubing within the outer sheath layer such that a distal end of the inner tubing is within the outer sheath layer lumen. In another embodiment, the outer introducer sheath layer1904may be advanced distally2200to align the distal end2202of the outer introducer sheath layer1904with the distal end2204of the inner cuttable tubing1906and/or the distal end2206of the flow diverter300. In another embodiment, the inner cuttable tubing1906and the flow diverter may be retracted into the outer introducer sheath layer1904. In yet another embodiment, the inner cuttable tubing1906and the flow diverter300are provided separately from outer introducer sheath layer1904and, after the cutting, the trimmed inner cuttable tubing1906and the flow diverter300are inserted into the outer introducer sheath1904, as illustrated in exemplaryFIGS.23-26.

In an alternative embodiment as shown inFIG.23, the customizing member901includes the inner cuttable tubing1906and the outer introducer sheath layer1904. In the embodiment ofFIG.23, the inner cuttable tubing1906and the flow diverter300are provided separately from outer introducer sheath layer1904. The inner cuttable tubing1906includes one or more locking elements2302. The one or more locking elements2302may be spaced around the circumference of the inner cuttable tubing1906. In one exemplary aspect, the inner cuttable tubing1906includes at least two locking elements2302located on opposite sides of the inner cuttable tubing1906, as shown.

In some aspects, the locking elements2302are located on the outer introducer sheath layer1904. The one or more locking elements2302may be spaced around the circumference of the outer introducer sheath layer1904. In one exemplary aspect, the outer introducer sheath layer1904includes at least two locking elements2302located on opposite sides of the outer introducer sheath layer1904.

In various embodiments, after cutting the inner cuttable tubing1906and the flow diverter300, the trimmed inner cuttable tubing1906and the flow diverter300are inserted into the outer introducer sheath1904and the locking elements2302are wedged between the outer introducer sheath layer1904and the inner cuttable tubing1906and are configured to lock the position of the outer introducer sheath layer1904relative to the inner cuttable tubing1906, as shown inFIG.24.

In another embodiment, the inner cuttable tubing1906and the flow diverter300are provided in the outer introducer sheath layer1904and the distal ends of the inner cuttable tubing1906and the flow diverter300extend beyond the distal end of the outer introducer sheath layer1904for cutting to a desired length. After cutting the inner cuttable tubing1906and the flow diverter300, the outer introducer sheath layer1904may be retracted such that the locking elements2302are wedged to the outer introducer sheath layer1904.

Alternatively, as shown inFIG.25, the inner cuttable tubing1906includes a flared end2502around the circumference of the proximal end2504of the inner cuttable tubing1906.

In various embodiments, the flared end2502is wedged between the inner cuttable tubing1906to the outer introducer sheath layer1904and is configured to lock the position of the outer introducer sheath layer1904relative to the inner cuttable tubing1906.

In various embodiments, after cutting the inner cuttable tubing1906and the flow diverter300, the trimmed inner cuttable tubing1906and the flow diverter300are inserted into the outer introducer sheath1904and the flared end2502is wedged between the outer introducer sheath layer1904and the inner cuttable tubing1906and are configured to lock the position of the outer introducer sheath layer1904relative to the inner cuttable tubing1906, as shown inFIG.26.

In another embodiment, the inner cuttable tubing1906and the flow diverter300are provided in the outer introducer sheath layer1904and the distal ends of the inner cuttable tubing1906and the flow diverter300extend beyond the distal end of the outer introducer sheath layer1904for cutting to a desired length. After cutting the inner cuttable tubing1906and the flow diverter300, the outer introducer sheath layer1904may be retracted over the flared end2502is wedged to the outer introducer sheath layer1904.

FIG.27is an illustration of one embodiment of packaging for a customizable flow diverter delivery system. In various embodiments, “packaging” may be interchangeably referred to as “housing” unless otherwise noted herein. System2700includes packaging2702which is primary packaging or packaging that is in direct contact with the flow diverter delivery device2704. Packaging2702may provide a backing for supporting the flow diverter delivery device2704during transportation, storage, or the like. For example, the packaging2702may include a packaging tray. In particular, the flow diverter delivery device2704may be removably coupled to the packaging2702via fastening members2706such as an adhesive, ties, clips, twists, or the like. The packaging2702may be formed of any material, including, but not limited to, paper, plastic, corrugated cardboard, glass, metal, wood, foam, etc., or any combination thereof. The fastening members2706may be integrally formed with the packaging2702and/or the fastening members2706may be separately formed and used with the packaging2702.

According to various embodiments, the flow diverter delivery device2704may include an elongate tubular member2708, such as an introducer, including any of the various embodiments described with respect to other figures. For example, the elongate tubular member2708is a cuttable introducer. The flow diverter delivery device2704may include a flow diverter2710at least partially contained within the lumen of the elongate tubular member2708in a constrained configuration. As shown inFIG.27, the flow diverter2710extends a first length L1beyond the distal end of the elongate tubular member2708. The flow diverter delivery device2704may include a deployment wire2712extending into the lumen of the elongate tubular member2708and movement of the deployment wire2712relative to the elongate tubular member2708moves the flow diverter2710relative to the elongate tubular member2708, as described in detail above.

The flow diverter delivery device2704may further include a peelable tubing2715extending along and around the distal portion of the elongate tubular member2708. The cuttable, peelable tubing2715may include a peelable FEP. In other embodiments, the cuttable, peelable tubing2715may include any polymer tubing material. In various embodiments, the tubing2715extends a second length L2beyond the distal end of the elongate tubular member2708. In an exemplary embodiment, the distal end of the flow diverter2710is within the tubing2715and the tubing2715is cuttable, as described in detail above. The tubing2715is peelably removable from the elongate tubular member2708.

As further shown inFIG.27, the packaging2702includes an integrated template2714. The template2714may include graduation markings2716. The graduation markings2716are configured to aid in cutting the flow diverter2710to a desired length. The template2714may correlate the graduation markings2716to a deployed length of the flow diverter2710. The graduation markings2716may be equally spaced according to various embodiments. For example, the graduation markings2716may be incremental increases along a scale. In other embodiments, the graduation markings2716are not equally spaced. For example, various lengths may be predetermined and marked on the template214. The template2714may be directly printed on the packaging2702in some embodiments. In other embodiments, the template2714is a sticker or insert that is coupled to the packaging2702in a manner known in the art. The packaging2702may further include an alignment member2718disposed below the graduation markings2716. The alignment member2718may be a clear tube, lumen, etc., for aligning the flow diverter delivery device2704relative to the graduation markings2716, e.g., to ensure that the flow diverter delivery device2704is straight and parallel to the graduation markings2716for accurately determining a desired length of the flow diverter2710. The inset ofFIG.27highlights the position of the alignment member2718relative to the graduation markings2716and the cutting aperture, slit, or notch2720.

In various embodiments, the alignment member2718may include a frictional surface that engages with the flow diverter delivery device2704for holding the flow diverter delivery device2704in place during the cutting. Furthermore, the alignment member2718frictionally engages with the flow diverter delivery device2704for preventing the health care professional for unintentionally pulling out the flow diverter delivery device2704too far and too fast (e.g., beyond the desired length).

According to at least some embodiments, the template2714including graduation markings2716may not be a physical template. For example, the template2714may be projected onto, or otherwise optically provided, the packaging2702or a component thereof. The template2714may be visible to a health care professional via a microscope, a mobile phone, or other imaging device to aid in cutting the flow diverter2710to a variable length.

The packaging2702including the template2714may further include a cutting aperture, slit, or notch2720extending through the packaging2702. The cutting aperture, slit, or notch2720may be disposed proximally of the graduation markings2716. In various embodiments, the cutting aperture, slit, or notch2720is slot for a pair of scissors, a blade, trimmers, clippers, snips, or other cutting tool, to be inserted into for cutting the flow diverter delivery device2704. In at least some embodiments, the cutting aperture, slit, or notch2720is sized and shaped for ensuring alignment of the scissors within the cutting aperture, slit, or notch2720and accuracy of the cut relative to the graduation markings2716. For example, the cutting aperture, slit, or notch2720is sized and shaped such that the scissors do not laterally translate (e.g., thereby varying the length of the flow diverter delivery device2704) once inserted into the cutting aperture, slit, or notch2720. Said another way, the width of the cutting aperture, slit, or notch2720constrains a cutting tool to aid in cutting the flow diverter at a desired location and/or at a desired angle. For example, according to various embodiments, a health care professional may cut the flow diverter at a right angle (e.g., perpendicular) to an axis of the flow diverter. In other embodiments, a 45 degree angle may be desired.

In some embodiments, the packaging2702may further include an opening2722for retraction and advancement of the flow diverter delivery device2704relative to the graduation markings2716. The opening2722may be a pinch opening for a health care professional to pinch through and laterally translate the flow diverter delivery device2704relative to the template2714and the graduation markings2716. Once aligned, the health care professional may pinch and hold the flow diverter delivery device2704through the opening2722to maintain the position of the flow diverter delivery device2704during the cutting. In exemplary embodiments, the opening2722is disposed proximally of the cutting aperture, slit, or notch2720such that the cutting aperture, slit, or notch2720is disposed between the opening2722and the alignment member2718and/or the graduation markings2716.

The packaging2702may further include a pair of scissors2724(or any cutting tool) for performing the cutting. Accordingly, the cutting aperture, slit, or notch2720may be sized and shaped to accommodate the scissors2724provided with the flow diverter delivery device2704for ensuring accuracy of the cutting.

In various embodiments, the packaging2702may include a torquer2726and/or various other components for use with the flow diverter delivery device2704. The packaging2702may include more or less components than those shown herein, as would be appreciated by one having ordinary skill in the art upon reading the present disclosure.

FIGS.28-30illustrate various embodiments of packaging for a customizable flow diverter delivery system.FIGS.28-30illustrate alternative configurations having additional openings, such as opening2804and opening3004, that provide additional handles for handling the packaging2702. Elements may have similar form and function unless otherwise noted herein. Accordingly, elements having similar form and function may be similarly numbered throughoutFIGS.28-30.FIG.28illustrates packaging2802having an exemplary alternative cutting aperture, slit, or notch2806that extends through a bottom edge of the packaging2802.FIG.29illustrates a simplified embodiment of packaging2902that does not include any openings and a cutting aperture, slit, or notch2904that extends through a bottom edge of the packaging2902.FIG.30illustrates packaging3002including an additional opening3004and a flap3006for covering the sharp ends of the scissors2724.FIG.30further includes an exemplary alternative cutting aperture, slit, or notch3008that extends through a bottom edge of the packaging3002.

FIG.31is a flowchart of a method of customizing a flow diverter delivery system. Method3100includes various embodiments for customizing a flow diverter for delivery into a neurovascular blood vessel to treat an aneurysm. Method3100includes providing a flow diverter system including any of the embodiments described in detail above. In particular, method3100includes using flow diverter system including packaging as described with respect toFIGS.27-30. Method3100includes step3102. Step3102includes determining a desired length of a flow diverter of a flow diverter system using the template for customizing the flow diverter. Advantageously, the health care professional is able to determine the desired length and customize the device to the desired length prior to inserting the device. In various embodiments, the template correlates the graduation markings to a deployed length of the flow diverter. Various embodiments of method3100describe a housing for the flow diverter system which may refer to any of the packaging embodiments described with respect toFIGS.27-30.

Step3104includes advancing or retracting the tubing relative to the housing to align the flow diverter to the template. Advancing or retracting the tubing relative to the template may include positioning the flow diverter relative to graduation markings equally spaced along the template. The graduation markings are configured to aid in cutting the flow diverter to the desired length. Step3104may further include positioning the tubing within an alignment member disposed below the graduation markings for guiding the flow diverter relative to the graduation markings and holding the flow diverter stationary during cutting. An opening disposed at a proximate end of the graduation markings in the housing may be used to advance or retract the tubing relative to the template.

Step3106includes, using a cutting aperture, slit, or notch disposed within the housing, cutting the tubing and the flow diverter such that the flow diverter is cut to the desired length. In various embodiments, the cutting aperture, slit, or notch is positioned between the opening and the graduation markings. Cutting the flow diverter such that the flow diverter is the desired length may include cutting the tubing provided with the flow diverter system. Cutting may further include using a cutting tool, such as provided scissors, to cut the flow diverter at a desired location and/or a desired angle via a cutting aperture, slit, or notch extending through the housing.

Step3108includes retracting the flow diverter into the elongate tubular member or advancing the elongate tubular member over the flow diverter. The flow diverter may be fully retracted into the elongate tubular member following the cutting. According to various embodiments, the flow diverter is retracted into the elongate tubular member by distally retracting a deployment wire coupled to the flow diverter. In various embodiments, method3100may include step3110including moving the deployment wire relative to the elongate tubular member such that the flow diverter moves relative to the elongate tubular member. Advancing the elongate tubular member over the flow diverter may include holding the deployment wire stationary while advancing the elongate tubular member.

In various embodiments, method3100may further step3112including separating the tubing from the distal portion of the elongate tubular member. For example, the tubing may be separated from the distal portion of the elongate tubular member after the flow diverter is retracted into the elongate tubular member. The tubing may be separated from the distal portion of the elongate tubular member by peeling the tubing from the distal portion of the elongate tubular member according to various embodiments described herein. Method3100may proceed with loading the flow diverter within the elongate tubular member into an microcatheter or the like for insertion into vasculature of a patient, as would be appreciated by one having ordinary skill in the art upon reading the present disclosure.

FIGS.32A-32Eillustrate exemplary process steps for customizing a flow diverter using a flow diverter delivery system as described herein. According to various embodiments, a health care professional may inject contrast into vasculature of a patient to perform fluoroscopic road mapping in order to measure and estimate the diameter of the target vessel and/or the neck width of the aneurysm. Accordingly, a desired length of a flow diverter may be determined.

FIG.32Aillustrates preparation of a customizable flow diverter according to embodiments of the present disclosure.FIG.32Aillustrates at least embodiments of step3104of method3100described with respect toFIG.31. In particular,FIG.32Aillustrates the device3202positioned within an opening3204. The device3202may be translated3206such that a distal end of the device3202is aligned3208with the template3211and a graduation marking corresponding to a desired length of the deployed flow diverter. For example, the device3202illustrated inFIG.32Awill have a final deployed length of 30 mm. In some embodiments, at least a portion of the device3202is positioned within an alignment member3203for maintaining the device3202in a straight configuration and parallel to the template3211for accurate measuring, etc. A health care professional may align the device3202and pinch the device3202through the opening3204for proceeding to the cutting3210illustrated inFIG.32B.

FIG.32Billustrates cutting3210the device3202to the desired length by inserting the scissors3212through a cutting aperture, slit, or notch3214, as described in detail above.FIG.32Billustrates at least embodiments of step3106of method3100described with respect toFIG.31.

FIG.32Cillustrates the device3202removed from the packaging such that the sheath3216is exposed. A health care professional should inspect the device3202and the sheath3216for any damage. The device3202is retracted into the sheath3216by advancing the sheath3216forward3220while holding the deployment wire3218in place. The sheath3216may be advanced forward3220until the device3202is fully retracted into the sheath3216.FIG.32Cillustrates at least embodiments of step3108of method3100described with respect toFIG.31.

FIG.32Dillustrates removing the peelable tubing3222from the sheath3216having the device3202retracted therein by pulling on one or more tabs3224.FIG.32Eillustrates inserting the sheath3216having the device3202retracted therein into a rotating hemostasis valve (RHV)3226. A distal tip of the sheath3216may be seated at the distal end of a microcatheter hub (not shown) and the RHV3226may be closed around the sheath3216to secure the RHV3226to the sheath3216. The device3202may then be advanced until the device3202is fully inserted into the microcatheter and the sheath3216may be removed, according to at least some embodiments. Further embodiments of deploying the device3202may include any of the embodiments described in the present disclosure.

Various embodiments of the present disclosure advantageously reduce the number of sizes (e.g., reduces the inventory) a health care provider has to maintain in stock. For example, instead of carrying a plurality of flow diverters lengths for each diameter, a health care provider is able to provide 26 variations of length and diameter by stocking only 3 sizes customizable flow diverter delivery systems as described herein and illustrated by Table 1 below. Said another way, a health care provider must maintain, track, and store 26 different products as opposed to 3 different products. Accordingly, embodiments of the customizable technology described herein provide the longest length (that is customizable to a desired shorter length) for each desired diameter, thereby reducing the number of SKUs in an inventory by 75% (from 158 SKUs to 26 SKUs, as shown in Table 1 below).

TABLE 1Size Offering Matrix for Customizable Flow DivertersUncontraintVesselDiameterDiameterLength (mm)(mm)(mm)101214162025303540Catheter ID (inch)2.252.00●●●●●0.0170.021/2.502.25●●●●●●0.0170.021/2.752.50●●●●●●0.0170.021/3.002.75●●●●●●0.0170.021/3.253.00●●●●●●0.0170.021/3.503.25●●●●●●0.0170.021/3.753.50●●●●●●0.0170.021/4.003.75●●●●●●0.0170.021/4.254.00●●●●●●0.0170.021/4.504.25●●●●●●●/0.021/4.754.50●●●●●●●/0.021/5.004.75●●●●●●●/0.021/5.255.00●●●●●●●/0.021/5.505.25●●●●●●//0.0275.755.50●●●●●●//0.0276.005.75●●●●●●//0.0276.256.00●●●●●●//0.027

In the foregoing specification, the invention is described with reference to specific embodiments thereof, but those skilled in the art will recognize that the invention is not limited thereto. Various features and aspects of the above-described invention can be used individually or jointly. Further, 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. The specification and drawings are, accordingly, to 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 read as open-ended terms of art.