Directable intravascular devices and methods - Patents.com

Abstract

This problem is solved by an intravascular stent that includes a stent body and at least one cover that covers a first portion of the stent body, the cover having a first region that is attached to the stent body and a second region that is not attached to the stent body. It is also possible to attach multiple covers in a stacked manner, and each cover has a free end that is not attached. This free end prevents the stiffness of the stent from increasing.

Description

[Technical field]

[0001] The present disclosure relates to medical devices used to treat vascular lesions (e.g., aneurysms, fistulas, ruptures, etc.) in intracranial or other tortuous vasculatures. In certain aspects, for example, the present disclosure relates to intravascular devices configured to deploy stents (e.g., flow bifurcation stents, covered stents, capped stents, palisade stents, bifurcated stents, variable porosity stents, etc.) to treat such vascular lesions. [Background technology]

[0002] The prior art teaches the use of a number of devices to treat vascular lesions. One such device is a differentially porosity (variable porosity) stent that includes asymmetric braids or coils to create areas of low or high blood flow as desired. Palisade and bifurcated devices have been used effectively in the aorta and its immediate sub-bifurcations, as well as in larger vessels with few tortuous vessels. The prior art has disclosed theoretical applications of such devices in intracranial and other tortuous distal vasculature, but has not described devices or methods that would allow such devices to be reliably positioned in a desired (rotational) orientation. The constraints of intracranial and other tortuous vasculature have prevented their use in these areas to date.

[0003] U.S. Patent No. 9,775,730 (Walzman) teaches a covered stent device that can be safely and effectively delivered and deployed in tortuous blood vessels to effectively divert blood flow from vascular abnormalities while allowing blood flow to healthy tissue distal to the target treatment area, yet still result in blood stasis and thrombus formation within aneurysms, fistulas, etc.

[0004] U.S. Patent Publ. No. 2019 / 0151072 Al (Walzman) teaches a capped stent that provides a cover with a single attachment point and overlappable free ends, thereby improving conformance to the target vessel over existing covered stents. U.S. Patent No. B2 (Berez et al.) teaches a vascular occlusion device 30 deployable on a microcatheter. The occlusion device includes an asymmetric braid or lattice density differential and corresponding / opposite variable porosity density to modify blood flow within the vessel while maintaining flow to the surrounding tissue. However, Dr. Berez et al. have not devised a method to consistently and reliably position such an intravascular placement device in an optimal radial orientation, and no such intravascular placement device exists.

[0005] This, combined with complete coverage on or near the opposing side, can completely block blood flow to the target aneurysm or fistula.Such endoleaks can be ameliorated in a number of ways.

[0006] As a common vascular disorder, it is the most common complication after endovascular aneurysm repair (EVAR) using a stent graft. In fact, it is the most common complication after endovascular aneurysm repair (EVAR) using a stent graft. Such endoleaks can be ameliorated in a number of ways. For example, Utility Model Nos. 15 / 732,147 and 15 / 732,365 to Walzman teach the use of hydrogels to prevent endoleaks.

[0007] The prior art also teaches endovascular coiling as a minimally invasive technique performed to prevent blood flow into some saccular aneurysms. This treatment prevents blood from flowing into the aneurysm as a result of the coil inducing embolism (clotting) of the aneurysm, thus preventing rupture and subsequent subarachnoid hemorrhage. However, endovascular coiling can lead to complications such as thromboembolism, cerebral embolism, aneurysm perforation, parent artery occlusion, coil migration, and arterial dissection. The prior art also teaches stent-assisted coiling. Stent-assisted coiling suffers from some of the same disadvantages associated with stent placement, and stenting the parent artery requires the long-term use of antiplatelet medication to reduce the risk of stenosis due to thrombosis in the stent.

[0008] The stent most directly covers the neck of the fistula or aneurysm, reconstructing the vessel wall and immediately redirecting blood flow to the normal path of the parent vessel. However, there are currently no covered nerve stents available in the United States. Although the U.S. Food and Drug Administration (FDA) has investigated and tested such nerve stents, none have been "FDA approved," meaning that the FDA has not determined that the benefits over existing treatment options outweigh the potential risks for the item's intended use. Furthermore, there are currently no covered stents that are effective for severely tortuous anatomies in other parts of the body, including but not limited to splenic artery aneurysms and pulmonary arteriovenous fistulas.

[0009] In particular, for carotid-cavernous fistulas (CCFs), which are abnormal connections between the cavernous sinus and the carotid arterial system.

[0010] Alternative treatments for aneurysms include surgical clipping of intracranial aneurysms, which involves clamping the neck of the aneurysm with a clip. This treatment has several drawbacks, including the need for craniotomy and physical manipulation of the brain. Surgical bypass may also be considered, but is usually associated with greater morbidity and mortality.

[0011] Additionally, the prior art teaches the use of flow diverters to divert flow away from an aneurysm by placing a mesh stent or stent-like structure along the parent artery at the aneurysm neck. The use of these devices allows for the formation of a thrombus within the aneurysm. However, technical complications may increase after deployment of the flow diverter.

[0012] Furthermore, they are not effective in treating fistulas or ruptured vessels because they do not completely block flow. Similarly, there is currently no effective vessel-sparing treatment for ectopic rupture of intracranial arteries. Current treatments require occlusion of the ruptured artery with coils and / or liquid embolic agents to stop bleeding, but they usually result in significant morbidity due to ischemic damage to that arterial territory. Furthermore, when treating aneurysms with these devices, the aneurysm thrombus over time. This leaves the patient at risk for aneurysm rupture during the lag period. This is particularly problematic when treating ruptured aneurysms with high short-term re-rupture rates. Furthermore, when using current branched stents, many branch vessels are often crossed by the stent, often resulting in stenosis at the origin of these branches, and sometimes occlusion and / or injury. Summary of the Invention [Problem to be solved by the invention]

[0013] A need exists for an endovascular device capable of endovascular intervention for immediate healing of selected endovascular aneurysms or fistulas while ameliorating the difficulties and shortcomings associated with currently available technology, and more particularly, a need exists for a covered stent that allows the stent to move freely and bend without kinking around tight bends in tortuous anatomical structures.

[0014] Most covered stents are constructed by fabricating a cylinder of the stent "skeleton" or "frame" from a semi-rigid material such as a metal alloy, and then attaching an impermeable "cover" to the frame. The prior art teaches that such attachments are diffusely distributed throughout the stent covering and along fixed intervals between the covering and frame, severely limiting the flexibility of the device.

[0015] All currently available flow shunt stents have a relatively uniform pattern of coverage and porosity throughout. A reliable means of successfully deploying a device with differential porosity along different radial segments circumferentially has not been developed.

[0016] In neuroendovascular procedures (and other tortuous vascular anatomies), there are no known devices or methods for precisely positioning such devices of different porosity to achieve the ideal ratio of coverage to porosity at the desired locations and allow flow at the desired locations. Unlike larger vasculature (e.g., the aorta), devices placed through intracranial or other tortuous circulatory anatomies are not susceptible to manual rotation at the hub end, which has the effect of rotating the intracranial end.

[0017] Thus, there is a need for a device that can be reproducibly positioned / landed in the proper orientation such that an area of ​​high density coverage and corresponding low porosity (in one extreme, complete impermeability, or in another extreme, palisades) is deployed on the desired side, while a low density coverage and corresponding high porosity (and / or in one extreme, palisades with no coverage at all) is deployed on the desired side. Furthermore, distal tortuous vasculature requires a branched coverage and diversion device. Currently, such a device is not available for use in neuroendovascular procedures, nor in other tortuous vascular anatomies.

[0018] Similarly, more effective bifurcated stent structures are needed in the heart, peripheral, and other vascular systems to minimize side branch occlusion during various stenting procedures. The systems and methods described herein facilitate precise positioning of palisades in multiple stent configurations to minimize the risk of branch occlusion and facilitate more effective placement of stents across the branches. These constructs can effectively treat atherosclerotic stenosis, aneurysmal disease, dissections, fistulas, and other conditions.

[0019] Thus, when such a device is deployed, the final orientation during positioning is random. For example, in the case just described, the opposite of ideal may occur; a palisade vessel may overlie the aneurysm, increasing flow to the lesion, while a dense coverage area may overlie the origin of a normal branch vessel, resulting in a lack of flow to that branch vessel and resulting in ischemic injury. This device can easily function in short, straight anatomy where the catheter can be easily and precisely rotated over its entire length from the proximal hub.

[0020] Again, using the extreme example of a palisade device, a branched device can be constructed in vivo by deploying a palisade device on the origin of a branch and another device from the palisade device on the branch. The second device can be slightly larger in diameter proximal to the palisade to allow for a slight overlap without covering the primary distal branch / vessel. Similarly, a device can be made that includes multiple branches through multiple palisades, provided all palisades are at the appropriate relative distance and orientation to the native branch.

[0021] This concept is elegantly described by Ruiz in U.S. Patent No. 6,261,279 (patent pending). In U.S. Patent No. 6,261,273Bl, "Access System [and] Method of Use for Branched Vessels," Ruiz describes the construction of a directional sheath or catheter in vivo, rather than an implant. However, like the Berez device, the Ruiz device can easily function in linear anatomy over short distances, where the catheter can be easily and precisely rotated over its entire length from its proximal hub.

[0022] In tortuous and / or long vascular anatomy, where the catheter does not respond in a similarly predictable manner, rotation is ineffective for positioning. This creates difficulties when a stent device, which is typically crimped for delivery, is advanced into a delivery catheter in a specific configuration, typically with a delivery wire and / or hypotube. The stent will exit the delivery catheter in an unpredictable configuration and orientation.

[0023] Furthermore, "Y" stents have heretofore not been practical to deploy or assemble at bifurcations in intracranial or other tortuous vascular anatomies. A need exists for Y, bifurcated, and other bifurcated stent devices that can be effectively deployed or assembled in such anatomies. Furthermore, there is a need for novel devices and methods to more accurately land the proximal ends of such stent devices in order to safely and precisely deploy such bifurcations with minimal palisade and consistent overlap.

[0024] Thus, a need exists for a covered or partially covered neural stent that can be used in intracranial or other tortuous extracerebral anatomies, where the high and low porosity regions of the stent device can be positioned as desired relative to one or more branch vessels and at least one aneurysm or fistula, respectively. Additionally, a need exists for similarly covered or partially covered branch devices. The present disclosure fulfills these unmet needs.

[0025] There is also a need for palisaded and variable covered and variable porosity stents, where the palisading and areas of reduced porosity around the circumference of the device can be precisely positioned in any anatomical structure, which can be used in vascular applications as well as vascular and non-vascular endoscopic applications. [overview]

[0026] Disclosed herein are methods and devices that facilitate correct orientation of an occlusion device 15 (e.g., in an intracranial context), such as a stent having differential porosity, with respect to desired regions of high or low blood flow (e.g., branch vessels and aneurysms, respectively). For example, in certain embodiments, the devices and methods described herein may be particularly adapted for use in treating aneurysms and fistulas, as well as vascular stenosis and other conditions in intracranial or other tortuous vascular systems.

[0027] The methods and devices described herein can be used in treatments that require precise orientation of a device (e.g., a stent) within the vasculature and that must navigate long, tortuous vessels before reaching a target site. For example, it is contemplated that the methods and devices described herein may be used in connection with the orientation of asymmetric discs at the neck of an aneurysm and the orientation of stents (e.g., blood vessels, 25 endoscopes, etc.) in the gastrointestinal / biliary tract.

[0028] For example, the (working) lumen of known delivery catheters (in which the stent is deployed) is generally tubular with a circular (circular) (cross-sectional) configuration, as is the outer diameter / surface of the wire 30 through which most balloon-mounted stents are delivered and the inner diameter / surface of known delivery balloon catheters. As a result, the stent will generally rotate during deployment in an unpredictable manner. Thus, achieving the desired radial placement can be cumbersome, resulting in extended procedure times, improper placement, and other adverse effects. Furthermore, as the catheter is advanced through tortuous anatomical structures, the catheter itself may rotate (twist) and rotate in an unpredictable manner. Thus, achieving the desired radial placement can be cumbersome, resulting in extended procedure times, improper placement, and other adverse effects. The methods and devices described herein address this shortcoming.

[0029] Differentially porosity (variable porosity) stents (or other such braided, mesh, or woven therapeutic devices) can be oriented to the degree of flow or obstruction desired. Some stents, described by Walzman (16 / 214,130 - "Cape Stents"), optionally have free-floating covers designed to optimize insertion into tortuous anatomy. Among their unique structural elements are a single circumferential attachment point (as small as 1 nm) at one end, overlapping circumferential shingles, and overlapping geometric shingles.

[0030] The devices described herein can optionally be deployed under blood flow stasis (e.g., via pharmacological means or via delivery via a balloon guide catheter or other means with temporary balloon inflation) to minimize the possibility of blood flow affecting positioning during sheath removal.

[0031] In other embodiments, it is contemplated that the aforementioned coatings do not completely surround (enclose) a given segment of the stent, thereby allowing for varying porosity around the circumference of the stent (e.g., the stent may include a first (coated) circumferential region of reduced porosity relative to a second (uncoated) circumferential region). Varying the porosity of the stent facilitates preservation of the origins of branch vessels that may arise from a parent vessel along the same section of the parent vessel pathology (e.g., opposite the neck of a fistula or aneurysm). The devices and methods described herein allow for more precise positioning (landing) of the stent. For example, when the palisade of a first stent is placed over the beginning of a bifurcation, the devices and methods described herein can facilitate precise placement of the second stent such that the second stent can be implanted in a precise location that overlaps the first stent in a desired area (e.g., around the palisade), thereby reducing (if not completely eliminating) leakage between the two stents while avoiding undesirable occlusion of the primary vessel by the second stent.

[0032] The disclosure also describes an inner "sheathless" hypotube or wire, which may include an inverted cone (e.g., wings) at its distal end configured to cover the stent in a proximal direction. The stent may be attached to the distal end of the outer hypotube. The inner hypotube passes through the outer hypotube, and its wings return over the distal end of the outer hypotube, covering and restraining the stent mounted thereon. Once the stent is in the desired position, the outer hypotube may be held in place while the inner hypotube is advanced. As the inner hypotube advances, its back wings also advance, releasing the restraint from the stent from proximally to distally. This allows the proximal stent to be released from restraint first and expand for deployment. If the proximal landing position is not optimal, the inner hypotube may be reseated by pulling back again. The stent may then be repositioned and deployment resumed.

[0033] The present disclosure describes catheters and wires that include non-circular cross-sectional configurations (e.g., shapes) that facilitate mating engagement with one another. Depending on the particular device and procedure, the catheter may be deployed first and the stent delivered over a wire of corresponding shape; where the shape of the wire correlates with the inner diameter of the stent delivery catheter. In some configurations, the wire is delivered to the lesion site first and the stent-loaded catheter is delivered over it. It is envisioned that any such system may be adapted for "rapid exchange" or "over-the-wire" delivery. In other configurations, a catheter having a particular non-circular inner diameter circumferential shape may be delivered over any wire to the lesion site first. The initial wire is then removed and a stent loaded onto an outer diameter wire of corresponding shape is delivered through the catheter to the lesion site. It is envisioned that the former configuration is more common with balloon-mounted stents and the latter configuration is more common with self-expanding stents. However, it should be understood that the former configuration may also be applied to self-expanding stents and the latter configuration may also be applied to balloon-mounted stents.

[0034] As described in more detail below, the interface between the devices facilitated by the aforementioned non-circular cross-sectional configurations (e.g., engagement between a wire and a catheter) allows relative axial (longitudinal) movement (e.g., sliding) between the devices while inhibiting (if not entirely preventing) relative rotation between the devices. Thus, the devices described herein provide sufficient freedom of movement to allow delivery of a catheter over a wire or delivery of a wire through a catheter without the application of force.

[0035] In some versions (e.g., for bifurcated stent placement), a wire can be placed in each of the first and second branches. The wire of the first branch is then placed through the distal end hole of the delivery catheter, and the catheter is oriented so that the side hole of the catheter is located at (or adjacent to) the stent side fence. The wire of the second branch can then be backloaded into the side hole (e.g., to facilitate proper positioning of the side hole relative to the origin of the side branch while maintaining wire access to the side branch).

[0036] It is also envisioned that the positioning of the initial wire or catheter determines how subsequent stents or wires are delivered based on the degree of rotation observed from the back of the wire or the hub of the catheter. For example, the rotation of the "12 o'clock marker" on the back of the wire at the hub of the catheter can be observed (measured) relative to the corresponding "12 o'clock marker" at the lesion site. In these versions, a dual lumen delivery catheter may be employed to deploy (deliver) one or more stents. Such a dual lumen delivery catheter includes a (first) first lumen extending between a proximal end hole and a distal end hole, and a (second) second lumen extending between a proximal end hole and a side hole, and is positioned at (or adjacent to) the palisade hole of the first (primary) stent. Through the use of the delivery catheter, the primary stent may be positioned (in any necessary or desired orientation) across a lesion in one branch (e.g., main branch) of a blood vessel relative to a side branch of the blood vessel. A wire (e.g., a guidewire) can then be fed through the secondary lumen and the side hole into the side branch prior to deployment of the primary stent. After deployment of the primary stent, the delivery catheter can be withdrawn while leaving the wire in place within the side branch of the vessel. The secondary stent can then be delivered (e.g., with an additional delivery catheter) and positioned either solely within the side branch or such that the secondary stent spans the main branch and the side branch (e.g., such that a first section or portion of the secondary stent is disposed within the main branch and a second section or portion of the secondary stent is disposed within the side branch). In certain embodiments and procedures, it is contemplated that the secondary stent will be positioned to overlie the primary stent. For example, it is contemplated that the secondary stent will be configured and positioned to overlie a proximal portion of the primary stent.

[0037] In one aspect of the disclosure, an intravascular device is disclosed that includes a primary (first) wire (e.g., a guidewire), a delivery catheter, and a primary (first) stent loaded onto (e.g., supported by) the delivery catheter. The primary wire includes a fixed non-circular cross-sectional configuration (e.g., a non-circular outer (circumferential) contour (surface, shape)) over a majority of its length. The primary wire also includes a (first) marker (e.g., a radiopaque marker) at or adjacent its proximal end, and a (second) marker (e.g., a radiopaque marker) at or adjacent its distal end. The markers are positioned at the same circumferential (rotational) position along the outer surface of the primary wire. In certain embodiments, for example, the markers are each positioned at the "12 o'clock" position.

[0038] The delivery catheter includes a proximal end, a distal end, and an inner primary lumen defining a fixed non-circular cross-sectional configuration (e.g., a non-circular inner contour (surface, shape)) that corresponds to the cross-sectional configuration defined by the primary wire. The delivery catheter includes an "over-the-wire" configuration to slidably receive the primary wire such that the delivery catheter is positioned (at least partially) relative to the primary wire. The corresponding non-circular cross-sectional configurations defined by the primary wire and delivery catheter allow the primary wire to be inserted into the delivery catheter in a number of discrete (rotational) orientations, the number of which is determined by the particular configuration of the primary wire and delivery catheter. For example, in certain embodiments, the primary wire and delivery catheter can include corresponding triangular cross-sectional configurations, which facilitate inserting the primary wire into the delivery catheter in three different (rotational) directions offset from one another by (approximately) 120°. The non-circular cross-sectional configurations of the primary wire and delivery catheter allow the relative (rotational) orientation of the primary wire and delivery catheter to be maintained during advancement of the delivery catheter within a blood vessel.

[0039] The delivery catheter can include a (third) marker (e.g., a radiopaque marker) at or adjacent its distal end. The delivery catheter is configured for insertion into and navigation through the blood vessel to the target lesion, arresting proximal to the target lesion, delivering the primary stent, and withdrawal from the blood vessel.

[0040] In use, the delivery catheter is rotated in a predetermined direction prior to insertion of the primary wire, resulting in a corresponding rotation of the primary stent, allowing advancement of the delivery catheter and primary stent into the blood vessel and deployment of the primary stent in the predetermined (rotational) direction. In certain embodiments, the delivery catheter can further include at least one balloon and at least one secondary lumen configured (solely) to support inflation and deflation of the at least one balloon.

[0041] In certain embodiments, the primary stent may be loaded onto at least one balloon.

[0042] In certain embodiments, a stent may include different porosity configurations, for example, a primary stent may include a first region (e.g., a coated region) that includes a first porosity and a second region (e.g., an uncoated region) that includes a second, different porosity.

[0043] In certain embodiments, the primary stent may include at least one palisade.

[0044] In certain embodiments, the primary stent may include at least one region that is substantially impermeable to fluids.

[0045] In certain embodiments, the intravascular device may further include at least one anchoring compound (eg, on the primary stent).

[0046] In certain embodiments, the primary stent may include at least one radiopaque marker.

[0047] In certain embodiments, at least one balloon can include at least one radiopaque marker. In certain embodiments, the primary stent can include at least one radiopaque marker.

[0048] In certain embodiments, a primary stent may be configured (eg, optimized) to facilitate treatment of a narrowed lumen of a blood vessel.

[0049] In certain embodiments, the intravascular device may include a lubricious surface coating.

[0050] In certain embodiments, the delivery catheter can include configurations that support rapid exchange.

[0051] In certain embodiments, the primary wire may include at least one anchor at or adjacent its distal end.

[0052] In certain embodiments, at least one anchor may include a serpentine (eg, spring-like) configuration.

[0053] In certain embodiments, at least one anchor can include a bifurcated wire segment, for example, the bifurcated wire segment can be bifurcated into at least two segments such that upon application of a predetermined radial force, the at least two segments are directed in different directions against the wall of the vessel.

[0054] In certain embodiments, at least one anchor may be configured such that, upon application of an external stimulus, the bifurcated wire segments move from a first (inserted, inactive, collapsed) configuration, in which at least two segments are disposed in generally adjacent relationship, to a second (anchored, active, expanded) configuration, in which the at least two segments are spaced apart from one another, thereby anchoring the primary wire within the blood vessel.

[0055] It is envisioned that the at least one anchor moves from the first configuration to the second configuration upon application of any suitable stimulus, including, for example, a thermal stimulus, an electrical stimulus, a mechanical stimulus, a magnetic stimulus, a hydrostatic pressure stimulus, etc.

[0056] In certain embodiments, at least one anchor can include a ball-wire.

[0057] In certain embodiments, the at least one anchor may include a retrievable stent.

[0058] In certain embodiments, it is envisioned that the primary wire and at least one anchor are delivered through a secondary catheter.

[0059] In certain embodiments, a secondary catheter may be inserted over the secondary wire.

[0060] In certain embodiments, the intravascular device has an inner lumen that defines a fixed, non-circular cross-sectional shape (e.g., such that the IVUS catheter has a non-circular inner contour (surface, shape) that corresponds to the cross-sectional configuration defined by the lumen and primary wire of the primary catheter) and can be advanced over the primary wire prior to insertion of the delivery catheter (e.g., to optimize imaging and orientation of the target lesion, vascular side branches, etc.) and then removed.

[0061] In certain embodiments, the IVUS catheter may include a (fourth) marker (e.g., a radiopaque marker) positioned corresponding to the (third) marker on the delivery catheter (e.g., at the “12 o'clock” position).

[0062] In certain embodiments, the delivery catheter may include a third lumen.

[0063] In certain embodiments, the tertiary lumen may include a "peel away" (side) slit to the rapid exchange length lumen.

[0064] In certain embodiments, the tertiary lumen can be configured to receive and deliver a tertiary wire (eg, to a side branch of a blood vessel).

[0065] In certain embodiments, the tertiary lumen may terminate in a side hole located proximal to the distal end hole defined by the inner lumen such that a tertiary wire can be delivered into the blood vessel through the side hole.

[0066] In certain embodiments, at least one balloon may include a barrier.

[0067] In certain embodiments, at least one balloon can be configured such that the palisades generally align with (eg, overlap or cover) a side hole defined by the tertiary lumen.

[0068] In certain embodiments, the primary stent includes palisades and is loaded onto at least one balloon such that the palisades of the primary stent are generally aligned (e.g., overlap or overlap) with the palisades and side holes of the at least one balloon.

[0069] In certain embodiments, the tertiary wire may include a distal anchor.

[0070] In certain embodiments, a tertiary wire may include a fixed, non-circular cross-sectional configuration (eg, a non-circular outer (circumferential) contour (surface, shape)) over a majority of its length.

[0071] In certain embodiments, a secondary delivery catheter may be employed to deliver the secondary stent, hi such embodiments, the secondary delivery catheter may include at least one balloon.

[0072] In certain embodiments, the secondary stent may be mounted on at least one balloon of the secondary delivery catheter.

[0073] In certain embodiments, the secondary stent may include at least one palisade. For example, the secondary stent may include an annular (e.g., circular, circular, elliptical, etc.) opening (hole) configured to overlap the ostium (origin) of a branch vessel.

[0074] In certain embodiments, the secondary stent can include at least one secondary compound affixed thereto.

[0075] In certain embodiments, the secondary delivery catheter may include an inner secondary lumen that defines a fixed non-circular cross-sectional configuration (e.g., a non-circular inner contour (surface, shape)) that corresponds to the cross-sectional configuration defined by the tertiary wire. The secondary delivery catheter may include an "over-the-wire" configuration that allows the tertiary wire to be slidably inserted into the secondary delivery catheter such that the secondary delivery catheter is positioned (at least partially) with respect to the tertiary wire. The non-circular cross-sectional configuration defined by the tertiary wire and secondary delivery catheter allows the tertiary wire to be inserted into the secondary delivery catheter in multiple discrete (rotational) orientations, the number of which is determined by the particular configuration of the tertiary wire and secondary delivery catheter. For example, in certain embodiments, the tertiary wire and secondary delivery catheter may include corresponding triangular cross-sectional configurations that facilitate insertion of the tertiary wire into the secondary delivery catheter in three different (rotational) orientations that are offset (approximately) 120° from one another. The non-circular cross-sectional configuration of the tertiary wire and secondary delivery catheter allows the relative (rotational) orientation of the tertiary wire and secondary delivery catheter to be maintained during advancement of the secondary delivery catheter within the blood vessel.

[0076] In use, the secondary delivery catheter is rotated to a predetermined orientation prior to insertion of the tertiary wire, resulting in a corresponding rotation of the secondary stent, allowing the secondary delivery catheter and secondary stent to be advanced into the blood vessel in the predetermined (rotational) orientation to deploy the secondary stent.

[0077] In certain embodiments, the intravascular device can include at least one energy transmission member.

[0078] In another aspect of the present disclosure, a wire for intraluminal use is disclosed, the wire including an anchor at a distal end thereof.

[0079] In certain embodiments, the anchor may include a bifurcated wire segment, for example, the bifurcated wire segment may be bifurcated into at least two segments such that upon application of a predetermined radial force, the at least two segments are oriented in different directions against the wall of the vessel.

[0080] In certain embodiments, the at least one anchor may be configured to move the bifurcated wire segments from a first (inserted, inactive, folded) configuration in which at least two segments are disposed in a generally adjacent relationship to a second (anchored, active, expanded) configuration in which the at least two segments are spaced apart from one another, thereby anchoring the primary wire within a blood vessel upon application of an external stimulus. It is envisioned that the at least one anchor may be moved from the first configuration to the second configuration upon application of any suitable stimulus (e.g., to a proximal end of the wire), including, for example, a thermal stimulus, an electrical stimulus, a mechanical stimulus, a magnetic stimulus, a hydrostatic pressure stimulus, etc.

[0081] In certain embodiments, the wire may further include a central segment that continues distally beyond the at least one anchor.

[0082] In another aspect of the present disclosure, an intravascular system for treating a blood vessel is disclosed. The intravascular system includes a catheter defining a first lumen and a first delivery device configured for insertion into the first lumen of the catheter. The first lumen terminates at a distal end hole and has a first non-circular cross-sectional shape. The first delivery device includes a first stent and a first elongated member supporting the first stent, the first elongated member and the first stent being movable through the first lumen to facilitate delivery of the first stent to a target location within the blood vessel. The first elongated member has a second non-circular cross-sectional configuration corresponding to the first non-circular cross-sectional configuration, thereby inhibiting rotation of the first elongated member within the catheter and controlling the orientation of the first stent relative to the catheter.

[0083] In certain embodiments, the first delivery device may be configured as a packaging catheter.

[0084] In certain embodiments, the packaging catheter may include a body and a pusher supporting a first stent. In such embodiments, the first elongate member is defined by the pusher, and the pusher is configured to be movable through the body such that the pusher and the first stent are insertable through the catheter and into a blood vessel.

[0085] In certain embodiments, the first stent may be configured to be self-expandable such that the first stent automatically expands within the blood vessel upon exposure from the catheter.

[0086] In certain embodiments, the first delivery device may be configured as a balloon catheter including a first expandable member. In such embodiments, the first elongate member is defined by a body of the balloon catheter such that the body of the balloon catheter is received by a first lumen of the catheter, and the first stent is positioned about the first expansion member such that the first stent deploys upon expansion of the first expansion member.

[0087] In certain embodiments, the first delivery device may include a second lumen extending therethrough.

[0088] In certain embodiments, the second lumen may terminate in a side hole.

[0089] In certain embodiments, the second lumen can include a third non-circular cross-sectional configuration.

[0090] In certain embodiments, the intravascular system may further include a second delivery device configured to be inserted within a second lumen of the first delivery device.

[0091] In certain embodiments, the second delivery device can include a second stent and a second elongate member supporting the second stent, such that the second elongate member and the second stent are movable through the second lumen to facilitate delivery of the second stent through a side hole to treat a side branch of a blood vessel.

[0092] In certain embodiments, the second elongate member can have a fourth non-circular cross-sectional configuration that corresponds to the third non-circular cross-sectional configuration, thereby inhibiting rotation of the second elongate member within the first delivery device and controlling the orientation of the second stent relative to the catheter.

[0093] In certain embodiments, the second stent may be configured to be self-expanding such that it automatically expands when exposed within the blood vessel.

[0094] In certain embodiments, the second delivery device may further include an expandable member supported by the second elongate member. In such embodiments, the second stent is supported by the expansion member such that upon expansion of the expansion member, the second stent deploys.

[0095] In another aspect of the present disclosure, an intravascular system for treating a blood vessel is disclosed. The intravascular system includes a first medical device and a second medical device. The first medical device includes: an elongate member; a first expandable member supported by the elongate member; and a first stent supported by the first expandable member such that upon expansion of the first expandable member, the first stent is deployed. The elongate member defines a first lumen extending from a proximal end hole to a distal end hole and a second lumen extending in a generally parallel relationship to the first lumen from the proximal end hole to a side hole located proximal to the distal end hole. The first expandable member includes a first palisade hole and the first stent includes a second palisade hole. The second medical device is configured to be inserted through the side hole, through the first palisade hole of the first expandable member, through the second palisade hole of the first stent, and into the second lumen to access a side branch of the blood vessel.

[0096] In certain embodiments, the second medical device is configured as a packaging catheter.

[0097] In certain embodiments, the packaging catheter may include a body configured to connect to a first medical device, a pusher configured to move within the body, and a second stent supported on the pusher such that the pusher and second stent are insertable through the first medical device via the second lumen and the side hole and into a side branch of a blood vessel.

[0098] In certain embodiments, the second stent may be configured to self-expand such that upon exposure through the side hole, the second stent automatically expands within the side branch of the vessel.

[0099] In certain embodiments, the second lumen defines a first non-circular cross-sectional shape and the pusher defines a second non-circular cross-sectional shape that corresponds to the first non-circular cross-sectional shape to inhibit rotation of the pusher and second stent within the second lumen, thereby controlling the orientation of the second stent relative to the first medical device.

[0100] In certain embodiments, the first non-circular cross-sectional configuration and the second non-circular cross-sectional configuration may each be defined by a plurality of straight line segments.

[0101] In certain embodiments, the first non-circular cross-sectional configuration and the second non-circular cross-sectional configuration may be such that the pusher is insertable into the second lumen in at least three different (rotational) orientations.

[0102] In certain embodiments, the second medical device may be configured as a guidewire.

[0103] In certain embodiments, a guidewire may be insertable through a side hole in the first medical device and into a side branch of a blood vessel.

[0104] In certain embodiments, the second medical device may be configured as a balloon catheter.

[0105] In certain embodiments, the balloon catheter may include a body; a second expandable member supported by the body; and a second stent supported by the second expandable member such that the second stent deploys upon expansion of the second expandable member.

[0106] In certain embodiments, the body of the balloon catheter may define a lumen configured to receive a guidewire such that the balloon catheter is insertable over the guidewire and into a side branch of a blood vessel.

[0107] In certain embodiments, the second lumen defines a first non-circular cross-sectional shape and the body of the balloon catheter defines a second non-circular cross-sectional shape corresponding to the first non-circular cross-sectional shape to inhibit rotation of the balloon catheter and second stent within the second lumen and to control the orientation of the second stent relative to the first medical device.

[0108] In another aspect of the present disclosure, a system for maintaining stent orientation during delivery is disclosed. The system includes a first medical device supporting a stent and a second medical device configured to receive the first medical device. The first medical device and the second medical device include corresponding non-circular cross-sectional configurations to inhibit rotation of the first medical device within the second medical device, thereby controlling the orientation of the stent.

[0109] In certain embodiments, the first medical device can be configured as a balloon catheter including an expansion member, in which the stent is supported by the expansion member such that the stent is deployed upon expansion of the expansion member.

[0110] In certain embodiments, the stent can be configured to be self-expanding such that the stent automatically expands upon exposure from the second medical device.

[0111] In another aspect of the present disclosure, an intravascular system is disclosed that includes a first medical device, a second medical device configured to receive the first medical device, and at least one pull wire. The first medical device and the second medical device include corresponding non-circular cross-sectional configurations to inhibit rotation of the first medical device within the second medical device. The at least one pull wire is connected to the second medical device to change an angular position of the second medical device and the first medical device via a torsional force applied to the second medical device by the at least one pull wire.

[0112] In certain embodiments, the at least one pull wire may be secured to an exterior surface of the second medical device.

[0113] In certain embodiments, the at least one pull wire may extend through a channel formed in the outer wall of the second medical device.

[0114] In certain embodiments, the intravascular system may further include an actuation mechanism connected to the at least one pullwire and configured to apply a torsional force to the second medical instrument.

[0115] In certain embodiments, the actuation mechanism may be supported on the body of the second medical device.

[0116] In certain embodiments, the at least one pull wire may include a first pull wire connected to the second medical device to change an angular position of the second medical device in a first direction, and a second pull wire connected to the second medical device to change an angular position of the second medical device in a second direction that is generally opposite the first direction.

[0117] In certain embodiments, the intravascular system may further include a first actuation mechanism connected to the first pull wire and configured to apply a first torsional force to the second medical device, and a second actuation mechanism connected to the second pull wire and configured to apply a second torsional force to the second medical device.

[0118] In another exemplary embodiment of the present disclosure, implants such as vascular implants, stents, occlusion devices including intrasaccular occlusion devices, heart valves, left atrial appendage implants, gastrointestinal implants, etc., can be customized to the exact dimensions of an anomaly or anatomical defect in an organ such as a tubular organ including blood vessels, gastrointestinal lumens, etc. For example, scanning methods including coronary CTA scans, MRA or magnetic resonance angiograms, conventional angiography scans, conventional CT and MRI scans, etc., can be utilized to obtain 3-D images, CAD models, or digital 3-D models of the anatomical defect. The generated models are input into the logic of a 3D printer that uses a print medium to generate the custom implant. The print medium can include any of the materials identified herein to create the implants, stents, and / or occlusion devices, etc. By way of example and not limitation, exemplary materials include biocompatible metals such as stainless steel, cobalt-chromium alloys, titanium, nickel-titanium alloys (nitinol), etc. Other metals such as gold, platinum, silver, iridium, tantalum, tungsten, etc., are also common in many medical devices and / or their alloys. Suitable biocompatible polymeric materials include polystyrene, polypropylene, polyvinyl chloride, polyethylene, polyurethane, polycarbonate, polyethylene terephthalate and / or polyether ether ketone. The 3-D printer can also apply various coatings, including but not limited to hydrogel coatings. In an exemplary embodiment, the implant is a mesh occlusion device for implantation within a vessel wall defect, such as an aneurysmal sac. In accordance with the present application, imaging of the aneurysmal sac is performed in the manner described above, and a three-dimensional model of the aneurysmal sac is generated. This 3D model is input into the logic of the 3D printer, which generates the occlusion device. The custom occlusion device corresponds almost exactly to the dimensions of the aneurysmal sac, thus filling the aneurysmal sac in a supporting relationship with the walls that define the aneurysmal sac. In certain embodiments, the custom occlusion device may be a self-expanding metal mesh. The degree of expansion can be determined via a mathematical model / algorithm based on the mesh material properties, dimensions, etc.In other exemplary embodiments, the custom occlusion device may be pouch-like and filled with drugs, medications, etc., and / or filled with a mesh frame. Markers may be placed on the custom occlusion device or implant to aid in deployment within the outpouch or aneurysm sac. The markers may correspond to distinct spots within the outpouch, i.e., physical biological markers, or may be selected by a programmer controlling the operation of the 3-D printer. The custom occlusion device may be implanted utilizing any of the instruments and methodologies described herein.

[0119] According to an exemplary embodiment, the method includes acquiring image data of an abnormality in a blood vessel, generating a model of a biological implant based on the image data, and forming the biological implant based on the model, the biological implant generally corresponding to a dimension of the abnormality. The method may further include introducing the biological implant into the abnormality. The abnormality may be an opening in an organ, and implanting the biological implant includes at least partially positioning the biological implant within the opening. In an exemplary embodiment, the opening is an aneurysm sac. Introducing the biological implant may include attaching the biological implant to at least one delivery apparatus. The at least one delivery device may include a catheter sized for intravascular application.

[0120] In an exemplary embodiment, the method further includes disposing at least one marker, e.g., one or more radiopaque markers, on the biological implant. The markers can be utilized to orient the biological implant relative to the aneurysm sac. In one exemplary embodiment, obtaining image data includes collecting data of physical fiducials on the aneurysm sac, and positioning the at least one marker includes disposing the marker to coincide with, generally align with, or be adjacent to the physical fiducials.

[0121] The bioimplant may be comprised of a mesh structure, a pouch, or a combination thereof, or any structure having dimensions for being positioned within the defect and providing a support function to the walls defining the defect. The bioimplant may be at least partially self-expandable. The bioimplant may include one or more hydrogel coatings.

[0122] In another exemplary embodiment, a biological implant for inserting a blood vessel comprises an implant member configured and dimensioned to correspond to a particular anatomical structure in the blood vessel, the implant member defining at least one of a size or shape determined at least in part based on image data obtained for the anatomical structure. In an exemplary embodiment, the implant member is configured and dimensioned to correspond to a dimension of an abnormality in the blood vessel, and at least one of a size or shape of the implant member is determined at least in part based on pre-treatment image data obtained for the abnormality. In another exemplary embodiment, the implant member is configured and dimensioned to correspond to a dimension of an outpouching in the blood vessel, and at least one of a size or shape of the implant member is determined at least in part based on pre-treatment image data obtained for the outpouching. In yet another exemplary embodiment, the implant member is configured and dimensioned to correspond to a dimension of an aneurysmal sac in the blood vessel, and at least one of a size or shape of the implant member is determined at least in part based on pre-treatment image data obtained for the aneurysmal sac.

[0123] In certain embodiments, one or more markers are attached to the implant member and correspond to physical references associated with the anomaly. The one or more markers may be positioned on the implant member based, at least in part, on pre-treatment image data obtained for the physical references associated with the anomaly. The one or more markers may include one or more radiopaque markers.

[0124] In an exemplary embodiment, the implant member is comprised of one of a mesh structure or a pouch. The implant member may be self-expandable.

[0125] Other embodiments are described in the following Detailed Description of Embodiments, which is to be read in conjunction with the accompanying figures. [Brief description of the drawings]

[0126] Throughout this disclosure, the term "vascular abnormality" should be understood to include aneurysms, lesions, fistulas, ruptures, and any other such malformations in a blood vessel. Additionally, the term "medical device" should be understood to include any of the catheters, wires, or other such structures (or components of such structures) described herein, and the term "elongated member" should be understood to include any of the elongated structures described herein (e.g., tubes, wires, catheter bodies, etc.). [Figure 1A] FIG. 1A is a perspective view of an intravascular system including a primary delivery catheter. [Figure 1B] FIG. 1B is a (partial) perspective view of the lumen of the primary delivery catheter seen in FIG. 1A positioned within an anatomical vessel (eg, a blood vessel). [Figure 1C] FIG. 1C is a (partial) cross-sectional view of a delivery device (eg, a pusher of a packaging catheter) disposed within the lumen of a primary delivery catheter and shown in a first (rotated) position. [Figure 1D] FIG. 1D is a (partial) cross-sectional view of the pusher disposed within the lumen of the primary delivery catheter and shown in a second (rotated) position. [Figure 2A] FIG. 2A is a perspective view of a packaging catheter and a primary delivery catheter during treatment of a vascular abnormality of a blood vessel. [Figure 2B] FIG. 2B is a perspective view of a primary delivery catheter shown in conjunction with an alternative embodiment of a delivery device configured as a balloon catheter during treatment of a vascular abnormality. [Figure 2C]FIG. 2C is a perspective view of a primary stent (or other such occlusive device) that can be positioned within a blood vessel via a delivery device and primary delivery catheter to treat a vascular abnormality. [Diagram 3] FIG. 3 is a perspective view showing the advancement of a primary stent through a vessel via a pusher during treatment of a vascular defect. [Figure 4] FIG. 4 is a (partial) perspective view of the primary delivery catheter. [Diagram 5] FIG. 5 is a (partial) perspective view of a primary delivery catheter that includes one or more markers (eg, radiopaque markers) to facilitate external visualization of the primary delivery catheter within the blood vessel. [Figure 6] FIG. 6 is a perspective view of the pusher, primary stent, and primary delivery catheter seen in FIG. 5, illustrating insertion of the pusher and primary stent into the primary delivery catheter. [Figure 7] 7A-7D are cross-sectional views illustrating various non-circular cross-sectional configurations of a lumen extending through a primary delivery catheter according to various embodiments of the present disclosure, and FIG 7E is a perspective view of an alternative embodiment of a primary delivery catheter that includes various markers (e.g., radiopaque markers) positioned at various (rotational) positions to facilitate external visualization of the primary delivery catheter. [Figure 8] FIG. 8 is a perspective view of the pusher. [Figure 9] FIG. 9 is a perspective view of a packaged catheter. [Figure 10] FIG. 10 is a perspective view of an alternative embodiment of a pusher that includes a tapered distal end. [Figure 11] FIG. 11 illustrates an alternative embodiment of a primary delivery catheter that includes a hub at its proximal end and includes a series of markers (eg, radiopaque markers). [Figure 12] FIG. 12 illustrates a pusher inserted into the primary delivery catheter seen in FIG. [Figure 13]FIG. 13 is a perspective view of an alternative embodiment of a delivery device including an outer hypotube configured to support a primary stent. [Figure 14] FIG. 14 is a perspective view of the inner hypotube inserted into the outer hypotube seen in FIG. [Figure 14A] FIG. 14A is a perspective view of an alternative embodiment of the outer and inner hypotubes. [Figure 15] FIG. 15 is a perspective view of a guidewire for use with the presently disclosed intravascular system. [Figure 16] FIG. 16 is a longitudinal cross-sectional view illustrating the deployment of a primary delivery catheter into a blood vessel over a guidewire for treating a vascular abnormality, according to one embodiment of the present disclosure. [Figure 17] FIG. 17 is a longitudinal cross-sectional view showing insertion of a pusher and primary stent through a primary delivery catheter. [Figure 18] FIG. 18 is a longitudinal cross-sectional view of an alternative embodiment of an intravascular system. [Figure 19] FIG. 19 is a cross-sectional view taken through line 19-19 of FIG. [Figure 20] FIG. 20 is a longitudinal cross-sectional view illustrating the deployment of a self-expanding secondary stent into a side branch of a blood vessel via a primary delivery catheter and a first delivery device. [Figure 21] FIG. 21 is a cross-sectional view taken through line 21-21 of FIG. [Figure 22] FIG. 22 is a longitudinal cross-sectional view showing deployment of a secondary guidewire through a primary delivery catheter and a first delivery device to a side branch of a vessel. [Diagram 23] FIG. 23 is a longitudinal cross-sectional view illustrating the deployment of a self-expanding secondary stent into a side branch of a vessel through a primary delivery catheter and a secondary delivery catheter received within the first delivery device. [Figure 24] FIG. 24 is a longitudinal cross-sectional view showing the deployment of a secondary expandable stent through a primary delivery catheter over a secondary guidewire and through a first delivery device into a side branch of a vessel. [Diagram 25]FIG. 25 is a longitudinal cross-sectional view illustrating the positioning of a secondary stent within a side branch of a vessel such that the secondary stent overlaps the primary stent. [Figure 26] FIG. 26 is a schematic diagram of an alternative embodiment of the delivery catheter seen in FIG. 1A shown in a first (initial, normal) configuration and including one or more steerable segments deflected by one or more pull wires. [Figure 27] FIG. 27 is a cross-sectional view of the delivery catheter seen in FIG. 26 taken along line 27-27. [Figure 28] FIG. 28 is a schematic diagram of the delivery catheter seen in FIG. 26 shown in a second (subsequent, deflected) configuration. [Figure 29A] FIG. 29A is a perspective view of an alternative embodiment of the delivery catheter seen in FIG. 1A that includes a puller wire for applying a torsional force to the delivery catheter. [Figure 29B] FIG. 29B is a perspective view of an alternative embodiment of the delivery catheter seen in FIG. 29A in which the pull wire includes a helical (spiral) distal segment and a (generally) straight proximal segment. [Diagram 30] FIG. 30 is a perspective view of an alternative embodiment of the delivery catheter seen in FIG. 29A. [Diagram 31] FIG. 31 is a perspective view of an alternative embodiment of the delivery catheter seen in FIG. 29A. [Diagram 32] FIG. 32 is a perspective view of an alternative embodiment of the delivery catheter seen in FIG. 29A. [Diagram 33] FIG. 33 is a perspective view of an alternative embodiment of the delivery catheter seen in FIG. 29A that includes multiple puller wires. [Diagram 34] FIG. 34 is a perspective view of an alternative embodiment of the delivery catheter seen in FIG. [Diagram 35] FIG. 35 is a perspective view of an alternative embodiment of the delivery catheter seen in FIG. [Diagram 36] FIG. 36 is a flow chart of one exemplary methodology for forming a custom bioimplant in accordance with the principles of the present disclosure. [Figure 37] FIG. 37 is a flow chart illustrating an exemplary methodology for inserting a bioimplant into a vascular organ. [Figure 38] FIG. 38 is an exemplary bioimplant manufactured according to the steps of the flowchart of FIG.

[0127] 1A provides a perspective view of an endovascular system 10 for treatment of an anatomical vessel, such as vessel V (FIG. 2A). In the illustrated embodiment, the endovascular system 10 includes a (primary) delivery catheter 100 that includes an elongate body (member) 102 extending along a longitudinal axis X.

[0128] The body 102 includes a proximal (first) end 104 defining a proximal end bore 106, a distal (second) end 108 defining a distal end bore 110, and a (generally) cylindrical outer cross-sectional configuration. A lumen 112 extends through the body 102 from the proximal end 104 to the distal end 108 and defines a non-circular cross-sectional (lateral) configuration. More specifically, in the particular embodiment illustrated, the lumen 112 defines a (generally) triangular cross-sectional (lateral) configuration. However, as described below, a variety of other non-circular cross-sectional (lateral) configurations are also contemplated by the present disclosure, including, for example, rectangular, pentagonal, hexagonal, octagonal, square, elliptical, star-shaped, etc.

[0129] Delivery catheter 100 is configured to deliver occlusion device 200 ( FIG. 2C ) (e.g., stent 202) to a target site within blood vessel V (or other such site within the patient's vasculature). As described in more detail below, in certain embodiments, occlusion device 200 may be carried (or otherwise supported) by an inflatable balloon (or other such member) that is connected to delivery catheter 100. Alternatively, occlusion device 200 may be carried (or otherwise supported) by a separate delivery device.

[0130] Although delivery catheter 100 and occlusion device 200 are each shown as including a (generally) circular outer cross-sectional configuration, it should be understood that the particular configurations of delivery catheter 100 and occlusion device 20 may be varied without departing from the scope of the present disclosure. For example, it is envisioned that delivery catheter 100 and occlusion device 20 may each include an outer cross-sectional configuration that is non-circular (e.g., elliptical, square, rectangular, triangular, trapezoidal, diamond, pentagonal, hexagonal, heptagonal, octagonal, non-angular, decagonal, etc.).

[0131] In one embodiment, for example, it is contemplated that the delivery catheter 100 is configured as a packaging catheter 300 ( FIG. 2A ) including an elongated pusher 302 (e.g., a wire) having a proximal end 304 and a distal end 306 that carries (or otherwise supports) the stent 202 in either a fixed or releasable (cuttable) manner. For example, it is contemplated that the stent 202 may be preloaded and crimped (or otherwise secured) to the distal end 306 of the pusher 302 such that the stent 202 may be separated from the pusher 302 and deployed within the vasculature. In such an embodiment, the packaging catheter 300 is preloaded with the pusher 302 and the stent 202, and is connected (directly or indirectly) to the delivery catheter 100 such that the stent 202 is deliverable from the packaging catheter 300 into the delivery catheter 100 and through the delivery catheter 100 into the blood vessel V via axial movement of the pusher 302.

[0132] In alternative embodiments, it is contemplated that the delivery device is configured as a secondary catheter (e.g., a balloon catheter 400 (FIG. 2B) or a hypotube) configured for insertion through the delivery catheter 100 and into the blood vessel V (FIG. 2A). In such embodiments, the stent 202 may be supported on an expandable member 406 (e.g., a balloon or other such suitable structure) of the balloon catheter 400 and deployed via inflation of the expandable member 406. In such embodiments, it is contemplated that the balloon catheter 400 is inserted through the delivery catheter 100 over a guide (delivery) wire 500 that extends into the blood vessel V.

[0133] Restraining (if not completely preventing) relative rotation between the stent 202 and the delivery catheter 100 facilitates control and proper positioning of the stent 202. For example, when the delivery catheter 100 is used in conjunction with the packaging catheter 300, the pusher 302 includes a non-circular (transverse) cross-sectional shape (e.g., a cross-sectional shape generally perpendicular to the longitudinal axis of the pusher 302) that corresponds to the cross-sectional shape defined by the lumen 112 of the delivery catheter 100, thereby limiting (if not completely preventing) rotation of the pusher 302 within the delivery catheter 100, thereby facilitating control of the (rotational) orientation of the stent 202 by manipulation of the delivery catheter 100 (and / or the pusher 302). Similarly, when the delivery catheter 100 is used in conjunction with the previously described balloon catheter 400, the balloon catheter 400 includes an exterior (lateral) non-circular cross-sectional configuration (e.g., a cross-sectional shape that is generally perpendicular to the longitudinal axis of the balloon catheter 400) to limit (if not completely prevent) rotation of the balloon catheter 400 within the delivery catheter 100, thereby facilitating control of the (rotational) orientation of the stent 202 by manipulation of the balloon catheter 400 (and / or delivery catheter 100). Regardless of the particular deployment method and medical device used, it should be understood that the configuration of the delivery catheter 100, pusher 302, and balloon catheter 400 is such that the pusher 302 and balloon catheter 400 are axially movable (slidable) within the delivery catheter 100 so as not to impede advancement of the pusher 302 and balloon catheter 400 into the vasculature.

[0134] Once the delivery catheter 100 is positioned within the vasculature (e.g., blood vessel V), imaging can be used to ascertain the orientation of the distal end 108 of the delivery catheter 100 relative to the proximal end 104 of the delivery catheter 100. For example, it is envisioned that each of the proximal and distal ends 104, 108 of the delivery catheter 100 includes a corresponding marker 114 (e.g., a radiopaque marker) positioned at a corresponding location (e.g., the "12 o'clock" position), as described in more detail below. The relative (rotational) position of the distal end 108 of the delivery catheter 100 (e.g., vascular anomalies (e.g., 3. Ascertain the extent to which the distal end 108 of the delivery catheter 100 is rotationally offset from the proximal end 104, relative to the aneurysm A (e.g., as a result of twisting or other such deflections experienced by the delivery catheter 100 during navigation through the vasculature). If employed, the delivery apparatus (e.g., pusher 302, balloon catheter 400, etc.), and thus the stent 202, can be rotated a corresponding amount to account for the observed degree of (rotational) offset of the distal end 108 of the delivery catheter 100 prior to insertion into the delivery catheter 100, thereby facilitating accurate orientation and deployment of the stent 202. Essentially, multiple In a somewhat tortuous anatomical structure, most known catheters, wires, and stents cannot be precisely rotated at the target site from the proximal end (hub) of the device. However, the present disclosure relies on a certain degree of random rotation during initial delivery of the guide (delivery) wire 500, delivery catheter 300, etc. being precisely recorded and subsequently accounted for, allowing for precise orientation, delivery, and placement of the stent 202. In some cases, a trial retrievable stent device or similar device may be used to determine or confirm the orientation of the guide wire, delivery catheter 300, etc. at the target site within the vasculature.

[0135] 1B provides a (partial) view of a delivery catheter 100 positioned within a blood vessel V such that a distal end 108 is located proximate (e.g., at or adjacent to) a vascular abnormality (e.g., aneurysm A) that is the subject of a medical procedure. For simplicity and clarity, only the lumen 112 of the delivery catheter 100 is shown.

[0136] FIG. 1C is a (partial) cross-sectional view of the delivery catheter 100 taken transversely (e.g., perpendicularly) to the longitudinal axis X (FIG. 1A), showing the pusher 302 of the packaging catheter 300 positioned within the lumen 112 in a first orientation.

[0137] FIG. 1D is a (partial) cross-sectional view of delivery catheter 100, with pusher 302 shown disposed within lumen 112 in a second, first orientation that is (rotationally) offset by (approximately) 120° from the first orientation seen in FIG. 1C.

[0138] While shown in the illustrated embodiment as a solid wire 308 (FIG. 2A), it should be understood that alternative configurations of pusher 302 are also contemplated herein. For example, it is contemplated that pusher 302 may define a lumen therein (e.g., to facilitate receipt of said 114 such that pusher 302 is advanceable into vessel V in an "over the wire" configuration).

[0139] 2C, the stent 202 includes a self-expanding, differentially porous configuration having a first (coated) region 204 having a first porosity and a second (uncoated) region 206 having a second, different (e.g., greater) porosity. In certain embodiments, it is contemplated that the first region 204 may be completely impermeable to fluids, blood, etc., and / or the second region 206 may be devoid of struts (e.g., threads), such that the second region 206 includes or otherwise defines one or more railings 208, holes, openings, or other such openings in the stent 202.

[0140] The present disclosure contemplates a variety of geometric configurations for stent 202, including both (generally) circular cross-sectional configurations, such as those seen in FIG. 2C (e.g., to correspond to the (generally) circular cross-sectional configuration of a blood vessel), and non-circular cross-sectional configurations (e.g., to facilitate placement and / or fixation of stent 202 within the vasculature).

[0141] 1C, as discussed above, the pusher 302 includes a non-circular cross-sectional (lateral) configuration corresponding to that defined by the lumen 112 of the delivery catheter. More specifically, in the particular embodiment illustrated, the pusher 302 includes a (generally) triangular cross-sectional (lateral) configuration. As discussed above in relation to the lumen 112 (and as described in more detail below), various other non-circular cross-sectional (lateral) configurations for the pusher 302 are also contemplated by the present disclosure. The corresponding non-circular cross-sectional configuration defined by the lumen 112 of the delivery catheter and the pusher 302 allows the pusher 302 to be received in a manner that allows longitudinal (axial) movement (e.g., sliding) of the pusher 302 through the delivery catheter 100 while inhibiting (if not entirely preventing) rotation of the pusher 302 within the delivery catheter 100, facilitating control of the orientation of the pusher 302, and thus the stent 202, relative to the delivery catheter 100.

[0142] Although described with respect to pusher 302, it should be understood that the anti-rotation principles resulting from a non-circular cross-sectional (transverse) configuration are likewise applicable to balloon catheters 400, guidewires, or other such medical devices inserted into a patient's vasculature.

[0143] The triangular cross-sectional configuration of lumen 112 is defined by vertices AA, BB, CC and three straight line segments a, b, c that intersect to define interior angles A, B, C of (approximately) 120°. For nomenclature purposes, rotating delivery catheter 100 counterclockwise by (approximately) 120° positions delivery catheter 100 (and thus pusher 302) in the manner shown in FIG. ID. However, it should be understood that the number of linear segments can be varied in alternative embodiments to define any suitable non-circular (transverse) cross-sectional configuration of lumen 112 (e.g., four segments, five segments, six segments, etc.).

[0144] The non-circular (cross-sectional) configuration of the lumen 112 allows the pusher 302 (or balloon catheter 400) to be inserted in multiple discrete (rotational) orientations. For example, in the illustrated embodiment, the triangular cross-sectional configuration of the lumen 112 allows the pusher 302, and thus the stent 202, to be received in one of three discrete (rotational) orientations that are offset from one another by (approximately) 120°. The variability in the (rotational) orientation of the pusher 302 and stent 202 tolerates and accommodates the (rotational) displacements that the distal end 108 of the delivery catheter 100 experiences (relative to the proximal end 104 and the aneurysm A discussed above) during insertion into the vessel V due to the tortuous nature of the vasculature. For example, if no (rotational) offset is observed between the distal end 108 and the proximal end 104 of the delivery catheter 100 (and aneurysm A) (e.g., such that the distal end 108 and the proximal end 104 remain in their initial "12 o'clock" positions), the pusher 302 (or balloon catheter 400) may be inserted in one (rotational) orientation (e.g., the corresponding "12 o'clock" position). However, if a (rotational) offset is observed between the distal end 108 and the proximal end 104 of the delivery catheter 100 (and aneurysm A), depending on the degree of (rotational) offset observed, the pusher 302 (or balloon catheter 400) may be inserted in one of a number of different (rotational) orientations, in the illustrated embodiment, the (rotational) offsets differ from one another by (approximately) 120° such that the stent 202 may be positioned within the vessel V as needed or desired to treat the aneurysm A.

[0145] To facilitate observation of the (rotational) orientation of the distal end 108 of the delivery catheter 100, pusher 302, balloon catheter 400, stent 202, etc., the delivery catheter 100, pusher 302, balloon catheter 400, stent 202, etc., may include one or more markers (e.g., radiopaque markers), as described in further detail below, which may be visualized using any suitable technique, such as, for example, X-ray, 3D X-ray, CT imaging, echocardiography, ultrasound, IVUS, etc.

[0146] 2A shows the packaging catheter 300 and delivery catheter 100, which in the illustrated embodiment are separated by a hub 600 having a port 602 such that the hub 600 is located between the delivery catheter 100 and the packaging catheter 300. It is contemplated that the hub 600 is a component of the packaging catheter 300 or the delivery catheter 100. Alternatively, it is contemplated that the hub 600 may be a separate (independent) component of the endovascular system 10 configured to interface (connect, engage) with the packaging catheter 300 and / or the delivery catheter 100 such that the packaging catheter 300 and the delivery catheter 100 are indirectly connected via the hub 600.

[0147] The packaging catheter 300 includes an elongate tubular body 310 having respective proximal and distal ends 312 and 314 and defining a lumen 316 configured to receive the pusher 302 and the stent 202. The hub 600 is configured to be releasably connected to the proximal end 104 of the delivery catheter 100 (e.g., via a corresponding hub on the delivery catheter 100) such that the pusher 302 and the stent 202 are insertable through a port 602 in the hub 600 and into the lumen 112 of the delivery catheter 100 and proximate (e.g., adjacent) the aneurysm. It is envisioned that the distal end 306 of the packaging catheter 300 and the proximal end 104 of the delivery catheter 100 are positioned within the hub 600 in (generally) alignment to facilitate movement of the pusher 302 from the elongate body 310 of the packaging catheter 300 into the lumen 112 of the delivery catheter 100.

[0148] In one method of use (seen in FIG. 2A ), delivery catheter 100 is advanced through blood vessel V to a target site (e.g., such that distal end 108 of delivery catheter 100 is located in proximity to (e.g., at or adjacent to) aneurysm A). Stent 202, pre-loaded in pusher 302, may then be advanced through delivery catheter 100 (e.g., via elongated body 310 and hub 600 of packaging catheter 300) and into blood vessel V such that stent 202 automatically expands (deploys) upon exposure from delivery catheter 100.

[0149] 2B illustrates the insertion of the balloon catheter 400 and stent 202 through the delivery catheter 100 and into the blood vessel V. As seen in FIG. 2B, the balloon catheter 400 includes an elongated (tubular) body (member) 402 defining a lumen 404 and an expandable member 406 supported by the elongated body 402. The stent 202 is positioned (secured) with respect to the expansion member 406 (e.g., via a crimp) such that the stent 202 is deployed via expansion (expansion) of the expansion member 406.

[0150] To facilitate proper placement of the balloon catheter 400 and stent 202, a guidewire 500, including respective proximal and distal ends 502, 504, is positioned within the blood vessel 100 such that the guidewire 500 is located in proximity to (e.g., at or adjacent to) the aneurysm A. The balloon catheter 400 is then advanced over the guidewire 500 (e.g., through the lumen 112 within the delivery catheter 100) and into the blood vessel V such that the guidewire 500 extends through a lumen 404 defined by the elongated body 402 of the balloon catheter 400.

[0151] To facilitate control and proper positioning of the stent 202, as indicated above, the balloon catheter 400 includes (defines) a non-circular cross-sectional (e.g., triangular) shape that corresponds to that defined by the lumen 112 of the delivery catheter 300, inhibiting (if not completely preventing) relative rotation between the balloon catheter 400 and the delivery catheter 300, thereby facilitating control of the (rotational) orientation of the stent 202 by manipulation of the balloon catheter 400.

[0152] To further facilitate control of the (rotational) orientation of the stent 202, in certain embodiments, it is envisioned that the lumen 404 of the balloon catheter 400 includes a non-circular cross-sectional (e.g., triangular) configuration corresponding to that defined by the guidewire 500 in order to inhibit (if not completely prevent) relative rotation between the balloon catheter 400 and the guidewire 500.

[0153] To anchor the guidewire 500 within the blood vessel V, in certain embodiments, it is envisioned that the guidewire 500 includes one or more anchors 506 at (or adjacent to) its distal end 504. For example, in a particular embodiment seen in FIG. 2B , the anchor 506 includes a bifurcated wire segment 508 that defines multiple segments 510 (e.g., a first segment 5lOi and a second segment 5lOi). When a predetermined radial force is applied to the anchor 506, the segments 510 are oriented in different directions within the wall of the blood vessel V.

[0154] It is envisioned that the anchor(s) 506 are configured to be moved from a first (inserted, inactive, collapsed) configuration, in which the bifurcated wire segments 508 are disposed in a generally adjacent relationship relative to one another and to the distal end 504 of the guidewire 500, to a second (anchored, active, expanded) configuration, in which the segments 510 are spaced apart from one another, thereby anchoring the guidewire 500 within the blood vessel V upon application of an external stimulus. It is envisioned that at least one anchor 506 may be moved from the first configuration to the second configuration upon application of any suitable stimulus, including, for example, a thermal stimulus, an electrical stimulus, a mechanical stimulus, a magnetic stimulus, a hydrostatic stimulus, etc.

[0155] In various embodiments of the present disclosure, it is contemplated that the configuration of anchor(s) 506 may be varied. For example, it is contemplated that anchor(s) 506 may include a serpentine (e.g., spring-like) configuration. Additionally or alternatively, it is contemplated that anchor(s) 506 may include a ball-wire, a retrievable stent, or any other structure suitable for the intended purpose of securing guidewire 500 relative to vessel V (e.g., maintaining the (rotational) position of distal end 504 of guidewire 500).

[0156] It should be understood that the above discussion regarding anchor(s) 506 is applicable to any of the guidewires (or embodiments thereof) described herein.

[0157] 3, the pusher 302 and stent 202 are illustrated and shown positioned within the blood vessel V following removal of the delivery catheter 100. In certain embodiments, it is contemplated that the distal end 306 of the pusher 302 may extend distally beyond the stent 202 or, alternatively, as seen in FIG. 3, the distal end 306 of the pusher 302 may be conjugated to the stent 202 such that the distal end 306 of the pusher 302 does not extend distally beyond the stent 202.

[0158] FIG. 4 is a (partial) perspective view of delivery catheter 100. For simplicity and clarity, only lumen 112 of delivery catheter 100 is shown. As seen in FIG. 4, the triangular cross-sectional configuration of lumen 112 defines three linear segments (sides) 116, which are identified at proximal end 104 of delivery catheter 100 by reference characters 114i, 114ii, 114iii, and at distal end 108 of delivery catheter 100 by reference characters 114iv, 114v, 114vi. As seen in FIG. 4, linear surface 118i extends between segments 114i, 114iv, linear surface 118ii extends between segments 114ii, 114vi, and linear surface 118iii extends between segments 114iii, 114vi along the axial length of delivery catheter 100. Although shown as being of a triangular configuration, it should be understood that alternative embodiments (not shown) may employ other non-circular cross-sectional configurations, such as, for example, rectangular, pentagonal, hexagonal, octagonal, square, oval, star, etc.

[0159] 5 provides a (partial) perspective view of delivery catheter 100 rotated 120° (clockwise) from the orientation seen in FIG. 4 so that face 118ii is visible. In the illustrated embodiment, markers 114 are fixed (or otherwise supported) on face 118ii. Markers 114 may be present in any suitable number and may be located in any suitable locations. As such, it is envisioned that one or more markers 114 may be located on face 118i or face 118iii instead of or in addition to face 118ii. In the particular embodiment illustrated, for example, the delivery catheter 100 includes a (first) marker 114i located at (or adjacent to) the proximal end 104 of the delivery catheter 100 (e.g., on the hub of the delivery catheter 100), a (second) marker 114ii located at (or adjacent to) the distal end 108 of the delivery catheter 100 (e.g., on the hub of the delivery catheter 100, which is located outside the body so as to be directly visualized), and a (third) marker 114iii located between markers 114i, 114ii, each of the markers 114 being oriented at the “12 o'clock” position.

[0160] 6 shows the stent 202 loaded onto the pusher 302 during insertion into the lumen 112 of the delivery catheter 100. As discussed above, the lumen 112 and the pusher 302 include corresponding non-circular (e.g., triangular) cross-sectional configurations that inhibit (if not completely prevent) relative rotation between the pusher 302 (and thus the stent 202) and the delivery catheter 100, while allowing relative axial (longitudinal) movement (e.g., sliding) of the pusher 302 (and thus the stent 202) through the lumen 112.

[0161] However, as described below, a variety of other non-circular cross-sectional (lateral) configurations are also contemplated by the present disclosure.

[0162] 7A-7D, as indicated above, the lumen 112 extending through the delivery catheter 100 (as well as the pusher 302, the guidewire 500, the lumen 404 within the balloon catheter 400, etc.) can include, for example, a square-shaped configuration (FIG. 7A), a pentagonal configuration (FIG. 7B), an arrow-shaped configuration (FIG. 7C), a star-shaped configuration (FIG. 7D), or any other suitable non-circular cross-sectional configuration that inhibits (if not completely prevents) relative rotation between the appropriate structures.

[0163] FIG. 7E illustrates a variation of a delivery catheter 100 in which the proximal end 104 includes markers 114i, 114ii at the "12 o'clock" and "6 o'clock" positions, respectively, and the distal end 108 includes a marker 114iii at the "12 o'clock" position.

[0164] FIG. 8 shows the pusher 302 .

[0165] FIG. 9 illustrates a packaging catheter 300 and a lumen 316 extending through an elongate body 310, which in the illustrated embodiment includes a non-circular (eg, triangular) cross-sectional configuration.

[0166] 10 illustrates an alternative embodiment of pusher 302 where distal end 306 includes a tapered configuration. However, it should be understood that distal end 306 of pusher 302 may include any suitable configuration in various embodiments of the present disclosure, such as, for example, rounded, pointed, etc.

[0167] FIG. 11 illustrates an embodiment of a delivery catheter 100 in which the proximal end 104 includes a hub 120. More specifically, the delivery catheter 100 is shown with the distal end 108 (e.g., after insertion into a vessel V (FIG. 2A)) offset (rotationally) from the proximal end 104, as indicated by markers 114i, 114ii included on the proximal and distal ends 104, 108, respectively. In the particular orientation seen in FIG. 11, the delivery catheter 100 is deflected (twisted) such that the marker 114ii on the distal end 108 is at a "10 o'clock" position (e.g., such that the distal end 108 of the delivery catheter 100 is (rotationally) offset by (approximately) 60° from the proximal end 104), as compared to the "12 o'clock" position of the marker 114i on the proximal end 104 provided on the hub 120.

[0168] FIG. 12 illustrates a pusher 302 inserted into the lumen 112 of the delivery catheter 100 seen in FIG.

[0169] 13 and 14 illustrate an alternative embodiment of the present disclosure in which a delivery device includes an elongated outer hypotube (member) 700 (FIG. 13) and an inner hypotube 800 (FIG. 14). The outer hypotube 700 supports a stent 202 (e.g., the stent 202 is secured to or otherwise connected to an outer surface 702 of the outer hypotube 700) and defines a lumen 704 extending therethrough. Although the outer hypotube 700 is illustrated as including a (generally) annular (circular, circular) cross-sectional configuration (e.g., for use during procedures in which rotation is not required), it should be understood that the outer hypotube 700 may include a non-circular cross-sectional configuration in alternative embodiments (e.g., for use during procedures in which rotation is required).

[0170] Although hypotubes 700, 800 are each shown as including a (generally) circular outer cross-sectional configuration, it should be understood that the particular configuration of hypotubes 700, 800 may be varied without departing from the scope of the present disclosure. For example, it is envisioned that hypotubes 700, 800 may each include an outer cross-sectional configuration that is non-circular (e.g., elliptical, square, rectangular, triangular, trapezoidal, diamond, pentagonal, hexagonal, heptagonal, octagonal, non-angular, decagonal, etc.).

[0171] The inner hypotube 800 includes wings 802 extending proximally (rearwardly) from its distal end 804 and defining a lumen 806 extending therethrough. The inner hypotube 800 is configured for insertion into the lumen 704 of the outer hypotube 700 (FIG. 13) such that the wings 802 are positionable relative to the stent 202 to cover and restrain the stent 202 during insertion into the vessel V; The stent 202 is unsheathed (exposed) by moving the inner hypotube 800 proximally within the lumen 704 of the outer hypotube 700, by moving the outer hypotube 700 proximally relative to the inner hypotube 800, etc.), thereby automatically expanding the stent 202 within the vessel V; During movement or repositioning of the stent 202 within the vessel V, the stent 202 can be resheathed (e.g., by moving the inner hypotube 800 distally within the lumen 704 of the outer hypotube 700, by moving the outer hypotube 700 distally relative to the inner hypotube 800, etc.).

[0172] It is contemplated that the lumen 806 extending through the inner hypotube 800 and / or the lumen 704 extending through the outer hypotube 700 may be configured to receive a guidewire (e.g., the guidewire 500 described above) to facilitate use in "over the wire" deployment. It is also contemplated that the inner hypotube 800 and / or the outer hypotube 700 may include a rapid exchange configuration (e.g., the inner hypotube 800 may include a side hole in communication with the lumen and / or the outer hypotube 700 may include a side hole in communication with the lumen configured to receive the guidewire 500).

[0173] FIG. 14A illustrates an alternative embodiment of the outer and inner hypotubes 700, 800 seen in FIGS. 13 and 14, which are identified by reference characters 700i and 800i, respectively, for use during an alternative procedure. The inner hypotube 800i includes a lumen 806i extending therethrough and supporting a stent 202 mounted (connected, supported) on its outer surface 808i. The outer hypotube 700i includes a lumen 704i configured to receive the inner hypotube 800i such that the inner hypotube 800i is longitudinally (axially) movable within the outer hypotube 700i. Upon sufficient relative longitudinal (axial) movement between the hypotubes 700i, 800i, the stent 202 is exposed from the distal end 706i of the outer hypotube 700i and is automatically deployed (expanded).

[0174] FIG. 15 illustrates a guidewire 500. In the illustrated embodiment, guidewire 500 includes a non-circular (e.g., triangular) cross-sectional configuration defining three straight sides (sides), identified by reference characters 512i, 512ii, 512iii. Although shown to be of a (generally) triangular configuration, it should be understood that alternative embodiments (not shown) may employ other non-circular cross-sectional configurations, such as, for example, rectangular, pentagonal, hexagonal, octagonal, square, oval, star, arrow, etc. In the configuration seen in FIG. 15, guidewire 500 is illustrated without any significant (rotational) offset between its respective proximal and distal ends 502, 504. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0175] Embodiments of the apparatus and apparatus variations of the present disclosure will now be described with reference to the above drawings. With reference to Figure 1A, a delivery catheter 100 is illustrated. As discussed above, the aforementioned lumen 112 extends through the delivery catheter 100 and includes a (first) non-circular transverse (side) cross-sectional configuration. Although the transverse (side) cross-sectional configuration of the lumen 112 is shown in Figure 1A as being (generally) triangular, a variety of other non-circular transverse (side) cross-sectional configurations are also contemplated by the present disclosure, including, for example, as discussed above, rectangular, pentagonal, hexagonal, octagonal, square-shaped, oval (elliptical), star-shaped, arrow-shaped, etc. The lumen 112 is configured to (slidably) receive an (elongated) medical device, such as, for example, the pusher 302 of the packaging catheter 300 (FIG. 2A), the balloon catheter 400 (FIG. 2B), the hypotube 700 (FIG. 13), the hypotube 800 (FIG. 14), the hypotube 700i (FIG. 14A), the hypotube 800i (FIG. 14A), the guidewire 500, etc. As described in more detail herein, a medical device intended for insertion into lumen 112 may be moved longitudinally (axially) (e.g., to permit (sliding) movement of the medical device through delivery catheter 100 while restricting (if not entirely preventing) rotation of the medical device within delivery catheter 100 to facilitate control of the (rotational) orientation of the medical device during deployment and positioning of stent 202. Depending on the particular geometry of the cross-sectional configuration defined by lumen 112 and the medical device, the medical device may be inserted into lumen 112 in a number of discrete (rotational) orientations. For example, in the context of the triangular cross-sectional configuration seen in FIG. 1A, an inserted medical instrument may be oriented in one of three different (rotational) orientations offset from one another by (approximately) 120°. However, it should be understood that the number of distinct (rotational) orientations and the offsets therebetween may vary depending on the particular cross-sectional configuration employed. For example, in the context of a square cross-sectional configuration, an inserted medical instrument may be oriented in one of four different (rotational) orientations offset from one another by (approximately) 90°.

[0176] 1B is a diagram showing delivery catheter 100 within blood vessel V, with only lumen 112 shown for simplicity and clarity. Delivery catheter 100 is positioned within blood vessel V such that distal end hole 110 is located proximate (e.g., at or adjacent) to aneurysm A (or other vascular abnormality) that is the subject of an associated medical procedure. Due to the generally straight configuration and shape of lumen 112, delivery catheter 100 includes a set orientation in which one side is positioned closest to the aneurysm A of interest.

[0177] FIG. 1C illustrates the pusher 302 positioned with the lumen 112 of the delivery catheter 100 in a first orientation, and FIG. 1D illustrates the pusher 302 and delivery catheter 100 positioned in a second, different orientation that is rotationally offset from the first orientation. More specifically, FIG. 1D shows the pusher 302 and delivery catheter 100 after a 120° counterclockwise rotation (or a 240° clockwise rotation). Rotation of the delivery catheter 100, and thus the pusher 302, allows the occlusion device 200 (e.g., stent 202) (FIGS. 2A, 2C) to be delivered and positioned in a required or desired orientation, for example, as dictated by the location of the aneurysm A. Similar setups can be used to deliver other devices, such as the aneurysm neck cap with an asymmetric shape for covering an asymmetric aneurysm neck previously described by Walzman (U.S. Pat. No. 10,543,015). It is envisioned that one or more supplemental (additional) occlusion device(s) 200 may be used as well during the course of a particular medical procedure. As described herein, the orientation of the medical instruments (e.g., pusher 302 and stent 202) inserted through the delivery catheter 100 may be fixed outside the patient's body by fixing the orientation of the medical instruments relative to the delivery catheter 100. The orientation of the delivery catheter 100 (e.g., relative to aneurysm A) may be established prior to insertion of the medical instruments into the lumen 112, such as via imaging, to facilitate proper insertion of the medical instruments to achieve proper orientation and placement of the stent 202 relative to aneurysm A without requiring rotational manipulation (e.g., pivoting) of the pusher 302 and thus the stent 202 inside the patient.

[0178] 2A shows a packaging catheter 300 connected to a delivery catheter 100 via a hub 600 such that the elongated body 310 is disposed external to the patient. In the illustrated embodiment, the lumen 316 extending through the elongated body 310 of the packaging catheter 300 includes a non-circular cross-sectional (side) configuration corresponding to that defined by the lumen 112 and the pusher 302 of the delivery catheter 100. Although shown in FIG. 2A as being (generally) triangular, it should be understood that the cross-sectional configuration defined by the lumen 316 of the elongated body 310 of the packaging catheter 300 may vary in alternative embodiments without departing from the scope of the present disclosure (e.g., depending on the particular cross-sectional configurations defined by the lumen 112 and the pusher 302 of the delivery catheter 100).

[0179] The distal end 306 of the pusher 302 (releasably) supports the stent 202 such that the stent 202 can be positioned proximate (e.g., close to or adjacent to) the aneurysm A. Insertion of the pusher 302 and stent 202 into the lumen 112 of the delivery catheter 100 is facilitated via positioning the distal end 20 of the packaging catheter 300 and the proximal end 104 of the delivery catheter 100 within the hub 600. To facilitate proper relative orientation of the packaging catheter 300 (e.g., pusher 302 and stent 202) and the delivery catheter 100, as well as proper orientation of the packaging catheter 300 within the blood vessel V, in the illustrated embodiment, the hub 600 includes one or more markers (e.g., radiopaque markers) 604, and the packaging catheter 300 includes one or more markers (e.g., radiopaque markers) 318 (e.g., first and second markers 318i, 318ii, respectively, positioned at (or adjacent) the proximal and distal ends 304, 306 of the elongate body 310) that are alignable with the marker(s) 114 on the delivery catheter 100. The marker(s) 604 on the hub 600, the marker(s) 318 on the packaging catheter 300, and the marker(s) 114 on the delivery catheter 100 are positioned at corresponding (rotational) positions such that the relative orientations of the packaging catheter 300, the hub 600, and the delivery catheter 100 can be viewed and controlled (e.g., via rotation of the packaging catheter 300, the pusher 302, and / or the elongated body 310 of the delivery catheter 100). In the illustrated embodiment, for example, the marker(s) 604 on the hub 600, the marker(s) 318 on the packaging catheter 300, and the marker(s) 114 on the delivery catheter 100 are each shown in the “12 o'clock” position. However, it should be understood that the markers 604, 318, and 114 may be positioned in any location suitable for the intended purpose of facilitating proper relative (rotational) orientation of the packaging catheter 300 (e.g., the pusher 302 and the stent 202) and the delivery catheter 100.

[0180] 2A , in use, packaging catheter 300 is connected to hub 600 such that marker 604 on hub 600 is oriented in the "12 o'clock" position. Depending on the particular configuration of stent 202, when positioned in this manner, pusher 302 and stent 202 may be oriented in a predetermined manner (e.g., such that first region 204 (or second region 206) of stent 202 faces (or is otherwise (rotationally) aligned with) aneurysm A.

[0181] 3 illustrates the positioning of pusher 302 and stent 202 within blood vessel V following removal of delivery catheter 100 (FIG. 2A). Once stent 202 is positioned proximate to aneurysm A (e.g., at or adjacent to aneurysm A), stent 202 can be actuated, released, or otherwise deployed such that stent 202 expands within blood vessel V. Alternatively, it is contemplated that stent 202 may be deployed via balloon catheter 400 (FIG. 2B) upon inflation of expansion member 406.

[0182] For example, in the particular embodiment shown, the stent 202 is oriented such that a first (covered, less porous) region 204 of the stent 202 abuts the aneurysm A, while a second (uncovered, more porous) region 206 of the stent 202 promotes (or otherwise permits) blood flow to side branches of the vessel V that the stent 202 may cross. The stent 202 is contemplated to include a (generally) cylindrical configuration when expanded, e.g., as seen in FIG. 2C, although it is contemplated that the configuration of the stent 202 may vary in alternative embodiments of the present disclosure (e.g., depending on the particular requirements of the surgical procedure, the configuration and / or orientation of the aneurysm A (or other vascular anomaly), etc.). It is also contemplated that the stent 202 may be (temporarily) crimped (or otherwise deformed) into an alternative shape when loaded into the pusher 302, the expandable member 406 of the balloon catheter 400, or other such suitable medical device. However, it should be understood that the configuration of the medical device supporting the stent 202 can be modified or changed as necessary or desired to facilitate placement of the stent 202 in the intended manner. For example, it is envisioned that the medical device supporting the stent 202 can include cylindrical or non-cylindrical configurations at various locations along its length (e.g., proximal to the stent 202, distal to the stent 202, and / or within the stent 202). It is envisioned that the medical device supporting the stent 202 can have a suitable configuration such that, for example, the expandable member 406 (circular, circular, tubular, toroidal) can be folded, contracted, and attached to an elongated member, such as the body 402 of the balloon catheter 400, such that the expandable member 406 (when contracted) and the stent 202 (when collapsed) can assume corresponding (e.g., similar or identical) configurations when crimped onto the expandable member 406. It is envisioned that an external crimper of the same configuration can be used during the crimping process.

[0183] 4, there is illustrated the lumen 112 of the delivery catheter 100. More specifically, FIG. 4 illustrates the delivery catheter 100 having no (rotational) offset between the distal end 108 and the proximal end 104. It is envisioned that the (generally) triangular (transverse) cross-sectional configuration of the lumen 112 may facilitate (or otherwise facilitate) identification of the (rotational) orientation of the lumen 112.

[0184] 5 shows the delivery catheter 100 rotated (approximately) 120° (clockwise) from the orientation seen in FIG. 4 so that the linear surface 555 is visible. In the particular embodiment shown, the linear surface 555 includes a marker(s) 114 that facilitates visualization and proper orientation of the delivery catheter 100 during placement within the vessel V by allowing the clinician to ascertain the orientation of the linear surface 555 relative to any appropriate component or anatomical structure of the endovascular system 10 (e.g., aneurysm A). With that information, it is envisioned that the packaging catheter 300 can be properly oriented (e.g., relative to the hub 600) so that the stent 202 can be oriented as needed or desired (e.g., with the first (covered, less porous) region 204 of the stent 202 abutting the aneurysm A) as the pusher 302 and stent 202 advance through the delivery catheter 100.

[0185] In certain embodiments, it is envisioned that the marker 114ii at the distal end 108 of the delivery catheter 100 may (further) assist in visualization of the (rotational) position of the distal end 108 of the delivery catheter 100 (e.g., relative to an aneurysm A, a lesion, a side branch of a vessel V, or other such anatomical structure).

[0186] 6 shows the stent 202 supported by the pusher 302 prior to insertion of the stent 202 and pusher 302 into the lumen 112 of the delivery catheter 100. During introduction into the vessel V, the stent 202 is crimped (or otherwise secured to the pusher 302) such that the stent 202 is in a first (initial, insertion) configuration in which the stent 202 includes a cross-sectional configuration that corresponds to the cross-sectional configuration defined by the pusher 302. Thus, in the illustrated embodiment, the stent 202 includes a (generally) triangular cross-sectional shape prior to deployment. However, upon expansion, the stent 202 moves to a second (subsequent, active) configuration in which the stent 202 includes a different cross-sectional shape than that defined by the stent 202 in the first configuration. For example, in the particular embodiment shown, when the stent 202 is deployed (exposed) from the distal end 108 of the delivery catheter 100 (within the blood vessel V) and is released from restraint by the delivery catheter 100, the stent 202 automatically expands to the (generally) cylindrical (tubular) configuration seen in FIG. 2C.

[0187] [First Method] In one method of use, the delivery catheter 100 is inserted into the vessel V with its proximal end 104 at or adjacent the hub 600 and the markers 114i, 114ii in the "12 o'clock" position, allowing one to ascertain (e.g., by external visualization using any suitable technique) the degree (if any) of (rotational) deflection experienced by the delivery catheter 100 during insertion into the vessel V. The packaging catheter 300, including the pusher 302 and the stent 202, is then inserted into the delivery catheter 100. In the particular method described, the stent 202 includes the above-mentioned differential porosity due to the disparity between the regions 204, 206 (FIG. 2C). After ascertaining (e.g., relative to the hub 600) the degree of (rotational) deflection (if any) that the distal end 108 of the delivery catheter 100 experiences, the packaging catheter 300 is oriented accordingly to reduce (if not completely eliminate) the (rotational) offset between the stent 202 and the distal end 108 of the delivery catheter 100.

[0188] As mentioned above, it is envisioned that the hub 600 and the packaging catheter 300 each include one or more markers 604, 318 to support more accurate relative (rotational) orientation between the packaging catheter 300 and the delivery catheter 100. The markers 604, 318 can be positioned at any location to point in any direction. The term "12 o'clock" should not be construed as limiting in any sense, but rather as an exemplary indication of location. For example, the clinician (user) may be instructed to rotate the hub 600 to the "3 o'clock" position, the "6 o'clock" position, the "9 o'clock" position, etc., which intuitively suggests a quarter turn, a half turn, a three-quarter turn, etc., respectively, with other "o'clocks" referring to approximate positions in between (e.g., the "2 o'clock" position, the "5 o'clock" position, the "11 o'clock" position, etc.). The same effect can be achieved by utilizing terms such as "East", "South", and "West" (or intermediate positions such as "ESE" or "NW") to refer to the "North" marker. The delivery catheter 100 and the packaging catheter 300 may be configured to rotate through a 360° range of motion (e.g., pre-associated (engaged, connected) with one another) to enable positioning of the delivery catheter 100 and the packaging catheter 300 in any manner desired or required by the particular procedure being performed (e.g., based on the size, location, nature of the vascular abnormality being treated, etc.).

[0189] After connection of the packaging catheter 300 and the delivery catheter 100 (e.g., via an interconnection with the hub 600), the stent 202 is inserted into the delivery catheter 100 in a particular orientation (e.g., relative to the "12 o'clock" marker 114 of the delivery catheter 100). After insertion into the delivery catheter 100, the final (rotational) orientation of the stent 202 is determined by (corresponding to) the (rotational) orientation of the distal end 108 of the delivery catheter 100. For example, even if introduced in the "12 o'clock" position at the hub 600, the stent 202 may be deployed in the "3 o'clock" position, the "6 o'clock" position, etc., depending on the degree (if any) of (rotational) deflection experienced by the delivery catheter 100 during navigation of the blood vessel V on the path to aneurysm A (for example), identifiable via the marker 114ii disposed at its distal end 108.

[0190] If the predicted (rotational) position of the stent 202 is not appropriate (e.g., if a different (rotational) position of the stent 202 is needed or desired), the stent 202 can be rotated appropriately (e.g., relative to the marker 114ii on the distal end 108 of the delivery catheter 100) prior to insertion into the delivery catheter 100 (e.g., via rotational manipulation of the packaging catheter 300 (e.g., the pusher 302)). Additionally or alternatively, the final t (rotational) position of the stent 202 can be determined via rotational manipulation of the delivery catheter 100 and thus after insertion of the pusher 302 and stent 202 into the delivery catheter (e.g., the delivery catheter, pusher 302, and stent 202 can be rotated together via a non-rotating interface provided by the corresponding non-circular (transverse) cross-sectional configurations defined by the pusher 302 and the lumen 112 extending through the delivery catheter 100).

[0191] In the context of the triangular (transverse) cross-sectional configuration of the pusher 302 and lumen 112, the packaging catheter 300 may be positioned in three discrete (rotational) positions prior to inserting the pusher 302 into the lumen 112 of the delivery catheter 100. To facilitate further (rotational) precision, it is envisioned that the stent 202 will be pre-loaded into the elongate body 310 of the packaging catheter 300 (e.g., during packaging by the manufacturer) in various (rotational) orientations, which may be identified via labeling on the device, its packaging, or the like.

[0192] This process can be repeated to ensure consistent alignment of the respective markers 114, 318 on the delivery catheter 100 and packaging catheter 300. Imaging can then be performed to ascertain the relative (rotational) positions of the markers 114, 318 in order to determine the required (rotational) orientation (e.g., "hour" on a "clock") of the stent 202 (prior to insertion into the delivery catheter 100) to achieve the required final (rotational) position within the vessel V.

[0193] In certain embodiments, prior to insertion of the stent 202, the final (rotational) position of the stent 202 may be confirmed via insertion of a test stent (or other such device). The test stent may be temporarily advanced in a predicted direction, visualized using any suitable imaging technique, and then removed prior to insertion and deployment of the stent 202. To facilitate such visualization, it is envisioned that the test stent (or other such device) may include one or more suitable markers (e.g., radiopaque markers). For example, in an example where the fence is identified during test insertion in the "7 o'clock" position (which is offset (approximately) 90° in a clockwise direction relative to the target branch vessel), the packaging catheter 300 may be reoriented to the "4 o'clock" position to facilitate proper orientation of the stent 202. Once the distal end 108 of the delivery catheter 100 has been imaged and it has been determined that the distal end 108 is in the required position, the stent 202 can be loaded into the delivery catheter 100 in the proper (required) orientation and advanced to the target site.

[0194] [Second Method] A second method of use will now be described, employing the steps, devices, markers, etc. described above in connection with the first method. As described above, while the lumen 112 extending through the delivery catheter 100 includes a unique (transverse) non-circular cross-sectional configuration, in an exemplary embodiment, the delivery catheter 100 includes an outer (transverse) cross-sectional configuration that is (generally) annular (e.g., circular, circular) to facilitate advancement of the delivery catheter 100 through a patient's vasculature, circulatory vessels, etc. The non-circular (transverse) cross-sectional configuration defined by the lumen 112 reduces (if not eliminates) relative rotation between the delivery catheter 100 and the inserted medical instrument (e.g., pusher 302, hypotube 700 (FIG. 13), hypotube 800 (FIGS. 13, 14), balloon catheter 400, etc.), improving precision during placement within the vessel V and increasing predictability of the final position of the stent 202.

[0195] Although lumen 112 is illustrated as including a (generally) triangular (cross-sectional) configuration, alternative configurations are contemplated herein (e.g., square, hexagonal, octagonal, pentagonal, a "house" silhouette, oval, elliptical, star-shaped, etc.). In the context of a star-shaped (cross-sectional) configuration, any style of star may be used, including, for example, a six-pointed star, a "Star of David", etc.

[0196] It is envisioned that the cross-sectional configuration of the lumen 316 extending through the elongate body 310 of the packaging catheter 300 may correspond to the cross-sectional configuration of the lumen 112 extending through the delivery catheter 100, as may be understood by reference to, for example, Figures 1A-2A. The interface defined by the lumen 316 and the medical device disposed therein (e.g., pusher 302, hypotube 700 (Figure 13), hypotube 800 (Figures 13, 14), etc.) is such that the lumen 316 permits longitudinal (axial) movement (e.g., axial) while inhibiting (if not entirely preventing) relative rotation between the medical device within the lumen 316 and the packaging catheter 300, thereby (substantially) maintaining the (rotational) position of the medical device relative to the packaging catheter 300 (and delivery catheter 100), thereby facilitating accurate and predictable deployment (e.g., of stent 202).

[0197] In another example, as seen in FIG. 2B, the guidewire 500 described above can be utilized to facilitate deployment of the stent 202 via the balloon catheter 400. In such an embodiment, the guidewire 500 can be advanced into the blood vessel V via any suitable intravascular method. To inhibit (if not completely prevent) relative rotation between the balloon catheter 400 and the guidewire 500, thereby facilitating control of the (rotational) orientation of the balloon catheter 400 and the stent 202, it is contemplated that the guidewire 500 and lumen 404 extending through the elongate body 402 of the balloon catheter 400 can include a corresponding non-circular (e.g., triangular) (transverse) cross-sectional configuration. In various embodiments, it is contemplated that the non-circular (transverse) cross-sectional configuration extends continuously along the entire length of the guidewire 500. Alternatively, it is contemplated that the non-circular (transverse) cross-sectional configuration extends only along a portion of the length of the guidewire 500.

[0198] To facilitate visualization of the guidewire 500 in vivo, the guidewire 500 may include one or more markers 514 (e.g., radiopaque or other such markers). For example, in the particular embodiment seen in FIG. 2B, the guidewire 500 includes a first marker 514i located at (or adjacent to) the proximal end 502 of the guidewire 500 (which may be external to the patient) and a second marker 514ii located at (or adjacent to) the distal end 504 of the guidewire 500, each of which may be located at the "12 o'clock" position (or any other suitable reference direction).) In one particular embodiment, it is envisioned that the marker(s) 514 are located at (or adjacent to) the transition between a first portion of the guidewire 500 that includes a non-circular (transverse) cross-sectional configuration and a second portion of the guidewire 500 that includes a (generally) circular (transverse) cross-sectional configuration. However, it is also envisioned that various distinct radiopaque markers 514 of differing radiodensities, shapes, or orientations, etc., may be utilized in association with guidewire 500 (or any of the components of intravascular system 10 described herein, including, e.g., delivery catheter 100, etc.) (e.g., to further facilitate visualization, differentiation, etc.). By visualization, the (rotational) position of marker 514ii may be determined relative to marker 514i, any vascular abnormality (e.g., aneurysm A), the origin of a side branch, etc.

[0199] Once the (rotational) position of the marker 514ii at the distal end 504 of the guidewire 500 has been determined, the balloon catheter 400 can be advanced over the guidewire 500 and into the blood vessel V such that the guidewire 500 is received within the lumen 404.

[0200] After balloon catheter 400 is positioned as desired within blood vessel V, expansion member 406 can be expanded to deploy (place) stent 202. As indicated above, if desired, a test stent (or other such device) can be deployed and recaptured prior to deploying stent 202 to confirm the rotational position of guidewire 500 at the target location (e.g., at or adjacent aneurysm A) and thus the predicted final location of stent 202.

[0201] In various alternative embodiments, it is envisioned that guidewire 500 and balloon catheter 400 may be configured (adapted) for use in both the "over the wire" configuration and the rapid exchange configuration as described above.

[0202] In another exemplary procedure, it is envisioned that the guidewire 500 may be used in combination with the packaging catheter 300 to facilitate placement and deployment of the pusher 302 and stent 202 through the delivery catheter 100. In such an embodiment, the guidewire 500 may be utilized to facilitate placement of the delivery catheter 100 into the blood vessel V over the guidewire 500. In such an embodiment, it is envisioned that the guidewire 500 and lumen 112 (FIG. 1A) extending through the delivery catheter 100 include a corresponding non-circular (transverse) cross-sectional configuration to inhibit (if not completely prevent) relative rotation between the delivery catheter 100 and the guidewire 500.

[0203] After the guidewire 500 is placed and the delivery catheter 100 is inserted over the guidewire 500 into the blood vessel V, the guidewire 500 can be removed to allow the pusher 302 and stent 202 to be inserted from the elongate body 310 of the packaging catheter 300 into the delivery catheter 100. As noted above, it is also envisioned that the pusher 302 and lumen 112 extending through the delivery catheter 100 include corresponding non-circular (transverse) cross-sectional configurations. Thus, in such embodiments, the (transverse) cross-sectional configuration defined by the lumen 112 extending through the delivery catheter 100 may be common (shared) to both the pusher 302 and the guidewire 500.

[0204] In such an embodiment, when the pusher 302 is advanced sufficiently through the delivery catheter 100, the stent 202 emerges from its distal end, at which point the external constraint applied to the stent 202 by the lumen 112 is removed such that the stent 202 is automatically deployed within the vessel V.

[0205] It is contemplated that an inner hypotube and an outer hypotube (e.g., a catheter) may be utilized in place of the pusher 302 during an "over the wire" procedure to facilitate delivery of the (self-expanding) stent 202. In the embodiment of the present disclosure seen in FIGS. 13 and 14, for example, the stent 202 is loaded (mounted) onto the outer hypotube 700. The inner hypotube 800 is disposed over the guidewire 500 (e.g., such that the guidewire 500 extends through the lumen 9094) and is received by the lumen 704 of the outer hypotube 700. It is contemplated that the lumen 9094 and the guidewire 500 include corresponding non-circular (transverse) cross-sectional configurations, which permit relative axial movement between the guidewire 500 and the inner hypotube 800 while restricting (if not completely preventing) relative rotation between the guidewire 500 and the inner hypotube 800, as discussed above. The wings 802 extend proximally from the inner hypotube 800 to cover (sheath) the stent 202 during insertion into the blood vessel V, thereby restraining the stent 202 to maintain the stent 202 in a collapsed configuration during insertion into the blood vessel V. Once positioned proximate (or adjacent) the aneurysm A, the relative longitudinal (axial) position of the hypotubes 9091, 9092 can be changed to unsheath the stent 202 (e.g., exposed from the wings 802), releasing the external restraint imposed by the wings 802 and allowing the stent 202 to expand (deploy).

[0206] In another embodiment shown in Figures 13A and 14A, the stent 202 is supported on an inner hypotube 800i which extends into an outer hypotube 700i such that the outer hypotube 700i covers the stent 202, thereby constraining the stent 202 and inhibiting its expansion during insertion into the vessel V, such that the guidewire 500 is received within a lumen 9094i of the inner hypotube 800i. As described in connection with hypotubes 9091, 9092, it is envisioned that the lumen 9094i and guidewire 500 include corresponding (transverse) cross-sectional configurations to permit relative axial movement between the guidewire 500 and the inner hypotube 800i while inhibiting (if not entirely preventing) relative rotation between the guidewire 500 and the inner hypotube 800i. Once the stent 202 is positioned as desired within the blood vessel V (e.g., proximal (or adjacent) to the aneurysm A), the outer hypotube 700i can be retracted (moved proximally), thereby exposing the stent 202 and removing the external restraint provided by the outer hypotube 700i to permit expansion (deployment) of the stent 202.

[0207] In various embodiments of the present disclosure, it is contemplated that the medical instruments described herein may include an energy member 900 (FIG. 2C) configured to deliver ultrasound, RF energy, or the like to a target site (e.g., aneurysm A). Delivery may be through or adjacent to a stent. For example, delivery of energy to a target site is contemplated to soften calcifications in the wall of a blood vessel V (e.g., in the context of intravascular lithotripsy similar to devices manufactured by Shockwave Medical, Inc.).

[0208] While shown as being associated with stent 202 (FIG. 2C), it should be understood that the energy component 900 may be associated with any of the medical devices (or components thereof) described herein, and energy may be delivered in any suitable manner using any suitable structure(s) (e.g., wire(s), etc.). For example, it is envisioned that the energy component 900 may be provided on (or otherwise in communication with) the delivery catheter 100, the balloon catheter 400 (e.g., expandable member 406), the guidewire 500, the pusher 302, the anchor(s) 506, etc.

[0209] In another embodiment of the present disclosure, the devices and methods described herein may be adapted for the treatment of bifurcated vessels, lesions, etc. With reference to Figures 16 and 17, an alternative embodiment of an endovascular system 10 is disclosed and is identified by the reference character 1000. The endovascular system 1000 includes a primary delivery catheter 1100 defining a lumen 1102 and a (first) delivery device 1200 configured for insertion through the delivery catheter 1100 into a blood vessel V to deploy a primary stent 1300 (e.g., a first palisade occlusion device), which may be substantially similar or identical to the stent 202 described above.

[0210] Although the primary delivery catheter 1100 and delivery device 1200 are each shown as including a (generally) circular outer cross-sectional configuration, it should be understood that the specific configurations of the primary delivery catheter 1100 and delivery device 1200 may be varied without departing from the scope of the present disclosure. For example, it is envisioned that the primary delivery catheter 1100 and delivery device 1200 may each include an outer cross-sectional configuration that is non-circular (e.g., elliptical, square, rectangular, triangular, trapezoidal, diamond, pentagonal, hexagonal, heptagonal, octagonal, non-angular, decagonal, etc.).

[0211] In the embodiment seen in Figure 17, the (first) delivery device 1200 is configured as the packaging catheter 300 (Figure 2A) previously described. In such an embodiment, the primary stent 1300 is carried (supported) on the pusher 302 and configured to self-expand upon exposure from the delivery catheter 1100. To inhibit relative rotation between the delivery catheter 1100 and the primary stent 1300, it is envisioned that the lumen 1102 of the delivery catheter 1100 and the pusher 302 may include a corresponding non-circular (e.g., triangular) (cross-sectional) configuration.

[0212] Alternatively, and with reference to Figures 18-25, it is envisioned that the (first) delivery device 1200 may be configured as a balloon catheter 1400. The balloon catheter 1400 includes an elongate body (member) 1402 having proximal and distal ends 1404, 1406 defining end holes 1408, 1410, respectively, and having a series of lumens 1412 extending therethrough. More specifically, the balloon catheter 1400 includes a (first) lumen 1412i, a (second) lumen 1412ii extending in (generally) parallel relationship with the lumen 1412i, and a (third) lumen 1412iii extending in (generally) parallel relationship with the lumen 1412i and / or the lumen 1412ii. The balloon catheter 1400 further includes an expandable member (balloon) 1414 secured to the elongate body 1402 and supporting the primary stent 1300. In the particular embodiment shown, the expandable member 406 includes a (first) palisade (aperture, opening) 1416 and the primary stent 1300 includes a (second) palisade (aperture, opening) 1302.

[0213] Although shown as including a (generally) circular outer cross-sectional configuration, it should be understood that the particular configuration of the balloon catheter 1400 may be varied without departing from the scope of the present disclosure. For example, it is envisioned that the balloon catheter 1400 may include an outer cross-sectional configuration that is non-circular (e.g., elliptical, square, rectangular, triangular, trapezoidal, rhombus, pentagonal, hexagonal, heptagonal, octagonal, non-diagonal, decagonal, etc.).

[0214] In certain embodiments, it is envisioned that the lumen 1412i extends between the respective proximal and distal end holes 1408, 1410 of the balloon catheter 1400. Alternatively, the lumen 1412i may extend only along a portion of the length of the balloon catheter 1400 (e.g., from the (first, proximal) side hole to the distal end hole 1410) to support rapid exchange of the balloon catheter 1400. The lumen 1412i is configured to receive a primary (first) guidewire 1500, which may be substantially similar or identical to the guidewire 500 described above. As discussed above in connection with other embodiments of the present disclosure, the lumen 1412i and primary guidewire 1500 may include a corresponding non-circular (cross-sectional) configuration to permit relative axial movement between the primary guidewire 1500 and the balloon catheter 1400 while constraining (if not entirely preventing) relative rotation between the primary guidewire 1500 and the balloon catheter 1400, facilitating control over the (rotational) orientation of the balloon catheter 1400 and thus the primary stent 1300. In such an "over-the-wire" configuration, it is envisioned that a third branch forming a proximal extension of the lumen 1412i will be present outside the patient's body.

[0215] The lumen 1412ii is configured to communicate fluid from an inflation source to the expandable member 1414. In the particular embodiment illustrated, it is contemplated that the lumen 1412ii may be configured solely to support the inflation and deflation of the expandable member 1414. However, in alternative embodiments, it is contemplated that the lumen 1412ii may be configured to receive one or more medical instruments and / or support other functionality of the balloon catheter 1400.

[0216] The lumen 1412iii extends to a (second, distal) side hole 1418 disposed proximate (e.g., at or adjacent) the expandable member 1414. For example, it is envisioned that the side hole 1418 may be disposed proximal or distal to the expandable member 1414. Alternatively, it is envisioned that the expandable member 1414 covers the side hole 1418 such that the side hole 1418 communicates with the barrier 1416 of the expandable member 406 and the barrier 1302 of the primary stent 1300, as seen, for example, in FIG.

[0217] In various embodiments, it is envisioned that lumen 1412iii may include a "peelable" side slit to the rapid exchange length lumen, similar to the configuration in Cordis Angioguard Rx. It is also envisioned that lumen 1412iii may extend proximally (e.g., along the entire intravascular course of lumen 1412ii) or may branch proximally (e.g., outside the patient) from lumen 1412iii.

[0218] The lumen 1412iii is configured to receive a secondary delivery (medical) device 1600 to facilitate delivery of a secondary stent 1700 (e.g., a second palisade occlusion device) to a side branch S of a blood vessel V, as described in further detail below. For example, it is envisioned that the secondary delivery apparatus 1600 includes the aforementioned pusher 302 (FIGS. 20, 23), the secondary (second) guidewire 1800 (FIG. 22), which may be substantially similar or identical to the aforementioned guidewire 500, or the aforementioned balloon catheter 400 (FIG. 24). As described above in connection with the lumen 1412i and the primary guidewire 1500, it is envisioned that the lumen 1412iii and a medical device inserted therethrough may include a corresponding (transverse) cross-sectional configuration to permit relative axial movement between the medical device and the balloon catheter 1400 while inhibiting (if not entirely preventing) relative rotation between the medical device and the balloon catheter 1400.

[0219] Although shown as including a (generally) circular outer cross-sectional configuration, it should be understood that the particular configuration of the secondary delivery device 1600 may vary without departing from the scope of the present disclosure. For example, it is envisioned that the secondary delivery device 1600 may include an outer cross-sectional configuration that is non-circular (e.g., elliptical, square, rectangular, triangular, trapezoidal, diamond, pentagonal, hexagonal, heptagonal, octagonal, non-diagonal, decagonal, etc.).

[0220] In the context of treating a bifurcation stenosis, a primary guidewire 1500 (FIG. 18) may be introduced into a main branch M of a blood vessel V across the margin of the stenosis (e.g., across the side branch S). ​​The primary guidewire 1500 may then be inserted into a lumen 1412i within the balloon catheter 1400 such that the balloon catheter 1400 may be advanced over the primary guidewire 1500 (e.g., via the primary delivery catheter 1100) into the blood vessel V such that the expandable member 1414 and primary stent 1300, and thus the respective fences 1416, 1302, are positioned proximate to the origin of the side branch S of the blood vessel V (e.g., at or adjacent to the side branch S), in the manner described herein. To further facilitate control over the (rotational) orientation of the balloon catheter 1400, and thus the primary stent 1300, it is envisioned that the lumen 1102 of the balloon catheter 1400 and the primary delivery catheter 1100 may include corresponding non-circular (transverse) cross-sectional configurations so as to permit relative axial movement between the balloon catheter 1400 and the delivery catheter 1100 while suppressing (if not completely preventing) relative rotation between the balloon catheter 1400 and the delivery catheter 1100.

[0221] Prior to expansion of the expansion member 1414 and deployment of the primary stent 1300, a secondary stent 1700 may be inserted (via the second delivery device 1600) into the side branch S of the blood vessel V, which secondary stent 1700 may be self-expanding or balloon-expandable.

[0222] In the context of a self-expanding secondary stent 1700, it is contemplated that the secondary stent 1700 is deployed using any of the devices and methods described hereinabove. For example, it is contemplated that the secondary stent 1700 is deployed utilizing the packaging catheter 300 (FIGS. 20, 23) previously described. In such an embodiment, the secondary stent 1700 may be supported by the pusher 302 (which extends through the elongated body 310 (FIG. 2A) of the packaging catheter 300) such that the secondary stent 1700 automatically expands upon exposure from the balloon catheter 1400. To facilitate such deployment, it is contemplated that the pusher 302 and secondary stent 1700 are advanced through the lumen 1412iii and the side hole 1418, through the palisade 1416 of the expandable member 1414, through the palisade 1302 of the primary stent 1300, and into the side branch S.

[0223] It is contemplated that the pusher 302 and secondary stent 1700 may be advanced directly through the lumen 1412iii in the manner illustrated in FIG. 20. Alternatively, it is contemplated that a secondary guidewire 1800 (FIG. 22) substantially similar or identical to the guidewire 500 and / or primary guidewire 1500 described above may be used. In such an embodiment, the secondary guidewire 1800 is inserted into the side branch S via the lumen 1412iii prior to introduction of the pusher 302 and secondary stent 1700. In certain embodiments, it is contemplated that the secondary guidewire 1800 may include one or more of the anchor(s) 506 (FIG. 25) described above in connection with the guidewire 500 and may be positioned in any suitable location.

[0224] To facilitate use with the secondary guidewire 1800, it is contemplated that the pusher 302 may include a lumen configured to receive the secondary guidewire 1800 (e.g., such that the pusher 302 includes a "hypotube" configuration). In such an embodiment, it is contemplated that the lumen extending through the pusher 302 may include a non-circular (e.g., triangular) cross-sectional (transverse) configuration corresponding to that of the secondary guidewire 1800 to facilitate control of the relative (rotational) position of the secondary guidewire 1800 and the pusher 302 to facilitate positioning of the secondary stent 1700 within the side branch S by inhibiting (if not completely preventing) relative rotation between the secondary guidewire 1800 and the pusher 302 in the manner described above.

[0225] 23, it is envisioned that a secondary delivery catheter 1900 (e.g., a hypotube) is utilized to deploy the pusher 302 and secondary stent 1700, which may be substantially similar or identical to the delivery catheter 100 (FIG. 1A) described above. In such an embodiment, the secondary delivery catheter 1900 includes a lumen 1902 configured to receive the secondary guidewire 1800 such that the secondary delivery catheter 1900 can be advanced over the secondary guidewire 1800, through the side hole 1418, through the barrier 1416 of the expandable member 1404, through the barrier 1302 of the primary stent 1300, and into the side branch S. The pusher 302 and secondary stent 1700 can then be inserted through the lumen 1902 of the secondary delivery catheter 1900 and into the side branch S. During such use, it is contemplated that the secondary guidewire 1800 may be removed from the secondary delivery catheter 1900 or that the secondary guidewire 1800 may remain in place (e.g., within lumen 1412iii and within lumen 1902 of the secondary delivery catheter 1900). For example, it is contemplated that the pusher 302 is advanced through the lumen 1902 of the secondary delivery catheter 1900 in adjacent relationship to the secondary guidewire 1800.

[0226] While shown as including a (generally) circular outer cross-sectional configuration, it should be understood that the particular configuration of the secondary delivery catheter 1900 may be varied without departing from the scope of the present disclosure. For example, it is envisioned that the secondary delivery catheter 1900 may include an outer cross-sectional configuration that is non-circular (e.g., elliptical, square, rectangular, triangular, trapezoidal, diamond, pentagonal, hexagonal, heptagonal, octagonal, non-angular, decagonal, etc.).

[0227] To facilitate control and proper positioning of the secondary stent 1700 within the side branch S, it is envisioned that the lumen 1902 extending through the secondary delivery catheter 1900 and the secondary guidewire 1800 includes a corresponding non-circular (e.g., triangular) (transverse) cross-sectional configuration to inhibit (if not completely prevent) relative rotation between the secondary delivery catheter 1900 and the secondary guidewire 1800, thereby facilitating control of the (rotational) orientation of the secondary stent 1700 in the manner described above.

[0228] 24, in the context of a balloon-expandable secondary stent 1700, it is envisioned that the secondary stent 1700 is deployed using the balloon catheter 400 (FIG. 2B) described above. During such use, after the secondary guidewire 1800 is inserted through the lumen 1412iii into the side branch S, the balloon catheter 400 is advanced over the secondary guidewire 1800 such that the secondary guidewire 1800 extends through the lumen 404 extending through the elongate body 402 of the balloon catheter 400. Once the balloon catheter 400 has been advanced sufficiently over the secondary guidewire 1800 into the side branch S, the expansion member 406 on the balloon catheter 400 carrying the secondary stent 1700 can expand to deploy the secondary stent 1700. To facilitate control and proper positioning of the secondary stent 1700 within the side branch S, it is envisioned that the lumen 404 and secondary guidewire 1800 include corresponding non-circular (e.g., triangular) cross-sectional configurations to inhibit (if not completely prevent) relative rotation between the balloon catheter 400 and the secondary guidewire 1800, thereby facilitating control of the (rotational) orientation of the secondary stent 1700 in the manner described above. Additionally or alternatively, it is envisioned that the lumen 1412iii and elongate body 402 of the balloon catheter 400 include corresponding non-circular (e.g., triangular) cross-sectional configurations to inhibit (if not completely prevent) relative rotation of the balloon catheter 400 within the lumen 1412iii.

[0229] In those embodiments in which the secondary stent 1700 includes substantially larger gaps (e.g., so as not to significantly (substantially) impede blood flow), it is contemplated that the secondary guidewire 1800 and the corresponding medical device supporting the secondary stent 1700 (e.g., pusher 302, balloon catheter 400, etc.) lack the non-circular (e.g., triangular) (cross-sectional) configuration described above. Instead, in such embodiments, it is contemplated that the secondary guidewire 1800 (and the corresponding medical device supporting the secondary stent 1700) instead has an annular (e.g., circular) cross-sectional configuration in order to develop and deploy a "Y" shaped stent system at the bifurcation, as described in further detail below. However, in the event that there is a need and / or desire to provide additional palisades to the secondary stent 1700 covering the origin of the side branch S, the secondary guidewire 1800 (and the corresponding medical device supporting the secondary stent 1700) can include a corresponding non-circular (cross-sectional) configuration to facilitate proper alignment of the palisades of the secondary stent 1700 in the manner described above.

[0230] In those embodiments employing a rapid-exchange configuration (e.g., where the primary guidewire 1500 extends through the side hole and distal end hole 1406 of the balloon catheter 1400), it is contemplated that the balloon catheter 1400 may be configured for use (deployment) in a substantially straight (e.g., non-torsed anatomy). In such a method of use, it is contemplated that the primary guidewire 1500 and lumen 1412i may lack the non-circular (e.g., triangular) (cross-sectional) configuration described above. Instead, in such an embodiment, it is contemplated that the primary guidewire 1500 and lumen 1412i may instead have an annular (e.g., circular) cross-sectional configuration, and the secondary guidewire 1800 may be advanced into the side branch S via the side hole 1418 and lumen 1412iii.

[0231] In the context of non-diameter anatomy (of a non-diameter length of the anatomy), advancement of the secondary guidewire 1800 through the lumen 1412iii, through the side hole 1418, and into the side branch S may align the secondary delivery device 1600 (e.g., balloon catheter 400), and the components and apparatus inserted therethrough (e.g., secondary stent 1700) in an intended manner (e.g., such that any palisades included in the secondary stent 1700 are disposed at the origin of the side branch S). ​​However, in most tortuous anatomy, it is envisioned that employing a corresponding non-circular (e.g., triangular) (transverse cross-sectional) configuration by the secondary guidewire 1800 and lumen 1412iii will facilitate proper preloading of the secondary stent 1700 in a desired orientation within the vessel V (e.g., such that any palisade(s) within the secondary stent 1700 are oriented toward the origin of the side branch S).

[0232] In various embodiments, medical devices (e.g., stents, expandable members, etc.) that include multiple fence portions are also contemplated herein (e.g., for use in the context of multiple side branches having multiple origins).

[0233] To facilitate proper positioning of the primary stent 1300 and / or secondary stent 1700, it is envisioned that one or more markers (e.g., radiopaque markers) may be included to identify their proximal and distal ends, and / or the proximal and distal ends of any palisades.

[0234] [Other methods] Using any of the devices and methods described above, the primary stent 1300 can be deployed so that the palisade 1302 (FIG. 17) of the primary stent 1300 is positioned proximate to the origin of the side branch S (e.g., at or adjacent to the origin of the side branch S). ​​A guidewire (e.g., secondary guidewire 1800) can then be advanced through the palisade 1302 of the primary stent 1300 and into the side branch S to facilitate deployment of the secondary stent 1700 using one of a variety of methods, as seen, for example, in FIGS. 20 and 22-24.

[0235] In one variant, as seen in FIG. 24, a secondary stent 1700 is delivered over a secondary guidewire 1800 via a balloon catheter 400, and is positioned so that the proximal end 1702 of the secondary stent 1700 overlaps the palisade portion 1302 of the primary stent 1300, as seen in FIG. 25. The devices and methods described herein facilitate precise and accurate positioning of the respective primary and secondary stents 1300, 1700 to control (e.g., reduce, minimize) the extent to which the secondary stent 1700 overlaps the primary stent 1300, thereby reducing (though not completely eliminating) leakage between the respective primary and secondary stents 1300, 1700 while avoiding unnecessary occlusion of the blood vessel V by the secondary stent 1700, and accommodating a taper of the side branch S, which may result in a larger (transverse) cross-sectional dimension at the origin of the side branch S (compared to more distal portions of the side branch S) (e.g., depending on the particular patient's anatomy).

[0236] In a second variation, it is envisioned that a secondary delivery catheter 1900 is utilized to deploy the secondary stent 1700, for example as described above, thereby employing a self-expanding configuration of the secondary stent 1700 such that the secondary stent 1700 is automatically deployed within the side branch S upon exposure of the secondary stent 1700 from the secondary delivery catheter 1900. It is envisioned that the secondary guidewire 1800 is (optionally) removed in such a procedure. This method (and corresponding medical device) also facilitates precise and accurate placement of the respective primary and secondary stents 1300, 1700 to control (e.g., reduce, minimize) the extent to which the secondary stent 1700 overlaps the primary stent 1300, providing the benefits described above (e.g., reduced (if not completely eliminated) leakage between the respective primary and secondary stents 1300, 1700, reduced (if not completely eliminated) unwanted occlusion of the vessel V by the secondary stent 1700, and accommodating tapering of the side branch S).

[0237] In a third variation, it is also envisioned that the primary delivery catheter 1100 is reused in place of the secondary delivery catheter 1900.

[0238] With respect to the second and third variations, challenges may arise with respect to landing the secondary stent 1700, particularly with "braided" or "braided" stents that may shrink proximally during deployment (e.g., compared to their insertion and pre-deployment length).

[0239] To address such challenges, it is envisioned that the secondary delivery catheter 1900 may be configured in a manner similar to that described above in connection with the respective hypotubes 700, 800 (FIGS. 13, 14) (e.g., corresponding to a filter-tip TAVR (transcatheter aortic valve replacement) catheter, where the wings 802 provide an outer restraint of the secondary stent 1700, thereby providing control over the expansion of the secondary stent 1700). To facilitate such use, as described above, it is envisioned that the lumen 806 extending through the inner hypotube 800 may include a non-circular (transverse) cross-sectional configuration corresponding to the secondary guidewire 1800, to permit relative axial movement between the inner hypotube 800 and the secondary guidewire 1800, while inhibiting (if not entirely preventing) relative rotation between the inner hypotube 800 and the secondary guidewire 1800 to facilitate precise control of the (rotational) orientation of the secondary stent 1700. In such a method of use, the secondary stent 1700 is loaded into the outer hypotube 700 and the inner hypotube 800 (and thus the wings 802) advance distally while the outer hypotube 700 remains longitudinally (axially) stationary (in relative terms). Relative longitudinal (axial) movement between the hypotubes 700, 800 allows for exposure (and optional re-sheathing) of the secondary stent 1700. It is envisioned that by increasing the (transverse) cross-sectional dimension of the lumen 806 extending through the secondary guidewire 1800 and inner hypotube 800, the relative rotation between the inner hypotube 800 and secondary guidewire 1800 may be further reduced (if not completely eliminated), thereby further increasing the accuracy of placement of the secondary stent 1700.

[0240] To offset or otherwise accommodate unpredictability in the expansion of the various "braided" or "braided" embodiments of the stents described herein (e.g., in such embodiments, it is contemplated that the rings (or other structures) will comprise (e.g., be formed partially or entirely of) any suitable material or combination of materials, such as, for example, Nitinol. It is also contemplated that longitudinal wires may (optionally) be connected to the stents described herein to facilitate resheathing, if desired.

[0241] It is also contemplated that the various stents described herein may be connected to one or more external members (e.g., wires, catheters, etc.). For example, it is contemplated that the external members may be connected to the proximal and distal ends of the secondary stent 1700 (which may be adapted for delivery in an "over the wire" or rapid exchange configuration). After the secondary guidewire 1800 is positioned in the side branch S (e.g., through the barrier 1302 of the primary stent 1300), the secondary stent 1700 may be advanced over the secondary guidewire 1800 to a desired location, and the inner hypotube 800 (FIG. 14) (and thus the wings 802) may be translated axially (e.g., relative to the outer hypotube 700) while holding the external member coupled to the secondary stent 1700 in place. The inner hypotube 800 (FIG. 14) (and thus the wings 802) may be moved axially (e.g., relative to the outer hypotube 700) to expose (unsheath) the secondary stent 1700.

[0242] In the case of secondary stent 1700 coupled to one or more external members, it is envisioned that the external members will expand along with the secondary stent 1700. In embodiments in which the secondary stent 1700 is supported by (e.g., attached to) an outer catheter or hypotube, such as the outer hypotube 700 (FIGS. 13, 14), the secondary stent 1700 will need to be unsheathed (e.g., exposed from the wings 802) before removal (e.g., from the outer hypotube 700). However, in embodiments in which the secondary stent 1700 does not have such an attachment, it is envisioned that the secondary stent 1700 will automatically expand and progressively detach (proximal to distal) as a result of relative longitudinal (axial) movement between the secondary stent 1700 and the wings 802.

[0243] Also contemplated are embodiments in which the secondary stent 1700 is circumferentially attached to an outer device (e.g., the outer hypotube 700) and includes at least one additional wire attached thereto (e.g., attached to a distal segment of the secondary stent 1700). Additional and alternative attachment(s) connections between the secondary stent 1700 and the outer hypotube 700 (or other such device) are also contemplated herein. For example, it is also contemplated that only a distal segment (portion) of the secondary stent 1700 is attached (connected) to the outer hypotube 700 (or other such device). In such embodiments, it is contemplated that longitudinal (axial) advancement of the outer hypotube 700 (or other such device) will pull the attached segment of the secondary stent 1700 and push the wings 802 (and inner hypotube 800 or other such device) together. ) Once the secondary stent 1700 is positioned as desired, the secondary stent 1700 can be unsheathed (proximal to distal) by advancing the inner hypotube 800 (or other such device) relative to the outer hypotube 700 (or other such device) and thus the secondary stent 1700. If it is determined that adjustment to the position of the secondary stent 1700 is required, the inner hypotube 800 (or other such device) can be moved in the opposite direction to resheath the secondary stent 1700, allowing it to be repositioned within the vasculature.

[0244] It is further envisioned that the proximal attachment between the secondary stent 1700 and the outer hypotube 700 (or other such device) may be severed upon unsheathing of the secondary stent 1700 to facilitate proper orientation and positioning of the secondary stent 1700 (e.g., a position such that the secondary stent 1700 overlaps the palisade 1302 of the primary stent 1300 without significantly (substantially) overlapping the main branch M of the vessel V). The secondary stent 1700 may then be detached once fully deployed.

[0245] In another embodiment, a quaternary catheter may be utilized to help secure the (rotational) position of the primary guidewire 1500 once it is inserted into the vessel V. In such an embodiment, it is envisioned that the quaternary catheter includes an internal lumen having a non-circular (e.g., triangular) (transverse) cross-sectional configuration (e.g., corresponding to that defined by the primary guidewire 1500) as described above. It is also envisioned that the quaternary catheter is hubless and includes a non-circular (e.g., triangular) (transverse) outer cross-sectional configuration, as well as proximal and distal markers (e.g., radiopaque markers) positioned at any suitable location (e.g., the "12 o'clock" position) as described above. The primary guidewire 1500 and quaternary catheter may be used as a guide (rail) system to facilitate delivery of the primary delivery catheter 1100 over the quaternary catheter and guidewire (e.g., further reducing the likelihood of undesired rotation occurring during delivery and / or deployment of the primary stent 1300).

[0246] 1A-2A, in one particular method, delivery catheter 100 may be utilized in association with pusher 302 and stent 202 according to the following steps: (i) inserting delivery catheter 100 into blood vessel V; (ii) advancing delivery catheter 100 over guidewire 500 ( FIG. 15 ) until distal end 108 of delivery catheter 100 is located proximate (e.g., at or near) the vascular abnormality (e.g., aneurysm A) to be treated; (iii) removing the guidewire 500; (iv) orienting the packaging catheter 300 (e.g., the elongate body 310, the pusher 302, and the stent 202) relative to the hub 600 to pre-orient the stent 202 relative to the aneurysm A; (v) inserting the packaging catheter 300 (e.g., the elongate body 310) into the port 602 of the hub 600; (vi) attaching the hub 600 to the proximal end 104 of the delivery catheter 100; (vii) advancing the pusher 302 (and the stent 202) from the elongated body 310 of the packaging catheter 300 into (and through) the delivery catheter 100 until the stent 202 is positioned proximate to (e.g., at or adjacent to) the aneurysm A; (viii) advancing the pusher 302 (and the stent 202) from the elongated body 310 of the packaging catheter 300 into (and through) the delivery catheter 100; (viii) partially withdrawing the delivery catheter 100 while manipulating (e.g., holding or advancing) the pusher 302 to fully expose the stent 202 from the delivery catheter 100, thereby deploying the stent 202; (ix) withdrawing the pusher 302; and (x) Withdraw the delivery catheter 100.

[0247] [Bifurcation or Y-shaped stent] 18-25, using any of the methodologies and devices described above, a "Y" shaped stent can be assembled (in vivo) from two stents (e.g., primary stent 1300 and secondary stent 1700), as seen in FIG. 25, which may be facilitated by the inclusion of multiple markers (e.g., radiopaque markers) on the stents 1300, 1700, medical devices used during placement of the stents 1300, 1700, etc. For example, once the primary stent 1300 is deployed (e.g., via expansion of the expansion member 1414), a secondary stent 1700 can be deployed in the side branch S, which may be self-expanding or balloon-expandable. In a self-expanding embodiment, for example, as seen in FIG. 23, a secondary delivery catheter 1900 is advanced into the side branch S (e.g., over a secondary guidewire 1800 (FIG. 22)). 22)) The secondary stent 1700 is inserted through the lumen 1412iii, through the side hole 1418 of the balloon catheter 1400, through the barrier 1416 of the expandable member 1414, through the barrier 1302 of the primary stent 1300, and into the side branch S such that it is automatically deployed (expanded) upon exposure from the secondary delivery catheter 1900.

[0248] In various embodiments, it is contemplated that the secondary stent 1700 is devoid of palisades and is positioned to reduce (e.g., minimize) overlap with the ends of the palisades 1302 of the primary stent 1300. Alternatively, it is contemplated that the secondary stent 1700 can be positioned to create a "Y" shaped construct (e.g., via the methods described above used to position the primary stent 1300) to promote proper overlap between the stents 1300, 1700 (e.g., relative to the origin of the side branch S).

[0249] As mentioned above, it is contemplated that the various medical devices described herein (e.g., catheters, stents, hypotubes, guidewires, etc.) include one or more radiopaque markers (or other such components) to aid in external visualization. Such markers are contemplated to be located at any suitable location on the corresponding medical device. For example, it is contemplated that the stents described herein include one or more markers at their proximal and / or distal ends. It is also contemplated that such markers are located to facilitate boundaries between regions of differing porosity. For example, in the case of the stent 202 seen in FIG. 2C, it is contemplated that one or more markers are located at the proximal and / or distal ends of the first (covered) region 204 and / or the second (uncovered) region 206. It is also contemplated that such markers are used to define or define palisades, such as, for example, palisades 1302 of the primary stent 1300.

[0250] The present disclosure contemplates bifurcated stent elements.

[0251] It is envisioned that the various stents described herein are fully or partially resheathable.

[0252] It is envisioned that the various stents described herein are removable from the medical device that supports the stent.

[0253] It is contemplated that the various medical devices (eg, catheters, stents, hypotubes, guidewires, etc.) and procedures described herein find application in a variety of endoscopic procedures.

[0254] It is contemplated that the various stents described herein may include any suitable (transverse) cross-sectional configuration, whether circular or non-circular (e.g., depending on the particular procedure being performed, the patient's anatomy, the particular location of the vascular anomaly being treated, the particular nature of the vascular anomaly, etc.).

[0255] The present disclosure may also find applicability in the context of introducing other devices, such as contoured mesh pouches for filling outpouchings, in a specific orientation. One of many examples of such openings is a vascular aneurysm. It is envisioned that the principles of the present disclosure may aid in the creation of custom implants (e.g., to contour to the configuration of a particular lesion) and the subsequent precise placement (deployment) of such custom implants.

[0256] Various medical devices (e.g., catheters, stents, hypotubes, guidewires, etc.) and procedures described herein may also be used to deliver coated devices. Suitable examples of such coatings include, but are not limited to, lubricious compounds, adhesive compounds, hydrogels, pharmaceuticals, chemotherapeutic agents, cells, proteins, etc., and combinations thereof. It is envisioned that such coatings may be disposed on any suitable surface (e.g., interior surfaces, exterior surfaces, interstices, and combinations thereof) of the medical device in question.

[0257] Various medical devices (e.g., catheters, stents, hypotubes, guidewires, etc.) and procedures described herein can be utilized (combined) with a multi-circumference balloon catheter previously described by Walzman (US2020 / 10,543,015) to facilitate further precision in orienting a delivery catheter in a desired (rotational) direction within a blood vessel (e.g., at an aneurysm or the neck of an aneurysm, or adjacent to an aneurysm).

[0258] It is envisioned that the various devices described herein may (optionally) include one or more steerable segments that are deflectable via one or more pull wires extending within the wall of the device consistent with the discussion below (e.g., to facilitate insertion, removal, and / or increased precision in the placement of the device). Although the following discussion is provided in the context of delivery catheter 100, it should be understood that the principles, elements, and structures described herein below may be incorporated into any of the devices described herein (e.g., hypotubes 700, 800 (FIGS. 13, 14), primary delivery catheter 1100 (FIG. 16), delivery device 1200 (FIG. 18), balloon catheter 1400 (FIG. 18), secondary delivery device 1600 (FIG. 20), secondary delivery catheter 1900 (FIG. 23), etc.).

[0259] 26-28, in the illustrated embodiment, a delivery catheter 100 includes a plurality of segments 122 and a plurality of (first) pull wires 124. More specifically, the delivery catheter 100 includes a plurality of inactive (passive) segments 122i and a plurality of active (steerable, deflectable, articulatable) segments 122a connected to the plurality of pull wires 124 and spaced apart along a longitudinal axis X of the delivery catheter 100. The inactive segments 122i and active segments 122a are arranged in a staggered manner such that the delivery catheter 100 alternates between the inactive segments 122i and the active segments 122a.

[0260] In the particular embodiment shown, each active segment 122a is connected to a corresponding (single) pull wire 124 that extends through the body 102 of the delivery catheter 100 (e.g., within its outer wall 126) such that the pull wire 124 corresponds in number to the active segment 122a and extends in a (generally) parallel relationship to the longitudinal axis X of the delivery catheter 100. Application of an axial (pulling) force to each of the pull wires 124 causes the corresponding active segment 122a to deflect (articulate), thereby reconfiguring (actively steering) the delivery catheter 100 between a first (initial, normal) configuration ( FIG. 26 ), in which the delivery catheter 100 comprises a (generally) straight configuration, and a second (subsequent, deflected) configuration ( FIG. 28 ), in which the delivery catheter 100 comprises a non-straight configuration.

[0261] The use of a single pull wire 124 connected to each active segment 122a reduces the number of pull wires 124 required, thus reducing the complexity in both the structure and operation of the delivery catheter 100. It is also contemplated that in other embodiments, multiple independently movable pull wires 124 may be included. In the particular embodiment illustrated, each pull wire 124 is received within a corresponding channel 128 ( FIG. 27 ) that extends through the outer wall 126 in a (generally) parallel relationship to the longitudinal axis X (e.g., such that the pull wire 124 is embedded within the delivery catheter 100).

[0262] To facilitate application of axial force to the pull wires 124, in certain embodiments, the delivery catheter 100 may include (or be connected to) a plurality of corresponding (first) activation mechanisms 130 (e.g., such that the number of pull wires 124 corresponds to the number of activation mechanisms 130). In the particular embodiment shown, the delivery catheter 100 includes (first) activation mechanisms 130i connected to the pull wires 124i and (second) activation mechanisms 130ii connected to the pull wires 124ii. The actuation mechanisms 130 may include any structure or mechanism suitable for the intended purpose of applying the axial force to the pull wires 124 required to deflect the delivery catheter 100 as needed or desired, such as, for example, a rotating wheel, a pulley system, a ratchet mechanism, a lever, etc. In certain embodiments, it is envisioned that the actuation mechanism(s) 130 and / or the pull wires 124 include one or more stop locks (or other such structures) to maintain the position of the pull wires 124 and corresponding segments 122.

[0263] It is also contemplated that in certain embodiments of the present disclosure, the actuation mechanism(s) 130 may be omitted and force may be applied manually to the pull wires 124 to facilitate coupling of the delivery catheter 100.

[0264] In certain embodiments, it is contemplated that the active segments 122a, pull wires 124, and actuation mechanism 130 may be configured (and connected) such that each pull wire 124 may be individually acted upon to deflect (steer) the corresponding segment 122a in only a single direction. In other embodiments, it is contemplated that the pull wires 124 may be provided at different circumferences of the delivery catheter 100 to facilitate steering in different directions.

[0265] In the particular embodiment shown, the delivery catheter 100 includes a first inactive segment 122i1; a first active segment 122a1 located distal to the segment 122i1; a second inactive segment 122a1 located distal to the segment 122a1; and a second active segment 122a2 located distal to the segment 122a1. Additionally, the delivery catheter 100 includes respective first and second puller wires 124i, 124ii located within channels 128 (FIG. 27). However, it is also envisioned that the first and second puller wires 124i, 124ii may be disposed within separate channels 128 (e.g., such that the number of channels 128 corresponds to the number of puller wires 124).

[0266] The pullwires 124i, 124ii are connected to the segments 122al, 122a2 at connection points 132i, 132ii, respectively (in addition to the actuation mechanisms 130i, 130ii) to facilitate reconfiguration of the delivery catheter 100 between a first configuration ( FIG. 26 ) and a second configuration ( FIG. 28 ). More specifically, upon reconfiguration of the delivery catheter 100, the active segments 122ai, 122aii define respective first and second bends 134i, 134ii ( FIG. 28 ), which may be either substantially similar (e.g., identical) or dissimilar, depending, for example, on the particular configuration of the segments 122al, 122a2, the materials of construction used in the delivery catheter 100, the particular requirements of the delivery catheter 100 as dictated by the endovascular procedure, etc. Although the bends 134i, 134ii are each illustrated in FIG. 28 as being (approximately) equal to 90 degrees, it is contemplated that the bends 134i, 134ii may be substantially within a range of about 0 degrees to about 270 degrees, depending on the particular configuration of the segments 122al, 122a2, the requirements of the endovascular procedure, the particular anatomy of the patient's vasculature, etc. For example, in one particular embodiment, it is contemplated that the segment 122al may be configured such that the bend 134i is substantially within a range of about 0 degrees to about 180 degrees (e.g., about 90 degrees to about 180 degrees) and the segment 122a2 may be configured such that the bend 134ii is substantially within a range of about 0 degrees to about 270 degrees (e.g., about 90 degrees to about 270 degrees).

[0267] In the particular embodiment shown, the connection points 132i, 132ii are shown as being (generally) angularly aligned (e.g., along the circumference of the delivery catheter 100) to facilitate deflection of the segments 122al, 122a2 in a similar (e.g., the same) direction, as seen in FIG. 28. However, it is also envisioned that the connection points 132i, 132ii may be angularly offset to facilitate deflection of the segments 122al, 122a2 in different directions. For example, the connection points 132i, 132ii may be (generally) diametrically opposed, such that the bends 134i, 134ii defined by the segments 122al, 122a2, respectively, curve in (generally) opposite directions.

[0268] 29A, it is also envisioned that the delivery catheter 100 includes one or more (second) pull wires 136 connected to (anchored, fixed) the delivery catheter 100, which may supplement or replace the pull wire(s) 124 (FIGS. 26-28). The pull wires 136 facilitate selective application of a torsional force to the delivery catheter 100, thus rotationally deflecting the delivery catheter 100 along all or a portion of its length (e.g., at or adjacent the distal end hole 110) to change the angular position of the delivery catheter 100. In contrast to the pull wires 124, the pull wires 136 extend non-parallel to the longitudinal axis X of the delivery catheter 100. In the particular embodiment illustrated, for example, the delivery catheter 100 includes a single pull wire 136 that is helically wound about the longitudinal axis X. However, it should be understood that the number of pull wires 136 may vary in alternative embodiments without departing from the present disclosure (e.g., it is contemplated that the delivery catheter 100 may include two pull wires 136, three pull wires 136, etc.).

[0269] It is envisioned that the rotational pull wires disclosed herein can extend completely or partially about a longitudinal axis X, i.e., can extend 360 degrees, less than 360 degrees, or more than 360 degrees (in one or more helices).

[0270] In some embodiments, the pulley wire may be straight for part or most of the device and helical for only a portion of its length. In some embodiments, the helical portion of the pulley wire extends to or near the distal end of the device. The helix of the wire may be configured such that rotation occurs at a desired segment of the device, for example to rotate the orientation of the distal end bore as desired.

[0271] FIG. 29B shows another embodiment of the present disclosure in which the pull wire(s) 136 includes a (first) distal segment 136a that extends non-parallel to the longitudinal axis X of the delivery catheter 100, and a (second) proximal segment 136b that extends (generally) parallel to the longitudinal axis X, at or adjacent the distal end 108 of the body 102 of the delivery catheter 100, and the proximal segment 136b includes a (generally) straight configuration.

[0272] It is contemplated that the delivery catheter 100 may define an overall length sufficient to permit rotational deflection of the delivery catheter 100 without significant (substantial) kinking, binding, or other such undesirable deformation. For example, in certain embodiments, it is contemplated that the delivery catheter 100 may define an overall length that is substantially within the range of (approximately) 50 cm to (approximately) 170 cm. However, overall lengths outside this range would not be beyond the scope of the present disclosure. It is also contemplated that kinking, binding, and other such undesirable deformation may be inhibited (if not entirely prevented) by utilizing one or more flexible and / or resilient materials in the construction of the delivery catheter 100.

[0273] It is contemplated that the pull wire 136 may be secured (connected) to the body 102 of the delivery catheter 100 in any suitable manner. For example, it is contemplated that the pull wire 136 may be secured to an outer surface 138 of the body 102, or that the pull wire 136 may extend through the body 102 of the delivery catheter 100 (e.g., into a corresponding (helical or partial helical) channel 140 formed in the outer wall 126 such that the pull wire 136 is embedded within the delivery catheter 100).

[0274] When a (pulling) force is applied to the pullwire 136, the body 102 of the delivery catheter 100 experiences an angular (torsional) deflection (displacement) that causes the distal end 108 of the body 102 to rotate about the longitudinal axis X, causing a corresponding rotation of any (medical) device disposed within the delivery catheter 100. For example, when the delivery catheter 100 (e.g., a first medical device) is used in conjunction with a packaging catheter 300 ( FIG. 2A ) (e.g., a second medical device), rotation of the delivery catheter 100 causes a corresponding rotation of the pusher 302 and thus the stent 202, as a result of the corresponding non-circular (transverse) cross-sectional configurations defined by the delivery catheter 100 and the pusher 302. Rotation facilitated by torsional forces applied to the delivery catheter 100 via the pullwires 136 allows for precise control over the rotational position of the delivery catheter 100 and packaging catheter 300 (or other such device received by the delivery catheter 100) by allowing for complementary variations in rotational positioning facilitated by corresponding non-circular (transverse) cross-sectional configurations defined by the delivery catheter 100 and pusher 302. Rotation of the delivery catheter 100 also allows for positioning of the device (e.g., the delivery catheter 100 and pusher 302) in any desired rotational orientation, regardless of the particular non-circular (transverse) cross-sectional configuration employed (e.g., triangular, square, rectangular, pentagonal, hexagonal, octagonal, elliptical, etc.).

[0275] To facilitate application of force to the pull wires 136, in certain embodiments, the delivery catheter 100 may include (or be connected to) one or more corresponding (second) actuation mechanisms 142 (e.g., such that the number of pull wires 136 corresponds to the number of actuation mechanisms 142). The actuation mechanisms 142 are connected to the pull wires 136 and may include, for example, a rotating wheel, a pulley system, a ratchet mechanism, a lever, or the like, any structure or mechanism suitable for the intended purpose of applying a torsional force thereto sufficient to cause rotation of the delivery catheter 100 as needed or desired. In certain embodiments, it is envisioned that the actuation mechanism(s) 142 and / or the pull wires 136 include one or more stop locks (or other such structures) for maintaining the rotational position(s) of the pull wires 136 and delivery catheter 100.

[0276] It is also contemplated that in certain embodiments of the present disclosure, the actuation mechanism(s) 142 may be omitted and force may be applied manually to the pull wires 136 to facilitate rotation of the delivery catheter 100.

[0277] In a particular embodiment shown in FIG. 29A, the delivery catheter 100 includes a single actuation mechanism 142 configured as a wheel 144 such that a force is applied to the pull wire 136 via rotation of the wheel 144. More specifically, the actuation mechanism 142 is supported on an access port (branch) 146 that extends laterally outward from the body 102 of the delivery catheter 100 (e.g., to aid in the insertion of one or more medical instruments, guidewires, etc.). However, it should be understood that the actuation mechanism 142 may be located in any suitable location. For example, FIG. 30 illustrates an alternative embodiment without an access port 146, in which the actuation mechanism 142 is supported directly on the body 102 of the delivery catheter 100.

[0278] FIG 31 illustrates another embodiment of the present disclosure in which the activation mechanism 142 is configured as a moveable (e.g., pivotable) lever 148 such that force is applied to the pull wire 136 via flexure (e.g., pivotable and / or axial movement of the lever) of the lever 148. While shown in FIG 31 as being supported by an access port 146, it should be understood that the lever 148 may be located in any suitable location. For example, FIG 32 illustrates another embodiment without an access port 146 in which the lever 148 is supported directly on the body 102 of the delivery catheter 100.

[0279] In some configurations illustrated in FIGS. 29A-32, the delivery catheter 100 is illustrated as including a single pull wire 136 and a single actuation mechanism 142, which allows for rotation of the delivery catheter 100 in only a single direction (e.g., counterclockwise in the direction indicated by arrow 1 ( FIG. 29A )). However, in alternative embodiments of the present disclosure, it is envisioned that the delivery catheter 100 may include multiple pull wires 136 and multiple corresponding actuation mechanisms 142 to facilitate rotation of the delivery catheter 100 in multiple directions (e.g., clockwise and counterclockwise). More specifically, FIG. 33 illustrates an embodiment of the present disclosure in which the delivery catheter 100 includes a (first) pull wire 136i connected to a (first) actuation mechanism 142i to apply a (first) torsional force to the delivery catheter 100, rotating the delivery catheter 100 in the (first) direction indicated by the arrow. (second) puller wire 136ii (in the (first) direction indicated by arrow 1) and (second) actuation mechanism 142ii (in the (second) direction indicated by arrow 2) that applies a (second) torsional force to delivery catheter 100, rotating delivery catheter 100 in the (second) direction indicated by arrow 2.

[0280] It is envisioned that the pull wires 136i, 136ii may be connected to the body 102 of the delivery catheter 100 at any suitable location. For example, to facilitate rotation in (generally) opposing directions 1, 2, it is envisioned that the pull wires 136i, 136ii are connected to the body 102 at respective connection points 150i, 150ii that are (generally) diametrically opposed, as seen in FIG.

[0281] While the particular embodiment seen in FIG. 33 is shown as being supported by a corresponding access port 146i, 146ii, respectively, it is contemplated that in certain embodiments the access ports 146i, 146ii may be eliminated and the activation mechanisms 142i, 142ii may be supported directly on the body 102 of the delivery catheter 100 (see FIG. 30). Additionally, while each of the activation mechanisms 142i, 142ii is illustrated in FIG. 33 as including a rotatable wheel 144, it should be understood that the activation mechanisms 142i and / or the activation mechanisms 142ii may instead include any of the levers 148 described above. For example, FIG. 34 illustrates an embodiment in which each of the activation mechanisms 142i, 142ii includes a lever 148, while FIG. 35 illustrates an embodiment in which the activation mechanism 142i includes a rotatable wheel 144 and the activation mechanism 142ii includes a lever 148. As such, embodiments of the present disclosure contemplate that the actuation mechanisms 142i, 142ii can be either similar (eg, identical) or dissimilar (eg, non-identical).

[0282] Stents that may be used with the catheters disclosed herein include those disclosed in Application Serial No. 15 / 341,820 (now U.S. Patent No. 9,775,730), Application Serial No. 15 / 732,544 (published US 2018-0243113), Application Serial No. 16 / 214,130 (published US 2019-0151072), and Application Serial No. 17 / 156,743, the entire contents of each of which are incorporated herein by reference.

[0283] Referring now to FIG. 36, another exemplary embodiment of the present disclosure will be described. In accordance with this embodiment, a biological implant introduced into an organ, including, for example, a vascular organ, a gastrointestinal organ, etc., is custom designed to correspond, and in an exemplary embodiment, precisely correspond, to the dimensions of the abnormality or defect into which the custom implant device is to be implanted. The custom biological implant may be any intravascular device, including a stent, a flow diverter, an occlusion device, a valve, including a heart valve, or any other type of vascular or bioprosthetic device. For example, the custom biological implant may include any of the implants described herein, including an intrasaccular occlusion device for insertion into an aneurysmal sac or opening as disclosed in U.S. Pat. No. 10,448,970, issued Oct. 22, 2019 to Walzman, entitled "Alternate Use for Hydrogel Intrasaccular Occlusion Device with Telescoping Central Support Element," the entire contents of which are incorporated herein.

[0284] FIG. 36 is a flow chart illustrating one exemplary methodology 2000 for forming a customized bioimplant according to the principles of the present disclosure. The methodology set forth in the flow chart of FIG. 36 is representative of one exemplary embodiment for customizing a bioimplant based on the dimensions of a subject's anomaly. Initially, an image of the subject's anomaly is obtained (STEP 2002). In certain embodiments, conventional imaging techniques are employed to obtain a three-dimensional image of the anomaly. Such imaging techniques include coronary CTA scans, magnetic resonance angiography (MRA), conventional angiography scans, conventional CT and MRI scans, and the like. The generated image may include certain physical biological markers within the anomaly, such as the neck of the opening, or other markings or defects, that may be used as reference points when the bioimplant is placed in the anomaly. Once the image is generated, a 3D model of the bioimplant is generated based on the 3D image data obtained in STEP 2002 (STEP 2004). Computational mathematics incorporated in various computer programs may be utilized to generate a 3-D model, a CAD model, or a digital 3-D model based on the STEP 2002-obtained bioimage data of the anatomical defect. In an exemplary embodiment, the acquired image data may be supplemented with one or more databases containing standardized dimensions for specific anatomical regions, such as, for example, blood vessel size, valve size, organ size, i.e., regions relevant to the location of a customized bioimplant, etc. The standardized data is used in calculations to generate the 3D model.

[0285] Once the 3D model is generated, the bioimplant is manufactured. (STEP 2006). In one exemplary embodiment, a 3-D printing process technique is implemented to manufacture the customized implant. More specifically, the 3-D model data is input into a 3-D printer. An "ink medium" is input into the 3-D printer. The "ink medium" may include any of the biocompatible metals, such as stainless steel, cobalt-chromium alloys, titanium, nickel-titanium alloys and / or alloys thereof, and / or biocompatible polymeric materials, such as polystyrene, polypropylene, polyvinyl chloride, polyethylene, polyurethane, polycarbonate, polyethylene terephthalate and / or polyether ether ketone. Additionally, the "ink medium" may include biological cells, pharmaceuticals, hydrogels, and the like. The printing process is controlled to apply multiple layers to form the bioimplant according to the input three-dimensional model. As previously mentioned, the bioimplant may be in the form of an intravascular occlusion device for introduction into the opening or aneurysmal sac. The intravascular occlusion device may be a mesh formed of any of the biocompatible metal and polymeric materials and / or combinations thereof previously mentioned. The mesh may be self-expanding. In this regard, the programming or algorithms controlling the manufacturing process of STEP 2006 take into account the self-expanding capabilities of the mesh material when calculating the expected final dimensions of the occlusion device that will fit precisely within the opening, abnormality or aneurysm sac. Alternatively, the occlusion device may be comprised of an outer shell or sac, which may optionally be filled with various materials, tissues, drugs, pharmaceutical compounds, hydrogels, etc. In other exemplary embodiments, the occlusion device may include various reinforcements, such as internal or external rigid or stiff bars.

[0286] One or more markers may be incorporated into the bioimplant to facilitate introduction into the outpouch in the correct orientation in the manner described herein above. In an exemplary embodiment, the markers that are in the patient's body during the procedure are visualized with imaging used during the particular procedure. The markers may be radiopaque, may be configured to be visualized via ultrasound and / or other imaging modalities, and / or may be visualized via imaging means or cameras associated with the instruments utilized during the procedure.

[0287] In other exemplary embodiments, the biological implant can have a "12 o'clock" marker selected by a computer program and / or a technician. In certain embodiments, one or more "12 o'clock" radiopaque markers are placed around the biological implant to correspond to identified anatomical physical markers within the abnormality.

[0288] Additionally, the bioimplant may be subjected to other steps (STEP 2008) possibly not included in STEP 2006, such as the addition of a biocompatible coating or other features to secure or anchor the bioimplant within the surgical site, e.g., the aneurysm sac or outpouch, e.g., placement of coils, anchors, and / or radiopaque markers. Alternatively, these additional steps may be performed in conjunction with STEP 2006 via a 3-D printer.

[0289] Referring now to FIG. 37, a flow chart 2100 is depicted depicting the placement of a bioimplant into a target site, e.g., an opening or an aneurysmal sac. Once the bioimplant is manufactured according to the methodology of FIG. 36, the bioimplant is loaded onto any of the catheter systems described hereinabove. (STEP 2102). The catheter system is introduced into the vascular organ (STEP 2104) and advanced to place the bioimplant adjacent to the target site, e.g., an aneurysmal sac (STEP 2106). As described hereinabove, in an exemplary embodiment, one or more radiopaque markers on the bioimplant may be aligned with one or more biophysical markers within the anomaly, e.g., an outpouching neck or any other physical reference point associated with the anomaly, to assist in properly aligning the bioimplant for deployment within the anomaly (STEP 2108). The bioimplant is then deployed within the anomaly. (STEP 2110). STEPs 2204-2210 are performed in conjunction with visualization means including one or more cameras associated with the catheter system and / or other medical imaging systems including fluoroscopy, CT scan, CT angiography, MRI scan, etc. Once deployed, confirmation that the bioimplant is properly oriented is confirmed via any of the scanning methodologies identified herein (STEP 2112). In an exemplary embodiment, confirmation may be determined by comparing markers (radiopaque) on the bioimplant that are positioned in the desired relationship to identified physical markings or reference points on the anomaly. If improperly oriented or positioned, the bioimplant may be repositioned and / or removed from the anomaly and redeployed within the anomaly.

[0290] In certain embodiments, the bioimplant is implanted into the opening or aneurysm sac using any of the delivery catheters and packaging catheter systems described herein above. For example, but not by way of limitation, the custom bioimplant can be loaded into the packaging catheter 300 and the delivery catheter 100 of FIG. 2A with the implant "12 o'clock marker" aligned with one or more corresponding "12 o'clock markers" located at the proximal and / or distal ends of the packaging catheter 300. The 12 o'clock marker of the packaging catheter 300 is then aligned with the marker 604 of the hub 600 releasably coupled to the delivery catheter 100. The marker 604 of the hub 600 can be any shape, including, but not limited to, a dot, a line, or any of the shapes identified herein in connection with the marker 114 of the delivery catheter. In certain embodiments, the marker 604 of the hub 600 can be any visible marking visible to the naked eye of a clinician or by a camera or other conventional technology while the hub 600 is positioned outside the body.

[0291] The delivery catheter 100 is introduced into the blood vessel and the marker 114 of the delivery catheter 100 is positioned in the correct orientation in or near the aneurysm. The bioimplant is advanced through the delivery catheter 100 and deployed into the aneurysm. If the delivery catheter has steering capabilities, proper alignment of the marker on the delivery catheter is accomplished via the steering mechanism. Alternatively, if there is no steering capability, calculations can be performed to determine the degree of rotational movement required by the delivery catheter 100 to align the markings on the delivery catheter with the physical markings identified on the abnormality or aneurysm. In accordance with this embodiment, the packaging catheter 300 can be rotated a corresponding degree for introduction into the delivery catheter 100, as described herein above.

[0292] Any of the methodologies and instruments described herein above in connection with Figures 1-35 may be utilized to introduce a bioimplant into a defect, opening, aneurysmal sac, etc. In one exemplary embodiment, the bioimplant may be deployed with a cover placed thereon to maintain the bioimplant in a constrained position. The cover may be released to allow the bioimplant to deploy into the defect. In other embodiments, the cover may be biodegradable, releasing the bioimplant to the target site once a certain level of degradation is achieved. One example of a cover type mechanism that may be utilized with a bioimplant may be similar to the wings 802 described in connection with the embodiment of Figure 14 herein.

[0293] FIG. 38 is an exemplary embodiment of a bioimplant, e.g., an occlusion device 2100 manufactured according to the methodology described in FIG. 36. For ease of illustration, the occlusion device 2200 is shown as a generally oval or circular occlusion device, but it is understood that the occlusion device 2200 generally corresponds, for example, more or less precisely to the shape of the opening or aneurysmal sac in which it is to be placed. The occlusion device 2200 may be a mesh or pouch-like structure 2202, optionally incorporating rigid elements 2204 on its inner or outer surface. Radiopaque markers 2206, created in the D-printing process (STEP 2006) or a subsequent process (STEP 2008), may be incorporated into the structure 2202 to assist the clinician in properly orienting the occlusion device for deployment outside the pouch. Alternatively or optionally, the radiopaque markers 2206 may be utilized to confirm proper positioning of the occlusion device outside the pouch.

[0294] Although the medical devices and procedures described herein are generally discussed in the context of intravascular use, it should be understood that the medical devices and procedures described herein may find broad applicability. For example, it is contemplated that the medical instruments and procedures described herein may be employed in the context of the gastrointestinal and genitourinary tracts, as well as in non-biological tracts.

[0295] This application is related, at least in part, to U.S. Application Serial No. 17 / 214,021, filed March 26, 2021, Provisional Application Serial No. 63 / 109,387, filed November 4, 2020, and U.S. Application Serial No. 16 / 888,813, filed May 31, 2020, Provisional Application Serial No. 62 / 921,574, filed June 25, 2019, U.S. Application Serial No. 16 / 852,488, filed April 19, 2020, and Provisional Application Serial No. 62 / 921,378, filed June 12, 2019. The entire contents of each of these applications / disclosures are incorporated herein by reference.

[0296] Those skilled in the art will understand that the above specific embodiments have been shown and described by way of example only. The principles and features of the present disclosure may be employed in numerous and varied embodiments thereof without departing from the scope and spirit of the present disclosure as claimed. The above-described embodiments illustrate but do not limit the scope of the present disclosure.

[0297] Although the present disclosure has been described with reference to specific embodiments thereof, it should be understood by those skilled in the art that various modifications may be made (and equivalents may be substituted) without departing from the true spirit and scope of the present disclosure. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps to the objective spirit and scope of the present disclosure. All such modifications are intended to be within the scope of the claims appended hereto.

[0298] Where a range of values ​​is provided, unless the context clearly dictates otherwise, each intervening value between the upper and lower limits of that range, to the tenth of the unit of the lower limit, and any other stated or intervening value within that stated range, is understood to be encompassed within the disclosure. Any upper and lower limits that may be independently included in these smaller ranges are also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where a stated range includes one or both of the limits, ranges excluding both of those included limits are also included in the disclosure.

[0299] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure belongs.Any method and material similar or equivalent to those described herein can also be used to carry out or test this disclosure, but exemplary methods and materials are described.All publications mentioned herein are incorporated by reference to disclose and describe the method and / or material related to which the publication is cited.

[0300] It must be noted that as used in this specification and the appended claims, the singular forms "a," "and," and "the" include plural references unless the context clearly dictates otherwise.

[0301] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application and each is incorporated by reference in its entirety. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the publication dates provided may be different from the actual publication dates which may need to be independently confirmed.

[0302] Moreover, those skilled in the art will understand that elements and features illustrated or described in connection with one embodiment may be combined with those of other embodiments without departing from the scope of the disclosure and will realize additional features and advantages of the disclosed subject matter based on the description provided.

[0303] Throughout this disclosure, terms such as "approximately," "generally," "substantially," and the like should be understood to allow for variation in any numerical range or concept with which they are associated. For example, use of terms such as "approximately" and "generally" is intended to be understood to encompass variations on the order of 25% (e.g., to allow for variations in manufacturing tolerances and / or design).

[0304] Although terms such as "first," "second," "third," and the like may be used herein to describe various operations, elements, components, regions, and / or sections, these operations, elements, components, regions, and / or sections should not be limited by the use of these terms in that these terms are used to distinguish one operation, element, component, region, or section from another operation, element, component, region, or section. Thus, unless expressly stated otherwise, a first operation, element, component, region, or section may be referred to as a second operation, element, component, region, or section without departing from the scope of this disclosure.

[0305] Each claim and each claim is incorporated herein as further disclosure and represents an embodiment of the present disclosure. Also, the phrases "at least one of A, B, and C" and "A and / or B and / or C" should be interpreted as including A only, B only, C only, or any combination of A, B, and C, respectively.

Claims

1. A system for treating a blood vessel, comprising: a catheter defining a first non-circular cross-sectional configuration and a primary lumen terminating in a distal end hole, the catheter comprising one or more markers disposed at a distal end of the catheter that indicate a rotational orientation of the distal end of the catheter relative to an abnormal orientation; 1. A bioimplant for at least partial insertion into said blood vessel, said bioimplant comprising: an implant member configured to be generated based on image data of the abnormality in the blood vessel, the implant member configured to correspond to a particular anatomical structure in the blood vessel; one or more features corresponding to the first non-circular cross-section that inhibit rotation of the bioimplant within the primary lumen of the catheter; the bioimplant comprising the first non-circular cross-sectional configuration of the catheter is configured to deliver the bioimplant in a predefined direction determined by an orientation of the bioimplant as it passes through the primary lumen of the catheter. system.

2. The system of claim 1, wherein the implant member is configured and dimensioned to correspond to dimensions of the abnormality in the blood vessel, and at least one of the size or shape of the implant member is determined at least in part based on pre-treatment image data obtained of the abnormality.

3. The system described in claim 2, wherein the implant member is configured and dimensioned to correspond to dimensions of an opening in the blood vessel, and at least one of the size or shape of the implant member is determined at least in part based on pre-treatment image data obtained for the opening.

4. The system described in claim 2, wherein the implant member is configured and dimensioned to correspond to dimensions of an aneurysm sac in the blood vessel, and at least one of the size or shape of the implant member is determined at least in part based on pre-treatment image data obtained of the aneurysm sac.

5. The system described in claim 1, comprising one or more markers provided on the implant, the one or more markers being positioned on the implant member based at least in part on pre-treatment image data obtained for one or more physical criteria associated with the abnormality.

6. The system described in claim 1, wherein the one or more markers include one or more radiopaque markers.

7. The system described in claim 2, wherein the implant member includes either a mesh structure or a pouch.

8. The system described in claim 2, wherein the implant member is self-expandable.

9. The system of claim 2, wherein the implant member is custom made to be optimally configured for a particular patient's particular anatomical structure using pre-procedure imaging to guide the customized size and shape of the implant member.

10. The system of claim 1, wherein the bioimplant comprises different porous configurations.

11. The system of claim 10, wherein the bioimplant includes a first region having a first porosity and a second region having a second, different porosity.

12. The system of claim 1, wherein the bioimplant comprises at least one adhesive compound.

13. The system described in claim 1, wherein the implant member is configured to be generated by a 3D printer.

14. The system of claim 1, wherein the bioimplant includes a 12 o'clock marker.

15. The system of claim 14, wherein the catheter includes one or more 12 o'clock markers on one or both of the proximal and distal ends of the catheter, and the 12 o'clock marker on the bioimplant is positioned to correspond to the one or more 12 o'clock markers on the catheter when the bioimplant is administered.

16. The system of claim 2, comprising an implant pusher member capable of propelling the bioimplant within the primary lumen of the catheter, the implant pusher member having an outer cross-sectional shape similar to the inner shape of the primary lumen of the catheter and having dimensions that enable it to slide without rotation within the primary lumen of the catheter.

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