EP4240280A1 - Dispositifs intravasculaires orientables et méthodes - Google Patents

Dispositifs intravasculaires orientables et méthodes

Info

Publication number
EP4240280A1
EP4240280A1 EP21889881.5A EP21889881A EP4240280A1 EP 4240280 A1 EP4240280 A1 EP 4240280A1 EP 21889881 A EP21889881 A EP 21889881A EP 4240280 A1 EP4240280 A1 EP 4240280A1
Authority
EP
European Patent Office
Prior art keywords
stent
medical device
catheter
lumen
delivery catheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21889881.5A
Other languages
German (de)
English (en)
Inventor
Daniel Ezra Walzmann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US17/214,021 external-priority patent/US20210259860A1/en
Application filed by Individual filed Critical Individual
Publication of EP4240280A1 publication Critical patent/EP4240280A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes

Definitions

  • the present disclosure relates to medical devices used to treat vascular pathologies (e.g., aneurysms, fistulas, ruptures, etc.) in intracranial or other tortuous blood vessels (vasculature).
  • vascular pathologies e.g., aneurysms, fistulas, ruptures, etc.
  • endovascular devices that are configured to deploy a stent (e.g., a flow-diverting stent, a covered stent, a caped stent, a fenestrated stent, a branched stent, a variable porosity stent, etc.) to treat such vascular pathologies.
  • a stent e.g., a flow-diverting stent, a covered stent, a caped stent, a fenestrated stent, a branched stent, a variable porosity stent, etc.
  • the prior art teaches the use of a number of devices to treat vascular pathologies.
  • One such device is a differentially porous (variable porosity) stent that includes asymmetrical braiding or coils so as to create areas of lesser or greater blood flow as may be desired.
  • Fenestrated and branched devices have been effectively employed in the aorta and its immediate branches, and other applications having larger blood vessels with little tortuosity.
  • no device or method has been described that can reliably deploy such devices in their desired (rotational) orientation. The constraints of intracranial or other tortuous vasculature have to date precluded the use thereof in these areas.
  • U.S. Pat. No. 9,775,730 (Walzman) teaches a covered stent device capable of safe and effective delivery and deployment into tortuous vessels to effectively divert blood flow away from the vascular abnormality while allowing blood to flow to healthy tissue distal to the targeted treatment area and still resulting in blood stasis and thrombus formation inside the aneurysm, fistula, etc.
  • U.S. Pat. Publ. No. 2019/0151072 Al (Walzman) teaches a caped stent providing a cover having a single attachment point and a free end that can be overlapped, thereby providing better conformity to target vessels than existing covered stents.
  • U.S. Pat. No. 8,398,701 B2 (Berez et al.) teaches a vascular occluding device deployable on a microcatheter.
  • the occluding device includes an asymmetrical braid or differential lattice densities, as well as and corresponding/opposite variable densities of porosity to modify blood flow in a vessel while maintaining flow to surrounding tissue.
  • Berez teaches that the flexibility of the device particularly suits it for treating aneurysms in the brain. Berez describes an embodiment including less coverage on one side at the same segment along the length of the cylinder versus the other side.
  • the area having less porosity should be positioned to cover an aneurysm for stagnation of flow in the aneurysm and subsequent thrombosis.
  • the other side of the device having more porosity should be positioned on one side of a vessel or covering a branch to allow continuation of adequate flow and to prevent obstruction of flow to the branch and its distal tissue.
  • Berez and others have not devised a way to consistently and reliably deploy such devices in the optimal desired radial orientation, and no such devices are available.
  • an endovascular device may provide additional porosity by including a fenestration, allowing no obstruction whatsoever of blood flow to the origin of a branch vessel. This may be combined with a full cover at or near an opposing side to cut blood flow to a target aneurysm or fistula altogether.
  • a common blood vessel difficulty is the persistent blood flow in the aneurysm sac extrinsic to an endograft. In fact, this is the most common complication after endovascular aneurysm repair (EVAR) with stent grafts.
  • EVAR endovascular aneurysm repair
  • Such endoleaks are ameliorated by a number of means.
  • Walzman’s utility applications 15/732,147 and 15/732,365 teach the use of hydrogel to prevent endoleaks.
  • the prior art also teaches endovascular coiling as a minimally invasive technique performed to prevent blood from flowing into some saccular aneurysms.
  • the stent-assisted coiling also has some of the same short comings related to stent placement and placing a stent in the parent artery requires prolonged use of anti-platelet agents to reduce the risk of thrombosis-based stenosis within the stent.
  • aneurysms and fistulas are ideally treated with covered stents, which can most directly cover the hole of the fistula or the neck of the aneurysm and reconstruct the vessel wall, immediately redirecting blood flow into the normal path of the parent vessel.
  • covered stents there is no covered neuro-stent currently available in the United States.
  • the U.S. Food and Drug Administration (FDA) has examined and tested such covered neuro-stents but none has “FDA approval,” which means that the FDA has not decided the benefits over the existing treatment options outweigh the potential risks for the item’s planned use.
  • FDA Food and Drug Administration
  • covers stents that are effective in severely tortuous anatomy in other parts of the body, including but not limited to splenic artery aneurysms and pulmonary arteriovenous fistulas.
  • a potentially significant use of covered neuro-stents is for the treatment of fistulas, particularly for Carotid cavernous fistula (CCF) which is an abnormal communication between the cavernous sinus and the carotid arterial system.
  • CCF Carotid cavernous fistula
  • aneurysms Other treatment of aneurysms includes surgical clipping of an intracranial aneurysm, which involves the application of a clip across the neck of the aneurysm.
  • This treatment has several shortcomings including that it requires an open operation and physical manipulation of the brain. Sometimes surgical bypass is considered as well, but typically is associated with even higher rates of morbidity and mortality.
  • prior art teaches the use of flow diversion devices to divert flow away from the aneurysm by placing a mesh stent or a structure similar to a stent, on the aneurysm neck along the parent artery.
  • the use of these devices allows for thrombus formation inside the aneurysm.
  • increased technical complications can develop following the deployment of flow diverters.
  • Most covered stents involve producing a cylinder of a stent “skeleton” or “frame” out of semirigid materials such as metal alloys, and then attaching an impermeable “cover” to said frame.
  • the prior art teaches such attachments are diffuse and located throughout the covering of a stent, along fixed intervals of said covering and frame, and consequently significantly limit flexibility of the device.
  • the ultimate orientation upon positioning would be random.
  • the exact opposite from ideal could occur. That is, the fenestration might end up over the aneurysm, thereby increasing flow to the lesion; while the area of high-density coverage might end up over the origin of a normal branch vessel, causing a lack of flow to said branch, and subsequent ischemic injury.
  • the device can work easily in straight anatomy of short distances, where a catheter can easily and accurately be rotated along its entire length from its proximal hub.
  • branched devices could also be built in vivo, by deploying a fenestrated device with the fenestration over the origin of a branch, and the deploying another device from the fenestration, and into the branch.
  • the second device can be slightly larger in diameter proximally, at the fenestration, to ensure slight overlap, without covering the primary distal branch/vessel.
  • a device could be built that includes multiple branches, through multiple fenestrations, provided all fenestrations are in proper relative distance and orientation to the native branches. This concept was described elegantly by Ruiz in U.S. Pat. No.
  • Ruiz discloses the building of a directional sheath or catheter in vivo, rather than an implant. Like the Berez device, however, the Ruiz device can work easily in straight anatomy of short distances, where a catheter can easily and accurately be rotated along its entire length from its proximal hub.
  • Rotation is not effective for positioning in tortuous and/or longer vascular anatomies, in which catheters do not respond in a similarly predictable fashion.
  • This presents a difficulty when a stent device, which is usually crimped for delivery, is advanced into a delivery catheter, typically using a delivery wire and/or hypotube, in a particular arrangement. The stent will exit the delivery catheter in an unpredictable arrangement or orientation.
  • Y shaped stents were not heretofore practical to deploy or assemble at branches in cranial or other tortuous vascular anatomy. There exists a need for Y, bifurcated, and otherwise branched stent devices that may be effectively deployed or assembled in such anatomy. Additionally, in order to safely deploy such branches without safely and accurately, and overlapping the fenestration only slightly consistently, novel devices and methods are needed to more precisely land the proximal end of such stent devices.
  • an occlusion device e.g., in an intracranial context
  • a stent having differential porosity e.g., branch vessels and aneurysms, respectively.
  • desired areas of greater or lesser blood flow e.g., branch vessels and aneurysms, respectively.
  • the devices and methods described herein may be particularly adapted for use in treating aneurysms and fistulas in intracranial or other tortuous vasculature, as well as vascular narrowing and other pathologies.
  • the methods and devices described herein may be used for treatments that require the precise orientation of a device (e.g., a stent) within the vasculature, which may require travel through long and twisted blood vessels prior to reaching the target area.
  • a device e.g., a stent
  • the methods and devices described herein may be used in connection with the orientation of asymmetric discs in aneurysm necks or stents in Gl/biliary tract (e.g., vascular, endoscopic, etc.).
  • Differentially porous (variable porosity) stents may be oriented to a degree of desired flow or blockage.
  • a single circumferential attachment point at one end (as small as 1 nm), overlapping circumferential shingles and overlapping geometric shingles.
  • the devices described herein may optionally be deployed under flow arrest (e.g., via pharmacologic means or via delivery through a balloon guide catheter with temporary balloon inflation or other means) to minimize the possibility of blood flow affecting positioning as it is unsheathed.
  • flow arrest e.g., via pharmacologic means or via delivery through a balloon guide catheter with temporary balloon inflation or other means
  • the aforementioned covering may not fully enclose (encircle) a given segment of the stent, thus allowing for variable porosity along the circumference of the stent (e.g., the stent may include a first (covered) circumferential area with decreased porosity relative to a second (uncover) circumferential area). Varying the porosity of the stent facilitates the preservation of the origin of a branch vessel that might arise from the parent vessel along the same segment of the pathology in the parent vessel pathology (e.g., opposite to a fistula or the neck of an aneurysm).
  • the devices and methods described herein allow for more accurate positioning (landing) of stents.
  • the devices and methods described herein facilitate the accurate placement of a second stent such that the second stent can be landed in a precise location so as to only overlap the first stent in a desired area (e.g., around the fenestration) and thereby reduce (if not completely eliminate) leaks between the two stents while avoiding unwanted obstruction of the primary vessel by the second stent.
  • a desired area e.g., around the fenestration
  • the present disclosure also describes an inner “unsheathing” hypotube or wire, which may include a reverse cone (e.g., wings) at a distal end thereof that are configured to cover a stent in the proximal direction.
  • the stent can be mounted on the distal end of an outer hypotube.
  • the inner hypotube goes through the outer hypotube, with its wings extending back over the distal end of the outer hypotube, and over the stent mounted thereon, and constrains the stent, which is often self-expanding in this variant. Once the stent is in the desired position, the outer hypotube can be held in place, while the inner hypotube is advanced.
  • the inner hypotube As the inner hypotube is advanced, its back wings are also advanced, and releases its constraint from the stent in a proximal to distal fashion. Thereby, the proximal stent is released from its constraint first, and expands for deployment. If the proximal portion position of landing is not optimal, it can be re-sheathed by pulling the inner hypotube back again. The stent can then be repositioned, and deployment can resume.
  • the present disclosure describes catheters and wires that includes non-circular transverse cross-sectional configurations (e.g., shapes) which facilitate mating engagement with each other.
  • the catheter may be deployed first, and a stent may be delivered therethrough over a corresponding shaped wire; wherein the wire shape correlates with inner diameter of the stent delivery catheter.
  • the wire is delivered first to the lesion site, and a stent mounted catheter is then delivered over it. It is envisioned that any such systems may be adapted for “rapid-exchange” or “over-the-wire” delivery.
  • a catheter with a particular non-circular inner diameter circumferential shape can first be delivered to a lesion site over any wire.
  • the initial wire is then removed and then a stent mounted on a corresponding-shaped outer-diameter wire is delivered through said catheter and to the lesion site.
  • the former configuration may be more common with balloon-mounted stents and that the latter configuration is more common with self-expanding stents. It should be appreciated, however, that the former configuration may also be applied to self-expanding stents and that the latter configuration may be applied to balloonmounted stents.
  • the interfaces between the devices facilitated by the aforementioned non-circular transverse cross-sectional configurations inhibit (if not entirely prevent) relative rotation between the devices while allowing for relative axial (longitudinal) movement (e.g., sliding), even in those embodiments in which a stent may be located between the devices (e.g., over a portion of the wire).
  • the devices described herein thus provide for adequate freedom of movement to permit the delivery of a catheter over a wire, or the delivery of a wire through a catheter, without undo force.
  • a wire can be placed in each of first and second branches.
  • the wire in the first branch may then be placed through a distal end hole of the delivery catheter and the catheter may be oriented such that a side-hole in the catheter is positioned at (or adjacent to) a stent side fenestration.
  • the wire in 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).
  • positioning of the initial wire or catheter can dictate the manner in which a subsequent stent or wire is delivered based upon an observed degree of rotation from the back of the wire or the hub of the catheter. For example, rotation of a “12 o’clock marker” on the back of the wire of the hub of the catheter may be observed (measured) relative to the a corresponding “12 o’clock marker” at the lesion site.
  • a dual-lumen delivery catheter may be employed to deploy (deliver) one or more stents.
  • Such dual-lumen delivery catheters include a (first) primary lumen that extends between a proximal end hole and a distal end hole and a (second) secondary lumen that extends between the proximal end hole and a side-hole, which is positioned at (or adjacent to) a fenestration in a primary (first) stent.
  • the primary stent can be positioned (deployed) across a lesion in one branch (e.g., a main branch) of the blood vessel (in any necessary or desired orientation) relative to a side branch of the blood vessel.
  • a wire e.g., a guide wire
  • a wire can be then be delivered through the secondary lumen and the side-hole into the side branch prior to deployment of the primary stent.
  • the delivery catheter can be withdrawn, leaving the wire in place within the side branch of the blood vessel.
  • a secondary stent can then be delivered (e.g., using an additional delivery catheter) and deployed either in the side branch exclusively 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 positioned within the main branch and a second section or portion of the secondary stent is positioned in the side branch).
  • secondary stent may be positioned so as to overlap the primary stent.
  • the secondary stent may be configured and positioned to overlap (overlie) a proximal portion of the primary stent.
  • an intravascular device in one aspect of the present disclosure, includes a primary (first) wire (e.g., a guide wire), a delivery catheter, and a primary (first) stent that is loaded onto (e.g., supported by) the delivery catheter.
  • the primary wire includes a fixed, non-circular transverse 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 to a proximal end thereof and a (second) marker (e.g., a radiopaque marker) at or adjacent to a distal end thereof.
  • the markers are located in identical circumferential (rotational) positions along an outer surface of the primary wire. In one particular embodiment, for example, the markers are each located in a “twelve o’clock” position.
  • the delivery catheter includes a proximal end, a distal end, and an inner primary lumen that defines a fixed, non-circular transverse cross-sectional configuration (e.g., a non-circular inner contour (surface, shape)) that corresponds to the transverse cross-sectional configuration defined by the primary wire.
  • the delivery catheter includes an “over-the-wire” configuration and slidably receives the primary wire such that the delivery catheter is (at least partially) positioned about the primary wire.
  • the primary wire is insertable into the delivery catheter in a plurality of discrete (rotational) orientations, the number of which is determined by the particular configurations of the primary wire and the delivery catheter.
  • the primary wire and the delivery catheter may include corresponding triangular transverse cross-sectional configurations, which facilitate insertion of the primary wire into the delivery catheter in three distinct (rotational) orientations that are offset from each other by (approximately) 120°.
  • the non-circular transverse cross-sectional configurations of the primary wire and the delivery catheter allow the relative (rotational) orientations of the primary wire and the delivery catheter to be maintained during advancement of the delivery catheter through the blood vessel.
  • the delivery catheter may include a (third) marker (e.g., a radiopaque marker) at or adjacent to the distal end thereof.
  • the delivery catheter is configured for insertion into and movement through a blood vessel to a target lesion, to stop at a location proximal to the target lesion, to deliver the primary stent, and for withdrawal from the blood vessel.
  • the delivery catheter is rotated into a predetermined orientation prior to insertion of the primary wire, which results in corresponding rotation of the primary stent to allow for advancement of the delivery catheter and the primary stent into the blood vessel, and deployment of the primary stent, in a predetermined (rotational) orientation.
  • the delivery catheter may further include at least one balloon and at least one secondary lumen that is (solely) configured to support inflation and deflation of the at least one balloon.
  • the primary stent may be loaded onto the at least one balloon.
  • the stent may include a differentially porous configuration.
  • the primary stent may include a first region including a first porosity (e.g., a covered area) and a second region including a second, different porosity (e.g., an uncovered area).
  • the primary stent may include at least one fenestration.
  • the primary stent may include at least one region that is substantially impermeable to fluid.
  • the intravascular device may further include at least one adhered compound (e.g., on the primary stent).
  • the primary stent may include at least one radiopaque marker.
  • the at least one balloon may include at least one radiopaque marker.
  • the primary stent may include at least one radiopaque marker.
  • the primary stent may be configured (e.g., optimized) to facilitate the treatment of a narrowed lumen of the blood vessel.
  • the intravascular device may include a lubricious surface coating.
  • the delivery catheter may include a configuration supporting rapid-exchange.
  • the primary wire may include at least one anchor at or adjacent to the distal end thereof.
  • the at least one anchor may include a tortuous (e.g., a spring-like) configuration.
  • the at least one anchor may include a branched wire segment.
  • the branched wire segment may split into at least two segments such that, upon the application of a predetermined radial force, the at least two segments are directed into walls of the blood vessel in different directions.
  • the at least one anchor may be configured such that the branched wire segment is moved from a first (insertion, inactive, collapsed) configuration, in which the at least two segments are positioned in generally adjacent relation, into a second (anchoring, active, expanded) configuration, in which the at least two segments are separated from each other to thereby anchor the primary wire within the blood vessel upon the application of an external stimulus.
  • the at least one anchor may be moved from the first configuration into the second configuration upon the application of any suitable stimulus including, for example, a thermal stimulus, an electric stimulus, a mechanical stimulus, a magnetic stimulus, a hydrostatic stimulus, etc.
  • the at least one anchor may include a balled wire.
  • the at least one anchor may include a retrievable stent.
  • the primary wire and the at least one anchor may be delivered through a secondary catheter.
  • the secondary catheter may be inserted over a secondary wire.
  • the intravascular device may include an IVUS catheter with an inner lumen that defines a fixed, non-circular transverse cross-sectional configuration (e.g., a noncircular inner contour (surface, shape)) that corresponds to the inner lumen of the primary catheter and the transverse cross-sectional configuration defined by the primary wire, whereby the IVUS catheter may be advanced over the primary wire and subsequently removed before insertion of the delivery catheter (e.g., to optimize imaging and orientation of the target lesion, side branch(es) of the blood vessel, etc.).
  • a fixed, non-circular transverse cross-sectional configuration e.g., a noncircular inner contour (surface, shape)
  • the IVUS catheter may include a (fourth) marker (e.g., a radiopaque marker) that is positioned in correspondence with the (third) marker on the delivery catheter (e.g., in the “twelve o’clock” position).
  • a (fourth) marker e.g., a radiopaque marker
  • the delivery catheter may include a tertiary lumen.
  • the tertiary lumen may include a “peel-away” (side) slit up to a rapid exchange length lumen.
  • the tertiary lumen may be configured to receive and deliver a tertiary wire (e.g., into a side branch of the blood vessel).
  • the tertiary lumen may terminate in a side-hole that is located proximally of a distal end hole defined by the inner lumen such that the tertiary wire is deliverable into the blood vessel through the side-hole.
  • the at least one balloon may include a fenestration.
  • the at least one balloon may be configured such that the fenestration is generally aligned with (e.g., overlaps or overlies) the side-hole defined by the tertiary lumen.
  • the primary stent may include a fenestration and may be loaded onto the at least one balloon such that the fenestration of the primary stent is generally aligned with (e.g., overlaps or overlies) the fenestration of the at least one balloon and the side-hole.
  • the tertiary wire may include a distal anchor.
  • the tertiary wire may include a fixed, non-circular transverse cross-sectional configuration (e.g., a non-circular outer (circumferential) contour (surface, shape)) over a majority of its length.
  • a fixed, non-circular transverse cross-sectional configuration e.g., a non-circular outer (circumferential) contour (surface, shape)
  • a secondary delivery catheter may be employed to deliver a secondary stent.
  • the secondary delivery catheter may include at least one balloon.
  • the secondary stent may be mounted on the at least one balloon of the secondary delivery catheter.
  • the secondary stent may include at least one fenestration.
  • the secondary stent may include an annular (e.g., round, circular, oval, etc.) opening (hole) that is configured to overlap an ostium (origin) of a vessel branch.
  • the secondary stent may include at least one secondary compound adhered thereto.
  • the secondary delivery may include an inner secondary lumen that defines a fixed, non-circular transverse cross-sectional configuration (e.g., a non-circular inner contour (surface, shape)) that corresponds to the transverse cross-sectional configuration defined by the tertiary wire.
  • the secondary delivery catheter may include an “over-the-wire” configuration, which allows for slidable insertion of the tertiary wire into the secondary delivery catheter such that the secondary delivery catheter is (at least partially) positioned about the tertiary wire.
  • the tertiary wire is insertable into the secondary delivery catheter in a plurality of discrete (rotational) orientations, the number of which is determined by the particular configurations of the tertiary wire and the secondary delivery catheter.
  • the tertiary wire and the secondary delivery catheter may include corresponding triangular transverse cross-sectional configurations, which facilitate insertion of the tertiary wire into the secondary delivery catheter in three distinct (rotational) orientations that are offset from each other by (approximately) 120°.
  • the non-circular transverse cross-sectional configurations of the tertiary wire and the secondary delivery catheter allow the relative (rotational) orientations of the tertiary wire and the secondary delivery catheter to be maintained during advancement of the secondary delivery catheter through the blood vessel.
  • the secondary delivery catheter is rotated into a predetermined orientation prior to insertion of the tertiary wire, which results in corresponding rotation of the secondary stent to allow for advancement of the secondary delivery catheter and the secondary stent into the blood vessel, and deployment of the secondary stent, in a predetermined (rotational) orientation.
  • the intravascular device may include at least one energy transfer component.
  • a wire for intraluminal use.
  • the wire includes an anchor at a distal end thereof.
  • the anchor may include a branched wire segment.
  • the branched wire segment may split into at least two segments such that, upon the application of a predetermined radial force, the at least two segments are directed into walls of the blood vessel in different directions.
  • the at least one anchor may be configured such that the branched wire segment is moved from a first (insertion, inactive, collapsed) configuration, in which the at least two segments are positioned in generally adjacent relation, into a second (anchoring, active, expanded) configuration, in which the at least two segments are separated from each other to thereby anchor the primary wire within the blood vessel upon the application of an external stimulus. It is envisioned that the at least one anchor may be moved from the first configuration into the second configuration upon the application of any suitable stimulus (e.g., to a proximal end of the wire) including, for example, a thermal stimulus, an electric stimulus, a mechanical stimulus, a magnetic stimulus, a hydrostatic stimulus, etc.
  • any suitable stimulus e.g., to a proximal end of the wire
  • the wire may further include a central segment that continues distally beyond the at least one anchor.
  • an intravascular system for treating of a blood vessel.
  • the intravascular system includes a catheter defining a first lumen and a first delivery device that is configured for insertion into the first lumen of the catheter.
  • the first lumen terminates in a distal end hole and has a first non-circular transverse cross-sectional configuration.
  • the first delivery device includes a first stent and a first elongated member that supports the first stent such that the first elongated member and the first stent are 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 transverse cross-sectional configuration that corresponds to the first non-circular transverse cross-sectional configuration to thereby inhibit rotation of the first elongated member within the catheter and control orientation of the first stent relative to the catheter.
  • the first delivery device may be configured as a packaging catheter.
  • the packaging catheter may include a body and a pusher that supports the first stent.
  • the first elongated member is defined by the pusher, which is configured for movement through the body such that the pusher and the first stent are insertable into the blood vessel through the catheter.
  • the first stent may be configured for self-expansion such that the first stent automatically expands in the blood vessel upon exposure from the catheter.
  • the first delivery device may be configured as a balloon catheter including a first inflatable member.
  • the first elongated member is defined by a body of the balloon catheter such that the body of the balloon catheter is received by the first lumen of the catheter and the first stent is positioned about the first inflatable member such that the first stent is deployed upon inflation of the first inflatable member.
  • the first delivery device may include a second lumen that extends therethrough.
  • the second lumen may terminate in a side hole.
  • the second lumen may include a third non-circular transverse cross-sectional configuration.
  • the intravascular system may further include a second delivery device that is configured for insertion into the second lumen of the first delivery device.
  • the second delivery device may include a second stent and a second elongated member that supports the second stent such that the second elongated member and the second stent are movable through the second lumen to facilitate delivery of the second stent through the side-hole to treat a side branch of the blood vessel.
  • the second elongated member may have a fourth non-circular transverse cross-sectional configuration that corresponds to the third non-circular transverse cross- sectional configuration to thereby inhibit rotation of the second elongated member within the first delivery device and control orientation of the second stent relative to the catheter.
  • the second stent may be configured for self-expansion such that the second stent automatically expands upon exposure in the blood vessel.
  • the second delivery device may further include an inflatable member that is supported by the second elongated member.
  • the second stent is supported by the inflatable member such that the second stent is deployed upon inflation of the inflatable member.
  • an intravascular system for treating of a blood vessel.
  • the intravascular system includes a first medical device and a second medical device.
  • the first medical device includes: an elongated member; a first inflatable member that is supported by the elongated member; and a first stent that is supported by the first inflatable member such that the first stent is deployed upon inflation of the first inflatable member.
  • the elongated member defines a first lumen that extending from a proximal end hole to a distal end hole and a second lumen that extends in generally parallel relation to the first lumen from the proximal end hole to a side-hole that is located proximally of the distal end hole.
  • the first inflatable member includes a first fenestration and the first stent includes a second fenestration.
  • the second medical device is configured for insertion into the second lumen to access a side branch of the blood vessel through the side-hole, through the first fenestration in the first inflatable member, and through the second fenestration in the first stent.
  • the second medical device is configured as a packaging catheter.
  • the packaging catheter may include: a body that is configured for connection to the first medical device; a pusher that is configured for movement through the body; and a second stent that is supported on the pusher such that the pusher and the second stent are insertable into the side branch of the blood vessel through the first medical device via the second lumen and the side-hole.
  • the second stent may be configured for self-expansion such that the second stent automatically expands in the side branch of the blood vessel upon exposure from the side-hole.
  • the second lumen may define a first non-circular transverse cross- sectional configuration and the pusher defines a second non-circular transverse cross-sectional configuration corresponding to the first non-circular transverse cross-sectional configuration so as to inhibit rotation of the pusher and the second stent within the second lumen to thereby control orientation of the second stent relative to the first medical device.
  • first non-circular transverse cross-sectional configuration and the second non-circular transverse cross-sectional configuration may each be defined by a plurality of linear segments.
  • first non-circular transverse cross-sectional configuration and the second non-circular transverse cross-sectional configuration may be such that the pusher is insertable into the second lumen in at least three distinct (rotational) orientations.
  • the second medical device may be configured as a guide wire.
  • the guide wire may be insertable into the side branch of the blood vessel through the side-hole in the first medical device.
  • the second medical device may be configured as a balloon catheter.
  • the balloon catheter may include: a body; a second inflatable member that is supported by the body; and a second stent that is supported by the second inflatable member such that the second stent is deployed upon inflation of the second inflatable member.
  • the body of the balloon catheter may define a lumen that is configured to receive a guide wire such that the balloon catheter is insertable into the side branch of the blood vessel over the guide wire.
  • the second lumen may define a first non-circular transverse cross- sectional configuration and the body of the balloon catheter may define a second non-circular transverse cross-sectional configuration that corresponds to the first non-circular transverse cross- sectional configuration to thereby inhibit rotation of the balloon catheter and the second stent within the second lumen and control orientation of the second stent relative to the first medical device.
  • a system for maintaining an orientation of a stent during delivery.
  • the system includes a first medical device supporting the stent and a second medical device that is configured to receive the first medical device.
  • the first medical device and the second medical device include corresponding non-circular transverse cross-sectional configurations to inhibit rotation of the first medical device within the second medical device and thereby control orientation of the stent.
  • the first medical device may be configured as a balloon catheter that includes an inflatable member.
  • the stent is supported by the inflatable member such that the stent is deployed upon inflation of the inflatable member.
  • an intravascular system includes a first medical device, a second medical device that is 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 transverse 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 vary an angular position of the second medical device and the first medical device via torsional force applied to second medical device by the at least one pull wire.
  • the at least one pull wire may be secured to an outer surface of the second medical device.
  • the at least one pull wire may extend through a channel formed in an outer wall of the second medical device.
  • the intravascular system may further include an activating mechanism that is connected to the at least one pull wire and configured to apply the torsional force to the second medical device.
  • the activating mechanism may be supported on a body of the second medical device.
  • the at least one pull wire may include a first pull wire that is connected to the second medical device to vary the angular position of the second medical device in a first direction and a second pull wire that is connected to the second medical device to vary an angular position of the second medical device in a second direction that is generally opposite to the first direction.
  • the intravascular system may further include a first activating mechanism that is connected to the first pull wire and configured to apply a first torsional force to the second medical device and a second activating mechanism that is connected to the second pull wire and configured to apply a second torsional force to the second medical device.
  • vascular abnormality should be understood to include aneurysms, lesions, fistulas, ruptures, and any other such malformation in a blood vessel.
  • 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 elongated structure (e.g., tube, wire, catheter body, or the like) described herein.
  • FIG. 1A is a perspective view of an intravascular system including a primary delivery catheter.
  • FIG. IB is a (partial) perspective view of a lumen of the primary delivery catheter seen in FIG. 1 A shown positioned within an anatomical vessel (e.g., a blood vessel).
  • an anatomical vessel e.g., a blood vessel
  • FIG. 1C is a (partial) transverse, cross-sectional view of a delivery device (e.g., a pusher of a packaging catheter) positioned within the lumen of the primary delivery catheter and shown in a first (rotational) position.
  • a delivery device e.g., a pusher of a packaging catheter
  • FIG. ID is a (partial) transverse, cross-sectional view of the pusher positioned within the lumen of the primary delivery catheter and shown in a second (rotational) position.
  • FIG. 2A is a perspective view of the packaging catheter and the primary delivery catheter during treatment of a vascular abnormality in a blood vessel.
  • FIG. 2B is a perspective view of the primary delivery catheter shown in connection with an alternate embodiment of the delivery device, which is configured as a balloon catheter, during treatment of the vascular abnormality.
  • FIG. 2C is a perspective view of a primary stent (or other such occlusion device) that is positionable within the blood vessel via the delivery device and the primary delivery catheter to treat the vascular abnormality.
  • FIG. 3 is a perspective view illustrating advancement of the primary stent through the blood vessel via the pusher during treatment of the vascular abnormality.
  • FIG. 4 is a (partial) perspective view of the primary delivery catheter.
  • FIG. 5 is a (partial) perspective view of the primary delivery catheter including one or more markers (e.g., radiopaque markers) to facilitate external visualization of the primary delivery catheter in the blood vessel.
  • markers e.g., radiopaque markers
  • FIG. 6 is a perspective view of the pusher, the primary stent, and the primary delivery catheter seen in FIG. 5 illustrating insertion of the pusher and the primary stent into the primary delivery catheter.
  • FIGS. 7A-7D are transverse, cross-sectional views illustrating a variety of non-circular cross-sectional configurations for the lumen extending through the primary delivery catheter according to various embodiments of the present disclosure.
  • FIG. 7E is a perspective view of an alternate embodiment of the primary delivery catheter, which includes a variety of markers (e.g., radiopaque markers) that are located in a variety of (rotational) positions to facilitate external visualization of the primary delivery catheter.
  • markers e.g., radiopaque markers
  • FIG. 8 is perspective view of the pusher.
  • FIG. 9 is a perspective view of the packaging catheter.
  • FIG. 10 is a perspective view of an alternate embodiment of the pusher, which includes a tapered distal end.
  • FIG. 11 illustrates an alternate embodiment of the primary delivery catheter, which includes a hub at a proximal end thereof and a series of markers (e.g., radiopaque markers).
  • markers e.g., radiopaque markers
  • FIG. 12 illustrates the pusher inserted into the primary delivery catheter seen in FIG. 11.
  • FIG. 13 is a perspective view of an alternate embodiment of the delivery device, which includes an outer hypotube that is configured to support the primary stent.
  • FIG. 14 is a perspective view of an inner hypotube inserted into the outer hypotube seen in FIG. 13.
  • FIG. 14A is a perspective view of alternate embodiments of the outer hypotube and the inner hypotube.
  • FIG. 15 is a perspective view of a guide wire for use with the presently disclosed intravascular system.
  • FIG. 16 is a longitudinal, cross-sectional view illustrating deployment of the primary delivery catheter into the blood vessel via the guide wire to treat the vascular abnormality according to one aspect of the present disclosure.
  • FIG. 17 is a longitudinal, cross-sectional view illustrating insertion of the pusher and the primary stent through the primary delivery catheter.
  • FIG. 18 is a longitudinal, cross-sectional view illustrating an alternate embodiment of the intravascular system.
  • FIG. 19 is a transverse, cross-sectional view taken through line 19-19 in FIG. 18.
  • FIG. 20 is a longitudinal, cross-sectional view illustrating deployment of a self-expanding secondary stent into a side branch of the blood vessel through a primary delivery catheter and a first delivery device.
  • FIG. 21 is a transverse, cross-sectional view taken through line 21-21 in FIG. 20.
  • FIG. 22 is a longitudinal, cross-sectional view illustrating deployment of a secondary guide wire through the primary delivery catheter and the first delivery device into the side branch of the blood vessel.
  • FIG. 23 is a longitudinal, cross-sectional view illustrating deployment of the selfexpanding secondary stent into the side branch of the blood vessel through a secondary delivery catheter that is received within the primary delivery catheter and the first delivery device.
  • FIG. 24 is a longitudinal, cross-sectional view illustrating deployment of a balloonexpandable secondary stent into a side branch of the blood vessel through the primary delivery catheter and the first delivery device over a secondary guide wire.
  • FIG. 25 is a longitudinal, cross-sectional view illustrating positioning of the secondary stent within the side branch of the blood vessel such that the secondary stent overlaps (overlies) the primary stent.
  • FIG. 26 is a schematic representation of an alternate embodiment of the delivery catheter seen in FIG. 1 A shown in a first (initial, normal) configuration and including one or more steerable segments that are deflected by one or more pull wires.
  • FIG. 27 is a transverse cross-sectional view of the delivery catheter seen in FIG. 26 taken along line 27-27.
  • FIG. 28 is a schematic representation of the delivery catheter seen in FIG. 26 shown in a second (subsequent, deflected) configuration.
  • FIG. 29 A is a perspective view of an alternate embodiment of the delivery catheter seen in FIG. 1 A that includes a pull wire to apply a torsional (twisting) force to the delivery catheter.
  • FIG. 29B is a perspective view of an alternate embodiment of the delivery catheter seen in FIG. 29A in which the pull wire includes a helical (spiraled) distal segment and a (generally) linear proximal segment.
  • FIG. 30 is a perspective view of an alternate embodiment of the delivery catheter seen in FIG. 29 A.
  • FIG. 31 is a perspective view of an alternate embodiment of the delivery catheter seen in FIG. 29A.
  • FIG. 32 is a perspective view of an alternate embodiment of the delivery catheter seen in
  • FIG. 29A is a perspective view of an alternate embodiment of the delivery catheter seen in FIG. 29A that includes a plurality of pull wires.
  • FIG. 34 is a perspective view of an alternate embodiment of the delivery catheter seen in FIG. 33.
  • FIG. 35 is a perspective view of an alternate embodiment of the delivery catheter seen in FIG. 33.
  • FIG. 1 A provides a perspective view of an intravascular system 10 for the treatment of an anatomical vessel (e.g., a blood vessel V (FIG. 2 A)).
  • the intravascular system 10 includes a (primary) delivery catheter 100 including an elongated body (member) 102 that extends along a longitudinal axis X.
  • the body 102 includes a proximal (first) end 104 defining a proximal end hole 106, a distal (second) end 108 defining a distal end hole 110, and a (generally) cylindrical outer transverse 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 transverse (lateral) cross-sectional configuration. More specifically, in the particular embodiment illustrated, the lumen 112 defines a (generally) triangular transverse (lateral) cross-sectional configuration.
  • non-circular transverse (lateral) cross-sectional configurations are also contemplated by the present disclosure including, for example, rectangles, pentagons, hexagons, octagons, squares, ovals, ellipse, stars, etc.
  • the delivery catheter 100 is configured to deliver an occlusion device 200 (FIG. 2C) (e.g., a stent 202) to a target site within the blood vessel V (or other such location within a patient’s vasculature).
  • an occlusion device 200 e.g., a stent 202
  • the occlusion device 200 may be carried (or otherwise supported) by an inflatable balloon (or other such member) that is connected to the delivery catheter 100.
  • the occlusion device 200 may be carried (or otherwise supported) by a separate delivery device.
  • the delivery catheter 100 and the occlusion device 200 are each shown as including a (generally) circular outer transverse cross-sectional configuration, it should be appreciated that the particular configurations of the delivery catheter 100 and the occlusion device 20 may be varied without departing from the scope of the present disclosure.
  • the delivery catheter 100 and the occlusion device 20 may each include an outer transverse cross- sectional configuration that is non-circular (e.g., oval, square, rectangular, triangular, trapezoidal, diamond, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal, etc.).
  • the delivery catheter 100 may be configured as a packaging catheter 300 (FIG. 2A) that includes an elongated pusher 302 (e.g., a wire) with a proximal end 304 and a distal end 306 that carries (or otherwise supports) the stent 202 in either a fixed or releasable (disconnectable) manner.
  • a packaging catheter 300 FIG. 2A
  • the stent 202 may be pre-loaded and crimped (or otherwise secured) to the distal end 306 of the pusher 302 such that the stent 202 can be separated from the pusher 302 and deployed within the vasculature.
  • the packaging catheter 300 is pre-loaded with the pusher 302 and the stent 202 and the packaging catheter 300 is connected to the delivery catheter 100 (either directly or indirectly) such that, via axial movement of the pusher 302, the stent 202 is deliverable from the packaging catheter 300, into and through the delivery catheter 100, and into the blood vessel V.
  • the delivery device may be configured as a secondary catheter (e.g., a balloon catheter 400 (FIG. 2B) or a hypotube) that is configured for insertion into the blood vessel V (FIG. 2 A) through the delivery catheter 100.
  • the stent 202 may be supported on an inflatable member 406 (e.g., a balloon or other such suitable structure) of the balloon catheter 400 and deployed via expansion of the inflatable member 406.
  • the balloon catheter 400 may be inserted through the delivery catheter 100 over a guide (delivery) wire 500 that extends into the blood vessel V.
  • the pusher 302 will include a non-circular (transverse) cross-sectional configuration (e.g., a cross- sectional configuration that is generally orthogonal in relation to a longitudinal axis of the pusher 302) corresponding to that defined by the lumen 112 of the delivery catheter 100 to limit (if not entirely prevent) rotation of the pusher 302 within the delivery catheter 100, thereby facilitating control over the (rotational) orientation of the stent 202 via manipulation of the delivery catheter 100 (and/or the pusher 302).
  • a non-circular (transverse) cross-sectional configuration e.g., a cross- sectional configuration that is generally orthogonal in relation to a longitudinal axis of the pusher 302
  • the balloon catheter 400 will include an outer (transverse) non-circular transverse cross-sectional configuration (e.g., a cross-sectional configuration that is generally orthogonal in relation to a longitudinal axis of the balloon catheter 400) corresponding to that defined by the lumen 112 to limit (if not entirely prevent) rotation of the balloon catheter 400 within the delivery catheter 100, thereby facilitating control over the (rotational) orientation of the stent 202 via manipulation of the balloon catheter 400 (and/or the delivery catheter 100).
  • an outer (transverse) non-circular transverse cross-sectional configuration e.g., a cross-sectional configuration that is generally orthogonal in relation to a longitudinal axis of the balloon catheter 400
  • the configurations of the delivery catheter 100, the pusher 302, and the balloon catheter 400 are such that the pusher 302 and the balloon catheter 400 are axially movable (slidable) through the delivery catheter 100 so as not to interfere with advancement of the pusher 302 and the balloon catheter 400 into the vasculature.
  • imaging can be used to confirm the orientation of the distal end 108 of the delivery catheter 100 relative to the proximal end 104 of the delivery catheter 100.
  • the respective proximal and distal ends 104, 108 of the delivery catheter 100 may include corresponding markers 114 (e.g., radiopaque markers) that are positioned in corresponding locations (e.g., at “12 o’clock” locations), as elaborated upon below.
  • Subsequent imaging with x- ray, 3-D x-rays, CT imaging, echocardiography, ultrasound, IVUS, or other modalities can then confirm the relative (rotational) position of the distal end 108 of the delivery catheter 100 (e.g., at, near, or adjacent to the vascular abnormality (e.g., the an aneurysm A) relative to the proximal end 104 of the delivery catheter 100 to ascertain the extent to which the distal end 108 of the delivery catheter 100 is rotationally offset from the proximal end 104 (e.g., as a result of twisting or other such deflection experienced by the delivery catheter 100 during navigation through the vasculature).
  • the vascular abnormality e.g., the an aneurysm A
  • the delivery device e.g., the pusher 302, the balloon catheter 400, etc.
  • the stent 202 can then be rotated a corresponding amount prior to insertion into the delivery catheter 100 to account for the observed degree of (rotational) offset of the distal end 108 of the delivery catheter 100, thereby facilitating accurate orientation and deployment of the stent 202.
  • the delivery device e.g., the pusher 302, the balloon catheter 400, etc.
  • the stent 202 can then be rotated a corresponding amount prior to insertion into the delivery catheter 100 to account for the observed degree of (rotational) offset of the distal end 108 of the delivery catheter 100, thereby facilitating accurate orientation and deployment of the stent 202.
  • most known catheters, wires, and stents cannot be accurately rotated at the target site from the proximal end (hub) of the device.
  • the present disclosure relies on a fixed degree of random rotation during initial delivery of the guide (delivery) wire 500, the delivery catheter 300, etc., to be recorded accurately and subsequently accounted for, allowing for accurate orientation, delivery, and placement of the stent 202.
  • trial retrievable stent devices or similar devices can also be used to determine or confirm the orientation of the guide wire, the delivery catheter 300, etc., at the target site in the vasculature.
  • FIG. IB provides a (partial) view of the delivery catheter 100 positioned within the blood vessel V such that the distal end 108 is located in proximity (e.g., at or adjacent) to the vascular abnormality (e.g., the aneurysm A) that is the subject of the medical procedure.
  • the vascular abnormality e.g., the aneurysm A
  • FIG. IB provides a (partial) view of the delivery catheter 100 positioned within the blood vessel V such that the distal end 108 is located in proximity (e.g., at or adjacent) to the vascular abnormality (e.g., the aneurysm A) that is the subject of the medical procedure.
  • the vascular abnormality e.g., the aneurysm A
  • FIG. 1C is a (partial) cross-sectional view of the delivery catheter 100 taken transversely (e.g., orthogonally) in relation to the longitudinal axis X (FIG. 1 A) and shown with the pusher 302 of the packaging catheter 300 positioned within the lumen 112 in a first orientation.
  • FIG. ID is a (partial) cross-sectional view of the delivery catheter 100 and the pusher 302 shown positioned within the lumen 112 in second first orientation that is (rotationally) offset from the first orientation seen in FIG. 1C by (approximately) 120°.
  • the pusher 302 may define a lumen therethrough (e.g., to facilitate receipt of the aforementioned 114 such that the pusher 302 is advanceable into the blood vessel V in an “over-the-wire” configuration).
  • the stent 202 includes a self-expanding, differentially porous configuration with a first (covered) region 204 having a first porosity and a second (uncovered) region 206 having a second, different (e.g., greater) porosity.
  • first region 204 may be completely impermeable to fluid, blood, etc.
  • second region 206 may be devoid of struts (threads, etc.) such that the second region 206 includes or otherwise defines one or more fenestrations 208, holes, apertures, or other such openings in the stent 202.
  • the present disclosure contemplates a variety of geometrical configurations for the stent 202 including, for example, both (generally) circular transverse cross-sectional configurations (e.g., so as to correspond to the (generally) circular transverse cross-sectional configuration of blood vessels), as seen in FIG. 2C, for example, and non-circular transverse cross-sectional configurations (e.g., to facilitate placement and/or anchoring of the stent 202 within the vasculature).
  • the pusher 302 includes a non-circular transverse (lateral) cross-sectional configuration corresponding to that defined by the lumen 112 of the delivery catheter.
  • the pusher 302 includes a (generally) triangular transverse (lateral) cross-sectional configuration. As discussed above (and elaborated upon below) in connection with the lumen 112, a variety of other non-circular transverse (lateral) cross-sectional configurations for the pusher 302 are also contemplated by the present disclosure.
  • the corresponding non-circular transverse cross-sectional configurations defined by the lumen 112 of the delivery catheter and the pusher 302 allow for receipt of the pusher 302 in a manner that allows for 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 to thereby facilitate control over the orientation of the pusher 302 and, thus, the stent 202, relative to the delivery catheter 100.
  • the triangular cross-sectional configuration of the lumen 112 is defined by three linear segments a, b, c that intersect to define vertices vertexes AA, BB, and CC and interior angles A, B, C of (approximately) 120°.
  • counterclockwise rotation of the delivery catheter 100 by (approximately) 120° will results in positioning of the delivery catheter 100 (and, thus, the pusher 302) in the manner illustrated in FIG. ID.
  • the number of linear segments may be varied in alternate embodiment so as to define any suitable non-circular (transverse) cross-sectional configuration for the lumen 112 (e.g., four segments, five segments, six segments, etc.).
  • the non-circular (transverse) cross-sectional configuration of the lumen 112 allows for insertion of the pusher 302 (or the balloon catheter 400) in a plurality of discrete (rotational) orientations.
  • the triangular transverse cross-sectional configuration of the lumen 112 allows for receipt of the pusher 302 and, thus, the stent 202, in one of three discreate (rotational) orientations that are offset from each other by (approximately) 120°.
  • Variability in the (rotational) orientation of the pusher 302 and the stent 202 allows for and accommodates (rotational) displacement experienced by the distal end 108 of the delivery catheter 100 (relative to the proximal end 104 and the aforementioned aneurysm A) during insertion into the blood vessel V by virtue of the tortuous nature of the vasculature.
  • the pusher 302 may be inserted in one (rotational) orientation (e.g., in a corresponding “12 o’clock” position).
  • the pusher 302 may be inserted in one of a plurality of different (rotational) orientations, which, in the illustrated embodiment, are (rotationally) offset from each other by (approximately) 120°, such that the stent 202 may be positioned in the blood vessel V as necessary or desired to treat the aneurysm A.
  • the delivery catheter 100, the pusher 302, the balloon catheter 400, the stent 202, etc. may include one or more markers (e.g. radiopaque markers), as discussed in further detail below, which may be visualized using any suitable technique such as, for example, x-ray, 3-D x-rays, CT imaging, echocardiography, ultrasound, IVUS, etc.
  • markers e.g. radiopaque markers
  • FIG. 2A illustrates the packaging catheter 300 and the 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.
  • the hub 600 may a component of the packaging catheter 300 or the delivery catheter 100.
  • the hub 600 may be a discrete (free-standing) component of the intravascular system 10 that is 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.
  • the packaging catheter 300 includes an elongated tubular body 310 having respective proximal and distal ends 312, 314 and defining a lumen 316 that is configured to receive the pusher 302 and the stent 202.
  • the hub 600 is configured for releasable connection 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 the port 602 in the hub 600, into the lumen 112 of the delivery catheter 100, and into proximity (e.g., at or adjacent) to the aneurysm A.
  • distal end 306 of the packaging catheter 300 and the proximal end 104 of the delivery catheter 100 may be disposed within the hub 600 in (general) alignment to facilitate movement of the pusher 302 from the elongated body 310 of the packaging catheter 300 into the lumen 112 of the delivery catheter 100.
  • the delivery catheter 100 is advanced through the blood vessel V to the target site (e.g., such that the distal end 108 of the delivery catheter 100 is located in proximity (e.g., at or adjacent) to the aneurysm A).
  • the stent 202 which is pre-loaded on the pusher 302, may be then be advanced through the delivery catheter 100 into the blood vessel V (e.g., via the an elongated body 310 of the packaging catheter 300 and the hub 600) such that the stent 202 is automatically expanded (deployed) upon exposure from the delivery catheter 100.
  • FIG. 2B illustrates insertion of the balloon catheter 400 and the stent 202 into the blood vessel V through the delivery catheter 100.
  • the balloon catheter 400 includes an elongated (tubular) body (member) 402 defining a lumen 404 and an inflatable member 406 that is supported by the elongated body 402.
  • the stent 202 is positioned about (secured to) the inflatable member 406 (e.g., via crimping) such that the stent 202 is deployed via expansion (inflation) of the inflatable member 406.
  • the guide wire 500 which includes respective proximal and distal ends 502, 504, is positioned within the blood vessel 100 such that the guide wire 500 is located in proximity (e.g., at or adjacent) to the aneurysm A.
  • the balloon catheter 400 is then advanced into the blood vessel V over the guide wire 500 (e.g., through the lumen 112 in the delivery catheter 100) such that the guide wire 500 extends through the lumen 404 defined by the elongated body 402 of the balloon catheter 400.
  • the balloon catheter 400 includes (defines) a non-circular transverse (e.g., triangular) cross-sectional configuration corresponding to that defined by the lumen 112 of the delivery catheter 300 to inhibit (if not entirely prevent) relative rotation between the balloon catheter 400 and the delivery catheter 300, thereby facilitating control over the (rotational) orientation of the stent 202 via manipulation of the balloon catheter 400.
  • a non-circular transverse (e.g., triangular) cross-sectional configuration corresponding to that defined by the lumen 112 of the delivery catheter 300 to inhibit (if not entirely prevent) relative rotation between the balloon catheter 400 and the delivery catheter 300, thereby facilitating control over the (rotational) orientation of the stent 202 via manipulation of the balloon catheter 400.
  • the lumen 404 of the balloon catheter 400 may include a non- circular transverse (e.g., triangular) cross-sectional configuration corresponding to that defined by the guide wire 500 to inhibit (if not entirely prevent) relative rotation between the balloon catheter 400 and the guide wire 500.
  • the guide wire 500 may include one or more anchors 506 at (or adjacent to) the distal end 504 thereof.
  • the anchor 506 includes a branched wire segment 508 that defines a plurality of segments 510 (e.g., a first segment 5 lOi and a second segment 510i).
  • the segments 510 are directed into the wall of the blood vessel V in different directions.
  • the anchor(s) 506 may be configured such that the branched wire segment 508 is moved from a first (insertion, inactive, collapsed) configuration, in which the segments 510 are positioned in generally adjacent relation to each other and to the distal end 504 of the guide wire 500, into a second (anchoring, active, expanded) configuration, in which the segments 510 are separated from each other to thereby anchor the guide wire 500 within the blood vessel V upon the application of an external stimulus.
  • the at least one anchor 506 may be moved from the first configuration into the second configuration upon the application of any suitable stimulus including, for example, a thermal stimulus, an electric stimulus, a mechanical stimulus, a magnetic stimulus, a hydrostatic stimulus, etc.
  • the configuration of the anchor(s) 506 may be varied.
  • the anchor(s) 506 may include a tortuous (e.g., a spring-like) configuration.
  • the anchor(s) 506 may include a balled wire, a retrievable stent, or any other structure suitable for the intended purpose of securing the guide wire $00 in relation to the blood vessel V (e.g., to maintain the (rotational) position of the distal end 504 of the guide wire 500).
  • anchor(s) 506 is applicable to any of the guide wires (or embodiments thereof) described herein.
  • the pusher 302 and the stent 202 are illustrated and shown located within the blood vessel V following removal of the delivery catheter 100.
  • the distal end 306 of the pusher 302 may extend distally beyond the stent 202 or, alternatively, that the distal end 306 of the pusher 302 may be coterminous with the stent 202 such that the distal end 306 of the pusher 302 does not extend distally beyond the stent 202, as seen in FIG. 3.
  • FIG. 4 provides a (partial) a view of the delivery catheter 100.
  • the triangular transverse cross-sectional configuration of the lumen 112 defines three linear segments (sides) 116, which are identified at the proximal end 104 of the delivery catheter 100 by the reference characters 114i, 114ii, 114iii and at the distal end 108 of the delivery catheter 100 by the reference characters 114iv, 114v, 114vi.
  • a linear face 118i extends between segments 114i, 114iv, a linear face 118ii extends between segments 114ii, 114vi, and a linear face 118iii extends between segments 114iii, 114vi along the axial length of the delivery catheter 100.
  • a linear face 118i extends between segments 114i, 114iv, a linear face 118ii extends between segments 114ii, 114vi, and a linear face 118iii extends between segments 114iii, 114vi along the axial length of the delivery catheter 100.
  • alternative embodiments may employ other non-circular cross-sectional configurations, such as, for example, rectangles, pentagons, hexagons, octagons, squares, ovals, ellipse, stars, etc.
  • FIG. 5 provides a (partial) a (partial) view of the delivery catheter 100 rotated 120° (clockwise) from the orientation seen in FIG. 4 such that the face 118ii is visible.
  • the markers 114 are secured to (or otherwise supported on) the face 118ii.
  • the markers 114 may be present in any suitable number and may be positioned in any suitable location. As such, it is envisioned that one or more markers 114 may be located on the face 118i or the face 118iii either instead of, or in addition to, the face 118ii.
  • 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 a hub of the delivery catheter 100 located externally of the body so as to allow for direct visualization), a (second) marker 114ii located at (or adjacent to) the distal end 108 of the delivery catheter 100, and a (third) marker 114iii located between the markers 114i, 114ii, wherein each of the markers 114 is oriented in a “12 o’clock” position.
  • FIG. 6 illustrates the stent 202 loaded onto the pusher 302 during insertion into the lumen 112 of the delivery catheter 100.
  • the lumen 112 and the pusher 302 include corresponding non-circular (e.g., triangular) transverse cross-sectional configurations that inhibit (if not entirely prevent) relative rotation between the pusher 302 (and, thus, the stent 202) and the delivery catheter 100 while allowing for relative axial (longitudinal) movement (e.g., sliding) of the pusher 302 (and, thus, the stent 202) through the lumen 112.
  • a variety of other non-circular transverse (lateral) cross- sectional configurations are also contemplated by the present disclosure.
  • the lumen 112 extending through the delivery catheter 100 may include a variety of non-circular transverse cross-sectional configurations such as, 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 transverse cross-sectional configuration that inhibits (if not entirely prevents) relative rotation between the pertinent structures.
  • FIG. 7E illustrates a variation on the delivery catheter 100 in which the proximal end 104 includes the markers 114i, 114ii in the “12 o’clock” position and the “6 o’clock” position, respectively, and the distal end 108 includes the marker 114iii in the “12 o’clock” position.
  • FIG. 8 shows the pusher 302.
  • FIG. 9 shows the packaging catheter 300 and the lumen 316 that extends through the elongated body 310 which, in the illustrated embodiment, includes a non-circular (e.g., triangular) transverse cross-sectional configuration.
  • FIG. 10 illustrates an alternate embodiment of the pusher 302, wherein the distal end 306 includes a tapered configuration. It should be appreciated, however, that distal end 306 of the pusher 302 may include any suitable configuration in various embodiments of the present disclosure such as, for example, rounded, pointed, etc.
  • FIG. 11 illustrates an embodiment of the 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 being (rotationally) offset from the proximal end 104 (e.g., subsequent to insertion into the blood vessel V (FIG. 2 A)), as indicated by the markers 114i, 114ii respectively included at the proximal and distal ends 104, 108. In the particular orientation seen in FIG.
  • the delivery catheter 100 is deflected (twisted) such that the marker 114ii at the distal end 108 is in a “10 o’clock” position when compared to the “12 o’clock” position of the marker 114i at the proximal end 104, which is provided on the hub 120 (e.g., such that the distal end 108 of the delivery catheter 100 is (rotationally) offset from the proximal end 104 by (approximately) 60°).
  • FIG. 12 illustrates the pusher 302 inserted into the lumen 112 of the delivery catheter 100 seen in FIG. 11.
  • FIGS . 13 and 14 illustrated an alternate embodiment of the disclosure in which the delivery device includes an elongated outer hypotube (member) 700 (FIG. 13) and an inner hypotube 800 (FIG. 14).
  • the outer hypotube 700 supports the stent 202 (e.g., the stent 202 is secured or otherwise connected to) an outer surface 702 of the outer hypotube 700) and defines a lumen 704 that extends therethrough.
  • outer hypotube 700 is illustrated as including a (generally) annular (circular, round) transverse cross-sectional configuration (e.g., for use during procedures in which rotation is not required), it should be appreciated that the outer hypotube 700 may include a non-circular transverse cross-sectional configuration in alternate embodiments (e.g., for use during procedures in which rotation is required).
  • hypotubes 700, 800 are each shown as including a (generally) circular outer transverse cross-sectional configuration, it should be appreciated that the particular configurations of the hypotubes 700, 800 may be varied without departing from the scope of the present disclosure.
  • the hypotubes 700, 800 may each include an outer transverse cross-sectional configuration that is non-circular (e.g., oval, square, rectangular, triangular, trapezoidal, diamond, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal, etc.).
  • the inner hypotube 800 includes wings 802 that extend proximally (rearwardly) from a distal end 804 thereof and defines a lumen 806 that extends 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 about the stent 202 to cover and constrain the stent 202 during insertion it the blood vessel V.
  • the stent 202 is exposed from the wings 802 by varying the relative longitudinal (axial) positions of the hypotubes 700, 800 (e.g.
  • the stent 202 may be re-sheathed (covered) (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 in relation to the inner hypotube 800, etc.).
  • 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 guide wire (e.g., the aforementioned guide wire 500) to facilitate use in an “over-the-wire” method of deployment.
  • a guide wire e.g., the aforementioned guide wire 500
  • the inner hypotube 800 and/or the outer hypotube 700 may include a rapid exchange configuration (e.g., it is envisioned that the inner hypotube 800 may include a side hole in communication with the lumen and/or that the outer hypotube 700 may include a side hole in communication with the lumen that is configured to receive the guide wire 500).
  • FIG. 14A illustrates alternate embodiments of the outer and inner hypotubes 700, 800 seen in FIGS. 13 and 14, which are identified by the reference characters 700i and 800i, respectively, for use during an alternate procedure.
  • the inner hypotube 800i includes a lumen 806i that extends therethrough and supports the stent 202, which is loaded (connected, supported) to an outer surface 808i thereof.
  • the outer hypotube 700i includes a lumen 704i that is configured to receive the inner hypotube 800i such that the inner hypotube 800i is longitudinally (axially) movable through the outer hypotube 700i.
  • the stent 202 Upon sufficient relative longitudinal (axial) movement between the hypotubes 700i, 800i, the stent 202 is exposed from a distal end 706i of the outer hypotube 700i and is automatically deployed (expanded).
  • FIG. 15 illustrates the guide wire 500.
  • the guide wire 500 includes a non-circular (e.g., triangular) transverse cross-sectional configuration that defines three linear faces (sides), which are identified by the reference characters 512i, 512ii, 512iii.
  • a non-circular transverse cross-sectional configuration that defines three linear faces (sides), which are identified by the reference characters 512i, 512ii, 512iii.
  • FIG. 15 illustrates the guide wire 500.
  • the guide wire 500 is illustrated without any significant (rotational) offset between the respective proximal and distal ends 502, 504 thereof.
  • the delivery catheter 100 is illustrated.
  • the aforementioned lumen 112 extends through the delivery catheter 100 and includes a (first) non- circular transverse (lateral) cross-sectional configuration.
  • the transverse (lateral) cross- sectional configuration of the lumen 112 is shown as being (generally) triangular in FIG. 1A, a variety of other non-circular transverse (lateral) cross-sectional configurations are also contemplated by the present disclosure including, for example, rectangular, pentagonal, hexagonal, octagonal, square-shaped, ovate (elliptical), stars-shaped, arrow-shaped, etc., as mentioned above.
  • the lumen 112 is configured to (slidably) receive an (elongated) medical device, such as, for example, the pusher 302 (FIG. 2A) of the packaging catheter 300, 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 guide wire 500, etc.
  • an (elongated) medical device such as, for example, the pusher 302 (FIG. 2A) of the packaging catheter 300, 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 guide wire 500, etc.
  • the medical device intended for insertion into the lumen 112 may include a (second) non-circular transverse (lateral) cross-sectional configuration corresponding to the (first) non-circular transverse (lateral) cross-sectional configuration defined by the lumen 112 so as to allow for longitudinal (axial) movement (e.g., sliding) of the medical device through the delivery catheter 100 while inhibiting (if not entirely preventing) rotation of the medical device within the delivery catheter 100 to thereby facilitate control over the (rotational) orientation of the medical device during deployment and placement of the stent 202.
  • the medical device will be insertable into the lumen 112 in a certain number of discrete (rotational) orientations.
  • discrete (rotational) orientations For example, in the context of the triangular transverse cross- sectional configuration seen in FIG. 1A, an inserted medical device will be orientable in one of three distinct (rotational) orientations that are offset from each other by (approximately) 120°.
  • the number of distinct (rotational) orientations, and the offset therebetween may be varied.
  • an inserted medical device will be orientable in one of four distinct (rotational) orientations that are offset from each other by (approximately) 90°.
  • FIG. IB illustrates the delivery catheter 100 within the blood vessel V.
  • the delivery catheter 100 is positioned within the blood vessel V such that the distal end hole 110 is located in proximity (e.g., at or adjacent) to the aneurysm A (or other vascular abnormality) that is the subject of the associated medical procedure. Due to the generally linear configuration and geometry of the lumen 1, the delivery catheter 100 includes a set orientation in which one side is positioned closest to the target aneurysm A.
  • FIG. 1C illustrates the pusher 302 positioned with the lumen 112 of the delivery catheter 100 in a first orientation
  • FIG. ID illustrates the pusher 302 and the delivery catheter 100 in a second, different orientation that is rotationally offset from the first orientation.
  • FIG. ID illustrates the pusher 302 and the delivery catheter 100 after 120° of counterclockwise rotation (or 240° of clockwise rotation).
  • Rotation of the delivery catheter 100 and, thus, the pusher 302 allows for the delivery and placement of the occlusion device 200 (e.g., the stent 202) (FIGS. 2A, 2C) in a necessary or desired orientation dictated by the location of the aneurysm A, for example.
  • the occlusion device 200 e.g., the stent 202
  • FIG. ID illustrates the pusher 302 and the delivery catheter 100 after 120° of counterclockwise rotation (or 240° of clockwise rotation).
  • Rotation of the delivery catheter 100 and, thus, the pusher 302 allows for the delivery and placement of the occlusion device 200 (e.g., the stent 202) (FIGS. 2A, 2C) in a necessary or desired orientation dictated by the location of the aneurysm A, for example.
  • a similar setup may be used to
  • one or more supplemental (additional) occlusion device(s) 200 may be used as well during the course of a particular medical procedure.
  • the orientation of the medical device e.g., the pusher 302 and the stent 202
  • the orientation of the delivery catheter 100 may be fixed outside the patient’s body by fixing the orientation of the medical device relative to the delivery catheter 100.
  • the orientation of the delivery catheter 100 e.g.
  • the stent 202 may be established prior to insertion of the medical device into the lumen 112 such as, for example, via imaging, so as to facilitate proper insertion of the medical device to achieve proper orientation and placement of the stent 202 with respect to aneurysm A without necessitating any rotational manipulation (e.g., turning) of the pusher 302 and, thus, the stent 202, inside the patient.
  • any rotational manipulation e.g., turning
  • FIG. 2 A illustrates the packaging catheter 300 connected to the delivery catheter 100 via the hub 600 such that the elongated body 310 is positioned externally of the patient.
  • the lumen 316 extending through the elongated body 310 of the packaging catheter 300 includes a non-circular transverse (lateral) cross-sectional configuration corresponding to that defined by the lumen 112 of the delivery catheter 100 and that defined by the pusher 302. Although shown as being (generally) triangular in FIG.
  • the transverse cross-sectional configuration defined by the lumen 316 of the elongated body 310 of the packaging catheter 300 may be varied in alternate embodiments without departing from the scope of the present disclosure (e.g., depending upon the particular transverse cross-sectional configurations defined by the lumen 112 of the delivery catheter 100 and the pusher 302).
  • the distal end 306 of the pusher 302 (releasably) supports the stent 202 such that the stent 202 is positionable in proximity (e.g., at or adjacent) to the aneurysm A.
  • the hub 600 include 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., respective (first and second) markers 318i, 318ii that are positioned at (or adjacent to) the proximal and distal ends 304, 306 of the elongated body 310) which can be aligned with the marker(s) 114 FIG.
  • markers e.g., radiopaque markers
  • the packaging catheter 300 includes one or more markers (e.g., radiopaque markers) 318 (e.g., respective (first and second) markers 318i, 318ii that are positioned at (or adjacent to) the proximal and distal ends 304, 306 of the elongated body 310) which can be aligned with the marker(s) 114 FIG.
  • 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 located in corresponding (rotational) positions, which allows the relative orientations of the packaging catheter 300, the hub 600, and the delivery catheter 100 to be ascertained and controlled (e.g., via rotation of the elongated body 310 of the packaging catheter 300, the pusher 302, and/or 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 each shown in the “12 o’clock” position.
  • the marker(s) 604, 318, and 114 may be located in any position 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.
  • the packaging catheter 300 is connected to the hub 600 such that the marker 604 on the hub 600 is oriented in the “12 o’clock” position.
  • the pusher 302 and the stent 202 may be oriented in a predetermined fashion (e.g., such that the first region 204 (or the second region 206) of the stent 202 faces (or is otherwise (rotationally) aligned with) the aneurysm A.
  • FIG. 3 illustrates positioning of the pusher 302 and the stent 202 within the blood vessel V following removal of the delivery catheter 100 (FIG. 2A).
  • the stent 202 may be activated, released, or otherwise deployed such that the stent 202 expands within the blood vessel V.
  • the stent 202 will automatically expand upon the removal of an external constraint (e.g., such as that provided by the delivery catheter 100).
  • the stent 202 may be deployed via the balloon catheter 400 (FIG. 2B) upon inflation of the inflatable member 406.
  • the stent 202 is oriented such that the first (covered, less porous) region 204 abuts the aneurysm A while the second (uncovered, more porous) region 206 of the stent 202 promotes (or otherwise permits) blood flow to any side branches of the blood vessel V the stent 202 may cross.
  • the stent 202 may include a (generally) cylindrical configuration upon expansion, as seen in FIG. 2C, for example, it is envisioned that the configuration of the stent 202 may varied in alternate embodiments of the disclosure (e.g., depending upon the particular requirements of the surgical procedure, the configuration and/or orientation of the aneurysm A (or other vascular abnormality), etc.).
  • the stent 202 may be (temporarily) crimped (or otherwise deformed) into an alternate shape when loaded onto the pusher 302, the inflatable member 406 of the balloon catheter 400, or other such suitable medical device. It should be appreciated, however, that the configuration of the medical device supporting the stent 202 may be altered or varied as necessary or desired to facilitate placement of the stent 202 in the intended manner.
  • the medical device supporting the stent 202 may include a cylindrical or non- cylindrical configuration in various locations along the length thereof (e.g., proximally of the stent 202, distally of the stent 202, and/or within the stent 202).
  • inflatable member 406 When being crimped on a (round, circular, tubular, toroidal) inflatable member 406, for example, it is envisioned that inflatable member 406 may be collapsed, deflated, and mounted on an elongate member, such as, for example, the body 402 of the balloon catheter 400, having a suitable configuration such that the inflatable member 406 (when deflated) and the stent 202 (when collapsed) may assume corresponding (e.g., similar or identical) configurations. It is envisioned that an external crimper of the same configuration may be used during the crimping process.
  • FIG. 4 illustrates the delivery catheter 100 devoid of any (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 promote (or otherwise facilitate) identification of the (rotational) orientation of the lumen 112.
  • FIG. 5 illustrates the delivery catheter 100 rotated (approximately) 120° (clockwise) from the orientation seen in FIG. 4 such that the linear face 555 is visible.
  • the linear side 555 includes the marker(s) 114, which promote visualization and proper orientation of the delivery catheter 100 during placement within the blood vessel V by allowing the clinician to ascertain the orientation of the linear face 555 relative to any suitable component of the intravascular system 10 or anatomical structure (e.g., the aneurysm A).
  • the packaging catheter 300 may be properly oriented (e.g., relative to the hub 600) such that, upon advancement of the pusher 302 and the stent 202 through the delivery catheter 100, the stent 202 may be oriented as necessary or desired (e.g., such that the first (covered, less porous) region 204 of the stent 202 abuts the aneurysm A).
  • the marker 114ii at the distal end 108 of the delivery catheter 100 may to (further) support visualization of the (rotational) position of the distal end 108 of the delivery catheter 100 (e.g., relative to the aneurysm A, a lesion, a side branch of the blood vessel V, or other such anatomical structures).
  • FIG. 6 illustrates the stent 202 supported on the pusher 302 prior to insertion of the stent 202 and the pusher 302 into the lumen 112 of the delivery catheter 100.
  • the stent 202 is in a first (initial, insertion) configuration in which the stent 202 includes a transverse cross-sectional configuration corresponding to that defined by the pusher 302.
  • the stent 202 includes a (generally) triangular transverse cross- sectional configuration prior to deployment.
  • the stent 202 moves into a second (subsequent, active) configuration in which the stent 202 includes a transverse cross- sectional configuration that may differ from that defined by the stent 202 in the first configuration.
  • the stent 202 upon deployment (exposure) of the stent 202 from the distal end 108 of the delivery catheter 100 (within the blood vessel V) and removal of the constraint provided by the delivery catheter 100, the stent 202 automatically expands into the (generally) cylindrical (tubular) configuration seen in FIG. 2C.
  • the delivery catheter 100 is inserted into the blood vessel V with the proximal end 104 thereof positioned at or adjacent to the hub 600 and the markers 114i, 114ii in the “12 o’clock” position, which allows the degree of (rotational) deflection experienced by the delivery catheter 100 during insertion into the blood vessel V (if any) to be ascertained (e.g., via external visualization using any suitable technique).
  • the packaging catheter 300 which includes the pusher 302 and the stent 202, is then inserted into the delivery catheter 100.
  • the stent 202 includes the differential porosity described above, which is attributable to the disparity between the regions 204, 206 (FIG. 2C).
  • the packaging catheter 300 is oriented accordingly to reduce (if not entirely eliminate) any (rotational) offset between the stent 202 and the distal end 108 of the delivery catheter 100.
  • the hub 600 and the packaging catheter 300 may include one or more markers 604, 318, respectively, to support more precise relative (rotational) orientation between the packaging catheter 300 and the delivery catheter 100.
  • the markers 604, 318 may be disposed in any position to point to any direction.
  • the term “12 o’clock” should be not construed as limiting in any way, but rather, as an exemplary indicator of position.
  • the clinician may be instructed to rotate the hub 600 to a “3 o’clock” position, to a “6 o’clock” position, to a “9 o’clock” position, etc., which intuitively suggests a quarter-turn, a half-turn, a three-quarter turn, etc., respectively, with other “times” referring to approximate positions therebetween (e.g., a “2 o’clock” position, a “5 o’clock” position, an “11 o’clock” position, etc.).
  • the same effect could be achieved by reference to a “North” marker, utilizing terminology such as “East,” “South,” and “West” (or interstitial positions such as “ESE” or “NW”).
  • the delivery catheter 100 and the packaging catheter 300 may be configured for rotation through a 360° range of motion (e.g., prior association (engagement, connection) with one another) to allow for positioning of the delivery catheter 100 and the packaging catheter 300 in any manner desired or necessitated by the particular procedure being conducted (e.g., based upon the size, location, nature, etc., of the vascular abnormality being treated).
  • the stent 202 is inserted into the delivery catheter 100 at a particular orientation (e.g., relative to the “12 o’clock” marker(s) 114 on the delivery catheter 100).
  • a particular orientation e.g., relative to the “12 o’clock” marker(s) 114 on the delivery catheter 100.
  • the final (rotational) orientation of the stent 202 will be dictated by (and will correspond to) the (rotational) orientation of the distal end 108 of the delivery catheter 100.
  • the stent 202 may be deployed in the “3 o’clock” position, the “6 o’clock” position, etc., depending upon the degree of (rotational) deflection experienced by the delivery catheter 100 during navigation of the blood vessel V en route to the aneurysm A (for example), if any, which is identifiable via the marker 114ii located at the distal end 108 thereof.
  • the stent 202 may be rotated accordingly (e.g., relative to the marker 114ii at 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)).
  • the final the (rotational) position of the stent 202 may be varied via rotational manipulation of the delivery catheter 100 and, thus, the pusher 302 and the stent 202, following insertion of the pusher 302 and the stent 202 into the delivery catheter (e.g., the delivery catheter, the pusher 302, and the stent 202 may be rotated in unison via the non-rotational interface provided by the corresponding noncircular (transverse) cross-sectional configurations defined by the pusher 302 and the lumen 112 extending through the delivery catheter 100).
  • the packaging catheter 300 may be positioned in three discrete (rotational) positions prior to insertion of the pusher 302 into the lumen 112 of the delivery catheter 100.
  • the stent 202 may be pre-loaded into the elongated body 310 of the packaging catheter 300 in a variety of (rotational) orientations (e.g., during packaging by the manufacturer), which may be identified via labeling on the device, its packaging, etc.
  • the process may be repeated to verify that the respective markers 114, 318 on the delivery catheter 100 and the packaging catheter 300 are consistently aligned. Imaging may then be performed to verify the relative (rotational) positions of the markers 114, 318 to determine the (rotational) orientation (e.g., the “hour” on the “clock”) required of the stent 202 (prior to insertion into the delivery catheter 100) to achieve the necessary final (rotational) position within the blood vessel V.
  • the relative (rotational) positions of the markers 114, 318 to determine the (rotational) orientation (e.g., the “hour” on the “clock”) required of the stent 202 (prior to insertion into the delivery catheter 100) to achieve the necessary final (rotational) position within the blood vessel V.
  • the final (rotational) position of the stent 202 may be confirmed via the insertion of a test stent (or other such device), which may be temporarily advanced in the predicted orientation, visualized using any suitable imaging technique, and then removed prior to insertion and deployment of the stent 202.
  • a test stent or other such device
  • the test stent may include one or more suitable markers (e.g., radiopaque markers).
  • the packaging catheter 300 may be re-oriented into the “4 o’clock” position to facilitate proper orientation of the stent 202.
  • the stent 202 may be loaded into the delivery catheter 100 in the appropriate (necessary) orientation and advanced to the target site.
  • the lumen 112 extending through the delivery catheter 100 includes a unique (transverse), non-circular cross- sectional configuration while, in an exemplary embodiment, the delivery catheter 100 includes an outer (transverse) cross-sectional configuration that is (generally) annular (e.g., round, 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 an inserted medical device (e.g., the pusher 302, the hypotube 700 (FIG. 13), the hypotube 800 (FIGS. 13, 14), the balloon catheter 400, etc.) to improve precision during placement within the blood vessel V to enhance predictability in the final position of the stent 202.
  • an inserted medical device e.g., the pusher 302, the hypotube 700 (FIG. 13), the hypotube 800 (FIGS. 13, 14), the balloon catheter 400, etc.
  • lumen 112 is (generally) illustrated as including a triangular (transverse) cross- sectional configuration
  • alternative configurations are also contemplated herein (e.g., square, hexagonal, octagonal, pentagonal, a “house” silhouette, oval, elliptical, star-shaped, etc.).
  • any style of star may be used including, for example, a six-pointed star, a “Star of David,” etc.
  • the (transverse) cross-sectional configuration of the lumen 316 extending through the elongated body 310 of the packaging catheter 300 may correspond to that of the lumen 112 extending through the delivery catheter 100, as can be appreciated through reference to FIGS. 1A-2A, for example.
  • the interface defined by the lumen 316 and the medical device positioned therein e.g., the pusher 302, the hypotube 700 (FIG. 13), the hypotube 800 (FIGS.
  • the lumen 316 permits longitudinal (axial) movement (e.g., sliding) of the medical device therethrough while inhibiting (if not entirely preventing) relative rotation between the medical device within the lumen 316 and the packaging catheter 300, which allows the (rotational) position of the medical device relative to the packaging catheter 300 (and the delivery catheter 100) to be (substantially) maintained, thereby facilitating accurate and predicable deployment (e.g., of the stent 202).
  • the aforementioned guide wire 500 may be utilized to facilitate deployment of the stent 202 via the balloon catheter 400, as seen in FIG. 2B.
  • the guide wire 500 may be advanced into the blood vessel V via any suitable endovascular method.
  • the guide wire 500 and the lumen 404 extending through the elongated body 402 of the balloon catheter 400 may include corresponding non-circular (e.g., triangular) (transverse) cross-sectional configurations.
  • the non-circular (transverse) cross-sectional configuration may extend continuously along an entire length of the guide wire 500. Alternatively, it is envisioned that the non-circular (transverse) cross-sectional configuration may only extend along a portion of the length of the guide wire 500.
  • the guide wire 500 may include one or more markers 514 (e.g., radiopaque or other such markers).
  • markers 514 e.g., radiopaque or other such markers.
  • the guide wire 500 includes a first marker 514i located at (or adjacent to) the proximal end 502 of the guide wire 500 (which may be located externally of the patient) and a second marker 514ii located at (or adjacent to) the distal end 504 of the guide wire 500), each of which may be located in the “12 o’clock” position (or any other suitable reference orientation).
  • the marker(s) 514 may be located at (or adjacent to) a transition between a first portion of the guide wire 500, which includes the non-circular (transverse) cross-sectional configuration, and a second portion of the guide wire 500, which includes a (generally) circular (transverse) cross-sectional configuration. It is also envisioned, however, that a variety of distinct radiopaque markers 514, such as those of a different radio-density, shape or orientation, etc., may be utilized (e.g., to further facilitate visualization, differentiation, etc.) in connection with the guide wire 500 (or any of the components of the intravascular system 10 described herein including, for example, the delivery catheter 100, etc.). Via visualization, the (rotational) position of the marker 514ii can be determined relative to the marker 514i, the any vascular abnormalities (e.g., the aneurysm A), the origin of a side branch, etc.
  • the marker(s) 514 may be located at (or adjacent to) a transition between
  • the balloon catheter 400 may be advanced into the blood vessel V over the guide wire 500 such that the guide wire 500 is received within the lumen 404.
  • the inflatable member 406 can be expanded to thereby deploy (implant) the stent 202.
  • a test stent (or other such device) may be deployed and recaptured prior to placement of the stent 202 to confirm the rotational position of the guide wire 500 and, thus, the predicted final position of the stent 202, at the target location (e.g., at or adjacent to the aneurysm A).
  • the guide wire 500 and the balloon catheter 400 may be configured (adapted) for use in both “over-the-wire” configurations, as discussed above, and rapid-exchange configurations.
  • the guide wire 500 may be used in combination with the packaging catheter 300 to facilitate placement and deployment of the pusher 302 and the stent 202 through the delivery catheter 100.
  • the guide wire 500 may be utilized to facilitate the placement of the delivery catheter 100 into the blood vessel V over the guide wire 500.
  • the guide wire 500 and the lumen 112 (FIG. 1 A) extending through the delivery catheter 100 may include corresponding non-circular (transverse) cross-sectional configurations to inhibit (if not entirely prevent) relative rotation between the deliveiy catheter 100 and the guide wire 500.
  • the guide wire 500 may be removed, thereby allowing for insertion of the pusher 302 and the stent 202 into to delivery catheter 100 from the elongated body 310 of the packaging catheter 300.
  • the pusher 302 and the lumen 112 extending through the delivery catheter 100 may include corresponding non-circular (transverse) cross-sectional configurations.
  • the (transverse) cross-sectional configuration defined by the lumen 112 extending through the delivery catheter 100 may be common to (shared by) both the pusher 302 and the guide wire 500.
  • the stent 202 upon sufficient advancement of the pusher 302 through the delivery catheter 100, the stent 202 emerges from the distal end thereof, 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 in the blood vessel V.
  • inner and outer hypotubes e.g., catheters
  • the stent 202 is loaded (mounted) on the outer hypotube 700.
  • the inner hypotube 800 is positioned over the guide wire 500 (e.g., such that the guide wire 500 extends through the lumen 9094) and is received by the lumen 704 of the outer hypotube 700.
  • the lumen 9094 and the guide wire 500 may include corresponding non-circular (transverse) cross-sectional configurations, which, as discussed above, allows for relative axial movement between the guide wire 500 and the inner hypotube 800 while inhibiting (if not entirely preventing) relative rotation between the guide wire 500 and the inner hypotube 800.
  • the wings 802 extend from the inner hypotube 800 in the proximal direction so as to cover (sheath) the stent 202 during insertion into the blood vessel V, thereby constraining the stent 202 so as to maintain the stent 202 in a collapsed configuration during insertion into the blood vessel V.
  • the relative longitudinal (axial) positions of the hypotubes 9091, 9092 can be varied to cause unsheathing of the stent 202 (e.g., exposure from the wings 802) so as to remove the external constraint provided by the wings 802 and permit expansion (deployment) of the stent 202.
  • the stent 202 is supported on an inner hypotube 800i, which extends into an outer hypotube 700i such that the outer hypotube 700i overlies the stent 202 to thereby constrain the stent 202 and inhibit expansion thereof during insertion into the blood vessel V.
  • the inner hypotube 800i is inserted over the guide wire 500 (e.g., such that the guide wire 500 is received within a lumen 9094i of the inner hypotube 800i).
  • the lumen 9094i and the guide wire 500 may include corresponding (transverse) cross-sectional configurations to inhibit (if not entirely prevent) relative rotation between the guide wire 500 and the inner hypotube 800i while allowing for relative axial movement between the guide wire 500 and the inner hypotube 800i.
  • the medical devices described herein may include an energy component 900 (FIG. 2C) that is configured to deliver ultrasound, RF energy, etc., to the target site (e.g., the aneurysm A). It can be delivered through the stent or adjacent the stent.
  • the delivery of energy to the target site may soften calcifications in the walls of the blood vessel V (e.g., in the context of an intravascular lithotripsy, similar to those devices produced by Shockwave Medical).
  • the energy component 900 may be associated with any of the medical devices (or components thereof) described herein and that energy may be delivered in any suitable manner using any suitable structure(s) (e.g., wire(s), etc.).
  • the energy component 900 may be provided on (or otherwise in communication with) the delivery catheter 100, the balloon catheter 400 (e.g., the inflatable member 406), the guide wire 500, the pusher 302, the anchor(s) 506, etc.
  • the devices and methods described herein may be adapted for the treatment of bifurcated vessels, lesions, etc.
  • an alternate embodiment of the intravascular system 10 is disclosed, which is identified by the reference character 1000.
  • the intravascular system 1000 includes a primary delivery catheter 1100 defining a lumen 1102 and a (first) delivery device 1200 that is configured for insertion into the blood vessel V through the delivery catheter 1100 to deploy a primary stent 1300 (e.g., a first fenestrated occlusion device), which may be substantially similar or identical to the aforedescribed stent 202.
  • a primary stent 1300 e.g., a first fenestrated occlusion device
  • the primary delivery catheter 1100 and the delivery device 1200 are each shown as including a (generally) circular outer transverse cross-sectional configuration, it should be appreciated that the particular configurations of the primary delivery catheter 1100 and the delivery device 1200 may be varied without departing from the scope of the present disclosure.
  • the primary delivery catheter 1100 and the delivery device 1200 may each include an outer transverse cross-sectional configuration that is non-circular (e.g., oval, square, rectangular, triangular, trapezoidal, diamond, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal, etc.).
  • the (first) delivery device 1200 is configured as the aforedescribed packaging catheter 300 (FIG. 2A).
  • the primary stent 1300 is carried (supported) on the pusher 302 and is configured for self-expansion upon exposure from the delivery catheter 1100.
  • the lumen 1102 of the delivery catheter 1100 and the pusher 302 may include corresponding non-circular (e.g., triangular) (transverse) cross-sectional configurations.
  • the (first) delivery device 1200 may be configured as a balloon catheter 1400.
  • the balloon catheter 1400 includes an elongated body (member) 1402 with proximal and distal ends 1404, 1406 respectively defining end holes 1408, 1410 and a series of lumens 1412 that extend therethrough. More specifically, the balloon catheter 1400 includes a (first) lumen 1412i, a (second) lumen 1412ii that extends in (generally) parallel relation to the lumen 1412i, and a (third) lumen 1412iii that extends in (generally) parallel relation to the lumen 1412i and/or the lumen 1412ii.
  • the balloon catheter 1400 further includes an inflatable member (balloon) 1414 that is secured to the elongated body 1402 and supports the primary stent 1300.
  • the inflatable member 406 includes a (first) fenestration (opening, aperture) 1416 and the primary stent 1300 includes a (second) fenestration (opening, aperture) 1302.
  • the particular configuration of the balloon catheter 1400 may be varied without departing from the scope of the present disclosure.
  • the balloon catheter 1400 may include an outer transverse cross-sectional configuration that is non-circular (e.g., oval, square, rectangular, triangular, trapezoidal, diamond, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal, etc.).
  • the lumen 1412i may extend between the respective proximal and distal end holes 1408, 1410 of the balloon catheter 1400.
  • the lumen 1412i may extend along only a portion of the length of the balloon catheter 1400 (e.g., from a (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) guide wire 1500, which may be substantially similar or identical to the aforedescribed guide wire 500.
  • the lumen 1412i and the primary guide wire 1500 may include corresponding non-circular (transverse) cross-sectional configurations so as to allow for relative axial movement between the primary guide wire 1500 and the balloon catheter 1400 while inhibiting (if not entirely preventing) relative rotation between the primary guide wire 1500 and the balloon catheter 1400 to facilitate control over the (rotational) orientation of the balloon catheter 1400 and, thus, the primary stent 1300.
  • the lumen 1412ii is configured to communicate fluid from a source of inflation to the inflatable member 1414.
  • the lumen 1412ii may be configured to exclusively support inflation and deflation of the inflatable member 1414. In alternate embodiments, however, it is envisioned that the lumen 1412ii may be configured to receive one or more medical devices and/or support other functionality of the balloon catheter 1400.
  • the lumen 1412iii extends to a (second, distal) side hole 1418 that is positioned in proximity (e.g. at or adjacent) to the inflatable member 1414.
  • the side hole 1418 may be positioned proximally or distally of the inflatable member 1414.
  • the inflatable member 1414 may overlie the side hole 1418, as seen in FIG. 18, for example, such that the side hole 1418 is in communication with the fenestration 1416 in the inflatable member 406 and the fenestration 1302 in the primary stent 1300.
  • the lumen 1412iii may include a “peel-away” side slit up to a rapid exchange length lumen, similar to the configuration in the Cordis Angioguard Rx. It is also envisioned that the lumen 1412iii may extend proximally (e.g., along the entire intravascular course of the lumen 1412ii) and may branch from the lumen 1412iii proximally (e.g., externally of the patient).
  • 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 fenestrated occlusion device) into a side branch S of the blood vessel V, as described in further detail below.
  • a secondary delivery device 1600 may include the aforedescribed pusher 302 (FIGS. 20, 23), a secondary (second) guide wire 1800 (FIG. 22), which may be substantially similar or identical to the aforedescribed guide wire 500, or the aforedescribed balloon catheter 400 (FIG. 24).
  • the lumen 1412iii and the medical device inserted therethrough may include corresponding (transverse) cross-sectional configurations so as to allows for 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.
  • the particular configuration of the secondary delivery device 1600 may be varied without departing from the scope of the present disclosure.
  • the secondary delivery device 1600 may include an outer transverse cross-sectional configuration that is non-circular (e.g., oval, square, rectangular, triangular, trapezoidal, diamond, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal, etc.).
  • the primary guide wire 1500 may be introduced into a main branch M of the blood vessel V, across a limb of the narrowing (e.g., across the side branch S).
  • the primary guide wire 1500 can then be inserted into the lumen 1412i in the balloon catheter 1400 such that the balloon catheter 1400 can be advanced into the blood vessel V over the primary guide wire 1500 (e.g,, through the primary delivery catheter 1100) such that the inflatable member 1414 and the primary stent 1300 and, thus, the respective fenestrations 1416, 1302, are positioned in proximity (e.g., at or adjacent) to the origin of the side branch S of the blood vessel V in the manner described herein.
  • the balloon catheter 1400 and the lumen 1102 of the primary delivery catheter 1100 may include corresponding non-circular (transverse) cross-sectional configurations so as to allow for relative axial movement between the balloon catheter 1400 and the delivery catheter 1100 while inhibiting (if not entirely preventing) relative rotation between the balloon catheter 1400 and the delivery catheter 1100.
  • the secondary stent 1700 Prior to expansion of the inflatable member 1414 and deployment of the primary stent 1300, the secondary stent 1700 may be inserted into the side branch S of the blood vessel V (via the second delivery device 1600), which may be either self-expanding or balloon-expandable.
  • the secondary stent 1700 may be deployed using any of the devices and methods discussed herein above.
  • aforedescribed packaging catheter 300 (FIGS. 20, 23) may be utilized to deploy the secondary stent 1700.
  • 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.
  • the pusher 302 and the secondary stent 1700 may be advanced through the lumen 1412iii and the side hole 1418, through the fenestration 1416 in the inflatable member 1414, through the fenestration 1302 in the primary stent 1300, and into the side branch S.
  • the pusher 302 and the secondary stent 1700 may be advanced directly through the lumen 1412iii in the manner illustrated in FIG. 20.
  • the secondary guide wire 1800 (FIG. 22) may be used, which may be substantially similar or identical to the guide wire 500 and/or the primary guide wire 1500 discussed above.
  • the secondary guide wire 1800 is inserted into the side branch S through the lumen 1412iii prior to introduction of the pusher 302 and the secondary stent 1700.
  • the secondary guide wire 1800 may include one or more of the anchor(s) 506 (FIG. 25) discussed above in connection with the guide wire 500, which may be positioned in any suitable location.
  • the pusher 302 may include a lumen that is configured to receive the secondary guide wire 1800 (e.g., such that the pusher 302 includes a “hypotube” configuration).
  • the lumen extending through the pusher 302 may include a non-circular (e.g., triangular) (transverse) cross-sectional configuration corresponding to that of the secondary guide wire 1800 to facilitate control over the relative (rotational) positions of the secondary guide wire 1800 and the pusher 302 to facilitate positioning of the secondary stent 1700 within the side branch S by inhibiting (if not entirely preventing) relative rotation between the secondary guide wire 1800 and the pusher 302 in the manner discussed above.
  • a secondary delivery catheter 1900 may be utilized to deploy the pusher 302 and the secondary stent 1700, which may be substantially similar or identical to the delivery catheter 100 (FIG. 1A) discussed above.
  • the secondary delivery catheter 1900 includes a lumen 1902 that is configured to receive the secondary guide wire 1800 to allow for advancement of the secondary delivery catheter 1900 over the secondary guide wire 1800 and into the side branch S through the side hole 1418, through the fenestration 1416 in the inflatable member 1404, through the fenestration 1302 in the primary stent 1300, and into the side branch S.
  • the pusher 302 and the secondary stent 1700 may then be inserted into the side branch S through the lumen 1902 of the secondary delivery catheter 1900.
  • the secondary guide wire 1800 may be removed from the secondary delivery catheter 1900 or that the secondary guide wire 1800 may remain in place in place (e.g., within the lumen 1412iii and within the lumen 1902 of the secondary delivery catheter 1900).
  • the pusher 302 may be advanced through the lumen 1902 of the secondary delivery catheter 1900 in adjacent relation to the secondary guide wire 1800.
  • the particular configuration of the secondary delivery catheter 1900 may be varied without departing from the scope of the present disclosure.
  • the secondary delivery catheter 1900 may include an outer transverse cross-sectional configuration that is non-circular (e.g., oval, square, rectangular, triangular, trapezoidal, diamond, pentagonal, hexagonal, heptagonal, octagonal, nonagonal, decagonal, etc.).
  • the lumen 1902 extending through the secondary delivery catheter 1900 and the secondary guide wire 1800 may include corresponding non-circular (e.g., triangular) (transverse) cross-sectional configurations to inhibit (if not entirely prevent) relative rotation between the secondary delivery catheter 1900 and the secondary guide wire 1800, thereby facilitating control over the (rotational) orientation of the secondary stent 1700 in the manner discussed above.
  • the secondary stent 1700 may deployed using the aforedescribed balloon catheter 400 (FIG. 2B).
  • the balloon catheter 400 is advanced over the secondary guide wire 1800 such that the secondary guide wire 1800 extends through the lumen 404 extending through the elongated body 402 of the balloon catheter 400.
  • the inflatable member 406 on the balloon catheter 400 which carries the secondary stent 1700, may be expanded to thereby deploy the secondary stent 1700.
  • the lumen 404 and the secondary guide wire 1800 may include corresponding non-circular (e.g., triangular) transverse cross-sectional configurations to inhibit (if not entirely prevent) relative rotation between the balloon catheter 400 and the secondary guide wire 1800, thereby facilitating control over the (rotational) orientation of the secondary stent 1700 in the manner discussed above.
  • the lumen 1412iii and the elongated body 402 of the balloon catheter 400 may include corresponding non-circular (e.g., triangular) transverse cross-sectional configurations to inhibit (if not entirely prevent) relative rotation of the balloon catheter 400 within the lumen 1412iii.
  • the secondary guide wire 1800 and the corresponding medical device supporting the secondary stent 1700 may be devoid of the non-circular (e.g., triangular) (transverse) cross-sectional configurations discussed above.
  • the secondary guide wire 1800 (and the corresponding medical device supporting the secondary stent 1700) may instead have annular (e.g., circular) transverse cross-sectional configurations to develop and deploy a “Y” configuration stent system at the bifurcation, as described in further detail below.
  • annular e.g., circular
  • the secondary guide wire 1800 (and the corresponding medical device supporting the secondary stent 1700) may include corresponding non-circular (transverse) cross-sectional configurations to facilitate proper alignment of the fenestration in the secondary stent 1700 in the maimer discussed above.
  • the balloon catheter 1400 may be configured for use (deployment) in substantially straight (e.g., non-tortuous anatomy).
  • the primary guide wire 1500 and the lumen 1412i may be devoid of the non-circular (e.g., triangular) (transverse) cross-sectional configurations discussed above.
  • the primary guide wire 1500 and the lumen 1412i may instead have annular (e.g., circular) transverse cross-sectional configurations and that the secondary guide wire 1800 may be advanced into the side branch S via the side hole 1418 and the lumen 1412iii.
  • advancement of the secondary guide wire 1800 through the lumen 1412iii, through the side hole 1418, and into the side branch S may facilitate alignment of the secondary delivery device 1600 (e.g., the balloon catheter 400), and the components and devices inserted therethrough (e.g., the secondary stent 1700) in the intended manner (e.g., such that any included fenestration(s) in the secondary stent 1700 are positioned at the origin of the side branch S).
  • the employ of corresponding non-circular (e.g., triangular) (transverse) cross-sectional configurations by the secondary guide wire 1800 and the lumen 1412iii may facilitate proper preloading of the secondary stent 1700 in the blood vessel V in the desired orientation (e.g., such that any fenestration(s) in the secondary stent 1700 are oriented towards the origin of the side branch S).
  • medical devices e.g., stents, inflatable members, etc.
  • multiple fenestrations are also contemplated herein (e.g., for use in the context of multiple side branches with multiple origins).
  • one or more markers may be included to identify the proximal and distal ends thereof and/or the proximal and distal ends of any fenestration(s).
  • the primary stent 1300 may be deployed such the fenestration 1302 (FIG. 17) in the primary stent 1300 is positioned in proximity (e.g., at or adjacent to) the origin of the side branch S.
  • a guide wire e.g., the secondary guide wire 1800
  • the secondary stent 1700 may be delivered over the secondary guide wire 1800 via the balloon catheter 400, as seen in FIG.
  • the devices and methods described herein facilitate precise, 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 and thereby reduce (if not completely eliminate) leaks between the respective primary and secondary stents 1300, 1700 while avoiding unwanted obstruction of the blood vessel V by the secondary stent 1700 and accommodating for tapering in the side branch S (e.g., depending upon the particular patient’s anatomy) that may result in a larger (transverse) cross-sectional dimension at the origin of the side branch S (when compared to more distal sections of the side branch S).
  • the secondary delivery catheter 1900 may be utilized to deploy the secondary stent 1700, as discussed above, which allows for the employ of a self-expanding configuration for the secondary stent 1700 such that the secondary stent 1700 is automatically deployed in the side branch S upon exposure of the secondary stent 1700 from the secondary delivery catheter 1900.
  • the secondary guide wire 1800 can be (optionally) removed.
  • This method also facilitates precise, 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 to realize the benefits discussed above (e.g., a reduction (if not completely elimination) of leaks between the respective primary and secondary stents 1300, 1700, a reduction (if not complete elimination) of unwanted obstruction of the blood vessel V by the secondary stent 1700, and accommodation for tapering in the side branch S).
  • control e.g., reduce, minimize
  • primary delivery catheter 1100 may be re-used instead of the secondary delivery catheter 1900.
  • challenges regarding landing of the secondary stent 1700 may arise, especially with “woven” or “braided” stents that may be subject to foreshortening during deployment (e.g., when compared to their length during insertion and prior to deployment).
  • the secondary delivery catheter 1900 may be configured in a manner similar to that discussed above in connection with the respective hypotubes 700, 800 (FIGS. 13, 14) (e.g., in correspondence with a filter-tip TAVR (transcatheter aortic valve replacement) catheter, whereby the wings 802 provide an outer constraint for the secondary stent 1700 to thereby provide control over expansion of the secondary stent 1700.
  • TAVR transcatheter aortic valve replacement
  • the lumen 806 extending through the inner hypotube 800 may include a non-circular (transverse) cross-sectional configurations corresponding to that of the secondary guide wire 1800 to allow for relative axial movement between the inner hypotube 800 and the secondary guide wire 1800 while inhibiting (if not entirely preventing) relative rotation between the inner hypotube 800 and the secondary guide wire 1800 to facilitate precise control over the (rotational) orientation of the secondary stent 1700.
  • the secondary stent 1700 is loaded onto the outer hypotube 700 and the inner hypotube 800 (and, thus, the wings 802) are advanced distally while the outer hypotube 700 remains (relatively) longitudinally (axially) stationary.
  • Relative longitudinal (axial) movement between the hypotubes 700, 800 allows for exposure (and optional re-sheathing (covering)) of the secondary stent 1700. It is envisioned that enlarging the (transverse) cross-sectional dimensions of the secondary guide wire 1 00 and the lumen 806 extending through the inner hypotube 800 may further reduce (if not entirely eliminate) relative rotation between the inner hypotube 800 and the secondary guide wire 1800, thereby further increasing precision in placement of the secondaiy stent 1700.
  • the proximal end of such stents may include one or more rings (or other such structures) to encourage more rapid expansion and/or increase apposition between the stent and the wall of the blood vessel V.
  • the ring(s) (or other structures) may include (e.g., may be formed partially or entirely from) any suitable material or combination of materials such as, for example, nitinol.
  • longitudinal wires may connected to the stents described herein to facilitate re-sheathing when desired.
  • the various stents described herein may be connected to one or more external members (e.g., wires, catheters, or the like).
  • external member(s) 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).
  • the secondary stent 1700 may be advanced over the secondary guide wire 1800 into the desired position and the external member(s) connected to the secondary stent 1700 may be held in place while the inner hypotube 800 (FIG. 14) (and, thus, the wings 802) is translated axially (e.g., relative to the outer hypotube 700) to exposing (un-sheath) the secondary stent 1700.
  • the external member(s) may expand with the secondary stent 1700.
  • 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), for example, the secondary stent 1700 requires unsheathing (e.g., exposure from the that the wings 802) prior to detachment (e.g., from the outer hypotube 700).
  • the secondary stent 1700 may automatically expand and detach (proximally to distally) in a progressive manner as a result of relative longitudinal (axial) movement between the secondary stent 1700 and the wings 802.
  • the secondary stent 1700 may be circumferentially attached to the outer device (e.g., the outer hypotube 700) and may include at least one additional wire attached thereto (e.g., to a distal segment of the secondary stent 1700). Additional and alternatively 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 envisioned that the only a distal segment (portion) of the secondary stent 1700 may be attached (connected) to the outer hypotube 700 (or other such device).
  • longitudinal (axial) advancement of the outer hypotube 700 may pull the attached segment of the secondary stent 1700 and push the wings 802 (and the inner hypotube 800 or other such device) in unison).
  • the secondary stent 1700 can be unsheathed 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, to thereby un-sheath the secondary stent 1700 (from proximal to distal).
  • the inner hypotube 800 (or other such device) can be moved in the opposite direction to re-sheath the secondary stent 1700 and allow for repositioning within the vasculature. It is further envisioned that proximal attachments between the secondary stent 1700 and the outer hypotube 700 (or other such device) may be disconnected upon unsheathing of the secondary stent 1700 to facilitate appropriate orientation and position of the secondary stent 1700 (e.g., such that the secondary stent 1700 overlaps the fenestration 1302 in the primary stent 1300) without significant (substantial) overlapping of the main branch M of the blood vessel V). The secondary stent 1700 can then be detached once fully deployed.
  • a quaternary catheter may be utilized to help fix the (rotational) position of the primary guide wire 1500.
  • the quaternary catheter may include an inner lumen with a non-circular (e.g., triangular) (transverse) cross-sectional configuration (e.g., corresponding to that defined by the primary guide wire 1500) as discussed above.
  • the quaternary catheter may be devoid of a hub and may include a non-circular (e.g., triangular) (transverse) outer cross-sectional configuration as well as proximal and distal markers (e.g., radiopaque markers) located in any suitable position (e.g., the “12 o’clock” position) as discussed above.
  • the primary guide wire 1500 and the quaternary catheter can be used as a guide (rail) system to facilitate delivery of the primary delivery catheter 1100 over the quaternary catheter and guidewire (e.g., to further reduce any likelihood of undesired rotation during delivery and/or deployment of the primary stent 1300).
  • the delivery catheter 100 may be utilized in connection with the pusher 302 and the stent 202 according to the following steps:
  • a “Y” shaped stent may be assembled (in vivo) from two stents (e.g., the primary stent 1300 and the secondary stent 1700), as seen in FIG. 25, which may be facilitated by the inclusion of a plurality of markers (e.g., radiopaque markers) on the stents 1300, 1700, the medical devices used during placement of the stents 1300, 1700, etc.
  • markers e.g., radiopaque markers
  • the secondary stent 1700 can be deployed in the side branch S, which may be either self-expanding or balloon-expandable.
  • the secondary delivery catheter 1900 is advanced into the side branch S (e.g. over the secondary guide wire 1800 (FIG.
  • the secondary stent 1700 may be devoid of any fenestrations and that the secondary stent 1700 may be positioned to reduce (e.g., minimize) overlap with edges of the fenestration 1302 in the primary stent 1300.
  • the secondary stent 1700 can be deployed to build a “Y” shaped construct (e.g., via the methods described above used to place the primary stent 1300) to facilitate proper overlap between the stents 1300, 1700 (e.g., relative to the origin of the side branch S).
  • the various medical devices may include one or more radiopaque markers (or other such components) to support external visualization. It is envisioned that such markers may be positioned in any suitable location on the corresponding medical device.
  • the stents described herein may include one or more marker(s) at the proximal and/or distal ends thereof. It is also envisioned that such marker(s) may be positioned to facilitate delineation between regions of varying porosity. For example, in the context of the stent 202 seen in FIG.
  • one or more marker(s) may be positioned at the proximal and/or distal ends of the first (covered) region 204 and/or the second (uncovered) region 206. It is also envisioned that such markers may be used to delineate or define fenestration(s) such as, for example, the fenestration 1 02 in the primary stent 1300.
  • the present disclosure contemplates branched stent elements.
  • the various stents described herein may include any suitable (transverse) cross-sectional configuration, whether circular or non-circular (e.g., depending upon the particular procedure being performed, the patient’s anatomy, the particular location of the vascular abnormality being treated, the particular nature of the vascular abnormality, etc.).
  • the present disclosure may also find applicability in the context of introducing other devices, such as contoured mesh sacs to fill an outpouching, in a particular orientation.
  • contoured mesh sacs to fill an outpouching, in a particular orientation.
  • One of many examples of such an outpouching is a vascular aneurysm.
  • the principles of the present disclosure may support the fabrication of custom implants (e.g., to contour to the configuration of a particular lesion) and subsequent accurate placement (deployment) of such custom implants.
  • the various medical devices e.g., catheters, stents, hypotubes, guide wires, etc.
  • procedures described herein can also be used to deliver coated devices.
  • Suitable examples of such coatings include (but are not limited to) lubricious compounds, sticky compounds, hydrogels, pharmaceuticals, chemotherapeutic agents, cells, proteins, etc., and combinations thereof. It is envisioned that such coatings may be located on any suitable surface of the pertinent medical device (e.g., on an inner surface, an outer surface, interstices, and combinations thereof).
  • the various medical devices e.g., catheters, stents, hypotubes, guide wires, etc.
  • procedures described herein may be utilized (combined) with the multiple circumferential balloon catheter previously described by Walzman (US 2020/10,543,015) to facilitate additional precision when orientating a delivery catheter in a desired (rotational) orientation within a blood vessel (e.g., at or adjacent to an aneurysm or the neck of an aneurysm).
  • the various devices described herein may (optionally) include one or more steerable segments that are deflectable via one or more pull wires that extend 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). While the following discussion is provided in the context of the delivery catheter 100, it should be appreciated that the principles, elements, and structures described herein below may be incorporated into any of the devices described herein (e.g., the hypotubes 700, 800 (FIGS. 13, 14), the primary delivery catheter 1100 (FIG. 16), the delivery device 1200 (FIG. 18), the balloon catheter 1400 (FIG. 18), the secondary delivery device 1600 (FIG. 20), the secondary delivery catheter 1900 (FIG. 23), etc.).
  • the 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, articulable) segments 122a that are connected to the plurality of pull wires 124 and spaced along the longitudinal axis X of the delivery catheter 100.
  • the inactive segments 122i and the active segments 122a are arranged in a staggered pattern such the delivery catheter 100 alternates between inactive segments 122i and active segments 122a.
  • each active segment 122a is connected to a corresponding (single) pull wire 124 that extends through (e.g., within) the body 102 of the delivery catheter 100 (e.g., within an outer wall 126 thereof) such that pull wires 124 correspond in number to the active segments 122a and extend in (generally) parallel relation to the longitudinal axis X of the delivery catheter 100.
  • the corresponding active segment 122a is deflected (articulated) to thereby reconfigure (actively steer) the delivery catheter 100 between a first (initial, normal) configuration (FIG.
  • each pull wire 124 is received within a corresponding channel 128 (FIG. 27) that extends through the outer wall 126 in (generally) parallel relation to the longitudinal axis X (e.g., such that the pull wires 124 are embedded within the delivery catheter 100).
  • the delivery catheter 100 may include (or may be connected to) a plurality of corresponding (first) activating mechanisms 130 (e.g., such that the number of pull wires 124 corresponds to the number of activating mechanisms 130).
  • the delivery catheter 100 includes a (first) activating mechanism 130i that is connected to the pull wire 124i and a (second) activating mechanism 130ii that is connected to the pull wire 124ii.
  • the activating 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 necessary or desired, such as, for example, rotating wheels, pulley systems, ratchet mechanism, levers, or the like.
  • the activating mechanism(s) 130 and/or the pull wires 124 may include one or more stop locks (or other such structures) to maintain the position(s) of the pull wires 124 and the corresponding segments 122.
  • the activating mechanism(s) 130 may be omitted and that force may be manually applied to the pull wires 124 to facilitate articulation of the delivery catheter 100.
  • the active segments 122a, the pull wires 124, and the activating mechanisms 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 a single direction only.
  • pull wires 124 may be provided on various circumferential surfaces of the delivery catheter 100 to facilitate steering in various directions.
  • the delivery catheter 100 includes a first inactive segment 122i 1 ; a first active segment 122al that is located distally of the segment 122il ; a second inactive segment 122i2 that is located distally of the segment 122al; and a second active segment 122a2 that is located distally of the segment 122i2.
  • the delivery catheter 100 includes respective first and second pull wires 124i, 124ii that are located within the channel 128 (FIG. 27). It is also envisioned, however, that the first and second pull wires 124i, 124ii may be located within separate channels 128 (e.g., such that the number of channels 128 corresponds to the number of pull wires 124).
  • the pull wires 124i, 124ii are connected to the segments 122a 1 , 122a2 at connection points 132i, 132ii (in addition to the activating mechanism 130i, 130ii), respectively, so as to facilitate reconfiguration of the delivery catheter 100 between the first configuration (FIG. 26) and the 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.
  • bends 134i, 134ii are each illustrated as being (approximately) equal to 90 degrees in FIG. 28, depending upon the particular configuration of the segments 122al, 122a2, the requirements of the endovascular procedure, the particular anatomy of the patient’s vasculature, etc., it is envisioned that the bends 134i, 134ii may lie substantially within the range of approximately 0 degrees to approximately 270 degrees.
  • the segment 122a 1 may be configured such that the bend 134i lies substantially within the range of approximately 0 degrees to approximately 180 degrees (e.g., approximately 90 degrees to approximately 180 degrees) and that the segment 122a2 may be configured such that the bend 134ii lies substantially within the range of approximately 0 degrees to approximately 270 degrees (e.g., approximately 90 degrees to approximately 270 degrees).
  • connection points 132i, 132ii are shown as being in (general) angular alignment (e.g., along a circumference of the delivery catheter 100), which facilitates deflection of the segments 122al, 122a2 in similar (e.g., identical) directions, as seen in FIG. 28. It is also envisioned, however, that the connection points 132i, 132ii may be angularly offset so as to facilitate deflection of the segments 122al, 122a2 in dissimilar directions. For example, the connection points 132i, 132ii may be oriented in (generally) diametric opposition such that the bends 134i, 134ii respectively defined by the segments 122al, 122a2 curve in (generally) opposite directions.
  • the delivery catheter 100 may include one or more (second) pull wires 136 that are connected (secured, anchored) to the delivery catheter 100, which may supplement or replace the pull wire(s) 124 (FIGS. 26-28).
  • the pull wire(s) 136 facilitate the selective application of a torsional (twisting) force to the delivery catheter 100 and, thus, rotational deflection of the delivery catheter 100 along all or a portion of the length thereof (e.g., at or adjacent to the distal end hole 110) to vary the angular position of the delivery catheter 100.
  • the pull wire(s) 136 extend in non-parallel relation to the longitudinal axis X of the delivery catheter 100.
  • the delivery catheter 100 includes a single pull wire 136 that is wound helically (spiraled) about the longitudinal axis X. It should be appreciated, however, that the number of pull wires 136 may be varied in alternate embodiments without departing from the present disclosure (e.g., it is envisioned that the delivery catheter 100 may include two pull wires 136, three pull wires 136, etc.).
  • pull wires for rotation disclosed herein can fully or partially extend about the longitudinal axis X, i.e., extend 360 degrees, less than 360 degrees or greater than 360 degrees (more than one spiral).
  • the pulley wires can be straight in part or most of the device and spiral in only part of its length. In some embodiments, the spiraling portion of the pulley wires extends until at or near the distal end of the device. The spiraling of the wires can be configured so rotation occurs in a desired segment of the device, for example, to rotate the orientation of the distal end hole as desired.
  • FIG. 29B illustrates another embodiment of the disclosure in which the pull wire(s) 136 include a (first) distal segment 136a that extends in non-parallel relation to the longitudinal axis X of the delivery catheter 100 and a (second) proximal segment 136b that extends in (generally) parallel relation to the longitudinal axis X.
  • the distal segment 136a includes a curved (non-linear) configuration that is wound helically (spiraled) about the longitudinal axis X (e.g., at or adjacent to the distal end 108 of the body 102 of the delivery catheter 100) and the proximal segment 136b includes a (generally) linear configuration.
  • the delivery catheter 100 may define an overall length sufficient to allow for rotational deflection of the delivery catheter 100 without any significant (substantial) kinking, binding, or other such undesirable deformation.
  • the delivery catheter 100 may define an overall length that lies substantially within the range of (approximately) 50 cm to (approximately) 170 cm. Overall lengths outside this range, however, would not be beyond the scope of the present disclosure.
  • 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 construction of the delivery catheter 100.
  • the pull wire 136 may be secured (connected) to the body 102 of the delivery catheter 100 in any suitable manner.
  • 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., within a corresponding (helical or partially helical) channel 140 formed in the outer wall 126 such that the pull wire 136 is embedded within the delivery catheter 100).
  • the body 102 of the delivery catheter 100 Upon the application of a (pulling) force to the pull wires 136, the body 102 of the delivery catheter 100 experiences angular (torsional) deflection (displacement), whereby the distal end 108 of the body 102 rotates about the longitudinal axis X, which causes corresponding rotation of any (medical) device positioned within the delivery catheter 100.
  • a (pulling) force to the pull wires 136
  • the body 102 of the delivery catheter 100 experiences angular (torsional) deflection (displacement), whereby the distal end 108 of the body 102 rotates about the longitudinal axis X, which causes corresponding rotation of any (medical) device positioned within the delivery catheter 100.
  • the delivery catheter 100 e.g., a first medical device
  • the packaging catheter 300 FIG.
  • rotation of the delivery catheter 100 causes corresponding rotation of the pusher 302 and, thus, the stent 202.
  • the rotation facilitated by the torsional force applied to the delivery catheter 100 via the pull wire 136 allows for precise control over the rotational positions of the delivery catheter 100 and the packaging catheter 300 (or other such device received by the delivery catheter 100) by allowing for supplemental variation in the rotational positioning facilitated by the corresponding noncircular (transverse) cross-sectional configurations defined by the delivery catheter 100 and the pusher 302.
  • Rotation of the delivery catheter 100 also allows for positioning of the devices (e.g., the delivery catheter 100 and the pusher 302) in any desired rotational orientation regardless of the particular non-circular (transverse) cross-sectional configurations employed (e.g., triangular, square-shaped, rectangular, pentagonal, hexagonal, octagonal, ovals, etc.).
  • the devices e.g., the delivery catheter 100 and the pusher 302
  • any desired rotational orientation regardless of the particular non-circular (transverse) cross-sectional configurations employed (e.g., triangular, square-shaped, rectangular, pentagonal, hexagonal, octagonal, ovals, etc.).
  • the delivery catheter 100 may include (or may be connected to) one or more corresponding (second) activating mechanisms 142 (e.g., such that the number of pull wires 136 corresponds to the number of activating mechanisms 142).
  • the activating mechanism(s) 142 are connected to the pull wire(s) 136 and may include any structure or mechanism suitable for the intended purpose of applying torsional force thereto sufficient to cause rotation of the delivery catheter 100 as necessary or desired, such as, for example, rotating wheels, pulley systems, ratchet mechanism, levers, or the like.
  • the activating mechanism(s) 142 and/or the pull wires 136 may include one or more stop locks (or other such structures) to maintain the rotational position(s) of the pull wires 136 and the delivery catheter 100.
  • the activating mechanism(s) 142 may be omitted and that force may be manually applied to the pull wires 136 to facilitate rotation of the delivery catheter 100.
  • the delivery catheter 100 includes a single activating mechanism 142 that is configured as a wheel 144 such that force is applied to the pull wire 136 via rotation of the wheel 144. More specifically, the activating 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 support in the insertion of one or more medical devices, guide wires, etc.). It should be appreciated, however, that the activating mechanism 142 may be positioned in any suitable location. For example, FIG. 30 illustrates an alternate embodiment that is devoid of the access port 146 in which the activating mechanism 142 is supported directly on the body 102 of the delivery catheter 100.
  • FIG. 31 illustrates another embodiment of the disclosure in which the activating mechanism 142 is configured as a movable (e.g., pivotable) lever 148 such that force is applied to the pull wire 136 via deflection of the lever 148 (e.g., pivotable and/or axial movement of the lever).
  • the lever 148 may be positioned in any suitable location.
  • FIG. 32 illustrates another embodiment that is devoid of the access port 146 in which the lever 148 is supported directly on the body 102 of the delivery catheter 100. In the several configurations illustrated in FIGS.
  • the delivery catheter 100 is illustrated as including a single pull wire 136 and a single activating mechanism 142, which allows for rotation of the delivery catheter 100 in a single direction only (e.g., counterclockwise in the direction indicated by arrow 1 (FIG. 29A)).
  • the delivery catheter 100 may include a plurality of pull wires 136 and a plurality of corresponding activating mechanisms 142 to facilitate rotation of the delivery catheter 100 in a plurality of directions (e.g., clockwise and counterclockwise). More specifically, FIG.
  • the delivery catheter 100 includes a (first) pull wire 136i that is connected to a (first) activating mechanisms 142i to thereby apply a (first) torsional force to the delivery catheter 100 and rotate the delivery catheter 100 in a (first) direction indicated by the arrow 1 and a (second) pull wire 136ii that is connected to a (second) activating mechanisms 142ii to thereby apply a (second) torsional force to the delivery catheter 100 and rotate the delivery catheter 100 in a (second) direction indicated by the arrow 2.
  • the pull wires 136i, 136ii may be connected to the body 102 of the delivery catheter 100 in any suitable locations.
  • the pull wires 136i, 136ii may be connected to the body 102 at respective connection points 150i, 150ii that are positioned in (generally) diametric opposition, as seen in FIG. 33.
  • FIG. 33 Although shown as being respectively supported on corresponding access ports 146i, 146ii in the particular embodiment seen in FIG. 33, in certain embodiments, it is also envisioned that the access ports 146i, 146ii may be eliminated and that the activating mechanisms 142i, 142ii may be supported directly on the body 102 of the delivery catheter 100 (see FIG. 30). Additionally, while the activating mechanisms 142i, 142ii are each illustrated as including rotatable wheels 144 in FIG. 33, it should be appreciated that the activating mechanisms 142i and/or the activating mechanism 142ii may instead include one of the aforementioned levers 148. For example, FIG.
  • FIG. 34 illustrates an embodiment in which each of the activating mechanisms I42i, 142ii includes a lever 148
  • FIG. 35 illustrates an embodiment in which the activating mechanism 142i includes a rotatable wheel 144 and the activating mechanism 142ii includes a lever 148.
  • the activating mechanisms 142i, 142ii may be either similar (e.g., identical) or dissimilar (e.g., non-identical).
  • the stent which can be utilized with the catheters disclosed herein include the stents from application serial no. 15/341,820 (now U.S. Patent No. 9,775,730), application serial no. 15/732,544 (Publication US 2018-0243113), application serial no. 16/214,130 (Publication US 2019-0151072), and application no. 17/156,743. The entire contents of each of these applications are incorporated herein by reference.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Dispositif intravasculaire orientable pour traiter un anévrisme, possédant un repère « à douze heures » sur une extrémité proximale et distale, et comportant un cathéter d'emballage possédant une lumière interne non circulaire fixe identique, un fil-poussoir présentant un dispositif d'occlusion monté amovible sur l'extrémité distale dudit fil-poussoir, précontraint dans une orientation circonférentielle fixe, avec des repères correspondants sur l'extérieur dudit cathéter d'emballage, un collet comportant une lumière interne qui est formée de façon à s'adapter à la lumière externe du cathéter d'emballage pour poser un fil de libération et une endoprothèse d'occlusion dans une orientation prédite, et conservant cette orientation lorsque que le fil et l'endoprothèse sont avancés dans ledit cathéter de pose, et lorsque que ledit cathéter de pose est retiré. Des méthodes d'utilisation de ces dispositifs sont divulguées.
EP21889881.5A 2020-11-04 2021-11-01 Dispositifs intravasculaires orientables et méthodes Pending EP4240280A1 (fr)

Applications Claiming Priority (3)

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US202063109387P 2020-11-04 2020-11-04
US17/214,021 US20210259860A1 (en) 2019-06-12 2021-03-26 Orientable intravascular devices and methods
PCT/US2021/057506 WO2022098591A1 (fr) 2020-11-04 2021-11-01 Dispositifs intravasculaires orientables et méthodes

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Publication number Priority date Publication date Assignee Title
AU660444B2 (en) * 1991-02-15 1995-06-29 Ingemar H. Lundquist Torquable catheter and method
WO2002071980A2 (fr) * 2001-03-09 2002-09-19 Georgia Tech Research Corporation Dispositif intravasculaire et procede pour etirer axialement des vaisseaux sanguins
AU2013274533A1 (en) * 2012-06-11 2014-12-04 E-Pacing, Inc. Vasculature closure devices and methods
WO2018073830A2 (fr) * 2016-10-21 2018-04-26 Javelin Medical Ltd. Systèmes, méthodes et dispositifs de protection contre l'embolie
US11045177B2 (en) * 2016-11-02 2021-06-29 Daniel Ezra Walzman Orientable intracranial occlusion device and method

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