Directable intracranial occlusion device and method

Abstract

An orientable intravascular device for treating an aneurysm having "12 o'clock" markings on both proximal and distal ends, the intravascular device comprising: a packaging catheter having identical fixed non-circular inner lumens; a push wire having an occluding device releasably disposed on the distal end of the push wire, preloaded in a fixed circumferential orientation, with corresponding markings on the exterior of the packaging catheter; and a hub having an inner lumen shaped to engage with the outer lumen of the packaging catheter to deliver the delivery wire and occluding stent in a predicted orientation and maintain such orientation as the delivery wire and stent are advanced through the delivery catheter and simultaneously withdrawn. Methods of using the orientable intravascular device are also disclosed.

Description

[0001] Cross-references

[0002] This application is a continuation-in-part (CIP) claiming priority to the following utility patent applications: 15 / 341,820 filed 11 / 02 / 16 (November 2, 2016) for Flow-Diverting Covered Stent (now U.S. Patent No. 9,775,730B1, issued October 3, 2017); and 12 / 09 / 18 filed December 9, 2018 for Caped CIP of application serial number 16 / 214,130 for Stent (capped stent), which is a CIP claiming priority benefit of application serial number 15 / 732,544 filed 11 / 22 / 17 (November 22, 2017), provisional serial number 62 / 921,378 filed 06 / 12 / 2019, and provisional serial number 62 / 497,851 filed 12 / 05 / 16 (December 5, 2016), the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to medical devices for treating aneurysms and fistulas within unhealthy blood vessels, and more particularly to intravascular devices, including flow-diverting stents, covered stents, capped stents, fenestrated stents, branched stents, and other variable porosity stents for use in the intracranial or other tortuous vasculature. Background Art

[0004] The prior art proposes the use of a variety of devices to treat aneurysms. One such device is a differentiated porous stent that has an asymmetric braid or coil to create areas of less or more blood flow as needed. Fenestration devices and branching devices have been effectively used in the aorta and its direct branches, as well as in other applications where the vessels are large and have little tortuosity. Although the prior art has disclosed theoretical applications of such devices in the intracranial and other tortuous and distal vasculature, no device or method has been described that can reliably deploy such devices in their desired radial direction. To date, the limitations of the intracranial or other tortuous vasculature have precluded the use of such devices in these areas. U.S. Patent No. 9,775,730B (Walzman) proposes a covered stent device that can be safely and effectively delivered and deployed into tortuous vessels to effectively divert blood flow away from aneurysms, fistulas, or ruptured vessels while allowing blood to flow to healthy tissue distal to the target treatment area, but still resulting in blood stasis and thrombosis within the aneurysm or fistula.

[0005] U.S. Patent Publication No. 2019 / 0151072A1 (Walzman) proposes a capped stent that provides a covering with a single attachment point and overlappable free ends, thereby providing better conformability to the target vessel than existing covered stents.

[0006] U.S. Patent No. 8,398,701 B2 (Berez et al.) proposes a vascular occlusion device that can be deployed on a microcatheter. The occlusion device includes an asymmetric braid or differentiated mesh density, and a corresponding / opposite variable porosity density to modify blood flow in the vessel while maintaining flow to surrounding tissue. Berez proposes that the flexibility of the device is particularly suitable for treating aneurysms in the brain. Berez describes an embodiment that includes lower coverage on one side relative to the other side along the same section of the length of the cylinder. For example, the area with lower porosity (i.e., greater coverage) should be positioned to cover the aneurysm to stagnate blood flow within the aneurysm and subsequently form a thrombus. The other side of the device with greater porosity should be located on one side of the vessel or covering a branch to allow continued adequate blood flow and prevent obstruction of blood flow to the branch and its distal tissue. However, Berez and others have not yet designed a way to consistently and reliably deploy such a device in the optimal desired radial orientation, and no such device is available.

[0007] In extreme cases, the intravascular device can provide additional porosity by including fenestrations so as not to impede blood flow to the origin of the branch vessel. This can be combined with full coverage on or near the opposite side to completely cut off blood flow to the target aneurysm or fistula.

[0008] A common vascular complication is persistent blood flow outside the endovascular graft within the aneurysm sac. In fact, this is the most common complication following endovascular aneurysm repair using stent-grafts. This type of endoleak can be ameliorated by various approaches. For example, Walzman's utility applications 15 / 732,147 and 15 / 732,365 propose the use of hydrogels to prevent endoleaks.

[0009] The prior art also proposes endovascular coil embolization as a minimally invasive technique for preventing blood from flowing into certain saccular aneurysms. This treatment causes the coil to induce aneurysm embolism (coagulation), thereby preventing blood from flowing into the aneurysm, which in turn prevents rupture and subsequent subarachnoid hemorrhage. However, endovascular coil embolization may lead to surgical complications, including thromboembolism, cerebral embolism, aneurysm perforation, parent artery occlusion, coil displacement, arterial dissection, etc. The prior art also proposes stent-assisted coil embolization. Stent-assisted coil embolization also has some of the same disadvantages associated with stent implantation. Placement of a stent in the parent artery requires long-term use of antiplatelet drugs to reduce the risk of in-stent thrombotic stenosis.

[0010] Some aneurysms and fistulas are ideally treated with a covered stent, which most directly covers the fistula's hole or the neck of the aneurysm and rebuilds the vessel wall, immediately redirecting blood flow into the normal path of the parent vessel. However, there are currently no covered nerve stents in the United States. The U.S. Food and Drug Administration (FDA) has examined and tested such covered nerve stents, but the covered nerve stents have not been "FDA-approved," meaning that the FDA has not determined that the benefits of the intended use outweigh the potential risks compared to existing treatment options. In addition, there are currently no covered stents that are effective for severely tortuous anatomy elsewhere in the body, including but not limited to splenic artery aneurysms and pulmonary arteriovenous fistulas.

[0011] A potentially important use of covered nerve stents is in the treatment of fistulas, particularly carotid cavernous fistulas (CCFs), which are abnormal communications between the cavernous sinus and the carotid arterial system.

[0012] Other treatments for aneurysms include surgical clipping of intracranial aneurysms, which involves applying a clip across the neck of the aneurysm. This treatment has several disadvantages, including the requirement for open surgery and physical manipulation of the brain. Surgical bypass is sometimes considered but is often associated with higher morbidity and mortality.

[0013] Additionally, existing technologies propose using blood flow diverting devices to redirect blood flow away from the aneurysm by placing a mesh stent or stent-like structure along the parent artery at the neck of the aneurysm. The use of these devices allows for thrombosis within the aneurysm. However, the deployment of the blood flow diverter can increase technical complexity.

[0014] In addition, because they cannot completely block blood flow, they are not effective in treating fistulas and ruptured blood vessels. Similarly, there is currently no effective vessel-sparing treatment for iatrogenic rupture of intracranial arteries. Current treatments require the use of coils and / or liquid embolic agents to seal the ruptured artery to stop bleeding, which often results in significant morbidity due to ischemic damage to the arterial region. In addition, when treating aneurysms with these devices, the aneurysm thrombus forms over time, which is a lag phase and does not heal immediately. This puts the patient at risk of aneurysm rupture during the lag phase. This is particularly problematic when treating ruptured aneurysms because ruptured aneurysms have a high short-term re-rupture rate. In addition, when current blood flow diverting stents are used, many branch vessels often intersect the device, which often leads to stenosis at the starting point of these branches, and sometimes also to occlusion and / or damage.

[0015] There is a need for an intravascular device that enables intravascular intervention to immediately heal selected intravascular aneurysms or fistulas while ameliorating the difficulties and disadvantages associated with currently available technologies. More specifically, there is a need for a stent graft that allows the stent to move and flex freely without kinking around sharp bends in tortuous anatomy.

[0016] Most stent grafts involve making a cylindrical stent "skeleton" or "frame" out of a semi-rigid material, such as a metal alloy, and then attaching an impermeable "covering" to the frame. Prior art suggests that such attachments are spread out at fixed intervals along the cover and frame and positioned throughout the stent's covering, thus significantly limiting the device's flexibility.

[0017] All currently available flow-diverting stents have a relatively uniform coverage pattern and porosity throughout. No reliable device has yet been developed to successfully deploy a device with differential porosity along different circumferential radial segments.

[0018] For neuroendovascular procedures (and other tortuous vascular anatomies), there are no known devices or methods that allow for precise positioning of such differentiated multi-porous devices to achieve the ideal coverage and porosity ratio where needed and to allow flow where needed. Unlike larger vasculature (e.g., the aorta), devices deployed through the intracranial or other tortuous circulatory anatomies are not susceptible to manual rotation of the hub end, which could cause the intracranial end to rotate.

[0019] Therefore, there is a need for a device that can be reproducibly positioned / placed in the proper orientation such that regions with dense coverage and correspondingly low porosity (or completely impermeable in the extreme case, or with fenestrations in the other extreme case) are deployed on the desired side, while regions with low-density coverage and correspondingly high porosity (and / or no fenestrations at all in the extreme case) are deployed on the desired side. Additionally, there is a need for branched coatings and flow diverting devices in distal and tortuous vasculature. Currently, such devices are not available for neuroendovascular procedures, and similarly, for other tortuous vascular anatomies, because there are no devices, systems, and methods to consistently and accurately deploy such devices in the desired orientation.

[0020] Similarly, in the cardiac, peripheral, and other vascular systems, more effective bifurcated stent configurations are needed to minimize obstruction of side branches during various stenting procedures. Current systems allow for accurate positioning of fenestrations in multi-stent configurations to minimize the risk of obstructing branches while more efficiently placing stents across bifurcations. These configurations can effectively treat atherosclerotic stenosis, aneurysmal disease, dissections, fistulas, and other pathologies.

[0021] Therefore, if such a device is deployed, its final orientation during positioning will be random. For example, in the scenario just described, the opposite of ideal could occur. That is, a fenestration could end up covering the aneurysm, thereby increasing blood flow to the lesion; whereas an area with high-density coverage could end up covering the origin of a normal branch vessel, resulting in insufficient blood flow to that branch and subsequent ischemic injury. The device works easily within short, straight anatomy, and the catheter can be easily and accurately rotated from its proximal hub along its entire length.

[0022] Similarly, using the extreme example of a fenestrated device, a branching device can be constructed in vivo by deploying a fenestrated device with a fenestration at the origin of a branch and deploying another device from the fenestration into the branch. The proximal diameter of the second device at the fenestration can be slightly larger to ensure slight overlap without covering the main distal end branch / vessel. Similarly, a device containing multiple branches can be constructed using multiple fenestrations, as long as all fenestrations are at the appropriate relative distance and orientation relative to the native branch.

[0023] Ruiz describes this concept well in U.S. Patent No. 6,261,273 B1, entitled Access System for Branched Vessels and Methods of Use. However, Ruiz discloses constructing a directional sheath or catheter within the body, rather than an implant. However, similar to the Berez device, the Ruiz device works easily in short, straight anatomy, and the catheter can be easily and accurately rotated from its proximal hub along its entire length.

[0024] Rotation is ineffective for positioning in tortuous and / or longer vascular anatomy, and the catheter will not respond in a similarly predictable manner. This can create difficulties when stent devices (typically crimped for delivery) are advanced into a delivery catheter in a specific arrangement using delivery wires and / or hypotubes. The stent will exit the delivery catheter in an unpredictable arrangement or orientation.

[0025] Furthermore, to date, "Y"-shaped stents have been impractical to deploy or assemble at bifurcations within intracranial or other tortuous vascular anatomy. A need exists for Y-shaped stents, bifurcated stents, or other branched stent devices that can be effectively deployed or assembled within such anatomy. Furthermore, novel devices and methods are needed to more precisely position the proximal end of such stent devices in order to safely deploy such bifurcations without unsafe and accurate placement, and with only slightly consistent overlap of the fenestrations.

[0026] Therefore, there is a need for a covered or partially covered neural stent that can be used within the cranium or other tortuous anatomies outside the brain, wherein the more porous and less porous regions of the device can be positioned as needed relative to one or more branching vessels and at least one aneurysm or fistula. Furthermore, there is a need for similar covered or partially covered branching devices. The present invention addresses these unmet needs.

[0027] There is also a need for fenestrated, variable coverage, and variable porosity stents where fenestrations and areas of reduced porosity along the circumference of the device can be accurately positioned in any anatomical structure. This can be used in vascular applications as well as vascular and non-vascular endoscopic applications. Summary of the Invention

[0028] The present invention discloses a method and apparatus for correctly orienting intracranial occlusive devices, such as stents with differential porosity, relative to desired areas of greater or lesser blood flow (e.g., branch vessels and aneurysms, respectively). The present invention is particularly useful for treating aneurysms and fistulas within the intracranial or other tortuous vasculature, as well as vascular stenoses and other pathologies.

[0029] The present invention may be used for treatments that require precise orientation of a device relative to other devices after delivery. The present invention is particularly useful for reorienting devices that have been passed through long, tortuous tubes before reaching the target area. The present invention may also be used for treatments that require precise orientation of a device relative to other structures after delivery. For example, the present invention may be particularly useful for orienting asymmetric discs in aneurysm necks or for orienting stents in the gastrointestinal / biliary tract (i.e., blood vessels, endoscopes, etc.).

[0030] Achieving this desired orientation is difficult due to several factors. The lumen of the delivery catheter (through which the stent is deployed) is typically circular. Similarly, the outer diameter / surface of the wire upon which most balloon mounted stents are delivered, as well as the inner diameter surface of the delivery balloon catheter, are also circular. Therefore, during deployment, the stent typically rotates within the lumen in an unpredictable manner. Furthermore, as the catheter is advanced through tortuous anatomy, the catheter itself may twist, and twist in an unpredictable manner. Therefore, achieving the desired radial placement becomes a matter of chance, and it is also possible to achieve the opposite of the desired result, with negative consequences. The following devices and procedures are disclosed to overcome this difficulty.

[0031] Differentiated porous stents or such braided, meshed, or woven therapeutic devices can be oriented to a desired degree of flow or obstruction. Some stents described by Walzman (16 / 214,130 - "Capped Stent") optionally have a free-floating cover. The floating cover is designed to optimize insertion into tortuous anatomical structures. Its unique structural elements include a single circumferential attachment point at one end (as small as 1 nm), overlapping circumferential tiles, and overlapping geometric tiles.

[0032] The disclosed device can optionally be deployed via pharmacological means or via delivery through a balloon guide catheter with temporary balloon inflation or other means under flow cessation to minimize the possibility of blood flow affecting positioning upon its desheathing.

[0033] In other embodiments, the covering may not completely surround a given segment of the framework, thereby allowing some stents to be covered or have reduced porosity along a portion of their circumference while being uncovered or having increased porosity on different circumferential sides of the same segment. This can sometimes allow the origin of a branch vessel to be preserved, which may originate from the parent vessel along the same segment of the parent vessel pathology (e.g., opposite a fistula or aneurysm neck). The present invention further discloses an apparatus and method for more accurately positioning the proximal end of a stent such that if a fenestration in a first stent is placed over the origin of a branch, and a second stent can be accurately placed so that the proximal segment of the second stent only slightly overlaps the first stent around the fenestration, thereby avoiding leakage between the two stents while also avoiding unnecessary obstruction of the main vessel by the proximal end of the second stent.

[0034] The unique device and method described herein can achieve more accurate "placement" of the proximal end of the stent. An inner "unsheathed" hypotube or wire is described, which may have reverse-tapered "wings" at its distal end that can return and pass over the stent. The stent can be mounted at the distal end of the outer hypotube. The inner hypotube passes through the outer hypotube, with its wings extending rearward over the distal end of the outer hypotube and over the stent mounted thereon, and constraining the stent, which in this variant is typically self-expanding. Once the stent is in the desired position, the outer hypotube can remain in place while the inner hypotube is advanced. As the inner hypotube is advanced, its rear wings are also advanced and release their constraints from the stent in a proximal-to-distal manner. Thus, the proximal stent is released from its constraints first and expands for deployment. If the proximal portion of the placement is not in the optimal position, the stent can be re-sheathed by pulling the inner hypotube forward again. The stent can then be repositioned and deployment can be resumed.

[0035] The present invention utilizes a catheter and a wire having a non-circular shape that fits snugly against one another. Depending on the device, the catheter may sometimes be deployed first, and then the stent may be delivered through the catheter over a correspondingly shaped wire; where the wire shape is correlated to the inner diameter of the stent delivery catheter. In some configurations, the wire is first delivered to the lesion, and then the stent-mounting catheter is delivered over the wire; these may be "rapid exchange" or "over the wire" delivery systems; in other configurations, a catheter having a specific non-circular inner diameter circumferential shape may be first delivered to the lesion over any wire, the initial wire removed, and then the stent mounted on a correspondingly shaped outer diameter wire delivered through the catheter to the lesion. Although not exclusive, the former configuration is more common with balloon-mounted stents, and the latter configuration is more common with self-expanding stents.

[0036] It is critical that all wire-catheter combinations be tight enough that the wire cannot rotate relative to the catheter, even on a portion of the wire with a stent between the two, while still having sufficient freedom of movement to allow the catheter to be delivered over the wire or through the catheter without requiring a release force.

[0037] In some versions of branched stents, wires may be placed in both branches, and one branch wire may be placed through a distal end hole of a delivery catheter, which may have a side hole at the location of the stent side window, and the wire of the second branch may be reversely installed into the side hole, which may help to properly position the side hole at the beginning of the side branch while also keeping the wire close to the side branch.

[0038] In other versions of branched stents, the initial positioning of the initial wire or catheter can determine the delivery method of subsequent stents or wires based on the degree of rotation from the rear of the wire or catheter hub and its corresponding "12 o'clock mark" relative to the "12 o'clock mark" at the lesion site. In these versions, some stents may also have a dual-lumen delivery catheter, in which the main lumen extends from the distal end hole and the secondary lumen ends at the side hole at the stent fenestration site. Thus, the stent can be positioned across the lesion in one branch with the appropriate orientation relative to the crossing side branch. Then, before deploying the first stent, the second wire can be delivered into the side hole end lumen, passed through the side hole, and delivered into the side branch. Then, after deploying the first stent, the stent delivery catheter can be withdrawn while leaving at least the side branch wire in place. The second stent can then be delivered into the side branch over a separate stent delivery catheter and deployed only in the side branch, or if necessary deployed in the side branch and extending into the main branch, overlapping the proximal portion of the first stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1AA perspective view of a cylindrical delivery catheter 330 having a triangular lumen 991 associated with the cross-sectional shape of the lumen of the catheter is shown. In other embodiments, with respect to the crossing of wires between catheters delivering stents (in some systems, the stent may be loaded onto a wire and delivered on the wire within a pre-positioned catheter), the wire will be delivered first and the stent will be mounted on a corresponding catheter for delivery, typically on the outside of a balloon mounted on the catheter. The key to properly positioning the device is that the wire and stent system, or catheter and stent system, is such that the catheter and wire cannot rotate relative to each other, but will maintain a constant circumferential orientation relative to each other; at the same time, they must also have sufficient looseness relative to each other to allow one to slide over the other without difficulty.

[0040] Once the initial geometrically non-circular wire or geometrically non-circular lumen catheter is optimally positioned, imaging can be used to confirm the orientation of the tip of the corresponding wire or catheter relative to its hub. The hub may have a "12 o'clock" marking, and the tip may have a corresponding radiopaque marking. Subsequent imaging using x-ray, 3D x-ray, CT imaging, echocardiography, ultrasound, IVUS, or other modalities can confirm the relative rotation of the tip relative to the hub near the target lesion. Any inner wire-mounted stent system or outer catheter-mounted stent system can then be rotated a corresponding amount before being loaded into the proximal hub of the catheter or onto the proximal wire, respectively, to account for the recorded rotation of the delivered catheter or wire, respectively, and ensure subsequent accurate delivery and deployment orientation. Fundamentally, in somewhat tortuous anatomies, most catheters, wires, and stents cannot be accurately rotated from the proximal hub at the target site. However, the present invention relies on the accurate recording and subsequent accounting of the fixed, random rotation of the initial wire or catheter during initial delivery to allow for accurate orientation of the device delivery and placement. In some cases, a trial retrievable stent device or similar device may also be used to determine or confirm the orientation of the wire or catheter at the lesion.

[0041] Figure 1A An embodiment of a delivery catheter 330 is shown having a generally circular cross-sectional outer diameter shape 91 with a non-circular inner lumen 991 , in this particular case triangular. Figure 1A Also shown is the proximal end 9991 of the delivery catheter.

[0042] Figure 1B An embodiment of a delivery catheter lumen 3 without a cylindrical sheath (not shown) is shown, the delivery catheter lumen having a proximal end 1 and a distal end 2, wherein the proximal end 1 is in the same geometric plane as the proximal end 9991 of the delivery catheter and has passed through the blood vessel 1000 so that the distal end hole 2 is located proximal to the target aneurysm 2000.

[0043] Figure 1C 1 is a cross-sectional view of a delivery catheter lumen 3 having a triangular lumen with vertices AA, BB, and CC and with an internal angle ABC and a push wire 300 passing therethrough. For naming purposes, if the top vertex of the triangular lumen, labeled A, is rotated 120° counterclockwise, vertex A will be located on the lower left side of the triangular lumen. Figure 1C The left side of FIG. 5 shows the initial relative orientation of vertices AA, BB, and CC and the internal ABC angle and the push wire 300 therethrough. Figure 1C The right side of the diagram shows the same lumen 3 with apexes AA, BB, and CC oriented 120° counterclockwise relative to each other and having an internal angle ABC, and the same push wire 300 passing therethrough but at an offset angle CAB, for delivering a differentiated porous occlusive device (not shown) in a 120° counterclockwise relative orientation. In short, a delivery catheter has a fixed relative position relative to the target vessel location when delivered to the target vessel location, and a push wire is in communication with the delivery catheter to allow delivery of an article (such as a porous occlusive device) to the target vessel location in the same fixed orientation as the delivery catheter, illustrating rotation between the proximal hub of the delivery catheter outside the patient's body and the distal end of the delivery catheter after random rotation during delivery through tortuous anatomy. Thus, if the distal end is observed to be in the desired orientation when delivering the occlusive device or other device at the 12 o'clock position, the occlusive device can be introduced from the packaging catheter into the delivery catheter without rotation when the distal end of the packaging catheter is introduced into the proximal hub of the delivery catheter. However, if the 12 o'clock mark is recorded as rotated relative to the target lesion, the degree of rotation can be recorded and the corresponding degree of rotation of the packaged catheter will rotate the occluding device to the desired position when delivered to the target lesion via the delivery catheter. Figure 1C In this case, the porous occlusive device is delivered to the target vascular location with the apexes AA, BB, and CC of the delivery catheter oriented 120° counterclockwise relative to each other.

[0044] Figure 2The proximal end 10 and distal end 20 of the stent packaging catheter 30 (outside the patient's body), the hub 700 attached to the delivery catheter lumen 3 (outside the patient's body), the packaging catheter hub port 701 (shown with the push wire 300 passing therethrough), and further showing the push wire 300 (extending through the delivery catheter lumen 3 in dotted lines) continuing through the delivery catheter lumen 3, with the distal end 303 of the push wire 300 releasably attached to the stent 301 proximal to the target aneurysm 2000 (note that in a preferred embodiment, 301 passes completely through the delivery catheter, where the stent is preloaded and curled onto the triangular outer surface of the wire); the distal end 20 of the stent packaging catheter 30 is disposed inside the hub port 701; the delivery catheter lumen 3 is oriented to have a triangular proximal end hole inside the port hub 701, and with Figure 2 The substantially similarly shaped distal end 20 of the stent packaging catheter 30 in the embodiment is aligned, and the triangular distal end hole 2 is proximal to the target aneurysm 2000 ); the delivery catheter lumen 3 is deployed within the vessel wall 1000 .

[0045] Figure 3 The delivery catheter lumen 3 ( Figure 2 ), thereafter, the push wire 300 and the stent 301 are positioned within the vessel wall 1000 at the distal end 303 of the push wire (it should be noted that in most embodiments the wire should extend slightly beyond the stent; although not required, the wire should continue at least to the distal end of the stent (i.e., within the stent, so 303 is not the distal end of the wire, which is located distally, but in most embodiments is not the end).

[0046] Figure 4 Shown is an internal view of a delivery catheter lumen 3 having a triangular shape consisting of proximal sides 4, 5 and 6 corresponding to distal side 44 ( Figure 5 44); facing side 444 shows the full length of the catheter side starting from the proximal side 4 and ending at the distal side 44. Alternative embodiments (not shown) may use other regular non-circular shapes such as rectangles, pentagons, squares, ovals, ellipses, star shapes, etc.

[0047] Figure 5 Shown Figure 4 The adjacent surface 555 of the interior of the delivery catheter (or Figure 4 Rotated 120 degrees clockwise once), face 555 begins at proximal side 5 and ends at distal side 55 (the angled distal sides 44 and 66 behind 55 are shown in dashed cutaway); face 555 further includes radiopaque orientation aid markers 5550.

[0048] It is important to note that although a triangular stent may be used, it is not a preferred embodiment because most blood vessels have a circular cross-section. The two preferred embodiments are: 1. First, a catheter with a "triangular" lumen is advanced to the lesion, and then a stent pre-loaded on a "triangular" wire is advanced through the catheter; 2. A "triangular" shaped wire is advanced to the lesion, and then a stent loaded on a catheter with a "triangular" lumen (most commonly on a balloon on the catheter) is advanced onto the stent.

[0049] In either case, the cylindrical stent must be preloaded and pre-crimped onto the wire (in the former case) or onto the balloon on the catheter (in the latter case). Most of the time, this loading and crimping is done during manufacturing and packaging, and the physician receives the pre-loaded stent. Only in the rarest of cases is the wire advanced through the triangular stent described above.

[0050] Figure 6 The stent 301 is shown loaded onto a push wire 300 without a cylindrical sheath (not shown), with arrows indicating the proximal end 303 of the push wire 300 (where the push wire 300 is triangular) entering the delivery lumen 555 and the distal end 3010 of the delivery lumen. The delivery lumen 555 has an internal cavity shaped to allow the triangular push wire 300 to enter and pass therethrough, and the stent 301 is crimped into a triangle thereon, wherein the distal end 3010 of the delivery lumen 555 and the edges of the triangle are in a plane with the delivery lumen 303 (i.e., edges 334, 355, and 366). In this substantially non-rotating example, the triangular edge 355 forms a planar length that terminates at edge 3550. On the planar surface, a radiopaque marker 55500 is present. Multiple radiopaque markers may be present to help confirm the position of the distal catheter. In a preferred embodiment, there is also a distinct 12 o'clock marking at the distal end, while there is a 12 o'clock marking directly visible outside the patient's body on the proximal end hub. It should be noted that the stent needs to be mounted on a wire or catheter (in this case, the wire), so in most embodiments, the wire will extend at least to the distal end of the stent, and usually slightly beyond / longer.

[0051] Figure 7A A delivery catheter lumen 3 is shown which may have an inner lumen in the shape of a square 8881, a pentagon 8882, an arrow 8883, or a star 8884. The inner lumen may be virtually any non-circular shape.

[0052] Figure 7BA delivery catheter lumen 3 is shown having a triangular lumen and a marking 8081 at the 12 o'clock position on the distal end, and a radiopaque marking 8082 at the 12 o'clock position on the proximal end, and in this example, a different radiopaque marking 8083 at the 6 o'clock position on the distal end.

[0053] Figure 8 A push wire 300 is shown.

[0054] Figure 9 An encapsulated catheter 3 is shown having a triangular shaped lumen 30 (dashed lines).

[0055] Figure 10 An embodiment is shown in which the distal end of the push wire 300 is tapered 9091. It should be noted that Figure 10 It is a non-limiting embodiment that the push wire 300 may have a rounded, pointed, or other tip at the distal end.

[0056] Figure 11 A torsion catheter is shown where the delivery catheter 3 has a triangular lumen, a marking on the proximal end hub 8081 at the 12 o'clock position and a corresponding 12 o'clock radiopaque marking on the distal end 8082 which has been rotated to the 10 o'clock position.

[0057] Figure 12 The delivery catheter lumen 3 is shown with the push wire 300 and markings at the 12 o'clock position on the proximal end hub 8081 .

[0058] Figure 13 A reverse sheathing stent is shown, more specifically, a stent 9090 loaded on an external pusher hypotube 9091. It should be noted that when rotation is not required, the external pusher hypotube 9091 can be circular as shown. If rotation is required, a non-circular surface is preferred.

[0059] Figure 14 An inner desheathing hypotube 9092 is shown having wings 9093 and a wire lumen 9094. The wings 9093 extend rearwardly and cover the stent 9090 mounted on the outer pusher sheath / outer hypotube 9091. It should be noted that, with the exception of the wings 9093 on the outside of the inner hypotube and stent 9090, the desheathing hypotube is inside the outer hypotube. Both the inner hypotube 9092 and the outer hypotube 9091 can optionally have a "through the wire" configuration and / or a rapid exchange configuration. Thus, by advancing the inner hypotube 9092 and holding the outer hypotube 9091 stationary, the stent graft 9090 is desheathed, the proximal end first.

[0060] Figure 15Wire 553 is shown, more specifically an external view of a delivery wire having a triangular shape, which is composed of proximal end sides labeled 554, 555 and 556, each proximal end side corresponding to a side and a distal end (e.g., 554 proximal end side, corresponding to 55444 facing side and 5544 distal end side). Figure 15 The facing side 55444 is shown, showing the full length of the wire side starting at the proximal side 554 and ending at the distal side 5544, showing in this example that there is no significant rotation between the proximal and distal ends of the wire. Alternative embodiments (not shown) may employ other non-circular shapes such as rectangular, pentagonal, square, oval, star-shaped, etc. 551 is the proximal end of the wire, and 552 is the distal end of the wire. DETAILED DESCRIPTION

[0061] With reference to the above-mentioned figures, embodiments of the device and device variants of the invention are explained.

[0062] refer to Figure 1A , shows a perspective view of a cylindrical delivery catheter 330 having a triangular lumen 1. The present invention discloses a conventional cylindrical delivery catheter having a linear lumen such as a triangle, square, other rectangular, star-shaped, hexagonal, etc. Alternatively, it may have a significant non-circular shape, such as an oval or elliptical. The linear lumen is designed to allow delivery of similarly shaped push wires adapted to be inserted into the lumen 1 at different, fixed relative positions.

[0063] Now refer to Figure 1B , shows an embodiment of a delivery catheter lumen 3 without a cylindrical sheath (not shown). The delivery catheter lumen 3 has a proximal end 1 and a distal end 2 and has been passed through a blood vessel 1000 so that the distal end hole 2 is proximal to the target aneurysm 2000. The delivery catheter lumen 3 is inserted into the blood vessel 1000 until it stops, so that the distal end 2 is proximal to the target aneurysm 2000. Due to the linear geometry of the lumen 1, the delivery catheter lumen 3 has a set orientation relative to the side closest to the target aneurysm 2000.

[0064] Now refer to Figure 1C, shows a cross-sectional view of a delivery catheter lumen 3 having a triangular lumen with ABC angles and a push wire 300 passing therethrough at an offset CAB angle, so as to deliver a differentiated porous occlusive device (not shown) or a fenestration device at a 240-degree counterclockwise rotation angle for deployment in a desired orientation. A similar arrangement can be used to deliver other devices such as the aneurysm neck cap previously described by Walzman (U.S. Patent No. 10,543,015), which can have an asymmetric shape to cover the neck of an asymmetric aneurysm, and other devices in their desired optimal orientation. When any occlusive device is used, a supplementary additional occlusive device may also be optionally used. The present invention provides that the orientation of the push wire can be fixed outside the patient's body by fixing its relative orientation relative to the delivery catheter lumen 3. The orientation of the delivery catheter lumen 3 relative to the target aneurysm 2000 (determined prior to inserting the push wire 300 via imaging) allows the user of the device of the present invention to correctly insert the push wire 300 to achieve the correct orientation relative to the aneurysm 2000 without having to rotate the push wire 300 within the patient's body.

[0065] Now refer to Figure 2 , showing the proximal end 10 and distal end 20 of a stent packaging catheter 30 (outside the patient's body), a hub 700 attached to a delivery catheter lumen 3 (outside the patient's body), a packaging catheter hub port 701 (showing a push wire 300 passing therethrough), further showing the push wire 300 (extending in dashed lines through the delivery catheter lumen 3) and continuing through the delivery catheter lumen 3, with the distal end 303 of the push wire 300 releasably attached to the stent proximal to the target aneurysm 2000 (Note: 301 is drawn to show that the stent is at the distal end of the delivery lumen, and Figure 2 The stent is not shown in the figure because it is covered by another structure of the present invention); the distal end 20 of the stent packaging catheter 30 is disposed inside the hub port 701, and the delivery catheter lumen 3 is oriented (see A, B and C triangular tip designations) with a triangular proximal end hole inside the hub port 701 and a triangular distal end hole 2 proximal to the target aneurysm 2000); the delivery catheter lumen 3 is deployed within the vessel wall 1000. In addition, the present invention discloses a single "12 o'clock" mark 8083 on the hub 700, and a single non-radiopaque "12 o'clock" mark 8081 on the distal catheter tip. More specifically, Figure 2 The delivery catheter lumen 3 is shown having a triangular lumen and a radiopaque marker 8081 on the distal end at the 12 o'clock position, and a marker 8082 on the proximal end of the delivery catheter hub 701 at the 12 o'clock position. Additionally, the packaging catheter also requires markings, but only on its distal end, as shown at 8084.

[0066] The packaging catheter 30 (having a corresponding 12 o'clock mark at its distal end 20) is engaged by the practitioner to the hub 700 at its 12 o'clock mark 8083 at the port 701 so that when the matching non-circular wires and inner catheter lumens of the present invention are used to deliver the differentiated porous flow diverting stent device, the stent 301 and the push wire 300 are oriented as desired so that the least porous surface of the stent 301 is substantially oriented toward the target aneurysm 2000. In extreme cases, the least porous portion of the stent may be completely impermeable to liquids and blood. In extreme cases, the least porous portion of the stent may have no struts at all, representing fenestrations or holes in the device.

[0067] Now refer to Figure 3 , showing the removal of the delivery catheter lumen 3 ( Figure 2 2000 ) is then positioned at a distal push wire 303 within the vessel wall 1000 and a stent 301. Once the stent 301 is proximally placed next to the aneurysm 2000, the stent 301 is activated or released from its external constraints and expands so that the substantially non-porous side of the stent 301 abuts the aneurysm 2000, while the other sides of the cylindrical elongated stent 301 are porous to promote blood flow to any side branches through which it may pass. When loaded on a balloon, the stent is typically always cylindrical when expanded (when loaded on a wire, catheter, or balloon, the stent may only be temporarily curled into an alternative shape), and the balloon is typically also circular / cylindrical, but the catheter or wire on which it is loaded needs to be of the appropriate shape, both proximal to the stent and typically distal to the stent, and most often along the balloon segment, so that the stent takes the correct route and remains in the correct orientation. Therefore, in some iterations, the deflated balloon is also curled down onto a continuously appropriately shaped catheter to assume the shape until it is also inflated. In this case, when crimped onto a round balloon, the balloon is deflated and mounted on a suitably shaped catheter, so that the deflated balloon and the unexpanded shape are crimped in the same shape (if necessary, sometimes an external crimper of the same shape can also be used during the crimping process). However, when the balloon is inflated and / or the stent is expanded, the balloon and / or stent will, in most embodiments, form a cylindrical shape.

[0068] Now refer to Figure 4 , shows an internal view of a delivery catheter lumen 3 having a triangular shape consisting of proximal sides 4, 5 and 6 corresponding to distal side 44 ( Figure 5 Facing side 444 shows the full length of the catheter side starting from the proximal side 4 and ending at the distal side 44. In this example, there is no significant rotation between the proximal and distal ends.

[0069] The orientation of the lumen of the delivery catheter lumen 3 should be clearly discernible. Figure 4A triangular shape is shown having sides 4, 5, and 6 on the proximal end and side 44 on the distal end of face 444. Alternative embodiments (not shown) may employ other defined non-circular shapes, such as rectangular or star shapes.

[0070] Now refer to Figure 5 , showing Figure 4 The adjacent surface 555 of the interior of the delivery catheter (or Figure 4 The facing side 555 further includes a radiopaque orientation aid marker 5550. Some preferred embodiments may also have a 12 o'clock radiopaque marker at the distal end for determining the rotational positioning of the distal catheter relative to a lesion or side branch or other structure. Figure 5 yes Figure 4 , which shows a relative plane 555 terminating at side 5 on the proximal end and 55 on the distal end. On the surface 555, radiopaque markers 5550 allow the user to determine the relative orientation of one side of the delivery catheter lumen 3. Using this information, the packaged catheter 30 can be properly oriented in the hub port 701 so that when the wire 300 and stent 301 are pushed proximal to the aneurysm 2000, they are properly aligned and oriented in the desired configuration.

[0071] Now refer to Figure 6 , shows stent 301 (note: 301 illustrates the location of the stent, which is typically covered by other features of the present invention) attached to push wire 300 at its distal end and aligned with the proximal end of delivery lumen 5555. Stent 301, when fully open and unconstrained, has a substantially cylindrical shape but is introduced in a triangular shape, cinched downward over the triangular wire, with the distal end of delivery lumen 555 and the triangular edges oriented in a plane with proximal end 303 (i.e., edges 334, 355, and 366). At distal end 3010 of delivery lumen 301, triangular edge 3550 is shown, with two additional triangular edges 3440 and 3660 disclosed in dashed lines. In this substantially non-rotating example, triangular edge 355 forms a planar length that terminates at edge 3550. Radiopaque marker 5550 is present in this plane.

[0072] The first method.

[0073] A delivery catheter having a "12 o'clock" mark and a fixed and continuous non-circular inner circumferential lumen shape at the proximal hub of the catheter is used. The 12 o'clock mark can be provided on the hub and the tip of the delivery catheter (i.e., a radiopaque object on the catheter tip). The user inserts a stent-encapsulating catheter having a differentiated porous stent or occlusion device mounted on a push wire into the catheter. After testing to determine the degree of rotation between the hub and the tip, the user rotates the encapsulating catheter at the hub to the desired indicator so that when the device is delivered to the target sight at the distal end of the delivery catheter, the device will be oriented in the desired position.

[0074] The indicator can be placed anywhere on the hub to point in any direction on the hub, but referring to it as a 12 o'clock indicator or marking is convenient for anyone familiar with an analog clock face to describe the position relative to the marking. For example, instructing the user to rotate the hub to "3 o'clock," "6 o'clock," or "9 o'clock" intuitively represents a quarter turn, a half turn, and three-quarters of a turn, respectively, while the other "times" refer to approximate positions between these 90 references (e.g., 2 o'clock, 5 o'clock, or 11 o'clock). By referring to the "North" marking, the same effect can be achieved using terms such as East, South, and West (or intervening positions such as ESE or NW), but "12 o'clock" is the preferred reference. The ability to manually rotate the delivery catheter within 360° of its relative orientation, rather than the terminology used, is important.

[0075] Using a packaging catheter with distal markings, a test stent or final stent or other directional device is advanced in a specific orientation relative to the 12 o'clock mark on the delivery catheter. Stents (or other marked intravascular devices) typically end up in a substantially similar orientation. If a stent is introduced at the 12 o'clock position at the hub, it will typically be delivered in any orientation where the distal end 12 o'clock mark is located. If a different position of the device is preferred, the device must be rotated by the corresponding angle and direction relative to the end marking in order to be deployed in the desired configuration. This rotation is achieved by rotating the delivery catheter by the desired amount and direction that the final device should be rotated relative to the end 12 o'clock mark, then introducing the final device into the delivery catheter, and then introducing the final device into the delivery catheter along the desired orientation. Obviously, when using a triangular lumen and wire, the packaging catheter can only be rotated to only three circumferential positions relative to the delivery catheter. To achieve additional rotational positioning options, the stent or other device can be pre-loaded into the delivery package to varying degrees relative to the 12 o'clock mark. This is typically done during the manufacturer's packaging, prior to delivery. The device and / or its packaging will be appropriately marked to determine the position of the device relative to the 12 o'clock mark at the distal end of the packaging catheter. This process can be repeated to verify that the markings on the delivery catheter and the packaging catheter are consistently aligned. The markings on the test stent / device are then imaged relative to the markings on the tip of the delivery catheter to determine the orientation (i.e., the "hour" on the "clock") that the stent needs to be loaded into the delivery catheter in order to achieve the desired orientation at the delivery site.

[0076] Optionally, an additional test stent / device temporarily advanced in the predicted orientation can be used to confirm orientation, and then imaging can be performed to confirm before the test device is removed and the permanent device is advanced and deployed.

[0077] By way of example, the test results show that the fenestration is deployed at "7 o'clock", which is 90 degrees clockwise relative to the target branch vessel. The treatment will then reorient the stent-packing catheter at "4 o'clock" so that it appears correctly oriented proximal to the target branch.

[0078] When the catheter tip orientation is imaged, a stent loaded with the proper orientation relative to similarly positioned hub markers can be deployed. Again, if necessary, a "test" device / stent with additional radiopaque markers can be reversibly deployed to confirm orientation.

[0079] Second method

[0080] A second method is disclosed that utilizes the steps and markings of the first method described above and additionally utilizes a delivery catheter having a lumen having a unique geometry across its entire cross-section. In an exemplary embodiment, the outer surface of the delivery catheter is generally cylindrical, substantially circular, to facilitate advancement through the circulatory vessel. The non-circular lumen minimizes the tendency of the deployed stent-encapsulating catheter or wire or combination thereof to rotate, thereby enhancing predictability of orientation.

[0081] The figures show triangular shaped lumens by way of example.

[0082] Alternatively, a square, hexagon, octagon, pentagon, "house" outline, egg, ellipse, star or other non-circular shape. Any type of star can be used, such as a six-pointed star, "Star of David" star or other star, as long as a single star is used throughout the lumen.

[0083] In another embodiment, the shape of the lumen of the packaging catheter may correspond to the shape of the lumen of the delivery catheter. Figure 1A and Figure 1B This correspondence is shown in FIG. This embodiment is configured so that the correspondingly shaped packaging catheter and delivery wire or hypotube are tight enough to not allow rotation, but loose enough to allow movement back and forth relative to each other. This embodiment will maintain a similar orientation by advancing the stent / device through the delivery catheter, thereby allowing accurate and predictable deployment in the proper and desired orientation.

[0084] Here again, a "12 o'clock" mark in the same orientation can be located on the hub and on the catheter tip (which is radiopaque on the catheter tip). Thus, when / if the catheter tip orientation is imaged, a stent loaded in the proper orientation relative to the similarly positioned hub mark can be used. The stent is typically loaded on a delivery wire of similar external shape to match the internal shape of the catheter. Again, a "test" device / stent with additional radiopaque markers can be reversibly deployed to confirm orientation if desired.

[0085] In another example, a wire that is substantially non-circular on the proximal side and extends to the target area in a continuous or nearly continuous manner is advanced via a standard intravascular method. The end of the wire (or the area on the wire where the non-circular shape ends) will have a radiopaque marker or other marker that can be effectively imaged when in vivo at the "12 o'clock" position of its circumference, wherein outside the patient's body, there is a matching "12 o'clock" mark on the proximal end of the wire. Most commonly, multiple other different radiopaque markers (such as those with different radiodensity, shape or orientation) may also be present at the tip of the wire (or the catheter in the aforementioned example). The relative position of the 12 o'clock mark relative to the lesion and / or branch orifice can thereby be determined on a rotational basis. Once the end marks and their relative rotation are observed, the appropriately oriented stent (loaded on a catheter having an inner lumen shape similar to and matching the outer surface of the wire, with the stent and optional ball balloon (on which the stent may be mounted) also curled down into a substantially similar shape) can then be loaded onto the back of the wire in the desired rotational orientation relative to the proximal 12 o'clock mark as described above, loaded onto the wire, and delivered to the target area, whereupon the stent or other device can be deployed and implanted. Likewise, if desired, a test device can optionally be deployed first and then recaptured to confirm the rotational position at the target lesion. These matching substantially non-circular wire and lumen configurations can be used for through-wire and rapid exchange configurations. In yet another example, the stent can be loaded into a catheter having an inner lumen substantially similar to and matching the wire, and the stent can then be delivered pre-loaded into the catheter and curled into a similar shape inside. This will be more commonly used for self-expanding stents. For many self-expanding stents using the wire-first approach, there may be an inner hypotube or catheter with the appropriate internal shape, the stent loaded outside of a section of the inner hypotube or catheter, and a second catheter or hypotube covering the stent. The inner hypotube or catheter would be loaded onto the wire, and once the stent is in the target location, the outer hypotube would be retracted to release the stent's external constraints and allow it to expand.

[0086] In another example, optimally suited for many bifurcation lesions, the delivery catheter may have multiple lumens. In one example for treating bifurcation stenosis, a substantially non-circular wire can first be introduced into one branch through the stenosis. A first stent can then be preloaded onto an appropriate balloon-mounted first catheter, having a fenestration that is optimally deployed at the origin of the second branch. The first lumen extending from the end port can be a full-length lumen extending from the distal end port to the proximal end port, or it can be a "quick-swap" configuration in which the main wire lumen extends from the end port to the proximal port. Another secondary lumen is used solely for inflating and deflating the balloon on the main catheter, where the fenestrated stent is mounted. In the currently described embodiment, the main catheter, stent, and balloon must all have fenestrations / distal ports on the same overlapping sides and segments. The distal port serves as the port for another tertiary lumen outside the patient's body, which extends proximally along the entire intravascular course of the balloon inflation lumen and branches proximally from the balloon inflation lumen. In the through-the-wire configuration, there will be a third branch outside the patient's body; a proximal extension of the main lumen. In the preferred current embodiment in which the main lumen has a rapid exchange configuration from the end hole to the proximal hole, the current embodiment can sometimes work in relatively straight and non-tortuous anatomical structures, even using a circular lumen and a circular wire, because the second wire can be advanced into the side branch via the distal hole and into the proximal tertiary lumen via its distal end hole. In a straight anatomical structure, advancing the wire through the lumen, out of the distal hole, and into the side branch can often help to align the entire construction and the pre-installed main stent into the appropriate configuration with a fenestration at the side branch orifice. However, in most tortuous anatomical structures, the basic non-circular wire and lumen of the main lumen are necessary to properly preload the main lumen into the desired configuration, so the fenestration faces the orifice of the side branch. Multiple fenestrations for multiple side branch orifices are also possible. Additional radiopaque markers can mark the proximal and distal ends of the stent, as well as the proximal and distal ends of any fenestrations. In the currently preferred single-fenestration, rapid exchange, substantially non-circular wire and main lumen configuration, a second wire can be pushed into the side branch through a third lumen prior to inflation of the main balloon and deployment of the main stent. If desired, the main wire mounted on the delivery catheter can then be removed while leaving the second wire in place in the side branch. The main wire can remain in place or be removed. A second stent mounted on a second catheter can then be advanced over the second wire and into the branch orifice and can then be deployed at the branch orifice. If the second stent has a substantial gap that does not significantly impede blood flow, a typical round wire and second stent catheter system can be used to develop and deploy a "y" shaped stent system at the bifurcation.However, if it is necessary and / or desired to have an additional fenestration in the second stent covering the origin of the branching point of the main distal end branch, the second wire should also be a substantially non-circular wire and a corresponding second catheter with a corresponding non-circular lumen should be used to properly align the fenestration in the second fenestrated stent device.

[0087] Common methods

[0088] Using any of the above devices and methods, a fenestration can be accurately deployed at the starting point of the branch vessel. A wire can then be advanced through the fenestration and into the branch, and: (a) a balloon-expandable device / stent can be delivered over the wire and deployed so that the proximal end minimally overlaps the fenestration of the first stent / device; in addition, the branch can also optionally have a taper so that it is slightly larger on the side of the fenestration than the portion that extends into the branch vessel; (b) a second delivery catheter (or the first delivery catheter can be reused) can be delivered into the branch (optionally removing the wire) and additional stents can be delivered through the delivery catheter. Likewise, the branch can also optionally have a taper so that it is slightly larger on the side of the fenestration than the portion that extends into the branch vessel. Option (b) is currently the most common and preferred delivery method for this series of devices.

[0089] However, delivery method (b) has difficulties in accurately placing the proximal stent, particularly "woven" or "braided" stents, which may shorten significantly and unpredictably during deployment (compared to their crimped length in the delivery catheter).

[0090] Therefore, another option is a novel delivery device for such stents. In this embodiment, the novel delivery device can be loaded into a device / catheter similar to a "winged inner catheter" of a filter-tip TAVR (transcatheter aortic valve replacement) catheter. The "wings" provide external constraints for the preloaded self-expanding stent, while the inner hypotube attached to the "wings" has an appropriate substantially non-circular lumen to extend over a similarly shaped wire in the desired orientation. The stent is loaded on the outer hypotube, preferably of the same non-circular configuration. To deploy the stent from the proximal end to the distal end, the inner hypotube of the stent and its attached "wings" are advanced while the outer hypotube and the stent thereon are held in place, thereby first releasing the proximal portion of the self-expanding stent and, when partially deployed, still allowing the stent to be re-sheathed by reverse motion. When using the first wire configuration of the present invention described herein, the larger the diameter of the wire, the less likely it is to rotate in an undesirable manner during catheter delivery while being guided through the angular lumen 1 of the delivery catheter. Alternative embodiments may have additional anchors at the ends of the wire. Examples of such anchors may include coils, springs, multi-pronged wire ends, retrievable stents, and the like.

[0091] A single or multiple external wires are attached to the stent, ideally to both the proximal and distal ends of the stent in the preferred embodiment (this can be "through the wire" or most ideally "rapid exchange"), and once the first wire is advanced through the fenestration into the branch, the second stent / device is advanced over the wire to the desired location. The wire to which the stent is attached (or alternatively, the outer catheter) remains in place while the "winged inner catheter" is advanced, exposing the stent / unsheathing the stent from the proximal end first.

[0092] The present invention also discloses a desheathing device for a branch stent. More specifically, the present invention proposes a device that desheathes the proximal portion first. In the above, if the stent is attached by a wire, the wire can expand with the stent. If the stent is attached to the outer catheter distally (the outer catheter is outside the inner catheter, but still inside the stent; the wings are outside the stent), then if attached, it is necessary to wait until the entire stent is desheathed before the proximal end can be separated. However, in a self-expanding non-attached stent, the stent will automatically expand and separate in a directionally proximal to distal manner at the inner catheter, and its overlapping "wings" covering the stent are pushed forward, thereby gradually releasing the stent from the constraint of the "wings". Alternatively, if the stent is circumferentially attached proximally to the outer catheter and also has at least one additional wire attached to the distal segment of the stent (or an additional attachment attached to the outer catheter at the distal segment of the stent), the proximal attachment can be detached after the proximal segment of the stent is unsheathed to ensure proper orientation and position that overlaps the fenestration but does not significantly overlap / overlap the main vessel, and then the distal stent can be detached once the entire stent is deployed.

[0093] The stent is optimally attached only distally to the "outer catheter" in order to advance the system, the outer catheter being pushed, which pulls on the attached stent and pushes on the wings of the inner catheter (and subsequently the entire inner catheter in unison). Then, when the stent is correctly positioned, the second stent can be unsheathed by holding the outer catheter (with the attached stent) in place and then advancing the inner catheter and its attached "wings" (which first unsheathes the proximal stent using a self-expanding stent), the proximal stent automatically expanding as it is unsheathed. If the position is closed, the inner catheter can be pulled back again and the proximal stent can be resheathed in a distally partially or fully removable version, and the stent can be repositioned and then unsheathed again.

[0094] In another embodiment, once the substantially non-circular main wire is advanced, a quaternary catheter (with proximal and distal "12 o'clock" markings but no hub) having a corresponding substantially non-circular lumen and a similar outer surface shape may be advanced first to help fix the rotational position of the wire. The main wire and the quaternary catheter may then be used as a wire / guide to deliver the main catheter in the desired configuration, reducing the chance of unwanted rotation during delivery and / or deployment of the main stent.

[0095] Additionally, when using a "braided" or "woven" stent, full expansion can be slow and unpredictable, and the proximal end of the stent (and optionally other portions) can have one or more nitinol wire loops to promote more immediate opening / self-expansion to its maximum diameter or vessel diameter and maximize stent-vessel wall attachment. A similar longitudinal wire can also be optionally attached to facilitate smooth re-sheathing when needed.

[0096] More specifically, a preferred method may be described using embodiments of the device wherein the push wire comprises an angular shape that conforms to the angular lumen of the delivery catheter (e.g., a triangular push wire and triangular lumen):

[0097] (a) inserting the delivery catheter into the body,

[0098] (b) advancing the proximal end of the delivery catheter over any main wire until the distal end of the delivery catheter is proximal to the target aneurysm,

[0099] (c) removing the main wire,

[0100] (d) orienting the packaged catheter with the internally formed push wire and the preloaded stent in a set orientation relative to the port of the hub to set the orientation of the stent relative to the target aneurysm,

[0101] (e) inserting the encapsulated catheter into the port of the hub,

[0102] (f) attaching the hub to the proximal end of the delivery catheter,

[0103] (g) pushing the push wire with the stent from the packaging catheter into the delivery catheter until the stent is proximal to the target aneurysm,

[0104] (h) partially withdrawing the delivery catheter while maintaining or advancing the push wire until the stent is fully exposed,

[0105] (i) deploying the differentiated porous occlusion device,

[0106] (j) extracting the push wire, and

[0107] (k) Withdrawing the delivery catheter.

[0108] Bifurcation Stent or Y-Shaped Stent - Using the aforementioned procedure, a "Y" shaped stent can be assembled in vivo from two stents using reference markings. In the above example, once the first fenestration occlusion device is deployed, the second delivery catheter or optionally the first delivery catheter can be reused and can be advanced over any wire, through the proximal stent, through the fenestration, and into the side branch. Another second stent closure device can then be deployed. The second stent closure device may not have a fenestration and be positioned to minimally overlap the edge of the fenestration of the first stent closure device at the proximal end of the deployed second stent closure device; or alternatively, the second fenestration device can be deployed in a manner similar to the first fenestration device to construct a "Y" shaped configuration, with the above method being used to ensure that the second fenestration (on the second stent) properly overlaps the orifice of the main vessel branch.

[0109] The present invention may utilize self-expanding components.

[0110] The present invention may employ a balloon expandable component.

[0111] The present invention may optionally include radiopaque components and / or radiopaque markers. These are particularly valuable at the ends of the stent and at the ends of covered or less porous areas, or for defining fenestrations. Radiopaque materials and markers may also optionally be present in more locations, sometimes even the entire area.

[0112] The present invention may have branched stent elements.

[0113] The stent elements of the present invention may optionally be fully resheathable.

[0114] The stent elements of the present invention may optionally be partially resheathable.

[0115] All stent elements of the present invention may optionally be detachable.

[0116] The above content can also be applied to various endoscopic surgeries.

[0117] Additionally, it should be noted that in preferred embodiments, the stent is cylindrical when fully expanded and curled down into a triangular (or other) shape, however, in some embodiments, the stent itself is triangular (or other shape), but most vessels are cylindrical.

[0118] The present invention can be used to similarly introduce other devices, such as undulating mesh balloons, to fill out an outward appearance in their preferred orientation. One of the many examples of such an outward appearance is a vascular aneurysm. In some embodiments, this can allow for custom implants to be manufactured to conform to the contours of a specific lesion, and subsequently for accurate orientation of the device for delivery and deployment.

[0119] The system of the present invention can also be used to deliver coated devices. Some examples of the many coatings that can be used include lubricating compounds, adhesive compounds, hydrogels, drugs, chemotherapeutic agents, cells, proteins, combinations of these coatings, and the like. The coating can be on an interior surface, an exterior surface, a gap, or a combination thereof.

[0120] The current system can also be further combined with the multi-circumferential balloon catheter previously described by Walzman (US 2020 / 10,543,015) to obtain additional precision in positioning the tip of the delivery catheter in the desired radial position of the blood vessel, aneurysm or aneurysm neck, thereby achieving optimal safety and accuracy of device delivery.

[0121] It will be appreciated by those skilled in the art that the above specific embodiments are shown and described by way of illustration only. The principles and features of the present disclosure may be used in various and multiple embodiments thereof without departing from the scope and spirit of the present disclosure as claimed. The above embodiments illustrate the scope of the present disclosure but do not limit the scope of the present disclosure.

Claims

1. An intravascular device, characterized in that The intravascular device comprises: (a) A delivery catheter having a proximal end, a distal end, a fixed non-circular lumen, a proximal hub with a "12 o'clock" marking, a corresponding "12 o'clock" marking at its distal end, the delivery catheter being capable of: (i) Move within the blood vessel to the target lesion, (ii) stopping proximal to the target lesion, and (iii) withdrawing from said blood vessel, (b) a packaging catheter having the same fixed non-circular lumen as the delivery catheter, a push wire having a proximal end, a distal end, and an occluding device releasably disposed on the distal end of the push wire, the occluding device being preloaded into the packaging catheter in a fixed circumferential orientation with corresponding markings on the outside of the packaging catheter, (c) the distal end of the fixed non-circular lumen of the packaging catheter is disposed within the interior of the hub, the fixed non-circular lumen of the delivery catheter is shaped to engage the fixed non-circular lumen of the packaging catheter, and the hub receives the outside of the distal end of the packaging catheter in one of at least two different fixed circumferential orientations, the distal end of the fixed non-circular lumen of the packaging catheter being adapted to deliver the distal end of the push wire into the proximal end of the fixed non-circular lumen of the delivery catheter, (d) the push wire comprises an outer shape that is identical to the inner shape of the fixed non-circular lumen of the packaging catheter and the fixed non-circular lumen of the delivery catheter, but having a smaller diameter, so as to enable the occluding device loaded thereon to slidably pass through the angular lumen, so that the push wire substantially maintains the circumferential orientation relative to the delivery catheter during movement of the distal end of the push wire through the blood vessel to the target aneurysm, (e) the packaging catheter is further capable of being rotated prior to engagement with the proximal port of the delivery catheter such that the push wire and the occlusion device therein are simultaneously rotated by the same amount, whereupon the push wire and the occlusion device can be advanced into the delivery catheter into a predicted circumferential orientation of the occlusion device and maintain said circumferential orientation as they are advanced through the delivery catheter and as the delivery catheter is withdrawn, wherein the amount of rotation is determined by a "12 o'clock" marking on the proximal hub and a corresponding "12 o'clock" marking on the delivery catheter at its distal end.

2. The device according to claim 1, characterized in that The occluding device is a stent.

3. The device according to claim 2, characterized in that The scaffold is differentially porous.

4. The device according to claim 3, characterized in that The bracket includes at least one window.

5. The device according to claim 4, characterized in that The scaffold comprises at least one fluid-impermeable region.

6. The device according to claim 2, characterized in that The scaffold comprises at least one fluid-impermeable region.

7. The device according to claim 2, characterized in that The device further comprises at least one adhesion compound.

8. The device according to claim 1, characterized in that The occlusive device is an asymmetrically shaped disc having at least one adhesive coil wire.

9. The device according to claim 2, characterized in that The device further comprises a lubricating surface coating.

10. The device according to claim 1, characterized in that The occluding device is an asymmetrical disc.

11. The device according to claim 10, characterized in that The pushing wire is a hypotube.

12. The device according to claim 10, characterized in that The device further comprises at least one adhesion compound.

13. The device according to claim 12, characterized in that At least one of the adhesion compounds is a hydrogel.

14. The device according to claim 1, wherein The occluding device is a mesh bag.

15. The device according to claim 14, characterized in that The device further comprises at least one adhesion compound.

16. The device according to claim 15, characterized in that At least one of the adhesion compounds is a hydrogel.

17. The device according to claim 1, characterized in that The delivery catheter includes at least one radiopaque marker along an intravascular segment of the delivery catheter.

18. The device according to claim 17, characterized in that At least one radiopaque marker is a 12 o'clock marking on the distal end of the delivery catheter.

19. The device according to claim 1, characterized in that The occluding device has at least one radiopaque marker along the push wire.

20. The device according to claim 1, wherein The occluding device comprises at least one radiopaque marker.

21. The device according to claim 1, characterized in that The push wire includes an angular shape that conforms to the angular lumen of the delivery catheter.

22. The device according to claim 1, characterized in that The fixed non-circular lumen and the push wire of the delivery catheter are non-angular.

23. The device according to claim 8, characterized in that The pushing wire is a hypotube.

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