Directable intracranial occlusion device and method

Abstract

The present invention provides a method and apparatus for correctly orienting an intracranial occlusion device, such as a stent having differential porosity, relative to a desired area with greater or lesser blood flow (e.g., a branch vessel and an aneurysm, respectively), the apparatus being particularly useful for treating aneurysms in the intracranial or other tortuous vasculature. An intravascular device is also provided, comprising a delivery catheter having a hub and an angular lumen, the angular lumen being capable of constraining a push wire within a packaging catheter to deploy the stent in a direction wherein the area with the smallest porosity is adjacent to the aneurysm, and the area with the largest porosity allows blood to flow to the branch or other vessels. The present invention also provides a method of using the intravascular device.

Description

[0001] This application is a continuation-in-part (CIP) claiming priority to utility patent applications: 15 / 341,820 filed on 11 / 02 / 16 (November 2, 2016) for Flow-Diverting Covered Stent (now U.S. Patent No. 9,775,730 Bl, issued on October 3, 2017); and 12 / 09 / 18 (December 9, 2018) for Caped Stent (capped stent) application serial number is CIP 16 / 214,130, which is a CIP claiming priority benefit of application serial numbers 15 / 732,544 filed on 11 / 22 / 17 (November 22, 2017) and 06 / 25 / 19 (June 25, 2019), filed provisional serial number 62 / 921574 and 12 / 05 / 16 (December 5, 2016), filed provisional serial number 62 / 497,851, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure relates to medical devices for treating aneurysms and fistulas within unhealthy blood vessels, and more particularly to intravascular devices, including blood flow diverting stents, covered stents, capped stents, fenestrated stents, branched stents, and other variable porosity stents for use in intracranial or other tortuous vasculature. Background Art

[0003] The prior art proposes the use of a variety of devices to treat aneurysms. One such device is a differentiated porous stent having an asymmetric braid or coil to create areas of less or more blood flow as desired. Fenestrating devices and branching devices have been used effectively 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 intracranial and in other tortuous and distal vasculature, no device or method has been described that can reliably deploy such devices in their desired radial orientation. To date, the limitations of the intracranial or other tortuous vasculature have precluded the use of such devices in these areas.

[0004] U.S. Patent 9,775,730 B (Walzman) proposes a covered stent device that can be safely and effectively delivered and deployed into tortuous blood vessels to effectively divert blood flow away from aneurysms, fistulas or ruptured blood vessels while allowing blood to flow to healthy tissue distal to the target treatment area, but still causing blood stasis and thrombosis within the aneurysm or fistula.

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

[0006] U.S. Patent 8,398,701 B2 (Berez et al.) proposes a vascular occlusion device that can be deployed via a microcatheter. The occlusion device includes an asymmetric braid or differentiated mesh density, and a corresponding / opposite variable porosity density to change blood flow in a blood vessel away from lesions such as an aneurysm 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 a lower coverage on one side relative to the other side of the same section along the length of the cylinder. For example, an area with less 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 blood vessel or cover the branch to allow blood flow to continue to be sufficient and prevent blood flow to the branch and its distal tissue from being blocked. 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. In extreme embodiments, this can be combined with a full cover on or near the opposite side to completely cut off blood flow to the target aneurysm or fistula.

[0008] A common vascular difficulty is persistent blood flow outside the endovascular graft in the aneurysm sac. In fact, this is the most common complication after endovascular aneurysm repair using a stent graft. Such endoleaks can be improved by a variety of methods. 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 intravascular 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, intravascular 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. The placement of a stent in the parent artery requires long-term use of antiplatelet drugs to reduce the risk of thrombotic stenosis within the stent.

[0010] Some aneurysms and fistulas are ideally treated with a covered stent, which would 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. However, no covered nerve stents are currently available in the United States. Such covered nerve stents have been examined and tested by the U.S. Food and Drug Administration (FDA), but the covered nerve stents are not "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 severe tortuous anatomy elsewhere in the body, including but not limited to splenic artery aneurysms and pulmonary arteriovenous fistulas.

[0011] An important potential use of covered neural 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 that it requires open surgery and physical manipulation of the brain. Surgical bypass is also sometimes considered, but is usually associated with higher morbidity and mortality.

[0013] In addition, the prior art proposes to use blood flow diverting devices to divert blood flow away from the aneurysm by placing a mesh stent or stent-like structure along the parent artery on the neck of the aneurysm. The use of these devices allows thrombosis to form within the aneurysm. However, after the blood flow diverter is deployed, the technical complexity may increase.

[0014] In addition, because they cannot completely block blood flow, they are generally not effective in treating fistulas and ruptured blood vessels. Similarly, there is currently no effective vascular preservation treatment for iatrogenic rupture of intracranial arteries. Current treatments typically require the use of coils and / or liquid embolic agents to seal the ruptured artery to stop bleeding, often resulting in significant morbidity due to ischemic damage to the arterial region. In addition, when treating aneurysms with these devices, the aneurysm will thrombose over time, which is a lag period, and will not heal immediately. This puts the patient at risk of aneurysm rupture during the lag period. This is particularly problematic when treating ruptured aneurysms because ruptured aneurysms have a high short-term re-rupture rate. In addition, when using current blood flow diverting stents, many branch vessels often cross the device, often leading to stenosis at the beginning of these branches, and sometimes 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 bend freely without kinking around sharp bends in tortuous anatomy.

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

[0017] All currently available blood flow diverting stents have a relatively uniform coverage pattern and porosity throughout. Reliable methods have not yet been developed to successfully deploy devices 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 a differentiated multi-porous device 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 anatomy are not susceptible to manual rotation of the hub end, resulting in rotation of the intracranial end.

[0019] Therefore, there is a need for a device that can be reproducibly positioned / placed in the proper orientation such that areas with dense coverage and corresponding low porosity (or completely impermeable in extreme cases) are deployed on the desired side, while areas with low-density coverage and corresponding high porosity (and / or fenestrations with no coverage at all in extreme cases) are deployed on the desired side. Additionally, there is a need for branched coatings and blood flow diverting devices in distal and tortuous vasculature. Currently, such devices are not available for use in neuroendovascular procedures, and similarly are not available 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] Therefore, if such a device is deployed, the final orientation when positioned will be random. For example, for the situation just described, the exact opposite of the ideal situation may occur. That is, the fenestration may end up covering the aneurysm, thereby increasing blood flow to the lesion, while the area with high-density coverage may cover the origin of a normal branching vessel, resulting in insufficient blood flow to the branch and subsequent ischemic injury.

[0021] Likewise, using the extreme example of the fenestration pattern of the present invention, a branching device can also be constructed in vivo by deploying a fenestration device with a fenestration at the beginning of the 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 a slight overlap without covering the main distal end branch / vessel.

[0022] Similarly, devices containing multiple branches can be constructed with multiple fenestrations, provided that all fenestrations are at appropriate relative distances and orientations relative to the native branches.

[0023] Ruiz describes this concept well in U.S. Patent 6,261,273 B1 for Access System for Branched Vessels and Methods of Use. However, Ruiz discloses constructing a directional sheath or catheter in vivo rather than an implant. However, similar to the Berez device, the Ruiz device works easily in short distances of 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 cause difficulties when a stent device (usually crimped for delivery) is advanced into a delivery catheter in a specific arrangement, typically using a delivery wire and / or hypotube. The stent will leave the delivery catheter in an unpredictable arrangement or orientation.

[0025] In addition, to date, it is impractical to deploy or assemble "Y" shaped blood flow diverting stents at branches in intracranial or other tortuous vascular anatomies. These stents with relatively low porosity have difficulty passing through branches and adversely affecting the flow to the crossing branches. In addition, such devices cannot usually be crossed with other wires, microcatheters and / or stents because the pores are not large enough. Y-shaped stents, bifurcated stents or other branch stent devices that can be effectively deployed or assembled in such anatomical structures are needed. In addition, in order to safely deploy such branches in unsafe and inaccurate situations, and only slightly overlap the fenestrations, novel devices and methods are needed to more accurately place the proximal ends of such stent devices.

[0026] Therefore, there is a need for a coated or partially coated neural stent that can be used in other tortuous anatomical structures inside the skull or outside the brain, and the more porous and less porous regions of the device can be positioned relative to one or more branch vessels and at least one aneurysm or fistula as needed. In addition, there is a need for similar coated or partially coated branch devices. The present invention meets these unmet needs. Summary of the invention

[0027] The present invention discloses embodiments that may include a hypotube rather than a solid wire to pass through a stenosis and serve as a track for subsequent delivery of an angioplasty balloon and stent. Such a hypotube may also be capable of delivering fluid therethrough to reduce the sump effect of flow reversal on the brain while maintaining retrograde flow sufficient to overcome external carotid artery blood flow and maintain retrograde flow through the lesion during at least one of angioplasty and stenting.

[0028] The present invention also discloses a method and apparatus for properly orienting an intracranial occlusive device, such as a stent with differential porosity, relative to a desired area with greater or lesser blood flow (e.g., a branch vessel and an aneurysm, respectively). The present invention is particularly useful for treating aneurysms and fistulas in the intracranial or other tortuous vasculature.

[0029] This desired orientation is difficult to achieve due to several factors. The lumen of the delivery catheter, through which the stent is deployed, is typically circular. Therefore, during deployment, the stent often rotates within the lumen in an unpredictable manner. In addition, 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 of the device 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 methods are disclosed to overcome this difficulty.

[0030] A differentiated porous stent or such braided, mesh or woven therapeutic device can be oriented to a desired degree of flow or obstruction.

[0031] Optionally a stent with a free floating cover. The floating cover is designed to optimize insertion in 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 devices may 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 desheathing thereof.

[0033] In other embodiments, the covering may not completely surround a given segment of the framework, thus allowing some stents to be covered along a portion of their circumference while being uncovered on a different circumferential side of the same segment. This may sometimes allow the preservation of the origin of a branch vessel that may originate from a parent vessel along the same segment of the parent vessel; for example, as opposed to a fistula or aneurysm neck.

[0034] The present invention further discloses an apparatus and method for more accurately positioning the proximal end of a stent, so that if a window hole in a first stent is placed at the starting point of a branch, a second stent can be accurately placed so that the most proximal segment of the second stent only slightly overlaps with the first stent around the window hole, thereby avoiding leakage between the two stents while also avoiding unnecessary obstruction of the main blood vessel by the proximal end of the second stent.

[0035] A more accurate "placement" of the proximal end of the stent can be achieved using the unique device and method described herein. An inner "unsheathed" hypotube or wire is described, which has a reverse tapered "wing" at its distal end, which can return and cover the stent. The stent can be mounted at the distal end of the outer hypotube. The inner hypotube or wire passes through the outer hypotube, and its wings extend backward over the distal end of the outer hypotube and over the stent mounted thereon, and constrain the stent, which is generally self-expanding. Once the stent is in the desired position, the outer hypotube can remain in place while the inner hypotube or wire is advanced. As the inner hypotube or wire is advanced, its rear wing is also advanced and releases its constraint from the stent in a proximal to distal manner. Therefore, the proximal stent is first released from its constraint and expanded 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 again. The stent can then be repositioned and deployment can be resumed again.

[0036] Some embodiments may incorporate a hypotube rather than a solid wire to pass through the stenosis and serve as a track for subsequent delivery of angioplasty balloons and stents. Such a hypotube may also be capable of delivering fluid therethrough to reduce the fluid collection effect of flow reversal on the brain while maintaining retrograde flow sufficient to overcome external carotid artery blood flow and maintain retrograde flow through the lesion during at least one of angioplasty and stenting.

[0037] Additionally, in some embodiments, flushing can be performed through the angioplasty balloon and / or its delivery catheter. Additionally, in some embodiments, an additional balloon mounted on the angioplasty balloon catheter and / or wire or hypotube, or a separate balloon, can be used to distally occlude the carotid artery during part of the procedure to prevent distal embolism while minimizing the accumulation of flow from the brain. Flow reversal can then be applied for a shorter duration during and after balloon deflation.

[0038] Additionally, in some embodiments, a series of angioplasty balloons and / or stents and their delivery catheters may be delivered sequentially, one above the other, and before the other, to minimize the number of device changes required, thereby reducing procedure time and associated risks.

[0039] The present invention also discloses an implementation scheme of the above branched stent form.

[0040] Additional embodiments may include a Y-configured stent in which a first stent has increased porosity with larger pores at the origin of a branch vessel, and a second stent that crosses the larger pores at the origin of the branch vessel has increased porosity where it crosses the main vessel where the main stent is placed. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1A A perspective view of a cylindrical delivery catheter 330 having a triangular shaped lumen 1 is shown.

[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 and having passed through a blood vessel 1000 such that the distal end hole 2 is located proximal to a target aneurysm 2000 .

[0043] Figure 1C is a cross-sectional view of a delivery catheter lumen 3 having a triangular lumen with angles ABC and a push wire 300 passing therethrough at an offset CAB angle to deliver a differentiated porous occlusive device (not shown) at a 120° angle for deployment in a desired orientation.

[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, the packaging catheter hub port 701 (showing the push wire 300 passing therethrough), and further showing the push wire 300 (extending through the delivery catheter lumen 3 in dashed lines) continuing through the delivery catheter lumen 3, the distal end 303 of the push wire 300 being releasably attached to the stent 301 proximal to the target aneurysm 2000. The distal end 20 of the stent packaging catheter 30 is disposed inside the hub port 701, the delivery catheter lumen 3 (oriented to have a triangular proximal end hole 1, 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.

[0045] Figure 3 The removal of the delivery catheter lumen 3 ( Figure 2 ) is then disposed at the push wire 300 and the stent 301 at the distal end 303 of the push wire within the vessel wall 1000.

[0046] Figure 4 An internal view of a delivery catheter lumen 3 having a triangular shape is shown, which is composed of proximal sides 4, 5 and 6 corresponding to distal side 44 ( Figure 5 44 shows the inclined distal side 55 and 66 behind 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 shapes, such as rectangular or star shapes.

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

[0048] Figure 6 Stent 301 is shown attached to push wire 300 at the distal end 303 of push wire 300 and the proximal end of stent 301. The stent 301 is triangular in shape, with the distal end 3010 and the triangular edges on a plane with the distal end 303 (i.e., edges 334, 355, and 366). At the distal end 3010 of stent 301, the triangular edge 3550 shown in dashed lines discloses two other triangular edges 3440 and 3660. The triangular edge 335 forms a plane length that terminates at edge 3550. On the plane, there is a radiopaque marker 55500.

[0049] Fig. 7A and Figure 7B The geometry of the delivery catheter lumen 3 is shown with the relative positions of the radiopaque markers.

[0050] Figure 8 One geometry of the push wire is shown;

[0051] Fig. 9 An encapsulated catheter is shown.

[0052] Fig.10 Options for packaging the catheter are shown.

[0053] Fig.11 and Fig.12 The positions of the radiopaque markers relative to each other are shown.

[0054] Fig.13 and Fig.14 An optional embodiment of a reverse desheathing stent is shown. DETAILED DESCRIPTION

[0055] Embodiments of the device and device variants of the invention are explained with reference to the above-mentioned figures.

[0056] refer to Figure 1A , showing 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 rectangle, star, hexagon, etc. The linear lumen is designed to allow a second push wire having a similar shape, which is suitable for insertion into the lumen 1 at a different, fixed relative position.

[0057] Reference now 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 located 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.

[0058] Reference now 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 occlusion device (not shown) at a 120° angle for deployment in a desired orientation. The present invention proposes 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 before inserting the push wire 300) 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 rotating the push wire 300 in the patient's body. The present disclosure includes the basic concept of an inner lumen with a non-circular geometry and a matching push wire or sea wave tube. This allows the user to avoid unwanted rotation of the device within the delivery catheter and within the blood vessel. It also allows delivery along a predictable radial orientation, using the markers at the hub and the corresponding radial markers at the tip of the delivery catheter, so that when the orientation of the delivery catheter tip is imaged after intracranial positioning or positioning in a similar tortuous anatomical structure, the degree of torsion (if any) relative to the corresponding hub marker and relative to the target lesion can be measured. Then, the stent device can be inserted with appropriate orientation relative to the hub marker, so that the desired orientation is delivered to the target vessel. For example, if the hub marker is located at the 12 o'clock position and the tip marker is located at the 4 o'clock position, the device / stent can be inserted because it is known that any porosity inserted at the hub at the 12 o'clock position will be consistently delivered through the catheter tip at the 4 o'clock position. Similarly, the stent device can be preloaded in a packaged catheter with similar geometry and similar 12 o'clock markings (or similar markings) relative to various radial circumferential orientations at the 12 o'clock position. Then, according to the desired orientation, the appropriate preloaded device can be selected and utilized. Alternatively, these devices can all be preloaded with the same orientation, and the packaging catheter can be rotated at different angles relative to the delivery catheter and its hub, so as to achieve the desired orientation of the stent device when the stent device is transferred from the packaging catheter to the delivery catheter. As is well known in the prior art, the packaging catheter is usually shorter than the delivery wire or delivery hypotube. The stent is preloaded on the delivery wire or hypotube in the packaging catheter. Then, the transfer of the stent device is achieved by matching the packaging catheter with the delivery catheter in the hub of the delivery catheter and then advancing / pushing the rear of the wire / hypotube extending from the rear of the packaging catheter. The wire / hypotube is advanced together with the stent mounted thereon, at least until the stent is completely in the delivery catheter, and the most common situation is until the majority of the push wire / hypotube is also advanced. The packaging catheter is removed from the remainder of the hypotube / wire, and the operator continues to push the hypotube / wire until the stent reaches the end of the delivery catheter. The stent can then be deployed by pushing the stent out, retracting the delivery catheter to unsheath it, and / or a combination of these.In addition, in a preferred embodiment, the push wire / hypotube, the encapsulated catheter, and the delivery catheter have matching geometries, wherein the encapsulated catheter and the delivery catheter (excluding the hub) have similar internal dimensions; the wire / hypotube fits tightly but slidably into the encapsulated catheter and the delivery catheter tube, fitting in a locking manner so that it can be advanced within the catheter but cannot rotate within the catheter. For example, in one embodiment, the push wire / hypotube has an outer triangular cross-sectional shape that fits into the inner triangular encapsulated catheter and the delivery catheter.

[0059] Reference now 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, a packaging catheter hub port 701 (showing a push wire 300 passing therethrough), further showing the push wire 300 (which extends through the delivery catheter lumen 3 in dashed lines and continues through the delivery catheter lumen 3), the distal end 303 of the push wire 300 being releasably attached to the stent 301 proximal to the target aneurysm 2000. The distal end 20 of the stent packaging catheter 30 is disposed inside the hub port 701, the delivery catheter lumen 3 (oriented to have a triangular proximal end hole 1, 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.

[0060] The packaging catheter 30 is coupled to the hub 700 at the port 701 so that the stent 301 and 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 .

[0061] Reference now Figure 3 , showing the removal of the delivery catheter lumen 3 ( Figure 2 1000 and stent 301 at the distal end 303 of the push wire are then disposed within the vessel wall 1000. Once the stent 301 is proximally placed next to the aneurysm 2000, the stent 301 is activated and expanded so that the substantially non-porous side of the stent 301 abuts the aneurysm 2000, while the other two sides of the triangular elongated stent 301 are porous to promote blood flow. In addition, the present invention discloses a single "12 o'clock" mark on the hub, as well as a single non-radiopaque "12 o'clock" mark on the distal catheter tip.

[0062] Reference now Figure 4 , showing an internal view of a delivery catheter lumen 3 having a triangular shape, the delivery catheter lumen consisting of proximal sides 4, 5 and 6 corresponding to distal side 44 ( Figure 544 shows the inclined distal side 55 and 66 behind 44); the facing side 444 shows the full length of the catheter side starting from the proximal side 4 and ending at the distal side 44.

[0063] The lumen orientation of the delivery catheter lumen 3 must be clearly discernible. Figure 4 A 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 regular shapes, such as a rectangular or star shape.

[0064] Reference now Figure 5 , showing Figure 4 The adjacent surface 555 of the interior of the delivery catheter (or Figure 4 Rotated 120 degrees once), the facing side 555 begins at the proximal side 5 and ends at the distal side 55 (the angled distal sides 44 and 66 behind 55 are shown in phantom cutaway); the facing side 555 further includes a radiopaque orientation aid marker 5550. Figure 5 yes Figure 4 , which shows the relative plane 555 terminating at the side end 5 on the proximal end and 55 on the distal end. On the surface of 555, the radiopaque orientation aid marker 5550 allows 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.

[0065] Reference now Figure 6 , shows a stent 301 attached to a push wire 300 at the distal end 303 of the push wire 300 and the proximal end of the stent 301. The stent 301 is triangular in shape, with the distal end 3010 and the triangular edges on a plane with the distal end 303 (i.e., edges 334, 355, and 366). At the distal end 3010 of the stent 301, the triangular edge 3550 shown in dashed lines discloses two other triangular edges 3440 and 3660. The triangular edge 335 forms a plane length that terminates at the edge 3550. On the plane, there is a radiopaque marker 55500.

[0066] The first method.

[0067] A delivery catheter with a "12 o'clock" mark at the proximal hub of the catheter is used. The 12 o'clock mark can be provided on the hub and the delivery catheter tip (i.e., the radiopaque on the catheter tip). The user inserts the stent encapsulating catheter with the differentiated porous stent or occlusion device mounted on the push wire. After testing, the user rotates the encapsulating catheter at the hub to the desired indicator.

[0068] The indicator may be located anywhere on the hub to point in any direction on the hub, but referring to it as a 12 o'clock indicator or marking facilitates description of the position relative to the marking by anyone familiar with an analog clock face. 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). The same effect can be achieved by referencing the "North" marking 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 over a 360° range of relative orientation, rather than the terminology used, is important.

[0069] Use the packaged catheter with distal markings to advance the test stent or final stent in a specific orientation relative to the 12 o'clock mark on the delivery catheter. The stent (or other marked intravascular device) usually ends with a substantially similar but unpredictable orientation. The process can be repeated to verify that the markings on the delivery catheter and the packaged catheter are consistently aligned. Then, the markings on the test stent / device are 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. Alternatively, use a stent preloaded in the delivery catheter in the desired orientation relative to the "12 o'clock" mark.

[0070] Optionally, an additional test stent / device temporarily advanced in the predicted orientation may be used to confirm the orientation, and then imaging may be performed to confirm the orientation before the test device is removed and the permanent device is advanced and deployed.

[0071] By way of example, the test results show that the fenestration is deployed at "7 o'clock", which is 90° clockwise relative to the target branch vessel. The treatment will then reorient the stent encapsulating catheter at "4 o'clock" so that it appears properly oriented proximal to the target branch.

[0072] 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.

[0073] Second method

[0074] A second method is disclosed that uses the steps and markings of the first method described above and, in addition, uses a delivery catheter having a lumen having a unique geometry throughout its cross-section. In a typical embodiment, the 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 a deployed stent encapsulating catheter or wire to rotate, thereby enhancing the predictability of orientation.

[0075] The accompanying drawings show a triangular lumen by way of example. Alternatively, a square, hexagon, octagon, pentagon, "house" outline or star shape. Any type of star shape may be used, such as a 6-pointed star, a "Star of David" star or other star shape or other geometric shape, as long as a single star shape is used throughout the lumen.

[0076] In another embodiment, the shape 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 . This embodiment is constructed so that the corresponding shapes of the packaging catheter and delivery wire / 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 appropriate and desired orientation.

[0077] Also here, 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 with the proper orientation relative to a similarly positioned hub marker can be used. Again, if desired, a "test" device / stent with additional radiopaque markers can be recoverably deployed to confirm orientation. When the tip marker orientation can be well imaged after intracranial delivery, or delivery into a similar tortuous vasculature, the tip marker orientation and its relative deflection on a rotational basis relative to the hub marker is most commonly used to determine rotational direction without the need for an optional recoverable test stent device.

[0078] Common methods

[0079] Using any of the above devices and methods, a fenestration can be accurately deployed at the beginning of a 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 extending into the branch vessel; (b) a second delivery catheter (or the first delivery catheter can be reused) can be delivered into the branch (the wire can be optionally removed) and additional branch stents (most commonly self-expanding) can be delivered through the delivery catheter. Similarly, the branch stent can also optionally have a taper so that it is slightly larger on the side of the fenestration than the portion extending into the branch vessel.

[0080] However, delivery method (b) has difficulty accurately placing proximal stents, particularly "woven" or "braided" stents, which may shorten significantly and unpredictably during deployment (compared to their crimped length in the delivery catheter).

[0081] 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, or in other words, a "central tube" and a "retention structure connected to the distal end of the central tube and extending in a direction from the distal end to the proximal end of the central tube" as described and patented by Walzman (US1030724262). The "wings" provide correct directional fixation while being guided through the angular lumen 1 of the delivery catheter. A single or multiple external wires are attached to the stent, in a preferred embodiment ideally to the proximal and distal ends of the stent (which can be "through the wire" or most ideally "rapid exchange"), once the first stent is deployed with the fenestration covering the branch vessel origin, a second wire is advanced through the fenestration into the branch and a second stent / device is advanced over the wire to the desired location, the second stent / device being constrained within the retention structure for delivery and having at least one second wire of the stent attached to the outside of the central tube and / or an outer tube attached to the stent. The wire to which the stent is attached (or alternatively, the outer catheter) is held in place while the "winged inner catheter" is advanced, exposing the stent / unsheathing the stent first from the proximal end.

[0082] The present invention also discloses a desheathing device for a branch stent. More specifically, the present invention proposes a device that first desheathes the proximal portion. In the above, if the stent is attached by a wire, the wire can expand with the stent. If the stent is attached to an outer catheter (the outer catheter is outside the inner catheter, but still inside the stent; the wing is outside the stent), it is necessary to wait until the entire stent is desheathed before the proximal end can be separated. Alternatively, if the stent is attached to the outer catheter circumferentially toward the proximal side 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 separated after the proximal segment of the stent is desheathed to ensure proper orientation and position that minimally overlaps the fenestration but does not significantly overlap / cover the main vessel, and then once the entire stent is deployed, the distal stent can be separated.

[0083] The stent is optimally attached only distally to the "outer catheter" in order to advance the system, the outer catheter is pushed, which pulls the attached stent and pushes the wing portion of the inner catheter (and then the entire inner catheter is pushed 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 (which unsheathes the proximal stent first). With a self-expanding stent, the proximal stent automatically expands as it is unsheathed. If the position is off, the inner catheter can be pulled back again and the proximal stent can be re-sheathed, and the stent can be repositioned and then unsheathed again.

[0084] Additionally, when using a "braided" or "woven" stent, full expansion may be slow and unpredictable, and the proximal end of the stent (and optionally other portions) may have a nitinol wire loop to facilitate more immediate opening / self-expansion to its maximum diameter. A similar longitudinal wire may also be optionally attached to facilitate smooth re-sheathing when necessary. Such loops may optionally be repeated at additional intervals along the stent device.

[0085] More specifically, a preferred method may be described using an embodiment 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):

[0086] (a) inserting the delivery catheter into the body,

[0087] (b) advancing the proximal end of the delivery catheter over a delivery wire until the distal end of the delivery catheter is proximal to a target aneurysm,

[0088] (c) removing the delivery wire,

[0089] (d) imaging the orientation of the distal end radial marker relative to the target aneurysm,

[0090] (e) orienting the packaged catheter relative to a 12 o'clock hub mark so as to optimize the orientation of the stent relative to the target aneurysm,

[0091] (f) inserting the packaged catheter into the hub,

[0092] (g) pushing the pushing wire until the stent is completely located in the delivery catheter,

[0093] (h) removing the encapsulated catheter,

[0094] (i) pushing the pushing wire until the stent is proximal to the target aneurysm,

[0095] (j) deploying a majority of the differentiated porous occlusion device,

[0096] (k) repeat imaging to confirm intended device orientation,

[0097] (l) fully deploying the remainder of the differentiated porous occluding device, and

[0098] (m) withdrawing the push wire and the delivery catheter.

[0099] Bifurcated stent or V-shaped stent

[0100] Using the aforementioned procedure, a "Y"-shaped stent can be assembled in vivo from two stents by referencing the markers.

[0101] The present invention may employ self-expanding components.

[0102] The present invention may employ a balloon expandable component.

[0103] The present invention may optionally include radiopaque components and / or radiopaque markers. These radiopaque components and / or radiopaque markers are particularly valuable at the ends of the stent and at the ends and edges of the coating area. Radiopaque materials and markers may also be optionally present in more places, sometimes even the entire area.

[0104] The present invention may have branched support elements.

[0105] The stent elements of the present invention may optionally be fully resheathable.

[0106] The stent elements of the present invention may optionally be partially resheathable.

[0107] All stent elements of the present invention may optionally be detachable.

[0108] Those skilled in the art will appreciate that the above specific embodiments are shown and described only by way of illustration. Without departing from the scope and spirit of the disclosure claimed, the principles and features of the present disclosure may be used in its various and multiple embodiments. The above embodiments illustrate the scope of the disclosure, but do not limit the scope of the disclosure.

Claims

1. An intravascular device, characterized in that: The intravascular device comprises: (a) A delivery catheter having a proximal end, a distal end, and an angular lumen, wherein the delivery catheter is capable of: (i) move within the blood vessel to the target aneurysm, (ii) stopping proximal to the target aneurysm and withdrawing from the blood vessel, (b) packaging a catheter, a push wire having a proximal end, a distal end, and a differentiated porous occlusive device releasably disposed on the distal end of the push wire, (c) a hub having a delivery catheter port and a packaging catheter port adapted to receive the distal end of the push wire, wherein the packaging catheter port is capable of receiving the distal end of the push wire in at least two orientations, (d) the push wire is capable of slidably passing the differentiated porous occlusion device through the angular lumen such that the push wire substantially maintains the 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 capable of rotating at the hub to rotate the distal end of the push wire to a predicted position of the differentiated porous occlusion device and maintain the position when the delivery catheter is withdrawn, wherein the differentiated porous occlusion device is transferred to the delivery catheter by engaging the packaging catheter and the delivery catheter.

2. The device according to claim 1, characterized in that The differentiated porous occlusive device is a stent.

3. The device according to claim 1, characterized in that The device further includes a "12 o'clock" marking at the hub.

4. The device according to claim 1, characterized in that The delivery catheter includes a radiopaque marker at the distal end of the delivery catheter.

5. The device according to claim 1, characterized in that The packaged catheter has a radiopaque marker at the distal end of the push wire.

6. 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.

7. The device according to claim 1, characterized in that The differentiated porous occlusive device includes a branched stent form.

8. An intravascular device, characterized in that: The intravascular device comprises: (a) A delivery catheter having a proximal end, a distal end, and an angular lumen, wherein the delivery catheter is capable of: (i) move within the blood vessel to the target aneurysm, (ii) stopping proximal to the target aneurysm, and (iii) withdrawn from said blood vessel, (b) a packaging catheter, a push hypotube, the push hypotube having a proximal end, a distal end, and a differentiated porous occlusion device releasably disposed on the distal end of the push hypotube, (c) a hub having a delivery catheter port and a packaging catheter port adapted to receive the distal end of the push hypotube, wherein the packaging catheter port is capable of receiving the distal end of the push hypotube in at least two orientations, (d) the push hypotube is capable of slidably passing the differentiated porous occlusion device through the angular lumen so that the push hypotube substantially maintains the orientation relative to the delivery catheter during movement of the distal end of the push hypotube through the blood vessel to the target aneurysm, (e) The packaging catheter is capable of rotating at the hub to rotate the distal end of the push sea wave tube to a predicted position of the differentiated porous occlusion device and maintain the position when the delivery catheter is withdrawn, wherein the differentiated porous occlusion device is transferred to the delivery catheter by engaging the packaging catheter and the delivery catheter.

9. The intravascular device according to claim 8, characterized in that The hypotube is adapted to convey fluid therethrough to reduce the fluid collection effect of flow reversal on the brain while maintaining retrograde flow sufficient to overcome external carotid artery blood flow, and to maintain retrograde flow through a lesion during at least one of angioplasty and stenting.

Images