Branch Point Flow Diversion Device

Abstract

To disclose a flow diversion device for the treatment of intracranial aneurysms and other medical conditions.SOLUTION: A flow diversion device may include a generally tubular wire stent frame formed from a plurality of zig-zag shaped wire elements that are coupled together. The device further includes a base layer of graft material coupled to the wire stent frame and surrounding at least a portion thereof, the wire stent frame maintaining the base layer in an open condition. In some embodiments, the base layer may be formed of porous graft material having a plurality of slits formed in the longitudinal direction. The slits may have a different shape in a compressed configuration and an expanded configuration. The slits provide a passageway for a small blood flow to maintain the long-term patency of important small side branches, while also reducing blood flow to the aneurysm to promote occlusion and avoid potential rupture.SELECTED DRAWING: Figure 20D

Description

Technical Field

[0001] (Related Application Data) This application is a non-provisional application and claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 62 / 607,019, filed on Dec. 18, 2017, and U.S. Provisional Patent Application No. 62 / 676,168, filed on May 24, 2018, the disclosures of which are hereby incorporated by reference in their entireties.

[0002] (Field of the Invention) The field of the present disclosure generally relates to medical devices, and more particularly, to flow diversion devices that can be used for the treatment of wide-neck fusiform aneurysms.

Background Art

[0003] Flow diversion devices such as the Pipeline embolization device, the Surpass flow diverter, and the Silk flow diverter are stent-like devices composed of tightly braided thin wire elements. These devices are intravascularly used to treat aneurysms by redirecting blood flow away from the aneurysm and inducing aneurysm thrombosis, preventing aneurysm rupture, and ultimately resulting in progressive shrinkage and occlusion of the aneurysm. Further, when used for fusiform aneurysms (i.e., aneurysms having no definable neck), flow diversion devices can promote the reconstruction of a smooth endothelial-lined channel continuous with the parent artery. Flow diversion devices direct blood away from the aneurysm, but the thin wire braid design allows the most conservative flow of blood there to maintain the patency of important small arterial branches adjacent to the aneurysm being treated. ​​​​​​​​​​​​ .

[0004] Large intracranial aneurysms (in the range of 10 to 25 mm in diameter) and particularly giant intracranial aneurysms (greater than 25 mm in diameter) are, in many cases, wide-necked (dome-to-neck diameter ratio less than 2) or fusiform. Typically, large and giant aneurysms have a low rate of occlusion, rupture, and survival, regardless of the form of treatment (e.g., open brain surgery or other endovascular techniques) used to treat them. The use of a super -woven stent device to divert blood flow away from the aneurysm has shown promising treatment results compared to open surgery and other conventional endovascular techniques, with or without the assistance of endovascular stents or balloon remodeling. .

Brief Description of the Drawings

[0005]

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Best Mode for Carrying Out the Invention

[0006] With reference to the drawings, this section describes specific embodiments and their detailed configurations and operations. The embodiments described herein are presented by way of example and not limitation. The features, structures, characteristics, and operating methods described may be combined in any suitable manner in one or more embodiments. Considering the disclosure herein, those skilled in the art will recognize that various embodiments can be implemented without one or more of the specific details or other methods, components, materials, etc. For clarity and brevity, specific aspects of the components or steps of a particular embodiment are presented without excessive detail that would be obvious to those skilled in the art considering the teachings of this specification and / or that would obscure the understanding of more suitable aspects of the embodiment. The inventor recognizes several drawbacks regarding current flow diversion devices. For example, one drawback is that the very fine braiding within the wire mesh tube of current devices makes it difficult to deliver the device into the skull, typically requiring a larger diameter and more ... ...

[0007] The inventor recognizes several drawbacks regarding current flow diversion devices. For example, one drawback is that the very fine braiding within the wire mesh tube of current devices makes it difficult to deliver the device into the skull, typically requiring a larger diameter and more ... require a rigid microcatheter and it is difficult to advance a folded stent device into the target region of an affected artery. In some situations, these large-bore, more rigid microcatheters are unstable and can cause inadvertent displacement of the flow diversion device into the aneurysm cavity. Further, once in place, such a stent device configuration can make its expansion somewhat difficult, which can have undesirable effects, such as (1) blocking normal blood flow to a part of the brain, thereby threatening a stroke, (2) forming an undesirable space between the outer surface of the stent and the inside of the blood vessel or the intima, allowing side branches to create endoleaks, which can in turn result in an undesirable maintenance of flow into the aneurysm cavity. Another drawback of such current flow diversion devices is that the positional instability of the device during deployment can cause an unexpected kickback of the device into the aneurysm. In addition, such current devices also create a large metal burden on the treated artery, which increases the risk of thromboembolic events and may require long-term therapy or treatment. As will be described in more detail below, the specific embodiments described herein can achieve various advantages including one or more of the following. (1) Provide a flow diversion device having a streamlined design to simplify intravascular introduction and reduce force when disposed on a delivery catheter, (2) Once in place for improved flow, the device

[0008]

[0009] ​​​​​​​​​To provide such a flow diversion device configured to promote the expansion of the aneurysm and (3) to provide a flow diversion device that effectively diverts blood from the aneurysm while maintaining sufficient blood flow to maintain the patency of arterial branches adjacent to the aneurysm treatment site is. Additional aspects and advantages will become apparent from the following detailed description of exemplary embodiments, which proceeds with reference to the accompanying drawings will.

[0010] Collectively, FIGS. 1-14 show various embodiments of a flow diversion device that can be used for the treatment of intracranial aneurysms and other medical procedures, as will be described in more detail below with reference to the figures is. Generally, referring to FIG. 1, the flow diversion device 100 is a stent-like device that includes a plurality of wire elements 1 05, and each individual wire element 105 is in the shape of a zigzag pattern and is coupled to adjacent wire elements to form a generally tubular stent structure. The wire elements 105 hold a thin base layer 135 and together form the support structure of the flow diversion device 100. The outer jacket 145 may surround the support structure formed from the wire elements 105 and the base layer 135, and the jacket 145 may be fused to the base layer 135 to provide additional rigidity and maintain the tubular shape of the flow diversion device 100 may. As described above, the flow diversion device 100 can be used intravascularly to divert blood flow from the aneurysm and induce aneurysm thrombosis and treat the aneurysm for other suitable medical procedures The additional details of these and other embodiments of the flow diversion device 100 are described herein with reference to the drawings

[0011] ​​​​​​Referring particularly to FIGS. 1 and 2, the following paragraphs describe additional details of the flow diversion device 100 and its components. As briefly described above, the flow diversion device 100 includes a plurality of wire elements 105 that are joined together to form a generally tubular self-expanding stent structure. In some embodiments, the wire elements 105 are composed of a metallic material exhibiting shape memory / superelastic properties such as nitinol (nickel-titanium alloy), elgiloy (cobalt, chromium, and nickel-based alloy), or other suitable shape memory alloys. In other embodiments, the wire elements 105 may instead be composed of other suitable materials including non-metallic materials that can create a tubular stent structure. In some embodiments, the wire elements 105 are joined together in an alternating or staggered pattern at one or more locations via a welding process or the like to create an "open cell" design that can conform without kinking to sharp curves in blood vessels. For example, referring particularly to FIG. 1A, adjacent wire elements 105a and 105b may be welded at a first junction 110, and a second junction 115 may leave a pair of ends 120, 125 of respective wire elements 105a, 105b free at a central junction 130 (i.e., ends 1 20, 125 are not welded or otherwise attached to each other). In this configuration, the staggered welds between adjacent wire elements 105a, 105b can help impart a high degree of flexibility to the flow diversion device 100 without sacrificing overall stability. The embodiment of the flow diversion device 100 in FIG. 1

[0012] Although showing a welding pattern at the interacting junction, it should be understood that the wire element 105 may instead be attached / connected in any one of a variety of suitable patterns. For example, in other embodiments, the wire element 105 may be attached at each junction to enhance stability, or in selected junctions for additional flexibility, may be attached in a non-alternating manner. In some embodiments, the flow diversion device 100 may use or include a small number of wire elements 105 to minimize resistance while the device 100 is advancing towards the target site. In addition, the diameter of each of these wire elements 105 is selected such that when the flow diversion device 100 is positioned at the target site, each wire element 105 has a sufficient inflation force, thereby reducing the possibility of incomplete inflation and, in turn, avoiding a dangerous occlusion of blood flow. For example, in one embodiment, the diameter of each wire element 105 may be 0.005 inches or less, having sufficient rigidity, flexibility, and

[0013] also ensuring that the flow diversion device 100 is securely fixed to the target vascular site so as to cover the mouth of the aneurysm, or having an appropriate inflation force that helps to ensure, as further described with particular reference to FIGS. 6A and 6B, providing a flow path through the fusiform aneurysm. In other embodiments, the diameter of each wire element 105 may be less than 0.010 inches. Referring to FIGS. 1 and 2, the flow diversion device 100 is polytetrafluoro ethylene and is selected such that when the flow diversion device 100 is positioned at the target site, each wire element 105 has a sufficient inflation force, thereby reducing the possibility of incomplete inflation and, in turn, avoiding a dangerous occlusion of blood flow. For example, in one embodiment, the diameter of each wire element 105 may be 0.005 inches or less, having sufficient rigidity, flexibility, and also ensuring that the flow diversion device 100 is securely fixed to the target vascular site so as to cover the mouth of the aneurysm, or having an appropriate inflation force that helps to ensure, as further described with particular reference to FIGS. 6A and 6B, providing a flow path through the fusiform aneurysm. In other embodiments, the diameter of each wire element 105 may be less than 0.010 inches. and is selected such that when the flow diversion device 100 is positioned at the target site, each wire element 105 has a sufficient inflation force, thereby reducing the possibility of incomplete inflation and, in turn, avoiding a dangerous occlusion of blood flow. For example, in one embodiment, the diameter of each wire element 105 may be 0.005 inches or less, having sufficient rigidity, flexibility, and also ensuring that the flow diversion device 100 is securely fixed to the target vascular site so as to cover the mouth of the aneurysm, or having an appropriate inflation force that helps to ensure, as further described with particular reference to FIGS. 6A and 6B, providing a flow path through the fusiform aneurysm. In other embodiments, the diameter of each wire element 105 may be less than 0.010 inches. Referring to FIGS. 1 and 2, the flow diversion device 100 is polytetrafluoro ethylene

[0014] Referring to FIGS. 1 and 2, the flow diversion device 100 is polytetrafluoro A tubular ultra-thin base of a graft material such as ethylene (polytetrafluoroethylene, PTFE) Layer 135, or other suitable graft material that promotes the flow diversion characteristics of the device 100 is included. The base layer 135 and the stent frame formed by the wire element 105 can be stitched material, crimping, adhesives, or perhaps one ultra-thin layer of the graft material, by any suitable means such as sealing it to another with a wire stent structure housed between the two layers 135, 145 may be attached to each other. To help ensure flow to and long-term patency of the important small side branches frequently found along the intracranial arteries, the graft material of the base layer 135 includes a plurality of micro-perforations / holes 140 spaced apart on the base layer 135 to allow a small amount of blood flow to flow into the side branches. The perforations / holes 140 may be mechanically created by using laser energy or by any other suitable means. The size and shape of the perforations 140 should not be so large as to reduce the structural integrity of the base layer 135, and may be designed to promote an increase in the flow passing "as needed" (e.g., the holes allow a larger flow to the patent side while allowing less flow to the aneurysm ).

[0015] In some embodiments, the perforations / holes 140 may be designed and cut on the base layer 135 such that the perforations / holes 140 expand or change shape with increased flow demand. For example the perforations / holes 140 may be semi-circular cutouts or slits in a pattern similar to that typically seen in a flag . As the blood flow to the base layer 135 increases, the semi circular cutouts cause the flaps of the graft material to be pulled away (with respect to the direction of blood flow), and the base layer 13​ It is possible to prevent excessive undulation of 5 (which may lead to its breakage or detachment). Preferably Or, in the absence of special properties of the perforation / hole 140, the porous graft material of the base layer 135 Nonetheless, it significantly inhibits the flow into the aneurysm sac, causing its gradual shrinkage and occlusion While still maintaining the patency of the collateral branches, it provides a reduced but sufficient Flow.

[0016] As shown in FIG. 1, the flow diversion device 100 may include radiopaque markers 150 at both the proximal 155 and distal 160 ends. Using fluoroscopy, the radiopaque markers 150 allow the operator to view the position of the flow diversion device 100 and determine whether the flow diversion device 100 is properly engaged with the inner wall of the blood vessel or other lumen. In other embodiments, the wire element 105 may also (or alternatively) include a radiopaque material to make the periphery / boundary of the stent frame visible. Referring specifically to FIG. 2, the base layer 135 of the graft material is fused to the outer jacket 145 to maintain the overall shape of the flow diversion device 100. In some embodiments, the jacket 145 may be made of polyurethane or other suitably strong, lightweight, and flexible polymer.

[0017] Referring specifically to FIG. 2, the base layer 135 of the graft material is fused to the outer jacket 145 to maintain the overall shape of the flow diversion device 100. In some embodiments, the jacket 145 may be made of polyurethane or other suitably strong, lightweight, and flexible polymer. Some embodiments, the jacket 145 may be made of polyurethane or other suitably strong, lightweight, and flexible polymer.

[0018] FIGS. 3-5 show exemplary embodiments for delivering the flow diversion device 100 into a blood vessel or other lumen 165 (see FIG. 6A). Referring particularly to FIGS. 3 and 4, the flow diversion device 100 is advanced through a delivery catheter 180 by a pusher / delivery wire 1 ​ It may advance in a compressed state between two metal bumpers 170 on the 75. Flow diversion When the device 100 is pushed to the target segment of the intracranial artery or other lumen 165 via the catheter 180, the catheter 180 can be removed to allow the device 100 to expand at the target site. In other embodiments, the flow diversion device 100 may alternatively be provided on a pusher wire and can be removed from the pusher wire by electrical or mechanical means when the device is expanded / deployed at the target site. Both of the above-described device delivery and deployment methods may allow for the retrieval of the flow diversion device to a certain extent if the deployment position is unsatisfactory.

[0019] Figures 6A and 6B schematically illustrate an exemplary flow diversion process of the deployed device 100 when used to treat an intracranial aneurysm. Referring to Figures 6A and 6B, the flow diversion device 100 is positioned adjacent to an intracranial aneurysm 185 (such as a large or giant, widemouth or fusiform intracranial aneurysm). When in a predetermined position, the porous graft material of the base layer 135 reduces / inhibits blood flow to the aneurysm 185, thereby gradually occluding it over time (as shown in Figure 6B). The graft material is porous so that a small amount of blood may flow into the aneurysm 185, but this flow is small enough that the likelihood of the aneurysm 185 continuing to grow is low. Further, the small flow across the graft material remains sufficient to maintain the patency of nearby collateral branches 190. In some treatments, about one week before deployment and 3 - 6 months after deployment of the flow diversion device 100 described ​​​​​​​​​Over a period of months, the patient may be treated with dual antiplatelet therapy (such as aspirin and clopidogrel (Plavi x)). To evaluate aneurysm shrinkage and occlusion, follow-up cerebral angiography may be performed 6 months and 12 months after device deployment. If aneurysm 185 is completely closed and determined to be no longer a problem, device 100 may be removed. In other examples the device 100 may be left permanently in place to avoid the potential for future problems .

[0020] Figures 7-14 summarize various other embodiments of medical procedures and processes that utilize the same concepts of the wire mesh frame and graft material base layer as described above with reference to the flow diversion device 100 of Figures 1-6. Further details of these embodiments will be described below.

[0021] Figures 7 and 8 show exemplary embodiments of an inferior vena cava (IVC ) filter 200 for assisting in the prevention of pulmonary embolism. Referring to Figure 7, the IVC filter 200 may include a plurality of wire elements 205 each in a zigzag shape, and each wire element 205 is welded or otherwise joined to adjacent elements to form a stent frame in a manner similar to that described for the wire elements 105 of the flow diversion device 100. The wire elements 205 at the distal end 210 of the IVC filter 200 are gathered together and welded or otherwise mechanically constrained together to produce a closed conical shape at the distal end 210. A graft material (e.g., PTFE, polyurethane, or having perforations 220 that can range in diameter from 25 micrometers to 100 micrometers ​​The porous base layer 215 (of other suitable materials) is provided in the mesh structure of the wire element 205 along at least the distal end 210 portion, or can be attached in another way. IVC filter 200's proximal end 225 includes a tubular configuration that can exert sufficient expansion force to act as an intravascular "anchor". Specifically referring to FIG. 7, in some embodiments, the proximal end 22 5 of the IVC filter 200 may be attached to a guide wire 230 that can be used to position the IVC filter 200 in the inferior vena cava together with the delivery catheter 235. Positioning the guide wire 230 at the proximal end 225 can be useful for inserting the IVC filter 200 through the femoral vein so that the porous graft material is in an appropriate position with respect to the direction of blood flow in the inferior vena cava. Referring to FIG. 8, in other embodiments, the distal end 210 of the IVC filter 200 is instead attached to the guide wire 230 and may be delivered to the inferior vena cava through, for example, the internal jugular vein. In both embodiments, the IVC filter 200 may be a temporary filter (a proximal wire or a distal wire can be used as the retrieval means of the IVC filter 200), or alternatively a permanent IVC filter 200. In such an embodiment where the IVC filter 200 is permanent, the IVC filter 200 may include a separation zone 240 positioned between the introduction guide wire 230 and the IVC filter 200 to enable separation of the IVC filter 200 when desired. Alternatively, the guide wire 230 may cover the IVC filter 200 and slide a retrieval / recoating catheter, and this may be retrieved if desired.

[0022] Specifically referring to FIG. 7, in some embodiments, the proximal end 22 5 of the IVC filter 200 may be attached to a guide wire 230 that can be used to position the IVC filter 200 in the inferior vena cava together with the delivery catheter 235. Positioning the guide wire 230 at the proximal end 225 can be useful for inserting the IVC filter 200 through the femoral vein so that the porous graft material is in an appropriate position with respect to the direction of blood flow in the inferior vena cava. Referring to FIG. 8, in other embodiments, the distal end 210 of the IVC filter 200 is instead attached to the guide wire 230 and may be delivered to the inferior vena cava through, for example, the internal jugular vein. In both embodiments, the IVC filter 200 may be a temporary filter (a proximal wire or a distal wire can be used as the retrieval means of the IVC filter 200), or alternatively a permanent IVC filter 200. In such an embodiment where the IVC filter 200 is permanent, the IVC filter 200 may include a separation zone 240 positioned between the introduction guide wire 230 and the IVC filter 200 to enable separation of the IVC filter 200 when desired. Alternatively, the guide wire 230 may cover the IVC filter 200 and slide a retrieval / recoating catheter, and this may be retrieved if desired. Specifically referring to FIG. 7, in some embodiments, the proximal end 22 5 of the IVC filter 200 may be attached to a guide wire 230 that can be used to position the IVC filter 200 in the inferior vena cava together with the delivery catheter 235. Positioning the guide wire 230 at the proximal end 225 can be useful for inserting the IVC filter 200 through the femoral vein so that the porous graft material is in an appropriate position with respect to the direction of blood flow in the inferior vena cava. Referring to FIG. 8, in other embodiments, the distal end 210 of the IVC filter 200 is instead attached to the guide wire 230 and may be delivered to the inferior vena cava through, for example, the internal jugular vein. In both embodiments, the IVC filter 200 may be a temporary filter (a proximal wire or a distal wire can be used as the retrieval means of the IVC filter 200), or alternatively a permanent IVC filter 200. In such an embodiment where the IVC filter 200 is permanent, the IVC filter 200 may include a separation zone 240 positioned between the introduction guide wire 230 and the IVC filter 200 to enable separation of the IVC filter 200 when desired. Alternatively, the guide wire 230 may cover the IVC filter 200 and slide a retrieval / recoating catheter, and this may be retrieved if desired. Specifically referring to FIG. 7, in some embodiments, the proximal end 22 5 of the IVC filter 200 may be attached to a guide wire 230 that can be used to position the IVC filter 200 in the inferior vena cava together with the delivery catheter 235. Positioning the guide wire 230 at the proximal end 225 can be useful for inserting the IVC filter 200 through the femoral vein so that the porous graft material is in an appropriate position with respect to the direction of blood flow in the inferior vena cava. Referring to FIG. 8, in other embodiments, the distal end 210 of the IVC filter 200 is instead attached to the guide wire 230 and may be delivered to the inferior vena cava through, for example, the internal jugular vein. In both embodiments, the IVC filter 200 may be a temporary filter (a proximal wire or a distal wire can be used as the retrieval means of the IVC filter 200), or alternatively a permanent IVC filter 200. In such an embodiment where the IVC filter 200 is permanent, the IVC filter 200 may include a separation zone 240 positioned between the introduction guide wire 230 and the IVC filter 200 to enable separation of the IVC filter 200 when desired. Alternatively, the guide wire 230 may cover the IVC filter 200 and slide a retrieval / recoating catheter, and this may be retrieved if desired. Specifically referring to FIG. 7, in some embodiments, the proximal end 22 5 of the IVC filter 200 may be attached to a guide wire 230 that can be used to position the IVC filter 200 in the inferior vena cava together with the delivery catheter 235. Positioning the guide wire 230 at the proximal end 225 can be useful for inserting the IVC filter 200 through the femoral vein so that the porous graft material is in an appropriate position with respect to the direction of blood flow in the inferior vena cava. Referring to FIG. 8, in other embodiments, the distal end 210 of the IVC filter 200 is instead attached to the guide wire 230 and may be delivered to the inferior vena cava through, for example, the internal jugular vein. In both embodiments, the IVC filter 200 may be a temporary filter (a proximal wire or a distal wire can be used as the retrieval means of the IVC filter 200), or alternatively a permanent IVC filter 200. In such an embodiment where the IVC filter 200 is permanent, the IVC filter 200 may include a separation zone 240 positioned between the introduction guide wire 230 and the IVC filter 200 to enable separation of the IVC filter 200 when desired. Alternatively, the guide wire 230 may cover the IVC filter 200 and slide a retrieval / recoating catheter, and this may be retrieved if desired. Specifically referring to FIG. 7, in some embodiments, the proximal end 22 5 of the IVC filter 200 may be attached to a guide wire 230 that can be used to position the IVC filter 200 in the inferior vena cava together with the delivery catheter 235. Positioning the guide wire 230 at the proximal end 225 can be useful for inserting the IVC filter 200 through the femoral vein so that the porous graft material is in an appropriate position with respect to the direction of blood flow in the inferior vena cava. Referring to FIG. 8, in other embodiments, the distal end 210 of the IVC filter 200 is instead attached to the guide wire 230 and may be delivered to the inferior vena cava through, for example, the internal jugular vein. In both embodiments, the IVC filter 200 may be a temporary filter (a proximal wire or a distal wire can be used as the retrieval means of the IVC filter 200), or alternatively a permanent IVC filter 200. In such an embodiment where the IVC filter 200 is permanent, the IVC filter 200 may include a separation zone 240 positioned between the introduction guide wire 230 and the IVC filter 200 to enable separation of the IVC filter 200 when desired. Alternatively, the guide wire 230 may cover the IVC filter 200 and slide a retrieval / recoating catheter, and this may be retrieved if desired. Specifically referring to FIG. 7, in some embodiments, the proximal end 22 5 of the IVC filter 200 may be attached to a guide wire 230 that can be used to position the IVC filter 200 in the inferior vena cava together with the delivery catheter 235. Positioning the guide wire 230 at the proximal end 225 can be useful for inserting the IVC filter 200 through the femoral vein so that the porous graft material is in an appropriate position with respect to the direction of blood flow in the inferior vena cava. Referring to FIG. 8, in other embodiments, the distal end 210 of the IVC filter 200 is instead attached to the guide wire 230 and may be delivered to the inferior vena cava through, for example, the internal jugular vein. In both embodiments, the IVC filter 200 may be a temporary filter (a proximal wire or a distal wire can be used as the retrieval means of the IVC filter 200), or alternatively a permanent IVC filter 200. In such an embodiment where the IVC filter 200 is permanent, the IVC filter 200 may include a separation zone 240 positioned between the introduction guide wire 230 and the IVC filter 200 to enable separation of the IVC filter 200 when desired. Alternatively, the guide wire 230 may cover the IVC filter 200 and slide a retrieval / recoating catheter, and this may be retrieved if desired. Specifically referring to FIG. 7, in some embodiments, the proximal end 22 5 of the IVC filter 200 may be attached to a guide wire 230 that can be used to position the IVC filter 200 in the inferior vena cava together with the delivery catheter 235. Positioning the guide wire 230 at the proximal end 225 can be useful for inserting the IVC filter 200 through the femoral vein so that the porous graft material is in an appropriate position with respect to the direction of blood flow in the inferior vena cava. Referring to FIG. 8, in other embodiments, the distal end 210 of the IVC filter 200 is instead attached to the guide wire 230 and may be delivered to the inferior vena cava through, for example, the internal jugular vein. In both embodiments, the IVC filter 200 may be a temporary filter (a proximal wire or a distal wire can be used as the retrieval means of the IVC filter 200), or alternatively a permanent IVC filter 200. In such an embodiment where the IVC filter 200 is permanent, the IVC filter 200 may include a separation zone 240 positioned between the introduction guide wire 230 and the IVC filter 200 to enable separation of the IVC filter 200 when desired. Alternatively, the guide wire 230 may cover the IVC filter 200 and slide a retrieval / recoating catheter, and this may be retrieved if desired. Specifically referring to FIG. 7, in some embodiments, the proximal end 22

[0023] In use, a stent-like body (having a closed cell design) composed of welding wire elements 205 centers itself within the inferior vena cava with a filter. Additionally, the perforated graft material of the base layer 215 is positioned to capture thromboemboli from the pelvis and / or lower extremities, which could otherwise cause a fatal pulmonary embolism if it reaches the lungs and contains the blood flow. Such an IVC filter 200 may be advantageous because pulmonary thromboemboli (PTE) are currently the third most common cause of death in the United States. In use, a stent-like body (having a closed cell design) composed of welding wire elements 205 centers itself within the inferior vena cava with a filter. Additionally, the perforated graft material of the base layer 215 is positioned to capture thromboemboli from the pelvis and / or lower extremities, which could otherwise cause a fatal pulmonary embolism if it reaches the lungs and contains the blood flow. Such an IVC filter 200 may be advantageous because pulmonary thromboemboli (PTE) are currently the third most common cause of death in the United States. In use, a stent-like body (having a closed cell design) composed of welding wire elements 205 centers itself within the inferior vena cava with a filter. Additionally, the perforated graft material of the base layer 215 is positioned to capture thromboemboli from the pelvis and / or lower extremities, which could otherwise cause a fatal pulmonary embolism if it reaches the lungs and contains the blood flow. Such an IVC filter 200 may be advantageous because pulmonary thromboemboli (PTE) are currently the third most common cause of death in the United States. In use, a stent-like body (having a closed cell design) composed of welding wire elements 205 centers itself within the inferior vena cava with a filter. Additionally, the perforated graft material of the base layer 215 is positioned to capture thromboemboli from the pelvis and / or lower extremities, which could otherwise cause a fatal pulmonary embolism if it reaches the lungs and contains the blood flow. Such an IVC filter 200 may be advantageous because pulmonary thromboemboli (PTE) are currently the third most common cause of death in the United States. In use, a stent-like body (having a closed cell design) composed of welding wire elements 205 centers itself within the inferior vena cava with a filter. Additionally, the perforated graft material of the base layer 215 is positioned to capture thromboemboli from the pelvis and / or lower extremities, which could otherwise cause a fatal pulmonary embolism if it reaches the lungs and contains the blood flow. Such an IVC filter 200 may be advantageous because pulmonary thromboemboli (PTE) are currently the third most common cause of death in the United States. In use, a stent-like body (having a closed cell design) composed of welding wire elements 205 centers itself within the inferior vena cava with a filter. Additionally, the perforated graft material of the base layer 215 is positioned to capture thromboemboli from the pelvis and / or lower extremities, which could otherwise cause a fatal pulmonary embolism if it reaches the lungs and contains the blood flow. Such an IVC filter 200 may be advantageous because pulmonary thromboemboli (PTE) are currently the third most common cause of death in the United States. In use, a stent-like body (having a closed cell design) composed of welding wire elements 205 centers itself within the inferior vena cava with a filter. Additionally, the perforated graft material of the base layer 215 is positioned to capture thromboemboli from the pelvis and / or lower extremities, which could otherwise cause a fatal pulmonary embolism if it reaches the lungs and contains the blood flow. Such an IVC filter 200 may be advantageous because pulmonary thromboemboli (PTE) are currently the third most common cause of death in the United States.

[0024] FIG. 9 shows an exemplary embodiment of an anchor filter device 300 that can be used in carotid arteries, coronary arteries, bypass graft angioplasty, and stents. Referring to FIG. 9, the anchor filter device 300 includes a similar stent-like scaffold made of welding wire elements 305 and a porous base layer 310 attached to the distal end 315 of the anchor filter device 300 in the same manner as described with reference to the IVC filter 200 of FIGS. 7 and 8. The proximal end 320 of the anchor filter device 300 may be attached to a guide wire 325 (such as a 0.014-inch to 0.018-inch proximal working wire). The guide wire 325 may run the length of the anchor filter device 300 and may appear distally as a short, formable wire extension 330 to accommodate navigation through a stenosis and into a more normal distal arterial segment while the anchor filter device 300 is in a folded state within a microcatheter 335 (about 3F outer diameter). Such an anchor filter device FIG. 9 shows an exemplary embodiment of an anchor filter device 300 that can be used in carotid arteries, coronary arteries, bypass graft angioplasty, and stents. Referring to FIG. 9, the anchor filter device 300 includes a similar stent-like scaffold made of welding wire elements 305 and a porous base layer 310 attached to the distal end 315 of the anchor filter device 300 in the same manner as described with reference to the IVC filter 200 of FIGS. 7 and 8. The proximal end 320 of the anchor filter device 300 may be attached to a guide wire 325 (such as a 0.014-inch to 0.018-inch proximal working wire). The guide wire 325 may run the length of the anchor filter device 300 and may appear distally as a short, formable wire extension 330 to accommodate navigation through a stenosis and into a more normal distal arterial segment while the anchor filter device 300 is in a folded state within a microcatheter 335 (about 3F outer diameter). Such an anchor filter device FIG. 9 shows an exemplary embodiment of an anchor filter device 300 that can be used in carotid arteries, coronary arteries, bypass graft angioplasty, and stents. Referring to FIG. 9, the anchor filter device 300 includes a similar stent-like scaffold made of welding wire elements 305 and a porous base layer 310 attached to the distal end 315 of the anchor filter device 300 in the same manner as described with reference to the IVC filter 200 of FIGS. 7 and 8. The proximal end 320 of the anchor filter device 300 may be attached to a guide wire 325 (such as a 0.014-inch to 0.018-inch proximal working wire). The guide wire 325 may run the length of the anchor filter device 300 and may appear distally as a short, formable wire extension 330 to accommodate navigation through a stenosis and into a more normal distal arterial segment while the anchor filter device 300 is in a folded state within a microcatheter 335 (about 3F outer diameter). Such an anchor filter device FIG. 9 shows an exemplary embodiment of an anchor filter device 300 that can be used in carotid arteries, coronary arteries, bypass graft angioplasty, and stents. Referring to FIG. 9, the anchor filter device 300 includes a similar stent-like scaffold made of welding wire elements 305 and a porous base layer 310 attached to the distal end 315 of the anchor filter device 300 in the same manner as described with reference to the IVC filter 200 of FIGS. 7 and 8. The proximal end 320 of the anchor filter device 300 may be attached to a guide wire 325 (such as a 0.014-inch to 0.018-inch proximal working wire). The guide wire 325 may run the length of the anchor filter device 300 and may appear distally as a short, formable wire extension 330 to accommodate navigation through a stenosis and into a more normal distal arterial segment while the anchor filter device 300 is in a folded state within a microcatheter 335 (about 3F outer diameter). Such an anchor filter device FIG. 9 shows an exemplary embodiment of an anchor filter device 300 that can be used in carotid arteries, coronary arteries, bypass graft angioplasty, and stents. Referring to FIG. 9, the anchor filter device 300 includes a similar stent-like scaffold made of welding wire elements 305 and a porous base layer 310 attached to the distal end 315 of the anchor filter device 300 in the same manner as described with reference to the IVC filter 200 of FIGS. 7 and 8. The proximal end 320 of the anchor filter device 300 may be attached to a guide wire 325 (such as a 0.014-inch to 0.018-inch proximal working wire). The guide wire 325 may run the length of the anchor filter device 300 and may appear distally as a short, formable wire extension 330 to accommodate navigation through a stenosis and into a more normal distal arterial segment while the anchor filter device 300 is in a folded state within a microcatheter 335 (about 3F outer diameter). Such an anchor filter device FIG. 9 shows an exemplary embodiment of an anchor filter device 300 that can be used in carotid arteries, coronary arteries, bypass graft angioplasty, and stents. Referring to FIG. 9, the anchor filter device 300 includes a similar stent-like scaffold made of welding wire elements 305 and a porous base layer 310 attached to the distal end 315 of the anchor filter device 300 in the same manner as described with reference to the IVC filter 200 of FIGS. 7 and 8. The proximal end 320 of the anchor filter device 300 may be attached to a guide wire 325 (such as a 0.014-inch to 0.018-inch proximal working wire). The guide wire 325 may run the length of the anchor filter device 300 and may appear distally as a short, formable wire extension 330 to accommodate navigation through a stenosis and into a more normal distal arterial segment while the anchor filter device 300 is in a folded state within a microcatheter 335 (about 3F outer diameter). Such an anchor filter device FIG. 9 shows an exemplary embodiment of an anchor filter device 300 that can be used in carotid arteries, coronary arteries, bypass graft angioplasty, and stents. Referring to FIG. 9, the anchor filter device 300 includes a similar stent-like scaffold made of welding wire elements 305 and a porous base layer 310 attached to the distal end 315 of the anchor filter device 300 in the same manner as described with reference to the IVC filter 200 of FIGS. 7 and 8. The proximal end 320 of the anchor filter device 300 may be attached to a guide wire 325 (such as a 0.014-inch to 0.018-inch proximal working wire). The guide wire 325 may run the length of the anchor filter device 300 and may appear distally as a short, formable wire extension 330 to accommodate navigation through a stenosis and into a more normal distal arterial segment while the anchor filter device 300 is in a folded state within a microcatheter 335 (about 3F outer diameter). Such an anchor filter device FIG. 9 shows an exemplary embodiment of an anchor filter device 300 that can be used in carotid arteries, coronary arteries, bypass graft angioplasty, and stents. Referring to FIG. 9, the anchor filter device 300 includes a similar stent-like scaffold made of welding wire elements 305 and a porous base layer 310 attached to the distal end 315 of the anchor filter device 300 in the same manner as described with reference to the IVC filter 200 of FIGS. 7 and 8. The proximal end 320 of the anchor filter device 300 may be attached to a guide wire 325 (such as a 0.014-inch to 0.018-inch proximal working wire). The guide wire 325 may run the length of the anchor filter device 300 and may appear distally as a short, formable wire extension 330 to accommodate navigation through a stenosis and into a more normal distal arterial segment while the anchor filter device 300 is in a folded state within a microcatheter 335 (about 3F outer diameter). Such an anchor filter device FIG. 9 shows an exemplary embodiment of an anchor filter device 300 that can be used in carotid arteries, coronary arteries, bypass graft angioplasty, and stents. Referring to FIG. 9, the anchor filter device 300 includes a similar stent-like scaffold made of welding wire elements 305 and a porous base layer 310 attached to the distal end 315 of the anchor filter device 300 in the same manner as described with reference to the IVC filter 200 of FIGS. 7 and 8. The proximal end 320 of the anchor filter device 300 may be attached to a guide wire 325 (such as a 0.014-inch to 0.018-inch proximal working wire). The guide wire 325 may run the length of the anchor filter device 300 and may appear distally as a short, formable wire extension 330 to accommodate navigation through a stenosis and into a more normal distal arterial segment while the anchor filter device 300 is in a folded state within a microcatheter 335 (about 3F outer diameter). Such an anchor filter device FIG. 9 shows an exemplary embodiment of an anchor filter device 300 that can be used in carotid arteries, coronary arteries, bypass graft angioplasty, and stents. Referring to FIG. 9, the anchor filter device 300 includes a similar stent-like scaffold made of welding wire elements 305 and a porous base layer 310 attached to the distal end 315 of the anchor filter device 300 in the same manner as described with reference to the IVC filter 200 of FIGS. 7 and 8. The proximal end 320 of the anchor filter device 300 may be attached to a guide wire 325 (such as a 0.014-inch to 0.018-inch proximal working wire). The guide wire 325 may run the length of the anchor filter device 300 and may appear distally as a short, formable wire extension 330 to accommodate navigation through a stenosis and into a more normal distal arterial segment while the anchor filter device 300 is in a folded state within a microcatheter 335 (about 3F outer diameter). Such an anchor filter device 300 can result from percutaneous transluminal angioplasty (PTA) and can help prevent distal debris embolization and atherosclerotic blood vessel stenting by filtering the debris of the procedure. When the procedure is completed, the anchor filter device 300 is folded by a microcatheter 335 slid along the proximal guidewire 325, whereupon the

[0025] device 300 is removed from the artery. In the case of very tortuous large vascular anatomical structures (such as in the elderly and hypertensive patients) of the aortic arch in the chest, proximal access in the innominate or left common carotid artery can be established using a stiffer (e.g., AL Z) 7-F coronary guide catheter, and then a 2.8F delivery microcatheter can be guided through the high-grade ICA stenosis via a 0.014-inch wire. This wire can then be removed and replaced with an anchor filter device deployed in the upper cervical ICA. Here, the working wire is stabilized, and then, in the chest arch tortuous anatomical structure with a bi-axial or tri-axial catheter system, it enables a more facile and rapid catheterization and may also be useful in preventing distal coagulative embolism during angioplasty and stenting of potentially stenotic coronary bypass grafts. When debris is trapped at the end of PTA and stenting, the filter

[0026] device is recaptured by advancing a retrieval catheter of approximately 2.8F over the Combinations with the old are used in a reverse or retrograde filter device 400 to soak chemotherapy agents embolization particles or a small amount of Y 90 It is possible to provide a mechanism for injecting wireless embolization particles. Referring to FIG. 10, the retrograde filter device 400 includes a plurality of wire elements 405 attached in the same manner as described above with respect to devices 100, 200, 300 and may include a wire mesh cuffield. In addition, the retrograde filter device 400 is provided around the proximal end 415 of the wire mesh frame of the retrograde filter device 400 or is otherwise attached and further includes a base layer 410 of perforated graft material (e.g., PTFE or polyurethane ene). The proximal end 415 of the wire mesh frame including the wire element 405 has an inner diameter of about 0.0114 inches or any other suitable inner diameter for injecting particles for radioactive embolization (e.g., bio spheres, polyvinyl alcohol particles TheraSphere particles) and is provided on a flexible hypo tube 420. In the case of radioactive embolization, the backflow of particles injected from the intra-arterial point of the embolization may cause particles to flow into important collateral channels (e.g., right gastric artery - in this case, radioactive Y

[0027] particles may induce non-healing ulcers in the gastric mucosa ). To avoid such problematic backflow, the proximal end 415 of the wire mesh stent has a conical shape, and the perforations 425 of the graft material of the base layer 410 generally allow forward flow within the target vessel 430 but do not allow backflow of the injected particles and avoid non-target embolization to proximal branches or collateral vessels 90 such that the size is such that From the arterial point of the embolization, the backflow of the injected particles may cause particles to flow into important collateral channels (e.g., right gastric artery - in this case, radioactive Y 90 particles may induce non-healing ulcers in the gastric mucosa ). To avoid such problematic backflow, the proximal end 415 of the wire mesh stent has a conical shape, and the perforations 425 of the graft material of the base layer 410 generally allow forward flow within the target vessel 430 but do not allow backflow of the injected particles and avoid non-target embolization to proximal branches or collateral vessels The perforations 425 of the graft material of the base layer 410 generally allow forward flow within the target vessel 430 but do not allow backflow of the injected particles and avoid non-target embolization to proximal branches or collateral vessels is made. As shown in FIG. 10, the distal end 435 of the wire mesh stent opens and may have a cylindrical or tubular shape, and the distal end 435 is not completely covered by the graft material of the base layer 410. Thus, the distal end 435 abuts against the inner wall of the target blood vessel and fully expands to securely maintain the retrograde filter device 400 in a fixed position.

[0028] FIG. 11 shows another exemplary embodiment of a flow diversion device 500 that can be used to divert blood flow from an aneurysm while maintaining sufficient blood flow to maintain the patency of a large collateral branch 598 (see FIG. 14). Referring to FIG. 11, the flow diversion device 500 is a self-expanding partial open cell stent frame 510 formed from a plurality of wire elements 505 coupled in a similar manner as described with respect to the flow diversion device 100 of FIG. 1. In some embodiments, the flow diversion device 5 00 may include radiopaque markers 515, 520 on the wire elements 505 at both the proximal end 525 and the distal end 530 of the stent frame 510, allowing an operator to monitor the position of the flow diversion device 500 using fluoroscopy. In other embodiments, the wire elements 505 may also include a radiopaque material so that the perimeter or boundary of the stent frame 510 can be monitored during the insertion and treatment procedures. Referring to FIG. 11, the flow diversion device 500 is a self-expanding partial open cell stent frame 510 formed from a plurality of wire elements 505 coupled in a similar manner as described with respect to the flow diversion device 100 of FIG. 1. In some embodiments, the flow diversion device 5 00 may include radiopaque markers 515, 520 on the wire elements 505 at both the proximal end 525 and the distal end 530 of the stent frame 510, allowing an operator to monitor the position of the flow diversion device 500 using fluoroscopy. In other embodiments, the wire elements 505 may also include a radiopaque material so that the perimeter or boundary of the stent frame 510 can be monitored during the insertion and treatment procedures.

[0029] The flow diversion device 500 includes an ultra-thin base layer 535 of a graft material such as polytetrafluoroethylene (PTFE), or other suitable graft material surrounding at least a portion of the stent frame 510, and the base layer 535 aids in controlling blood flow to the treatment site. ​ It includes a plurality of perforations / holes 540 formed therein. Preferably, the base layer 535 is made of stainless positioned at a substantially central portion of the stent frame 510, leaving the proximal end 52 5 and the distal end 530 without the base layer 535. As will be described in more detail below, the base layer 535 is blocked or reduced in blood flow therethrough by relatively small-sized perforations 540, while the opening of the stent frame 510 as well as the proximal end 525 and the distal end 530 allows an increase in blood flow to a large side branch 598 adjacent to the treatment site of the aneurysm 555. In some embodiments, a portion of the boundary 545 of the base layer 535 may include a radiopaque marker / material 550, enabling the operator to accurately place the stent frame 510 at a specific treatment site and ensuring that the diverted blood flow is directed away from the aneurysm 555, while also directing sufficient blood flow to the large side branch 598 adjacent to the aneurysm 555 as will be described in more detail below with reference to FIGS. 12-14.

[0030] In some embodiments, the flow diversion device 500 is attached to a guide wire 565 and may include an anchor stent 560 extending forward from the distal end 530 of the stent frame 510. Referring to FIG. 11, the anchor stent 560 is generally a tubular self-expanding mesh structure similar in structure to the stent frame 510. The anchor stent 560 includes a plurality of connector struts 570 that converge at the strut tip 596 to which the guide wire 565 is attached. In some embodiments, the anchor stent 560 also has a radiopaque marker 57 at the opposite end of the connector strut 570. It may include 5. During use, the anchor stent 560 ensures that appropriate treatment is provided for the aneurysm 555 by providing means to fix the flow diversion device 500 in a determined position.

[0031] Figures 12 - 14 show exemplary embodiments for delivering the flow diversion device 500 to the target site for treating the aneurysm 555. Generally referring to Figures 12 - 14, the delivery catheter 580 advances into the blood vessel 585 beyond the treatment site where the aneurysm 555 is located. As illustrated in Figure 12, when the catheter 580 is in a predetermined position, the flow diversion device 500 advances through the catheter 580 via the guide wire 590, and the flow diversion device 500 is in a compressed state when moving through the catheter 580. When the flow diversion device 500 reaches the end 595 of the catheter 580, the anchor stent 560 extends outward from the end 595 and expands radially against the inner wall of the blood vessel 585 to stabilize the catheter 580 as shown in Figure 13. When the anchor stent 560 is fully expanded, the catheter 580 may be retracted away from the target site, and by retracting the catheter 580, the flow diversion device 500 is uncovered. In one embodiment of the deployment process, the guide wire 590 is held stationary while the catheter 580 is retracting, and the anchor stent 560 helps to hold the flow diversion device 500 in a predetermined position at the target site. Referring to Figure 14, when the catheter 580 is fully retracted, the flow diversion device 500 is in the target position, and the movement

[0032] The base layer 535 adjacent to the aneurysm 555 redirects blood away from the aneurysm 555 and closes the aneurysm 555 over time. Additionally, as previously described, the open proximal end 525 and distal end 530 of the stent frame 510 provide an increased blood flow to larger collateral branches 598 that may be near the aneurysm 555, and the perforations 540 in the base layer 535 provide sufficient flow to smaller collateral branches 598.

[0033] When the treatment is complete and the flow diversion device 500 is ready for removal, the flow diversion device 500 may be recoated by advancing the catheter 580 towards the proximal end 525 of the stent frame 510. As the catheter 580 moves forward the flow diversion device 500 is folded into the catheter 580. When the entire device 500 is coated within the catheter 580, the catheter 580 may be removed along with the device 500.

[0034] Figures 15A - 16 illustrate an exemplary flow diversion device in a folded configuration and an expanded configuration. Figure 15A shows a flow diversion device 600 having a similar stent - like scaffold made from a welded wire element 605 having the zig - zag pattern previously considered. The flow diversion device 600 may further include a base layer 610 of a graft material such as PTFE, or other suitable graft material. The base layer 610 may be attached to the stent frame by any suitable means, such as via a suture material, crimping, or an adhesive. In some embodiments, the base layer 610 is a wire stent structure housed between two layers 610 and 620 and sealed to the outer layer 620, as shown in Figure 15B. ​​​​​​​ It may be.

[0035] As shown in FIGS. 15B and 15C, the flow diversion device 600 may include radiopaque markers 650 at both the proximal 6 55 and distal 660 ends. In the illustrated embodiment, the welding wire element 605 may extend beyond the base layer 610 at the proximal 655 and distal 660 ends. Using fluoroscopy, the radiopaque marker 650 enables the operator to view the position of the flow diversion device 600 and determine whether the flow diversion device 600 is properly engaged with the inner wall of a blood vessel or other lumen. In other embodiments, the wire element 605 may also include a radiopaque material to allow the periphery / boundary of the stent frame to be visible.

[0036] Expansion of the stent-like scaffold of the flow diversion device 600 may be assisted by a plurality of slits / windows 640 disposed within the base layer 61 0. In embodiments including a base layer 610 and an outer layer 620, the slits 640 in the base layer 610 and the outer layer 6 20 may be aligned with each other. The slits 640 may be disposed longitudinally, i.e., aligned with the longitudinal axis of the flow diversion device 600. The slits 640 may have a length of less than 1 mm.

[0037] In the compressed configuration, the slits 640 are closed and open during expansion of the flow diversion device 600. For example, FIG. 16 shows the flow diversion device 600 in an expanded configuration, where the slits 640 are expanded in a rhombus or diamond shape. The expanded slits 640 ​​​allows a small amount of blood flow to pass through the base layer 610 towards the collateral, along the intracranial artery and helps ensure flow to the small collateral vessels that are frequently seen and long-term patency However, most of the blood flow is diverted to pass through the aneurysm, causing progressive contraction and occlusion of the aneurysm. The slit / window 640 may be mechanically generated by using laser energy or by any other suitable means. The size and shape of the slit 64 0 are designed to promote increased through-flow "as needed" without being so large as to compromise the structural integrity of the base layer 610 (e.g., the holes allow for greater flow to the patent collateral but less flow to the aneurysm ). )

[0038] As previously discussed, the flow diversion device may include an inner layer (e.g., base layer 610) and an outer layer (e.g., outer layer 620) of implant material having a scaffold (e.g., welded wire element 605) therebetween The longitudinal slit 640 may coincide on the inner and outer layers of the implant material The flow diversion device 600 may also be a single base layer attached to a stent having longitudinal slits .

[0039] In addition to the straight slits that expand into diamond-shaped (or rhomboid-shaped) windows, expandable slits may be manufactured in a variety of different shapes. FIGS. 17A-17C show alternative slit designs . For example, FIG. 17A shows a slit 640' having opposing Y-shaped slits in a folded configuration that expand to an hourglass-shaped window that expands in an expanded configuration . FIG . 17B shows a slit 640’’ having an X-shaped slit in a folded configuration that expands to an hourglass-shaped window in an expanded configuration. FIG. 17C shows a slit 640’’’ having a Y-shaped slit in a folded configuration that expands to a V-shaped window in an expanded configuration. FIGS. 18A-18B and 19 illustrate exemplary embodiments of a flow diversion device 700 configured to apply flow diversion for an aneurysm 750 occurring at a bifurcation point within an artery, such as a cerebral artery. FIG. 18A shows an exemplary bifurcation point 760. FIG. 18B shows a flow diversion device 700 having a scaffold stent 705 including a raised portion or barrel-like segment 710 at a central portion of the scaffold stent 705. The flow diversion device 700 can completely cover an inlet to the aneurysm cavity 750. The raised portion 710 can expand to a larger dimension than required for the blood vessel lumen at the bifurcation point 760. FIG. 19 shows the flow diversion device 700 disposed within a blood vessel 770 at the bifurcation point 760. The flow diversion device 700 contracts and occludes the aneurysm 750 over a period of time. The flow diversion device can include a plurality of slits / windows 740 similar to the slits discussed in relation to FIGS. 15A-17C. The slits / windows 740 of the expanded flow diversion device 700 can permit blood flow to a collateral branch 780.

[0040] FIGS. 20A-20D illustrate embodiments of a flow diversion device for a wide-mouth aneurysm at a bifurcation point. The flow diversion devices of FIGS. 20A-20D are adapted for arterial bifurcation points, such as in cerebral arteries. The flow diversion device 700 can completely cover an inlet to the aneurysm cavity 750. The raised portion 710 can expand to a larger dimension than required for the blood vessel lumen at the bifurcation point 760. FIG. 19 shows the flow diversion device 700 disposed within a blood vessel 770 at the bifurcation point 760. The flow diversion device 700 contracts and occludes the aneurysm 750 over a period of time. The flow diversion device can include a plurality of slits / windows 740 similar to the slits discussed in relation to FIGS. 15A-17C. The slits / windows 740 of the expanded flow diversion device 700 can permit blood flow to a collateral branch 780. The flow diversion device 700 can completely cover an inlet to the aneurysm cavity 750. The raised portion 710 can expand to a larger dimension than required for the blood vessel lumen at the bifurcation point 760. FIG. 19 shows the flow diversion device 700 disposed within a blood vessel 770 at the bifurcation point 760. The flow diversion device 700 contracts and occludes the aneurysm 750 over a period of time. The flow diversion device can include a plurality of slits / windows 740 similar to the slits discussed in relation to FIGS. 15A-17C. The slits / windows 740 of the expanded flow diversion device 700 can permit blood flow to a collateral branch 780. The flow diversion device 700 can completely cover an inlet to the aneurysm cavity 750. The raised portion 710 can expand to a larger dimension than required for the blood vessel lumen at the bifurcation point 760.

[0041] FIGS. 20A-20D illustrate embodiments of a flow diversion device for a wide-mouth aneurysm at a bifurcation point. The flow diversion devices of FIGS. 20A-20D are adapted for arterial bifurcation points, such as in cerebral arteries. may also be used. FIG. 20A shows a flow diversion device 800 that can be Y-shaped and has a proximal rim 801 and two distal rims 802 and 803. The Y-shaped flow diversion device 800 may be in the form of a braided wire device having a plurality of wire elements 805. The braided wire design of the Y-structure creates sufficient flow stagnation within the bifurcation aneurysm, but allows only enough flow to maintain the collateral and perforating patents, and has a self-expanding woven nitinol wire design with countless thin closed wire cells having a cell diameter of less than 0.5 mm. The wire elements 805 may have a diameter of about 75% chromium-cobalt alloy and 25% platinum-tungsten alloy wire and can be manufactured with a diameter of 0.0008 to 0.0017 inches. Each rim 801, 802, and 803 may each have 48 to 60 wires. Two of the rims 802 and 803 of the flow diversion device 800 may extend into the distal branch vessel from under the wide-mouthed saccular aneurysm (see FIGS. 21A - 21C). The proximal rim 801 of the flow diversion device 800 may fix the flow diversion device 800 within the proximal parent vessel of the bifurcation aneurysm. The Y-shaped flow diversion device 800 may be self-expanding. FIGS. 20B - 20D show a Y-shaped flow diversion device 800' comprising a plurality of wire elements 805' that form a zigzag self-expanding wire stent (e.g., made of nitinol and having a wire diameter of about 0.001 inches). The plurality of wires 805' may function as a scaffold for an ultra-thin bifurcated tubular layer of PTFE. FIG. 20

[0042] C shows a Y-shaped flow diverter device 800' in a folded configuration. The flow diverter device 800' may include a plurality of thin slits / windows 840' disposed within an ultrathin branched tubular layer 810'. FIG. 20D shows the Y-shaped flow diverter device 800' in an expanded configuration such that when the flow diverter device 800' is fully expanded, the slits 840' may create diamond-shaped windows within the PTFE layer 810'. These slits / windows 840' (less than 0.5 mm in diameter) are low and may create sufficient flow restriction in the aneurysm cavity to create a final occlusion stagnation. In some embodiments, the Y-shaped flow diverter device may be expanded by a balloon. For example, the device may be composed of a plurality of zigzag wiring elements that create innumerable micro-gaps between the small wires of the zigzag that are small enough to promote flow diversion when the balloon is expanded. The distal flow diverter rim may be crimped to a separate ultra-small profile balloon catheter that proximally mates to a single balloon catheter capable of crimping a proximal balloon-expandable stent. Two distal balloon-expandable rims may advance beyond a separate 0.014-inch guide wire within the arterial rim that forms the bifurcation point. When in place, all three stent rims may be balloon-expanded. Such a balloon-expandable Y-shaped flow diverter may also be provided with a windowed ultrathin PTFE tubular layer that may also act to form flow diversion while maintaining the patency of the side branches and perforating branches. FIGS. 21A - 21C show the Y-shaped flow diverter device 900 treating a bifurcation aneurysm.

[0043] ​​​​​​​​​​​​Shows the process of constriction. Figure 21A shows an aneurysm 95 0 located at the bifurcation point 960 of the blood vessel 970. Figure 21B shows a flow diversion device 9 00 deployed and expanded at the bifurcation point 960. The flow diversion device 900 stagnates the blood flow to the aneurysm 950 but can maintain the patency of the collateral 980. After a certain period such as 6 months, the aneurysm 950 can contract as shown in Figure 21 C.

[0044] An example of the use of such a Y-shaped flow diversion device can be a wide-mouthed aneurysm at the junction between the A2 segment of the anterior cerebral artery, the origin of the internal frontal branch, and the pericallosal artery. It may also be one. When two distal flow diverter rims are positioned at the origins of the internal frontal branch and the pericallosal artery , the proximal rim is deployed within the A2 segment. Flow diversion leads to flow stagnation in the aneurysm lumen (dead-end sac) and the ultimate complexity of this structure. Other examples where the use of a Y-shaped flow diversion device may be useful can be the base tip of an ICA terminal wide-mouthed aneurysm.

[0045] In some embodiments, the flow diversion device may advance to the deployment site via a dissected Y-shaped sheath 1000 as shown in Figures 22A - 22D. The Y-shaped sheath 1000 may include a proximal rim 1001 and two distal rims 1002 and 1003. The Y-shaped sheath 1000 may further have score lines 1005 along the inner surfaces of its distal rims 1002 and 1003 that intersect at the leg portion 1004 of the "Y" of the sheath 1000. The leg portion 1004 of the Y-shaped sheath 1000 further includes small holes or windows 1006. Figure 22B shows the Y-shaped sheath 10 inserted into the bifurcation point 1060 of the vessel to treat the aneurysm 1050 ​​​​ 00. The Y-sheath 1000 is guided through the use of guidewires 1020 and 1030. 22C shows a flow diversion device 1100. 10. The Y-sheath 10 is retracted into the catheter 1010 and removed to deploy the 00. The score line 1005 indicates that the sheath 1000 is inserted proximally into the catheter 1010. When pulled out, the score line 1005 separates or tears. The separation may be assisted by an electrolytic mechanism. Once retracted, the flow diversion device 1100 treats the aneurysm 1050. may be left in place at branch point 1060 for

[0046] Alternatively, the self-expanding Y-structure flow diversion device 1300 may be as shown in FIG. As shown in 3D, the bifurcation aneurysm 12 is secured to the aneurysm via a helical containment strand system 1200. 50. The helical containment strand system 1200 can be introduced into a delivery catheter 1240. and a pusher catheter 1230 may be used to perform flow diversion. This can aid in deploying the device 1300 and the helical containment strand system 1200. The helical containment strand system 1200 includes multiple guidewires 1204 and 1205. The flow diversion device 1300 may include guidewires 1204 and 1205. The helical containment strand system 1200 may be advanced over a polyvinyl alcohol Flexible handrails made of polyvinyl alcohol (PVA), nylon, or Teflon. The helical containment bands 1210 and 1220 may include hypotubes or helical containment bands 1210 and 1220. As shown in FIG. 23A, 10 and 1220 are in a folded configuration or a thin state and restrain the flow diverter version device 1300 of the Y-structure. They can be wound around the periphery of the flow diverter device 13 00 of the Y-structure and are allowed to advance to the deployed position as shown in FIG. 23A. The first helical receiving band 1210 may be wound around the proximal sheath rim 1201 and the distal sheath rim 1202. The second helical receiving band 12 20 may be wound around the proximal sheath rim 1201 and the distal sheath rim 1203. The distal ends of the thin helical receiving bands 1210 and 1220 are distal receiving stoppers (olives) 1214 and 1224 that suppress the flow diverter device 1300 of the self-expanding Y-structure, and may include distal receiving rings 1212 and 1222 respectively coupled thereto. The distal receiving rings 1212 and 1222 may have a ring shape surrounding the flow diverter device 1300. The distal receiving stops 1214 and 1224 may include lumens to which the guide wires 1204 and 1205 can be coupled. As shown in FIG. 23B, the distal receiving stops 1214 and 1224 may be separated from the distal receiving rings 1212 and 1222 by either electrolysis or mechanical separation. After separation between the distal receiving rings 121 2 and 1222 and the distal receiving stops 1214 and 1224, the helical receiving bands 1210 and 1220 are pulled in a proximally oriented direction, allowing the flow diverter device 1300 of the Y-structure to expand as shown in FIG. 2 3C. The helical receiving bands 1210 and 1220 can be pulled in a proximally oriented direction, while the distal receiving rings 1212 and 1 222 remain. The helical receiving bands 1210 and 1220 are pulled in a proximally oriented direction, allowing the flow diverter device 1300 of the Y-structure to expand as shown in FIG. 2 3C. The helical receiving bands 1210 and 1220 can be pulled in a proximally oriented direction, while the distal receiving rings 1212 and 1 When the distal receiving rings 222 reach the legs 1306 of the Y-structure, it may open or break along the predetermined axial seams 1213 and 1223. FIG. 2 3D shows the flow diversion device 1300 of the Y-structure in the deployed or expanded configuration.

[0047] In some embodiments, prior to deployment, the patient may be treated with oral aspirin and Plavix or another suitable antiplatelet drug regimen and may be heparinized during the procedure. The insertion procedure can be initiated with an intermediate-sized delivery catheter (4-4.5F, outer diameter) advancing into the parent vessel just proximal to the bifurcation aneurysm. Next, a 0.014-inch diameter exchange guide wire can be advanced into the distal arterial rim of the bifurcation. Over these exchange guide wires, the bifurcation flow diversion device (its various iterations) is advanced through the intermediate catheter until it reaches a sufficient position adjacent to the ostium of the bifurcation aneurysm. Then, the device is deployed and its delivery catheter is removed. Thereafter, the patient is maintained on an antiplatelet drug regimen, e.g., aspirin and clopidogrel or prasugrel. The patient may undergo a 6-month cerebral angiogram to evaluate aneurysm occlusion.

[0048] Self- or balloon-expandable Y-shaped flow diversion devices made from braided or woven wires or myriad zigzag wirings may also be useful at other locations such as the biliary system, the bifurcation of the trachea (carina), the site of a tumor, etc. The Y-shaped flow diversion device is coated with yttrium and then the beta-emitting isotope Y is generated 90 It may be placed in a nuclear reactor or other high-energy particle environment that can be obtained. Such a Y structure is used to kill both biliary obstructions (e.g., due to cholangiocarcinoma) and tumor cells with beta rays and can be used. Y 90 The branched blood vessel stent impregnated with is useful for combating the development of in-stent stenosis using beta radiation and may be useful.

[0049] Figure 24 shows a stent-like device including a plurality of wire elements 1405, each individual wire element 1405 is formed into an oval ring pattern and interwoven with other oval ring patterns to show an embodiment of a flow diversion device 1400 that is a stent-like device. Each individual wire element 1405 may be joined or welded to an adjacent wire element 1405 at a joining position 1410 to form a generally tubular stent structure. The oval ring structure shown in FIG. 24 may be beneficial for the flexibility intended in the previously discussed Y-structure flow diversion device and may be beneficial.

[0050] The subject matter disclosed in any part of this specification can be combined with the subject matter of one or more other parts of this specification and this is intended, provided that such combinations are not mutually exclusive or impossible to implement. In addition, many variations, improvements, and modifications of the concepts described herein are possible.

[0051] The terms and descriptions used above are described merely by way of example and are not meant to be limiting. Those skilled in the art will recognize that many variations can be made to the details of the above embodiments without departing from the principles underlying the invention and will recognize that many variations can be made to the details of the above embodiments without departing from the principles underlying the invention. ​​​

Claims

1. A bifurcated flow diversion device, comprising a woven wire stent frame formed from a plurality of wire elements, said woven wire stent frame having a Y-shaped configuration, said Y-shaped configuration being covered by a peelable Y-shaped sheath, said peelable Y-shaped sheath comprising two distal sheath rims and a proximal sheath rim, said two distal sheath rims and said proximal sheath rim each having a score line along an inner surface, said score lines intersecting at a window in a leg of said peelable Y-shaped sheath, said score lines being configured to be separable when said peelable Y-shaped sheath is pulled in the direction of said proximal sheath rim, said window exposing said woven wire stent frame.

2. The bifurcated flow diversion device according to claim 1, wherein said plurality of wire elements form diamond-shaped gaps in an expanded configuration.

3. The bifurcated flow diversion device according to claim 1, wherein the diameter of said plurality of wire elements is 0.0127 cm or less.

4. The bifurcated flow diversion device according to claim 1, wherein said plurality of wire elements for each of said proximal sheath rim and said at least two distal sheath rims of said woven wire stent frame includes 48 to 60 wires.

5. The bifurcated flow diversion device according to claim 1, wherein said wire stent frame is made of nitinol.

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