Vascular occlusion device

Abstract

A vascular occlusion device that occludes blood flow in a vascular system having high blood pressure or high blood flow. The vascular occlusion device may comprise a support frame that withstands high blood pressure or high flow. The support frame may comprise a central portion, a distal support arm extending distally from the ring portion, and a proximal support arm extending proximally from the ring portion. In one embodiment, the distal support arm may comprise one or more distal hinges, and the proximal support arm may comprise one or more proximal hinges. In another embodiment, the distal support arm and the proximal support arm may each comprise a helical coil.

Description

Background Art

[0001] There are several reasons why vascular occlusion is desirable. Situations where vascular occlusion is desirable include, for example, treatment of aneurysms, left atrial appendage, atrial septal defect, fistula, patent foramen ovale, patent ductus arteriosus, treatment of vascular occlusion, or treatment aimed at various occlusions in the neurovascular and peripheral vascular systems. Vascular occlusion devices are more likely to fail in larger-sized vascular systems (e.g., with a diameter of 16 - 22 millimeters) when blood pressure is high or blood flow is high.

Summary of the Invention

[0002] The present invention generally relates to vascular plugs.

[0003] In some exemplary embodiments, the vascular plug is composed of a braided mesh portion that expands from a generally linear configuration to a three-dimensional shape. For example, the mesh portion can expand into a generally spherical, concave, flat elliptical, or shape of a plurality of connected bulbs.

[0004] The vascular plug may include a flexible membrane that unfolds inside the mesh portion during expansion. For example, the flexible membrane may be composed of a circular flat membrane disposed substantially perpendicular to the linear axis of the vascular plug. In another example, the flexible membrane may expand at a position non-perpendicular to the linear axis of the vascular plug.

[0005] In some exemplary embodiments, the flexible membrane is composed of PET, ePTFE, or a thin metal membrane.

[0006] In some exemplary embodiments, the vascular plug may include an elastic member within the mesh portion to assist in the expansion of the vascular plug within the patient's body.

[0007] In some exemplary embodiments, the vascular plug may include a support frame to assist in withstanding high blood pressure and increased blood flow in large vascular systems.

[0008] In some examples, the support frame may include a central portion for supporting the membrane. In some examples, the central portion may be a substantially circular ring.

[0009] In some exemplary embodiments, the support frame may include a distal support arm having at least one hinge when the vascular plug is deployed. In some such exemplary embodiments, the distal support arm may include one or more hinges such as an upper distal hinge and a lower distal hinge.

[0010] In some exemplary embodiments, the support frame may include a proximal support arm having at least one hinge when the vascular plug is deployed. In some such exemplary embodiments, the proximal support arm may include one or more hinges such as an upper proximal hinge and a lower proximal hinge.

[0011] In some exemplary embodiments, the upper distal hinge may be at a higher position relative to the ring portion than the upper proximal hinge, and the lower distal hinge may be at a higher position relative to the ring portion than the lower proximal hinge.

[0012] In some exemplary embodiments, each hinge may comprise a curved portion of each of the distal support arm and the proximal support arm. These curved portions may curve upward or downward.

[0013] In some exemplary embodiments, the hinge functions as a joint, buffer, shock absorber, spring, movable part, more flexible region, etc. for maintaining the structural integrity of the support frame and the interconnected flexible membrane under high pressure or increased flow rate.

[0014] In some exemplary embodiments, the proximal support arm and the distal support arm may extend in opposite directions from the central portion to which the flexible membrane is connected.

[0015] In some exemplary embodiments, the support frame including the central portion, the proximal support arm, the distal support arm, and the hinge may all be formed from a pair of wires.

[0016] In some exemplary embodiments, the support frame may include a proximal coil and / or a distal coil that function as springs.

[0017] The present invention also relates to a method of deploying a vascular plug having a support frame within a patient's vasculature.

[0018] In some exemplary embodiments, the vascular occlusion device may include two or more membranes, and each membrane may support at least one membrane.

[0019] In some exemplary embodiments, the vascular occlusion device may include a first membrane and a second membrane.

[0020] In some exemplary embodiments, the first membrane and the second membrane may be arranged linearly.

[0021] In some exemplary embodiments, the first membrane and the second membrane may have substantially the same shape and / or dimensions.

[0022] In some exemplary embodiments, the first membrane and the second membrane may be interconnected by at least one support arm.

[0023] In some exemplary embodiments, at least one support arm connecting the first membrane and the second membrane may be configured in an inverted U shape.

[0024] In some exemplary embodiments, at least one support arm connecting the first membrane and the second membrane may be configured in a U shape.

[0025] In some exemplary embodiments, at least one support arm connecting the first membrane and the second membrane may be configured in an S shape.

[0026] In some exemplary embodiments, at least one support arm connecting the first membrane and the second membrane may be constituted by a pair of wires.

[0027] In some exemplary embodiments, the vascular occlusion device may include a single lobe or mesh portion, and two or more membranes may be disposed inside the lobe or mesh portion.

[0028] In some exemplary embodiments, the vascular occlusion device may include a plurality of lobes or mesh portions, and one or more membranes may be disposed inside each of the lobes or mesh portions.

[0029] In some exemplary embodiments, the vascular occlusion device may include a pair of lobes or mesh portions, where the first lobe or mesh portion may have a low braiding density and the second lobe or mesh portion may have a high braiding density.

[0030] In some exemplary embodiments, the internal support frame of the vascular occlusion device may include a flexible segment formed from a coil or the like.

Brief Description of the Drawings

[0031] These and other aspects, features, and advantages of the embodiments of the present invention will become apparent and clear from the following description of the embodiments of the present invention.

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[0059] Hereinafter, specific embodiments of the present invention will be described with reference to the accompanying drawings. However, the present invention may be implemented in many different forms and should not be construed as limited to the embodiments described herein. Rather, these exemplary embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the present invention to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present invention. In the drawings, like numbers refer to like elements.

[0060] Vascular plugs are used for various occlusions within the vascular system. Generally, these plugs have a shape that conforms to the blood vessel or the abnormal site of the blood vessel, thereby occluding and preventing blood flow through or to the target area. Plugs can be used to treat various conditions including aneurysms, left atrial appendage, atrial septal defect, fistula, patent foramen ovale, patent ductus arteriosus, vascular occlusion, and for various occlusions in the neurovascular and peripheral vascular systems.

[0061] Vascular plugs generally do not fill the target lumen but rather conform to the shape of the target lumen to facilitate more rapid occlusion, enabling more rapid occlusion than other occlusion devices such as embolization coils. Vascular plugs are generally larger than other occlusion devices (such as embolization coils) because the device is not configured to fill the target lumen but rather to conform to the target lumen. Due to the larger outer shape, problems can occur when delivering it compared to other occlusion devices. Therefore, vascular plugs need to balance the need for rapid occlusion and the ease of delivery in order to effectively deliver the plug to the treatment site targeted.

[0062] Specific examples of embodiments will be described below. However, it should be understood that any of the features in the embodiments can be mixed and combined with each other in any combination. Therefore, the present invention should not be limited to only these embodiments, and broader combinations are possible.

[0063] Figures 1 to 12 show various aspects of the vascular plug 100 connected to the distal end of the pusher 120, whereby the plug 100 can be advanced through the catheter 125 to the target position in the patient. When the mesh portion 102 of the vascular plug 100 is expanded, the flexible membrane 104 is also expanded within the mesh portion 102 to form an occlusion or barrier at the target position. The flexible membrane 104 may assist in occlusion by having a function of promoting the thrombus formation reaction after placement.

[0064] Figures 1-4 illustrate embodiments of an expandable vascular plug 100 for use in occluding a vascular system. Figures 5-6 illustrate embodiments of a support frame 110 of the vascular plug 100. Figure 7 shows the vascular plug 100 compressed and in a linear shape within a catheter 125. Figures 8-9 show the vascular plug 100 in its expanded shape. Figures 10-12 show another exemplary embodiment of the support frame 110 of the vascular plug 100.

[0065] The mesh portion 102 has a radially compressed shape when constrained within the catheter 125 and assumes a radially expanded shape when unconstrained. Thus, the mesh portion 102 may expand from an elongated compressed cylindrical or linear shape (e.g., when disposed within the catheter 125) to a shape that is expanded and shorter in the longitudinal direction. The expanded shape may generally be spherical or may be various other regular or irregular shapes that conform to various vascular systems, such as generally cylindrical (but not limited to) as shown in the figures. The mesh portion 102 may have an internal space whose volume increases when the mesh portion 102 expands to its expanded shape.

[0066] The wires of the mesh portion 102 can be formed from a variety of materials such as nitinol, cobalt chrome, stainless steel wire, or combinations thereof, but are not limited thereto. In one embodiment, the mesh portion 102 may be composed of 48-144 nitinol wires having a diameter in the range of about 0.0008-0.005 inches. Optionally, one or more radiopaque wires may be used to form the mesh portion 102 to further improve the visibility of the vascular plug 100 during the procedure.

[0067] As can be best seen in FIGS. 1-4, a proximal end of the mesh portion 102 may be provided with a proximal cap member 103A at the end, and a distal end of the mesh portion 102 may be provided with a distal cap member 103B at the end. The proximal cap member 103A and the distal cap member 103B may be formed or manufactured in various ways. As an example, the proximal cap member 103A and the distal cap member 103B can be formed by bundling and welding the wires of the mesh portion 102, welding individual metal caps to the wires, crimping metal caps to the wires, or attaching individual caps to the wires using an adhesive. In an exemplary embodiment, the proximal cap member 103A and the distal cap member 103B may be at least partially composed of a radiopaque material so as to be used as a marker visible to a physician during the procedure. The proximal cap member 103A may be configured to engage (e.g., removably connect or couple) with a pusher 120.

[0068] Referring to FIGS. 1 and 3, the vascular plug 100 may include a flexible membrane 104 that expands upon deployment. The membrane 104 may assume a radially expanded shape when the mesh portion 102 assumes a radially expanded shape, thereby restricting the passage of fluid (e.g., blood) through the mesh portion 102.

[0069] The shape of the membrane 104 upon deployment may vary depending on the embodiment. In the illustrated exemplary embodiment, the flexible membrane 104 may have a circular shape upon deployment. However, any other shape may be utilized as long as it is a shape capable of occluding the vascular system. Generally, the shape of the membrane 104 when deployed and expanded substantially conforms to the shape of the central portion 111 to which the membrane 104 is attached.

[0070] The flexible membrane 104 may be composed of a material that can be deployed, straightened, or stretched, or any material that can be expanded into a large, preferably flat area. The flexible membrane 104 may be composed of various flexible materials that are biocompatible and increase the thrombogenic response useful for forming occlusions in patients. For example, polyethylene terephthalate (PET) or expanded polytetrafluoroethylene (ePTFE) can be used. In another exemplary embodiment, a composite of PET and ePTFE can be used. In another exemplary embodiment, the flexible membrane 104 can be composed of a thin metal film created by methods such as sputtering or vacuum deposition.

[0071] As shown in FIGS. 1-4, the flexible membrane 104 may be supported by a support frame 110. The support frame 110 may be disposed within the internal cavity of the mesh portion 102. As described in more detail below, the support frame 110 may be formed of a pair of elastic wires 110A, 110B that are adjustable between a linear shape (such as fitting within the catheter 125 with the entire body compressed) and an expanded shape (such as the shape after being expanded within the vascular system). The elastic wires 110A, 110B may be composed of various flexible and elastic materials such as nitinol, without limitation. Elastic wires 110A, 110B are available in various sizes (e.g., diameters) and may be 12 mm or more in some embodiments. However, in some embodiments, the size of the elastic wires 110A, 110B may be less than 12 mm.

[0072] It will be understood that the systems and methods related to the support frames 110, 210 of the vascular plugs 100, 210 shown and / or described in this application can be utilized in a wide variety of vascular plugs 100, 200 having various shapes, orientations, materials, and configurations. As an example, the systems and methods described in this application can be utilized in any of the exemplary embodiments of the "Vessel Occluder" shown and described in U.S. Patent No. 10,470,773. U.S. Patent No. 10,470,773 is hereby incorporated by reference in its entirety.

[0073] Figures 5 and 6 show an exemplary embodiment of the support frame 110 of the vascular plug 100. As best seen in FIG. 5, an exemplary embodiment of the support frame 110 may include a central portion 111. The illustrated central portion 111 includes a ring portion, which may be circular in shape when expanded. However, in some exemplary embodiments, the central portion 111 may have other shapes (e.g., square, oval, etc.) suitable for different vascular systems.

[0074] The central portion 111 may be oriented such that the plane of the central portion 111 is generally perpendicular to the axis between the proximal and distal ends of the mesh portion 102 (e.g., the longitudinal axis between the proximal cap member 103A and the distal cap member 103B). By orienting it in this way, the flexible membrane 104 expands almost completely across the entire cavity of the mesh portion 102, blocking the passage of the patient's fluid between the proximal and distal ends of the vascular plug 100. However, the flow of fluid relative to the flexible membrane 104 may sometimes shift the flexible membrane 104 during use, which is oriented at a right angle, and the flexible membrane 104 may be at a non-right angle to the longitudinal axis extending to the vascular plug 100.

[0075] The central portion 111 may expand to a size or diameter similar to the maximum inner diameter region of the mesh portion 102 when expanded. In some exemplary embodiments, the central portion 111 may expand to a size slightly larger than the inner diameter of the vascular system in which the vascular plug 100 is deployed. Accordingly, the diameter of the membrane 104 may be larger than the size of the target blood vessel. Such a shape is desirable because as a fluid such as blood flows across the membrane 104, it will cause the central portion 111 to shift slightly from the right-angle plane. By ensuring that the central portion 111 is slightly larger than the inner diameter of the vascular system 130 in which the vascular plug 100 is deployed, even if the fluid flows across the membrane 104 and shifts the central portion 111, the entire vascular system 130 is reliably covered (e.g., without gaps).

[0076] How to fix the flexible membrane 104 to the central part 111 varies depending on the embodiment. In some exemplary embodiments, the flexible membrane 104 may be fixed to the central part 111 by forming a laminate layer on the flexible membrane 104 and forming the laminate layer to wrap around the wires 110A and 110B of the central part 111 and return to itself. For example, depending on the embodiment, the flexible membrane 104 may be first formed of PET. Thereafter, an ePTFE layer may be disposed or laminated on the PET layer and the central part 111. Alternatively, the flexible membrane 104 may be sewn to the central part 111 with metal wires, polymer fibers, etc. In another exemplary embodiment, various adhesives may be used to fix the flexible membrane 104 to the central part 111. In another exemplary embodiment, the membrane 104 may be coupled to a polymer sleeve on the central part 111 formed of a heat-shrinkable plastic such as PET or cross-linked PET. In another exemplary embodiment, a PET heat-shrinkable tube (PET HS tube) may be used under the membrane 104, thereby preventing the membrane 104 from slipping around the frame 110 and enabling it to be coupled to the ePTFE / PET-ePTFE layer. In yet another exemplary embodiment, the flexible membrane 104 may be directly sewn or adhered to the mesh portion 102, such as the wire forming the mesh portion 102.

[0077] In exemplary embodiments as shown in FIGS. 5 and 6, the central part 111 may be supported by a proximal support arm 112 and a distal support arm 113. The proximal support arm 112 may extend from the central part 111 in a first direction (e.g., the proximal direction), and the distal support arm 113 may extend from the central part 111 in a second direction (e.g., the distal direction), i.e., the opposite direction. The first direction is the proximal direction, and the second direction is the distal direction. As shown in FIGS. 1 to 4, one end of the proximal support arm 112 may be connected to the proximal side cap member 103A. Similarly, one end of the distal support arm 113 may be connected to the distal side cap member 103B.

[0078] Although a support frame 110 having a single proximal support arm 112 and a single distal support arm 113 is illustrated, in an exemplary embodiment of the support frame 110, additional proximal support arms 112 and / or distal support arms 113 may be provided according to the application. For example, in some embodiments, the support frame 110 may include two or more proximal support arms 112 and two or more distal support arms 113. In such embodiments, the two or more proximal support arms 112 may converge at a proximal cap member, and the two or more distal support arms 113 may converge at a distal cap member.

[0079] As best seen in FIGS. 5 and 6, the proximal support arm 112 may include one or more proximal hinges 112A, 112C connected by one or more ascending connecting portions 112B or descending connecting portions 112D. These proximal hinges 112A, 112C may function as other connection structures that prevent breakage of the vascular plug 100 under high pressure or high flow conditions, which are common in large vascular systems, by absorbing forces due to joints, shock absorbers, springs, elastic assist members, movable parts, more flexible regions, or fluid flow, and assisting the elasticity of the support frame 110.

[0080] In one exemplary embodiment, the proximal support arm 112 may include a first proximal hinge 112A and a second proximal hinge 112C. The first proximal hinge 112A may constitute an upper proximal hinge 112A, and the second proximal hinge 112C may constitute a lower proximal hinge 112C. Thus, in the exemplary embodiment, the first proximal hinge 112A may form a peak, and the second proximal hinge 112C may form a valley.

[0081] In the illustrated exemplary embodiment, the first and second proximal hinges 112A, 112C each have a rounded (e.g., semi-circular) curve. More specifically, it can be seen that the first proximal hinge 112A is composed of a downward curve (generally also referred to as a concave curve, a convex upward curve, or a concave downward curve), and the second proximal hinge 112C is composed of an upward curve (generally also referred to as a convex curve, a convex downward curve, or a concave upward curve). However, it will be understood that depending on different embodiments, the shapes of the proximal hinges 112A, 112C can be different. For example, in some embodiments, the proximal hinges 112A, 112C may each form a triangular or square shape.

[0082] Referring to FIG. 6, the first and second proximal hinges 112A, 112C may extend between the first hinge 112A and the second hinge 112C and be connected to each other by a first connecting portion 112B that connects them. Thus, the first connecting portion 112B may be composed of a downward elongated member that connects the peak of the first proximal hinge 112A and the valley of the second proximal hinge 112C. Similarly, the second hinge 112C and the central portion 111 may be connected by a second connecting portion 112D. Thus, the second connecting portion 112D may be composed of an upward elongated member that connects the valley of the second proximal hinge 112C and the central portion 111.

[0083] Continuing to refer to FIGS. 5 and 6, it can be seen that the distal support arm 113 may similarly include one or more distal hinges 113A, 113C connected by one or more upward connecting portions 113B or downward connecting portions 113D. These distal hinges 113A, 113C may function as joints, shock absorbers, springs, elastic assist members, movable parts, more flexible regions, or other connection structures that assist the elasticity of the support frame 110 and prevent damage to the blood vessel plug 100 under high pressure or high flow conditions that are common in large vascular systems.

[0084] In one exemplary embodiment, the distal support arm 113 may include a first distal hinge 113A and a second distal hinge 113C. The first distal hinge 113A may be constituted by a lower distal hinge 113A, and the second distal hinge 113C may be constituted by an upper distal hinge 113C. Thus, in the exemplary embodiment, the first distal hinge 113A may constitute a peak, and the second distal hinge 113C may constitute a valley.

[0085] In the illustrated embodiment, the first and second distal hinges 113A, 113C each have a rounded (e.g., semi-circular) curve. More specifically, it can be seen that the first distal hinge 113A is constituted by an upward curve, and the second distal hinge 113C is constituted by a downward curve. However, it will be understood that depending on different embodiments, the shapes of the distal hinges 113A, 113C may be different. For example, in some embodiments, the distal hinges 113A, 113C may each constitute a triangular or square shape.

[0086] As shown, the second proximal hinge 112C may be closer to the central portion 111 and the membrane 104 than the first proximal hinge 112A. Similarly, the second distal hinge 113C may be closer to the central portion 111 and the membrane 104 than the first distal hinge 113A.

[0087] As shown in FIG. 6, the first and second distal hinges 113A, 113C of the distal support arm 113 may extend between the first distal hinge 113A and the second distal hinge 113C and may be connected to each other by a first connecting portion 113B that connects them. Thus, the first connecting portion 113B may be constituted by an upward elongated member that connects the valley of the first distal hinge 113A and the peak of the second distal hinge 113C. Similarly, the second distal hinge 113C and the central portion 111 may be connected by a second connecting portion 113D. Thus, the second connecting portion 113D may be constituted by a downward elongated member that connects the peak of the second distal hinge 113C and the central portion 111.

[0088] The distal support arm 113 may be symmetric or a mirror image of the proximal support arm 112. However, depending on the embodiment, the proximal support arm 112 and the distal support arm 113 may not be mirror images of each other or may not be symmetric. Although exemplary embodiments have been described and shown for the specific shapes, orientations, and positions of the hinges 112A, 112C, 113A, 113C and the connecting portions 112B, 112D, 113B, 113D of the proximal support arm 112 and the distal support arm 113 respectively, it will be understood that various other shapes, orientations, and positions can be utilized depending on the different embodiments. For example, as described above, the arrangement of the first proximal hinge 112A having a downward curve or peak and the second distal hinge 113C, and the second proximal hinge 112C having an upward curve or valley and the second distal hinge 113A may be the reverse arrangement in some exemplary embodiments.

[0089] Therefore, it will be understood from the foregoing description and the accompanying drawings that the described content and the illustrated content may be reversed. For example, the first proximal hinge 112A of the proximal support arm 112 may form a valley, and the second proximal hinge 112C of the proximal support arm 112 may form a peak. Similarly, the first distal hinge 113A of the distal support arm 113 may form a peak, and the second distal hinge 113C of the distal support arm 113 may form a valley.

[0090] In the figure, it is shown that the proximal support arm 112 includes a pair of proximal hinges 112A and 112C, and the distal support arm 113 includes a pair of distal hinges 113A and 113C. However, it will be understood that in exemplary embodiments, one or both of the proximal support arm 112 and / or the distal support arm 113 may include additional hinges 112A, 112C, 113A, 113C. For example, the proximal support arm 112 may include three or more proximal hinges 112A, 112C, and / or the distal support arm 113 may include three or more distal hinges 113A, 113C. It is preferable that each of the proximal support arm 112 and the distal support arm 113 includes an even number of hinges 112A, 112C, 113A, 113C. However, in exemplary embodiments, one or both of the proximal support arm 112 and the distal support arm 113 may include only a single hinge 112A, 113A.

[0091] Referring to FIG. 6, it can be seen that the first proximal hinge 112A may be lower in height than the second distal hinge 113C, and the second proximal hinge 112C may be higher in height than the first distal hinge 113A. However, in embodiments, various other configurations can be utilized. For example, the reverse configuration can also be used, in which case the first proximal hinge 112A may be higher in height than the second distal hinge 113C, and the second proximal hinge 112C may be lower in height than the first distal hinge 113A. In another exemplary embodiment, the first proximal hinge 112A may be the same height as the second distal hinge 113C, and the second proximal hinge 112C may be the same height as the first distal hinge 113A.

[0092] Continuing to refer to FIG. 6, it can be seen that each of the proximal and distal connecting portions 112B, 112D, 113B, 113D may extend in an angled orientation. More specifically, the first proximal connecting portion 112B may be angled or curved toward the second proximal connecting portion 112D, or the second proximal connecting portion 112D may be angled or curved toward the first proximal connecting portion 112B. The first distal connecting portion 113B may be angled or curved toward the second distal connecting portion 113D, or the second distal connecting portion 113D may be angled or curved toward the first distal connecting portion 113B. Depending on the embodiment, instead of this, one or more of the connecting portions 112B, 112D, 113B, 113D may extend linearly (e.g., vertically) rather than obliquely.

[0093] Referring to the angles of each of the hinges 112A, 112C, 113A, 113C and the angles of each of the connecting portions 112B, 112D, 113B, 113D, it will be understood that these angles can vary depending on the embodiment. In the illustrated exemplary embodiment, these angles are each shown as forming acute angles. However, these angles may be larger or smaller than those shown in the illustrated exemplary embodiment. For example, the angle between the first and second proximal connecting portions 112B, 112D and / or the angle between the first and second distal connecting portions 113B, 113D may be larger or smaller than that shown in FIG. 6.

[0094] As best seen in FIG. 5, the support frame 110 is generally formed from a pair of wires 110A, 110B and may be fixed to each other in various ways. More specifically, it can be seen that the first wire 110A and the second wire 110B may be fused in parallel to form a proximal support arm 112 having proximal hinges 112A, 112C and proximal connections 112B, 112D. Then, the wires 110A, 110B are separated from each other to form a central portion 111 and then fused again to form a distal support arm 113 having distal hinges 113A, 113C and distal connections 113B, 113D. In such an embodiment, the entire support frame 110 including the support arms 112, 113, hinges 112A, 112C, 113A, 113C, and connections 112B, 112D, 113B, 113D may be integrally formed from a pair of wires 110A, 110B.

[0095] FIGS. 7-9 illustrate embodiments of a vascular plug 100 for use in occluding a vasculature 130. During operation, a catheter 125 having a pusher 120 therein may be advanced through a patient's vasculature 130 (e.g., a blood vessel or lumen) until the distal end of the catheter 125 is adjacent to a target occlusion site as shown in FIG. 7. By way of example, the distal end of the catheter 125 may be positioned within or at the mouth of an aneurysm.

[0096] As shown in FIG. 7, the vascular plug 100 may be delivered to the vasculature 130 in a compressed, compact, linear, cylindrical configuration. In an exemplary embodiment, the vascular plug 100 may be disposed within the catheter 125 for delivery, and the catheter 125 may be advanced through the vasculature 130 by an elongate pusher 120. Various types of catheters 125 are available for delivering the vascular plug 100. By way of example, in some embodiments, TERUMO GLIDECATH 4F, 5F, 5F XP catheters may be utilized to deliver the vascular plug 100, but are not limited thereto.

[0097] After reaching the occlusion site, the vascular plug 100 is exposed at the distal end of the catheter 125, and the pusher 120 may be advanced distally (or the catheter 125 may be retracted as necessary) so as to be disposed at a desired occlusion site (e.g., within an aneurysm or within a blood vessel). When the vascular plug 100 is exposed, the mesh portion 102 and the flexible membrane 104 may be expanded to substantially block the flow of body fluids such as blood passing therethrough.

[0098] FIG. 8 shows an exemplary embodiment of the expanded vascular plug 100 before delivery to the occlusion site and removal of the pusher 120. As shown, the pusher 120 may be removably connected to the proximal end of the vascular plug 100, e.g., to the proximal cap member 103A. As shown in FIG. 8, the vascular plug 100 may be expanded to an expanded shape as the pusher 120 is advanced or the catheter 125 is retracted. Generally, the expanded vascular plug 100 is disposed to substantially cover the inner diameter of the vasculature 130 at the occlusion site.

[0099] After delivering the vascular plug 100 to the occlusion site, the pusher 120 may be removed from the vascular plug 100 and withdrawn from the vasculature 130. The method of removing the pusher 120 may vary depending on the embodiment. As an example, a removal system as shown and described in U.S. Patent Publication Nos. 8182506, US20060200192, US20100268204, US20110301686, US20150289879, US20151073772, and US20150173773 (all of which are incorporated by reference in their entirety) may be utilized.

[0100] However, alternatively, in some exemplary embodiments, the vascular plug 100 may be used only temporarily. In such exemplary embodiments, the vascular plug 100 is temporarily deployed within the vasculature 130 and then withdrawn into the catheter 125. For example, it may be beneficial to use the vascular plug 100 to temporarily occlude a space within a patient's vasculature during an endovascular procedure (e.g., while placing a coil, while delivering a liquid embolization agent).

[0101] FIG. 9 shows the expanded vascular plug 100 removed from the pusher 120, and the pusher 120 is not shown as it has been withdrawn previously. As shown in FIG. 9, body fluids such as blood may form thrombi on both the membrane 104 and the mesh portion 102. The structure and shape of the support frame 110 with hinges 112A, 112C, 113A, 113C function to maintain the vascular plug 100 in a predetermined position to cover the inner diameter of the vasculature 130 with the membrane 104 even when the diameter of the vasculature 130 is large (e.g., 8 - 22 millimeters) and is susceptible to high pressure and / or high flow.

[0102] FIGS. 10 - 12 illustrate additional exemplary embodiments of the support frame 110 of the vascular plug 100. In such exemplary embodiments, the proximal support arm 112 may include a proximal coil 115 and the distal support arm 113 may include a distal coil 116. However, it will be understood that in some embodiments, the vascular plug 100 may include only one of the proximal coil 115 or the distal coil 116. For example, in some embodiments, the proximal support arm 112 may include the proximal coil 115 and the distal support arm 113 may not include the distal coil 116.

[0103] In the exemplary embodiments shown in FIGS. 10 to 12, it can be seen that an exemplary embodiment of the vascular plug 100 may be composed of a support frame 110 having a central portion 111 to which the membrane 104 can be fixed. The central portion 111 may form a circular structure like a ring or may have various other shaped structures as described above. It can be understood that the support frame 110 shown in FIGS. 10 to 12 may be disposed (not shown) within the mesh portion 102 as tactically arranged.

[0104] Continuing to refer to FIGS. 10 to 12, the proximal coil 115 may be formed in the proximal direction from the central portion 111, and the distal coil 116 may be formed in the distal direction from the central portion 111. The proximal coil 115 and the distal coil 116 may function as springs that individually or together absorb or resist the force due to the fluid flow to maintain the optimal position and orientation (e.g., perpendicular or slightly off-axis orientation) of the membrane 104 for occluding the vascular system 130.

[0105] In the illustrated embodiment, the winding of the proximal coil 115 may have a decreasing diameter in the proximal direction from the central portion 111. The winding of the distal coil 116 may have a decreasing diameter in the distal direction from the central portion 111. The proximal coil 115 and the distal coil 116 may be connected to each other at their widest segments.

[0106] In an exemplary embodiment, the proximal coil 115 and the distal coil 116 may be mirror images of each other or substantially similar. In another embodiment, the proximal coil 115 and the distal coil 116 may not be mirror images and may not be substantially similar. In such embodiments, the widest diameter and the narrowest diameter, the number of turns, the rate of width reduction, the effective length, and / or various other characteristics of each of the proximal coil 115 and the distal coil 116 may be different from each other.

[0107] The proximal coil 115 and the distal coil 116 may each comprise one or more wires 110A. In the exemplary embodiments shown in FIGS. 10-12, a single wire 110A may form both the proximal coil 115 and the distal coil 116. In such an embodiment, a single wire 110A may be thermally fixed in shape to a second shape composed of the proximal support arm 112, the proximal coil 115 formed from a helical winding with an increasing diameter, the distal coil 116 formed from a helical winding with a decreasing diameter, and the distal support arm 113. In another embodiment, two or more wires 110A, 110B may be connected to each other and thermally fixed in shape to a desired helical coil shape either separately or together.

[0108] The central portion 111 of the support frame 110 of the vascular plug 100 may constitute a circular or oval ring in which the proximal coil 115 extends in the proximal direction and the distal coil 116 extends in the distal direction. In the exemplary embodiments shown in FIGS. 10-12, the central portion 111 consists of a pair of identical concentric rings spaced apart from each other. The membrane 104 may be fixed to the circular or oval ring of the central portion 111 or to a pair of identical concentric rings by various methods described above in this application. In an exemplary embodiment, the distance between the pair of rings forming the central portion 111 may be substantially the same as the width of the membrane 104, and the membrane 104 may be sandwiched between the pair of rings forming the central portion 111.

[0109] Referring to FIGS. 10-12, the widest winding of the proximal coil 115 may be connected to the first ring of the central portion 111 by the proximal connector 115A, and the widest winding of the distal coil 116 may be connected to the second ring of the central portion 111 by the distal connector 116A. The proximal connector and the distal connector may be integrally formed from the same single wire 110A forming the proximal coil 115 and the distal coil 116, or may be composed of separate wire segments.

[0110] The proximal connector 115A and the distal connector 116A may extend at various angles. In an exemplary embodiment, the proximal connector 115A and the distal connector 116A may each extend at a right angle between the proximal coil 115 and the distal coil 116 and the central portion 111 (not shown). The figures show an embodiment in which the proximal connector 115A is disposed at the top of the support frame 110 of the blood vessel plug 100 and the distal connector 116A is disposed at the bottom. However, it will be understood that the proximal connector 115A and the distal connector 116A may be disposed at various other positions in the radial periphery and are not limited to the specific configuration shown in the illustrated exemplary embodiment.

[0111] The method of manufacturing the support frame 110 may vary depending on the embodiment. In an exemplary embodiment, the support frame 110 may be heat-fixed to a desired shape such that the support frame 110 naturally forms into the desired shape when unrestrained. For example, fixtures such as tapered mandrels may be used to manufacture the embodiments shown in FIGS. 10-12, whereby one or more wires 110A, 110B may be heat-fixed into the desired spiral coils as shown, but is not limited thereto.

[0112] FIGS. 13-23 show additional exemplary embodiments of the blood vessel plug 200, and a plurality of membranes 204A, 204B may be used. It will be understood that any or all of the functions and features such as the formation, composition, orientation, arrangement, size, etc. of the membranes described above with respect to FIGS. 1-12 are equally applicable to the additional embodiments shown in FIGS. 13-23 and described below. On the other hand, it will be understood that any or all of the functions and features described below with respect to FIGS. 13-23 are equally applicable to the embodiments described above with respect to FIGS. 1-12.

[0113] By using multiple membranes, the occlusion performance of various peripheral embolization products can be improved, and the potential impact on the overall length of the device and tracking performance can be minimized. Figures 13 to 15, Figures 18 to 19, and Figure 24 show exemplary embodiments of a single-lobe vascular plug 200 having multiple membranes 204A, 204B within a single mesh portion 202. Figures 21 to 23 show exemplary embodiments of a double-lobe vascular plug 250, where a pair of different mesh portions 250A, 250B each have their own internal membranes 254A, 254B.

[0114] Figures 13 to 15 show exemplary embodiments of the vascular plug 200. The vascular plug 200 may include a pair of membranes 204A, 204B that can be deployed within the mesh portion 202. In the exemplary embodiment shown in Figure 13, only two membranes 204A, 204B are shown, but it will be understood that two or more membranes, such as three or more, may be utilized in any of the exemplary embodiments of the vascular plugs 100, 200 illustrated and / or described in this application.

[0115] Continuing to refer to Figures 13 to 15, it can be seen that the vascular plug 200 may include a mesh portion 202. The mesh portion 202 may be adjustable between at least two shapes. For example, the mesh portion 202 may be adjustable between a folded shape for delivery and / or retrieval and an expanded shape for deployment within the body. Although the mesh portion 202 is shown as having a substantially tubular cylindrical shape in Figure 13, it will be understood that the expanded shape of the mesh portion 202 may have various other shapes.

[0116] The mesh portion 202 may include an internal space, and the volume of the internal space may be larger in the expanded shape than in the folded shape. The support frame 210 may be disposed in the internal space of the mesh portion 202, and the support frame 210 may similarly be adjustable between a folded shape and an expanded shape. The support frame 210 may include one or more membrane supports 211A, 211B, and may support one or more membranes 204A, 204B, respectively. As an example, the support frame 210 may include a first membrane support 204A that supports the first membrane 204A and a second membrane support 204B that supports the second membrane 204B.

[0117] Figures 16-17 show exemplary embodiments of the support frame 210 of the blood vessel plug 200. As shown, the support frame 210 may include one or more support arms 212, 213, 214. The first (proximal) support arm 212 may be sized and shaped to fit within the proximal region inside the mesh portion 202. The second (distal) support arm 213 may be sized and shaped to fit within the distal region inside the mesh portion 202. The third (intermediate) support arm 214 may be sized and shaped to fit within the intermediate region inside the mesh portion 202 between the first support arm 212 and the second support arm 213. The third support arm 214 may have a substantially S-shaped configuration.

[0118] Continuing to refer to Figures 16-17, it can be seen that the support frame 210 includes one or more membrane supports 211A, 211B, each configured to support one or more membranes 204A, 204B. In the exemplary embodiment shown, the first membrane support 211A may support the first membrane 204A, and the second membrane support 211B may support the second membrane 204B. However, in some embodiments, one or more of the membrane supports 211A, 211B may support two or more of these membranes 204A, 204B.

[0119] The shapes, sizes, orientations, and positions of the membrane supports 211A and 211B can vary in different embodiments and should not be construed as being limited by the exemplary embodiments shown in the figures. In the exemplary embodiments, the membrane supports 211A and 211B may have substantially the same shape and / or substantially the same dimensions. In another exemplary embodiment, one or more of the membrane supports 211A and 211B may have a different shape and / or different dimensions from one or more of the remaining membrane supports 211A and 211B.

[0120] In the exemplary embodiments shown in FIGS. 16 to 17, it can be seen that the membrane supports 211A and 211B may have a substantially circular or ring shape. The shape of the membrane supports 211A and 211B may be the same as the cross-sectional shape of the mesh portion 202. In the figures, the membranes 204A and 204B are shown as having substantially the same shape as the membrane supports 211A and 211B to which they are attached, but it will be understood that in some embodiments, the shapes of the membranes 204A and 204B may be different from those of the membrane supports 211A and 211B. Generally, the membrane supports 211A and 211B in the exemplary embodiments shown in FIGS. 16 to 17 may have the same features as, for example, the central portion 111 shown in FIGS. 5 to 6.

[0121] As shown in FIGS. 13 to 17, the support frame 210 may be composed of a proximal support arm 212, a first membrane support 211A, an intermediate support arm 214, a second membrane support 211B, and a distal support arm 213. However, it will be understood that more or fewer support arms 212, 213, 214 may be utilized depending on the embodiment. Furthermore, more or fewer membrane supports 211A and 211B may be utilized depending on the embodiment, as previously described in this application.

[0122] The proximal support arm 212 may be sized and shaped to at least partially conform to the proximal segment within the mesh portion 202. As best seen in FIGS. 13-15, the first or proximal end of the proximal support arm 212 may be secured within the proximal cap 203A. The second or distal end of the mesh portion 202 may be attached to or integrated with the first membrane support 211A. Thus, the proximal support arm 212 may extend between the proximal end of the mesh portion 202 and the first membrane support 211A.

[0123] The distal support arm 213 may be sized and shaped to at least partially conform to the distal segment within the mesh portion 202. As best seen in FIGS. 13-15, the first or proximal end of the distal support arm 213 may be attached to or integrated with the second membrane support 211B. The second or distal end of the distal support arm 213 may be secured within the distal cap 203B. Thus, the distal support arm 213 may extend between the distal end of the mesh portion 202 and the second membrane support 211B of the membrane support.

[0124] The intermediate support arm 214 may be sized and shaped to at least partially conform to the intermediate segment within the mesh portion 202. The intermediate support arm 214 may function to connect the first membrane support 211A and the second membrane support 211B to each other, as shown in FIGS. 13-17. In the exemplary embodiment shown, the intermediate support arm 214 may extend in a substantially diagonal orientation, such as between the upper end of the first membrane support 211A and the lower end of the second membrane support 211B, or vice versa. However, alternatively, in some embodiments, the intermediate support arm 214 may extend linearly, such as parallel to a longitudinal axis extending through the center of the mesh portion 202. The intermediate support arm 214 may also extend in various other orientations, as described in more detail below.

[0125] Referring to FIGS. 13 to 15, in some exemplary embodiments, the proximal support arm 212 and the distal support arm 213 may each extend in an arc along a substantially diagonal path. For example, the proximal support arm 212 may extend downward in an arc between the proximal cap 203A and the lower end of the first membrane support 211A. On the other hand, the distal support arm 213 may extend downward in an arc between the upper end of the second membrane support 211B and the distal cap 203B. However, various other orientations can be utilized for one or both of the proximal support arm 212 and the distal support arm 213, depending on the exemplary embodiment.

[0126] The number of wires forming the support frame 210 may vary depending on the embodiment. FIG. 14 shows an exemplary embodiment in which the support frame 210 is formed by a single wire 210A and is thermally fixed to expand to the expanded shape shown when unrestrained. FIGS. 15 to 17 show exemplary embodiments in which the support frame 210 can be formed by a pair of wires 210A, 210B. In such exemplary embodiments, the first wire 210A and the second wire 210B may extend in proximity to each other to form the support arms 212, 213, 214, or may branch to form the membrane supports 211A, 211B.

[0127] FIG. 16 shows an embodiment in which the wires 210A, 210B are arranged slightly spaced apart from each other with respect to segments of the support arms 212, 213, 214 of the support frame 210. FIG. 17 shows an embodiment in which the wires 210A, 210B are fixed to each other to form pairs of wires 210A, 210B for segments of the support arms 212, 213, 214 of the support frame 210. Depending on the embodiment, three or more wires 210A, 210B may be used to form all or part of the support frame 210.

[0128] Figures 18 to 20 show exemplary embodiments of the vascular plug 200 with a slightly modified support frame 210 as compared to the exemplary embodiments described above. In such exemplary embodiments, the proximal support arm 212 and the distal support arm 213 may each extend substantially linearly across the proximal segment and the distal segment inside the mesh portion 202, and may have a steeper inclination immediately before transitioning to the membrane supports 211A, 211B or immediately before connecting to the membrane supports 211A, 211B.

[0129] Also, the intermediate support arm 214 may form an inverted U shape, and the first end of the intermediate support arm 214 may be integrated with or attached to the lower end of the first membrane support 211A, and the second end of the intermediate support arm 214 may be integrated with or attached to the lower end of the second membrane support 211B. It can also be seen that an inverted shape can be used, and the intermediate support arm 214 may instead form a U shape, the first end of the intermediate support arm 214 may be integrated with or attached to the upper end of the first membrane support 211B, and the second end of the intermediate support arm 214 may be integrated with or attached to the upper end of the second membrane support 211B.

[0130] Figures 18 to 19 show exemplary embodiments in which the support frame 210 can be formed of a single wire. Figure 20 shows an exemplary embodiment in which the support frame 210 can be formed of a pair of wires 210A, 210B. As shown in Figure 20, the pair of wires 210A, 210B may be fastened or fixed to each other by means of fasteners, clamps, bands, etc. It will be understood that a similar configuration can be utilized in any of the other embodiments illustrated and / or described in the present application. It will also be understood that one or more fasteners, clamps, bands, etc. may be formed of a radiopaque material to form a radiopaque marker for visualization purposes.

[0131] Figures 21 to 23 and Figures 25 to 27 show exemplary embodiments of the multi-lobe vascular plug 250, which includes a first mesh portion 250A and a second mesh portion 250B, and each of the mesh portions 250A and 250B has an interior in which a membrane 254A, 254B can be disposed. In the illustrated embodiment, it can be seen that the first mesh portion 250A may have a first membrane 254A, and the second mesh portion 250B may have a second membrane 254B.

[0132] Using multiple lobes in the vascular plug 250 can be beneficial over a single-lobe design. One lobe can provide radial force and stability, and the other lobe can provide a more dense braid. By adding lobes, the device can be tailored to a specific procedure, such as using the first lobe to enter the aneurysmal sac space and deploying additional lobes into the inflow or outflow vessels. Making the stiffness of the lobes variable (e.g., each lobe having a different stiffness) may allow opportunities to optimize tracking, reduce recoil force, minimize "jumping" during delivery, and reduce the overall profile of the device.

[0133] To enhance the occlusion effect, an internal membrane may be disposed inside one or both of the lobes. A mismatch in length between the folded internal membrane and the folded external braided structure may be addressed, for example, by using flexible springs or laser-cut hypo tubes at one or both ends of the internal wireframe to match the lengths. Such a configuration allows for greater flexibility in following torsion.

[0134] FIG. 21 shows an exemplary embodiment of a vascular plug 250 having a double-lobe, single-membrane design. As shown in FIG. 21, the vascular plug 250 may include a first mesh portion 250A and a second mesh portion 250B. The first mesh portion 250A and the second mesh portion 250B may be interconnected with each other and may be separated in an interconnect region 255 where the diameter is reduced as compared to the mesh portions 250A, 250B themselves. One or more membranes may be disposed inside one or both of the mesh portions 250A, 250B and / or inside the interconnect region 255 between the two mesh portions 250A, 250B (not shown). The proximal side of the first mesh portion 250A may terminate at a proximal cap 253A, and the distal side of the second mesh portion 250B may terminate at a distal cap 253B.

[0135] It will be appreciated that the braiding density of each mesh portion 250A, 250B, i.e., the number of picks per inch, may be different. Thus, the first (proximal) mesh portion 250A may have a higher braiding density than the second (distal) mesh portion 250B, or vice versa. In this way, the mesh portion 250A with a lower density may enhance the radial force for stability, and the mesh portion 250B with a higher density may weaken the radial force by including more wires and / or wires with a smaller diameter in the braided portion.

[0136] The method of interconnecting the two lobes, or the two mesh portions 250A, 250B, may vary depending on the embodiment. Generally, the interconnect region 255 between the two mesh portions 250A, 250B may include a junction. In an exemplary embodiment, the lumens may be laser welded to the interconnect region 255 to connect the two mesh portions 250A, 250B while maintaining the passageway therebetween.

[0137] FIG. 22 shows an exemplary embodiment of a vascular plug 250 having a double lobe, double membrane design. As shown in FIG. 22, the vascular plug 250 may include a first mesh portion 250A having a first membrane 254A and a second mesh portion 250B having a second membrane 254B. The first mesh portion 250A and the second mesh portion 250B may be interconnected with each other and may be separated at an interconnect region 255 where the diameter is reduced as compared to the mesh portions 250A, 250B themselves. The proximal side of the first mesh portion 250A may end at a proximal cap 253A, and the distal side of the second mesh portion 250B may end at a distal cap 253B.

[0138] As in the embodiments described above, the first mesh portion 250A may have a density different from that of the second mesh portion 250B. Further, the respective dimensions of the mesh portions 250A, 250B and / or the membranes 254A, 254B may be different from each other (e.g., the diameter or length of the first mesh portion 250A may be different from that of the second mesh portion 250B).

[0139] FIG. 23 shows another exemplary embodiment of a vascular plug 250 having a double lobe, double membrane design. In the illustrated embodiment, the interconnect region 255 between the two mesh portions 250A, 250B may include one or more connectors 255A, 255B such as fasteners, clamps, bands, joints, etc., to interconnect the two mesh portions 250A, 250B with each other.

[0140] FIG. 24 shows an exemplary embodiment of a vascular plug 250 having a single lobe, double membrane design. As shown in FIG. 24, the single tubular mesh portion 250A may include an internal space, and in the internal space, a spiral support frame 260 that supports a pair of membranes 254A, 254B, or a single membrane 254A extending along the length of the spiral frame 260 may be disposed.

[0141] FIG. 25 shows an exemplary embodiment of a vascular plug 250 exiting a delivery device 300, the vascular plug 250 may have a first mesh portion 250A with a loose (low density) braided pattern and a second mesh portion 250B with a denser braided pattern. The interconnect region between the mesh portions 250A, 250B may include a connector 255A, and in some embodiments, the connector 255A may be radiopaque for visualization purposes.

[0142] FIG. 26 shows the use of a multi-lobe vascular plug 250 in the treatment of a saccular aneurysm 450 of a blood vessel 400. As shown, the first mesh portion 250A may be disposed within the blood vessel 400 adjacent to the aneurysm 450, and the second mesh portion 250B may be disposed within the aneurysm 450 itself. Another vascular plug 350 may be deployed in the inflow or outflow vessel 450.

[0143] FIG. 27 shows a multi-lobe vascular plug 250 including a single membrane. As shown in FIG. 27, a support frame 260 may extend across between the two mesh portions 250A, 250B, and a membrane support 261 may be disposed on the first mesh portion 250A. The support frame 260 may include a flexible segment 265, which may assist in a uniform and consistent folding of the internal and external structures even if each of the mesh portions 250A, 250B has different properties (e.g., density or dimensions). The flexible segment 265 may comprise a coil and may be integrated with or attached to the support frame 260. The membrane support 261 is shown as being disposed inside the first (proximal) mesh portion 250A, but in some embodiments, an additional membrane support 261 may be disposed inside the second (distal) mesh portion 250B. In another exemplary embodiment, each mesh portion 250A, 250B may include its own membrane.

[0144] Claims:

[0145] Embodiments are described in the following numbered claims.

[0146] Claim 1: A vascular plug for treating a patient, comprising a mesh portion having a radially compressed shape, a radially expanded shape, and an interior, a proximal support arm disposed in a proximal region inside the mesh portion, the proximal support arm having a first proximal hinge, a distal support arm disposed in a distal region inside the mesh portion, the distal support arm having a first distal hinge, and a membrane supported by the proximal support arm and the distal support arm inside the mesh portion.

[0147] Claim 2: A vascular plug for treating a patient according to claim 2, wherein the first distal hinge has a concave upward curve.

[0148] Claim 3: A vascular plug for treating a patient according to claim 2, wherein the first distal hinge has a concave upward curve.

[0149] Claim 4: A vascular plug for treating a patient according to claim 1, further comprising a second distal hinge.

[0150] Claim 5: A vascular plug for treating a patient according to claim 1, further comprising a second proximal hinge.

[0151] Claim 6: A vascular plug for treating a patient according to claim 1, further comprising a second distal hinge and a second proximal hinge.

[0152] Claim 7: A vascular plug for treating a patient according to claim 6, wherein the first proximal hinge has a concave downward curve and the second proximal hinge has a concave upward curve.

[0153] Claim 8: A vascular plug for treating a patient according to claim 7, wherein the first distal hinge has a concave upward curve and the second distal hinge has a concave downward curve.

[0154] Item 9: A vascular plug for treating the patient according to Item 8, wherein the second proximal hinge is closer to the membrane than the first proximal hinge, and the second distal hinge is closer to the membrane than the first distal hinge.

[0155] Item 10: A vascular plug for treating the patient according to Item 6, wherein the first proximal hinge is lower in height than the second distal hinge.

[0156] Item 11: A vascular plug for treating the patient according to Item 10, wherein the second proximal hinge is lower in height than the first distal hinge.

[0157] Item 12: A vascular plug for treating the patient according to Item 6, wherein the proximal support arm includes a first proximal connecting portion extending between the first proximal hinge and the second proximal hinge, and a second proximal connecting portion extending between the second proximal hinge and the membrane.

[0158] Item 13: A vascular plug for treating the patient according to Item 12, wherein the distal support arm includes a first distal connecting portion extending between the first distal hinge and the second distal hinge, and a second distal connecting portion extending between the second distal hinge and the membrane.

[0159] Item 14: A vascular plug for treating the patient according to Item 1, further comprising a central portion for supporting the membrane, wherein the proximal support arm extends proximally from the central portion, and the distal support arm extends distally from the central portion.

[0160] Item 15: A vascular plug for treating a patient, comprising an elongated pusher, a mesh portion connected to the distal end of the elongated pusher, the mesh portion having a radially compressed shape when constrained within a catheter and assuming a radially expanded shape when unconstrained, a support frame disposed within the mesh portion, the support frame having a central portion, a proximal support arm connected to the proximal side of the central portion and extending from the proximal side of the central portion, and a distal support arm connected to the distal side of the central portion and extending from the distal side of the central portion, and a membrane fixed to the central portion, the membrane assuming a radially expanded shape when the mesh portion assumes a radially expanded shape. The proximal support arm comprises a first proximal movable segment and a second proximal movable segment, and the distal support arm comprises a first distal movable segment and a second distal movable segment.

[0161] Item 16: A vascular plug for treating a patient according to Item 15, wherein the first proximal movable segment has a concave downward curve, the second proximal movable segment has a concave upward curve, the first distal movable segment has a concave upward curve, and the second distal movable segment has a concave downward curve.

[0162] Item 17: A vascular plug for treating a patient according to Item 15, wherein the first proximal movable segment, the second proximal movable segment, the first distal movable segment, and the second distal movable segment each comprise a hinge, a joint, or a spring.

[0163] Item 18: A vascular plug for treating a patient according to Item 15, wherein the support frame is formed of only two wires.

[0164] Item 19: A support frame for a vascular plug, comprising a ring portion that supports a membrane, a proximal support arm connected to the proximal side of the ring portion and extending from the proximal side of the ring portion, the proximal support arm having a first buffer portion that absorbs a force generated from the flow of blood against the membrane, and a distal support arm connected to the distal side of the ring portion and extending from the distal side of the ring portion, the distal support arm having a second buffer portion that absorbs a force generated from the flow of blood against the membrane.

[0165] Item 20: The support frame for a vascular plug according to Item 19, wherein the first buffer portion comprises a proximal helical coil, and the second buffer portion comprises a distal helical coil.

[0166] Item 21: A vascular plug for treating a patient, comprising a first mesh portion that forms a first lobe, a second mesh portion that forms a second lobe, and an interconnecting region having a reduced diameter compared to the first mesh portion and the second mesh portion.

[0167] Item 22: The vascular plug according to Item 21, wherein the first mesh portion has a first braiding density, the second mesh portion has a second braiding density, and the first braiding density is different from the second braiding density.

[0168] Item 23: The vascular plug according to Item 22, wherein the first braiding density is higher than the second braiding density.

[0169] Item 24: The vascular plug according to Item 22, wherein the first braiding density is lower than the second braiding density.

[0170] Item 25: The vascular plug according to Item 21, further comprising a first membrane inside the first mesh portion and a second membrane inside the second mesh portion.

[0171] Item 26: The vascular plug according to Item 21, further comprising a membrane inside the first mesh portion.

[0172] Item 27: The vascular plug according to Item 21, further comprising a membrane inside the second mesh portion.

[0173] Item 28: The vascular plug according to Item 21, wherein the interconnecting region comprises a junction.

[0174] Item 29: The vascular plug according to Item 21, further comprising a passage interconnecting the first mesh portion, the second mesh portion, and the interconnecting region.

[0175] Item 30: The vascular plug according to Item 21, wherein the interconnecting region comprises a connector.

[0176] Item 31: The vascular plug according to Item 30, wherein the connector includes a radiopaque marker.

[0177] Item 32: The vascular plug according to Item 21, including a support frame inside the first mesh portion and the second mesh portion.

[0178] Item 33: The vascular plug according to Item 32, wherein the support frame comprises a membrane support.

[0179] Item 34: The vascular plug according to Item 33, wherein the membrane support is disposed inside the first mesh portion.

[0180] Item 35: The vascular plug according to Item 32, wherein the distal portion of the support frame includes a flexible segment.

[0181] Item 36: The vascular plug according to Item 35, wherein the flexible segment comprises a coil.

[0182] The present invention has been described with respect to specific embodiments and uses, but those skilled in the art can generate additional embodiments and modifications in light of this teaching without departing from the spirit of the invention claimed or exceeding its scope. Therefore, it should be understood that the drawings and descriptions herein are provided as an example to facilitate understanding of the present invention and should not be construed as limiting its scope.

Claims

1. A vascular plug for treating a patient, comprising: a mesh portion having a radially compressed shape, a radially expanded shape, and an interior; a proximal support arm disposed in a proximal region of the interior of the mesh portion, the proximal support arm comprising a first proximal hinge; a distal support arm disposed in a distal region of the interior of the mesh portion, the distal support arm comprising a first distal hinge; and a membrane supported by the proximal support arm and the distal support arm within the interior of the mesh portion.

2. A vascular plug for treating a patient according to claim 1, wherein the first proximal hinge has a concave downward curve.

3. A vascular plug for treating a patient according to claim 2, wherein the first distal hinge has a concave upward curve.

4. A vascular plug for treating a patient according to claim 1, further comprising a second distal hinge.

5. A vascular plug for treating a patient according to claim 1, further comprising a second proximal hinge.

6. A vascular plug for treating a patient according to claim 1, further comprising a second distal hinge and a second proximal hinge.

7. A vascular plug for treating a patient according to claim 6, The vascular plug, wherein the first proximal hinge has a concave downward curve and the second proximal hinge has a concave upward curve. **Claim 8** A vascular plug for treating a patient according to claim 7, wherein the first distal hinge has a concave upward curve and the second distal hinge has a concave downward curve. **Claim 9** A vascular plug for treating a patient according to claim 8, wherein the second proximal hinge is closer to the membrane than the first proximal hinge, and the second distal hinge is closer to the membrane than the first distal hinge. **Claim 10** A vascular plug for treating a patient according to claim 6, wherein the first proximal hinge has a height lower than that of the second distal hinge. **Claim 11** A vascular plug for treating a patient according to claim 10, wherein the second proximal hinge has a height lower than that of the first distal hinge. **Claim 12** A vascular plug for treating a patient according to claim 6, wherein the proximal support arm includes a first proximal connecting portion extending between the first proximal hinge and the second proximal hinge, and a second proximal connecting portion extending between the second proximal hinge and the membrane. **Claim 13** A vascular plug for treating a patient according to claim 12, wherein the distal support arm includes a first distal connecting portion extending between the first distal hinge and the second distal hinge, and a second distal connecting portion extending between the second distal hinge and the membrane. **Claim 14** A vascular plug for treating a patient according to claim 1, further comprising a central portion for supporting the membrane, the proximal support arm extending proximally from the central portion, and the distal support arm extending distally from the central portion, a vascular plug characterized by this.

15. A vascular plug for treating a patient, an elongated pusher, a mesh portion connected to the distal end of the elongated pusher, having a radially compressed shape when constrained within a catheter and a radially expanded shape when unconstrained, the mesh portion, a support frame disposed inside the mesh portion, having a central portion, a proximal support arm connected to the proximal side of the central portion and extending from the proximal side of the central portion, and a distal support arm connected to the distal side of the central portion and extending from the distal side of the central portion, the support frame, a membrane fixed to the central portion, the membrane having a radially expanded shape when the mesh portion has a radially expanded shape, comprising. The proximal support arm comprises a first proximal movable segment and a second proximal movable segment, The distal support arm comprises a first distal movable segment and a second distal movable segment, a vascular plug characterized by this.

16. A vascular plug for treating a patient according to claim 15, the first proximal movable segment has a concave downward curve, the second proximal movable segment has a concave upward curve, the first distal movable segment has a concave upward curve, and the second distal movable segment has a concave downward curve, a vascular plug characterized by this.

17. A vascular plug for treating a patient according to claim 15, The vascular plug is characterized in that the first proximal movable segment, the second proximal movable segment, the first distal movable segment, and the second distal movable segment each include a hinge, a joint, or a spring.

18. A vascular plug for treating a patient according to claim 15, wherein the support frame is formed of only two wires.

19. A support frame for a vascular plug, including a ring portion for supporting a membrane, a proximal support arm connected to the proximal side of the ring portion and extending from the proximal side of the ring portion, the proximal support arm having a first buffer portion for absorbing a force generated from the flow of blood against the membrane, a distal support arm connected to the distal side of the ring portion and extending from the distal side of the ring portion, the distal support arm having a second buffer portion for absorbing a force generated from the flow of blood against the membrane, and characterized by comprising the distal support arm.

20. A support frame for a vascular plug according to claim 19, wherein the first buffer portion includes a proximal helical coil and the second buffer portion includes a distal helical coil.

21. A vascular occlusion device, including a mesh portion having a radially compressed shape, a radially expanded shape, and an interior, a support frame disposed inside the mesh portion, the support frame including a first membrane support and a second membrane support, a first membrane supported by the first membrane support, and a second membrane supported by the second membrane support, and characterized by comprising the second membrane.

22. A vascular occlusion device according to claim 21, The vascular occlusion device, wherein the first membrane support has dimensions substantially the same as those of the second membrane support.

23. The vascular occlusion device according to claim 21, wherein the first membrane support has dimensions larger than those of the second membrane support, the vascular occlusion device being characterized thereby.

24. The vascular occlusion device according to claim 21, wherein the first membrane support has a shape substantially the same as that of the second membrane support, the vascular occlusion device being characterized thereby.

25. The vascular occlusion device according to claim 24, wherein the first membrane support and the second membrane support are each configured in a circular shape, the vascular occlusion device being characterized thereby.

26. The vascular occlusion device according to claim 21, wherein the first membrane support has a shape different from that of the second membrane support, the vascular occlusion device being characterized thereby.

27. The vascular occlusion device according to claim 21, wherein the support frame is composed of only two wires, the vascular occlusion device being characterized thereby.

28. The vascular occlusion device according to claim 21, wherein the support frame includes a proximal support arm disposed in a proximal region inside the mesh portion and a distal support arm disposed in a distal region inside the mesh portion, the vascular occlusion device being characterized thereby.

29. The vascular occlusion device according to claim 28, wherein the proximal support arm is connected to the proximal side of the first membrane support and extends from the proximal side of the first membrane support, the vascular occlusion device being characterized thereby.

30. The vascular occlusion device according to claim 29, wherein the distal support arm is connected to the distal side of the second membrane support and extends from the distal side of the second membrane support, and the vascular occlusion device is characterized in that.

31. The vascular occlusion device according to claim 30, wherein the support frame includes an intermediate support arm connected between the first membrane support and the second membrane support, and the vascular occlusion device is characterized in that.

32. The vascular occlusion device according to claim 31, wherein the support frame includes a proximal support arm connected to the first membrane support and a distal support arm connected to the second membrane support, and the vascular occlusion device is characterized in that.

33. The vascular occlusion device according to claim 31, wherein one end of the intermediate support arm is connected to the upper end of the first membrane support, and the other end is connected to the lower end of the second membrane support, and the vascular occlusion device is characterized in that.

34. The vascular occlusion device according to claim 31, wherein the intermediate support arm is formed by a first wire and a second wire, and the vascular occlusion device is characterized in that.

35. The vascular occlusion device according to claim 34, wherein the first wire abuts against the second wire to form a wire pair, and the vascular occlusion device is characterized in that.

36. The vascular occlusion device according to claim 34, wherein the first wire is spaced apart from the second wire, and the vascular occlusion device is characterized in that.

37. The vascular occlusion device according to claim 31, wherein The first end of the intermediate support arm is connected to the lower end of the first membrane support, and the second end of the intermediate support arm is connected to the lower end of the second membrane support. A vascular occlusion device characterized by this.

38. A vascular occlusion device according to claim 37, wherein the intermediate support arm includes an inverted U shape. A vascular occlusion device characterized by this.

39. A vascular occlusion device, a mesh portion having a radially compressed shape, a radially expanded shape, and an interior, a proximal support arm disposed in the proximal region of the interior of the mesh portion, a distal support arm disposed in the distal region of the interior of the mesh portion, a first membrane supported by the proximal support arm within the interior of the mesh portion, a second membrane supported by the distal support arm within the interior of the mesh portion, and an intermediate support arm connected between the first membrane and the second membrane. A vascular occlusion device characterized by comprising these.

40. A vascular occlusion device according to claim 39, wherein the intermediate support arm is configured in an inverted U shape. A vascular occlusion device characterized by this.

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