Vascular occlusion device

Abstract

A vascular occlusion device for occluding blood flow in vasculature with higher blood pressure or increased blood flow velocity. The vascular occlusion device may include a support frame for withstanding higher blood pressure or increased flow rates. The support frame may include a central portion, a distal support arm extending in a distal direction from the ring portion, and a proximal support arm extending in a proximal direction from the ring portion. In one embodiment, the distal support arm may include one or more distal hinges, and the proximal support arm may include one or more proximal hinges. In another embodiment, the distal support arm and the proximal support arm may each include a helical coil.

Description

Background Art

[0001] Vascular occlusion may be desirable for a variety of reasons. Exemplary situations where vascular occlusion may be desirable include treatment of aneurysms, left atrial appendages, atrial septal defects, fistulas, patent foramen ovale, patent ductus arteriosus, vascular closures, or various occlusion purposes in the neurovasculature and peripheral vasculature. Vascular occlusive devices may be susceptible to malfunction in vasculature having larger sizes (e.g., up to 16-22 mm in diameter) and having higher blood pressure or increased blood flow. Summary of the invention

[0002] The present invention generally relates to a vascular plug.

[0003] In some example embodiments, the vascular plug includes a braided mesh portion that expands from a generally linear configuration to a three-dimensional shape. For example, the mesh portion can expand to a generally spherical shape, a concave shape, a flattened oval shape, or a plurality of connected spheroids.

[0004] The vascular plug may include a flexible membrane disposed within the mesh portion when expanded. For example, the flexible membrane may include a circular flat membrane arranged substantially perpendicular to the linear axis of the vascular plug. In another example, the flexible membrane may expand to a position that is not perpendicular to the axis of the vascular plug.

[0005] In some example embodiments, the flexible film may be composed of PET, ePTFE, or a thin metal film.

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

[0007] In some example embodiments, a vascular plug may include a scaffold to help withstand higher blood pressure and increased blood flow in the larger vasculature.

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

[0009] In some example embodiments, the support frame may include a distal support arm having at least one hinge when the vascular plug is deployed. In some such example 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, when the vascular plug is deployed, the support frame can include a proximal support arm having at least one hinge. In some such exemplary embodiments, the proximal support arm can 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 have a higher height relative to the ring portion than the upper proximal hinge, and the lower distal hinge may have a higher height relative to the ring portion than the lower proximal hinge.

[0012] In some example embodiments, the hinges may each include a curved portion of the respective distal support arm and the proximal support arm. Such a curved portion may be an upward curve or a downward curve.

[0013] In some example embodiments, the hinges function as joints, dampers, shock absorbers, springs, articulated regions, regions of increased flexibility, etc., to maintain the structural integrity of the support frame and interconnected flexible membranes under high pressures or increased flow rates.

[0014] In some exemplary embodiments, the proximal support arm and the distal support arm may extend in opposite directions from a central portion of the flexible membrane connection.

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

[0016] In some exemplary embodiments, the support frame can include a proximal coil and / or a distal coil that can act as a spring.

[0017] The present invention also relates to a method of deploying a vascular plug having a stent within the vasculature of a patient.

[0018] In some exemplary embodiments, a vaso-occlusive device may include two or more membrane supports, each membrane support supporting at least one membrane.

[0019] In some exemplary embodiments, a vaso-occlusive device may include a first membrane and a second membrane.

[0020] In some example embodiments, the first film and the second film may be linearly aligned.

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

[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 film and the second film may include an inverted U-shape.

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

[0025] In some example embodiments, at least one supporting arm connecting the first film and the second film may include an S-shape.

[0026] In some example embodiments, at least one support arm connecting the first film and the second film may include a pair of wires.

[0027] In some exemplary embodiments, a vaso-occlusive device may include a single leaf or mesh portion having two or more membranes within the leaf or mesh portion.

[0028] In some exemplary embodiments, a vaso-occlusive device may include a plurality of leaves or mesh portions, each of which has one or more membranes disposed within the interior thereof.

[0029] In some exemplary embodiments, a vaso-occlusive device may include a pair of leaves or mesh portions, including a first leaf or mesh portion having a lower weave density and a second leaf or mesh portion having a higher weave density.

[0030] In some example embodiments, an inner support frame of a vaso-occlusive 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 that can be achieved by embodiments of the present invention will become apparent and will be explained in the following description of embodiments of the present invention with reference to the accompanying drawings, in which:

[0032] Figure 1 is an isometric view of a vascular occlusive device according to one embodiment of the present invention;

[0033] Figure 2 is a side view of a vascular occlusive device according to one embodiment of the present invention;

[0034] Figure 3 is an end view of a vascular occlusive device according to one embodiment of the present invention;

[0035] Figure 4 is a side view of a vascular occlusive device attached to a push rod according to one embodiment of the present invention;

[0036] Figure 5 is an isometric view of a support frame for a vascular occlusive device according to one embodiment of the present invention;

[0037] Figure 6 is a side view of a support frame for a vascular occlusive device according to one embodiment of the present invention;

[0038] Figure 7 is a side view of a vascular occlusive device inserted into a vasculature in a compact configuration according to one embodiment of the present invention;

[0039] Figure 8is a side view of a vascular occlusive device deployed in vasculature according to one embodiment of the present invention;

[0040] Fig. 9 is a side view of a vascular occlusive device for use in a vascular system according to one embodiment of the present invention;

[0041] Fig.10 is an isometric view of a support frame and a membrane for a vascular occlusive device according to one embodiment of the present invention;

[0042] Fig.11 is an isometric view of a support frame for a vascular occlusive device according to one embodiment of the present invention;

[0043] Fig.12 is a side view of a support frame for a vascular occlusive device according to one embodiment of the present invention;

[0044] Fig.13 is an isometric view of a vascular occlusive device according to one embodiment of the present invention;

[0045] Fig.14 is a side view of a vascular occlusive device according to one embodiment of the present invention;

[0046] Fig.15 is a side view of a vascular occlusive device according to one embodiment of the present invention;

[0047] Fig.16 is an upper perspective view of a support frame for a vascular occlusive device according to one embodiment of the present invention;

[0048] Fig.17 is a perspective view of a support frame for a vascular occlusive device according to one embodiment of the present invention;

[0049] Fig.18 is a perspective view of a vascular occlusive device according to one embodiment of the present invention;

[0050] Fig.19 is a side view of a vascular occlusive device according to one embodiment of the present invention;

[0051] Fig. 20 is a perspective view of a support frame for a vascular occlusive device according to one embodiment of the present invention;

[0052] Fig.21 is a side view of a vascular occlusive device according to one embodiment of the present invention;

[0053] Fig. 22 is a perspective view of a vascular occlusive device according to one embodiment of the present invention;

[0054] Fig.23 is a side view of a vascular occlusive device according to one embodiment of the present invention;

[0055] Fig.24 is a side view of a vascular occlusive device according to one embodiment of the present invention;

[0056] Fig.25 is a side view of a vascular occlusive device according to one embodiment of the present invention;

[0057] Fig.26 is a side view of a vascular occlusive device deployed in vasculature according to one embodiment of the present invention;

[0058] Fig. 27 is a side view of a vascular occlusive device according to one embodiment of the present invention. DETAILED DESCRIPTION

[0059] Specific embodiments of the present invention will now be described with reference to the accompanying drawings. However, the present invention can be implemented in many different forms and should not be construed as being limited to the embodiments described herein; on the contrary, these embodiments are provided to make the present disclosure thorough and complete and to 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 accompanying drawings, the same numbers represent the same elements.

[0060] Vascular plugs are used for various occlusive purposes in the vasculature. These plugs typically conform to the shape of a blood vessel or vascular abnormality, thereby blocking and preventing blood flow through or to a target area. Plugs can be used to treat a variety of conditions, including aneurysms, left atrial appendages, atrial septal defects, fistulas, patent foramen ovale, patent ductus arteriosus, vascular closures, or can also be used for various occlusive purposes in the neurovasculature and peripheral vasculature.

[0061] Vascular plugs typically provide faster occlusion than other occlusive devices, such as embolic coils, because the plug conforms to the shape of the target space, rather than filling the target space, thereby promoting faster occlusion. Vascular plugs are typically larger than other occlusive devices, such as embolic coils, because they are designed to conform to the target space, rather than fill the target space. This larger profile compared to other occlusive devices can make delivery an issue, and therefore, vascular plugs need to balance the need for rapid occlusion with the need for ease of delivery in order to effectively deliver the plug to the target treatment site.

[0062] Specific example embodiments are described below. However, it should be understood that any features from any embodiment can be mixed and matched with each other in any combination. Therefore, the present invention should not be limited to these embodiments, but covers any wider combination.

[0063] Figure 1-12 Various aspects of a vascular plug 100 are shown, which can be connected to the distal end of a push rod 120, thereby allowing the plug 100 to be advanced to a desired target location in a patient's body through a catheter 125. When the mesh portion 102 of the vascular plug 100 expands, the flexible membrane 104 also expands within the mesh portion 102 to form a blockage or barrier at the target location. The flexible membrane 104 can be used to promote a thrombotic reaction after implantation to aid occlusion.

[0064] Figure 1-4 An example embodiment of a vascular plug 100 is shown in an expanded configuration for occluding vasculature. Figure 5-6 An example embodiment of a scaffold 110 of a vascular plug 100 is shown. Figure 7 The vascular plug 100 is shown in a compressed linear configuration within a catheter 125 . Figure 8-9 The vascular plug 100 is shown in use in an expanded configuration. Figure 10-12 Another example embodiment of a scaffold 110 for use with a vascular plug 100 is shown.

[0065] When constrained in the catheter 125, the mesh portion 102 can have a radially compressed configuration, and when unconstrained, can have a radially expanded configuration. Therefore, the mesh portion 102 can expand from an elongated, compressed, cylindrical or linear shape (e.g., when located in the catheter 125) to a longitudinally shorter and expanded shape. The expanded shape can be generally spherical, or can also present various other regular or irregular shapes to accommodate different vascular systems, such as but not limited to a generally cylindrical shape as shown. The mesh portion 102 may include an interior space that can expand to a larger volume when the mesh portion 102 expands into the expanded shape.

[0066] The wires of the mesh portion 102 can be formed of various materials, such as, but not limited to, nitinol, cobalt-chromium alloy, stainless steel wires, or combinations thereof. In one example, the mesh portion 102 can be composed of 48-144 nitinol wires having a diameter ranging from about 0.0008-0.005 inches. Optionally, one or more radiopaque wires can be used to generate the mesh portion 102 to further enhance visualization of the vascular plug 100 during surgery.

[0067] like Figure 1-4As shown, the proximal end of the mesh portion 102 can terminate at a proximal cap member 103A, and the distal end of the mesh portion 102 can terminate at a distal cap member 103B. The proximal cap member 103A and the distal cap member 103B can be formed or manufactured in various ways. For example, the proximal cap member 103A and the distal cap member 103B can be formed by welding the wires of the mesh portion 102 together, welding the wires to discrete metal caps, crimping metal cap members onto the wires, or using an adhesive to attach discrete caps to the wires. The proximal cap member 103A and the distal cap member 103B in the exemplary embodiment can be at least partially composed of a radiopaque material so that it can be used as a visual marker by a doctor during surgery. The proximal cap member 103A can be configured to engage (e.g., detachably connect or couple) with the push rod 120.

[0068] refer to Figure 1 and Figure 3 , it can be seen that the vascular plug 100 can include a flexible membrane 104 that expands when deployed. Because the mesh portion 102 adopts a radially expanded configuration, the membrane 104 can adopt a radially expanded configuration, thereby restricting the passage of fluid (eg, blood) through the mesh portion 102.

[0069] In different embodiments, the shape of the membrane 104 when deployed can vary. In the exemplary embodiment shown in the drawings, the flexible membrane 104 can have a circular shape when deployed. However, any other shape capable of occluding the vascular system can be utilized. Typically, the shape of the membrane 104 when deployed and expanded will substantially match the shape of the central portion 111 to which it is attached.

[0070] The flexible membrane 104 can be composed of any material that can be unfolded, straightened, stretched or otherwise expanded to an enlarged and preferably flat area. The flexible membrane 104 can be composed of various flexible materials that are biocompatible and increase the thrombotic response to help form an occlusion in the patient. For example, polyethylene terephthalate (PET) or expanded polytetrafluoroethylene (ePTFE) can be used. In another exemplary embodiment, a composite material of PET and ePTFE can be used. In another exemplary embodiment, the flexible membrane 104 can be composed of a thin metal film, such as a thin metal film formed by sputtering or vacuum deposition.

[0071] like Figure 1-4As shown, the flexible membrane 104 can be supported by a support frame 110. The support frame 110 can be positioned in the lumen of the mesh portion 102. As will be described in more detail below, the entire support frame 110 can be formed by a pair of elastic wires 110A, 110B, which can be adjusted between a compressed linear configuration (e.g., for installation in a catheter 125) and an expanded configuration (e.g., expanded in a vascular system). The elastic wires 110A, 110B can include various flexible elastic materials, such as but not limited to nitinol. The size (e.g., diameter) of the elastic wires 110A, 110B can vary, and in some embodiments, can be 12 mm or larger. However, in some embodiments, the size of the elastic wires 110A, 110B can be less than 12 mm.

[0072] It should be understood that the systems and methods shown and / or described herein in connection with the scaffolds 110, 210 of the vascular plugs 100, 210 can be used with a variety of different vascular plugs 100 and 200 having a variety of different shapes, orientations, materials, and configurations. As an example, the systems and methods described herein can be used with any example embodiment of the "vascular occluder" shown and described in U.S. Patent No. 10470773. The entire contents of U.S. Patent No. 10470773 are incorporated herein by reference.

[0073] Figure 5 and Figure 6 An exemplary embodiment of a support frame 110 of a vascular plug 100 is shown. Figure 5 As best shown, an example embodiment of the support frame 110 can include a central portion 111. The central portion 111 is shown as including a ring portion that can be circular when expanded, although in some example embodiments, the central portion 111 can include other shapes (e.g., square, oval, etc.) to accommodate different vasculatures.

[0074] The central portion 111 can 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). This orientation allows the flexible membrane 104 to expand almost completely through the lumen of the mesh portion 102 and thereby prevent fluid from the patient from passing between the proximal and distal ends of the vascular plug 100. However, it should be understood that, in use, the flow of fluid through the flexible membrane 104 will in many cases force the flexible membrane 104 to deviate slightly from its perpendicular orientation, such that the flexible membrane 104 is at a non-perpendicular angle relative to the longitudinal axis extending through the vascular plug 100.

[0075] The central portion 111 can expand to a width or diameter similar to the size of the largest inner diameter area of ​​the expanded mesh portion 102. In some exemplary embodiments, the central portion 111 can expand to a size slightly larger than the inner diameter of the vascular system in which the vascular plug 100 is deployed. Therefore, the diameter of the membrane 104 may be too large compared to the target vessel size. This configuration may be ideal because the flow of fluid (such as blood) through the membrane 104 may cause the central portion 111 to deviate slightly from the vertical 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, it can be ensured that the vascular system 130 is completely covered (e.g., without any gaps) even when the central portion 111 moves against the membrane 104 due to such fluid flow.

[0076] The manner in which the flexible membrane 104 is secured to the central portion 111 may vary in different embodiments. In some exemplary embodiments, the flexible membrane 104 may be secured to the central portion 111 by forming a laminated layer on the flexible membrane 104, around the wires 110A, 110B of the central portion 111 and on itself. For example, in some embodiments, the flexible membrane 104 may initially be made of PET. Then, a layer of ePTFE may be disposed or laminated on the PET layer and the central portion 111. Alternatively, the flexible membrane 104 may be sewn to the central portion 111 with metal wire, polymer fibers, etc. In another exemplary embodiment, the flexible membrane 104 may be attached or secured to the central portion 111 using various adhesives. In another exemplary embodiment, the membrane 104 may be bonded to a polymer sleeve on the central portion 111, the polymer sleeve being made of PET or a heat shrinkable plastic such as cross-linked PET. In another exemplary embodiment, a PET HS tube below the membrane 104 may be used to prevent the membrane 104 from sliding around the frame 110 and bonded to the ePTFE / PET ePTFE layer. In another exemplary embodiment, the flexible membrane 104 may be sewn or adhered directly to the mesh portion 102 , such as to form a thread of the mesh portion 102 .

[0077] In e.g. Figure 5 and Figure 6 In the exemplary embodiment shown, the central portion 111 can be supported by a proximal support arm 112 and a distal support arm 113. The proximal support arm 112 can extend from the central portion 111 in a first (e.g., proximal) direction, and the distal support arm 113 can extend in a second (e.g., distal) direction opposite the central portion 111. The first direction can be a proximal direction, and the second direction can be a distal direction. Figure 1-4 As shown, one end of the proximal support arm 112 can be connected to the proximal cover member 103A. Similarly, one end of the distal support arm 113 can be connected to the distal cover member 103B.

[0078] Although the figures show a support frame 110 formed of only a single proximal support arm 112 and a single distal support arm 113, it should be understood that additional proximal and / or distal support arms 112, 113 may be included in the exemplary embodiments of the support frame 110 to accommodate different applications. For example, in some exemplary embodiments, the support frame 110 may include two or more proximal support arms 112 and two or more distal support arms 113. In such an embodiment, the two or more proximal support arms 112 may meet at the proximal cover member, and the two or more distal support arms 113 may meet at the distal cover member.

[0079] like Figure 5 and Figure 6 As best shown in FIG. 1 , the proximal support arm 112 may include one or more proximal hinges 112A, 112C connected by one or more rise or fall links 112B, 112D. Such proximal hinges 112A, 112C may function as joints, shock absorbers, springs, elasticity assists, articulated regions, regions of increased flexibility, or other connection structures that aid in the resilience of the support frame 110 by absorbing forces from the flowing fluid and thereby prevent failure of the vascular plug 100 under high pressure or flow rate conditions commonly found in large vasculature.

[0080] In an 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 include an upper proximal hinge 112A, and the second proximal hinge 112C may include a lower proximal hinge 112C. Therefore, in an exemplary embodiment, the first proximal hinge 112A may include a peak and the second proximal hinge 112C may include a valley.

[0081] The accompanying drawings illustrate example embodiments of a first proximal hinge 112A and a second proximal hinge 112C, each of which includes a circular curve (e.g., a semicircle). More specifically, it can be seen that the first proximal hinge 112A can include a downward curve (also commonly referred to as a concave curve, an upwardly convex curve, or a downwardly concave curve), and the second proximal hinge 112C can include an upward curve (commonly referred to as a convex curve, a downwardly convex curve, or an upwardly concave curve). However, it should be understood that in different embodiments, the shape of each of the proximal hinges 112A, 112C can vary. For example, in some embodiments, each proximal hinge 112A, 112C can include a triangular or square shape.

[0082] refer to Figure 6, it can be seen that the first proximal hinge 112A and the second proximal hinge 112C can be connected together by a first link 112B, which extends between and connects the first hinge 112A and the second hinge 112C. Therefore, the first link 112B can include a descending slender member connecting the peak of the first proximal hinge 112A with the valley of the second proximal hinge 112C. Similarly, the second link 112D can connect the second hinge 112C with the central portion 111. Therefore, the second link 112D can include an ascending slender member connecting the valley of the second proximal hinge 112C with the central portion 111.

[0083] Continue to refer Figure 5 and Figure 6 , it can be seen that the distal support arm 113 can similarly include one or more distal hinges 113A, 113C connected by one or more ascending or descending links 113B, 113D. Such distal hinges 113A, 113C can be used as joints, shock absorbers, springs, elastic assist devices, articulated areas, areas of increased flexibility, or other connecting structures that contribute to the elasticity of the support frame 110 and prevent the vascular plug 100 from malfunctioning under high pressure or flow conditions commonly found in larger vascular systems.

[0084] In an 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 include a lower distal hinge 113A, and the second distal hinge 113C may include an upper distal hinge 113C. Therefore, in an exemplary embodiment, the first distal hinge 113A may include a valley, and the second distal hinge 113C may include a peak.

[0085] The accompanying drawings illustrate embodiments of a first distal hinge 113A and a second distal hinge 113C, each hinge comprising a circular curve (e.g., a semicircle). More specifically, it can be seen that the first distal hinge 113A can include an upward curve, and the second distal hinge 113C can include a downward curve. However, it should be understood that the shape of each of the hinges 113A, 113C can vary in different embodiments. For example, in some embodiments, each of the hinges 113A, 113C can include a triangular or square shape.

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

[0087] like Figure 6As shown, the first distal hinge 113A and the second distal hinge 113C of the distal support arm 113 can be connected together by a first link 113B, which extends between and connects the first distal hinge 113A and the second distal hinge 113C. Therefore, the first link 113B can include an ascending elongated member connecting the valley of the first distal hinge 113A with the peak of the second distal hinge 113C. Similarly, the second link 113D can connect the second distal hinge 113C with the central portion 111. Therefore, the second link 113D can include a descending elongated member connecting the peak of the second distal hinge 113C with the central portion 111.

[0088] The distal support arm 113 may be symmetrical or a mirror image of the proximal support arm 112. However, in some embodiments, the proximal support arm 112 and the distal support arm 113 may not be mirror images or symmetrical to each other. Although exemplary embodiments are shown and described by specific configurations, orientations, and positions of the respective hinges 112A, 112C, 113A, 113C and the links 112B, 112D, 113B, 113D of the respective proximal support arms 112 and distal support arms 113, it should be understood that various other configurations, orientations, and positions may be used in different embodiments. For example, in some exemplary embodiments, the previously described arrangement of the first proximal hinge 112A and the second distal hinge 113C having a downward curve or peak, and the arrangement of the second proximal hinge 112C and the second distal hinge 113A having an upward curve or valley may be reversed.

[0089] Therefore, it should be understood that the foregoing description and drawings may be opposite to what is described and shown. For example, the first proximal hinge 112A of the proximal support arm 112 may include a valley, and the second proximal hinge 112C of the proximal support arm 112 may include a peak. Similarly, the first distal hinge 113A of the distal support arm 113 may include a peak, and the second distal hinge 113C of the distal support arm 113 may include a valley.

[0090] Although the figures show that the proximal support arm 112 includes a pair of proximal hinges 112A, 112C, and the distal support arm 113 includes a pair of distal hinges 113A, 113C, it should be understood that in some example embodiments, one or both of the proximal and / or distal support arms 112, 113 may include additional hinges 112A, 112.C, 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. Preferably, each of the proximal support arm 112 and the distal support arm 113 will include an even number of hinges 112A, 112C, 113A, 113C. However, in some example 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] refer to Figure 6 , it can be seen that the height of the first proximal hinge 112A may be lower than the height of the second distal hinge 113C, and the height of the second proximal hinge 112C may also be lower than the first distal hinge 113A. However, various other configurations may be utilized in different embodiments. For example, the opposite configuration may be used, wherein the height of the first proximal hinge 112A is greater than the height of the second distal hinge 113C, and the height of the second proximal hinge 112C is greater than the height of the first distal hinge 113A. In another exemplary embodiment, the first proximal hinge 112A may be at the same height as the second distal hinge 113C, and the second proximal hinge 112C may be at the same height as the first distal hinge 113A.

[0092] Continue to refer Figure 6 , it can be seen that each of the proximal and distal links 112B, 112D, 113B, 113D can extend at an angled orientation. More specifically, it can be seen that the first proximal link 112B can be angled or bent toward the second proximal link 112D, the second proximal link 112D can be angled or bent toward the first proximal link 112B, the first distal link 113B can be angled or bent toward the second distal link 113D, and the second distal link 113D can be angled or bent toward the first distal link 113.B. In some embodiments, one or more of the links 112B, 112D, 113B, 113D can instead extend linearly (e.g., vertically) rather than extending at an angle.

[0093] With respect to the angles of each of the hinges 112A, 112C, 113A, 113C and the angles between the corresponding links 112B, 112D, 113B, 113D, it should be understood that in different embodiments, these angles may vary. In the exemplary embodiments shown in the figures, each of these angles is shown as comprising an acute angle. However, such angles may be greater or less than the angles shown in the exemplary embodiments of the figures. For example, in one aspect, the angle between the first proximal link 112B and the second proximal link 112D and / or the angle between the first distal link 113B and the third distal link 113D may be greater or less than Figure 6 Angle shown.

[0094] like Figure 5 As best shown, the entire support frame 110 can be formed from a pair of wires 110A, 110B, which can be secured to each other by various methods. More specifically, it can be seen that the first wire 110A and the second wire 110B can be fused together side by side to form a proximal support arm 112, including proximal hinges 112A, 112C and proximal links 112B, 112D. The wires 110A, 110B can then be separated from each other to form a central portion 111, and then fused together to form a distal support arm 113, including distal hinges 113A, 113C and distal links 113B, 113D. In this embodiment, the entire support frame 110, including the support arms 112, 113, hinges 112A, 112C, 113A, 113C and links 112B, 112D, 113B, 113D, may be integrally formed from a pair of wires 110A, 110B.

[0095] Figure 7-9 An example embodiment of a vascular plug 100 for occluding a vascular system 130 is shown. In operation, a catheter 125 and a push rod 120 therein can be advanced within a patient's vascular system 130 (e.g., a blood vessel or lumen) until the distal end of the catheter 125 is adjacent to a target occlusion site, such as Figure 7 For example, the distal end of catheter 125 can be positioned within or at the opening of the aneurysm.

[0096] like Figure 7 As shown, the vascular plug 100 can be delivered to the vascular system 130 in a compressed, compact, linear, cylindrical configuration. In an exemplary embodiment, the vascular plug 100 can be placed in a catheter 125 for delivery; the catheter 125 is pushed through the vascular system 130 by an elongated push rod 120. Various types of catheters 125 can be used to deliver the vascular plug 100. As a non-limiting example, in some embodiments, the TERUMO GLIDEATH 4F, 5F and 5F XP catheters can be used to deliver the vascular plug 100.

[0097] After reaching the occlusion site, the push rod 120 can be advanced distally (or alternatively, the catheter 125 can be retracted) so that the vascular plug 100 is exposed at the distal end of the catheter 125 and located at the 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 can expand to substantially prevent body fluids (e.g., blood) from flowing through it.

[0098] Figure 8 An example embodiment is shown in which the expandable vascular plug 100 has been delivered to the occlusion site before the push rod 120 is separated. As shown, the push rod 120 can be removably connected to the proximal end of the vascular plug 100, such as to the proximal cap member 103A. Figure 8 As shown, the vascular plug 100 can expand to its expanded configuration when the push rod 120 is advanced or the catheter 125 is retracted. The expanded vascular plug 100 will generally be positioned to substantially cover the inner diameter of the vasculature 130 at the occlusion site.

[0099] After the vascular plug 100 is delivered to the occlusion site, the push rod 120 can be removed from the vascular plug 100 and removed from the vascular system 130. The disassembly method of the push rod 120 can vary in different embodiments. For example, a disassembly system as shown and described in U.S. Patents and Publication Nos. 8,182,506, US20060200192, US20100268204, US20110301686, US20150289879, US20151073772, and US20150173773 can be used, all of which are incorporated herein by reference in their entirety.

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

[0101] Fig. 9 The expanded, inflated vascular plug 100 is shown removed from the push rod 120, which is not visible because it was previously withdrawn. Fig. 9 As shown, bodily fluids, such as blood, may form thrombi on the membrane 104 and mesh portion 102. The structure and shape of the support frame 110, including the hinges 112A, 112C, 113A, 113C, are used to maintain the vascular plug 100 in place, with the membrane 104 covering the inner diameter of the vasculature 130, even in larger diameter (e.g., 8-22 mm) vasculature 130 that is susceptible to higher pressures and / or increased flow rates.

[0102] Figure 10-12 Another example embodiment of a support frame 110 of a vascular plug 100 is shown. In this exemplary embodiment, it can be seen that the proximal support arm 112 can include a proximal coil 115, and the distal support arm 113 can include a distal coil 116. However, it should be understood that in some embodiments, the vascular plug 100 can include only one of the proximal coil 115 or the distal coil 116. For example, in some embodiments, only the proximal support arm 112 can include the proximal coil 115, while the distal support arm 113 does not include the distal coil 116, or vice versa.

[0103] exist Figure 10-12 In the illustrated example embodiment, it can be seen that the example embodiment of the vascular plug 100 can include a support frame 110, which includes a central portion 111, and the membrane 104 can be fixed in or on the central portion 111. The central portion 111 can form a circular structure, such as a ring, or can be composed of various other shapes as described above. Although not shown, it should be understood that, as described above, Figure 10-12 The support frame 110 shown in FIG. 1 may be located within the interior space of the mesh portion 102 .

[0104] Continue to refer Figure 10-12 , a proximal coil 115 can be formed from the central portion 111 in a proximal direction, and a distal coil 116 can be formed from the central portion 111 in a distal direction. The proximal coil 115 and the distal coil 116 can act alone or together as springs to absorb or resist forces from fluid flow and thereby maintain an optimal position and orientation (e.g., vertical or slightly off-axis) of the membrane 104 to occlude the vasculature 130.

[0105] In the illustrated embodiment, the diameter of the windings of the proximal coil 115 may decrease in the proximal direction from the central portion 111. The diameter of the windings of the distal coil 116 may decrease 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 respective widest sections.

[0106] In example embodiments, the proximal coil 115 and the distal coil 116 may be mirror images or substantially similar to each other. In other embodiments, the proximal coil 115 and the distal coil 116 may not be mirror images or substantially similar. In these embodiments, the respective widest and narrowest diameters, number of windings, width reduction rate, effective length, and / or various other characteristics of the respective proximal coil 115 and the distal coil 116 may differ from each other.

[0107] The proximal coil 115 and the distal coil 116 may each include one or more wires 110A. Figure 10-12In the illustrated embodiment, a single wire 110A can form both the proximal coil 115 and the distal coil 116. In this embodiment, the single wire 110A can be heat set into a secondary shape consisting of the proximal support arm 112, the proximal coil 115 formed of a spiral winding with an increasing diameter, the distal coil 116 in the form of a spiral winding with a decreasing diameter, and the distal support arm 113. In other embodiments, two or more wires 110A, 110B can be connected together and heat set individually or together into the desired spiral coil shape.

[0108] The central portion 111 of the support frame 110 of the vascular plug 100 may include a circular or oval ring, from which the proximal coil 115 extends in the proximal direction, and the distal coil 116 extends in the distal direction. Figure 10-12 In the exemplary embodiment shown, the central portion 111 includes a pair of identical concentric rings spaced apart from each other. The membrane 104 can be secured to the circular or oval rings of the central portion 111 or secured between the pair of identical concentric rings using various methods such as discussed previously herein. In an exemplary embodiment, the distance between the pair of rings forming the central portion 111 can be substantially similar to the width of the membrane 104, so that the membrane 104 can be sandwiched between the pair of rings forming the central portion 111.

[0109] refer to Figure 10-12 , it can be seen that the widest winding of the proximal coil 115 can be connected to the first loop of the central portion 111 by a proximal connector 115A, and the widest winding of the distal coil 116 can be connected to the second loop of the central portion 111 by a distal connector 116A. The proximal connector and the distal connector can be integrally formed from the same single wire 110A that forms the proximal coil 115 and the distal coil 116, or can be composed of separate wire segments.

[0110] The proximal connector 115 and the distal connector 116 may extend at various angles. Although not shown, in some example embodiments, the proximal connector 115A and the distal connector 116A may extend at right angles between the respective proximal / distal coils 115, 116 and the central portion 111. The figures show an embodiment in which the proximal connector 115A is located at the top of the support frame 110 of the vascular plug 100 and the distal connector 116A is located at the bottom thereof. However, it should be understood that the proximal connector 115A and the distal connector 116A may be positioned at various other positions along the radial circumference and therefore should not be construed as being limited to the specific configuration shown in the example embodiments shown in the figures.

[0111] The manner in which the support frame 110 is manufactured may vary in different embodiments. In one exemplary embodiment, the support frame 110 may be heat-formed into a desired configuration so that the support frame 110 naturally forms the desired configuration when not constrained. As a non-limiting example, Figure 10-12 The illustrated embodiment may be manufactured using a fixture, such as a tapered mandrel, to heat set the one or more wires 110A, 110B into the desired helical coil shape shown in the figure.

[0112] Figure 13-23 Other example embodiments of the vascular plug 200 that may utilize multiple membranes 204A, 204B are shown. Figure 1-12 Any and all of the previous features or characteristics discussed, such as but not limited to film formation, composition, orientation, location and size, also apply to Figure 13-23 Other embodiments shown and discussed below. On the contrary, it should also be understood that the following Figure 13-23 Any and all features or characteristics discussed apply equally to Figure 1-12 The previous embodiments shown and discussed above.

[0113] The use of multiple membranes may provide improved occlusion performance in a variety of peripheral embolization products while minimizing potential impact on overall device length and tracking performance. Figure 13-15 , 18 - 19 , and 24 illustrate example embodiments of a single-leaf vascular plug 200 having multiple membranes 204A, 204B within a single mesh portion 202 . Figure 21-23 An example embodiment of a bilobed vascular plug 250 is shown having a pair of distinct mesh portions 250A, 250B, each with its own intima 254A, 254B.

[0114] Figure 13-15 An exemplary embodiment of a vascular plug 200 is shown. The vascular plug 200 may include a pair of membranes 204A, 204B, which may be deployed within a mesh portion 202. Fig.13 Only two membranes 204A, 204B are shown in the illustrated exemplary embodiment, but it should be understood that more than two membranes, such as three or more membranes, may be used in any of the exemplary embodiments of the vascular plug 100, 200 shown and / or described herein.

[0115] Continue to refer Figure 13-15 , 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 configurations. For example, the mesh portion 202 may be adjustable between a folded configuration, such as for use during delivery and / or retrieval, and an expanded configuration, such as for use during deployment in vivo. Fig.13A generally tubular cylindrical shape of the mesh portion 202 is shown, but it should be understood that the mesh portion 202 may include various other shapes when in the expanded configuration.

[0116] The mesh portion 202 may include an interior space, the volume of the interior space being larger in the expanded configuration than in the folded configuration. The support frame 210 may be positioned within the interior space of the mesh portion 202, and the support frame 210 may similarly be adjusted between the folded configuration and the expanded configuration. The support frame 210 may include one or more membrane supports 211A, 211B, each of which supports one or more membranes 204A, 204B. For example, the support frame 210 may include a first membrane support 204A supporting a first membrane 204A and a second membrane support 204B supporting a second membrane 204B.

[0117] Figure 16-17 An exemplary embodiment of a support frame 210 for a vascular plug 200 is shown. 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 a proximal region within the mesh portion 202. The second (distal) support arm 213 may be sized and shaped to fit within a distal region within the mesh portion 202. The third (inner) support arm 214 may be sized and shaped to fit within an inner region within the mesh portion 202 between the first support arm 212 and the second support arm 213. The third support arm 214 may include a generally S-shaped configuration.

[0118] Continue to refer Figure 16-17 , it can be seen that the support frame 210 can include one or more membrane supports 211A, 211B, each of which is configured to support one or more membranes 204A, 204B therein. In the exemplary embodiment shown, the first membrane support 211A can support the first membrane 204A, and the second membrane support 2110 can support the second membrane 204B. However, in some embodiments, one or more membrane supports 211A, 211B can support two or more such membranes 204A, 204B.

[0119] The shape, size, orientation and position of the membrane supports 211A, 211B may vary in different embodiments and should therefore not be construed as being limited by the scope of the example embodiments shown in the accompanying drawings. In example embodiments, the membrane supports 211A, 211B may include substantially the same shape and / or substantially the same size. In other example embodiments, one or more of the membrane supports 211A, 211B may have a different shape and / or size than one or more of the remaining membrane supports 211a, 211B.

[0120] exist Figure 16-17 In the exemplary embodiment shown, it can be seen that the membrane supports 211A, 211B can include a generally circular or annular shape. The shape of the membrane supports 211A, 211B can be similar to the shape of the cross-section of the mesh portion 202. Although the figures show that the shapes of the membranes 204A, 204B are substantially the same as the membrane supports 211A, 211B to which they are attached, it should be understood that in some exemplary embodiments, the membranes 204A and 204B can be different shapes from the membrane supports 211A and 211B to which they are associated. In general, it should be understood that Figure 16-17 The membrane supports 211A, 211B of the exemplary embodiment shown may have a configuration similar to that of, for example, Figure 5-6 The same features are shown for the central portion 111 .

[0121] like Figure 13-17 As shown, the support frame 210 may include a proximal support arm 212, a first membrane support 211A, an inner support arm 214, a second membrane support 211B, and a distal support arm 213. However, it should be understood that more or fewer support arms 212, 213, 214 may be used in different embodiments. In addition, as described above in this document, more or fewer membrane supports 211A, 211B may be used in different embodiments.

[0122] The proximal support arm 212 can extend at least partially through the proximal section of the interior of the mesh portion 202. Figure 13-15 As shown, the first or proximal end of the proximal support arm 212 can be fixed in the proximal cover 203A. The second or distal end of the mesh portion 202 can be attached to or formed as one piece with the first membrane support 211A. Therefore, the proximal support arm 212 can extend between the proximal end of the mesh portion 202 and the first membrane support 211A.

[0123] The distal support arm 213 can extend at least partially through the distal section of the interior of the mesh portion 202. Figure 13-15 As best shown, the first or proximal end of the distal support arm 213 can be connected or formed integrally with the second membrane support 211B. The second or distal end of the distal support arm 213 can be fixed within the distal cap 203B. Thus, the distal support arm 213 can extend between the distal end of the mesh portion 202 and the second membrane support 211B.

[0124] The inner support arm 214 can extend through the inner section inside the mesh portion 202. The inner support arm 214 can be used to interconnect the first support member 211A and the second membrane support member 211B, such as Figure 13-17In the exemplary embodiment shown, it can be seen that the inner support arm 214 can extend in a generally diagonal direction, 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, in some example embodiments, the inner support arm 214 can instead extend linearly, such as parallel to a longitudinal axis extending through the center of the mesh portion 202. The inner support arm 214 can also extend in various other directions, such as those discussed in more detail below.

[0125] refer to Figure 13-15 , it can be seen that in one example embodiment, each of the proximal support arm 212 and the distal support arm 213 can extend in an arc along a substantially diagonal path. For example, the proximal support arm 212 can extend downward in an arc between the proximal cover 203A and the lower end of the first membrane support 211A. Conversely, the distal support arm 213 can extend downward in an arc between the upper end of the second membrane support 211B and the distal cover 203B. However, in different example embodiments, one or both of the proximal support arm 212 and the distal support arm 213 can adopt various other orientations.

[0126] In different embodiments, the number of wires forming the support frame 210 may vary. Fig.14 An example embodiment is shown in which the support frame 210 is formed from a single wire 210A, wherein the wire can be heat set to expand into the expanded configuration shown when unconstrained. Figure 15-17 Example embodiments are shown where the support frame 210 may be formed from a pair of wires 210A, 210B. In these example embodiments, the first wire 210A and the second wire 210B may extend proximate to each other to form support arms 212, 213, 214 and diverge to form membrane supports 211A, 211B.

[0127] Fig.16 An embodiment is shown in which the lines 210A, 210B for the support arm 212, 213, 214 segments of the support frame 210 are slightly spaced apart from one another. Fig.17 An embodiment is shown in which the wires 210A, 210B are secured to each other to form pairs of wires 210A, 210B for support arm 212, 213, 214 segments of support frame 210. In some embodiments, three or more wires 210A, 210B may be used to form all or part of support frame 210.

[0128] Figure 18-20An example embodiment of a vascular plug 200 is shown in which the support frame 210 is slightly modified compared to the example embodiments discussed previously. It can be seen that in this example embodiment, the proximal support arm 212 and the distal support arm 213 can extend substantially linearly through the corresponding proximal and distal segments of the interior of the mesh portion 202, with a steeper incline before transitioning to or connecting to the membrane supports 211A, 211B.

[0129] It can also be seen that the inner support arm 214 can form an inverted U-shaped configuration, with the first end of the inner support arm 214 being integral with or attached to the lower end of the first membrane support 211A, and the second end of the inner support arm 214 being integral with or attached to the lower end of the second membrane support 211B. Although not shown, the opposite configuration can also be used, wherein the inner support arm 214 is instead formed into a U-shaped configuration, with the first end of the inner support arm 214 being integral with or attached to the upper end of the first membrane support 211B, and the second end of the inner support arm 214 being integral with or attached to the upper end of the second membrane support 211B.

[0130] Figure 18-19 An example embodiment is shown where support frame 210 may be formed from a single wire. Fig. 20 2 shows an example embodiment in which the support frame 210 can be formed from a pair of wires 210A, 210B. Fig. 20 As shown, the paired wires 210A, 210B can be tightened or secured together by ties, clips, bands, etc. It should be understood that the same configuration can be used for any other embodiments shown and / or described herein. It should also be understood that one or more ties, clips, bands, etc. can be formed of a radiopaque material to form a radiopaque marker for visualization purposes.

[0131] Figure 21-23 25-27 show an exemplary embodiment of a multi-lobed vascular plug 250, which may include a first mesh portion 250A and a second mesh portion 250B, wherein each mesh portion 250A, 250B has an interior portion in which a membrane 254A, 254B may be located. 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] The use of multiple leaves in the vascular plug 250 can provide benefits over a single leaf design. One leaf can provide radial force and stability, while another leaf can provide a denser braid. The use of additional leaves can adapt the device to certain procedures, such as using the first leaf to enter the saccular space of the aneurysm, and deploying any additional leaves in the inflow or outflow vessels. The use of leaves of variable stiffness (e.g., where the stiffness of each leaf is different) can optimize trackability, reduce recoil forces, minimize "jumps" during delivery, and have the opportunity to reduce the overall profile of the device.

[0133] The inner membrane can be placed within one or both leaves to improve occlusion. Any length mismatch between the folded inner membrane and the folded outer braided structure can be resolved by, for example, utilizing flexible springs or laser cutting one or both ends of the inner wireframe of the hypotube to achieve length matching. This configuration can also provide greater flexibility when tracking through tortuosity.

[0134] Fig.21 An example embodiment of a vascular plug 250 having a bilobed, single membrane design is shown. Fig.21 As shown, 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 to each other and separated by an interconnection region 255, the diameter of which is reduced compared to the mesh portions 250A, 250B themselves. Although not shown, one or more membranes may be located within one or both mesh portions 250A, 250B and / or within the interconnection region 255 between the two mesh portions 250A and 250B. The first mesh portion 250A may terminate proximally in a proximal cap 253A, and the second mesh portion 250B may terminate distally in a distal cap 253B.

[0135] It should be understood that the braid density or picks per inch of each mesh portion 250A, 250B can be different. Thus, the first (proximal) mesh portion 250A can have a higher braid density than the second (distal) mesh portion 250B, and vice versa. In this way, the lower density mesh portion 250A can provide greater radial force to achieve stability, while the higher density mesh portion 250B can provide lower radial force by including more wires and / or smaller diameter wires in the braid.

[0136] In different embodiments, the manner in which the two leaves or two web portions 250A, 250B are interconnected to each other may be different. Typically, the interconnection region 255 between the two web portions 250A, 250B may include a joint. In an exemplary embodiment, the lumen may be laser welded to the interconnection region 255 to connect the two web portions 250A, 250B together while maintaining a channel therebetween.

[0137] Fig. 22 An example embodiment of a vascular plug 250 having a dual leaflet, dual membrane design is shown. Fig. 22 As shown, 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 to each other and separated by an interconnection region 255, and the diameter of the interconnection region 255 is reduced compared to the mesh portions 250A, 250B themselves. The first mesh portion 250A may terminate proximally in a proximal cap 253A, and the second mesh portion 250B may terminate distally in a distal cap 253B.

[0138] As with the previous embodiment, the first web portion 250A may have a different density than the second web portion 250B. In addition, the sizes of the various web portions 250A, 250B and / or membranes 254A, 254B may differ from one another (e.g., the first web portion 250A may have a different diameter or length than the second web portion 250B).

[0139] Fig.23 Another exemplary embodiment of a vascular plug 250 having a dual leaflet, dual membrane design is shown. In the illustrated embodiment, it can be seen that the interconnection region 255 between the two mesh portions 250A, 250B can include one or more connectors 255A, 255B, such as ties, clamps, bands, connectors, etc., to interconnect the two mesh portions 250A, 250 to each other.

[0140] Fig.24 An example embodiment of a vascular plug 250 having a single leaflet, dual membrane design is shown. Fig.24 As shown, a single tubular mesh portion 250A may include an interior space in which a helical support frame 260 is positioned, the frame supporting a pair of membranes 254A, 254B, or a single membrane 254A extending along the length of the helical frame 260.

[0141] Fig.25 An exemplary embodiment of a vascular plug 250 exiting a delivery device 300 is shown, wherein the vascular plug 250 has a first mesh portion 250A including a looser (less dense) weave pattern and a second mesh portion 250B including a denser weave pattern. The interconnection region between the mesh portions 250A, 250B can include a connector 255A, which in some embodiments can be radiopaque for visualization purposes.

[0142] Fig.26A scenario of use of the multi-leaf vascular plug 250 for treating a saccular aneurysm 450 in a blood vessel 400 is shown. As shown, a first mesh portion 250A can be located within the blood vessel 400, adjacent to the aneurysm 450, and a second mesh portion 250B can be located within the aneurysm 450 itself. A separate vascular plug 350 can also be deployed in an inflow or outflow vessel 450.

[0143] Fig. 27 A multi-lobed vascular plug 250 comprising a single membrane is shown. Fig. 27 As shown, the support frame 260 can extend through and between the two mesh portions 250A, 250B, and the membrane support 261 is located in the first mesh portion 250A. The support frame 260 may include a flexible segment 265 to assist in uniform and consistent invagination of the internal and external structures, even when each mesh portion 250A, 250B may have different characteristics (e.g., density or size). The flexible segment 265 may include a coil, etc., and may be formed integrally with the support frame 260 or attached thereto. It should be understood that although the membrane support 261 is shown as being located inside the first (proximal) mesh portion 250A, in some embodiments, an additional membrane support 262 may be located inside the second (distal) mesh portion 250. In other exemplary embodiments, each mesh portion 250A, 250B may include its own membrane.

[0144] Terms:

[0145] Exemplary implementations are listed in the following numbered clauses:

[0146] Item 1. A vascular plug for treating a patient, comprising: a mesh portion having a radial compression configuration, a radial expansion configuration and an interior; a proximal support arm located in a proximal region of the interior of the mesh portion, the proximal support arm comprising a first proximal hinge; a distal support arm located 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 in the interior of the mesh portion.

[0147] Clause 2. A vascular plug for treating a patient according to Clause 2, wherein the first distal hinge has an upwardly concave curve.

[0148] Clause 3. A vascular plug for treating a patient according to Clause 2, wherein the first distal hinge has an upwardly concave curve.

[0149] Clause 4. The vascular plug for treating a patient according to Clause 1, further comprising a second distal hinge.

[0150] Clause 5. The vascular plug for treating a patient according to Clause 1, further comprising a second proximal hinge.

[0151] Clause 6. The vascular plug for treating a patient according to Clause 1, further comprising a second distal hinge and a second proximal hinge.

[0152] Clause 7. A vascular plug for treating a patient as recited in Clause 6, wherein the first proximal hinge has a curve that is concave downward, and wherein the second proximal hinge has a curve that is concave upward.

[0153] Clause 8. A vascular plug for treating a patient as recited in Clause 7, wherein the first distal hinge has an upwardly concave curve, and wherein the second distal hinge has a downwardly concave curve.

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

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

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

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

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

[0159] Clause 14. The vascular plug for treating a patient according to Clause 1, further comprising a central portion for supporting the membrane, wherein the proximal support arm extends from the central portion in a proximal direction, and wherein the distal support arm extends from the central portion in a distal direction.

[0160] Item 15. A vascular plug for treating a patient, comprising: an elongated push rod; a mesh portion connected to the distal end of the elongated push rod, the mesh portion having a radially compressed configuration when constrained in a catheter, and a radially expanded configuration when not constrained; a support frame located inside the mesh portion, the support frame having a central portion, a proximal support arm connected to the proximal end of the central portion and extending from the proximal end, and a distal support arm connected to the distal end of the central portion and extending from the distal end; and a membrane fixed to the central portion, the membrane having a radially expanded configuration when the mesh portion is in its radially expanded configuration; wherein the proximal support arm has a first proximal joint segment and a second proximal joint segment; and, wherein the distal support arm has a first distal joint segment and a second distal joint segment.

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

[0162] Clause 17. A vascular plug for treating a patient according to Clause 15, wherein the first proximal joint segment, the second proximal joint segment, the first distal joint segment and the second distal joint segment are all composed of hinges, joints or springs.

[0163] Clause 18. A vascular plug for use in treating a patient according to Clause 15, wherein the scaffold is formed from only two wires.

[0164] Item 19. A support frame for a vascular plug, comprising: a ring portion for supporting a membrane; a proximal support arm, which is connected to the proximal end of the ring portion and extends from the proximal end, the proximal support arm having a first damping device for absorbing the force of blood flow on the membrane; and a distal support arm, which is connected to the distal end of the ring portion and extends from the distal end, the distal support arm having a second damping device for absorbing the force of blood flow on the membrane.

[0165] Clause 20. The vascular plug support according to Clause 19, wherein the first damping means is comprised of a proximal helical coil, and wherein the second damping means is comprised of a distal helical coil.

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

[0167] Clause 22. The vascular plug of Clause 21, wherein the first mesh portion has a first weave density, wherein the second mesh portion has a second weave density, and wherein the first weave density is different than the second weave density.

[0168] Clause 23. The vascular plug of Clause 22, wherein the first braid density is greater than the second braid density.

[0169] Clause 24. The vascular plug of Clause 22, wherein the first braid density is lower than the second braid density.

[0170] Clause 25. The vascular plug of Clause 21, further comprising a first membrane located inside the first mesh portion and a second membrane located inside the second mesh portion.

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

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

[0173] Clause 28. The vascular plug of Clause 21, wherein the interconnection region comprises a joint.

[0174] Clause 29. The vascular plug of Clause 21, further comprising a channel interconnecting the first mesh portion, the second mesh portion, and the interconnection region.

[0175] Clause 30. The vascular plug of Clause 21, wherein the interconnection region comprises a connector.

[0176] Clause 31. The vascular plug of Clause 30, wherein the connector comprises a radiopaque marker.

[0177] Clause 32. The vascular plug according to Clause 21, further comprising a support frame located inside the first mesh portion and the second mesh portion.

[0178] Clause 33. The vascular plug of Clause 32, wherein the support scaffold comprises a membrane support.

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

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

[0181] Clause 36. The vascular plug of Clause 35, wherein the flexible segment comprises a coil.

[0182] Although the present invention has been described according to specific embodiments and applications, according to this teaching, those skilled in the art can produce other embodiments and modifications without departing from or exceeding the spirit or scope of the claimed invention. Therefore, it should be understood that the drawings and descriptions herein are provided by way of example to facilitate understanding of the present invention and should not be interpreted as limiting its scope.

Claims

1. A vascular plug for treating a patient, comprising: a web portion having a radially compressed configuration, a radially expanded configuration, and an interior; a proximal support arm located in a proximal region of the interior of the web portion, the proximal support arm including a first proximal hinge; a distal support arm located in a distal region of the interior of the web portion, the distal support arm including a first distal hinge; as well as A membrane is supported by the proximal support arm and the distal support arm in the interior of the mesh portion.

2. The vascular plug for treating a patient according to claim 1, wherein: The first proximal hinge has a curve that is concave downward.

3. The vascular plug for treating a patient according to claim 2, wherein: The first distal hinge has an upwardly concave curve.

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

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

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

7. The vascular plug for treating a patient according to claim 6, wherein: The first proximal hinge has a curve that is concave downward, and wherein the second proximal hinge has a curve that is concave upward.

8. The vascular plug for treating a patient according to claim 7, wherein: The first distal hinge has an upwardly concave curve, and wherein the second distal hinge has a downwardly concave curve.

9. The 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 wherein the second distal hinge is closer to the membrane than the first distal hinge.

10. The vascular plug for treating a patient according to claim 6, wherein: The first proximal hinge has a lower height than the second distal hinge.

11. The 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.

12. The vascular plug for treating a patient according to claim 6, wherein: The proximal support arm includes a first proximal link extending between the first proximal hinge and the second proximal hinge, and a second proximal link extending between the second proximal hinge and the membrane.

13. The vascular plug for treating a patient according to claim 12, wherein: The distal support arm includes a first distal link extending between the first distal hinge and the second distal hinge, and a second distal link extending between the second distal hinge and the membrane.

14. The vascular plug for treating a patient according to claim 1, further comprising a central portion for supporting the membrane, wherein: The proximal support arm extends from the central portion in a proximal direction, and wherein the distal support arm extends from the central portion in a distal direction.

15. A vascular plug for treating a patient, comprising: a long, thin putter; a mesh portion connected to the distal end of the elongated push rod, the mesh portion having a radially compressed configuration when constrained in the catheter and a radially expanded configuration when unconstrained; a support frame located inside the mesh portion, the support frame having a central portion, a proximal support arm connected to a proximal end of the central portion and extending from the proximal end, and a distal support arm connected to a distal end of the central portion and extending from the distal end; and a membrane secured to the central portion, the membrane having a radially expanded configuration when the web portion is in its radially expanded configuration, Wherein, the proximal support arm has a first proximal joint segment and a second proximal joint segment; and Wherein, the distal support arm has a first distal joint segment and a second distal joint segment.

16. A vascular plug for treating a patient according to claim 15, wherein: The first proximal joint segment has a curve that is concave downward, wherein the second proximal joint segment has a curve that is concave upward, wherein the first distal joint segment has a curve that is concave upward, and wherein the second distal joint segment has a curve that is concave downward.

17. The vascular plug for treating a patient according to claim 15, wherein: The first proximal joint segment, the second proximal joint segment, the first distal joint segment and the second distal joint segment all include hinges, joints or springs.

18. The vascular plug for treating a patient according to claim 15, wherein: The support frame is formed by only two wires.

19. A support frame for a vascular plug, comprising: a ring portion for supporting the membrane; a proximal support arm connected to and extending from a proximal end of the ring portion, the proximal support arm having a first damping means for absorbing a force of blood flow on the membrane; and A distal support arm is connected to and extends from the distal end of the ring portion, wherein the distal support arm has a second damping device for absorbing the force of blood flow on the membrane.

20. The support frame for vascular plug according to claim 19, wherein: The first damping means consists of a proximal helical coil, and wherein the second damping means consists of a distal helical coil.

21. A vascular occlusive device comprising: a web portion having a radially compressed configuration, a radially expanded configuration, and an interior; a support frame, which is located in the interior of the mesh portion, the support frame comprising a first membrane support member and a second membrane support member; a first membrane supported by the first membrane support; and A second membrane is supported by the second membrane support.

22. The vaso-occlusive device of claim 21, wherein: The first membrane support has substantially the same size as the second membrane support.

23. The vaso-occlusive device of claim 21, wherein: The first membrane support is larger than the second membrane support.

24. The vaso-occlusive device of claim 21, wherein: The first membrane support has substantially the same shape as the second membrane support.

25. The vaso-occlusive device of claim 24, wherein: The first membrane support and the second membrane support are both composed of a circular shape.

26. The vaso-occlusive device of claim 21, wherein: The first membrane support has a different shape than the second membrane support.

27. The vaso-occlusive device of claim 21, wherein: The support frame consists of only two wires.

28. The vaso-occlusive device of claim 21, wherein: The support frame includes a proximal support arm located in a proximal region of the interior of the mesh portion and a distal support arm located in a distal region of the interior of the mesh portion.

29. The vaso-occlusive device of claim 28, wherein: The proximal support arm is connected to and extends from a proximal end of the first membrane support.

30. The vaso-occlusive device of claim 29, wherein: The distal support arm is connected to and extends from the distal end of the second membrane support.

31. The vaso-occlusive device of claim 30, wherein: The support frame includes an inner support arm connected between the first membrane support member and the second membrane support member.

32. The vaso-occlusive device of 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.

33. The vaso-occlusive device of claim 31, wherein: The inner support arm has a first end connected to an upper end of the first membrane support and a second end connected to a lower end of the second membrane support.

34. The vaso-occlusive device of claim 31, wherein: The inner support arm is formed by a first wire and a second wire.

35. The vaso-occlusive device of claim 34, wherein: The first wire abuts against the second wire to form a wire pair.

36. The vaso-occlusive device of claim 34, wherein: The first line is spaced apart from the second line.

37. The vaso-occlusive device of claim 31, wherein: A first end of the inner support arm is connected to a lower end of the first membrane support, and wherein a second end of the inner support arm is connected to a lower end of the second membrane support.

38. The vaso-occlusive device of claim 37, wherein: The inner support arm comprises an inverted U-shape.

39. A vascular occlusive device comprising: a web portion having a radially compressed configuration, a radially expanded configuration, and an interior; a proximal support arm located in a proximal region of the interior of the mesh portion; a distal support arm located in a distal region of the interior of the mesh portion; a first membrane supported by the proximal support arms in the interior of the mesh portion; a second membrane supported by the distal support arm in the interior of the mesh portion; and a medial support arm connected between the first membrane and the second membrane.

40. The vaso-occlusive device of claim 39, wherein: The inner support arm has an inverted U-shape.

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