Device for treating vascular malformation

Abstract

A device (720) for treating vascular malformation is provided, comprising a bore section (430), an occlusion section (432), and a connection section (434). When the apparatus (720) is unconstrained, the bore and occluding segments (430, 432) are shaped to define bore and occluding segment curves (440, 450) wound about non-coaxial bore and occluding segment central axes (442, 452), respectively, at varying distances from the axes (442, 452). The bore segment curve (440) defines a bore segment central opening (462). A projection of the occluded segment curve (450) occludes at least 25% of a segment central opening cross-sectional area of a segment central opening (462); the occlusion section curve (450) projects in a direction along the bore section central axis (442) onto a bore section plane perpendicular to the bore section central axis (442). Other embodiments are also described.

Description

[0001] Cross - Reference to Related Applications

[0002] This application is a divisional application of the application with the filing date of December 24, 2019, application number 201980085845.6, and invention title "Device for Treating Vascular Malformations". This application claims the priority of US Provisional Patent Application No. 62 / 785,013, filed on December 26, 2018, which has been assigned to the assignee of this application and is incorporated herein by reference. Technical Field

[0003] The present invention generally relates to minimally invasive techniques for treating vascular malformations such as aneurysms. Background Art

[0004] Aneurysms are local dilations of arteries caused by weakening of the arterial wall. In the past, brain aneurysms were often treated by direct surgery, such as installing a clip at the base of the aneurysm to prevent blood from passing between the aneurysm and the vascular lumen. Subsequently, minimally invasive techniques were developed to treat such aneurysms, such as filling the aneurysm with endovascular embolization coils, causing the aneurysm to eventually become a solid mass of coils and thrombus. Summary of the Invention

[0005] In some embodiments of the present invention, a device for treating a vascular malformation is provided. The device is configured to bridge a vascular malformation, such as an aneurysm, such as the neck of a wide-neck aneurysm, to prevent herniation of coils. The device includes an orifice section, an intra-vascular-malformation docking section, and a connecting section. The orifice section is configured to bridge the neck of the vascular malformation, which helps prevent herniation, i.e., endovascular embolization coils from protruding from the aneurysm. The intra-vascular-malformation docking section is configured to facilitate entanglement with endovascular embolization coils, which helps connect the device to the endovascular embolization coils to form a single mass.

[0006] The device is generally configured such that when unconstrained (by the patient's anatomy, a microcatheter, or other means):

[0007] The hole section is formed to define a hole section curve that winds around the central axis of the hole section at a varying distance from the central axis of the hole section for at least 2 turns (usually at least 2.5 turns);

[0008] The intravascular malformation docking section is formed to define a docking section curve that winds around the central axis of the docking section at a varying distance or a constant distance from the central axis of the docking section for at least 0.5 to 2 turns (e.g., 0.75 to 2 turns, e.g., 1 to 2 turns); and

[0009] The connecting section connects the hole section curve and the docking section curve.

[0010] Providing a docking section curve with only 0.5 to 2 turns generally makes it easier to deploy the intravascular malformation docking section in an aneurysm than providing a docking section curve with more turns, while providing a winding level similar to that of intravascular embolization coils.

[0011] In some embodiments of the present invention, a device for treating vascular malformations is provided. The device is configured to bridge the neck of a vascular malformation (e.g., an aneurysm, e.g., a wide-neck aneurysm). The device includes a hole section, an occlusion section, and a connecting section. The hole section is configured to bridge the neck of the vascular malformation and prevent blood from flowing into the aneurysm, thereby embolizing the aneurysm. The occlusion section is configured to at least partially occlude a central opening of the hole section.

[0012] The device is generally configured such that when unconstrained (by the patient's anatomy, a microcatheter, or other means):

[0013] The hole section is formed to define a hole section curve that winds around the central axis of the hole section at a varying distance from the central axis of the hole section for at least 2.5 turns;

[0014] The occlusion section is formed to define an occlusion section curve that winds around the central axis of the occlusion section at a varying distance from the central axis of the occlusion section for at least 2 turns; and

[0015] The connecting section connects the hole section curve and the occlusion section curve.

[0016] The hole section curve defines the above-mentioned central opening of the hole section, and the central opening of the hole section has a cross-sectional area of the central opening of the hole section, which is equal to at least 2% of the total cross-sectional area of the hole section defined by the outermost ring of the hole section curve. The measured cross-sectional area of the central opening of the hole section and the total cross-sectional area of the hole section are perpendicular to the central axis of the hole section;

[0017] The central axis of the hole section is not coaxial with the central axis of the occlusion section; and

[0018] A projected occlusion of the occlusion section curve occludes at least 25% (e.g., at least 50%) of the cross-sectional area of the central opening of the hole section; the occlusion section curve is projected onto a hole section plane perpendicular to the central axis of the hole section in a direction along the central axis of the hole section.

[0019] Therefore, according to an application of the present invention, there is provided a device for treating vascular malformations, the device comprising:

[0020] A hole section;

[0021] An occlusion section; and

[0022] A connecting section,

[0023] wherein the device is configured such that when the device is unconstrained:

[0024] The hole section is shaped to define a hole section curve that winds around the central axis of the hole section at a varying distance from the central axis of the hole section for at least 2.5 turns;

[0025] The occlusion section is shaped to define an occlusion section curve that winds around the central axis of the occlusion section at a varying distance from the central axis of the occlusion section for at least 2 turns;

[0026] The connecting section connects the hole section curve and the occlusion section curve;

[0027] The hole section curve defines a central opening of the hole section, the central opening of the hole section having a cross-sectional area of the central opening of the hole section, the cross-sectional area of the central opening of the hole section being equal to at least 2% of the total cross-sectional area of the hole section defined by the outermost ring of the hole section curve, the measured cross-sectional area of the central opening of the hole section and the total cross-sectional area of the hole section being perpendicular to the central axis of the hole section;

[0028] The central axis of the hole section is not coaxial with the central axis of the occlusion section; and

[0029] A projected occlusion of the occlusion section curve occludes at least 25% of the cross-sectional area of the central opening of the hole section, wherein the occlusion section curve is projected onto a hole section plane perpendicular to the central axis of the hole section in a direction along the central axis of the hole section.

[0030] For some applications, the device is configured such that when the device is unconstrained, the projected occlusion of the occlusion section curve occludes at least 50% of the cross-sectional area of the central opening of the hole section.

[0031] For some applications, the device is configured such that when the device is unconstrained, the cross-sectional area of the central opening of the hole section is equal to at least 3% of the total cross-sectional area of the hole section.

[0032] For some applications, the device is configured such that when the device is unconstrained, the occluding section curve winds around the central axis of the occluding section for a number of turns, the number of turns being equal to at least 0.5 turn and less than the number of turns that the hole section curve winds around the central axis of the hole section.

[0033] For some applications, the device is configured such that when the device is unconstrained, the occluding section curve defines a central opening of the occluding section, the central opening of the occluding section having a cross-sectional area of the central opening of the occluding section, the cross-sectional area of the central opening of the occluding section being equal to at least 2% of the total occluding section area defined by the outermost ring of the occluding section curve, and the measured cross-sectional area of the central opening of the occluding section and the total occluding section area are perpendicular to the central axis of the occluding section.

[0034] For some applications, the device is configured such that when the device is unconstrained, the central axis of the occluding section does not pass through the central opening of the hole section.

[0035] For some applications, the device is configured such that when the device is unconstrained, the occluding section curve has an outermost diameter of the occluding section, the outermost diameter of the occluding section being equal to 50% to 150% of the outermost diameter of the hole section of the hole section curve.

[0036] For some applications, the device is configured such that when the device is unconstrained, the connecting section is straight or the connecting section has an average radius of curvature different from the average radius of curvature of the outermost ring of the hole section curve.

[0037] For some applications, the device is configured such that when the device is unconstrained, the connecting section connects the outermost ring of the hole section curve to the hole section curve.

[0038] For some applications, the device includes a wire formed to define the hole section, the occluding section, and the connecting section.

[0039] For some applications, the device is configured such that when the device is unconstrained, the cross-sectional area of the central opening of the hole section is at least 0.25 square millimeters.

[0040] For some applications, the device is configured such that when the device is unconstrained, the cross-sectional area of the central opening of the occluding section is at least 0.25 square millimeters.

[0041] For some applications, the hole section, the occlusion section, and the connection section include one or more shape memory alloys.

[0042] For some applications, the hole section, the occlusion section, and the connection section include one or more superelastic alloys.

[0043] For any of the applications described above, the device can be configured such that when the device is unconstrained, the plane of the hole section is parallel to a plane of the occlusion section perpendicular to the central axis of the occlusion section or defines an angle less than 30 degrees. For some applications, the device is configured such that when the device is unconstrained, the plane of the hole section is parallel to the plane of the occlusion section or defines an angle less than 15 degrees. For some applications, the device is configured such that when the device is unconstrained, the plane of the hole section is parallel to the plane of the occlusion section.

[0044] For any of the applications described above, the device can be configured such that when the device is unconstrained, the distance between the centroid of the hole section curve measured along the central axis of the hole section and the centroid of the occlusion section curve is 20% to 80% of the outermost diameter of the hole section curve. For some applications, the device is configured such that when the device is unconstrained, the distance is between 25% and 75% of the outermost diameter of the hole section.

[0045] For any of the applications described above, the device is configured such that when the device is unconstrained, the distance between the geometric center of the central opening of the hole section measured along the central axis of the hole section and the occlusion section curve is 20% to 80% of the outermost diameter of the hole section curve. For some applications, the device is configured such that when the device is unconstrained, the distance is between 25% and 75% of the outermost diameter of the hole section.

[0046] For any of the applications described above, the device can be configured such that when the device is unconstrained, the central axis of the hole section and the central axis of the occlusion section are parallel to each other. For some applications, the device is configured such that when the device is unconstrained, the distance between the central axis of the hole section and the central axis of the occlusion section is 20% to 80% of the outermost diameter of the hole section curve.

[0047] For any of the applications described above, the device can be configured such that when the device is unconstrained, the hole section curve is a three-dimensional curve. For some applications, the device is configured such that when the device is unconstrained, the three-dimensional curve is a conical spiral.

[0048] For any of the applications described above, the device can be configured such that when the device is unconstrained, an outermost diameter of a hole segment of the hole segment curve is from 2 millimeters to 10 millimeters. For some applications, the device is configured such that when the device is unconstrained, the outermost diameter of the hole segment is from 4 millimeters to 7 millimeters.

[0049] For any of the applications described above, the device can be configured such that when the device is unconstrained, an outermost diameter of an occlusion segment of the occlusion segment curve is from 3 millimeters to 10 millimeters. For some applications, the device is configured such that when the device is unconstrained, the outermost diameter of the occlusion segment is from 4 millimeters to 8 millimeters.

[0050] For any of the applications described above, a kit can be provided, the kit including the device and a microcatheter, the device removably disposed in the microcatheter for delivery to the vascular malformation. For some applications, the occlusion segment is disposed further in the microcatheter than the connection segment, and the connection segment is disposed further in the microcatheter than the hole segment. For some applications, the kit further includes a push tube removably disposed in the microcatheter, and a distal end of the push tube is removably connected to a proximal end of the hole segment.

[0051] According to an application of the present invention, a method of treating a vascular malformation is further provided, the method including: implanting: (a) an occlusion portion of a device within the vascular malformation; (b) a connection portion of the device; and (c) a hole segment of the device within a portion of the vascular malformation to partially cover a hole of the vascular malformation, the portion of the vascular malformation including one or more anatomical features selected from the group consisting of a neck of the vascular malformation and a wall of the vascular malformation, such that:

[0052] The hole segment is shaped to define a hole segment curve that winds around a hole segment central axis at a varying distance from the hole segment central axis for at least 2.5 turns;

[0053] The occlusion segment is shaped to define an occlusion segment curve that winds around an occlusion segment central axis at a varying distance from the occlusion segment central axis for at least 2 turns;

[0054] The connection segment connects the hole segment curve and the occlusion segment curve;

[0055] The hole segment curve defines a hole segment central opening having a hole segment central opening cross-sectional area that is equal to at least 2% of a total hole segment cross-sectional area defined by an outermost ring of the hole segment curve, the measured hole segment central opening cross-sectional area and the total hole segment cross-sectional area being perpendicular to the hole segment central axis;

[0056] The central axis of the hole section is not coaxial with the central axis of the occlusion section; and

[0057] A projected occlusion of the occlusion section curve occludes at least 25% of the central opening cross-sectional area of the hole section, wherein the occlusion section curve is projected onto a hole section plane perpendicular to the central axis of the hole section in a direction along the central axis of the hole section.

[0058] For some applications, implanting the occlusion section, the connection section, and the hole section includes:[[]]

[0059] Inserting the occlusion section, the connection section, and the hole section into a blood vessel, while the occlusion section, the connection section, and the hole section are removably disposed in a microcatheter;

[0060] Deploying the occlusion section from the microcatheter into the vascular malformation;

[0061] Deploying the connection section from the microcatheter; and

[0062] Deploying the hole section from the microcatheter into a portion of the vascular malformation.

[0063] For some applications, deploying the occlusion section, the connection section, and the hole section includes deploying the occlusion section, then deploying the connection section, and then deploying the hole section.

[0064] For some applications, inserting the occlusion section, the connection section, and the hole section into the blood vessel includes pushing the hole section distally using a pusher tube, the pusher tube is removably disposed in the microcatheter, and a distal end of the pusher tube is removably connected to a proximal end of the hole section.

[0065] For some applications, the vascular malformation is an aneurysm, and implanting the occlusion section includes implanting the occlusion section into the aneurysm.

[0066] For some applications, the device is configured such that when the device is unconstrained, the projected occlusion of the occlusion section curve occludes at least 50% of the central opening cross-sectional area of the hole section.

[0067] According to an application of the present invention, there is also provided a device for treating a vascular malformation, the device comprising:[[]]

[0068] A hole section;

[0069] An intravascular malformation docking section; and

[0070] A connection section,

[0071] wherein the device is configured such that when the device is unconstrained,

[0072] The hole section is formed to define a hole section curve that winds around the central axis of the hole section at a varying distance from the central axis of the hole section for at least 2.5 turns;

[0073] The intravascular malformation docking section is formed to define a docking section curve that winds around the central axis of the docking section at a varying distance or a constant distance from the central axis of the docking section for 0.5 to 2 turns; and

[0074] The connecting section connects the hole section curve and the docking section curve and has an average radius of curvature that is different from the average radius of curvature of the outermost ring of the hole section curve.

[0075] For some applications, the device is configured such that when the device is unconstrained:

[0076] A connecting section slope of the connecting section is equal to: (a) a rise distance between two end points of the connecting section measured along the central axis of the hole section divided by (b) a run distance equal to a length of the connecting section between the two end points of the connecting section measured along the connecting section; and

[0077] A hole section slope of the hole section is equal to: (a) a rise distance between two end points of the hole section measured along the central axis of the hole section divided by (b) a run distance equal to a length of the hole section between the two end points of the hole section measured along the hole section; and

[0078] The connecting section slope is greater than the hole section slope.

[0079] For some applications, the device is configured such that when the device is unconstrained:

[0080] A connecting section slope of the connecting section is equal to (a) a rise distance between two end points of the connecting section measured along the central axis of the hole section divided by (b) a run distance equal to a length of the connecting section between the two end points of the connecting section measured along the connecting section; and

[0081] The connecting section slope is greater than 10%.

[0082] For some applications, the device is configured such that when the device is unconstrained, a length of the connecting section is at least 15% of an outer diameter of the hole section curve of the hole section.

[0083] For some applications, the device is configured such that when the device is unconstrained, the length of the connecting section does not exceed 90% of the outer diameter of the hole section.

[0084] For some applications, the device is configured such that when the device is unconstrained, the average radius of curvature of the connecting section is greater than the average radius of curvature of the outermost ring of the hole section curve.

[0085] For some applications, the device is configured such that when the device is unconstrained, the average radius of curvature of the connecting section is at least 1 millimeter.

[0086] For some applications, the device is configured such that when the device is unconstrained, the average radius of curvature of the connecting section is equal to at least 50% of the outermost diameter of the hole section.

[0087] For some applications, the device is configured such that when the device is unconstrained, the connecting section connects the outermost ring of the hole section curve to the docking section curve.

[0088] For some applications, the device is configured such that when the device is unconstrained, the docking section curve has a docking section outermost diameter that is equal to 15% to 80% of a hole section outermost diameter of the hole section curve.

[0089] For some applications, the device is configured such that when the device is unconstrained, the docking section outermost diameter is equal to 25% to 50% of the hole section outermost diameter.

[0090] For some applications, the device is configured such that when the device is unconstrained, the docking section curve has a docking section outermost diameter that is equal to 100% to 150% of a hole section outermost diameter of the hole section curve.

[0091] For some applications, the device is configured such that when the device is unconstrained, the docking section curve has 0.75 to 2 turns.

[0092] For some applications, the device is configured such that when the device is unconstrained, the docking section curve has 1 to 2 turns.

[0093] For some applications, the device is configured such that when the device is unconstrained, the docking section curve has 0.5 to 1.25 turns.

[0094] For some applications, the device is configured such that when the device is unconstrained, the docking section curve has 0.75 to 1.25 turns.

[0095] For some applications, the device is configured such that when the device is unconstrained, the docking section curve has 0.9 to 1.1 turns.

[0096] For some applications, the device is configured such that when the device is unconstrained, the docking section curve has 1 to 1.1 turns.

[0097] For some applications, the device is configured such that when the device is unconstrained, the connecting section is straight.

[0098] For some applications, the device is configured such that when the device is unconstrained, a closest distance between the hole section curve measured along the hole section central axis and the docking section curve is 4% to 100% of an outermost diameter of the hole section of the hole section curve.

[0099] For some applications, the device is configured such that when the device is unconstrained, the closest distance is between 4% and 50%.

[0100] For some applications, the device is configured such that when the device is unconstrained, a distance between a centroid of the hole section curve measured along the hole section central axis and a centroid of the docking section curve is 7% to 100% of an outermost diameter of the hole section of the hole section curve.

[0101] For some applications, the device is configured such that when the device is unconstrained, the distance is 10% to 50% of the outermost diameter of the hole section.

[0102] For some applications, the device is configured such that when the device is unconstrained, a hole section plane perpendicular to the hole section central axis and a docking section plane perpendicular to the docking section central axis are parallel or define an angle less than 30 degrees.

[0103] For some applications, the device is configured such that when the device is unconstrained, the hole section plane is parallel to the docking section plane.

[0104] For some applications, the device is configured such that when the device is unconstrained, the hole section central axis and the docking section central axis are coaxial or a distance between them is less than 50% of an outermost diameter of the hole section of the hole section curve.

[0105] For some applications, the device is configured such that when the device is unconstrained, a hole section plane perpendicular to the hole section central axis and a docking section plane perpendicular to the docking section central axis define an angle greater than 60 degrees.

[0106] For some applications, the device is configured such that when the device is unconstrained, the angle is greater than 75 degrees.

[0107] For some applications, the device is configured such that when the device is unconstrained, a hole segment plane perpendicular to the central axis of the hole segment and a docking segment plane perpendicular to the central axis of the docking segment define an angle of 30 degrees to 60 degrees.

[0108] For some applications, the device includes a wire, which, when the device is unconstrained, is shaped to define the hole segment, the intravascular malformation docking segment, and the connecting segment.

[0109] For some applications, the device is configured such that when the device is unconstrained, the hole segment curve is a three-dimensional curve.

[0110] For some applications, the device is configured such that when the device is unconstrained, the three-dimensional curve is a conical helix.

[0111] For some applications, the device is configured such that when the device is unconstrained, the outermost diameter of the hole segment curve is between 2 and 10 millimeters.

[0112] For some applications, the device is configured such that when the device is unconstrained, the outermost diameter of the hole segment is between 4 and 7 millimeters.

[0113] For some applications, the device is configured such that when the device is unconstrained, the docking segment curve winds around the central axis of the docking segment at a constant distance from the central axis of the docking segment.

[0114] For some applications, the device is configured such that when the device is unconstrained, the hole segment curve defines a central opening having a hole segment central opening cross-sectional area that is equal to at least 2% of the total hole segment cross-sectional area defined by the outermost ring of the hole segment curve, and the measured hole segment central opening cross-sectional area and the total hole segment cross-sectional area are perpendicular to the central axis of the hole segment.

[0115] For some applications, the device is configured such that when the device is unconstrained, the hole segment curve defines a central opening having a hole segment central opening cross-sectional area of at least 0.25 square millimeters.

[0116] For some applications, the hole segment, the intravascular malformation docking segment, and the connecting segment include one or more shape memory alloys.

[0117] For some applications, the hole segment, the intravascular malformation docking segment, and the connecting segment include one or more superelastic alloys.

[0118] For any of the applications described above, a kit can be provided, the kit including: the device and a microcatheter, the device removably disposed in the microcatheter for delivery to the vascular malformation. The intravascular malformation docking segment is disposed further in the microcatheter than the connection segment, which in turn is disposed further than the aperture segment. For some applications, the kit further includes a pusher tube removably disposed in the microcatheter, and a distal end of the pusher tube is removably connected to a proximal end of the aperture segment.

[0119] According to one application of the present invention, a method of treating a vascular malformation is also provided, the method including:

[0120] Implanting: (a) an intravascular malformation docking segment of a device within the vascular malformation; (b) a connection segment of the device; and (c) an aperture segment of the device within a portion of the vascular malformation so as to at least partially cover an aperture of the vascular malformation, the portion of the vascular malformation including one or more anatomical features selected from the group consisting of: a neck of the vascular malformation and a wall of the vascular malformation, such that:

[0121] The aperture segment is shaped to define an aperture segment curve that winds around the aperture segment central axis at a varying distance from the aperture segment central axis for at least 2.5 turns;

[0122] The intravascular malformation docking segment is shaped to define a docking segment curve that winds around the docking segment central axis at a varying distance or a constant distance from the docking segment central axis for 0.5 to 2 turns;

[0123] The connection segment connects the aperture segment curve and the docking segment curve and has an average radius of curvature that is different from an average radius of curvature of an outermost loop of the aperture segment curve; and

[0124] Implanting an intravascular embolization coil into the vascular malformation such that the intravascular embolization coil tangles with the intravascular malformation docking segment.

[0125] For some applications, implanting the intravascular malformation docking segment, the connection segment, and the aperture segment includes:

[0126] Inserting the intravascular malformation docking segment, the connection segment, and the aperture segment into a blood vessel while the intravascular malformation docking segment, the connection segment, and the aperture segment are removably disposed in a microcatheter;

[0127] Deploying the intravascular malformation docking segment from the microcatheter into the vascular malformation;

[0128] Deploying the connection segment from the microcatheter; and

[0129] Deploy the hole section from the microcatheter into a portion of the vascular malformation.

[0130] For some applications, deploying the intravascular malformation docking section, the connection section, and the hole section includes deploying the intravascular malformation docking section, then the connection section, and then the hole section.

[0131] For some applications, inserting the intravascular malformation docking section, the connection section, and the hole section into the blood vessel includes pushing the hole section distally using a pusher tube removably disposed within the microcatheter, with a distal end of the pusher tube removably connected to a proximal end of the hole section.

[0132] For some applications, the vascular malformation is an aneurysm, and implanting the intravascular malformation docking section includes implanting the intravascular malformation docking section within the aneurysm.

[0133] For some applications, the device is configured such that when the device is unconstrained:

[0134] A connection section slope of the connection section is equal to: (a) a rise distance between two end points of the connection section measured along a central axis of the hole section divided by (b) a run distance equal to a length of the connection section between the two end points of the connection section measured along the connection section; and

[0135] A hole section slope of the hole section is equal to: (a) a rise distance between two end points of the hole section measured along a central axis of the hole section divided by (b) a run distance equal to a length of the hole section between the two end points of the hole section measured along the hole section; and

[0136] The connection section slope is greater than the hole section slope.

[0137] For some applications, the device is configured such that when the device is unconstrained:

[0138] A connection section slope of the connection section is equal to (a) a rise distance between two end points of the connection section measured along a central axis of the hole section divided by (b) a run distance equal to a length of the connection section between the two end points of the connection section measured along the connection section; and

[0139] The connection section slope is greater than 10%.

[0140] For some applications, the device is configured such that when the device is unconstrained, a length of the connection section is at least 15% of an outer diameter of a hole section curve of the hole section.

[0141] For some applications, the device is configured such that when the device is unconstrained, the length of the connecting section does not exceed 90% of the outermost diameter of the hole section.

[0142] For some applications, the device is configured such that when the device is unconstrained, the average radius of curvature of the connecting section is greater than the average radius of curvature of the outermost ring of the curve of the hole section.

[0143] For some applications, the device is configured such that when the device is unconstrained, the average radius of curvature of the connecting section is at least 1 millimeter.

[0144] For some applications, the device is configured such that when the device is unconstrained, the average radius of curvature of the connecting section is equal to at least 50% of the outermost diameter of the hole section.

[0145] For some applications, the device is configured such that when the device is unconstrained, the connecting section connects the outermost ring of the curve of the hole section to the curve of the docking section.

[0146] For some applications, the device is configured such that when the device is unconstrained, the curve of the docking section has an outermost diameter of the docking section, and the outermost diameter of the docking section is equal to 15% to 80% of an outermost diameter of the hole section of the curve of the hole section.

[0147] For some applications, the device is configured such that when the device is unconstrained, the outermost diameter of the docking section is equal to 25% to 50% of the outermost diameter of the hole section.

[0148] For some applications, the device is configured such that when the device is unconstrained, the curve of the docking section has an outermost diameter of the docking section, and the outermost diameter of the docking section is equal to 100% to 150% of an outermost diameter of the hole section of the curve of the hole section.

[0149] For some applications, the device is configured such that when the device is unconstrained, the curve of the docking section has 0.75 to 2 turns.

[0150] For some applications, the device is configured such that when the device is unconstrained, the curve of the docking section has 1 to 2 turns.

[0151] For some applications, the device is configured such that when the device is unconstrained, the curve of the docking section has 0.5 to 1.25 turns.

[0152] For some applications, the device is configured such that when the device is unconstrained, the curve of the docking section has 0.75 to 1.25 turns.

[0153] For some applications, the device is configured such that when the device is unconstrained, the docking section curve has 0.9 to 1.1 turns.

[0154] For some applications, the device is configured such that when the device is unconstrained, the docking section curve has 1 to 1.1 turns.

[0155] For some applications, the device is configured such that when the device is unconstrained, the connecting section is straight.

[0156] For some applications, the device is configured such that when the device is unconstrained, a closest distance between the hole section curve measured along the hole section central axis and the docking section curve is 4% to 100% of an outermost diameter of the hole section curve.

[0157] For some applications, the device is configured such that when the device is unconstrained, the closest distance is between 4% and 50%.

[0158] For some applications, the device is configured such that when the device is unconstrained, a distance between a centroid of the hole section curve measured along the hole section central axis and a centroid of the docking section curve is 7% to 100% of an outermost diameter of the hole section curve.

[0159] For some applications, the device is configured such that when the device is unconstrained, the distance is 10% to 50% of the outermost diameter of the hole section.

[0160] For some applications, the device is configured such that when the device is unconstrained, a hole section plane perpendicular to the hole section central axis and a docking section plane perpendicular to the docking section central axis are parallel or define an angle less than 30 degrees.

[0161] For some applications, the device is configured such that when the device is unconstrained, the hole section plane is parallel to the docking section plane.

[0162] For some applications, the device is configured such that when the device is unconstrained, the hole section central axis and the docking section central axis are coaxial or a distance between them is less than 50% of an outermost diameter of the hole section curve.

[0163] For some applications, the device is configured such that when the device is unconstrained, a hole section plane perpendicular to the hole section central axis and a docking section plane perpendicular to the docking section central axis define an angle greater than 60 degrees.

[0164] For some applications, the device is configured such that when the device is unconstrained, the angle is greater than 75 degrees.

[0165] For some applications, the device is configured such that when the device is unconstrained, a hole section plane perpendicular to the central axis of the hole section and a docking section plane perpendicular to the central axis of the docking section define an angle of 30 degrees to 60 degrees.

[0166] For some applications, the device includes a wire, which when the device is unconstrained, is shaped to define the hole section, the intravascular malformation docking section, and the connecting section.

[0167] For some applications, the device is configured such that when the device is unconstrained, the hole section curve is a three-dimensional curve.

[0168] For some applications, the device is configured such that when the device is unconstrained, the three-dimensional curve is a conical helix.

[0169] For some applications, the device is configured such that when the device is unconstrained, the outermost diameter of the hole section curve is between 2 and 10 millimeters.

[0170] For some applications, the device is configured such that when the device is unconstrained, the outermost diameter of the hole section is between 4 and 8 millimeters.

[0171] For some applications, the device is configured such that when the device is unconstrained, the docking section curve winds around the central axis of the docking section at the constant distance from the central axis of the docking section.

[0172] For some applications, the device is configured such that when the device is unconstrained, the hole section curve defines a central opening, which has a cross-sectional area of the hole section central opening, and the cross-sectional area of the hole section central opening is equal to at least 2% of the total cross-sectional area of the hole section defined by the outermost ring of the hole section curve. The measured cross-sectional area of the hole section central opening and the total cross-sectional area of the hole section are perpendicular to the central axis of the hole section.

[0173] For some applications, the device is configured such that when the device is unconstrained, the hole section curve defines a central opening, which has a cross-sectional area of the hole section central opening of at least 0.25 square millimeters.

[0174] For some applications, the hole section, the intravascular malformation docking section, and the connecting section include one or more shape memory alloys.

[0175] For some applications, the hole section, the intravascular malformation docking section, and the connecting section include one or more superelastic alloys.

[0176] In conjunction with the accompanying drawings, a more complete understanding of the present invention will be achieved through the following detailed description of embodiments of the present invention, wherein: BRIEF DESCRIPTION OF THE DRAWINGS

[0177] Embodiments of the present invention will now be described; reference is made to the accompanying drawings, which illustrate non-limiting examples of how the concepts of the present invention may be reduced to practice.

[0178] Figures 1A to 1D is a schematic view of a device for treating vascular malformations according to an application of the present invention;

[0179] Figure 2 is a schematic view of a kit according to an application of the present invention;

[0180] Figure 3 is a schematic view of another device for treating vascular malformations according to an application of the present invention;

[0181] Figure 4 is a schematic view of yet another device for treating vascular malformations according to an application of the present invention;

[0182] Figure 5 is a schematic view of yet another device for treating vascular malformations according to an application of the present invention;

[0183] Figures 6A to 6E is for deployment according to an application of the present invention Figures 1A to 1D is a schematic view of a method of a device for treating vascular malformations;

[0184] Figures 7A to 7B is a schematic view of another device for treating vascular malformations according to an application of the present invention; and

[0185] Figure 8 is for deployment according to an application of the present invention Figures 7A to 7B is a schematic view of a device for treating vascular malformations. DETAILED DESCRIPTION

[0186] Figures 1A to 1D is a schematic view of a device 20 for treating vascular malformations according to an application of the present invention. For some applications, the device 20 is configured to bridge the neck of a vascular malformation, such as an aneurysm, such as a wide-neck aneurysm, to prevent coil herniation, as described in more detail below with reference to Figures 6A to 6E For example, the aneurysm may be a saccular aneurysm formed in the wall of a blood vessel (usually an artery), such as a cerebral aneurysm, a coronary aneurysm, a ventricular aneurysm, a Valsalva sinus aneurysm, an aneurysm after cardiac surgery, or an aortic aneurysm. Alternatively, the vascular malformation may be any congenital and / or non-congenital vascular anomaly, such as, but not limited to, a fistula, a tumor, or an arteriovenous malformation.

[0187] Device 20 includes a hole section 30, an intravascular malformation docking section 32, and a connecting section 34. As described in more detail below Figures 6A to 6E The hole section 30 is configured to bridge the neck of the vascular malformation, which helps prevent coil prolapse, i.e., endovascular embolization coils protruding from the aneurysm. The intravascular malformation docking section 32 is configured to facilitate entanglement with the endovascular embolization coil 210 (described below Figure 6E ), which helps connect the device 20 to the endovascular embolization coil 210 to form a single mass.

[0188] Device 20 is generally configured such that when unconstrained (by the patient's anatomy, a microcatheter, or other means):

[0189] The hole section 30 is shaped to define a hole section curve 40 (marked in Figure 1C ), the hole section curve 40 winding around the hole section central axis 42 at a varying distance (e.g., at a monotonically varying distance) from the hole section central axis 42 for at least 2 turns (generally at least 2.5 turns), and / or not more than 10 turns, e.g., between 2 (e.g., 2.5) and 10 turns (marked in Figures 1B to 1D );

[0190] The intravascular malformation docking section 32 is shaped to define a docking section curve 50 (marked in Figure 1C ), the docking section curve 50 winding around the docking section central axis 52 at a varying distance or a constant distance from the docking section central axis 52 for 0.5 to 2 turns (e.g., between 0.75 and 2 turns, e.g., between 1 and 2 turns, or between 0.5 and 1.25 turns, e.g., between 0.75 and 1.25 turns, e.g., between 0.9 and 1.1 turns, e.g., between 1 and 1.1 turns) (marked in Figures 1B to 1D ); and

[0191] The connecting section 34 connects the hole section curve 40 to the docking section curve 50 and generally has an average radius of curvature that is different from the average radius of curvature of the outermost ring 60 of the hole section curve 40 (marked in Figures 1C to 1D ).

[0192] Device 20 also generally has the characteristics listed above when implanted in a vascular malformation, in part because the size of device 20 is selected based on the size of the vascular malformation.

[0193] As used in this application, a "turn" of a curve is a 360-degree turn of the curve around a central axis.

[0194] For some applications, when device 20 is unconstrained, the hole segment curve 40 is a three-dimensional curve. For some of these applications, when device 20 is unconstrained, the three-dimensional curve is a conical helix.

[0195] For some applications, when device 20 is unconstrained, the hole segment curve 40 defines a central opening 62 (labeled in Figures 1C to 1D ), the central opening having a hole segment central opening cross-sectional area that is equal to at least 2% of the total hole segment cross-sectional area of the hole segment curve defined by an outermost ring 60 (labeled in Figures 1C to 1D ) of the hole segment curve, the measured hole segment central opening cross-sectional area and the total hole segment cross-sectional area being perpendicular to the hole segment central axis 42. Alternatively or additionally, for some applications, when device 20 is unconstrained, the central opening 62 has a hole segment central opening cross-sectional area of at least 0.25 square millimeters (mm 2 ).

[0196] For some applications, device 20 includes a wire 54 that is shaped to define a hole segment 30, an intravascular malformation docking segment 32, and a connection segment 34. For some applications, as shown, the wire 54 is coiled to define a primary winding 56, for example around an inner wire 58 that may or may not extend along the length of device 20 (labeled in Figure 2 ). The curves described herein are large curves and do not relate to such optional microcoiling but rather to the large structures described herein, such as hole segment 30 and connection segment 34. For certain applications, the hole segment 30, the intravascular malformation docking segment 32, and the connection segment 34 include one or more shape memory alloys and / or one or more superelastic alloys.

[0197] As Figure 1B and Figure 1C shown, the hole segment curve 40 has a hole segment outermost diameter D1. Generally, when device 20 is unconstrained, the hole segment outermost diameter D1 is at least 2 millimeters (mm) (e.g., at least 4 mm), not more than 10 mm (e.g., not more than 8 mm; e.g., not more than 7 mm), and / or between 2 and 10 mm (e.g., between 2 and 8 mm; e.g., between 4 and 7 mm).

[0198] As Figure 1C shown, the docking segment curve 50 has a docking segment outermost diameter D2. Generally, the docking segment outermost diameter D2 is at least 1 mm, not more than 10 mm, and / or between 1 and 10 mm.

[0199] For some applications, when device 20 is unconstrained, the docking segment outermost diameter D2 is equal to 15% to 80% of the hole segment outermost diameter D1, e.g., 25% to 50%.

[0200] For some applications, as shown, when the device 20 is unconstrained, the connecting segment 34 connects the outermost ring 60 of the hole segment curve 40 to the docking segment curve 50. Alternatively, when the device 20 is unconstrained, the connecting segment 34 connects an innermost ring of the hole segment curve 40 to the docking segment curve 50 (configuration not shown).

[0201] As Figure 1C shown, for some applications, a length L of the connecting segment 34 is at least 15% (e.g., at least 20%; e.g., at least 30%; e.g., at least 50%) of the outermost diameter D1 of the hole segment, not more than 90% (e.g., not more than 70%), and / or between 15% and 90% (e.g., between 50% and 70%; e.g., about 60%). In a configuration where the connecting segment 34 is curved, the length L is measured along the curve of the connecting segment 34 (rather than on a straight line between the endpoints of the connecting segment 34).

[0202] Generally, when the device 20 is unconstrained, the average curvature radius of the connecting segment 34 is different from the average curvature radius of the outermost ring 60 of the hole segment curve 40. For example, when the device 20 is unconstrained, the average curvature radius of the connecting segment 34 can be greater than, e.g., greater than 100% of the average curvature radius of the outermost ring 60 of the hole segment curve 40; or, when the device 20 is unconstrained, the average curvature radius of the connecting segment 34 is less than, e.g., less than 100% of the average curvature radius of the outermost ring 60 of the hole segment curve 40. Alternatively or additionally, for some applications, when the device 20 is unconstrained, the average curvature radius of the connecting segment 34 is at least 1 mm, e.g., at least 1.5 mm (e.g., at least 2 mm) (and, generally, a length L of the connecting segment 34 is at least 30% (e.g., at least 50%) of the outermost diameter D1 of the hole segment, not more than 90% (e.g., not more than 70%), and / or between 30% and 90% (e.g., between 50% and 70%; e.g.: about 60%). Further alternatively or additionally, for some applications, when the device 20 is unconstrained, the average curvature radius of the connecting segment 34 is equal to greater than 50% of the outermost diameter D1 of the hole segment (and, generally, the length of the connecting segment 34 is as described above).

[0203] For other applications, when the device 20 is unconstrained, the connecting segment 34 is straight.

[0204] A connecting segment slope of the connecting segment 34 is equal to the quotient of:

[0205] (a) As Figure 1A and Figure 1BAs shown, a rise distance DRISE between two end points 72A, 72B of the connection segment 34 measured along the central axis 42 of the hole segment (the rise distance DRISE is measured between the centroids of a plurality of cross-sections of the connection segment 34 at the two end points 72A, 72B), divided by

[0206] (b) As Figure 1C shown, is equal to a run distance DRUN of the length L of the connection segment 34 between the two end points 72A, 72B of the connection segment 34; in a configuration where the connection segment 34 is curved, the length L is measured along the curve of the connection segment 34 (rather than on a straight line between the two end points 72A, 72B of the connection segment 34).

[0207] A hole segment slope of the hole segment 30 is equal to the quotient of:

[0208] (a) A rise distance between two end points 74A, 74B of the hole segment 30 measured along the central axis 42 of the hole segment (the rise distance is measured between the centroids of a plurality of cross-sections of the hole segment 30 at the two end points 74A, 74B), divided by

[0209] (b) A run distance equal to the length of the hole segment 30 between the two end points 74A, 74B of the hole segment 30 measured along the hole segment 30; the length is measured along the curve of the hole segment 30 (rather than on a straight line between the two end points 74A, 74B of the hole segment 30).

[0210] By way of example and not limitation, the hole segment slope of the configuration shown in the figure is zero.

[0211] Generally, when the device 20 is unconstrained, the connection segment slope is greater than the hole segment slope. Alternatively or additionally, for some applications, when the device 20 is unconstrained, the connection segment slope is greater than 0.1.

[0212] For some applications, as Figure 1B shown, when the device 20 is unconstrained, a closest distance D3 between the hole segment curve 40 and the docking segment curve 50 measured along the central axis 42 of the hole segment is between 4% and 100% of the outermost diameter D1 of the hole segment; for example, between 4% (e.g., 5%) and 50%; for example, between 4% (e.g., 5%) and 25%. Alternatively or additionally, for some applications, as Figure 1B shown, when the device 20 is unconstrained, a distance D4 between a centroid 64 of the hole segment curve 40 and a centroid 66 of the docking segment curve 50 measured along the central axis of the hole segment is between 7% and 100% of the outermost diameter D1 of the hole segment; for example, between 10% and 100%; for example, between 10% and 50%.

[0213] For some applications, as Figure 1BAs shown, when the device 20 is unconstrained, a hole section plane 68 perpendicular to the hole section central axis 42 is parallel to a docking section plane 70 perpendicular to the docking section central axis 52 (e.g., as Figures 1A to 1D shown) or defines an angle less than 30 degrees. For some of these applications, when the device 20 is unconstrained (configuration not shown), the hole section central axis 42 is coaxial with the docking section central axis 52 (e.g., as Figures 1A to 1D shown), or the distance between them is less than 50% (e.g., less than 25%) of the outermost diameter D1 of the hole section.

[0214] Refer to Figure 2 , which is a schematic diagram of a set 80 for an application according to the present invention. The set 80 includes a device 20 and a microcatheter 82, wherein the device 20 is removably arranged for delivery to a vascular malformation.

[0215] Refer to Figure 3 , which is a schematic diagram of a device 120 for treating a vascular malformation for an application according to the present invention. Except as described below, the device 120 is the same as the device 20 referred to above with reference to Figures 1A to 2 . A connection section 134 connects a hole section curve 140 of a hole section 130 to a docking section curve 150 of an intravascular malformation docking section 132, and generally has an average curvature radius different from the average curvature radius of the outermost ring of the hole section curve 140. When the device 20 is unconstrained, the outermost diameter D5 of the docking section curve 150 is 100% to 150% of the outermost diameter D6 of the hole section curve 140.

[0216] Refer to Figure 4 , which is a schematic diagram of a device 220 for treating a vascular malformation for an application according to the present invention. Except as described below, the device 220 is the same as the device 20 referred to above with reference to Figures 1A to 2 . In this configuration, when the device 20 is unconstrained, the hole section plane 68 and the docking section plane 70 define an angle α greater than 60 degrees; for example, greater than 75 degrees (e.g., 90 degrees).

[0217] Refer to Figure 5 , which is a schematic diagram of a device 320 for treating a vascular malformation for an application according to the present invention. Except as described below, the device 320 is the same as the device 20 referred to above with reference to Figures 1A to 2 . In this configuration, when the device 20 is unconstrained, the hole section plane 68 and the docking section plane 70 define an angle β between 30 and 60 degrees; for example, between 40 and 50 degrees (e.g., 45 degrees).

[0218] Refer to Figures 6A to 6E, which is a schematic diagram of a method for deploying a device for treating vascular malformations (e.g., aneurysm 200) according to an application of the present invention. The method can also be used to deploy the device 120 described above with reference to Figure 3 ; the device 220 described above with reference to Figure 4 ; or the device 320 described above with reference to Figure 5 .

[0219] As Figure 6A shown, generally, the intravascular malformation docking segment 32, the connecting segment 34, and the hole segment 30 are inserted into a blood vessel 202, and the intravascular malformation docking segment 32, the connecting segment 34, and the hole segment 30 are removably disposed in the microcatheter 82. Generally, the intravascular malformation docking segment 32 is disposed further in the microcatheter 82 than the connecting segment 34, and the connecting segment 34 is disposed further than the hole segment 30. Generally, a pusher tube 84 is removably disposed in the microcatheter 82, and a distal end 86 of the pusher tube 84 is removably connected to a proximal end 88 of the hole segment 30.

[0220] As Figure 6B shown, the intravascular malformation docking segment 32 is deployed from the microcatheter 82 into the vascular malformation, such as the aneurysm 200.

[0221] As Figure 6C shown, the connecting segment 34 is deployed from the microcatheter 82.

[0222] As Figure 6D shown, the hole segment 30 is deployed from the microcatheter 82 into a part of the vascular malformation (e.g., aneurysm 20) to at least partially cover a hole 204 of the vascular malformation, and the part of the vascular malformation includes one or more anatomical features selected from the group consisting of a neck 206 of the vascular malformation and a wall 208 of the vascular malformation.

[0223] The hole segment 30 is deployed such that:

[0224] The hole segment 30 is shaped to define a hole segment curve 40 that winds around the hole segment central axis 42 at a varying distance (e.g., at a monotonically varying distance) from the hole segment central axis 42 for at least 2.5 turns (marked in Figures 1A to 1D );

[0225] The intravascular malformation docking segment 32 is shaped to define a docking segment curve 50 (marked in Figures 1B to 1C ) that winds around the docking segment central axis 52 at a varying distance or a constant distance from the docking segment central axis 52 for 0.5 to 2 turns; and

[0226] The connecting segment 34 connects the hole segment curve 40 and the docking segment curve 50 (marked inFigures 1B to 1C is connected to the (middle) and is generally straighter than the hole section curve 40 and straighter than the docking section curve 50.

[0227] As Figure 6E shown, the method generally further includes implanting an intravascular embolization coil 210 into a vascular malformation, such as an aneurysm 200, such that the intravascular embolization coil 210 tangles with the intravascular malformation docking section 32 (labeled in Figures 6B to 6D the middle). The hole section 30 reduces (generally prevents) the risk of coil prolapse, that is, the intravascular embolization coil 210 leaving the vascular malformation and entering the parent vessel, especially in malformations with wide openings, such as wide-neck aneurysms, and / or vascular malformations located at bifurcations. The anatomical structure of a wide-neck aneurysm generally does not allow the aneurysm sac to retain the intravascular embolization coil 210 by itself, and a prolapsed or protruding intravascular embolization coil can cause an ischemic stroke.

[0228] Now refer to Figures 7A to 7B , which is a schematic diagram of a device 420 for treating a vascular malformation according to an application of the present invention. The device 420 is configured to bridge the neck of a vascular malformation, such as an aneurysm, such as a wide-neck aneurysm, to prevent coil prolapse, as described in more detail below with reference to Figure 8 . For example, the aneurysm can be of the type described in reference Figures 1A to 1D above. The device 420 can implement any features of the device 20 described above with reference to Figures 1A to 2 that are not inconsistent with the features of the device 420 described below.

[0229] The device 420 includes a hole section 430, an occlusion section 432, and a connection section 434. As described in more detail below with reference to Figure 8 , the hole section 430 is configured to bridge the neck of the vascular malformation in order to block blood flow into the aneurysm, thereby embolizing the aneurysm. When deployed, the occlusion section 432 at least partially occludes a hole section central opening 462, as described below.

[0230] The device 420 is generally configured such that when unconstrained (by the patient's anatomy, a microcatheter, or other means):

[0231] The hole section 430 is shaped to define a hole section curve 440 that winds around the hole section central axis 442 at a varying distance from the hole section central axis 442 (e.g., at a monotonically varying distance), winding at least 2.5 turns (e.g., at least 3 turns) and / or not more than 10 turns, e.g., between 2.5 (e.g.: 3) and 10 turns;

[0232] The occlusion section 432 is shaped to define an occlusion section curve 450 that wraps around an occlusion section central axis 452 at a varying distance from the occlusion section central axis 452 and wraps around the occlusion section central axis 452 at least 2 turns (e.g., at least 2.5 turns) and / or no more than 10 turns, such as between 2 (e.g., 2.5) and 10 turns;

[0233] The connection section 434 connects the hole section curve 440 to the occlusion section curve 450 (and optionally has an average curvature radius different from the average curvature radius of an outermost ring 460 of the hole section curve 440);

[0234] The hole section curve 440 defines a hole section central opening 462 that has a hole section central opening cross-sectional area equal to at least 2% (e.g., at least 3%; e.g., at least 5%) of a total hole section cross-sectional area of the hole section curve 440 defined by the outermost ring 460 of the hole section curve 440, with the measured hole section central opening cross-sectional area and the total hole section cross-sectional area being perpendicular to the hole section central axis 442;

[0235] The hole section central axis 442 is not coaxial with the occlusion section central axis 452; and

[0236] A projection of the occlusion section curve 450 occludes at least 25% (e.g., at least 50%; e.g., at least 60%) of the hole section central opening cross-sectional area, with the occlusion section curve 450 being projected onto a hole section plane perpendicular to the hole section central axis 442 in a direction along the hole section central axis 442.

[0237] (In other words, for example Figure 7B as shown in, if the occlusion section curve 450 is projected onto a hole section plane perpendicular to the hole section central axis 442 in a direction along the hole section central axis 442, the projection of the occlusion section curve 450 will occlude at least 25% (e.g., at least 50%; e.g., at least 60%) of the hole section central opening cross-sectional area.)

[0238] The device 420 typically also has the features listed above when implanted into a vascular malformation, partly because the size of the device 420 is selected based on the size of the vascular malformation.

[0239] For some applications, when the device 420 is unconstrained, the hole section curve 440 is a three-dimensional curve. For some of these applications, when the device 420 is unconstrained, the three-dimensional curve is a conical spiral.

[0240] For some applications, device 420 includes a wire 454 that is shaped to define a pore section 430, an occlusion section 432, and a connection section 434. For some applications, as shown, the wire 454 is microcoiled to define a primary winding, such as around an inner wire, which may or may not extend along the length of device 420 (labeled as device 20 in Figure 2 ). The curves described herein are large curves and do not relate to such optional microcoiling, but rather to the large structures described herein, such as pore section 430 and connection section 434. For some applications, pore section 430, occlusion section 432, and connection section 432 include one or more shape memory alloys and / or one or more superelastic alloys.

[0241] As Figure 7B shown, the pore section curve 440 has a pore section outermost diameter D7. Generally, when device 420 is unconstrained, the pore section outermost diameter D7 is at least 2 mm (e.g., at least 4 mm), no more than 10 mm (e.g., no more than 8 mm; e.g., no more than 7 mm), and / or between 2 and 10 mm (e.g., between 2 and 8 mm; e.g., between 4 and 7 mm).

[0242] As Figure 7B shown, the occlusion section curve 450 has an occlusion section outermost diameter D8. Generally, the occlusion section outermost diameter D8 is at least 3 mm (e.g., at least 4 mm), no more than 10 mm (e.g., no more than 8 mm), and / or between 3 and 10 mm (e.g., between 4 and 8 mm).

[0243] For some applications, when device 420 is unconstrained, the occlusion section outermost diameter D8 is equal to 50% to 150% of the pore section outermost diameter D7.

[0244] For some applications, as shown, when device 420 is unconstrained, connection section 434 connects the outermost ring 460 of pore section curve 440 to occlusion section curve 450. Alternatively, when device 420 is unconstrained, connection section 344 connects an innermost ring of pore section curve 440 to occlusion section curve 450 (configuration not shown).

[0245] Connection section 434 may have any of the characteristics (including shape and dimensions) described above with reference to Figures 1A to 1D connection section 34.

[0246] For some applications, device 420 is configured such that when device 420 is unconstrained, the pore section plane is parallel to an occlusion section plane perpendicular to occlusion section axis 452 (as shown) or defines an angle less than 30 degrees (e.g., less than 15 degrees). For some applications, device 420 is configured such that when device 420 is unconstrained, the pore section plane is parallel to the occlusion section plane.

[0247] For some applications, such as Figure 7B shown in, the device 420 is configured such that when the device 420 is unconstrained, the center axis 452 of the occlusion section does not pass through the central opening 462 of the hole section.

[0248] For some applications, the device 420 is configured such that when the device 420 is unconstrained, the occlusion section curve 450 winds around the center axis 452 of the occlusion section for a number of turns, the number of turns being equal to at least 0.5 turn (e.g., at least 1 turn), less than the number of turns that the hole section curve 440 winds around the center axis 442 of the hole section.

[0249] For some applications, the device 420 is configured such that when the device 420 is unconstrained, the occlusion section curve 450 defines an occlusion section central opening 476, the occlusion section central opening 476 having an occlusion section central opening cross-sectional area that is equal to at least 2% (e.g., at least 3%; e.g., at least 5%) of the total occlusion section cross-sectional area of the occlusion section curve 450 defined by an outermost ring 478 of the occlusion section curve 450, the measured occlusion section central opening cross-sectional area and the total occlusion section cross-sectional area being perpendicular to the center axis 452 of the occlusion section.

[0250] For some applications, the device 420 is configured such that when the device 420 is unconstrained, the cross-sectional area of the central opening of the hole section is at least 0.25 mm 2 . Alternatively or additionally, for some applications, the device 420 is configured such that when the device 420 is unconstrained, the cross-sectional area of the central opening of the occlusion section is at least 0.25 mm 2 .

[0251] For some applications, as Figure 7A shown, when the device 420 is unconstrained, a distance D9 between a centroid 464 of the hole section curve 440 and a centroid 466 of the occlusion section curve 450 measured along the center axis 442 of the hole section is 10% (e.g., 20%; e.g., 25%) to 100% (e.g., 80%; e.g., 75%) of the outermost diameter D7 of the hole section (marked in Figure 7B ), e.g., between 20% and 80% (e.g., between 25% and 75%).

[0252] For some applications, the device 420 is configured such that when the device 420 is unconstrained, a distance between a geometric center of the central opening 462 of the hole section and the occlusion section curve 450 measured along the center axis 442 of the hole section is 10% (e.g., 20%; e.g., 25%) to 100% (e.g., 80%; e.g., 75%) of the outermost diameter D7 of the hole section, e.g., between 20% and 80% (e.g., between 25% and 75%).

[0253] For some applications, such as Figure 1B shown, when the device 420 is unconstrained, a hole segment plane 68 perpendicular to the hole segment central axis 42 is parallel to a docking segment plane 70 perpendicular to the docking segment central axis 52 (e.g., as Figures 1A to 1D shown) or defines an angle less than 30 degrees. For some of these applications, when the device 420 is unconstrained, the hole segment central axis 42 is coaxial with the docking segment central axis 52 (e.g., as Figures 1A to 1D shown) or a distance between them is less than 50% of the outermost diameter D7 of the hole segment (e.g., less than 25%) (configuration not shown).

[0254] For some applications, such as Figure 7A shown, the device 420 is configured such that when the device 420 is unconstrained, the hole segment central axis 442 is parallel to the occlusion segment central axis 452. For some of these applications, a distance D10 between the hole segment central axis 442 and the occlusion segment central axis 452 is 20% to 80% of the outermost diameter D7 of the hole segment.

[0255] For some applications, a kit is provided that includes the device 420 and a microcatheter, wherein the device 420 is removably provided for delivery to a vascular malformation. The microcatheter can implement any of the features described above with reference to Figure 2 the microcatheter 82.

[0256] For some applications, the occlusion segment 432 is disposed further in the microcatheter than the connection segment 434, and the connection segment 434 is further than the hole segment 430.

[0257] For some applications, the kit further includes a push tube (e.g., the push tube 84, described above with reference to Figure 6A ) that is removably disposed in the microcatheter, and a distal end of the push tube is removably connected to a proximal end of the hole segment 430.

[0258] Refer to Figure 8 , which is a schematic diagram of the deployment of the device 420 for treating a vascular malformation (e.g., aneurysm 200) according to an application of the present invention. The device 420 can be deployed as described above with reference to Figures 6A to 6D the device 20.

[0259] As Figure 8 shown, the hole segment 430 is deployed from a microcatheter within a portion of a vascular malformation (e.g., aneurysm 200) to at least partially cover a hole 204 of the vascular malformation, and the portion of the vascular malformation includes one or more anatomical features selected from the group consisting of a neck 206 of the vascular malformation and a wall 208 of the vascular malformation.

[0260] Different from the device 20 described above for reference Figure 6E The method of deploying the deployment device 420 generally does not include implanting an endovascular embolization coil 210 into a vascular malformation (e.g., aneurysm 200). Instead, the aperture segment 430 is configured to bridge the neck of the vascular malformation to block blood flow into the aneurysm, thereby embolizing the aneurysm. Upon deployment, the occlusion segment 432 at least partially occludes the central aperture 462 of the aperture segment, thereby reducing blood flow through the central aperture 462 of the aperture segment, and there is no need to also implant an endovascular embolization coil 210 into the vascular malformation. Even though the occlusion segment 432 generally does not contact the aperture segment 430 surrounding the periphery of the central aperture 462 of the aperture segment, and there is a gap between the occlusion segment 432 and the central aperture 462 of the aperture segment, the gap is small enough to sufficiently reduce blood flow within a relatively short period of time, thereby effectively occluding the central aperture 462 of the aperture segment.

[0261] Alternatively, an endovascular embolization coil 210 is additionally implanted, such as the device 20 described above for reference Figure 6E described.

[0262] In one embodiment, the techniques and devices described in one or more of the following applications incorporated herein by reference are combined with the techniques and devices described herein:

[0263] U.S. Patent Application Publication No. 2017 / 0367708 to Mayer et al.; and

[0264] PCT Publication No. WO 2017 / 221252 to Mayer et al.

[0265] Those skilled in the art will understand that the present invention is not limited to what is specifically shown and described above. Instead, the scope of the present invention includes combinations and sub - combinations of the various features described above, as well as variations and modifications thereof that do not exist in the prior art and that would occur to those skilled in the art upon reading the above description.

Claims

1. An apparatus for treating vascular malformations, characterized in that, The device comprises: a hole section; a blocking section; and a connecting section, wherein, the device is configured such that when the device is unconstrained: the hole section is shaped to define a hole section curve that winds around the hole section central axis at a varying distance from the hole section central axis for at least 2.5 turns; the blocking section is shaped to define a blocking section curve that winds around the blocking section central axis at a varying distance from the blocking section central axis for at least 2 turns; the connecting section connects the hole section curve and the blocking section curve; the hole section curve defines a hole section central opening having a hole section central opening cross-sectional area that is equal to at least 2% of the total hole section cross-sectional area defined by the outermost ring of the hole section curve, the measured hole section central opening cross-sectional area and the total hole section cross-sectional area being perpendicular to the hole section central axis; the hole section central axis is non-coaxial with the blocking section central axis; and a projected blockage of the blocking section curve blocks at least 25% of the hole section central opening cross-sectional area, wherein the blocking section curve is projected onto a hole section plane perpendicular to the hole section central axis in a direction along the hole section central axis.

2. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the projected blockage of the blocking section curve blocks at least 50% of the hole section central opening cross-sectional area.

3. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the hole section central opening cross-sectional area is equal to at least 3% of the total hole section cross-sectional area.

4. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the blocking section curve winds around the blocking section central axis for a number of turns that is equal to at least 0.5 turn and less than the number of turns that the hole section curve winds around the hole section central axis.

5. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the blocking section curve defines a blocking section central opening having a blocking section central opening cross-sectional area that is equal to at least 2% of the total blocking section cross-sectional area defined by the outermost ring of the blocking section curve, the measured blocking section central opening cross-sectional area and the total blocking section cross-sectional area being perpendicular to the blocking section central axis.

6. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the blocking section central axis does not pass through the hole section central opening.

7. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the blocking section curve has a blocking section outermost diameter that is equal to 50% to 150% of a hole section outermost diameter of the hole section curve.

8. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the connecting section is straight or the connecting section has an average curvature radius that is different from an average curvature radius of the outermost ring of the hole section curve.

9. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the connecting section connects the outermost ring of the hole section curve to the hole section curve.

10. The device according to claim 1, characterized in that: The device includes a wire, and the wire is formed to define the hole section, the occlusion section, and the connection section.

11. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the cross-sectional area of the central opening of the hole section is at least 0.25 square millimeters.

12. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the cross-sectional area of the central opening of the occlusion section is at least 0.25 square millimeters.

13. The device according to claim 1, characterized in that: The hole section, the occlusion section, and the connection section include one or more shape memory alloys.

14. The device according to claim 1, characterized in that: The hole section, the occlusion section, and the connection section include one or more superelastic alloys.

15. The device according to any one of claims 1 to 14, characterized in that: The device is configured such that when the device is unconstrained, the plane of the hole section is parallel to a plane of the occlusion section perpendicular to the central axis of the occlusion section or defines an angle less than 30 degrees.

16. The device according to claim 15, characterized in that: The device is configured such that when the device is unconstrained, the plane of the hole section is parallel to the plane of the occlusion section or defines an angle less than 15 degrees.

17. The device according to claim 16, characterized in that: The device is configured such that when the device is unconstrained, the plane of the hole section is parallel to the plane of the occlusion section.

18. The device according to any one of claims 1 to 14, characterized in that: The device is configured such that when the device is unconstrained, the distance between the centroid of the curve of the hole section measured along the central axis of the hole section and the centroid of the curve of the occlusion section is 20% to 80% of the outermost diameter of the hole section of the curve of the hole section.

19. The device according to claim 18, characterized in that: The device is configured such that when the device is unconstrained, the distance is 25% to 75% of the outermost diameter of the hole section.

20. The device according to any one of claims 1 to 14, characterized in that: The device is configured such that when the device is unconstrained, the distance between the geometric center of the central opening of the hole section measured along the central axis of the hole section and the curve of the occlusion section is 20% to 80% of the outermost diameter of the hole section of the curve of the hole section.

21. The device according to claim 20, characterized in that: The device is configured such that when the device is unconstrained, the distance is 25% to 75% of the outermost diameter of the hole section.

22. The device according to any one of claims 1 to 14, characterized in that: The device is configured such that when the device is unconstrained, the central axis of the hole section and the central axis of the occlusion section are parallel to each other.

23. The device according to claim 22, wherein: The device is configured such that when the device is unconstrained, the distance between the central axis of the hole section and the central axis of the occlusion section is 20% to 80% of the outermost diameter of the hole section of the curve of the hole section.

24. The device according to any one of claims 1 to 14, characterized in that: The device is configured such that when the device is unconstrained, the curve of the hole section is a three-dimensional curve.

25. The device according to claim 24, wherein: The device is configured such that when the device is unconstrained, the three-dimensional curve is a conical spiral.

26. The device according to any one of claims 1 to 14, characterized in that: The device is configured such that when the device is unconstrained, the outermost diameter of the hole section of the curve of the hole section is 2 millimeters to 10 millimeters.

27. The device according to claim 26, characterized in that: The device is configured such that when the device is unconstrained, the outermost diameter of the hole section is 4 millimeters to 8 millimeters.

28. The device according to any one of claims 1 to 14, characterized in that: The device is configured such that when the device is unconstrained, the outermost diameter of the occlusion section of the curve of the occlusion section is 3 millimeters to 10 millimeters.

29. The device according to claim 28, wherein: The device is configured such that when the device is unconstrained, the outermost diameter of the occlusion section is 4 millimeters to 8 millimeters.

30. A set, characterized in that, The set includes: the device according to any one of claims 1 to 29, and the set further includes a microcatheter, and the device is removably disposed in the microcatheter for delivery to the vascular malformation.

31. The kit according to claim 30, characterized in that: The occluding section is disposed further in the microcatheter than the connecting section, and the connecting section is disposed further than the aperture section.

32. The kit according to claim 30, characterized in that: The set further includes a push tube removably disposed in the microcatheter, and a distal end of the push tube is removably connected to a proximal end of the aperture section.

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