Devices for treating vascular malformations

Abstract

A device (720) for treating vascular malformations is provided, comprising a bore segment (430), an occlusion segment (432), and a connecting segment (434). When the device (720) is unconstrained, the bore segment and the occlusion segment (430, 432) are shaped to define a bore segment curve and an occlusion segment curve (440, 450) that are each wrapped around a non-coaxial bore segment and occlusion segment central axis (442, 452) at varying distances from the axis (442, 452). The bore segment curve (440) defines a bore segment central opening (462). A projection of the occlusion segment curve (450) occludes at least 25% of a bore segment central opening cross-sectional area of ​​a bore segment central opening (462); the occlusion segment curve (450) is projected onto a bore segment plane perpendicular to the bore segment central axis (442) in a direction along the bore segment central axis (442). Other embodiments are also described.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 785,013, filed on December 26, 2018, which has been assigned to the assignee of the present 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 with direct surgery, such as installing a clip at the base of the aneurysm to prevent blood from passing between the aneurysm and the lumen of the blood vessel. Then, attempts were made to develop minimally invasive techniques to treat such aneurysms, such as filling the aneurysm with intravascular embolization coils, which eventually turned the aneurysm into a solid mass of coils and thrombi. 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 the neck of a vascular malformation, such as an aneurysm, such as a wide-necked aneurysm, to prevent coil herniation. 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 coil herniation, i.e., protrusion of endovascular embolization coils from the aneurysm. The intravascular malformation docking section is configured to facilitate entanglement with an intravascular embolization coil, which helps connect the device to the intravascular embolization coil to form a single mass.

[0006] The device is typically configured so that when unconstrained (by the patient's anatomy, a microcatheter, or otherwise):

[0007] The bore segments are shaped to define a bore segment curve that wraps around a bore segment central axis at least 2 times (typically at least 2.5 times) at a varying distance from the bore segment central axis;

[0008] The intravascular malformation docking segment is shaped to define a docking segment curve, which wraps around the docking segment central axis at a varying distance or a constant distance from the docking segment central axis by at least 0.5 to 2 turns (e.g., 0.75 to 2 turns, e.g., 1 to 2 turns); and

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

[0010] Providing a butt segment curve with only 0.5 to 2 turns generally makes it easier to deploy an intravascular malformation butt segment in an aneurysm than providing a butt segment curve with a greater number of turns while providing a similar level of winding as an intravascular embolization coil.

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

[0012] The device is typically configured so that when unconstrained (by the patient's anatomy, a microcatheter, or otherwise):

[0013] The bore segment is shaped to define a bore segment curve, the bore segment curve wrapping around a bore segment central axis at a varying distance from the bore segment central axis at least 2.5 times;

[0014] The occlusion segment is shaped to define an occlusion segment curve, the occlusion segment curve wraps around an occlusion segment central axis at a varying distance from the occlusion segment central axis at least 2 times; and

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

[0016] The bore segment curve defines the bore segment center opening, the bore segment center opening has a bore segment center opening cross-sectional area, the bore segment center opening cross-sectional area is equal to at least 2% of a total bore segment cross-sectional area of ​​the bore segment curve defined by an outermost ring of the bore segment curve, and the measured bore segment center opening cross-sectional area and the total bore segment cross-sectional area are perpendicular to the bore segment center axis;

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

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

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

[0020] One hole segment;

[0021] an occluded segment; and

[0022] A connecting segment,

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

[0024] The bore segment is shaped to define a bore segment curve, the bore segment curve wrapping around a bore segment central axis at a varying distance from the bore segment central axis at least 2.5 times;

[0025] The occlusion segment is shaped to define an occlusion segment curve, the occlusion segment curve wraps around the occlusion segment central axis at least 2 times at a varying distance from the occlusion segment central axis;

[0026] The connecting segment connects the hole segment curve with the occlusion segment curve;

[0027] The bore segment curve defines a bore segment center opening, the bore segment center opening has a bore segment center opening cross-sectional area, the bore segment center opening cross-sectional area is equal to at least 2% of a total bore segment cross-sectional area of ​​the bore segment curve defined by an outermost ring of the bore segment curve, and the measured bore segment center opening cross-sectional area and the total bore segment cross-sectional area are perpendicular to the bore segment center axis;

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

[0029] A projection of the occluded section curve blocks at least 25% of the central opening cross-sectional area of ​​the hole section, wherein the occluded 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 projection of the occluded segment curve occludes at least 50% of the central opening cross-sectional area of ​​the bore segment.

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

[0032] For some applications, the device is configured such that when the device is unconstrained, the occlusion segment curve wraps around the occlusion segment central axis a number of turns equal to at least 0.5 turns less than the number of turns that the hole segment curve wraps around the hole segment central axis.

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

[0034] For some applications, the device is configured such that when the device is unconstrained, the occlusion segment central axis does not pass through the bore segment central opening.

[0035] For some applications, the device is configured such that when the device is unconstrained, the occlusion segment curve has an occlusion segment outermost diameter that is equal to 50% to 150% of an aperture segment outermost diameter of the aperture segment curve.

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

[0037] For some applications, the device is configured such that when the device is unconstrained, the connecting segment connects the outermost ring of the bore segment curve with the bore segment curve.

[0038] For some applications, the apparatus includes a wire shaped to define the hole segment, the occluded segment, and the connecting segment.

[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 bore segment is at least 0.25 square millimeters.

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

[0041] For some applications, the hole segment, the occlusive segment, and the connecting segment include one or more shape memory alloys.

[0042] For some applications, the hole segment, the occluder segment, and the connecting segment include one or more superelastic alloys.

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

[0044] For any of the applications described above, the device may be configured such that when the device is unconstrained, a distance between a centroid of the bore segment curve and a centroid of the occlusion segment curve measured along the bore segment center axis is between 20% and 80% of a bore segment outermost diameter of the bore segment curve. For some applications, the device is configured such that when the device is unconstrained, the distance is between 25% and 75% of the bore segment outermost diameter.

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

[0046] For any of the applications described above, the device may be configured such that when the device is unconstrained, the bore segment central axis and the occluded segment central axis are parallel to each other. For some applications, the device is configured such that when the device is unconstrained, the bore segment central axis and the occluded segment central axis are at a distance from each other that is 20% to 80% of the outermost diameter of a bore segment of the bore segment curve.

[0047] For any of the applications described above, the device may be configured such that when the device is unconstrained, the bore segment 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 so that when the device is unconstrained, the outermost diameter of a hole segment of the hole segment curve is 2 mm to 10 mm. For some applications, the device is configured so that when the device is unconstrained, the outermost diameter of the hole segment is 4 mm to 7 mm.

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

[0050] For any of the applications described above, a kit may be provided, the kit comprising the device and a microcatheter, the device being removably disposed in the microcatheter for delivery to the vascular malformation. For some applications, the occlusion segment is disposed more distally in the microcatheter than the connecting segment, which in turn is disposed more distally than the hole segment. For some applications, the kit further comprises a push tube, the push tube being removably disposed in the microcatheter, and a distal end of the push tube being removably connected to a proximal end of the hole segment.

[0051] According to an application of the present invention, a method for treating a vascular malformation is also provided, the method comprising: implanting: (a) an occluding portion of a device in the vascular malformation; (b) a connecting portion of the device; and (c) a hole segment of the device in a portion of the vascular malformation so as to partially cover a hole of the vascular malformation, the portion of the vascular malformation comprising one or more anatomical features, the anatomical features being selected from the group consisting of a neck of the vascular malformation and a wall of the vascular malformation, such that:

[0052] The bore segment is shaped to define a bore segment curve, the bore segment curve wrapping around a bore segment central axis at least 2.5 times at a varying distance from the bore segment central axis;

[0053] The occlusion segment is shaped to define an occlusion segment curve, and the occlusion segment curve wraps around the occlusion segment central axis at least 2 times at a varying distance from the occlusion segment central axis;

[0054] The connecting segment connects the hole segment curve with the occlusion segment curve;

[0055] The bore segment curve defines a bore segment center opening, the bore segment center opening has a bore segment center opening cross-sectional area, the bore segment center opening cross-sectional area is equal to at least 2% of a total bore segment cross-sectional area of ​​the bore segment curve defined by an outermost ring of the bore segment curve, and the measured bore segment center opening cross-sectional area and the total bore segment cross-sectional area are perpendicular to the bore segment center axis;

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

[0057] A projection of the occluded section curve blocks at least 25% of the central opening cross-sectional area of ​​the hole section, wherein the occluded 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 occluding segment, the connecting segment, and the hole segment includes:

[0059] Inserting the occluding segment, the connecting segment and the hole segment into a blood vessel, while the occluding segment, the connecting segment and the hole segment are removably disposed in a microcatheter;

[0060] deploying the occlusive segment from the microcatheter into the vascular malformation;

[0061] deploying the connecting segment from the microcatheter; and

[0062] The hole segment is deployed from the microcatheter into the portion of the vascular malformation.

[0063] For some applications, deploying the occlusive segment, the connecting segment, and the bore segment includes deploying the occlusive segment, then deploying the connecting segment, and then deploying the bore segment.

[0064] For some applications, inserting the occluding segment, the connecting segment, and the hole segment into the blood vessel includes pushing the hole segment distally using a push tube, wherein the push tube 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.

[0065] For some applications, the vascular malformation is an aneurysm, and implanting the occluding segment includes implanting the occluding segment within the aneurysm.

[0066] For some applications, the device is configured such that when the device is unconstrained, a projection of the occluded segment curve occludes at least 50% of a cross-sectional area of ​​a central opening of the bore segment.

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

[0068] One hole segment;

[0069] A malformed intravascular docking segment; and

[0070] A connecting segment,

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

[0072] The bore segment is shaped to define a bore segment curve, the bore segment curve wrapping around a bore segment central axis at least 2.5 times at a varying distance from the bore segment central axis;

[0073] The intravascular malformation docking segment is shaped to define a docking segment curve, and the docking segment curve wraps around the central axis of the docking segment by 0.5 to 2 turns at a varying distance or a constant distance from the central axis of the docking segment; and

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

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

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

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

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

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

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

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

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

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

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

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

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

[0087] For some applications, the device is configured such that when the device is unconstrained, the connecting segment connects the outermost loop of the hole segment curve with the docking segment curve.

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

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

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

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

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

[0093] For some applications, the device is configured such that when the device is unconstrained, the docking segment 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 segment curve has a turn of 0.75 to 1.25.

[0095] For some applications, the device is configured such that when the device is unconstrained, the docking segment 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 segment curve has 1 to 1.1 turns.

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

[0098] For some applications, the apparatus is configured such that when the apparatus is unconstrained, a closest distance between the bore segment curve and the butt segment curve measured along the bore segment center axis is 4% to 100% of a bore segment outermost diameter of the bore segment 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 center of mass of the bore segment curve and a center of mass of the docking segment curve measured along the bore segment center axis is 7% to 100% of a bore segment outermost diameter of the bore segment curve.

[0101] For some applications, the apparatus is configured such that when the apparatus is unconstrained, the distance is between 10% and 50% of an outermost diameter of the bore segment.

[0102] For some applications, the apparatus is configured such that when the apparatus is unconstrained, a bore segment plane perpendicular to the bore segment central axis is parallel to or defines an angle of less than 30 degrees with a docking segment plane perpendicular to the docking segment central axis.

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

[0104] For some applications, the device is configured such that when the device is unconstrained, the bore segment central axis is coaxial with the docking segment central axis or is at a distance from one another that is less than 50% of an outermost diameter of a bore segment of the bore segment curve.

[0105] For some applications, the apparatus is configured such that when the apparatus is unconstrained, a bore segment plane perpendicular to the bore segment central axis and a docking segment plane perpendicular to the docking segment 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 apparatus is configured such that when the apparatus is unconstrained, a bore segment plane perpendicular to the bore segment central axis and a docking segment plane perpendicular to the docking segment central axis define an angle of 30 to 60 degrees.

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

[0109] For some applications, the apparatus is configured such that when the apparatus is unconstrained, the bore 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 spiral.

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

[0112] For some applications, the device is configured such that when the device is unconstrained, the hole segment has an outermost diameter of 4 to 7 mm.

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

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

[0115] For some applications, the device is configured such that when the device is unconstrained, the bore segment curve defines a central opening having a bore 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 may be provided, the kit comprising: the device and a microcatheter, the device being removably disposed in the microcatheter for delivery to the vascular malformation. The intravascular malformation docking segment is disposed in the microcatheter further than the connecting segment, which in turn is disposed further than the hole segment. For some applications, the kit further comprises a push tube, the push tube being removably disposed in the microcatheter, and a distal end of the push tube being removably connected to a proximal end of the hole segment.

[0119] According to an application of the present invention, a method for treating vascular malformations is also provided, the method comprising:

[0120] implanting: (a) an intravascular malformation docking segment of a device within the vascular malformation; (b) a connecting segment of the device; and (c) an orifice segment of the device within a portion of the vascular malformation to at least partially cover an orifice of the vascular malformation, the portion of the vascular malformation comprising 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 bore segment is shaped to define a bore segment curve, the bore segment curve wrapping around a bore segment central axis at least 2.5 times at a varying distance from the bore segment central axis;

[0122] The intravascular malformation docking segment is shaped to define a docking segment curve, and the docking segment curve wraps around the central axis of the docking segment by 0.5 to 2 turns at a varying distance or a constant distance from the central axis of the docking segment;

[0123] The connecting section connects the hole section curve and the docking section curve and has an average curvature radius, which is different from an average curvature radius of an outermost ring of the hole section curve; and

[0124] The intravascular embolization coil is implanted into the vascular malformation so that the intravascular embolization coil is entangled with the abutting section of the vascular malformation.

[0125] For some applications, implanting the malformation docking segment, the connecting segment, and the hole segment in the blood vessel includes:

[0126] Inserting the intravascular malformation docking segment, the connecting segment and the hole segment into a blood vessel, while the intravascular malformation docking segment, the connecting segment and the hole segment are removably arranged in a microcatheter;

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

[0128] deploying the connecting segment from the microcatheter; and

[0129] The hole segment is deployed from the microcatheter into the portion of the vascular malformation.

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

[0131] For some applications, inserting the intravascular malformation docking segment, the connecting segment, and the hole segment into the blood vessel includes using a push tube to push the hole segment distally, wherein the push tube 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.

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

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

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

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

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

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

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

[0139] The slope of the connecting section is greater than 10%.

[0140] For some applications, the device is configured such that when the device is unconstrained, a length of the connecting segment is at least 15% of an outermost diameter of a bore segment of the bore segment curve.

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

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

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

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

[0145] For some applications, the device is configured such that when the device is unconstrained, the connecting segment connects the outermost loop of the hole segment curve with the docking segment curve.

[0146] For some applications, the device is configured such that when the device is unconstrained, the docking segment curve has a docking segment outermost diameter that is equal to 15% to 80% of a bore segment outermost diameter of the bore segment curve.

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

[0148] For some applications, the device is configured such that when the device is unconstrained, the docking segment curve has a docking segment outermost diameter that is equal to 100% to 150% of a bore segment outermost diameter of the bore segment curve.

[0149] For some applications, the device is configured such that when the device is unconstrained, the docking segment curve has between 0.75 and 2 turns.

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

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

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

[0153] For some applications, the device is configured such that when the device is unconstrained, the docking segment 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 segment curve has 1 to 1.1 turns.

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

[0156] For some applications, the apparatus is configured such that when the apparatus is unconstrained, a closest distance between the bore segment curve and the butt segment curve measured along the bore segment center axis is 4% to 100% of a bore segment outermost diameter of the bore segment 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 center of mass of the bore segment curve and a center of mass of the docking segment curve measured along the bore segment center axis is 7% to 100% of a bore segment outermost diameter of the bore segment curve.

[0159] For some applications, the apparatus is configured such that when the apparatus is unconstrained, the distance is between 10% and 50% of an outermost diameter of the bore segment.

[0160] For some applications, the apparatus is configured such that when the apparatus is unconstrained, a bore segment plane perpendicular to the bore segment central axis is parallel to or defines an angle of less than 30 degrees with a docking segment plane perpendicular to the docking segment central axis.

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

[0162] For some applications, the device is configured such that when the device is unconstrained, the bore segment central axis is coaxial with the docking segment central axis or is at a distance from one another that is less than 50% of an outermost diameter of a bore segment of the bore segment curve.

[0163] For some applications, the apparatus is configured such that when the apparatus is unconstrained, a bore segment plane perpendicular to the bore segment central axis and a docking segment plane perpendicular to the docking segment 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 apparatus is configured such that when the apparatus is unconstrained, a bore segment plane perpendicular to the bore segment central axis and a docking segment plane perpendicular to the docking segment central axis define an angle of 30 to 60 degrees.

[0166] For some applications, the device includes a wire that is shaped to define the hole segment, the vascular malformation abutment segment, and the connecting segment when the device is unconstrained.

[0167] For some applications, the apparatus is configured such that when the apparatus is unconstrained, the bore segment 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 spiral.

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

[0170] For some applications, the device is configured such that when the device is unconstrained, the hole segment has an outermost diameter of 4 to 8 mm.

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

[0172] For some applications, the device is configured such that when the device is unconstrained, the bore segment curve defines a central opening having a bore segment central opening cross-sectional area, the bore segment central opening cross-sectional area being equal to at least 2% of a total bore segment cross-sectional area of ​​the bore segment curve defined by the outermost ring of the bore segment curve, the measured bore segment central opening cross-sectional area and the total bore segment cross-sectional area being perpendicular to the bore segment central axis.

[0173] For some applications, the device is configured such that when the device is unconstrained, the bore segment curve defines a central opening having a bore segment central opening cross-sectional area of ​​at least 0.25 square millimeters.

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

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

[0176] The present invention will be more fully understood through the following detailed description of the embodiments of the present invention in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0177] Embodiments of the invention will now be described; with reference to the accompanying drawings which illustrate non-limiting examples of how the inventive concept can be reduced to practice.

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

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

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

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

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

[0183] FIG. 6A to FIG. 6E is a method for developing an application according to the present invention Figures 1A to 1D A schematic diagram of a method of a device for treating a vascular malformation;

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

[0185] Figure 8 is an expansion of the application according to the present invention FIG. 7A to FIG. 7B Schematic diagram of a device for treating vascular malformations. DETAILED DESCRIPTION

[0186] Figures 1A to 1D is a schematic diagram of a device 20 for treating a vascular malformation 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-necked aneurysm, to prevent coil herniation, as described below with reference to FIG. 6A to FIG. 6E For example, an 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 sinus of Valsalva aneurysm, an aneurysm after cardiac surgery, or an aortic aneurysm. Alternatively, a 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] The device 20 includes a hole section 30, a vascular malformation docking section 32, and a connecting section 34. FIG. 6A to FIG. 6E As described in more detail, the hole segment 30 is configured to bridge the neck of the vascular malformation, which helps prevent coil dislodgement, i.e., the endovascular embolization coils protruding from the aneurysm. The endovascular malformation docking segment 32 is configured to facilitate the endovascular embolization coil 210 (hereinafter referred to as Fig. 6E ) entanglement, which helps to connect the device 20 with the intravascular embolic coil 210 to form a single mass.

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

[0189] The bore segment 30 is shaped to define a bore segment curve 40 (marked at Figure 1C ), the hole segment curve 40 is wound around the hole segment center axis 42 at a varying distance (e.g., at a monotonically varying distance) from the hole segment center axis 42 by at least 2 turns (usually at least 2.5 turns), and / or no more than 10 turns, for example, between 2 (e.g., 2.5) and 10 turns (marked in Figures 1B to 1D middle);

[0190] The intravascular malformation abutment segment 32 is shaped to define a pair of abutment segment curves 50 (marked at Figure 1C ), the docking section curve 50 is wound around the docking section central axis 52 at a varying distance or a constant distance from the docking section central axis 52 by 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 at Figures 1B to 1D in); and

[0191] The connecting section 34 connects the hole section curve 40 with the docking section curve 50 and generally has an average radius of curvature which is substantially the same as an outermost ring 60 (marked at Figure 1C to Figure 1D The average radius of curvature of the

[0192] The device 20 also generally has the features listed above when implanted in a vascular malformation, in part because the size of the 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 about a central axis.

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

[0195] For some applications, when the device 20 is unconstrained, the bore segment curve 40 defines a central opening 62 (marked at Figure 1C to Figure 1D The central opening has a hole section central opening cross-sectional area, and the hole section central opening cross-sectional area is equal to an outermost ring 60 (marked at Figure 1C to Figure 1D The measured cross-sectional area of ​​the hole segment center opening and the total hole segment cross-sectional area are perpendicular to the hole segment center axis 42. Alternatively or additionally, for some applications, when the device 20 is unconstrained, the center opening 62 has a cross-sectional area of ​​at least 0.25 square millimeters (mm 2 ) of the hole section center opening cross-sectional area.

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

[0197] like Figure 1B and Figure 1C As shown, the hole segment curve 40 has a hole segment outermost diameter D1. Typically, when the device 20 is unconstrained, the hole segment outermost diameter D1 is at least 2 millimeters (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).

[0198] like Figure 1C As shown, the butt joint curve 50 has a butt joint outermost diameter D2. Typically, the butt joint outermost diameter D2 is at least 1 mm, no more than 10 mm, and / or between 1 and 10 mm.

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

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

[0201] like Figure 1C As shown, for some applications, the 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%), no more than 90% (e.g., no more than 70%), and / or between 15% and 90% (e.g., between 50% and 70%; e.g., about 60%) of the outermost diameter D1 of the hole segment. In the 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 end points of the connecting segment 34).

[0202] Typically, when the device 20 is unconstrained, the average radius of curvature of the connecting segment 34 is different from the average radius of curvature of the outermost ring 60 of the hole segment curve 40. For example, when the device 20 is unconstrained, the average radius of curvature of the connecting segment 34 can be greater than, for example, greater than 100% of the average radius of curvature of the outermost ring 60 of the hole segment curve 40; or, when the device 20 is unconstrained, the average radius of curvature of the connecting segment 34 can be less than, for example, less than 100% of the average radius of curvature 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 radius of curvature of the connecting segment 34 is at least 1 mm, such as at least 1.5 mm (e.g., at least 2 mm) (and, typically, a length L of the connecting segment 34 is at least 30% (e.g., at least 50%), no more than 90% (e.g., no more than 70%), and / or between 30% and 90% (e.g., between 50% and 70%; for example: about 60%) of the outermost diameter D1 of the hole segment). Further alternatively or additionally, for some applications, when the device 20 is unconstrained, the average radius of curvature of the connecting segment 34 is equal to or greater than 50% of the outermost diameter D1 of the hole segment (and, typically, the length of the connecting segment 34 is as described above).

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

[0204] A connection section slope of the connection section 34 is equal to the quotient of:

[0205] (a) If Figure 1A and Figure 1BAs shown, a rise distance DRISE between the two end points 72A, 72B of the connecting section 34 measured along the hole section center axis 42 (the rise distance DRISE is measured between the centroids of multiple cross sections of the connecting section 34 at the two end points 72A, 72B), divided by

[0206] (b) If Figure 1C As shown, a running distance DRUN is equal to the length L of the connecting segment 34 between the two end points 72A, 72B of the connecting segment 34; in the 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 two end points 72A, 72B of the connecting segment 34).

[0207] The bore section slope of the bore section 30 is equal to the quotient of:

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

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

[0210] By way of example and not limitation, the configurations shown in the figures have bore segments with a slope of zero.

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

[0212] For some applications, such as Figure 1B As shown, when the device 20 is unconstrained, a minimum distance D3 between the bore segment curve 40 and the butt segment curve 50 measured along the bore segment center axis 42 is between 4% and 100% of the bore segment outermost diameter D1; for example, between 4% (e.g., 5%) and 50%; for example, between 4% (e.g., 5%) and 25%. Alternatively or additionally, for some applications, such as Figure 1B As 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 center 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, such as Figure 1BAs shown, when the device 20 is unconstrained, a bore section plane 68 perpendicular to the bore section center axis 42 is parallel to a pair of docking section planes 70 perpendicular to the docking section center axis 52 (e.g., as shown in FIG. Figures 1A to 1D For some of these applications, when the device 20 is unconstrained (configuration not shown), the bore segment central axis 42 is coaxial with the docking segment central axis 52 (e.g., as shown in FIG. Figures 1A to 1D As shown), or a distance between each other is less than 50% (for example, less than 25%) of the outermost diameter D1 of the hole segment.

[0214] refer to Figure 2 , which is a schematic diagram of a kit 80 according to the application of the present invention. Kit 80 includes device 20 and a microcatheter 82, wherein device 20 is removably configured for delivery to a vascular malformation.

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

[0216] refer to Figure 4 , which is a schematic diagram of a device 220 for treating vascular malformations according to the application of the present invention. Except as described below, the device 220 is the same as the above reference Figures 1A to 2 The device 20 described is the same. In this configuration, when the device 20 is unconstrained, the bore section plane 68 defines an angle α with the abutment section plane 70 that is greater than 60 degrees; for example, greater than 75 degrees (eg, 90 degrees).

[0217] refer to Figure 5 , which is a schematic diagram of a device 320 for treating vascular malformations according to the application of the present invention. Except as described below, the device 320 is the same as the above reference Figure 1A to Figure 2 The device 20 described is the same. In this configuration, when the device 20 is unconstrained, the bore section plane 68 defines an angle β with the abutment section plane 70 between 30 and 60 degrees; for example, between 40 and 50 degrees (eg, 45 degrees).

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

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

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

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

[0222] like Fig.6D As shown, the hole segment 30 is deployed from the microcatheter 82 into a portion of a vascular malformation (e.g., an aneurysm 20) so as to at least partially cover a hole 204 of the vascular malformation, wherein 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.

[0223] The bore segment 30 is developed such that:

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

[0225] The intravascular malformation abutment segment 32 is shaped to define a abutment segment curve 50 (marked at Figure 1B to Figure 1C ), the docking section curve 50 is wound around the docking section central axis 52 for 0.5 to 2 turns at a variable distance or a constant distance from the docking section central axis 52; and

[0226] The connecting section 34 connects the hole section curve 40 with the docking section curve 50 (marked at Figure 1B to Figure 1C ) and is generally straighter than the hole section curve 40 and straighter than the butt section curve 50.

[0227] like Fig. 6E As shown, the method generally further includes implanting an intravascular embolization coil 210 into a vascular malformation, such as an aneurysm 200, so that the intravascular embolization coil 210 is aligned with the intravascular malformation docking segment 32 (marked at FIG. 6B to FIG. 6D The hole segment 30 reduces (usually prevents) the risk of coil dislodgement, i.e., the endovascular embolization coil 210 leaving the vascular malformation and entering the parent vessel, particularly in malformations with wide openings, such as wide-necked aneurysms, and / or vascular malformations located at bifurcations. The anatomical structure of wide-necked aneurysms generally does not allow the aneurysm sac to retain the endovascular embolization coil 210 itself, and dislodged or protruding endovascular embolization coils can lead to ischemic stroke.

[0228] Reference now FIG. 7A to FIG. 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-necked aneurysm, to prevent coil dislodgement, as described below with reference to Figure 8 For example, an aneurysm may be a reference Figures 1A to 1D The device 420 may implement the above-described type. Figures 1A to 2 Any features of the device 20 described that are not inconsistent with features of the device 420 described below.

[0229] The device 420 includes a hole section 430, a blocking section 432 and a connecting section 434. Figure 8 In more detail, the hole segment 430 is configured to bridge the neck of the vascular malformation so as to block blood flow into the aneurysm, thereby embolizing the aneurysm. When deployed, the occluding segment 432 at least partially occludes a hole segment central opening 462, as described below.

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

[0231] The bore segment 430 is shaped to define a bore segment curve 440 that wraps around a bore segment central axis 442 at a varying distance (e.g., at a monotonically varying distance) from the bore segment central axis 442 by at least 2.5 turns (e.g., at least 3 turns) and / or no more than 10 turns, e.g., between 2.5 (e.g., 3) and 10 turns;

[0232] The occlusion segment 432 is shaped to define an occlusion segment curve 450, which winds 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, around an occlusion segment central axis 452 at a varying distance from the occlusion segment central axis 452;

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

[0234] The bore segment curve 440 defines a bore segment center opening 462, the bore segment center opening 462 having a bore segment center opening cross-sectional area, the bore segment center opening cross-sectional area being equal to at least 2% (e.g., at least 3%; e.g., at least 5%) of a total bore segment cross-sectional area of ​​the bore segment curve 440 defined by the outermost ring 460 of the bore segment curve 440, the measured bore segment center opening cross-sectional area and the total bore segment cross-sectional area being perpendicular to the bore segment center axis 442;

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

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

[0237] (In other words, for example Figure 7B As shown in FIG. 4 , if the occluded segment curve 450 is projected onto a bore segment plane perpendicular to the bore segment center axis 442 in a direction along the bore segment center axis 442, the projection of the occluded segment curve 450 will block at least 25% (e.g., at least 50%; e.g., at least 60%) of the bore segment center opening cross-sectional area. )

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

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

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

[0241] like Figure 7B As shown, the hole segment curve 440 has a hole segment outermost diameter D7. Typically, when the device 420 is unconstrained, the hole segment 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] like Figure 7B As shown, the occluded segment curve 450 has an occluded segment outermost diameter D8. Typically, the occluded segment 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 the device 420 is unconstrained, the outermost diameter D8 of the occluded segment is equal to 50% to 150% of the outermost diameter D7 of the hole segment.

[0244] For some applications, as shown, when the device 420 is unconstrained, the connecting segment 434 connects the outermost loop 460 of the hole segment curve 440 with the occlusion segment curve 450. Alternatively, when the device 420 is unconstrained, the connecting segment 344 connects an innermost loop of the hole segment curve 440 with the occlusion segment curve 450 (configuration not shown).

[0245] The connecting section 434 may have the Figures 1A to 1D Any characteristics described for the connecting section 34 (including shape and size).

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

[0247] For some applications, such as Figure 7B As shown in FIG. 4 , the device 420 is configured such that the occluder segment central axis 452 does not pass through the bore segment central opening 462 when the device 420 is unconstrained.

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

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

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

[0251] For some applications, such as Fig. 7A As shown, when the device 420 is configured to be unconstrained, a distance D9 between a centroid 464 of the bore segment curve 440 and a centroid 466 of the occluded segment curve 450 measured along the bore segment center axis 442 is equal to the outermost diameter D7 of the bore segment (marked at Figure 7B 10% (e.g., 20%; e.g., 25%) to 100% (e.g., 80%; e.g., 75%) of the total cost of ownership, 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 bore segment central opening 462 measured along the bore segment central axis 442 and the occlusion segment curve 450 is 10% (e.g., 20%; e.g., 25%) to 100% (e.g., 80%; e.g., 75%) of the bore segment outermost diameter D7, for example, between 20% and 80% (e.g., between 25% and 75%).

[0253] For some applications, such as Figure 1B As shown, when the device 420 is unconstrained, a bore section plane 68 perpendicular to the bore section center axis 42 is parallel to a pair of docking section planes 70 perpendicular to the docking section center axis 52 (e.g., as shown in FIG. Figures 1A to 1D For some of these applications, when the device 420 is unconstrained, the bore section center axis 42 is coaxial with the docking section center axis 52 (e.g., as shown in FIG. Figures 1A to 1D shown) or a distance between each other that is less than 50% (eg, less than 25%) of the outermost diameter D7 of the hole segment (configuration not shown).

[0254] For some applications, such as Fig. 7A As shown, the device 420 is configured such that when the device 420 is unconstrained, the bore section central axis 442 and the occluded section central axis 452 are parallel to each other. For some of these applications, the bore section central axis 442 and the occluded section central axis 452 are spaced apart by a distance D10 that is 20% to 80% of the bore section outermost diameter D7.

[0255] For some applications, a kit is provided that includes a device 420 and a microcatheter, wherein the device 420 is removably configured to be delivered to a vascular malformation. The microcatheter can implement the above-referenced Figure 2 Any of the features described for microcatheter 82.

[0256] For some applications, occlusive segment 432 is disposed further in the microcatheter than connecting segment 434 , which in turn is disposed further than orifice segment 430 .

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

[0258] refer to Figure 8 , which is a schematic diagram of the deployment of a device 420 for treating a vascular malformation (eg, an aneurysm 200) according to an application of the present invention. The device 420 may be as described above with reference to FIG. 6A to FIG. 6D What is described for device 20 is expanded.

[0259] like Figure 8 As shown, a hole segment 430 is deployed from a microcatheter within a portion of a vascular malformation (e.g., an aneurysm 200) so as to at least partially cover a hole 204 of the vascular malformation, wherein 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] Reference to above Fig. 6E Unlike the device 20 described above, the method of deploying the device 420 generally does not include implanting an intravascular embolic coil 210 in a vascular malformation (e.g., an aneurysm 200). Instead, the hole segment 430 is configured to bridge the neck of the vascular malformation to block blood flow into the aneurysm, thereby embolizing the aneurysm. When deployed, the occluding segment 432 at least partially occludes the hole segment central opening 462, thereby reducing blood flow through the hole segment central opening 462, and does not require implanting an intravascular embolic coil 210 in the vascular malformation. Even though the occluding segment 432 generally does not contact the hole segment 430 around the periphery of the hole segment central opening 462, and there is a gap between the occluding segment 432 and the hole segment central opening 462, the gap is small enough to sufficiently reduce blood flow in a relatively short period of time, thereby effectively occluding the hole segment central opening 462.

[0261] Alternatively, an intravascular embolic coil 210 is additionally implanted, such as described above with reference to Fig. 6E Device 20 is described.

[0262] In one embodiment, the techniques and devices described in one or more of the following applications, which are 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 by Mayer et al.

[0265] Those skilled in the art will appreciate that the present invention is not limited to the contents specifically shown and described above. On the contrary, the scope of the present invention includes the combination and sub-combination of the various features described above, as well as changes 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. A device for treating vascular malformations, characterized in that: The device comprises: One hole segment; A malformed intravascular docking segment; and A connecting segment, wherein the device is configured such that when the device is unconstrained, The bore segment is shaped to define a bore segment curve, the bore segment curve wrapping around a bore segment central axis at a varying distance from the bore segment central axis at least 2.5 times; The intravascular malformation docking segment is shaped to define a docking segment curve, and the docking segment curve wraps around the docking segment central axis by 0.5 to 2 turns at a varying distance or a constant distance from the docking segment central axis; and The connecting section connects the hole section curve and the docking section curve and has an average curvature radius, which is different from an average curvature radius of an outermost ring of the hole section curve.

2. The device according to claim 1, characterized in that The device is configured such that when the device is unconstrained: A connection segment slope of the connection segment is equal to: (a) a rise distance between two end points of the connection segment measured along the central axis of the bore segment divided by (b) a run distance equal to a length of the connection segment between two end points of the connection segment measured along the connection segment; and A bore segment slope of the bore segment is equal to: (a) a rise distance between two end points of the bore segment measured along the bore segment center axis divided by (b) a run distance equal to a length of the bore segment between two end points of the bore segment measured along the bore segment; and The slope of the connecting section is greater than the slope of the hole section.

3. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained: A connection segment slope of the connection segment is equal to the quotient of (a) a rise distance between two end points of the connection segment measured along the central axis of the bore segment divided by (b) a run distance equal to a length of the connection segment between two end points of the connection segment measured along the connection segment; and The slope of the connecting section is greater than 10%.

4. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, a length of the connecting segment is at least 15% of the outermost diameter of a hole segment of the hole segment curve.

5. The device according to claim 4, characterized in that: The device is configured such that when the device is unconstrained, the length of the connecting segment does not exceed 90% of the outermost diameter of the hole segment.

6. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the average radius of curvature of the connecting segment is greater than the average radius of curvature of the outermost ring of the hole segment curve.

7. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the average radius of curvature of the connecting segment is at least 1 mm.

8. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the average radius of curvature of the connecting segment is equal to at least 50% of the outermost diameter of the hole segment.

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

10. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the docking segment curve has a docking segment outermost diameter, which is equal to 15% to 80% of a hole segment outermost diameter of the hole segment curve.

11. The device according to claim 10, characterized in that: The device is configured such that when the device is unconstrained, the outermost diameter of the docking segment is equal to 25% to 50% of the outermost diameter of the hole segment.

12. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the docking segment curve has a docking segment outermost diameter that is equal to 100% to 150% of a hole segment outermost diameter of the hole segment curve.

13. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the docking segment curve has between 0.75 and 2 turns.

14. The device according to claim 13, characterized in that: The device is configured such that when the device is unconstrained, the docking segment curve has 1 to 2 turns.

15. The device according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the docking segment curve has a turn of 0.5 to 1.

25.

16. The device according to claim 15, characterized in that: The device is configured such that when the device is unconstrained, the docking segment curve has a turn of 0.75 to 1.

25.

17. The device according to claim 16, characterized in that: The device is configured such that when the device is unconstrained, the docking segment curve has 0.9 to 1.1 turns.

18. The device according to claim 17, characterized in that: The device is configured such that when the device is unconstrained, the docking segment curve has 1 to 1.1 turns.

19. 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.

20. The device according to claim 1, characterized in that: The device is configured so that when the device is unconstrained, a closest distance between the hole segment curve and the docking segment curve measured along the hole segment center axis is 4% to 100% of a hole segment outermost diameter of the hole segment curve.

21. The device according to claim 20, characterized in that: The apparatus is configured such that when the apparatus is unconstrained, the closest distance is between 4% and 50% of the outermost diameter of the bore segment of the bore segment curve.

22. The device according to claim 1, characterized in that: The device is configured so that when the device is unconstrained, a distance between a centroid of the bore segment curve and a centroid of the docking segment curve measured along the bore segment center axis is 7% to 100% of a bore segment outermost diameter of the bore segment curve.

23. The device according to claim 22, characterized in that: The apparatus is configured such that when the apparatus is unconstrained, the distance is between 10% and 50% of the outermost diameter of the bore segment.

24. The device according to claim 1, characterized in that: The apparatus is configured such that when the apparatus is unconstrained, a bore section plane perpendicular to the bore section central axis is parallel to or defines an angle of less than 30 degrees with a docking section plane perpendicular to the docking section central axis.

25. The device according to claim 24, characterized in that: The device is configured such that when the device is unconstrained, the bore segment plane is parallel to the docking segment plane.

26. The device according to claim 25, characterized in that: The device is configured so that when the device is unconstrained, the center axis of the hole segment is coaxial with the center axis of the docking segment or a distance between the center axis of the hole segment and the center axis of the docking segment is less than 50% of the outermost diameter of a hole segment of the hole segment curve.

27. The device according to claim 1, characterized in that: The apparatus is configured such that when the apparatus is unconstrained, a bore section plane perpendicular to the bore section central axis and a docking section plane perpendicular to the docking section central axis define an angle greater than 60 degrees.

28. The device according to claim 27, characterized in that: The device is configured such that when the device is unconstrained, the angle is greater than 75 degrees.

29. The device according to claim 1, characterized in that: The apparatus is configured such that when the apparatus is unconstrained, a bore section plane perpendicular to the bore section central axis and a docking section plane perpendicular to the docking section central axis define an angle of 30 to 60 degrees.

30. The device according to claim 1, characterized in that: The device includes a wire that is shaped to define the hole segment, the intravascular malformation abutment segment, and the connecting segment when the device is unconstrained.

31. The device according to claim 1, characterized in that: The apparatus is configured such that when the apparatus is unconstrained, the bore segment curve is a three-dimensional curve.

32. The device according to claim 31, characterized in that: The device is configured such that when the device is unconstrained, the three-dimensional curve is a conical spiral.

33. The device according to claim 1, characterized in that: The device is configured so that when the device is unconstrained, the outermost diameter of a hole segment of the hole segment curve is between 2 and 10 mm.

34. The device according to claim 33, characterized in that: The device is configured such that when the device is unconstrained, the outermost diameter of the hole segment is between 4 and 7 mm.

35. The apparatus according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the docking segment curve wraps around the docking segment central axis at the constant distance from the docking segment central axis.

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

37. The apparatus according to claim 1, characterized in that: The device is configured such that when the device is unconstrained, the bore segment curve defines a central opening having a bore segment central opening cross-sectional area of ​​at least 0.25 square millimeters.

38. The apparatus according to claim 1, characterized in that: The hole segment, the intravascular malformation docking segment, and the connecting segment include one or more shape memory alloys.

39. The device according to claim 1, characterized in that: The hole segment, the intravascular malformation docking segment, and the connecting segment include one or more superelastic alloys.

40. A kit comprising a device according to any one of claims 1 to 39, characterized in that The kit also includes a microcatheter in which the device is removably disposed for delivery to the vascular malformation.

41. The kit according to claim 40, characterized in that: The intravascular malformation docking section is arranged in the microcatheter further than the connecting section, and the connecting section is arranged further than the hole section.

42. The kit according to claim 40, characterized in that: The kit further comprises a push tube, which is removably disposed in the microcatheter, and a distal end of the push tube is removably connected to a proximal end of the hole section.

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