Devices, systems, and methods for treating intracranial aneurysms

Abstract

Systems and methods for treating an aneurysm according to embodiments of the present technology include delivering an occlusive member intravascularly to an aneurysmal cavity through an elongated shaft and transforming a shape of the occlusive member within the cavity. The method can include introducing embolic elements into a space between the occlusive member and an inner surface of a wall of the aneurysm. In some embodiments, the elongated shaft is detachably coupled to a distal portion of the occlusive member.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Applications 62 / 930,421, 62 / 930,487, 62 / 930,303, 62 / 930,324, 62 / 930,333, and 62 / 930,357, all filed November 4, 2019, each of which is incorporated herein by reference in its entirety. Technical Field

[0003] This technology relates to systems, devices, and methods for treating intracranial aneurysms. Background Technology

[0004] An intracranial aneurysm is a part of an intracranial blood vessel that bulges outward from the main channel of the vessel. This condition typically occurs in sections of blood vessels that are unusually fragile due to congenital abnormalities, trauma, high blood pressure, or other causes. Once an intracranial aneurysm forms, there is a significant risk of it eventually rupturing and causing a high-risk medical emergency leading to death from hemorrhage. Vascular surgery is usually required when an unruptured intracranial aneurysm is detected or when a patient survives an initial rupture of an intracranial aneurysm. A routine type of vascular surgery used to treat intracranial aneurysms involves placing a platinum coil within the internal volume of the aneurysm using a microcatheter. Over time, the presence of the coil can lead to thrombus formation. Ideally, the neck of the aneurysm closes at the site of the thrombus and is replaced by new endothelial tissue. Blood then bypasses the aneurysm, reducing the risk of rupture (or re-rupture) and associated bleeding. Unfortunately, long-term recanalization (i.e., restoration of blood flow to the internal volume of the aneurysm) after this type of vascular surgery occurs in many cases, particularly for intracranial aneurysms with relatively wide necks and / or relatively large internal volumes.

[0005] Another common type of vascular surgery used to treat intracranial aneurysms involves deploying a shunt within the relevant intracranial vessel. The shunt is typically a mesh tube that causes blood to preferentially flow along the main channel of the vessel, while blood stagnates within the aneurysm. Stagnant blood within the aneurysm eventually forms a thrombus, leading to closure of the aneurysm neck and the growth of new endothelial tissue, much like platinum coil therapy. A significant drawback of shunts is that it can take weeks or months for the aneurysm thrombus to form, and it can take significantly longer for the aneurysm neck to be covered by endothelial cells to function fully. This delay can be unacceptable when the risk of aneurysm rupture (or re-rupture) is high. Furthermore, shunts often require antiplatelet therapy to prevent thrombus formation within the main channel of the vessel at the shunt site. Antiplatelet therapy may be contraindicated shortly after the initial aneurysm rupture, as the risk of re-rupture is high at this point, and if re-rupture occurs, antiplatelet therapy often exacerbates intracranial hemorrhage. For these and other reasons, the treatment of intracranial aneurysms requires innovation. Given the severity of this condition, innovation in this field has the potential to save lives immediately. Summary of the Invention

[0006] The present invention is based, for example, on various aspects described below, including references to Figure 1A-15C Note: For convenience, various examples of different aspects of the present invention are described as numbered clauses (1, 2, 3, etc.). These are provided as examples and do not limit the scope of the invention.

[0007] 1. A method for treating an aneurysm, the method comprising:

[0008] Position the distal end of the slender shaft within the aneurysm cavity;

[0009] While the distal end of the elongated shaft is positioned within the aneurysm cavity, the occlusion member is released from the elongated shaft, causing the occlusion member to self-expand to present a first expanded state, wherein the occlusion member forms a first shape, and wherein, in the first expanded state, the occlusion member surrounds an internal region having a first internal volume; and

[0010] An embolic element is delivered between the occlusion member and the aneurysm wall to transform the occlusion member into a second dilated state, wherein the occlusion member defines a second internal volume smaller than a first internal volume, and wherein the occlusion member in the second dilated state forms a second shape that differs from the first shape in the first dilated state.

[0011] 2. The method of any one of the preceding clauses, wherein converting the occlusion member into a second expanded state comprises injecting embolic material to push a portion of the sidewall of the expandable mesh in a direction away from the aneurysm wall and toward the internal region of the occlusion member.

[0012] 3. The method of any one of the preceding clauses, wherein transforming the occlusion member into a second expansion shape comprises injecting embolic material to reverse a portion of the sidewall of the occlusion member such that the portion bulges toward the aneurysm wall in a first expansion state and is recessed toward the aneurysm wall in a second expansion state.

[0013] 4. The method of any one of the preceding clauses, wherein the embolic element comprises a liquid embolism.

[0014] 5. The method of any one of the preceding clauses, wherein the embolization element comprises one or more embolization coils.

[0015] 6. The method of any one of the preceding clauses, wherein delivery of the embolic element occurs after the occlusion member is in the first expanded state.

[0016] 7. The method of any one of the preceding clauses, wherein the blocking member is a mesh.

[0017] 8. The method of any one of the preceding clauses, wherein the occluding member is a woven fabric.

[0018] 9. The method of any one of the preceding clauses, wherein the occlusion member is a double-layered woven fabric.

[0019] 10. The method of any one of the preceding clauses, wherein the occlusion member has a spherical or substantially spherical shape in the first expansion state.

[0020] 11. The method of any one of the preceding clauses, wherein the occlusion member is cup-shaped or bowl-shaped in the second expansion state.

[0021] 12. The method of any one of the preceding clauses, wherein the second shape is a predetermined three-dimensional shape.

[0022] 13. The method of any one of the preceding clauses, wherein the occlusion member forms a multilayer braid at the aneurysm neck in the second dilated state.

[0023] 14. The method of any one of the preceding clauses, wherein the occlusion member comprises a plurality of braided filaments that, in an expanded state, present a predetermined three-dimensional shape.

[0024] 15. The method of any one of the preceding clauses, wherein the occlusion member comprises a braid formed of 24, 32, 36, 48, 64 or 72 filaments.

[0025] 16. The method of any one of the preceding clauses, wherein the occlusion member comprises a braid formed of multiple threads, some or all of which have a diameter of about 0.001 inches (0.00254 cm).

[0026] 17. The method of any one of the preceding clauses, wherein the occlusion member comprises a braid formed of multiple threads, some or all of which have the same diameter.

[0027] 18. The method of any one of the preceding clauses, wherein the occlusion member comprises a braid formed of a plurality of threads, wherein at least some of the threads have different diameters.

[0028] 19. The method of any one of the preceding clauses, wherein the occluding member forms a closed spherical shape in an expanded state, and the mesh has a hole in its distal portion.

[0029] 20. The method of any one of the preceding clauses, wherein, in the expanded state, the occluding member forms one of a sphere, an elongated sphere, or an oblate spheroid.

[0030] 21. The method of any one of the preceding clauses, wherein the occlusion member comprises an inner layer and an outer layer.

[0031] 22. The method of any one of the preceding clauses, wherein the occlusion member comprises an inner layer and an outer layer that meet at a fold at the distal portion of the occlusion member.

[0032] 23. The method according to Clause 22, wherein the expandable mesh includes a hole at the distal portion, the hole being defined by the fold.

[0033] 24. The method of any one of the preceding clauses, wherein the occlusion member comprises an inner layer and an outer layer that meet at a fold at a proximal portion of the occlusion member.

[0034] 25. The method according to Clause 24, wherein the expandable mesh includes a hole at the distal portion, the hole being defined by the fold.

[0035] 26. The method according to any one of the preceding clauses, wherein the maximum cross-sectional dimension of the occlusion member is 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm or 8.0 mm.

[0036] 27. The method of any one of the preceding clauses, wherein the blocking member is formed of a plurality of filaments with a first end and a second end fixed at the connector.

[0037] 28. The method according to any one of the preceding clauses, wherein the expandable web is formed of a plurality of filaments, the plurality of filaments being formed of an inner core material surrounded by an outer material.

[0038] 29. The method according to Clause 28, wherein the inner core material is a radiopaque material and the outer material is a hyperelastic material.

[0039] 30. The method of any one of the preceding clauses, wherein the occlusion member is a laser-cut tube.

[0040] 31. The method of any one of the preceding clauses, wherein the occlusion member comprises a plurality of filaments.

[0041] 32. The method according to Clause 31, wherein the filaments are interwoven.

[0042] 33. The method described in accordance with Clause 31 or Clause 32, wherein the filaments are woven.

[0043] 34. The method according to any one of clauses 31 to 33, wherein each of the filaments has a first end and a second end opposite to the first end, and wherein the first end and the second end of the filament are fixed relative to each other at a connector.

[0044] 35. The method according to clause 34, wherein the connector is disposed at the distal end of the blocking member.

[0045] 36. The method according to Clause 34, wherein the connector is disposed at the proximal end of the occlusion member.

[0046] 37. The method according to any one of clauses 31 to 36, wherein each of the filaments terminates at only one end of the occlusion member.

[0047] 38. The method according to clause 37, wherein the filament forms an opening at the end of the occluding member opposite to the only end.

[0048] 39. The method according to Clause 38, wherein the reverse portion of each of the filaments defines the opening.

[0049] 40. The method according to Clause 39, wherein the reversed portions of the filaments are configured to move relative to each other.

[0050] 41. The method of any one of the preceding clauses, wherein the embolic element comprises a biopolymer and a chemical crosslinking agent.

[0051] 42. The method according to clause 41, wherein the biopolymer comprises chitosan, chitosan derivatives, chitosan analogs, or combinations thereof.

[0052] 43. The method described in accordance with Clause 41 or Clause 42, wherein the chemical crosslinking agent includes genipin, genipin derivatives, genipin analogs, or combinations thereof.

[0053] 44. The method according to any one of clauses 41 to 43, wherein the embolic element further comprises a physical crosslinking agent.

[0054] 45. The physical crosslinking agent according to the method of Clause 44 comprises β-glycerol phosphate, β-glycerol phosphate derivatives, β-glycerol phosphate analogs, or combinations thereof.

[0055] 46. ​​The method described in accordance with Clause 41, wherein

[0056] The biopolymers include chitosan, chitosan derivatives, chitosan analogs, or combinations thereof;

[0057] The chemical crosslinking agent includes genipin, genipin derivatives, genipin analogs, or combinations thereof; and

[0058] The physical crosslinking agent includes β-glycerol phosphate, β-glycerol phosphate derivatives, β-glycerol phosphate analogs, or combinations thereof.

[0059] 47. The method of any one of the preceding clauses, wherein the embolic element comprises a contrast agent.

[0060] 48. The method according to Clause 47, wherein the contrast agent is selected to provide reduced radiation impermeability.

[0061] 49. The method according to Clause 47 or Clause 48, wherein the contrast agent comprises iohexol, iohexol derivatives, iohexol analogs, or combinations thereof.

[0062] 50. A method for treating an aneurysm, the method comprising:

[0063] An expandable occlusive member in its initial dilated state is positioned within the aneurysm, wherein, in the initial dilated state, the expandable occlusive member provides multiple layers across the neck of the aneurysm; and

[0064] By introducing embolic elements into the aneurysm cavity, the number of layers of the occlusion device across the aneurysm neck is doubled.

[0065] 51. The method according to Clause 50, wherein the number of layers is one.

[0066] 52. The method according to Clause 50, wherein the number of layers is two.

[0067] 53. The method according to any one of clauses 50 to 52, wherein the layer is a mesh layer.

[0068] 54. The method according to any one of clauses 50 to 53, wherein the occlusive member has a first shape in an initial expansion state, and wherein the introduction of an embolic element transforms the occlusive member from the initial expansion state to a second expansion state, wherein the occlusive member forms a second shape different from the first shape.

[0069] 55. The method according to Clause 54, wherein the volume enclosed by the first shape is greater than the volume enclosed by the second shape.

[0070] 56. A method for therapeutic imaging of an aneurysm, the method comprising:

[0071] Obtain the first image and visualize it:

[0072] An occlusion component positioned within an aneurysm, the occlusion component comprising a first radiopaque marker; and

[0073] A conduit having a distal portion located within an aneurysm, the distal portion of the conduit including a second radiopaque marker; and

[0074] Acquire a second image in which the first radiopaque marker is farther away from the second radiopaque marker than in the first image.

[0075] 57. The method according to Clause 56, wherein in the second image, the first radiopaque marker is positioned close to the second radiopaque marker.

[0076] 58. The method according to clauses 56 to 57, wherein, in the second image, the first radiopaque marker is positioned closer to the neck of the aneurysm compared to the first image.

[0077] 59. The method according to any one of clauses 56 to 58, wherein, in the first image, the first radiopaque marker is positioned in the distal half of the occluder member.

[0078] 60. The method according to any one of clauses 56 to 59, wherein, in the first image, a first transmissive marker is positioned on the distal surface of the occluder member.

[0079] 61. The method according to any one of clauses 56 to 60, wherein, in the first image, the first opaque line is located near the mark of the second opaque line.

[0080] 62. The method according to clauses 56 to 61, wherein, in the first image and the second image, the second radiopaque marker is closer to the dome setting of the aneurysm than the first radiopaque marker.

[0081] 63. The method according to clauses 56 to 62, wherein, in the second image, a nontransparent occlusion element is visible in the space between the first nontransparent mark and the second nontransparent mark.

[0082] 64. The method according to clauses 56 to 62 further includes acquiring a third image, wherein the first radiopaque marker is farther away from the second radiopaque marker than in the second image.

[0083] 65. The method according to clauses 56 to 62, wherein acquiring the first image and acquiring the second image each include acquiring a fluorescence mirror image.

[0084] 66. A method for treating an aneurysm, the method comprising:

[0085] The distal end of the slender shaft is positioned at or near the aneurysm cavity. The distal end of the shaft includes an occlusion member that is detachably coupled to an slender member that is slidably disposed within the slender shaft. The distal end of the occlusion member is coupled to the distal end of the slender member and the proximal end of the occlusion member can slide on the slender member.

[0086] Push the elongated member distally from the distal opening in the elongated shaft to pull the distal end of the occluder distally through the distal opening to push the occluder out of the shaft and allow the occluder to expand to the first expansion state.

[0087] When the occluder is in the first expanded state, the elongated member is pulled proximally so that the distal wall of the occluder faces the proximal wall of the occluder, causing the occluder to form a second expanded state in which at least a portion of the occluder is reversed; and

[0088] The embolic element is delivered through a slender member to a location between the occlusive member and the aneurysm wall.

[0089] 67. The method of Clause 66, wherein, as the occlusion member self-expands, the proximal end of the occlusion member slides distally along the elongated member.

[0090] 68. The method of any one of the preceding clauses, wherein delivery of the embolic element occurs simultaneously with the proximal pulling of the elongated member.

[0091] 69. The method of any one of the preceding clauses further includes reversing the blocking member at a predetermined longitude defined by the curved region.

[0092] 70. The method of any one of the preceding clauses, wherein the blocking member is a mesh.

[0093] 71. The method of any one of the preceding clauses, wherein the occluding member is a woven fabric.

[0094] 72. The method of any one of the preceding clauses, wherein the occlusion member is a double-layered woven fabric.

[0095] 73. The method of any one of the preceding clauses, wherein the occlusion member has a spherical or substantially spherical shape in the first expansion state.

[0096] 74. The method of any one of the preceding clauses, wherein the occlusion member is cup-shaped or bowl-shaped in the second expansion state.

[0097] 75. The method of any one of the preceding clauses, wherein the second shape is a predetermined three-dimensional shape.

[0098] 76. The method of any one of the preceding clauses, wherein the occlusion member forms a multilayer braid at the aneurysm neck in the second dilated state.

[0099] 77. The method of any one of the preceding clauses, wherein the occlusion member comprises a plurality of braided filaments that, in an expanded state, present a predetermined three-dimensional shape.

[0100] 78. The method of any one of the preceding clauses, wherein the occluding member includes a recessed portion at its distal portion.

[0101] 79. The method of Clause 78, wherein the opening of the elongated member is adjacent to the recessed portion, such that the embolic element is delivered into the recessed portion.

[0102] 80. A method for treating an aneurysm, the method comprising:

[0103] The distal end of the slender shaft is positioned at or near the aneurysm cavity. The distal end of the shaft includes an occlusion member that is detachably coupled to an slender member that is slidably disposed within the slender shaft. The distal end of the occlusion member is coupled to the distal end of the slender member and the proximal end of the occlusion member can slide on the slender member.

[0104] Pushing the elongated member distally through the distal opening in the elongated shaft to pull the distal end of the occluder distally through the distal opening to push the occluder out of the shaft and allow the occluder to expand to a first expanded state; and

[0105] When the occlusion member is in the first expansion state, the elongated member is pulled proximally so that the distal wall of the occlusion member faces the proximal wall of the occlusion member, thereby forming the second expansion state in which the occlusion member collapses.

[0106] 81. The method of Clause 80 further includes delivering an embolic element through an elongated member to a location between the occlusal member and the aneurysm wall.

[0107] 82. A system comprising:

[0108] The slender axis that defines the lumen;

[0109] An elongated member slidably disposed within the lumen of an elongated shaft, the elongated member having a proximal region and a distal region, wherein the distal region is configured to be positioned intravascularly at or within an aneurysm lumen.

[0110] A closing member, confined within the lumen of the shaft, includes a proximal portion having an opening and a distal portion detachably coupled to a distal region of an elongated member extending through the opening, such that...

[0111] The slender member is pushed from the distal opening in the slender shaft to pull the occluder through the distal opening, thereby pushing the occluder out of the shaft and allowing the occluder to expand to the expanded state.

[0112] 83. The system described in Clause 82 further includes an embolization element configured to be delivered to the aneurysm cavity through the elongated member while the elongated member is coupled to the distal portion of the occlusion member.

[0113] 84. The system described in Clause 83, wherein the embolic element is a liquid embolism, one or more embolic coils, or both.

[0114] 85. The system of any one of clauses 82 to 84, wherein a portion of the occlusion member surrounding the elongated member at the opening is configured to slide relative to the elongated member when the occlusion member self-expands.

[0115] 86. The system of any one of clauses 82 to 85, wherein the occlusion member includes one or more preferentially curved regions surrounding all or part of the circumference of the occlusion member.

[0116] 87. The system described in Clause 86, wherein all or a portion of the one or more preferred bending regions comprises a radiopaque material.

[0117] 88. The system of any one of clauses 82 to 87, wherein the expansion state is a first expansion state and the occlusion member has a first shape in the first expansion state, and wherein, when the occlusion member is in the first expansion state in the aneurysm lumen and is connected to the elongated member, proximal movement of the elongated member causes the distal wall of the occlusion member to collapse toward the proximal wall of the occlusion member, thereby transforming the occlusion member into a second expansion state, wherein the occlusion member has a shape different from the first shape.

[0118] 89. A method for treating an aneurysm, the method comprising:

[0119] The distal end of the slender shaft is positioned at or near the aneurysm cavity. The distal end of the shaft includes an occlusion member that is detachably coupled to an slender member that is slidably disposed within the slender shaft. The distal end of the occlusion member is coupled to the distal end of the slender member and the proximal end of the occlusion member can slide on the slender member.

[0120] Push the elongated member distally from the distal opening in the elongated shaft to pull the distal end of the occluder distally through the distal opening to push the occluder out of the shaft and allow the occluder to expand to the first expansion state.

[0121] When the occluder is in the first expanded state, the elongated member is pulled proximally so that the distal wall of the occluder faces the proximal wall of the occluder, causing the occluder to form a second expanded state in which at least a portion of the occluder is reversed; and

[0122] The embolic element is delivered through a slender member to a location between the occlusive member and the aneurysm wall.

[0123] 90. The method of Clause 89, wherein, as the occlusion member self-expands, the proximal end of the occlusion member slides distally along the elongated member.

[0124] 91. The method described in Clause 89 or Clause 90, wherein delivery of the embolic element occurs simultaneously with the proximal pulling of the elongated member.

[0125] 92. The method of any one of clauses 89 to 91 further includes reversing the occluder at a predetermined longitude defined by a curvature along the occluder.

[0126] 93. The method of any one of clauses 89 to 92, wherein the occluding member has a spherical or substantially spherical shape in the first expansion state.

[0127] 94. The method of any one of clauses 89 to 93, wherein the occluding member is cup-shaped or bowl-shaped in the second expansion state.

[0128] 95. The method of any one of clauses 89 to 94, wherein the occlusion member forms a multilayer braid in the neck of the aneurysm in a second dilated state, the multilayer braid comprising a first layer corresponding to the distal wall of the occlusion member and a second layer corresponding to the proximal wall of the occlusion member.

[0129] 96. A method for treating an aneurysm, the method comprising:

[0130] The distal portion of the slender shaft is positioned at or near the aneurysm cavity, the distal portion of which includes an occlusion member detachably coupled to an slender member slidably disposed within the slender shaft, wherein the distal region of the occlusion member is coupled to the distal end of the slender member.

[0131] Expand the occluder within the aneurysm cavity;

[0132] Pull the slender member proximally, thereby reversing the first part of the occlusion member onto the second part of the occlusion member, wherein the first and second parts meet at the circumferential fold.

[0133] Pushing the elongated member distally causes the second part to move away from the first part and at least partially reverses the reversal of the occlusion member; and

[0134] The embolic element is delivered to the space between the distal wall of the occlusive member and the wall of the aneurysm via a slender member.

[0135] 97. The method described in Clause 96 further includes delivering an embolic element through an elongated member to a location between the occlusal member and the aneurysm wall.

[0136] 98. The method of Clause 96 or Clause 97, wherein the proximal pulling of the elongated member occurs for the first time, and the method further comprises a second proximal pulling of the elongated member after the first and after pushing the elongated member distally, wherein the second proximal pulling of the elongated member causes the distal wall of the occlusion member to face the proximal wall of the occlusion member, such that the occlusion member forms a cup or bowl shape.

[0137] 99. The method described in Clause 98, wherein the delivery of the embolic element occurs simultaneously with the second proximal pull of the elongated member.

[0138] 100. The method of any one of clauses 96 to 99, wherein, as the occlusion member expands, the proximal region of the occlusion member slides distally relative to the elongated member.

[0139] 101. The method of any one of Clauses 96 to 100 further includes separating the elongated member from the distal region of the occlusion member and withdrawing the elongated member from the body.

[0140] 102. A treatment system comprising:

[0141] Electrolytically etchable core wire, having a proximal portion, a distal portion, and a separation zone between the proximal and distal portions;

[0142] An occlusion member having a proximal hub connected to a distal portion of the core wire, the occlusion member being configured to be positioned at or near the treatment site; and

[0143] A conduit extending along at least a portion of the core wire, the conduit having a lumen configured to allow an embolic element to pass through it.

[0144] 103. The treatment system of any one of the preceding clauses, wherein the distal portion of the conduit is configured to be disposed at or near the treatment site together with the occlusion member.

[0145] 104. The treatment system according to any one of the preceding clauses, wherein the treatment site includes an aneurysm sac.

[0146] 105. The treatment system according to any one of the preceding clauses, wherein the conduit comprises a flexible tubular member.

[0147] 106. The treatment system according to any one of the preceding clauses further includes a core needle configured to be removably disposed within the lumen of the conduit.

[0148] 107. The treatment system of any one of the preceding clauses, wherein the core needle is rigider than the tubing.

[0149] 108. The treatment system according to any one of the preceding clauses, wherein the core needle is metal.

[0150] 109. The treatment system of any one of the preceding clauses, wherein the conduit has a distal portion having a smaller cross-sectional dimension than the proximal portion of the conduit.

[0151] 110. The treatment system of any one of the preceding clauses, wherein the core needle has a distal portion having a smaller cross-sectional dimension than the proximal portion of the core needle.

[0152] 111. The treatment system of any one of the preceding clauses, wherein the conduit is coupled to an elongated member such that the two cannot slide relative to each other.

[0153] 112. The treatment system of any one of the preceding clauses, wherein the conduit is connected to the elongated member by one or more belts or clamps.

[0154] 113. The treatment system of any one of the preceding clauses, wherein one or more belts or clamps circumferentially surround the conduit and the core wire.

[0155] 114. The treatment system of any one of the preceding clauses, wherein the conduit is connected to the elongated member by an adhesive.

[0156] 115. The treatment system of any one of the preceding clauses, wherein the conduit is connected to the elongated member via a surrounding sheath.

[0157] 116. The treatment system of any one of the preceding clauses, wherein the surrounding sheath comprises a heat-shrinkable polymer.

[0158] 117. The treatment system according to any one of the preceding clauses, wherein the heat-shrinkable polymer comprises PTFE.

[0159] 118. The treatment system of any one of the preceding clauses, wherein the conduit comprises a tubular member, a hypotube, and / or a catheter.

[0160] 119. The treatment system of any one of the preceding clauses, wherein the conduit includes a liner extending through the lumen of the tubular member, the liner extending distally beyond the distal end of the tubular member.

[0161] 120. The treatment system of any one of the preceding clauses, wherein the lining comprises extruded PTFE.

[0162] 121. The treatment system of any one of the preceding clauses, wherein at least a portion of the conduit along its length has an inner diameter between 0.005 inches and 0.015 inches.

[0163] 122. The treatment system of any one of the preceding clauses, wherein the core wire includes a proximal insulation layer that circumferentially contacts a proximal portion of the core wire and a distal insulation layer that circumferentially contacts a distal portion of the core wire.

[0164] 123. The treatment system of any one of the preceding clauses, wherein the separation region has a microstructure with a crystallinity lower than that of the proximal and distal portions of the core wire.

[0165] 124. The treatment system of any one of the preceding clauses, wherein the separation region has a more amorphous microstructure than each of the proximal and distal portions of the core wire.

[0166] 125. The treatment system according to any one of the preceding clauses, wherein the core wire is made of a conductive material.

[0167] 126. The treatment system of any one of the preceding clauses, wherein the separation zone has an axial length of less than 0.010 inches.

[0168] 127. The treatment system of any one of the preceding clauses, wherein the separation zone has an axial length greater than or equal to 0.005 inches and less than 0.010 inches.

[0169] 128. The treatment system of any one of the preceding clauses, wherein the core wire includes an anchoring end remote from the hub, the anchoring end having a maximum cross-sectional dimension greater than the internal cross-sectional dimension of the lumen of the hub.

[0170] 129. The treatment system according to any one of the preceding clauses, wherein the separation zone is axially located between the proximal portion of the core wire and the distal portion of the core wire.

[0171] 130. The treatment system according to any one of the preceding clauses, wherein the occlusion member is an occlusion member or intracapsular device configured to be implanted within the aneurysm.

[0172] 131. The treatment system according to any one of the preceding clauses, wherein the occlusion member comprises an expandable mesh having a constrained state for delivery to the aneurysm and an expanded state having at least a portion of the mesh configured to be disposed across the neck of the aneurysm.

[0173] 132. The treatment system according to any one of the preceding clauses, wherein the expandable mesh comprises a plurality of braided filaments, the plurality of braided filaments having a predetermined three-dimensional shape in the expanded state.

[0174] 133. The treatment system according to any one of the preceding clauses, wherein the expandable mesh comprises a weave formed of 24, 32, 36, 48, 64 or 72 filaments.

[0175] 134. The treatment system of any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of multiple threads, some or all of which have a diameter of at least 0.001 inches.

[0176] 135. The treatment system of any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of multiple threads, some or all of which have the same diameter.

[0177] 136. The treatment system of any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of multiple threads, at least some of which have different diameters.

[0178] 137. The treatment system according to any one of the preceding clauses, wherein, in the expanded state, the expandable mesh forms one of a sphere, an elongated sphere, or an oblate spheroid.

[0179] 138. The treatment system of any one of the preceding clauses, wherein the expandable mesh comprises an inner layer and an outer layer.

[0180] 139. The treatment system according to any one of the preceding clauses, wherein the maximum cross-sectional dimension of the expandable mesh is 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm or 8.0 mm.

[0181] 140. The treatment system according to any one of the preceding clauses, wherein the expandable mesh is a laser cutting tube.

[0182] 141. The treatment system of any one of the preceding clauses, wherein the expandable mesh comprises a plurality of interwoven filaments.

[0183] 142. The treatment system of any one of the preceding clauses, wherein the occlusion member is bent at least most of its entire length.

[0184] 143. The treatment system according to any one of the preceding clauses, wherein the occlusion member is collapsible upon contact with the embolic element.

[0185] 144. The treatment system according to any one of the preceding clauses, wherein the occlusive member is collapsible upon contact with the synthetic gel or fluid.

[0186] 145. The treatment system of any one of the preceding clauses, wherein the occlusion member is configured to rotate about the conduit.

[0187] 146. The treatment system of any one of the preceding clauses, wherein the occlusion member is rotatably and slidably connected to the conduit.

[0188] 147. The treatment system of any one of the preceding clauses, wherein the occlusion member has an orifice in its distal portion, and wherein the conduit extends through the orifice.

[0189] 148. The treatment system of any one of the preceding clauses, wherein the occlusion member is configured to move axially along the elongated member.

[0190] 149. The treatment system according to any one of the preceding clauses, wherein the embolic element is a liquid embolism.

[0191] 150. The treatment system according to any one of the preceding clauses, wherein the embolic element comprises a biopolymer and / or a chemical crosslinking agent.

[0192] 151. The treatment system according to any one of the preceding clauses, wherein the biopolymer comprises chitosan, chitosan derivatives, chitosan analogs, or combinations thereof.

[0193] 152. The treatment system of any one of the preceding clauses, wherein the chemical crosslinking agent comprises genipin, genipin derivatives, genipin analogs, or combinations thereof.

[0194] 153. A system comprising:

[0195] The treatment system mentioned in any of the preceding clauses; and

[0196] An elongated shaft having a lumen extending through it, wherein a treatment system is configured to be slidably disposed within the lumen of the elongated shaft.

[0197] 154. A system comprising:

[0198] The treatment system mentioned in any of the preceding clauses;

[0199] A first elongated shaft having a first lumen extending therethrough, wherein the treatment system is configured to be slidably disposed within the first lumen; and

[0200] A second elongated shaft having a second lumen extending therethrough, wherein the first elongated shaft is configured to be slidably disposed within the second lumen.

[0201] 155. The system according to 154, wherein the first elongated axis is a microcatheter and the second elongated axis is a delivery or guiding catheter.

[0202] 156. The system of any one of the preceding clauses, wherein the microcatheter has a nominal inner diameter of about 0.017 inches or less, about 0.021 inches or less, or about 0.027 inches or less.

[0203] 157. A method for treating an aneurysm, comprising:

[0204] Provide the treatment system as described in any of the foregoing clauses.

[0205] 158. The method described in any one of the preceding clauses further comprises:

[0206] Position the distal end of the conduit within the aneurysm cavity; and

[0207] While the distal end of the slender member is positioned within the aneurysm cavity, the occlusion member is released from the slender member, causing the occlusion member to self-expand to present an expanded state.

[0208] 159. The method according to any one of the preceding clauses, wherein the release occlusion member includes a separation zone of the electrolytically etched core wire.

[0209] 160. The method according to clause 158 above, wherein releasing the blocking member includes delivering current to the core wire.

[0210] 161. The method according to any one of the preceding clauses, wherein locating the distal end of the conduit comprises advancing the distal end of the conduit toward the dome or distal end of the aneurysm such that the distal end of the conduit extends beyond the distal end of the microcatheter surrounding the conduit.

[0211] 162. The method described in any of the preceding clauses further includes positioning the distal end of the conduit together with the occlusion member within the aneurysm cavity.

[0212] 163. The method of any one of the preceding clauses, wherein locating the distal end of the conduit includes advancing the conduit distally in which a core needle is disposed.

[0213] 164. The method described in any of the preceding clauses further includes retracting the core needle proximally relative to the conduit.

[0214] 165. The method described in any one of the preceding clauses further includes removing the core needle from the lumen of the pipe.

[0215] 166. The method of any one of the preceding clauses, wherein releasing the occluding member includes allowing the occluding member to self-expand to present a first expanded state in which the occluding member forms a first shape, wherein, in the first expanded state, the occluding member surrounds an internal region having a first internal volume, the method further comprising

[0216] An embolic element is delivered between the occlusion member and the aneurysm wall to transform the occlusion member into a second dilated state, wherein the occlusion member defines a second internal volume smaller than a first internal volume, and wherein the occlusion member in the second dilated state forms a second shape that differs from the first shape in the first dilated state.

[0217] 167. The method of any one of the preceding clauses, wherein converting the occlusion member into a second expanded state comprises injecting embolic material to push a portion of the sidewall of the expandable mesh in a direction away from the aneurysm wall and toward the internal region of the occlusion member.

[0218] 168. The method of any one of the preceding clauses, wherein transforming the occlusion member into a second expansion shape comprises injecting embolic material to reverse a portion of the sidewall of the occlusion member such that the portion bulges toward the aneurysm wall in a first expansion state and is recessed toward the aneurysm wall in a second expansion state.

[0219] 169. The method of any one of the preceding clauses, wherein the embolic element comprises a liquid embolism.

[0220] 170. The method of any one of the preceding clauses, wherein the embolization element comprises one or more embolization coils.

[0221] 171. The method of any one of the preceding clauses, wherein delivery of the embolic element occurs after the occlusion member is in the first expansion state.

[0222] 172. The method of any one of the preceding clauses, wherein the blocking member is a mesh.

[0223] 173. The method of any one of the preceding clauses, wherein the occluding member is a woven fabric.

[0224] 174. The method of any one of the preceding clauses, wherein the occlusion member is a double-layered woven fabric.

[0225] 175. The method of any one of the preceding clauses, wherein the occlusion member has a spherical or substantially spherical shape in the first expansion state.

[0226] 176. The method of any one of the preceding clauses, wherein the occlusion member is cup-shaped or bowl-shaped in the second expansion state.

[0227] 177. The method of any one of the preceding clauses, wherein the second shape is a predetermined three-dimensional shape.

[0228] 178. The method of any one of the preceding clauses, wherein the occlusion member forms a multilayer braid at the aneurysm neck in the second dilated state.

[0229] 179. The method of any one of the preceding clauses, wherein the occlusion member comprises a plurality of braided filaments that, in an expanded state, present a predetermined three-dimensional shape.

[0230] 180. The method of any one of the preceding clauses, wherein the occlusion member comprises a braid formed of 24, 32, 36, 48, 64 or 72 filaments.

[0231] 181. The method of any one of the preceding clauses, wherein the occluding member comprises a braid formed of multiple threads, some or all of which have a diameter of about 0.001 inches (0.00254 cm).

[0232] 182. The method of any one of the preceding clauses, wherein the occlusion member comprises a braid formed of multiple threads, some or all of which have the same diameter.

[0233] 183. The method of any one of the preceding clauses, wherein the occlusion member comprises a braid formed of a plurality of threads, wherein at least some of the threads have different diameters.

[0234] 184. The method of any one of the preceding clauses, wherein the occluding member forms a closed spherical shape in an expanded state, and the mesh has a hole in its distal portion.

[0235] 185. The method of any one of the preceding clauses, wherein, in the expanded state, the occluding member forms one of a sphere, an elongated sphere, or an oblate spheroid.

[0236] 186. The method of any one of the preceding clauses, wherein the occlusion member comprises an inner layer and an outer layer.

[0237] 187. The method of any one of the preceding clauses, wherein the occlusion member comprises an inner layer and an outer layer that meet at a fold at a distal portion of the occlusion member.

[0238] 188. The method of any one of the preceding clauses, wherein the expandable mesh includes a hole at the distal portion, the hole being defined by the fold.

[0239] 189. The method of any one of the preceding clauses, wherein the occlusion member comprises an inner layer and an outer layer that meet at a fold at a proximal portion of the occlusion member.

[0240] 190. The method of any one of the preceding clauses, wherein the expandable mesh includes a hole at the distal portion, the hole being defined by the fold.

[0241] 191. The method according to any one of the preceding clauses, wherein the maximum cross-sectional dimension of the occlusion member is 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm or 8.0 mm.

[0242] 192. The method of any one of the preceding clauses, wherein the blocking member is formed by a plurality of filaments with a first end and a second end fixed at the hub or connector.

[0243] 193. The method according to any one of the preceding clauses, wherein the expandable web is formed of a plurality of filaments, the plurality of filaments being formed of an inner core material surrounded by an outer material.

[0244] 194. The method of any one of the preceding clauses, wherein the inner core material is a radiopaque material and the outer material is a hyperelastic material.

[0245] 195. The method of any one of the preceding clauses, wherein the occlusion member is a laser-cut tube.

[0246] 196. The method of any one of the preceding clauses, wherein the occlusion member comprises a plurality of filaments.

[0247] 197. The method of any one of the preceding clauses, wherein the filaments are interwoven.

[0248] 198. The method described in any of the preceding clauses, wherein the filaments are woven.

[0249] 199. The method of any one of the preceding clauses, wherein each of the filaments has a first end and a second end opposite to the first end, and wherein the first end and the second end of the filament are fixed relative to each other at a connector.

[0250] 200. The method of any one of the preceding clauses, wherein the connector is disposed at the distal end of the blocking member.

[0251] 201. The method of any one of the preceding clauses, wherein the connector is disposed at the proximal end of the blocking member.

[0252] 202. The method of any one of the preceding clauses, wherein each of the filaments terminates at only one end of the occlusion member.

[0253] 203. The method of any one of the preceding clauses, wherein the filament forms an opening at the end of the occluding member opposite to the only end.

[0254] 204. The method of any one of the preceding clauses, wherein the reverse portion of each of the filaments defines the opening.

[0255] 205. The method of any one of the preceding clauses, wherein the reversed portions of the filaments are configured to move relative to each other.

[0256] 206. The method of any one of the preceding clauses, wherein the embolic element comprises a biopolymer and a chemical crosslinking agent.

[0257] 207. The method of any one of the preceding clauses, wherein the biopolymer comprises chitosan, chitosan derivatives, chitosan analogs, or combinations thereof.

[0258] 208. The method of any one of the preceding clauses, wherein the chemical crosslinking agent comprises genipin, genipin derivatives, genipin analogs, or combinations thereof.

[0259] 209. The method of any of the preceding clauses, wherein the embolic element further comprises a physical crosslinking agent.

[0260] 210. The method of any one of the preceding clauses, wherein the physical crosslinking agent comprises β-glycerol phosphate, β-glycerol phosphate derivatives, β-glycerol phosphate analogs, or combinations thereof.

[0261] 211. The method according to any one of the preceding clauses, wherein

[0262] The biopolymers include chitosan, chitosan derivatives, chitosan analogs, or combinations thereof;

[0263] The chemical crosslinking agent includes genipin, genipin derivatives, genipin analogs, or combinations thereof; and

[0264] The physical crosslinking agent includes β-glycerol phosphate, β-glycerol phosphate derivatives, β-glycerol phosphate analogs, or combinations thereof.

[0265] 212. The method of any one of the preceding clauses, wherein the embolic element comprises a contrast agent.

[0266] 213. The method of any one of the preceding clauses, wherein the contrast agent is selected to provide reduced radiation impermeability.

[0267] 214. The method of any one of the preceding clauses, wherein the contrast agent comprises iohexol, iohexol derivatives, iohexol analogs, or combinations thereof.

[0268] 215. A treatment system comprising:

[0269] An electrolytically corroded pipe having a proximal portion, a distal portion, a separation zone between the proximal and distal portions, and a lumen configured to allow a plugging element to pass through it; and

[0270] A closure member having a proximal hub connected to a distal portion of a conduit, the closure member being configured to be positioned at or near a treatment site.

[0271] 216. The treatment system of any one of the terms of this document, wherein the separation zone includes a portion of the conduit configured to be cut off in response to the delivery of an electric current thereto.

[0272] 217. The treatment system according to any one of the clauses herein, wherein the detachment zone is axially located between the proximal portion of the conduit and the distal portion of the conduit.

[0273] 218. The treatment system according to any one of the clauses herein, wherein the conduit includes a sidewall having one or more holes formed therein within the separation zone.

[0274] 219. The treatment system according to any one of the clauses herein, wherein the conduit includes sidewalls having a reduced thickness in the separation zone.

[0275] 220. The treatment system according to any one of the clauses herein, wherein the conduit has a lower material density in the separation zone than in the proximal and distal portions.

[0276] 221. The treatment system according to any one of the clauses herein, wherein the separation region has a microstructure with a lower degree of crystallinity than each of the proximal portion and the distal portion of the conduit.

[0277] 222. The treatment system of any one of the clauses herein, wherein the separation zone has a more amorphous microstructure than each of the proximal portion and the distal portion of the conduit.

[0278] 223. The treatment system according to any one of the clauses herein, wherein the conduit is conductive.

[0279] 224. The treatment system according to any one of the clauses herein, wherein the conduit is metallic.

[0280] 225. The treatment system according to any one of the clauses herein, wherein the conduit comprises a hypotube.

[0281] 226. The treatment system according to any one of the clauses herein, wherein the conduit comprises a catheter.

[0282] 227. The treatment system of any one of the terms of this document, wherein the wall thickness of the tube is between about 0.0005 inches and about 0.0015 inches, or about 0.001 inches.

[0283] 228. The treatment system according to any one of the terms of this document, wherein the conduit has an outer diameter of less than about 0.027 inches, less than about 0.021 inches, less than about 0.017 inches, or less than about 0.015 inches.

[0284] 229. The treatment system according to any one of the terms of this document, wherein the conduit has an inner diameter of less than about 0.015 inches, less than about 0.012 inches, less than about 0.010 inches, or less than about 0.008 inches.

[0285] 230. The treatment system described in any one of the clauses herein further includes a liner extending through the lumen of the tubing.

[0286] 231. The treatment system according to any one of the clauses herein, wherein the liner includes an elongated tubular member having a lumen configured to allow an embolic element to pass through it.

[0287] 232. The treatment system according to any one of the clauses herein, wherein the liner is slidably disposed within the tubing lumen.

[0288] 233. The treatment system according to any one of the clauses herein, wherein the lining is electrically insulating.

[0289] 234. The treatment system according to any one of the clauses herein, wherein the lining comprises a polymer.

[0290] 235. The treatment system according to any one of the clauses herein, wherein the lining comprises polytetrafluoroethylene (PTFE).

[0291] 236. The treatment system of any one of the terms of this document, wherein the wall thickness of the liner is between about 0.0005 inches and about 0.0015 inches, or about 0.001 inches.

[0292] 237. The treatment system according to any one of the clauses herein, wherein the lining has an outer diameter of less than about 0.027 inches, less than about 0.021 inches, less than about 0.017 inches, or less than about 0.010 inches.

[0293] 238. The treatment system of any one of the terms herein, wherein the lining has an inner diameter of less than about 0.015 inches, less than about 0.012 inches, less than about 0.010 inches, less than about 0.008 inches, or less than about 0.006 inches.

[0294] 239. The treatment system according to any one of the clauses herein, wherein the liner has a sidewall that is continuous along the separation zone.

[0295] 240. The treatment system according to any one of the clauses herein, wherein when the liner is disposed within the conduit, the distal end of the liner extends distally from the distal end of the conduit.

[0296] 241. The treatment system according to any one of the provisions of this document, wherein when the liner is disposed within the conduit, the distal end of the liner is substantially adjacent to the distal end of the conduit.

[0297] 242. The treatment system of any one of the clauses herein, wherein the liner is configured to slidably retract relative to the occlusion member after the separation zone has been cut.

[0298] 243. The treatment system described in any one of the clauses herein also includes a sheath extending above the conduit.

[0299] 244. The treatment system described in any one of the clauses herein, wherein the sheath is electrically insulating.

[0300] 245. The treatment system according to any one of the clauses herein, wherein the sheath comprises a polymer.

[0301] 246. The treatment system according to any one of the clauses herein, wherein the sheath comprises polytetrafluoroethylene (PTFE).

[0302] 247. The treatment system of any one of the terms of this document, wherein the wall thickness of the sheath is between about 0.0005 inches and about 0.002 inches, or about 0.0015 inches.

[0303] 248. The treatment system according to any one of the terms of this document, wherein the sheath has an outer diameter of less than about 0.027 inches, less than about 0.021 inches, less than about 0.017 inches, or less than about 0.010 inches.

[0304] 249. The treatment system according to any one of the terms of this document, wherein the sheath has an inner diameter of less than about 0.015 inches, less than about 0.012 inches, or less than about 0.010 inches.

[0305] 250. The treatment system according to any one of the terms of this document, wherein the sheath comprises a proximal portion extending over the proximal portion of the conduit and a distal portion extending over the distal portion of the conduit.

[0306] 251. The treatment system according to any one of the clauses herein, wherein the sheath includes a gap between the proximal portion and the distal portion.

[0307] 252. The treatment system according to any one of the clauses herein, wherein the proximal portion of the sheath and the distal portion of the sheath are discrete segments separated from each other by gaps.

[0308] 253. The treatment system according to any one of the clauses herein, wherein the gap between the proximal portion of the sheath and the distal portion of the sheath is axially aligned with the separation zone.

[0309] 254. The treatment system of any one of the clauses herein, wherein the sheath does not extend fully beyond the tubing separation zone.

[0310] 255. The treatment system according to any one of the clauses herein, wherein the proximal portion of the sheath is configured to retract proximally relative to the occlusion member after the conduit is cut at the separation zone.

[0311] 256. The treatment system according to any one of the clauses herein, wherein the distal portion of the sheath is fixedly coupled to the occlusion member.

[0312] 257. The treatment system of any one of the clauses herein, wherein the distal portion of the sheath extends distally beyond the hub of the occlusal member.

[0313] 258. The treatment system according to any one of the clauses herein, wherein the distal portion of the sheath extends distally beyond the distal end of the occlusion member.

[0314] 259. The treatment system according to any one of the clauses herein, wherein the distal portion of the sheath extends distally beyond the distal end of the conduit.

[0315] 260. The treatment system according to any one of the clauses herein, wherein the distal portion of the sheath extends distally beyond the distal end of the liner.

[0316] 261. The treatment system according to any one of the clauses herein, wherein the distal portion of the conduit is configured to be disposed at or near the treatment site together with the occlusion member.

[0317] 262. The treatment system described in any one of the clauses herein, wherein the treatment site includes the aneurysm sac.

[0318] 263. The treatment system according to any one of the clauses herein, wherein the conduit has a distal portion having a smaller cross-sectional dimension than the proximal portion of the conduit.

[0319] 264. The treatment system according to any one of the clauses herein, wherein the occlusion member is connected to the conduit by one or more belts or clamps.

[0320] 265. The treatment system of any one of the provisions herein, wherein one or more bands or clamps circumferentially surround the proximal portion of the conduit and the occlusion member.

[0321] 266. The treatment system according to any one of the clauses herein, wherein the occlusion member is connected to the conduit by an adhesive.

[0322] 267. The treatment system described in any one of the clauses herein, wherein the occlusion member is an occlusion member or intracapsular device configured to be implanted within an aneurysm.

[0323] 268. The treatment system of any one of the provisions herein, wherein the occlusion member comprises an expandable mesh having a constrained state for delivery to the aneurysm and an expanded state in which at least a portion of the mesh is configured to be disposed across the neck of the aneurysm.

[0324] 269. The treatment system according to any one of the clauses herein, wherein the expandable mesh comprises a plurality of braided filaments, the plurality of braided filaments having a predetermined three-dimensional shape in the expanded state.

[0325] 270. The treatment system according to any one of the clauses herein, wherein the expandable mesh comprises a weave formed of 24, 32, 36, 48, 64 or 72 filaments.

[0326] 271. The treatment system according to any one of the terms of this document, wherein the expandable mesh comprises a braid formed of multiple threads, some or all of which have a diameter of at least 0.001 inches.

[0327] 272. The treatment system according to any one of the clauses herein, wherein the expandable mesh comprises a braid formed of multiple threads, some or all of which have the same diameter.

[0328] 273. The treatment system according to any one of the clauses herein, wherein the expandable mesh comprises a braid formed of multiple threads, at least some of which have different diameters.

[0329] 274. The treatment system according to any one of the clauses herein, wherein, in the expanded state, the expandable mesh forms one of a sphere, an elongated sphere, or an oblate spheroid.

[0330] 275. The treatment system described in any one of the clauses herein, wherein the expandable mesh comprises an inner layer and an outer layer.

[0331] 276. The treatment system according to any one of the clauses herein, wherein the maximum cross-sectional dimension of the expandable mesh is 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm or 8.0 mm.

[0332] 277. The treatment system according to any one of the clauses herein, wherein the expandable mesh is a laser cutting tube.

[0333] 278. The treatment system according to any one of the clauses herein, wherein the expandable mesh comprises multiple interwoven filaments.

[0334] 279. The treatment system according to any one of the clauses herein, wherein the occlusion member is bent at least for most of its entire length.

[0335] 280. The treatment system described in any one of the clauses herein, wherein the occlusive member is collapsible upon contact with the embolic element.

[0336] 281. The treatment system described in any one of the clauses herein, wherein the occlusive member is collapsible upon contact with a synthetic gel or fluid.

[0337] 282. The treatment system according to any one of the clauses herein, wherein the occlusion member is configured to rotate about the conduit.

[0338] 283. The treatment system according to any one of the clauses herein, wherein the occlusion member is rotatably and slidably connected to the conduit.

[0339] 284. The treatment system according to any one of the provisions of this document, wherein the occlusion member has an orifice in its distal portion, and wherein the conduit extends through the orifice.

[0340] 285. The treatment system according to any one of the clauses herein, wherein the occlusion member has a hole in its distal portion, and wherein the liner extends through the hole.

[0341] 286. The treatment system according to any one of the clauses herein, wherein the occlusion member has a hole in its distal portion, and wherein the sheath extends through the hole.

[0342] 287. The treatment system described in any one of the clauses herein, wherein the embolic element is a liquid embolism.

[0343] 288. The treatment system described in any one of the clauses herein, wherein the embolic element comprises a biopolymer and / or a chemical crosslinking agent.

[0344] 289. The therapeutic system according to any one of the provisions of this document, wherein the biopolymer comprises chitosan, chitosan derivatives, chitosan analogs or combinations thereof.

[0345] 290. The therapeutic system according to any one of the provisions of this document, wherein the chemical crosslinking agent comprises genipin, genipin derivatives, genipin analogs or combinations thereof.

[0346] 291. A system comprising:

[0347] The treatment system described in any one of the clauses herein; and

[0348] An elongated shaft having a lumen extending through it, wherein a treatment system is configured to be slidably disposed within the lumen of the elongated shaft.

[0349] 292. A system comprising:

[0350] The treatment system described in any one of the clauses herein;

[0351] A first elongated shaft having a first lumen extending therethrough, wherein the treatment system is configured to be slidably disposed within the first lumen; and

[0352] A second elongated shaft having a second lumen extending therethrough, wherein the first elongated shaft is configured to be slidably disposed within the second lumen.

[0353] 293. The system according to 154, wherein the first elongated axis is a microcatheter and the second elongated axis is a delivery or guiding catheter.

[0354] 294. The system of any one of the terms herein, wherein the microcatheter has a nominal inner diameter of about 0.015 inches or less, about 0.017 inches or less, about 0.021 inches or less, or about 0.027 inches or less.

[0355] 295. A method for treating an aneurysm, comprising:

[0356] Provide the treatment system as described in any one of the terms of this document.

[0357] 296. The method described in any one of the clauses herein further comprises:

[0358] Position the distal end of the conduit within the aneurysm cavity; and

[0359] While positioning the distal end of the conduit within the aneurysm cavity, the occlusion component is released from the conduit, causing the occlusion component to self-expand to present an expanded state.

[0360] 297. The method described in any one of the clauses herein, wherein the release occlusion member comprises a separation zone of the electrolytically corroded conduit.

[0361] 298. The method according to clause 158 above, wherein releasing the blocking member includes delivering current to the conduit.

[0362] 299. The method of any one of the clauses herein, wherein locating the distal end of the conduit comprises advancing the distal end of the conduit toward the dome or distal end of the aneurysm such that the distal end of the conduit extends beyond the distal end of the microcatheter surrounding the conduit.

[0363] 300. The method of any one of the clauses herein, wherein locating the distal end of the conduit comprises advancing the distal end of the liner toward the dome or distal end of the aneurysm such that the distal end of the liner extends beyond the distal end of the microcatheter surrounding the conduit.

[0364] 301. The method described in any one of the clauses herein further includes positioning the distal end of the conduit, sheath, and / or liner together with the occlusion member within the aneurysm cavity.

[0365] 302. The method described in any one of the clauses herein further includes retracting the liner proximally relative to the distal portion of the pipe.

[0366] 303. The method described in any one of the clauses herein further includes removing the lining from the lumen of the pipe.

[0367] 304. The method of any one of the provisions herein, wherein releasing the occlusion member includes allowing the occlusion member to self-expand to present a first expanded state in which the occlusion member forms a first shape, wherein, in the first expanded state, the occlusion member surrounds an internal region having a first internal volume, the method further comprising

[0368] An embolic element is delivered between the occlusion member and the aneurysm wall to transform the occlusion member into a second dilated state, wherein the occlusion member defines a second internal volume smaller than a first internal volume, and wherein the occlusion member in the second dilated state forms a second shape that differs from the first shape in the first dilated state.

[0369] 305. The method of any one of the clauses herein, wherein converting the occlusion member to a second expanded state comprises injecting an embolic element to push a portion of the sidewall of the expandable mesh in a direction away from the aneurysm wall and toward the internal region of the occlusion member.

[0370] 306. The method of any one of the clauses herein, wherein transforming the occlusion member into a second dilatation shape comprises injecting embolic material to reverse a portion of the sidewall of the occlusion member such that the portion bulges toward the aneurysm wall in a first dilatation state and is recessed toward the aneurysm wall in a second dilatation state.

[0371] 307. The method of any one of the clauses herein, wherein the embolic element comprises a liquid embolism.

[0372] 308. The method described in any one of the clauses herein, wherein the embolization element comprises one or more embolization coils.

[0373] 309. The method of any one of the clauses herein, wherein delivery of the embolic element occurs after the occlusion member is in the first expanded state.

[0374] 310. The method described in any one of the clauses herein, wherein the occlusion element is a mesh.

[0375] 311. The method described in any one of the clauses herein, wherein the occluding element is a woven fabric.

[0376] 312. The method described in any one of the clauses herein, wherein the occlusion member is a double-layered braided fabric.

[0377] 313. The method of any one of the clauses herein, wherein the occlusion member has a spherical or substantially spherical shape in the first expansion state.

[0378] 314. The method of any one of the clauses herein, wherein the occlusion member is cup-shaped or bowl-shaped in the second expansion state.

[0379] 315. The method of any one of the clauses herein, wherein the second shape is a predetermined three-dimensional shape.

[0380] 316. The method of any one of the clauses herein, wherein the occlusion member forms a multilayer braid at the aneurysm neck in the second dilated state.

[0381] 317. The method of any one of the clauses herein, wherein the occlusion member comprises a plurality of braided filaments that, in an expanded state, present a predetermined three-dimensional shape.

[0382] 318. The method of any one of the clauses herein, wherein the occlusion member comprises a braid formed of 24, 32, 36, 48, 64 or 72 filaments.

[0383] 319. The method of any one of the clauses herein, wherein the occlusion member comprises a braid formed of multiple threads, some or all of which have a diameter of about 0.001 inches (0.00254 cm).

[0384] 320. The method of any one of the clauses herein, wherein the occlusion member comprises a braid formed of multiple threads, some or all of which have the same diameter.

[0385] 321. The method of any one of the clauses herein, wherein the occlusion member comprises a braid formed of a plurality of threads, wherein at least some of the threads have different diameters.

[0386] 322. The method of any one of the clauses herein, wherein the occluding member forms a closed spherical shape in an expanded state, and the mesh has a hole in its distal portion.

[0387] 323. The method of any one of the clauses herein, wherein, in the expanded state, the occlusion member forms one of a sphere, an elongated sphere, or an oblate spheroid.

[0388] 324. The method described in any one of the clauses herein, wherein the occlusion member comprises an inner layer and an outer layer.

[0389] 325. The method of any one of the clauses herein, wherein the occlusion member comprises an inner layer and an outer layer that meet at a fold at a distal portion of the occlusion member.

[0390] 326. The method of any one of the terms of this document, wherein the expandable mesh includes a hole at the distal portion, the hole being defined by the fold.

[0391] 327. The method of any one of the clauses herein, wherein the occlusion member comprises an inner layer and an outer layer that meet at a fold at a proximal portion of the occlusion member.

[0392] 328. The method of any one of the terms of this document, wherein the expandable mesh includes a hole at the distal portion, the hole being defined by the fold.

[0393] 329. The method of any one of the clauses herein, wherein the maximum cross-sectional dimension of the occluder is 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm or 8.0 mm.

[0394] 330. The method of any one of the clauses herein, wherein the blocking member is formed by a plurality of filaments with a first end and a second end fixed at a hub or connector.

[0395] 331. The method of any one of the clauses herein, wherein the expandable web is formed of a plurality of filaments, the plurality of filaments being formed of an inner core material surrounded by an outer material.

[0396] 332. The method of any one of the clauses herein, wherein the inner core material is a radiopaque material and the outer material is a hyperelastic material.

[0397] 333. The method described in any one of the clauses herein, wherein the occlusion member is a laser-cut tube.

[0398] 334. The method described in any one of the clauses herein, wherein the occlusion member comprises a plurality of filaments.

[0399] 335. The method described in any one of the clauses herein, wherein the filaments are interwoven.

[0400] 336. The method described in any one of the clauses herein, wherein the filaments are woven.

[0401] 337. The method of any one of the clauses herein, wherein each of the filaments has a first end and a second end opposite to the first end, and wherein the first end and the second end of the filament are fixed relative to each other at a connector.

[0402] 338. The method described in any one of the clauses herein, wherein the connector is disposed at the distal end of the blocking member.

[0403] 339. The method described in any one of the clauses herein, wherein the connector is disposed at the proximal end of the occlusion member.

[0404] 340. The method of any one of the provisions of this document, wherein each of the filaments terminates at only one end of the occlusion member.

[0405] 341. The method of any one of the clauses herein, wherein the filament forms an opening at the end of the occluding member opposite to the only end thereof.

[0406] 342. The method of any one of the clauses herein, wherein the reverse portion of each of the filaments defines the opening.

[0407] 343. The method of any one of the clauses herein, wherein the reversed portions of the filaments are configured to move relative to each other.

[0408] 344. The method described in any one of the clauses herein, wherein the embolic element comprises a biopolymer and a chemical crosslinking agent.

[0409] 345. The method of any one of the provisions of this document, wherein the biopolymer comprises chitosan, chitosan derivatives, chitosan analogs, or combinations thereof.

[0410] 346. The method of any one of the clauses herein, wherein the chemical crosslinking agent comprises genipin, genipin derivatives, genipin analogs, or combinations thereof.

[0411] 347. The method of any of the provisions herein, wherein the embolic element further comprises a physical crosslinking agent.

[0412] 348. The method of any one of the clauses herein, wherein the physical crosslinking agent comprises β-glycerol phosphate, β-glycerol phosphate derivatives, β-glycerol phosphate analogs, or combinations thereof.

[0413] 349. The method described in any one of the clauses herein, wherein

[0414] The biopolymers include chitosan, chitosan derivatives, chitosan analogs, or combinations thereof;

[0415] The chemical crosslinking agent includes genipin, genipin derivatives, genipin analogs, or combinations thereof; and

[0416] The physical crosslinking agent includes β-glycerol phosphate, β-glycerol phosphate derivatives, β-glycerol phosphate analogs, or combinations thereof.

[0417] 350. The method described in any one of the provisions of this document, wherein the embolic element comprises a contrast agent.

[0418] 351. The method of any one of the clauses herein, wherein the contrast agent is selected to provide reduced radiation impermeability.

[0419] 352. The method of any one of the clauses herein, wherein the contrast agent comprises iohexol, iohexol derivatives, iohexol analogs, or combinations thereof. Attached Figure Description

[0420] Many aspects of this disclosure can be better understood by referring to the following figures. The components in the figures are not necessarily to scale; rather, the focus is on clearly illustrating the principles of this disclosure.

[0421] Figure 1A A perspective view of a system for treating aneurysms according to the present technology is shown.

[0422] Figure 1B The present invention is shown Figure 1A An enlarged view of the distal portion of the treatment system.

[0423] Figure 1C and 1D This is a cross-sectional view of a clogging member in an expanded state according to the present technology.

[0424] Figure 2 An embolization kit according to this technology is shown.

[0425] Figure 3A-3G An example method for treating aneurysms using the treatment system of this technology is described.

[0426] Figure 4A-5B Various types of images are shown that can be used to confirm and / or monitor the deployment of treatment systems based on this technology.

[0427] Figure 6 A system for treating aneurysms according to this technology is shown.

[0428] Figures 7A-7J An example method for treating aneurysms using the treatment system of this technology is described.

[0429] Figure 8A A schematic side view of a treatment system according to this technical aspect is shown.

[0430] Figure 8B It shows Figure 8A A schematic side sectional view of a part of the treatment system.

[0431] Figures 9A-9C The illustration shows the delivery of the occlusion member and embolization element to the treatment site according to aspects of the present technology.

[0432] Figure 10 A schematic side view of another embodiment of a treatment system according to the present technical aspect is shown.

[0433] Figure 11A A schematic side view of a treatment system according to this technical aspect is shown.

[0434] Figure 11B It shows Figure 11A A schematic side sectional view of the treatment system shown.

[0435] Figure 11C The electrolytic separation is shown Figure 11B A schematic side sectional view of the treatment system.

[0436] Figure 12 A schematic side sectional view of a portion of another embodiment of the treatment system is shown.

[0437] Figure 13 A schematic side sectional view of a portion of another embodiment of the treatment system is shown.

[0438] Figure 14 A schematic side sectional view of a portion of another embodiment of the treatment system is shown.

[0439] Figure 15A -C illustrates the delivery of the occlusion member and embolization element to the treatment site according to an aspect of the present technology. Detailed Implementation

[0440] A method for treating intracranial aneurysms according to at least some embodiments of the present technology includes positioning an expandable occlusive member within the aneurysm and introducing an embolic element between the occlusive member and the aneurysm wall. The introduction of the embolic element both fills the space within the aneurysm lumen and deforms the occlusive member from a first expanded state to a second expanded state to reinforce the occlusive member at the neck of the aneurysm. The deformation of the occlusive member from the first expanded state to the second expanded state provides the additional advantage of providing the physician with visual confirmation that the delivery volume of the embolic element is sufficient to fill the aneurysm lumen. In addition to providing structural support and anchoring for the embolic element, the occlusive member also provides a scaffold for tissue remodeling and diverts blood flow from the aneurysm. Furthermore, the embolic element applies substantially uniform pressure on the occlusive member toward the neck of the aneurysm, thereby pressing a portion of the occlusive member positioned adjacent to the neck against the inner surface of the aneurysm wall, such that the occlusive member forms a complete and stable seal at the neck.

[0441] Once the occlusion device has been deployed within the aneurysm and the embolization element has been delivered, the occlusion device can be detached from the delivery assembly. A suitable dissection mechanism must be as small as possible to be guided to the treatment site through the narrow opening of the catheter, while on the other hand, it must safely and reliably dislocate the intra-sac implant. Failure to reliably dislocate the intra-sac implant can result in the inadvertent removal of the occlusion device from the lumen to be occluded, thereby damaging and / or tearing the lumen or vessel wall. In some embodiments, an electrolytic dissection mechanism as described herein can be used to facilitate reliable, controlled dissection of the occlusion device.

[0442] The occlusion member can be implanted in a body cavity or blood vessel. In addition to the occlusion member, the treatment system may also include a voltage source, a cathode, a delivery conduit, and a catheter. The occlusion member and the delivery conduit can be coupled together such that both can slide longitudinally within the catheter. In some embodiments, a core wire can be engaged with the occlusion member and adapted to function as an anode, such that a portion of the core wire is designed to be electrolytically eroded at one or more points, allowing one or more portions of the occlusion member to be released from the core wire upon contact with body fluids. The delivery conduit can be configured to extend along its length adjacent to the core wire. The delivery conduit can be configured to allow one or more embolic elements to pass through it for intracapsular delivery. In some embodiments, a core needle can be removably disposed within the conduit to provide enhanced conduit rigidity and maneuverability as the conduit is advanced to the treatment site. Once the core needle is removed, the embolic element can be passed through the conduit and delivered to the treatment site. Once the occlusion member and any embolic element are deployed, current can be applied to the core wire to electrolytically erode the core wire in the separation zone. After the core wire is severed in the separation zone, the core wire and conduit can be retracted, and the occlusion member can remain in place at the treatment site.

[0443] In some embodiments, the occlusion member may be coupled to a distal portion of the tubing, and the tubing may include a separation zone configured to be electrolytically cut off. In various instances, the tubing may be adapted to function as an anode, such that a portion of the tubing is designed to be electrolytically corroded at one or more points, thereby allowing the occlusion member to be released from the tubing upon contact with bodily fluids. The delivery tubing may be configured to allow one or more embolic elements to pass through it for intracapsular delivery. The embolic element may pass through the tubing and be delivered to the treatment site. Once the occlusion member and any embolic element are deployed, an electric current may be applied to the tubing to electrolytically corrode the tubing in the separation zone. After the tubing is cut off in the separation zone, the tubing may retract, and the occlusion member may remain in place at the treatment site. In some embodiments, an inner liner and / or an outer sheath extend along at least a portion of the tubing length. The outer sheath may include a gap or opening aligned with the separation zone, such that the separation zone of the tubing is exposed to bodily fluids upon treatment.

[0444] Specific details of the systems, apparatus, and methods for treating intracranial aneurysms according to embodiments of the present technology are referenced herein. Figure 1A-15C The description is provided below. While these systems, apparatuses, and methods may be described herein primarily or entirely in the context of treating saccular intracranial aneurysms, other contexts are also within the scope of this technology. For example, suitable features of the systems, apparatuses, and methods for treating saccular intracranial aneurysms may be performed in the context of treating non-saccular intracranial aneurysms, abdominal aortic aneurysms, thoracic aortic aneurysms, renal artery aneurysms, arteriovenous malformations, tumors (e.g., by obstructing the vessels supplying the tumor), perivascular leaks, varicose veins (e.g., by obstructing one or more main veins, such as the great saphenous vein), hemorrhoids, and endoleaks that seal adjacent artificial heart valves, covering stents, and abdominal aortic aneurysm devices. Furthermore, it should generally be understood that other systems, apparatuses, and methods besides those disclosed herein are also within the scope of this disclosure. For example, systems, apparatuses, and methods according to embodiments of this technology may have different and / or additional configurations, components, processes, etc., than those disclosed herein. Furthermore, systems, apparatuses, and methods according to embodiments of this disclosure may be performed without one or more of the configurations, components, procedures, etc., disclosed herein without departing from the technology.

[0445] I. Overview of this technical system

[0446] Figure 1A The illustration shows a view of a system 10 for treating intracranial aneurysms according to one or more embodiments of the present technology. Figure 1AAs shown, system 10 includes a treatment system 100 and an embolization kit 200 for use with one or more components of the treatment system 100. The treatment system 100 may include an occlusion member 102 (shown in an expanded state) detachably coupled to a delivery system, and the delivery system may be configured to position the occlusion member 102 intravascularly within the aneurysm. The embolization kit 200 may include one or more substances or devices, individually or in combination, forming an embolization element configured to co-occupy the internal volume of the aneurysm with the occlusion member 102. In some embodiments, the treatment system 100 may be configured to deliver the embolization element (and / or one or more precursors thereof) to the aneurysm. Additionally or alternatively, system 10 may include a separate delivery system (not shown) for delivering the embolization element (and / or one or more precursors thereof) into the aneurysm lumen.

[0447] like Figure 1A As shown, the treatment system 100 has a proximal portion 100a and a distal portion 100b, the proximal portion being configured for external positioning during treatment, and the distal portion being configured for intravascular positioning within a blood vessel (e.g., an intracranial vessel) at or near the treatment site of the aneurysm. The treatment system 100 may include a handle 103 at the proximal portion 100a, an occlusion member 102 at the distal portion 100b, and a plurality of elongated shafts or members extending between the proximal and distal portions 100a and 100b. In some embodiments, for example... Figure 1A As shown, the treatment system 100 may include a first elongated shaft 109 (e.g., a guiding catheter or balloon guiding catheter), a second elongated shaft 108 (e.g., a microcatheter) configured to be slidably disposed within the lumen of the first elongated shaft 109, and an elongated member 106 configured to be slidably disposed within the lumen of the second elongated shaft 108. In some embodiments, the treatment system 100 may exclude the first elongated shaft 109 and include only the second elongated shaft 108.

[0448] Figure 1B This is an enlarged view of the distal portion 100b of the treatment system 100. Please refer to it together. Figure 1A and 1BThe occlusion member 102 may be detachably coupled to the distal end of the elongated member 106. For example, the elongated member 106 may include a first connector 112 at its distal end, and the occlusion member 102 may include a second connector 114 configured to be detachably coupled to the first connector 112. The treatment system 100 may also include a conduit 116 extending distally from the handle 103 (e.g., via port 110) to the distal portion 100b of the treatment system 100. The conduit 116 is configured to deliver an embolic element (and / or one or more precursors thereof) through one or more components of the delivery system (e.g., the first or second elongated shafts 109, 108, the elongated member 106, etc.) to a location outside the occlusion member 102. Thus, the embolic element may be positioned between the occlusion member 102 and the inner wall of the aneurysm lumen, as described in more detail below.

[0449] According to some embodiments, the second elongated shaft 108 is typically configured to follow and enter brain-associated blood vessels above a conventional guidewire in the neck anatomy, and can also be selected according to several standard designs commonly available. Thus, the second elongated shaft 108 can have a length of at least 125 cm, and more specifically, a length between about 125 cm and about 175 cm. In some embodiments, the second elongated shaft 108 can have an inner diameter of about 0.015 inches (0.0381 cm), 0.017 inches (0.043 cm), about 0.021 inches (0.053 cm), or about 0.027 inches (0.069 cm). Other designs and sizes are contemplated.

[0450] The elongated member 106 is movable within the first and / or second elongated shafts 109, 108 to position the occlusion member 102 in a desired location. The elongated member 106 may have sufficient flexibility to allow manipulation of the occlusion member 102 through a tortuous channel, such as forward and / or retraction. The tortuous channel may include, for example, a catheter lumen, a microcatheter lumen, a blood vessel, a urinary tract, a biliary tract, and an airway. The elongated member 106 may be formed of any material and size suitable for the task to which the system is to be used. In some embodiments, the elongated member 106 may include a solid metal wire. In some embodiments, the elongated member 106 may include any other suitable form of shaft, such as an elongated tubular shaft.

[0451] In some embodiments, the elongated member 106 may comprise stainless steel, nitinol, cobalt-chromium alloy, or other metals or alloys. In some embodiments, the elongated member 106 may be coated with a coating, such as polytetrafluoroethylene, over a portion or all of its length. The elongated member 106 may have a diameter that is substantially constant along its length, or the elongated member 106 may have a diameter that tapers radially inward along at least a portion of its length as it extends in the distal direction.

[0452] According to several embodiments, the conduit 116 may be a conduit or elongated shaft that delivers goods separately from the second elongated shaft 108.

[0453] A. Examples of Selected Blocking Components

[0454] Figure 1C This is a cross-sectional view of the occlusion member 102, shown in an expanded state and separated from the treatment system 100. (Reference) Figure 1B and 1C The occlusion member 102 may include an expandable element having a small profile or constrained state when positioned within a catheter (e.g., a second elongated shaft 108) for delivery to the aneurysm, and an expanded state configured to be positioned within the aneurysm (e.g., a cerebral aneurysm).

[0455] According to some embodiments, the occlusion member 102 may include a mesh 101 formed of multiple braided filaments, which have been heat-set to present a predetermined shape surrounding the internal volume 130 when the mesh 101 is in an expanded, unconstrained state. Example shapes include spherical shapes, such as spheres, elongated spheres, oblate spheroids, etc. Figure 1C As shown, the mesh 101 may have inner and outer layers 122, 124, having proximal ends fixed relative to each other at the second connector 114 and meeting distally at a fold 128 around the hole 126. Although the inner and outer layers 122, 124 are depicted as spaced apart from each other along their length, they may contact each other along all or part of their length. For example, the inner layer 122 may press radially outward against the outer layer 124. In some embodiments, the closure member 102 may be formed of a single layer or a mesh or braid.

[0456] In some embodiments, the distal ends of the inner and outer layers 122, 124 are fixed relative to each other at the distal connector and meet proximally at the proximal fold around the hole. In any case, in some embodiments, the conduit 116 may be configured to be slidably positioned through some or all of the second connector 114, the internal volume 130 of the expansion mesh 101, and the opening 126.

[0457] Inner and outer layers 122 and 124 may be in the distal portion (e.g., as shown in the image). Figure 1C(As shown) they conform to each other to form a curved distal surface. For example, at least in the distal portion of the occluder 102, the inner and outer layers 122 and 124 may extend distally and radially inward toward the aperture 126. In some embodiments, the outer and / or inner layers 122 and 124 extend distally and radially outward from the second connector 114 and then distally and radially inward to the distal end of the occluder 102 (e.g., fold 128). The occluder 102 and / or its layers may be curved along its entire length or may have one or more generally straight portions. In some embodiments, the curved surface transitions to a flat or substantially flat distal surface surrounding the aperture 126. In some embodiments, the curved surface transitions to the distal surface surrounding the aperture 126 and has a radius of curvature greater than the average radius of curvature of the remainder of the occluder 102. Having a flat or substantially flat distal surface, or a distal surface with a radius of curvature greater than the average radius of curvature of the remainder of the occlusion member 102, can facilitate the delivery of the embolic element 230 because it creates a small gap between the distal surface of the occlusion member 102 and the dome of the aneurysm A (see example...). Figure 3B In some embodiments, the surface of the occluder 102 surrounding the hole 126 is curved and / or has a radius of curvature substantially the same as the rest of the occluder 102.

[0458] In any case, the inner layer 124 may have a shape that substantially conforms to the shape of the outer layer 124, or the inner layer 122 and the outer layer 124 may have different shapes. For example, as Figure 1D As shown, the inner layer 122 may have a smaller diameter or cross-sectional dimension than the outer layer 124. Such a configuration may be advantageous because the embolic element 230 experiences less resistance, at least initially, when pushing the distal wall of the occlusion member 102 downward toward the neck (as described in more detail below).

[0459] In any case, the proximal and distal portions of the net 101 can form a generally closed surface. However, unlike the proximal portion of the net 101, the portions of the filaments located at or near the fold 128 in the distal portion of the net 101 can move relative to each other. Therefore, the distal portion of the net 101 has the characteristics of a closed end and also some characteristics of an open end (such as a conventional support), such as some degrees of freedom of movement for the distal portion of the filaments and the opening through which the conduit 116, guide wire, conduit, or other elongated member can pass.

[0460] In some embodiments, each of the plurality of filaments has a first end located on the proximal portion of the net 101 and a second end also located on the proximal portion of the net 101. Each filament may extend distally from its corresponding first end along the body of the net 101 to the fold 128, reverse, and then extend proximally along the body of the net to its corresponding second end at the proximal portion of the net 101. Thus, each of the plurality of filaments has a first length forming the inner layer 122 of the net 101, a second length forming the outer layer 124 of the net 101, and both the first and second ends are fixed to the proximal portion of the net 101. In some embodiments, the closure member 102 may comprise a net formed of a single layer, or a net formed of three or more layers.

[0461] In some embodiments, the distal surface of the mesh 101 is completely closed (i.e., excluding the holes). In some embodiments, the filaments are fixed relative to both the proximal and distal ends of the closure member 102.

[0462] Mesh 101 can be formed from metal wire, polymer wire, or both, and the wire can have shape memory and / or hyperelastic properties. Mesh 101 can be formed from 24, 32, 36, 48, 64, 72, 96, 128, or 144 filaments. Mesh 101 can be formed from a range of filament or wire sizes, such as wires with diameters from about 0.0004 inches to about 0.0020 inches, or from about 0.0009 inches to about 0.0012 inches. In some embodiments, each of the threads or filaments has a diameter of approximately 0.0004 inches, approximately 0.0005 inches, approximately 0.0006 inches, approximately 0.0007 inches, approximately 0.0008 inches, approximately 0.0009 inches, approximately 0.001 inches, approximately 0.0011 inches, approximately 0.0012 inches, approximately 0.0013 inches, approximately 0.0014 inches, approximately 0.0015 inches, approximately 0.0016 inches, approximately 0.0017 inches, approximately 0.0018 inches, approximately 0.0019 inches, or approximately 0.0020 inches. In some embodiments, all the filaments of the braided mesh 101 may have the same diameter. For example, in some embodiments, all the filaments have a diameter of approximately 0.001 inches. In some embodiments, some of the filaments may have different cross-sectional diameters. For example, some filaments may have a slightly thicker diameter to give the braided layer additional strength. In some embodiments, some of the filaments may have a diameter of about 0.001 inches, and some of the filaments may have a diameter greater than 0.001 inches. Thicker filaments can impart greater strength to the braid without significantly increasing the delivery profile of the device, where finer threads provide some strength while filling the matrix density of the braid.

[0463] The occlusion member 102 can have different shapes and sizes in an expanded, unrestrained state. For example, the occlusion member 102 can be bullet-shaped, barrel-shaped, egg-shaped, top-shaped, bowl-shaped, plate-shaped, cylindrical or roughly cylindrical, barrel-shaped, chalice-shaped, etc.

[0464] B. Selected Examples of Embolization Kits

[0465] The embolization kit 200 may include one or more precursors for generating a liquid embolism. For example, the embolization kit 200 may include a first container 202 containing a first precursor material 203 (schematically shown), a second container 204 containing a second precursor material 205 (also schematically shown), and a mixing device 206 adapted to mix the first and second precursor materials 203, 205. The mixing device 206 may include a mixing syringe 208 (separately identified as mixing syringes 208a, 208b) and a connector 210 extending between respective outlets (not shown) of the mixing syringes 208. The mixing syringes 208a, 208b each include a plunger 212 and a barrel 214, the plunger 212 being slidably received within the barrel.

[0466] The embolization kit 200 may also include a syringe 216 configured to receive a mixture of first and second precursor materials 203, 205 and deliver the mixture to the proximal portion 100b of the treatment assembly 100. The syringe 216 may include a barrel 220, an outlet 222 at one end of the barrel 220, and a plunger 224 slidably received within the barrel 220 via the opposite end. The handle 103 of the treatment system 100 may have a connector configured to form a robust fluid connection between the lumen and the outlet 222 of the syringe 216.

[0467] The first and second precursor materials 203 and 205 may each comprise a biopolymer and a chemical crosslinking agent, respectively. The chemical crosslinking agent may be selected to form covalent crosslinks between the chains of the biopolymer. In some embodiments, the biopolymer of the first precursor material 203 comprises chitosan or a derivative or analog thereof, and the chemical crosslinking agent of the second precursor material 205 comprises genipin or a derivative or analog thereof. Other suitable crosslinking agents used with chitosan include glutaraldehyde, functionalized polyethylene glycol, and their derivatives and analogs. In other embodiments, the biopolymer of the first precursor material 203 may comprise collagen or a derivative or analog thereof, and the chemical crosslinking agent of the second precursor material 205 may comprise hexamethylene diisocyanate or a derivative or analog thereof. Optionally or additionally, genipin or its derivatives or analog thereof may be used as a chemical crosslinking agent for collagen-based biopolymers. In other embodiments, the biopolymer of the first precursor material 203 and the chemical crosslinking agent of the second precursor material 205 may comprise, alone or in combination, other suitable compounds.

[0468] The chemical crosslinking agent that mixes the biopolymer of the first precursor material 203 and the chemical crosslinking agent of the second precursor material 205 can initiate the chemical crosslinking of the biopolymer. After the first and second precursor materials 203 and 205 are mixed, the chemical crosslinking of the biopolymer occurs for a sufficient period of time to allow the resulting embolic element 230 to be delivered to the aneurysm before becoming too viscous to move through the lumen of conduit 116. Furthermore, the time period for the biopolymer to undergo chemical crosslinking can be short enough to reach the target deployment viscosity within a reasonable time after delivery (e.g., in the range of 10-60 minutes; or at most 40 minutes, 30 minutes, 20 minutes, or 10 minutes). The target deployment viscosity can be high enough to cause the embolic element 230 to aggregate and remain within the internal volume of the aneurysm without reinforcing the neck.

[0469] In at least some cases, the biopolymer has a non-zero degree of chemical crosslinking within the first precursor material 203 prior to mixing with the chemical crosslinking agent. This is useful, for example, for customizing the curing window of the embolization element 230 so that it corresponds well to the expected amount of time required to deliver the material to the aneurysm. The degree of chemical crosslinking of the biopolymer within the first precursor material 203 prior to mixing with the chemical crosslinking agent, the ratio of the biopolymer to the chemical crosslinking agent, and / or one or more other variables can be selected to give the embolization element 230 a viscosity suitable for delivery to the aneurysm through the lumen of conduit 116 for a suitable period of time (e.g., in the range of 10 to 40 minutes) after mixing the first and second precursor materials 203, 205. In at least some cases, the first precursor material 203 and the second precursor material 205 are mixed in a ratio such that the weight ratio of the biopolymer to the chemical crosslinking agent in the resulting embolization element 230 is in the range of 10:1 to 100:1, for example, 10:1 to 30:1, or 15:1 to 50:1, or 15:1 to 25:1. In a specific instance, the first precursor material 203 and the second precursor material 205 are mixed such that the biopolymer in the resulting embolization element 230 is mixed with the chemical crosslinking agent in a weight ratio of 30:1.

[0470] Using a biopolymer instead of an artificial polymer in the first precursor material 203 may be advantageous because biopolymers are more readily absorbed by the body and / or for other reasons. Furthermore, using a chemical crosslinking agent instead of a physical crosslinking agent (i.e., a crosslinking agent that forms non-covalent crosslinks between the chains of the biopolymer) in the second precursor material 205 may be advantageous because chemically crosslinked polymers tend to be more cohesive than physically crosslinked polymers and / or for other reasons. In the case of forming a tissue scaffold within an aneurysm, high cohesiveness of the embolic element 230 may be more important than in other cases where the solidified embolic element 230 is fixed within the aneurysm 302. For example, high cohesiveness of the embolic element 230 can reduce or eliminate the possibility that a piece of the embolic element 230 may detach during delivery and enter the patient's cerebral blood flow.

[0471] The first and second precursor materials 203, 205 may include other components and / or system 200 may include other precursor materials intended to be mixed with the first and second precursor materials 203, 205. For example, the first, second, and / or another precursor material may include a physical crosslinking agent. The presence of a physical crosslinking agent can be used to form a physical crosslink that is complementary to the chemical crosslinking of the chemical crosslinking agent. The combination of chemical and physical crosslinking can enhance the cohesiveness of the embolic element 230. Suitable physical crosslinking agents for use with chitosan-based biopolymers include β-glycerophosphates, mannitol, glucose, and their derivatives and analogues. In these and other cases, the embolic element 230 may include a variety of chemical crosslinking agents and / or a variety of physical crosslinking agents.

[0472] A contrast agent is another component that can be added to the precursor material. The presence of a contrast agent within the embolization element 230 is useful for visualizing the delivery of the embolization element 230 using fluoroscopy. One problem with the use of conventional platinum coils in intracranial aneurysms is that the coil's persistent radiolucency often interferes with the visualization of other aspects of treatment in subsequent imaging. For example, the presence of a platinum coil within the aneurysm may make it difficult or impossible to detect the presence of blood-borne contrast agents by fluoroscopy, which would otherwise indicate recanalization. In at least some embodiments of this technology, the contrast agent within the embolization element 230 is selected to provide radiolucency linearity that decreases over time. For example, the contrast agent may initially be radiolucent to facilitate the delivery of the embolization element 230, and then become less radiolucent to facilitate subsequent imaging. In certain instances, the first, second, and / or another precursor material includes iohexol or a derivative or analogue thereof as a suitable contrast agent.

[0473] In animal studies, the liquid embolization of this technique has been shown to provide (a) complete or near-complete volume filling of the aneurysm's internal volume, and (b) complete or near-complete coverage of the aneurysm neck with new endothelial tissue. Among other things, these features are expected to result in lower recanalization rates and faster aneurysm occlusion than platinum coil therapy. Furthermore, the injectable stent material is expected to be bioresorbed, thus reducing its volume over time. Therefore, unlike platinum coils, injectable stents are expected to have little or no long-term mass effect. Additionally, the injectable stent material can be configured to have reduced radiopaque linearity; therefore, when configured in this way, it will not interfere with future CT and MRI imaging and surgery. Embodiments of this technique may have these and / or other features and advantages relative to conventional counterparts, whether or not such features and advantages are described herein.

[0474] In some embodiments, the embolization kit 200 and / or the embolization element 230 can be any embolization or occlusion device, such as one or more embolization coils, polymer hydrogels, polymer fibers, mesh devices, or combinations thereof. The embolization kit 200 may include one or more precursors that, once mixed together, form the embolization element 230 that remains within the aneurysm. In some embodiments, the embolization kit 200 may include a premixed embolization element.

[0475] II. Selection of Treatment Methods for Aneurysms

[0476] Figure 3A-3G An example method for treating aneurysm A using system 10 of the present technology is described. First, a physician can advance a second elongated shaft 108 intravascularly toward the intracranial aneurysm (or any other treatment location such as those described herein) with the occlusion member 102 in a low profile. The distal portion of the second elongated shaft 108 can be advanced through the neck N of the aneurysm A to position the distal opening of the second elongated shaft 108 within the lumen of the aneurysm A. The elongated member 106 can be advanced distally relative to the second elongated shaft 108 to push the occlusion member 102 through the opening at the distal end of the second elongated shaft 108, thereby releasing the occlusion member 102 from the shaft 108 and allowing the occlusion member 102 to self-expand to a first dilated state.

[0477] Figure 3A The occlusion member 102 is shown in its first dilated state, positioned within the aneurysm lumen and still connected to the elongated member 106. (See image.) Figure 3A As shown, in the first expanded state, the blocking member 102 can take on a predetermined shape that surrounds the internal volume 130 (see...). Figure 1C In this first dilated state, the occlusion member 102 can substantially conform to the shape of the aneurysm A. For example... Figure 3BAs shown, where the occlusion member 102 and the delivery system are shown in cross-section, a conduit 116 can be advanced through the internal volume 130 of the occlusion member 102 such that the distal opening of the conduit 116 is at or distal to the orifice 126 in the distal portion of the occlusion member 102. An embolic element 230 can be delivered through the conduit 116 to the space between the occlusion member 102 and the inner surface of the aneurysm wall W.

[0478] In some embodiments, the method includes mixing first and second precursor materials 203, 205 ( Figure 2 To form an embolic element 230. The mixing of the first and second precursor materials 203, 205 can occur before the embolic element 230 is introduced into the treatment system 100 and / or during delivery of the embolic element to the aneurysm via conduit 116. In a particular example, the first precursor material 203 is loaded into one cylinder 214, the second precursor material 205 is loaded into another cylinder 214, and a mixing syringe 208 is connected via a connector 210. To mix the first and second precursor materials 203, 205, the plunger 212 is alternately depressed, causing the first and second precursor materials 203, 205 to repeatedly move from one cylinder 214 to another cylinder 214. After the precursor materials are properly mixed, the resulting embolic element 230 can be loaded into the cylinder 220 of syringe 216. Syringe 216 can then be connected to the proximal end of conduit 116 to deliver the embolic element 230 to the aneurysm A via conduit 116. As the embolization element 230 passes through the lumen of the conduit 116, the chemical cross-linking of the biopolymer can continue to occur.

[0479] Still referencing Figure 3B When the embolizing element 230 is delivered between the dome of the aneurysm A and the distal portion 132 of the wall of the occlusion member 102, pressure is established between the aneurysm wall W and the occlusion member 102. Figure 3B-3D As shown in the progress diagram, when the force on the occlusion member 102 reaches a threshold level, the embolization element 230 pushes the distal wall 132 downward toward the neck N of the aneurysm A. The embolization element 230 applies a substantially uniform pressure on the distal surface of the occlusion member 102, which causes the occlusion member 102 to collapse inward, such that the circular distal wall 132 transitions from a concave shape toward the neck N of the aneurysm A to a convex shape toward the neck N. The pressure and the reversal of the distal portion of the wall 132 form an annular fold 136 defining the distal edge of the occlusion member 102. As the occlusion member 102 continues to reverse, the position of the fold 136 moves toward the neck N, which continues until the distal half of the occlusion member 102 has been reversed. In some embodiments, the occlusion member 102 may include one or more portions configured to preferentially bend or flex, such that the occlusion member 102 folds with a desired longitude (e.g., as described below regarding...). Figure 5A-7J(Discussed in more detail). Furthermore, as the occlusion member 102 collapses, the distance between the walls of the distal portion 132 and the proximal portion decreases, thus reducing the internal volume 130 of the occlusion member 102. With the collapse of the occlusion member 102, the conduit 116 can remain stationary, advance distally, and / or retract proximally.

[0480] During and after the delivery of the embolic element 230, no or substantially no embolic element 230 migrates through the orifice of the occlusion member 102 and into the internal volume 130. In other words, all or substantially all of the embolic element 230 remains on the outer surface or exterior of the occlusion member 102. The compression of the occlusion member by the embolic element 230 provides the physician with a real-time “flattening” or “aneurysm filling indicator” under a single-plane imaging method (e.g., fluoroscopy) so that the physician can confirm at what point the aneurysm is completely filled. See below for reference. Figure 4A-5B Additional details are described regarding the devices, systems, and methods used for monitoring and / or confirming deployment. Filling as much space as possible within the aneurysm is beneficial, as leaving gaps within the aneurysm sac can lead to delayed healing and an increased risk of aneurysm recanalization and / or rupture. While the cross-neck stent provided by the occlusion member 102 facilitates blood thrombosis in any gaps and neck healing, basic lumen filling prevents acute rupture and is independent of the neck stent (i.e., occlusion member 102). Conventional devices cannot confirm complete or substantially complete aneurysm filling on monoplane imaging.

[0481] Once the embolic element 230 has been delivered, the conduit 116 can be withdrawn. In some embodiments, the embolic element 230 may fill greater than 40% of the aneurysm sac volume. In some embodiments, the embolic element 230 may fill greater than 50% of the aneurysm sac volume. In some embodiments, the embolic element 230 may fill greater than 60% of the aneurysm sac volume. In some embodiments, the embolic element may fill greater than 65%, 70%, 75%, 80%, 85%, or 90% of the aneurysm sac volume.

[0482] Figure 3E The second expanded state of the occlusion member 102 is shown in cross-section, wherein the embolization element 230 occupies the remaining volume of the aneurysm A. Figure 3F The diagram shows a fully filled occluded member 102 with the embolization element 230 removed, thus revealing the second shape of the occluded member 102. As shown, the embolization element 230 can be delivered until the occluded member 102 completely collapses, leaving the occluded member 102 with essentially no internal volume.

[0483] In the second dilated state, the occlusion member 102 can form a bowl shape extending through the neck of the aneurysm A. The wall of the occlusion member 102 in the distal portion can now be positioned to contact or be adjacent to the wall of the occlusion member 102 in the proximal portion. The distal wall 132 can contact the proximal wall 134 along its entire or substantially its entire length. In some embodiments, the distal wall 132 can contact the proximal wall 134 only along a portion of its length, while the remaining length of the distal wall 132 is very close to but does not contact the proximal wall 134.

[0484] Collapse of the occlusion member 102 itself toward the neck N of the aneurysm can be particularly beneficial, as it doubles the number of layers passing through the neck and thus increases occlusion at the neck N. For example, collapse or inversion of the distal wall 132 on the proximal wall 134 can reduce the porosity of the occlusion member 102 at the neck N. In those embodiments where the occlusion member 102 is a mesh or braided device such that the distal wall 132 has a first porosity and the proximal wall 134 has a second porosity, deformation of the distal wall 132 on or immediately adjacent to the proximal wall 134 reduces the effective porosity of the occlusion member 102 at the neck N. The resulting multilayer structure has lower porosity than the first and second porosities alone. Furthermore, the embolization element 230 along the distal wall 132 provides additional occlusion. In some embodiments, the embolization element 230 completely or substantially completely blocks the pores of adjacent layers or walls of the occlusion member 102, preventing blood from flowing through the embolization element 230 into the aneurysm lumen. The goal is to block the aneurysm as much as possible, because leaving gaps allows blood to flow in and / or pool, which could continue to stretch the wall of aneurysm A. Dilatation of aneurysm A could lead to recanalization and / or entry of the occlusion component 102 and / or embolization element 230 into the parent vessel and / or could potentially cause aneurysm A to rupture. Both of these situations can be fatal to the patient.

[0485] In embodiments where the wall of the occlusion member 102 comprises an inner and outer layer, the modified or second shape of the occlusion member 102 forms four layers at the neck N of the aneurysm A. In embodiments where the wall of the occlusion member 102 comprises a single layer, the modified or second shape of the occlusion member 102 forms two layers at the neck N of the aneurysm A. As previously described, the neck cover provided by the double layer provides additional surface area for endothelial cell growth, reduces the porosity of the occlusion member 102 at the neck N (compared to two or one layer), and prevents the embolic element 230 from protruding into the carrier vessel. During and after delivery, the embolic element 230 applies substantially uniform pressure on the occlusion member 102 toward the neck N of the aneurysm A, thereby pressing a portion of the occlusion member 102 located adjacent to the neck against the inner surface of the aneurysm wall, such that the occlusion member 102 forms a complete and stable seal at the neck N.

[0486] like Figure 3GAs shown, the first connector 112 can be separated from the second connector 114 and the elongated member 106 and the second elongated shaft 108 can be retracted, thereby allowing the occlusion member 102 and the embolization element 230 to be implanted into the aneurysm A.

[0487] Over time, natural vascular remodeling mechanisms and / or bioresorption of the occlusive element 230 can lead to thrombus formation and / or the transformation of trapped thrombus into fibrous tissue within the internal volume of aneurysm A. These mechanisms can also result in cell death at the aneurysm wall and the growth of new endothelial cells between and on top of the filaments or struts of the occlusion device 102. Ultimately, the thrombus and cells on the aneurysm wall can be completely degraded, leaving a successfully remodeled vascular area.

[0488] In some embodiments, the contrast agent may be delivered during the advancement of the occlusion member 102 and / or the embolization element 230 in the vascular system, during the deployment of the occlusion member 102 and / or the embolization element 230 at the aneurysm A, and / or after the deployment of the occlusion member 102 and / or the embolization element 230 but before the start of withdrawal from the delivery system. The contrast agent may be delivered via the second elongated shaft 108, the conduit 116, or via another catheter or device typically used for delivering contrast agents. The aneurysm (and the device therein) may be imaged before, during, and / or after the injection of the contrast agent, and the images may be compared to confirm the degree of occlusion of the aneurysm.

[0489] According to some aspects of this technology, system 10 may include separate first and second elongated shafts (e.g., microcatheters) (not shown), the first dedicated to delivering embolic elements and the second dedicated to delivering occlusive components. In an example method of treating an aneurysm, the first elongated shaft may be advanced intravascularly into the aneurysm and through the neck, such that the distal end of the first elongated shaft is positioned within the aneurysm lumen. In some embodiments, the first elongated shaft may be positioned within the aneurysm lumen such that the distal end of the shaft is close to the dome of the aneurysm.

[0490] A second elongated axis, including an occlusion member (e.g., occlusion member 102), can be advanced intravascularly into the aneurysm and positioned within the aneurysm cavity adjacent to the first elongated axis. The occlusion member can then be deployed within the aneurysm sac. When the occlusion member deploys, it pushes the first elongated axis outward toward one side of the aneurysm, and when fully deployed, the occlusion member holds or “traps” the first elongated axis between the outer surface of the occlusion member and the inner surface of the aneurysm wall.

[0491] The embolic element (e.g., embolic element 230) can then be delivered via a first elongated axis to a position between the inner surface of the aneurysm wall and the outer surface of the occlusion member. For this purpose, it may be advantageous to initially position the distal end of the first elongated axis near the dome (or more distal surface) of the aneurysm wall. In this way, the "trapped" first elongated axis will be secured by the occlusion member, allowing the embolic element to gradually fill the open space in the aneurysm sac between the dome and the occlusion member. As described elsewhere in this document, the filling of the embolic element, from the dome to the neck, compresses and presses the occlusion member against the tissue surrounding the aneurysm neck as it fills the space in the sac above the occlusion member. Again, as described elsewhere in this document, the occlusion member, compressed by the embolic element, provides a "flat or aneurysm filling indicator" not provided by conventional single-plane imaging methods. For example, the filling of the embolic element can be completed when it occupies approximately 50-80% of the aneurysm volume.

[0492] III. Selected devices, systems, and methods for monitoring deployment

[0493] The proper deployment of the embolization element 230 and the occlusion member 102 can be monitored and / or confirmed using one or more medical imaging techniques, such as fluorescence fluoroscopy. Figure 4A-5B Examples of various types of fluoroscopic images are shown, which physicians can use at different stages of deployment to monitor the position of the occlusion member 102 within aneurysm A, monitor the degree to which aneurysm A is filled by the embolic element 230, and / or confirm the degree of occlusion of aneurysm A by the deployed system. As described in more detail below, the devices and systems of this technology can be configured to provide unique visual indicators that provide physicians with confirmation of the degree of aneurysm occlusion via one or more medical imaging techniques. As described in more detail below, the visual indicators may include specific variations in the shape of all or part of the occlusion member 102, specific variations in the relative positions of one or more radiopaque markers on the occlusion member 102 and / or delivery system (e.g., conduit 116), specific variations in the shape of the embolic element 230, etc.

[0494] Although the following discussion is for reference Figure 4A The two-dimensional image shown in –5B is used, but the system and method of this technique can be used with three-dimensional imaging techniques. Furthermore, Figure 4A-5BThis represents a two-dimensional image in which only the aneurysm slice (and the device therein) is visible. Although in some cases the inner and outer layers of the occlusion member 102 (where such layers are present) can be distinguished from each other in a radiographic image, in this example, these layers appear as a single thick layer. As used herein, “correct deployment” or “successful deployment” can refer to (a) the aneurysm A being completely (e.g., greater than 80%) or substantially completely (e.g., greater than 50%) filled with the occlusion element 230, (b) the occlusion member 102 being completely or substantially completely reversed or collapsed onto itself above the neck N of the aneurysm A, or both.

[0495] The occlusion member 102 may include one or more non-transmissive markings, such as Figure 4A – Markers 402, 404, 406, and 114 (collectively referred to as “marker 401”) are shown in –4C. Marker 401 may be arranged in a specific spatial arrangement around occlusion member 102 such that the relative movement of the marks indicates the degree of deployment stage of occlusion member 102 and / or embolization element 230. Marker 401 may be positioned at any location along occlusion member 102. For example, occlusion member 102 may include one or more radiopaque marks 402 (only one shown for illustration) at or along its distal wall 132, one or more radiopaque marks 404 (only one shown for illustration) at or along its proximal wall 134, and one or more radiopaque marks 406 (only one shown for illustration) at or along the middle portion of the wall. Furthermore, connector 114 of occlusion member 102 may be radiopaque. Markers 401 may be positioned on one, some, or all of the layers of the occlusion member 102 (at least in embodiments where the occlusion member 102 includes multiple layers). In some embodiments, each mark 401 may include a radiopaque strip or clip attached to one or more struts, filaments, wires, etc., of the occlusion member 102. In some embodiments, each mark 401 may include a radiopaque material coated or otherwise incorporated into the wall of the occlusion member 102. Each mark 401 may have the same or different shapes, lengths, and / or profiles.

[0496] In some embodiments, in addition to having one or more markings 401, or instead of having one or more markings, the occlusion member 102 itself may be partially or entirely formed of a radiopaque material, such as one or more radiopaque wires. Figures 4A-4CIn the illustrated example, the occlusion member 102 is formed of a radiopaque material and also includes radiopaque markers 402, 404, and 406. The occlusion member 102 is formed of a plurality of drawn filled tube (“DFT”) wires, each including a core formed of a radiopaque material (e.g., platinum) surrounded by an outer non-radiopaque material (at least relative to the core material). Markers 402, 404, and 406 are formed entirely of radiopaque material and therefore have a higher density of radiopaque material. Therefore, markers 402, 404, and 406 appear darker than the occlusion member 102 in the image. In some embodiments, the occlusion member 102 may have a radiopaque linearity different from that of one or more of the markers 402, 404, and 406, such that the walls of the occlusion member 102 and the walls of the markers 406 can be distinguished from each other in the radiographic image. The walls of the occlusion member 102 may be more transparent or less radiopaque than one or more of the markers 402, 404, and 406.

[0497] In some embodiments, one or more components of the conveying system may include one or more radiopaque markers. For example, pipe 116 may include one or more radiopaque markers positioned along its length. Figures 4A-4C In the illustrated embodiment, the conduit 116 may include a radiopaque marker 400 located at or near its distal end. The conduit 116 may have one or more additional markers (not shown) located along its length, for example, along the length of the extension of the conduit 116 through the internal volume 130 of the closure member 102.

[0498] like Figure 4A As shown, when the occlusion member 102 is first deployed within the aneurysm (e.g., allowing self-expansion), the radiopaque markers 402, 404, and 406 of the occlusion member 102 will be in a first position relative to each other and to the radiopaque markers of the conduit 116. For example, when the occlusion member 102 is first deployed, markers 402 and 404 are separated by a first distance d1. As the embolization element 230 is delivered through the conduit 116 and into the aneurysm sac, the occlusion member 102 can deform, as previously described... Figure 3A-3G As described, this deformation can cause the radiopaque marker 401 carried by the occlusion member 102 to move relative to each other to a second position. For example, a physician can confirm the progress of deployment by observing that markers 402 and 404 are now separated by a distance d2. The radiopaque marker 401 can also move relative to the radiopaque marker 400 of the conduit 116, which may remain in the same or substantially the same position within the aneurysm. By comparing images of the radiopaque markers 400 and / or 401 in the first relative position and images of the radiopaque markers 400 and / or 401 in the second relative position, a clinician can visually confirm that the embolization element 230 has filled a certain percentage of the aneurysm A.

[0499] For example, according to some aspects of the present technology, confirmation that the aneurysm is adequately filled (i.e., 50% or more) can be indicated by moving one or more distal wall markers 402 to the vicinity of and / or contacting one or more proximal wall markers 404. Because the embolization element 230 applies substantially uniform pressure on the distal wall 132 and pushes downward toward the neck N as it fills the space between the occlusion member 102 and the aneurysm wall, moving one or more distal wall markers 402 to a position adjacent to the proximal wall markers 404 indicates to the physician that the aneurysm A is substantially filled (e.g., 50% or more) by the embolization element 230. This relative positioning also indicates that the distal wall 132 now provides additional occlusion at the neck N of the aneurysm and that the occlusion member 102 is in its second expanded shape. In some embodiments, instead of one or more proximal markers 404, or in addition to these proximal markers, the connector 114 may also be used as a proximal indicator.

[0500] In some embodiments, confirmation that the aneurysm is adequately filled (i.e., 50% or more) can be indicated by moving one or more distal wall markers 402 away from the conduit marker 400 (or a marker fixed to another component of the delivery system) by a predetermined distance. For example, when the occlusion member 102 is in a first dilated state or shape ( Figure 4A In the second expansion state or shape ( ), the distal wall mark 402 may be adjacent to the pipe mark 400. Figure 4C In this configuration, the distal wall marker 402 may be separated from the conduit marker 400 by a distance approximately equal to the distance D in the dilated state when the occlusion member 102 was initially positioned within the aneurysm A. As explained above, this relative positioning of one or more distal wall markers 402 and conduit markers 400 indicates to the physician that the aneurysm A is substantially filled with the embolic element 230 (e.g., 50% or more). This relative positioning also indicates that the distal wall 132 now provides additional occlusion at the neck N of the aneurysm and that the occlusion member 102 is in its second dilated shape.

[0501] In some embodiments, one or more intermediate marks 406 may be used to confirm and / or monitor deployment. For example, one or more intermediate marks 406 may be positioned at or near the desired reversal plane of the occluder member 102. In this example, using an occluder member 102 that is deformed into a bowl shape and is approximately spherical, the reversal plane is located at or near the centerline of the occluder member 102 in its expanded state. This is because, in the fully reversed state, the distal half of the occluder member 102 will be located within / fitted with the proximal half of the occluder member 102 (e.g., ...). Figure 4C (As shown). Therefore, the centerline of the occlusion member 102 is the desired reversal plane. The occlusion member 102 can be non-transmissive (e.g., Figures 4A-4C(as shown), but to a lesser degree than intermediate mark 406, so that the wall of occluder 102 and mark 406 can be distinguished from each other in the radiographic image. Therefore, the top edge 136 of occluder 102 is shown. Figure 4C An image adjacent to or at the intermediate marker 406 can indicate that aneurysm A is substantially filled with embolic element 230 (e.g., 50% or more). This relative positioning also indicates that the distal wall 132 now provides additional occlusion at the neck N of the aneurysm and that the occlusion member 102 is in its second dilated shape.

[0502] Shape changes of the occlusion member 102 and / or positional changes of different portions of the occlusion member 102 relative to each other can also indicate appropriate deployment. As discussed earlier, the occlusion member 102 presents a first expanded shape upon initial deployment and has a second expanded shape after deformation by the embolic element 230. In some embodiments, the second expanded shape represents a partial or complete reversal from the first expanded shape, which can be confirmed by observing the changed contour of the occlusion member 102 in a radiographic image. For example, in this example where the occlusion member 102 has a generally spherical first expanded state, a C-shaped image is shown (e.g., Figure 4C (As shown in the image) can indicate that the desired filling and / or deployment has been completed. In the 3D image, the second expansion shape may have a bowl shape. In some embodiments, confirmation of complete or substantially complete deployment can be indicated by the distal sidewall 500 within a predetermined distance of the proximal sidewall 502.

[0503] In some embodiments, appropriate deployment can be confirmed by observing the distance between the inverted wall (here, distal wall 132) and the relatively stationary wall (here, proximal wall 134). Figure 4C As shown, when the distal wall 132 collapses downward onto or near the proximal wall 134, the occlusion member 102 appears in the image to have twice the thickness in the proximal portion. Furthermore, as the occlusion member 102 is reversed, the density of the radiopaque material doubles, so the doubled portion of the occlusion member 102 appears darker in the image.

[0504] like Figure 5A and 5B As shown, in some embodiments, certain portions of the occlusion member 102 may be coated with a radiopaque material, such that variations in the shape or orientation of these portions indicate the desired location of the occlusion member 102. For example, as Figure 5AAs shown, the distal half 500 of the occlusion member 102 may be coated with a radiopaque material, while the proximal half 502 may be uncoated or otherwise less radiopaque than the distal half 500. Therefore, confirmation of complete or substantially complete deployment can be indicated by the adjacency of the less radiopaque distal wall 500 to the proximal wall 502. For example, confirmation of complete or substantially complete deployment can be indicated by the distal wall 500 being within a predetermined distance of the proximal wall 502. Confirmation can also be obtained from the change in shape of the distal wall 500 from flat or convex (towards a dome) to concave.

[0505] The shape of the embolic element 230 can also provide an indication of deployment progress. For example, the shape of the lower portion (closer to the neck N) of aneurysm A can indicate the extent to which the aneurysm is filled by the embolic element 230 and / or the degree of deformation of the occlusion member 102. Since most aneurysms have a generally spherical or globular shape, the lower boundary of the embolic element 230 may have a radius of curvature that decreases as more is injected and more occlusion members 102 are reversed. For example, in Figure 4B In this configuration, when aneurysm A is partially filled with embolic element 230 and occlusion member 102 only partially collapses or reverses, the distal wall 132 has a first radius of curvature. Figure 4C In the case where the aneurysm A is substantially or completely filled, the radius of curvature of the distal wall 132 is smaller than the radius of curvature of the distal wall 132 in the partially deformed state.

[0506] Additionally or alternatively, the extent of deployment of the occlusion member 102 and / or the degree of filling of the aneurysm A can be further determined by injecting contrast agent into the parent vessel and imaging the aneurysm to determine how much contrast agent enters the aneurysm cavity. Shape

[0507] The apparatus, system, and method of this technique can be particularly advantageous compared to conventional apparatus used for two-dimensional imaging. In two-dimensional imaging (e.g., fluoroscopy), the image may only reflect a slice or orthographic view of the aneurysm (and the device or material within it). Therefore, any voids or gaps in the filling may not be apparent in the slice because the image slice does not cross-section the voids within the aneurysm A, or the cross-section or orthographic view of the stagnant area may present different shapes depending on how the image is viewed. The physician may have to take multiple images to determine the overall amount of filling in the aneurysm. In contrast, the occlusion member 102 of this technique has a unique shape that dynamically adjusts to introduce the embolization element 230 in a predictable and measurable manner, indicating the degree of filling of the embolization element 230 in a single two-dimensional radiograph.

[0508] The apparatus, systems, and methods disclosed herein include using one, some, or all of the methods disclosed above to confirm and / or observe various stages of system deployment in aneurysms, including complete or substantially complete deployment.

[0509] IV. Selected Embodiments

[0510] Figure 6 The distal portion of a treatment system 600 for treating aneurysms according to the present technology is shown. The treatment system 600 may be part of a system that also includes an embolization kit (not shown). The embolization kit may be substantially the same as the embolization kit 200 described above. Figure 6 As shown, the treatment system 600 may include an occlusion member 602 (shown in an expanded state) detachably coupled to a delivery system, and the delivery system may be configured to position the occlusion member 602 intravascularly within the aneurysm. In some embodiments, the treatment system 600 may be configured to deliver an embolic element (and / or one or more precursors thereof) to the aneurysm. Additionally or alternatively, the system may include a separate delivery system (not shown) for delivering the embolic element (and / or one or more precursors thereof) into the aneurysm lumen.

[0511] Similar to treatment system 100, treatment system 600 has a proximal portion (not shown) and a distal portion 600b, the proximal portion being configured for external positioning during treatment, and the distal portion being configured for intravascular positioning within a blood vessel (e.g., an intracranial vessel) at or near the treatment site of the aneurysm. Treatment system 600 may include a handle at the proximal portion, an occlusion member 602 at the distal portion 600b, and a plurality of elongated shafts or members extending between the proximal and distal portions. In some embodiments, for example... Figure 6 As shown, the treatment system 600 may include a first elongated shaft (e.g., a guiding catheter or balloon guiding catheter) (not shown), a second elongated shaft 108 (e.g., a microcatheter) configured to be slidably disposed within the lumen of the first elongated shaft, and an elongated member 616 configured to be slidably disposed within the lumen of the second elongated shaft 108. The elongated member 616 also serves as the conduit, compared to the delivery system of the treatment system 100. Therefore, the treatment system 600 does not include a separate elongated member 616 and conduit. In some embodiments, the treatment system 600 omits the first elongated shaft and includes only the second elongated shaft 108.

[0512] The distal end of the occlusion member 602 may be detachably coupled to the distal end of the elongated member 616. For example, the elongated member 616 may include a first connector 612 at its distal end, and the occlusion member 602 may include a second connector 614 configured to be detachably coupled to the first connector 612. The elongated member 616 may be configured to deliver an embolic element (and / or one or more precursors thereof) through one or more components of the delivery system (e.g., a first or second elongated shaft 109, 108) to a location outside the occlusion member 602. Thus, the embolic element may be positioned between the occlusion member 102 and the inner wall of the aneurysm lumen, as described in more detail below.

[0513] According to some embodiments, the second elongated shaft 108 is typically configured to follow and enter brain-associated blood vessels above a conventional guidewire in the neck anatomy, and can also be selected according to several standard designs commonly available. Thus, the second elongated shaft 108 can have a length of at least 125 cm, and more specifically, a length between about 125 cm and about 175 cm. In some embodiments, the second elongated shaft 108 can have an inner diameter of about 0.015 inches (0.0381 cm), 0.017 inches (0.043 cm), about 0.021 inches (0.053 cm), or about 0.027 inches (0.069 cm). Other designs and sizes are contemplated.

[0514] The elongated member 616 is movable within a first and / or second elongated axis to position the occlusion member 602 in a desired location. The elongated member 616 may have sufficient flexibility to allow manipulation of the occlusion member 602 through a tortuous channel, such as forward and / or retraction. The tortuous channel may include, for example, a catheter lumen, a microcatheter lumen, a blood vessel, a urinary tract, a biliary tract, and an airway. The elongated member 616 may be formed of any material and size suitable for the task to which the system is to be used. In some embodiments, the elongated member 616 may include any other suitable form of axis, such as an elongated tubular axis.

[0515] In some embodiments, the elongated member 616 may comprise stainless steel, nitinol, cobalt-chromium alloy, or other metals or alloys. In some embodiments, the elongated member 616 may be coated with, for example, polytetrafluoroethylene along part or all of its length. The elongated member 616 may have a diameter that is substantially constant along its length, or the elongated member 616 may have a diameter that tapers radially inward along at least a portion of its length as it extends in the distal direction.

[0516] C. Examples of Selected Blocking Components

[0517] Still referencing Figure 5A , Figure 5B The occlusion member 602 may include an expandable element that has a small profile or a constrained state when positioned within a catheter (e.g., a second elongated shaft 108) for delivery to the aneurysm, and an expanded state configured to be positioned within the aneurysm (e.g., a cerebral aneurysm). According to some embodiments, the occlusion member 602 may include a mesh formed of multiple braided filaments that have been heat-set to present a predetermined shape surrounding the internal volume 130 when in an expanded, unconstrained state. Example shapes include spherical shapes, such as spheres, elongated spheres, oblate spheroids, etc. Figure 6As shown in the cross-sectional view, the mesh may have inner and outer layers 622, 624, having distal ends fixed relative to each other at the second connector 614 and meeting distally at a proximal fold 628 surrounding the proximal hole 626. Although the inner and outer layers 622, 624 are depicted as spaced apart from each other along their length, they may contact each other along all or part of their length. For example, the inner layer 622 may be radially outwardly pressed against the outer layer 624. In some embodiments, the closure member 602 may be formed of a single layer or a mesh or braid.

[0518] The elongated shaft 616 may be configured to be slidably positioned through some or all of the second connector 614, the internal volume 130 of the expanded mesh, and the opening 626. Because the occluding member 602 is coupled to the elongated shaft 616 at its distal end (e.g., via the first and second connectors 612, 614), axial movement of the elongated shaft 616 results in axial movement of at least the distal portion of the occluding member 602. The proximal portion of the occluding member 602 remains free to slide along the elongated shaft 616 through the proximal aperture 626. In some embodiments, when the occluding member 602 is loaded in the elongated member 616, the occluding member 602 is positioned about the elongated member 616 between the elongated member 616 and the second elongated shaft 108.

[0519] Inner and outer layers 622 and 624 may be in the distal portion (e.g., as shown in the image). Figure 5A (As shown) They conform to each other to form a curved distal surface. For example, at least in the distal portion of the occlusion member 602, the inner and outer layers 622 and 624 may extend distally and radially inward toward the aperture 626. In some embodiments, the outer and / or inner layers 622 and 624 extend distally and radially outward from the fold 628 at the aperture 626, then distally and radially inward to the ridge, and then proximally to the second connector 614 to form a pawl or recess 604 at the distal end of the occlusion member 602. For example, the distal surface of the occlusion member 602 may be recessed toward the dome of the aneurysm. The distal recess 604 may facilitate delivery of the embolic element 230 because it creates a small gap between the distal surface of the occlusion member 602 and the dome of the aneurysm A (see, for example...). Figure 7B ).

[0520] The occlusion member 602 and / or its layers may be curved along its entire length, or may have one or more generally straight portions. In some embodiments, the curved surface transitions to a flat or substantially flat distal surface surrounding the orifice 626. In some embodiments, the curved surface transitions to the distal surface surrounding the orifice 626 and has a radius of curvature greater than the average radius of curvature of the remainder of the occlusion member 602. Having a flat or substantially flat distal surface, or a distal surface with a radius of curvature greater than the average radius of curvature of the remainder of the occlusion member 602, can facilitate the delivery of the embolic element 230 because it creates a small gap between the distal surface of the occlusion member 602 and the dome of the aneurysm A. In some embodiments, the surface of the occlusion member 602 surrounding the orifice 626 is curved and / or has a radius of curvature substantially the same as the remainder of the occlusion member 602.

[0521] In any case, the inner layer 624 may have a shape that substantially conforms to the shape of the outer layer 624, or the inner layer 622 and the outer layer 624 may have different shapes. For example, the inner layer 622 may have a smaller diameter or cross-sectional dimension than the outer layer 624 (e.g., as shown in the image). Figure 1D (As shown). Such a configuration may be beneficial because the embolic element 230 experiences less resistance, at least initially, when pushing the distal wall of the occlusion member 602 downward toward the neck (as described in more detail below).

[0522] In any case, the proximal and distal portions of the net can form a generally closed surface. However, unlike the second connector 614 on the distal portion of the net, the portions of the filaments located at or near the fold 628 on the proximal portion of the net can move relative to each other. Thus, the distal portion of the net has the characteristics of a closed end and also some characteristics of an open end (such as a conventional support), such as some degrees of freedom of movement of the proximal portion of the filament and the opening through which the elongated shaft 616, guide wire, conduit, or other elongated member can pass.

[0523] In some embodiments, each of the plurality of filaments has a first end located on the distal portion of the net and a second end also located on the distal portion of the net (e.g., at the second connector 614). Each filament may extend distally from its corresponding first end to a ridge, then proximally along the body of the net to a fold 628, reverse, then extend distally along the body of the net to a ridge, then proximally to its corresponding second end at the distal portion of the net. Thus, each of the plurality of filaments has a first length forming an inner layer 622 of the net, a second length forming an outer layer 624 of the net, and both the first and second ends are secured to the distal portion of the net. In some embodiments, the closure member 602 may comprise a net formed of a single layer, or a net formed of three or more layers.

[0524] In some embodiments, the proximal and / or distal surfaces of the mesh are completely closed (i.e., without pores). In some embodiments, the filaments are fixed relative to both the proximal and distal ends of the closure member 602, and the elongated member 616 is configured to be slidably disposed through each of the proximal and distal hubs.

[0525] In some embodiments, the occlusion member 602 and / or the mesh may include a preferential bending region 604, at which the occlusion member 602 and / or the mesh are configured to preferentially bend or flex when subjected to a counterforce (e.g., a force applied by the occlusion element 230, as described in more detail below). The bending region 604 may form a continuous band around the circumference of the occlusion member 602, or it may be located at selected locations around the circumference of the occlusion member 602, all at substantially the same axial location along the mesh. In those embodiments where the occlusion member 602 comprises multiple layers, no layers, some or all of the layers may include the bending region 604. The bending region 604 may include, for example, a thinner portion of the mesh, which is generally weaker than the surrounding portions and therefore more likely to bend under stress. The bending region 604 may also be formed by thermally fixing the mesh in an inverted or collapsed state such that the mesh preferentially inverts at a desired level.

[0526] The mesh forming the occlusion member 602 can be made of metal wire, polymer wire, or both, and the wire can have shape memory and / or hyperelastic properties. The mesh can be formed from 24, 32, 36, 48, 64, 72, 96, 128, or 144 filaments. The mesh can be formed from a range of filament or wire sizes, such as wires with diameters from about 0.0004 inches to about 0.0020 inches, or from about 0.0009 inches to about 0.0012 inches. In some embodiments, each of the threads or filaments has a diameter of approximately 0.0004 inches, approximately 0.0005 inches, approximately 0.0006 inches, approximately 0.0007 inches, approximately 0.0008 inches, approximately 0.0009 inches, approximately 0.001 inches, approximately 0.0011 inches, approximately 0.0012 inches, approximately 0.0013 inches, approximately 0.0014 inches, approximately 0.0015 inches, approximately 0.0016 inches, approximately 0.0017 inches, approximately 0.0018 inches, approximately 0.0019 inches, or approximately 0.0020 inches. In some embodiments, all the filaments in the braid may have the same diameter. For example, in some embodiments, all the filaments have a diameter of approximately 0.001 inches. In some embodiments, some of the filaments may have different cross-sectional diameters. For example, some filaments may have a slightly thicker diameter to give the braided layer additional strength. In some embodiments, some of the filaments may have a diameter of about 0.001 inches, and some of the filaments may have a diameter greater than 0.001 inches. Thicker filaments can impart greater strength to the braid without significantly increasing the delivery profile of the device, where finer threads provide some strength while filling the matrix density of the braid.

[0527] The occlusion member 602 can have different shapes and sizes in an expanded, unrestrained state. For example, the occlusion member 602 can be bullet-shaped, barrel-shaped, egg-shaped, top-shaped, bowl-shaped, disc-shaped, cylindrical, or approximately cylindrical, barrel-shaped, chalice-shaped, etc.

[0528] D. Selected Examples of Embolization Kits

[0529] and Figure 6-7J The embolization kit used with the treatment system shown is substantially similar to the embolization kit 200 described above.

[0530] E. Selected deployment method

[0531] Figures 7A-7J An example method for treating aneurysms using the treatment system of this technology is described. First, with the occlusion member 602 in a low profile, the physician advances the second elongated axis 108 intravascularly toward the intracranial aneurysm (or any other treatment location such as those described herein). Figure 7AAs shown, the second elongated shaft 108 can be positioned at or just near the neck. Optionally, the distal portion of the second elongated shaft 108 can be advanced through the neck N of the aneurysm A to position the distal opening of the second elongated shaft 108 within the lumen of the aneurysm A. In either case, the elongated member 616 can be advanced distally through the neck N and into the aneurysm lumen (if not already in the aneurysm lumen), thereby pulling the distal end of the occlusion member 602. When the occlusion member 602 is released from its constrained state within the second elongated shaft 108, the occlusion member 602 expands toward a first expansion state, as... Figure 7B As shown. In the first expanded state, the occlusion member 602 can take on a predetermined shape that surrounds the internal volume 130. In this first expanded state, the occlusion member 602 can substantially conform to the shape of the aneurysm A.

[0532] Before delivering the embolic agent 230, the physician can pull the elongated member 616 proximally to check the location of the occlusion member 602 within the aneurysm A. For example... Figure 7B and 7C As shown, for example, the elongated member 616 can be pulled proximally to force the distal wall toward the neck N and proximal wall. Due to the bend region 603, the occlusion member 602 can preferentially fold and form a distal edge at the bend region 603. The ability to examine the position of the occlusion member 602 in its collapsed state before delivering the embolization element 230 can be beneficial, especially in wide-necked aneurysms, because the initial pathway into the aneurysm may be too steep for the distal edge 136 (see [reference needed]) to be visible once the occlusion member 602 has completely collapsed or reversed. Figure 7C The occlusion member 602 may be located near or aligned with the neck of aneurysm A. In those cases, the occlusion member 602 may not fully cover the neck N and therefore may not be adequately anchored in aneurysm A. It should be understood that even in embodiments where the occlusion member 602 does not have a curved region 603, the elongated member 616 may be used to check the positioning of the occlusion member 602.

[0533] like Figure 7D-7H As shown, the embolization element 230 can be delivered via an elongated member 616 into the space between the occlusion member 602 and the inner surface of the aneurysm wall W. In some embodiments, the method includes mixing first and second precursor materials 203, 205 ( Figure 2To form an embolic element 230. The mixing of the first and second precursor materials 203, 205 can occur before the embolic element 230 is introduced into the treatment system 100 and / or during delivery of the embolic element to the aneurysm via the elongated member 616. In a particular example, the first precursor material 203 is loaded into one cylinder 214, the second precursor material 205 is loaded into another cylinder 214, and the mixing syringe 208 is connected via a connector 210. To mix the first and second precursor materials 203, 205, the plunger 212 is alternately pressed, causing the first and second precursor materials 203, 205 to repeatedly move from one cylinder 214 to another cylinder 214. After the precursor materials are properly mixed, the resulting embolic element 230 can be loaded into the cylinder 220 of the syringe 216. The syringe 216 can then be connected to the proximal end of the elongated member 616 to deliver the embolic element 230 to the aneurysm A via the elongated member 616. As the embolic element 230 passes through the lumen of the elongated member 616, the chemical cross-linking of the biopolymer can continue to occur.

[0534] Still referencing Figure 7D –7H, when the embolic element 230 is delivered between the dome of the aneurysm A and the distal portion of the wall of the occlusion member 602, pressure is established between the aneurysm wall W and the occlusion member 602. When the force on the occlusion member 602 reaches a threshold level, the embolic element 230 pushes the distal wall downward toward the neck N of the aneurysm A. If desired, the elongated member 616 can be pulled proximally during and / or between different injections of the embolic element 230, which facilitates the reversal of the occlusion member 602.

[0535] As detailed above, the embolic element 230 applies substantially uniform pressure to the distal surface of the occlusion member 602, causing the occlusion member 602 to collapse inward on itself (with or without the aid of the elongated member 616). The pressure and the reversal of the distal portion of the wall create an annular fold 136 that defines the distal edge of the occlusion member 602. As the occlusion member 602 continues to reverse, the position of the fold moves toward the neck N, continuing until the distal half of the occlusion member 602 has reversed. Furthermore, as the occlusion member 602 collapses, the distance between the walls of the distal and proximal portions decreases, thus reducing the internal volume 130 of the occlusion member 602. As the occlusion member 602 collapses, the elongated member 616 can remain stationary, advance distally, and / or retract proximally.

[0536] During and after the delivery of the embolic element 230, no or substantially no embolic element 230 migrates through the orifice of the occlusion member 602 and into the internal volume 130. In other words, all or substantially all of the embolic element 230 remains on the outer surface or exterior of the occlusion member 602. The compression of the occlusion member by the embolic element 230 provides the physician with a real-time “flattening” or “aneurysm filling indicator” under single-plane imaging methods (e.g., fluoroscopy) so that the physician can confirm at what point the aneurysm is completely filled. (See above reference) Figure 4A-5B Additional details are described regarding the devices, systems, and methods used for monitoring and / or confirming deployment. Filling as much space as possible within the aneurysm is beneficial, as leaving gaps within the aneurysm sac can lead to delayed healing and an increased risk of aneurysm recanalization and / or rupture. While the cross-neck stent provided by the occlusion member 602 facilitates blood thrombosis in any gaps and neck healing, essential lumen filling prevents acute rupture and is independent of the neck stent (i.e., occlusion member 602). Conventional devices cannot confirm complete or near-complete aneurysm filling on monoplane imaging.

[0537] Once the delivery of the embolic element 230 is complete, the elongated member 616 can be withdrawn. In some embodiments, the embolic element 230 may fill greater than 40% of the aneurysm sac volume. In some embodiments, the embolic element 230 may fill greater than 50% of the aneurysm sac volume. In some embodiments, the embolic element 230 may fill greater than 60% of the aneurysm sac volume. In some embodiments, the embolic element may fill greater than 65%, 70%, 75%, 80%, 85%, or 90% of the aneurysm sac volume.

[0538] Figure 7I The second expanded state of the occlusion member 602 is shown in cross-section, where the embolization element 230 occupies the remaining volume of the aneurysm A. As shown, the embolization element 230 can be delivered until the occlusion member 602 completely collapses so that the occlusion member 602 has essentially no internal volume. In the second expanded state, the occlusion member 602 can form a bowl shape extending through the neck of the aneurysm A. The wall of the occlusion member 602 in the distal portion can now be positioned to contact or be adjacent to the wall of the occlusion member 602 in the proximal portion. In some cases, due to the presence of the second connector 614, a small gap can be maintained between portions of the distal and proximal walls when the occlusion member 602 is in its second or folded state.

[0539] Collapse of the occlusion member 602 itself toward the neck N of the aneurysm can be particularly beneficial, as it doubles the number of layers passing through the neck and thus increases occlusion at the neck N. For example, collapse or inversion of the distal wall 132 on the proximal wall can reduce the porosity of the occlusion member 602 at the neck N. In those embodiments where the occlusion member 602 is a mesh or braided device such that the distal wall has a first porosity and the proximal wall has a second porosity, deformation of the distal wall on or immediately adjacent to the proximal wall reduces the effective porosity of the occlusion member 602 at the neck N. The resulting multilayer structure has lower porosity than the first and second porosities alone. Furthermore, the embolization element 230 along the distal wall provides additional occlusion. In some embodiments, the embolization element 230 completely or substantially completely blocks the pores of adjacent layers or walls of the occlusion member 602, preventing blood from flowing through the embolization element 230 into the aneurysm lumen. It is desirable to block the aneurysm as much as possible, as leaving gaps allows blood to flow in and / or pool, which may continue to stretch the wall of the aneurysm A. Dilation of aneurysm A could lead to recanalization and / or occlusion component 602 and / or embolization component 230 entering the parent vessel and / or could cause rupture of aneurysm A. Both of these situations can be fatal to the patient.

[0540] In embodiments where the wall of the occlusion member 602 comprises an inner and an outer layer, the modified or second shape of the occlusion member 602 forms four layers at the neck N of the aneurysm A. In embodiments where the wall of the occlusion member 602 comprises a single layer, the modified or second shape of the occlusion member 602 forms two layers at the neck N of the aneurysm A. As previously described, the neck cover provided by the double layer provides additional surface area for endothelial cell growth, reduces the porosity of the occlusion member 602 at the neck N (compared to two or one layer), and prevents the embolic element 230 from protruding into the carrier vessel. During and after delivery, the embolic element 230 applies substantially uniform pressure on the occlusion member 602 toward the neck N of the aneurysm A, thereby pressing a portion of the occlusion member 602 located adjacent to the neck against the inner surface of the aneurysm wall, such that the occlusion member 602 forms a complete and stable seal at the neck N.

[0541] In some embodiments, the elongated member 616 can be moved proximally and distally to move the distal wall of the occlusion member 602 to redistribute the embolic element 230 around the occlusion member 602 and the aneurysm wall. As a result, the occlusion member 602 will be locked and prevented from migrating after treatment. In this case, the occlusion member 602 may not need to completely fill the sac.

[0542] like Figure 7I As shown in –7J, the first connector 612 can be separated from the second connector 614 and the elongated member 616 and the second elongated shaft 108 can be retracted, thereby allowing the occlusion member 602 and the embolization element 230 to be implanted into the aneurysm A.

[0543] Over time, natural vascular remodeling mechanisms and / or bioresorption of the occlusive element 230 can lead to thrombus formation and / or the transformation of trapped thrombus into fibrous tissue within the internal volume of aneurysm A. These mechanisms can also result in cell death at the aneurysm wall and the growth of new endothelial cells between and on top of the filaments or struts of the occlusion device 602. Ultimately, the thrombus and cells on the aneurysm wall can be completely degraded, leaving a successfully remodeled vascular area.

[0544] In some embodiments, the contrast agent may be delivered during the advancement of the occlusion member 602 and / or the embolization element 230 in the vascular system, during the deployment of the occlusion member 602 and / or the embolization element 230 at the aneurysm A, and / or after the deployment of the occlusion member 602 and / or the embolization element 230 but before the start of withdrawal from the delivery system. The contrast agent may be delivered via the second elongated shaft 108, the elongated member 616, or via another catheter or device typically used for delivering contrast agents. The aneurysm (and the device therein) may be imaged before, during, and / or after the injection of the contrast agent, and the images may be compared to confirm the degree of occlusion of the aneurysm.

[0545] V. Example systems with electrolytic separation mechanisms

[0546] A. Separation of core wires via electrolytic corrosion

[0547] Figure 8A A schematic side view of the treatment system 800 is shown, while Figure 8B It shows Figure 8A The diagram shows a side sectional view of the distal portion of the treatment system 800, where the occlusion member delivery assembly is omitted for clarity. As described in more detail below, the treatment system 800 may include an occlusion member delivery assembly 810 and an embolic element delivery assembly 850, which can be coupled together via one or more connectors 880. In operation, the occlusion member delivery assembly 810 facilitates the placement of the occlusion member 102 at the treatment site and the release of the occlusion member 102 from its delivery assembly 810 using electrolytic separation. The embolic element delivery assembly 850, which may extend adjacent to and substantially parallel to a portion or all of the length of the occlusion element delivery assembly 810, facilitates the delivery of the embolic element 230 (…). Figure 2-3G It is introduced through it to be placed on the treatment site.

[0548] The occlusion member delivery assembly 810 includes an occlusion member 102 coupled to the distal end of the elongated member 106. In some embodiments, the elongated member 106 may be in the form of an electrolytically etchable core wire 812, which may be a single piece or composed of multiple separate components joined together. According to some embodiments, such as Figure 8A and 8BAs shown, the electrolytically etchable core wire 812 includes a proximal portion 814, a distal portion 816, and a separation region 818 disposed between the proximal portion 814 and the distal portion 816. At least a portion of the core wire 812, including the separation region 818, may be coated with a conductive material, such as carbon, gold, platinum, tantalum, combinations thereof, etc. One or more metallic coatings may be applied using known electroplating techniques.

[0549] The core wire 812, including the separation region 818, may comprise one or more of the following materials: ceramic materials, plastics, base metals or alloys thereof, and preferably stainless steel. Some of the most suitable combinations of materials for forming electrolytic corrosion points may include one or more of the following: stainless steel, preferably AISI 301, 304, 316 types or subgroups thereof; Ti or TiNi alloys; cobalt-based alloys; noble metals; or noble metal alloys, such as Pt, Pt metal, Pt alloys, Au alloys, or Sn alloys. Furthermore, the ceramic materials and plastics used to form the medical device may be conductive.

[0550] According to some embodiments, a portion of the core wire 812 may be coated with a non-conductive material. A proximal insulation layer 820 may be disposed on at least a portion of the outer surface of the proximal portion 814 of the core wire 812. For example, the proximal insulation layer 820 may circumferentially surround the outer surface of the proximal portion 814. A distal insulation layer 822 may be provided on at least a portion of the outer surface of the distal portion 816 of the core wire 812. For example, the distal insulation layer 822 may circumferentially surround and contact the outer surface of the distal portion 816. The proximal and distal insulation layers 820, 822 may be non-conductive or insulating polymers, such as polyimide, polypropylene, polyolefin, combinations thereof, etc.

[0551] According to some embodiments, the proximal and distal insulation layers 820, 822 expose the separation region 818 of the core wire 812. When in contact with a bodily fluid such as blood, this fluid acts as an electrolyte, allowing current to concentrate on the uncoated separation region 818. The proximal and distal insulation layers 820, 822 prevent the proximal portion 814 and the distal portion 816 from being exposed to the fluid. Therefore, electrical energy conducted along the core wire 812 is concentrated in the separation region 818, thereby reducing the time required to corrode the separation region 818. The proximal and distal insulation layers 820, 822 can be overmolded, co-extruded, sprayed, or dip-coated relative to the core wire 812.

[0552] Laser ablation can be used to selectively remove coatings to a controlled length, thereby minimizing the time required to corrode the component. Lengths as small as 0.0005" and as large as 0.1" or longer can be removed. According to some embodiments, the length of the separation zone 818 can be greater than 0.005" and / or less than 0.010" to provide sufficient exposure to achieve a separation time of less than 30 seconds. In some embodiments, the separation zone 818 can have a smaller cross-sectional profile or outer diameter than the proximal and / or distal portions 814, 816. In some embodiments, the separation zone 818 can include additional or alternative material to facilitate electrolytic corrosion of the zone.

[0553] According to some embodiments, a distal insulation layer 822 is radially disposed between the distal portion 816 of the core wire 812 and the hub 824 of the closure member 102. For example... Figure 8B As shown, the inner band 826 of the hub 824 circumferentially surrounds and contacts the distal insulating layer 822. The outer band 828 surrounds the inner band 826 such that the proximal portion of the layer of the occlusion member 102 is sandwiched between the inner band 826 and the outer band 828 of the hub 824.

[0554] like Figure 8B As shown, the distal insulating layer 822 electrically isolates the blocking member 102 from the charge conducted along the length of the core wire 812. The proximal end of the distal insulating layer 822 can be positioned proximal to the hub 824, and the distal end of the distal insulating layer 822 can be positioned distal to the hub 824. Similarly, the proximal end of the distal portion 816 can be positioned proximal to the hub 824, and the distal end of the distal portion 816 can be positioned distal to the hub 824, such that the distal portion 816 extends through the cavity formed by the hub 824 and distally beyond the cavity.

[0555] The core wire 812 may include an anchoring end 830 at its distal end. The anchoring end 830 may be located distal to the hub 824. For example, the anchoring end 830 may be located inside the occlusion member 102. The anchoring end 830 may have a maximum cross-sectional dimension larger than the inner cross-sectional dimension of the inner strip 826. This prevents the core wire 812 from moving proximally completely through the inner strip 826. For example, the interface between the distal insulation layer 822 and the inner strip 826, or the interface between the distal insulation layer 822 and the core wire 812, may allow the core wire 812 to move to a certain extent relative to the inner strip 826. To prevent the core wire 812 from being removed distally from within the inner strip 826, the anchoring end 27 may have a dimension that prevents it from completely proximally passing through the inner strip 826.

[0556] Optionally, the proximal end of the distal insulating layer 822 may be connected to the proximal end of the hub 824, and / or the distal end of the distal insulating layer 822 may be connected to the distal end of the hub 824. Similarly, the proximal end of the distal portion 816 may be connected to the proximal end of the hub 824, and / or the distal end of the distal portion 816 may be connected to the distal end of the hub 824.

[0557] According to some embodiments, the separation region 818 can be configured such that its corrosive portion defines a unique structure configured to enhance electrolytic corrosion while maintaining its structural characteristics. Reduced corrosion resistance will decrease the time required to deploy intravascular and / or intracapsular implants, thereby reducing overall procedure time. According to some embodiments, the corrosion resistance of the separation region 818 is reduced by exposure to laser or other energy, resulting in a thermally modified structure of the separation region 818. As a result, the separation region 818 will have a microstructure different from that of the material outside the region (e.g., the proximal portion 814 and / or distal portion 816 of the core wire 812). This will reduce the time required for electrolytic plating of the material, thereby accelerating the separation time.

[0558] Laser energy can create surface defects, thereby reducing corrosion resistance. Laser energy can also alter the microstructure of specific regions, leading to uneven corrosion rates. Therefore, preferred corrosion sites can have faster separation times. According to some embodiments, the proximal portion 814 and / or the distal portion 816 have microstructures with a higher degree of crystallinity than the microstructure of the separation region 818. According to some embodiments, the separation region 818 includes microstructures that are more amorphous than each of the microstructures of (i) the proximal portion 814 and (ii) the distal portion 816. According to some embodiments, the treatment method includes providing an electrolytically etchable core wire 812 comprising a proximal portion 814, a distal portion 816, and a separation region 818 between the proximal portion 814 and the distal portion 816. The separation region 818 is processed to create microstructures in the separation region 818 that are more amorphous than each of the microstructures of (i) the proximal portion 814 and (ii) the distal portion 816.

[0559] like Figure 8AAs shown, the embolic element delivery assembly 850 may extend adjacent to the occlusion member delivery assembly 810. In some embodiments, the embolic element delivery assembly 850 includes a conduit 852 defining a lumen 854 extending therethrough. The lumen 854 may terminate at a distal opening 856. In some embodiments, the conduit 852 may be an elongated, flexible tubular member, such as a catheter, a thiourea tube, a polymer tube, etc. The lumen 854 may be coated with a lubricating material or lined to facilitate the passage of the embolic element therethrough. In some embodiments, the conduit 852 is sized such that the distal opening 856 is located near, entirely distal to, or at least partially distal to the occlusion member 102, while the occlusion member 102 is in an unexpanded state. In some embodiments, the conduit 852 is sized and configured such that the distal opening 856 is located distal to the hub 824 of the occlusion member 102, such that an embolic element delivered therethrough can be delivered to a region adjacent to or distal to the occlusion member 102.

[0560] like Figure 8A As shown, the conduit 852 and its lumen 854 may each have cross-sectional dimensions that vary along the length of the conduit 852. For example, the conduit 852 may include a proximal portion 858, a distal portion 860, and a transition portion 862 between the proximal and distal portions 858, 860. In some embodiments, the proximal portion 858 has a larger cross-sectional dimension than the distal portion 860, and the transition portion 862 may have a tapered profile or diameter. In some embodiments, instead of or in addition to any tapering transition, the transition portion 862 may also include one or more steps or abrupt transitions. In the illustrated embodiment, the wall thickness of the conduit 852 is substantially uniform, such that the cross-sectional dimensions of the conduit 852 and the lumen 854 decrease in a stepwise manner. In some embodiments, the wall thickness may vary, for example, such that as the outer cross-sectional dimension of the conduit 852 decreases in a stepwise manner according to a first profile, the lumen 854 decreases in a stepwise manner according to a different profile (e.g., with more or less taper), or in some cases, the lumen 854 may be substantially uniform along its length. In some other embodiments, the conduit 852 may have a substantially constant diameter along its length, or it may taper gradually over substantially its entire length.

[0561] The mandrel 864 is sized and constructed to be slidably received within the lumen 854 of the conduit 852. In operation, the mandrel 864 can provide increased stiffness to enhance the maneuverability of the conduit 852, which might otherwise be too flexible to allow maneuverability through surrounding guide tubes. In various embodiments, the mandrel 864 can be metallic, polymeric, rubber, or any other suitable material. In some embodiments, the mandrel 864 is substantially stiffer than the conduit 852. Figure 8AAs shown, the core needle 864 may have an outer cross-sectional dimension substantially corresponding to the lumen 854 of the conduit 852, for example having a proximal portion 866, a distal portion 868, and a transition portion 870 therebetween. Alternatively, the core needle 864 may have a constant cross-sectional dimension.

[0562] As previously described, the occlusion component delivery assembly 810 and the embolization element delivery assembly 850 can be connected together via one or more couplers 880. Figure 8A In the illustrated embodiment, the connectors include a first connector 880a and a second connector 880b. The connector 880 may be a loop or band extending circumferentially around both the conduit 852 and the core wire 812 to secure them together. Such a band may be made of any suitable material, such as a polymer or metal, and may optionally be radiopaque to facilitate visualization of the system 800 as it progresses through the vascular system. The band may be coiled over components 810, 850, with or without adhesives or welding, to secure them in place. Although two such connectors 880 are shown, the number of connectors may vary; for example, one, three, four, five, or more connectors may be used to secure the conduit 852 and the core wire 812 together. In some embodiments, the connector 880 may take the form of an adhesive that secures at least a portion of the core wire 812 to at least a portion of the conduit 852. In some embodiments, the connector 880 may include a surrounding sheath, such as a polymeric material that can surround the conduit 852 and the core wire 812 to securely hold them together, for example, it may be heat-shrinkable or otherwise tightly adhered to the conduit 852 and the core wire 812. In various embodiments, the occlusion component delivery assembly 810 and the embolization element delivery assembly 850 may be coupled together such that they cannot slide or rotate relative to each other. In other embodiments, the two assemblies 810, 850 may be slidably coupled together such that the embolization element delivery assembly 850 can slidably advance or retract relative to the occlusion component delivery assembly 810. In other embodiments, the two assemblies 810, 850 may be separate such that each assembly can be advanced individually to the treatment site simultaneously or sequentially.

[0563] Figures 9A-9C The treatment site is shown where the occlusion member 102 and the embolization element 230 are delivered into the aneurysm sac. (See diagram.) Figure 9A As shown, system 800 can be positioned within a second elongated shaft 108 (e.g., a microcatheter) for intravascular advancement until the microcatheter is located at or adjacent to the aneurysm sac. In the illustrated embodiment, the distal end of the second elongated shaft 108 extends within the aneurysm sac; however, in other embodiments, the distal end of the second elongated shaft 108 may be positioned at or near the neck of the aneurysm.

[0564] In such Figure 9AAs shown, system 800 has been advanced within elongated shaft 108 such that occlusion member 102 is maintained in a constrained low-profile configuration within shaft 108, while at least a portion of conduit 852 extends near occlusion member 102 and within shaft 108. In various embodiments, shaft 108 may have an inner diameter of about 0.017 inches or less, about 0.021 inches or less, or about 0.027 inches or less.

[0565] like Figure 9B As shown, once the distal opening 856 of the conduit 852 is positioned at or near the treatment site (e.g., within the aneurysm sac), the elongated shaft 108 can retract to deploy the occlusion member 102 within the aneurysm sac (e.g., allowing the occlusion member 102 to self-expand). Before, during, or after the deployment of the occlusion member 102, the core needle 864 can be removed from the lumen 854 of the conduit 852. As the core needle 864 is removed and the occlusion member 102 expands, the distal portion of the conduit 852 can take on a curved shape, for example, curving along the inner wall of the aneurysm sac and / or along the outer surface of the occlusion member 102. In the illustrated embodiment, the distal opening of the conduit 852 is located at the most distal portion of the aneurysm sac, at the dome of the sac.

[0566] At this location, the embolization element 230 can be advanced through conduit 852 and into the region distal to the occlusion member 102 of the aneurysm. In the case of a fluid or gel, a syringe or other injector can be used to propel the embolization element 230 through lumen 854. In the case of a microcoil or other structured embolization element, a delivery line or other suitable mechanism can be slidably advanced through lumen 854 of conduit 852 to position the embolization element 230 into the aneurysm sac.

[0567] As previously mentioned Figure 3A-3G As described, the introduction of the embolic element 230 may cause the occlusion member 102 to deform, for example, at least partially fold over itself, to provide enhanced protection in the neck region of the aneurysm. Once the embolic element 230 has been delivered and the occlusion member 102 has been deformed, the occlusion member 102 may be cut off from the core wire 812 as described above. For example, a power source or other current source may be used to generate a current through the core wire 812, causing the core wire 812 to electrolytically corrode at the separation region 818.

[0568] like Figure 9C As shown, after the occlusion member 102 is severed by electrolytic corrosion through the separation zone 818, the core wire 812 and the embolization element delivery assembly 850 can retract proximally, while the occlusion member 102 and the embolization element 230 remain positioned within the aneurysm. As the embolization element delivery assembly 850 retracts, the distal portion of the conduit 852 can slide around the expanded occlusion member 102 and out of the neck of the aneurysm.

[0569] Figure 10 A schematic side view of another embodiment of a treatment system 1000 according to the present technical aspect is shown. The treatment system 1000 may include several generally similar to those described above. Figure 8A and 8B Features of the block member. For example, the block member delivery assembly 810 includes a core wire 812 having a separation region 818 located near the hub 824 of the block member 102. The core wire 812 may be coated with an insulating material along part or all of its length (at least the separation region 818 is not covered by the insulating material).

[0570] The core wire 812 extends generally parallel to and adjacent to the embolization element delivery assembly 1050. The assembly 1050 may include components related to the above. Figure 8A and 8B Several similar features are described, such as a conduit 852 having a defined lumen 854 extending therethrough. In the illustrated embodiment, the conduit 852 may be in the form of an extruded polymer tube (e.g., PTFE) or other suitable material. The conduit 852 may be sufficiently lubricated to facilitate the slidable passage of the embolic element therethrough. The conduit 852 may include a proximal portion 858 and a distal portion 860. In the illustrated embodiment, the conduit 852 has a substantially uniform diameter or cross-sectional dimension along its length, and the lumen 854 also has a substantially uniform diameter or cross-sectional dimension along its length. In some embodiments, the cross-sectional dimensions of the outer surfaces of the lumen 854 or the conduit 852 may vary along their length.

[0571] and Figure 8A The core needle 864 is the opposite. Figure 10 The system 1000 shown relies on a surrounding reinforcing member 1064 at least around the proximal portion 858 of the conduit 852. The reinforcing member 1064 can be, for example, a thiouret tube, catheter, or other suitable tubular member with sufficient stiffness, circumferential strength, and / or other structural features to allow the assembly 1050 to be pushed through the surrounding delivery catheter without a core needle. Because the distal portion 860 of the conduit 852 is not surrounded by the reinforcing member 1064, the distal portion 860 can be more flexible than the other portions of the assembly 1050. This can help position the distal opening 856 of the conduit 852 at the treatment site (e.g., as shown in the image). Figure 9B (as shown in the diagram). In some embodiments, the reinforcing member 1064 may extend substantially the entire length of the pipe 852.

[0572] like Figure 10 As shown, the core wire 812 of the occlusion component delivery assembly 810 is connected together to the occlusion element delivery assembly via first and second connectors 1080a and 1080b. Figure 8A The discrete bands shown are opposite. Figure 6The first connector 1080a shown may take the form of an elongated sleeve that circumferentially surrounds at least a portion of the length of the reinforcing member 1064 and the core wire 812. For example, the first connector 1080a may be a tightly fitting polymer sheath, such as PTFE that has been heat-shrinked to appropriate locations on the reinforcing member 1064 and the core wire 812. Distal from the first connector 1080a is a second connector 1080b, which may take the form of another elongated sleeve that circumferentially surrounds the reinforcing member 1064 and the core wire 812. The second connector 1080b may be a more flexible polymeric material or other suitable material, such as polyether block amide (PEBA), thermoplastic polyurethane (PTU), or any other suitable material. The more flexible second connector 1080b can be used to better tolerate relative movement of the portion of the core wire 812 extending away from the reinforcing member 1064, because movement of the core wire 812 can exert an outward force on the second connector 1080b. This is particularly useful during the resheathing process, where the partially or fully deployed occluder 102 retracts into the surrounding conduit, allowing relatively high forces to be applied to the core wire 812 and the second connector 1080b. In some embodiments, the two connectors 1080a and 1080b can be replaced by a single connector made of any suitable material, or additional connectors can be used.

[0573] Although Figure 10 The embodiments are illustrated with the core wire 812 extending proximally along the outer surface of the reinforcing member 1064, but in some embodiments, the proximally portion of the core wire 812 may be replaced by or integrated into the reinforcing member 1064. For example, in the case where a hyaluronic acid tube serves as the reinforcing member 1064, the hyaluronic acid tube may be configured to transmit current along its length to the distally coupled core wire 812, which extends away from the hyaluronic acid tube and is coupled to the occlusion member 102. In another embodiment, the reinforcing member 1064 may include a braided conduit, and the current may be carried by one or more conductors extending within the conduit wall and electrically communicating with the core wire 812.

[0574] Figure 10 The system 1000 shown can be similar to Figures 9A-9CThe method shown differs in that system 1000 does not include a core needle to be removed after the distal opening 856 of conduit 852 is initially positioned at the treatment site. Therefore, system 1000 can advance through the vascular system until the occlusion member 102 and the distal opening 856 of conduit 852 are positioned at or near the treatment site (e.g., within the aneurysm sac). The occlusion member 102 can be deployed (e.g., by retracting the surrounding elongated member 108 to allow self-expansion of the occlusion member 102) and the embolization element 230 can be delivered through the lumen 854 of the conduit to the treatment site. After the deployment of the occlusion member 102 and the delivery of the embolization element 230, the occlusion member 102 can be electrolytically detached from the core wire 812, and system 1000 can be retracted proximally, leaving the occlusion member 102 and embolization element 230 in place within the aneurysm or other treatment site.

[0575] B. Separation via electrolytic corrosion of pipes

[0576] Figure 11A A schematic side view of the treatment system 1100 is shown, while Figure 11B It shows Figure 11A The treatment system 1100 is shown as a side sectional view of its distal portion. As described in more detail below, the treatment system 1100 may include a conduit assembly 1102 releasably coupled to the occlusion member 102. In operation, the treatment system 1100 facilitates the placement of the occlusion member 102 at the treatment site and the release of the occlusion member 102 from the conduit assembly 1102 using electrolytic dissociation. As described in more detail below, the distal portion of the conduit assembly 1102 may remain in place with the occlusion member 102 after electrolytic dissociation. Furthermore, the conduit assembly 1102 may facilitate the placement of the embolization element 230 ( Figure 2-3G It is introduced through it to be placed at the treatment site (e.g., within the aneurysm sac accompanied by the occlusion member 102).

[0577] While several examples involve the use of electrolytic separation, other techniques may be used in various embodiments to cut off the pipe and release the occlusion member 102. For example, instead of electrolytic separation or in addition to electrolytic separation, embodiments of this technology may utilize thermal separation, mechanical separation, chemical separation, or any other suitable separation technique.

[0578] Let's refer to each other. Figure 11A and 11B The conduit assembly 1102 may be in the form of an elongated tubular member defining a lumen 1104. The conduit assembly 1102 may be connected to the proximal hub 1106 of the occlusion member 102 such that the lumen 1104 extends distally beyond the proximal hub 1106. For example... Figure 11BAs shown, the inner band 1108 of the hub 1106 circumferentially surrounds a portion of the conduit assembly 1102. An outer band 1110 surrounds the inner band 1108, such that the proximal portion of the layer of the occlusion member 102 is sandwiched between the inner band 1108 and the outer band 1110 of the hub 1106. Such bands can be made of any suitable material, such as polymers or metals, and may optionally be radiopaque to facilitate visualization of the system 1100 as it advances through the vascular system. The bands may be coiled, with or without adhesives or welding, to secure them in place. In operation, the embolization element can be introduced through the lumen 1104 to the treatment site (e.g., within an aneurysm sac) and adjacent to the occlusion member 102. In some instances, the inner band 1108 may have an inner diameter of approximately 0.020 inches, while the outer band 1110 may have an outer diameter of approximately 0.023 inches.

[0579] In various embodiments, the conduit assembly 1102 may include a single tubular member or a plurality of tubular members arranged coaxially. Furthermore, any one tubular member may be integral or may be formed from a plurality of separate components joined together. Additionally or alternatively, some or all of the tubular members may include one or more coatings along some or all of their respective lengths. In some embodiments, one or more tubular members may be slidably movable relative to other tubular members. Alternatively or additionally, one or more tubular members may be fixed relative to other tubular members (e.g., non-slidably coupled).

[0580] exist Figure 11A-11B In the illustrated embodiment, the conduit assembly 1102 includes a conduit 1120 in the form of an elongated tubular member. An outer sheath 1130 extends along the radially outer surface of the conduit 1120, and an inner liner 1140 extends along the radially inner surface of the conduit 1120. As described in more detail below, the conduit 1120 may include a separation region 1126 configured to be electrolytically corroded when current is supplied to the conduit 1120. The outer sheath 1130 and / or the inner liner 1140 may be electrically insulating, such that the current carried by the conduit 1120 is confined within the conduit 1120 and concentrated in the separation region 1126. In the presence of an electrolytic medium such as blood, current is transferred from the conduit 1120 through the separation region 1126 to the surrounding medium.

[0581] In various embodiments, the conduit assembly 1102 may have a length sufficient to allow the occlusion member 102 to be positioned at an intravascular treatment site (e.g., within an aneurysm sac) while the proximal end of the conduit assembly 1102 extends outside the patient's body. For example, the conduit assembly 1102 may have a length greater than about 50 inches, 60 inches, 70 inches, or 80 inches. The conduit assembly 1102 may have an outer diameter adapted to allow the assembly 1102 to be slidably advanced through a delivery catheter. For example, the conduit assembly 1102 may have an outer diameter less than about 0.027 inches, less than about 0.021 inches, or less than about 0.017 inches.

[0582] exist Figure 11A-11B In the illustrated example, the conduit assembly 1102 extends through the hub 1106 of the closure member 102, wherein the diameter at the hub 1106 decreases in a stepped manner, resulting in a narrower lumen 1104 extending through the hub 1106 and away from the hub 1106 in the distal portion of the conduit assembly 1102. In some embodiments, this stepped diameter decrease can be achieved by coiling the hub 1106 onto the conduit assembly 1102. However, in other embodiments, the conduit assembly 1102 does not need to have such a stepped inner and / or outer diameter decrease. For example, the conduit assembly 1102 may have an outer and / or inner diameter that is substantially constant along its length, or an outer and / or inner diameter that tapers gradually along part or all of its length.

[0583] As described above, the conduit assembly 1102 includes a conduit 1120 that may be radially disposed between an outer sheath 1130 and an inner liner 1140. The conduit 1120 includes a proximal portion 1122, a distal portion 1124, and a separation region 1126 axially disposed between the proximal portion 1122 and the distal portion 1124. In some embodiments, the conduit 1120 may be a conductive tubular member, such as a thiourea tube, conduit, or other suitable tubular member. In some embodiments, a portion of the conduit 1120, including the separation region 1126, may be coated with a conductive material, such as carbon, gold, platinum, tantalum, combinations thereof, etc. One or more metallic coatings may be applied using known electroplating techniques. In various embodiments, the conduit 1120 may have cuts (e.g., helical cuts, grooves, etc.) along at least a portion of its length to achieve desired mechanical properties (e.g., column strength, flexibility, kink resistance, etc.).

[0584] The conduit 1120 can be sized to facilitate intravascular advancement to the treatment site and accommodate a lumen 1104 sufficient to allow the embolic element to be advanced therethrough. In some embodiments, the wall thickness of the conduit 1120 can be between approximately 0.0005 inches and approximately 0.0015 inches, or in some instances approximately 0.001 inches. The outer diameter of the proximal portion of the conduit 1120 can be less than approximately 0.027 inches, less than approximately 0.021 inches, or less than approximately 0.017 inches. Alternatively or additionally, the conduit 1120 can have an inner diameter less than approximately 0.015 inches, less than approximately 0.012 inches, less than approximately 0.010 inches, or less than approximately 0.008 inches. Figure 11B As shown, the conduit 1120 may have a stepped-decreasing diameter where it passes through the hub 1106. For example, the conduit 1120 may have an outer diameter of approximately 0.016 inches close to the hub 1106, and an outer diameter of approximately 0.014 inches within the hub 1106. This reduced diameter can be achieved by crimping the strap of the hub 1106 onto the conduit 1120, or by shaping the conduit 1120 into a stepped-decreasing profile before attaching it to the hub 1106.

[0585] The conduit 1120, including the separation zone 1126, may comprise one or more of the following materials: ceramic materials, plastics, base metals or alloys thereof, such as stainless steel or nickel-titanium. Some of the most suitable combinations of materials for forming electrolytic corrosion points may include one or more of the following: stainless steel, preferably AISI 301, 304, 316 types or subgroups thereof; Ti or TiNi alloys; cobalt-based alloys; noble metals; or noble metal alloys, such as Pt, Pt metal, Pt alloys, Au alloys, or Sn alloys. Furthermore, the ceramic materials and plastics used to form the medical device may be conductive.

[0586] In some embodiments, the separation zone 1126 may include features that facilitate electrolytic separation, such as features configured to reduce the time required to supply current to the conduit 1120 before cutting off the conduit at the separation zone 1126. In some embodiments, the separation zone 1126 may include sidewalls having one or more openings 1128 formed therein, which may take the form of one or more windows, slits, holes, openings, or other such features. The openings 1128 may both increase the surface area to volume ratio at the separation zone 1126 and reduce the total amount of material forming the sidewalls of the conduit 1120 at the separation zone 1126. As a result, when current is supplied to the conduit 1120 and the separation zone 1126 is exposed to an electrolytic medium such as blood, the sidewall material of the conduit 1120 at the separation zone 1126 may be more susceptible to electrolytic corrosion. As a complement to or alternative to the openings 1128, the separation zone 1126 may include a reduced sidewall thickness of the conduit 1120 and / or otherwise provide a lower material density than the proximal and distal portions 1122, 1124 of the conduit 1120. In some embodiments, the separation region 1126 may be surface-treated (e.g., using laser or chemical treatment) to create a microstructure at the separation region 1126 that differs from the microstructure of the proximal and distal portions 1122, 1124 of the conduit 1120 to facilitate electrolytic separation. For example, the separation region 1126 may have a microstructure with a lower crystallinity than each of the proximal portion 1122 and the distal portion 1124 of the conduit. As another example, the separation region 1126 may have a more amorphous microstructure than each of the proximal portion 1122 and the distal portion 1124 of the conduit.

[0587] According to some embodiments, a portion of the conduit 1120 may be covered with an electrically insulating material. For example, a sheath 1130 made of or comprising an electrically insulating material may extend along at least a portion of the length of the conduit 1120 on the radially outer surface of the conduit 1120. For example, the sheath 1130 may include a proximal portion 1132 circumferentially surrounding the outer surface of the proximal portion 1122 of the conduit. The sheath 1130 may also include a distal portion 1134 circumferentially surrounding the outer surface of the distal portion 1124 of the conduit. A gap or void 1136 may separate the proximal and distal portions 1132, 1134 of the sheath. In some embodiments, the proximal and distal portions 1132, 1134 of the sheath may be discrete components that are not interconnected, while in other embodiments, the proximal and distal portions 1132, 1134 may be connected across the void 1136, for example, by strands of connecting material.

[0588] The sheath 1130 may be made wholly or partially of a non-conductive or insulating polymer, such as polyimide, polypropylene, polyolefin, combinations thereof, etc. In some embodiments, the sheath 1130 is in the form of an extruded polymer tube (e.g., PTFE), and the sheath 1130 extends distally beyond the hub 1106 and distally beyond the distal end of the conduit 1120. Thus, in some embodiments, the sheath 1130 may define a distal opening of the conduit assembly 1102. In some embodiments, when the closure member 102 is in its expanded state, the distal end of the sheath 1130 is positioned adjacent to or away from the distal end of the closure member 102. According to some embodiments, when the closure member 102 is in its low-profile state, the distal end of the sheath 1130 is positioned adjacent to or away from the distal end of the closure member 102.

[0589] The sheath 1130 can be sized to facilitate intravascular advancement to the treatment site and accommodate a lumen 1104 sufficient to allow the embolic element to be advanced therethrough. In some embodiments, the wall thickness of the sheath 1130 can be between about 0.0005 inches and about 0.002 inches, or in some instances about 0.0015 inches. The outer diameter of the sheath 1130 at its proximal portion can be less than about 0.027 inches, less than about 0.021 inches, less than about 0.017 inches, or less than about 0.015 inches. Alternatively or additionally, the sheath 1130 can have an inner diameter less than about 0.015 inches, less than about 0.012 inches, less than about 0.010 inches, or less than about 0.008 inches. Figure 11B As shown, the sheath 1130 may have a stepped-decreasing diameter, similar to the diameter described above regarding pipe 1120.

[0590] According to some embodiments, the gap 1136 between the proximal and distal portions 1132, 1134 of the sheath exposes the separation zone 1126 of the lower conduit 1120. When in contact with a bodily fluid such as blood, this fluid acts as an electrolyte, allowing current to concentrate on the uncovered separation zone 1126. The proximal and distal portions 1122, 1124 of the sheath prevent the proximal portion 1122 and the distal portion 1124 of the conduit from being exposed to the fluid. Therefore, electrical energy conducted along the conduit 1120 is concentrated in the separation zone 1126, thereby reducing the time required to corrode the separation zone 1126. The proximal and distal portions 1132, 1134 of the sheath can be slidably disposed on, overmolded, co-extruded, sprayed, or dip-coated relative to the conduit 1120.

[0591] The size of the gap 1136 between the proximal portion 1132 and the distal portion 1134 of the sheath can be determined to achieve the desired exposure of the underlying separation zone 1126. According to some embodiments, the gap 1136 can be as small as 0.0005 inches and as large as 0.1 inches or longer. According to some embodiments, the length of the separation zone 1126 can be greater than 0.005 inches and / or less than 0.010 inches to provide sufficient exposure to achieve a separation time of less than 30 seconds.

[0592] According to some embodiments, the distal portion 1134 of the sheath is radially disposed between the distal portion 1124 of the conduit 1120 and the hub 1106 of the closure member 102. For example... Figure 11B As shown, the inner strip 1108 of the hub 1106 circumferentially surrounds and contacts the distal portion 1134 of the sheath 1130. The distal portion 1134 of the insulating sheath electrically isolates the closure member 102 from the charge conducted along the length of the conduit 1120. The proximal end of the distal portion 1134 of the sheath may be positioned proximal to the hub 1106, and the distal end of the distal portion 1134 of the sheath may be positioned distal to the hub 1106. Alternatively, the proximal end of the distal portion 1134 of the sheath may be adjacent to the proximal end of the hub 1106, and / or the distal end of the distal portion 1134 of the sheath may be adjacent to the distal end of the hub 1106.

[0593] As described above, the liner 1140 may be disposed radially inside the conduit 1120. The liner 1140 may be an elongated tubular member and may be made of an electrically insulating material. In some embodiments, the liner 1140 may have an inner surface defining a lumen 1104 along at least a portion of the length of the conduit assembly 1102. Thus, the inner surface of the liner 1140 may be continuous and uninterrupted along its length, such that liquid embolizing material passing through it is contained within the lumen 1104 until it reaches the distal end of the liner 1140. In particular, the liner 1140 may provide a continuous and uninterrupted surface along the separation region 1126 of the conduit 1120, such that any embolizing element cannot pass through the opening 1128 in the conduit 1120 at the separation region 1126 from within the lumen 1104.

[0594] In various embodiments, the liner 1140 may extend distally to adjoin the conduit 1120 (e.g., at or near the distal end of the hub 1106), or alternatively, the liner 1140 may extend distally beyond the hub 1106 and / or distally beyond the distal end of the conduit 1120. The liner 1140 may be made of or coated with a lubricating material to facilitate the passage of the plugging element therethrough. In some embodiments, the liner 1140 is in the form of an extruded polymer tube (e.g., PTFE) or other suitable electrical insulating material. Additionally or alternatively, the liner 1140 may be co-extruded, sprayed, or dip-coated relative to the conduit 1120.

[0595] The liner 1140 can be sized to facilitate intravascular advancement to the treatment site and accommodate a lumen 1104 sufficient to allow the embolic element to be advanced therethrough. In some embodiments, the wall thickness of the liner 1140 can be between about 0.0005 inches and about 0.0015 inches, or in some instances about 0.001 inches. The outer diameter of the liner 1140 at its proximal portion can be less than about 0.027 inches, less than about 0.021 inches, or less than about 0.017 inches. Alternatively or additionally, the liner 1140 can have an inner diameter less than about 0.015 inches, less than about 0.012 inches, less than about 0.010 inches, or less than about 0.008 inches. Figure 11B As shown, the liner 1140 may have a stepped-decreasing diameter where it passes through the hub 1106, similar to the diameters of the pipe 1120 and the sheath 1130 described above.

[0596] In some embodiments, the embolic element can be delivered through the lumen 1104 of the conduit assembly 1102. The lumen 1104 may terminate at a distal opening (not shown). As described above, in some embodiments, the conduit assembly 1102 may include an elongated, flexible tubular member, such as a conduit, a thiourea tube, a polymer tube, etc. The lumen 1104 may be coated with a lubricating material or lined to facilitate the passage of the embolic element therethrough. In some embodiments, the conduit assembly 1102 is sized such that the distal opening is located near, entirely distal to, or at least partially distal to the occlusion member 102, while the occlusion member 102 is in an unexpanded state. The size and configuration of the conduit assembly 1102 may allow the distal opening to be located distal to the hub 1106 of the occlusion member 102, such that an embolic element delivered therethrough can be delivered to a region adjacent to or distal to the occlusion member 102.

[0597] Figure 11C A treatment system 1100 is shown with the tubing assembly 1102 partially retracted after the tubing 1120 is electrolytically severed at the separation zone 1126. As shown, the distal portion 1122 of the sheath and the distal portion 1124 of the tubing can remain connected to the hub 1106 of the occlusion member 102, while the proximal portion 1122 of the sheath, the distal portion 1122 of the tubing, and the liner 1140 retract proximally. According to some embodiments, the tubing assembly 1120 can retract through the surrounding conduit and be completely removed from the body.

[0598] Figure 12 A schematic side view of another embodiment of a treatment system 1200 according to the present technical aspect is shown. The treatment system 1200 may include several generally similar to those described above. Figure 11A –11C's characteristics. However, in Figure 12In the illustrated treatment system 1200, the liner 1140 includes a proximal portion 1142 and a distal portion 1124, which are spaced apart from each other by a gap 1146 axially aligned with the separation zone 1126. In this configuration, after the conduit 1120 is electrolytically cut off at the separation zone 1126, the distal portion 1144 of the liner can be held in place together with the occlusion member 102, the distal portion 1124 of the conduit, and the distal portion 1134 of the sheath. Thus, the proximal portion 1142 of the liner can be retracted together with the proximal portion 1122 of the conduit and the proximal portion 1132 of the sheath.

[0599] Figure 13 A schematic side view of another embodiment of a treatment system 1300 according to the present technical aspect is shown. The treatment system 1300 may include several generally similar to those described above. Figure 11A -12 is a characteristic of the feature. However, in Figure 6 In the treatment system 1300 shown, the liner 1140 terminates at or near the separation zone 1126. In this configuration, the lumen 1104 is defined by the liner 1140 along a portion of the length of the treatment system 1300 and by the inner surface of the conduit 1120 along the distal portion of the conduit assembly 1102.

[0600] Figure 14 A schematic side view of another embodiment of a treatment system 1400 according to the present technical aspect is shown. The treatment system 1400 may include several generally similar to those described above. Figure 11A -13 is a characteristic of the feature. However, in Figure 14 In the treatment system 1400 shown, the sheath 1130 terminates distally at or near the distal end of the hub 1106. Therefore, the sheath 1130 and the conduit 1120 can be substantially common-end. Simultaneously, the liner 1140 can extend distally beyond the hub 1106 and beyond the distal ends of the conduit 1120 and the sheath 1130. Thus, in this configuration, the lumen 1104 is defined along its entire length by the inner surface of the liner 1140. After the conduit 1120 is cut off at the separation zone 1126, the liner 1140 can retract proximally together with the proximal portion 1122 of the conduit and the proximal portion 1132 of the sheath. Therefore, after this proximal retraction, no tubular member extends into the interior of the occlusion member 102, which is consistent with the above regarding... Figure 11A-11C The described embodiments form a contrast. This arrangement may be advantageous if it is necessary to remove any tubular elements from within the aneurysm sac after the deployment of the occlusion member 102 and any embolic elements.

[0601] Figures 15A-15C The treatment site is shown where the occlusion member 102 and the embolization element 230 are delivered into the aneurysm sac. (See diagram.) Figure 15AAs shown, the treatment system 1100 can be positioned within a second elongated axis 108 (e.g., a microcatheter) for intravascular advancement until the microcatheter is located at or adjacent to the aneurysm sac. In the illustrated embodiment, the distal end of the second elongated axis 108 extends within the aneurysm sac; however, in other embodiments, the distal end of the second elongated axis 108 may be positioned at or near the neck of the aneurysm.

[0602] In such Figure 15A As shown, system 1100 has been advanced within elongated shaft 108 such that occlusion member 102 is maintained in a constrained low-profile configuration within shaft 108, while at least a portion of conduit assembly 1102 extends in proximity to occlusion member 102 and within shaft 108. In various embodiments, shaft 108 may have an inner diameter of about 0.017 inches or less, about 0.021 inches or less, or about 0.027 inches or less.

[0603] like Figure 15B As shown, once the distal opening 1150 of the conduit assembly 1102 is positioned at or near the treatment site (e.g., within the aneurysm sac), the elongated shaft 108 can retract to deploy the occlusion member 102 within the aneurysm sac (e.g., allowing the occlusion member 102 to self-expand). In this position, the embolization element 230 can be advanced through the conduit assembly 1102 and into the region distal to the occlusion member 102 from the aneurysm. In the case of fluids or gels, a syringe or other injector can be used to propel the embolization element 230 through the lumen 1104. In the case of microcoils or other structural embolization elements, a delivery line or other suitable mechanism can be slidably advanced through the lumen 1104 of the conduit assembly 1102 to position the embolization element 230 into the aneurysm sac.

[0604] As previously mentioned Figure 3A-3G As described, the introduction of the embolic element 230 can cause the occlusion member 102 to deform, for example, at least partially fold over itself, to provide enhanced protection in the neck region of the aneurysm. Once the embolic element 230 has been delivered and the occlusion member 102 has been deformed, the occlusion member 102 can be cut off from the conduit assembly 1102 as described above. For example, a power source or other current source can be used to generate current through the conduit 1120, causing the conduit 1120 to undergo electrolytic corrosion at the separation zone 1126.

[0605] like Figure 15CAs shown, after the occlusion member 102 is released by electrolytic corrosion through the separation zone 1126, the conduit assembly 1102 can be retracted proximally while the occlusion member 102 and the embolization element 230 remain positioned within the aneurysm. When the conduit assembly 1102 is retracted, the distal portion of the conduit assembly (e.g., the distal portion 1134 of the sheath 1130 and / or the distal portion 1124 of the conduit 1120) can remain within the aneurysm and connected to the occlusion member 102.

[0606] End

[0607] The description of embodiments of this technology is not intended to be exhaustive or to limit the technology to the exact forms disclosed above. Singular or plural terms may also include plural or singular terms, respectively, where context permits. As those skilled in the art will recognize, although specific embodiments and examples of this technology have been described above for illustrative purposes, various equivalent modifications can be made within the scope of this technology. For example, while the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide other embodiments.

[0608] Furthermore, unless the word “or” is explicitly limited to referring only to a single item that is exclusive to other items in a list of two or more items, its use in this list can be understood to include: (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term “comprising” is used throughout to mean that at least one or more of the described features are included, such that no larger number of the same features and / or other features of additional types are excluded. It should also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the present technology. Furthermore, while advantages associated with certain embodiments of the present technology have been described in the context of those embodiments, other embodiments may also present such advantages, and not all embodiments are required to present such advantages to fall within the scope of the present technology. Therefore, this disclosure and associated technology may cover other embodiments not explicitly shown or described herein.

Claims

1. A treatment system comprising: Electrolytically etchable core wire, having a proximal portion, a distal portion, and a separation zone between the proximal and distal portions; An occlusion member having a proximal hub connected to a distal portion of a core wire, the occlusion member having a constrained state for delivery to an aneurysm and an expanded state in which at least a portion of the occlusion member is configured to extend across the neck of the aneurysm. and A conduit extending along at least a portion of the core wire, the conduit having a distal end configured to be disposed within the aneurysm together with an occlusal member, and the conduit having a lumen configured to allow an embolic element to pass through it. The distal end of the conduit extends distally beyond the distal end of the occlusion member, such that the introduction of the embolic element causes the occlusion member to fold at least partially over itself, and the occlusion member is capable of forming a bowl shape extending through the neck of the aneurysm to provide enhanced protection in the neck region of the aneurysm.

2. The treatment system of claim 1, wherein the conduit comprises a flexible tubular component.

3. The treatment system of claim 1, further comprising a core needle configured to be removably disposed within the lumen of the conduit.

4. The treatment system of claim 1, wherein the conduit has a distal portion having a smaller cross-sectional dimension than the proximal portion of the conduit.

5. The treatment system of claim 1, wherein the conduit is coupled to the core wire such that the two cannot slide relative to each other.

6. The treatment system of claim 1, wherein the core wire includes a proximal insulating layer that circumferentially contacts a proximal portion of the core wire and a distal insulating layer that circumferentially contacts a distal portion of the core wire.

7. The treatment system of claim 1, wherein the embolic element is a liquid embolism.

8. A treatment system comprising: Electrolytically etchable core wire, having a proximal portion, a distal portion, and a separation zone between the proximal and distal portions; An occlusion member having a proximal hub connected to a distal portion of the core wire, the occlusion member being configured to be positioned at or near the treatment site; and A conduit extending along at least a portion of the core wire, the conduit having a lumen configured to allow a plugging element to pass through it. The treatment site includes an aneurysm sac, and the occlusion member is configured to be disposed within the aneurysm sac, and the distal portion of the conduit is configured to be disposed within the aneurysm sac for delivering the embolic element into the aneurysm sac. The distal end of the conduit extends distally beyond the distal end of the occlusion member, such that the introduction of the embolic element causes the occlusion member to fold at least partially over itself, and the occlusion member is capable of forming a bowl shape extending through the neck of the aneurysm to provide enhanced protection in the neck region of the aneurysm.

9. The treatment system of claim 8, wherein the distal portion of the conduit is configured to be disposed at or near the treatment site together with the occlusion member.

10. The treatment system of claim 8, wherein the conduit comprises a flexible tubular member.

11. The treatment system of claim 8, further comprising a core needle configured to be removably disposed within the lumen of the conduit.

12. The treatment system of claim 8, wherein the distal portion of the conduit has a smaller cross-sectional dimension than the proximal portion of the conduit.

13. The treatment system of claim 8, wherein the conduit is coupled to the core wire such that the two cannot slide relative to each other.

14. The treatment system of claim 8, wherein the occlusion member comprises an expandable mesh having a constrained state for delivery to the aneurysm and an expanded state in which at least a portion of the mesh is configured to be disposed across the neck of the aneurysm.

15. A treatment system comprising: A core component having a proximal portion, a distal portion, and a separation region between the proximal and distal portions; An occlusion implant, which is connected to the distal portion of the core member, is configured to be delivered to the aneurysm; and A conduit extending along at least a portion of the core member, the conduit having a lumen configured to allow an embolic element to pass through into the aneurysm. After the core member is severed via the separation zone, the proximal portion of the core member and the conduit can be removed, while the occlusive implant and the distal portion of the core member remain within the aneurysm. The distal end of the conduit extends distally beyond the distal end of the occlusion implant, such that the introduction of the embolic element causes the occlusion implant to fold at least partially over itself, and the occlusion implant is capable of forming a bowl shape that extends through the neck of the aneurysm to provide enhanced protection in the neck region of the aneurysm.

16. The treatment system of claim 15, wherein the occlusion implant comprises an expandable mesh having a constrained state for delivery to the aneurysm and an expanded state in which at least a portion of the mesh is configured to be disposed across the neck of the aneurysm.

17. The treatment system of claim 15, wherein the conduit comprises a flexible tubular member.

18. The treatment system of claim 15, wherein the separation zone includes a portion of the core member configured to be severed by electrolytic corrosion.

19. A treatment system comprising: Pipes that can be electrolytically corroded include: A proximal portion, a distal portion, and a separation region between the proximal and distal portions, wherein the separation region includes a sidewall in which one or more holes are formed; and A lumen configured to allow an embolic element to pass through; and An expandable occlusion member having a proximal hub connected to a distal portion of the conduit, the occlusion member being configured to be positioned at the intracapsular treatment site. The distal end of the lumen extends distally beyond the distal end of the occlusion member, such that the introduction of the embolic element causes the occlusion member to fold at least partially over itself, and the occlusion member is capable of forming a bowl shape extending through the neck of the intracapsular treatment site to provide enhanced protection in the neck region of the intracapsular treatment site.

20. The treatment system of claim 19, wherein the separation zone includes a portion of the conduit configured to be cut off in response to the supply of current thereto.

21. The treatment system of claim 19, further comprising a liner extending through the lumen of the conduit.

22. The treatment system of claim 21, wherein the liner includes an elongated tubular member having a second lumen configured to allow an embolic element to pass through it.

23. The treatment system of claim 21, wherein the liner is configured to slidably retract relative to the occlusion member after the separation zone is cut off.

24. The treatment system of claim 19, wherein the embolic element is a liquid embolism.

25. The treatment system of claim 19 further includes an electrically insulating sheath extending over the conduit, wherein the sheath does not extend fully over the separation zone.

26. A treatment system comprising: A conduit having sidewalls defining a lumen configured to allow an embolizing element to pass through it, the conduit having a proximal portion, a distal portion, and an electrolytically corrodeable separation zone between the proximal and distal portions; and A blocking member, connected to the distal portion of the conduit, is configured to be positioned at or near the treatment site. The treatment site includes an aneurysm sac, and the occlusion member is configured to be disposed within the aneurysm sac, and the distal portion of the conduit is configured to be disposed within the aneurysm sac for delivering the embolic element into the aneurysm sac. The distal end of the conduit extends distally beyond the distal end of the occlusion member, such that the introduction of the embolic element causes the occlusion member to fold at least partially over itself, and the occlusion member is capable of forming a bowl shape extending through the neck of the aneurysm to provide enhanced protection in the neck region of the aneurysm.

27. The treatment system of claim 26, wherein the sidewall of the conduit has a reduced thickness in the separation zone.

28. The treatment system of claim 26 further includes a liner extending through the lumen of the conduit.

29. The treatment system of claim 28, wherein the liner includes an elongated tubular member having a second lumen configured to allow an embolic element to pass through it.

30. The treatment system of claim 28, wherein the liner is configured to slidably retract relative to the occlusion member after the separation zone is cut off.

31. The treatment system of claim 26, wherein the embolic element is a liquid embolism.

32. The treatment system of claim 26 further includes an electrically insulating sheath extending over the conduit, wherein the sheath does not extend fully over the separation zone.

33. A treatment system comprising: The first tubular member includes: The sidewalls that define the lumen; and A separation zone, which includes one or more holes formed in the sidewall; A second tubular member is disposed within the lumen of the first tubular member, the second tubular member having a sidewall continuous along at least the separation region, and the second tubular member being in a conveying configuration relative to the first tubular member; and An implant, which is connected to a first tubular member at a location distal to the separation zone, The implant is an intrasac device configured for implantation within an aneurysm, and the distal portion of the second tubular member is configured to be disposed within the aneurysm sac for delivering an embolic element into the aneurysm sac. The distal end of the second tubular member extends distally beyond the distal end of the implant, such that the introduction of the embolizing element causes the implant to fold at least partially over itself, and the implant is able to form a bowl shape extending through the neck of the aneurysm to provide enhanced protection in the neck region of the aneurysm.

34. The treatment system of claim 33, wherein the second tubular member defines a second lumen, the second lumen being configured to allow the embolic element to pass through therethrough.

35. The treatment system of claim 33, wherein the separation zone includes a portion of the first tubular member configured to be cut off in response to the supply of current thereto.

36. The treatment system of claim 33, wherein the second tubular member is configured to slidably retract relative to the implant after transection in the separation zone.

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