Systems and methods for treating aneurysms

Abstract

Treatment of an aneurysm can be improved by delivering an occlusive member (e.g., an expandable braid) with embolic elements (e.g., coils, embolic material) to an aneurysm sac. A delivery system for such treatment can include an occlusive member configured to be positioned within an aneurysm sac and having a proximal hub. An elongate tubular member has an engagement member removably coupled to the proximal hub, for example, via a threaded engagement or via an interference fit of one or more engagement members or via a breakable coupling. A conduit extending within or adjacent the elongate member is configured to receive embolic elements therethrough for delivery to the aneurysm sac.

Description

[0001] Cross-reference to related applications

[0002] This application claims the priority of U.S. Provisional Applications No. 62 / 930,421, No. 62 / 930,487, No. 62 / 930,303, No. 62 / 930,324, No. 62 / 930,333, and No. 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] Intracranial aneurysms are parts of intracranial blood vessels that bulge outward from the main channel of the vessel. This often occurs in sections of vessels that are abnormally weak due to congenital abnormalities, trauma, high blood pressure, or other causes. Once an intracranial aneurysm forms, there is a significant risk that it will eventually rupture and cause a medical emergency with a high risk of death due to bleeding. Vascular surgery is usually indicated 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 for treating intracranial aneurysms involves placing a platinum coil within the internal volume of the aneurysm using a microcatheter. Over time, the presence of the coil will induce 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, thus reducing the risk of aneurysm rupture (or re-rupture) and associated bleeding. Unfortunately, in many cases, long-term recanalization (i.e., restoration of blood flow to the internal volume of the aneurysm) occurs after this type of vascular surgery, especially for intracranial aneurysms with a relatively wide neck and / or a relatively large internal volume.

[0005] Another standard type of vascular surgery for treating intracranial aneurysms involves deploying a shunt within the relevant intracranial vessel. The shunt is typically a mesh tube that allows blood to preferentially flow along the main channel of the vessel, while blood stagnates within the aneurysm. Stagnant blood within the aneurysm should eventually form a thrombus, leading to closure of the aneurysm neck and the growth of new endothelial tissue, such as with platinum coil therapy. A significant drawback of shunts is that it can take weeks or months for the aneurysm thrombus to form, and a significantly longer time is required for the aneurysm neck to be fully covered with endothelial cells for complete effectiveness. 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 because the risk of re-rupture is high, and if re-rupture occurs, antiplatelet therapy tends to exacerbate intracranial hemorrhage. For these and other reasons, innovation is needed in the treatment of intracranial aneurysms. Given the severity of this situation, innovations in this field have direct life-saving potential. Summary of the Invention

[0006] For example, the present invention is illustrated by various aspects described below. For convenience, various examples of the various aspects of the present invention are described as numbered clauses (1, 2, 3, etc.). These clauses are provided as examples but do not limit the present invention. It should be noted that any dependent clauses may be combined in any combination and placed in the corresponding independent clauses. Other clauses may be presented in a similar manner.

[0007] 1. A treatment system comprising:

[0008] An occlusion member configured to be positioned within an aneurysm sac, the occlusion member including a hub;

[0009] An elongated tubular member having a removable engagement member connected to the hub, the elongated tubular member defining a first lumen extending therethrough; and

[0010] A conduit extending within a first lumen, the conduit defining a second lumen configured to receive a plugging element passing through it.

[0011] 2. The treatment system according to any one of the preceding clauses, wherein the coupling member is removably coupled to the hub via an interference fit.

[0012] 3. The treatment system according to any one of the preceding clauses, wherein the hub has a recess, and the engaging member includes a protrusion configured to be removably received within the recess.

[0013] 4. The treatment system according to any one of the preceding clauses, wherein the elongated tubular component comprises a hypo tube.

[0014] 5. The treatment system according to any one of the preceding clauses further includes a control element configured to extend within the first lumen.

[0015] 6. The treatment system according to any one of the preceding clauses, wherein the control element actuates the engagement member to engage with the hub.

[0016] 7. The treatment system according to any one of the preceding clauses, wherein the control element comprises a wire or a rod.

[0017] 8. The treatment system according to any one of the foregoing clauses, wherein the control element restricts or prevents the engagement member from disengaging from the hub.

[0018] 9. The treatment system according to any one of the preceding clauses, wherein the control element is slidably removable from the first lumen.

[0019] 10. The treatment system according to any one of the preceding clauses, wherein the control element extends within the second lumen.

[0020] 11. The treatment system according to any one of the preceding clauses, wherein the control element extends beside the conduit outside the second lumen.

[0021] 12. The treatment system according to any one of the preceding clauses, wherein the conduit comprises a flexible tubular member.

[0022] 13. The treatment system according to any one of the preceding clauses further includes a limiting member disposed radially adjacent to the connecting member.

[0023] 14. The treatment system according to any one of the preceding clauses, wherein the limiting member includes an expandable element configured to apply a radially outward force on the engaging member.

[0024] 15. The treatment system according to any one of the preceding clauses, wherein the limiting member is coupled to a pull wire such that the limiting member is slidably retractable relative to the engaging member and / or movable relative to the engaging member.

[0025] 16. The treatment system according to any one of the preceding clauses, wherein the limiting element is disposed within the second lumen.

[0026] 17. The treatment system according to any one of the preceding clauses, wherein the limiting element is incorporated within the wall of the conduit.

[0027] 18. The delivery system according to any one of the preceding clauses, wherein the limiting element includes a reinforcing portion of the conduit.

[0028] 19. A treatment system comprising:

[0029] An occlusion member configured to be positioned at a treatment site, the occlusion member including a hub;

[0030] A conduit having a engagement portion that removably threads into the hub; and

[0031] A lumen that extends through the conduit and is configured to deliver an embolic element through it to the treatment site.

[0032] 20. The treatment system according to any one of the preceding clauses, wherein the hub includes radially inward threads, and wherein the engagement portion includes corresponding radially outward threads.

[0033] 21. The treatment system according to any one of the preceding clauses, wherein the conduit may be rotatably engaged or disengaged from the hub.

[0034] 22. The treatment system according to any one of the preceding clauses, wherein the conduit is capable of engaging or disengaging from the hub by rotation of the conduit.

[0035] 23. The treatment system according to any one of the preceding clauses, wherein the embolic element is configured to be delivered distal to the occlusion member.

[0036] 24. The treatment system according to any one of the preceding clauses, wherein the conduit comprises a hypotube or a catheter.

[0037] 25. The treatment system according to any one of the preceding clauses, wherein the conduit, when threadedly engaged with the hub, includes a proximal portion extending proximally from the hub and a distal portion extending distally from the hub.

[0038] 26. The treatment system according to any one of the preceding clauses, wherein the distal portion of the conduit extends distally beyond the occlusion member in its expanded state.

[0039] 27. A treatment system comprising:

[0040] An occlusion member configured to be positioned within the aneurysm;

[0041] A distal conduit, which is connected to the occlusion member and defines a first lumen;

[0042] A proximal conduit having a engagement portion that threadedly engages with the occlusion member, the proximal conduit defining a second lumen therethrough, and the proximal conduit being configured such that when the proximal conduit is threadedly engaged with the occlusion member, the first lumen and the second lumen are in fluid communication and are configured to deliver an embolic element through therethrough.

[0043] 28. The treatment system according to any one of the preceding clauses, wherein the occlusion member comprises a hub having radially inward threads, and wherein the engagement portion comprises corresponding radially outward threads.

[0044] 29. The treatment system according to any one of the preceding clauses, wherein the distal conduit includes radially inward threads, and wherein the engagement portion includes corresponding radially outward threads.

[0045] 30. The treatment system according to any one of the preceding clauses, wherein the proximal conduit is capable of engaging or disengaging with the occlusion member by rotation of the proximal conduit.

[0046] 31. The treatment system according to any one of the preceding clauses, wherein the embolic element is configured to be delivered via the distal conduit at a location distal to the occlusive member in its extended state.

[0047] 32. The treatment system according to any one of the preceding clauses, wherein the proximal conduit comprises a hypotube or catheter.

[0048] 33. The treatment system according to any one of the preceding clauses, wherein the proximal conduit, when threadedly engaged with the hub, includes a proximal portion extending proximally from the hub and a distal portion extending distally from the hub.

[0049] 34. 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 extended state, wherein in the extended state at least a portion of the mesh is configured to be positioned across the neck of the aneurysm.

[0050] 35. 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 presenting a predetermined three-dimensional shape in the expanded state.

[0051] 36. 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.

[0052] 37. The treatment system according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of threads, wherein some or all of the threads have a diameter of at least 0.001 inches.

[0053] 38. The treatment system according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of threads, wherein some or all of the plurality of threads have the same diameter.

[0054] 39. The treatment system according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of threads, wherein at least some of the plurality of threads have different diameters.

[0055] 40. The treatment system according to any one of the preceding clauses, wherein in the extended state, the expandable mesh forms one of a sphere, an elongated sphere, or an oblate spheroid.

[0056] 41. The treatment system according to any one of the preceding clauses, wherein the scalable mesh comprises an inner layer and an outer layer.

[0057] 42. The treatment system according to any one of the preceding clauses, wherein the maximum cross-sectional size of the scalable 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.

[0058] 43. The treatment system according to any one of the preceding clauses, wherein the expandable mesh is a laser cutting tube.

[0059] 44. The treatment system according to any one of the preceding clauses, wherein the expandable mesh comprises a plurality of interwoven filaments.

[0060] 45. The treatment system according to any one of the preceding clauses, wherein the occlusion member is bent at least for most of its entire length.

[0061] 46. ​​The treatment system according to any one of the preceding clauses, wherein the occlusive member is contractile upon contact with a synthetic gel or fluid.

[0062] 47. The treatment system according to any one of the preceding clauses, wherein the occlusion member is configured to rotate about the conduit.

[0063] 48. The treatment system according to any one of the preceding clauses, wherein the occlusion member is rotatably and slidably connected to the conduit.

[0064] 49. The treatment device according to any one of the preceding clauses, wherein the occlusion member has an orifice at its distal portion, and wherein the elongated tubular member extends through the orifice.

[0065] 50. The treatment system according to any one of the preceding clauses, wherein the occlusion member is configured to move axially along the elongated tubular member.

[0066] 51. The treatment system according to any one of the preceding clauses, wherein the embolic element is a liquid embolism.

[0067] 52. The treatment system according to any one of the preceding clauses, wherein the embolic element comprises a biopolymer and / or a chemical crosslinking agent.

[0068] 53. The treatment system according to any one of the preceding clauses, wherein the biopolymer comprises chitosan, chitosan derivatives, chitosan analogs, or combinations thereof.

[0069] 54. The treatment system according to any one of the preceding clauses, wherein the chemical crosslinking agent comprises genipin, a derivative of genipin, an analog of genipin, or a combination thereof.

[0070] 55. A system comprising:

[0071] The treatment system mentioned in any one of the foregoing clauses; and

[0072] An elongated shaft having a lumen extending therethrough, wherein the treatment system is configured to be slidably disposed within the first lumen of the elongated shaft.

[0073] 56. A system comprising:

[0074] The treatment system mentioned in any of the preceding clauses;

[0075] 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

[0076] 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.

[0077] 57. The treatment system according to any one of the preceding clauses, wherein the first elongated axis is a microcatheter and the second elongated axis is a delivery catheter or a guiding catheter.

[0078] 58. A method for treating an aneurysm, comprising:

[0079] Provide the treatment system as described in any of the foregoing clauses.

[0080] 59. The method according to any one of the foregoing clauses further comprises:

[0081] Positioning the distal end of the conduit of the treatment system within the aneurysm cavity; and

[0082] When the distal end of the conduit is positioned within the aneurysm cavity, the occlusion member of the treatment system is released from the conduit, causing the occlusion member to self-expand to present an expanded state.

[0083] 60. The method according to any one of the preceding clauses further includes delivering the embolic element through the distal end of the distal conduit to the treatment site.

[0084] 61. The method according to any one of the preceding clauses, wherein releasing the occluding member comprises retracting the control element relative to the engaging member.

[0085] 62. The method according to any one of the preceding clauses, wherein releasing the blocking member comprises deflecting the engaging member away from the hub.

[0086] 63. The method according to any one of the preceding clauses, wherein releasing the occluding member comprises retracting the engaging member relative to the hub.

[0087] 64. The method according to any one of the preceding clauses, wherein releasing the occlusion member comprises retracting the restraint relative to the engagement member and then retracting the engagement member relative to the hub.

[0088] 65. The method according to any one of the preceding clauses, wherein releasing the occlusion member comprises rotating the pipe relative to the hub or the occlusion member.

[0089] 66. The method according to any one of the preceding clauses further includes retracting the proximal conduit proximally while the occlusion member is in place at the treatment site.

[0090] 67. A treatment system comprising:

[0091] An occlusion member configured to be positioned at a treatment site;

[0092] A distal conduit, the distal conduit being connected to the occlusion member and having a first lumen extending through the distal conduit;

[0093] A proximal conduit having a second lumen extending through the proximal conduit and in fluid communication with the first lumen; and

[0094] A connector extending between the distal conduit and the proximal conduit, the connector being configured to deform or break at least partially, thereby disengaging the proximal conduit from the distal conduit.

[0095] 68. The treatment system according to any of the preceding clauses, wherein the coupling extends between the distal portion of the proximal conduit and the proximal portion of the distal conduit.

[0096] 69. The treatment system according to any one of the preceding clauses, wherein a first end of the connector is circumferentially attached to the outer surface of the proximal conduit and a second end of the connector is circumferentially attached to the outer surface of the distal conduit.

[0097] 70. The treatment system according to any one of the preceding clauses, wherein the coupling includes an expandable element.

[0098] 71. The treatment system according to any one of the preceding clauses, wherein the coupling includes an expandable element.

[0099] 72. The treatment system according to any one of the preceding clauses, wherein the coupling comprises an elastic material.

[0100] 73. The treatment system according to any one of the preceding clauses, wherein the connecting member includes a balloon.

[0101] 74. The treatment system according to any one of the preceding clauses, wherein the coupling includes a rupture zone, the coupling being configured to rupture along the rupture zone.

[0102] 75. The treatment system according to any one of the preceding clauses, wherein the ruptured area includes one or more perforations in the coupling.

[0103] 76. The treatment system according to any one of the preceding clauses, wherein the rupture zone comprises a series of perforations arranged circumferentially around the connector.

[0104] 77. The treatment system according to any one of the preceding clauses, wherein the ruptured area includes a region of the connector having a thinner wall thickness than an adjacent region of the connector.

[0105] 78. The treatment system according to any one of the preceding clauses, wherein the coupling defines an internal volume between the inner surface of the coupling and the outer surfaces of the proximal conduit and the distal conduit.

[0106] 79. The treatment system according to any of the preceding clauses, wherein the distal portion of the proximal conduit is adjacent to the proximal portion of the distal conduit.

[0107] 80. The treatment system according to any one of the preceding clauses, wherein the distal portion of the proximal conduit is at least partially received within the first lumen.

[0108] 81. The treatment system according to any one of the preceding clauses, wherein the proximal portion of the distal conduit is at least partially received within the second lumen.

[0109] 82. The treatment system according to any of the preceding clauses, wherein the proximal conduit and the distal conduit are removably connected together via friction engagement.

[0110] 83. The treatment system according to any one of the preceding clauses further includes an infusion shaft having a third lumen in fluid communication with an internal volume defined by the coupling.

[0111] 84. The treatment system according to any one of the preceding clauses, wherein the infusion shaft is configured to deliver fluid to the internal volume to expand the coupling.

[0112] 85. The treatment system according to any one of the preceding clauses, wherein the fluid comprises saline solution.

[0113] 86. The treatment system according to any one of the preceding clauses, wherein the infusion axis extends along the outer surface of the proximal conduit.

[0114] 87. The treatment system according to any one of the preceding clauses, wherein the infusion shaft extends within the wall of the proximal conduit.

[0115] 88. The treatment system according to any one of the preceding clauses, wherein the infusion axis extends semi-circularly or circumferentially around the proximal conduit.

[0116] 89. The treatment system according to any one of the preceding clauses, wherein the infusion axis extends semi-annularly or circumferentially around the second lumen.

[0117] 90. The treatment system according to any one of the preceding clauses further includes a plurality of infusion shafts in fluid communication with an internal volume defined by the coupling.

[0118] 91. The treatment system according to any one of the preceding clauses further includes an expandable element below the coupling, the expandable element being configured to cause the coupling to break when expanding from a low-profile configuration to an extended configuration.

[0119] 92. The treatment system according to any one of the preceding clauses, wherein the expandable element comprises a stent.

[0120] 93. The treatment system according to any one of the preceding clauses, wherein the expandable element comprises a braid.

[0121] 94. The treatment system according to any one of the preceding clauses, wherein the expandable element comprises a shape memory material.

[0122] 95. The treatment system according to any one of the preceding clauses, wherein the expandable element comprises a hyperelastic material.

[0123] 96. The treatment system according to any one of the preceding clauses, wherein the first lumen and the second lumen are configured together to deliver an embolic element through them.

[0124] 97. The treatment system according to any one of the preceding clauses, wherein the occlusion member includes a proximal hub, and wherein the proximal hub is fixed to the distal conduit.

[0125] 98. 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 an aneurysm.

[0126] 99. 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 extended state, wherein in the extended state at least a portion of the mesh is configured to be positioned across the neck of the aneurysm.

[0127] 100. 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 presenting a predetermined three-dimensional shape in the expanded state.

[0128] 101. 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.

[0129] 102. The treatment system according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of threads, wherein some or all of the threads have a diameter of at least 0.001 inches.

[0130] 103. The treatment system according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of threads, wherein some or all of the plurality of threads have the same diameter.

[0131] 104. The treatment system according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of threads, wherein at least some of the plurality of threads have different diameters.

[0132] 105. The treatment system according to any one of the preceding clauses, wherein in the extended state, the expandable mesh forms one of a sphere, an elongated sphere, or an oblate spheroid.

[0133] 106. The treatment system according to any one of the preceding clauses, wherein the scalable mesh comprises an inner layer and an outer layer.

[0134] 107. The treatment system according to any one of the preceding clauses, wherein the maximum cross-sectional size of the scalable 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.

[0135] 108. The treatment system according to any one of the preceding clauses, wherein the expandable mesh is a laser cutting tube.

[0136] 109. The treatment system according to any one of the preceding clauses, wherein the expandable mesh comprises a plurality of interwoven filaments.

[0137] 110. The treatment system according to any one of the preceding clauses, wherein the occlusion member is bent at least for most of its entire length.

[0138] 111. The treatment system according to any one of the preceding clauses, wherein the occlusive member is contractile when contacted by a synthetic gel or fluid.

[0139] 112. The treatment system according to any one of the preceding clauses, wherein the occlusion member is configured to rotate about the conduit.

[0140] 113. The treatment system according to any one of the preceding clauses, wherein the occlusion member is rotatably and / or slidably coupled to the conduit.

[0141] 114. The treatment system according to any one of the preceding clauses, wherein the occlusion member has an orifice at its distal portion, and wherein the elongated member extends through the orifice.

[0142] 115. The treatment system according to any one of the preceding clauses, wherein the distal element is configured to move axially along the elongated member.

[0143] 116. The treatment system according to any one of the preceding clauses, wherein the embolic element is a liquid embolism.

[0144] 117. The treatment system according to any one of the preceding clauses, wherein the embolic element comprises a biopolymer and / or a chemical crosslinking agent.

[0145] 118. The therapeutic system according to any one of the preceding clauses, wherein the biopolymer comprises chitosan, chitosan derivatives, chitosan analogs, or combinations thereof.

[0146] 119. The treatment system according to any one of the preceding clauses, wherein the chemical crosslinking agent comprises genipin, a derivative of genipin, an analog of genipin, or a combination thereof.

[0147] 120. A system comprising:

[0148] The treatment system mentioned in any one of the foregoing clauses; and

[0149] An elongated shaft having a lumen extending therethrough, wherein the treatment system is configured to be slidably disposed within the first lumen of the elongated shaft.

[0150] 121. A system comprising:

[0151] The treatment system mentioned in any of the preceding clauses;

[0152] 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

[0153] 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.

[0154] 122. The treatment system according to any one of the preceding clauses, wherein the first elongated axis is a microcatheter and the second elongated axis is a delivery catheter or a guiding catheter.

[0155] 123. A method for treating an aneurysm, comprising:

[0156] Provide the treatment system as described in any of the foregoing clauses.

[0157] 124. The method according to any one of the preceding clauses further includes:

[0158] Positioning the distal end of the distal conduit of the treatment system within the aneurysm cavity; and

[0159] When the distal end of the conduit is positioned within the aneurysm cavity, the occlusion member is released, causing the occlusion member to self-expand to present an expanded state.

[0160] 125. The method according to any one of the preceding clauses further includes delivering the embolic element through the distal end of the distal conduit to the treatment site.

[0161] 126. The method according to any one of the preceding clauses, wherein releasing the occlusion member comprises rupturing the coupling to disengage the proximal conduit from the distal conduit.

[0162] 127. The method according to any one of the preceding clauses further includes retracting the proximal conduit proximally while holding the distal conduit and the occlusion member in place at the treatment site.

[0163] 128. The method according to any one of the preceding clauses, wherein breaking the coupling includes expanding the coupling.

[0164] 129. The method according to any one of the preceding clauses, wherein breaking the coupling includes expanding the coupling.

[0165] 130. The method according to any one of the preceding clauses, wherein rupturing the coupling comprises delivering fluid into an internal volume defined by the coupling.

[0166] 131. The method according to any one of the preceding clauses, wherein rupturing the coupling comprises injecting brine into the internal volume defined by the coupling.

[0167] 132. A treatment device comprising:

[0168] A conduit having a distal portion and a lumen extending through the conduit;

[0169] A connector slidably connected to the distal portion, allowing the connector to move axially relative to the pipe;

[0170] A blocking member, the blocking member being connected to a connecting member; and

[0171] A fixing member is connected to the pipe proximal to the connector, the fixing member including a distal portion removably connected to the connector.

[0172] 133. The treatment device according to any one of the preceding clauses, wherein movement of the conduit relative to the coupling causes the fixing member to disengage from the coupling.

[0173] 134. The treatment device according to any one of the preceding clauses, wherein the distal movement of the conduit relative to the coupling causes the distal portion of the fixing member to move radially away from the coupling.

[0174] 135. The treatment device according to any one of the preceding clauses, wherein the fixation member includes a proximal portion coupled to the conduit, and wherein movement of the conduit relative to the coupling in the distal direction causes the distal portion of the fixation member to move radially away from the coupling.

[0175] 136. The treatment device according to any one of the preceding clauses, wherein the fixation member comprises at least one of an elastic material, nitinol, stainless steel, cobalt chromium, platinum, or an alloy thereof.

[0176] 137. The treatment device according to any one of the preceding clauses, wherein the radial dimension of the distal portion of the fixation member is greater than the radial dimension of the remaining portion of the fixation member.

[0177] 138. The treatment device according to any one of the preceding clauses, wherein the distal portion includes a damage-resistant end.

[0178] 139. The treatment device according to any one of the preceding clauses, wherein the fixation member comprises a continuous surface extending along its entire length.

[0179] 140. The treatment device according to any one of the preceding clauses, wherein the fixation member is heat-treated to have a concave shape and / or a convex shape.

[0180] 141. The treatment device according to any one of the preceding clauses, wherein the fixation member is heat-treated such that at least a portion of the fixation member bends inward toward the conduit and / or the coupling.

[0181] 142. The treatment device according to any one of the preceding clauses, wherein at least a portion of the fixation member proximal to the distal portion is substantially linear or straight.

[0182] 143. The treatment device according to any one of the preceding clauses, wherein the fixation member is a first fixation member, and the treatment device further includes a second fixation member connected proximally to the conduit via the connector, the second fixation member including a distal portion configured to be removably connected to the connector.

[0183] 144. The treatment device according to any one of the preceding clauses, wherein the fixing member surrounds the circumference of the conduit.

[0184] 145. The treatment device according to any one of the preceding clauses, wherein the fixation member includes a proximal portion connected to the conduit.

[0185] 146. The treatment device according to any one of the preceding clauses, wherein the fixation member includes a proximal portion coupled to the conduit, and the treatment device further includes a stop member fixedly coupled to the conduit proximal to the coupling member, wherein the proximal portion of the fixation member is coupled to the conduit via the stop member.

[0186] 147. The treatment device according to any one of the preceding clauses, wherein the coupling is rotatably movable relative to the conduit.

[0187] 148. The treatment device according to any one of the preceding clauses, wherein the coupling is disposed around the outermost surface of the conduit.

[0188] 149. The treatment device according to any one of the preceding clauses, wherein the coupling has a generally curved, circular, polygonal or hexagonal shape.

[0189] 150. The treatment device according to any one of the preceding clauses, wherein the proximal end of the occlusion member is connected to the distal portion of the conduit via the coupling.

[0190] 151. The treatment device according to any one of the preceding clauses, wherein at least a portion of the coupling is radiopaque.

[0191] 152. The treatment device according to any one of the preceding clauses, wherein the coupling includes an intermediate region recessed relative to the proximal region of the coupling.

[0192] 153. The treatment device according to any one of the preceding clauses, wherein the size of the intermediate region is substantially the same as or larger than the size of the distal portion of the fixation member.

[0193] 154. The treatment device according to any one of the preceding clauses, wherein the distal portion of the fixation member is at least partially positioned in the intermediate region such that the fixation member is removably coupled to the connector via the distal portion.

[0194] 155. The treatment device according to any one of the preceding clauses, wherein the coupling includes an inner band and an outer band at least partially surrounding the inner band, wherein a portion of the occlusion member is coupled to the coupling between the inner band and the outer band.

[0195] 156. The treatment device according to any one of the preceding clauses, wherein the outer band includes a first outer band and a second outer band spaced apart from the first outer band to define an intermediate region between the first outer band and the second outer band.

[0196] 157. The treatment device according to any one of the preceding clauses, wherein the size of the intermediate region is substantially the same as or larger than the size of the distal portion of the fixation member.

[0197] 158. The treatment device according to any one of the preceding clauses, wherein the distal portion of the fixation member is at least partially positioned in the intermediate region such that the fixation member is removably coupled to the connector via the distal portion.

[0198] 159. The treatment device according to any one of the preceding clauses, wherein the conduit is a thiopancreatic tube or a tubular element.

[0199] 160. The treatment device according to any one of the preceding clauses, wherein the hypotube or tubular element extends at least partially through the occlusion member and / or extends distally beyond the occlusion member.

[0200] 161. The treatment device according to any one of the preceding clauses, wherein the hyaluronic acid tube or tubular element has a cross-sectional dimension of at least 0.012 inches.

[0201] 162. The treatment device according to any one of the preceding clauses, wherein the tubular element is a microcatheter.

[0202] 163. The treatment device according to any one of the preceding clauses, wherein the microcatheter has a cross-sectional dimension of at least 0.035 inches.

[0203] 164. The treatment device according to any one of the preceding clauses, wherein the conduit is a microcatheter or tubular element.

[0204] 165. The treatment device according to any one of the preceding clauses, wherein the microcatheter has a cross-sectional dimension of at least 0.012 inches.

[0205] 166. The treatment device according to any one of the preceding clauses, wherein the occlusion member is an occlusion member or intracapsular device configured to be implanted within an aneurysm.

[0206] 167. The treatment device according to any one of the preceding clauses, wherein the occlusion member is disposed around the conduit and connected to the outer surface of the conduit via the coupling.

[0207] 168. The treatment device 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 at least a portion of the mesh being configured to be positioned across the neck of the aneurysm.

[0208] 169. The treatment device 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.

[0209] 170. The treatment device 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.

[0210] 171. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of threads, wherein some or all of the threads have a diameter of at least 0.001 inches.

[0211] 172. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of wires, wherein some or all of the plurality of wires have the same diameter.

[0212] 173. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises a braid formed of a plurality of wires, wherein at least some of the plurality of wires have different diameters.

[0213] 174. The treatment device according to any one of the preceding clauses, wherein in the extended state, the expandable mesh forms one of a sphere, an elongated sphere, or an oblate spheroid.

[0214] 175. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises an inner layer and an outer layer.

[0215] 176. The treatment device according to any one of the preceding clauses, wherein the maximum cross-sectional size 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.

[0216] 177. The treatment device according to any one of the preceding clauses, wherein the expandable mesh is a laser cutting tube.

[0217] 178. The treatment device according to any one of the preceding clauses, wherein the expandable mesh comprises a plurality of interwoven filaments.

[0218] 179. The treatment device according to any one of the preceding clauses, wherein the occlusion member is bent at least for most of its entire length.

[0219] 180. The processing apparatus according to any one of the preceding clauses, wherein the occlusion member is retractable upon contact with the synthetic gel or fluid.

[0220] 181. The treatment device according to any one of the preceding clauses, wherein the occlusion member is configured to rotate about the conduit.

[0221] 182. The treatment device according to any one of the preceding clauses, wherein the occlusion member is rotatably and slidably connected to the conduit.

[0222] 183. The treatment device according to any one of the preceding clauses, wherein the distal element has a hole at its distal portion, and wherein the elongated member extends through the hole.

[0223] 184. The treatment device according to any one of the preceding clauses, wherein the distal element is configured to move axially along the elongated member.

[0224] 185. The treatment device according to any one of the preceding clauses further includes an embolization element, wherein the conduit is configured to deliver the embolization element to a target site.

[0225] 186. The treatment device according to any one of the preceding clauses, wherein the embolic element is a liquid embolism.

[0226] 187. The treatment device according to any one of the preceding clauses, wherein the embolic element comprises a biopolymer and / or a chemical crosslinking agent.

[0227] 188. The therapeutic device according to any one of the preceding clauses, wherein the biopolymer comprises chitosan, chitosan derivatives, chitosan analogs, or combinations thereof.

[0228] 189. The treatment device according to any one of the preceding clauses, wherein the chemical crosslinking agent comprises genipin, a derivative of genipin, an analog of genipin, or a combination thereof.

[0229] 190. A treatment system comprising:

[0230] The treatment device according to any one of the foregoing clauses; and

[0231] An elongated shaft having a lumen extending therethrough, wherein the treatment device is configured to be slidably disposed within the first lumen of the elongated shaft.

[0232] 191. A treatment system comprising:

[0233] Treatment device according to any one of the foregoing clauses;

[0234] A first conduit having a first lumen extending therethrough, wherein the treatment device is configured to be slidably disposed within the first lumen; and

[0235] 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.

[0236] 192. The treatment system according to any one of the preceding clauses, wherein the first elongated axis is a microcatheter and the second elongated axis is a delivery catheter or a guiding catheter.

[0237] 193. A method for treating an aneurysm, comprising providing a treatment device according to any of the preceding clauses.

[0238] 194. The method according to any one of the preceding clauses further includes positioning the distal end of the conduit of the treatment device within the aneurysm cavity; and releasing the occlusion member of the treatment device from the conduit when the distal end of the conduit is positioned within the aneurysm cavity, such that the occlusion member self-expands to present an expanded state.

[0239] 195. The method according to any one of the preceding clauses, wherein releasing the occlusion member comprises separating the fixing member of the treatment device from the coupling of the treatment device.

[0240] 196. The method according to any one of the preceding clauses, wherein the fixation member comprises a distal portion of the connector coupled to the connector when the distal end of the conduit is positioned within the aneurysm cavity, and wherein disengaging the fixation member comprises disengaging the distal portion of the fixation member by disengaging the conduit distally relative to the connector.

[0241] 197. The method according to any one of the preceding clauses, wherein positioning 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.

[0242] 198. The method according to any one of the preceding clauses, wherein the distal end of the conduit is in a first position after positioning, the method further comprising, after positioning the distal end of the conduit, repositioning the distal end of the conduit by (i) retracting the distal end of the conduit away from the dome or distal end of the aneurysm, and (ii) after retraction, advancing the distal end of the conduit toward the dome or distal end of the aneurysm such that the distal end has a second position different from the first position.

[0243] 199. The method according to any one of the preceding clauses, wherein retraction of the distal end comprises retracting the distal end to the proximal side of the distal terminus of the catheter.

[0244] 200. The method according to any one of the preceding clauses, wherein advancing the distal end to the second position comprises advancing the distal end without withdrawing the guiding catheter or the delivery catheter from the patient.

[0245] 201. The method according to any one of the preceding clauses, wherein in the first extended state, the occlusion member forms a predetermined three-dimensional shape.

[0246] 202. The method according to any one of the preceding clauses, wherein in the first extended state, the occluding member defines a first hollow interior.

[0247] 203. The method according to any one of the preceding clauses further includes delivering an embolic element between the occlusion member and the wall of the aneurysm to convert the occlusion member into a second extended state, in which the occlusion member defines a second hollow interior having a volume smaller than the first volume.

[0248] 204. The method according to any one of the preceding clauses, wherein in the second extended state, the occlusion member forms a three-dimensional shape different from the three-dimensional shape in the first extended state.

[0249] 205. The method according to 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

[0250] An embolic element is delivered between the occlusion member and the aneurysm wall to transform the occlusion member into a second extended state, in which the occlusion member defines a second internal volume smaller than the first internal volume, wherein the occlusion member forms a second shape in the second extended state, the second shape being different from the first shape in the first extended state.

[0251] 206. The method according to any one of the preceding clauses, wherein transforming the occlusion member into the second extended shape comprises injecting the embolic material to push a portion of the sidewall of the expandable mesh in a direction away from the wall of the aneurysm and toward the internal region of the occlusion member.

[0252] 207. The method according to any one of the preceding clauses, wherein transforming the occlusion member into the second extended shape comprises injecting the embolizing material to reverse a portion of the sidewall of the occlusion member, such that the portion protrudes toward the aneurysm wall in the first extended state and is recessed toward the aneurysm wall in the second extended state.

[0253] 208. The method according to any one of the preceding clauses, wherein the embolic element comprises a liquid embolism.

[0254] 209. The method according to any one of the preceding clauses, wherein the embolization element comprises one or more embolization coils.

[0255] 210. The method according to any one of the preceding clauses, wherein the delivery of the embolic element is performed after the occlusion member is in the first extended state.

[0256] 211. The method according to any one of the preceding clauses, wherein the occlusion member is a grid.

[0257] 212. The method according to any one of the preceding clauses, wherein the occluding member is a woven fabric.

[0258] 213. The method according to any one of the preceding clauses, wherein the occlusion member is a double-layered braided fabric.

[0259] 214. The method according to any one of the preceding clauses, wherein the occlusion member has a spherical or substantially spherical shape in the first expansion state.

[0260] 215. The method according to any one of the preceding clauses, wherein the occlusion member is cup-shaped or bowl-shaped in the second expansion state.

[0261] 216. The method according to any one of the preceding clauses, wherein the second shape is a predetermined three-dimensional shape.

[0262] 217. The method according to any one of the preceding clauses, wherein the occlusion member forms a multilayer braid at the neck of the aneurysm in the second extended state.

[0263] 218. The method according to any one of the preceding clauses, wherein the occlusion member comprises a plurality of braided filaments, the plurality of braided filaments having a predetermined three-dimensional shape in the extended state.

[0264] 219. The method according to any one of the preceding clauses, wherein the occlusion member comprises a braid formed of 24, 32, 36, 48, 64 or 72 filaments.

[0265] 220. The method according to any one of the preceding clauses, wherein the occlusion member comprises a braid formed of a plurality of threads, wherein some or all of the threads have a diameter of about 0.001 inches (0.00254 cm).

[0266] 221. The method according to any one of the preceding clauses, wherein the occlusion member comprises a braid formed of a plurality of threads, wherein some or all of the plurality of threads have the same diameter.

[0267] 222. The method according to 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 plurality of threads have different diameters.

[0268] 223. The method according to any one of the preceding clauses, wherein the occluding member forms a closed spherical shape in the expanded state, and the mesh has a hole at the distal portion.

[0269] 224. The method according to any one of the preceding clauses, wherein in the extended state, the occlusion member forms one of a sphere, an elongated sphere, or an oblate spheroid.

[0270] 225. The method according to any one of the preceding clauses, wherein the occlusion member comprises an inner layer and an outer layer.

[0271] 226. The method according to 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.

[0272] 227. The method according to any one of the preceding clauses, wherein the expandable mesh includes a hole located at the distal portion, the hole being defined by the fold.

[0273] 228. The method according to 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 proximal portion of the occlusion member.

[0274] 229. The method according to any one of the preceding clauses, wherein the expandable mesh includes a hole located at the distal portion, the hole being defined by the fold.

[0275] 230. The method according to any one of the preceding clauses, 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.

[0276] 231. The method according to any one of the preceding clauses, wherein the occlusion member is formed of a plurality of filaments having a first end and a second end fixed at the hub or coupling.

[0277] 232. The method according to any one of the preceding clauses, wherein the occlusion member is formed of a plurality of filaments, the plurality of filaments being formed of an inner core material surrounded by an outer material.

[0278] 233. The method according to any one of the preceding clauses, wherein the inner core material is a non-transparent ray material and the outer material is a hyperelastic material.

[0279] 234. The method according to any one of the preceding clauses, wherein the occlusion member is a laser-cut tube.

[0280] 235. The method according to any one of the preceding clauses, wherein the occlusion member comprises a plurality of filaments.

[0281] 236. The method according to any one of the preceding clauses, wherein the filaments are interwoven.

[0282] 237. The method according to any one of the preceding clauses, wherein the filaments are woven.

[0283] 238. The method according to 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 coupling.

[0284] 239. The method according to any one of the preceding clauses, wherein the connecting member is disposed at the distal end of the blocking member.

[0285] 240. The method according to any one of the preceding clauses, wherein the connecting member is disposed at the proximal end of the occlusion member.

[0286] 241. The method according to any one of the preceding clauses, wherein each of the filaments terminates only at one end of the distal element.

[0287] 242. The method according to any one of the preceding clauses, wherein the filament forms an opening at the end of the distal element opposite to the only end.

[0288] 243. The method according to any one of the preceding clauses, wherein the reverse portion of each of the filaments defines the opening.

[0289] 244. The method according to any one of the preceding clauses, wherein the reverse portions of the filaments are configured to move relative to each other.

[0290] 245. The method according to any one of the preceding clauses, wherein the embolic element comprises a biopolymer and a chemical crosslinking agent.

[0291] 246. The method according to any one of the preceding clauses, wherein the biopolymer comprises chitosan, chitosan derivatives, chitosan analogs, or combinations thereof.

[0292] 247. The method according to any one of the preceding clauses, wherein the chemical crosslinking agent comprises genipin, a derivative of genipin, an analog of genipin, or a combination thereof.

[0293] 248. The method according to any one of the preceding clauses, wherein the embolic element further comprises a physical crosslinking agent.

[0294] 249. The method according to any one of the preceding clauses, wherein the physical crosslinking agent comprises β-glycerophosphate, a derivative of β-glycerophosphate, an analog of β-glycerophosphate, or a combination thereof.

[0295] 250. The method according to any one of the preceding clauses, wherein:

[0296] The biopolymers include chitosan, chitosan derivatives, chitosan analogs, or combinations thereof.

[0297] The chemical crosslinking agent includes genipin, genipin derivatives, genipin analogs, or combinations thereof; and

[0298] The physical crosslinking agent includes β-glycerophosphate, derivatives of β-glycerophosphate, analogs of β-glycerophosphate, or combinations thereof.

[0299] 251. The method according to any one of the preceding clauses, wherein the embolic element comprises a contrast agent.

[0300] 252. The method according to any one of the preceding clauses, wherein the contrast agent is selected to provide reduced radiopaque linearity.

[0301] 253. The method according to any one of the preceding clauses, wherein the contrast agent comprises iohexol, a derivative of iohexol, an analog of iohexol, or a combination thereof.

[0302] Further features and advantages of the present invention are described below, and will be apparent in part from the description, or may be learned by practicing the present invention. The advantages of the present invention will be realized and obtained through the structures specifically pointed out in the written description and its claims and drawings. Attached Figure Description

[0303] Many aspects of the invention can be better understood by referring to the following accompanying drawings. The components in the drawings are not necessarily to scale; rather, the focus is on clearly illustrating the principles of this disclosure.

[0304] Figure 1A A perspective view of a system for treating aneurysms according to the present technology is shown.

[0305] Figure 1B The present invention is shown Figure 1A A magnified view of the distal portion of the treatment system.

[0306] Figure 1C and 1D This is a cross-sectional view of a clogging member in an expanded state according to this technology.

[0307] Figure 2 An embolization kit according to this technology is shown.

[0308] Figure 3A-3G An exemplary method for treating aneurysms using a treatment system based on this technology is described.

[0309] Figures 4A-4C These are cross-sectional views of the separation components of the treatment system based on various aspects of this technology at different separation stages.

[0310] Figures 5A-5C The delivery of occlusion components and embolization elements according to aspects of the present technology to the treatment site is illustrated.

[0311] Figures 6A-6C This is a cross-sectional view of another embodiment of the separation part of the treatment system according to various aspects of this technology at different separation stages.

[0312] Figure 7Another embodiment of a separate portion of a treatment system according to various aspects of the present technology is shown.

[0313] Figure 8 Another embodiment of a separate portion of a treatment system according to various aspects of the present technology is shown.

[0314] Figures 9A-9C This is a cross-sectional view of another embodiment of the separation part of the treatment system according to various aspects of this technology at different separation stages.

[0315] Figure 10A and 10B This is a cross-sectional view of another embodiment of the separation part of the treatment system according to various aspects of this technology at different separation stages.

[0316] Figure 11 Detailed views of the separate parts of the treatment system according to various aspects of this technology are shown.

[0317] Figures 12A-12C Separation methods according to various aspects of this technology are shown.

[0318] Figures 13A-13D The delivery of occlusion components and embolization elements to the treatment site according to various aspects of the present technology is illustrated.

[0319] Figure 14 Another embodiment of a separate portion of a treatment system according to various aspects of the present technology is shown.

[0320] Figure 15 Another embodiment of a separate portion of a treatment system according to various aspects of the present technology is shown.

[0321] Figure 16A and 16B Another embodiment of a separate portion of a treatment system according to various aspects of the present technology is shown.

[0322] Figure 17A This is a cross-sectional side view of the connecting component according to an embodiment of the present technology.

[0323] Figure 17B According to the implementation scheme of this technology, after the slender components of the system have been partially withdrawn... Figure 17A A cross-sectional side view of the component shown.

[0324] Figure 17C According to the implementation scheme of this technology, after the slender member has been further withdrawn... Figure 17B A cross-sectional side view of the component shown.

[0325] Figure 18-20 It is based on the implementation scheme of this technology. Figure 17AA cross-sectional side view of another embodiment of the component shown.

[0326] Figures 21A-21H It is an embodiment of the present technology for use via Figure 17A A cross-sectional side view of the method of delivering, repositioning, and / or re-equipping the treatment device for the components shown. Detailed Implementation

[0327] 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 amount of the embolic element adequately fills 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 redirects 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 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.

[0328] Once the occlusion component has been deployed within the aneurysm and the embolization element has been delivered, the occlusion component can be dissociated from the delivery assembly. A suitable dissociation mechanism must be as small as possible to be guided through the narrow opening of the catheter to the treatment site, while on the other hand, it must reliably and safely produce dissociation of the intra-sac implant. In the absence of reliable dissociation of the intra-sac implant, withdrawal of the delivery line and catheter may result in the inadvertent removal of the occlusion component from the lumen to be closed, thereby damaging and / or rupturing the lumen or the vessel wall. In some embodiments, interference fits, threaded engagements, fracturing couplings, one or more fixation components, or any other mechanical or other type of dissociation mechanism as described herein can be used to facilitate reliable, controlled dissociation of the occlusion component.

[0329] This article refers to Figure 1A-21HSpecific details of systems, apparatuses, and methods for treating intracranial aneurysms according to embodiments of the present technology are described herein. 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 the present technology. For example, suitable features of the systems, apparatuses, and methods for treating saccular intracranial aneurysms may be implemented in the context of treating non-saccular intracranial aneurysms, abdominal aortic aneurysms, thoracic aortic aneurysms, renal artery aneurysms, arteriovenous malformations, tumors (e.g., via obstruction of vessels supplying the tumor), perivascular leaks, varicose veins (e.g., via obstruction of one or more trunk veins, such as the great saphenous vein), hemorrhoids, and sealing endoleaks adjacent to artificial heart valves, covered stents, and abdominal aortic aneurysm devices, among other examples. 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 the present 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 not have one or more of the configurations, components, processes, etc. disclosed herein without departing from the present technology.

[0330] I. Overview of this technical system

[0331] Figure 1A A view of a system 10 for treating intracranial aneurysms according to one or more embodiments of the present technology is shown. Figure 1A As shown, system 10 includes a treatment system 100 and an embolization kit 200 used with one or more components of the treatment system 100. The treatment system 100 may include an occlusion member 102 (shown in an extended 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 an embolization element (and / or one or more precursors thereof) to the aneurysm. Alternatively or additionally, system 10 may include a separate delivery system (not shown) for delivering an embolization element (and / or one or more precursors thereof) to the aneurysm lumen.

[0332] like Figure 1AAs 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 at or near a treatment site within a blood vessel (e.g., an intracranial vessel) at or near the thrombus. 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 components 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 does not include the first elongated shaft 109, but only includes the second elongated shaft 108.

[0333] Figure 1B This is an enlarged view of the distal portion 100b of the treatment system 100. (See also...) Figure 1A and 1B The occlusion member 102 is detachably coupled to the distal end of the elongated tubular element 106. For example, the elongated member 106 may include a first coupling 112 at its distal end, and the occlusion member 102 may include a second coupling 114 configured to be detachably coupled to the first coupling 112. In some embodiments, the first coupling 112 and the second coupling 114 may employ an interference-fit mechanical separation mechanism (as referred to below). Figure 4A-8 (More detailed description), threaded mechanical separation mechanism (as shown in the following reference) Figure 9A-10B (More detailed description), mechanical separation mechanism for the fractured coupling (as referred to below) Figure 11-16B (Describe in more detail) or mechanical couplings including one or more fixed components (as described below) Figure 17A-21H (described in more detail below). The treatment system 100 may also include a conduit 116 extending distally from the handle 103 (e.g., via port 110) to a 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 a delivery system (e.g., a first elongated shaft 109 or a second elongated shaft 108, an elongated member 106, etc.) to a location outside the occlusion member 102. In this way, the embolic element can be positioned between the occlusion member 102 and the inner wall of the aneurysm lumen, as described in more detail below.

[0334] According to some embodiments, the second elongated shaft 108 is typically configured to follow and enter brain-associated blood vessels above a conventional guideline in the cervical 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 inner diameter of the second elongated shaft 108 can be 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.

[0335] 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 be flexible enough to allow the occlusion member 102 to be manipulated through a tortuous channel, such as advance 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 comprise a solid metal wire. In some embodiments, the elongated member 106 may comprise any other suitable form of shaft, such as an elongated tubular shaft.

[0336] In some embodiments, the elongated member 106 may comprise stainless steel, nitinol, or other metals or alloys. In some embodiments, the elongated member 106 may be coated with, for example, polytetrafluoroethylene along part 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.

[0337] According to several embodiments, conduit 116 may be a conduit or elongated shaft that is delivered separately from the second elongated shaft 108.

[0338] A. Example of selecting blocking devices

[0339] Figure 1C This is a cross-sectional view of the occlusion member 102, showing it in an expanded state and separated from the treatment system 100. (See reference...) Figure 1B and 1C The occlusion member 102 may include an expandable element that has a low profile or constrained state when positioned within a catheter (e.g., a second elongated shaft 108) for delivery to the aneurysm, and is configured to be in an expanded state positioned within the aneurysm (e.g., a cerebral aneurysm).

[0340] According to some embodiments, the occlusion member 102 may include a mesh 101 formed of a plurality of braided filaments, which, when the mesh 101 is in an expanded, unconstrained state, have been heat-set into a predetermined shape having an internal volume 130. Example shapes include spheres, such as spheres, elongated spheres, oblate spheroids, etc. Figure 1C As shown, the mesh 101 may have an inner layer 122 and an outer layer 124, the inner and outer layers having proximal ends fixed relative to each other at the second connector 114 and meeting distally at a distal fold 128 surrounding the aperture 126. Although the inner layer 122 and outer layer 124 are depicted as spaced apart from each other along their length, they may contact each other in whole or in part along their length. For example, the inner layer 122 may press radially outward against the outer layer 124. In some embodiments, the occlusion member 102 may be formed of a single layer or a mesh or braid.

[0341] In some embodiments, the distal ends of the inner layer 122 and the outer layer 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 expanded mesh 101, and the opening 126.

[0342] The inner layer 122 and the outer layer 124 may be aligned with each other at the distal portion (e.g., as shown in the image). Figure 1C (As shown), to form a curved distal surface. For example, at least in the distal portion of the occlusion member 102, the inner layer 122 and the outer layer 124 may extend distally and radially inward toward the orifice 126. In some embodiments, the outer layer 122 and / or the inner layer 124 extend distally and radially outward from the second coupling 114, and then distally and radially inward to the distal end of the occlusion member 102 (e.g., fold 128). The occlusion member 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 into a substantially flat distal surface surrounding the orifice 126. In some embodiments, the curved surface transitions to a distal surface surrounding the orifice 126 and having a radius of curvature greater than the average radius of curvature of the remainder of the occlusion member 102. Having a flat or substantially flat distal surface, or a distal surface having a radius of curvature greater than the average radius of curvature of the remainder of the occlusion member 102, is advantageous for delivering 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 (e.g., see...). Figure 3B In some embodiments, the surface of the occlusion member 102 surrounding the orifice 126 is curved and / or has a radius of curvature substantially the same as the rest of the occlusion member 102.

[0343] In any case, the inner layer 124 may have a shape substantially the same as that 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 size than the outer layer 124. An advantage of this structure is that the embolic element 230 experiences less resistance, at least initially, when the distal wall of the occlusal member 102 is pushed downward toward the neck (as described in more detail below).

[0344] In any case, the proximal and distal portions of mesh 101 can form a generally closed surface. However, unlike the proximal portion of mesh 101, the portion of the filament at or near the fold 128 in the distal portion of mesh 101 can move relative to each other. Therefore, the distal portion of mesh 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 of the distal portion of the filament and an opening through which conduit 116, wires, pipes, or other slender members can pass.

[0345] In some embodiments, each of the plurality of filaments has a first end positioned at a proximal portion of the grid 101 and a second end also positioned at a proximal portion of the grid 101. Each filament can extend distally from its corresponding first end along the body of the grid 101 to the fold 128, fold, and then proximally along the grid body to its corresponding second end at the proximal portion of the grid 101. Thus, each of the plurality of filaments has a first length forming an inner layer 122 of the grid 101, a second length forming an outer layer 124 of the grid 101, and a first end and a second end fixed at the proximal portion of the grid 101. In some embodiments, the occlusion member 102 may comprise a grid formed of a single layer or a grid formed of three or more layers.

[0346] In some embodiments, the distal surface of the mesh 101 is completely closed (i.e., does not contain any holes). In some embodiments, the filament is fixed relative to both the proximal and distal ends of the occlusion member 102.

[0347] 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 approximately 0.0004 inches to approximately 0.0020 inches, or from approximately 0.0009 inches to approximately 0.0012 inches. In some embodiments, each of the wires 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 of the filaments may have a slightly thicker diameter to give the braided layer additional strength. In some implementations, 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 braid matrix density.

[0348] The occlusion element 102 can have different shapes and sizes in an extended, unconstrained state. For example, the occlusion element 102 can be bullet-shaped, barrel-shaped, egg-shaped, gyroscope-shaped, bowl-shaped, disc-shaped, cylindrical, or approximately cylindrical, barrel-shaped, cup-shaped, etc.

[0349] B. Example of embolization kit selection

[0350] 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 precursor material 203 and the second precursor material 205. The mixing device 206 may include mixing syringes 208 (identified as mixing syringes 208a and 208b, respectively) and a coupling 210 extending between respective outlets (not shown) of the mixing syringes 208. The mixing syringes 208a and 208b each include a plunger 212 and a cylinder 214 slidably housed therein.

[0351] The embolization kit 200 may also include a syringe 216 configured to receive a mixture of a first precursor material 203 and a second precursor material 205 and to 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 coupling configured to form a robust fluid connection between the lumen and the outlet 222 of the syringe 216.

[0352] The first precursor material 203 and the second precursor material 205 may each comprise a biopolymer and a chemical crosslinking agent. The chemical crosslinking agent may be selected to form covalent crosslinks between the biopolymer chains. 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 deacetylated 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. Alternatively 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 other suitable compounds, alone or in combination.

[0353] Mixing the biopolymer of the first precursor material 203 with the chemical crosslinking agent of the second precursor material 205 initiates chemical crosslinking of the biopolymer. Following mixing of the first and second precursor materials 203, the biopolymer undergoes chemical crosslinking for a sufficient duration 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 for chemical crosslinking of the biopolymer 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, 30, 20, or 10 minutes). The target deployment viscosity can be high enough to keep the agglomerate of the embolic element 230 within the internal volume of the aneurysm without reinforcing the neck.

[0354] 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 can be used, for example, to customize 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 via the lumen of conduit 116 during a suitable time period (e.g., a time period in the range of 10 to 40 minutes) after the first precursor material 203 and the second precursor material 205 are mixed. In at least some cases, the first precursor material 203 and the second precursor material 205 are mixed in a certain proportion such that the weight ratio of the biopolymer to the chemical crosslinking agent in the resulting embolic 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 example, the first precursor material 203 and the second precursor material 205 are mixed in a certain proportion such that the weight ratio of the biopolymer to the chemical crosslinking agent in the resulting embolic element 230 is 30:1.

[0355] Using a biopolymer instead of a synthetic polymer in the first precursor material 203 may be advantageous because biopolymers tend to be 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 and / or for other reasons. In the case of forming a tissue scaffold within an aneurysm, high adhesiveness of the embolization element 230 may be more important than in other cases to secure the solidified embolization element 230 within the aneurysm 302. For example, high adhesiveness of the embolization element 230 can reduce or eliminate the possibility of fragments of the embolization element 230 breaking off freely during delivery and entering the patient's cerebral blood flow.

[0356] The first precursor material 203 and the second precursor material 205 may include other components and / or the kit 200 may include other precursor materials intended to be mixed with the first precursor material 203 and the second precursor material 205. For example, the first precursor material, the second precursor material, and / or another precursor material may include a physical crosslinking agent. The presence of a physical crosslinking agent can be used to form physical crosslinks, which complement the chemical crosslinks from the chemical crosslinking agent. The combination of chemical and physical crosslinks can enhance the cohesiveness of the embolic element 230. Suitable physical crosslinking agents for chitosan-based biopolymers include β-glycerophosphate, 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.

[0357] 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 persistent radiopaqueness of the coil often interferes with 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 a blood-carrying contrast agent that would otherwise indicate reperfusion by fluoroscopy. In at least some embodiments of the present technology, the contrast agent within the embolization element 230 is selected to provide radiopaque linearity that decreases over time. For example, the contrast agent may initially be radiopaque to facilitate the delivery of the embolization element 230, and then become less radiopaque to facilitate subsequent imaging. In certain embodiments, the first, second, and / or another precursor material comprises iohexol or a derivative or analogue thereof as a suitable contrast agent.

[0358] In animal studies, the fluid embolization of this technique has 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 by new endothelial tissue. These features, among others, 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 bioabsorbable, thus reducing in 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 radiopaqueness; thus, when configured in this way, it will not interfere with future CT and MRI imaging and procedures. 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.

[0359] In some embodiments, the embolization kit 200 and / or 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 retained within the aneurysm. In some embodiments, the embolization kit 200 may include a premixed embolization element.

[0360] In some embodiments, the embolization kit 200 and / or 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 retained within the aneurysm. In some embodiments, the embolization kit 200 may include a premixed embolization element.

[0361] Further details regarding suitable embolic elements can be found in U.S. Patent Application No. 15 / 299,929, filed October 21, 2016, the disclosure of which is incorporated herein by reference in its entirety.

[0362] II. The chosen method for treating aneurysms

[0363] Figure 3A-3GAn exemplary method for treating an aneurysm A using system 10 of the present technology is described. First, a physician may advance a second elongated shaft 108 intravascularly toward the intracranial aneurysm (or other treatment site, such as any of those described herein) with the occlusion member 102 in a low-profile state. The distal portion of the second elongated shaft 108 may 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. An elongated member 106 may 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 expansion state. Releasing the occlusion member 102 from the shaft 108 and allowing the occlusion member 102 to self-expand to the first expansion state may optionally or additionally include withdrawing the shaft 108 relative to the elongated member 106.

[0364] Figure 3A The occlusion member 102 is shown in its first expanded state, positioned within the aneurysm cavity, and still connected to the elongated member 106. (See diagram.) Figure 3A As shown, in the first extended state, the blocking member 102 can take on a predetermined shape that closes the internal volume 130 (see...). Figure 1C In this first extended state, the occlusion member 102 can generally conform to the shape of the aneurysm A. For example... Figure 3B As shown, the occlusion member 102 and the delivery system are shown in cross-section. A conduit 116 is advanceable through the internal volume 130 of the occlusion member 102 such that the distal opening of the conduit 116 is located at or distal to an orifice 126 in the distal portion of the occlusion member 102. An embolic element 230 can be delivered via the conduit 116 to the space between the occlusion member 102 and the inner surface of the aneurysm wall W.

[0365] In some embodiments, the method includes mixing a first precursor material 203 and a second precursor material 205. Figure 2To form an embolic element 230. The mixing of the first precursor material 203 and the second precursor material 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 of the cylinders 214, the second precursor material 205 is loaded into the other cylinder 214, and the mixing syringe 208 is coupled via coupling 210. To mix the first precursor material 203 and the second precursor material 205, the plunger 212 is pressed alternately, causing the first precursor material 203 and the second precursor material 205 to repeatedly move from one cylinder 214 to the other 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 coupled to the proximal end of conduit 116 to deliver the embolic element 230 through conduit 116 and into the aneurysm A. As the embolization element 230 passes through the lumen of the conduit 116, the chemical cross-linking of the biopolymer can continue to occur.

[0366] Still refer to 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 created between the aneurysm wall W and the occlusion member 102. Figure 3B-3D As the progress shows, 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 substantially uniform pressure on the distal surface of the occlusion member 102, which causes the occlusion member 102 to contract inward on itself, thereby transitioning the circular distal wall 132 from a concave surface toward the neck N of the aneurysm A to a convex surface toward the neck N. The pressure and flipping of the distal portion of the wall 132 creates an annular fold 136, which defines the distal edge of the occlusion member 102. As the occlusion member 102 continues to flip, the position of the fold 136 moves toward the neck N, which continues until the distal half of the occlusion member 102 is flipped. In some embodiments, the occlusion member 102 may include one or more portions configured to preferably flex or bend, such that the occlusion member 102 folds in the desired longitudinal direction. Furthermore, when the closure member 102 contracts, the distance between the wall at the distal portion 132 and the wall at the proximal portion decreases, thus reducing the internal volume 130 of the closure member 102. When the closure member 102 contracts, the conduit 116 can remain stationary, advance distally, and / or retract proximally.

[0367] During and after 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. Under single-plane imaging methods (e.g., fluoroscopy), compression of the occlusion member with the embolic element 230 provides the physician with a real-time “leveling” or “aneurysm filling indicator,” allowing the physician to confirm at what point the aneurysm volume is completely filled. Filling as much space as possible within the aneurysm is beneficial, as leaving gaps within the aneurysm sac can lead to delayed healing and increase the risk of aneurysm recanalization and / or rupture. While the stent provided by the occlusion member 102 across the neck helps to form a thrombus in any gap and heal in the neck, substantial filling of the lumen prevents abrupt rupture and is independent of the neck stent (i.e., the occlusion member 102). Conventional devices cannot provide confirmation of complete or substantially complete aneurysm filling under single-plane imaging.

[0368] Once the delivery of the embolic element 230 is complete, the conduit 116 can be withdrawn. In some embodiments, the embolic element 230 can fill more than 40% of the aneurysm sac volume. In some embodiments, the embolic element 230 can fill more than 50% of the aneurysm sac volume. In some embodiments, the embolic element 230 can fill more than 60% of the aneurysm sac volume. In some embodiments, the embolic element can fill more than 65%, 70%, 75%, 80%, 85%, or 90% of the aneurysm sac volume.

[0369] Figure 3E The second extended state of the occlusion member 102, shown in cross-section, is illustrated, with the embolization element 230 occupying the remaining volume of the aneurysm A. Figure 3F The occlusion member 102 with the embolic element 230 completely removed is shown, thus revealing the second shape of the occlusion member 102. As shown, the embolic element 230 can be delivered until the occlusion member 102 is fully retracted, such that the occlusion member 102 has essentially no internal volume.

[0370] In the second extended state, the occlusion member 102 may be formed in a bowl shape, extending across the neck of the aneurysm A. The wall of the occlusion member 102 at the distal portion may now be positioned to contact or be directly adjacent to the wall of the occlusion member 102 at the proximal portion. The distal wall 132 may contact the proximal wall 134 along its entire or substantially entire length. In some embodiments, the distal wall 132 may contact the proximal wall 134 only along a portion of its length, while the remaining length of the distal wall 132 is closely adjacent to, but not in contact with, the proximal wall 134.

[0371] It is particularly advantageous for the occlusion member 102 to contract toward the neck N of the aneurysm, as this doubles the number of layers across the neck and thus increases occlusion at the neck N. For example, contraction or flipping of the distal wall 132 onto 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, the deformation of the distal wall 132 onto or within the proximal wall 134 reduces the effective porosity of the occlusion member 102 at the neck N. Thus, 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 occludes the pores of adjacent layers or walls of the member 102, preventing blood from flowing through the embolization element 230 into the aneurysm lumen. The aim is to occlude as much of the aneurysm as possible, as leaving gaps allows blood to flow in and / or pool, which can then extend beyond the wall of aneurysm A. Dilatation of aneurysm A can lead to recanalization and / or protrusion of the occlusion element 102 and / or embolization element 230 into the parent vessel and / or rupture of aneurysm A. Both scenarios are fatal to the patient.

[0372] In embodiments where the wall of the occlusion member 102 comprises an inner and outer layer, the deformation 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 deformation 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 toward the neck N of the aneurysm A on the occlusion member 102, thereby pressing the portion of the occlusion member 102 near 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.

[0373] like Figure 3G As shown, the first connector 112 is detachable from the second connector 114, and the elongated member 106 and the second elongated shaft 108 can be retracted, thereby leaving the occlusion member 102 and the embolization element 230 implanted within the aneurysm A. For example, the occlusion member 102 can be detached from the elongated member 106 using any mechanical separation mechanism described in more detail below.

[0374] Over time, the natural vascular remodeling mechanisms and / or bioresorption of the embolic element 230 may lead to thrombus formation and / or the transformation of the entrapped thrombus into fibrous tissue within the internal volume of aneurysm A. These mechanisms may also result in cell death at the aneurysm wall and the growth of new endothelial cells between and above the filaments or struts of the occlusive component 102. Ultimately, the thrombus and cells on the aneurysm wall may completely degrade, leaving a successfully remodeled vascular area.

[0375] In some embodiments, contrast agent may be delivered during the advancement of the occlusion member 102 and / or embolization element 230 in the vascular system, during the deployment of the occlusion member 102 and / or embolization element 230 at the aneurysm A, and / or after the deployment of the occlusion member 102 and / or embolization element 230 before the start of withdrawal of the delivery system. The contrast agent may be delivered via the second elongated shaft 108, conduit 116, or via another catheter or device typically used for delivering contrast agents. The aneurysm (and the devices therein) may be imaged before, during, and / or after the injection of contrast agent, and the images may be compared to confirm the degree of aneurysm occlusion.

[0376] According to some aspects of this technology, system 10 may include separate first and second elongated shafts (e.g., microcatheters) (not shown), the first elongated shaft being dedicated to delivering embolic elements and the second elongated shaft being dedicated to delivering occlusive members. In an exemplary method of treating an aneurysm, the first elongated shaft may be advanced intravascularly to the aneurysm and through the neck, such that the distal tip 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.

[0377] A second elongated axis, including an occlusion member (e.g., occlusion member 102), can be advanced intravascularly into the aneurysm and positioned adjacent to the first elongated axis within the aneurysm lumen. The occlusion member can then be deployed within the aneurysm sac. When deployed, the occlusion member pushes the first elongated axis outward toward the side of the aneurysm, and when fully deployed, the occlusion member holds or “constrains” the first elongated axis between the outer surface of the occlusion member and the inner surface of the aneurysm wall.

[0378] The embolic element (e.g., embolic element 230) can then be delivered via a first elongated axis to a location between the inner surface of the aneurysm wall and the outer surface of the occlusion member. For this reason, it may be advantageous to initially position the distal tip of the first elongated axis near the dome (or a more distal surface) of the aneurysm wall. In this way, the first elongated axis is "constrained" 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 herein, as the space in the sac above the occlusion member is filled from the dome toward the neck, the filling of the embolic element pushes and compresses the occlusion member against the tissue surrounding the aneurysm neck. Again, as described elsewhere herein, the compression of the occlusion member with the embolic element provides a "leveling or aneurysm filling indicator" not provided by conventional single-plane imaging methods. The filling of the embolic element can be completed, for example, when it occupies approximately 50%–80% of the aneurysm volume.

[0379] III. Example of interference separation

[0380] Figures 4A-4C A detailed view of the separation portion 400 of a treatment system (e.g., treatment system 100 described herein) at different stages of separation is shown. As described in more detail below, the separation portion 400 may include mechanisms for releasably securing the occlusion member 102 to a conduit for delivering the occlusion member 102 to the treatment site and facilitating the delivery of the embolic element to the treatment site, similar to those described above. Figure 3A-3G The method described. For example... Figures 4A-4C As shown, an elongated tubular element 106 can be coupled to the occlusion member 102 via a hub 402. The hub 402 includes an outer band 404 surrounding an inner band 406, with this proximal portion of the occlusion member 102 held between the inner band 404 and the outer band 406 of the hub 402. The hub 402 may include a recess 408, such as a hole, window, or pawl formed within the inner band 406. The recess 408 may extend some or all of the inner band 406. In some embodiments, the recess 408 may take other configurations, such as the recess being axially positioned between two adjacent bands of the hub.

[0381] The elongated tubular element 106 may have an engagement element 410 configured to releasably engage (e.g., at least partially received therein) a recess 408 of the hub 402. The engagement element 410 may be a ridge, protrusion, projection, enlargement, or any other suitable structure configured to releasably engage with the recess 408. In some embodiments, the engagement element 410 may have a circular surface, for example, generally spherical or near-spherical. In some embodiments, the engagement element 410 may have at least one rounded proximal surface configured to contact the distally facing surface of the recess 408. Thus, when the engagement element 410 contacts the distally facing surface of the recess 408, the bending of the engagement element 410 may push the engagement element 410 radially inward relative to the hub 402. In some embodiments, the engagement element 410 may be located at the distal end of the elongated element 106.

[0382] In the illustrated embodiment, the elongated member 106 has a tapered distal edge 412 such that the engaging member 410 protrudes only from one radial side of the elongated member 106. In some embodiments, the tapered distal edge can be formed by removing a portion of the tubular elongated member, such as a stainless steel hyaluronic acid tube, along a distal portion extending at least axially along the tubular elongated member, such that the resulting portion of the elongated member no longer forms a closed tube and is more flexible than the original elongated member in the corresponding region. The engaging member 410 can then be formed or attached to the distal end of the elongated member. In other embodiments, the elongated member 106 may include a plurality of engaging members 410, any number of which can engage simultaneously or individually with the recess of the hub 402 or other suitable structures. In some embodiments, the engaging member 410 may extend partially or completely circumferentially around the elongated member 106, such as an annular ridge or protrusion, which is disposed on the outer surface of the elongated member 106 and configured to releasably engage the recess 408 of the hub 402.

[0383] Engaging member 410 can be radially inwardly deflected to separate or disengage from recess 408 of hub 402. To maintain engagement with hub 402, control element 416 can be radially positioned adjacent to engaging member 410 on the side of recess 408 opposite the portion of recess 408 in which engaging member 410 is received. Control element 416 prevents engaging member 410 from radially deflecting away from recess 408, thus holding engaging member 408 in a “locked” position relative to hub 402 and closure member 102.

[0384] In some embodiments, the control element 416 includes a wire, rod, shaft, or other elongated structure that extends through the lumen of the elongated tubular member 106 to be removably positioned near the engagement member 410. In some embodiments, the control element 416 may be in the form of an elongated wire, for example made of nitinol, stainless steel, or any other suitable material. The control element 416 can be slidably removed such that in a first position (e.g., Figure 4A As shown, the control element 416 is disposed radially adjacent to the engagement member 410 and prevents it from separating from the hub 402.

[0385] The conduit 116, which defines a lumen 420 therein, can extend within the lumen of the elongated member 106. As previously described, the conduit 116 can be an elongated, flexible tubular member configured to deliver an embolic element (e.g., embolic element 230) through it to a treatment site. Figure 4A As shown, control element 416 may be located within lumen 420 of conduit 116. Conduit lumen 420 may have a tapered diameter, for example, a smaller diameter in a distal portion configured to be positioned at or distal to hub 402, and a larger diameter in a proximal portion configured to be positioned proximal to hub 402. In other embodiments, conduit lumen 420 may have a substantially uniform diameter along some or all of its length. As shown, elongated member 106 may optionally have an outer liner 414 disposed thereon to span the outer surface of elongated member 106 and any exposed portion of conduit 116. The outer liner 414 may be in the form of a tube and may extend along some or all of the length of elongated member 106. In some embodiments, the outer liner 414 extends only on the distal portion of elongated member 106 to extend over tapered end 412 without covering engagement member 410.

[0386] exist Figure 4B and 4C In the configuration shown, the control element 416 has been removed, for example, by proximal retraction within the lumen 420 of the conduit 116. Once the control element 416 has been moved in this way, the embolization element 230 can be introduced through the lumen 420. After the introduction of the embolization element 230, the proximal retraction of the elongated member 106 causes the engaging member 410 to abut the recess 408 and deflect radially inward or otherwise disengage from the recess 408, and also deforms the conduit 116. As the elongated member 106 continues to retract proximal, the engaging member 410 can be completely removed from the hub 402, the elongated member 106 can be removed from the body, while the occlusion member 102 and the hub 402 remain in proper position at the treatment site.

[0387] The engagement member 410, recess 408, and control element 416 illustrate an example of an interference fit mechanism for releasably securing the closure member 102 to the elongated member 106 and / or conduit 116. In various embodiments, any number of interference fit mechanisms may be used. For example, instead of engaging with the recess 408, the engagement member 410 may extend distally beyond the distal end of the hub 402, or may engage with any other structural feature coupled to the closure member 102. The wall thicknesses of the engagement member 410, the control element 416, and adjacent engagement members 410 of the conduit 116 may be configured such that the combined diameter of these elements is larger than the lumen of the hub 402, while the combined diameter of the wall thicknesses of the engagement member 410 and adjacent engagement members 410 of the conduit 116 is smaller than the lumen of the hub 402, and therefore, the engagement member 410 cannot retract through it when the control element 416 is retained within the lumen of the hub 402. However, once the control element 416 is removed, the engaging member 410 can retract proximally through the hub 402, causing the engaging member 410 to abut against the recess 408 and deflect radially inward or otherwise disengage from the recess 408, while also deforming the conduit 116 to release the closure member 102. As another example, multiple control elements 416 instead of a single control element can be used to provide an interference fit. Similarly, multiple engaging members 410 can be provided instead of a single engaging member.

[0388] Figures 5A-5C The diagram illustrates the delivery of the occlusion component 102 and the embolization element 230 to the treatment site within the aneurysm sac. (See diagram for reference.) Figure 5A As shown, the system can be positioned within a second elongated axis 108 (e.g., a microcatheter) for intravascular advancement until the microcatheter is located at or near 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 proximal to the neck of the aneurysm. Figure 5A As shown, the system has been advanced within the elongated shaft 108, such that the occlusion member 102 is maintained in a constrained low-profile configuration within the shaft 108. In various embodiments, the 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.

[0389] like Figure 5BAs shown, once the distal opening of conduit 116 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, after, or simultaneously with the deployment of the occlusion member 102, the control element 416 can be retracted proximally from the lumen of conduit 116. With the control element 416 removed, the embolization element 230 can be delivered through conduit 116 and into the region of the aneurysm distal to the occlusion member 102. In the case of fluids or gels, a syringe or other injector can be used to push the embolization element 230 through the lumen. In the case of microcoils or other structural embolization elements, a delivery line or other suitable mechanism can be slidably advanced through the lumen of the conduit to position the embolization element 230 into the aneurysm sac.

[0390] As referenced above Figure 3A-3G The introduction of the embolic element 230 allows the occlusion member 102 to deform, for example, at least partially fold over itself, to provide increased protection in the neck region of the aneurysm. Once the embolic element 230 is delivered and the occlusion member 102 is deformed, the occlusion member 102 can be separated from the elongated member 106, as described above. Figures 4A-4C For example, the elongated member 106 can retract, thereby allowing the engaging member 410 to deflect away from the hub 402 at least temporarily. Because the control element 416 has been previously removed, the engaging member 410 can disengage from the recess 408 and deform the conduit 116 when the elongated member 106 retracts, without any interference or resistance from the control element 416.

[0391] like Figure 5C As shown, after the occlusion member 102 disengages from the second elongated member 106, the elongated member 106 and the surrounding elongated shaft 108 can retract proximally. Alternatively, the elongated member 106 can retract proximally into the surrounding elongated shaft 108. After this separation, the occlusion member 102 and the embolization element 230 can remain positioned within the aneurysm.

[0392] Figures 6A-6C Another embodiment of the separation portion 600 is shown. Here, the control element 416 extends within the lumen of the elongated member 106 but is positioned outside the lumen 420 of the conduit 116. In this configuration, the presence of the control element 416 effectively causes the lumen 420 of the conduit 116 to contract radially adjacent to the engaging member 410, thereby pushing the engaging member 410 into a position where it locks or engages with the recess 408 of the hub 402. In operation, after the occlusion member 102 is positioned at the treatment site, the control element 416 can be removed (e.g., retracted proximally), after which the lumen 420 of the conduit 116 can be restored to its open state, for example, when an embolic element is introduced through it. Figure 6BAs shown, in this state, the embolic element can be delivered through the lumen 420 and delivered to the treatment site. Once the occlusion member 102 and any embolic element have been delivered, the elongated member 106 can retract proximally, thereby causing the engaging member 410 to deflect radially inward and disengage from the recess 408 of the hub 402, while also deforming the conduit 116, as... Figure 6C As shown. Before, after, or simultaneously with the deployment of the occlusion member 102, the control element 416 can retract proximally from within the lumen of the elongated member 106.

[0393] Figure 7 Another embodiment of the separation portion 700 is shown. Here, a restraint 702 is coupled to or integrated into a portion of the conduit 116, which is configured to be disposed radially adjacent to the engagement member 410. The restraint 702 may be configured to apply a radially outward force, thereby pushing the engagement member 410 toward the recess 408 of the hub. The restraint 702 may be a radially outwardly biased member, such as a bracket, braid, coil, etc., which is positioned within the lumen 420 of the conduit 116 and configured to provide sufficient circumferential strength to retain the engagement member 410 in a locked or engaged configuration. Alternatively or additionally, the restraint 702 may include a reinforcing portion of the wall of the conduit 116, such as having increased wall thickness, embedded metal reinforcement, or other structural features that resist deformation and retain the engagement member 410 in a “locked” configuration at least partially accommodated within the recess 408.

[0394] To release the engaging member 410 from its locked position, the conduit 116 can be slidably advanced distally or retracted proximally, causing the restraint 702 to be axially disaligned with the engaging member 410. This axial displacement of the restraint 702 can occur before, during, or after the embolic element is introduced into the treatment site through the lumen 420 of the conduit 116. Once the restraint is no longer axially aligned with the engaging member, the proximal retraction of the elongated member 106 causes the engaging member 410 to contact the sidewall of the recess 408 and deflect radially inward to disengage from the hub 402.

[0395] exist Figure 8 In the shown separation portion 800, the restraint 702 is connected to the drawstring 802, allowing it to be removed or at least moved axially while the conduit 116 remains in place. In this configuration, the drawstring 802 can be retracted proximally, thereby removing the restraint 702, or at least positioning the restraint 702 at least partially close to the engagement member 410. In this state, even when the conduit 116 is in place, the engagement member 410 is able to deflect radially inward away from the recess 408. Thus, the proximally retracted elongated member 106 and engagement member 410 release the engagement member 410 from the recess 408, while also deforming the conduit 116 and allowing removal of the engagement member 106 and the conduit 116 from the treatment site.

[0396] Advantageously, when using the separation section 700 or 800, the occlusion member 102 remains securely fixed to the elongated member 106 and the conduit 116 remains in place during the delivery of the embolic element to the treatment site. The clinician does not need to begin disengaging the elongated member 106 and / or the conduit 116 from the occlusion member 102 until the embolic element has been fully deployed and the occlusion member 102 has reached its final position.

[0397] IV. Example of thread separation section

[0398] Figures 9A-9C A threaded separation portion 900 at various separation stages is shown. As shown, the separation portion 900 includes a conduit 902 detachably connected to a hub 402 via a threaded engagement. The conduit 902 may be a hypotube, microcatheter, or other suitable tubular member having a lumen 904 configured to deliver an embolic element (e.g., embolic element 230) through it to a treatment site. The conduit 902 includes an engagement portion 906, which may take the form of radially outward-facing threads (e.g., external threads). The threads may be formed as protrusions extending away from the outer surface of the conduit 902 or as recesses formed in the outer surface of the conduit 902. In some embodiments, the threads may be discrete components adhered to or otherwise fastened to the outer surface of the conduit 902. For example, the threads may engage with a bushing that fits onto and adheres to the outer surface of the conduit 902. The engagement portion 906 of the pipe 902 can be configured to releasably engage with a corresponding engagement portion 908 of the hub 402, which can take the form of a radially inward thread (e.g., an internal thread) provided on the radially inner surface of the inner band 406 of the hub 402. Alternatively or alternatively, any other suitable mechanical interlocking structure can be used in place of the thread.

[0399] Conduit 902 may include a distal portion 910 extending distally beyond the joining portion 906. In the connection configuration ( Figure 9A As shown in the diagram, the distal portion 910 extends distally relative to the hub 402. In some embodiments, the distal portion 910 may terminate at a distal end (not shown) that, in the expanded state, is located at, near, or away from the distal end of the occlusion member 102. In this orientation, an embolic element delivered through the lumen 904 of the conduit 902 can be delivered to a region located distal to the expanded occlusion member 102.

[0400] After the embolic element is delivered through lumen 904, conduit 902 can be released from hub 402 by rotating conduit 902 relative to hub 402, as... Figure 9B and 9CAs shown. Once fully disengaged, conduit 902 can be removed from the body (e.g., retracted proximally via surrounding guide conduit), and occlusion member 102 and bearing 402 can remain in their proper positions within the body.

[0401] One advantage of this threaded disengagement mechanism is that the occlusion member 102 remains securely attached to the conduit 902 during delivery of the embolic element to the treatment site. The clinician does not need to begin disengaging the conduit 902 from the occlusion member 102 until the embolic element is fully deployed and the occlusion member 102 has reached its final position. At this stage, the conduit 902 can be rotated (e.g., by grasping the proximal portion of the conduit 902 and rotating it manually with machine assistance) to disengage the threads of the engagement portion 906 from the corresponding threads of the engagement portion 908.

[0402] Figure 10A and 10B Another embodiment of the threaded separation portion 1000 at different stages of separation is shown. In the illustrated embodiment, the conduit 902 takes the form of a proximal conduit 902, also having an externally threaded engagement portion 906 configured to mate with a corresponding internally threaded engagement portion 908 carried by the inner band 406 of the hub 402. However, in this embodiment, the proximal conduit 902 terminates at or near the distal end of the engagement portion 906; in the connection configuration, this distal end may also be located at or near the distal end of the hub 402. In some embodiments, the engagement portion 906 may include threads formed as recesses in the outer surface of the conduit 902, opposite to protrusions extending away from the outer surface of the conduit 902. Thus, the overall external dimensions can be reduced because the hub 402 can have a smaller radial dimension to engage with the engagement portion 906 of the conduit 902.

[0403] The distal conduit 1002 may be nonremovably coupled to the hub 402, for example, at least partially secured between the inner band 406 and the outer band 404 of the hub 402. The distal conduit 1002 may be an elongated tubular member extending through part or all of the length of the occlusion member 102. The distal conduit 1002 may be made of a biocompatible material, such as PTFE, stainless steel, nitinol, or any other suitable material. In operation, when the proximal conduit 902 is coupled to the socket 402, the lumen 904 of the proximal conduit is in fluid communication with the lumen 1004 of the distal conduit 1002, thereby providing a common lumen through which an embolic element (e.g., embolic element 230) may be delivered to the treatment site.

[0404] After the embolic element is delivered through lumens 904 and 1004, the conduit 902 can be released from the hub 402 by rotating the conduit 902 relative to the hub 402, as... Figure 10BAs shown. Once fully disengaged, conduit 902 can be removed from the body (e.g., by retracting proximally through the surrounding guide conduit), leaving occlusion member 102, hub 402, and distal conduit 1002 in place within the body.

[0405] V. Exemplary fractable detachable portion

[0406] Figure 11 A detailed view of the separation portion 1100 of a treatment system (e.g., treatment system 100 described above herein) is shown. As described in more detail below, the separation portion 1100 may include mechanisms for releasably securing the occlusion member 102 to a conduit for delivering the occlusion member 102 to the treatment site and facilitating the delivery of the embolic element to the treatment site, as referenced above. Figure 3A-3G As described. Figure 11 As shown, the distal conduit 1102 can be coupled to the closure member 102 via a hub 1104. The hub 1104 includes an outer band 1106 surrounding an inner band 1108, with this proximal portion of the layers of the closure member 102 held between the inner band 1106 and the outer band 1108 of the hub 1104. In some embodiments, the inner band 1108 may circumferentially surround and attach to the distal conduit 1102 (e.g., using adhesives, welding, etc.). In some embodiments, the distal conduit 1102 can be coupled to the closure member 102 using other mechanisms, such as direct adhesion to the mesh of the closure member 102 using non-circular clamps or fasteners or any other suitable coupling mechanism. The connection between the distal conduit 1102 and the hub 1104 can be permanent or substantially permanent, such that after deployment, the distal conduit 1102 remains coupled to the closure member 102 via the hub 1104 within the body.

[0407] The distal conduit 1102 may be an elongated tubular member defining a distal lumen 1110. The distal conduit 1102 may be configured to deliver an embolic element (e.g., embolic element 230) through it. In some embodiments, the distal conduit 1102 may be sized such that the embolic element delivered therethrough may be in its extended or partially extended state (e.g., as...). Figure 3B The obstruction member 102 (shown) is located at the distal end of the distal end of the distal conduit 1102. In some embodiments, the distal conduit 1102 may be sized such that its distal end terminates within the internal volume of the obstruction member 102 in its expanded state.

[0408] The distal conduit 1102 is releasably connected to the proximal conduit 1112 via a connector 1114. The proximal conduit 1112 may be an elongated tubular member defining a proximal lumen 1116, such as a microcatheter, a hypotube, etc. In some embodiments, the proximal conduit 1112 may be long enough that its proximal end can be positioned outside the body, while its distal end is connected to the distal conduit 1102 at or near the intravascular treatment site.

[0409] In the connection configuration, the proximal conduit 1112 is adjacent to the distal conduit 1102, such that the proximal lumen 1116 is in fluid communication with the distal lumen 1110. In some embodiments, the two lumens 1116, 1110 may be substantially coaxial, allowing an embolic element delivered through the proximal lumen 1116 to pass unimpeded through the proximal lumen 1116 and into the distal lumen 1110 for delivery to the treatment site. In the illustrated embodiment, the proximal end of the distal conduit 1102 is at least partially received within the lumen 1116 of the proximal conduit 1112. The proximal lumen 1116 and the distal conduit 1102 may be sized such that the distal conduit 1102 can be fittedly received within the proximal lumen 1116 to form a substantially fluid-impermeable seal, while still allowing the distal conduit 1102 to slide out of the proximal lumen 1116 after the connection 1114 ruptures as described elsewhere herein. In some embodiments, alternatively, the distal end of the proximal conduit 1112 may be at least partially received within the proximal end of the distal lumen 1110 of the distal conduit 1102. Alternatively, the proximal conduit 1112 and the distal conduit 1102 may be abutted together without either extending within the lumen of the other. Regardless of the configuration, the connection configuration allows the embolic element to be delivered through the proximal lumen 1116 and the distal lumen 1110 to the treatment site with little or no leakage of the embolic element at the junction of the proximal conduit 1112 and the distal conduit 1102.

[0410] As previously described, the proximal conduit 1112 and the distal conduit 1102 can be releasably secured together by a coupling 1114. The coupling 1114 can be connected at a first end to the distal portion of the proximal conduit 1112 and at a second end to the proximal portion of the distal conduit 1102, thereby defining an internal volume 1118 between the inner surface of the coupling 1114 and the outer surfaces of the proximal and distal conduits 1112. In some embodiments, the coupling 1114 is a flexible member configured to expand (e.g., extend) in response to the introduction of fluid into the internal volume 1118. The coupling 1114 can extend circumferentially around one or both of the conduits 1102, 1112, or in some embodiments, it can extend only on a portion of the outer surface of one or both of the conduits 1102, 1112. In some implementations, multiple discrete connectors may be provided at the junction of pipes 1102, 1112, for example, radially separated from each other around the circumference of pipes 1102, 1112.

[0411] In some embodiments, the connector 1114 is configured to rupture, tear, break, separate, or otherwise detach to allow the proximal conduit 1112 and the distal conduit 1102 to become disengaged from each other. This rupture may be responsive to expansion or dilation of the connector 1114 exceeding a threshold level, or may be achieved by any other suitable means for rupturing the connector 1114. In some embodiments, the connector 1114 may be a balloon, for example made of a biocompatible polymer and configured to rupture, break, or tear upon exceeding a threshold pressure or expansion volume. In some embodiments, the connector 1114 may include a rupture zone configured to preferentially tear, break, separate, or break to allow the proximal conduit 1112 and the distal conduit 1102 to disengage. For example, the connector 1114 may include one or more pre-formed cracks, cuts, perforations, holes, areas with smaller wall thicknesses, or any other feature that allows preferential tearing of the predefined rupture zone. In some embodiments, the rupture zone may be located in the distal portion of the connector 1114 such that after rupture, a large portion of the connector 1114 remains attached to the proximal conduit 1112 and is thus removed from the body when the proximal conduit 1112 is removed, while a small portion of the connector 1114 remains attached to the distal conduit 1102 after rupture.

[0412] The infusion shaft 1120 may be disposed within a proximal lumen 1116 and has a distal portion disposed within an internal volume 1118 of the connector 1114. The infusion shaft 1120 may have an internal lumen (not shown) in fluid communication with the internal volume 1118 of the connector 1114. The proximal end of the infusion shaft 1120 may be coupled to a fluid source for infusing fluid into the fluid source. In operation, a biocompatible fluid (e.g., saline) may be delivered through the lumen of the infusion shaft 1120 and into the internal volume 1118 defined by the connector 1114. Under sufficient fluid volume and / or pressure, the connector 1114 may rupture, thereby allowing the distal conduit 1102 (and its coupled occlusion member 102) to be released and separated from the proximal conduit 1112.

[0413] Figures 12A-12C This illustrates the separation of the proximal conduit 1112 and the distal conduit 1102 due to a rupture in the connector 1114. Figure 12A In this embodiment, connector 1114 extends from proximal conduit 1112 to distal conduit 1112 and is in a low-profile configuration for delivery to the treatment site via a conduit (e.g., a second elongated member 108). For example, connector 1114 may be in an unextended configuration such that the outermost radial dimension of connector 1114 is not significantly larger than the outermost radial dimension of either proximal or distal conduit 1112. Connector 1114 may be configured to preferentially tear, rupture, or break along rupture zone 1202. As described above, rupture zone 1202 may include one or more pre-formed tears, incisions, perforations, holes, areas with smaller wall thicknesses, or any other features that allow preferential tearing of the pre-defined rupture zone. In some embodiments, a series of pre-formed incisions may extend in a dashed line that extends substantially circumferentially around connector 1114. In the illustrated embodiment, rupture zone 1202 is located near the distal portion of connector 1114. In other embodiments, the rupture zone 1202 may be positioned at other longitudinal locations along the coupling 1114, or may be omitted entirely. Alternatively or additionally, multiple rupture zones 1202 may be provided along the coupling 1114 to ensure rupture at acceptable pressure levels.

[0414] exist Figure 12B In, for example, by introducing via infusion shaft 1120 ( Figure 11 The delivered fluid causes the connector 1114 to expand or swell. The fluid can be, for example, brine or any other suitable biocompatible fluid. In the case of a pre-formed crack in the rupture zone 1202, some fluid may begin to leak or seep from the crack or hole in the connector 1114 before rupture. In some cases, this leakage or seepage can amplify the pre-formed tear in the rupture zone 1202, causing the connector 1114 to rupture completely along the rupture zone 1202, as... Figure 12CAs shown. This rupture along the rupture zone 1202 leaves a proximal segment 1114a connected to the proximal conduit 1112 and a distal segment 1114b connected to the distal conduit 1102. Following this rupture, the proximal conduit 1112 can be separated from the distal conduit 1102, for example, by retracting the proximal conduit 1102 proximally relative to the distal conduit 1102. The proximal conduit 1112 can then be removed from the body (e.g., by retracting it proximally through a guiding or delivery catheter around the body), while the distal conduit 1102 and the occlusion member 102 remain positioned at the treatment site (e.g., with an aneurysm sac).

[0415] Figures 13A-13C The diagram illustrates the delivery of the occlusion component 102 and the embolization element 230 to the treatment site within the aneurysm sac. (See diagram for reference.) Figure 13A As shown, the treatment system can be positioned within an elongated shaft 108 (e.g., a microcatheter) for intravascular advancement until the distal end of the shaft 108 is located at or near the aneurysm sac. In the illustrated embodiment, the distal end of the elongated shaft 108 extends within the aneurysm sac; however, in other embodiments, the distal end of the elongated shaft 108 may be positioned at or proximal to the neck of the aneurysm.

[0416] exist Figure 13A As shown, the treatment system has been advanced within the elongated shaft 108, such that the occlusion member 102 is maintained in a constrained low-profile configuration within the shaft 108, while the distal conduit 1102 extends through it. In various embodiments, the 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.

[0417] like Figure 13B As shown, 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 the case of occlusion member 102 expansion, the distal end of the distal conduit 1102 is positioned at, near, or distally beyond the distal end of the occlusion member 102. For example, the distal conduit 1102 can be positioned such that an embolic element 230 delivered through it can be delivered to a region distal to the occlusion member 102, such as at or near the dome of the aneurysm sac. In this position, the embolic element 230 can be advanced through the proximal conduit 1112 and the distal conduit 1102 and into the aneurysm to reach a region distal to the occlusion member 102. In the case of fluids or gels, a syringe or other injector can be used to push the embolic element 230 through the lumen of conduits 1102, 1112. In the case of a microcoil or other structured embolization element, a delivery line or other suitable mechanism can be slidably advanced through the lumen of conduits 1102, 1112 to position the embolization element 230 into the aneurysm sac.

[0418] Figure 13C The occlusion member 102 is shown after the complete delivery of the embolic element 230. (Refer to the preceding text.) Figure 3A-3G The introduction of the embolic element 230 allows the occlusion member 102 to deform, for example, at least partially fold over itself, to provide increased protection in the neck region of the aneurysm. Once the embolic element has been delivered and the occlusion member 102 has deformed, the distal conduit 1102 and the occlusion member 102 can be separated from the proximal conduit 1112, as previously described. Figures 12A-12C The connection 1114 may be extended, for example, by stretching or otherwise extending until it breaks.

[0419] like Figure 13D As shown, after the connector 1114 ruptures, the proximal conduit 1112 can retract proximally, and the distal conduit 1102 can remain in place, connected to the occlusion member 102 at the treatment site. The proximal conduit 1112 and the first elongated shaft 108 can then be removed from the body.

[0420] Figure 14 Another embodiment of the separation section 1400 of the treatment system is shown. The separation section 1400 may be similar to the previously described separation section 1100, except that the infusion shaft 1120 extends along the outer surface of the proximal conduit 1112 to terminate at a distal end 1121 in fluid communication with the internal volume 1118 of the coupling 1114. In some embodiments, this arrangement can enhance the fluid tightness seal at the junction of the proximal conduit 1112 and the distal conduit 1102 because the outer surface of the distal conduit 1102 can be in direct circumferential contact with the inner surface of the proximal conduit 1112. In operation, fluid delivered via the infusion shaft 1120 can cause the coupling 1114 to expand and rupture, as described elsewhere herein.

[0421] Figure 15Another embodiment of the separation section 1500 of the treatment system is shown. The separation section 1500 may be similar to the separation section 1100 previously described, except that a plurality of infusion shafts 1120a, 1120b extend within the lumen 1116 of the proximal conduit 1112. The infusion shafts 1120a, 1120b may be discrete tubular members extending along the lumen 1116 of the proximal conduit 1112, each terminating at a corresponding distal end 1121a, 1121b within an internal volume 1118 defined by the coupling 1114. Although two shafts 1120a, 1120b are shown, three, four, five, six, or more discrete shafts 1120 may be provided in operation. This arrangement facilitates the symmetrical expansion of the coupling 1114 in response to fluid pressure by delivering fluid to the internal volume 1118 at multiple locations around the circumference of the proximal conduit 1112. In some embodiments, the infusion shaft 1120 may define an annular or semi-annular lumen therein, the lumen extending at least partially circumferentially around the proximal lumen 1116. For example, in some embodiments, the shaft 1120 may define an annular lumen completely surrounding the proximal lumen 1116, such that fluid delivered therethrough can exit the distal end 1121 to the inner volume 1118 along the entire circumference of the distal conduit 1112. This symmetrical fluid delivery can facilitate uniform expansion of the coupling 1114 and ensure that the coupling 1114 breaks down around the entire circumference.

[0422] Figure 16A and 16B Another embodiment of the separation portion 1600 of the treatment system is shown, which relies on an expandable element 1602 to expand and rupture the coupling 1114. The expandable element 1602 can be used to replace or supplement the infusion shaft 1120 previously described herein. In some embodiments, the expandable element 1602 can be attached, for example, along the distal portion to the outer surface of the proximal conduit 1112, such that the expandable element 1602 is positioned within the internal volume 1118 defined by the coupling 1114. Figure 16A As shown, in its unexpanded state, the expandable element 1602 can collapse and contact the proximal conduit 1112. Figure 16B In the expanded state shown, the expandable element 1602 expands radially outward, thereby compressing the connector 1114 into an expanded state. When fully expanded, the connector 1114 may rupture as previously described herein. In some embodiments, as an alternative or supplement to the positioning on the outer surface of the distal conduit 1112, the expandable element 1602 may be positioned on the outer surface of the proximal conduit 1102.

[0423] The expandable element 1602 can be any suitable structure configured to expand radially and push the coupling 1114 radially outward until it breaks. In some embodiments, the expandable element 1602 can be a support, mesh, braid, coil, or any other suitable structure configured to mechanically expand from a contracted configuration to an expanded configuration. The expandable element 1602 can be made of an elastic or hyperelastic material (e.g., nitinol) and can be a shape memory material. In some embodiments, the expandable element 1602 can be shaped to an expanded configuration and can remain only when constrained by an surrounding sheath (e.g., a second elongated member 108 or other suitable sheath). Figure 16A The expandable element 1602 is shown in its unexpanded state. When the restraint sheath is retracted, the expandable element 1602 may present its expanded state, thereby causing the coupling 1114 to rupture. In some embodiments, the expandable element 1602 may transition to its expanded state in response to actuation caused by a temperature change (e.g., infusion of cold or hot fluid, or in response to an increase in temperature once located within the body). Alternatively or alternatively, a drawstring or any other suitable actuation mechanism may be used to transition the expandable element 1602 to its expanded state. In some embodiments, the expandable element 1602 may be configured to re-insert within the surrounding guide or delivery catheter for removal from the body. For example, retracting the proximal conduit 1112 proximally relative to the surrounding guide or delivery catheter may result in pushing the expandable element 1602 into its low-profile state for removal from the body.

[0424] VI. Example of a separate part with a fixed component

[0425] Figures 17A-17C This is a cross-sectional side view of the connecting assembly 1700 (“assembly 1700”) according to an embodiment of the present technology. Figure 17A The assembly 1700 is shown with the occlusion member 102 in a constrained state during delivery. Figure 17B The assembly 1700 is shown during the deployment of the occlusion member 102. Figure 17C The assembly 1700 is shown after the occlusion member 102 has been deployed. (See diagram.) Figure 17A As shown, during delivery of the occlusion member 102 via the vascular system, the occlusion member 102 may be disposed around a conduit 116 and typically housed within or surrounded by a second elongated shaft 108. In some embodiments, the conduit 116 may have a diameter of at least about 1 French inch or 0.012 inches (D1), and the second elongated shaft 108 may have a larger diameter of at least about 2 French inch or 0.24 inches (D2). The proximal portion 102a of the occlusion member 102 is coupled to a coupling 1710, which can be connected to the previously referenced... Figure 1A-3GThe first coupling 112 corresponds to this. The coupling 1710 can be slidably and / or rotatably coupled to the pipe 116, such that the coupling 1710 and the pipe 116 can move axially (e.g., distally and proximally) and / or rotate relative to each other.

[0426] The connector 1710 secures the occluding member 102 to it (e.g., via a crimp or other connecting device) and prevents the occluding member 102 from sliding proximally beyond the connector 1710. Figure 17A As shown, the connector 1710 may include an inner strip 1718 disposed around the conduit 116, and a first outer strip 1712 and a second outer strip 1714, each disposed around the inner strip 1718. A proximal portion 102a of the blocking member 102 is disposed and secured to the connector 310 between the inner strip 1718 and the first and second outer strips 1712 and 1714. The first outer strip 1712 is distal to and spaced from the second outer strip 1714 to define an intermediate region 1716 therebetween corresponding to a gap or void. The gap or void is recessed relative to the radially outermost surface of the first outer strip 1712 and / or the second outer strip 1714. (Refer to...) Figure 18 and 19 Other embodiments of the connector 1710 are shown and described.

[0427] like Figure 17A As shown, one or more retaining members 1720 (“retaining members 1720”) are detachably connected to the coupling 1710 and therein connected to the blocking member 102. The retaining member 1720 may be an elongated structure including a proximal portion 1720a and a distal portion 1720b. In some embodiments, the retaining member 1720 may be a single structure disposed around the conduit 116, while in other embodiments, the retaining member 1720 may include one or more separate structures. For example, Figure 17A The shown fastening member 1720 comprises two separate structures. The fastening member 1720, including a proximal portion 1720a and / or a distal portion 1720b, may be formed at least partially of a hyperelastic and / or radiopaque material such as nitinol. The fastening member 1720 may also be formed at least partially of a platinum, chromium-cobalt (“CrCo”) alloy, stainless steel alloy, or combinations thereof (including nitinol). The fastening member 1720 may include continuous and / or adjacent surfaces extending along the proximal portion 1720a and the distal portion 1720b. In some embodiments, the fastening member 1720 may be heat-treated to maintain a specific shape (e.g., a bent shape). For example, as... Figure 17AAs shown, a portion of the distal portion 1720b of the retaining member 1720 bends inward toward the conduit 116. This shape allows the distal portion 1720b to move radially away from the conduit 116 as the conduit 116 moves relative to the coupling 1710 and / or the blocking member 102 in a distal direction. In some embodiments, the retaining member 1720 may have a substantially linear or straight shape.

[0428] The proximal portion 1720a of the fixing member 1720 may be fixed to the conduit 116, for example, via a stop 1722 (e.g., a buffer), such that the proximal portion 1720a, the stop 1722, and / or the conduit 116 are fixed in place relative to each other. The fixing member 1720 and / or the stop 1722 may correspond to the previously referenced Figure 1A-3F The second connecting member 114 is described. A stop 1722 restricts axial movement of the connecting member 310 along the conduit 116. Additionally, since the connecting member 1710 is axially movable along the conduit 116, the stop 1722 can abut against and provide thrust thereon during distal advancement of the blocking member 102 toward the target delivery site. The stop 1722 may be at least partially formed of a radiopaque material, such as platinum, nitinol, CrCo alloys, stainless steel alloys, or combinations thereof.

[0429] The distal portion 1720b may have a circular, cubic, hexagonal, or other shape, which is non-invasive, and its cross-sectional dimensions are larger than the cross-sectional dimensions of at least a portion of the remainder of the fixing member 1720. The distal portion 1720b may be positioned between or within a portion of the connecting member 1710. Figure 17AAs shown, the distal portion 1720b is positioned radially outside the inner band 1718 and the closure member 102, and axially between the first outer band 1712 and the second outer band 1714. The radially innermost surface of the distal portion 1720b is radially inside the outermost surface of the first outer band 1712 and / or the second outer band 1714. As detailed elsewhere herein, the distal portion 1720b is detachably coupled to the coupling 310 and therein to the closure member 102. In some embodiments, during delivery (e.g., as the closure member 102 is advanced toward the target location), the retaining member 1720 remains coupled to the coupling 1710 and is only disengaged from the coupling 1710 when the distal portion 1720b extends distally beyond the distal end of the surrounding second elongated shaft 108. In other words, the retaining member 1720 remains connected to the connector 1710, and the connector 1710 and / or the distal portion 1720b is contained within the second elongated shaft 108. In such an embodiment, the distance or spacing between the radially outermost surfaces of the second elongated shaft 108 and the second outer band 1714 may be less than the dimension (D3) of the distal portion 1720b, such that the spacing and the second outer band 1714 prevent the distal portion 1720b from being completely removed from the intermediate region 1716.

[0430] Figure 17B According to the embodiment of this technology, after the second elongated shaft 108 is at least partially retracted relative to the blocking member 102... Figure 17A A cross-sectional side view of component 1700 shown. Figure 17B As shown, at least a portion of the closure member 102, the connector 1710, and the retainer 1720 extends distally beyond the distal end of the second elongated shaft 108. In this configuration, the retainer 1720 can disengage from the connector 1710, thereby releasing the closure member 102 from the retainer 1720. When the second elongated shaft 108 retracts proximally relative to the closure member 102 and / or the conduit 116, the retainer 1720, or more specifically the distal portion 1720b, moves radially away from the connector 1710, thereby separating itself from the connector 1710 and the closure member 102. That is, the retainer 1720 can be configured (e.g., heat-treated) to self-expand, such that after the second elongated shaft 108 is withdrawn, the distal portion 1720b self-expands and thereby disengages itself from the connector 1710.

[0431] As described in detail elsewhere herein, in some embodiments, the distal portion 1720b remains positioned within the intermediate region 1716 and is thus coupled to the connector 1710 even after the second elongated shaft 108 is retracted proximally. That is, retracting the second elongated shaft 108 proximally beyond the distal portion 1720b can disengage the retaining member 1720 from the connector 1710 and / or the closure member 102 without itself. This may be partly because the distal end (not shown) of the conduit 116 can exert a distal axial force on the closure member 102, which creates tension between the connector 1710 and the distal portion 1720b. In such embodiments, the retaining member 1720 can disengage from the connector 1710 only after the conduit 116 has moved distally relative to the connector 1710. In doing so, the proximal portion 1720a moves toward the connector 1710, thereby radially pushing the distal portion 1720b outward and disengaging the retaining member 1720 from the connector 1710 and / or the blocking member 102. In other words, the distal movement of the conduit 116 relative to the connector 1710 causes the distal portion 1720b of the retaining member 1720 to move radially away from the conduit 116, thereby disengaging the connector 1710 and the blocking member 102 from the retaining member 1720.

[0432] Figure 17C This is a cross-sectional side view of component 1700 shown in 17B after the blocking member 102 has been further advanced distally relative to the second elongated axis 108, according to an embodiment of the present technology. Figure 17C As shown, after the distal portion 1720b disengages from the connector 1710 and occludes the member 102 therein, the distal portion 1720b may move toward the conduit 116 as the conduit 116 retracts proximally (e.g., due to heat treatment). As described elsewhere herein, after the occlusion member 102 is released from the fixation member 1720 and / or deployed (e.g., within an aneurysm), the occlusion member 102 may self-expand to an expanded state.

[0433] Figure 18 It is based on the implementation scheme of this technology. Figure 17A A cross-sectional side view of an embodiment of component 1700 shown. Figure 18 As shown, component 1800 includes reference Figure 17A Many features are shown and described, but include a second coupling 1810 (or "coupling 1810") that differs from the aforementioned coupling 1710. Coupling 1810 is formed by an outer band 1812 and an inner band 1813 surrounding the conduit 116. The outer band 1812 may include a proximal region 1814a, a distal region 1814c, and an intermediate region 1814b therebetween. The intermediate region 1814b is functionally compatible with the previously referenced... Figure 17AThe described intermediate region 1716 is generally similar. That is, the intermediate region 1814b may define a gap between the proximal region 1814a and the distal region 1814c, which is recessed relative to the radially outermost surface of the proximal region 1814a and / or the distal region 1814c. The inner band 1813 may be surrounded by the outer band 1812. The closure member 102 may be coupled to the connector 1810, for example, by a proximal portion of the closure member 102 disposed between the outer band 1812 and the inner band 1813. The connector 1810 may be slidably and / or rotatably coupled to the conduit 116 such that the connector 1810 and the conduit 116 may be axially (e.g., distally and proximally) and / or rotated relative to each other.

[0434] Figure 19 It is based on the implementation scheme of this technology. Figure 17A A cross-sectional side view of another embodiment of component 1700 shown. (See also...) Figure 19 As shown, component 1900 has a reference Figure 17A Many features are shown and described, but include a connector 1912 that differs from the aforementioned connector 1710. Connector 1910 includes, as referenced... Figure 17A The first outer belt 1712 and the second outer belt 1714, and the first inner belt 1912 and the second inner belt 1914. The first outer belt 1712 and the second outer belt 1714 are respectively disposed around the first inner belt 1912 and the second inner belt 1914, which are disposed around the conduit 116. The connector 1910 is slidably and / or rotatably connected to the conduit 116, such that the connector 1910 and the conduit 116 are axially (e.g., distally and proximally) movable and / or rotated relative to each other.

[0435] In some implementations, such as Figure 20 As shown, the conduit can be formed from a microcatheter. Implementations using microcatheter devices for injecting embolic elements through which can be particularly advantageous, as microcatheters are typically constructed as leak-proof devices. Figure 20 As shown, the occlusion member 102 is disposed around and is typically housed within or surrounded by the elongated shaft 108. The second elongated shaft 108 may have a diameter of at least about 1 French inch or 0.012 inches (D1), and the elongated shaft 108 may have a larger diameter of at least about 2 French inch or 0.24 inches (D2). The occlusion member 102 is coupled to a coupling member 1710, which is slidably and / or rotatably coupled to the second elongated shaft 108, such that the coupling member 1710 and the second elongated shaft 108 are axially (e.g., distal and proximal) movable and / or rotated relative to each other.

[0436] Figures 21A-21HThis document illustrates a method for delivering an occlusion member to a target site after re-inserting the occlusion member within an elongated shaft and / or repositioning the elongated shaft within the target site, according to embodiments of the present technology. As previously described, embodiments of the present technology involve advancing an occlusion member to a target site, such as an aneurysm lumen, via a delivery system and deploying the occlusion member thereto. In practice, advancing the occlusion member may require positioning the delivery system in a specific location, such as within the central portion of the aneurysm lumen and not too close to the lateral walls of the aneurysm. In cases where the delivery system is improperly advanced to the target site, the delivery system may need to be withdrawn from the target site and repositioned to allow proper deployment of the occlusion member. In some embodiments, the occlusion member may be partially deployed, thus requiring re-insertion (e.g., within a delivery catheter) before repositioning. As used herein, "re-insertion" may refer to a method or mechanism for withdrawing a partially deployed occlusion member back into the elongated member or shaft of the delivery system.

[0437] Figure 21A A delivery system for deploying an occlusion device to a target site, such as a cerebral aneurysm (A), is shown. The delivery system includes a conduit 116 (e.g., a hypotube), a second elongated shaft 108 (e.g., a microcatheter) surrounding a portion of the conduit 116, a first elongated shaft 108 (e.g., a delivery catheter) surrounding a portion of the second elongated shaft 108, and an assembly 1700 disposed within a lumen between the conduit 116 and the second elongated shaft 108. Figure 21A As shown, the delivery system is incorrectly positioned within the aneurysm (A) and needs to be withdrawn and repositioned before the occlusion member can be fully deployed. In some embodiments, if the occlusion member of the separation assembly 1700 has been partially deployed (i.e., not fully deployed), the occlusion member can be re-inserted into the second elongated shaft 108 by the assembly 1700 before withdrawing the conduit 116 and the second elongated shaft 108. Figure 21B The delivery system is shown after the conduit 116 and the second slender shaft 108 have been withdrawn from the aneurysm (A) before repositioning.

[0438] Figure 21C The delivery system is shown after proper positioning within the aneurysm (A). Component 1700 is shown as generally illustrated. Figure 21D As shown, the blocking member 102 is connected to the connector 1710, which is detachably connected to the pipe 116 via the fastener 1720, as previously described. The structure of the assembly 1700 prevents or inhibits the connector 1710 and the blocking member 102 from disengaging from the fastener 1720 and the pipe 116, while at least a portion of the fastener 1720 is included within the second elongated shaft 108.

[0439] Figure 21EThe delivery system is shown after the second elongated shaft 108 is partially retracted proximally relative to the conduit 116. For illustrative purposes, Figure 21E and 21F The blocking member 102 and its extensions are not shown. For example... Figure 21F As shown, the second elongated shaft 108 retracts proximally beyond the distal portion 1720b of the fixing member 1720. As described elsewhere herein (e.g., see reference 1720b). Figure 17A and 17B Simply withdrawing the second elongated shaft 108 alone can cause the retaining member 1720 to disengage from the connector 1710. However, in some embodiments, as described elsewhere herein, simply withdrawing the second elongated shaft 108 alone may not disengage the retaining member 1720 from the connector 1710. In these embodiments, after the second elongated shaft 108 has retracted proximally beyond the distal portion 1720b, it may be necessary to move the conduit 116 and the proximal portion 1720a of the retaining member 1720 distally relative to the connector 1710 to separate the connector 1710 and the occlusion member 102 from the retaining member 1720. As previously stated, distal movement of the conduit 116 relative to the connector 1710 is necessary to disengage the connector because the conduit 116 applies a distal axial force on the occlusion member 102, which creates tension between the connector 1710 and the distal portion 1720b. After the second slender shaft 108 is retracted proximally beyond the distal portion 1720b, tension can be maintained in the connection arrangement between the connector 1710 and the fixing member 1720.

[0440] Figure 21G and 21H The delivery system is shown after the conduit 116 has been advanced distally relative to the coupling 1710 and the closure member 102. For illustrative purposes, Figure 21G and 21H The blocking member 102 and its extensions are not shown. For example... Figure 21H As shown, advancing the conduit 116 distally relative to the connector 1710 allows the distal portion 1720b to move radially outward away from the connector 1710, thereby separating the occlusion member 102 from the fixing member 1720. In doing so, the occlusion member 102 can be deployed, for example, by self-expanding to its expanded state and filling at least a majority of the aneurysm lumen.

[0441] VII. in conclusion

[0442] Although numerous embodiments of the systems and methods related to the treatment of hemorrhagic stroke have been described above, this technology can be applied to other applications and / or other methods. Furthermore, other embodiments besides those described herein are within the scope of the technology. Additionally, several other embodiments of the technology may have different configurations, components, or processes than those described herein. Therefore, those skilled in the art will accordingly understand that the technology may have other embodiments with additional elements, or that the technology may have other embodiments that do not have the features described above. Figure 1A –21H shows and describes several features.

[0443] The description of embodiments of this technology is not intended to be exhaustive or to limit the technology to the exact forms disclosed above. Where the context permits, singular or plural terms may also include plural or singular terms, respectively. 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, although 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.

[0444] Unless otherwise stated, all figures used in the specification and claims to represent dimensions, percentages, or other numerical values ​​should be understood to be modified by the term "about" in all cases. Therefore, unless otherwise specified, the numerical parameters set forth in the specification and appended claims are approximations that may vary depending on the desired properties sought to be obtained by this technique. To a minimum, and without attempting to limit the application of the equivalence principle to the scope of the claims, each numerical parameter should be interpreted at least according to the number of significant digits reported and by applying general rounding techniques. Furthermore, all scopes disclosed herein should be understood to encompass any and all subscopes contained herein. For example, the scope "1 to 10" encompasses (and includes) any and all subscopes between (and including) the minimum value of 1 and the maximum value of 10, i.e., any and all subscopes having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10, such as 5.5 to 10.

[0445] Furthermore, unless the word “or” is explicitly limited to referring only to a single item that is exclusive to another item in a list of two or more items, the use of “or” in such lists may 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 enumerated features are included, without excluding any larger number of the same features and / or other features of additional types. 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 art. Furthermore, while advantages associated with certain embodiments of the art 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 art. Therefore, this disclosure and associated art may cover other embodiments not explicitly shown or described herein.

Claims

1. A treatment system comprising: An occlusion implant configured to be positioned within an aneurysm sac, the occlusion implant comprising a hub; An elongated tubular member having a engagement member releasably engaged with the hub, the elongated tubular member defining a first lumen extending therethrough; A conduit extending within a first lumen, the conduit defining a second lumen configured to receive an embolic element therethrough for delivery to the aneurysm sac; as well as A control element or restraint, wherein the control element is configured to extend within the first lumen and push the engagement member to engage the hub, and the restraint is positioned within the second lumen of the conduit, radially adjacent to the engagement member, and the restraint is configured to apply a radially directed force on the engagement member.

2. The treatment system of claim 1, wherein the coupling member is removably coupled to the hub via an interference fit.

3. The treatment system of claim 1, wherein the hub has a recess, and the engaging member includes a protrusion configured to be removably received within the recess.

4. The treatment system of claim 1, wherein the control element comprises a line or rod configured to restrict the engagement member from disengaging from the hub.

5. The treatment system of claim 1, wherein the control element is slidably removable from the first lumen.

6. The treatment system of claim 1, wherein the occlusion implant comprises an expandable mesh having a constrained state for delivery to the aneurysm sac and an expanded state, wherein in the expanded state at least a portion of the expandable mesh is configured to be positioned across the neck of the aneurysm sac.

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