Devices, systems, and methods for treating intracranial aneurysms

Abstract

Systems and methods for treating aneurysms according to embodiments of the present technology include intravascular delivery of an occlusion member into the aneurysm lumen and deforming the shape of the occlusion member by introducing an embolizing element into the space between the occlusion member and the inner surface of the aneurysm wall.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to 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] An intracranial aneurysm is a part of an intracranial blood vessel that bulges outward from the main channel of the blood vessel. This condition typically occurs in parts of blood vessels that are abnormally fragile due to congenital abnormalities, trauma, high blood pressure, or other causes. Once an intracranial aneurysm forms, there is a significant risk that the aneurysm will eventually rupture, leading to a high-risk medical emergency resulting in death due to hemorrhage. Vascular surgery is usually indicated when an unruptured intracranial aneurysm is detected or when a patient has survived an initial rupture of an intracranial aneurysm. A routine type of vascular surgery used to treat intracranial aneurysms involves placing a platinum coil within the internal volume of the aneurysm using a microcatheter. Over time, the presence of the coil can lead to thrombus formation. Ideally, the neck of the aneurysm closes at the site of the thrombus and is replaced by new endothelial tissue. Blood then bypasses the aneurysm, thus reducing the risk of aneurysm rupture (or re-rupture) and associated bleeding. Adversely, long-term recanalization (i.e., restoration of blood flow to the internal volume of the aneurysm) after this type of vascular surgery occurs in many cases, particularly for intracranial aneurysms with relatively wide necks and / or relatively large internal volumes.

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

[0006] The present invention is based, for example, on various aspects described below, including references to Figure 1A-5B The following description is provided. For convenience, various examples of different aspects of the present invention are described as numbered clauses (1, 2, 3, etc.). These are provided as examples and do not limit the scope of the present invention.

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

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

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

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

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

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

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

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

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

[0016] 7. The method according to any one of the preceding clauses, wherein the occlusion element is a grid.

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

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

[0019] 10. 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.

[0020] 11. 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.

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

[0022] 13. 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 dilated state.

[0023] 14. 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 an expanded state.

[0024] 15. 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.

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

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

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

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

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

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

[0031] 22. 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 distal portion of the occlusion member.

[0032] 23. The method according to Clause 22, wherein the expandable mesh includes holes in the distal portion, the holes being defined by folds.

[0033] 24. 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 in the proximal portion of the occlusion member.

[0034] 25. The method according to Clause 24, wherein the expandable mesh includes holes in the distal portion, the holes being defined by folds.

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

[0036] 27. The method according to any one of the preceding clauses, wherein the occlusion member is formed of a plurality of filaments having first and second ends fixed at the connector.

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

[0038] 29. The method described in Clause 28, wherein the inner core material is a non-transparent material and the outer material is a hyperelastic material.

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

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

[0041] 32. The method described in Clause 31, wherein the filaments are interwoven.

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

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

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

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

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

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

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

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

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

[0051] 42. The method according to Clause 42, wherein the biopolymer includes chitosan, a type of chitosan, an analogue of chitosan, or a combination thereof.

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

[0053] 44. The method according to any one of clauses 42 to 44, wherein the embolic element further comprises a physical crosslinking agent.

[0054] 45. The physical crosslinking agent according to the method described in Clause 45 includes β-glycerophosphate, derivatives of β-glycerophosphate, analogs of β-glycerophosphate, or combinations thereof.

[0055] 46. ​​The method described in accordance with Clause 42, wherein

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

[0057] Chemical crosslinking agents include genipin, genipin derivatives, genipin analogs, or combinations thereof; and

[0058] Physical crosslinking agents include β-glycerophosphate, derivatives of β-glycerophosphate, analogs of β-glycerophosphate, or combinations thereof.

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

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

[0061] 49. The method described under Clause 48 or Clause 49, wherein the contrast agent comprises iohexol, a derivative of iohexol, an analog of iohexol, or a combination thereof.

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

[0063] The expandable occlusion member in its initial expanded state is positioned within the aneurysm, wherein, in its initial expanded state, the expandable occlusion member provides multiple layers through the neck of the aneurysm; and

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

[0065] 51. The method described in Clause 51, wherein the number of layers is one.

[0066] 52. The method described in Clause 51, wherein the number of layers is two.

[0067] 53. The method according to any one of clauses 51 to 53, wherein the layer is a mesh layer.

[0068] 54. The method according to any one of clauses 51 to 54, wherein the occluding member has a first shape in an initial expansion state, and wherein the introduction of an embolic element transforms the occluding member from the initial expansion state to a second expansion state, wherein the occluding member forms a second shape different from the first shape.

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

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

[0071] Use the following visualization to obtain the first image:

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

[0073] A catheter having a distal portion positioned within the aneurysm, the distal portion of the catheter including a second radiopaque marker; and

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

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

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

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

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

[0079] 61. The method according to any one of clauses 56 to 60, wherein, in the first image, the first radiopaque marker is positioned proximal to the second radiopaque marker.

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

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

[0082] 64. The method according to any one of clauses 56 to 63, further comprising acquiring a third image, wherein the first radiopaque marker is farther away from the second radiopaque marker than in the second image.

[0083] 65. The method according to any one of clauses 56 to 64, wherein acquiring the first image and acquiring the second image each comprise acquiring a perspective image.

[0084] 66. A method for preparing a clogging device, the method comprising:

[0085] Obtain a tubular mesh with an inner cavity passing through it;

[0086] Obtain a forming component having an outer surface and an inner surface;

[0087] Flip the mesh over the forming member so that a first portion of the mesh fits the outer surface of the forming member and a second portion of the mesh fits the inner surface of the forming member;

[0088] Set the shape of the grid when positioning it above the forming member.

[0089] 67. The method according to Clause 1, wherein the inner surface of the forming member is arc-shaped and defines a cavity in the forming member.

[0090] 68. The method described in Clause 1 or Clause 2, wherein the forming member has a substantially hemispherical shape.

[0091] 69. The method according to any one of clauses 1 to 3, wherein the forming member includes an inner cavity extending therethrough.

[0092] 70. The method according to any one of clauses 1 to 4, wherein the forming member is a first forming member, the inner surface is a first mating surface, and the method further comprises positioning a second portion of the mesh between the first mating surface of the first forming member and the second mating surface of the second forming member, such that the second portion of the mesh conforms to the first and second mating surfaces of the first and second forming members, respectively.

[0093] 71. The method according to Clause 5 further includes a second portion of compressing the mesh between the first and second mating surfaces.

[0094] 72. The method according to any one of clauses 1 to 6, wherein setting the shape of the mesh involves heat-treating the mesh when it is positioned on the forming member.

[0095] 73. The method according to any one of clauses 1 to 7, wherein after the shape of the grid is set, the first and second portions of the grid form a double-layered sidewall that encloses the open volume.

[0096] 74. The method according to Clause 8, wherein the double-layered sidewalls have a generally hollow hemispherical shape.

[0097] 75. The method described in Clause 8 or Clause 9, wherein the open volume has a substantially hemispherical shape.

[0098] 76. The method described in Clause 9, wherein the open volume is approximately disk-shaped.

[0099] 77. The method according to any one of clauses 1 to 11, wherein after the shape of the grid is set, the grid includes a generally tubular third portion.

[0100] 78. The method according to any one of clauses 8 to 12 further comprises connecting a connecting element to the grid between the third portion of the grid and the first and second portions of the grid.

[0101] 79. The method according to any one of Clauses 1 to 13 further comprises positioning the elongated member within the cavity of the grid.

[0102] 80. The method according to any one of clauses 1 to 14 further comprises positioning the elongated member within the cavity forming the member.

[0103] 81. The method described in accordance with Clause 14 or Clause 15, wherein the elongated member is a mandrel.

[0104] 82. The method according to any one of clauses 14 to 16, wherein the elongated member comprises a generally tubular shape.

[0105] 83. The method according to any one of clauses 1 to 17, wherein the mesh has a sufficiently low porosity to prevent blood from flowing through the mesh.

[0106] 84. The method according to any one of clauses 1 to 18, wherein the mesh comprises a plurality of braided filaments.

[0107] 85. The method according to any one of clauses 1 to 19, wherein the mesh comprises a plurality of interwoven filaments.

[0108] 86. The method according to any one of clauses 1 to 20, wherein the grid is a laser-cut tube.

[0109] 87. The method according to any one of clauses 1 to 21, wherein the grid comprises at least two layers.

[0110] 88. The method according to any one of Clauses 1 to 22, wherein the mesh comprises an elastic and / or hyperelastic material.

[0111] 89. The method according to any one of clauses 1 to 23 further comprises connecting the connecting element to the grid.

[0112] 90. The method according to Clause 24, wherein the connecting element is connected to the grid such that the connecting element surrounds the circumference of the grid.

[0113] 91. The method described in Clause 24 or Clause 25, wherein the connecting element comprises a marking tape or binding wire.

[0114] 92. The method according to any one of Clauses 24 to 26, wherein the connecting element is non-transparent.

[0115] 93. The method according to any one of clauses 1 to 27, wherein the forming member has a generally cylindrical shape.

[0116] 94. The method according to Clause 28, wherein the forming member defines an inner cavity extending therethrough.

[0117] 95. The method according to Clause 29, wherein the inner surface is the wall of the cavity.

[0118] 96. The method according to any one of clauses 1 to 30, wherein after the shape of the mesh is set and the mesh is removed from the forming member, the mesh comprises a bowl-shaped shape having an opening extending through the thickness of the bowl-shaped member.

[0119] 97. The method according to any one of clauses 1 to 31, wherein, when positioned above the forming member, a first portion of the mesh is separated from a second portion of the mesh by the thickness of the forming member between the inner and outer surfaces.

[0120] 98. A method for preparing a clogging device, the method comprising:

[0121] A tubular mesh is obtained having an inner lumen extending therethrough and a porosity configured to substantially prevent blood from flowing through the mesh, the mesh comprising first and second end portions and an intermediate portion therebetween;

[0122] Obtain a forming component, which includes:

[0123] A first component having a generally spherical shape and an inner cavity extending therethrough, wherein the first component has a first mating surface, the first mating surface comprising at least a portion of the outer surface of the first component; and

[0124] The second component has a generally hemispherical shape and a cavity with an arcuate surface, the second component having an inner cavity extending through it;

[0125] Position at least a first portion of the middle section of the grid above the outer surface of the second member;

[0126] Position at least a portion of the first end portion of the mesh within the cavity of the first member;

[0127] Position at least a second portion of the middle part of the grid between the first mating surface of the first member and the arcuate surface of the second member, such that the second portion substantially conforms to the first mating surface and the arcuate surface;

[0128] Set the shape of the grid when the grid is positioned on the forming component.

[0129] 99. The method described in Clause 33 further comprises positioning the elongated member within the cavity of the tubular mesh.

[0130] 100. The method described in accordance with Clause 33 or Clause 34 further comprises positioning the elongated member within the cavity of the second member.

[0131] 101. The method according to any one of clauses 33 to 35, further comprising positioning the elongated member within the cavity of the first member.

[0132] 102. The method according to any one of clauses 34 to 36, further comprising conforming the first and second end portions of the mesh to the outer surface of the elongated member.

[0133] 103. The method according to any one of clauses 33 to 37 further comprises attaching the connecting element to the second end portion of the grid at a location adjacent to the outer surface of the second member.

[0134] 104. The method according to any one of clauses 33 to 38 further comprises attaching the connecting element to the first end portion of the grid at a location adjacent to the arcuate surface of the second member.

[0135] 105. The method according to Clause 38 or Clause 39, wherein the connecting element surrounds the circumference of the grid at the respective first or second end portion.

[0136] 106. The method according to any one of clauses 38 to 40, wherein the connecting element comprises marking tape or binding wire.

[0137] 107. The method according to any one of clauses 33 to 41, wherein the mesh is self-expanding.

[0138] 108. The method according to any one of clauses 33 to 42, wherein the tubular mesh comprises a plurality of woven or interwoven filaments.

[0139] 109. The method described in Clause 43, wherein at least some of the filaments contain elastic and / or hyperelastic materials.

[0140] 110. The method according to any one of clauses 33 to 44, wherein positioning a second portion of the middle portion of the grid between a first mating surface of the first member and an arcuate surface of the second member comprises positioning the first member at least partially within a cavity of the second member.

[0141] 111. The method according to any one of clauses 33 to 45, further comprising a second portion of the intermediate portion of the compressed mesh between the first mating surface and the arcuate surface.

[0142] 112. The method according to any one of clauses 33 to 46 further comprises fixing the position of the grid relative to the forming component before setting the shape of the grid.

[0143] 113. The method according to any one of clauses 33 to 47, wherein setting the shape of the mesh involves heat treatment of the mesh and the forming components.

[0144] 114. The method according to any one of clauses 33 to 48, wherein, after the shape of the grid is set, the grid comprises a wavy profile configuration, wherein the first and second end portions of the grid have substantially tubular shapes and the middle portion of the grid is substantially bowl-shaped.

[0145] 115. A method for preparing a clogging device, the method comprising:

[0146] A tubular mesh is obtained having an inner lumen extending therethrough and a porosity configured to substantially prevent blood from flowing through the mesh, the mesh comprising first and second end portions and an intermediate portion therebetween;

[0147] A forming member is obtained, the forming member having a first surface, a second surface opposite to the first surface along the thickness of the forming member, sidewalls therebetween, and an inner cavity extending through the first and second surfaces of the forming member;

[0148] At least a first portion of the middle portion of the mesh is positioned within the cavity of the forming member, such that a first end portion of the mesh extends away from a first surface of the forming member in a first direction, and a second end portion of the mesh extends away from a second surface of the forming member in a second direction opposite to the first direction.

[0149] A mesh is flipped over the forming member such that the first and second end portions of the mesh extend away from the second surface of the forming member in a second direction, wherein the flipping of the mesh causes the first end portion of the mesh to substantially conform to the first and second surfaces and sidewalls of the forming member; and

[0150] Set the shape of the grid when positioning it on the forming component.

[0151] 116. The method according to Clause 50 further comprises positioning the elongated member within the cavity of the tubular mesh and within the cavity forming the member.

[0152] 117. The method according to Clause 51 further comprises conforming the first and second end portions of the mesh to the outer surface of the elongated member.

[0153] 118. The method according to any one of clauses 50 to 52, wherein the sidewalls are annular, such that the forming member comprises a generally cylindrical shape.

[0154] 119. The method according to any one of clauses 50 to 53 further comprises attaching the connecting element to the grid at a location adjacent to the second surface of the forming member.

[0155] 120. The method described in Clause 54, wherein the connecting element is a marking tape or a binding wire.

[0156] 121. The method according to any one of clauses 50 to 53, wherein the tubular mesh comprises a single layer.

[0157] 122. The method according to any one of clauses 50 to 56, wherein the tubular mesh comprises a plurality of woven or interwoven filaments.

[0158] 123. The method described in accordance with Clause 57, wherein at least some of the filaments contain elastic and / or hyperelastic materials.

[0159] 124. The method according to any one of clauses 50 to 58, wherein the shape of the grid is formed by subjecting the grid and the forming member to a heat treatment process.

[0160] 125. The method according to any one of clauses 50 to 59, wherein, after the shape of the grid is set, the grid comprises a wavy profile configuration comprising a substantially tubular open end portion, a substantially tubular intermediate portion, and a substantially disc-shaped closed end portion disposed at an angle to the open end and the intermediate portion.

[0161] 126. The method according to clause 60, wherein the forming member is a first forming member, and after the shape of the grid is set, the grid is a wavy-shaped grid, the method further comprising:

[0162] Separate the wavy mesh shape from the first forming member;

[0163] Obtain a forming assembly comprising a second forming member and a third forming member, wherein:

[0164] The second forming member includes a main body portion having a first surface, a second surface opposite to the first surface along the thickness of the second forming member, a sidewall therebetween, a protrusion extending from the first surface in a first direction, and an inner cavity extending through the main body portion and the protrusion; and

[0165] The third forming member includes a main body portion having a first surface, a second surface opposite to the first surface along the thickness of the third forming member, sidewalls therebetween, and an inner cavity extending through the main body portion;

[0166] The middle portion of the wavy mesh is positioned within the cavity of the second forming member, such that the closed end portion of the wavy mesh extends from the first surface of the second forming member, and the open end portion of the wavy mesh extends from the second surface of the second forming member.

[0167] The closed end portion of the corrugated mesh is positioned between the first surface and protrusion of the second forming member and the second surface of the third forming member, such that the closed end portion of the corrugated mesh conforms to the first surface and protrusion of the second forming member; and

[0168] The second shape is based on the second and third forming components to set the wavy outer mesh.

[0169] 127. The method described in Clause 61, wherein the protrusion is substantially cylindrical.

[0170] 128. The method according to Clause 61 or Clause 62, wherein a first portion of the cavity of the second forming member includes a first diameter, and a second portion of the cavity of the second forming member includes a second diameter different from the first diameter.

[0171] 129. The method according to any one of clauses 61 to 63, further comprising positioning the elongated shaft within the cavity of the wavy-shaped grid, the cavity of the second forming member, and the cavity of the third forming member.

[0172] 130. The method according to any one of clauses 61 to 64 further comprises connecting the connecting element to the corrugated grid.

[0173] 131. The method according to any one of clauses 61 to 65, wherein, after setting the second shape of the wavy-shaped mesh, the wavy-shaped mesh comprises a substantially tubular open end portion, a substantially tubular intermediate portion and a closed end portion disposed at an angle to the open end and the intermediate portion, wherein the closed end portion is substantially disc-shaped with a protruding area.

[0174] 132. The method described in Clause 66, wherein the protruding area is substantially cylindrical.

[0175] 133. A device for treating an aneurysm, the device comprising:

[0176] The grid has an expanded, unconstrained state, the grid being formed of a plurality of braided filaments, each of the filaments having a first end and a second end, wherein the grid has a proximal portion and a distal portion configured to be positioned above the neck of the aneurysm;

[0177] A first connector at the proximal portion, wherein the first ends are fastened relative to each other at the first connector; and

[0178] A second connector at the distal portion, wherein the second ends are fastened relative to each other at the second connector.

[0179] The grid is formed by walls comprising a first portion, a second portion, and a ridge, wherein the first portion extends between a first connector and a ridge, and the second portion extends between a ridge and a second connector.

[0180] The mesh includes a cavity at the distal portion, and all or part of the distal connector is located within the cavity.

[0181] 134. The apparatus according to clause 133, wherein the grid has a single-layer delivery configuration. Attached Figure Description

[0182] Many aspects of this disclosure can be better understood by referring to the following figures. The components in the figures are not necessarily to scale; rather, the focus is on clearly illustrating the principles of this disclosure.

[0183] Figure 1A A perspective view of a system for treating aneurysms according to this technique is shown.

[0184] Figure 1B This illustrates the technology. Figure 1A An enlarged view of the distal portion of the treatment system shown.

[0185] Figure 1C and 1D This is a cross-sectional view of a clogging member in an expanded state according to the present technology.

[0186] Figure 2 An embolization kit according to this technology is shown.

[0187] Figure 3A-3G An example method for treating aneurysms using the treatment system of this technology is described.

[0188] Figure 4A-5B Various types of images are shown that can be used to confirm and / or monitor the deployment of treatment systems based on this technology.

[0189] Figure 6A A side view of a clogging member configured according to several embodiments of the present technology.

[0190] Figure 6B and 6C They are respectively Figure 6A Isometric and cross-sectional views of the occlusion element are shown.

[0191] Figure 7 and 8 Cross-sectional views of different blocking members configured according to several embodiments of the present technology.

[0192] Figure 9A A side view of a clogging member configured according to several embodiments of the present technology.

[0193] Figure 9B To illustrate deployment in a transparent tube Figure 9A Side view of the occlusion component.

[0194] Figure 10A , 10B 10C and 10C are respectively isometric views, cross-sectional views and side views of a blocking member configured according to several embodiments of the present technology.

[0195] Figure 11A and 11B The images are side views and cross-sectional views of a clogging member configured according to several embodiments of the present technology.

[0196] Figure 12 To illustrate deployment in a transparent tube Figure 11A and 11B The side view of the occlusion member shown.

[0197] Figure 13A and 13B The images are side views and cross-sectional views of a clogging member configured according to several embodiments of the present technology.

[0198] Figure 14A and 14B The images are side views and cross-sectional views of a clogging member configured according to several embodiments of the present technology.

[0199] Figure 15A and 15B The images are side views and cross-sectional views of a clogging member configured according to several embodiments of the present technology.

[0200] Figure 16 Depicts forming components configured according to several embodiments of the present technology.

[0201] Figures 17A-17D This is a cross-sectional view of the forming components and grids at different stages of a method for preparing a clogging device according to several embodiments of the present technology.

[0202] Figure 18A Depicts forming components configured according to several embodiments of the present technology.

[0203] Figure 18B For the section 18B-18B along the line Figure 18A The cross-sectional view of the component shown is shown.

[0204] Figures 19A-19C This is a cross-sectional view of the forming components and grids at different stages of a method for preparing a clogging device according to several embodiments of the present technology.

[0205] Figure 20A Depicts forming components configured according to several embodiments of the present technology.

[0206] Figure 20B For the section taken along line 20B-20B Figure 20A The cross-sectional view of the forming component is shown in the figure.

[0207] Figures 21A-21C This is a cross-sectional view of the forming components and grids at different stages of a method for preparing a clogging device according to several embodiments of the present technology.

[0208] Figure 21D A cross-sectional view of a grid configured according to several embodiments of the present technology. Detailed Implementation

[0209] A method for treating an intracranial aneurysm 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 a visual confirmation to the physician that the delivery amount of the embolic element is sufficient to fill the aneurysm lumen. In addition to providing structural support and anchoring for the embolic element, the occlusive member provides a scaffold for tissue remodeling and diverts blood flow from the aneurysm. Furthermore, the embolic element applies substantially uniform pressure on the occlusive member toward the neck of the aneurysm, thereby pressing a portion of the occlusive member positioned adjacent to the neck against the inner surface of the aneurysm wall, such that the occlusive member forms a complete and stable seal at the neck.

[0210] Specific details of the systems, apparatus, and methods for treating intracranial aneurysms according to embodiments of the present technology are referenced herein. Figure 1A-5BThe description is provided below. While these systems, apparatuses, and methods may be described herein primarily or entirely in the context of treating saccular intracranial aneurysms, other contexts are also within the scope of this technology. For example, suitable features of the systems, apparatuses, and methods described 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 occlusion of vessels supplying the tumor), perivascular leaks, varicose veins (e.g., via occlusion of one or more main veins, such as the great saphenous vein), hemorrhoids, and endoleaks sealing adjacent artificial heart valves, covered stents, and abdominal aortic aneurysm devices, as well as other examples. Furthermore, it should be understood that, generally, other systems, apparatuses, and methods besides those disclosed herein are within the scope of this disclosure. For example, systems, apparatuses, and methods according to embodiments of this technology may have configurations, components, procedures, etc., different from and / or additional to those disclosed herein. Furthermore, systems, apparatuses, and methods according to embodiments of this disclosure may be implemented without one or more of the configurations, components, procedures, etc., disclosed herein without departing from the technology.

[0211] I. System Overview of the Invention Technology

[0212] Figure 1A A view illustrating a system 10 for treating intracranial aneurysms according to one or more embodiments of the present technology. Figure 1A As shown, system 10 includes a treatment system 100 and an embolization kit 200 for use with one or more components of the treatment system 100. The treatment system 100 may include an occlusion member 102 (shown in an expanded state) detachably connected to a delivery system, and the delivery system may be configured to intravascularly position the occlusion member 102 within the aneurysm. The embolization kit 200 may include one or more substances or devices, individually or in combination, forming an embolization element configured to co-occupy the internal volume of the aneurysm with the occlusion member 102. In some embodiments, the treatment system 100 may be configured to deliver the embolization element (and / or one or more precursors thereof) to the aneurysm. Alternatively or additionally, system 10 may include a separate delivery system (not shown) for delivering the embolization element (and / or one or more precursors thereof) into the aneurysm lumen.

[0213] like Figure 1A As shown, the treatment system 100 has a proximal portion 100a configured for external positioning during treatment and a distal portion 100b configured for intravascular positioning within a blood vessel (such as an intracranial vessel) at or near a treatment site at the aneurysm. The treatment system 100 may include a handle 103 at the proximal portion 100a, an occlusion member 102 at the distal portion 100b, and a plurality of elongated shafts or members extending between the proximal and distal portions 100a and 100b. In some embodiments, such as Figure 1AAs shown, the treatment system 100 may include a first elongated shaft 109 (such as a guiding catheter or balloon guiding catheter), a second elongated shaft 108 (such as a microcatheter) configured to be slidably disposed within the lumen of the first elongated shaft 109, and an elongated member 106 configured to be slidably disposed within the lumen of the second elongated shaft 108. In some embodiments, the treatment system 100 may exclude the first elongated shaft 109 and include only the second elongated shaft 108.

[0214] Figure 1B This is an enlarged view of the distal portion 100b of the treatment system 100. (See also: [link to reference]) Figure 1A and 1B The occlusion member 102 is detachably coupled to the distal end of the elongated member 106. For example, the elongated member 106 may include a first connector 112 at its distal end, and the occlusion member 102 may include a second connector 114 configured to be detachably coupled to the first connector 112. The treatment system 100 may also include a catheter 116 extending distally from the handle 103 (e.g., via port 110) to a distal portion 100b of the treatment system 100. The catheter 116 is configured to deliver an embolic element (and / or one or more precursors thereof) through one or more components of the delivery system (e.g., the first or second elongated shafts 109, 108, the elongated member 106, etc.) to a location outside the occlusion member 102. Thus, the embolic element can be positioned between the occlusion member 102 and the inner wall of the aneurysm lumen, as described in more detail below.

[0215] According to some embodiments, the second elongated shaft 108 is typically configured to follow and enter cerebral blood vessels associated with the brain along a conventional guideline in the neck anatomy, and may also be selected according to several standard designs commonly available. Thus, the second elongated shaft 108 may have a length of at least 125 cm, and more specifically, a length between about 125 cm and about 175 cm. In some embodiments, the second elongated shaft 108 may have an inner diameter of about 0.015 inches (0.0381 cm), 0.017 inches (0.043 cm), about 0.021 inches (0.053 cm), or about 0.027 inches (0.069 cm). Other designs and sizes are contemplated.

[0216] The elongated member 106 is movable within the first and / or second elongated shafts 109, 108 to position the occlusion member 102 in a desired location. The elongated member 106 may have sufficient flexibility to allow manipulation of the occlusion member 102 through tortuous channels, such as advance and / or retraction. Tortuous channels may include, for example, catheter lumens, microcatheter lumens, blood vessels, urinary tracts, biliary tracts, and airways. 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.

[0217] 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 some 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.

[0218] According to several embodiments, the catheter 116 may be a catheter or elongated shaft that is delivered separately from the second elongated shaft 108.

[0219] A. Selected examples of occlusion components

[0220] Figure 1C This is a cross-sectional view of the occlusion member 102, shown in an expanded state and detached from the treatment system 100. (Reference) Figure 1B and 1C The occlusion member 102 may include an expandable element having a low profile or constrained state when positioned within a catheter (such as a second elongated shaft 108) for delivery to the aneurysm and wherein the expandable element is configured to be positioned within the aneurysm (such as a cerebral aneurysm) in an expanded state.

[0221] According to some embodiments, the occlusion member 102 may comprise 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 to present a predetermined shape encapsulating the internal volume 130. Example shapes include spherical shapes, such as spheres, elongated spheres, oblate spheroids, etc. Figure 1CAs shown, the mesh 101 may have an inner layer 122 and an outer layer 124, having proximal ends fixed relative to each other at the second connector 114 and meeting distally at a distal fold 128 around the hole 126. Although the inner layer 122 and the outer layer 124 are depicted as spaced apart from each other along their length, they may contact each other along all or part of their length. For example, the inner layer 122 may be radially outwardly pressed against the outer layer 124. In some embodiments, the occlusion member 102 may be formed of a single layer or a mesh or braid.

[0222] 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 orifice. In any case, in some embodiments, the conduit 116 may be configured to be slidably positioned through some or all of the inner volume 130 of the second connector 114, the expansion mesh 101, and the opening 126.

[0223] Inner layer 122 and outer layer 124 may be in the distal portion (e.g., as shown in the image). Figure 1C (As shown) they are abutted against each other to form a curved distal surface. For example, at least in the distal portion of the occluder 102, the inner layer 122 and the outer layer 124 may extend distally and radially inward toward the aperture 126. In some embodiments, the outer layer 122 and / or the inner layer 124 extend distally and radially outward from the second connector 114 and then distally and radially inward to the distal end of the occluder 102 (e.g., fold 128). The occluder 102 and / or its layers may be curved along its entire length or may have one or more generally straight portions. In some embodiments, the curved surface transitions to a flat or substantially flat distal surface surrounding the aperture 126. In some embodiments, the curved surface transitions to the distal surface surrounding the aperture 126 and has a radius of curvature greater than the average radius of curvature of the remainder of the occluder 102. A distal surface having a flat or substantially flat surface, or a distal surface with a radius of curvature greater than the average radius of curvature of the remainder of the occlusion member 102, is advantageous for delivery of the embolic element 230 because it creates a small gap between the distal surface of the occlusion member 102 and the dome of the aneurysm A (see example). Figure 3B In some embodiments, the surface of the occluder 102 surrounding the hole 126 is curved and / or has a radius of curvature substantially the same as the rest of the occluder 102.

[0224] In any case, the inner layer 124 may have a shape that substantially conforms to the shape of the outer layer 124, or the inner layer 122 and the outer layer 124 may have different shapes. For example, such as Figure 1DAs shown, the inner layer 122 may have a smaller diameter or cross-sectional dimension than the outer layer 124. This configuration may be advantageous because the embolic element 230 experiences less resistance, at least initially, when pushing the distal wall of the occlusion member 102 downward toward the neck (as described in more detail below).

[0225] In any case, both the proximal and distal portions of mesh 101 can form a generally closed surface. However, unlike the proximal portion of mesh 101, portions of the filaments 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 filaments and an opening through which conduits 116, wires, guide tubes, or other elongated members can pass.

[0226] In some embodiments, each of the plurality of filaments has a first end positioned on the proximal portion of the mesh 101 and a second end positioned on the proximal portion of the mesh 101. Each filament may extend distally from its corresponding first end along the body of the mesh 101 to a fold 128, reverse, and then proximally along the mesh body to its corresponding second end at the proximal portion of the mesh 101. Thus, each of the plurality of filaments has a first length forming an inner layer 122 of the mesh 101, a second length forming an outer layer 124 of the mesh 101, and both the first and second ends are secured to the proximal portion of the mesh 101. In some embodiments, the occlusion member 102 may comprise a mesh formed of a single layer, or a mesh formed of three or more layers.

[0227] In some embodiments, the distal end surface of the mesh 101 is completely closed (i.e., excluding holes). In some embodiments, the filaments are fixed relative to each other at the proximal and distal ends of the closure member 102.

[0228] Mesh 101 may be formed from metal wire, polymer wire, or both, and the wire may have shape memory and / or hyperelastic properties. Mesh 101 may be formed from 24, 32, 36, 48, 64, 72, 96, 128, or 144 filaments. Mesh 101 may 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, the diameter of each wire or filament in the conductor or filament is about 0.0004 inches, about 0.0005 inches, about 0.0006 inches, about 0.0007 inches, about 0.0008 inches, about 0.0009 inches, about 0.001 inches, about 0.0011 inches, about 0.0012 inches, about 0.0013 inches, about 0.0014 inches, about 0.0015 inches, about 0.0016 inches, about 0.0017 inches, about 0.0018 inches, about 0.0019 inches, or about 0.0020 inches. In some embodiments, all filaments of the braided mesh 101 may have the same diameter. For example, in some embodiments, all filaments have a diameter of about 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 embodiments, some of the filaments may have a diameter of about 0.001 inches, and some of the filaments may have a diameter greater than 0.001 inches. Thicker filaments can impart greater strength to the braid without significantly increasing the delivery profile of the device, where thinner wires provide some strength while filling the braid matrix density.

[0229] The occlusion member 102 can have different shapes and sizes in an expanded, unrestrained state. For example, the occlusion member 102 can be bullet-shaped, barrel-shaped, egg-shaped, top-shaped, bowl-shaped, disc-shaped, cylindrical or roughly cylindrical, barrel-shaped, chalice-shaped, etc.

[0230] B. Selected instance of embolization kit

[0231] 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 a mixing syringe 208 (separately identified as mixing syringes 208a, 208b) and a connector 210 extending between respective outlets (not shown) of the mixing syringes 208. The mixing syringes 208a, 208b each include a plunger 212 and a barrel 214 in which the plunger 212 is slidably received.

[0232] 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 deliver the mixture to the proximal portion 100b of the treatment assembly 100. The syringe 216 may include a barrel 220, an outlet port 222 at one end of the barrel 220, and a plunger 224 slidably housed within the barrel 220 via the opposite end. The handle 103 of the treatment system 100 may have a connector configured to form a robust fluid connection between the lumen of the syringe 216 and the outlet port 222.

[0233] The first precursor material 203 and the second precursor material 205 may each comprise a biopolymer and a chemical crosslinking agent, respectively. The chemical crosslinking agent may be selected to form covalent crosslinks between the chains of the biopolymer. In some embodiments, the biopolymer of the first precursor material 203 comprises chitosan or a derivative or analog thereof, and the chemical crosslinking agent of the second precursor material 205 comprises genipin or a derivative or analog thereof. Other suitable crosslinking agents used with chitosan include glutaraldehyde, functionalized polyethylene glycol, and their derivatives and analogs. In other embodiments, the biopolymer of the first precursor material 203 may comprise collagen or a derivative or analog thereof, and the chemical crosslinking agent of the second precursor material 205 may comprise hexamethylene diisocyanate or a derivative or analog thereof. Alternatively or additionally, genipin or its derivatives or analog thereof may be used as a chemical crosslinking agent for collagen-based biopolymers. In still other embodiments, the biopolymer of the first precursor material 203 and the chemical crosslinking agent of the second precursor material 205 may comprise, alone or in combination, other suitable compounds.

[0234] The chemical crosslinking agent that mixes the biopolymer of the first precursor material 203 and the second precursor material 205 can initiate the chemical crosslinking of the biopolymer. After the first precursor material 203 and the second precursor material 205 are mixed, the chemical crosslinking of the biopolymer occurs for a sufficient period of time to allow the resulting embolic element 230 to be delivered to the aneurysm before becoming too viscous to move through the lumen of the catheter 116. Furthermore, the time period for the biopolymer to undergo chemical crosslinking can be short enough to reach the target deployment viscosity within a reasonable time after delivery (e.g., in the range of 10-60 minutes; or at most 40 minutes, 30 minutes, 20 minutes, or 10 minutes). The target deployment viscosity can be high enough to cause the embolic element 230 to aggregate and remain within the internal volume of the aneurysm without reinforcing the neck.

[0235] In at least some cases, the biopolymer has a non-zero degree of chemical crosslinking within the first precursor material 203 prior to mixing with the chemical crosslinking agent. This is useful, for example, for customizing the curing window of the embolization element 230 so that it corresponds well to the expected amount of time required to deliver the material to the aneurysm. The degree of chemical crosslinking of the biopolymer within the first precursor material 203 prior to mixing with the chemical crosslinking agent, the ratio of the biopolymer to the chemical crosslinking agent, and / or one or more other variables may be selected to cause the embolization element 230 to have a viscosity suitable for delivery to the aneurysm via the lumen of the catheter 116 after mixing the first precursor material 203 and the second precursor material 205. In at least some cases, the first precursor material 203 and the second precursor material 205 are mixed in a weight ratio of biopolymer to chemical crosslinking agent in the resulting embolization element 230 ranging from 10:1 to 100:1, such as 10:1 to 30:1, or 15:1 to 50:1, or 15:1 to 25:1. In a specific instance, the first precursor material 203 and the second precursor material 205 are mixed to make the biopolymer in the resulting embolization element 230 mixed with the chemical crosslinking agent in a weight ratio of 30:1.

[0236] Using a biopolymer instead of an artificial polymer in the first precursor material 203 may be advantageous because biopolymers are more readily absorbed by the body and / or for other reasons. Furthermore, using a chemical crosslinking agent instead of a physical crosslinking agent (i.e., a crosslinking agent that forms non-covalent crosslinks between the chains of the biopolymer) in the second precursor material 205 may be advantageous because chemically crosslinked polymers tend to be more cohesive than physically crosslinked polymers and / or for other reasons. In the case of forming a tissue scaffold within an aneurysm, the high cohesiveness of the embolization element 230 may be more important than other contexts regarding securing the solidified embolization element 230 within the aneurysm 302. For example, high cohesiveness of the embolization element 230 may reduce or eliminate the possibility of a piece of embolization element 230 detaching during delivery and entering the patient's cerebral blood flow.

[0237] The first precursor material 203 and the second precursor material 205 may include other components and / or the system 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, second, and / or another precursor material may include a physical crosslinking agent. The presence of a physical crosslinking agent can be used to form a physical crosslink that is complementary to the chemical crosslinking of the chemical crosslinking agent. The combination of chemical and physical crosslinking can enhance the cohesiveness of the embolic element 230. Suitable physical crosslinking agents for use with chitosan-based biopolymers include β-glycerophosphates, mannitol, glucose, and their derivatives and analogs. 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.

[0238] 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 facilitates visualization of the delivery of the embolization element 230 using fluoroscopy. One problem with the use of conventional platinum coils in intracranial aneurysms is that the coil's persistent radiopaqueness often interferes with visualization of other aspects of treatment in subsequent imaging. For example, the presence of a platinum coil within the aneurysm can make it difficult or impossible to detect the presence of blood-borne contrast agents by fluoroscopy, which would otherwise indicate recanalization. In at least some embodiments of this technology, the contrast agent within the embolization element 230 is selected to provide radiopaqueness 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 instances, the first, second, and / or another precursor material includes iohexol or a derivative or analogue thereof as a suitable contrast agent.

[0239] In animal studies, the liquid embolization of this technique has been demonstrated to provide (a) complete or near-complete volume filling of the aneurysm's internal volume, and (b) complete or near-complete coverage of the aneurysm neck with new endothelial tissue. Among other things, these features are expected to result in lower recanalization rates and faster aneurysm occlusion than platinum coil therapy. Furthermore, the injectable stent material is expected to be bioresorbed and thus reduce 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 radiopaque linearity; therefore, 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.

[0240] In some embodiments, the embolization kit 200 and / or the embolization element 230 may be any embolization or occlusion device, such as one or more embolization coils, one or more polymeric hydrogels, polymeric 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.

[0241] II. Selected methods for treating aneurysms

[0242] Figure 3A-3GAn example method for treating aneurysm A using system 10 of this technology is described. First, with the occlusion member 102 in a low-profile state, a physician advances a second elongated shaft 108 toward the intracranial aneurysm (or any other treatment location as described herein). The distal portion of the second elongated shaft 108 may be advanced through the neck N of the aneurysm A to locate the distal opening of the second elongated shaft 108 within the lumen of the aneurysm A. The 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 into a first dilated state.

[0243] Figure 3A The occlusion member 102 is shown in its first dilated state, positioned within the aneurysm lumen and still connected to the elongated member 106. (See diagram) Figure 3A As shown, in the first expanded state, the occlusion member 102 can present a predetermined shape that encloses the internal volume 130 (see Figure 100). Figure 1C In this first dilated state, the occlusion member 102 can substantially conform to the shape of the aneurysm A. For example... Figure 3B As illustrated, the occlusion member 102 and the delivery system are shown in cross-section. A catheter 116 can be advanced through the internal volume 130 of the occlusion member 102 such that the distal opening of the catheter 116 is located at or distal to the orifice 126 in the distal portion of the occlusion member 102. An embolic element 230 can be delivered through the catheter 116 into the space between the occlusion member 102 and the inner surface of the aneurysm wall W.

[0244] In some embodiments, the method includes mixing a first precursor material 203 and a second precursor material 205. Figure 2 To form an embolic element 230. The mixing of the first precursor material 203 and the second precursor material 205 may occur before the embolic element 230 is introduced into the treatment system 100 and / or during delivery of the embolic element to the aneurysm through the catheter 116. In a particular example, the first precursor material 203 is loaded into one of the barrels 214, the second precursor material 205 is loaded into the other barrel 214, and the mixing syringe 208 is connected via a connector 210. To mix the first precursor material 203 and the second precursor material 205, the plunger 212 is alternately pressed, thereby causing the first precursor material 203 and the second precursor material 205 to move repeatedly from one barrel 214 to another barrel 214. After the precursor materials are properly mixed, the resulting embolic element 230 may be loaded into the barrel 220 of the syringe 216. The syringe 216 may then be coupled to the proximal end of the catheter 116 to deliver the embolic element 230 through the catheter 116 and into the aneurysm A. As the embolic element 230 passes through the lumen of the catheter 116, the chemical cross-linking of the biopolymer can continue to occur.

[0245] See again Figure 3B When the embolizing element 230 is delivered between the dome of the aneurysm A and the distal portion 132 of the wall of the occlusion member 102, pressure is established between the aneurysm wall W and the occlusion member 102. Figure 3B-3D As shown, 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, causing the occlusion member 102 to collapse inward, such that the circular distal wall 132 transitions from a concave shape toward the neck N of the aneurysm A to a convex shape toward the neck N. The pressure and reversal of the distal portion of the wall 132 form an annular fold 136 defining the distal edge of the occlusion member 102. As the occlusion member 102 continues to reverse, the position of the fold 136 moves toward the neck N, which continues until the distal half of the occlusion member 102 has been reversed. In some embodiments, the occlusion member 102 may include one or more portions configured to preferably bend or fold, such that the occlusion member 102 folds with a desired longitudinal direction. Furthermore, as the occlusion member 102 collapses, the distance between the walls of the distal portion 132 and the proximal portion decreases, and therefore the internal volume 130 of the occlusion member 102 also decreases. As the occlusion member 102 collapses, the conduit 116 can remain stationary, advance distally, and / or retract proximally.

[0246] 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. The compression of the occlusion member with the embolic element 230 provides the physician with a real-time “flattening” or “aneurysm filling indicator” under a single-plane imaging method (such as fluoroscopy), allowing the physician to confirm at what point the aneurysm is completely filled. See below for reference. Figure 4A-5B Describe additional details regarding the devices, systems, and methods used for monitoring and / or confirming deployment. Filling as much space as possible within the aneurysm is beneficial, as leaving gaps within the aneurysm sac can lead to delayed healing and an increased risk of aneurysm recanalization and / or rupture. While the stent across the neck provided by the occlusion member 102 facilitates blood thrombosis in any gaps and neck healing, essential lumen filling prevents acute rupture and is independent of the neck stent (i.e., occlusion member 102). Conventional devices cannot confirm complete or near-complete aneurysm filling on monoplane imaging.

[0247] Once the embolic element 230 has been delivered, the catheter 116 can be withdrawn. In some embodiments, the embolic element 230 may fill more than 40% of the aneurysm sac volume. In some embodiments, the embolic element 230 may fill more than 50% of the aneurysm sac volume. In some embodiments, the embolic element 230 may fill more than 60% of the aneurysm sac volume. In some embodiments, the embolic element may fill more than 65%, 70%, 75%, 80%, 85%, or 90% of the aneurysm sac volume.

[0248] Figure 3E The second expanded state of the occlusion member 102, shown in cross-section, is illustrated, wherein the embolization element 230 occupies the remaining volume of the aneurysm A. Figure 3F The fully occluded member 102 is shown, with the embolization element 230 removed, thus revealing the second shape of the occluded member 102. As shown, the embolization element 230 can be delivered until the occluded member 102 completely collapses, such that the occluded member 102 has essentially no internal volume.

[0249] In the second dilated state, the occlusion member 102 may form a bowl shape extending through the neck of the aneurysm A. The wall of the occlusion member 102 at its distal portion may now be positioned to contact or be adjacent to the wall of the occlusion member 102 at its proximal portion. The distal wall 132 may contact the proximal wall 134 along its entire or substantially its 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 very close to but does not contact the proximal wall 134.

[0250] Collapse of the occlusion member 102 itself toward the neck N of the aneurysm may be particularly beneficial, as it doubles the number of layers passing through the neck and thus increases occlusion at the neck N. For example, collapse or inversion of the distal wall 132 onto the proximal wall 134 can reduce the porosity of the occlusion member 102 at the neck N. In embodiments where the occlusion member 102 is a mesh or braided device, such that the distal wall 132 has a first porosity and the proximal wall 134 has a second porosity, deformation of the distal wall 132 on or immediately adjacent to the proximal wall 134 reduces the effective porosity of the occlusion member 102 above the neck N. The resulting multilayer structure has a 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 occlusion member 102, preventing blood from flowing through the embolization element 230 into the aneurysm lumen. As much of the aneurysm as possible needs to be occluded, as leaving gaps allows blood to flow in and / or pool, which can continue to stretch the wall of aneurysm A. Dilatation of aneurysm A can lead to recanalization of the occlusion component 102 and / or protrusion and / or entry of the embolic element 230 into the parent vessel and / or rupture of aneurysm A. Both of these situations can be fatal to the patient.

[0251] 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 above 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 above the neck N of the aneurysm A. As previously mentioned, the neck coverage provided by the doubled layers provides additional surface area for endothelial cell growth, reduces the porosity of the occlusion member 102 at the neck N (compared to two or one layer), and prevents the embolic element 230 from protruding into the carrier vessel. During and after delivery, the embolic element 230 applies substantially uniform pressure on the occlusion member 102 toward the neck N of the aneurysm A, thereby pressing the portion of the occlusion member 102 located 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.

[0252] like Figure 3G As shown, the first connector 112 can be disengaged from the second connector 114 and the elongated member 106 and the second elongated shaft 108 can be retracted, thereby allowing the occlusion member 102 and the embolization element 230 to be implanted into the aneurysm A.

[0253] 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 trapped thrombus into fibrous tissue within the internal volume of the 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 occlusion device 102. Ultimately, the thrombus and cells at the aneurysm wall may completely degrade, leaving a successfully remodeled vascular area.

[0254] In some embodiments, the 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 through the second elongated shaft 108, the catheter 116, or through another catheter or device typically used for delivering the contrast agent. The aneurysm (and devices therein) may be imaged before, during, and / or after the injection of the contrast agent, and the images may be compared to confirm the degree of aneurysm occlusion.

[0255] According to some aspects of this technology, system 10 may include separate first and second elongated shafts (e.g., microcatheters) (not shown), a first embolic element dedicated to delivery, and a second occlusive member dedicated to delivery. In an example method of treating an aneurysm, the first elongated shaft may be advanced intravascularly into the aneurysm and through the neck, such that the distal 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 tip of the shaft is close to the dome of the aneurysm.

[0256] A second elongated shaft containing an occlusion member (such as occlusion member 102) can be advanced intravascularly into the aneurysm and positioned within the aneurysm cavity adjacent to the first elongated shaft. The occlusion member can then be deployed within the aneurysm sac. When deployed, the occlusion member pushes the first elongated shaft outward toward one side of the aneurysm, and when fully deployed, the occlusion member holds or “traps” the first elongated shaft between the outer surface of the occlusion member and the inner surface of the aneurysm wall.

[0257] The embolic element (such as embolic element 230) can then be delivered through the first elongated axis to a position 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 more distal surface) of the aneurysm wall. In this way, the "trapped" first elongated axis will be secured by the occlusion member, allowing the embolic element to gradually fill the open space in the aneurysm sac between the dome and the occlusion member. As described elsewhere in this document, the filling of the embolic element, from the dome to the neck, compresses and presses the occlusion member against the tissue surrounding the aneurysm neck as it fills the space in the sac above the occlusion member. Again, as described elsewhere in this document, the compression of the occlusion member with the embolic element provides a "flattening or aneurysm filling indicator" not provided by conventional single-plane imaging methods. For example, the filling of the embolic element can be completed when it occupies approximately 50%–80% of the aneurysm volume.

[0258] III. Selected devices, systems, and methods for monitoring deployment

[0259] Proper deployment of the embolic element 230 and the occlusion member 102 can be monitored and / or confirmed using one or more medical imaging techniques, such as fluoroscopy. Figure 4A-5B Examples of various types of fluoroscopic images are provided, which physicians can use at different stages of deployment to monitor the position of the occlusion member 102 within the aneurysm A, monitor the degree to which the aneurysm A is filled by the embolization element 230, and / or confirm the degree of occlusion of the aneurysm A by the deployment system. As described in more detail below, the devices and systems of this technology can be configured to provide unique visual indicators that provide physicians with confirmation of the degree of aneurysm occlusion via one or more medical imaging techniques. As described in more detail below, the visual indicators may include specific variations in the shape of all or part of the occlusion member 102, specific variations in the relative positions of one or more radiopaque markers on the occlusion member 102 and / or delivery system (such as catheter 116), specific variations in the shape of the embolization element 230, etc.

[0260] Although the following discussion is for reference Figure 4A-5B The images shown are two-dimensional, but the system and method of this technique can be used with three-dimensional imaging techniques. Furthermore, Figure 4A-5BThis represents a two-dimensional image in which only the aneurysm slice (and the device therein) is visible. Although in some cases the inner and outer layers of the occlusion member 102 (where such layers are present) can be distinguished from each other in a radiographic image, in this example, these layers appear as a single thick layer. As used herein, “proper deployment” or “successful deployment” may refer to (a) the aneurysm A being completely (e.g., greater than 80%) or substantially completely (e.g., greater than 50%) filled with the occlusion element 230, (b) the occlusion member 102 being completely or substantially completely reversed or collapsed onto itself above the neck N of the aneurysm A, or both.

[0261] The blocking member 102 may include one or more non-transmissive markings, such as Figures 4A-4C The markings 402, 404, 406, and 114 are shown (collectively, “marker 401”). Marker 401 can be arranged in a specific spatial arrangement around the occlusion member 102 such that relative movement of the markings indicates the degree of deployment stage of the occlusion member 102 and / or the embolization element 230. Marker 401 can be located at any location along the occlusion member 102. For example, the occlusion member 102 may include one or more radiopaque markings 402 (only one shown for illustration) at or along the distal wall 132, one or more radiopaque markings 404 (only one shown for illustration) at or along the proximal wall 134, and one or more radiopaque markings 406 (only one shown for illustration) at or along the middle portion of the wall. Furthermore, the connector 114 of the occlusion member 102 may be radiopaque. Marker 401 can be located on one, some, or all layers of the occlusion member 102 (at least in those embodiments where the occlusion member 102 includes multiple layers). In some embodiments, a separate marker 401 may comprise a radiopaque strip or clip attached to one or more struts, filaments, wires, etc., of the occlusion member 102. In some embodiments, a separate marker 401 may comprise a radiopaque material coated on or otherwise incorporated into the wall of the occlusion member 102. The separate markers 401 may have the same or different shapes, lengths, and / or cross-sections.

[0262] In some embodiments, in addition to having one or more markings 401 or instead of having one or more markings 401, the occlusion member 102 itself may be partially or entirely formed of a radiopaque material, such as one or more radiopaque wires. Figures 4A-4CIn the example depicted, the occlusion member 102 is formed of a radiopaque material and also includes radiopaque markers 402, 404, and 406. The occlusion member 102 is formed of a plurality of drawn filled tube (“DFT”) wires containing a core formed of a radiopaque material (such as platinum), the core being surrounded by an outer radiopaque material (at least relative to the core material). Markers 402, 404, and 406 are formed entirely of radiopaque material and therefore have a higher density of radiopaque material. Therefore, markers 402, 404, and 406 appear darker than the occlusion member 102 in the image. In some embodiments, the occlusion member 102 may have radiopaque material different from that of one or more of the markers 402, 404, and 406, such that the walls of the occlusion member 102 and the markers(s)406 can be distinguished from each other in the radiographic image. The walls of the occlusion member 102 may be more radiopaque than one or more of the markers 402, 404, and 406.

[0263] In some embodiments, one or more components of the delivery system may include one or more radiopaque markers. For example, conduit 116 may include one or more radiopaque markers positioned along its length. Figures 4A-4C In the depicted embodiment, catheter 116 may include a radiopaque marker 400 located at or near its distal end. Catheter 116 may have one or more additional markers (not shown) located along its length, such as along the length of catheter 116 extending through the internal volume 130 of occlusion member 102.

[0264] like Figure 4A As shown, when the occlusion member 102 is first deployed within the aneurysm (e.g., allowing self-expansion), one or more radiopaque markers 402, 404, 406 of the occlusion member 102 will be in a first position relative to each other and relative to the radiopaque markers of the catheter 116. For example, when the occlusion member 102 is first deployed, markers 402 and 404 are separated by a first distance d1. As the embolization element 230 is delivered through the catheter 116 and into the aneurysm sac, the occlusion member 102 can be positioned as previously described. Figure 3A-3GThe deformation described. This deformation can cause one or more radiopaque markers 401 carried by the occlusion member 102 to move to a second position relative to each other. For example, a physician can confirm the progress of deployment by observing that markers 402 and 404 are now separated by a distance d2. One or more radiopaque markers 401 can also move relative to one or more radiopaque markers 400 of catheter 116, which may remain in the same or substantially the same position within the aneurysm. By comparing images of radiopaque markers 400 and / or 401 in the first relative position and images of radiopaque markers 400 and / or 401 in the second relative position, a clinician can visually confirm that the embolization element 230 has filled a certain percentage of the aneurysm A.

[0265] For example, according to some aspects of this technology, confirmation that the aneurysm is adequately filled (i.e., 50% or more) can be indicated by moving one or more distal wall markers 402 very close to one or more proximal wall markers 404, and / or touching one or more proximal wall markers 404. Because the embolization element 230 applies substantially uniform pressure on the distal wall 132 and pushes downward toward the neck N as it fills the space between the occlusion member 102 and the aneurysm wall, the movement of one or more distal wall markers 402 to a position adjacent to the proximal wall markers 404 indicates to the physician that the aneurysm A is substantially filled (e.g., 50% or more) by the embolization element 230. This relative positioning also indicates that the distal wall 132 now provides additional occlusion at the neck N of the aneurysm and that the occlusion member 102 is in its second expanded shape. In some embodiments, the connector 114 may be used as a proximal indicator, replacing or supplementing one or more proximal markers 404.

[0266] In some embodiments, confirmation that the aneurysm is adequately filled (i.e., 50% or more) can be indicated by moving one or more distal wall markers 402 a predetermined distance away from the catheter marker 400 (or a marker attached to another component of the delivery system). For example, when the occlusion member 102 is in a first dilated state or shape ( Figure 4A In the second dilated state or shape ( ), the distal wall mark 402 may be adjacent to the catheter mark 400. Figure 4C Under these conditions, the distal wall marker 402 may be separated from the catheter marker 400 by a distance approximately equal to the diameter D of the occlusion member 102 in its dilated state when initially positioned within the aneurysm A. As explained above, this relative positioning of one or more distal wall markers 402 and catheter markers 400 indicates to the physician that the aneurysm A is substantially filled with the embolic element 230 (e.g., 50% or more). This relative positioning also indicates that the distal wall 132 now provides additional occlusion at the neck N of the aneurysm and that the occlusion member 102 is in its second dilated shape.

[0267] In some embodiments, one or more intermediate marks 406 may be used to confirm and / or monitor deployment. For example, one or more intermediate marks 406 may be located at or near the desired reversal plane of the occluder member 102. In this example, using an occluder member 102 that is deformed into a generally spherical shape resembling a bowl, the reversal plane is at or near the centerline of the occluder member 102 in its expanded state. This is because, in the fully reversed state, the distal half of the occluder member 102 will be located within / fitted with the proximal half of the occluder member 102 (e.g., ...). Figure 4C (As shown). Therefore, the centerline of the occlusion member 102 is the desired reversal plane. The occlusion member 102 can be non-transmissive (e.g., Figures 4A-4C As shown), but to a lesser extent than (one or more) intermediate marks 406, such that the wall of the occlusion member 102 and (one or more) marks 406 are distinguishable from each other on a radiographic image. Therefore, the top edge 136 of the occlusion member 102 is shown. Figure 4C An image of the adjacent (one or more) intermediate markers 406 or thereon may indicate that the aneurysm A is substantially filled with the embolic element 230 (e.g., 50% or more). This relative positioning also indicates that the distal wall 132 now provides additional occlusion at the neck N of the aneurysm and that the occlusion member 102 is in its second dilated shape.

[0268] The shape variation of the occlusion member 102 and / or the positional variation of different portions of the occlusion member 102 relative to each other can also indicate proper deployment. As previously discussed, the occlusion member 102 presents a first expansion shape upon initial deployment and has a second expansion shape after deformation by the occlusion element 230. In several embodiments, the second expansion shape represents a partial or complete reversal from the first expansion shape, which can be confirmed on a radiographic image by observing the changed profile of the occlusion member 102. For example, in this example where the occlusion member 102 has a first expansion shape that is generally spherical, a C-shaped image is shown (e.g., Figure 4C (As shown in the image) This can indicate that the desired filling and / or deployment has been completed. In the 3D image, the second expansion shape may have a bowl shape. In some embodiments, confirmation of complete or substantially complete deployment can be indicated by the distal sidewall 500 within a predetermined distance of the proximal sidewall 502.

[0269] In some embodiments, proper deployment can be confirmed by observing the distance between the inverted wall (here, distal wall 132) and the relatively stationary wall (here, proximal wall 134). Figure 4C As shown, when the distal wall 132 collapses downward onto or near the proximal wall 134, the occlusion member 102 appears in the image to have twice the thickness in the proximal portion. Furthermore, as the occlusion member 102 is reversed, the density of the radiopaque material doubles, and therefore the doubled portion of the occlusion member 102 appears darker in the image.

[0270] like Figure 5A and 5B As shown, in some embodiments, certain portions of the occlusion member 102 may be coated with a radiopaque material, such that variations in the shape or orientation of these portions indicate the desired location of the occlusion member 102. For example, such as Figure 5A As shown, the distal half 500 of the occlusion member 102 may be coated with a radiopaque material, while the proximal half 502 may be uncoated or further radiopaque than the distal half 500. Therefore, confirmation of complete or substantially complete deployment can be indicated by the more radiopaque distal wall 500 adjacent to the proximal wall 502. For example, confirmation of complete or substantially complete deployment can be indicated by the distal wall 500 within a predetermined distance of the proximal wall 502. Confirmation can also be obtained from the distal wall 500, whose shape changes from flat or convex (towards a dome) to concave in the aneurysm A.

[0271] The shape of the embolic element 230 can also provide an indication of deployment progress. For example, the shape of the lower portion (closer to the neck N) of aneurysm A can indicate the extent to which the aneurysm is filled by the embolic element 230 and / or the degree of deformation of the occlusion member 102. Since most aneurysms have a generally spherical or globular shape, the lower boundary of the embolic element 230 may have a decreasing radius of curvature as more is injected and more occlusion members 102 are reversed. For example, in Figure 4B In this configuration, when aneurysm A is partially filled with embolic element 230 and occlusion member 102 only partially collapses or reverses, the distal wall 132 has a first radius of curvature. Figure 4C In the case where the aneurysm A is substantially or completely filled, the radius of curvature of the distal wall 132 is smaller than the radius of curvature of the distal wall 132 in a partially deformed state.

[0272] Alternatively, the extent of deployment of the occlusion member 102 and / or the degree of filling of the aneurysm A can be further determined by injecting contrast agent into the carrier vessel and imaging the aneurysm to determine how much contrast agent enters the aneurysm cavity.

[0273] The apparatus, system, and method of this technique are particularly advantageous compared to conventional apparatus used for two-dimensional imaging. In two-dimensional imaging (e.g., fluoroscopy), the image may only reflect a slice or orthographic view of the aneurysm (and the device or material within it). Therefore, any voids or gaps in the filling may not be apparent in the slice because the image slice does not cross-section the voids within the aneurysm A, or the cross-section or orthographic view of the stagnant area may present different shapes depending on how the image is viewed. The physician may have to take multiple images to determine the general amount of filling in the aneurysm. In contrast, the occlusion member 102 of this technique has a unique shape that dynamically adjusts to introduce the occlusion element 230 in a predictable and measurable manner, indicating the degree of filling of the occlusion element 230 in a single two-dimensional radiographic image.

[0274] The apparatus, systems, and methods disclosed herein include using one, some, or all of the methods disclosed above to confirm and / or observe various stages of system deployment in aneurysms, including complete or substantially complete deployment.

[0275] IV. Examples of occlusion components

[0276] Intrasacral treatment of saccular aneurysms with a particular morphology (such as wide-necked aneurysms) typically requires an occlusion device that is excessively large relative to the size of the aneurysm to provide the radial force needed for neck protection and stability. In several of the foregoing embodiments, the occlusion member has a substantially spherical first expansion state (e.g., see...). Figure 3A When these occlusion components are too large and implanted, some of them elongate, causing the occlusion component to protrude into the tumor-bearing vessel. To address this challenge and avoid or reduce the elongation of the occlusion component, in some embodiments of this technology, the occlusion component is configured to present a semi-collapsed shape upon initial deployment (similar to...). Figure 3C (The hemispherical shape shown). However, sometimes these hemispherical occluders elongate during or after deployment, causing the distal portion 132 of the occluder wall to bend distally in the first expanded state (rather than being generally flat or bending proximally toward the proximal wall 134), before the embolic element is introduced. In this case, the elongated shape makes subsequent reversal of the occluder via delivery of the embolic element (as discussed herein) particularly challenging.

[0277] Several embodiments of the blocking member of this technology are configured to address the aforementioned challenges. For example, the following describes... Figure 6A-15B Several such embodiments are described. The occlusion member detailed herein allows for sufficient oversize without causing therapeutically prohibitive elongation, eliminates the need for device reversal when the embolization element is delivered, reduces or eliminates protrusion of the occlusion member into the carrier vessel, and provides a good fit to the contour of the aneurysm neck.

[0278] Figure 6AA slightly tilted side view of a blocking member 600 configured according to several embodiments of the present technology. Figure 6B and 6C These are the isometric view and cross-sectional view of the occluder member 600, respectively. Please refer to both. Figures 6A-6C The occlusion member 600 may include a mesh having a proximal portion 600a, a distal portion 600b, a proximal connector 604, and a distal connector 606 configured to be positioned above the neck of the aneurysm. In some embodiments, the mesh is biased toward a predetermined shape when it is in an expanded, unconstrained state. The mesh may be formed by a wall surrounding an inner region 618 and including a first portion 614, a second portion 612, and an annular ridge 610. The first portion 614 and the second portion 612 may be separated by a distance d that increases toward the central longitudinal axis of the occlusion member 600. In some embodiments, the distance d may generally be constant or may decrease toward the central longitudinal axis of the device. The first portion 614 of the wall may extend between the proximal connector 604 and the ridge 610, and the second portion 612 of the wall may extend between the ridge 610 and the distal connector 606.

[0279] Compared with the distal sidewalls disclosed herein that have an outwardly curved shape away from the internal region in the first expansion state (see, for example) Figure 1C Compared to a closure member that is substantially flat in its first expanded state (distal wall 132), the second portion 612 of the closure member 600 bends inward toward the inner portion 618 in its first expanded state, thereby forming a cavity 608 at the distal portion 600b of the closure member 600. For example, the cavity 608 may be defined by the second portion 612 of the wall and a plane located on the ridge 610. Figures 6A-6C As shown, all or a portion of the distal connector 606 can therefore be positioned within the cavity 608, below the plane defined by the ridge 610. In some embodiments, the occlusion member 600 and / or the mesh includes a recessed portion 616 at the proximal portion 600a surrounding all or a portion of the proximal connector 604. In some embodiments, the occlusion member 600 and / or the mesh does not include the recessed portion 616 at the proximal portion 600a.

[0280] Because the second portion 612 is proximally curved, the occlusion member 600 is less likely to elongate and / or elongate less when deployed in an aneurysm (compared to occlusion members with laterally curved or substantially flat distal walls). Furthermore, the curved second portion 612 simulates the semi-collapsed state discussed herein (e.g., see reference...). Figure 1A-5B Therefore, the occlusion member 600 does not need to rely on the proximal force applied by the embolization element to cause the occlusion member 600 to reverse. Instead, the embolization element can fill the space between the second portion 612 and the aneurysm wall, whether or not it causes the second portion 612 to move toward the first portion 614.

[0281] In some embodiments, such as Figures 6A-6C As shown, the occlusion member 600 and / or the mesh is formed of a plurality of braided filaments 602, each having first and second ends and a length measured between them. Compared to the occlusion members disclosed herein in which the first and second ends of the filaments are fastened relative to each other at the same location (e.g., a proximal connector), the first and second ends of the filaments 602 forming the occlusion member 600 are fastened relative to each other at separate connectors. For example, the first ends of the filaments 602 may be fastened relative to each other at a proximal connector 604, and the second ends of the filaments 602 may be fastened relative to each other at a distal connector 606. Thus, the second ends of the filaments 602 terminate within a cavity 608, below the plane defined by the ridge 610. The resulting mesh structure thus has a “single-layer” delivery configuration, wherein the longitudinal distance between the distal connector 606 and the proximal connector 604 is greater than the longitudinal distance between the distal connector 606 and the proximal connector 604 when the occlusion member 600 is in an expanded state. Therefore, when the occlusion member 600 is in the delivery configuration, the occlusion member 600 elongates such that any portion of the filament 602, which has no or substantially no filament, radially overlaps another portion of the same filament 602. When the occlusion member 602 is released from the delivery sheath, the proximal connector 604 and the distal connector 606 move longitudinally closer together, thereby creating the bowed second portion 612 and the cavity 608.

[0282] The single-layer delivery configuration of the occlusion member 600 (and occlusion members 700, 800, 900, etc.) advantageously allows for a grid with a lower delivery profile, and thus enables the occlusion member to be delivered through a delivery conduit of a smaller diameter compared to occlusion members with a two-layer delivery configuration (e.g., occlusion member 102, occlusion member 1000, occlusion member 1100, occlusion member 1300, etc.) or a four-layer delivery configuration (e.g., occlusion member 1400, occlusion member 1500, etc.).

[0283] In some embodiments, the second portion 612 of the wall may have a profile and / or shape substantially conforming to the profile and / or shape of the first portion 614 of the wall, or the first portion 612 and the second portion 614 may have different profiles and / or shapes. In these and other embodiments, the radius of curvature of all or a portion of the second portion 612 of the wall may be different from the radius of curvature of all or a portion of the first portion 614 of the wall. In these and other embodiments, the radius of curvature of the second portion 612 of the wall may be greater than, less than, or substantially equal to the radius of curvature of the first portion 614 of the wall. The second portion 612 of the occlusion member 600 may have a substantially constant slope along its length (i.e., between the ridge 610 and the distal connector 606), or all or a portion of its length may bulge toward the aneurysm wall (while still maintaining the lumen 608), and / or all or a portion of its length may be recessed toward the aneurysm wall.

[0284] The mesh of the occlusion member 600 may be formed from metal wire, polymer wire, or both, and the wire may contain an elastic material and / or a material with shape memory and / or hyperelastic properties. The mesh may be formed from 24, 32, 36, 48, 64, 72, 96, 128, or 144 filaments. The mesh may 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 wire or filament in the braid 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 filaments in the braided mesh may have the same diameter. For example, in some embodiments, all 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 embodiments, some of the filaments may have a diameter of about 0.001 inches, and some of the filaments may have a diameter greater than 0.001 inches. Thicker filaments can impart greater strength to the braid without significantly increasing the delivery profile of the device, where thinner wires provide some strength while filling the braid matrix density.

[0285] Figure 7 and 8 Cross-sectional views of different blocking members 700, 800 configured according to several embodiments of the present technology. Figure 7Several features of the blocking member 700 shown may be substantially similar to those of the blocking member 600. However, Figure 7 The occlusion member 700 shown has a second portion 712, which includes a region recessed along most of its length toward the inner region 718, and has a ridge 710 that is wider than the ridge 610. Figure 8 Several features of the blocking member 800 shown may be substantially similar to those of the blocking member 600. However, Figure 8 The spacing between the first portion 812 and the second portion 814 of the occlusion member 800 is small, and the distance d between the first portion 812 and the second portion 814 is approximately constant. As a result, the occlusion member 800 has a bowl-shaped configuration in the first expanded state.

[0286] Figure 9A A side view of a blocking member 900 configured according to several embodiments of the present technology. Figure 9A Several features of the blocking member 900 shown may be substantially similar to those of the blocking member 600. Figure 9A In the middle, the occlusion member 900 has a fairly shallow cavity 908. Figure 9B As shown in a transparent tube in a slender, expanded state. Figure 9A A side view of the occlusion element. (e.g.) Figure 9B As shown, the second portion 912 extends distally, such that the distal portion 900b is in a first expanded state compared to the blocking member 900. Figure 9A ( ) when further away from the proximal part 900a.

[0287] It should be understood that the occlusion member of this technology with a single-layer delivery configuration can have different shapes, sizes, and configurations and is not limited to the embodiments depicted in the figures. Furthermore, the elongated shaft for delivering the embolic element can be positioned through one or both of the proximal and distal connectors.

[0288] Figure 10A , 10B 10C and 10C are respectively isometric views, cross-sectional views, and side views of a blocking member 1000 configured according to several embodiments of the present technology. (See also:) Figures 10A-10C The occlusion member 1000 may include a mesh having a proximal portion 1000a, a distal portion 1000b, and a proximal connector configured to be positioned above the neck of the aneurysm. Figures 10A-10C(Not depicted in the image). In some embodiments, when the mesh is in an expanded, unconstrained state, the mesh is biased toward a predetermined shape. The mesh may be formed by a wall surrounding an inner region and comprising a first portion 1014, a second portion 1012, and an annular ridge 1010. The first portion 1014 and the second portion 1012 may be separated by a distance d. In some embodiments, the distance d may generally be constant or may increase toward the central longitudinal axis of the device. The first portion 1014 of the wall may extend between the proximal connector and the ridge 1010, and the second portion 1012 of the wall may extend between the ridge 1010 and the proximal connector.

[0289] Compared with the distal sidewalls disclosed herein that have an outwardly curved shape away from the internal region in the first expansion state (see, for example) Figure 1C Compared to the distal wall 132 of the occluding member 1000, which is substantially flat in the first expanded state, the second portion 1012 of the occluding member 1000 bends inward toward the inner portion in the first expanded state, thereby forming a cavity 1008 at the distal portion 1000b of the occluding member 1000, thus forming a bowl-shaped or chalice-shaped shape. For example, the cavity 1008 may be defined by the second portion 1012 of the wall and a plane located on the ridge 1010.

[0290] Because the second portion 1012 is offset proximally, the occlusion member 1000 is less likely to elongate and / or elongate less when deployed in an aneurysm (compared to occlusion members with an outwardly curved or substantially flat distal wall). Furthermore, the curved second portion 1012 simulates the semi-collapsed state discussed herein (e.g., reference...). Figure 1A-5B Therefore, the occlusion member 600 does not need to rely on the proximal force applied by the embolization element to cause the occlusion member 1000 to reverse. Instead, the embolization element can fill the space between the second portion 1012 and the aneurysm wall, causing or not causing the second portion 1012 to move toward the first portion 1014.

[0291] In some embodiments, such as Figures 10A-10C As shown, the occlusion member 1000 and / or the mesh is formed of a plurality of braided filaments 1002, each having first and second ends and a length measured between them. Compared to the occlusion member 600, the first and second ends of the filaments of the occlusion member 1000 are fastened to the same position relative to each other (proximal connector, not shown). The proximal connector is configured to attach to the first and second ends at the most distal region of the first and second end sets. Figures 10A-10C As shown, the second end converges at the bottom of cavity 1008 and forms a proximal extension column extending into the converged first end. The resulting mesh structure thus has a “double-layer” delivery configuration, wherein the first and second portions 1014, 1012 of the wall radially overlap each other when the occlusion member 1000 is in a low profile state and contained within the delivery conduit.

[0292] Figure 11A and 11B These are side views and cross-sectional views of a blocking member 1100 configured according to several embodiments of the present technology. Figure 11A and 11B As shown, the occlusion member 1100 may have a dual-layer delivery configuration. In some embodiments, the occlusion member 1100 has a first portion 1114 that extends proximally from the ridge 1110, then turns and extends distally toward the proximal connector 1104. Thus, the first and second portions extend longitudinally toward each other to meet at the proximal connector 1104. Figure 12 As shown in an expanded, elongated configuration within a transparent tube Figure 11A and 11B Side view of the occlusion component.

[0293] Figure 13A and 13B These are side views and cross-sectional views of a blocking member 1300 configured according to several embodiments of the present technology. Figure 13A and 13B As shown, the occlusion member 1300 may have a double-layer delivery configuration. Compared to the occlusion member 1100, the occlusion member 1300 has a substantially constant distance d between the first portion 1314 and the second portion 1312, such that the occlusion member 1300 has a disk shape in the first expanded state.

[0294] Figure 14A and 14B These are side views and cross-sectional views of a blocking member 1400 configured according to several embodiments of the present technology. Figure 14A and 14B As shown, the occlusion member 1400 has a "four-layer" delivery configuration, wherein portions 1414a, 1414b, 1412a, and 1412b radially overlap each other when the occlusion member 1400 is in a low-profile state within the delivery conduit. Unlike previous embodiments, the ridge 1410 is formed by a bend in the first portion 1414a and does not correspond to the meeting point of the first portion 1414 and the second portion 1412. Instead, the first portion 1414 and the second portion 1412 meet at a fold 1413 located within the cavity 1408.

[0295] Figure 15A and 15B These are side views and cross-sectional views of a blocking member 1500 configured according to several embodiments of the present technology. Figure 15A and 15B As shown, the occlusion member 1500 has a "four"-layer delivery configuration. The occlusion member 1500 has a second portion 1512, which has a substantially constant slope.

[0296] V. Selected manufacturing method

[0297] This technology relates to blocking devices and related manufacturing methods. See below for reference. Figure 16-21D This describes the specific details of these and other methods for manufacturing the mesh structures of this technology.

[0298] In some embodiments, the forming component of this technology includes a plurality of forming members. For example, Figure 16 A forming component 1600 (or "component 1600") according to several embodiments of the present technology is depicted, shown in an unassembled state. Figure 16 As shown, component 1600 may include a first component 1602 and a second component 1604 (collectively referred to as “components 1602, 1604”). Components 1602 and 1604 may be configured to be positioned adjacent to each other such that when the mesh is positioned between components 1602 and 1604, the mesh substantially conforms to the surface of each of components 1602 and 1604. The shape of each of components 1602 and 1604 may be based on the desired predetermined shape of the occlusion device and / or the geometry of the aneurysm to be treated. Suitable shapes for components 1602 and 1604 include, but are not limited to, spherical and non-spherical shapes, cylinders, hemispheres, polyhedra (e.g., cuboids, tetrahedrons (e.g., pyramids), octahedrons, prisms, etc.), oblate spheroids, plates (e.g., disks, polygonal plates), bowls, non-spherical surfaces of revolution (e.g., tori, cones, cylinders, or other shapes that rotate about a central point or a coplanar axis), and combinations thereof.

[0299] According to some embodiments, such as Figure 16 As shown, the first member 1602 has a generally spherical shape. The first member 1602 may have an inner cavity 1606 extending through at least a portion of the first member 1602. For example, as Figure 16 As shown, the cavity 1606 may extend through the thickness of the first member 1602. Additionally, the cavity 1606 may extend along the longitudinal axis of the first member 1602. In some embodiments, the diameter of the cavity 1606 is at least partially based on the diameter of the tubular mesh. Alternatively, the diameter of the cavity 1606 may be selected such that the first member 1602 can receive at least a portion of an elongated member, such as a mandrel, within the cavity 1606. The first member 1602 may have a first mating surface 1608 comprising at least a portion of the outer surface of the first member 1602. According to several embodiments, the first mating surface 1608 is configured to influence the shape of the wavy profile mesh as described herein, because at least a portion of the mesh may conform to the first mating surface 1608 during the shaping process.

[0300] like Figure 16As shown, the second member 1604 may have a generally hemispherical shape, defining a cavity 1610 (e.g., a hollow hemispherical shape) having a second mating surface 1612. The second mating surface 1612 may be arcuate (see...). Figure 16 The second member 1604 may be configured to receive at least a portion of the first member 1602 within a cavity 1610 of the second member 1604. Therefore, in some embodiments, the shape of the second mating surface 1612 is based on the shape of the first mating surface 1608 of the first member 1602. Figure 16 The second member 1604 depicted includes a thickness 1614 between the outer surface 1616 of the second member 1604 and the second mating surface 1612. The thickness 1614 across the second member 1604 may be uniform or non-uniform. The second member 1604 may include an inner cavity 1618 extending through the second member 1604 and / or along the longitudinal axis of the second member 1604. The inner cavity 1618 may have a constant diameter, or the diameter of the inner cavity 1618 may vary along the length of the inner cavity 1618. In some embodiments, a first portion of the inner cavity 1618 may have a first diameter sufficient to receive at least a portion of the mandrel and / or mesh within the first portion of the inner cavity 1618. A second portion of the inner cavity 1618 may have a second diameter substantially equal to the diameter of the inner cavity 1606 of the first member 1602. Although not in Figure 16 As depicted, however, the second member 1604 may include protrusions extending from the outer surface 1616 and / or the second mating surface 1612. The protrusions may be configured to influence the shape of the mesh, facilitate the connection of the mesh to the second member 1604, align the mesh with the second member 1604, etc.

[0301] Figures 17A-17D The illustration depicts various stages of an example method for forming a wavy mesh shape of a closure device using component 1600 and a mesh 1720 comprising a first end portion 1720a, a second end portion 1720b, and an intermediate portion 1720c therebetween. The mesh 1720 may have a tubular configuration with an inner cavity 1722 extending along the length of the mesh 1720. Although Figure 17A The grid 1720 shown comprises a single layer, but grid 1720 may comprise any suitable number of layers, as previously described. The grid used to form the closure device of this technology may initially comprise a tubular configuration, such as a braided mesh tube. The mesh tube may comprise one, two, three, or more layers. The number of layers may be selected based on the desired characteristics of the closure device. For example, a grid comprising two layers may have lower porosity and be able to exert greater radial force than a single-layer grid. In some embodiments, the grid is flipped or reversed such that the tubular grid comprises inner and outer layers that meet at the fold.

[0302] like Figure 17AAs shown, the method may include positioning at least a first portion 1720c1 of the middle portion 1720c of the mesh 1720 above the second member 1604, such that the first portion 1720c1 substantially conforms to the outer surface 1616 of the second member 1604, and a first end portion 1720a and a second end portion 1720b extend away from the second member 1604 in opposite directions. Positioning the first portion 1720c1 of the middle portion 1720c of the mesh 1720 above the second member 1604 may include stretching the mesh 1720.

[0303] According to some embodiments, such as Figure 17A As shown, at least a portion of the mandrel 1724 is positioned within the inner cavity 1722 of the mesh 1720 and / or the inner cavity 1618 of the second member 1604. The mandrel 1724 may have a generally tubular shape with a circular cross-sectional shape. Alternatively, the mandrel 1724 may have another suitable cross-sectional shape, including but not limited to rectangular, oval, etc. The cross-sectional shape of the mandrel 1724 may be constant or may vary along the length of the mandrel 1724. The mandrel 1724 may have a substantially constant thickness along its length, or the thickness of the mandrel 1724 may vary along its length. In some embodiments, a first connecting element 1726 is used to connect at least a portion of the mesh 1720 to the mandrel 1724 such that the mesh 1720 substantially conforms to the shape of the mandrel 1724. The first connecting element 1726 may be removably or permanently connected to the mesh 1720 and / or the mandrel. Figure 17A As shown, a first connecting element 1726 may circumferentially surround the grid 1720. The first connecting element 1726 may be, for example, a binding wire, coil, adhesive, weld, marking tape, and / or other suitable connecting element. The first connecting element 1726 may be non-transparent to facilitate visualization of the closure device. In some embodiments, a plurality of connecting elements 1726 are connected to multiple portions of the grid.

[0304] Furthermore, one or more connecting elements may be used to facilitate the mesh 1720 to adhere to the first member 1602 and / or the second member 1604. For example, such as Figure 17B As shown, the second connecting element 1728 can be connected to the mesh 1720 at a location adjacent to the second mating surface 1612 of the second member 1604, such that the second portion 1720c2 of the middle portion 1720c of the mesh 1720 is positioned within the cavity 1610 of the second member 1604. As described herein with reference to the first connecting element 1726, the second connecting element 1728 can be, for example, binding wire, coil, adhesive, weld, marking tape, and / or other suitable connecting elements. The second connecting element 1728 can be removably or permanently connected to the mesh 1720, the mandrel 1724, and / or the second member 1604. Figure 17BAs shown, the second portion 1720c2 of the middle portion 1720c of the mesh 1720 may not exactly fit the second mating surface 1612 of the second member 1604. In some embodiments, additional connecting elements may be employed to make the second portion 1720c2 substantially fit the second mating surface 1612 of the second member 1604. Additionally or separately, the first member 1602 as described herein may be at least partially received within the cavity 1610 of the second member 1604 so that the second portion 1720c2 of the middle portion 1720c of the mesh 1720 fits the second mating surface 1612 of the second member 1604.

[0305] In some embodiments, such as Figure 17B As shown, at least a portion of the first end portion 1720a of the mesh 1720 is positioned within the cavity 1606 of the first member 1602. Alternatively, at least a portion of the mandrel 1724 may be positioned within the cavity 1606 of the first member 1602 to facilitate alignment of the first member 1602 and the second member 1604 and / or to facilitate positioning the first end portion 1720a of the mesh 1720 within the cavity 1606 of the first member 1602. In some embodiments, the cavity 1606 of the first member 1602 is configured to radially constrain the tubular first end portion 1720a of the mesh 1720 during the shape-setting process.

[0306] like Figure 17C As shown, the method may include positioning the first member 1602 at least partially within the cavity 1610 of the second member 1604, such that a second portion 1720c2 of the middle portion 1720c of the mesh 1720 substantially conforms to the second mating surface 1612 of the second member 1604 and / or the first mating surface 1608 of the first member 1602. In some embodiments, the second portion 1720c2 is compressed between the first member 1602 and the second member 1604. The first member 1602 and the second member 1604 may be fixed in place before the shape of the mesh 1720 is set.

[0307] According to some embodiments, shaping the grid 1720 involves subjecting the component 1600 and the grid 1720 to a heat treatment process. One example of a heat treatment process may include heating the component 1600 and the grid 1720 to a selected temperature (e.g., but not limited to, between 540 and 660 degrees Celsius) and continuing for a selected time period (e.g., but not limited to, between 5 and 15 minutes), followed by rapid cooling. Rapid cooling can be achieved by any suitable cooling process, such as, but not limited to, water quenching or air cooling. In other instances, the time and temperature of the heat treatment may differ from those discussed above, for example, based on the desired material properties of the occlusion device. In specific instances, the heat treatment process may be performed in an air or vacuum furnace, a salt bath, a fluidized sand bed, or other suitable system. The heat treatment process may consist of a single procedure or multiple procedures. After the heat treatment is completed, the grid 1720 has the desired corrugated profile shape and configuration (e.g., substantially corresponding to the component 1600). In other instances, other suitable heat treatment processes may be employed, including, but not limited to, resistance heating or heating by flowing an electric current through the grid 1720. In some embodiments, the shape of the mesh 1720 is configured to incorporate a non-thermal process, such as mechanical deformation.

[0308] The corrugated mesh 1720 is detachable and removable from assembly 1600. In some embodiments, the first connecting element 1726 and / or the second connecting element 1728 may be removed from the mesh 1720. Alternatively, one or both of the first connecting element 1726 and the second connecting element 1728 may remain attached to the mesh 1720. One or more additional post-processing operations may be provided on the corrugated mesh 1720, including but not limited to abrasive blasting, shot peening, polishing, chemical etching, electropolishing, electroplating, coating, ultrasonic cleaning, sterilization, or other cleaning or decontamination procedures.

[0309] Figure 17D A cross-sectional view is depicted of a wavy profile mesh 1720, separated from component 1600 and having a predetermined shape in an expanded, unconstrained state. The first end portion 1720a and the second end portion 1720b of the wavy profile mesh 1720 may each contain a generally tubular configuration. (As shown...) Figure 17D As shown, the first portion 1720c1 of the middle portion 1720c of the mesh 1720 may have a shape based on the outer surface 1616 of the second member 1604, and the second portion 1720c2 of the middle portion 1720c of the mesh 1720 may have a shape based on the first mating surface 1608 and the second mating surface 1612. Therefore, the middle portion 1720c of the mesh 1720 can form a double-layered sidewall enclosing an open volume. The double-layered sidewall may have a generally hollow hemispherical shape, such as... Figure 17DAs shown. Furthermore, the double-layered sidewalls can enclose an open volume with a generally hemispherical shape. Therefore, the thickness 1614 of the second member 1604 affects the size of the open volume enclosed by the wavy-shaped mesh 1720. As... Figure 17D As shown and as previously described, the first connecting element 1726 and / or the second connecting element 1728 may remain connected to the corrugated mesh 1720. Before the occlusion device is deployed, the corrugated mesh 1720 may be connected to additional components (e.g., occlusion material, connecting elements, etc.) and / or assembled within the delivery system.

[0310] although Figure 16-17D The first component 1602 and the second component 1604, respectively having generally spherical and hemispherical shapes, are depicted; however, the components forming the assembly of this technology may each contain any suitable shape, as previously described. For example, Figure 18A and 18B Isometric views and cross-sectional views of the forming member 1800 configured according to several aspects of the present technology are depicted respectively. Figure 18A and 18B The forming member 1800 shown can be used to form a double-layered wavy mesh having an open first end portion and a closed second end portion positioned at an angle relative to the first end portion. The forming member 1800 may include a first surface 1802, a second surface 1804 opposite to the first surface 1802 along a thickness 1806 of the forming member 1800, and a sidewall 1808 therebetween. In some embodiments, the first surface 1802 and the second surface 1804 are generally circular and / or the sidewall 1808 is generally annular, such that the forming member 1800 has a generally cylindrical shape. However, the forming member 1800 may comprise any suitable shape, including but not limited to spheres, non-spheres, cylinders, hemispheres, polyhedra (e.g., cuboids, tetrahedrons (e.g., pyramids), octahedrons, prisms, etc.), oblate spheroids, plates (e.g., disks, polygonal plates), bowls, non-spherical surfaces of revolution (e.g., torus, cones, or another shape rotating about a central point or a coplanar axis), and combinations thereof. The thickness 1806 of the forming member 1800 may be constant along the length of the forming member 1800 or may vary along the length of the forming member 1800. As previously described, the thickness 1806 of the forming member 1800 may affect the size of the open volume of the wavy profile mesh formed by the forming member 1800. The forming member 1800 may be contained between the first surface 1802 and the second surface 1804 and / or extend at least partially through the cavity 1810 of the forming member 1800 along the longitudinal axis of the forming member 1800. As described herein, the lumen 1810 may contain any suitable length and diameter.

[0311] Figures 19A-19CVarious stages of an exemplary method for forming a wavy-shaped mesh of a closure device using a forming member 1800 and a single-layer tubular mesh 1920 having a first end portion 1920a, a second end portion 1920b, an intermediate portion 402c therebetween, and an inner cavity 1922 extending along the length of the mesh 1920. For example... Figure 19A As shown, the method may include positioning a middle portion 1920c of a mesh 1920 within a cavity 1810 of a forming member 1800, such that a first end portion 1920a of the mesh 1920 extends away from a first surface 1802 of the forming member 1800 in a first direction, and a second end portion 1920b of the mesh 1920 extends away from a second surface 1804 of the forming member 1800 in a second direction opposite to the first direction. In some embodiments (see...) Figure 19A The mandrel 1924 is positioned within the inner cavity 1922 of the grid 1920 and / or within the inner cavity 1810 of the forming member 1800.

[0312] like Figure 19B As shown, the method may include flipping the mesh 1920 to position a first portion 1920a1 of the first end portion 1920a of the mesh 1920 over a first surface 1802 of the forming member 1800, and positioning a second portion 1920a2 of the first end portion 1920a of the mesh 1920 over a sidewall 1808 of the forming member 1800. In some embodiments, such as... Figure 19B As shown, the connecting element 1926 is connected to the mesh 1920 and / or the mandrel 1924 such that the third portion 1920a3 of the first end portion 1920a of the mesh 1920 substantially conforms to the second surface 1804 forming the member 1800. As described herein, the connecting element 1926 may be, for example, binding wire, adhesive, weld, marking tape, and / or other suitable connecting elements. Figure 19B As shown, the connecting element 1926 can circumferentially surround the grid 1920 and / or the mandrel 1924. Although Figure 19B The diagram shows that the connecting element 1926 is connected only to a portion of the grid 1920, but the connecting element 1926 can be connected to any length of the grid 1920 and / or the mandrel 1924. The connecting element 1926 can be positioned adjacent to the second surface 1804 of the forming member 1800, such as... Figure 19BAs shown, a third portion 1920a3 of the first end portion 1920a of the mesh 1920 extends along a substantially straight path between the sidewall 1808 of the forming member 1800 and the connecting element 1926, such that the third portion 1920a3 substantially conforms to the second surface 1804 of the forming member 1800. However, in some embodiments, the connecting element 1926 may be positioned further away from the second surface 1804 of the forming member 1800, such that the third portion 1920a3 of the first end portion 1920a of the mesh 1920 extends along a substantially curved path between the sidewall 1808 of the forming member 1800 and the connecting element 1926. In several embodiments, no connecting element is connected to the mesh 1920. Alternatively or additionally, another forming member may be used to conform the mesh 1920 to the forming member 1800 and / or the desired shape. In any case, a fourth portion 1920a4 of the first end portion 1920a of the mesh 1920 extends away from the second surface 1804 of the forming member 1800 in a second direction. As previously stated, the shape of the grid 1920 may include subjecting the forming member 1800 and the grid 1920 to a heat treatment process.

[0313] Figure 19C Depicting by Figure 19A and 19B The method depicted in the diagram produces a double layer of wavy-shaped mesh 1920, separate from the forming member 1800. The wavy-shaped mesh 1920 includes closed end portions 1920d formed by the middle portion 1920c of the first end portion 1920a and the first portion 1920a1, second portion 1920a2, and third portion 1920a3 of the mesh 1920. The wavy-shaped mesh 1920 also includes open end portions 1920e formed by the fourth end portion 1920a4 of the first end portion 1920a and the second end portion 1920b of the mesh 1920. (As shown...) Figure 19C As shown, the open end portion 1920e of the grid 1920 may have a substantially tubular configuration, and the closed end portion 1920d of the grid 1920 may be positioned at an angle to the open end portion 1920e. The closed end portion 1920d of the grid 1920 encloses the open volume. In some embodiments, the open volume is substantially disc-shaped. As previously described, the size of the open volume may be at least partially based on the thickness 1806 of the forming member 1800. The connecting element 1926 may be held positioned around the grid 1920 (see...). Figure 19C (or can be removed.)

[0314] According to some embodiments, shaping a mesh to produce a wavy profile mesh may involve a single shape setting procedure. However, in some embodiments, shaping the mesh may involve two or more shape setting procedures (e.g., two or more heat treatment processes). For example, a first wavy profile mesh (e.g., a first forming component or member, such as forming member 1800) is generated by a first shape setting procedure using a first forming component or member. Figure 19C The grid 1920 shown can be connected to a second forming component or member, as in Figure 20A and 20B The forming component 2000 (or “component 2000”) is depicted in the figure, and a second shape setting procedure is performed to generate a second wavy shape mesh. Figure 20A and 20B The illustrated component 2000 includes a first member 2002 and a second member 2003. The first member 2002 has a first surface 2004, a second surface 2006 opposite to the first surface 2004 along a thickness 2008 of the first member 2002, and a sidewall 2010 therebetween. Figure 20A As shown, the first surface 2004 and the second surface 2006 may be generally rectangular, such that the first member 2002 has a shape generally corresponding to a rectangular prism. The first member 2002 may include an inner cavity 2012 that at least partially extends through a thickness 2008 of the first member 2002. Figure 20A and 20B As shown, in some embodiments, the diameter of the cavity 2012 may vary across the thickness 2008 of the first member 2002. For example, the cavity 2012 may include a first portion 2012a having a first diameter and a second portion 2012b having a second diameter different from the first diameter. The first portion 2012a of the cavity 2012 may be configured to receive at least a portion of the second member 2003 and / or the mesh. The second portion 2012b of the cavity 2012 may be configured to receive at least a portion of the mandrel and / or the mesh.

[0315] Similarly, the second member 2003 has a first surface 2014, a second surface 2016 opposite to the first surface 2014 along the thickness 2018 of the second member 2003, and a sidewall 2020 therebetween. The second member 2003 may also have a shape generally corresponding to a rectangular prism or another suitable shape. The thickness 2018 of the second member 2003 may be the same as or different from the thickness 2008 of the first member 2002. Figure 20A and 20B As shown, in some embodiments, the second member 2003 includes a protrusion 2022 extending in a first direction away from the first surface 2014 of the second member 2003. Although the protrusion 2022 in... Figure 20AThe protrusion 2022 is depicted as generally cylindrical, but it can have any suitable shape based on the desired shape of the resulting wavy mesh. The second member 2003 may also include an inner cavity 2024 extending along the thickness 2018 of the second member 2003 between the first surface 2014 and the second surface 2016. The inner cavity 2024 may have a constant diameter (see...). Figure 20A and 20B The diameter may be varied along the thickness 2018 of the second member 2003. The inner cavity 2024 may be configured to accommodate at least a portion of the mesh and / or the mandrel.

[0316] Figures 21A-21C This describes the various stages of an instance method for conforming mesh 2120 using component 2000. Mesh 2120 may be a wavy profile mesh with a previously set shape. For example, Figures 21A-21C The double-layer grid 2120 shown has a shape similar to Figure 19C The shape of the grid 1920 shown is illustrated. The grid 2120 includes closed end portions 2120d and open end portions 2120e arranged at an angle to the closed end portions 2120d. In other instances, component 2000 can be used to source from a source having... Figures 21A-21C The grid 2120 shown is constructed from grids of different shapes (e.g., tubular shapes) to create a wavy profile grid. For example... Figure 21A As depicted, at least a portion of the open end portion 2120e of the mesh 2120 may be positioned within the cavity 2024 of the second member 2003, such that at least a portion of the closed end portion 2120d of the mesh 2120 is positioned above the protrusion 2022 of the second member 2003. As described herein, in some embodiments, the mandrel 624 is positioned within the cavity of the mesh 2120 and / or the cavity 2024 of the second member 2003. Alternatively or additionally, one or more connecting elements may be coupled to the mesh 2120, as described herein. One or more connecting elements may be coupled to the mesh 2120 before, during, or after the shaping of the mesh 2120. One or more connecting elements may be coupled to the mesh 2120 when it is attached to the assembly 2000 and / or after the mesh 2120 has been removed from the assembly 2000.

[0317] like Figure 21B As shown, the method may include substantially conforming the closed end portion 2120d of the mesh 2120 to the protrusion 2022 and / or the first surface 2014 of the second member 2003. For example, as Figure 21BAs shown, the method may include positioning a first member 2002 adjacent to a second member 2003 such that a first portion 2120d1 of the closed end portion 2120d of the mesh 2120 and at least a portion of the protrusion 2022 are received within a first portion 2012a of the cavity 2012 of the first member 2002. A second portion 2120d2 of the closed end portion 2120d of the mesh 2120 may substantially conform to the sidewall of the protrusion, and a third portion 2120d3 of the closed end portion 2120d of the mesh 2120 may substantially conform to the first surface 2014 of the second member 2003 and the second surface 2006 of the first member 2002. As previously described, in some embodiments, at least a portion of the mandrel 624 may be positioned within the cavity 2012. In some embodiments, the mesh 2120 is compressed between the first member 2002 and the second member 2003. The first member 2002 and the second member 2003 may be fixed in place before the shape of the mesh 2120 is set. As described herein, setting the shape of the grid 2120 may include subjecting the component 2000 and the grid 2120 to a heat treatment process.

[0318] Figure 21C Depicting by Figure 21A and 21B The method depicted in the diagram produces a double-layered, wavy mesh 2120. The mesh 2120 has closed end portions 2120d and open end portions 2120e disposed at an angle to the closed end portions 2120d. The open end portions 2120e may have a substantially tubular configuration. In some embodiments, such as... Figure 21C As shown, the closed end portion 2120d encloses an open volume, which is generally disk-shaped and has a protruding region formed by a first portion 2120d1 and a second portion 2120d2 of the closed end portion 2120d of the grid 2120. The shape of the protruding region may be based on the shape of the protrusion 2022 of the second member 2003. For example, when formed above a cylindrical protrusion 2022, the protruding region may be substantially cylindrical. The first portion 2120d1 of the closed end portion 2120d may be generally parallel to the third portion 2120d3 of the closed end portion 2120d of the grid 2120. Figure 21C As shown, the first portion 2120d1 can be offset from the third portion 2120d3 by the length of the second portion 2120d2. The second portion 2120d2 can be substantially perpendicular to the first portion 2120d1 and the third portion 2120d3. Although Figure 21CThe grid 2120 shown depicts a first portion 2120d1, a second portion 2120d2, and a third portion 2120d3 extending along a substantially straight path; however, in some embodiments, the first portion 2120d1, the second portion 2120d2, and / or the third portion 2120d3 and / or the open portion 2120e of the closed end portion 2120d extend along a curved path (see [link]). Figure 21D Furthermore, although Figure 21C The first portion 2120d1 and the third portion 2120d3 are depicted to be arranged at an angle of approximately 90 degrees to the second portion 2120d2, and the first portion 2120d1 is arranged at an angle of approximately 90 degrees to the closed end portion 2120d of the grid 2120. However, in some embodiments, the angle described above may be different from 90 degrees.

[0319] in conclusion

[0320] The description of embodiments of this technology is not intended to be exhaustive or to limit the technology to the exact forms disclosed above. Singular or plural terms may also include plural or singular terms, respectively, where context permits. As those skilled in the art will recognize, although specific embodiments and examples of this technology have been described above for illustrative purposes, various equivalent modifications can be made within the scope of this technology. For example, while the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0321] Furthermore, unless the word “or” is explicitly limited to meaning only a single item exclusive to other items in a list referring to two or more items, its use in this list can be understood to include: (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term “comprising” is used throughout to mean at least one or more of the described features, such that no larger number of the same features and / or other features of additional types are excluded. It should also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the present technology. Furthermore, while advantages associated with certain embodiments of the present technology have been described in the context of those embodiments, other embodiments may also present such advantages, and not all embodiments are required to present such advantages to fall within the scope of the present technology. Therefore, this disclosure and associated technology may cover other embodiments not explicitly shown or described herein.

Claims

1. A method for making an occlusive device, the method comprising: obtaining a tubular mesh having an internal lumen therethrough; obtaining a forming member having an outer surface and an inner surface; inverting the mesh over the forming member such that a first portion of the mesh conforms to the outer surface of the forming member and a second portion of the mesh conforms to the inner surface of the forming member; setting a shape of the mesh while positioned over the forming member.

2. The method of claim 1, wherein the inner surface of the forming member is arcuate and defines a cavity in the forming member.

3. The method of claim 1, wherein the forming member includes an internal lumen extending therethrough.

4. The method of claim 1, wherein the forming member is a first forming member, the inner surface is a first mating surface, and the method further comprises positioning the second portion of the mesh between the first mating surface of the first forming member and a second mating surface of a second forming member such that the second portion of the mesh conforms to the first mating surface of the first forming member and the second mating surface of the second forming member, respectively.

5. The method of claim 4, further comprising compressing the second portion of the mesh between the first mating surface and the second mating surface.

6. The method of claim 1, wherein setting the shape of the mesh comprises heat treating the mesh while positioned on the forming member.

7. The method of claim 1, wherein, After setting the shape of the mesh, the first portion of the mesh and the second portion of the mesh form a double-walled side wall that encloses an open volume.

8. The method of claim 7, wherein the double-walled side wall has a generally hollow hemispherical shape.

9. The method of claim 7 or claim 8, wherein the open volume has a substantially hemispherical shape.

10. The method of claim 9, wherein the open volume is generally disc-shaped.

11. The method of claim 1, wherein, After setting the shape of the mesh, the mesh includes a third portion that is generally tubular.

11. The method of claim 10, wherein the third portion of the mesh is positioned between the first portion of the mesh and the second portion of the mesh.

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