Sealing device

Abstract

A system for treating aneurysms includes an intrasac device that can be delivered using a catheter. The device may include at least one expandable structure adapted to transition from a compressed configuration to an expandable configuration when released into the aneurysm. The expandable structure may have a specific shape or porosity. Multiple expandable structures may also be used, in which case each expandable structure may have a unique shape or porosity distribution. The morphology of the aneurysm and the orientation of any connecting arteries determine the type, size, shape, number, and porosity distribution of the expandable structures used in treating the aneurysm.

Description

[0001] This application is a divisional application of the invention patent application entitled "Blocking Device", with an international application date of November 13, 2013, international application number PCT / US2013 / 069955, and national application number 201380070058.7.

[0002] Cross-reference to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 61 / 725,768, filed November 13, 2012, the full contents of which are incorporated herein by reference. Technical Field

[0004] This disclosure generally relates to systems and methods for delivering and deploying medical devices within blood vessels, and more particularly, to systems and methods for delivering and deploying endovascular therapeutic devices within a patient's vascular system to embolize and occlude aneurysms (especially cerebral aneurysms). Background Technology

[0005] The walls of the vascular system (especially the walls of arteries) can form pathologically dilated areas known as aneurysms. Aneurysms are known to have thin, weak walls that are prone to rupture. An aneurysm can result from weakening of the blood vessel walls due to disease, injury, or congenital abnormalities. Aneurysms can be found in various parts of the body, most commonly in the abdominal aorta and intracranial aneurysms or cerebral aneurysms in the neurovascular system. When the weakened wall of an aneurysm ruptures, especially in the case of a ruptured cerebral aneurysm, it can lead to death.

[0006] Aneurysms are generally treated by removing the weakened portion of the vessel from the arterial circulation. Such enhancement is performed in several ways to treat cerebral aneurysms, including: (i) surgical clipping, in which a metal clip is fixed around the base of the aneurysm; (ii) tamponade of the aneurysm with small flexible coils (microcoils); (iii) “filling” or “tamponade” of the aneurysm using embolizing material; (iv) occlusion of the parent vessel supplying the aneurysm using a removable balloon or coil; and (v) endovascular stent implantation.

[0007] In the standard procedure for introducing a compressible stent into a blood vessel and positioning it within a stenotic area or aneurysm, a guiding catheter with a distal tip is percutaneously introduced into the patient's vascular system. The guiding catheter is advanced within the blood vessel until its distal tip is adjacent to the stenosis or aneurysm. An inner catheter and a guidewire positioned within the lumen of a second inner catheter are advanced through the distal end of the guiding catheter. The guidewire is then pushed out of the distal end of the guiding catheter into the blood vessel until the distal portion of the guidewire carrying the compressible stent is positioned at the lesion site within the blood vessel. Once the compressible stent is positioned at the lesion site, the stent is released and inflated to support the blood vessel. Summary of the Invention

[0008] Additional features and advantages of this subject matter will be set forth in the following description and will be apparent in part from the description, or may be learned by practice of the subject matter. The advantages of this subject matter will be realized and obtained through this written description, its embodiments, and the structures particularly pointed out in the accompanying drawings.

[0009] Systems and procedures for treating aneurysms may include an intrasac device having one or more expandable components, which can be inserted into the aneurysm to promote embolic healing. The components may have specific characteristics, including porosity, composition, material, shape, size, interconnectivity, interlocking, coating, etc. These characteristics can be selected to achieve the desired therapeutic or placement of the intrasac device.

[0010] The intra-aneural device may include a single component having two or more segments with different average porosities. In some embodiments, the intra-aneural device may include multiple components, each having an average porosity. In any embodiment, the intra-aneural device may be positioned within the aneurysm according to a desired porosity distribution. If necessary, the intra-aneural device may be repositioned within the aneurysm during inflation.

[0011] Intra-sac devices can optionally include one or more components of a desired shape, allowing clinicians to implant intra-sac devices tailored to the aneurysm. Multiple individual, independent components can operate together to form a composite unit with one or more desired characteristics. According to some embodiments, such components can have an interlocking structure capable of including frame components.

[0012] When used in conjunction with a frame component, the intrasac device allows the inflatable component to be securely held within the aneurysm. The frame component may include a foam or braided structure. Furthermore, one or more inflatable components may be inserted into the lumen of the frame component or into a lumen formed by the frame component.

[0013] Alternatively, the intracapsular device can be configured to provide multiple interconnected expandable components extending in a linear, planar, or three-dimensional array or matrix. These arrays or matrices can be deployed entirely or partially into the target aneurysm, allowing clinicians to select the portion of the array or matrix for implantation.

[0014] For example, the subject matter is illustrated according to the aspects described below. For convenience, various examples of aspects of the subject matter are described as numbered embodiments (1, 2, 3, etc.). These are provided as examples and do not limit the subject matter. It should be noted that any of the dependent embodiments can be combined with each other or with one or more other independent embodiments in any combination to form independent embodiments. Other embodiments can be provided in a similar manner. The following is a non-limiting overview of some embodiments provided herein:

[0015] Example 1. A device for treating an aneurysm, comprising a foam component having a first segment and a second segment, the first segment having an average porosity different from that of the second segment, the component being capable of expanding from a compressed configuration to an expanded configuration when released from a catheter into the aneurysm.

[0016] Example 2. The apparatus according to Example 1, wherein the component self-expands to employ its expansion configuration.

[0017] Example 3. The apparatus according to Example 1, wherein the component is adapted to expand upon exposure to a heat-generating reagent.

[0018] Example 4. The apparatus according to Example 1, wherein the component is adapted to swell upon exposure to a chemical reagent.

[0019] Example 5. The apparatus according to Example 1, wherein the first segment includes a first material and the second segment includes a second material different from the first material, and the first segment and the second segment are connected to each other.

[0020] Example 6. The apparatus according to Example 5, wherein the first segment is connected to the second segment by chemical bonding, thermal bonding or mechanical pressing.

[0021] Example 7. The apparatus according to Example 1, wherein the component further includes a third segment connected to the second segment, the third segment having an average porosity different from that of the second segment.

[0022] Example 8. The apparatus according to Example 7, wherein the third material is different from the first material.

[0023] Example 9. The apparatus according to Example 7, wherein the second segment is joined to the third segment using an adhesive.

[0024] Example 10. The apparatus according to Example 7, wherein the second segment includes a second material and the third segment includes a third material different from the second material.

[0025] Example 11. The apparatus according to Example 7, wherein the porosity of the third segment is different from that of the first segment.

[0026] Example 12. The apparatus according to Example 11, wherein the first segment includes an average porosity between approximately 1 μm and approximately 150 μm, and the third segment includes an average porosity between approximately 150 μm and approximately 300 μm.

[0027] Example 13. The apparatus according to Example 1 further includes a transition region between the first segment and the second segment, the transition region having an average porosity between the porosities of the first segment and the second segment.

[0028] Example 14. The apparatus according to Example 13, wherein the porosity of the transition region varies spatially from approximately the porosity of the first segment to approximately the porosity of the second segment.

[0029] Example 15. The apparatus according to Example 13, wherein the porosity of the first segment and the second segment gradually varies spatially from the end of the first segment to the opposite end of the second segment.

[0030] Example 16. The apparatus according to Example 13, wherein the porosity of the transition region decreases from the porosity of the first segment to the porosity of the second segment.

[0031] Example 17. The apparatus according to Example 1, wherein, in the expansion configuration, the component includes a generally spherical shape that is laterally divided into a first segment and a second segment.

[0032] Example 18. The apparatus according to Example 17, wherein the first segment and the second segment correspond to the first and second hemispheres of the generally spherical shape.

[0033] Example 19. The apparatus according to Example 1 further includes a third section connected to the second section, wherein the first section, the second section, and the third section together form the generally spherical shape.

[0034] Example 20. The device according to Example 1, wherein the component further includes a bioactive coating.

[0035] Example 21. The device according to Example 20, wherein the bioactive coating comprises a thrombotic drug.

[0036] Example 22. The apparatus according to Example 1, wherein the component further includes an expansion-limiting coating configured to control the expansion rate of the component.

[0037] Example 23. The apparatus according to Example 1, wherein the first segment includes an average porosity between approximately 1 μm and approximately 100 μm, and the second segment includes an average porosity between approximately 100 μm and approximately 200 μm.

[0038] Example 24. The device according to Example 1, wherein the shape of the component is selected from the group consisting of cylinder, hemisphere, polyhedron, elongated sphere, oblate spheroid, plate, bowl, hollow structure, clover shape, non-spherical surface of revolution and combinations thereof.

[0039] Example 25. The device according to Example 24 further includes a second foam component, the shape of which is selected from the group consisting of spheres, cylinders, hemispheres, polyhedra, elongated spheres, oblate spheroids, plates, bowls, hollow structures, clover shapes, non-spherical surfaces of revolution, and combinations thereof.

[0040] Example 26. The apparatus according to Example 25, wherein the foam component and the second foam component have different dimensions from each other.

[0041] Example 27. The apparatus according to Example 25, wherein the foam component and the second foam component have different shapes from each other.

[0042] Example 28. The apparatus according to Example 25, wherein the foam component and the second foam component have a mating structure configured to abut against each other in a complementary configuration and at least restrict the degrees of freedom of movement of each of the foam component and the second foam component.

[0043] Example 29. The apparatus according to Example 25 further includes a plurality of additional foam components having a generally spherical shape.

[0044] Example 30. A system for treating an aneurysm includes a plurality of foam components that, when released from a catheter into the aneurysm, are capable of expanding from a compressed configuration to an expanded configuration, each of the plurality of components having an average porosity different from the average porosity of another of the plurality of components, the plurality of components being capable of being positioned within the aneurysm to form a composite foam component having a composite porosity configured to provide a therapeutic effect.

[0045] Example 31. The system according to Example 30, wherein each of the first group of the plurality of components includes a first average porosity, and each of the second group of the plurality of components includes a second average porosity different from the first average porosity.

[0046] Example 32. The system according to Example 31, wherein the first average porosity is between about 1 μm and about 100 μm, and the second average porosity is between about 100 μm and about 200 μm.

[0047] Example 33. The system according to Example 30, wherein at least one of the plurality of components is substantially spherical in shape.

[0048] Example 34. According to the system of Example 30, the shape of at least one of the plurality of components is selected from the group consisting of spheres, cylinders, hemispheres, polyhedra, elongated spheres, oblate spheroids, plates, bowls, hollow structures, clover shapes, non-spherical surfaces of revolution, and combinations thereof.

[0049] Example 35. The system according to Example 30, wherein each of the plurality of components is interconnected to another of the plurality of components via filaments.

[0050] Example 36. The system according to Example 35, wherein each of the plurality of components is interconnected to at least two other components of the plurality of components.

[0051] Example 37. The system according to Example 30, wherein the plurality of components self-expand to adopt their expanded configuration.

[0052] Example 38. The system according to Example 30, wherein the plurality of components are adapted to expand upon exposure to a heat reagent.

[0053] Example 39. The system according to Example 30, wherein the plurality of components are adapted to swell upon exposure to a chemical reagent.

[0054] Example 40. The system according to Example 30, wherein at least one of the plurality of components includes a bioactive coating.

[0055] Example 41. The system according to Example 30, wherein at least one of the plurality of components includes a thrombotic drug.

[0056] Example 42. The system according to Example 30, wherein at least one of the plurality of components includes an expansion-limiting coating configured to control the expansion rate of the component.

[0057] Example 43. The system according to Example 30, wherein each of the plurality of components has a different size than the other of the plurality of components.

[0058] Example 44. The system according to Example 30, wherein each of the plurality of components has a shape different from the other of the plurality of components.

[0059] Example 45. The system according to Example 30, wherein the first component and the second component of the plurality of components have a mating structure configured to abut against each other in a complementary configuration and to at least restrict the degrees of freedom of movement of each of the first component and the second component of the plurality of components.

[0060] Example 46. A device for treating an aneurysm, comprising a foam component having a region of variable average porosity and a radiopaque marker visible under imaging and locatable relative to the region, such that the component is easy to identify and orient when implanted into the aneurysm from a catheter, and the component is capable of expanding from a compressed configuration to an expanded configuration when released into the aneurysm.

[0061] Example 47. The apparatus according to Example 46, wherein the region includes a first segment and a second segment, the second segment having an average porosity different from the average porosity of the first segment.

[0062] Example 48. The apparatus according to Example 47, wherein the region further includes a third segment adjacent to the second segment, the third segment having an average porosity different from that of the second segment.

[0063] Example 49. The apparatus according to Example 48, wherein the second segment is connected to the third segment by chemical bonding, thermal bonding or mechanical pressing.

[0064] Example 50. The apparatus according to Example 48, wherein the porosity of the third segment is different from the porosity of the first segment.

[0065] Example 51. The apparatus according to Example 46, wherein the region includes a first material and a second material different from the first material, the first material and the second material being connected to each other.

[0066] Example 52. The apparatus according to Example 51, wherein the region further includes a third material different from the first material.

[0067] Example 53. The apparatus according to Example 46, wherein the marking comprises a material incorporated into the component to make the component visible under imaging.

[0068] Example 54. The apparatus according to Example 53, wherein the marking comprises bismuth or tantalum, which is mixed with a foam material to form the component.

[0069] Example 55. The apparatus according to Example 46, wherein the mark is attached to the outside of the component.

[0070] Example 56. The apparatus according to Example 55, wherein the marking includes a coating or material bonded to or mechanically attached to the component.

[0071] Example 57. The device according to Example 46, wherein the shape of the component is selected from the group consisting of cylinder, hemisphere, polyhedron, elongated sphere, oblate spheroid, plate, bowl, hollow structure, clover shape, non-spherical surface of revolution and combinations thereof.

[0072] Example 58. The device according to Example 57 further includes a second foam component, the shape of which is selected from the group consisting of spheres, cylinders, hemispheres, polyhedra, elongated spheres, oblate spheroids, plates, bowls, hollow structures, clover shapes, non-spherical surfaces of revolution, and combinations thereof.

[0073] Example 59. The apparatus according to Example 58, wherein the foam component and the second foam component have different dimensions from each other.

[0074] Example 60. The apparatus according to Example 58, wherein the foam component and the second foam component have different shapes from each other.

[0075] Example 61. The apparatus according to Example 58, wherein the foam component and the second foam component have a mating structure configured to abut against each other in a complementary configuration and at least restrict the degrees of freedom of movement of each of the foam component and the second foam component.

[0076] Example 62. The apparatus according to Example 58 further includes a plurality of additional foam components having a generally spherical shape.

[0077] Example 63. A method for treating an aneurysm, comprising: advancing a foam component through the lumen of a catheter, the component including a first segment and a second segment, the first segment having an average porosity different from the average porosity of the second segment; releasing the component into the aneurysm; allowing the component to expand from a compressed configuration to an expanded configuration within the aneurysm; and positioning the component within the aneurysm such that the first segment is positioned remote from the neck of the aneurysm and the second segment is positioned adjacent to the neck of the aneurysm.

[0078] Example 64. The method according to Example 63, wherein the positioning includes rotating the component.

[0079] Example 65. The method according to Example 63, wherein the positioning includes maintaining the position of the component relative to the aneurysm neck during expansion into the expansion configuration.

[0080] Example 66. The method according to Example 63, wherein the aneurysm is arranged adjacent to the bifurcation of the mother vessel into two output vessels, and wherein the positioning further includes positioning the bifurcation adjacent to the second segment and allowing flow through the bifurcation and into at least one of the first or second output vessels.

[0081] Example 67. The method according to Example 66, wherein the first segment includes an average porosity between approximately 1 μm and approximately 150 μm.

[0082] Example 68. The method according to Example 66, wherein the second segment includes an average porosity between approximately 100 μm and approximately 200 μm.

[0083] Example 69. The method according to Example 63, wherein the component further includes a third segment disposed between the first segment and the second segment, the third segment having an average porosity different from that of the second segment, wherein the positioning includes positioning the component such that the first segment is positioned at the base of the aneurysm and the third segment is positioned between the base and the neck of the aneurysm.

[0084] Example 70. The method according to Example 63, wherein the positioning includes aligning a radiopaque marker relative to the aneurysm to locate the second segment adjacent to the aneurysm neck.

[0085] Example 71. The method according to Example 70, wherein the alignment includes aligning the marker with the base of the aneurysm.

[0086] Example 72. The method according to Example 63 further includes injecting a liquid embolizing material into the aneurysm after positioning the component.

[0087] Example 73. The method according to Example 63 further includes implanting a support structure into the aneurysm before releasing the component into the aneurysm, and wherein the release includes releasing the component into the aneurysm through the wall of the support structure.

[0088] Example 74. The method according to Example 73, wherein the support structure includes a generally closed cavity, and the release further includes releasing the component into the cavity.

[0089] Example 75. A system for treating an aneurysm, comprising: a first foam component, which, when released into the aneurysm, is capable of expanding from a compressed configuration to an expanded configuration, wherein the first component has a first shape in the expanded configuration; and a second foam component, independent of the first component and freely movable relative to the first component, which, when released into the aneurysm, is capable of expanding from a compressed configuration to an expanded configuration, wherein the second component has a second shape in the expanded configuration; wherein at least one of the first and second shapes is selected from the group consisting of a cylinder, a hemisphere, a polyhedron, an elongated sphere, an oblate spheroid, a plate, a bowl, a hollow structure, a cloverleaf shape, a non-spherical surface of revolution, and combinations thereof.

[0090] Example 76. The system according to Example 75, wherein the first shape and the second shape are different from each other.

[0091] Example 77. The system according to Example 75, wherein the first component and the second component have different dimensions from each other.

[0092] Example 78. The system according to Example 75 further includes a third foam component having a third shape different from the first shape.

[0093] Example 79. The system according to Example 78, wherein the third shape is approximately spherical.

[0094] Example 80. The system according to Example 78, wherein the first, second and third components have different dimensions from each other.

[0095] Example 81. The system according to Example 78, wherein the first, second and third components have different shapes from each other.

[0096] Example 82. The system according to Example 75 further includes third, fourth and fifth foam components, each of the third, fourth and fifth components having a shape different from the first component and the second component.

[0097] Example 83. The system according to Example 75 further includes third, fourth and fifth foam components, each of the third, fourth and fifth components having dimensions different from the first component and the second component.

[0098] Example 84. The system according to Example 75, wherein the first component and the second component have first and second mating structures configured to abut against each other in a complementary configuration.

[0099] Example 85. The system according to Example 84, wherein the mating structure is operable to restrict at least two degrees of freedom of movement of other components.

[0100] Example 86. The system according to Example 84, wherein in the complementary configuration, the first component restricts at least two degrees of freedom of movement of the second component.

[0101] Example 87. The system according to Example 84, wherein in the complementary configuration, the first component restricts at least three degrees of freedom of movement of the second component.

[0102] Example 88. The system according to Example 87, wherein the first component restricts four, five, or six degrees of freedom of movement of the second component.

[0103] Example 89. The system according to Example 84, wherein in the complementary configuration, the first component and the second component are interconnected to form a composite structure.

[0104] Example 90. The system according to Example 84, wherein in the complementary configuration, the first component and the second component are interconnected to form a composite structure, and wherein the first component and the second component have different average porosities from each other.

[0105] Example 91. The system according to Example 84 further includes a third foam component having a third mating structure configured to at least abut against the first mating structure, wherein in the complementary configuration, the first component restricts at least two degrees of freedom of movement of the third component.

[0106] Example 92. The system according to Example 91, wherein the first component restricts four, five, or six degrees of freedom of movement of the third component.

[0107] Example 93. The system according to Example 75, wherein the first component and the second component have different average porosities from each other.

[0108] Example 94. The system according to Example 75, wherein the first component includes a first coating and the second component is substantially without the first coating.

[0109] Example 95. The system according to Example 75, wherein the component further includes a bioactive coating.

[0110] Example 96. The system according to Example 95, wherein the bioactive coating comprises a thrombotic drug.

[0111] Example 97. The system according to Example 75, wherein the component further includes an expansion-limiting coating configured to control the expansion rate of the component.

[0112] Example 98. A system for treating aneurysms, comprising a plurality of separate and independently expandable components, each of which, when released into the aneurysm, is capable of expanding from a compressed configuration to an expanded configuration, each of the components having a different shape from one another, wherein the shape is selected from the group consisting of cylinders, hemispheres, polyhedra, elongated spheres, oblate spheroids, discs, bowls, hollow structures, clover shapes, non-spherical surfaces of revolution, and combinations thereof.

[0113] Example 99. The system according to Example 98, wherein the components have different dimensions from each other.

[0114] Example 100. The system according to Example 98 further includes at least one additional component that is generally spherical.

[0115] Example 101. The system according to Example 98 further includes a plurality of additional components that are generally spherical.

[0116] Example 102. The system according to Example 101, wherein the plurality of additional components have different dimensions from each other.

[0117] Example 103. The system according to Example 98, wherein at least two of the components have mating structures configured to abut against each other in a complementary configuration to restrict the degrees of freedom of movement of the components.

[0118] Example 104. The system according to Example 103, wherein the components each have a mating structure configured to abut against each other in a complementary configuration.

[0119] Example 105. The system according to Example 104, wherein in the complementary configuration, the components are interconnected to form a composite structure.

[0120] Example 106. The system according to Example 103, wherein in the complementary configuration, the components are interconnected to form a composite structure, and wherein the components have different porosities from each other.

[0121] Example 107. A method for treating an aneurysm, comprising: positioning a distal opening of a catheter adjacent to the aneurysm; and releasing a plurality of separate and independently expandable foam components into the aneurysm; wherein the shape of the plurality of components is selected from the group consisting of cylinders, hemispheres, polyhedra, elongated spheres, oblate spheroids, discs, bowls, hollow structures, clover shapes, non-spherical surfaces of revolution, and combinations thereof.

[0122] Example 108. The method according to Example 107, wherein the release includes releasing the plurality of components based on the shape of the aneurysm.

[0123] Example 109. The method according to Example 108 further includes selecting the plurality of components based on the shape of the aneurysm.

[0124] Example 110. The method according to Example 107, wherein the release includes interconnecting at least two components to establish a composite structure.

[0125] Example 111. The method according to Example 107, wherein the release includes releasing the plurality of components into the aneurysm to fill the aneurysm, such that the plurality of components, as a complex, provide a lower porosity near the neck of the aneurysm relative to the base of the aneurysm.

[0126] Example 112. The method according to Example 107 further includes imaging of the aneurysm.

[0127] Example 113. The method according to Example 112, wherein the imaging includes determining the shape of the aneurysm to select the plurality of components.

[0128] Example 114. The method according to Example 112 further includes repositioning the first of the plurality of components within the aneurysm after the first component has been released into the aneurysm.

[0129] Example 115. The method according to Example 114, wherein the repositioning includes repositioning the first component such that the plurality of components are arranged as a composite within the aneurysm to provide a lower porosity near the aneurysm neck relative to the aneurysm base.

[0130] Example 116. The method according to Example 107 further includes implanting the frame device into the aneurysm before releasing the plurality of components into the aneurysm.

[0131] Example 117. The method according to Example 116, wherein the release includes releasing the plurality of components into the cavity of the frame device.

[0132] Example 118. A method for treating an aneurysm, comprising: positioning a distal opening of a catheter adjacent to the aneurysm; advancing a frame device into the aneurysm, the frame device having an inner lumen and an outer surface for contacting the wall of the aneurysm; and releasing at least one expandable member into the lumen of the device when at least a portion of the outer surface of the device contacts the wall of the aneurysm; wherein the frame device comprises at least one of a foam or a braided structure.

[0133] Example 119. The method according to Example 118, wherein the aneurysm is a saccular aneurysm, and before releasing the at least one expandable member, the device expands such that the outer surface contacts the inner surface of the aneurysm, the inner surface having a cross-sectional profile larger than the through profile of the neck of the aneurysm.

[0134] Example 120. The method according to Example 118, wherein the release includes causing the device to expand to contact the wall of the aneurysm.

[0135] Example 121. The method according to Example 118, wherein the device comprises a generally closed three-dimensional expansion shape.

[0136] Example 122. The method according to Example 118, wherein the component includes at least one of foam, coil, or braided structure.

[0137] Example 123. According to the method of Example 121, the three-dimensional shape is selected from the group consisting of spheres, cylinders, hemispheres, polyhedra, elongated spheres, oblate spheroids, non-spherical surfaces of revolution, and combinations thereof.

[0138] Example 124. The method according to Example 118, wherein the device comprises four quadrants, and the release comprises causing at least a portion of each quadrant to contact the wall of the aneurysm.

[0139] Example 125. The method according to Example 124, wherein the device comprises a generally spherical expanded shape.

[0140] Example 126. The method according to Example 118, wherein the device includes an opening into a cavity of the device, and the release includes injecting the at least one expandable member into the cavity of the device through an orifice of the device.

[0141] Example 127. The method according to Example 126, wherein the device includes a braided material and the opening is an opening formed between filaments of the braided material.

[0142] Example 128. The method according to Example 126, wherein the frame device has a closed end and an open end opposite to the closed end, the open end forming the opening, and wherein the release advance includes aligning the opening with the neck of the aneurysm.

[0143] Example 129. The method according to Example 128, wherein the open end includes a plurality of filamentary ends extending into the cavity of the device and forming the opening, the plurality of filamentary ends collectively forming a tubular portion extending into the cavity of the device, wherein the release includes allowing the at least one expandable member to expand within the cavity of the device such that the tubular portion deflects to contact the inner wall of the device, thereby closing the opening.

[0144] Example 130. The method according to Example 118, wherein the release includes releasing a plurality of expandable components into the aneurysm such that the plurality of expandable components, as a composite, provide a lower average porosity relative to the average porosity at the base of the aneurysm near the neck of the aneurysm.

[0145] Example 131. According to the method of Example 118, the shape of the at least one expandable component is selected from the group consisting of cylinder, hemisphere, polyhedron, elongated sphere, oblate spheroid, plate, bowl, hollow structure, clover shape, non-spherical surface of revolution and combinations thereof.

[0146] Example 132. The method according to Example 118, wherein the release includes releasing at least one coil into the cavity of the device.

[0147] Example 133. The method according to Example 118, wherein the release includes releasing at least one expandable component into the cavity of the device.

[0148] Example 134. The method according to Example 133, wherein the at least one expandable component comprises an expandable composite, the expandable composite comprising a first portion and a second portion having different porosities from each other.

[0149] Example 135. A method for treating an aneurysm, comprising: implanting a stent into the lumen of a mother vessel from which the aneurysm has formed, such that the stent extends across at least a portion of the aneurysm; and releasing at least one expandable component into the internal volume of the aneurysm between the wall of the aneurysm and the outer surface of the stent; wherein the expandable component comprises at least one of a foam or a braided structure.

[0150] Example 136. The method according to Example 135, wherein the aneurysm includes a fusiform aneurysm.

[0151] Example 137. The method according to Example 135, wherein the aneurysm includes a wide-necked aneurysm.

[0152] Example 138. The method according to Example 135, wherein the portion includes a neck.

[0153] Example 139. The method according to Example 135, wherein the at least one expandable component comprises a plurality of expandable components, and the release comprises releasing the plurality of components based on the relative dimensions of the expandable components.

[0154] Example 140. The method according to Example 139 further includes selecting the at least one expandable component based on the shape of the internal volume.

[0155] Example 141. According to the method of Example 140, the at least one expandable component includes a shape selected from the group consisting of cylinders, hemispheres, polyhedra, elongated spheres, oblate spheroids, plates, bowls, hollow structures, clover shapes, non-spherical surfaces of revolution, and combinations thereof.

[0156] Example 142. The method according to Example 135, wherein the at least one expandable component includes a first portion and a second portion, the first portion having an average porosity greater than that of the second portion, and the release includes positioning the at least one expandable component such that the first portion abuts against the outer surface of the stent device and the second portion extends along the inner wall of the aneurysm.

[0157] Example 143. The method according to Example 135, wherein the release includes releasing a plurality of expandable components into the internal volume.

[0158] Example 144. The method according to Example 135, wherein the internal volume of the aneurysm extends around the circumference of the stent device, and the release includes placing a plurality of expandable components into the internal volume surrounding the circumference of the stent device.

[0159] Example 145. The method according to Example 144, wherein at least one of the plurality of expandable components includes a flat or cylindrical surface, and the release includes positioning at least one of the plurality of expandable components such that the flat or cylindrical surface substantially conforms to the outer surface of the support device.

[0160] Example 146. A system for treating an aneurysm, comprising: an intrasac device including a first expandable component and a second expandable component adapted to transition from a compressed configuration to an expandable configuration when deployed into an aneurysm, the first component and the second component being interconnected by a non-helical coupling such that the first component and the second component can be advanced into the aneurysm as interconnecting units; wherein the first component includes at least one of a shape or average porosity different from that of the second component.

[0161] Example 147. According to the system of Example 146, the shape of the first component is selected from the group consisting of cylinder, hemisphere, polyhedron, elongated sphere, oblate spheroid, plate, bowl, hollow structure, clover shape, non-spherical surface of revolution and combinations thereof.

[0162] Example 148. The system according to Example 146, wherein the second component comprises a generally spherical shape.

[0163] Example 149. The system according to Example 146, wherein at least one of the first component or the second component comprises a foam or woven structure.

[0164] Example 150. The system according to Example 146, wherein at least one of the first component or the second component includes a coil.

[0165] Example 151. The system according to Example 146, wherein the first component includes an average porosity between approximately 1 μm and approximately 100 μm, and the second component includes an average porosity between approximately 100 μm and approximately 200 μm.

[0166] Example 152. The system according to Example 146 further includes a third component interconnected with the second component, such that the first, second and third components are interconnected in series.

[0167] Example 153. The system according to Example 146, wherein the connector interconnecting the first component and the second component comprises a filament.

[0168] Example 154. The system according to Example 146, wherein the connecting member has a preset shape such that, in the expanded position, the first component and the second component are spaced apart from each other in a preset orientation.

[0169] Example 155. The system according to Example 146 further includes a guide sheath configured to receive the device therein, such that the device can be loaded into a guide catheter for delivery to the aneurysm.

[0170] Example 156. A system for treating an aneurysm, comprising: an intrasac device including at least three expandable components adapted to transition from a compressed configuration to an expanded configuration when deployed into an aneurysm, each of the at least three components being interconnected to at least two of the at least three components such that the at least three expandable components can be advanced into the aneurysm as interconnecting units.

[0171] Example 157. The system according to Example 156, wherein the at least three expandable components comprise at least four expandable components.

[0172] Example 158. The system according to Example 157, wherein at least two of the at least four expandable components are interconnected with at least three of the at least four expandable components, such that the device includes a multi-planar shape.

[0173] Example 159. The system according to Example 156, wherein the at least three components are interconnected by filaments.

[0174] Example 160. The system according to Example 156, wherein the at least three components are interconnected by filaments having a predetermined shape such that, in the expanded position, the at least three components are spaced apart from each other in a predetermined orientation.

[0175] Example 161. The system according to Example 156, wherein the device includes at least one central expandable member, the at least one central expandable member being positioned such that when the device is in an expanded configuration, the central expandable member is centrally interconnected with a plurality of expandable members.

[0176] Example 162. The system according to Example 161, wherein the at least one central expandable component has an expansion dimension greater than the expansion dimension of each of the remaining components.

[0177] Example 163. The system according to Example 161, wherein the at least one central expandable component has an average porosity greater than the average porosity of each of the remaining components among the plurality of components.

[0178] Example 164. The system according to Example 158, wherein the shape of the multi-plane includes a polyhedron.

[0179] Example 165. The system according to Example 164, wherein the shape of the multi-plane includes a pyramid.

[0180] Example 166. The system according to Example 164, wherein the multi-plane shape includes a prism.

[0181] Example 167. The system according to Example 156, wherein the first component of the at least three components has a different shape or average porosity than the second component of the at least three components.

[0182] Example 168. The system according to Example 156, wherein the shape of the first component is selected from the group consisting of cylinders, hemispheres, polyhedra, elongated spheres, oblate spheroids, plates, bowls, hollow structures, clover shapes, non-spherical surfaces of revolution, and combinations thereof.

[0183] Example 169. The system according to Example 156, wherein the second component comprises a generally spherical shape.

[0184] Example 170. The system according to Example 156, wherein the first component includes an average porosity between approximately 1 μm and approximately 100 μm, and the second component includes an average porosity between approximately 100 μm and approximately 200 μm.

[0185] Example 171. The system according to Example 156 further includes a guide sheath configured to receive the device therein, such that the device can be loaded into a guide catheter for delivery to the aneurysm.

[0186] Example 172. A method for treating an aneurysm, comprising: advancing an intrasac device toward the aneurysm through the lumen of a catheter, the device comprising a plurality of expandable components, each expandable component being adapted to transition from a compressed configuration to an expanded configuration when deployed from the catheter into the aneurysm, each of the plurality of components being interconnected via a coupling.

[0187] Example 173. The method according to Example 172 further includes: advancing the device into an aneurysm such that a first component is disposed within the aneurysm and a second component interconnected with the first component via the coupling is disposed within the lumen of the catheter; disconnecting the coupling between the first component and the second component to release the first component into the aneurysm; retaining the second component within the lumen; and retracting the catheter.

[0188] Example 174. The method according to Example 172 further includes advancing a plurality of expandable components into the aneurysm prior to the transection.

[0189] Example 175. The method according to Example 172, wherein each of the plurality of components is interconnected in series via the connector.

[0190] Example 176. The method according to Example 172, wherein the cutting includes retracting the catheter proximally relative to the second catheter such that the coupling between the first component and the second component is clamped between the distal end of the catheter and the edge of the second catheter.

[0191] Example 177. The method according to Example 172, wherein the plurality of expandable components are arranged in decreasing size, and the advancement includes allowing the initial expandable component deployed into the aneurysm to expand before advancing a subsequent expandable component into the aneurysm.

[0192] Example 178. The method according to Example 177, wherein the advancement includes observing the fit of the expanded component within the aneurysm to determine whether to advance the additional component into the aneurysm.

[0193] Example 179. The method according to Example 178, wherein the device comprises a non-transparent material.

[0194] Example 180. The method according to Example 178, wherein the coupling between the plurality of expandable components comprises a non-transparent material.

[0195] Example 181. The method according to Example 178, wherein each of the plurality of expandable components of the device comprises a radiopaque material.

[0196] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory, and are intended to provide further explanation of the technical subject matter. Attached Figure Description

[0197] The accompanying drawings, which are included in and form part of this specification, and are used to provide a further understanding of the subject matter, illustrate various aspects of this disclosure and, together with the description, serve to explain the principles of the subject matter.

[0198] Figure 1 This is a schematic diagram illustrating an aneurysm within a blood vessel in which an intracapsular device has been implanted, according to some embodiments.

[0199] Figure 2 This is a schematic diagram of a mesh foam that can be used in an intracapsular device according to some embodiments.

[0200] Figure 3 This is a schematic diagram of an intracapsular device with a specific porosity according to some embodiments.

[0201] Figure 4 This is a schematic diagram of an intracapsular device comprising two portions having different porosities, according to some embodiments.

[0202] Figure 5 According to some embodiments Figure 4 The diagram shows an enlarged view of the transition region of the intracapsular device, where the transition region includes a direct transition between different porosities.

[0203] Figure 6 According to some embodiments Figure 4 The enlarged view of the transition region of the intracapsular device shown in the figure illustrates that the transition region includes a gradual transition between different porosities.

[0204] Figure 7 This is a schematic diagram of an intracapsular device comprising three parts arranged with a specific porosity distribution, according to some embodiments.

[0205] Figure 8 This is a schematic diagram of an intracapsular device comprising three parts arranged with a specific porosity distribution, according to some embodiments.

[0206] Figure 9 This is a schematic diagram of an intracapsular device comprising four sections with different porosities, according to some embodiments.

[0207] Figure 10 This is a schematic diagram of an intracapsular device having a channel extending therethrough, according to some embodiments.

[0208] Figure 11 This is a schematic diagram of an intracapsular device having a channel extending therethrough, according to some embodiments.

[0209] Figure 12A-12R This is a view showing an optional configuration of the foam structure used for the internal device.

[0210] Figure 13-15 The hollow structure of the bladder device according to some embodiments is shown.

[0211] Figure 16-18 An interlocking structure of an intracapsular device according to some embodiments is shown.

[0212] Figure 19-21 An alternative embodiment of an intracapsule device comprising a coated foam structure is shown.

[0213] Figure 22-25 A delivery system and delivery process for delivering intracavitary devices are shown according to some embodiments.

[0214] Figure 26 An intracystic device having a radiopaque material and positioned within an aneurysm is shown according to some embodiments.

[0215] Figure 27-30 An intracystic device based on porosity distribution and positioned within an aneurysm is shown according to some embodiments.

[0216] Figure 31A-34 The diagram illustrates, according to some embodiments, a device for joining one or more expandable components. Figure 22 The optional engagement mechanism for the conveying system is shown.

[0217] Figure 35 A delivery system for delivering intracavitary devices is shown according to some embodiments.

[0218] Figure 36 A delivery system for delivering an intracavitary device, comprising multiple expandable components, is shown according to some embodiments.

[0219] Figure 37 This illustrates a delivery system, according to some embodiments, that is advanceable along a guidewire for delivering an intracapsular device comprising multiple inflatable components.

[0220] Figure 38 An intrasac device, having a specific shape and made of radiopaque material, is shown according to some embodiments and is positioned within a saccular aneurysm.

[0221] Figure 39 An intrasac device comprising multiple expandable components, located within a saccular aneurysm according to some embodiments, is shown.

[0222] Figure 40 An intrasac device comprising multiple interlocking expandable components, located within a saccular aneurysm, is shown according to some embodiments.

[0223] Figure 41An intrasac device comprising multiple expandable components, located within a saccular aneurysm according to some embodiments, is shown.

[0224] Figure 42 An intrasac device comprising multiple expandable components, extending across a fusiform aneurysm, is shown according to some embodiments.

[0225] Figure 43 A schematic diagram illustrating the process of inserting embolic fluid and an intrasac device including a single expandable component into an aneurysm according to some embodiments.

[0226] Figure 44 This diagram illustrates the process of inserting embolic fluid and an intrasac device comprising multiple expandable components into an aneurysm according to some embodiments.

[0227] Figure 45 The diagram illustrates a conveying process, according to some embodiments, for delivering coils or foam into the interior of an inner frame device.

[0228] Figure 46 This illustrates a coil-filled, similar device according to some embodiments. Figure 45 A partial cross-sectional view of the intracapsular frame device shown.

[0229] Figure 47 This illustrates a similar structure, according to some embodiments, filled with at least one foam component. Figure 45 A partial cross-sectional view of the intracapsular frame device shown.

[0230] Figure 48 Another embodiment of an intracavitary frame device, according to some embodiments, is shown, which is filled with at least one foam component.

[0231] Figure 49 Another embodiment of an intracavitary frame device, according to some embodiments, is shown, which is filled with at least one foam component.

[0232] Figures 50-52 These are schematic diagrams of different intracapsular frame devices according to some embodiments.

[0233] Figures 53-56 An embodiment of an intracapsular device comprising a strip with a foam structure is shown.

[0234] Figures 57A-57C It shows that it can be used alone or in combination with each other. Figures 53-56 The cross-sectional shape of the intracapsular structure is shown.

[0235] Figure 58A An embodiment of an intracavitary device comprising a plurality of interconnected expandable components in a compressed state is shown according to some embodiments.

[0236] Figure 58B The illustration shows, according to some embodiments, a plurality of interconnected expandable components in an expanded state. Figure 58A The intracapsular device.

[0237] Figure 59A An embodiment of an intracapsular device comprising layers of interconnected expandable components in a compressed state is shown, according to some embodiments.

[0238] Figure 59B Another embodiment of an intracapsular device comprising layers of interconnected expandable components in a compressed state, according to some embodiments, is shown.

[0239] Figure 60A An embodiment of an intracapsular device comprising a three-dimensional array of interconnected expandable components in a compressed state is shown according to some embodiments.

[0240] Figure 60B Another embodiment of an intracapsular device comprising a three-dimensional array of interconnected expandable components in a compressed state is shown, according to some embodiments.

[0241] Figures 61-63 A conveying system and conveying process for conveying multiple interconnected expandable components are shown according to some embodiments. Detailed Implementation

[0242] In the following detailed description, numerous specific details are set forth to provide a complete understanding of the subject matter. It should be understood that the subject matter can be implemented without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail to avoid obscuring the subject matter.

[0243] Intracapsular implantation devices and procedures for treating aneurysms can be improved by adjusting one or more physical properties of the implant material. Such properties can include porosity, composition, material, shape, size, interconnectivity, interlocking properties, coatings, etc. By modifying one or more of these properties, the morphology or properties of the target aneurysm and the orientation of any connecting arteries can be specifically considered and addressed to achieve optimal treatment.

[0244] According to some embodiments, the porosity, composition, or materials of the intra-sac device can facilitate the treatment of aneurysms. The intra-sac device may include an expandable component. When deployed into the aneurysm, the intra-sac device can expand from a first compressed configuration to a second expanded configuration.

[0245] Optionally, the intracapsular device may include an expandable component having an average porosity that varies from a first end of the component to a second end opposite the first end. Optionally, the intracapsular device may include a composite structure comprising a first segment and a second segment or material with different porosities. For example, the first and second segments may be separated by a transition region. The transition region may include an abrupt or gradual transition in porosity, wherein the porosity spatially varies between a first porosity and a second porosity from one end of the transition region to the other opposite end of the transition region.

[0246] When used herein, "porosity" can generally refer to the average porosity obtainable by sampling a specified portion or section of an expandable component. "Porosity" can be defined as the ratio of the volume of pores in a component to the volume of the component as a whole. Porosity can be measured by a fluid displacement test. Depending on the art, the test may be performed using, for example, a liquid or a gas, as needed or required. In some embodiments, a chromatography chamber can be used to measure the displacement of gases within the chamber to calculate the average porosity of a specified internal device or a portion thereof. Other methods and systems can be used to measure the porosity of a portion or the entirety of an expandable component.

[0247] In some embodiments, the composite structure of the intracapsule device may include three materials with different porosities. Furthermore, the composite structure of the intracapsule device may include four, five, six, or more different materials with different porosities.

[0248] According to some embodiments, one or more of the intrasac devices can be released into the target aneurysm and, in some embodiments, are specifically oriented relative to the aneurysm or neck and / or one or more perforating vessels (e.g., perforating arteries or arterioles) adjacent to the aneurysm.

[0249] In some embodiments, the intrasac device can be repositioned within the aneurysm while it is inflating. Repositioning the device may allow the clinician to locate a lower porosity segment of the device near the neck of the aneurysm. Repositioning the device may also allow the clinician to locate a higher average porosity segment of the device near one or more perforating blood vessels (e.g., perforating arteries or arterioles) adjacent to the aneurysm. Repositioning the device may also allow the clinician to locate a lower porosity segment of the device near the bifurcation. Repositioning the device may also allow the clinician to locate a higher average porosity segment of the device toward or within the base of the aneurysm.

[0250] The intrasac implantation device and implantation procedure for treating aneurysms disclosed herein may also include adjusting the shape or size of the intrasac device. According to some embodiments, a single expandable component having a specific or selected shape or size that can be adapted to the shape or size of the aneurysm may be implanted into the aneurysm. Furthermore, multiple expandable components, each having such a specific or selected shape or size, may also be implanted into the aneurysm. The shape or size of one or more expandable components can be selected from a variety of spherical or non-spherical shapes. Each shape may be solid or hollow.

[0251] According to some embodiments, a composite intracapsular device comprising at least two mating expandable components (e.g., multiple interconnectable or engageable expandable components) can be provided. Each expandable component may include one or more engagement structures configured to interact with a corresponding engagement structure of another mating expandable component.

[0252] For example, mating expandable components can all include engagement structures configured to interact with corresponding engagement structures of another mating expandable component. The mating expandable components can be delivered into the aneurysm and disposed in situ such that the engagement structures are aligned and properly interconnected, thereby mating the expandable components. In some embodiments, the mating of the expandable components can interlock the components into units. For example, the expansion of one component within a recess of another component can cause the components to interlock with each other. Furthermore, in some embodiments, the mating components can restrict at least one degree of freedom of movement of the other component.

[0253] *According to some embodiments in which multiple expandable components are used, the expandable components (whether interconnected by wires or filaments or not, thereby allowing them to move independently of each other) can be arranged in the form of a composite component. The composite component can provide desired properties that may be difficult to obtain in a single component formed from a single, continuous block of material.

[0254] Various conveying systems and processes can be implemented to convey devices of a specific size or shape and, in some embodiments, multiple inflatable intracavitary devices. Examples of these systems and processes are further discussed herein.

[0255] According to some embodiments of the delivery process, the target aneurysm can be imaged and analyzed to determine its three-dimensional shape. Based on the shape of the target aneurysm, one or more expandable components can be selected, possessing unique porosity, composition, material, shape, size, interconnectivity, interlocking, or coating, etc. Imaging devices may include 3D CTA or MRI (MRA) imaging, through which the size and shape of the aneurysm can be determined. Such imaging can provide a basis for selecting one or more endovascular devices of a corresponding shape for insertion within the aneurysm. Expandable components or different combinations of their properties can be used.

[0256] Optionally, in some embodiments, the intra-sac device may have a predetermined configuration, regardless of whether the intra-sac device has only one or more expandable components. The predetermined configuration may be based on a typical aneurysm shape, thereby allowing for the selection of a specific intra-sac device. However, individual components of the intra-sac device may also be arranged based on their porosity. Thus, clinicians can determine the shape of the aneurysm and generate a desired intra-sac device configuration for treating the aneurysm.

[0257] In some embodiments, the inflatable components of the bladder device may be molded or manufactured into various geometric or partial geometries.

[0258] For example, to accommodate various aneurysm configurations, the shape or size of (one or more) expandable components can be selected from a variety of spherical or non-spherical shapes, including cylinders, hemispheres, noodle shapes, polyhedra (e.g., cubes, tetrahedrons (e.g., pyramids), octahedrons, prisms), coils, elongated spheres, oblate spheroids, discs (e.g., round discs, polygonal discs), bowls (e.g., open containers, such as hollow, hemispherical containers or other open, hollow containers, whether hemispherical, circular or other shapes), hollow structures (e.g., containers of any shape with cavities or voids, which may, for example, be larger in size than the width of any wall of the structure), clover shapes (multiple radially extending protrusions with rounded or smooth corners), non-spherical surfaces of revolution (e.g., torus, cones, cylinders or other shapes rotating about a central point or coplanar axis), and combinations thereof. Each shape can be solid or hollow.

[0259] According to some embodiments, at least a portion of the intracapsular device may include a coating or material for enhancing the therapeutic, inflationary, or imaging properties or characteristics of at least one or each inflatable component of the intracapsular device.

[0260] In some embodiments, the intracapsular device may be configured such that its expandable components are coated with a biocompatible material to promote endothelialization or provide a therapeutic effect.

[0261] Optionally, the expandable component may also include an expansion-limiting coating that slows the expansion of the component from its natural rate of expansion to a slower rate of expansion, such that during expansion, the position of the component can be adjusted within the aneurysm or, if necessary, the component can be removed from the aneurysm. Examples of polymers that can be used as expansion-limiting coatings include hydrophobic polymers, organic nonpolar polymers, PTFE, polyethylene, polyphenylene sulfide, oils, and other similar materials.

[0262] Various delivery systems and processes for delivering intrasac devices comprising one or more expandable components can be implemented, as described herein. Furthermore, systems and methods are provided for delivering intrasac devices to aneurysms and / or recapture devices for removal or repositioning.

[0263] Intracapsular implantation devices and procedures for treating aneurysms may include interconnecting individual components of the intracapsular device. According to some embodiments, multiple expandable components may be interconnected along lines, filaments, or other disconnectable or fractureable materials. Expandable components may be connected in a linear configuration, a planar matrix, or a three-dimensional matrix. The size and configuration of such interconnected linear, planar, or three-dimensional matrix expandable components may be determined based on desired porosity, size, shape, transmissivity, or other properties disclosed herein.

[0264] In some embodiments, a method is provided for deploying interconnected expandable components into an aneurysm. The interconnected components may be pre-configured prior to implantation (e.g., multiple components may be linked together to form a single, monolithic device, or multiple components may be selected to be removed from a larger series or array of components) and subsequently inserted into a delivery catheter. Thereafter, the entire series or assembly of interconnected expandable components of the intra-sac device may be expelled or deployed into the aneurysm, allowing expansion within the aneurysm.

[0265] However, according to some embodiments, an entire series or array of components can be loaded into the delivery catheter, and when implantation and observation of packing behavior are performed, clinicians can determine that selected portions of the interconnected expandable components are sufficient for the designated aneurysm. Subsequently, selected portions of the interconnected expandable components can be broken off or cut in situ to release them into the aneurysm.

[0266] Additionally, although in some embodiments a single expandable component can be used alone to fill the aneurysm and provide the desired packing density, multiple expandable components can also be used to fill the aneurysm and provide the desired packing density. Optionally, the fluid embolization and / or frame component can be used in combination with one or more expandable components to facilitate delivery, aneurysm engagement, or increase packing density. Any of these embodiments can allow for increased packing density to prevent aneurysm recanalization.

[0267] Now refer to the attached diagram, Figure 1 An embodiment of an intrasac device 10 located within an aneurysm 12 in a blood vessel 14 is shown. The intrasac device 10 can be particularly adapted for use in a subject's tortuous neurovascular system for at least partial deployment within a cerebral aneurysm.

[0268] Cerebral aneurysms can present themselves in the shape of a berry, also known as a berry-shaped or saccular aneurysm, which is a bulge in a neurovascular bundle. Berry-shaped aneurysms can be located at bifurcation points or other branching points of the blood vessels. Other types of aneurysms, including fusiform aneurysms, can also be treated using embodiments of the endovascular devices disclosed herein.

[0269] The intracapsular device 10 may include at least one inflatable component. In some embodiments, the intracapsular device 10 may include a plurality of inflatable components. Furthermore, a designated inflatable component of the intracapsular device 10 may have one or more characteristics different from those of another inflatable component of the intracapsular device 10.

[0270] The expandable component can be formed from a material that is highly compressible and subsequently expands upon release into the aneurysm and contact with a fluid, such as fluid within the aneurysm. In some embodiments, the expandable component may be formed at least partially from a biocompatible, solid foam. As used herein, “foam” can include solid or semi-solid gels, swellable materials (whether swellable when hydrated or swellable / self-swellable without hydration), and materials having pores and gaps. “Foam” can include hydrophobic or hydrophilic materials. “Foam” can also include materials that are highly compressible and configured to expand upon contact with a fluid, upon exposure to a thermal agent, upon exposure to a chemical agent, or upon disengagement from a delivery mechanism. In some embodiments, the foam material may be configured to expand to approximately two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, twenty, or more times its collapsed size when expanded to its expanded size.

[0271] For example, Figure 2A schematic diagram of foam material 20 is shown. Suitable foam materials may include biocompatible foams, such as PVA (polyvinyl alcohol). Additionally, suitable foam materials may include mesh foams. In some embodiments, a “mesh” foam may include a random arrangement of pores having irregular shapes and sizes or a non-random arrangement of pores having regular, patterned shapes or sizes. Suitable foams under the trade name PacFoam, available from UFP Technologies of Costa Mesa, California, are also known. In some embodiments, the foam material forming the expandable component may be configured to include at least approximately 20 pores per inch (“PPI”), at least approximately 30 PPI, at least approximately 40 PPI, at least approximately 50 PPI, at least approximately 60 PPI, at least approximately 70 PPI, or at least approximately 80 PPI, or combinations thereof.

[0272] Other materials may also be used to form one or more parts of the intracapsular device or its expandable component. Such materials may include, but are not limited to, polyvinyl alcohol (PVA), water-soluble synthetic polymers (such as polyethylene glycol (PEG), polyvinylpyrrolidone (PVP)), and other similar materials.

[0273] The porosity of the expandable component can vary along any one or more of its portions, including any combination of pore sizes of 1 micrometer or larger. Furthermore, the pore size can range from approximately 1 μm to approximately 400 μm, approximately 5 μm to approximately 300 μm, approximately 8 μm to approximately 200 μm, approximately 10 μm to approximately 150 μm, approximately 15 μm to approximately 80 μm, or in some embodiments, approximately 20 μm to approximately 50 μm. Additionally, at least a portion or segment of the device may include an average porosity between approximately 1 μm and approximately 150 μm. Furthermore, at least a portion or segment may include an average porosity between approximately 100 μm and approximately 200 μm. Furthermore, at least a portion or segment may include an average porosity between approximately 200 μm and approximately 300 μm. When multiple segments or portions are used to form a composite expandable component, each segment or portion may have an average porosity within any of the aforementioned ranges.

[0274] According to some embodiments, in a compressed state, the expandable component or intracavitary device can be compressed to 50%, 40%, 30%, 20%, 10% or less of its expanded state (which can be measured by its maximum diameter or cross-sectional dimension) for delivery through a standard microcatheter. In some embodiments, the foam material can be configured to expand to approximately two to twenty times its collapsed size when expanded to its expanded size.

[0275] In cases where the intracapsule device is not self-expanding but expandable through a chemical reaction, the chemical can be introduced into the lumen of the delivery conduit for delivery to the intracapsule device. Alternatively, the delivery conduit may include a separate lumen for introducing the catalyst. Thermally expanding foam can be activated by introducing heated brine or some other suitable biocompatible fluid through any of the aforementioned lumens of the delivery conduit. Alternatively, a heating element can be included within the delivery conduit to transfer heat to the foam structure, resulting in corresponding expansion. Suitable heating elements, schematically identified as reference numerals, may include resistive elements(s), microwave antennas, radio frequency devices, ultrasonic devices, etc.

[0276] As described above, some embodiments of the expandable component can be configured to provide a specific porosity distribution. The porosity distribution may include a consistent average porosity throughout the expandable component, or multiple regions, portions, or materials with different average porosities connected to form a composite expandable component.

[0277] For example, Figure 3 The embodiments shown can be configured to have a low average porosity structure. For illustrative purposes, a hexagonal pattern with a larger space is used to illustrate the low porosity structure compared to the hexagonal pattern with a smaller space used to illustrate medium and high porosity structures. The low porosity structure can provide a higher packing density, which can promote thrombus formation by providing higher resistance to flow through it. When such a low porosity structure is implanted in an aneurysm, such a structure can substantially pack the aneurysm with a higher packing density, thereby isolating the aneurysm from the parent vessel and minimizing the blood flow velocity within the aneurysm while supporting the aneurysm wall.

[0278] Conversely, as porosity increases, the packing density decreases, providing less support for thrombosis compared to low-porosity structures, due to the lower resistance to flow through them. However, some embodiments disclosed herein achieve the goal that high-porosity structures can also support aneurysm walls, beneficially aiding healing and thrombosis to select aneurysm morphology, allowing flow to other vessels (e.g., branch vessels, perforating arteries, or arterioles), and / or allowing the introduction of other materials, such as fluid emboli.

[0279] Furthermore, in some embodiments, composite, variable, or multi-porosity expandable components (whether using a single expandable component with multiple porosities or multiple expandable components with different porosities) can advantageously allow the intrasac device to mimic the natural function of the vascular system while promoting healing through thrombosis, pressure relief or reduction, or aneurysm contraction. Additionally, in embodiments using a single expandable component, the single expandable component can be configured to advantageously secure the intrasac device within a wide-necked aneurysm by facilitating engagement with a sufficient amount of aneurysm wall, thereby preventing device displacement from the aneurysm or protrusion into the parent vessel.

[0280] Figure 3 An expandable component 50 is shown, exhibiting a lower density or higher porosity due to its larger pore size. As described above, the foam component 50 can allow some blood flow through it to maintain branch vessels while still providing support for the aneurysm wall. Furthermore, according to some embodiments, the expandable component 50, or a portion thereof, can be packed with a liquid embolism during or after placement of the intrasac device. Injection of the liquid embolism can increase the overall packing density within the expandable component 50.

[0281] A suitable fluid embolism is Onyx, manufactured by Covidien LP in Irvine, California. TM Fluid embolization system. Onyx TM Fluid embolization systems are non-viscous fluids used in the treatment of cerebral arteriovenous insufficiency. (Onyx) TM The liquid embolization system comprises an EVOH (ethylene vinyl alcohol) copolymer dissolved in DMSO (dimethyl sulfoxide) and suspended micronized tantalum powder to provide a contrast for visualization under fluorescence. Other liquid embolization solutions are also possible.

[0282] Figure 4-9 Additional embodiments of the expandable component are shown. For example, Figure 4 An expandable component 60 having first and second portions 62, 64 is shown. The first and second portions 62, 64 may be formed of different materials. For example, the first portion 62 may comprise a first material with a higher average porosity, and the second portion 64 may comprise a second material with a lower average porosity. The first and second portions 62, 64 may be joined together by any chemical, thermal, or mechanical bonding method known in the art or to be found thereafter. The first and second portions 62, 64 may be permanently attached to each other or releasably attached to each other upon expansion.

[0283] Figure 5-6 Show Figure 4 An enlarged view of the transition region 66 of the expandable component 60. According to some embodiments, Figure 5The transition region 66a is shown to include a direct, abrupt transition between the porosities of the first and second portions 62, 64. The transition region 66a provides an open flow path between the first and second portions 62, 64. Therefore, the transition region 66a cannot serve as a barrier to fluid flow. However, in some embodiments, the transition region 66a can provide at least a partial or complete barrier to fluid flow between the first and second portions 62, 64. In such embodiments, the composite structure of the expandable component 60 may comprise segments or sections of separately formed material, which are then joined together to create a composite unit or whole. Individual segments or the first and second portions 62, 64 may comprise the same material (any of the materials described herein) or a combination of different materials. The first and second portions 62, 64 may be combined by chemical, thermal, or mechanical methods known in the art.

[0284] Figure 6 A transition region 66b, which may include an intermediate portion 68, is shown. This intermediate portion has an average porosity higher than that of the second segment 64 but lower than that of the first segment 62. The transition region 66b provides an open flow path between the first, second, and / or intermediate portions 62, 64, 68. Therefore, similar to transition region 66a, transition region 66b cannot serve as a barrier to fluid flow. However, in some embodiments, transition region 66b can provide at least a partial or complete barrier to fluid flow between the first, second, and / or intermediate portions 62, 64, 68. In such embodiments, the intermediate portion 68 may have a spatially gradual porosity transition from low to high porosity (and vice versa). The transition region 66b can be formed by varying the gas used in the manufacture of the variable porosity structure. Furthermore, during the manufacture of the expandable component 60, regions within the blank can be identified based on average porosity, and the expandable component can be trimmed from them. In some embodiments, certain regions having porosities that spatially vary from one end of a region to the other, opposite ends, can be identified.

[0285] Figure 7-9 Show Figure 1-4 The diagrams show additional embodiments of the expandable components. These diagrams all include expandable components with composite structures having two or more foam segments with different corresponding porosities (or pore densities), sizes, and / or shapes.

[0286] For example, Figure 7An expandable component 80 is shown having first, second, and third portions 82, 84, and 86. The second portion 84 may include a lower porosity than the first and third portions 82 and 86. In some embodiments, the first and third portions 82 and 86 may include the same porosity (e.g., the first and third portions 82 and 86 may include the same material or be formed or cut from the same material). However, in some embodiments, the first and third portions 82 and 86 may include different porosities (e.g., the first and third portions 82 and 86 may include different materials or be formed or cut from different materials). Additionally, the first, second, and third portions 82, 84, and 86 may include different sizes and / or shapes or have substantially the same size and / or shape. According to some embodiments, the size and shape characteristics may be configured as described below.

[0287] Figure 8 Similarly, an expandable component 90 having first, second, and third portions 92, 94, and 96 is shown. Generally, the second portion 94 has a higher porosity than the first and third portions 92 and 96. Additionally, Figure 9 Also shown is an expandable component 100 having first, second, third, and fourth segments 102, 104, 106, and 108, each of which may have different porosities, shapes, and / or sizes. The porosity, size, or shape of portions of the expandable components 90 and 100 may be as described above regarding... Figure 7 The configuration is similar. Therefore, in addition to the instructions... Figure 8-9 Some embodiments are shown that may include different Figure 7 Aside from the variations in porosity, size, and shape shown, the discussion of such properties will not be repeated.

[0288] Foam composites can be formed to provide different support and / or flow distributions. As described herein, materials such as bismuth or tantalum can be blended with foams to provide transmissivity linearity. Moreover, transmissivity markings can be attached to foams by bonding them together or mechanically pressing them into the foam.

[0289] As described above, in some embodiments, only a single expandable component needs to be introduced into the aneurysm. In some embodiments, this can prove superior to conventional methods (such as inserting, for example, multiple embolization coils) by significantly reducing the time required to perform the embolization procedure.

[0290] Additionally, in some embodiments, multiple expandable components can be provided for insertion into the aneurysm. For example, multiple expandable components with different average porosities can be implanted into the aneurysm and have a composite or cumulative porosity distribution spatially spanning the aneurysm. This allows multiple expandable components to operate as a unit in very similar manner to a single expandable component, if filling the same aneurysm itself would be effective. (The following is a further section...) Figure 36-42 Such embodiments are described in more detail below. The expandable components can be arranged and positioned within the lumen of the catheter or otherwise positioned for delivery to the aneurysm. The size of each expandable component can be compressed to a fraction of its normal, expanded size and delivered to the target aneurysm.

[0291] Furthermore, in some embodiments, one or more expandable components may include one or more flow regions. The flow regions may be used alone or in conjunction with any of the variable porosity distributions disclosed herein (including...). Figure 4-9 (As shown in the diagram) combination.

[0292] For example, Figure 10-11 An expandable component with at least one flow region is shown. Figure 10 An expandable component 30 is shown having a pair of flow regions 32 formed in the body 34. Figure 11 Similarly, another embodiment of an expandable member 40 having a single flow region 42 formed in the body 44 is shown. While the bodies 34, 44 may have a generally constant porosity that impedes fluid flow and generally promotes thrombus formation, the flow regions 32, 43 can be configured to allow fluid flow through the flow regions. For example, the flow regions 32, 42 of the expandable members 30, 40 may provide a path for blood flow or allow the performance of auxiliary procedures (such as the introduction of embolization, anti-inflammatory agents, antibiotics, or thrombolytic agents) and / or allow the deployment of an embolic coil within the expandable members 30, 40. Any of these members 30, 40 may allow blood to flow through regions of the expandable member with high porosity to collateral branch vessels while still providing stasis in the aneurysm.

[0293] According to some embodiments, flow regions 32, 42 may include passages, channels, or elongated voids within the bodies 34, 44. Furthermore, in embodiments where flow regions 32, 42 comprise material, the material of flow regions 32, 42 may have a significantly higher porosity than the surrounding regions within the bodies 34, 44. Although Figure 10-11 The illustration shows only a single or dual flow region, but some embodiments may be configured to include three, four or more flow regions formed therein.

[0294] In some embodiments, the flow region may be partially or completely separated from other parts of the body by a barrier. For example, the flow region may include an inner cavity formed through the body, and the inner cavity may include an inner wall (not shown) extending therethrough. The inner wall may include a continuous surface. However, the inner wall may also include one or more perforations extending through the wall, through which the inner cavity of the flow region is in fluid communication with a surrounding area of ​​the body. Thus, the flow region can provide isolated flow through the body or flow in communication with other areas of the body of the expandable component.

[0295] Figure 12A-12R Various examples of shapes that can be used according to some embodiments are shown. Variations (whether proportional allocation, combination, or other modifications) can be made in accordance with the teachings herein. Without limitation, Figure 12A-12R The shapes shown may include a sphere 120, a hemisphere 121, a cube 122, a pyramid 123, an octahedron 124, an octagonal prism 125, a pentagonal prism 126, a coil 127, an elongated sphere 128, an oblate spheroid 129, a clover-shaped disk 130, a star-shaped disk 131, a paraboloid of revolution 132, a hollow sphere 133, a bowl 134, a torus 135, a cylinder 136, a cone 137, or combinations thereof.

[0296] In particular, in some embodiments, an intracapsular device may be provided comprising a first expandable component and a second expandable component, at least one of which has a shape selected from the group consisting of: cylinder, hemisphere, polyhedron, elongated sphere, oblate spheroid, disc, bowl, hollow structure, cloverleaf shape, non-spherical surface of revolution, and combinations thereof. Additional expandable components having a generally spherical shape may be provided.

[0297] According to some embodiments, the intracapsular device may include a first expandable component and a second expandable component with different shapes. Furthermore, the first and second expandable components may have different dimensions. A third expandable component may be used, which may have the same or different dimensions or shapes compared to one or both of the first and second expandable components. Therefore, the first, second, and third expandable components can all have different dimensions and / or shapes compared to each other. This principle can be applied to additional components, such as fourth, fifth, sixth components, etc.

[0298] Furthermore, the aforementioned shape can be solid or at least partially hollow (e.g., having cavities or voids therein). The hollow expandable component can include a braided structure (e.g., a braided ball), a foam structure, etc. The hollow expandable component can be released into the aneurysm alone or in combination with other occlusive materials (such as a fluid embolization, an additional expandable component, or a coil).

[0299] For example, Figure 13-15 The hollow structure that can be used according to an embodiment of the internal device is shown. Figure 13-15 Intraocular devices 150a, 150b, and 150c are shown. Each device 150a, 150b, and 150c may include a shape having hollow bodies 152a, 152b, and 152c, which in turn may define cavities 154a, 154b, and 154c. The hollow bodies 152a, 152b, and 152c are advantageous, at least because they allow the intraocular devices 150a, 150b, and 150c to have a more compact compressible state than their non-hollow counterparts (which have the same dimensions when inflated). Furthermore, since the bodies 152a, 152b, and 152c are hollow, the intraocular devices 150a, 150b, and 150c can provide a larger packing volume within the aneurysm while using less material. Furthermore, since the intracapsular devices 150a, 150b, and 150c can be compressed to a considerably smaller size in their compressed state, they can be delivered through smaller microcatheters.

[0300] Additionally, in some embodiments, the intra-sac devices 150a, 150b, 150c may be configured to include openings 156a, 156b, 156c communicating with lumens 154a, 154b, 154c to allow the introduction, for example, at least one additional inflatable, fluid-emergent, or embolic coil, for further tamponade and / or support of the aneurysm. Instead of openings 156a, 156b, 156c, clinicians may perforate the intra-sac devices 150a, 150b, 150c before or during the surgical procedure. During such a procedure or surgical operation, the intra-sac devices 150a, 150b, 150c can be used as an intra-sac frame device.

[0301] For example, the intrasac devices 150a, 150b, and 150c can expand within the aneurysm, allowing them to extend across the neck of the aneurysm, with openings 156a, 156b, and 156c accessible through the neck (see, for example). Figure 40 and 44 According to some embodiments, although the intrasac device extends across the neck, it may not contact or may come into contact with the neck of the aneurysm. Furthermore, in embodiments including an open end, the intrasac devices 150a, 150b, 150c may be oriented such that the open end faces the base of the aneurysm and the closed end (including openings 156a, 156b, 156c) extends across the neck of the aneurysm.

[0302] Optionally, openings 156a, 156b, and 156c may allow the introduction of a second, smaller expandable component with a hollow interior. A third expandable component, smaller than the second expandable component, can then be introduced into the hollow interior of the second expandable component. Additional smaller foam structures can be added in a similar manner. Figure 13 , 14 Figures 1 and 15 show spherical, ellipsoidal, and prismatic foam structures 402, respectively.

[0303] In an alternative embodiment, the intracapsule devices 150a, 150b, 150c can receive any of the aforementioned solid foam structures of the previous embodiments until the cavities 154a, 154b, 154c are filled to the desired capacity.

[0304] Figure 16-18 Interlocking structures of intracapsular devices according to some embodiments are shown. For example, Figures 16-17 show composite intracapsular devices 160a and 160b having first and second portions or components 162a, 162b, 164a, 164b. The first and second portions 162a, 162b, 164a, 164b may include corresponding engagement structures 166a, 166b, 168a, 168b.

[0305] When the first and second parts 162a, 162b, 164a, and 164b are in their expanded state, Figure 16-17 The intra-sac devices 160a and 160b shown can be configured such that the corresponding engagement structures 166a, 166b, 168a, and 168b provide a loose fit with each other. However, according to some embodiments, the protrusions of the corresponding engagement structures 166a, 166b, 168a, and 168b can be excessively large relative to the recesses of the corresponding engagement structures 166a, 166b, 168a, and 168b, causing the protrusions to expand to create an interference fit within the recesses, thereby fixing the first portions 162a and 162b relative to the second portions 164a and 164b in the expanded state. In such embodiments, when the first and second portions 162a, 162b, 164a, and 164b expand within the aneurysm, the protrusions and recesses can be guided toward each other. Besides the engagement structures shown, other engagement structures, such as balls and sockets, grooves, pins, etc., can be provided.

[0306] Furthermore, in embodiments with only two interconnecting portions, such interconnecting portions can be configured to restrict at least two degrees of freedom of movement of the opposing portions. Movement can be restricted in two or more of the following directions: vertical translation, forward / backward translation, horizontal translation, lateral pivoting or rolling, left / right rotation or yaw, and forward / backward tilt or pitch. Additionally, in some embodiments (such as...) Figure 16-17In the embodiments shown, at least three degrees of freedom of motion of a portion can be restricted. For example, the interconnection between portions in such embodiments can restrict four, five, or all six degrees of freedom of motion of a specified portion.

[0307] Figure 18 An intracapsular device 180 is shown having a plurality of interconnecting portions 182, 184, 186. These interconnecting portions 182, 184, 186 can be configured to abut against each other in a complementary configuration, thereby providing a composite structure. In some embodiments, the interconnecting portions 182, 184, 186 can be configured to restrict at least two, three, four, five, or six degrees of freedom of movement of another component.

[0308] With expandable components (such as) Figure 16-18 The embodiments shown can be delivered to an aneurysm and arranged in situ such that the connecting structures are properly aligned and interconnected to allow the expandable components to mate. In some embodiments, the mating of the expandable components can interlock the components into a composite structure or unit, with... Figure 16 Same as in China.

[0309] As described above, according to some embodiments, at least a portion of the intracapsular device may include a coating or material for enhancing the therapeutic, inflationary, or imaging properties or characteristics of at least one or each inflatable component of the intracapsular device.

[0310] The intracapsular device can be configured such that its expandable components are coated with biocompatible materials to promote endothelialization or provide therapeutic effects.

[0311] For example, Figure 19 An alternative embodiment of this disclosure is shown. According to this embodiment, the intracapsular device 190 includes an expandable component 192, which may be coated and / or embedded with at least one coating 194, such as a bioactive material or reagent.

[0312] Coating 194 may include thrombotic coatings (such as fibrin, fibrinogen, etc.), antithrombotic coatings (such as heparin (and its derivatives), urokinase, or t-PA), and endothelial promoting coatings or promoters (such as VEGF and RGD peptides) and / or combinations thereof. Drug-eluting coatings and drug-eluting foam complexes (such as anti-inflammatory or antibiotic coatings) are also foreseeable. These drug-eluting components may include nutrients, antibiotics, anti-inflammatory agents, antiplatelet agents, anesthetics (such as lidocaine), and antiproliferative agents (e.g., paclitaxel derivatives). Hydrophilic, hygroscopic, and hydrophobic materials / reagents are also foreseeable.

[0313] As also described above, in some embodiments, the expandable component may also include an expansion-limiting coating that slows the expansion of the component from its natural rate of expansion to a slower rate of expansion, such that during expansion, the position of the component can be adjusted within the aneurysm or, if necessary, the component can be removed from the aneurysm. Examples of polymers that can be used as expansion-limiting coatings include hydrophobic polymers, organic nonpolar polymers, PTFE, polyethylene, polyphenylene sulfide, oils, and other similar materials.

[0314] In embodiments, only specific segments of the intracapsular device may be embedded or coated with a reagent to provide desired properties to one or more expandable components. For example, such as Figure 20 As shown, the intracapsular device 200 may include a non-thrombotic coating 202, which may be applied to the lower half 204 of the expandable member 206 to minimize clotting at that location. Such a coating may be desirable in aneurysms located at bifurcation sites, allowing blood flow to the branch artery to pass through a segment with a foam structure having a non-thrombotic coating. The coated area 202 may have a different color than the remainder of the expandable member 206 to aid surgeon identification of the area.

[0315] Optionally, the coating region 202 may also include a radiopaque material to aid surgeons in visualizing the expandable component 206 and positioning it in the desired orientation relative to the aneurysm. The expandable component 206 can have radiopaque properties by incorporating a radiopaque filler (such as bismuth) into the material (which in some embodiments includes foam material) or attaching radiopaque markings. Optionally, radiopaque material can be attached to the expandable component 206, for example, by impregnation, spraying, or otherwise mechanical, chemical, or thermal attachment, injection, or mixing.

[0316] Figure 21 Show Figures 19-20 Another embodiment of the intracapsular device shown. Figure 21 The image shows an intracapsular device 220 including a star-shaped expandable component 222, which may be partially or completely coated and / or embedded with a material 224, such as any of the aforementioned reagents. The star shape provides increased surface area due to the presence of a wave 226 on the outer surface of the expandable component 222.

[0317] Once the expandable component is delivered to the aneurysm, it can expand back to its full size or expanded state, confined within the neck of the aneurysm, with minimal protrusion within the mother vessel. The foam can be self-expanding, chemically expandable, thermally expandable, or pH-responsive or light-expandable. Shape memory foams, such as polyurethane foam, can be used.

[0318] Various delivery systems and processes are available for delivering intrasac devices comprising one or more expandable components, as described herein. Furthermore, systems and methods are provided for delivering intrasac devices to aneurysms and / or recapture devices for removal or repositioning.

[0319] For example, according to some embodiments, Figure 22-25 A delivery system and delivery process for implanting an intracapsular device are illustrated. In the illustrated embodiment, the delivery catheter 300 is advanced within a blood vessel 302 until the distal end 304 of the delivery catheter 300 is positioned adjacent to a target site (such as an aneurysm 306).

[0320] The carrier assembly 320 can be configured to engage the intra-sac device 330 and deliver the intra-sac device 330 into the aneurysm 306. The carrier assembly 320 may include a core component 322 and an engagement component 324. The core component 322 may be interconnected with the engagement component 324. The engagement component 324 may include components having a closed position (see [link to documentation]). Figure 22 ) and opening location (see Figure 23 At least two arm components 340. In the closed position, the arm components 340 can engage at least a portion of the intracapsular device 330 to facilitate distal advancement and retention of the intracapsular device 330 within the lumen of the catheter 300.

[0321] The carrier assembly 320, disposed within the lumen of the delivery catheter 300, can be advanced distally through the catheter 300 until it reaches the distal end 304 of the catheter 300. Upon reaching the distal end 304, the carrier assembly 320 can be actuated to release the intra-balloon device 330 into the aneurysm 306, such as... Figure 23 As shown in the image.

[0322] The arm component 340 may be spring-loaded or configured to spring open from a closed position when pushed out or distally beyond the distal end 304 of the catheter 300. However, the arm component 340 may also be manually actuated using a proximal control mechanism, thereby allowing the arm component 340 to continue engaging the intracannular device 330, even after the arm component 340 has moved outside the lumen of the catheter 300. For example, such a proximal control mechanism may include a proximal extension coupled to a first arm component 340, the proximal retraction of which causes the first arm component 342 to retract into the catheter 300, thus releasing the intracannular device 330. Various other control mechanisms (such as those disclosed herein) may also be implemented according to some embodiments.

[0323] After the intrasac device 330 has been deployed into the aneurysm 306, the intrasac device 330 can begin to inflate. Clinicians can carefully monitor the orientation of the intrasac device 330 relative to the neck of the aneurysm 306 or the surrounding vascular system.

[0324] According to some embodiments, if the intracystic device 330 has specific characteristics (such as porosity distribution, coating, shape, etc.) intended for placement at a certain location within the aneurysm 306, then when the intracystic device 330 inflates, a clinician can position the intracystic device 330 by manually rotating, moving, holding, or otherwise adjusting its position within the aneurysm 306. Figure 24-25 The process is illustrated in the diagram. Therefore, by gently manipulating at least one of the arm components 340, the clinician can access the intrasac device 330 to ensure the correct orientation of the intrasac device 330 within the aneurysm 306. Although in Figure 22-25 The operation of the expandable device is shown against the background of carrier assembly 320, but various other deployment or delivery devices (such as...) can be used. Figure 31A-37 or Figures 61-63 The locations of those (shown) operating the expandable devices.

[0325] During such a process, the intra-sac device 330 may be advantageously coated with an expansion-limiting coating (such as those described above). In such embodiments, the expansion-limiting coating may allow the intra-sac device 332 to expand slowly, thus providing clinicians with a greater, and in some cases specified or anticipated, period of time to adjust the position of the intra-sac device 330 within the aneurysm 306 after the intra-sac device 330 is released.

[0326] Figure 26 The placement of an intrasac device 370 within an aneurysm 306 is illustrated. The intrasac device 370 may include a radiopaque material 372. The radiopaque material 372 may be located at a specific end of the intrasac device 370 (in this case, on a first portion 374 of the intrasac device 370 having a lower porosity than its second portion 376). Figure 26 In the illustration, the intracapsular device 370 is in an intermediate inflated state (i.e., it is not yet fully inflated), and as the device 370 inflates, the clinician can adjust its position based on the visualization of the radiopaque material 372. The clinician can visualize the orientation of different segments or portions of the intracapsular device relative to the neck of the aneurysm or the surrounding vascular system, and here, the first portion 374, aligned with the radiopaque material 372 and the neck 380 of the aneurysm 306 (or, in some embodiments, the base of the aneurysm 306) to maintain low porosity, is adjacent to or extends across the neck 380 of the aneurysm of the intracapsular device 370.

[0327] Figure 27-30 Different aneurysm configurations and surrounding vascular systems are shown to allow for optimal treatment by obtaining a specific orientation of the intrasacral device within the aneurysm.

[0328] For example, Figure 27The intracapsular device 390 is shown oriented such that its low-porosity segment 392 is positioned or extends across the neck 380 of the aneurysm 306, while the higher-porosity segment 396 is positioned in the base of the aneurysm 306. Figure 27 Also provided above about Figure 22-25 A diagram illustrating the final result of the process. Therefore, after continued expansion, Figure 22-25 The intracapsular device 330 shown can be obtained Figure 27 The position or expansion state shown.

[0329] Figure 28 Artery 500 is shown, having an aneurysm 502 and a neck 506 adjacent to the aneurysm 502 extending through a perforating vascular 504 of the aneurysm 502. In this case, an intrasac device 520 can be positioned within the aneurysm 502 such that a high-porosity segment 522 extends across the neck 506 of the aneurysm 502 to allow blood flow into the perforating vascular 504, as indicated by arrow 530.

[0330] Figure 29 Artery 550 is shown, having an aneurysm 552 and a perforating vascular bundle 554 extending from the base of the aneurysm 552. In this configuration, an intrasac device 560 may be positioned within the aneurysm 552 such that a first, high-porosity segment or channel 562 of the intrasac device 560 provides a fluid pathway for blood to flow through the neck 564 of the aneurysm 552 toward and into the perforating vascular bundle 554, as indicated by arrow 570. Additionally, the intrasac device 560 may be configured to include one or more low-porosity segments 572, 574 that may tend to induce thrombosis and protect the aneurysm wall.

[0331] Figure 30 The intracapsular device 590 is shown oriented such that its low-porosity segment 592 is positioned or extends across the neck 594 of the aneurysm 596 located at the bifurcation of the blood vessel. As shown, the high-porosity segment 598 can be positioned within the base of the aneurysm 596. Therefore, flow through the bifurcation (as indicated by arrow 600) can be diverted using the low-porosity segment 592, thereby reducing pressure on the aneurysm 596.

[0332] Now for reference Figure 31A-34 Provides engagement mechanisms for delivery and recapture systems, such as Figure 22 As shown in the diagram. These engagement mechanisms can provide secure engagement and release of one or more expandable components. Furthermore, the system can recapture the device for removal or repositioning.

[0333] As mentioned above Figure 22 The joining mechanism described above, Figure 31A-34The engagement mechanism shown can move between closed and open positions to engage with the intrasac device and deliver the intrasac device into the aneurysm.

[0334] Figures 31A-31B Systems and methods for delivering an intra-balloon device to an aneurysm and / or a recapture device for removal or repositioning are illustrated. In one embodiment, the delivery system may include a guide catheter or sheath 630. A delivery / retrieval component 680 may be disposed within the lumen of the catheter 630. The delivery / retrieval component 680 may include an elongated element 682 having a plurality of clamping elements 684 at one end. The delivery / retrieval component 680 may be sized to traverse the longitudinal lumen of the guide sheath 630. The clamping elements 684 may be adapted to open and close around the intra-balloon device 650. In some embodiments, the clamping elements 684 may be generally biased to the open position.

[0335] In some embodiments, the transport / retrieval component 680 may include an alligator retrieval device, generally shown in Figures 31A-31B, manufactured by Covidien LP. The alligator retrieval device may include a flexible line having multiple clamping arms or elements (e.g., four arms) at its distal end. Other embodiments of the clamping element 58 include cloverleaf designs, fishhook designs, or soluble couplings, as correspondingly shown in Figures 31A-34.

[0336] In use, the access catheter is advanced within the neurovascular system, which is conventional in the art. Suitable microcatheters adapted for navigating through tortuous neurovascular spaces to approach the treatment site are disclosed in commonly assigned U.S. Patent No. 7,507,229, the entire contents of which are incorporated herein by reference.

[0337] The clamping element 684 of the delivery / retrieval component 680 is positioned around the in-bag device 650 (FIG. 31A), and the delivery / retrieval component 680 retracts into the guide sheath 630 such that the clamping element 684 moves inward during engagement with the inner wall surface of the guide sheath 630 to compress the foam structure of the in-bag device 650, such as... Figure 31B As shown in the diagram. The intra-sac device 650 is retracted into the guide sheath 630. The guide sheath 630, having the delivery / retrieval component 682 and the intra-sac device 650 positioned therein, is advanced through an access catheter approaching the aneurysm. The access catheter can be removed if necessary, or it can remain in place. Thereafter, the guide sheath 630 is oriented relative to the aneurysm in the desired orientation. Any of the engagement devices shown herein can be used for the delivery and retrieval of the inflatable component.

[0338] The delivery / retrieval component 682 is advanced through the guide sheath 630, whereby, upon exiting the distal end of the guide sheath 630, the clamping element 684 of the delivery / retrieval component 682 opens to release the intra-sac device 650. In the event that the intra-sac device 650 is improperly positioned within the aneurysm or displaced, the clamping element 684, in its open configuration and extending beyond the guide sheath 630, is positioned to surround the intra-sac device 650 within the vascular system. The delivery / retrieval component 682 is retracted into the guide sheath 630, whereby the clamping element 684 compresses the foam material of the intra-sac device 650 to allow the device 650 to be received within the lumen of the guide sheath 630. Subsequently, by deploying the delivery / retrieval component 682 in the manner described herein, the intra-sac device 650 can be removed from the neurovascular system or repositioned within the aneurysm.

[0339] Figures 32A-32B Similarly, a coupling mechanism 620 in the form of a "cloverleaf" pattern is shown. The coupling mechanism 620 can be disposed within the conduit 630 and advanced distally until it exits the lumen of the conduit 630 at a distal end 632. Upon exiting, the loop 640 of the coupling mechanism 620 can be released from the coupling pouch device 650. Figure 31B As shown, upon release, the intracapsular device 650 may not tend to snag or attach to the loop 640. Therefore, the engagement mechanism 620 can provide quick and reliable disengagement from the intracapsular device 650.

[0340] Figures 33A-33B Another embodiment of the engagement mechanism 670, featuring a "fishhook" design, is shown. Similar to engagement mechanisms 324 and 620, this engagement mechanism is movable between closed and open positions when disengaged from the distal end 632 of the catheter 630. The engagement mechanism 670 may include a plurality of hooks 672 configured to puncture or otherwise at least partially penetrate the intrasac device 650. Upon release, the hooks 672 can detach from the intrasac device 650 to release the intrasac device 650 into the aneurysm.

[0341] Figure 34An embodiment of the system is shown, wherein the delivery member 690 is attached to the intraaneural device 650 using a soluble coupling 692. The soluble coupling 692 may extend between the intraaneural device 650 and an opening or engagement member of the delivery member 690. According to some embodiments, the engagement member of the delivery member 690 may be engaged with the soluble coupling 692 using a hook, loop, or other elongated member (such as those disclosed above in other delivery systems). The soluble coupling 692 may be actuated by chemical corrosion (e.g., electrolysis), thermal corrosion, pH changes, light changes, etc. Furthermore, the releasable connection 692 may be implemented by an electrical, hydraulic, or pneumatic connection, wherein release of the intraaneural device 650 is achieved by activation of any of these systems. For example, once the intraaneural device 650 is positioned within the aneurysm, any of the aforementioned devices may be actuated to release the intraaneural device 650 from the delivery member 690.

[0342] Figure 35 A microcatheter delivery system for implanting an intra-balloon device 720 into an aneurysm is shown. The delivery system 730 may include a delivery catheter 732 and a push element 734 disposed within the delivery catheter 732. The intra-balloon device 720 can be compressed and positioned within the lumen of the delivery catheter 732 in its normal configuration and predetermined geometry.

[0343] The delivery catheter 732 can be introduced into the neurovascular system and advanced to the treatment site. Once properly oriented relative to the aneurysm, the actuating element 734 is actuated, for example, by advancing a handle or actuator operably connected to the proximal end of the actuating element 734, causing the distal or remote end of the actuating element 734 to expel the intrasac device 720. The intrasac device 720 can inflate to fill the aneurysm.

[0344] Additionally, according to some embodiments, the actuating element 734 may include a radiopaque material or component 736 disposed on the contact portion 738 of the actuating element 734. As the actuating element 734 is advanced within the lumen of the catheter 732, the radiopaque material 736 allows the clinician to visualize the position of the intracapsular device 720 to ensure that the actuating element 734 is properly positioned within the lumen of the catheter 732.

[0345] Figure 36An alternative embodiment of the delivery system is shown. According to this embodiment, system 760 includes a guide sheath 762 and a delivery member 764 disposed within the guide sheath 762. The delivery member 764 may be a push rod that can be advanced within the guide sheath 762. The intracystic device of this disclosure includes a plurality of intracystic pellets 770a, 770b disposed within the guide sheath 762 for sequential discharge via the delivery member 764. For example, the plurality of pellets may include a frame shape that has been compressed and folded into a frame pellet 770a. Pellet 770a will be the last pellet to enter the aneurysm (after pellet 770b). Therefore, the frame pellet 770a may tend to inflate to extend across the neck of the aneurysm (but does not necessarily need to contact the opening of the aneurysm).

[0346] These intrasac devices or spheres 770a, 770b may be smaller in size than the aforementioned intrasac devices to allow for multiple and strategic deployments within the aneurysm. Any embodiment of the aforementioned intrasac devices may be contained within spheres 770a, 770B. Furthermore, the delivery member 764 may comprise one or more radiopaque materials or components 772 to facilitate visualization of the location of the delivery member 764 within the sheath 762.

[0347] Figure 37 Another delivery system 790 according to some embodiments is shown. Delivery system 790 may include an over-the-wire system having a guide member 792 including a guide wire lumen 794. Guide member 792 may also include a delivery lumen 796 in which a pusher 798 may be disposed for axial movement to deliver an intra-balloon device comprising a plurality of inflatable components 800. Such embodiments allow system 790 to define a minimum cross-sectional profile, thereby allowing system 790 to extend into and through each narrow vessel to treat aneurysms in smaller vessels.

[0348] Figure 38-42 Various implementations of some of the embodiments disclosed herein are illustrated. For example, Figure 38 An intrasac component 820 implanted in an aneurysm 830 is shown. As shown, the intrasac component 820 comprises a generally octahedral shape. This shape facilitates the secure anchoring of the intrasac component 820 within the aneurysm 830, assuming an expanded waist and tapered end, which allows the intrasac component 820 to fit well within a berry-shaped or sac-like aneurysm. Additionally, the intrasac component 820 also includes a radiopaque material or marking 822 for placing and positioning the intrasac component 820 within the aneurysm 830.

[0349] Figure 39An intrasac device 840 positioned within an aneurysm 830 is shown. The intrasac device 840 includes a first expandable member and second expandable members 842, 844. The first expandable member 842 has a generally conical or paraboloidal shape. The second expandable member 844 has a generally hemispherical shape. The first expandable member and the second expandable members 842, 844 may include corresponding first and second mating surfaces 852, 854.

[0350] Upon initial insertion into the aneurysm, both the first expandable component and the second expandable components 842, 844 readily mate within the aneurysm 830 before expansion. During expansion, neither the first expandable component nor the second expandable components 842, 844 completely fills the aneurysm 830. Therefore, if either the first or second expandable component 842, 844 is positioned independently within the aneurysm 830, significant movement and potential protrusion of the corresponding component can occur within the aneurysm 830. However, when the first expandable component and the second expandable components 842, 844 expand within the aneurysm 830, the first and second mating surfaces 852, 854 can cause the first expandable component and the second expandable component 842, 844 to become aligned within the aneurysm 830. Figure 39 As shown, such alignment can tend to prevent misalignment of the first or second inflatable components 842, 844, thus securing the intrasac device 840 within the aneurysm 830.

[0351] According to some embodiments, the first and second mating surfaces 852, 854 within the capsule can be substantially flat. However, as Figure 40 As shown, some embodiments can be configured such that the intrasac device 860 positioned within the aneurysm 830, including first and second mating surfaces 870, 872 of the first expandable member and the second expandable members 880, 882, can include an engagement mechanism 884. The engagement mechanism 884 can include engagement structures such as recesses and corresponding protrusions, as shown. The engagement mechanism 884 can include one of various structures, such as one or more recesses and one or more corresponding protrusions, including hemispherical, cylindrical, conical, or other geometrically mating recesses and protrusions. Therefore, the engagement mechanism 84 can tend to prevent slippage between the first and second mating surfaces 870, 872, thus tending to result in the first expandable member and the second expandable members 880, 882 functioning as a composite unit.

[0352] As mentioned above Figure 13-15Some embodiments of the intracapsular device may include a hollow component that can be implanted into an aneurysm. While multiple hollow components can be implanted into an aneurysm as a system, a single hollow component can also be fixed in place and subsequently filled with one or more expandable components. Thus, the hollow component can serve as a support or frame structure with a closed lumen configured to receive additional components therein.

[0353] For example, Figure 41 An intracapsular device 900 is shown in the form of a hollow expandable component 902 implanted in an aneurysm 904 along with a plurality of expandable components 906. As shown, the hollow component 902 may be in the form of a hollow hemispherical shell, which can serve as a support or frame structure for the aneurysm and additional expandable components placed therein. The hollow component 902 may have an outer surface 908 that contacts the inner wall 912 of the aneurysm 904. As shown, the contact between the outer surface 908 and the aneurysm wall 912 may be along a portion of the aneurysm wall 912 having a cross-sectional profile larger than the size of the opening or through the profile of the neck 920 of the aneurysm 904. Furthermore, the contact between the outer surface 908 and the aneurysm wall 912 may be at least along the lower half of the aneurysm 904.

[0354] In some embodiments, the outer surface 908 of the hollow component 902 may contact a first segment of the aneurysm wall 912 adjacent to the aneurysm neck 920 and a second segment of the aneurysm wall 912 adjacent to the aneurysm dome 918 opposite to the aneurysm neck 920. For example, the aneurysm 904 or the aneurysm wall 912 may be considered according to quadrants, and the outer surface 908 may contact at least three quadrants of the aneurysm wall 912. In some embodiments, the outer surface 908 may contact at least a portion of each quadrant of the aneurysm wall 912. Contact of the outer surface 908 with the aneurysm wall 912 may tend to secure the hollow component 902 within the aneurysm 904 to prevent any portion of the hollow component 902 from shifting or protruding from the aneurysm 904.

[0355] Still referencing Figure 41 The expandable component 906 can be inserted into or injected into the cavity of the hollow component 902 through an opening 910 formed in the sidewall of the hollow component 902. The opening 910 can be sized such that the expandable component 906 can be inserted through the opening 910 in its compressed state, but when expanded, the expandable component 906 will not be able to exit through the opening 910. Also as shown, the expandable component 906 can self-position during expansion into an irregular shape that can fill the dome 918 of the aneurysm 904. In addition, the intracapsular device 900 can provide a lower porosity near the neck 920 of the aneurysm 904, while having a higher porosity adjacent to the dome 918.

[0356] According to some embodiments, the support or frame component may include a stent extending along the lumen adjacent to the aneurysm. The aneurysm may be saccular or berry-shaped, wide-necked or fusiform. For example, the stent may be used with various intrasac devices described above (such as... Figure 22-30 It can be used in combination with any of the ones shown in 38-41 (which are shown for treating saccular aneurysms). In some embodiments, the frame component can advantageously secure the intrasac device within the wide-necked aneurysm by facilitating engagement with a sufficient amount of aneurysm wall to prevent the device from shifting from the aneurysm or protruding into the parent vessel.

[0357] Figure 42 The implementation of the intra-sac device 940 in a method for treating a fusiform aneurysm 950 is illustrated. As shown, the intra-sac device 940 may include a stent 952 extending across the aneurysm 950. The stent 952 may be deployed at the target location using a catheter and any of a variety of deployment methods, such as balloon inflation or self-inflation.

[0358] When it expands to contact the inner wall of the lumen 954, the stent 952 can isolate, separate, or partition the lumen 956 of the fusiform aneurysm 950 from the central portion of the lumen 954.

[0359] When the stent 952 is in place, at least one expandable component 960 can be released into the lumen 956 between the inner wall of the aneurysm 950 and the outer surface 962 of the stent 952. (One or more) expandable components 960 can be inserted into the lumen 956 through an opening in the wall of the stent 952 (or through the gaps in the braid if the stent 952 is braided).

[0360] When used herein, one or more expandable components 960 may have one or more properties that improve the effectiveness of the intrasac device 940. Furthermore, the properties of the expandable components 960 may be selected based on the shape or construction of the aneurysm 950, as described above. Figure 42 As shown, the expandable component may have a specific shape to fill the cavity 956 (e.g., a segmented ball having a cavity cavity extending through the segment, thus providing a flatter cylindrical surface that can abut against the outer surface of the support 952). However, any of a variety of other shapes may also be selected and inserted into the cavity 956.

[0361] According to some embodiments, after the intrasac device has been implanted into the aneurysm, materials (such as liquid embolization (as described above), drugs, radiopaque materials, contrast agents, or other reagents) can be injected or inserted into the aneurysm. Injection or insertion can occur before, during, or after the expansion of the intrasac device within the aneurysm. Thus, materials can be absorbed into at least a portion of the intrasac device or fill any remaining voids within the aneurysm surrounding the intrasac device. Injection of liquid embolization can advantageously increase the overall packing density of the device. Figure 43 and 44 An embodiment is shown in which a combination of a liquid embolism and an intrasac device is inserted into an aneurysm.

[0362] For example, Figure 43 The illustration shows material 980 (e.g., a liquid embolism, a drug, a radiopaque material, a contrast agent, or other reagent) being inserted into an aneurysm 982 along with an intracapsular device 984. The intracapsular device 984 may have a high porosity, which allows material 980 to penetrate the intracapsular device 984.

[0363] Figure 44 The illustration shows material 990 injected into aneurysm 992. As shown, material 990 can flow to aneurysm 982 and enter the gaps formed between the expandable components of the intrasac device 994. In such an embodiment, the components of the intrasac device 994 can have a low porosity so that material 998 does not tend to... Figure 43 The components of the intracapsular device 994 penetrate as many times as those in the embodiment shown.

[0364] Therefore, various materials can be injected or inserted into the aneurysm to assist or supplement the treatment provided by the intracapsular device.

[0365] Figures 45-52 Additional embodiments of an intracavitary device are shown that uses a support or frame component or structure in combination with a secondary expandable component.

[0366] Figures 45-46 An embodiment is shown in which an intracapsular device 1100a is used to treat an aneurysm 1000. The intracapsular device includes a frame structure 1102a having a closed end 1104 and an open end 1106. In some embodiments, the frame structure 1102a may be formed of a woven material.

[0367] In one embodiment, the closed end 1104 of the frame structure is sealed via a clip 1108, adhesive, or may be thermally welded using known techniques. The closed end 1104 may be flipped relative to the remaining frame structure 1102a and suspended inwardly within it. The open end 1106 of the frame structure 1102a may be diametrically opposed to the closed end 1104. Individual filamentary ends 1110 of the frame structure at the open end 1106 may also be flipped and arranged inside the frame structure 1102a.

[0368] Figure 45 The introduction of a coil through the open end 1106 of the frame structure 1102a is depicted. Suitable braiding materials, structures, and methods for manufacturing the frame structure 1102a are disclosed in the following patents: U.S. Patent No. 6,168,622, jointly assigned to Mazzocchi; U.S. Patent No. 8,142,456, published March 27, 2012; U.S. Patent Application Publication No. 2011 / 0319926, filed November 11, 2010; and U.S. Patent Application Publication No. 2012 / 0330341, filed June 22, 2011, the entire contents of each of which are incorporated herein by reference. Braiding materials may include stainless steel, cobalt-chromium-nickel-titanium alloys, etc.

[0369] like Figures 45-46 As shown in the embodiments, the frame structure 1102a can be deployed in the aneurysm 1000 and filled with coils 1120. However, as Figures 47-49 As shown, the intracavitary devices 1100b, 1100c, and 1100d may include frame structures 1102b, 1150, and 1160 that can be filled with at least one expandable component 1130, 1140 (e.g., a foam component). The configuration, selection, and use of the expandable components 1130 and 1140 have been discussed above and will not be repeated here for the sake of brevity. However, any embodiment disclosed herein can be used in conjunction with frame structure 1102a. Furthermore, in embodiments using expandable components (such as foam components), foam can advantageously provide a higher packing density compared to conventional coil packing and achieve this purpose in a single device.

[0370] The frame structure 1102a, combined with coils, expandable components, or other materials, can also provide the benefit of good neck coverage while preventing the embolization device from protruding into the maternal artery. Furthermore, the use of such a system can increase embolization volume efficiency and achieve stasis.

[0371] As shown in the figure, the frame structure 1102a can provide support or scaffolding for auxiliary capsule components or materials (including coils, expandable components, or other materials such as liquid emboli, drugs, radiopaque materials, contrast agents, or other reagents). The coil 1120 or expandable component 1130 may contain or be coated with a bioactive coating that promotes specific clinical theories (such as endothelialization, thrombosis, etc.).

[0372] Simply refer to Figures 50-52 These figures illustrate examples of frame structures that can be used as support or frame components according to some embodiments. Figure 50 In this device, the braiding apparatus 1200 may include a single-layer outer portion 1202, formed by flipping the tubular braid so that the inner portion 1204 of the braid extends through the central portion of the apparatus 1200. The ends of the inner and outer portions 1202, 1204 meet at a first end 1206. Although the filament ends of the inner and outer portions 1202, 1204 may remain free (as clusters) or unbound, the first end 1206 may include a connector or connecting device 1208 for binding the inner and outer portions 1202, 1204 together. In some embodiments, the connector or connecting device 1208 may be recessed within the apparatus 1200, but it is... Figure 50 It is highlighted in the middle.

[0373] Figure 51 Another embodiment of the frame structure is shown, wherein the braiding device 1230 includes at least one layer 1232 extending around the periphery of the device 1230. In some embodiments, a single layer may be used, but multiple braided layers are also feasible. The device 1230 may include first and second ends 1234, 1236, which may be flipped or recessed into the device 1232 forming a smooth outer surface of the device 1230. The first and second ends 134, 136 may be open or closed. As shown, the first and second ends 1234, 1236 may include connecting devices 1240, 1242 for closing the two ends 1234, 1236. However, one or both of the first and second ends 1234, 1236 may also be open, thereby allowing their filament ends to be free and unbound.

[0374] Figure 52 Another embodiment of the frame structure is shown, wherein the braiding device 1250 includes a double-layered housing 1252 having a generally closed end 1254 and a normally open end 1256. The open end 1256 can be flipped or recessed into the device 1250.

[0375] Refer again Figures 45-46And 48-49, after the framework structures 1102a, 1150, 1160 have been released and expanded to contact the inner wall of the aneurysm 1000, the catheter 1112 (as its distal end 1114) can be inserted between the filaments of the framework structures (see 48-49). Figure 48 ) or in the open ends of the frame structure (see Figure 45 and 49 The process of implanting coils, expandable components or other materials into frame structures 1102a, 1150, 1160 is performed.

[0376] In performing a method for placing a frame structure within an aneurysm and injecting coils, one or more expandable components, or other materials into the frame structure, the open end or widest gap of the frame structure may be positioned at the neck of the aneurysm to facilitate insertion of the distal end 1114 of catheter 1112 into the open end of the frame structure or between the filaments (i.e., the gap). In embodiments having a braided material for the frame structure, the braid pattern may be appropriately aligned to facilitate material entry into the frame structure. As in other embodiments disclosed herein, the frame structure may include radiopaque materials or components that facilitate visualization and allow clinicians to align the frame structure within the aneurysm as needed.

[0377] like Figures 46-47 As shown in Figure 49, after the coil, expandable component, or other material has been inserted into the interior of the braiding device through the open end of the braiding device, the open end may collapse onto itself or the inner surface of the frame structure as the coil, expandable component, or other material is positioned or expanded within the cavity of the frame structure. Figure 49 As shown, the distal end 1114 of the conduit 1112 can be retracted, thus allowing the open tube portion 1162 to close itself in response to the expansion force from one or more expansion members or materials. Furthermore, in some embodiments, such as Figure 52 As shown, the open end 1256 can define a generally tubular portion that can deflect to contact the inner wall of the frame structure when at least one expandable component is released into and expands within the cavity of the frame structure. Thus, the open end can tend to be self-sealing, thereby preventing protrusion of coils, expandable components, or other materials disposed within the frame structure.

[0378] The combined effects of coils, expandable components, and / or other materials within the insert frame structure can provide the advantages and benefits described above regarding various other expandable components. Consequently, clinicians can determine and control a wide range of intracapsular implant properties, including porosity, composition, materials, shape, size, interconnectivity, interlocking, coatings, etc.

[0379] According to some embodiments, a system or kit having a frame structure and at least one coil, expandable component and / or other materials can be provided.

[0380] Intracapsular implantation devices and procedures for treating aneurysms can be improved by interconnecting individual components of the intracapsular device. According to some embodiments, multiple expandable components can be interconnected along wires, filaments, or other disconnectable or fractureable materials. The expandable components can be arranged in a linear configuration (see...). Figure 53-57C ), planar matrix (see Figures 58A-59B They can be connected either as linear, planar, or three-dimensional matrices (see Figures 60A-60B). Such interconnected linear, planar, or three-dimensional matrix expandable components can be sized and configured according to desired porosity, size, shape, transmissivity, or other characteristics disclosed herein, which will not be repeated here for the sake of brevity.

[0381] In some embodiments, a method is provided by which interconnected expandable components can be released into an aneurysm. The interconnected components may be pre-configured prior to implantation (e.g., a selected number of components may be removed from a larger series or array of components) and subsequently inserted into a delivery catheter. Thereafter, the entire series or assembly of interconnected expandable components of the intra-sac device can be released into the aneurysm.

[0382] However, according to some embodiments, an entire series or array of components (which may exceed the available space in the aneurysm in their expanded state) can be loaded into the delivery catheter, and when implantation and observation of the packing behavior are performed, the clinician can determine that selected portions of the interconnected expandable components are sufficient for the designated aneurysm. Subsequently, selected portions of the interconnected expandable components can be broken off in situ or cut to release them into the aneurysm.

[0383] Now for reference Figure 53-57C The figures illustrate various embodiments of linearly interconnected expandable components. As shown in these figures, intracapsular devices 1300a, 1300b, 1300c, and 1300d may include strips 1302a, 1302b, 1302c, and 1302d of expandable components. Strips 1302a, 1302b, 1302c, and 1302d may include spaces separating adjacent expandable components or breaks to facilitate selective removal of the expandable components. Strips 1302a, 1302b, 1302c, and 1302d allow clinicians to remove the desired number of expandable components required for the surgical procedure before initiating the procedure or to remove the desired number of components in situ. Intracapsular devices with interconnected expandable components can be delivered with or without a support or frame structure.

[0384] Expandable components 1302a, 1302b, 1302c, 1302d can be interconnected along one or more ropes, filaments, carriers, indentations, reduced-size sections, or perforated lines (which may or may not include filaments or ropes) 1304a, 1304b, 1304c, 1304d. For example, Figure 53 An intracapsular device 1300a is shown, which has a plurality of indentations 1304a separating adjacent inflatable components (which may also include perforated lines or be replaced by perforated lines). Figure 54 An intracapsular device 1300b is shown, which has a plurality of inflatable components formed or molded along a filament or rope 1304b. Furthermore, Figures 55-56 It may include filaments or reduced-diameter expandable portions 1304c, 1304d that interconnect adjacent expandable components.

[0385] According to some embodiments, ropes, filaments, carriers, indentations, reduced-size sections, or perforated lines extending between adjacent expandable components can enhance the maneuverability of the intracapsular devices 1300a, 1300b, 1300c, and 1300d into the aneurysm.

[0386] In addition, such as Figures 57A-57C As shown, the inflatable components of the intracapsular devices 1300a, 1300b, 1300c, and 1300d may include one or more cross-sectional profiles, such as rectangle 1320 (see Figure 1300b). Figure 57A ), square 1330 (see Figure 57B ) or rounded shape (e.g., circle) 1340 (see Figure 57C Various other cross-sectional profiles can be provided, such as polygons with three, five, six, seven, or eight sides, clover shapes, etc. Additionally, according to some embodiments, a single intracapsular device may include inflatable components with different or identical cross-sectional shapes.

[0387] Furthermore, according to some embodiments, the continuously expandable components of the intra-sac devices 1300a, 1300b, 1300c, 1300d can be reduced in size, which can allow for the selection of subgroups of expandable components of the intra-sac devices 1300a, 1300b, 1300c, 1300d based on the size or shape of a specific target aneurysm.

[0388] Figure 58A-60B Additional embodiments of intracapsular devices that can have non-linear configurations are shown. For example, Figure 58AAn embodiment of an intracapsular device 1400, according to some embodiments, includes a layered or planar array of multiple interconnected expandable components 1402 in a compressed state. The expandable components 1402 may be interconnected by one or more cords, filaments, carriers, indentations, reduced-size segments, or perforated lines (which may or may not include filaments or cords) 1406. The expandable components 1402 may have the same or different shapes, sizes, or material properties from one another. For example, such as... Figures 58A-58B As shown, the intracapsular device 1400 may include a central inflatable member 1404, the central inflatable member having an expansion dimension much larger than that of the surrounding inflatable members 1402. Therefore, as... Figure 58B As shown, when released into the aneurysm, the intrasac device 1400 can expand to a configuration in which the central component 1404 is anchored in the aneurysm 1420 by the surrounding expandable components 1402.

[0389] Similar to Figures 58A-58B The embodiments shown can provide various embodiments in which peripheral or anchoring expandable components can be interconnected with other components in the matrix to enhance the fit or engagement of the intrasacral device within the aneurysm. Furthermore, such peripheral expandable components can have properties different from those of the central expandable component, such as having a coating or other properties that beneficially affect the effectiveness of the intrasacral device within the aneurysm.

[0390] Figures 59A-59B Embodiments of intracapsular devices 1450, 1460 are shown, comprising an array of layers, rings, or planar arrays of interconnected expandable components 1452, 1462 in a compressed state. The expandable components 1452, 1462 may be interconnected by one or more cords, filaments, carriers, indentations, reduced-size segments, or perforated lines (which may or may not include filaments or cords) 1454, 1464. For example, each of the expandable components 1452, 1462 may be connected to at least two other expandable components 1452, 1462.

[0391] Figures 60A-60B Embodiments of intracapsular devices 1480, 1490 are shown, comprising a three-dimensional or multiplanar array of interconnected expandable components 1482, 1492 in a compressed state. The expandable components 1482, 1492 may be interconnected by one or more cords, filaments, carriers, indentations, reduced-size segments, or perforated lines (which may or may not include filaments or cords) 1484, 1494. For example, each of the expandable components 1482, 1492 may be connected to at least two other expandable components 1482, 1492 to create a three-dimensional array. Similar to... Figures 58A-59BThe layered or planar array shown, or the three-dimensional array, may have expandable components, each with properties different from the other components, such as having a coating or other properties that beneficially affect the efficacy of the intrasacral device within the aneurysm.

[0392] The advantageous features of intracystic devices with strip configurations allow clinicians to quickly and easily assess the target aneurysm and specifically tailor the intracystic device for the surgical procedure. Customization of the intracystic device strips can be completed either before implantation or on-site. Furthermore, the interconnectivity of components tends to ensure that no components are lost.

[0393] Figures 61-63 A transport system and transport process for transporting interconnected expandable components are illustrated according to some embodiments. As described above, the configuration of the strips 1302a, 1302b, 1302c, and 1302d allows clinicians to remove the desired number of expandable components required for the surgical procedure.

[0394] Before initiating the implantation of the interconnected intrasac device strips, clinicians can determine the size and dimensions of the aneurysm 1500 using imaging equipment. Once the dimensions are determined, clinicians can determine the configuration of the intrasac device or interconnected expandable component strips 1502 to be implanted. Figure 61 As shown, the strip 1502 can be delivered using an implant delivery assembly 1504, which may include a catheter 1506 and a pusher 1508.

[0395] In some embodiments of the delivery process, after determining the configuration of the strip 1502, the clinician can prepare the strip 1502 by removing unnecessary expandable components from it before inserting it into the delivery assembly 1504. The strip 1502 is then introduced into the aneurysm according to any of the foregoing methods.

[0396] However, in some embodiments of the delivery process, the clinician may load the strip 1502 into the catheter 1506 before trimming any expandable components from the strip 1502. The clinician can then push the strip 1502 through the distal end 1510 of the catheter 1506, which causes the individual expandable components 1520 to begin expanding within the aneurysm 1500. While expansion is occurring, the clinician can determine whether additional expandable components 1520 should be deployed into the aneurysm 1500. If necessary, the pusher 1508 can be moved distally to push one or more additional expandable components 1520 out of the catheter 1506. Once a sufficient number of expandable components 1520 are determined to be inserted into the aneurysm 1500, the clinician can break or separate the strip 1502 by trimming or tearing along the fracture, indentation, or scribe line and separating the respective expandable components 1520.

[0397] The breaking or separation of adjacent expandable components can be performed by actuating the cutting device 1540. In some embodiments, the cutting device 1540 may include a second conduit 1542 nested within the conduit 1506. The second conduit 1542 may include a distal portion 1544 extending from one side of the second conduit 1542 and having an opening 1546. The distal portion 1544 may be circular and may guide the expandable component 1520 through the opening 1546. To trim the strip 1502, the second conduit 1542 may be retracted proximally relative to the conduit 1506, thus causing the opening 1546 to close against the distal end 1510 of the conduit 1506, thereby severing the ties or filaments extending between adjacent expandable components 1520.

[0398] Subsequently, the distal portion 1544 of the second catheter 1542 can be further retracted into the catheter 1506 and the delivery assembly 1504 can be removed from the target site.

[0399] Many of the features described herein can be used with any of the disclosed embodiments. For example, any embodiment may include spatially varying average porosity, any of the various disclosed shapes, any of the various disclosed materials or coatings, any of the disclosed 2-D or 3-D interconnect configurations, any of the disclosed interlocking configurations or structures, any of the disclosed delivery systems, etc.

[0400] The devices and methods described herein are not limited to the deployment and use of medical devices or stents within the vascular system, but can include a wide range of further therapeutic applications. Other treatment sites can include areas or parts of the body containing any hollow anatomical structures.

[0401] The foregoing description is provided to enable those skilled in the art to implement the various configurations described herein. Although the subject matter has been described with particular reference to the figures and configurations, it should be understood that these are for illustrative purposes only and should not be construed as limiting the scope of the subject matter.

[0402] There are many other ways to implement the techniques described herein. The various functions and elements described herein differ from those shown but are not departing from the scope of the techniques described herein. Various modifications to these configurations will be apparent to those skilled in the art, and the general principles defined herein can be applied to other configurations. Therefore, those skilled in the art can make many changes and modifications to the techniques described herein without departing from the scope of the techniques described herein.

[0403] It should be understood that the specific order or hierarchy of steps in the disclosed process is an illustrative example of an exemplary method. Based on design preferences, it should be understood that the specific order or hierarchy of steps in the process may be rearranged. Some steps may be performed simultaneously. The appended method claims employ elements of each step in the sampling order and are not intended to limit the scope to the specific order or hierarchy employed.

[0404] When used herein, the phrase “at least one of” preceding a list of items and separating any one of the items with the terms “and” or “or” modifies the list as a whole, not each component of the list (i.e., each item). The phrase “at least one of” does not require selection of at least one of each of the listed items; rather, the phrase allows for the meaning of including at least one of any of the items and / or at least one of any combination of the items and / or at least one of each of the items. As an example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” both mean only A, only B, or only C; any combination of A, B, and C; and / or at least one of each of A, B, and C.

[0405] Terms such as “top,” “bottom,” “front,” and “rear” used in this disclosure should be understood to refer to any frame of reference, rather than a typical gravitational frame of reference. Therefore, the top surface, bottom surface, front surface, and rear surface may extend upwards, downwards, diagonally, or horizontally in a gravitational frame of reference.

[0406] Furthermore, within the scope of the terms “comprising,” “having,” etc., used in the specification or claims, when “comprising” is interpreted as a conversion term in the claims, such a term is intended to be inclusive in a manner similar to the term “comprising.”

[0407] The term “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous relative to other embodiments.

[0408] Unless otherwise specified, references to elements in the singular are not intended to mean "one and only one," but rather "one or more." Male pronouns (e.g., his) include female and asexual (e.g., his and its), and vice versa. The term "some" refers to one or more. Underlined and / or italic headings and subheadings are merely for convenience and do not limit the scope of the subject matter, nor are they referenced in connection with the description of the subject matter. All structural and functional equivalents of the various configurations of elements described in this disclosure that are known to or will be known hereafter by those skilled in the art are expressly incorporated herein by reference and are intended to be covered by the subject matter. Moreover, the disclosure herein is not intended to be offered to the public, regardless of whether such disclosure is expressly stated in the foregoing description.

[0409] Although the detailed description contains many details, these should not be construed as limiting the scope of the subject matter, but merely as illustrating different examples and aspects of the subject matter. It should be understood that the scope of the subject matter includes other embodiments not discussed in detail above. Various other modifications, variations, and modifications may be made to the arrangement, operation, and details of the methods and apparatuses of the subject matter disclosed herein without departing from the scope of this disclosure. Unless otherwise stated, elements referenced in the singular are not intended to mean "one and only one," but rather "one or more," unless explicitly stated otherwise. Furthermore, an apparatus or method need not solve every problem (or every advantage) that can be solved (or obtained) by the different embodiments of this disclosure in order to be included within the scope of this disclosure. The use of "may" and its derivatives herein should be understood in the sense of "feasibly" or "optionally," rather than in the sense of "definitely capable."

Claims

1. A system for treating an aneurysm, comprising: a catheter configured to be positioned in proximity to an aneurysm; a self-expanding foam component configured to be advanced through the catheter and positioned within an aneurysm in an expanded state, the foam component having an inner lumen and an outer surface for contacting a wall of the aneurysm, wherein the foam component has a bowl shape in the expanded state; and a liquid embolization configured to be delivered to the inner lumen of the foam component when the foam component is positioned within the aneurysm, wherein the foam component has a first section having a first average porosity between 1 pm to 150 pm, a second section having a second average porosity, and a third section coupled to the second section and having a third average porosity between 150 pm to 300 pm, and the second average porosity is different from the first average porosity and the third average porosity. the foam component assumes a preset shape in the expanded state.

2. The system of claim 1, wherein, the liquid embolization is delivered to the inner lumen of the foam component through the catheter.

3. The system of claim 1, wherein, the liquid embolization is configured to increase an overall packing density of the foam component.

4. The system of claim 1, wherein, the liquid embolization is configured to increase an overall packing density of the foam component.

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