WO2014145005A2 - Occlusive device - Google Patents

Abstract

An aneurysm embolization device can include one or more occlusive components. The device can have a generally ellipsoidal body having a webbed portion and an interior chamber. The occlusive components included in the device can be one or more of: a plurality of occlusive segments attached to the webbed portion; at least one occlusive region coupled to the webbed portion; or an intermittent coating disposed on pores of the webbed portion.

Description

OCCLUSIVE DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the priority benefit of U.S. Provisional Application No. 61 /793,494, filed March 15, 2013, the entirety of which is incorporated herein by reference.

BACKGROUND

Field of the Inventions

[0002] The present inventions relate to implantable devices. More specifically, the present inventions relate to occlusive devices that can be implanted intravenously, and in some embodiments, for aneurysm therapy.

Description of the Related Art

[0003] Walls of the vasculature, particularly arterial walls, may develop areas of pathological dilatation called aneurysms. As is well known, aneurysms have thin, weak walls that are prone to rupturing. Aneurysms can be the result of the vessel wall being weakened by disease, injury or a congenital abnormality. Aneurysms could be found in different parts of the body with the most common being abdominal aortic aneurysms and brain or cerebral aneurysms in the neurovasculature. When the weakened wal l of an aneurysm ruptures, it can result in death, especially if it is a cerebral aneurysm that ruptures.

[0004] Aneurysms are general ly treated by excluding the weakened part of the vessel from the arterial circulation. For treating a cerebral aneurysm, such reinforcement is done in many ways including: (i) surgical cl ipping, where a metal clip is secured around the base of the aneurysm; (ii) packing the aneurysm with small, flexible wire coils (m icro- coi ls); (i ii) using embolic materials to "fill" or "pack" an aneurysm; (iv) using detachable balloons or coils to occlude the parent vessel that supplies the aneurysm; and (v) intravascular stenting.

[0005] In conventional methods of introducing a compressed stent into a vessel and positioning it within in an area of stenosis or an aneurysm, a guiding catheter having a distal tip is percutaneous ly introduced into the vascular system of a patient. The guiding catheter is advanced within the vessel until its distal tip is proximate the stenosis or aneurysm. A guidewire positioned within an inner lumen of a second, inner catheter and the inner catheter are advanced through the distal end of the guiding catheter. The guidewire is then advanced out of the distal end of the guiding catheter into the vessel until the distal portion of the guidewire carrying the compressed stent is positioned at the point of the lesion within the vessel. Once the compressed stent is located at the lesion, the stent may be released and expanded so that it supports the vessel.

[0006] Numerous companies have pursued bal l-type embolization devices for aneurysm treatment. Generally, braid-ball embolic devices for aneurysm treatment and/or other types of embolization operate through blood flow disruption and subsequent thrombus formation.

[0007] The braid density of the device has an effect on blood flow through the device. Greater braid density in the implant results in greater flow disruption, less time to occlusion, and/or improved likelihood of durable occlusion. The size of microcatheter through which the device can be tracked to achieve endovascuiar access sets the primary limitation on the amount of braid (i.e., size and number of filaments) that may be included in the device. Device configuration for tracking then becomes the remaining design variable that can be leveraged to achieve desired performance.

SUMMARY

[0008] Systems and procedures for treating aneurysms can include an embolization device having one or more expandable components that can be inserted into an aneurysm to facilitate a thrombotic, healing effect. The components can have distinct and specific characteristics, including porosity, composition, material, shape, size, coating, and the l ike. These characteristics can be selected in order to achieve a desired treatment or placement of the device.

[0009] An aneurysm embolization device is provided that can comprise one or more occlusive components, coatings, materials, filaments, segments, or features. The device can comprise a generally ellipsoidal body having a webbed portion and an interior chamber. The webbed portion can comprise a laser cut, woven, knitted, braided, or mesh material. The components can comprise one or more of: a plurality of occlusive segments attached to the webbed portion, at least one occlusive region coupled to the webbed portion, and/or an intermittent coating disposed on pores of the webbed portion. [0010] In some embodiments, a porous device can comprise a coating or occlusive segment placement density that can enable the device to have a substantially constant porosity along a section thereof (along which the porosity would otherwise vary, often significantly, without the presence of the coating or occlusive segments).

[0011] For example, the pore size at a given location relative to another location can change substantially, such as from an end section of the body to an equator thereof. In order to achieve a common, cumulative, or net porosity that is substantially equal along a substantial portion of the device, some embodiments comprise an additional component that is coupled to the body of the device.

[0012] A "net porosity" can be defined as the resultant porosity of (i) one or more layers of a web, mesh, weave, knit, or braid, in combination with (ii) any coating disposed thereon.

[0013] In accordance with an aspect of at least some of the embodiments disclosed herein is the realization that in different areas of the device, a selected coating configuration or occlusive segment placement density can be used in response to a given pore size or braid density in order to achieve substantially equivalent effective porosities (e.g., net porosities) in the different areas of the device.

[0014] For example, two areas having different braid densities can be treated using different coating configurations or occlusive segment coverage densities such that the two areas have substantially the same net porosity.

[0015] The subject technology is illustrated, for example, according to various aspects described below. Various examples of the subject technology are described as numbered clauses ( 1 , 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology. It is noted that any of the dependent clauses may be combined in any combination, and placed into a respective independent clause, e.g., clause 1 or clause 5. The other clauses can be presented in a similar manner.

[0016] Clause 1 . An aneurysm embol ization device comprising: a body comprising a webbed portion and an interior chamber; and a plurality of occlusive segments that each comprise (i) a coupling portion interconnecting the segment with the webbed portion, and (ii) a protruding portion having a long axis that extends away from the webbed portion. [0017] Clause 2. The device of Clause 1 , wherein the protruding portions extend within the chamber such that free ends of the protruding portions are positioned within the chamber.

[0018] Clause 3. The device of C lause 2, wherein substantially al l of the free ends of the protruding portions are positioned within the chamber.

[0019] Clause 4. The device of Clause 2, wherein the long axes are directed substantially centrally inward within the chamber.

[0020] Clause 5. The device of any of Clauses 1 to 4, wherein the long axes of some of the segments are directed away from the chamber.

[0021] Clause 6. The device of any of Clauses 1 to 5, wherein some of the segments comprises a coupling portion and first and second protruding portions extending away from the coupling portion, wherein the first protruding portion is directed away from the chamber and the second protruding portion is directed centrally inward toward the chamber.

[0022] Clause 7. The device of any of Clauses 1 to 6, wherein the body comprises a closed, rounded three-dimensional shape.

[0023] C lause 8. The device of Clause 7, wherein the body comprises an ellipsoidal shape.

[0024] Clause 9. The device of any of Clauses 1 to 8, wherein the webbed portion comprises a braided material.

[0025] Clause 1 0. The device of any of Clauses 1 to 9, wherein each of the plurality of segments comprises a filament coupled to the webbed portion.

[0026] Clause 1 1 . The device of any of Clauses 1 to 10, wherein the plurality of segments are distributed in a coverage ratio of at least 1 occlusive segment per 5x5 section of pores.

[0027] Clause 12. The device of any of Clauses 1 to 1 1 , wherein the plurality of segments are distributed in a coverage ratio of at least 1 occlusive segment per 4x4 section of pores.

[0028] Clause 13. The device of any of Clauses 1 to 12, wherein the plurality of segments are distributed in a coverage ratio of at least 1 occlusive segment per 3x3 section of pores.

[0029] Clause 14. The device of any of Clauses 1 to 13, wherein the webbed portion comprises pores and is subdivided to define circumferential bands extending about and along the entire the longitudinal axis, the plurality of segments being distributed along all of the circumferential bands in a coverage ratio of at least 1 occlusive segment per 50 pores.

[0030] Clause 15. The device of Clause 14, wherein the coverage ratio is at least 10 occlusive segments per 50 pores.

[0031] Clause 16. The device of any of Clauses 1 4 to 15, wherein each circumferential band represents less than 1 /4 of a longitudinal dimension of the body.

[0032] Clause 17. The device of any of Clauses 14 to 16, wherein each circumferential band represents less than 1 /8 of a longitudinal dimension of the body.

[0033] Clause 1 8. The device of any of Clauses 14 to 17, wherein the segments are distributed substantially evenly along the webbed portion.

[0034] C lause 19. The device of any of Clauses 1 to 1 8, wherein the body comprises two closed ends and a midsection between the closed ends, wherein when viewed in cross-section, a greater number of occlusive segments are coupled to the body adjacent to the midsection that adjacent to the closed ends.

[0035] Clause 20. The device of Clause 19, wherein when seen in cross- section, a number of occlusive segments coupled to the body gradually increases approaching the m idsection.

[0036] Clause 21 . The device of any of Clauses 1 to 20, wherein a segment distribution density, measured as a number of occlusive segments per unit area of the body, gradually increases approaching the midsection.

[0037] Clause 22. The device of any of Clauses 1 to 21 , wherein each of the plurality of segments is configured such that the protruding portion defines a length and the coupl ing portion of each segment is spaced apart at a distance from adjacent coupling portions along the webbed portion, wherein the distance is at least as great as the combined lengths of the segment protruding portion and the adjacent segment protruding portion such that the segment protruding portion and the adjacent segment protruding portion move without contacting each other.

[0038] Clause 23. The device of Clause 22, wherein each of the occlusive segments comprises first and second protruding portions coupled to the webbed portion at a midsection of the segment.

[0039] Clause 24. The device of any of Clauses 1 to 23, wherein the protruding portions of the plurality of segments do not overlap each other. [0040] Clause 25. An aneurysm embolization device comprising: a hollow body comprising a plurality of crossings along a webbed portion thereof; and a plurality of occlusive segments, each coupled to the webbed portion at a respective crossing; wherein the occlusive segments are distributed along the webbed portion in a coverage density of at least one occlusive segment per 5x5 section of crossings.

[0041] Clause 26. The device of Clause 25, wherein the coverage density is at least one occlusive segment per 4x4 section of crossings.

[0042] Clause 27. The device of any of Clauses 25 to 26, wherein the coverage density is at least one occlusive segment per 3x3 section of crossings.

[0043] Clause 28. The device of any of Clauses 25 to 27, wherein the body comprises a braided material.

[0044] C lause 29. The device of any of Clauses 25 to 28, wherein the body comprises a tubular material into which the webbed portion is etched.

[0045] Clause 30. The device of any of Clauses 25 to 29, wherein the body comprises a closed, rounded three-dimensional shape.

[0046] Clause 31 . The device of Clause 30, wherein the body comprises an ellipsoidal shape.

[0047] C lause 32. An aneurysm embolization device comprising: a hollow body having an interior chamber, first and second ends, and a midsection between the first and second ends; and a flow-occluding structure, separate from the body, comprising filament sections, the sections comprising end regions that are coupled to the body, the structure extending between the chamber between the first end and the midsection.

[0048] Clause 33. The device of Clause 32, wherein the structure comprises individual, separate fi laments coupled at their ends to the body.

[0049] Clause 34. The device of any of Clauses 32 to 33, wherein the structure comprises a filament coupled to the body at multiple, relatively remote locations such that the filament extends across the chamber multiple times to define the filament sections.

[0050] Clause 35. The device of any of Clauses 32 to 34, wherein the body comprises a longitudinal axis extending between the first and second ends, wherein the structure crosses the longitudinal axis.

[0051] Clause 36. The device of any of Clauses 32 to 35, wherein the structure is positioned entirely between the first end and the midsection. [0052] Clause 37. The device of any of Clauses 32 to 36, wherein the structure comprises a central region, adjacent to an axis extending between the first and second ends, having a higher porosity than a peripheral region adjacent to the body.

[0053] Clause 38. The device of any of Clauses 32 to 37, wherein the structure comprises a central region, adjacent to an axis extending between the first and second ends, having a lower porosity than a peripheral region adjacent to the body.

[0054] Clause 39. The device of Clause 38, wherein the structure comprises an open central region.

[0055] Clause 40. The device of any of Clauses 32 to 39, further comprising a second flow-occluding structure, separate from and coupled to the body, extending between the first and second ends and intersecting the flow-occluding structure.

[0056] Clause 41 . The device of Clause 40, wherein the second structure extends transversely relative to the structure.

[0057] Clause 42. The device of any of Clauses 32 to 41 , wherein the first and second ends are closed.

[0058| Clause 43. The device of any of Clauses 32 to 42, wherein the body comprises a closed, rounded three-dimensional shape.

[0059] Clause 44. The device of any of Clauses 32 to 43, wherein the body comprises a braided material.

[0060] Clause 45. An aneurysm embolization device comprising: a hollow, webbed body comprising pores; and a coating distributed along the body to fill at least some of the pores; wherein less than 80% of the filled pores are positioned contiguously.

[0061 ] Clause 46. The device of Clause 45, wherein less than 70% of the fil led pores are positioned contiguously.

[0062] Clause 47. The device of any of Clauses 45 to 46, wherein less than 60% of the fi lled pores are positioned contiguously.

[0063] Clause 48. The device of any of Clauses 45 to 47, wherein less than 50% of the filled pores are positioned contiguously.

[0064] Clause 49. The device of any of Clauses 45 to 48, wherein less than 40% of the fil led pores are positioned contiguously.

[0065] Clause 50. The device of any of Clauses 45 to 49, wherein less than 30% of the filled pores are positioned contiguously. [0066] Clause 51 . The device of any of Clauses 45 to 50, wherein a given 4x4 section of pores comprises less than 6 filled pores.

[0067] Clause 52. The device of any of Clauses 45 to 51 , wherein a given 4x4 section of pores comprises less than 4 filled pores.

[0068] Clause 53. The device of any of Clauses 45 to 52, wherein across a given unit area of the body, the pores define a cumulative area of between about 10 mm2 and about 250 mm2.

[0069] Clause 54. The device of any of Clauses 45 to 53, wherein across a given unit area of the body, the pores define a cumulative area of between about 40 mm2 and about 150 mm2.

[0070] Clause 55. The device of any of Clauses 45 to 54, wherein across a given unit area of the body, the pores define a cumulative area of between about 70 mm2 and about 100 mm2.

[0071] Clause 56. The device of any of Clauses 45 to 55, wherein the body comprises a dual layer braided material.

|0072] Clause 57. The device of any of Clauses 45 to 56, wherein the body comprises a single layer braided material.

[0073] Clause 58. The device of any of Clauses 45 to 57, wherein fil led pores adjacent an end of the body comprise a drug-eluting material.

[0074] Clause 59. An aneurysm embolization device comprising: a hollow, webbed body comprising pores; and a coating distributed along the body to fill at least some of the pores; wherein the body comprises a substantially spherical shape having an equator and defining an axis extending between ends of the body, wherein half of the spherical shape comprises horizontal slices separated by planes extending normal to and spaced at equal lengths along the axis, wherein the number of filled pores successively increases in each slice approaching the equator.

[0075] Clause 60. The device of Clause 59, wherein the slices comprise, in a direction from the equator toward an end of the body, first, second, third, and fourth horizontal slices.

[0076] Clause 61. The device of Clause 60, wherein a ratio of filled pores in the first slice to filled pores in the fourth slice is between about 5 : 1 and about 3.5 : 1 .

[0077] Clause 62. The device of any of Clauses 60 to 61 , wherein a ratio of filled pores in the first slice to filled pores in the fourth slice is between about 4: 1 . [0078] Clause 63. The device of any of Clauses 60 to 62, wherein a ratio of fi l led pores in the second slice to fi lled pores in the fourth slice is between about 3.5 : 1 and about 2.5 : 1.

[0079] Clause 64. The device of any of Clauses 60 to 63, wherein a ratio of fi lled pores in the second sl ice to filled pores in the fourth slice is between about 3 : 1.

[0080] Clause 65. The device of any of Clauses 60 to 64, wherein a ratio of filled pores in the third slice to filled pores in the fourth slice is between about 2.5: 1 and about 1.5 : 1 .

[0081] Clause 66. The device of any of Clauses 60 to 65, wherein a ratio of fi lled pores in the third slice to filled pores in the fourth slice is between about 2: 1 .

[0082] Clause 67. The device of any of Clauses 59 to 66, wherein the body comprises a dual layer braided material.

[0083] Clause 68. The device of any of Clauses 59 to 67, wherein the body comprises a single layer braided material.

[0084] Clause 69. The device of any of Clauses 59 to 68, wherein filled pores adjacent an end of the body comprise a drug-eluting material.

[0085] Clause 70. An aneurysm embolization device comprising: a hollow, webbed body comprising pores; and a coating distributed along the body to fill at least some of the pores such that the body comprises filled pores and open pores; wherein the body comprises a substantially spherical shape having an equator and defining an axis extending between ends of the body, wherein the spherical shape comprises horizontal slices separated by planes extending normal to and spaced at equal lengths along the axis, wherein the ratio of filled pores to open pores successively increases in each slice approaching the equator.

[0086] Clause 71 . The device of Clause 70, wherein the ratio of filled pores to open pores in the active webbed portion is from about 1 :5 to about 1 :2.

[0087] Clause 72. The device of any of Clauses 70 to 71 , wherein the slices comprise, in a direction from the equator toward an end of the body, first, second, third, and fourth horizontal slices.

[0088] Clause 73. The device of Clause 72, wherein a ratio of filled pores to open pores in the first slice is between about 1 : 1 .5 and about 1 :2.5.

[0089] Clause 74. The device of any of Clauses 72 to 73, wherein a ratio of filled pores to open pores in the first slice is about 1 :2. [0090] Clause 75. The device of any of Clauses 72 to 74, wherein a ratio of filled pores to open pores in the second slice is between about 1 :2.5 and about 1 :3.5.

[0091] Clause 76. The device of any of Clauses 72 to 75, wherein a ratio of filled pores to open pores in the second slice is about 1 :3.

[0092] Clause 77. The device of any of Clauses 72 to 76, wherein a ratio of filled pores to open pores in the third slice is between about 1 :3.5 and about 1 :4.5.

[0093] Clause 78. The device of any of Clauses 72 to 77, wherein a ratio of filled pores to open pores in the third slice is about 1 :4.

[0094] Clause 79. The device of any of Clauses 72 to 78, wherein a ratio of filled pores to open pores in the fourth slice is between about 1 :4.5 and about 1 :5.5.

[0095] Clause 80. The device of any of Clauses 72 to 79, wherein a ratio of filled pores to open pores in the fourth slice is about 1 :5.

[0096] Clause 81 . The device of any of Clauses 70 to 80, wherein filled pores adjacent an end of the body comprise a drug-eluting material.

[0097] Clause 82. The device of any of the preceding Clauses, wherein the body comprises a single layer braided material.

[0098] Clause 83. The device of any of the preceding Clauses, wherein the body comprises a dual layer braided material.

[0099] Clause 84. An aneurysm embolization device comprising any combination of the features disclosed herein.

[0100] Clause 85. An aneurysm embol ization device comprising a body having a plurality of selectively fil led pores and an occlusive filamentary structure attached to the body.

[0101] Clause 86. A method for manufacturing any of the implants in any of the preceding Clauses.

[0102] Additional features and advantages of the subject technology will be set forth in the description below, and in part wi ll be apparent from the description, or may be learned by practice of the subject technology. The advantages of the subject technology will be realized and attained by the structure particularly pointed out in the written description and embodiments hereof as wel l as the appended drawings.

[0103] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology. BRIEF DESCRIPTION OF THE DRAWINGS

[0104] Various features of illustrative embodiments are described below with reference to the drawings. The illustrated embodiments are intended to illustrate, but not to limit, the inventions. The drawings contain the following figures:

[0105] Figure 1 is a side, cross-sectional view of a device expanded within an aneurysm, according to some embodiments.

[0106] Figure 2 is a side, cross-sectional view of a device having a plurality of occlusive segments, according to some embodiments.

[0107] Figure 3 is a side, cross-sectional view of a device having a plurality of occlusive segments, wherein the device is in a collapsed or delivery configuration, according to some embodiments.

[0108] Figure 4 is an enlarged side, cross-sectional view of a portion of a device, according to some embodiments.

[0109] Figure 5 is a side, cross-sectional view of a device, according to some embodiments.

[0110] Figures 6A-6C illustrate schematic views of occlusive segment spacing patterns in a webbed portion of a device, according to some embodiments.

[0111] Figures 7-9 illustrate side, cross-sectional views of devices having at least one occlusive structure, according to some embodiments.

[0112] Figures 10-1 1 illustrate side, cross-sectional views of devices having at least one occlusive structure, wherein the device is in a collapsed or delivery configuration, according to some embodiments.

[0113] Figures 12-15 illustrate patterns of an occlusive structure, according to some embodiments.

[0114] Figures 16-1 8 illustrate side views of devices having an intermittent coating, according to some embodiments.

[0115] Figures 19A-19C illustrate schematic views of coating filled cell patterns in a webbed portion of a device, according to some embodiments.

DETAILED DESCRIPTION

[0116] In the following detailed description, numerous specific details are set forth to provide a full understanding of the subject technology. It should be understood that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.

[0117] Further, while the present description sets forth specific details of various embodiments, it will be appreciated that the description is illustrative only and should not be construed in any way as lim iting. Additionally, it is contemplated that although particular embodiments of the present inventions may be disclosed or shown in the context of aneurysm therapy, such embodiments can be used in a blood vessel occlusion. Furthermore, various applications of such embodiments and modifications thereto, which may occur to those who are skilled in the art, are also encompassed by the general concepts described herein.

[0118] Delivery systems, devices, and methods of making the devices are provided herein. The device can be useful for treating neurovascular defects. One use is in intracranial aneurysm embolization/occlusion and another in parent vessel occlusion (PVO) or sacrifice. Further, some embodiments can comprise features related to certain aspects of the present assignee's U.S. Patent No. 8, 142,456, the entirety of which is incorporated herein by reference.

[0119] In particular, some embodiments disclosed herein can comprise a webbed body and a plurality of occlusive segments that are coupled to the webbed body and extend there from in order to faci litate a thrombogenic response within the vessel to be occluded. Various patterns and segment configurations can advantageously improve the likelihood of a healing response from the vessel.

[0120] Further, in some embodiments, the occlusive segments can extend between opposing inner sides of the webbed body in order to provide a more uniform porosity or flow resistance through the body. For example, the occlusive segments can extend within an interior chamber of the body. In some embodiments, the occlusive segments can be positioned along only one side of an equator of the body. Additionally, the occlusive segments can also be positioned along a longitudinal axis extending through the equator of the body, thereby further enhancing the flow resistance and decreasing the porosity of the device within the chamber.

[0121] In addition, some embodiments optional ly comprise a coating disposed over pores of the body. The coating can fill various pores such that the effective porosity of the body can be substantially constant (or within a desired range) along the outer surface of the body, regardless of the braid density and pore size.

[0122] Thus, in some embodiments, pores of a given location of the body can be selectively filled (or coating removed therefrom) and/or coupled to occlusive material or segments, based on the pore size at the given location relative to another location, such as an end section of the body, in order to achieve a common, cumulative, or net porosity that is substantial ly equal along a substantial portion of the device.

[0123] As noted above, the "net porosity" can be defined as the resultant porosity of one or more layers of a web, mesh, or braid and any coating disposed thereon. Accordingly, in accordance with an aspect of at least some of the embodiments disclosed herein is the realization that in different areas of the device, a selected coating configuration or occlusive segment placement density can be used in response to a given pore size or braid density in order to achieve substantially equivalent effective porosities (e.g., net porosities) in the different areas of the device. For example, two areas having different braid densities can be treated using different coating configurations and/or occlusive segment placement densities such that the two areas have substantially the same net porosity.

[0124] Further, in some embodiments, a lower portion of the device, which can be configured to span the neck of the aneurysm, can have a net porosity that is substantially constant or within a desired range along the lower portion. Furthermore, in embodiments in which the body comprises a generally spherical shape, a lower spherical sector, less than the hem isphere, can have a substantially constant (non-zero) porosity therealong.

[0125] Some embodiments of the device can be formed from tubular braid stock or knitted. The device can comprise a resi lient material such as Nitinol, that defines an open volume (ellipsoidal, spheroidal, spherical, substantially spherical/round, heart- shaped, ovoid, barrel-shaped or otherwise configured in cross section, etc.) in an uncompressed/unconstrained state. The device can be set within an aneurysm sac at a vascular bifurcation or sidewall aneurysm. The device can be delivered by access through the trunk vessel (e.g., the basilar artery), preferably through a commercially available microcatheter (not shown) with a delivery system as detailed below.

[0126] In some embodiments, the device can have a predetermined configuration, whether or not the device has only a single or multiple expandable components. The predetermined configuration can be based on typical aneurysm shapes, thereby allowing selection of a specific device. However, individual components of a device can also be arranged based on desired properties.

[0127] In some embodiments, expandable component(s) of the device may be shape set or manufactured into a variety of geometrical or partial geometrical shapes.

[0128] Additionally, although in some embodiments, a single device can be used alone to fill the aneurysm and provide a desired packing density or fill volume, a plural ity of expandable devices can also be used to fill the aneurysm and provide a desired packing density or fill volume.

[0129] As used herein, "porosity" can generally refer to an average porosity, which can be sampled across a given portion or section of an expandable component. "Porosity" can be defined as the ratio of the volume of the pores of in a component to the volume of the component as a whole. Porosity can be measured by a fluid displacement test. For example, liquid or gas testing can be used, as necessary or desirable, according to skill in the art. In some embodiments, a chromatography chamber can be used to measure displacement of a gas within the chamber, enabling the calculation of an average porosity of a given intrasaccu lar device or portion thereof. Other methods and systems can be used to measure porosity of portions of or the entirety of an expandable component.

[0130] The porosity of the expandable component may vary along any portion(s) thereof, including any combination of pore sizes of 1 micron or greater.

[0131 ] For example, at least a portion or section of the device can comprise an average porosity of between about 1 μηι and about 1 50 μιη. Further, at least a portion or section can comprise an average porosity of between about 100 μηι and about 200 μιη. Furthermore, at least a portion or section can comprise an average porosity of between about 200 μηι and about 300 μηι. When a composite expandable component is formed using multiple sections or portions, each section or portion can have an average porosity within any of the ranges discussed above.

[0132] Further, the pore sizes can range from about 1 μηι to about 800 μηι, from about 5 μηι to about 750 μιτι, from about 8 μηι to about 700 μιτι, from about 10 μιτι to about 600 μηι, from about 20 μιτι to about 500 μιτι, or in some embodiments, from about 30 μηι to about 400 μιτι.

Devices with Occlusive Segments [0133] In accordance with some embodiments, the presence of the occlusive filaments, segments, or material along the webbed portion or surface of the device can increase the surface area or surface density of the device along the webbed portion. This increase in surface area or surface density can promote thrombus formation at or along the surface of the webbed portion.

[0134] Figure 1 illustrates an embodiment of a device in which a plurality of occlusive segments is coupled to a webbed portion or outer surface of the device. The presence of the occlusive segments can increase the surface area or surface density of the webbed portion, especially in the localized areas where the segments are attached or integrated with the webbed portion. This increase in surface area can tend to induce a thrombogenic response.

[0135] Referring now to the drawings. Figure 1 illustrates an embodiment of an embolization device 10 positioned within an aneurysm 12 in a blood vessel 14. The device 10 can be particularly adapted for use in the tortuous neurovasculature of a subject for at least partial deployment in a cerebral aneurysm.

[0136] A cerebral aneurysm may present itself in the shape of a berry, i.e., a so-called berry or saccular aneurysm, which is a bulge in the neurovascular vessel. Berry aneurysms may be located at bifurcations or other branched vessels. Other types of aneurysms, including fusiform aneurysms, can also be treated using embodiments of the devices disclosed herein.

[0137J As illustrated in Figures 1 -2, the device 10 can comprise a body 20 having an interior chamber 22 defined by a webbed portion 24 and a plurality of occlusive segments 30 that are coupled to the device 10. In accordance with some embodiments, the occluding segments 30 can be attached to the webbed portion 24 of the body 20. The occlusive segments 30 can occluding blood flow at an endovascular site and within the chamber 22, as well as facilitate thrombosis within the aneurysm 12 to promote a healing response.

[0138] The webbed portion 24 of the device 10 can comprise a plurality of intersecting structural components. In some embodiments, the webbed portion 30 can be formed as a plurality of cutouts from a single-piece expandable body. For example, the webbed portion 24 can be formed as a laser cut stent or device or a woven, knit, or braided mesh device. However, in other embodiments, the webbed portion 30 can be formed from a plurality of intersecting wires or filaments, as in a woven, knitted, braided, or mesh material.

[0139] As shown in Figure 2, the occlusive segments 30 can be coupled to any of a variety of locations on the body 20. The occlusive segments 30 can be unitarily formed with the webbed portion 24 from a single, continuous piece of material and/or formed separately from the webbed portion 24 and attached thereto.

[0140] For example, the occluding segments 30 can comprise a plurality of fiber members that are coupled to the webbed portion 24. The fiber members can be tied or adhered to the device 10.

[0141] The occluding segments 30 can also be flexible or resilient. For example, Figure 3 illustrates the device 10 disposed within a catheter 60. As shown, the occlusive segments 30 can be compressible and deflectable such that the device 10 can be compressed towards a collapsed configuration, as shown in Figure 3. Thereafter, when advanced to a target location, the device 10 can be expanded into an expanded configuration, such as that illustrated in Figures 1-2, and the segments 30 can extend away from the webbed portion 24 thereby tending to optimize the symbolic effect of the segments 30.

[0142] In some embodiments, the segments 30 can be spaced apart from each other such that when compressed into a compact profile for delivery, the segments 30 do not overlap, as illustrated in Figure 3. For example, in embodiments in which the compressed device 10 is passed through a cyl indrical profile, the segments 30 can be spaced apart from each other in a repeating pattern that enables the segments 30 to be oriented in the compact profile to avoid overlap with each other.

[0143] Accordance with some embodiments, each occlusive segment 30 can be configured such that its freely extending length does not interfere with adjacent occlusive segments, which may could otherwise thwart recapture or the thrombotic effect of the device 10. Referring to Figure 4, the segments 30 can comprise a coupling portion 70 and one or more protruding portion 72. The coupling portion can interconnect the segment 30 with the webbed portion 24 of the body 20. Further, the protruding portion 72 can comprise a long axis which, according to some embodiments, can be configured to extend away from the coupling portion 70. In particular, the long axis of the protruding portion 72 can extend transversely relative to the webbed portion 24, such as in a direction normal to the surface of the webbed portion 24. [0144] As shown in Figure 4, the protruding portions 72 can also define an axial length, measured from the coupling portion 70 to a free end of the protruding portion 72.

[0145] In accordance with some embodiments, the device 10 can be configured such that the segments 30 are coupled to the webbed portion 24 at a distance 80 that is at least equal to the sum of the axial lengths of adjacent protruding portions 72. Accordingly, in such embodiments, adjacent protruding portions 72 can move freely without becoming entangled with each other.

[0146] Further, in accordance with some embodiments, each occlusive segment 30 can be configured such that its axial length can be from about 0.5 mm and about 4 mm, from about 0.7 mm and about 3 mm, from about 1 mm to about 2.5 mm, from about 1 .2 mm and about 2 mm, and in some embodiments, about 1 .5 mm. The axial length can be determined as a function of the size of the device. For example, the axial length can be from about 1 /25 to about 1 /2 of a diameter of the device, from about 1 /20 to about 2/5 of a diameter of the device, from about 1 /1 5 to about 1 /3 of a diameter of the device, from about 1 /10 to about 3/ 10 of a diameter of the device, from about 1 /8 to about 1 /4 of a diameter of the device, and in some embodiments, about 1 /5 of a diameter of the device.

[0147] In accordance with some embodiments, the occlusive segments 30 can be trimmed, "spun," or reoriented, if necessary, so that the long axis of the segment is directed inwardly toward or outward away from an interior of the device. In some embodiments, the free ends of the segments can be positioned inside and/or outside of the inner volume of the device. Figure 2 illustrates an embodiment in which all of free ends are inside the inner volume. Further, Figure 5 illustrates a device 100 in which free ends of a plurality of occluding segments 130, coupled to the webbed portion 124 of the device 1 00, are positioned inside and outside of the device 100.

[0148] As shown in Figure 5, the long axes of the protruding portions of the occluding segments 1 30 can extend into the chamber 120 and/or outwardly away from the chamber 120. Further, the segments 130 can be arranged in a pattern such that approaching and equator 150 of the device 100, the number of segments 130 per unit area ("segment density") increases. This increase in segment density can occur, in some embodiments, when approaching the equator 150 from either one or both ends opposite the equator 1 50. [0149] For example, the device 100 can be geometrically subdivided into a series of longitudinal, circumferential bands or slices that have substantially equal heights or thicknesses, as measured along a longitudinal axis 152 of the device 100. Figure 5 illustrates the device 1 00 subdivided into four slices, a first, second, third, and fourth slice 160, 162, 164, and 166. As will be appreciated, the number of geometric slices can be increased, thereby decreasing the variation of the segment density between successive slices.

[0150] In accordance with some embodiments disclosed herein, the segment density or number of segments 130 per slice can decrease in the direction from the first slice 160 toward the fourth slice 166. Further, in some embodiments, the segment density of a slice can also decrease in the direction from the first slice 160 toward the fourth slice 166.

[0151] The segments can be attached to the webbed portion at one or more locations thereon. One or more segments can be coupled or tied to a single wire or length of the webbed portion, coupled or tied to a pair of wires or lengths of wires of the webbed portion, or coupled or tied to select regions, cells, windows, or crossings of the webbed portion.

[0152] The segments can be coupled to the webbed portion in a substantially uniform distribution or segment density. The distribution of the segments or segment density can be measured in terms of a unit surface area or the number of pores 204 in a given section. For example, in the embodiments il lustrated in Figures 6A-6C, the occlusive segments 200 are distributed substantially evenly across the webbed portion 202 based on an average number of occlusive segments per number of pores 204.

[0153] Further, the distribution of the segments or segment density can be shown in Figure 6A, which illustrates an arrangement wherein the segments 200 are coupled to the webbed portion 202 such that the ratio of segments to pores 204 is between 1 :36 and 1 :9. In addition, Figure 6B illustrates an arrangement wherein the segments 200 are coupled to the webbed portion 202 such that the ratio of segments to pores 204 is between 1 : 16 and 1 :8. Further, Figure 6C illustrates an arrangement wherein the segments 200 are coupled to the webbed portion 202 such that the ratio of segments to pores 204 is between 1 :9 and 4:9. Various other ratios and distributions can be provided in order to tend to ensure that the webbed portion is covered evenly with segments or that the segments are distributed generally evenly on the webbed portion. Devices with Secondary Occlusive Structures

[0154] In accordance with some embodiments, a device can be provided that includes a webbed body and at least one additional structure of occlusive material covering at least a portion of a region or area of the interior and/or exterior of the body. The occlusive structure can comprise a flexible, elastic, ductile, and/or resilient material.

[0155] The occlusive structure can be placed, formed, or attached to the device such that, when the device is used in an aneurysm, the occlusive layer can be configured to at least partially span or cover a neck of the aneurysm. The occlusive structure can be formed separately from the device and attached to the device during assembly. In accordance with aspects of some embodiments, the occlusive structure can provide a disruptive structure that promotes healing and endothelial growth at the neck of an aneurysm using a ductile, flexible structure formed, for example, from a plurality of individual filaments. Accordingly, in some embodiments, the occlusive structure can increase the rate of complete occlusion of the aneurysmal sac.

[0156] Figure 7 illustrates a side, cross-sectional view of a device 300 implanted into an aneurysm 12. The device 300 comprises a hollow body 302 and a flow occluding structure, occlusive layer, or region 304. The flow occluding structure 304 can extend crosswise within the device 300. The structure 304 can serve to increase the density of the braid or mesh near the aneurysm neck 16, as generally shown in Figure 7.

[0157] In some embodiments, the structure 304 can extend between an end of the device and a midsection or equator 308 of the device 304.

[0158] For example, in some embodiments, the structure 304 can extend across an interior circumference of the device 300 and extend within a longitudinal band or between spaced apart planes extending transversely relative to a longitudinal axis 20 of the device 300. Thus, the structure 304 can be formed as a composite disk shape within the chamber 306 of the device 300. However, in accordance with some embodiments, the occluding structure 304 need not be disc-shaped.

[0159] For example, as illustrated in Figure 8, a device 350 can be provided that comprises a body 352 and an occlusive structure 354 coupled to the body. The occlusive structure 354 can be an occlusive volume or section having an amorphous shape, such as a plurality of filaments that are anchored at various (non-planar) points of the device 350. Further, the occlusive structure 354 can be a three-dimensional web of filaments that are attached to a webbed body 352 of the device 350.

[0160] Accordingly, in some embodiments, the occlusive structure can serve to provide a secondary means for occluding flow into or within the device.

[0161] Further, some embodiments can be provided that comprise more than one occlusive structure, as illustrated in Figure 9.

[0162] In the embodiment illustrated in Figure 9, the device 400 comprises a webbed body 402 and first and second occlusive structures 404, 406 coupled to the webbed portion 402. As similarly illustrated in Figures 7-8, the first occlusive structure 404 can extend transversely relative to a longitudinal axis 20 of the device 400. The second occlusive structure 406 can extend transverse relative to the first occlusive structure 404. Further, the second occlusive structure 406 can also extend parallel or transverse relative to the longitudinal axis 20 of the device 400. Possible alignments of the occlusive structures 404, 406 are illustrated in the embodiment of Figure 9, but can include other various geometries, alignments, and volumetric shapes.

[0163] Additionally, Figure 9 also illustrates that in some embodiments, the device 400 can comprise more than one occlusive structure 404, 406. The structure 404, 406 can be independent, separate layers or regions or cross each other within the device 400. Indeed, a three-dimensional array or arrangement of layers or regions can further promote thrombus formation and healing within the aneurysm sac and accelerate the healing response at the aneurysm neck.

[0164] Some embodiments of the device 400 can comprise a double layer, ovoid shaped body or shell 402 and at least one layer of occlusive material, as shown in Figure 9. The layer of occlusive material can comprise a single structure or a horizontally layered or planar mesh of braid 404 that is attached to or within the device body. The horizontally layered material can comprise a single, planar layer, or multiple fibers that extend within a horizontal layer of a certain thickness. When the device 400 is deployed, the structure 404 can be expanded to assume a dense, horizontal layering (see e.g., Figures 7-9) or generally planar net (see e.g., Figures 12-15) near and/or parallel to the neck of the aneurysm.

[0165] Figure 10 illustrates that during delivery and advancement of a device 450 within a catheter 60 to a treatment site, when the device 450 is crimped or compressed within an introducer or delivery catheter, the occlusive structure 452 can be flexible enough to compress within the elongated space inside the device, as illustrated in Figure 10.

[0166] Further, in embodiments that comprise an occlusive structure extending in a vertical layer or generally parallel relative to a longitudinal axis of the device (see e.g., Figure 9) (which is (i) the axis toward which the device may be deflected when compressed for delivery, and (ii) the axis along which the device experiences elongation when compressed for delivery), the material of the occlusive structure can elastically deform in order to stretch as first and second ends of the device, to which at least a portion of the occlusive structure is attached, are separated in opposing directions.

[0167] However, in some embodiments, as illustrated in Figure 1 1 , a device 470 can be compressed within a catheter 60, such that first and second ends 472, 474 and sides 476 of the device 470 are collapsed toward each other. In such a configuration, multiple transverse occlusive structures 480, 482 can be present in the device 470 and the device 470 can collapse without creating stress on the occlusive structures 480, 482 of the device 470.

[0168] In some embodiments, the occlusive structure can be woven into the device. The occlusive structure can comprise a plurality of filament sections coupled at their ends to the webbed body of the device. The occlusive structure can be formed separately from the device and attached to the device during assembly. The occlusive structure can be configured to provide a higher density in a central region and/or peripheral region of the pattern. For example, the occlusive structure can be woven, anchored, or coupled to the device by interconnecting the occlusive structure with the webbed portion or interstices of the device.

[0169] As shown in Figures 1 2-15, which are cross-sectional views taken along the vertical or longitudinal axis of the device, the occlusive structure can include a variety of patterns, such as: multi-point patterns 500, 502 (embodiments shown in Figures 12-1 3, which can comprise a variety of overlaid geometric shapes, such as squares, triangles, and other polygon shapes and stars), peripheral high-density patterns 504 (embodiment shown in Figure 14, which can comprise a plurality of secant lines that extend from one portion of the sidewall to the other without crossing a central zone of the device), and central high-density patterns 506 (embodiment shown in Figure 1 5, which can include a woven mesh that is suspended in a central region of the device). [0170] The placement and arrangement of the occlusive structure can advantageously enhance the effective porosity (defined as a net or collective porosity along a region of the device). For example, in embodiments wherein the device comprises a woven, knitted, braided, or mesh material, ends (e.g., top and bottom ends) of the device can tend to have a much higher braid density than the equator of the device. In many situations, an end portion of the device may provide a desired porosity, effective to induce thrombosis within the aneurysm. However, if the end portion is shifted away from a center of the neck of the aneurysm, the average porosity of the device now exposed to the neck is changed and does not provide the desired porosity across the neck.

[0171] Accordingly, as shown in Figure 8, some embodiments can be configured such that an extended end region 360 of the device 350 (which may be positioned at the neck of the aneurysm and moved within a range of positions), the effective porosity can be substantial ly constant or within a certain range along the end region 360 due to the incorporation of the occlusive structure 354. Accordingly, the device 350 can be inserted into the aneurysm and oriented in a variety of positions, each of which allows the device 350 to provide a desired porosity across the neck 1 6 of the aneurysm 12.

[0172] As such, some embodiments can advantageously compensate for different aneurysm neck geometries and/or situations where the occlusive structure 354 of the device 350 may be difficult to align with the aneurysm neck 1 6.

[0173] Additionally, although Figures 12-1 5 i l lustrate a horizontally layered or generally planar configuration of the occlusive structure, some embodiments can be configured such that the illustrated patterns, as well as other patterns disclosed herein, are formed in three dimensions, not being limited or bound by a single plane. Further, as disclosed herein, three-dimensional and horizontally layered occlusive structures or regions can be present in some embodiments of the device.

[0174] The occlusive structure can be configured to assume a taut configuration or a loose configuration when the device is expanded. For example, if the occlusive structure assumes a loose configuration, the structure can move very slightly with the direction of blood flow, agitating blood flow and initiating a thrombolytic cascade within the sac.

[0175] Further, some embodiments can be configured such that the occlusive layer is formed from either or both of a polymer (e.g., suture) or metal material. For example, if made from polymer, the occlusive layer can be formed from filaments that can be frayed to further increase their disruption of flow into the aneurysm sac.

[0176] Additionally, the occlusive structure can comprise one or more thrombogenic materials or coatings intended to elicit and enhanced thrombogenic response.

Devices with Selectively Filled Pores

[0177] In accordance with some embodiments, at least a portion of an embolization device can comprise a coating that is selectively disposed therealong in an arrangement that provides a substantially constant (or desired range of) porosity along the portion of the device.

[0178] For example, in a woven, knitted, braided, or mesh device, the ratio of fi l led pores to open pores can be correlated with the size of the pores across the portion of the device such that the coating fi lls a sufficient number of pores in an area of lower braid density in order to provide an effective porosity in the low-braid-density section that is substantially equal to an effective porosity in a high-braid-density section. Various metrics for establishing such a correlation are provided herein.

[0179] In accordance with some embodiments, at least a portion of the device can comprise a coating or material for enhancing therapeutic, expansive, or imaging properties or characteristics of at least one or every expandable component of the device.

[0180] In some embodiments, at least a portion of the device can be coated with a biocompatible material to promote endothelial ization or provide a therapeutic effect.

[0181] In accordance with some embodiments, a device can be provided that comprises a coating extending along less than the entire outer surface of the device. For example, in some embodiments, the device can comprise a braid ball device 600, 620, 640, as illustrated in Figures 1 6-18. Each of the devices 600, 620, 640 can comprise a coating 602, 622, 642 can be disposed on the device such that windows or pores of a webbed, woven, knitted, braided, or mesh portion of the device are selectively filled or open.

[0182] Some embodiments comprising a coating can be configured to provide improved (or inhibited) compression and expansion, while offering surface area or density improvement in order to enhance the occlusive or disruptive ability of the device while also promoting endothelial growth and healing. For example, the device can be placed in an aneurysmal sac and the coating can extend along at least a portion of the device that spans the neck of the aneurysm. Accordingly, the presence of the coating can disrupt flow and promote endothelial growth across the aneurysm neck.

[0183] In accordance with some embodiments, as shown in Figures 16-1 8, the coating can be disposed on a selected number of the pores. For example, the coating can be disposed on the device such that less than 80% of the pores of the device are filled and positioned adjacent to a plurality of filled pores. Further, in some embodiments, less than 60% of the pores of the device are filled and positioned adjacent to a plurality of filled pores. Further, in some embodiments, less than 40% of the pores of the device are filled and positioned adjacent to a plurality of filled pores. Further, in some embodiments, less than 20% of the pores of the device are filled and positioned adjacent to a plurality of fi lled pores. Further, in some embodiments, less than 1 0% of the pores of the device are filled and positioned adjacent to a plurality of filled pores. For example, a pore is not "adjacent" to or contiguous with another pore if the pores are not touching or are separated by a third pore. As an illustration, in a 3x3 (square) matrix of pores, the center pore is adjacent to or contiguous with each of the other eight pores.

[0184] Additionally, the ratio of open pores to closed pores can also be used as a metric for the selectiveness of the coating. For example, the ratio of open pores to closed pores can be from about 50: 1 to about 1 : 10. Further, the ratio of open pores to closed pores can be from about 30: 1 to about 1 :6. The ratio of open pores to closed pores can be from about 1 5 : 1 to about 1 :3. Additionally, the ratio of open pores to closed pores can be from about 10: 1 to about 1 :2. The ratio of open pores to closed pores can be from about 5 : 1 to about 3 :2. The ratio of open pores to closed pores can be from about 4: 1 to about 1 : 1 . Furthermore, the ratio of open pores to closed pores can be from about 3 : 1 to about 2: 1 .

[0185] Figures 19A-19C illustrate embodiments of webbed portions 670, 680, 690, which comprise respective filled pores 672, 682, 692 and open pores 674, 684, 694. As discussed above with respect to Figure 5 (the discussion of which will not be repeated herein for brevity), a device can be subdivided into a plurality of slices, and the ratio of filled pores to open pores can vary from sliced to slice.

[0186] Referring to the discussion of the first through fourth slices made above with respect to Figure 5, in some embodiments, the number of filled pores can change in each slice. For example, in some embodiments, the number of fi lled pores can successively increase in each slice approaching the equator.

[0187] Further, in accordance with some embodiments, the ratio of filled pores in the first slice to filled pores in the fourth slice can be between about 5 : 1 and about 3.5: 1 . The ratio of filled pores in the first slice to filled pores in the fourth slice can be between about 4: 1 . The ratio of filled pores in the second slice to filled pores in the fourth slice can be between about 3.5 : 1 and about 2.5: 1 . The ratio of filled pores in the second slice to filled pores in the fourth slice can be between about 3 : 1 . The ratio of filled pores in the third slice to filled pores in the fourth slice can be between about 2.5 : 1 and about 1 .5 : 1 . The ratio of filled pores in the third slice to filled pores in the fourth slice can be between about 2: 1 .

[0188] Other various ratios and relationships can be derived and established regarding the number or ratio of filled or open pores between slices, the ratio of fi lled pores to open pores in a given slice or between slices, or ratios between pore size and filled pores in a given slice or between slices, including those disclosed herein.

[0189] The ratio of filled pores to open pores can increase on a slice-by-sl ice basis, approaching the equator of the device. Accordingly, some embodiments can advantageously be configured such that the net porosity at the equator is comparable to or substantial ly the same as the net porosity at the top or bottom ends of the device, as discussed herein.

[0190] Figure 1 6 illustrates a device 600 having a coating 602 disposed across portions of a surface of the device 600, such that the coating 602 has a generally higher percentage of filled pores, and therefore, a higher percentage of filled pores adjacent to other filled pores. Figure 1 7 illustrates a device 620 having a coating 622 disposed across a first region or hemisphere of the device 620 (which can be configured to be disposed or extend across the aneurysm neck), such that the coating 622 has a generally higher percentage of fi lled pores, and therefore, a higher percentage of filled pores adjacent to other filled pores. Figure 1 8 illustrates another device 640 having a coating 642 disposed across a first region or hemisphere the device 640 (which can be configured to be disposed or extend across the aneurysm neck), such that the coating 642 has a generally lower percentage of filled pores, and therefore, a lower percentage of filled pores adjacent to other filled pores. [0191] According to some embodiments, the filled pores of a device can be covered or spanned by a variety of materials, such as a biocompatible polymers, biocompatible hydrogels, biocompatible polyurethanes, including thermoplastic polyurethanes such as Tecophilic®, or other suitable coatings. Further, the coating can comprise one or more drugs. Furthermore, the coating can be nonresorbable or resorbable.

[0192] In accordance with some embodiments, various coating deposition techniques can be employed to create discontinuous or continuous patterns of coatings. The coating techniques can comprise one or more of dip coating, spray coating (such as electrosonic spray coating), spin coating, electrodeposition, or other coating techniques. These techniques can be implemented to coat only a portion of the device.

[0193] Further, in some embodiments, a portion of the device can be exposed to the coating technique while another portion of the device is not coated at all, for example, by dipping, spraying, or otherwise applying a coating to only a portion of the device. For example, the device can be coated up to a desired level.

[0194] Accordingly, such devices can be manufactured and take advantage of surface tension properties, which may allow the filled pores to be determined individually. For example, a desired quantity of filled pores can be punctured or picked by a pin after a coating has been applied (which can be performed manually or by employing robotics, perhaps using a vision/selection system).

[0195] For example, in some embodiments, a fixture could be used that comprises pins arranged and configured to enter or pass through identified or selected pores anywhere on the braid ball device. These pins could remove coating either by vacuum (suction), pressure (blow out pore coating), or mechanical press or contact (no suction or blowing).

[0196] In such a fixture, the pin outside diameter can be sized to allow the pin to enter the selected pore. The amount of pins used in the fixture could depend on the amount of area that is desired to be coating-free.

[0197] For example, because the braid density is greater at the top and bottom ends of the device, an embodiment that attempts to provide a substantially constant average (or desired range of) porosity between the central, equatorial portion and the end portions (top to equator to bottom) should remove more coating at the top and bottom ends than in the central, equatorial portion. [0198] Additionally, subsequent processing techniques can also be applied to the device in order to modify a coating that has been placed thereon. After a coating has been applied to the device, at least a portion the coating can be removed. A portion of the coating can be removed using techniques that reduce the surface area coverage or thickness of the coating. The coating can be selectively ablated from the device, for example, using a computer-controlled laser system. The coating can also be removed using other techniques such as other ablation techniques, electropolishing, or other removal techniques.

[0199] Furthermore, in some embodiments that use a woven, knitted, braided, or mesh portion, one or more filaments are fibers of the mesh can be coated prior to manufacturing the mesh. Thus, the mesh can comprise one or more filaments that are coated while the remainder of the filaments are bare. In accordance with some embodiments, the mesh can be configured such that the coated filament(s) are oriented or positioned within the mesh according to a desired pattern, such as along only one end (e.g., the proximal end that can be positioned at the ostium of the aneurysm) or along half or more of the surface of the device. Further, the coated filament(s) can create a "stripe" pattern that can be configured to optimize surface area without interfering with the compression of the device in the delivery catheter.

[0200] Moreover, selective pore filling can also be performed by surface treatment of selected portions or filaments of the braided device to prevent adhesion of the coating. This treatment could be applied to select wires, for example, between 20%- 80% of the wires. In accordance with some embodiments, the number of treated wires is directly proportional to the number of pores that will remain open or unfilled.

[0201] Further, some embodiments can comprise one or more of the features disclosed in U. S. Patent No. 6,746,468 or U.S. Patent Publication No. 2004/009027, which relate to braided spherical devices that have selectively coated filaments.

[0202] Optionally, a liquid embolic and/or a framing component can be used in combination with one or more devices to facilitate delivery, engagement with the aneurysm, or increase of the packing density or fill volume. Any of these embodiments can al low increased packing density or fill volume to avoid recanalization of the aneurysm. The injection of a l iquid embolic can increase the overal l packing density or fill volume within the device. [0203] One suitable liquid embolic is the Onyx™ liquid embolic system manufactured by Covidien LP, Irvine, CA. Onyx™ liquid embolic system is a non- adhesive liquid used in the treatment of brain arteriovenous malformations. Onyx™ liquid embolic system is comprised of an EVOH (ethylene vinyl alcohol) copolymer dissolved in DMSO (dimethyl sulfoxide), and suspended micronized tantalum powder to provide contrast for visualization under fluoroscopy. Other liquid embolic solutions are also envisioned.

[0204] The coating may incjude thrombogenic coatings such as fibrin, fibrinogen or the like, anti-thrombogenic coatings such as heparin (and derivatives thereof), or t-PA, and endothelial promoting coatings or facilitators such as, e.g., VEGF and RGD peptide, and/or combinations thereof. Drug eluting coatings and a drug eluting foam composite, such as anti-inflammatory or antibiotic, coatings are also envisioned. These drug eluting components may include nutrients, antibiotics, anti-inflammatory agents, antiplatelet agents, anesthetic agents such as lidocaine, and anti-proliferative agents, e.g. taxol derivatives such as paclitaxel. Hydrophilic, hygroscopic, and hydrophobic materials/agents are also envisioned.

[0205] In some embodiments, one or more portions of the device can also comprise an expansion-limiting coating that slows expansion of the component from its natural rate of expansion to a slower rate of expansion such that in the process of expanding, the position of the component can be adjusted within the aneurysm or the component can be removed from the aneurysm, if necessary. Examples of polymers that can be used as expansion-limiting coatings can include hydrophobic polymers, organic non-polar polymers, PTFE, polyethylene, polyphenylene sulfide, oils, and other similar materials.

[0206] In embodiments, only specific segments of the device may be embedded or coated with an agent to provide desired characteristics to the expandable component(s). For example, the device can comprise a non-thrombogenic coating applied to less than the entire first portion or second portion to minimize clotting at this location. Such coatings may be desirable in aneurysms located at a bifurcation such that blood flow to branch arteries is permitted through the segment of the foam structure having the non- thrombogenic coating. The coated area may be a different color than the remaining portion of the expandable component to assist the surgeon in identifying this area. [0207] Optionally, the coated area can also comprise radiopaque material to assist the surgeon in visualization and placement of portions of the device in a desired orientation relative to the aneurysm. The device can have radiopacity characteristics either by adding radiopaque filler to the piece of material, such as bismuth, or attaching radiopaque markers. Alternatively, a radiopaque material can be attached to the device, such as by dipping, spraying, or otherwise mechanically, chemically, or thermally attached, injected into, or blended into to the device.

[0208] According to some embodiments, if the device has a specific characteristic, such as a porosity profile, coating, shape, etc., intended for placement in a certain location of the aneurysm, the clinician can position the device by manually rotating, moving, maintaining the position of, or otherwise adjusting the position of the device within the aneurysm as the device expands. Thus, by gently manipulating the device, the clinician can adjust the device to ensure proper orientation of the device within the aneurysm. The position of the expandable device can be manipulated using various deployment or delivery devices.

[0209] Many of the features discussed herein can be used with any of the disclosed embodiments. For example, any of the embodiments can comprise an average porosity that varies spatially, any of the variety of disclosed shapes, any of the various disclosed materials or coatings, any of the disclosed 2-D or 3-D interconnected configurations, any of the disclosed inter-engagement configurations or structures, any of the disclosed delivery systems, etc.

[0210] The apparatus and methods discussed herein are not limited to the deployment and use of a medical device within the vascular system but may include any number of further treatment applications. Other treatment sites may include areas or regions of the body including any hollow anatomical structures.

[0211] The foregoing description is provided to enable a person skilled in the art to practice the various configurations described herein. While the subject technology has been particularly described with reference to the various figures and configurations, it should be understood that these are for illustration purposes only and should not be taken as limiting the scope of the subject technology.

[0212] There may be many other ways to implement the subject technology. Various functions and elements described herein may be partitioned differently from those shown without departing from the scope of the subject technology. Various modifications to these configurations will be readily apparent to those skilled in the art, and generic principles defined herein may be appl ied to other configurations. Thus, many changes and modifications may be made to the subject technology, by one having ordinary skill in the art, without departing from the scope of the subject technology.

[0213] It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0214] As used herein, the phrase "at least one of^" preceding a series of items, with the term "and" or "or" to separate any of the items, modifies the l ist as a whole, rather than each member of the list (i.e., each item). The phrase "at least one of does not require selection of at least one of each item listed; rather, the phrase al lows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrases "at least one of A, B, and C" or "at least one of A, B, or C" each refer to 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.

[0215] Terms such as "top," "bottom," "front," "rear" and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

[0216] Furthermore, to the extent that the term "include," "have," or the like is used in the description or the claims, such term is intended to be inclusive in a manner sim ilar to the term "comprise" as "comprise" is interpreted when employed as a transitional word in a claim.

[0217] The word "exemplary" is used herein to mean "serving as an example, instance, or il lustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

[0218] A reference to an element in the singular is not intended to mean "one and only one" unless specifically stated, but rather "one or more." Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. The term "some" refers to one or more. Underlined and/or italicized headings and subheadings are used for convenience only, do not limit the subject technology, and are not referred to in connection with the interpretation of the description of the subject technology. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the subject technology. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the above description.

[0219] Although the detailed description contains many specifics, these should not be construed as limiting the scope of the subject technology but merely as illustrating different examples and aspects of the subject technology. It should be appreciated that the scope of the subject technology includes other embodiments not discussed in detail above. Various other modifications, changes and variations may be made in the arrangement, operation and details of the method and apparatus of the subject technology disclosed herein without departing from the scope of the present disclosure. Unless otherwise expressed, reference to an element in the singular is not intended to mean "one and only one" unless explicitly stated, but rather is meant to mean "one or more." In addition, it is not necessary for a device or method to address every problem that is solvable (or possess every advantage that is achievable) by different embodiments of the disclosure in order to be encompassed within the scope of the disclosure. The use herein of "can" and derivatives thereof shall be understood in the sense of "possibly" or "optionally" as opposed to an affirmative capability.

Claims

WHAT IS CLAIMED IS:

1 . An aneurysm embolization device comprising:

a body comprising a webbed portion and an interior chamber; and a plurality of occlusive segments that each comprise (i) a coupling portion interconnecting the segment with the webbed portion, and (ii) a protruding portion having a long axis that extends away from the webbed portion.

2. The device of Claim 1 , wherein the protruding portions extend within the chamber such that free ends of the protruding portions are positioned within the chamber.

3. The device of Claim 2, wherein substantially all of the free ends of the protruding portions are positioned within the chamber.

4. The device of Claim 2, wherein the long axes are directed substantially centrally inward within the chamber.

5. The device of any of Claims 1 to 4, wherein the long axes of some of the segments are directed away from the chamber.

6. The device of any of Claims 1 to 5, wherein some of the segments comprises a coupling portion and first and second protruding portions extending away from the coupling portion, wherein the first protruding portion is directed away from the chamber and the second protruding portion is directed centrally inward toward the chamber.

7. The device of any of Claims 1 to 6, wherein the body comprises a closed, rounded three-dimensional shape.

8. The device of Claim 7, wherein the body comprises an ellipsoidal shape.

9. The device of any of Claims 1 to 8, wherein the webbed portion comprises a braided material.

10. The device of any of Claims 1 to 9, wherein each of the plurality of segments comprises a filament coupled to the webbed portion.

1 1 . The device of any of Claims 1 to 10, wherein the plurality of segments are distributed in a coverage ratio of at least 1 occlusive segment per 5x5 section of pores.

12. The device of any of Claims 1 to 1 1 , wherein the plurality of segments are distributed in a coverage ratio of at least 1 occlusive segment per 4x4 section of pores.

1 3. The device of any of Claims 1 to 12, wherein the plurality of segments are distributed in a coverage ratio of at least 1 occlusive segment per 3x3 section of pores.

14. The device of any of Claims 1 to 13, wherein the webbed portion comprises pores and is subdivided to define circumferential bands extending about and along the entire the longitudinal axis, the plurality of segments being distributed along all of the circumferential bands in a coverage ratio of at least 1 occlusive segment per 50 pores.

15. The device of Claim 14, wherein the coverage ratio is at least 10 occlusive segments per 50 pores.

1 6. The device of Claim 14, wherein each circumferential band represents less than 1 /4 of a longitudinal dimension of the body.

17. The device of Claim 14, wherein each circumferential band represents less than 1 /8 of a longitudinal dimension of the body.

1 8. The device of Claim 14, wherein the segments are distributed substantially evenly along the webbed portion.

19. The device of any of Claims 1 to 1 8, wherein the body comprises two closed ends and a midsection between the closed ends, wherein when viewed in cross- section, a greater number of occlusive segments are coupled to the body adjacent to the midsection that adjacent to the closed ends.

20. The device of Claim 19, wherein when seen in cross-section, a number of occlusive segments coupled to the body gradually increases approaching the midsection.

21. The device of any of Claims 1 to 20, wherein a segment distribution density, measured as a number of occlusive segments per unit area of the body, gradually increases approaching the midsection.

22. The device of any of Claims 1 to 21 , wherein each of the plural ity of segments is configured such that the protruding portion defines a length and the coupling portion of each segment is spaced apart at a distance from adjacent coupling portions along the webbed portion, wherein the distance is at least as great as the combined lengths of the segment protruding portion and the adjacent segment protruding portion such that the segment protruding portion and the adjacent segment protruding portion move without contacting each other.

23. The device of Claim 22, wherein each of the occlusive segments comprises first and second protruding portions coupled to the webbed portion at a midsection of the segment.

24. The device of any of Claims 1 to 23, wherein the protruding portions of the plurality of segments do not overlap each other.

25. An aneurysm embol ization device comprising:

a hollow body comprising a plurality of crossings along a webbed portion thereof; and

a plurality of occlusive segments, each coupled to the webbed portion at a respective crossing;

wherein the occlusive segments are distributed along the webbed portion in a coverage density of at least one occlusive segment per 5x5 section of crossings.

26. The device of Claim 25, wherein the coverage density is at least one occlusive segment per 4x4 section of crossings.

27. The device of any of Claims 25 to 26, wherein the coverage density is at least one occlusive segment per 3x3 section of crossings.

28. The device of any of Claims 25 to 27, wherein the body comprises a braided material.

29. The device of any of Claims 25 to 28, wherein the body comprises a tubular material into which the webbed portion is etched.

30. The device of any of Claims 25 to 29, wherein the body comprises a closed, rounded three-dimensional shape.

3 1 . The device of Claim 30, wherein the body comprises an ellipsoidal shape.

32. An aneurysm embolization device comprising:

a hollow body having an interior chamber, first and second ends, and a midsection between the first and second ends; and

a flow-occluding structure, separate from the body, comprising filament sections, the sections comprising end regions that are coupled to the body, the structure extending between the chamber between the first end and the midsection.

33. The device of Claim 32, wherein the structure comprises individual, separate filaments coupled at their ends to the body.

34. The device of any of Claims 32 to 33, wherein the structure comprises a filament coupled to the body at multiple, relatively remote locations such that the filament extends across the chamber multiple times to define the filament sections.

35. The device of any of Claims 32 to 34, wherein the body comprises a longitudinal axis extending between the first and second ends, wherein the structure crosses the longitudinal axis.

36. The device of any of Claims 32 to 35, wherein the structure is positioned entirely between the first end and the midsection.

37. The device of any of Claims 32 to 36, wherein the structure comprises a central region, adjacent to an axis extending between the first and second ends, having a higher porosity than a peripheral region adjacent to the body.

38. The device of any of Claims 32 to 37, wherein the structure comprises a central region, adjacent to an axis extending between the first and second ends, having a lower porosity than a peripheral region adjacent to the body.

39. The device of Claim 38, wherein the structure comprises an open central region.

40. The device of any of Claims 32 to 39, further comprising a second flow- occluding structure, separate from and coupled to the body, extending between the first and second ends and intersecting the flow-occluding structure.

41 . The device of Claim 40, wherein the second structure extends transversely relative to the structure.

42. The device of any of Claims 32 to 41 , wherein the first and second ends are closed.

43. The device of any of Claims 32 to 42, wherein the body comprises a closed, rounded three-dimensional shape.

44. The device of any of Claims 32 to 43, wherein the body comprises a braided material.

45. An aneurysm embolization device comprising:

a hollow, webbed body comprising pores; and

a coating distributed along the body to fill at least some of the pores; wherein less than 80% of the filled pores are positioned contiguously.

46. The device of Claim 45, wherein less than 70% of the filled pores are positioned contiguously.

47. The device of any of Claims 45 to 46, wherein less than 60% of the filled pores are positioned contiguously.

48. The device of any of Claims 45 to 47, wherein less than 50% of the filled pores are positioned contiguously.

49. The device of any of Claims 45 to 48, wherein less than 40% of the filled pores are positioned contiguously.

50. The device of any of Claims 45 to 49, wherein less than 30% of the filled pores are positioned contiguously.

51. The device of any of Claims 45 to 50, wherein a given 4x4 section of pores comprises less than 6 filled pores.

52. The device of any of Claims 45 to 5 1 , wherein a given 4x4 section of pores comprises less than 4 filled pores.

53. The device of any of Claims 45 to 52, wherein across a given unit area of the body, the pores define a cumulative area of between about 10 mm² and about 250 mm².

54. The device of any of Claims 45 to 53, wherein across a given unit area of the body, the pores define a cumulative area of between about 40 mm^" and about 150 mm'.

55. The device of any of Claims 45 to 54, wherein across a given unit area of the body, the pores define a cumulative area of between about 70 mm" and about 1 00 mm².

56. The device of any of Claims 45 to 55, wherein the body comprises a dual layer braided material.

57. The device of any of Claims 45 to 56. wherein the body comprises a single layer braided material.

58. The device of any of Claims 45 to 57, wherein filled pores adjacent an end of the body comprise a drug-eluting material.

59. An aneurysm embolization device comprising:

a hollow, webbed body comprising pores; and

a coating distributed along the body to fill at least some of the pores;

wherein the body comprises a substantially spherical shape having an equator and defining an axis extending between ends of the body, wherein half of the spherical shape comprises horizontal slices separated by planes extending normal to and spaced at equal lengths along the axis, wherein the number of filled pores successively increases in each slice approaching the equator.

60. The device of Claim 59, wherein the slices comprise, in a direction from the equator toward an end of the body, first, second, third, and fourth horizontal slices.

61 . The device of Claim 60, wherein a ratio of filled pores in the first slice to filled pores in the fourth slice is between about 5 : 1 and about 3.5: 1.

62. The device of any of Claims 60 to 61 , wherein a ratio of filled pores in the first slice to filled pores in the fourth slice is between about 4: 1 .

63. The device of any of Claims 60 to 62, wherein a ratio of filled pores in the second slice to filled pores in the fourth slice is between about 3.5 : 1 and about 2.5 : 1.

64. The device of any of Claims 60 to 63, wherein a ratio of filled pores in the second slice to filled pores in the fourth slice is between about 3 : 1.

65. The device of any of Claims 60 to 64, wherein a ratio of filled pores in the third slice to filled pores in the fourth slice is between about 2.5: 1 and about 1.5: 1 .

66. The device of any of Claims 60 to 65, wherein a ratio of filled pores in the third slice to filled pores in the fourth slice is between about 2: 1 .

67. The device of any of Claims 59 to 66, wherein the body comprises a dual layer braided material.

68. The device of any of Claims 59 to 67, wherein the body comprises a single layer braided material.

69. The device of any of Claims 59 to 68, wherein fi lled pores adjacent an end of the body comprise a drug-eluting material.

70. An aneurysm embolization device comprising:

a hollow, webbed body comprising pores; and

a coating distributed along the body to fill at least some of the pores such that the body comprises filled pores and open pores;

wherein the body comprises a substantially spherical shape having an equator and defining an axis extending between ends of the body, wherein the spherical shape comprises horizontal slices separated by planes extending normal to and spaced at equal lengths along the axis, wherein the ratio of filled pores to open pores successively increases in each slice approaching the equator.

71. The device of Claim 70, wherein the ratio of filled pores to open pores in the active webbed portion is from about 1 :5 to about 1 :2.

72. The device of any of Claims 70 to 71 , wherein the slices comprise, in a direction from the equator toward an end of the body, first, second, third, and fourth horizontal slices.

73. The device of Claim 72, wherein a ratio of filled pores to open pores in the first slice is between about 1 : 1.5 and about 1 :2.5.

74. The device of any of Claims 72 to 73, wherein a ratio of filled pores to open pores in the first slice is about 1 :2.

75. The device of any of Claims 72 to 74, wherein a ratio of filled pores to open pores in the second slice is between about 1 :2.5 and about 1 :3.5.

76. The device of any of Claims 72 to 75, wherein a ratio of filled pores to open pores in the second slice is about 1 :3.

77. The device of any of Claims 72 to 76, wherein a ratio of filled pores to open pores in the third slice is between about 1 :3.5 and about 1 :4.5.

78. The device of any of Claims 72 to 77, wherein a ratio of filled pores to open pores in the third slice is about 1 :4.

79. The device of any of Claims 72 to 78, wherein a ratio of filled pores to open pores in the fourth slice is between about 1 :4.5 and about 1 :5.5.

80. The device of any of Claims 72 to 79, wherein a ratio of filled pores to open pores in the fourth slice is about 1 :5.

81 . The device of any of Claims 70 to 80, wherein filled pores adjacent an end of the body comprise a drug-eluting material.

82. The device of any of the preceding claims, wherein the body comprises a single layer braided material.

83. The device of any of the preceding claims, wherein the body comprises a dual layer braided material.